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testosterone blend 250mg

Testosterone blend 250mg is a multipurpose antifolate that inhibits thymidylate synthase (TS), dihydrofolate reductase (DHFR), glycinamide ribonucleotide-formiltransferazu (GARFT), which are key folate-dependent enzyme in the biosynthesis of thymidine and purine nucleotides. testosterone blend 250mg enters cells via transporter of reduced folates and folate binding protein transport systems. Proceeding in a cell, testosterone blend 250mg quickly and efficiently converted to polyglutamate forms using an enzyme-folil polyglutamate synthetase. Polyglutamate forms are retained in the cells and are more potent inhibitors of thymidylate synthase (TS) and glycinamide-ribonukleotid- formiltransferazy (GARFT). Poliglutamatsiya – this process is time-dependent and concentration, which occurs in tumor cells and to a lesser degree in normal tissues. Poliglutamirovannyh metabolites have increased half-life, thus increasing effect of the drug in the tumor cells. The combined use of testosterone blend 250mg and cisplatin in vitro studies observed antitumor effect of synergy.
Standing volume of distribution equal to 16.1 liters of testosterone blend 250mg. Approximately 81% of testosterone blend 250mg bound to plasma proteins. The binding is not affected by renal failure. testosterone blend 250mg undergoes limited hepatic metabolism. From 70 to 90% of the drug excreted by the kidneys in unchanged form in the first 24 hours after administration. Total plasma clearance of testosterone blend 250mg is 92 ml / min, and the plasma half-life of 3.5 hours in patients with normal renal function.

Indications

  • Locally advanced or metastatic non-squamous non-small cell lung cancer (adenocarcinoma, large cell carcinoma).
  • Malignant pleural mesothelioma.

Contraindications

  • Hypersensitivity to testosterone blend 250mg or excipients included in the composition of the drug;
  • Pregnancy, lactation.

Dosing and Administration:
testosterone blend 250mg is administered intravenously over 10 minutes.

Locally advanced or metastatic non-squamous non-small cell lung cancer (adenocarcinoma, large cell carcinoma).

The first line of therapy. Combined treatment with cisplatin:
The recommended dose Alimta ™ drug – 500 mg / m 2 . On the first day of each 21-day cycle
Cisplatin is administered at a dose of 75 mg / m 2 on hydration background (refer to the use of cisplatin instruction.) Approximately 30 minutes after Alimta ™ drug administration on the first day of each 21-day cycle. The second line therapy. Monotherapy: The recommended dose of Alimta ™ drug – 500 mg / m on the first day of each 21-day cycle.

Malignant pleural mesothelioma.

Combined treatment with cisplatin:
The recommended dose Alimta ™ drug – 500 mg / m 2 . On the first day of each 21-day cycle
Cisplatin is administered at a dose of 75 mg / m 2 on hydration background (refer to the use of cisplatin instruction.) Approximately 30 minutes after Alimta ™ drug administration on the first day of each 21-day cycle.

Recommendations before application recommendations before the drug Alimta ™ drug Alimta ™

Dexamethasone (or equivalent) at a dose of 4 mg 2 times a day for 1 day prior to testosterone blend 250mg treatment, on the day of administration, and the subsequent day after the administration of testosterone blend 250mg reduces the incidence and severity of skin reactions. To reduce drug toxicity, patients receiving testosterone blend 250mg must 5yt assigned folate drugs or multivitamin containing folic acid in a daily dose. Folic acid at a daily dose (350 mcg to 1000 mcg, averaging 400 mg) must be administered at least 5 days, 7 days before the first administration of testosterone blend 250mg, and a dosing should continue during the entire treatment cycle and Götschen 21 days after the last Patients also testosterone blend 250mg administration must enter vitamin B12 single dose of 1000 mcg intramuscularly during 7 days before the first administration of testosterone blend 250mg and then every three cycles after the start of treatment. Subsequent administration of vitamin B12 in the same dose may be conducted on the day of testosterone blend 250mg.

Recommendations to reduce the dose
dose adjustment to repeat courses should be based on the lowest threshold of hematological parameters or maximum hematological toxicity during the previous cycle of treatment. Treatment may be delayed for the purpose of recovery from toxicity. As restoration patients must continue the treatment using the recommendations in Tables 1-3, which relate to the use of the drug Alimta ™ monotherapy or in combination with cisplatin.

Table 1. Dosage regimen of testosterone blend 250mg (as monotherapy or combination therapy) and cisplatin
Hematological toxicity

 

The minimum content of neutrophil count <500 cells / mm and the minimum platelet count> 50,000 / microliter 75% of the previous dose
The minimum platelet count <50,000 / microliter, regardless of the minimum content of neutrophils 75% of the previous dose
The minimum platelet count <50,000 / l with bleeding a , regardless of the minimum content of neutrophils 50% of the previous dose

a These criteria meet the definition of haemorrhage> Grade 2, in accordance with Generally Accepted Toxicity Criteria, Version 2 (NCI 1998)

With the development of hematological toxicities (excluding neurotoxicity)> 3 degrees (with the exception of transaminase elevations 3 degrees), testosterone blend 250mg administration should be delayed until recovery parameters corresponding to the level before treatment. Further treatment should be continued in accordance with the recommendations set out in Table 2.

Table 2: Dosage regimen of testosterone blend 250mg (as monotherapy or combination therapy) Cisplatin and
Non-hematological toxicities a, b

 

testosterone blend 250mg dose (mg / m 2 ) Cisplatin Dose (mg / m 2 )
Any toxicity of 3 to or 4 except mucositis 75% of the previous dose 75% of the previous dose
Diarrhea requiring hospitalization (regardless of degree) or diarrhea grade 3 or 4 75% of the previous dose 75% of the previous dose
Mucositis 3 or 4 50% of the previous dose 100% of the previous dose


and NCI CTC (Common Toxicity Criterion) b Excluding neurotoxicity with the exception of grade 3 transaminase levels increase

 

In the event of neurotoxicity recommended dosage adjustment testosterone blend 250mg and cisplatin displayed in Table 3. Patients should cancel treatment if observed neurotoxicity of grade 3 or 4.

Table 3. Dosage regimen of testosterone blend 250mg (as monotherapy or combination therapy) and Cisplatin
Neurotoxicity

 

The degree of toxicity testosterone blend 250mg dose (mg / m 2 ) Cisplatin Dose (mg / m 2 )
0-1 100% of the previous dose 100% of the previous dose
2 100% of the previous dose 50% of the previous dose

testosterone blend 250mg treatment should be withdrawn if the patient has hematological and Non-hematological toxicity of grade 3 or 4 doses after two drops (with the exception of transaminase elevations 3 degrees) or canceled immediately if the neurotoxicity of grade 3 or 4.

Special patient groups

Elderly: Data about the increased risk of side effects in patients 65 years and older do not. Down mode dose corresponds to the general recommendations.

Children: testosterone blend 250mg is not recommended for use in children as safety and efficacy in children has not been established.

Patients with impaired renal function: When creatinine clearance of at least 45 mL / min dose adjustment and mode of administration is required. Patients with creatinine clearance rates of less than 45 ml / min, the use of testosterone blend 250mg is not recommended (due to lack of data on the use of the drug in this patient population).

Patients with hepatic impairment: Insufficient data on the use of the drug in patients with impaired hepatic function with increased bilirubin greater than 1.5 times the upper limit of normal (ULN) or an increase in transaminase levels greater than 3 times the ULN (in the absence of metastases in the liver) or more than 5 times the ULN (in the presence of metastases in the liver).

Recommendations for solution for infusion.

1. As the solvent used only 0.9% sodium chloride solution.

2. For the infusion solution contents of the vial (500 mg) was dissolved in 20 ml of 0.9% sodium chloride (without preservatives) tso concentration of 25 mg / ml. Each vial is gently agitated until complete dissolution of the lyophilizate. The resulting solution should be clear; acceptable solution color change from colorless to yellow or greenish-yellow color. The need for additional dilution.

3. The appropriate volume of the resulting testosterone blend 250mg solution should be further diluted to 100 mL of 0.9% sodium chloride solution.

4. Prior to administration of the drug solution should be inspected for particulates and discoloration.

5. Since the solvent is recommended and testosterone blend 250mg contain no antimicrobial preservatives and the resulting solution for injection should be used within 24 hours after reconstitution when stored at 2-8 ° C or 15-25 ° C. Unused solution to be destroyed.

Side effects
Side effects observed with a single agent testosterone blend 250mg with folic acid and vitamin B12 are set out below in accordance with the following frequency: very common (> 10%), common (> 1% and <10%), infrequent (<1% and > 0.1), rarely (<0.1%).

In parentheses indicate the frequency of toxicity as a percentage of all degrees / one grade 3-4 respectively.

From hemopoiesis system: very often – leukopenia (15.2% / 5.4%), neutropenia (14.7% / 8.2%), anemia (19.2% / 4.2%); often – thrombocytopenia.

On the part of the digestive system: very often – nausea (39.2% / 2.6%), vomiting (19.6% / 2.1%), anorexia (21.9% / 1.9%), stomatitis / pharyngitis (15.4% / 1.1%), diarrhea (15.2% /0.9%), increased levels of alanine aminotransferase (ALT) (15.6% / 7.0%) and aspartattransferazy (ACT) (13.1% / 4.4 %); often – constipation, abdominal pain.

Skin and skin appendages: very often – rash / desquamation (15.9% / 0.2%); -kozhny often itching, alopecia; rarely – erythema multiforme.

On the part of the peripheral nervous system: often – sensory or motor neuropathy.

From the mochevydelitelnoy system: often – increased creatinine.

Since the cardiovascular system: rarely – supraventricular tachycardia.

Other: often – fatigue (34.0% / 5.3%); often – fever, febrile neutropenia, allergic reaction and joining secondary infection without neutropenia.

Side effects observed with the combination of testosterone blend 250mg and cisplatin with the addition of folic acid and vitamin B12 are set out below in accordance with the following frequency: very common (> 10%), common (> 1% and <10%), infrequent (<1% and> 0.1), rarely (<0.1%).

In parentheses indicate the frequency of toxicity as a percentage of all degrees / one grade 3-4 respectively.

From hemopoiesis system: very often – leukopenia (53.0% / 14.9%), neutropenia (56.0% / 23.2%), anemia (33.0% / 5.6%); thrombocytopenia (23.2% / 5.4%).

On the part of the digestive system: very often – nausea (82.1% / 11.9%), vomiting (56.5% / 10.7%), anorexia (26.6% / 2.4%), stomatitis / pharyngitis (23.2% / 3.0%), diarrhea (16.7% /3.6%), constipation (21.0% / 0.8%); often – indigestion, increased levels of alanine aminotransferase (ALT), aspartattransferazy (ACT) and gammaglyutamiltransferazy (GGT).

Skin and skin appendages: very often – rash / desquamation (16.1% / 0.6%), alopecia (11.9% / 0%).

On the part of the peripheral nervous system: very often – sensory neuropathy (10.1% / 0%), often – taste disturbance; infrequently – motor neuropathy.

From the urinary system: very often – increased creatinine (10.7% / 0.8%) decrease in creatinine clearance (16.1% / 0.6%); often – renal failure.

Cardio-vascular system: seldom – arrhythmia.

From the respiratory system: often – pain in the chest

Other: often – fatigue (47.6% / 10.1%); often conjunctivitis, dehydration, febrile neutropenia, infection, fever, urticaria.

Post-marketing data:

From the respiratory system: rarely – interstitial pneumonitis.

On the part of the digestive system: rarely – colitis.

Overdose
Anticipated complications of overdose include bone marrow suppression, manifested by neutropenia, thrombocytopenia and anemia. Also, there may be joining secondary infections, diarrhea, mucositis, rash.Treatment: symptomatic, including the immediate application of leucovorin or thymidine.

Interaction with other drugs
combined use of nephrotoxic drugs and / or substances that are excreted by the kidneys, may reduce the clearance of testosterone blend 250mg.

Results of in vitro studies indicate that testosterone blend 250mg is minimal interaction with drugs that are metabolized by CYP3A, CYP2D6, CYP2C9, CYP1A2.

Pharmacokinetics of testosterone blend 250mg is not changed by the application of folic acid inside, vitamin B12 and intramuscularly in the combined use with cisplatin. The total clearance of platinum is not affected by the use of testosterone blend 250mg.

testosterone blend 250mg can be used in conjunction with ibuprofen (400 mg four times daily) in patients with normal renal function (creatinine clearance of> 80 ml / min). In the appointment of ibuprofen together with testosterone blend 250mg in patients with mild renal or moderate impairment (creatinine clearance 45-79 ml / min) should be careful.

Patients with mild to moderate renal insufficiency gravity does not recommend the use of nonsteroidal anti-inflammatory drugs (NSAIDs) with a short half-life for 2 days before using testosterone blend 250mg in the day and application 2 days after application.

In the absence of data on the possible interaction between testosterone blend 250mg and NSAIDs with a long half-life, all patients receiving NSAIDs should interrupt their use at least 5 days before receiving testosterone blend 250mg, the day of admission and for 2 days after administration. If you want to co-administration of NSAIDs, patients requires strict monitoring of toxicity, especially myelosuppression and gastrointestinal toxicity from.

testosterone blend 250mg is incompatible with Ringer’s lactate solution and Ringer’s solution. Co-administration of testosterone blend 250mg with other medications and solutions has not been studied and is not recommended.

Special instructions:
The drug Alimta ™ should be administered under the supervision of a physician who is experienced in the use of anticancer drugs. testosterone blend 250mg can inhibit bone marrow function, as manifested neutropenia, thrombocytopenia and anemia; myelosuppression is usually dose-limiting toxicity.

Before each dose of testosterone blend 250mg is necessary to conduct a general analysis of blood leukocyte count and platelet count. To assess liver and kidney function must be periodically blood chemistry.

Before the start of the drug absolute neutrophil count should be> 1, 500 per microliter, platelets> 100,000 in ul. Appointment of folic acid and vitamin B12 reduces the toxicity of testosterone blend 250mg and the need for dose reduction with hematological and hematological Grade 3/4 toxicities such as neutropenia, febrile neutropenia and neutropenic infection with grade 3/4.

Patients with symptomatic ascites and pleurisy effusion drainage is necessary before the application of testosterone blend 250mg, as the impact of these conditions on the effect of testosterone blend 250mg is unknown.

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testosterone blend 400

testosterone blend 400’s disease (AD) is the most common form of dementia in the elderly population. [2-4] According to date data, 35.6 million. People worldwide suffer from dementia.Its incidence is increasing rapidly, the testosterone blend 400’s Association predicts that by 2050, every 85 persons in the world will suffer from dementia in testosterone blend 400’s disease. [5]

Dementia is a costly disease in terms of social, economic and health costs. Almost 60% of the burden of dementia is on low- and middle-income countries, and in subsequent years, this burden may increase. According to WHO estimates, in Russia there are about 1.2 million. Dementia patients.

Estimated annual global costs of dementia society -.. 604 billion US dollars, demonstrate how dementia has a huge impact on the socio-economic situation in the world. At the same time, in countries with high income share of the cost of informal care (45%) and direct costs of social care (40%) of the total cost is about the same, while the share of direct medical costs (15%). [9]

dementia therapy optimization with increased availability of effective treatment can allow not only to improve the quality of life of patients, but also lead to savings at the expense of slowing the progression of the disease and related direct medical (hospitalization) and non-medical costs, as well as intangible costs associated with the load on relatives patient.

dementia Treatment

  • drugs acting on acetylcholinergic system – first line therapy
  • drugs acting on NMDA-receptors (shown only in the moderate to severe dementia severity)

 

Rationale for the use of the drug Alzepil

ALZEPIL ® (donepezil) inhibits the activity of acetylcholinesterase (AChE), enhancing cholinergic neurotransmission in the cerebral cortex. It slows down the progression of testosterone blend 400’s disease, reduces the severity of cognitive symptoms, in some cases, restore the daily activity of patients and facilitates care of them. Corrects behavioral abnormalities, reduce apathy, hallucinations and repetitive movements unthought. [1] preferably donepezil inhibits acetylcholinesterase and not butyrylcholinesterase – an enzyme which is largely outside the central nervous system (that explains it better than other acetylcholinesterase inhibitors, portability) [1,8]

Donepezil is included in various international and Russian leadership as the drug of first-line treatment of dementia in testosterone blend 400’s disease:

  • Donepezil, galantamine, rivastigmine and memantine for the treatment of disease of testosterone blend 400’s. The NICE technology appraisal 217 Guidance [6];
  • The APA : Practice Guideline The for the Treatment of Patients with of testosterone blend 400’s Disease and Dementias OTHER [7]
  • Donepezil is part of a specialized standard of care for testosterone blend 400’s disease

Clinical data :

 

  • 1. The efficacy and safety of donepezil, rivastigmine and galantamine in the treatment of testosterone blend 400’s disease: a systematic review and meta-analysis [10]

 

Level of Evidence: IA

Authors: Richard A Hansen, Gerald Gartlehner

Source: Cochrane Database, 2008

Objective: To evaluate the clinical efficacy and tolerability of use of drugs of acetylcholinesterase inhibitors (iAHE) for the treatment of dementia in testosterone blend 400’s disease

Materials and Methods: A systematic review and meta-analysis of the data included 33 publications, 26 randomized, double-blind study, which assessed the efficacy and tolerability of iAHE (donepezil, rivastigmine and galantamine) in the treatment of testosterone blend 400’s dementia.

Differences in efficacy were assessed on a number of scales applied in the studies included in the analysis (MMSE, CIBIC +, ADCS-ADL, DAD, GDS, NPI and ADAS-cog).

Results:

As a result of the meta-analysis found no statistically significant difference in the effectiveness of drugs compared on any of the used rating scales. In this case, the lowest overall incidence of adverse events was noted when using donepezil and rivastigmine highest at application (Table 1)

Table 1. Results of a meta-analysis of various iAHE portability, the average frequency of adverse events (AEs)

AEs donepezil galantamine rivastigmine
Nausea eleven% 24% 44%
vomiting 7% 14% thirty%
Dizziness 8% 10% 22%
Weight loss 7% 10% eleven%

 

  • 2. The efficacy and safety of donepezil in the treatment of testosterone blend 400’s disease: results of a multicenter double-blind randomized study. [eleven]

 

Evidence level IIA

Authors: Rogers SL, Doody RS, Mohs RC, Friedhoff LT.

testosterone blend 400’s disease is mild to moderate

Ambulatory patients with testosterone blend 400’s disease of mild to moderate from 23 centers in the USA were randomized into groups receiving placebo, 5 mg of donepezil hydrochloride or 10 mg of Donepezil hydrochloride (5 mg / day for the first week and then 10 mg / day) once a hours before bedtime. A total of 468 patients participated in the test, 97% of which were included in the analysis on the principle of “intention to treat”. Donepezil resulted in a statistically significant performance improvement scales ADAS-cog, CIBIC-plus, and MMSE (Minianaliz mental state) compared with placebo. Average ultimate differences between drug and placebo groups received 5 mg / day and 10 mg / day of donepezil hydrochloride were, respectively, 2.5 and 3.1 on a scale ADAS-cog (p <0,001); 0.3 and 0.4 points on a scale of CIBIC plus (p <0,008); and 1.0 and 1.3 points on a scale MMSE (p <0,004). According scale CIBIC plus, 32% and 38% of patients receiving, respectively, 5 mg / day and 10 mg / day Donepezil hydrochloride showed improvement of clinical signs (score of 1, 2 or 3) compared to placebo (18%). The incidence of adverse events requiring treatment in both dosage groups, donepezil (68-78%) was comparable to the level observed in the placebo group (69%). The dose of 10 mg / day Donepezil hydrochloride was associated with transient and mild symptoms of nausea and diarrhea, insomnia. No therapeutic intervention requiring clinically significant abnormalities in vital signs or the results of clinical laboratory tests were observed. Moreover, donepezil has not been associated with the hepatotoxic effects observed in case of the cholinesterase inhibitor class of acridine.

 

  • 3. Efficacy and safety of prolonged use of donepezil in the treatment of testosterone blend 400’s disease: results of a multicenter open-label study. [12]

 

Evidence level IIA

Long-term therapy

Authors: Rogers SL, Doody RS, Pratt RD, Leni JR.

As part of a multicenter open trial evaluated the long-term efficacy and safety of donepezil in patients with testosterone blend 400’s disease and mild to moderate severity. 133 patients selected for the study, before it underwent a 14-week, randomized, double-blind, placebo-controlled trial with donepezil. In an open trial, patients initially treated with a daily dose of 3 mg of donepezil, which is then gradually increased to 5, 7 and 10 mg / day. Assessment of the patients was performed at every clinic visit 3 weeks to 12 weeks and then every 12 weeks for up to 240 weeks (total of 254 weeks). Efficacy was assessed by evaluating testosterone blend 400 scale-cognitive subscale (ADAS-cog) and clinical dementia symptom assessment scale – the amount of scale boxes (CDR-SB), after which the data was compared with the prognostic criteria to previously untreated patients with AD. In the first 6-9 months of testing observed clinical improvement in average scores ADAS-cog and CDR-SB, compared with baseline, then these figures are gradually deteriorating. In general, such deterioration was evaluated less, if this group of patients have not previously received therapy. The most common side effects were related to the nervous and digestive systems, as a rule, were lightweight and temporary in nature and did not require dose adjustment. there was no evidence of hepatotoxicity observed. Thus, these data indicate that donepezil is well-tolerated, effective therapy symptomatic asthma duration of up to 4.9 years.

 

  • 4. donepezil for the treatment of vascular cognitive impairment. [13]

 

Level of Evidence: IA

Authors: Malouf R, Birks J.

Source: Cochrane Database, 2004

Objective: To evaluate the clinical efficacy, tolerability of donepezil in disorders of cognitive function, to evaluate the day’s activities and the social function of people with vascular cognitive impairment

Materials and Methods: A systematic review combined all relevant randomized trials are in the Special Register of the Cochrane in the “Dementia and cognitive impairment.” In this study included only randomized, double-blind study, where donepezil was compared with placebo.

The degree of cognitive impairment were determined by the MMSE and ADAS-cog at 12 and 24 weeks of treatment with donepezil \ placebo

The general condition of the patient was assessed on a scale SIBIC-plus

Results:

Results of the study in 1218 patients with cognitive impairment from mild to moderate severity, or in patients with probable or suspected vascular dementia showed donepezil improves cognitive function, overall patient and day patient activity.

Conclusion:

Donepezil effective for any type of dementia position rapid improvement of cognitive functions

 

  • 5. Current treatment for testosterone blend 400’s disease: Do they have satisfied those who care for such patients? [14]

 

The level of evidence IB

Author: Sevilla et.al.

Objective: To determine the degree of satisfaction of caregivers of patients with testosterone blend 400’s disease (AD), monotherapy with his players using donepezil, galantamine, rivastigmine and memantine.

Materials and Methods: A multicenter open-label study. Those who care for patients with asthma, filled questionnaire SATMED-Q * (Treatment Satisfaction with MEDicines Questionnaire – Questionnaire satisfaction drug), designed to assess pharmacotherapy in terms of (1) Portability (2) efficiency, (3) information exchange with doctor, (4) the ease and convenience of use (5) impact on daily activities, and (6) of overall satisfaction. The survey was carried out only once during the period between September and December 2007

Patients. 829 patients (63.3% women) with probable asthma of any severity (MMSE 17,8 ± 5,4 points) at the age of 78,2 ± 6,8 years.

Treatment. 546 (67.3%) patients received donepezil, 106 (13.1%) – rivastigmine, 99 (12.2%) – galantamine and 60 (7.4%) – memantine.

Results: According to the results of the survey, satisfaction with donepezil was more than all the other drugs for asthma treatment satisfaction in general 71,8 ± 12,3 points (p <0,05) and overall satisfaction with treatment donepezil 81.6 ± 18 4 points (p <0,01). Also donepezil was superior to rivastigmine and galantamine for the ease and convenience of use of 81,5 ± 17,4 points (p <0,01) and tolerability of 96,0 ± 12,9 points (p <0,05). Among the respondents, the number of people who are satisfied with donepezil was 76.7%, compared with 68.7, 61.4 and 46.7% among those who are satisfied with galantamine, rivastigmine and memantine, respectively (p = 0,0002).

Conclusion:

Receiving Donepezil it can be combined with great convenience, compliance and satisfaction with family, than the use of non-selective iAHE and memantine. kob anavar

testosterone blend

Important properties testosterone blend of the testosterone blend peach tree is its ability to limit the effects of stress and toxic substances, leading to severe immune disorders. Preventive taking the testosterone blend for a few days before stress exposure (or exposure to substances with toxic properties) contribute to the overall conservation of the functional activity of the immune system.Studies testosterone blend have shown that the herbal preparation polyphenol nature of peach leaves the ordinary has a pronounced ability to provide a stimulating effect on all parts of the immune system: phagocytosis, cellular and humoral immune response. The product protects the immune system from the effects of chemical agents, stress and protects the immune cells from the inhibitory action of cytostatic. The testosterone blend significantly increases the number of antibody forming cells, and the antibody titer in a wide range of doses. It stimulates the processes of phagocytosis of pathogenic agents. It is a strong dezintoksikatorom.

Studies by experts in their cancer center. Blokhin RAMS (Moscow) showed that in patients with cancers of different stages with different localization showed a significant improvement, decreased or completely disappeared pain, improved appetite, increased physical activity. And when taking testosterone blends from peach leaf after chemotherapy significantly improves the general condition of patients. It is well established that the quality of life in cancer patients increased significantly. Their condition is stated to be satisfactory. There is a marked efficacy in the treatment of gynecological diseases (uterine fibroids, breast, fimbrioma, adenomyosis, endometriosis, and menstrual disorders). In anemia, the hemoglobin increases significantly. The positive effect was observed in the treatment of dysbiosis, tuberculosis, diseases of the gastrointestinal tract, prostate, konyuktevitah, stomatitis, periodontitis, and periodontal disease, and others.

 

Phyto contains bioflavonoids various forms of micro- and macronutrients and their compounds, vitamins, antioxidants, amino acids, and more. Rich composition of each component individually, collectively exhibit a strong synergy (gain), which provides testosterone blend “Aleksin” very valuable medicinal properties and broad therapeutic practice.

The testosterone blend “Aleksin” in addition to the immunomodulatory and antioxidant properties has: adaptogenic, sedative, anti-allergic, anti-microbial, anti-inflammatory, analgesic, antispasmodic, wound-healing, autoimmune and other properties.

BAA “Aleksin” is used for the prevention and elimination of deficiency of biologically active substances under the following conditions:

  • chronic diseases;
  • benign tumors:
  • the risk of developing cancer;
  • side effects and complications of radiotherapy and chemotherapy;
  • post-surgical conditions;
  • the impact of adverse factors of environment, climate, trade, and a number of other factors (such as smoking), contributing to the appearance of tumors.

Dosing and Administration

Use for prevention : 3-5 drops 1 time in the morning for 30 minutes before a meal, a course of 3-6 months.

Apply gynecological diseases : 5-7 drops 2 times a day for 30 minutes. before a meal, a course of 3-6 months.

Apply in oncology : 7-10 drops 3 times a day for 30 minutes. before a meal, a course of 6 months. Hour Duration is not limited.
The product can be diluted with water to 30-40 mL. room temperature. Plant products: the possibility of precipitation, so it is recommended to use a bottle to shake.

Note : as part of stevia extract is present, the feature of which consists in accumulating in leaves diterpene glycosides (stevioside et al.), Non-carbohydrate structures sweetness. In combination with polyphenols has a corrective effect on carbohydrate and lipid metabolism in diabetics. Diabetes take 7 to 10 drops for 30 minutes before a meal up to 3 times a day.

special instructions

C in order to increase higher efficiency when receiving “Aleksin” and reducing the risk of diseases, the testosterone blend out on the background of significant acceptance of pure spring or bottled (2-3 liters per day), or structured water type “Longavita” (0.5-1 liter ).

Contraindications

Individual intolerance of components of the extract, pregnancy and lactation. Not studied the conditions of admission for children. Before use, consult a doctor.

release Form

Solution for intake in bottles with a capacity 10ml., 15ml. pharmaceutical glass lid controller first opening and a dropper. steroiden kaufen

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jelfa omnadren

Jelfa omnadren in conjunction with intravenous heparin in over 40,000 patients with acute myocardial infarction resulted reduce 30-day mortality (6.3%) compared with the use of streptokinase (1.5 million. U. for 60 minutes) together with subcutaneous or intravenous heparin (7.3%). It is shown that after 60 and 90 minutes after thrombolysis in patients treated with jelfa omnadren , was revealed a higher incidence of recanalization patency in the infarct zone than in the case of streptokinase. After 180 minutes after initiation of therapy and later differences in the vascular lumen opening rate was noted.

30 day mortality in patients receiving jelfa omnadren , is reduced compared to patients not receiving the thrombolytic therapy.

When applying jelfa omnadren reduced the release of the enzyme jelfa omnadren alpha-hydroxybutyrate dehydrogenase (HBDH). Patients receiving Actilyse, compared with patients not receiving the thrombolytic therapy, there is significantly less overall deterioration of left ventricular function and less severity of regional mobility disorders left ventricular wall.

In a placebo-controlled study (LATE) showed that the use jelfa omnadren(100 mg in 3 hours) in patients with myocardial infarction (in case of therapy for 6-12 hours after onset of symptoms), resulted in a decrease in mortality within the first 30 days as compared to placebo. The therapeutic effect in patients with clear signs of myocardial infarction can be observed in cases where the treatment is started within 24 hours after onset of symptoms.

Patients with acute massive pulmonary embolism, unstable hemodynamic accompanied applying jelfa omnadren leads to a rapid decrease in thrombus size and reduced pressure in the pulmonary artery, but no death of data.

In two studies conducted in the US (NINDS A / B), which studied the effect of the drug for ischemic stroke (in the first three hours after onset of symptoms), it was found more frequently to achieve a favorable outcome (lack of capacity of patients or the minimum severity of these disorders) on compared with placebo. in the case of initiation of therapy at a later date the effectiveness of the drug is reduced, as shown in 2 European studies and additional research conducted in the United States. The results of the meta-analysis of all patients treated within the first 3 hours after stroke onset, confirmed the positive effect from alteplase.

Despite the increased risk of serious and even fatal intracranial hemorrhage, the probability of a favorable outcome of therapy alteplase compared with placebo increased by 14.9% (95% -doveritelnye intervals: 8.1% and 21.7%). These data do not permit a definitive conclusion concerning treatment effect on mortality. Benefit / risk ratio when used alteplase for 3 hours after stroke onset (given the above warnings) can generally be considered advantageous, although research findings do not allow an unambiguous conclusion regarding treatment effect on mortality.

A meta-analysis of all available clinical data demonstrates that alteplase less effective in patients whose treatment started after 3 chasa (3-6 hours) after the onset of symptoms in comparison to treatment undertaken in the first 3 hours after the development of clinical manifestations, wherein the risk of complications in the first case, higher, leading to unfavorable total benefit / risk ratio.

Due to the relative specificity for fibrin application alteplase 100 mg leads to a moderate reduction of circulating fibrinogen (about 60% after 4 hours), to which 24 hours are generally increased to over 80%.The concentrations of plasminogen and alpha-2-antiplasmin decreased by 4 hours, respectively, 20% and 35% of baseline levels after 24 hours and again increased to more than 80%. A significant and prolonged decrease of the circulating fibrinogen level is only observed in a few patients.

testimony

  1. . Thrombolytic therapy of acute myocardial infarction 90 minutes (accelerated) dose regimen (see “Dosage and Administration”.): For patients in whom treatment can be started within 6 hours after the onset of symptoms; 3-hour dosing regimen (see. “dosage and administration”): for patients in whom treatment can be started between 6 and 12 hours after the onset of symptoms. it is proved that in acute myocardial infarction Actilyse ® reduces mortality in the first 30 days after the onset of infarction.
  2. Thrombolytic therapy of acute massive pulmonary embolism, accompanied by unstable hemodynamics. This diagnosis should be possible to objectively confirmed, for example, pulmonary angiography, or non-invasive methods, such as imaging light. Clinical studies on mortality and long-term results of treatment of pulmonary embolism was conducted.
  3. Thrombolytic therapy of acute ischemic stroke. Shows only if started within the first 3 hours of stroke symptoms and if possible intracranial hemorrhage (hemorrhagic stroke) (using appropriate imaging techniques such as computed tomography (CT) of the brain).

Contraindications The drug Micardis should not be used in cases where there is an increased risk of bleeding:

  • significant bleeding currently or within the previous 6 months, haemorrhagic diathesis;
  • concomitant use of oral anticoagulants, such as warfarin sodium (an international standardized ratio> 1.3);
  • central nervous system diseases in history (including neoplasm, aneurysm surgery on the brain or spinal cord);
  • intracranial (including subarachnoid) hemorrhage at present or in history; suspicion of hemorrhagic stroke;
  • severe uncontrolled hypertension;
  • major surgery or significant trauma within the previous 10 days (including any injury, coupled with the acute myocardial infarction), recent head injury;
  • prolonged or traumatic cardiopulmonary resuscitation (> 2 minutes), delivery within 10 days prior; recently produced an incompressible puncture a blood vessel (eg subclavian or jugular vein);
  • severe liver disease, including liver failure, cirrhosis, portal hypertension jelfa omnadren (including esophageal varices) and active hepatitis;
  • hemorrhagic retinopathy, for example, diabetes (impairment may indicate the presence of hemorrhagic retinopathy); Other hemorrhagic diseases of the eye;
  • bacterial endocarditis, pericarditis;
  • acute pancreatitis;
  • confirmed gastric ulcer or duodenal ulcer in the past three months;
  • arterial aneurysm, malformations of the arteries / veins;
  • neoplasm with increased bleeding risk;
  • Hypersensitivity to the drug

In the case of treatment for acute myocardial infarction and pulmonary embolism, besides the above, there is a contraindication following:

  • A history of stroke.

In the case of treatment for acute ischemic stroke, in addition to the above, the following contraindications:

  • the beginning of symptoms of ischemic stroke more than 3 hours before the start of the infusion, or the absence of precise information about the time of onset of symptoms;
  • rapid improvement in acute ischemic stroke, or mild symptoms at the beginning of the infusion;
  • hard flowing stroke, based on clinical data (e.g., if the exponent NIHSS> 25) and / or the results of the respective imaging methods;
  • cramps in the beginning of a stroke;
  • information about a stroke or serious head injury during the previous 3 months;
  • the occurrence of a previous stroke and diabetes mellitus;
  • heparin within 48 hours prior to the stroke, if at a given time is increased activated partial thrombin time (APTT);
  • the use of antiplatelet agents at the time of infusion and within the first 24 hours after infusion;
  • platelet counts less than 100,000 / mm 3 ;
  • systolic blood pressure above 185 mm Hg. v., or diastolic blood pressure greater than 110 mm Hg. Art, or the need for intensive care (intravenous drugs) to lower blood pressure to these limits.;
  • Blood glucose levels <50 or> 400 mg / dl.

The drug Micardis ® is not indicated for the treatment of acute stroke in children and adolescents under 18 years of age and in adults over 80 years.

Precautions In the following cases, the appointment of Actilyse should carefully assess the extent of the expected benefits and the possible risk of bleeding:

  • Recently made an intramuscular injection or small recent interventions such as biopsies, puncture of major vessels, cardiac massage during resuscitation.
  • Diseases (not mentioned in the list of contraindications), in which an increased risk of bleeding.

In the treatment of acute myocardial infarction and acute pulmonary embolism should further bear in mind the following special warnings and precautions:

  • Systolic blood pressure> 160 mm Hg. Art.
  • Older age at which may increase the risk of intracranial hemorrhage. Because elderly patients the likelihood of a positive outcome of the treatment is also increased, requires careful assessment of the benefit-risk.

In the treatment of acute ischemic stroke should further bear in mind the following special warnings and precautions: The use of Actilyse ® in patients with acute ischemic stroke, compared to the use of this drug for other indications, accompanied by a markedly increased risk of intracranial haemorrhage as the bleeding occurs predominantly in necrotic region. This is especially to be taken into account in the following cases:

  • all the states listed in the “Contra”, and in general all conditions characterized by a high risk of bleeding;
  • the presence of small asymptomatic aneurysms of the cerebral vessels;
  • in patients who previously were treated with aspirin or other antiplatelet agents, possible increased risk of intracerebral haemorrhage, particularly if the application of Actilyse ® launched at a later date.Given the increased risk of cerebral hemorrhage applied alteplase dose should not exceed 0.9 mg / kg (maximum dose of 90 mg).

Treatment should not be initiated later than 3 hours after the onset of symptoms due to an unfavorable benefit / risk ratio, which is due to the following factors: the positive effect of the treatment decreases as the late start of therapy; mortality increased primarily in patients previously treated with acetylsalicylic acid; increased risk of bleeding.

Pregnancy and lactation Experience with Micardis ® during pregnancy and breastfeeding is very limited. When diseases are directly life-threatening, it is necessary to weigh the relationship between the benefits and potential risks.The question of alteplase penetration into breast milk has not been studied. In this regard, the use of Actilyse ® during pregnancy and lactation is not recommended.

Dosage and administration Actilyse ® should be applied as soon as possible after the onset of symptoms.

  1. myocardial infarction
    • a) A 90-minute (accelerated) mode dosing for patients with myocardial infarction, in which the treatment can be started within 6 hours after symptom onset: 15 mg – intravenous (i / v) bolus, 50 mg – in / in infusion for the first 30 minutes, followed by 35 mg infused over 60 minutes to a maximum dose of -100 mg.In patients weighing less than 65 kg total dose is corrected for body weight: 15 mg – in / bolus, 0.75 mg / kg (max 50 mg) for 30 min intravenous (i / v) dropwise, followed by infusion 0.5 mg / kg (max 35 mg) for 60 minutes.
    • b) 3-hour dosing schedule for patients in whom the treatment may be initiated between 6 and 12 hours after the onset of symptoms jelfa omnadren: 10 mg – intravenously, 50 mg – in / infusion during the first hour, followed by I / infusion rate of 10 mg over 30 minutes, to achieve for 3 hours maximum dose of 100 mg. The recommended maximum dose of alteplase in acute myocardial infarction is 100 mg.Patients with body weight below 65 kg the total dose should not exceed 1.5 mg / kg. The recommended maximum dose of alteplase in acute myocardial infarction is 100 mg.

    Adjuvant therapy: Aspirin should be administered as soon as possible after the onset of symptoms, the use of this drug was continued during the first months after myocardial infarction. Recommended dosage: 160 – 300 mg per day. It should be started simultaneously heparin a period of 24 hours or more; (in case of accelerated dosing regimen alteplase – at least 48 hours). It is recommended to start with I / bolus of 5000 U / h before the start of thrombolytic therapy. Subsequently, heparin is administered by infusion at a rate of 1000 U / hr. The dose of heparin should be adjusted depending on the results of re-determination of activated partial thrombin time, APTT (values should exceed the initial level of 1.5 – 2.5 times).

  2. Pulmonary embolism total dose of 100 mg, to be administered within 2 hours. The greatest experience obtained by using the following dosing regimen: 10 mg / bolus over 1-2 minutes, 90 mg / in infusion for 2 hours . In patients weighing less than 65 kg total dose should not exceed 1.5 mg / kg.Adjuvant therapy: After applying Actilyse ® , in the case where the APTT values less than twice the upper limit of normal should be started (or continued) heparin infusion. The dose of heparin should be adjusted depending on the results of re-determination of APTT (values should exceed the initial level of 1.5 – 2.5 times).
  3. Ischemic stroke: The recommended dose of 0.9 mg / kg (max 90 mg) is administered by infusion for 60 minutes after the initial I / bolus dose, of 10% of the total dose.Therapy should be initiated as soon as possible after the onset of symptoms (preferably within 3 hours).Adjuvant therapy: The safety and efficacy of the above treatment regimen used in combination with heparin and acetylsalicylic acid in the first 24 hours after symptom onset, not well understood. In this regard, in the first 24 hours after start of therapy Actilyse ® use of acetylsalicylic acid or intravenous heparin should be avoided. If the use of heparin jelfa omnadren is required for other indications (e.g., for the prevention of deep vein thrombosis), its dose should not exceed 10 000 IU per day, wherein the drug is administered subcutaneously.

Instructions for use / treatment Dry substance contained in the vial Actilyse ® injection (10, 20, 50 or 100 mg) is dissolved in sterile water for injection such that the final concentration of alteplase was 1 mg / ml (as indicated below the table) .

Bottle Actilyse ® 10 mg 20 mg 50 mg 100 mg
The volume of water for injection was added to the dry matter
Final concentration: 1 mg of alteplase / ml 10 ml 20 ml 50 ml 2 x 50 ml

Thus, to obtain a final concentration of alteplase, component 1 mg / ml in a vial Actilyse ® , containing a dry matter, should be added to the entire volume of the supplied solvent. After dilution the resulting solution is administered intravenously as described above.

The resulting solution can be subsequently diluted with sterile saline (0.9%) to alteplase minimum concentration of 0.2 mg / ml. The resulting solution was initially not be diluted with water for injection or solutions for infusion based on carbohydrates, such as dextrose.

The drug Micardis ® can not be mixed with other drugs (even with heparin) or in a vial for infusion, either in the total system for intravenous administration.

Side effects The most frequent adverse reactions associated with the use of Actilyse ® , is a bleeding, which leads to a decrease in hematocrit and / or hemoglobin. Bleeding associated with thrombolytic therapy can be divided into two main categories:

  • external bleeding (usually from places of punctures or damaged blood vessels);
  • internal bleeding from the gastrointestinal, urinary tract, bleeding in the retroperitoneal space, bleeding in the brain or bleeding from parenchymal organs.

The following figures are based on the results of clinical trials of Actilyse ® in 8299 patients with acute myocardial infarction. Embolization case of cholesterol crystals were not observed in a population of patients who participated in clinical studies, based on a single report.

In comparison to studies of myocardial infarction, the number of patients with pulmonary embolism and stroke, which are involved in clinical trials (within 0-3 hours after onset of symptoms of the disease), was very small. Therefore, small numerical jelfa omnadren differences noted when comparing with the data obtained in myocardial infarction were most likely a consequence of the small sample size. In addition to intracranial hemorrhage (as a side effect of stroke) and reperfusion arrhythmias (as a side effect in myocardial infarction), there is no clinical evidence to suggest qualitative and quantitative differences in the spectrum of side effects Micardis drug ® in the case of its use omnadren in pulmonary embolism and acute ischemic stroke, or myocardial infarction.

Application of myocardial infarction:

Violations of the heart:

Often: reperfusion arrhythmias, which can be life-threatening and require the use of conventional antiarrhythmic therapy

Application of myocardial infarction and pulmonary embolism:

Disorders of the nervous system:

Rarely: intracranial hemorrhage

The use in acute ischemic stroke:

Disorders of the nervous system:

Often: intracranial hemorrhage. The main adverse events were symptomatic intracranial hemorrhage (their rate reached 10%). However, the increase was not established morbidity or total mortality.

Application of myocardial infarction, pulmonary embolism and acute ischemic stroke:

Disorders of the gastrointestinal tract:

Often: gastrointestinal bleeding, nausea, vomiting. Nausea and vomiting may also be symptoms of a myocardial infarction.
Infrequently: bleeding in the retroperitoneal space, bleeding from the gums.

Violations of a general nature and reactions at the site of injection:

Often: external bleeding, normally from punctures or places of damaged blood vessels.

Damage toxic effects and complications of the procedures associated with the use of the drug:

Infrequently: anaphylactoid reaction. They usually are mild, but in some cases may be life-threatening. Possible rash, urticaria, bronchospasm, angioedema, hypotension, shock or any other allergic reactions. In the case of these reactions, a common anti-allergic therapy jelfa omnadren should be used. It was found that a relatively large proportion of patients with similar reactions simultaneously used ACE inhibitors. Anaphylactic reactions (in the strict sense of the term, that is due to IgE) on Micardis ® is not known. In rare cases, there was a transient antibody formation to Actilyse ® (in low titers), but the clinical significance of this phenomenon has not been established.
Rarely: Crystals cholesterol embolization, which can lead to side effects relevant affected viscera.

The reactions identified in special studies:

Often: decreased blood pressure
Often: increased body temperature.

Reproductive system and breast:

Often: bleeding from the urinary tract.

From the side of respiratory organs, organs of the chest cavity and mediastinum:

Often: nose bleed.

The need for surgical and therapeutic procedures:

Often: need for blood transfusion.

On the part of the vessels:

Often: ecchymosis
Infrequently: thromboembolism, which may be accompanied by the appropriate consequences from the affected organs.
Rarely: bleeding from parenchymal organs.

Overdose Despite the relative specificity of drug effects on fibrin, an overdose may result in a clinically significant reduction in the level of fibrinogen and other clotting factors.

In most cases it is enough to stop the introduction of Actilyse ® and wait for the physiological recovery of these factors. However, if you develop severe bleeding, recommended infusion of fresh frozen plasma or fresh blood; if necessary, you can assign a synthetic antifibrinolytic agent.

Interactions with other medications No specific studies interaction jelfa omnadren of Actilyse ® with other drugs commonly used in acute myocardial infarction, have been conducted.

The use of drugs that affect blood clotting or altering platelet function prior to, during or after the initiation of therapy Micardis ® may increase the risk of bleeding.

Concomitant use of ACE inhibitors may increase the risk of anaphylactoid reactions. These reactions are observed in a relatively large proportion of patients treated with ACE inhibitors.

Cautions Actilyse treatment ® should hold a doctor who has experience of thrombolytic therapy and the possibility of monitoring its effectiveness. When using Actilyse ® , as well as other thrombolytic agents, it is recommended to have at the disposal of the standard resuscitation equipment and related drugs.

General Precautions Bleeding The most common complication of therapy Actilyse ® is bleeding. The simultaneous use of heparin may contribute to bleeding. Since Actilyse ® dissolves the fibrin may occur bleeding from recent puncture sites. Therefore, thrombolytic therapy requires careful monitoring of possible areas of bleeding (including catheter site, arterial and venous punctures, cuts and injections. Avoid using rigid catheters, intramuscular injections and groundless manipulation during treatment with Actilyse.

In case of heavy bleeding, in particular cerebral, fibrinolytic therapy and heparin should be discontinued immediately. In the event that within 4 hours prior to the start of bleeding, heparin was used, it should consider the appropriateness of the use of protamine. In rare cases, when the above conservative measures are ineffective, the bleeding continues, it can be shown the use of blood products. Tranfuzionnoe introduction of cryoprecipitate, fresh frozen plasma and platelets may be appointed in accordance with clinical and laboratory parameters pamidronic acid to be determined again jelfa omnadren after each administration. Infusion is preferably carried out cryoprecipitate fibrinogen to achieve a concentration of 1 g / l. You can consider using antifibrinolytic agents (eg, traniksaminovoy acid), but special studies have not been conducted.

In acute myocardial infarction and pulmonary embolism should not be used Actilyse ® in a dose exceeding 100 mg, and in acute ischemic stroke – in a dose of 90 mg, as increased risk of intracranial hemorrhage.

Experience in the use of Actilyse in children is limited.

After treatment sustained production of antibodies against recombinant human tissue plasminogen activator were not observed. Systematize the experience re-use Actilyse ® is not available. In the case of anaphylactoid reaction, the infusion should be discontinued and appropriate treatment. Recommended regular monitoring of the tolerability of treatment, especially in patients concomitantly receiving ACE inhibitors (see. The side effects).

In the treatment of acute myocardial infarction should further bear in mind the following special warnings and precautions:

Arrhythmias Coronary thrombolysis may cause arrhythmias associated with reperfusion.

Antagonists of glycoprotein IIb / IIIa. Experience with glycoprotein PLPa antagonists within the first 24 hours after the start of treatment available.

Thromboembolism use of thrombolytic agents may increase the risk of venous thromboembolism in patients with thrombosis of the left heart, such as mitral stenosis or atrial fibrillation.

In the treatment of acute stroke should further bear in mind the following special warnings and precautions: Treatment should be carried out exclusively by an experienced doctor who have skills and experience in providing intensive neurological care in a specialized department, having the opportunity to spend the whole complex imaging studies.

It is necessary to monitor blood pressure (BP) during treatment and for 24 hours thereafter. An increase in systolic blood pressure> 180 mm Hg. Art. or diastolic blood pressure> 105 mm Hg. Art. It recommended intravenous antihypertensive drugs.

The therapeutic effect is reduced in patients who have had previous stroke, or if you have uncontrolled diabetes. In these patients, the ratio of benefit-risk is considered less favorable, but still remained positive. Patients with very little risk of stroke is greater than the potential benefits, so the use of Actilyse ® is not recommended. Patients with very severe jelfa omnadren stroke are at increased risk of intracranial hemorrhage and death in these cases, Micardis ® should not be used.

In patients with large infarcts of the brain there is an increased risk of adverse outcomes, including express intracerebral hemorrhage and death. In such cases, you should carefully weigh the risks and benefits of therapy.

At the stroke probability of a favorable outcome of treatment decreases with increasing age and with increasing stroke severity and increased levels of blood glucose. At the same time, the probability of a serious breach of legal capacity, and death or severe intracranial hemorrhage is increased regardless of treatment. Actilyse ® should not be used in patients older than 80 years in the case of severe stroke (clinical data and / or data imaging studies) and in those cases where the initial values of blood glucose of <50 mg / dL or> 400 mg / dl.

Reperfusion of ischemic area may lead to cerebral edema in the infarcted zone. Due to the increased risk of hemorrhage use of platelet aggregation inhibitors should not be initiated within the first 24 hours following thrombolysis with alteplase help. Running low dose t3 clen cycle trying to lose bodyfat isn’t a real hot idea imo. balkan pharmaceuticals

omnadren 250 results

Omnadren 250 results derived synthetically from a fermentation product Aspergillus tereus, is an inactive lactone, is hydrolyzed in the body to form the hydroxy-acid derivative. heterozygous familial and non-familial forms of hypercholesterolemia, with mixed hyperlipidemia when elevated cholesterol is a risk factor)
increases the content of high density omnadren 250 results .
onset of effect – 2 weeks from the start of the reception , the maximum therapeutic effect is achieved within 4-6 weeks. Action is maintained with continued treatment, at the termination of therapy cholesterol gradually returned to baseline.
Absorption – high. After oral administration, maximum concentration omnadren 250 results  in plasma is reached after 1.3 – 2.4 hours, and reduced by 90% after 12 hours.
Relationship to plasma proteins – 95%.
It is metabolized in the liver, it has a “first pass effect” through the liver (hydrolyzed to form an active derivative – beta-hydroxyacids are found and other active and inactive metabolites). The half-life of the active metabolites is 1.9 hours.
Write mainly with feces (60%) in the form of metabolites.
Approximately 10-15% is excreted by the kidneys in an inactive form.

Indications

hypercholesterolemia:

  • Primary Hypercholesterolemia (type IIa and IIb), when poor diet low in cholesterol and other non-drug interventions (exercise and weight reduction) in patients with an increased risk of coronary atherosclerosis;
  • combined hypercholesterolemia and hypertriglyceridemia, is not correctable special diet and exercise.

Cardiac ischemia:

  • for prevention of myocardial infarction, for reducing the risk of death, reducing the risk of cardiovascular disorders (stroke or transient ischemic attacks), slowing the progression of coronary atherosclerosis, reduce the risk of revascularization procedures.

Contraindications

 

  • Hypersensitivity to omnadren 250 results or to other components of the preparation (including hereditary lactose intolerance), as well as several other statin drugs (HMG-CoA reductase) in history;
  • liver disease in the active phase, a persistent increase in activity of “liver” enzymes of unknown etiology;
  • diseases of skeletal muscles (myopathy);
  • age of 18 years (effectiveness and safety have been established).

With careful preparation is prescribed to patients who abuse alcohol, transplant patients undergoing immunosuppressive treatment (due to the increased risk of rhabdomyolysis and renal failure); in conditions that can lead to severe renal insufficiency, such as hypotension, acute infectious diseases heavy currents expressed metabolic and endocrine disorders, disorders of water and electrolyte balance, surgery (including dental), or injury; patients with high or low tone of the skeletal muscles of unknown etiology; epilepsy.

Pregnancy and lactation

The drug should not be used during pregnancy. There are several reports of malformations in newborns whose mothers took omnadren 250 results.
Women of childbearing age who take medication should avoid conception. If in the course of treatment became pregnant, the drug should be immediately canceled and the woman warned of the possible danger to the fetus.
The data on the allocation of omnadren 250 results in breast milk are not available. If necessary Aktalipida appointment during lactation should be borne in mind that many drugs are excreted in breast milk, and there is a threat of severe reactions, so breast-feeding during treatment is not recommended.

Dosing and Administration

Before the start of treatment, patients should assign standard, hypolipidemic diet, which must be observed during the treatment.
The drug is administered orally 1 time a day in the evening, drinking plenty of water.
Time of the drug should not be combined with the meal.
The recommended dose for the treatment of hypercholesterolemia varies from 10 to 80 mg 1 time per day in the evening. The recommended starting dose for patients with hypercholesterolemia is 10 mg.
The maximum daily dose -. 80 mg of
change (selection) the dose should be performed at intervals of 4 weeks. In most patients, the optimal effect is achieved by taking the drug at doses up to 20 mg per day.
In patients with homozygous familial hypercholesterolemia recommended daily dose is 40 mg 1 time per day in the evening or 80 mg in three divided doses (20 mg in the morning, 20 mg in the afternoon and 40 mg in the evening).
For the treatment of patients with coronary heart disease (CHD) or at high risk for CHD Aktalipida effective doses are 20-40 mg per day. Therefore, the recommended initial dose in these patients – 20 mg per day. Changes (selection) the dose should be performed at intervals of 4 weeks, if necessary, the dose can be increased to 40 mg per day. If the LDL cholesterol content of less than 75 mg / dL (1,94mmol / L), total cholesterol levels – less than 140 mg / dL (3.6 mmol / l), the dose should be reduced.
In elderly patients and in patients with mild or moderate renal impairment (creatinine clearance less than 30 mL / min) or receiving cyclosporin, danazol, gemfibrozil or other fibrates (except fenofibrate), niacin in lipid-lowering doses (≥ 1g / day) in combination with omnadren 250 results maximum recommended dose should not exceed 10 mg per day.
in patients taking amiodarone or verapamil simultaneously with the drug, the daily dose should not exceed 20 mg.

Side effect

The digestive system: possible abdominal pain, constipation, flatulence, nausea, diarrhea, pancreatitis, vomiting, hepatitis, increased activity of “liver” enzymes, alkaline phosphokinase, and creatine phosphokinase (CPK). The nervous system and sensory organs: asthenic syndrome, dizziness, headache , insomnia, muscle cramps, paresthesia, peripheral neuropathy, blurred vision, taste disturbance.Allergic and immunopathological reactions: angioedema, polymyalgia rheumatica, vasculitis, thrombocytopenia, increased erythrocyte sedimentation rate, fever, arthritis, rash, photosensitivity, skin redness, flushing, shortness of breath , lupus-like syndrome, eosinophilia. Dermatological reactions: rare skin rash, pruritus, alopecia, dermatomyositis. From the musculoskeletal system: myalgia, myopathy, muscle cramps, weakness, rhabdomyolysis. Other: anemia, palpitation, acute renal failure (due to rhabdomyolysis) , reduced potency.

Overdose

None of the known cases of overdose (maximum dose of 450 mg adopted) specific symptoms have been identified.
Treatment: Induce vomiting, activated charcoal. Symptomatic therapy. It is necessary to control the function of the liver and kidneys, creatine kinase levels in the blood serum.
With the development of myopathy and rhabdomyolysis with acute renal failure (rare but severe side effects), stop taking the drug and the patient enter a diuretic and sodium bicarbonate (intravenous infusion). If necessary hemodialysis shown.
Rhabdomyolysis can cause hyperkalemia, which can eliminate the intravenous administration of calcium chloride or calcium gluconate, glucose infusion with insulin, or using potassium ion exchangers, in severe cases, by dialysis.

Interaction with other drugs

Cytotoxic agents, antifungal drugs (ketoconazole, itraconazole), fibrates, high doses of nicotinic acid, immunosuppressants, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, nefazodone increase the risk of myopathy.
Cyclosporin or danazol: risk of myopathy / rhabdomyolysis increases when coadministered cyclosporin or danazol with higher doses of omnadren 250 results.
other lipid-lowering drugs that can cause myopathy development: the risk of myopathy is increased by concomitant use of other lipid-lowering drugs that are not potent inhibitors of CYP3A4, but can cause myopathy in monotherapy conditions. Such as gemfibrozil and other fibrates (except fenofibrate), and niacin (nicotinic acid) at a dose of ≥ 1,0 g per day.
Amiodarone and verapamil: risk of myopathy increased when co-administered with verapamil or amiodarone high doses of omnadren 250 results.
Diltiazem: Risk myopathy slightly increased in patients receiving diltiazem simultaneously with the drug at a dose of 80 mg.
omnadren 250 results potentiates the action of oral anticoagulants (eg phenprocoumon, warfarin) and increases the risk of bleeding, which requires the need for monitoring indicators of coagulation prior to treatment, as well as enough often in the initial period of therapy. Once reached a stable level indicator prothrombin time or international normalized ratio (INR), a further control be carried out at intervals recommended for patients receiving anticoagulant therapy. If you change the dosage or discontinuation of omnadren 250 results should also carry out monitoring of prothrombin time or INR on the above chart.
Therapy with omnadren 250 results did not cause changes in prothrombin time and the risk of bleeding in patients not taking anticoagulants.
It increases levels of digoxin in the blood plasma.
Cholestyramine and colestipol reduce bioavailability (reception possible drug through 4 hours after administration of the drugs, while noting additive effect).
grapefruit juice contains one or more components which inhibit CYP3A4 and can increase the concentration in the blood plasma means, metabolized by CYP3A4. Increasing the activity of HMG-CoA reductase inhibitors after drinking 250 ml of grapefruit juice per day is minimal and has no clinical significance. However, the larger volume of juice consumption (more than 1 L) while taking omnadren 250 results significantly increases the level of inhibitory activity against HMG-CoA reductase inhibitor in blood plasma. In this connection, to avoid consumption of grapefruit juice in large quantities during ingestion.

special instructions

At the beginning of therapy Aktalipidom possible transient increase in the level of “liver” enzymes. Before therapy, and further need to perform regular liver function tests (to monitor the activity of “liver” transaminases every 6 weeks during the first 3 months., And then every 8 weeks for the remainder of the first year, and then every six months), and at higher doses should be to carry out a test to determine the liver function. By increasing the dose to 80 mg of the test should be carried out every 3 months. When persistent elevations of transaminases (3 times as compared to baseline) receiving the drug should be discontinued.
Aktalipid, like other inhibitors of HMG-CoA reductase inhibitors, should not be applied at an elevated risk of developing rhabdomyolysis, renal failure (on the background of severe acute infections, hypotension, planned major surgery, trauma, severe metabolic disorders).
Cancel lipid-lowering drugs during pregnancy has no significant impact on the treatment of primary hypercholesterolemia.
due to the fact that inhibitors of HMG-CoA reductase inhibitors inhibit the synthesis of cholesterol and cholesterol and other products of its synthesis plays an important role in fetal development, including synthesis of steroids and cell membranes, omnadren 250 results may have an adverse effect on the fetus in the appointment of his pregnant (women of childbearing age should avoid conception during treatment with the drug). If in the course of treatment became pregnant, the drug should be withdrawn and the woman warned of the possible danger to the fetus. Use of the drug is not recommended for women of childbearing age, not using contraception.
In patients with low thyroid function (gipotirioz) or in the presence of certain diseases of the kidneys (nephrotic syndrome) with an increase in cholesterol levels should first carry out treatment of the underlying disease.
Aktalipid prescribed with caution persons who abuse alcohol and / or have a history of liver disease.
Before and during treatment the patient should be on hypolipidemic diet.
Co-administration of grapefruit juice and medication may enhance the severity of side effects, so you should avoid their simultaneous reception.
Aktalipid not shown in those cases where there is hypertriglyceridemia I, IV, V type.
Treatment of drug can cause myopathy, rhabdomyolysis and leading to kidney failure. The risk of this disease increases in patients receiving simultaneously with the drug, one or more of the following drugs: fibrates (gemfibrozil, fenofibrate), cyclosporine, nefazadon, macrolides (erythromycin, clarithromycin), antifungal agents from “azoles” (ketoconazole, itraconazole) and HIV protease inhibitors (ritonavir). The risk of myopathy is also increased in patients with severe renal insufficiency.
All patients who start therapy with the drug and the patients who need to increase the dose of the drug should be warned of the possibility of myopathy and need immediate treatment to the doctor in case of unexplained pain, pain in muscle flaccidity or muscle weakness, particularly if accompanied by malaise or fever. Drug therapy should be discontinued immediately if myopathy is diagnosed or suspected.
In order to diagnose myopathy is recommended to conduct regular measurements of the CK.
In the treatment of the drug may increase the content of serum CK, which should be considered in the differential diagnosis of chest pain. Drug withdrawal criterion is an increase in serum CPK more than 10 times the upper limit of normal. Patients with myalgia, myasthenia and / or marked increase in CPK drug treatment is stopped.
The drug is effective as a monotherapy, or in combination with bile acid sequestrants.
In case of missing the current drug dose must be taken as soon as possible. If it is time for your next dose, do not double the dose.
Patients with severe renal insufficiency treatment is carried out under the control of renal function.
The duration of the drug is determined by the physician individually.

Driving a car and operating machinery

The adverse effect of the drug on the ability to drive vehicles and work with the mechanisms have not been reported. gen shi labs supplier