CONTRAINDICATIONS -Allergiya To the ingredients of the vaccine, particularly tetanus toxoid -Allergicheskaya reaction to previous administration of the vaccine to prevent infections caused by Haemophilus influenzae type b (Hib infections). -Ostrye Disease, exacerbation of chronic diseases – vaccination is carried out within 2-4 weeks. after recovery (remission). In non-severe forms of respiratory and intestinal infections vaccination may take place immediately after the normalization of temperature.
DOSAGE AND ADMINISTRATION Enter the vial of vaccine the entire contents of the syringe with the solvent, shake the vial until complete dissolution of the omnadren 250 jelfa. The resulting solution is colorless and transparent. The vaccine is administered by intramuscular or deep subcutaneous injection in a single dose of 0.5 ml. Prior to administration, make sure that the needle does not hit a blood vessel. Children under 2 years – the introduction of the vaccine is carried out in the middle third of the anterolateral area of the thigh. In children older than 2 years – the introduction of the vaccine is carried out in the region of the deltoid muscle. COURSE vaccination at the beginning of the vaccination at the age up to 6 months: 3 injections with an interval of 1-2 months. Revaccination is performed once a year after the third vaccination. At the beginning of the vaccination at the age of 6 months to 12: 2 injections omnadren 250 at intervals of 1 month. Revaccination is carried out once at the age of 18 months. At the beginning of the vaccination at the age from 1 year to 5 years: a single injection.
ADVERSE REACTIONS In clinical studies noted: Normally (1-10% or more) local reactions: pain, erythema, swelling and / or inflammation, induration at the injection site, irritability, vomiting. It is possible (not more than 10%) increase in temperature body, prolonged crying. Sometimes (not more than 1%) increase in body temperature above 39 ° C. during the practical application on the basis of passive farmakonablyudeniya very rare (less than 0.01% of the application) were noted: -periferichesky lower swelling extremities (see. section “Special instructions”) -reaction hypersensitivity, febrile or afebrile seizures, hives, rash and itching. in very preterm infants (born at 28 weeks or earlier) for 2-3 days after vaccination may be observed lengthening cases the time intervals between the respiratory movements (see. “Special instructions” section).
SPECIAL INSTRUCTIONS ACT-HIB does not generate immunity against infection by other serotypes of Haemophilus influenzae, as well as against meningitis of other etiology. Contained in the vaccine tetanus protein, can not be regarded as a substitute for vaccination against tetanus. Immunosuppressive therapy, or immune deficiency may be the cause of a weak immune response to the vaccine. Isolated cases of peripheral edema of the lower extremities occurred in children under the age of 4 months. after the 1st or 2nd vaccine injection containing Hib-component (71%), more than half of the cases arise for 6 h. The reactions were developed when administered Hib component in the combination vaccines (for example, diphtheria, tetanus and pertussis ). The swelling spread to one or both lower limbs (with preobla-daniem edema on the limb where the vaccine was introduced). These reactions may be accompanied by tenderness omnadrenu, or unusual high-pitched cry, cyanosis or skin discoloration, redness, petechiae, or transient purpura, fever, rash. These events were spontaneously within 24 h., Without any residual effects, they are not associated with any adverse events of the heart and respiratory system. The potential risk of apnea and the need for respiratory monitoring for 48-72 h should be considered when carrying out the primary course of immunization in very preterm infants born at 28 weeks or earlier, in particular, have a history of having signs of immaturity of the respiratory system. Because of the use of immunization a group of children is high, vaccination should not be delayed or regarded as contraindicated.
INTERACTION WITH OTHER DRUGS ACT-HIB can be used simultaneously with other vaccines of national immunization schedule and calendar of preventive vaccination on epidemic indications provided using different syringes and injection in different parts of the body. The doctor omnadrenu should be informed about the recently held either coincides with vaccine administration child of any other drug (including – OTC).
PACKAGING 1 dose of the vaccine in a vial and 0.5 ml of solvent in a syringe (with a fixed needle or without) a closed cell package. If the syringe has a fixed needle, the packaging is invested 2 separate sterile needle. 1 closed cell package with instructions for use in a cardboard box. bm pharmaceuticals