Composition, form of production and packaging
Lyophilizate for the preparation of a solution for w / m and / or administration in the form of a powder or a dense mass of white or grayish-white color; The applied solvent is a colorless, clear, odorless liquid, free from visible mechanical inclusions.
1 f. (1 dose)
purified capsular polysaccharide (PRP) Hib * 10 Ојg
conjugated to tetanus toxoid (approximately 30 Ојg)
Excipients: lactose as a stabilizer (10.08 mg per 1 dose).
Solvent: 0.9% solution of sodium chloride - 0.5 ml (per 1 dose).
* - Haemophilus influenzae type b 20,752.
The vaccine meets WHO requirements for the production of biological products and for conjugated Hib vaccines.
1 dose - glass bottles (1) complete with a solvent (1 pc.) - cardboard boxes.
1 dose - glass bottles (1) complete with a solvent (1 pc.) - cardboard boxes.
1 dose - glass bottles (1) complete with a solvent (syringes with 1 or 2 needles) - blisters (1) - cardboard boxes.
Lyophilizate for the preparation of a solution for w / m and / or administration in the form of a powder or a dense mass of white or grayish-white color; The applied solvent is a colorless, clear, odorless liquid, free from visible mechanical inclusions.
1 f. (10 doses)
purified capsular polysaccharide (PRP) Hib * 100 Ојg
conjugated to tetanus toxoid (approximately 30 Ојg per 1 dose)
Excipients: lactose as a stabilizer (10.08 mg per 1 dose).
Solvent: 0.9% solution of sodium chloride - 5 ml (per 10 doses).
* - Haemophilus influenzae type b 20,752.
The vaccine meets WHO requirements for the production of biological products and for conjugated Hib vaccines.
10 doses - glass bottles (1) complete with a solvent (1 pc.) - cardboard boxes.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2008.
PHARMACHOLOGIC EFFECT
Vaccine for the prevention of diseases caused by Haemophilus influenzae type b.
Antibodies in a protective titre of 0.15 Ојg / ml appear after 1 month after the end of the vaccination course in 95-100% of children, and 1 month after revaccination - in 100% of children. In this case, 94.7% of the latest antibody titers are 10 Ојg / ml.
Hibericx does not protect against diseases caused by other types of Haemophilus influenzae , and bacterial meningitis of another etiology
PHARMACOKINETICS
The pharmacokinetics of the Hiberica vaccine has not been studied.
INDICATIONS
- Prevention of infection caused by Haemophilus influenzae type b, in children aged 6 weeks to 5 years.
DOSING MODE
Children at the age of 6 weeks - 6 months : at the onset of vaccination up to 6 months of age, the course consists of three inoculations at intervals of 1 month (2, 3, 4 or 3, 4, 5 months of life) or 1.5 months (3, 4.5, 6 months life) or 2 months between doses (2, 4 and 6 months of life). The vaccination scheme varies from country to country; in the Russian Federation, the onset of vaccination against Haemophilus influenzae type b infection is envisaged at 3 months of age. Revaccination is carried out once for 2 years.
Vaccination is recommended to be carried out simultaneously with vaccination against poliomyelitis, pertussis, diphtheria and tetanus. In this regard, according to the National Calendar of preventive vaccinations of the Russian Federation, scheme 3, 4.5, and 6 months with a booster at the age of 18 months is preferable.
Children aged 6 months - 1 year: at the onset of vaccination after 6 months of age, the course consists of 2 inoculations at an interval of 1 month. Revaccination is carried out once for 2 years. For example, vaccination at 6 and 7 months of the child's life and revaccination in 18 months of the child's life.
The vaccine can be administered concomitantly with vaccination against poliomyelitis, pertussis, diphtheria, tetanus, measles, mumps and rubella.
Children aged 1-5 years: At the onset of vaccination after 1 year, the vaccine is administered once.
Rules for the preparation and administration of a solution
The vaccine is given in / m. Patients with thrombocytopenia and other disorders of the blood coagulation system are given a vaccine sc.
The solvent should be examined before use for the presence of foreign particles and the physical properties of the solution. If there are foreign particles or change the appearance of the solution, it should not be used.
Immediately before use, the applied solvent in the vial of the vaccine is applied at a rate of 0.5 ml per dose. The vial is shaken well until the contents are completely dissolved. The lyophilisate usually dissolves within no more than 1 minute. The dissolved preparation is a clear, colorless liquid. If it looks different, and if there are foreign particles, the vaccine is not used. A new needle should be used to administer the vaccine. When using the vaccine in a multi-dose package, a new sterile syringe and needle should be used each time to take the drug. The drug should be removed from the bottle with strict adherence to aseptic rules to prevent contamination of the contents. The preparation from the opened vial should be used during the working day.
Hibericks can not be administered in / in any circumstances.
SIDE EFFECT
Local reactions: in the first 48 hours after the introduction of the vaccine are possible: minor spontaneously disappearing hyperemia; weak swelling and tenderness at the injection site.
Systemic reactions: during the first 48 hours after the introduction of the vaccine, fever, loss of appetite, anxiety, nausea, diarrhea, unusual crying can develop, which usually are mild and do not require therapy. Very rarely recorded allergic reactions (including anaphylactic shock).
CONTRAINDICATIONS
- acute infectious and non-infectious diseases;
- exacerbation of chronic diseases (vaccinations are carried out 1 month after recovery);
- mild forms of respiratory, intestinal and other infections, accompanied by an increase in body temperature (vaccinations can be carried out after normalizing the temperature);
- hypersensitivity to vaccine components, including tetanus toxoid;
- development of allergic reactions to the previous administration of Haemophilus influenzae type b vaccine.
SPECIAL INSTRUCTIONS
HIV infection is not a contraindication to the use of Hibericks.
In connection with the possibility of developing anaphylactic reaction in isolated cases, the vaccinated should be under medical supervision for 30 minutes, and the treatment rooms should be provided with anti-shock therapy.
Although Hibericx administration may cause a slight immune response to tetanus toxoid, the introduction of a vaccine can not replace tetanus vaccination.
In persons receiving Hibericks, a capsular polysaccharide is excreted in the urine, therefore, the determination of the antigen in the urine within 1-2 weeks after vaccination is of no diagnostic value in case of suspected infection with Haemophilus influenzae type b.
OVERDOSE
Data on the overdose of the Hiberica vaccine are not available.
DRUG INTERACTION
In accordance with the rules existing in the Russian Federation, Hibericks can be administered simultaneously (on the same day) with other vaccines of the National calendar of preventive vaccinations, as well as inactivated vaccines of the vaccination calendar for epidemic indications. In this case, drugs should be injected with different syringes into different parts of the body.
In persons receiving immunosuppressive therapy, as with other vaccines, an adequate immune response may not be achieved.
TERMS OF RELEASE FROM PHARMACY
The vaccine is dispensed by prescription.
TERMS AND CONDITIONS OF STORAGE
The vaccine, packed together with the solvent, should be stored in a dark place at a temperature of 2 В° to 8 В° C; Do not freeze.
The vaccine, packaged separately from the solvent, should be stored and transported at a temperature of 2 В° to 8 В° C in a dark place. Freezing is not allowed.
The solvent packaged separately from the vaccine should be stored and transported at a temperature of 2 В° to 25 В° C; Do not freeze.
Shelf life of the vaccine is 3 years, the solvent is 5 years.
Keep the vaccine and thinner out of the reach of children.
