Composition, form of production and packaging
Lyophilizate for the preparation of a solution for intravenous administration of white color; The attached solvent is a clear, colorless, odorless liquid.
1 dose (0.5 ml)
polysaccharide Haemophilus influenzae B 9.5-14.3 Ојg
tetanus toxoid 19-28.6 Ојg
Excipients: stabilizer - sucrose - 20-30 mg / dose.
Solvent: water d / and - 0.5 ml / 1 dose.
1 dose - ampoules (5) complete with a solvent (5 pcs.) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2011.
PHARMACHOLOGIC EFFECT
Vaccine for the prevention of infections caused by Haemophilus influenzae type b.
One month after the completion of the full course of vaccination, 90-100% of children in the serum are found to have antibodies to the capsular polysaccharide in an amount of> 0.15 Ојg / ml, 80% of the antibodies exceed 1 Ојg / ml.
INDICATIONS
- Prevention of purulent-septic diseases, (meningitis, septicemia, epiglotitis, etc.) caused by Haemophilus influenzae type b in children from 3 months of age to 5 years.
DOSING MODE
The vaccine is injected intramuscularly into the upper outer quadrant of the gluteus muscle. It is necessary to make sure that the needle of the syringe does not penetrate into the lumen of the blood vessel. Do not administer intravenously.
Patients with thrombocytopenia and other disorders of the blood coagulation system receive the vaccine subcutaneously.
Before use, the solvent should be inspected for foreign matter. In the presence of foreign particles or change in appearance, the solvent should not be used.
Immediately before use in a vial with a lyophilizate vaccine, apply a syringe solvent at a rate of 0.5 ml per dose. The ampoule is shaken well until the content is completely dissolved. The dissolution time should not exceed 3 minutes. The dissolved preparation is a clear, colorless liquid. If there are any foreign inclusions or if there is a discoloration, the vaccine is not used.
The drug in the opened ampoule is not subject to storage.
The procedure for administering the vaccine is carried out with strict adherence to aseptic rules.
The vaccination course consists of:
- for children aged 3 to 6 months from 3 injections of 0.5 ml at intervals of 1-1.5 months.
- for children aged 6 to 12 months from 2 injections of 0.5 ml at intervals of 1-1.5 months.
- for children from 1 year to 5 years, a single injection of 0.5 ml.
Revaccination is carried out once at the age of 15-18 months in children vaccinated in the first year of life.
SIDE EFFECT
In the first 48 hours after the administration of the vaccine, tenderness is possible at the injection site, which usually disappears in 24-48 hours, as well as the development of minor hyperemia and swelling (up to 1%).
In the first 48 hours after the introduction of the vaccine, a subfebrile temperature reaction may develop, a decrease in appetite, anxiety, unusual crying, which are usually mild and do not require therapy. Allergic reactions (including anaphylactic shock) were not recorded.
Adverse reactions in most cases are of low intensity and short-term.
Parents should be warned that in case of development of adverse reactions other than those indicated, you should consult a doctor.
CONTRAINDICATIONS
- strong reactions (temperature above 40 В° C, swelling and hyperemia over 8 cm in diameter) for the previous inoculation;
- acute infectious and non-infectious diseases, exacerbations of chronic diseases;
- hypersensitivity to any component of the vaccine, especially tetanus toxoid.
Children who have undergone acute illnesses are vaccinated 1 month after recovery (remission). With mild ARVI, acute intestinal and other diseases, vaccinations are carried out after the temperature is normalized.
In each case of a physical illness, the question of
indications for vaccination are decided by the doctor.
SPECIAL INSTRUCTIONS
As with any vaccine, the vaccine should be monitored for at least 30 minutes, and vaccination sites should be provided with anti-shock therapy. All persons before vaccination should be examined by a doctor (paramedic) with obligatory thermometry.
Vaccination is conducted by the average medical staff under the guidance of a doctor.
The use of the vaccine in children with congenital or acquired immunodeficiency, as well as in patients who have undergone immunosuppressive therapy, may cause an inadequate immune response.
Although the haemophilus type B vaccine contains tetanus antitoxin, its use does not replace vaccination against tetanus.
Given that the vaccine contains sucrose, inoculation of diabetic patients should be conducted with caution, taking into account the condition of the patient.
Immunodeficiency, HIV infection, and course therapy with steroid drugs are not contraindications to vaccination.
DRUG INTERACTION
The hemophilic type B conjugated vaccine can be used concomitantly with other vaccines of the national calendar of preventive vaccinations: against diphtheria and tetanus (ADS and ADS-M); pertussis, diphtheria and tetanus (DTP with whole-cell and acellular pertussis component), hepatitis B (HBV); DTP-GV; Bubo-Kok and poliomyelitis live or inactivated vaccine. In this case, drugs must be injected with different syringes into different anatomical zones.
TERMS OF RELEASE FROM PHARMACY
For treatment and prevention institutions.
TERMS AND CONDITIONS OF STORAGE
The vaccine is transported and stored in accordance with SP 3.3.2.1248-03 at a temperature of 2 В° C to 8 В° C. Do not freeze. Keep out of the reach of children. Shelf life - 2 years. The vaccine after the expiry date should not be used.
