Hemophilus type b conjugated vaccine - instructions for use, dose, side effects, contraindications

Active substanceHaemophilus type B conjugated vaccineHaemophilus type B conjugated vaccine

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lyophilizate w / m

FBUN RostovNIIMP of Rospotrebnadzor Russia

Dosage form: & nbsp lyophilizate for the preparation of a solution for intramuscular injection

Composition:

One dose of reconstituted vaccine contains:

Active substances: capsular polysaccharide Haemophilus influenzae a type b from 9.5 to 14.3 μg, tetanus toxoid from 19.0 to 28.6 μg.

Excipients: sucrose - from 20 to 30 mg.

Solvent:

water for injection - 0.5 ml.

Description:Vaccine represents white lyophilizate.

Solvent - Clear, colorless liquid.

Pharmacotherapeutic group:MIBP vaccine

ATX: & nbsp

J.07.A.G. Vaccine for the prevention of infections caused by Haemophilus influenza B

Pharmacodynamics:

Immunological properties

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 μg / ml, 80% of the antibodies exceed 1 μg / ml.

Indications:

Prevention of purulent-septic diseases (meningitis, septicemia, epiglottitis, etc.) caused by Haemophilus influenzae a type b in children from 3 months of age to 5 years.

Contraindications:

- Allergic reaction to the previous administration of preparations containing tetanus toxoid;

- allergic reaction to previous administration of the haemophilus type b conjugated;

- hypersensitivity to any component of the vaccine, especially tetanus toxoid;

- strong reactions (temperature above 40 ° C, swelling and hyperemia over 8 cm in diameter) for the previous inoculation;

- acute infectious and non-infectious diseases, exacerbations of chronic diseases.

Vaccinations are carried out 1 month after recovery (remission). For non-severe acute respiratory viral infections, acute intestinal diseases, etc., inoculations are carried out after normalizing the temperature.

In each case of a physical illness, the doctor decides the question of the indications for vaccination.

Dosing and Administration:

The vaccine is injected intramuscularly into the upper-upper surface of the middle part of the thigh. Do not administer intravenously. Patients with thrombocytopenia and other disorders of the blood coagulation system receive the vaccine subcutaneously.

Solvent - water for injections, included in the kit or commercial preparation - water for injections, registered in the Russian Federation before use should be inspected for physical condition and absence of foreign particles.In the presence of foreign particles or change in appearance, it should not be used.

Immediately before use in a vial of lyophilisate 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 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.

In accordance with the national calendar of preventive vaccinations, the vaccination course includes a triple injection of vaccine at the age of 3 months, 4.5 months, 6 months. with a single booster at 18 months. At the beginning of vaccination at the age of 6 to 12 months. the drug is administered twice with an interval of 1-1.5 months. Revaccination is carried out once in 18 months. Children aged 1 to 5 years are given a single vaccine.

Side effects:

In the first 48 hours after the administration of the vaccine, pain may occur at the injection site, which usually disappears after 24-48 hours, 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 adverse reactions other than those indicated, you should consult your doctor.

Interaction:

It is allowed to introduce vaccines (except vaccines for the prevention of tuberculosis) used in the national calendar of preventive vaccinations, in the same day with different syringes in different parts of the body.

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 underwent immunosuppressive therapy, may cause an inadequate immune response.

Although the vaccine is a hemophilic type b contains tetanus toxoid, its use does not replace vaccination against tetanus.

Given that the vaccine contains sucrose, vaccination for children with diabetes should be done with caution, taking into account the condition of the patient.

Immunodeficiency, HIV infection, and maintenance therapy with steroid drugs are not contraindications to vaccination.

Form release / dosage:

Lyophilizate for solution for intramuscular injection, 0.5 ml / dose.

Packaging:

Packaging with solvent contains: 5 ampoules of 1 dose of lyophilizate vaccine and 5 ampoules with a solvent (water for injection) to 0.5 ml / 1 dose in a pack with instruction for use.

Packaging without solvent contains: 10 ampoules of 1 dose of lyophilizate vaccine in a pack with instructions for use.

Storage conditions:

The vaccine is transported and stored in accordance with SP 3.3.2.3332-16 "Conditions for the transport and storage of immunobiological medicinal products" at a temperature of 2 ° C to 8 ° C. Do not freeze.

Keep out of the reach of children.

Shelf life:

2 years.

A vaccine with expired shelf life is not subject to application.

Terms of leave from pharmacies:For hospitals

Registration number:LP-000499

Date of registration:23.03.2011 / 26.07.2016

Expiration Date:Unlimited

The owner of the registration certificate:FBUN RostovNIIMP of RospotrebnadzorFBUN RostovNIIMP of Rospotrebnadzor Russia

Manufacturer: & nbsp

FBUN RostovNIIMP of Rospotrebnadzor Russia

Representation: & nbspFBUN RostovNIIMP of RospotrebnadzorFBUN RostovNIIMP of RospotrebnadzorRussia

Information update date: & nbsp06.02.2017

Illustrated instructions

Instructions

Haemophilus type B conjugated vaccine (HAEMOPHILUS INFLUENZAE TYPE B VACCINE CONJUGATED)