Vaccine for the prevention of viral hepatitis B, diphtheria, whooping cough and tetanus - instructions for use, dose, side effects, contraindications

Clinical and pharmacological group: & nbsp

Vaccines, serums, phages and toxoids

Included in the formulation

Bubo®-Kok

suspension w / m

COMBIOTECH NPK, ZAO Russia

Vaccine against pertussis, diphtheria, tetanus and hepatitis B adsorbed liquid (DTP-Hep B vaccine)

suspension w / m

MICROGEN FGUP Scientific and Production Association Russia

Included in the list (Order of the Government of the Russian Federation No. 2782-r of 30.12.2014):

VED

АТХ:

J.07 Vaccines

Pharmacodynamics:

The vaccine is a mixture of formaldehyde-killed pertussis microbes of the 1st phase and aluminum hydroxide sorbed on the aluminum gel of diphtheria and tetanus toxoid and the recombinant yeast surface antigen of the hepatitis B virus (HBsAg).

The introduction of the drug in accordance with the approved vaccination scheme causes the formation of specific immunity against hepatitis B, diphtheria, tetanus and pertussis.

Pharmacokinetics:

No data.

Indications:

Prevention of pertussis, diphtheria, tetanus and hepatitis B in children.

ICD-10

XXI.Z20-Z29.Z24.6 The need for immunization against viral hepatitis

XXI.Z20-Z29.Z27.1 The need for immunization against diphtheria-tetanus-pertussis [CDS]

Contraindications:

Progressive diseases of the nervous system; afefrilnye convulsions in the anamnesis; an allergic reaction to baker's yeast; strong reactions (a rise in temperature in the first two days above 40 ° C, at the site of administration of the vaccine - edema and hyperemia over 8 cm in diameter),post-vaccination complications for the introduction of a previous dose of a vaccine or hepatitis B vaccine.

Carefully:

No data.

Pregnancy and lactation:

The drug is used to vaccinate children and is not used in pregnancy and lactation.

Dosing and Administration:

Vaccinations are given in a timely manner, providing simultaneous vaccinations against hepatitis B, pertussis, diphtheria and tetanus.

Children vaccinated with the hepatitis B monovalent during the first 24 hours of life and not at risk are immunized with vaccine at the age of 3 and 6 months. The second vaccination against pertussis, diphtheria and tetanus is carried out at 4.5 months.

Children who are not vaccinated with hepatitis B vaccine before 3 months of age are immunized with the vaccine three times according to the scheme of 3 months, 4.5 months, 6 months. Reduction of intervals is not allowed. If it is necessary to increase the intervals, the next vaccination should be carried out as soon as possible, determined by the state of children's health.

In the presence of one or two vaccinations in children who are not vaccinated with hepatitis B vaccine, the vaccine can be administered with a vaccine that is missing up to three.At the same time, the number of inoculations against hepatitis B missing up to three is carried out with the hepatitis B single-agent at intervals of 1 and 6 months after the first administration. Revaccination against pertussis, diphtheria and tetanus is carried out once at the age of 18 months. (if the timing of vaccinations is violated - 12-13 months after the completed vaccination course).

If the child has not received a revaccination at the age of 4 years, then it is performed with ADS-toxoid for age 4 years - 5 years 11 months 29 days or ADS-M-anatoxin for the age of 6 years and older.

The vaccine is injected intramuscularly into the anterior thoracic region of the thigh in a dose of 0.5 ml. Before vaccination, the ampoule must be shaken thoroughly until a homogeneous suspension is obtained.

Opening of ampoules and the vaccination procedure are carried out with strict adherence to aseptic and antiseptic rules. The drug in the opened ampoule is not subject to storage. The preparation is not suitable for use in ampoules with broken integrity, lack of marking, changing physical properties (discoloration, presence of non-developing flakes), expired shelf life, improper storage. The introduction of the drug is registered in the established accounting forms with the number of the series,shelf life, manufacturer, date of introduction, the nature of the reaction to the administration of the drug.

Side effects:

A part of the vaccinated in the first two days can develop short-term general (fever, malaise) and local (soreness, hyperemia, swelling) reactions. In rare cases, complications may develop: seizures (usually associated with fever), episodes of piercing screaming, allergic reactions (Quincke's edema, urticaria, polymorphic rash).

Given the possibility of developing allergic reactions of immediate type in especially sensitive children, it is necessary to provide medical supervision of the vaccinated for 30 minutes. Vaccination sites should be provided with anti-shock therapy.

When the child develops a strong general reaction (a rise in temperature in the first two days above 40 ° C, at the site of administration of the vaccine - edema and hyperemia over 8 cm in diameter) or postvaccinal complications, further inoculations are discontinued. If the child was vaccinated twice, the vaccination against diphtheria and tetanus is considered complete, and the vaccination against hepatitis B is completed with a single vaccine one month after the second vaccination.If the child received one vaccination with the vaccine, the vaccination can be continued with a vaccine of combined hepatitis B and diphtheria-tetanus toxoid with a reduced content of antigens, which is administered only once at 3 months, and then one month later, a hepatitis B monovalent is administered.

In both cases, the first revaccination is performed with ADS-M-anatoxin 9-12 months after the last vaccination with a vaccine or a combination hepatitis B vaccine and a diphtheria-tetanus toxoid with a reduced antigen content. If a strong reaction has developed after the third vaccination with the vaccine, the first revaccination is performed with ADS-M-anatoxin after 12-18 months. Subsequent revaccinations are carried out in decreed ages with ADS-M-anatoxin.

If the temperature rises above 38.5 ° C, more than 1% of the vaccinated or the occurrence of pronounced local reactions (swelling of soft tissues larger than 5 cm in diameter, infiltration with a diameter of more than 2 cm), more than 4% of the vaccinated, and the development of post-vaccination complications of grafting with this drug stop .

Overdose:

Cases of overdose are not established.

Interaction:

Vaccination with the vaccine can be carried out simultaneously with other vaccines of the national calendar of preventive vaccinations (with the exception of BCG vaccine) or 1 month after vaccination against other infections.

Special instructions:

Children who have had acute illnesses are vaccinated not earlier than four weeks after recovery, with mild forms of respiratory diseases (rhinitis, mild hyperemia of the throat, etc.), inoculation is allowed 2 weeks after recovery.

Patients with chronic diseases are vaccinated no earlier than four weeks after reaching a stable remission.

In order to identify contraindications, the doctor (paramedic at the FAP) on the day of vaccination is conducting a survey of parents and examining the child with mandatory thermometry. Children temporarily released from vaccination should be monitored and accounted for and promptly vaccinated.

The development of febrile seizures after the introduction of the vaccine is not a contraindication to its subsequent administration, in this case, with an increase in temperature should be prescribed in the age-related dosage paracetamol within 1-2 days.

Stable manifestations of an allergic disease (localized skin manifestations,latent bronchospasm, etc.) are not contraindications to vaccination, which can be performed against the background of appropriate therapy.

Information about the possible effect of the drug on the ability to drive vehicles, mechanisms.

Not applicable. The drug is used to vaccinate children.

Instructions

Vaccine for the prevention of viral hepatitis B, diphtheria, whooping cough and tetanus (Vaccinum ad prophylaxim hepatitis epidemicae B, diphtheriae, pertussis et tetani)