Suspension for the / m administration is yellowish white, homogeneous, separated when standing on a colorless transparent liquid and a loose sediment of a yellowish white color, completely broken when shaken.
vaccine for the prevention of viral hepatitis B, diphtheria, pertussis and tetanus 0.5 ml, including:
Bordetella pertussis 10 billion
diphtheria toxoid 15 FU
tetanus toxoid 5 EU
hepatitis B virus antigen surface recombinant (HBsAg) 5 Ојg
Excipients: aluminum hydroxide 0.3-0.55 mg, formaldehyde - not more than 50 Ојg; preservative - thiomersal - 35-50 mcg.
0.5 ml - ampoules (10) - containers (1) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2011.
The vaccine is a mixture of formaldehyde-killed whooping pertussis microbes and aluminum diphtheria and tetanus toxoid hydroxide sorbent and recombinant yeast surface antigen of hepatitis B virus (HBsAg) sorbed on aluminum gel.
- prevention of pertussis, diphtheria, tetanus and hepatitis B in children.
Inoculations with the DTP-Hep B vaccine are carried out in time, 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 DTP-Hep B vaccine at the age of 3 and 6 months. The second vaccination against pertussis, diphtheria and tetanus is carried out with a DTP vaccine at 4.5 months.
Children not vaccinated with hepatitis B vaccine up to 3 months of age are immunized with DTP-Hep B vaccine three times according to the 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 DTP vaccine vaccinations in children not vaccinated with hepatitis B vaccine, up to 3 vaccines can be administered with DTP-Hep B vaccine. At the same time, up to 3 vaccines against hepatitis B are administered with a hepatitis B single vaccine with an interval of 1 and 6 months after the first administration. Revaccination against pertussis, diphtheria and tetanus is carried out by the DTP vaccine 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 DTP vaccine after 4 years of age, then it is performed with a DSA-toxin for age 4 years - 5 years 11 months 29 days or ADS-M-anatoxin for the age of 6 years and older.
The DTP-Hep B vaccine is administered intramuscularly to 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 preparation of the drug is registered in the prescribed registration forms with the indication of the serial number, expiration date, manufacturer, date of introduction, the nature of the reaction to the administration of the drug.
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 particularly 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 (the temperature increases in the first two days above 40 В° C, at the injection site - swelling and hyperemia over 8 cm in diameter) or postvaccinal complications, further vaccinations with DTP-Hep B vaccine stop him. If the child was vaccinated DTP-Hep vaccine B twice, the course of vaccination against diphtheria and tetanus is considered complete, and vaccination against hepatitis B is completed with a single dose of monovaccine 1 month after the second vaccination. If the child received one vaccination with the DTP-Hep B vaccine, the vaccination can be continued with a combination hepatitis B vaccine and diphtheria-tetanus toxoid with a reduced antigen content, which is administered only once, after 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 after 9-12 months after the last vaccination with DTP-Hep B vaccine or a combination hepatitis B vaccine and diphtheria-tetanus toxoid with a reduced antigen content. If a strong reaction has developed after the third vaccination with DTP-Hep B 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.
When the temperature rises above 38.5 В° C, more than 1% of vaccinated or the emergence of severe local reactions (swelling of soft tissues with a diameter of more than 5 cm, infiltration with a diameter of more than 2 cm) in more than 4% of vaccinated, as well as the development of postvaccinal complications, series terminate.
- progressive diseases of the nervous system;
- afebrile convulsions in the anamnesis;
- an allergic reaction to baker's yeast;
- strong reactions (a rise in temperature in the first two days above 40 В° C, at the injection site - swelling and hyperemia over 8 cm in diameter), post-vaccination complications for the introduction of a previous dose of the DTP-Hep B vaccine, or DTP vaccine, or hepatitis vaccine AT.
PREGNANCY AND LACTATION
The drug is used to vaccinate children and is not used in pregnancy and lactation.
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, when the temperature rises, paracetamol should be prescribed at an age-related dosage for 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.
Cases of overdose are not established.
Vaccines with DTP-Hep B vaccine can be administered concomitantly with other vaccines of the national calendar of preventive vaccinations (with the exception of BCG vaccine) or 1 month after vaccinations against other infections.
TERMS OF RELEASE FROM PHARMACY
For treatment and prevention institutions.
TERMS AND CONDITIONS OF STORAGE
Store at a temperature between 2 В° and 8 В° C in accordance with SP 188.8.131.528-03. Freezing is not allowed. Keep out of the reach of children.
Transport at a temperature of 2 В° to 8 В° C in accordance with SP 184.108.40.2068-03. Freezing is not allowed.
Shelf life - 18 months. The drug with expired shelf life is not subject to application.
The information is provided for your information, do not self-medicate, it is dangerous for your health.