Composition, form of production and packaging
Suspension for the / m introduction yellowish white, homogeneous, without foreign inclusions, separating when standing on a colorless transparent liquid and loose, completely shattered by shaking.
vaccine for the prevention of diphtheria, pertussis and tetanus 0.5 ml, including:
Bordetella pertussis 10 billion
diphtheria toxoid 15 FU
tetanus toxoid 5 EU
Excipients: aluminum hydroxide - no more than 0.55 mg, formaldehyde - not more than 50 Ојg, merthiolate 42.5-57.5 Ојg (preservative).
0.5 ml - ampoules (5) - packings contour mesh (2) - packs cardboard.
0.5 ml - ampoules (10) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2011.
The introduction of the drug in accordance with the approved scheme causes the formation of specific immunity against pertussis, diphtheria and tetanus.
- prevention of pertussis, diphtheria and tetanus in children.
Vaccines DTP vaccine is carried out at the age of 3 months to reach the age of 3 years 11 months 29 days (vaccinations for children who have recovered whooping cough, carry out ADS-toxoid).
The drug is injected intramuscularly into the antero-external region of the thigh in a dose of 0.5 ml (single dose). Before vaccination, the ampoule must be shaken thoroughly until a homogeneous suspension is obtained.
The vaccination course consists of 3 vaccinations with an interval of 1.5 months (3 months, 4.5 months and 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 the child's health.
Revaccination is carried out once at the age of 18 months (if the timing of vaccinations is violated - 12-3 months after the last vaccination with DTP vaccine.
If the child has not received a DTP vaccine before the age of 11 11 months and 29 days has not received a DTP vaccine, then ADS-toxoid (for ages 4 years - 5 years 11 months 29 days) or ADS-M-anatoxin (6 years and older) is performed.
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: convulsions (usually associated with fever, episodes of piercing screaming, allergic reactions, urticaria, polymorphic rash, and Quincke's edema).
Given the possibility of developing allergic reactions of immediate type in especially sensitive children, it is necessary to provide medical supervision for those vaccinated within 30 minutes. Vaccination sites should be provided with anti-shock therapy.
- progressive diseases of the nervous system;
- afebrile convulsions in the anamnesis,
- development of a strong general response to the previous administration of DTP vaccine (rise in temperature for the first two days to 40 В° C or higher, appearance of edema and hyperemia over 8 cm in diameter at the site of injection) or complications.
Children with contraindications to the use of the vaccine can be vaccinated with ADS-anatoxin in accordance with the instructions for its use
If the child is vaccinated twice, the vaccination course against diphtheria and tetanus is considered complete; if the child received one vaccination, the vaccination can be continued with ADS-M-anatoxin, which is administered once, not earlier than three months later.
In both cases, the first revaccination is performed with ADS-M-anatoxin 9-12 months after the last inoculation. If the complication develops after the third vaccination with DTP vaccine, the first revaccination is performed with ADS-M-anatoxin after 12-18 months. Subsequent revaccinations are carried out at 7, at 14 and every subsequent 10 years with ADS-M toxoid.
PREGNANCY AND LACTATION
Do not use during pregnancy and lactation.
Children who have had acute illnesses are vaccinated no earlier than 4 weeks after recovery; for 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 after reaching a stable remission (at least 4 weeks).
With an increase in temperature 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, infiltrates with a diameter of more than 2 cm), more than 4% of vaccinated, and the development of severe post-vaccination complications, the preparation of this series is discontinued.
Stable manifestations of an allergic disease (localized skin manifestations, latent bronchospasm, etc.) are not a contraindication to vaccination, which can be performed against the background of appropriate therapy.
Children born with a weight less than 2 kg are vaccinated under normal physical and psychomotor development; lag in weight is not a basis for postponing vaccination.
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 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.
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 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.
Cases of overdose are not established.
DTP vaccine can be administered simultaneously (on the same day) with poliomyelitis vaccine and other preparations of the national calendar of preventive vaccinations (with the exception of BCG), as well as inactivated vaccines of the vaccination schedule for epidemiological indications.
TERMS OF RELEASE FROM PHARMACY
For treatment and prophylactic institutions
TERMS AND CONDITIONS OF STORAGE
Store at a temperature of 2 to 8 В° C in accordance with SP 22.214.171.1248-03. Keep out of the reach of children.
Transport at a temperature of 2 to 8 В° C in accordance with SP 126.96.36.1998-03. Freezing is not allowed.
Shelf life - 18 months. The drug with expired shelf life is not subject to application.