Vaccine pertussis-diphtheria-tetanus adsorbed (DTP vaccine) (Vaccinum pertussico-diphtherico-tetanicum aluminio hydroxydato adsorptum)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Dosage form: & nbsp

suspension for intramuscular injection

Composition:

In 1 dose (0.5 ml) contains:

Preservative preparation

Active substances:

Diphtheria toxin - 15 flocculating units (Lf);

Anatoxin tetanus - 5 units of binding (EU);

Pertussis microbial cells - 10 billion.

Excipients: Aluminum hydroxide (Al3+) - not more than 0.55 mg; Formaldehyde - no more than 50 mcg; Preservative - thiomersal - from 42,5 to 57,5 ​​mcg.

Preparation without preservative

Active substances:

Diphtheria toxin - 15 flocculating units (Lf);

Anatoxin tetanus - 5 units of binding (EU);

Pertussis microbial cells-10 billion.

Excipients:

Aluminum hydroxide (Al3+) - not more than 0.55 mg;

Formaldehyde - no more than 50 mcg.

Description:

A homogeneous suspension of yellowish white color without foreign inclusions, separated when standing on a colorless transparent liquid and loose sediment, completely shattered by shaking.

The preparation is a mixture of formaldehyde-killed whooping pertussis microbes and aluminum hydroxide sorbed on diphtheria and tetanus toxoids.

Pharmacotherapeutic group:MIBP vaccine
ATX: & nbsp
  • Combination of vaccines for the prevention of viral and bacterial infections
    • Pharmacodynamics:

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

    Indications:Prevention of pertussis, diphtheria and tetanus in children.
    Contraindications:

    Contraindications to vaccination are Progressive diseases of the nervous system, afefrilnye convulsions in the anamnesis, development for the previous administration of a DTP vaccine with a strong overall response (increase temperature in the first two days to 40 ° C and above, the appearance at the site of administration of edema and hyperemia over 8 cm in diameter) or complications.

    Note 1. Children with contraindications to the use of the vaccine can be vaccinated with ADS-anatoxin in accordance with the instruction for its use.

    Note 2. 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.

    With an increase in temperature above 38.5 ° C, more than 1% of vaccinated or the emergence of severe local reactions (swelling of soft tissue 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 postvaccinal complications , inoculations with the drug of this series are 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.

    Pregnancy and lactation:Not applicable.
    Dosing and Administration:

    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 - 12-13 months after the last vaccination with DTP vaccine).

    Note. 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.

    The preparation is not suitable for use in ampoules with broken integrity, lack of marking, with changing physical properties (discoloration, presence of unbreakable 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.

    Precautions for use.

    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).

    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: convulsions (usually associated with fever, episodes piercing screaming, allergic reactions, urticaria, polymorphic rash, 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.

    Overdose:

    Cases of overdose are not established.

    Interaction:DTP vaccine can be administered simultaneously (on the same day) with poliomyelitis vaccine and other preparations of the national calendar of prophylactic vaccinations (with the exception of BCG), as well as with inactivated vaccines of the vaccination schedule for epidemiological indications.
    Effect on the ability to drive transp. cf. and fur:Not applicable.
    Form release / dosage:Suspension for intramuscular injection.
    Packaging:Suspension for intramuscular administration (with a preservative) of 0.5 ml (one inoculation dose) or 1 ml (two inoculations) in an ampoule.
    Suspension for intramuscular administration (without preservative) of 0.5 ml (one inoculum dose) in an ampoule.
    10 ampoules with instructions for use and a scapegrator ampoule in a box (pack) of cardboard.
    By 5 ampoules in a contoured cell pack made of a polyvinyl chloride film or the like. 2 contour squares in a pack of cardboard with instructions for use and a scarifier ampoule.
    When packaging ampoules that have a break ring or a point for dissection, the ampoule scapegrator is not inserted.
    Storage conditions:

    At a temperature of 2 to 8 ° C in accordance with SP 3.3.2.3332-16.
    Freezing is not allowed.
    Keep out of the reach of children.

    Conditions of transportation.

    At a temperature of 2 to 8 ° C in accordance with SP 3.3.2.3332-16.
    Freezing is not allowed.

    Shelf life:18 months. The drug with expired shelf life is not subject to application.
    Terms of leave from pharmacies:For hospitals
    Registration number:LS-000659
    Date of registration:18.08.2010 / 29.06.2016
    Expiration Date:Unlimited
    The owner of the registration certificate:MICROGEN FGUP Scientific and Production Association MICROGEN FGUP Scientific and Production Association Russia
    Manufacturer: & nbsp
    Information update date: & nbsp12.01.2017
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