Active substanceVaccine for the prevention of diphtheria, pertussis and tetanusVaccine for the prevention of diphtheria, pertussis and tetanus
Dosage form: & nbsp
Suspension for intramuscular injection
Composition:
The DTP vaccine consists of a suspension of killed pertussis microbes and purified diphtheria and tetanus toxoids sorbed on aluminum hydroxide.
One dose (0.5 ml) contains 10 international units (ME) of inactivated pertussis microbes, 15 flocculating units (Lf) of diphtheria, 5 units of tetanus toxoid binding (EC), 0.25 to 0.55 mg of aluminum hydroxide in recalculated to aluminum (sorbent), from 42.5 to 57.5 μg thiomersal (preservative).
Description:
The suspension is grayish white, separated when standing on a loose sediment of grayish-white color, shattering when shaken, and a clear, colorless supernatant.
Pharmacotherapeutic group:MIBP vaccine
ATX: & nbsp

J.07.C.A.02   Vaccine against diphtheria-pertussis-tetanus

J.07.C.A   Combination of vaccines for the prevention of viral and bacterial infections

Pharmacodynamics:
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, hypersensitivity to the components of the drug, the development of the previous introduction of DTP vaccine strong general (temperature increase in the first two days to 40 ° C and above) or local (edema and hyperemia over 3 cm in diameter) of the reaction.
Pregnancy and lactation:
Application during pregnancy and during breastfeeding is possible only on absolute epidemiological indications, taking into account the risk / benefit ratio, i.e.when the intended benefit to the mother exceeds the estimated risk for the fetus or infant.
Dosing and Administration:
Inoculations of DTP vaccine are carried out at the age of 3 months to 4 years. Vaccinations for children who have had pertussis are carried out with diphtheria-tetanus toxoid. The drug is injected intramuscularly into the upper-upper surface of the mid-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 drug is not suitable for use in ampoules with broken integrity, lack of marking, with changing physical properties (discoloration, presence of non-breakable flakes), 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 established registration forms with the indication of the serial number, expiry date, manufacturer, date of introduction.
The vaccination course consists of 3 vaccinations at intervals of 1.5 months.
The reduction of the interval 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.
DTP vaccine is administered in accordance with the "National Calendar of Prophylactic Inoculations".
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).
Side effects:
In individual vaccinated in the first two days, there may develop short-term general (fever, malaise) and local (pain, hyperemia, swelling at the injection site) reactions.
In extremely rare cases, allergic reactions (Quincke's edema, hives, polymorphic rash), slight exacerbation of allergic diseases can develop. Given the possibility of developing allergic reactions of immediate type in particularly sensitive individuals, vaccinated patients should be provided with medical supervision for 30 minutes. Vaccination sites should be provided with anti-shock therapy.
Those who gave severe DTP forms for the introduction of DTP vaccine, then stop the planned vaccinations with the drug.
Overdose:Symptoms of overdose are not revealed.
Interaction:
DTP vaccine can be administered simultaneously with polio vaccine and other drugs national calendar vaccinations except BCG vaccine.
Special instructions:
With increasing temperature above 38,5 ° C more than 1% of the vaccinees or overt local reactions (swelling of the soft tissue with a diameter greater than 5 cm; infiltrates diameter greater than 2 cm) is more than 4% of vaccinees, and the development of severe complications post-vaccination, vaccinated the preparation of this series is discontinued.
Persons who have had acute infectious diseases are vaccinated not earlier than 1 month after clinical recovery. In milder forms of respiratory disease (rhinitis, slight hyperemia pharynx etc.) grafting allowed 2 weeks after recovery.
Patients with chronic diseases are vaccinated not earlier than 1 month after reaching a stable remission.
Patients with allergic diseases are vaccinated 2-4 weeks after the end of the exacerbation, while stable manifestations of the disease (localized skin conditions, hidden bronchospasm, etc.) are not contraindications 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.
Immunodeficiency, HIV infection, as well as supporting course therapy, including steroid hormones and psychopharmaceuticals, are also not contraindications to vaccination.
In order to identify contraindications, the doctor (paramedic assistant of the feldsher-midwife station) on the day of vaccination is conducting a survey of parents and examining the vaccinated with mandatory thermometry. Persons temporarily released from vaccination should be monitored and accounted for and promptly vaccinated.
Note 1. Children with contraindications to the use of DTP vaccine, as well as children who have recovered whooping cough, can be vaccinated with ADS-M-anatoxin in accordance with the instruction for its use.
Note 2. With the development of a previous general DTP vaccine or a general or local reaction or complications, proceed as follows. If the child received one vaccination, the vaccination can be continued with ADS-M-anatoxin, which is administered once with a dose of 0.5 ml not earlier than 3 months.If the child is vaccinated twice, the vaccination course against diphtheria and tetanus is considered complete. In both cases, the first revaccination is performed with ADS-M-anatoxin 9-12 months after the last inoculation with a single dose of 0.5 ml. If complications occurred after the third vaccination with DTP vaccine, a first booster vaccination carried Td toxoid in 12-18 months single dose of 0.5 ml. Subsequent revaccinations are performed at 7, at 14 and every subsequent 10 years with ADS-M-anatoxin once with 0.5 ml dose.
Effect on the ability to drive transp. cf. and fur:The drug does not affect the ability to drive vehicles.
Form release / dosage:
Suspension for intramuscular injection.
Packaging:
In ampoules containing 0.5 ml (one inoculation dose) and 1.0 ml (two inoculations).
5 ampoules in the outline of the cell. In a pack of cardboard, 2 contour packagings are placed together with the instructions for use and the ampoule scarifier.
In a pack of cardboard with a separating snake placed 10 ampoules with instruction for use and ampoule scarifier.
When using ampoules with a break ring or break point, the ampoule scapegrator is not inserted.
Storage conditions:

Storage conditions: Store in a dry, protected from light place at a temperature of 4 to 8 ° C. Do not freeze.

Transport conditions: It should be transported in a dry, protected from light place at a temperature of 4 to 8 ° C. Do not freeze.

Shelf life:
2.5 years. Do not use after the expiration date.
Terms of leave from pharmacies:For hospitals
Registration number:P N002666 / 01-2003
Date of registration:01.07.2008 / 21.09.2012
Expiration Date:Unlimited
The owner of the registration certificate:BIOMED them. I.I.Mechnikova, OJSC BIOMED them. I.I.Mechnikova, OJSC Russia
Manufacturer: & nbsp
Information update date: & nbsp12.01.2017
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