Vaccine pertussoid and diphtheritic and tetanic the adsorbed (AKDS-vaccine)

General characteristics. Structure:

Active ingredients: 15 flocculating units (Lf) of a diphtherial anatoxin, 5 binding units (BU) of tetanic anatoxin, 10 billion pertussoid microbic cells.

Excipients: aluminum hydroxide, formaldehyde. Preservative - is mertiolit.

Pharmacological properties:

Pharmacodynamics. Administration of drug according to the approved scheme causes formation of specific immunity against whooping cough, diphtheria and tetanus.

Indications to use:

Prevention of whooping cough, diphtheria and tetanus at children.

Route of administration and doses:

Inoculations spend by the AKDS-vaccine aged from 3 months to achievement of age 3 years 11 months 29 days (inoculations to the children who had whooping cough carry out by ADS-anatoxin).

The drug is administered intramusculary to the anteroexternal area of a hip in a dose by 0,5 ml (single dose). Before an inoculation the ampoule needs to be stirred up carefully before receiving a homogeneous suspension.

The course of vaccination consists of 3 inoculations with an interval of 1,5 months (3 months, 4,5 months and 6 months).

Reduction of intervals is not allowed. In need of increase in intervals the next inoculation should be carried out to perhaps next time determined by the state of health of the child.

The revaccination is carried out once at the age of 18 months (at disturbance of terms    of inoculations – in 12-13 months after the last vaccination by the AKDS-vaccine).

Note. If the child before achievement of 3 years 11 months 29 days did not receive a revaccination the AKDS-vaccine, then it is carried out   by ADS-anatoxin (for age 4 years – 5 years 11 months 29 days) or ADS-m-anatoxin (6 years and are more senior).

Drug in ampoules with the broken integrity, lack of marking is not suitable for use, at change of physical properties (discoloration, existence of not breaking flakes), at the expired period of validity, the wrong storage.

Opening of ampoules and the procedure of vaccination are carried out at strict observance of rules of an asepsis and antiseptics. Drug in the opened ampoule is not subject to storage.

Administration of drug is registered in the established registration forms with the indication of number of a series, period of validity, manufacturer, Date of Introduction, the nature of reaction to administration of drug.

Features of use:

The children who had acute diseases impart not earlier than in 4 weeks after recovery; at easy forms of respiratory diseases (rhinitis, an easy hyperemia of a pharynx, etc.) the inoculation is allowed in 2 weeks after recovery. Patients with chronic diseases impart on reaching permanent remission (not less than 4 weeks).

Use at pregnancy and during breastfeeding. It is not applicable.

Side effects:

At a part of the days imparted in the first two the short-term general can develop (temperature increase, an indisposition) and local (morbidity, a hyperemia, puffiness) reactions.

In rare instances complications can develop: the spasms (which are usually connected with temperature increase, shriek episodes, allergic reactions, urticaria, polymorphic rash, a Quincke's edema).

Considering a possibility of development of allergic reactions of immediate type in especially sensitive children, for vaccinated it is necessary to provide medical observation within 30 min.

Venues of inoculations have to be provided with means of antishock therapy.

Interaction with other medicines:

The AKDS-vaccine can be entered at the same time (in one day) with a poliomyelitic vaccine and other drugs of a national calendar of preventive inoculations (except for BTsZh), and also with the inactivated vaccines of a calendar of preventive inoculations according to epidemic indications.

Contraindications:

Contraindications to vaccination are the progressing diseases of a nervous system, afebrilny spasms in the anamnesis, development on the previous introduction of the AKDS-vaccine of strong general reaction (temperature increase in the first two days to 40 °C and above, emergence in an injection site of hypostasis and a hyperemia over 8 cm in the diameter) or complications.

Note 1. Children with contraindications to use of a vaccine can be imparted by ADS-anatoxin according to the instruction for its use.

Note 2. If the child is imparted twice, the course of vaccination against diphtheria and tetanus is considered finished; if the child received one inoculation, vaccination can be continued by ADS-m-anatoxin which is entered once not earlier than in three months. In both cases the first revaccination is carried out by ADS-m-anatoxin in 9-12 months after the last inoculation. If the complication developed after the third vaccination by the AKDS-vaccine, the first revaccination is carried out by ADS-m-anatoxin in 12-18 months. The subsequent revaccinations carry out in 7, in 14 and each next 10 years of ADS-M by anatoxin.

At temperature increase it is above 38,5 °C more, than at 1% vaccinated or emergence of the expressed local reactions (hypostasis of soft tissues with a diameter more than 5 cm; infiltrates with a diameter more than 2 cm) more, than at 4% vaccinated, and also development of heavy postvaccinal complications, inoculations by drug of this series stop.

Stable displays of an allergic disease (the localized skin manifestations, the hidden bronchospasm, etc.) are not a contraindication to vaccination which can be carried out against the background of the corresponding therapy.
Children, the been born weighing less than 2 kg, impart at normal physical and psychomotor development; lag in weight is not the basis to a vaccination delay.

For the purpose of identification of contraindications the doctor (the paramedic on medical and obstetrical center) in day of an inoculation conducts survey of parents and survey of the child with obligatory thermometry. The children who are temporarily exempted from an inoculation have to be put under observation and the account and are timely imparted.

Storage conditions:

The vaccine is stored and transported according to the joint venture 3.3.2.028-95 in the dry, protected from light place at a temperature from 4 to 8 °C. The drug which underwent freezing is not subject to use. A period of validity - 18 months. Drug is not subject to expired use.

Issue conditions:

According to the recipe

Packaging:

In ampoules on 0,5 ml (one inoculative dose) or 1 ml (two inoculative doses). On 10 ampoules with the application instruction and the scarificator ampoule in a box (pack) from a cardboard. On 5 ampoules in a blister strip packaging from a film polyvinyl chloride or import. On the 2nd blister strip packagings in a pack with the application instruction and the scarificator ampoule. When packaging the ampoules having a ring of a break or a point for opening the scarificator ampoule is not put.