M-44 Q fever vaccine live

General characteristics. Structure:

Active ingredients: from 5х107 to 5х109 minimum infecting doses (MIDE) коксиелл Burnett for chicken embryos.

Excipients: drying environment components: sucrose, the drinking milk pasteurized.

Pharmacological properties:

Pharmacodynamics. Single introduction of a vaccine is followed by development of specific immunity in 3-4 weeks after an inoculation.

Indications to use:

Specific prevention of the Q fever is carried out aged from 14 years. The contingents which are subject to inoculations:

• the persons performing works on preparation, storage, processing of raw materials and the livestock products received from farms where diseases of a cattle Q fever are registered;
• the persons performing works on preparation, storage and processing of agricultural products in enzootichny territories on the Q fever;
• the persons working with live cultures of activators of the Q fever.

Route of administration and doses:

The vaccine is entered once nakozhno by a scarification method in a dose of 0,05 ml. The revaccination is carried out by a dose of 0,05 ml not earlier than in 1 year after primary immunization to persons in whose serum there are no specific fixators.

With a vaccine just before an inoculation bring 0,5 ml of sodium of chloride of solution for injections of 0,9% in an ampoule. The vaccine has to be dissolved within 2 min. with formation of a dense homogeneous suspension of pink color with a grayish, yellowish or brownish shade.

The place of an inoculation (outside surface of an average third of a shoulder) is processed by 70% solution of alcohol or ether (use of other disinfecting solutions is not allowed). After their evaporation put with an eyedropper or the syringe through a needle 2 drops of a divorced vaccine at distance of 30-40 mm. The sterile scarificator through each drop of a vaccine applied on skin make three crosswise notches 8-10 mm long at distance of 3-4 mm from each other so that blood appeared small "dewdrops". The flat party of the scarificator rub a vaccine in notches then the vaccine has to dry up within 5-10 min. The subsequent processing of the place of an inoculation is not carried out.

The dissolved vaccine is suitable for the use within 30 min. at storage under a sterile napkin at the room temperature and within 60 min. at storage at a temperature from 2 to 10 °C.

Administration of drug is registered in the established registration forms with the indication of Date of Introduction, a dose, the manufacturing enterprise, number of a series, reaction to an inoculation.

Features of use:

Before the use each ampoule with a vaccine is carefully looked through. Drug in the presence in an ampoule of cracks, foreign inclusions, an unusual vaccine of coloring and other defects, and also the broken marking and the expired period of validity is unsuitable to use.

Use at pregnancy and during breastfeeding. Use at pregnancy and in the period of a lactation contraindicated.

Side effects:

The general reaction to an inoculation develops for 2-3 days at separate vaccinated and is expressed in a one-day indisposition, a fever, a headache and temperature increase to 37,5 °C.

The local reaction which is characterized by reddening and a nodular swelling on the course of notches usually develops not less, than at 90% vaccinated. Duration of local reaction makes 3-4 days.

Interaction with other medicines:

Inoculations carry out not earlier than in 1 month after the previous immunization by other vaccines. Simultaneous inoculations by vaccines against the Q fever and a brucellosis are allowed.

The brucellous vaccine is entered according to the application instruction of drug into other hand.

Contraindications:

• acute infectious and noninfectious diseases; chronic diseases in an aggravation stage; inoculations carry out not earlier than a month from the moment of recovery or remission;
• allergic diseases (according to the anamnesis): bronchial asthma, atopic dermatitis, pollinosis, etc.; an allergy to egg;
• chronic diseases of upper respiratory tracts and lungs;
• general diseases of connecting fabric;
• immunodeficiency (primary and secondary);
• pregnancy and period of a lactation;
• malignant diseases.

The possibility of vaccination of the persons having the diseases which are not specified in this list of contraindications is defined by the doctor, proceeding from the state of health imparted.

Just before an inoculation the doctor performs careful medical examination with thermometry and poll of the contraindications vaccinated for identification. At a temperature above 37 °C of an inoculation do not carry out.

Storage conditions:

To store and transport according to the joint venture 3.3.2.1248-03 at a temperature from 2 to 8 °C. Freezing is not allowed. To store in the place, unavailable to children. A period of validity - 2 years.

Issue conditions:

According to the recipe

Packaging:

Lyophilisate for preparation of suspension for cutaneous scarifying drawing – on 10 doses in an ampoule. Solvent - sodium chloride solution for injections of 0,9% - on 5 ml in an ampoule. On 5 ampoules of a vaccine and 5 ampoules of solvent in a pack from a cardboard bandbox together with the scarificator ampoule and the application instruction. When packaging ampoules with a ring of a break or a point for opening the scarificator ampoule is not put.