Vaccine E typhous combined live (ZhKSV-E)

General characteristics. Structure:

Active ingredients: 1000 to 100000 minimum infecting doses of rickettsiae for chicken embryos (MIDE) and not less than 16 antigenic units of soluble antigen at titration in reaction of binding complement.

Excipient: cow's milk the fat-free sterile.

The vaccine E typhous combined live (ZhKSV-E), lyophilisate for preparation of suspension for hypodermic introduction, represents a suspension of the live rickettsiae of Provachek of a vaccinal strain Madrid E which are grown up in fabric of vitellicles of the developing chicken embryos, in a combination with soluble antigen from Provachek's rickettsiae of a virulent strain Breynl, lyophilized in the sterile fat-free cow's milk.

Pharmacological properties:

Pharmacodynamics. Single introduction of a vaccine is followed by development of specific immunity on 15-30 days after vaccination.

Indications to use:

Specific prevention of a sapropyra aged from 18 up to 60 years. The vaccine is applied on epidpokazaniye in the situations posing a threat of infection with a sapropyra and also to protection of the laboratory personnel working with Provachek's rickettsiae.

Route of administration and doses:

The vaccine is entered once subcutaneously into the infrascapular area in a dose of 0,25 ml. The revaccination is carried out by a dose of 0,25 ml not earlier than in 1 year after vaccination.

Features of use:

Before the use each ampoule with a vaccine is carefully looked through. 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, this ampoule is rejected and neutralize boiling within 30 min. or immersion of the broken ampoule in 3% chloroamine solution on 1 days.

With a vaccine just before an inoculation bring 5 ml of sodium of chloride of solvent for preparation of dosage forms for injections of 0,9% in an ampoule. The vaccine has to be dissolved within 2 min. with formation of homogeneous suspension of light yellow color. At longer dissolution, and also existence in the dissolved drug of not breaking flakes, ampoule contents is not subject to use and has to be destroyed as it is stated above.

Opening of ampoules and the procedure of vaccination are carried out at strict observance of rules of an asepsis and antiseptics. The dissolved vaccine is suitable for the use within 30 min. at its storage under a sterile napkin at the room temperature and for 60 min. at its storage at a temperature from 2 to 8 °C. The vaccine dissolved and not used during this term is destroyed in the ways stated above.

The carried-out inoculation is registered in the corresponding registration forms with the indication of date, a dose, the manufacturing enterprise, number of a series, reaction to an inoculation.

Side effects:

Local reaction to introduction can be observed in the form of an insignificant swelling or infiltration of fabrics without clear boundary and morbidity at 10-20% vaccinated.

The early general reactions coming in the closest 6-72 h after an inoculation at     7-12% vaccinated can be expressed in one – two-day temperature increase to subfebrile and complaints to weakness and dizziness.

Late general reactions which are display of a vaccinal infection appear later 9-18 (rarely later) days after an inoculation at 2-3% vaccinated and are expressed in temperature increase for 1-4 days, a headache, an indisposition, frequent by muscle pains.

At a revaccination of ZhKSV-E of reaction to introduction of a vaccine usually are not observed.

Interaction with other medicines:

It is not revealed.

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 chicken protein;
• degenerative and progreduated diseases of a nervous system;
• diseases of kidneys and adrenal glands;
• general diseases of connecting fabric;
• immunodeficiency (primary and secondary);
• pregnancy and period of a lactation.

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.

Inoculations carry out not earlier than in 1 month after the previous immunization by other preventive drugs.

Storage conditions:

The vaccine is stored according to the joint venture 3.3.2.1.1248-03 at a temperature from 2 to 8 °C in the place, unavailable to children. Freezing is not allowed.

Issue conditions:

According to the recipe

Packaging:

Lyophilisate for preparation of suspension for hypodermic introduction. A vaccine E typhous combined live - on 20 doses in ampoules. Solvent - chloride sodium solvent for preparation of dosage forms for injections of 0,9% - on 5 ml in ampoules. 5 ampoules of a vaccine and 5 ampoules of solvent place in a pack from a cardboard with the scarificator ampoule and the application instruction (it is allowed when packaging ampoules with notches, rings and points for opening the scarificator not to put).