Vaccine tubercular for the sparing primary immunization (BTsZh-M)

General characteristics. Structure:

Active ingredient: 0,025 mg of microbic cells of BTsZh (ivy mycobacteria of a vaccinal strain of BTsZh-1).

Excipient: glutamate sodium monohydrate (stabilizer). 1 dose makes 0,1 ml of divorced suspension. Drug does not contain preservatives and antibiotics. Is issued complete with solvent – chloride sodium solution for injections of 0,9%.

Pharmacological properties:

Pharmacodynamics. Live mycobacteria of a strain of BTsZh-1, breeding in an organism of vaccinated, lead to development of long immunity to tuberculosis.

Indications to use:

Active specific prevention of tuberculosis.

Route of administration and doses:

Vaccine BTsZh-M is applied vnutrikozhno in a dose of 0,025 mg of 0,1 ml. Vaccine BTsZh-M impart:

1. In maternity homes of all healthy newborns for 3-7 day of life the day before or in day of an extract from maternity hospital in territories with an indicator of incidence of tuberculosis not higher than 80 on 100 000 population;
2. In maternity homes of premature newborns with the body weight of 2000 and more grams, at recovery of initial body weight, the day before or in day of an extract from maternity hospital;
3. In departments of nursing of premature newborn medical hospitals (the 2nd stage of nursing) - children with the body weight of 2300 and more before an extract from a hospital;
4. In children's policlinics of the children who did not receive an antitubercular inoculation in maternity hospital on medical contraindications and subject to vaccination in connection with removal of contraindications.

Children to whom vaccination in the first days of life was not carried out are vaccinated within the first two months in children's policlinic or other treatment and prevention facility without preliminary tuberculinodiagnosis.

To children at the age of 2 months is also more senior before vaccination preliminary statement of Mantoux reaction from 2 THOSE PPD-L is necessary. Children with negative reaction to tuberculine are vaccinated. Reaction is considered negative at total absence of infiltrate (hyperemia) or existence of ukolochny reaction (1,0 mm). The interval between Mantoux reaction and vaccination has to be not less than 3 days and no more than 2 weeks.

Specially trained medical personnel of maternity homes (departments), departments of nursing of premature, children's policlinics or medical and obstetrical centers have to carry out inoculations. Vaccination of newborns is carried out in the specially allotted room after survey of children by the pediatrician in the morning. In policlinics selection of children on vaccination is preposted by the doctor (paramedic) with obligatory thermometry in day of an inoculation, the accounting of medical contraindications and data of the anamnesis. If necessary hold consultation with specialists doctors, a blood analysis and urine. In order to avoid contamination by live mycobacteria of BTsZh combination in one day of an inoculation against tuberculosis with other parenteral manipulations is inadmissible.

The fact of performance of vaccination is registered in the established registration forms with the indication of date of an inoculation, the manufacturing enterprise, number of a series and period of validity of a vaccine.

The vaccine is dissolved just before the use by sterile the solution for injections of 0,9% attached to a vaccine of chloride sodium. Solvent has to be transparent, colourless and not have foreign inclusions.

The neck and head of an ampoule are rubbed off alcohol. The vaccine is soldered under vacuum therefore at first nadpilivat and is careful, by means of tweezers, break off the place of a zapayka. Then nadpilivat and break off an ampoule neck, having wrapped the nadpilenny end in a sterile gauze napkin.

With a vaccine transfer to an ampoule the sterile syringe 2 ml of sodium of chloride of solution for injections of 0,9%. The vaccine has to be dissolved within 1 min. Existence of flakes which have to break at 2-4-fold hashing by means of the syringe is allowed. The dissolved vaccine has an appearance of a muddy coarse-dispersion suspension of light yellow color. In the presence in divorced drug of large flakes which do not break at 3-4-fold hashing by the syringe or the deposit a vaccine is not used, the ampoule is destroyed.

The divorced vaccine needs to be protected from action solar and daylight (for example, the cylinder from black paper) and to use right after cultivation. The divorced vaccine is suitable for use no more than 1 hour at storage in aseptic conditions at a temperature from 2 to 8 °C. Maintaining the protocol with the indication of time of cultivation of drug and destruction of an ampoule with a vaccine is obligatory.

For one inoculation the tuberkulinovy syringe gain 0,2 ml (2 doses) of a divorced vaccine, then produce through a needle in a sterile cotton plug 0,1 ml of a vaccine to force out air and to bring the syringe piston under the necessary graduation - 0,1 ml. Before each set it is necessary to mix a vaccine accurately 2-3 times by means of the syringe. The vaccine can be entered by one syringe only to one child.

Vaccine BTsZh-M is entered strictly vnutrikozhno on border of an upper and average third of an outside surface of the left shoulder after pretreatment of skin of 70% alcohol. The needle is entered a cut up into a blanket of the tense skin. At first enter insignificant quantity of a vaccine to be convinced that the needle entered precisely vnutrikozhno, and then all dose of drug (only 0,1 ml). At the correct technology of introduction the papule of whitish color with a diameter of 7-9 mm, disappearing usually in 15-20 min. has to be formed.

Features of use:

Administration of drug under skin is inadmissible as at the same time "cold" abscess is formed.

Use one-time sterile tuberkulinovy syringes with a capacity of 1 ml with fine needles with a short cut to vaccination. For entering into an ampoule with a vaccine of solvent use the one-time sterile syringe with a capacity of 2 ml with a long needle. It is forbidden to use syringes and needles expired and insulin syringes which have no graduation in ml.

It is forbidden to carry out an inoculation by a needleless injektor. After each injection and cotton plugs presoak the syringe with a needle in disinfecting solution (5% solution of Chloroamine B or 3% hydrogen peroxide solution), and then on a centralized basis destroy. Use for other purposes of the tools intended for carrying out inoculations against tuberculosis is forbidden. The vaccine is stored in the refrigerator (under the lock) in the room for inoculations. The persons which do not have relations to vaccination to the inoculative room are not allowed.
Ampoules with a vaccine before opening are carefully looked through.

Drug is not subject to use at:
- lack of marking on an ampoule or the wrong filling of marking (has to contain the abbreviated name of drug (Vaccine BTsZh-M), quantity of doses, a dosage - 0,025 mg / a dose, number of a series (alphanumeric designation), date of issue, a period of validity);
- the expired period of validity;
- existence of cracks and notches on an ampoule;
- change of physical properties of drug (discoloration, etc.).

Imposing of a bandage and processing is forbidden by solution of iodine and other disinfecting solutions of an injection site of a vaccine during development of local inoculative reaction: infiltrate, a papule, a pustule, an ulcer what it is necessary to warn the child's parents surely about.

More complete information about performing vaccinal prevention of tuberculosis is provided in the Order of the Russian Ministry of Health No. 109 "About improvement of antitubercular actions in the Russian Federation" of March 21, 2003.

Use at pregnancy and during breastfeeding. It is not applicable. Drug is used for vaccination of children.

Side effects:

On site intradermal introduction of vaccine BTsZh-M local specific reaction in the form of infiltrate, papules, pustules, ulcers of 5-10 mm in size in the diameter consistently develops. At initially vaccinated normal inoculative reaction appears in 4-6 weeks.

The place of reaction should be protected from mechanical irritation, especially during hydrotherapeutic procedures. Reaction is exposed to involution within 2-3 months, sometimes and in longer terms. At 90-95% vaccinated on site inoculations the superficial scar to 10 mm in the diameter forms.

Complications after vaccination meet seldom and usually have local character (lymphadenites - regional, are more often axillary, sometimes over - or subclavial, is more rare - ulcers, cold abscesses, hypodermic infiltrates, keloids).

Extremely seldom meet a persistent and dessiminirovanny BTsZh-infection without a lethal outcome (a lupus, osteitises, etc.), post-BTsZh a syndrome of allergic character which arises soon after an inoculation (a knotty erythema, a ring-shaped granuloma, rashes, etc.) is extremely rare - generalized defeat of BTsZh at a congenital immunodeficiency disorder.

Complications come to light in various terms after an inoculation - from several weeks to one year and more.

Interaction with other medicines:

Other preventive inoculations can be carried out with an interval not less than 1 month to (except for vaccination against a viral hepatitis In) and after vaccination of BTsZh-M.

Contraindications:

1. Prematurity of the newborn - body weight at the birth less than 2000.
2. Acute diseases. Vaccination is postponed until the end of acute displays of a disease and an exacerbation of chronic diseases (a pre-natal infection, it is purulent - septic diseases, a hemolitic disease of newborns of a medium-weight and severe form, severe defeats of a nervous system with the expressed neurologic symptomatology, generalized skin defeats, etc.).
3. Immunodeficiency (primary), malignant new growths.
4. At purpose of immunodepressants and radiation therapy the inoculation is carried out not earlier than in 6 months after the end of treatment.
5. The generalized infection of BTsZh revealed at other children in a family.
6. HIV infection at the child with clinical displays of secondary diseases.
7. HIV infection at mother of the newborn who was not receiving anti-retrovirus therapy during pregnancy.

The persons which are temporarily exempted from inoculations have to be put under observation and the account, and are imparted after an absolute recovery or removal of contraindications. In case of need conduct the corresponding clinical laboratory examinations.

Storage conditions:

At a temperature of 2-8 °C. To store in the place, unavailable to children. A period of validity - 1 year.

Issue conditions:

According to the recipe

Packaging:

In the ampoules containing 0,5 mg of drug (20 doses) complete with solvent - chloride sodium solution for injections of 0,9% on 2 ml in an ampoule. One pack contains 5 ampoules of vaccine BTsZh-M and 5 ampoules of sodium of chloride of solution for injections of 0,9% (5 sets).