Vaccine tubercular (BTsZh)

General characteristics. Structure:

Active ingredient: 0,05 mg of microbic cells of BTsZh (live mycobacteria of a vaccinal strain of BTsZh-1).

Excipient: glutamate sodium monohydrate (stabilizer). Drug does not contain preservatives and antibiotics. Is issued complete with chloride sodium solvent 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 is applied vnutrikozhno in a dose of 0,05 mg of 0,1 ml of solvent (solution chloride sodium to injections of 0,9%). Primary immunization is performed to healthy newborn children for 3-7 day of life (as a rule, in day of an extract from a maternity home).

The children who are not imparted in the period of a neonatality owing to diseases, receive vaccine BTsZh-M after recovery. To children at the age of the 2nd month is also more senior 2 THOSE prepost Mantoux reaction of the purified tuberculine in standard cultivation and vaccinate only tuberkulinotritsatelny.

Revaccinations are subject the children at the age of 7 and 14 years having negative reaction to Mantoux reaction about 2 THOSE PPD-L. The Mantoux test is considered negative at total absence of infiltrate, a hyperemia or in the presence of ukolochny reaction (1 mm). The children infected with tuberculosis mycobacteria having negative reaction to Mantoux reaction are not subject to a revaccination. The interval between statement of Mantoux reaction and a revaccination 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. When carrying out a revaccination at schools all above-mentioned requirements have to be observed. 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 (revaccination) is registered in the established registration forms with the indication of date of an inoculation, the name of a vaccine, the manufacturing enterprise, number of a series and period of validity of drug.

The vaccine is dissolved just before 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.

For receiving a dose of 0,05 mg of BTsZh in 0,1 ml of solvent to the ampoule containing 20 doses of a vaccine transfer the sterile syringe 2 ml of sodium of chloride of solution for injections of 0,9%, and to the ampoule containing 10 doses of a vaccine - 1 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 3-4-fold accurate agitation and hashing of contents by a fence back in the syringe is allowed. The dissolved vaccine has an appearance of muddy coarse-dispersion suspension of light yellow color. In the presence in divorced drug of large flakes which do not break at 2-4-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 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 about 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 inoculation is carried out right after set to the syringe of an inoculative dose. The vaccine can be entered by one syringe only to one child.

Vaccine BTsZh 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 (revaccination). 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 the syringe with a needle and cotton plugs presoak 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 of BTsZh 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 the label on an ampoule or the wrong filling of the label (on the label of an ampoule with a vaccine specify: the abbreviated name of drug (Vaccine BTsZh), quantity of doses, a dosage - 0,05 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 iodine and other disinfecting solutions of an injection site of a vaccine during development of local inoculative reaction: infiltrate, papule, pustule, ulcer.

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. Use at pregnancy and during breastfeeding is contraindicated.

Side effects:

On site intradermal introduction of vaccine BTsZh 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. Reaction is exposed to involution within 2-3 months, sometimes and in longer terms. At revaktsinirovanny local reaction develops in 1-2 weeks. The place of reaction should be protected from mechanical irritation, especially during hydrotherapeutic procedures. At 90-95% vaccinated on site inoculations the superficial hem 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, a keloid cicatrix, "cold" abscesses, hypodermic infiltrates). Very seldom a persistent and dessiminirovanny BTsZh-infection without a lethal outcome (a lupus, osteitises, osteomyelites, etc.), post-BTsZh a syndrome of allergic character which arises soon after an inoculation (a knotty erythema, a ring-shaped granuloma, rashes, an acute anaphylaxis), in some cases – a generalized BTsZh-infection meet 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 before vaccination of BTsZh. An exception is vaccination for prevention of a viral hepatitis In in case of primary immunization.

Contraindications:

Vaccination:

1. Body weight at the birth - 2500.
2. Pre-natal hypotrophy of the III-IV degree.
3. Acute diseases and exacerbation of chronic 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.).
4. Children from the infected HIV of mothers should refrain from introduction of BTsZh to age of 18 months when its HIV status is specified.
5. Immunodeficiency (primary), malignant new growths.
6. At purpose of immunodepressants and radiation therapy the inoculation is carried out not earlier than in 6 months after the end of treatment.
7. The generalized infection of BTsZh revealed at other children in a family.
8. The children having contraindications to vaccination by vaccine BTsZh take root vaccine BTsZh-M.

Revaccination:

1. Acute infectious and noninfectious diseases, exacerbation of chronic diseases, including allergic. The inoculation is carried out in 1 month after recovery or approach of remission.
2. Immunodeficiency, malignant diseases of blood and new growth. At purpose of immunodepressants and radiation therapy the inoculation is carried out not earlier than in 6 months after the end of treatment.
3. The TB patients, persons who had tuberculosis and infected with mycobacteria.
4. Positive and doubtful reaction to Mantoux reaction about 2 THOSE PPD-L.
5. The complicated reactions to the previous introduction of vaccine BTsZh (a keloid cicatrix, lymphadenitis, etc.).

At contact with infectious patients in a family, child care facility, etc. inoculations carry out upon termination of the term of a quarantine or the maximum term of an incubation interval for this disease.

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:

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 intradermal introduction of 0,05 mg / a dose. On 10 doses or 20 doses in an ampoule complete with solvent - chloride sodium solution for injections of 0,9% - on 2 ml (for a vaccine on 20 doses) or 1 ml (for a vaccine on 10 doses) in an ampoule. On 5 ampoules of a vaccine and 5 ampoules of sodium of chloride of solution for injections of 0,9% (5 sets) in a pack from a cardboard. Put the application instruction and a knife in a pack ampoule or the scarificator ampoule.