Composition, form of production and packaging
Lyophilizate for the preparation of a suspension for intradermal administration and cutaneous scarification in the form of a porous mass of white with a yellow shade of color.
vaccine for the prevention of tularemia (one dose for the cutaneous scarification application is 0.1 ml and contains (2.0 В± 0.5) вЂў 10 8 living microbial cells, the dose for intradermal administration is 0.1 ml and contains (1.0 В± 0.1) вЂў 10 7 live microbial cells) 1 dose
Excipients: sucrose - 0.0033 g, sodium glutamate monohydrate - 0.00495 g, thiourea - 0.00165 g, gelatin - 0.0033 g.
The composition of the solvent: water d / u.
15 -50 cutaneous doses - ampoules (5) complete with a solvent of 5 ml amp. 5 pieces. - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2014.
The vaccine, after 20-30 days after vaccination, ensures the development of immunity lasting up to 5 years.
Prevention of tularemia from 7 years of age (from 14 years - in the outbreaks of field type).
Inoculations are subject to a population residing on enzootic tularemia territories, as well as persons arriving on these territories performing the following works:
- irrigation and drainage;
- other works on excavating and moving soil;
- Deratization and disinsection;
- logging, clearing and improvement of the forest, recreation and recreation areas of the population.
Vaccination is carried out once dermally or intradermally. Revaccination is carried out according to indications after 5 years of the same
In order to identify contraindications, the doctor (paramedic) on the day of vaccination conducts a survey and examination of the vaccine with mandatory thermometry. At a temperature above 37 В° C, the graft is delayed. If necessary, conduct a laboratory examination.
Before each vaccination, the vaccinee is required to determine the presence of specific immunity with the help of one of the serological or skin-allergic reactions.Inoculations are subject to negative reaction.
The vaccination is recorded in the prescribed registration forms, indicating the name of the preparation, the date of vaccination, the dose, the name of the manufacturer, the serial number, the reaction to the vaccination.
Vaccination by the cutaneous method:
Dry vaccine is diluted with water for injection, which is supplied with the drug, at a rate of 0.1 ml per dose. The ampoule is shaken for 3 minutes until a homogeneous suspension is formed.
The inoculation is carried out on the outer surface of the middle third of the shoulder. The skin before inoculation is treated with alcohol or a mixture of alcohol with ether, the use of other disinfectants is not allowed. After evaporation of the alcohol with ether, one drop of the diluted vaccine is applied to the treated area of вЂ‹вЂ‹the skin with a sterile eye dropper in two places at a distance of 30-40 mm from each other. The skin of the shoulder is slightly stretched and a pair of parallel incisions of 10 mm in length are made through each drop of the vaccine, using a sterile scarifier (ospothrivial pen).
The serrations should not bleed, the blood should act only in the form of small dewdrops. The flat side of the ospothrivial pen, the vaccine is rubbed into the notches for 30 seconds and allowed to dry for 5-10 minutes.
For intradermal needle-free administration, the vaccine is diluted in the same way as for cutaneous scarification application. Then, with a sterile syringe, 1 ml is transferred to a sterile injection bottle, to which 19 ml of sodium chloride solution for injection is added 0.9%. 20 ml of the obtained suspension contains 200 doses of the vaccine for intradermal administration. The injection site of the vaccine is pretreated with alcohol or a mixture of alcohol and ether. The vaccine is injected intradermally in a volume of 0.1 ml into the outer surface of the middle third of the shoulder according to the instructions for the use of the BI-3M injector with the anti-infectious protector PPI-2 under the regime intended for intradermal administration.
Precautions for use.
It is strictly forbidden to inject the vaccine diluted for cutaneous scarification application intradermally!
It is not possible to use a vaccine whose package integrity is damaged, with changed physical properties (foreign impurities, insoluble flakes), expired, if storage conditions are violated.
Opening of ampoules and the procedure for administering the drug are carried out with strict adherence to aseptic and antiseptic rules. A diluted vaccine, preserved with aseptic rules, can be used for 2 hours.
Given the possibility of developing an anaphylactic shock in certain highly sensitive individuals, the vaccinated should be under medical supervision for at least 30 minutes. Vaccination sites should be provided
means of anti-shock therapy.
Local reaction in case of skin grafting should develop in all vaccinated. On the spot incisions from 4-5 days, and in some vaccinated - at a later date (up to 10 days) - develops hyperemia and edema with a diameter of up to 15 mm. In the course of incisions, vesicles as large as millet grains may appear. From 10-15 days on a place of an inoculation the crust is formed, local phenomena subsided, after branch of a crust on a skin there is a hem. Sometimes there may be a slight short-term increase and soreness of the regional lymph nodes. With a negative result along the incisions, only a small redness is noted for 1 -2 days.
With the intradermal route of administration, a local reaction of up to 9 days is characterized by mild hyperemia and skin infiltration up to 40 mm in diameter, rarely by regional lymph nodes. The general reaction occurs in isolated cases from 3-4 days and is expressed by malaise, headache, rarely - a short-term rise in temperature to 38 В° C. These phenomena disappear after 2-3 days. It is extremely rare in vaccinated in the third to fourth week after vaccination, there are general and local reactions of an allergic nature.
In individuals who have previously suffered from tularemia or revaccinated, the general and local reactions to vaccination develop more rapidly. The extinction of grafting reactions in this case is faster than in those who were vaccinated initially.
Vaccination of the vaccine with cutaneous scarification application is checked after 5-7 days, and in case of absence of skin reaction - repeatedly for 12-15 days.Evaluation of the results of intradermal vaccination is carried out 4-5 days after vaccination. A positive reaction is the presence of hyperemia and infiltration with a diameter of at least 5 mm. Persons with a lack of a positive vaccination result are subject to re-vaccination 30 days after the determination of the presence of specific immunity.
- a history of tularemia;
- a positive serological or skin-allergic reaction to tularemia;
- acute infectious and non-infectious diseases, chronic diseases at the stage of exacerbation - vaccinations are given no earlier than 1 month after recovery of remission);
- Primary and secondary immunodeficiencies. In the treatment of steroids, antimetabolites, chemo- and X-ray therapy, vaccinations are given no earlier than 6 months after the end of treatment;
- systemic connective tissue diseases;
- malignant neoplasms and malignant diseases of the blood;
- common relapsing skin diseases;
- allergic diseases (bronchial asthma, anaphylactic shock, Quincke's edema in the anamnesis);
- pregnancy and lactation.
PREGNANCY AND LACTATION
The use of the drug is contraindicated.
APPLICATION FOR CHILDREN
Children under 7 years old have been vaccinated
Impact on the ability to drive vehicles and manage mechanisms
Special precautions for the destruction of unused medicinal product.
Ampules with unused vaccine are inactivated by boiling for 30 minutes, then they are disposed of in accordance with SanPiN 188.8.131.528-99 "Rules for Collection, Storage and Disposal of Waste of Treatment and Prevention Institutions".
Symptoms of overdose, measures to provide assistance for overdose are not established.
Simultaneous dermal vaccination of adults with live vaccines against tularemia, brucellosis and plague (in different parts of the body) is allowed.
TERMS OF RELEASE FROM PHARMACY
For treatment and prevention institutions.
TERMS AND CONDITIONS OF STORAGE
Store in accordance with SP 184.108.40.2068-03 at a temperature of 2 to 8 В° C out of the reach of children. Shelf life - 2 years.