Composition, form of production and packaging
Lyophilizate for the preparation of solution for intravenous administration 1 dose
vaccine for the prevention of typhus 0.25 ml,
contains a suspension of live rickettsia Provachek vaccine strain Madrid E from 1,000 to 100,000 MIDe
soluble antigen from rickettsia Provachek virulent strain Brejl 16 antigenic units.
Solvent: sodium chloride injection for 0.9%.
ampoules (1) complete with a solvent (5 ml amp 1 pc.) - a set (5) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2013.
PHARMACHOLOGIC EFFECT
Single administration of the vaccine is accompanied by the development of specific immunity for 15-30 days after vaccination.
INDICATIONS
- Specific prophylaxis of typhus at the age of 18 to 60 years.
The vaccine is used for epidemiological indications in situations that present a threat of infection with typhus, as well as for the protection of laboratory personnel working with Provachek rickettsia.
DOSING MODE
The vaccine is injected once subcutaneously into the subscapular region at a dose of 0.25 ml. Revaccination is done with a dose of 0.25 ml not earlier than one year after vaccination.
SIDE EFFECT
Local response to the introduction can be observed in the form of a slight swelling or infiltration of tissues without clear boundaries and pain in 10-20% of the vaccinated.
Early common reactions occurring in the next 6-72 hours after inoculation in 7-12% of vaccinated people can be expressed in one-two-day rise in temperature to subfebrile and complaints of weakness and dizziness.
Late general reactions that are a manifestation of a vaccinal infection appear later 9-18 (rarely later) day after vaccination in 2-3% of vaccinated patients and are expressed in a rise in temperature for 1-4 days, headache, malaise, often muscle pain.
When revaccination of GADG-E reaction to the introduction of the vaccine is usually not observed.
CONTRAINDICATIONS
- acute infectious and non-infectious diseases; chronic diseases in the acute stage. Vaccinations are carried out not earlier than a month from the moment of recovery or remission;
- allergic diseases (according to anamnesis): bronchial asthma, atopic dermatitis, pollinosis, etc .; allergy to chicken protein;
- degenerative and progredient diseases of the nervous system;
- kidney and adrenal gland diseases;
- systemic diseases of connective tissue;
- immunodeficiency states (primary and secondary);
- pregnancy and lactation.
Possibility of vaccination of persons suffering from diseases not indicated in this list of contraindications; determines the doctor, based on the health status of the vaccinated.
Immediately before vaccination, the doctor conducts a thorough medical examination with thermometry and a survey of vaccinees to identify contraindications. At a temperature above 37 В° C vaccinations are not carried out.
Vaccinations are carried out not earlier than 1 month after the pre-immunization with other preventive drugs.
PREGNANCY AND LACTATION
Contraindicated in pregnancy and lactation.
APPLICATION FOR FUNCTIONS OF THE LIVER
Contraindicated in the use of kidney disease
APPLICATION FOR CHILDREN
The vaccine is used in patients aged 18 to 60 years.
APPLICATION IN ELDERLY PATIENTS
The vaccine is used in patients aged 18 to 60 years.
SPECIAL INSTRUCTIONS
Precautions for use
Before use, every ampoule with the vaccine is carefully scanned. If there are cracks in the ampoule, foreign inclusions, unusual coloring vaccine and other defects, as well as broken labeling and expired shelf life, this ampoule is rejected and rendered harmless by boiling for 30 minutes or by immersing the broken ampoule in a 3% chloramine solution for 1 day.
In the ampoule with the vaccine, 5 ml of sodium chloride solution of 0.9% for injection are immediately administered before inoculation. The vaccine should dissolve within 2 minutes to form a homogeneous suspension of light yellow color. For longer dissolution, as well as the presence of non-developing flakes in the dissolved preparation, the contents of the ampoule are not subject to application and should be destroyed, as indicated above.
Opening of ampoules and the vaccination procedure are carried out with strict adherence to aseptic and antiseptic rules. The dissolved vaccine is usable for 30 minutes when stored under a sterile tissue at room temperature and at
for 60 minutes when stored at a temperature of 2 to 8 В° C. Dissolved and not used during this period, the vaccine is destroyed by the methods indicated higher.
The vaccination is recorded in the appropriate registration forms with the date, dose, manufacturer, serial number, response to vaccination.
Impact on the ability to drive vehicles and manage mechanisms
Influence on the ability to drive vehicles, mechanisms is not established.
DRUG INTERACTION
Not identified.
TERMS OF RELEASE FROM PHARMACY
For treatment and prevention institutions.
TERMS AND CONDITIONS OF STORAGE
The vaccine is stored in accordance with SP 3.3.2.1.1248-03 at a temperature of 2 to 8 В° C in a place inaccessible to children. Freezing is not allowed.
