The vaccine is smallpox
Producer: Federal state unitary enterprise NPO Mikrogen Russia
Code of automatic telephone exchange: J07BX
Release form: Liquid dosage forms. Lyophilisate for preparation of solution for cutaneous scarifying drawing and intradermal introduction.
General characteristics. Structure:
Active ingredient: not less than 106 ospoobrazuyushchy units (OOE) of a virus of a variolovaccine.
Excipient: peptone – the stabilizer – in final concentration of 5-10%. A vaccine produce complete with solvent – glycerin solution of 50%.
Deystvuyushche solvent substance: glycerin.
Excipient: phosphatic and citrate buffered solution of Mac-Ilveyna of 0,004 M.
Note. Structure of phosphatic and citrate buffered solution of Mac-Ilveyna of 0,004 M: citric acid monohydrate, sodium hydrophosphate dodecahydrate, water.
Indications to use:
Prevention of natural smallpox according to epidemic indications. Vaccination (revaccination) of the persons working with viruses of a variolovaccine and smallpox of animals, pathogenic for the person.
Route of administration and doses:
The vaccine is applied nakozhno by method of scarification or by method of a multiple stabbing.
As the place of vaccination serves the outside surface of a shoulder 8-10 cm lower than a shoulder joint, free from vaccinal hems. On site vaccination wipe skin with ether or acetone, or solution of alcohol of 70%, and after drying carry out an inoculation.
Before dissolution of a vaccine and both ends of an ampoule with solvent wipe the end of an ampoule with a vaccine with the tampon moistened with ether or solution of alcohol of 70%, after drying make an incision the scarificator ampoule and by means of the same tampon break off the end of an ampoule with a vaccine and one end of an ampoule with solvent. With a vaccine from above insert the open end of an ampoule with solvent into an open ampoule, and then break off the second end of an ampoule with solvent. Solvent flows down in an ampoule with a vaccine. Solvent is mixed with a vaccine by means of a sterile glass stick (the dissolved vaccine – opalescent liquid from whitish-gray to light-yellow color without deposit and foreign inclusions).
The ampoule with the dissolved vaccine is covered with a sterile napkin or cotton wool.
Scarification method: at vaccination put with a glass stick one drop
vaccines (•), at a revaccination - 3 drops at distance not less than 2 cm from each other (• • •).
In a vaccine site of application by a sterile ospoprivivatelny feather do the single not bleeding cut 0,5 cm long and slightly rub a vaccine to the place of a cut the flat party of the same ospoprivivatelny feather.
Method of a multiple stabbing: apply an individual bifurcation (two-tooth) needle to an inoculation. The end of a sterile needle is immersed in an ampoule with a divorced vaccine and then with the same needle perpendicularly to skin put at vaccination – 5 pricks, at a revaccination – 15 pricks at distance of 1 mm from each other. On site inoculations have to appear small droplets of a lymph or blood.
The place of vaccination leave open within 5-10 min. Overlaying of a bandage to the place of vaccination is not allowed.
Accounting of results of vaccination. Skin reaction at vaccination, and also a revaccination through long term (20–25 years and more), is characterized by formation on site of an inoculation of vaccinal elements. For the 3-4th day after vaccination there is a reddening, a swelling and a small knot papule which increases, around it the narrow zone of reddening appears. For the 6th day the papule is transformed to a vesicle - a bubble with transparent contents.
To 7 – to the 8th day around a vesicle wider rim of reddening - an areola is formed. From the 8th day the vesicle turns into a pustule. It reaches the maximum size to 8 – to the 10th day then there is a reaction fading, formation of a crust and after its falling away – formation of a hem (usually on the 3rd week).
The described clinic is called reaction on primary type and is noted at not immune persons. At a revaccination, except this reaction, the so-called accelerated and immediate reactions take place. At the accelerated reaction all stages of development of vaccinal elements proceed with the maximum expressiveness on 4 in an expedited manner – the 5th day. At immediate reaction the erythema, consolidation and sometimes a papule appear already in 24 – 48 h. Transition of a papule to a vesicle is in certain cases observed. The similar type of reaction to an inoculation is usually noted at persons with the high level of immunity to smallpox.
Negative skin reaction – lack of vaccinal elements in the place of an inoculation is extremely seldom observed. In such cases the humoral answer needs to be investigated by determination of content of virus neutralizing antibodies in blood serum of vaccinated.
The accounting of results of vaccination is carried out on 8 days after an inoculation, the accounting of results of a revaccination – on 2–4 days. Vaccination is considered a pustule, successful at development, a revaccination – at development of a pustule, vesicle or erythema and consolidation. Results of vaccination (revaccination) note in the corresponding registration forms.
Side effects:
In response to introduction of a vaccine development of side local and general reactions is possible.
Local reactions: pain in the place of an injection, local lymphadenitis.
General (system) reactions: an indisposition, a headache, temperature increase to 39 °C.
Strong reactions and complications are in rare instances observed.
Treat strong reactions: temperature increase is above 39 °C, a hyperemia and puffiness which are going beyond a shoulder; necroses on site inoculations in the first 3 days; additional pustules at a temperature above 38 °C.
Treat complications: autoinoculation; the generalized, gangrenous (progressing) vaktsiniya; vaccinal eczema; entsefalichesky reaction (synonyms: encephalopathy, neurotoxic syndrome, convulsive syndrome, febrile spasms); postvaccinal encephalitis (encephalomeningitis, encephalomyelitis); polyradiculoneuritis; serous meningitis.
On the frequency of reaction arise:
Very often (≥1/10) – pain in the place of an injection, local lymphadenitis, temperature increase to 38,5 ºС.
Often (1/10 - 1/100) - temperature increase higher than 38,5 ºС
Interaction with other medicines:
Other diseases inoculations can be carried out not earlier than in 30 days after a vaccination/revaccination against smallpox.
Contraindications:
The list of the diseases which are a contraindication to an inoculation according to epidemic indications defines the Russian Ministry of Health.
When carrying out inoculations the persons working with a virus of a vaccine and viruses of smallpox of animals, pathogenic for the person need to adhere to the following list of medical contraindications:
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Nosological forms
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Admissibility of an inoculation
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1. Acute diseases (infectious and noninfectious), including the reconvalescence period:
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Not earlier than 2 months after recovery
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a) infectious hepatitises (except hepatitis C), a meningococcal infection, infectious diseases with a long chronic current (sepsis and so forth);
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Not earlier than 6 months after recovery
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b) hepatitis C;
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It is contraindicated
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c) chronic pneumonia
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Not earlier than 12 months since the beginning of remission
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Note: at contact with infectious patients of an inoculation carry out upon termination of the term of a quarantine or the maximum incubation interval for this disease.
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2. Tuberculosis (pulmonary and extra pulmonary)
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Upon termination of an active phase, according to the conclusion of the phthisiatrician |
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3. Skin diseases:
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It is contraindicated
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b) other acute and chronic diseases or disturbance of an integument (burns, impetigo, herpes, wind smallpox herpes zoster, pustulous diseases)
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Not earlier than 2 months after recovery
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4. Immunosuppressive states:
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It is contraindicated
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b) immunodepressive therapy (treatment by antimetabolites, high doses of corticosteroids within 14 days and more, radio - and a roentgenotherapy and so forth)
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It is contraindicated
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5. Nervous and mental diseases:
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It is contraindicated
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Note: inoculations of this contingent proodit after inspection by the neuropathologist
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b) the hydrocephaly compensated a Down syndrome, Littl's disease;
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According to the conclusion of the neuropathologist
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c) TsNS injuries without the residual phenomena,
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According to the conclusion of the neuropathologist, against the background of anti-convulsive therapy
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According to the conclusion of the psychoneurologist
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6. Diseases of cardiovascular system:
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It is contraindicated
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b) other forms of pathology:
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Not earlier than 6 months after recovery (remission), according to the conclusion of specialists
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7. Diseases of internals:
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It is contraindicated
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b) diseases of biliary tract;
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Not earlier than 6 months after recovery (on condition of sanitation)
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c) peptic ulcer of a stomach and 12 perstny guts, nonspecific ulcer colitis;
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It is contraindicated
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d) diffusion glomerulonephritis, nephropathy inborn, chronic renal failure;
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It is contraindicated
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e) pyelonephritis;
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Not earlier than 3 years since the beginning of klinikolaboratorny remission
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e) toxic nephropathy (tranzitorny)
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Not earlier than 6 months after recovery
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8. Diseases of endocrine system:
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It is contraindicated
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9. General diseases of connecting fabric:
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It is contraindicated
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10. Blood diseases:
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It is contraindicated
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b) hemolitic states;
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Not earlier than 2 years from the moment of full kliniko-hematologic remission according to the conclusion of the specialist
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c) anemias are scarce
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After recovery
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11. Allergic diseases:
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It is contraindicated
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b) an asthmatic bronchitis, an asthmatic syndrome (against the background of a respiratory infection);
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After recovery according to the conclusion of the allergist
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c) heavy anaphylactic reactions (shock, a Quincke's disease of a throat, etc.) on various food-borne, medicinal and other allergens;
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It is contraindicated
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d) an allergy to vaccine components;
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It is contraindicated
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e) allergic reactions to separate allergens (various rashes, clinical frustration and so forth)
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Not less than 6 months after reaction
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Note: inoculations after the diseases specified in item 11 carry out against the background of antigistaminiy therapy
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12. Diseases of an ear, throat, nose:
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Not earlier than 2 months after operation or sanitation
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Not earlier than 3 months from the moment of remission
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13. Pregnancy (all terms) and breastfeeding period
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It is contraindicated
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14. Operative measure
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Not earlier than 2 months after recovery
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Storage conditions:
According to the joint venture 3.3.2.1248-03 at a temperature from 2 to 8 °C. To store in the place, unavailable to children. Freezing is not allowed. A period of validity - a vaccine - 2 years; solvent - 3 years.
Issue conditions:
According to the recipe
Packaging:
Lyophilisate for preparation of solution for intradermal introduction and cutaneous scarifying drawing complete with solvent. A vaccine on 20 doses (from the volume of 0,2 ml) in an ampoule. Solvent on 0,3 ml in a two-final capillary ampoule. On 5 ampoules of a vaccine and 5 ampoules of solvent or on 10 ampoules of a vaccine and 10 ampoules of solvent in a pack. Put the application instruction, the scarificator in a pack ampoule and a glass stick.
