Universal reference book for medicines
Name of the drug: VACCINE LIVING VOICE (SMALLPOX VACCINE LIVE (SMALLPOX VACCINE))

Active substance: smallpox vaccine

Type: Vaccine for prophylaxis of smallpox

Producer: NGO MIKROGEN (Russia)
Composition, form of production and packaging
Lyophilizate for the preparation of a solution for intradermal administration
and cutaneous scarification in the form of a homogeneous porous mass from whitish gray to light yellow color.

1 dose

vaccine for the prevention of smallpox not less than 1 × 10 6 OOE (from 1 × 10 8 to 2 × 10 9 OOE in 1 ml)

Solvent: 50% of the glycerol solution.

10 doses - ampoules (5) complete with a solvent of 0.2 ml amp.
5 pieces. - packs cardboard.
10 doses - ampoules (10) complete with a solvent of 0.2 ml amp.
10 pieces. - packs cardboard.
20 doses - ampoules (5) complete with a solvent of 0.3 ml amp.
5 pieces. - packs cardboard.
20 doses - ampoules (10) complete with a solvent of 0.3 ml amp.
10 pieces. - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2014.

PHARMACHOLOGIC EFFECT

The vaccine forms a specific immunity against smallpox for a duration of at least 5 years.

INDICATIONS

- prevention of smallpox for epidemic indications;

- Vaccination (revaccination) of persons working with vaccinia viruses and smallpox vaccines, pathogenic to humans.

DOSING MODE

The vaccine is applied by skin by the method of scarification or by the method of multiple piercing.

The place of vaccination is the outer surface of the shoulder 8-10 cm below the shoulder joint, free of vaccine scars.
The skin at the vaccination site is wiped with ether or acetone, or with a 70% solution of ethyl alcohol, and after inoculation is inoculated.
Before dissolving the vaccine, the end of the ampoule with the vaccine and the both ends of the ampoule with the solvent are wiped with a pad moistened with ether or a solution of 70% ethanol, after drying, the ampoule is cut with a scarifier and the end of the vial with the vaccine and one end of the ampoule with the solvent are broken off with the same swab.
In the open ampoule with the vaccine, the open end of the ampoule with the solvent is inserted from above, and then the second end of the ampoule with the solvent is broken off. The solvent flows into the ampoule with the vaccine. The solvent is mixed with the vaccine with a sterile glass rod (dissolved vaccine - opalescent liquid from whitish gray to light yellow color without sediment and foreign inclusions). The ampoule with the dissolved vaccine is covered with a sterile tissue or cotton wool. Method of scarification: when vaccinated with a glass rod, apply one drop of vaccine (•), with booster - 3 drops at a distance of at least 2 cm from each other ( ). At the site of vaccine application with a sterile ospivyvivatelnym pen make a single necrotic incision length of 0.5 cm and slightly rub the vaccine into the place of incision with the flat side of the same ospovyvivatelnogo pen.
Method of multiple piercing: for the inoculation use an individual bifurcation (two-tooth) needle.
The end of the sterile needle is immersed in an ampoule with a diluted vaccine and then the same needle perpendicular to the skin is applied during vaccination - 5 injections, with revaccination - 15 injections at a distance of 1 mm from each other. Small drops of lymph or blood should appear on the site of the vaccination. Place the vaccine open for 5-10 minutes. Do not apply bandages to the vaccination site.
Recording of vaccination results

The skin reaction during vaccination, as well as revaccination after a long period (20-25 years and more), is characterized by the formation of vaccine elements on site.
On the 3-4th day after the vaccination, redness, swelling and a nodule-papule appear, which increases, a narrow zone of redness appears around it. On the 6th day the papule is transformed into a vesicle - a vial with clear contents. By the 7th-8th day around the vesicles, a wider reddening rim is formed - the areola. From the 8th day the vesicle turns into a pustule. The maximum size it reaches by the 8th-10th day, after which the reaction disappears, the formation of crust and after its fall off - scar formation (usually in the 3rd week).
The described clinic is called a reaction of the primary type and is noted in non-immune individuals.
When revaccination, in addition to this reaction, there are so-called accelerated and immediate reactions. With an accelerated reaction, all stages of development of the vaccine elements proceed at an accelerated rate with a maximum severity on the 4th-5th day. With the immediate reaction of erythema, densification and sometimes papules appear after 24-48 hours. In some cases, the passage of the papule into the vesicle occurs. A similar type of reaction to vaccination is usually observed in individuals with a high level of immunity to smallpox.Very rarely there is a negative skin reaction - the absence of vaccine elements at the site of vaccination. In such cases, the humoral response should be investigated by determining the content of virus neutralizing antibodies in the serum of the vaccinated.
The results of vaccination are taken into account 8 days after vaccination, the results of revaccination are taken into account for 2-4 days.
Vaccination is considered successful in the development of pustules, revaccination - with the development of pustules, vesicles or erythema and densities. The results of vaccination (revaccination) are noted in the corresponding registration forms.
SIDE EFFECT

In response to the introduction of the vaccine, local and general side reactions may develop.

Local reactions: pain at the injection site, local lymphadenitis.

General (systemic) reactions: malaise, headache, fever to 39 ° C.

In rare cases, there are strong reactions and complications.

Strong reactions include: fever above 39 ° C, hyperemia and puffiness that extend beyond the shoulder;
necroses at the site of inoculation in the first 3 days; additional pustules at a temperature above 38 ° C.
Complications include: autoinoculation: generalized, gangrenous (progressing) vaccine;
vaccinal eczema; Encephalic reaction (synonyms: encephalopathy, neurotoxic syndrome, convulsive syndrome, febrile seizures); postvaccinal encephalitis (meningoencephalitis, encephalomyelitis); polyradiculoneuritis; serous meningitis.
According to the frequency of reaction there are:

Very often (? 1/10) - pain at the injection site, local lymphadenitis, an increase in temperature to 38.5 ° C.

Often (1/10 -1/100) - increase in temperature above 38.5 ° C.

CONTRAINDICATIONS

The list of diseases that are a contraindication to vaccination for epidemiological indications is determined by the Ministry of Health of Russia.

When vaccinating people working with the vaccine virus and animal pox viruses that are pathogenic to humans, the following list of medical contraindications should be adhered to:

Nosological forms Admissibility of vaccination

1. Acute diseases (infectious and non-infectious), including the period of convalescence: Not earlier than 2 months after recovery

a) infectious hepatitis (except for hepatitis C), meningococcal infection, infectious diseases with protracted chronic course (sepsis, etc.);
Not earlier than 6 months after recovery
b) hepatitis C;
Contraindicated
c) chronic pneumonia. Not earlier than 12 months from the beginning of remission

Note: when contacting infectious patients, vaccinations are carried out at the end of the quarantine period or the maximum incubation period for this disease.

2. Tuberculosis (pulmonary and extrapulmonary) At the end of the active phase, at the conclusion of the phthisiatrician

3. Skin diseases: a) common dermatosis (pemphigus, psoriasis, eczema, atopic dermatitis), including in the anamnesis;
Contraindicated
b) other acute and chronic diseases or skin disorders (burns, impetigo, herpes, chicken pox-herpes zoster, pustular diseases). Not earlier than 2 months after recovery

4. Immunosuppressive conditions: a) syndrome of congenital or acquired immunodeficiency (including HIV infection), leukemia, malignant neoplasms, organ transplantation, cellular and humoral immunodeficiencies;
Contraindicated
b) immunosuppressive therapy (treatment with antimetabolites, high doses of corticosteroids for 14 days or more, radio and X-ray therapy, etc.) Contraindicated

5. Nervous and mental illnesses: a) traumas of the central nervous system (CNS) with residual events, encephalitis and encephalomyelitis (including post-vaccination), meningitis, poliradiculoneuritis (including in anamnesis), epilepsy, hydrocephalus in the stage of decompensation or subcompensation, demyelinating and degenerative lesions of the nervous system (muscular degeneration, etc.), stroke;
Contraindicated
Note: Inoculations of this contingent will be passed after examination by a neurologist

b) compensated hydrocephalus, Down's disease, Little's disease;
At the conclusion of a neurologist
c) traumas of the central nervous system without residual phenomena, febrile convulsions in the anamnesis, according to the conclusion of the neurologist, against the background of anticonvulsant therapy

d) mental illness According to the conclusion of a psychoneurologist

6. Diseases of the cardiovascular system: a) decompensated heart defects, subacute septic endocarditis, myocarditis, pericarditis, hypertension II-III degree, angina pectoris, myocardial infarction;
Contraindicated
b) other forms of pathology: - hypertension 1 st., heart defects in the stage of indemnification of angina pectoris (mild forms). Not earlier than 6 months after recovery (remission), according to the conclusion of specialists

7. Diseases of internal organs: a) cirrhosis of the liver, chronic hepatitis, hepatocerebral dystrophy, acute and chronic pancreatitis;
Contraindicated
b) diseases of the biliary tract;
Not earlier than 6 months after recovery (on condition of sanation)
c) peptic ulcer of stomach and duodenum, ulcerative colitis;
Contraindicated
d) diffuse glomerulonephritis, congenital nephropathy, chronic renal failure;
Contraindicated
e) pyelonephritis;
Not earlier than 3 years since the beginning of clinical laboratory remission
f) toxic nephropathies (transient) Not earlier than 6 months after recovery

8. Diseases of the endocrine system: a) diabetes mellitus, severe forms of thyrotoxicosis and adrenal insufficiency or dysfunction, myxedema, thymomegaly, congenital fermentopathy Contraindicated


9. Systemic diseases of connective tissue: a) systemic lupus erythematosus, discoid lupus, rheumatism, rheumatoid arthritis, systemic vasculitis, systemic scleroderma, etc. Contraindicated

10. Blood diseases: a) leukemia, lymphogranulomatosis, aplastic anemia, hemophilia, Verlhof disease;
Contraindicated
b) hemolytic conditions;
Not earlier than 2 years from the moment of complete clinical and hematologic remission on the conclusion of a specialist
c) anemia deficit After recovery

11. Allergic diseases: a) bronchial asthma;
Contraindicated
b) asthmatic bronchitis, asthmatic syndrome (against respiratory infection);
After recovery from the conclusion of an allergist
c) severe anaphylactic reactions (shock, angioedema, laryngeal edema, etc.) on a variety of food, medicinal and other allergens;
Contraindicated
d) allergy to vaccine components;
Contraindicated
e) allergic reactions to individual allergens (various rashes, clinical disorders, etc.) Not less than 6 months after the reaction

Note: Inoculations after the diseases specified in clause 11 are performed against the background of antihistamine therapy

12. Diseases of the ear, throat, nose: a) chronic tonsillitis and adenoiditis, requiring surgical treatment;
Not earlier than 2 months after surgery or sanitation
b) chronic otitis Not earlier than 3 months from the moment of remission

13. Pregnancy (all terms) and the period of breastfeeding Contraindicated

14. Surgery Not earlier than 2 months after recovery

PREGNANCY AND LACTATION

The introduction of the vaccine is contraindicated in pregnancy and during breastfeeding.

SPECIAL INSTRUCTIONS

Persons subject to vaccination must be examined by a doctor with mandatory thermometry!

In order to prevent the transfer of the vaccine virus to persons suffering from skin diseases, the latter should not be contacted with grafted before the crust falls or within 28 days after vaccination.

Vaccination is not recommended in hot months.

Only medical personnel who have undergone special training are entitled to vaccination.

It is necessary to carefully guard the place of introduction of the vaccine against damage, it is strictly forbidden to wet it.

After the vaccination, the vaccinated person is given medical supervision to evaluate the results of vaccination and to timely identify unusual reactions and post-vaccination complications.

The instruments used for vaccination should be sterile and non-expendable.
Opening of ampoules and vaccination is carried out with strict adherence to aseptic and antiseptic rules.
The drug is not suitable for use in ampoules with broken integrity, marking, with a change in physical properties, with expired shelf life.
The vaccine is used only within one working day, but no later than 6 hours after its dilution.
The remainder of the vaccine solution, materials, instruments used in the smallpox vaccine are disinfected by boiling for 30 minutes or immersion in a 3% chloramine solution or 3% hydrogen peroxide solution, then autoclaved for 45 minutes at 132 ° C, steam pressure 0 , 20 MPa.

Influence on ability to drive vehicles, mechanisms

No information.

OVERDOSE

Cases of overdose are not described.

DRUG INTERACTION

Vaccinations against other diseases can be performed no earlier than 30 days after vaccination / revaccination against smallpox.

TERMS OF RELEASE FROM PHARMACY

For treatment and prevention institutions.

TERMS AND CONDITIONS OF STORAGE

In accordance with SP 3.3.2.1248-03 at a temperature of 2 to 8 ° C.
Keep out of the reach of children. Freezing is not allowed. Shelf life - vaccine - 2 years; solvent - 3 years.
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