Vaccine smallpox alive (Vaccine smallpox) (SMALLPOX VACCINE LIVE (SMALLPOX VACCINE))

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
Read on
Active substanceVaccine for the prevention of smallpoxVaccine for the prevention of smallpox
Dosage form: & nbsplyophilizate for the preparation of a solution for intradermal administration and cutaneous scarification
Composition:

1 vaccine dose of vaccine contains:

active substance: vaccinia virus not less than 106 oPoobrazuyuschih units (OOE);

auxiliary substance: Peptone - stabilizer - in a final concentration of 5-10%.

The vaccine is released with a solvent - glycerin solution 50%.

1 ml of solvent contains:

active substance: glycerol 563 mg;

auxiliary substance: phosphate-citrate buffer solution of McIlwain 0.004 M to 1 ml.

Note.

The composition of phosphate-citrate buffer solution of Mak-Ilvein 0.004 M: klemon monohydrate 0.042 mg; sodium hydrogen phosphate dodecahydrate 0.641 mg; water up to 1 ml.

Description:

Vaccine - porous mass from whitish-gray to light-yellow color.

Solvent - transparent, colorless, syrupy, odorless liquid.

Pharmacotherapeutic group:MIBP vaccine
ATX: & nbsp

J.07   Vaccines

J.07.B.X   Other vaccines for the prevention of viral infections

Pharmacodynamics:

The smallpox live vaccine is a vaccinia virus grown on scarified calves, partially released from the bacterial flora by treatment with chlorhexidine with bigluconate. The smallpox vaccine contains from 1x108 up to 2х109 of the unit-forming units (OOE) in 1 ml.

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

Indications:

Prevention of smallpox according to epidemic indications.

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

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

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 in contact with infectious patients, vaccinations are carried out at the end of the quarantine period or the maximum incubation period for the disease.

2. Tuberculosis (pulmonary and extrapulmonary)

At the end of the active phase, at the conclusion of the phthisiatrician

3. Skin diseases:

a) common dermatoses (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) congenital or acquired immunodeficiency syndrome (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 diseases:

a) traumas of the central nervous system (CNS) with residual events, encephalitis and encephalomyelitis (including post-vaccination), meningitis, polyradiculoneuritis (including in the anamnesis), epilepsy, hydrocephalus in the stage of decompensation or subcompensation, demyelinating and degenerative lesions of the nervous system muscular degeneration, etc.), stroke;

Contraindicated

b) compensated hydrocephalus, Down's disease, Little's disease;

At the conclusion of a neurologist

c) CNS trauma without residual effects, 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 the psychoneurologist

Note: Inoculations of this contingent are performed after examination by a neuropathologist.

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:


- hypertensive disease of the 1st degree, heart defects in the stage of indigestion compensation (lung 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 the clinic-laboratory remission

e) 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 fermentopathies

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 scarce

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 of the larynx, 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.)

At least 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 adenoids, requiring surgical treatment;

Not earlier than 2 months after surgery or sanitation

b) chronic otitis media

Not earlier than 3 months after the 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.

Dosing and Administration:

The vaccine is used on skin scarification method, or a method of multiple nakalyvaniya.

Vaccination is the place on the outer surface of the shoulder of 8-10 cm below the shoulder joint of vaccine free of scarring. The skin at the site of vaccination is rubbed with ether or acetone, or a solution of ethanol 70% and after drying is carried inoculation.

Before dissolving vaccine end of the ampoule with the vaccine and both ends with a solvent ampoule wipe swab moistened with ether or a solution of ethanol 70% after drying incised lancet ampulnam and using the same tampon break off end of the ampoule with the vaccine and one end of the ampoule with a solvent.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 vaccination - 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 inoculation, an individual bifurcation (two-tooth) needle is used. 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. It reaches its maximum size by the 8th-10th day, after which the reaction disappears, crust formation occurs and, after its falloff, scar formation (usually at week 3).

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 effects:

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: increase in temperature above 39 ° С, hyperemia and puffiness, which go 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 (progressive) vaccine; vaccinal eczema; encephalic reaction (synonyms: encephalopathy, neurotoxic syndrome, convulsive syndrome, febrile convulsions); 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) - temperature increase above 38.5 ° С.

Overdose:

Cases of overdose are not described.

Interaction:

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

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 have the right to be vaccinated.

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% solution of chloramine or 3% hydrogen peroxide solution, then autoclaved for 45 minutes at 132 ° C, steam pressure 0 , 20 MPa.

Effect on the ability to drive transp. cf. and fur:

No information.

Form release / dosage:

Lyophilizate for preparation of solution for intradermal scarification and epicutaneous application together with the solvent.

Packaging:

Vaccine 20 doses (from a volume of 0.2 ml) in an ampoule.

Solvent 0.3 ml in a two-point capillary ampoule. 5 vials and 5 solvent vaccine vials or ampoules 10 and 10 vials of vaccine solvent in a pack.

In the pack put the instructions for use, the scarifier ampoule and glass rod.

Storage conditions:

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.

Transportation conditions

In accordance with SP 3.3.2.1248-03 at a temperature of 2 to 8 ° C. A single short-term (not more than 24 hours) transportation at a temperature of 9 to 20 ° C is allowed. Freezing is not allowed.

Shelf life:Vaccine - 2 years; solvent - 3 years.
Do not use after expiry date.
Terms of leave from pharmacies:For hospitals
Registration number:P N001141 / 01
Date of registration:26.05.2008 / 12.02.2014
Expiration Date:Unlimited
The owner of the registration certificate:MICROGEN FGUP Scientific and Production Association MICROGEN FGUP Scientific and Production Association Russia
Manufacturer: & nbsp
Information update date: & nbsp12.01.2017
Illustrated instructions
    Instructions
    Up