Active substanceVaccine for the prevention of smallpoxVaccine for the prevention of smallpox
Dosage form: & nbspchewing tablets
Composition:

The vaccine dose of the drug contains from 1x106 up to 3х107 OOE of the vaccine virus.

Filler excipients: lactose 87.8%; sucrose 10.0%; calcium stearate 2.0%; vanillin 0.2%.

In 1 tablet weighing from 0.2 to 1.0 g is contained:

dry virus-containing material - not more than 30%;

filler - not less than 70%.

Description:Tablets are round, biconcave, with a risk, solid edges, 8-13 mm in diameter, light brown in color, having a light brown fine-grained surface on the fracture, with the smell of vanilla.
Pharmacotherapeutic group:MIBP vaccine
ATX: & nbsp

J.07   Vaccines

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

Pharmacodynamics:

TEOVak (vaccine small embryonic live) is a vaccine virus, dried with a stabilizer (lactose), grown in the chorionaleantoic membrane and chick embryo fetus and pressed together with the filler into tablets.

The vaccine forms a specific immunity against smallpox and smallpox.

Indications:

Active prophylaxis of smallpox and diseases caused by smallpox viruses, pathogenic to humans.

The drug is intended for revaccination of adults against smallpox according to epidemic indications and planned revaccination of individuals working with variola viruses, vaccines and smallpox animals, pathogenic to humans.

Contraindications:

The list of diseases that are a contraindication to vaccinations for epidemiological indications is determined by the Ministry of Health and Social Development of the Russian Federation.

Individuals subject to routine vaccination should be pre-examined by a physician with mandatory thermometry.

When carrying out routine vaccinations to persons working with variola viruses, vaccines and smallpox animals that are pathogenic to humans, the following contraindications should be observed.

Nosological form

Admissibility of vaccinations

1. Primary immunodeficiencies

Contraindicated

2. Acute diseases (infectious, non-infectious), including the period of convalescence

Not earlier than 2 months after recovery

Viral hepatitis

Not earlier than 6 months after recovery

Meningococcal infection

Not earlier than 6 months after recovery

Infectious diseases with prolonged and chronic course (sepsis, dysentery)

Not earlier than 6 months after recovery

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

3. Treatment with steroids, antimetabolites, X-ray therapy

Not earlier than 12 months after the end of therapy

4. Tuberculosis (pulmonary and extrapulmonary)

At the end of the active phase

5. Chronic pneumonia

Not earlier than 12 months after the remission

b. Allergic diseases:

- bronchial asthma;

Not earlier than 12 months after the remission

- asthmatic bronchitis, asthmatic syndrome (against respiratory infection)

Not earlier than 6 months after recovery

7. Allergic reactions in the anamnesis:

- severe anaphylactic reactions (shock, angioedema of the larynx, etc.) on food, medicinal and other allergens;

Contraindicated

- Allergic reactions to individual allergens (rashes, clinical disorders, etc.)

Not earlier than 6 months after the reaction on the conclusion of an allergist

8. Skin diseases:

- chronic common dermatoses with frequent exacerbations (pemphigus, psoriasis, eczema, neurodermatitis);

Contraindicated

- pustular diseases;

Not earlier than 2 months after recovery

- burns

After recovery

9. Nervous and mental diseases:

- traumas of the central nervous system with pronounced residual effects, postvaccinal encephalitis in history, epilepsy with constant seizures, chronic and recurrent progeny encephalitis, demyelinating and degenerative lesions of the nervous system (muscular degeneration, progressive muscular dystrophy, etc.), stroke;

Contraindicated

- epilepsy with rare seizures, febrile convulsions, CNS trauma without residual effects;

Not earlier than 12 months after the last seizure or recovery on the background of anticonvulsant therapy

- infectious diseases of the central nervous system in the form of meningitis, encephalitis of polyradiculoneuritis of any etiology (including meningococcal)

Not earlier than 2 years after recovery

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

10. Diseases of the mouth, ear, throat and nose:

- Diseases of the mouth, nasal cavity (rhinitis, periodontal disease, stomatitis, sinusitis),pharynx and larynx (sore throats, pharyngitis and laryngitis);

Not earlier than 2 months (after surgery or sanitation)

- chronic tonsillitis and adenoiditis, requiring surgical treatment;

Not earlier than 2 months (after surgery or sanitation)

- chronic otitis media

Not earlier than 3 months after the remission

11. Diseases of the cardiovascular system:

- Decompensated heart defects, subacute septic endocarditis, hypertensive disease of 3 st, severe forms of angina and myocardial infarction;

Contraindicated

- rheumatism;

Not earlier than 3 years from the date of remission on the conclusion of a rheumatologist

- myocarditis, vasculitis, myocardial infarction and angina (mild forms), hypertension 1 and 2 items, heart defects in the stage of compensation

Not earlier than 6 months after recovery (remission) at the conclusion of a specialist

12. Diseases of the liver and pancreas:

- cirrhosis of the liver, chronic hepatitis, hepatocellular dystrophy, acute and chronic pancreatitis;

Contraindicated

- bile duct disease

Not earlier than 6 months after recovery (under condition of sanation of bile)

13. Peptic ulcer of stomach and duodenum, ulcerative colitis

In remission

14. Kidney Diseases:

- glomerulonephritis, nephropathy, chronic renal failure;

Contraindicated

- pyelonephritis:

Not earlier than 1 year from the moment of clinical and laboratory remission

-toxic nephropathies (transient)

Not earlier than 6 months after recovery

15. Diseases of the endocrine system:

diabetes mellitus, severe forms of thyrotoxicosis and insufficiency (or dysfunction) of the adrenal glands, myxedema, thymomegaly

Contraindicated

16. Diseases of the blood:

leukemia, lymphogranulomatosis, aplastic anemia, hemophilia, Verlhof disease;

Contraindicated

- hemorrhagic vasculitis (capillarotoxicosis), hemolytic conditions;

Not earlier than 2 years from the moment of complete clinical and laboratory remission on the conclusion of a specialist

- deficiency anemia;

After recovery

- secondary immunodeficiencies

After recovery

17. Systemic diseases of connective tissue

Contraindicated

18. Pregnancy (all terms)

Contraindicated

19. Surgery

Not earlier than 2 months after recovery

20. Malignant neoplasms

Contraindicated

Dosing and Administration:

The drug is dosed according to the attached insert (1/2 part of the tablet divided by risk, one or more tablets) depending on the specific activity of the series (indicated on the inner package).The tablet preparation is chewed and kept in the mouth until completely dissolved, but not less than 2-3 minutes, after which it is not recommended to drink, smoke and eat for 30 minutes.

The vaccination is recorded in the prescribed registration forms with the name and amount of the drug (tablets), series and reactions to the vaccination.

It is not suitable for the use of the drug in the absence of the insert leaflet, with expired shelf life and with fixed cases of violation of the storage and transportation regime from 2 to 8 ° C. Unsuitable tablets (broken form, changed color, etc.) are not subject to use and are destroyed by soaking in a disinfectant having an alkaline pH (2% sodium hydroxide solution or 5% chloramine solution) for 1.5 hours.

Side effects:

Vaccines can develop common reactions, expressed in a short (up to 48 h) increase in body temperature that occurs 3-4 days after vaccination, and worsening of well-being.

Local phenomena can be expressed in the form of painless hyperemia of the pharynx, which occurs in the vaccinated for 4-5 days after the administration of the drug and disappears after 1-2 days. In case of damage to the mucosa (prolonged sucking, etc.)traumatic manipulations) can develop painless papules, vesicles and erosion, disappearing after 1-2 days.

With remote revaccination (15 years or more after the first vaccination), the severity and number of common reactions increases. To a local post-vaccination reaction, bacterial tonsillitis accompanied by lymphadenitis can join.

The aggravated local vaccination process develops on 4-9 days after vaccination (sore throat when swallowing, perspiration, tenderness of the submaxillary lymph nodes, fever to 38-39 ° C, hyperemia of the soft palate, anterior palatine arch and inflammation of the tonsils). Single aphthae on the gums and congestion hyperemia can develop. Whenconnects, as a rule, the rightoutsiderYuthe lymphadenitis with an increase in lymph nodes up to 2.5 cm. The burdened local vaccination process proceeds clinically according to the type of ulcerative necrotic tonsillitis, which completely stops on 14-17 days after inoculation with a combination of antibiotic and interferon treatment started in a fever more than 38 ° C in time.

Interaction:

Not installed.

Special instructions:

Immunization with the vaccine TEOVak conducted not earlier than a month after vaccination against other infections, taking into account the counterzani.

Do not vaccinate if damaged (integrity violation) oral mucosa, because in these cases can develop complicated reactions (papules, vesicles, erosions).

In the case of local complications vaccinal process bacterial infectious clinically flowing type necrotizing tonsillitis and raising the temperature more than 38,5 ° C, it is necessary to start a combination of antibiotics (cefotaxime intramuscularly daily for 3-9 1.0 g of 3 times per day, or doxycycline 2 capsules in the first reception, and then 1 capsule 2 times a day or ciprofloxacin 500 mg twice a day or gentamicin 80 mg twice a day or amoxicillin 500 mg 3 times a day or others depending on the sensitivity of microbes) and immunomodulators (interferon (reaferon, etc.) 5-7 days intramuscularly for 1 million ME, 2 times a day and local lubrication of the mucosa to 1-3 million IU / ml, at least 2-3 times a day or other drugs), as well as symptomatic and restorative means.

Form release / dosage:Tablets are chewable.
Packaging:

In glass bottles of type FO-10, 10 tablets, 10 bottles in a pack of cardboard.

In glass bottles of the type II-250-2- MTO on 275 tablets, each bottle in a pack of cardboard.

In packages of contour cells type "Servak" 10 tablets, 10 contour squares in a box of cardboard.

The package contains instructions for use and a leaflet.

Storage conditions:

Transport and store at temperatures from 2 before 8 ° C, in accordance with the JV 3.3.2-1248-03, in a place inaccessible to children.

Shelf life:

2 years.

Terms of leave from pharmacies:For hospitals
Registration number:P N001038 / 02
Date of registration:06.08.2010
The owner of the registration certificate:48 CSRI MINISTRY OF THE RUSSIAN FEDERATION 48 CSRI MINISTRY OF THE RUSSIAN FEDERATION Russia
Manufacturer: & nbsp
Information update date: & nbsp16.12.2015
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