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Instructions

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Instruction for use: TEOVac

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Dosage form: Tablets; Chewing tablets; divisible Coated tablets

Active substance: Vaccinum ad prophylaxim variolae

ATX

J07B Vaccines viral

Pharmacological group:

Vaccines, serums, phages and toxoids

The nosological classification (ICD-10)

B03 Smallpox: Smallpox

Z25.8 The need for immunization against another clarified single viral illness: Vaccination against smallpox

Z29.1 Prophylactic immunotherapy: Vaccination against viral infections; donor Vaccination; Vaccination and revaccination; Vaccination of newborns; Vaccination against hepatitis B; Immunization; Correction of the immune status; Therapeutic and prophylactic immunization; Preventive immunization; Specific immunoprophylaxis; Stimulation of the processes of nonspecific immunit

Composition

The tablets covered with a cover, divisible 1 tab.

Dry virus-containing material not more than 30%

Filler - not less than 70%

Excipients:

Filler - lactose - 87,8%; Sucrose - 10%; Calcium stearate - 2%; Vanillin - 0,2%

Shells - acetylphthalylcellulose - 83%, castor oil - 17% or shellac - 83%, oleic acid - 17%

Tablets chewing 1 tab.

Dry virus-containing material not more than 30%

Filler - not less than 70%

Filler excipients: lactose - 87.8%; Sucrose - 10%; Calcium stearate - 2%; Vanillin - 0,2%

Description of dosage form

The tablets covered with a cover, divisible. Round, covered with a shell, biconvex with a risk of integral edges 8-13 mm in diameter white with a gray tinge or dark brown color, depending on the type of shell, having on the fracture a light brown fine-grained surface with the smell of vanilla.

Tablets are chewing. Round, biconcave, with a risk, solid edges with a diameter of 8-13 mm, light brown in color, having a light brown fine-grained surface on the fracture, with the smell of vanilla.

Characteristic

TEOVac (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 coated tablets.

The vaccine dose of the drug contains from 1 106 to 3 107 OOE of the vaccine virus.

Pharmachologic effect

Mode action - immunostimulating.

Pharmacological (immunobiological) properties

The vaccine forms a specific immunity against smallpox and smallpox.

Indication of the drug TEOVac

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

Revaccination of adults against smallpox according to epidemic indications;

Planned revaccination of persons 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 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, including: 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 protracted and chronic course (sepsis, dysentery) Not earlier than 6 months after recovery
In 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 this 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 from the moment of remission
6. Allergic diseases
- bronchial asthma Not earlier than 12 months from the moment of 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) to food, medicinal and other allergens Contraindicated
- allergic reactions to individual allergens (rash, clinical disorders) Not earlier than 6 months after the reaction on the conclusion of an allergist
8. Diseases and skin lesions:
- 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 illness:
- traumas of the CNS with pronounced residual phenomena, 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), stroke Contraindicated
- epilepsy with rare seizures, febrile convulsions, CNS traumas without residual effects: Not earlier than 12 months after the last seizure on the background of anticonvulsant therapy
- infectious diseases of the central nervous system in the form of meningitis, encephalitis, polyradicoloneuritis of any etiology (including meningococcal) Not earlier than 2 years after recovery
Inoculations of this contingent are performed after examination by a neuropathologist
10. Diseases of the oral cavity, ear, throat and nose:
- Diseases of the oral cavity, nasal cavity (rhinitis, periodontal disease, stomatitis, sinusitis), pharynx and larynx (sore throats, pharyngitis and laryngitis) Not earlier than 2 months (after surgery or recovery)
- 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 the 3rd degree, 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
12. Diseases of the liver and pancreas
- cirrhosis of the liver, chronic hepatitis, hepatocellular dystrophy, acute and chronic pancreatitis Contraindicated
- diseases of the biliary tract 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 (other than toxic), 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, 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
- anemia scarce 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

Side effects

Vaccines can develop common reactions, expressed in a short (for 48 h) increase in body temperature that occurs 3-4 days after vaccination, and deterioration 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 administration of the drug and disappears after 1-2 days. In case of damage to the mucosa (prolonged sucking and other traumatic manipulations), painless papules, vesicles and erosions disappearing after 1-2 days can develop.

With remote revaccination (after 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 may join. The aggravated local vaccination process develops on the 4th-9th day after vaccination (sore throat when swallowing, perspiration, tenderness of the submandibular 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. As a rule, right-sided submandibular lymphadenitis with lymph node enlargement up to 2.5 cm is attached. The burdened local vaccination process proceeds clinically according to the type of ulcerous necrotic tonsillitis, which completely stops on the 14-17th day after inoculation, which was started in time with fever more than 38 With combined treatment with antibiotics and interferon.

Interaction

Not installed.

Dosing and Administration

Inside, chewing and holding in the mouth until completely dissolved. The drug is dosed according to the attached insert (1/2 table, divided by risk, 1 or more tab.) 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 vaccine is recorded in the prescribed registration forms with the name and quantity of the drug (tablets), series and the reaction 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 transport regime (from 2 to 8 C). Unsuitable tablets (the broken form, the changed color) to use are not subject and are destroyed by soaking in a disinfectant having an alkaline pH (2% sodium hydroxide solution or 5% chloramine solution) for 1.5 hours.

Special instructions

Immunization with the vaccine TEOVac conducted not earlier than a month after vaccination against other infections, taking into account contraindications. You should not vaccinate if damage (breach of integrity) of the oral mucosa, because in these cases, complicated reactions (papules, vesicles, erosions) may develop. In case of aggravation of the local vaccinal process by bacterial infectious, clinically proceeding according to the type of ulcerative-necrotic tonsillitis and a temperature increase of more than 38.5 C, it is necessary to start the combined treatment with antibiotics (1 / 3m cefatoxime 1 g 3 times a day for 3-9 days or Doxycycline 2 capsules - in the 1st dose, 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 Day, or other antibiotics, depending on the sensitivity of the mics Obov) and immunomodulators (interferon (reaferon) IM in 1 million ME 2 times a day, for 5-7 days and topically, lubrication of the mucosa to 1-3 million IU / ml, at least 2-3 times a day) , As well as symptomatic and restorative means.

Release form

The tablets covered with a cover, divisible. In glass bottles, cans, bottles, polymer cans of 10, 20, 30, 50, 60, 75, 100, 125, 150, 175, 250, 275 and 450 tab. Or packs of contour-type cell type "Servak" for 10 tab.

Tablets are chewing. In glass bottles, cans, bottles, polymer cans of 10, 20, 30, 50, 60, 75, 100, 125, 150, 175, 250, 275 and 450 tab. Or packs of contour-type cell type "Servak" for 10 tab.

Manufacturer

FGU "48 Central Research Institute of the Ministry of Defense of the Russian Federation" (FSI "48 CSRI of the Ministry of Defense of Russia").

The address of production: branch of FSI "48 Central Research Institute of the Ministry of Defense of Russia" - "Virology center". 141306, Moscow 

Complaints on physical and other properties of the drug should be sent to the State Research Institute for Standardization and Control of Medical Biological Preparations. L.A. Tarasevich Rospotrebnadzor. 119002, Moscow

About cases of increased reactogenicity or development of postvaccinal complications should be reported by telegraph or telephone, followed by the presentation of medical documentation in the FGUN GISK them. L.A. Tarasevich and the manufacturing company.

Conditions of supply of pharmacies

For treatment and preventive and sanitary facilities.

Storage conditions of the drug TEOVac

In a dry, the dark place at a temperature of 2-8 C.

Keep out of the reach of children.

Shelf life of the drug TEOVac

2 years. 6 months after re-control

Do not use after the expiry date printed on the package.

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