Ospavir - instructions for use, dose, side effects, contraindications

Active substanceVaccine for the prevention of smallpoxVaccine for the prevention of smallpox

Similar drugsTo uncover

Vaccine smallpox alive (Vaccine smallpox)

lyophilizate PC cutaneous

MICROGEN FGUP Scientific and Production Association Russia

OspaVir®

lyophilizate PC

MICROGEN FGUP Scientific and Production Association Russia

TEOVAK

pills inwards

48 CSRI MINISTRY OF THE RUSSIAN FEDERATION Russia

TEOVAK

pills inwards

48 CSRI MINISTRY OF THE RUSSIAN FEDERATION Russia

Dosage form: & nbsplyophilizate for the preparation of a solution for subcutaneous administration

Composition:

The vaccine is released in a kit with a solvent - sodium chloride solution 0.9%.

Composition of the vaccine

1 dose of the drug (lyophilizate from a 0.5 ml vaccine) contains:

active substance: inactivated antigen of the vaccine virus - 50 μg (calculated value, determined by the total protein content);

Excipients: gelatin (stabilizer) - in a final concentration of 1%; sucrose (stabilizer) - at a final concentration of 5%; salts of the buffer system: acid citric monohydrate; sodium hydrogen phosphate anhydrous or sodium hydrogen phosphate dihydrate, or sodium hydrophosphate dodecahydrate *.

* The content of salts of the buffer system in the finished product is not determined.

Notes.

1. Salts of the buffer system are introduced into the vaccine in the form of a phosphate-citrate buffer solution of McIlwain 0.004 M.

2. The composition of phosphate-citrate buffer solution of Mak-Ilvein 0.004 M: citric acid monohydrate acid 0.042 mg; sodium hydrophosphate anhydrous 0.511 mg or sodium hydrogen phosphate dihydrate 0.641 mg, or sodium hydrophosphate dodecahydrate 1.289 mg; water up to 1 ml.

The drug does not contain antibiotics and preservatives.

Composition of solvent

1 ml of solvent contains: sodium chloride 9 mg; water for injection up to 1 ml.

Description:

The vaccine is a lyophilized white mass.

Solvent - Clear, colorless liquid.

Pharmacotherapeutic group:MIBP vaccine

ATX: & nbsp

J.07 Vaccines

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

Pharmacodynamics:

The vaccine stimulates a person to develop immunity to the virus of smallpox.

Characteristics of the preparation

OspaVir® is a vaccine virus grown on calves' skin, treated with freon 113 (chladone 113) and inactivated by gamma radiation of Co⁶⁰.

Pharmacokinetics:

There is no information.

Indications:

Primary vaccination of children from the age of two, adolescents and adults with a two-stage method of vaccination against smallpox.

Contraindications:

Children up to two years.

Pregnancy and the period of breastfeeding.

Persons previously vaccinated against smallpox (revaccination).

Acute infectious and non-infectious diseases, exacerbation of chronic diseases are temporary contraindications for vaccination. Scheduled vaccinations are carried out 2-4 weeks after recovery or during the period of convalescence or remission. For non-severe acute respiratory viral infections, acute intestinal diseases, etc., vaccinations are carried out immediately after the normalization of temperature (MU 3.3.1.1095-02).

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

Dosing and Administration:

A disposable sterile syringe is used to dissolve and administer the vaccine. The vials are opened and the vaccine is dissolved immediately before the injection. Before opening, the neck of the ampoule with the solvent and vaccine is treated with tampons moistened with 70% ethyl alcohol solutions or disposable alcohol wipes.

One dose of vaccine OspaVir^®dissolved in 0.5 ml of the solvent for 3 minutes, slightly shaking the ampoule (dissolved vaccine - colorless or yellowish opalescent liquid).

After dissolution, the entire volume of the vaccine is injected subcutaneously into the region of the left shoulder at 8-10 cmbelow the shoulder joint, after pretreating the site of administration of the vaccine with a solution of ethyl alcohol 70%.

The subsequent vaccination is carried out with a small live vaccine in accordance with the instructions for use of the preparation "Vaccine smallpox live" by the method of scarification or multiple puncturing on the right shoulder on the 8th day after the administration of the inactivated smallpox vaccine.

In exceptional cases, when vaccine smallpox alive for some reason can not be introduced within the prescribed period, the vaccination can be carried out within 2 months from the moment of vaccine administration OspaVir^®.

Verification of the results of the second stage of vaccination is carried out on the 7-8th day after the introduction of vaccine smallpox live. Vaccination is considered successful in the development of a skin reaction, which is characterized by the formation on site vaccines vaccine elements: papules, vesicles, pustules.

In the absence of a skin reaction, the question of the repeated administration of live smallpox vaccine is decided individually one month after the determination of the level of virus neutralizing antibodies in serum in specialized diagnostic centers.

REPEATED INTRODUCTION OF VACCINE ISPAVIR^® NOT ALLOWED!

Side effects:

In response to the introduction of OspaVir vaccine^® possible the development of local and general reactions.

Local Reactions: insignificant soreness at the injection site, local lymphadenitis in the first 3 days. After 1-2 days, vaccinated patients may have a slight hyperemia at the injection site, in some cases accompanied by mild infiltration.

General (systemic) reactions: malaise, headache, fever to 37.5 ° C.

Local and general reactions, as a rule, disappear after 24-48 hours.

According to the frequency of reaction there are:

Very often (≥1 / 10) - pain at the injection site, headache.

Often (1 / 10-1 / 100) - local lymphadenitis, malaise, fever to 37.5 ° C.

Overdose:

Cases of overdose are not described.

Interaction:

Not installed.

Special instructions:

Before the introduction of the vaccine, a mandatory examination with thermometer grafting is carried out. Persons with fever are not allowed to vaccinate!

After the vaccination, the vaccinated person should be followed by medical observation for at least 30 minutes. Places of vaccination should be provided with anti-shock therapy.

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.

Precautions for use

Persons subject to vaccination must be examined by a doctor / medical commission in advance in order to identify contraindications.

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

No information.

Form release / dosage:

Lyophilizate for the preparation of a solution for subcutaneous administration.

Packaging:

Vaccine - 1 dose per ampoule.

Solvent - 0.5 ml in the ampoule.

Issued in the kit (1 ampoule vaccine and 1 ampoule solvent). For 5 sets in a pack of cardboard with instructions for use and a scapegrator ampoule.

When packaging ampoules that have a break ring or a point for dissection, the ampoule scapegrator is not inserted.

Storage conditions:

In accordance with SP 3.3.2.1248-03 at a temperature of 2 to 8 ° C. Freezing is not allowed.

Keep out of the reach of children.

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:

2 years.

The drug with expired shelf life is not subject to application.

Terms of leave from pharmacies:For hospitals

Registration number:LSR-005198/08

Date of registration:03.07.2008 / 22.09.2014

Expiration Date:Unlimited

The owner of the registration certificate:MICROGEN FGUP Scientific and Production Association MICROGEN FGUP Scientific and Production Association Russia

Manufacturer: & nbsp

MICROGEN FGUP NGO Russia

Representation: & nbspMICROGEN FGUP Scientific and Production Association MICROGEN FGUP Scientific and Production Association Russia

Information update date: & nbsp14.06.2017

Illustrated instructions

Instructions

OspaVir® (OspaVir®)