Active substanceVaccine for the prevention of rabiesVaccine for the prevention of rabies
Dosage form: & nbsp

lyophilizate for the preparation of solution for intramuscular administration 1 dose complete with a solvent - water for injections.

Composition:

One dose of the vaccine (1 ml) contains:

Active ingredient:

Inactivated rabies virus strain Flury LEP, grown in the culture of chick embryo cells - no less than 2.5 ME;

Auxiliary components:

Trishydroxymethylaminomethane -3.5 mg, sodium chloride 4.5 mg, EDTA (Titripleke III) 0.25 mg, potassium-L-glutamate 0.9 mg, polygeline 10.5 mg, sucrose 20-100 mg.

The vaccine does not contain preservatives.

Description:The porous mass is white, hygroscopic.
Pharmacotherapeutic group:inactivated vaccine
ATX: & nbsp

J.07   Vaccines

Indications:

Active immunization against rabies.

A) Pre-exposure immunization.

Immunization administered routinely is recommended to persons at risk of becoming infected with rabies virus: veterinarians; students studying veterinary medicine; hunters; forestry workers; employees of slaughterhouses, staff of laboratories working with rabies virus or infected material; in cases of planned visits to regions endemic for rabies.

B) Postexpositional immunization.

It is carried out after contact with animals with confirmed or suspected disease rabies.

Contraindications:

A) Pre-exposure immunization.

1. Acute infectious diseases or exacerbation of chronic diseases. Vaccinations are conducted no earlier than 2 weeks after recovery.

2.Allergic reactions to antibiotics (neomycin, chlortetracycline and amphotericin B) and components that are part of the Rabipur® vaccine.

3. Complications, including systemic allergic reactions that developed after the previous administration of the Rabipur® vaccine.

4. Pregnancy.

B) Postexpositional immunization.

Since the disease is fatal, there are no contraindications for post-exposure immunization (see section "Special instructions and cautions").

Pregnancy and lactation are not a contraindication for post-exposure immunization.

Pregnancy and lactation:

Pregnancy and lactation are not a contraindication for post-exposure immunization.

Cases of harm attributed to the use of this vaccine in pregnant women have not been documented.

Information on the penetration of the Rabipur® vaccine into mother's milk is not available.
Dosing and Administration:

A single dose for immunization is 1 ml.

PRE-EXPOSURE IMMUNIZATION

Immunization according to the scheme: 1 ml of the immunizing dose at 0, 7 and 21 or 28 days. REVAKCINATION

- Persons with a constant risk of infection are advised to monitor the level of specific antibodies in the blood every 6 months.

- People with a frequent risk of infection are advised to check their antibody levels every two years.

In the case of a decrease in the level of antibodies in the blood below 0.5 IU / ml, one single booster dose is given by one immunizing dose.

It is necessary to take into account the fact that immunization with the Rabipur® vaccine provides a pronounced immune response and a protective level of specific antibodies that circulate for a long time.

In cases where the serological response is not possible, the first revaccination is recommended one year after the immunization course. Subsequent revaccinations are performed once every five years with a single immunizing dose.

POSTEXPOSITION VACCINATION

Begin the vaccination as soon as possible.

For indications for use, see Table 1.

Table 1. Relevant post-exposure immunization schedules, depending on contact categories.

Contact category

Nature of contact (Contact with an animal in whom rabies is suspected or suspected to be a disease, contact at an autopsy)

Vaccination schedule

I

- Touching or feeding animals in the absence of mucus membranes and mucous membranes. Patient's skin without damage before and after contact.

Vaccination is not required.

In case of doubt, vaccination is recommended

according to the scheme: 1.0 ml of Rabipur ® at 0, 3, 7, 14, 30 and 90 days.

II

Inflammation of intact skin; abrasions, scratches, superficial necrotic bites of the trunk, upper and lower extremities (except bites of dangerous localization: head, face, neck, hand, fingers and feet) caused by domestic and farm animals.

In the case of a bite, an immediate treatment is given to a domestic animal or a known animal according to the scheme: 1.0 ml of Rabipur ® at 0, 3, 7.14, 30 and 90 days).

In the case of a bite, an unknown or suspicious rabies animal is assigned immediate combined treatment (active and passive immunization) according to the pattern: rabies immunoglobulin at day 0 and Rabipur® 1.0 ml at 0.37.14.30 and 90 days.

If the observed pet remains healthy for 10 days, the treatment is discontinued. In other cases, treatment should continue.

If laboratory evidence of the absence of rabies in an animal, the treatment is precautionary.

III

-Any oblivion of the mucous membranes, any bites of the head, face, neck, hand, fingers and toes, genitals; single or multiple deep, bleeding laceration wounds inflicted by domestic or farm animals.-Any oblivion and damage caused by wild carnivorous cattle, bats and rodents.

Immediate combination treatment (active and passive immunization) according to the scheme: rabies immunoglobulin on day 0 and Rabipur® 1.0 ml at 0.37.14.30 and 90 days.

If the observed pet remains healthy for 10 days, the treatment is discontinued. In other cases, treatment should continue.

If the absence of rabies in an animal is proven in laboratory, the treatment is stopped.

* The patient should be warned that the immunization is not completed. In the event of subsequent contact with a rabid suspected rabies, a full vaccination course is necessary.

If it is necessary to carry out a combined course of anti-rabies treatment, an antirabies immunoglobulin is first introduced and, no more than 30 minutes later, the Rabipur® vaccine is administered after it. Heterologous anti-rabies immunoglobulin is prescribed in a dose of 40 ME for 1 kg of body weight, and homologous rabies immunoglobulin - in a dose of 20 ME per 1 kg of body weight. Do not exceed or decrease the dose, nor do you re-enter it due to the danger of reducing the effectiveness of vaccination.If the rabies immunoglobulin is unavailable at the time of the first injection, it should be administered no later than 3 days after the bite for immunoglobulin of rabies from the horse's serum (heterologous), and no later than 7 days after the bite for the rabies immunoglobulin from human serum homologous).

Persons who have been fully immunized.

In order to address the issue of the tactics of providing anti-rabies care to persons who have an indication in the history of a complete course of anti-rabies vaccination, it is recommended that the level of anti-rabies antibodies in the blood be determined. The protective level of antibodies is 0.5 IU / ml.

Depending on the timing of the course of anti-rabies vaccination, the regimens listed in Table 2 should be followed. Persons with immuno-deficient conditions.

Table 2. Schemes of vaccination of persons previously immunized after bite.

Interval after the course of vaccination

Vaccination schedule

Less than 1 year (subject to receiving a full course of immunization)

Vaccination in 0,3,7 days to 1,0 ml of Rabipur®

More than 1 year

Full immunization according to the scheme of post-exposure prophylaxis (in accordance with the type of injury).




Persons with immuno-deficient conditions.

Persons with immunodeficient conditions receiving post-exposure anti-rabies treatment, it is recommended to monitor the protective level of antibodies in the blood 14 days after the end of the vaccination course. Depending on the level detected, sKeepantibodies, additional vaccine administration may be necessary. If the antibody level is lower than the protective level (0.5 IU / ml), an additional three-fold administration of the vaccine is necessary according to the scheme of 0.7, 21 or 28 days.

Sposabout the application.

The Rabipur vaccine can be used to vaccinate all age groups.

Restored vaccine: a clear or slightly opalescent liquid, colorless or light yellow in color.

The lyophilizate must be dissolved in the water for injection supplied in the package, just before use. Before administration, the solution should be shaken gently. The dissolved vaccine is not subject to storage and should be used immediately after the preparation of the solution.

Rabipur® must be injected intramuscularly into the deltoid muscle, or into the anterior lateral surface of the thigh in young children (up to 18 months).

You can not inject the vaccine into the gluteus muscle.


Side effects:

In assessing the side effects of the drug, the following data on their frequency were taken as the basis, obtained by the manufacturer:

Very often> 10%

Often from 1 to 10%

Occasionally, from 0.1 to 1%

Rarely from 0.01 to 0.1%

Very rarely <0.01%, including isolated cases

Based on data from clinical trials and clinical use of the vaccine, the following information was provided on the incidence of adverse events:

Local reactions in the area of ​​injection and general reactions

Very often: Pain in the area of ​​injection, compaction at the injection site, fever, fatigue.

Often: Erythema injection site.

Very rarely: Tremor.

Nervous system:

Very often: Headache.

Very rarely: Paresthesia, radicular injuries, polyneuropathy, including Guillain-Barre syndrome, paralysis, visual neuritis.

Muscles and Joints:

Very often: Myalgia.

Very rarely: Arthritis.

Other

Very often: Disruption of the gastrointestinal tract.

Very rarely: Dizziness, increased sweating, lymphadenopathy, hypersensitivity

There was no statistically significant increase in the incidence of primary manifestations of autoimmune diseases (eg, multiple sclerosis) after vaccination.However, in some cases this can not be completely ruled out, vaccination can cause symptoms of autoimmune diseases in patients with a genetic predisposition.

Interaction:

During the course of post-exposure vaccination, it is recommended to refrain from the simultaneous administration of immunosuppressive drugs and antimalarial medicines.

In patients receiving immunosuppressive therapy, as well as in individuals with primary or secondary immunodeficiency, vaccination may not be effective enough to produce the necessary immune response (see also the section on "Dosage").

Anti-rabies immunoglobulin should be used in strictly defined quantities. Do not exceed or reduce the dose, nor do you re-enter it due to the danger of reducing the effectiveness of concomitant vaccination.

During the course of postexposure immunization, simultaneous use of tetanus toxoid and tetanus toxoid antitoxin is allowed. After the vaccination against rabies vaccination against other infectious diseases is allowed no earlier than 2 months.Pre-exposure immunization is performed no earlier than 1 month after vaccination against another infectious disease.

Special instructions:

In post-exposure vaccination, individuals with clinical symptoms such as rash, edema of the lips and / or epiglottis, lagging or bronchospasm, hypotension or shock, in the case of previously observed serious allergic reactions to vaccine components (including poligelin), including antibiotics used in the production process of the vaccine (amphotericin B, chlortetracycline, neomycin), another rabies vaccine should be used. Vaccination should be carried out only with careful clinical observation in a room provided with anti-shock therapy.

VACCINA IN NO EVENT SHOULD BE INTRODUCED IN-INTRAVENOUSLY!

Accidental entry of a vaccine into a blood vessel can be accompanied by a severe reaction, up to a shock. In such cases immediate measures should be taken to prevent such a reaction.

It is inadmissible to mix in one syringe a vaccine and an antirabic immunoglobulin.

Measures for emergency wound treatment (local treatment).

For persons in contact with rabies suspected of rabies, the following measures are mandatory: as soon as possible after a bite or injury, all wounds and injuries should be immediately washed with a large amount of water using soap or other detergent for several minutes (up to 15 minutes ). Then the edges of the wound should be treated with 70% ethyl alcohol or 5% alcohol solution of iodine.

If possible, the wounds should not be stitched. Sealing is shown only in the following cases:

- with extensive wounds: several leading skin seams after pre-treatment of the wound;

- the imposition of skin sutures on the wounds of the face,

- Sewing bleeding vessels to stop external bleeding.

In the presence of indications for the use of rabies immunoglobulin, it is used immediately before the application of sutures. The recommended dose of immunoglobulin should be administered as deep as possible into the wound and the surrounding areas. The remaining immunoglobulin should be administered intramuscularly to a site different from the site of administration of the vaccine, preferably to the gluteus muscle.

If necessary, prevent tetanus.

Form release / dosage:Lyophilizate for the preparation of solution for intramuscular injection 1 dose complete with a solvent.
Packaging:1 dose of vaccine in a glass bottle of class I (USP), sealed with a cork made of bromobutyl rubber with an aluminum-plastic lid, water for injection of 1 ml in a glass ampoule of class I (USP), one sterile 2 ml syringe with a Luer nozzle with a separate needle. One tray of polypropylene with a bottle, ampoule and a syringe-tube in a pack of cardboard along with instructions for use.
Storage conditions:

Store in a dark place at a temperature of 2 to 8 ° C. Do not freeze. Keep out of the reach of children!

Shelf life:

Vaccine (lyophilizate - complete with a solvent) - 4 years.

Lyophilizate for the preparation of solution for intramuscular injection - 4 years. Solvent (water for injection) - 5 years. Do not use the vaccine after the expiry date printed on the package. Expiration date is the last day of the month indicated on the package.

Terms of leave from pharmacies:For hospitals
Registration number:П N010268
Date of registration:07.07.2010
The owner of the registration certificate:Novartis Vaccines & Diagnostics GmbH & Co. KG Novartis Vaccines & Diagnostics GmbH & Co. KG Germany
Manufacturer: & nbsp
Representation: & nbspNOVARTIS CONSUMER HELS S.A. (part of Novartis groups) NOVARTIS CONSUMER HELS S.A. (part of Novartis groups) Switzerland
Information update date: & nbsp19.01.2015
Illustrated instructions
    Instructions
    Up