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

lyophilizate for the preparation of a solution for intramuscular administration.

Composition:

The vaccine is an antirabic culture concentrate concentrated purified inactivated, a lyophilizate for the preparation of a solution for intramuscular injection, is a preparation containing a vaccine rabies virus, a Vnukovo-32 strain grown in a primary culture of Syrian hamster kidney cells, inactivated by ultraviolet rays, concentrated and purified by ultrafiltration .

One dose of the vaccine contains: vaccine rabies virus, strain "Vnukovo-32", inactivated - at least 2.5 International Units (ME), stabilizers: human albumin - 5.0 mg, sucrose - 75.0 mg, gelatin - 10.0 mg.

The vaccine does not contain preservatives and antibiotics.

Description:

The vaccine is a porous mass of white color. It is hygroscopic.

Pharmacotherapeutic group:MIBP vaccine
ATX: & nbsp

J.07   Vaccines

Pharmacodynamics:

Immunological properties.

The vaccine induces the development of humoral and cellular immunity against rabies, provides a protective level of specific antibodies with a maximum rise to 45 days.

Indications:

Treatment-and-prophylactic immunization: contact and bites of people with rabies sick animals, animals with suspected rabies, wild or unknown animals.

Prophylactic immunization: with prophylactic purpose, immunize people who have a high risk of rabies (laboratory staff working with street rabies virus, veterinarians, gamekeepers, hunters, foresters, persons engaged in catching and keeping animals and other professional groups).

Contraindications:

Contraindications for treatment-and-prophylactic immunization are absent. Pregnancy is not a contraindication.

Contraindications for Ppreventive immunization.

1. Acute infectious and non-infectious diseases, chronic diseases in the stage of exacerbation or decompensation - vaccinations are carried out not earlier than one month after recovery (remission).

2. Systemic allergic reactions to the previous administration of COCAV vaccine (generalized rash, Quincke's edema, etc.).

3. Pregnancy.

Pregnancy and lactation:

The use of the drug is possible only with a therapeutic and prophylactic goal for life indications.

Dosing and Administration:

The contents of the ampoule with the vaccine should be dissolved in 1.0 ml of water for injection. The dissolution time should not exceed 5 minutes. Dissolved vaccine is a clear or slightly opalescent liquid from colorless to light yellow color. Storage of dissolved vaccine for more than 5 minutes is not allowed.

Dissolved vaccine is administered slowly intramuscularly in the deltoid muscle of the shoulder, children under 5 years old - in the upper part of the anterolateral surface of the thigh.

The introduction of the vaccine into the gluteal region is not allowed.

Rendering anti-rabic help

Anti-rabies care consists of local treatment of wounds, scratches, abrasions and the subsequent administration of a vaccine to prevent rabies COCAV or, in the presence of indications, combined administration of immunoglobulin anti-rabies (AIG) and a vaccine for the prevention of rabies COCAV. The interval between the introduction of AIG and COCAV is not more than 30 minutes.

Local wound treatment

Local treatment of wounds (bites, scratches, abrasions) and places of mourning should begin immediately or as soon as possible after a bite or injury. It consists in extensive washing for a few minutes (up to 15 minutes) of the wound surface with water with soap or other detergent (detergent) or, in the absence of soap or detergent, the place of damage is washed with a jet of water. After this, the edges of the wound should be treated with 70% ethyl alcohol or 5 % alcohol solution of iodine.

If possible, sutures should be avoided.

Sealing is shown only in the following cases:

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

- for cosmetic indications (application of skin seams to facial wounds);

stitching of bleeding vessels to stop external bleeding.

In the presence of indications for the use of anti-rabies immunoglobulin, it is used immediately before suturing (see section The dose of anti-rabies immunoglobulin (AID)

After local treatment of wounds (injuries), immediately begin treatment preventive immunization.

Treatment and prophylactic immunization

Detailed Scheme of treatment and prophylactic immunization and notes on the scheme are presented below in the "Prophylactic Vaccine Vaccine for the Prevention of Rabies COCAV and Immunoglobulin Anti-Rabies (AIG) Vaccine."

Treatment of all people exposed to the risk of infection with rabies is subject to treatment and prophylaxis. If there are indications for the combined treatment, then first AIG is introduced and, no more than 30 minutes after it is injected COCAB.

Immunoglobulin anti-rabies (AIG) appoint as soon as possible after contact with a rabid animal or animal with suspected rabies, wild or unknown animals.

Before the introduction heterologous (horse) immunoglobulin anti-rabies it is necessary to check the individual sensitivity of the patient to the horse's proteins (see "Instructions for the use of anti-rabies immunoglobulin from horse blood serum"). Heterologous anti-rabies immunoglobulin Enter not later than 3 days after the bite.

Before the introduction homologous (human) immunoglobulin anti-rabies individual sensitivity is not checked. Homologous anti-rabies immunoglobulin Enter not later than 7 days after the bite.

The dose of immunoglobulin anti-rabies (AIG). Heterologous (horse) anti-rabies immunoglobulin is prescribed in a dose of 40 ME per 1 kg of body weight. The volume of heterologous immunoglobulin administered antirabies should not exceed 20 ml. Homologous (human) anti-rabies immunoglobulin is prescribed in a dose of 20 ME per 1 kg of body weight.

Introduction of AIG. As much of the recommended dose of AIG can be infiltrated into the tissue around the wound and deep inside the wound. An unused portion of the dose of the drug is administered intramuscularly to a site other than the administration of an antirabies vaccine.

Scheme of curative and prophylactic vaccinations vaccine for prophylaxis

rabies COCAV and immunoglobulin anti-rabies (AIG)

Category:

ria

damaged

the

Nature of contact

Data on the animal

Treatment

1

There are no damages to the skin, there are no discomforts of the skin, there are no mucus membranes.

A patient with rabies

Not assigned

2

Inflammation of intact skin, abrasions, scratches, superficial bites of the trunk, upper and lower extremities (except for the head, face, neck, hand, fingers and toes) caused by domestic and farm animals.

If within 10 days of monitoring the animal it remains zdooovym. then treatment ppekoashat (ie after the 3rd injection).

If the absence of rabies in an animal has been laboratory proved. then the treatment is translated from the moment of establishment of absence of rabies.

In all other cases, when it is impossible to observe the animal for 10 days (killed, killed, run away, etc.), continue treatment according to the indicated scheme.

Prescribe immediate treatment: COCAV 1.0 mL at 0, 3, 7.14, 30, 90 day

3

Any mucus membranes, any bites of the head, face, neck, hand, fingers and toes, genitals; single or multiple deep ragged wounds inflicted by domestic or farm animals.

Any damnation and damage caused by wild carnivorous animals, bats and rodents.

If it is possible to observe the animal and it remains for 10 days zdooovym. then the treatment poekoashayut (ie after the third injection).

If the absence of rabies in an animal has been laboratory proved. then the treatment is translated from the moment of establishment of absence of rabies.

In all other cases, when it is impossible to observe the animal, continue treatment according to the indicated scheme.

Initiate immediate combination therapy with immunoglobulin anti-rabies: AIG on day 0 (see Immunoglobulin anttoabic dose (AIH)) and vaccine for rabies prevention: COCAB 1.0 mL at 0, 3, 7, 14, 30 and 90 day

Notes to the Scheme of curative and prophylactic vaccinations vaccine for the prevention of rabies COCAV and immunoglobulin anti-rabies (AIG):

1. Doses and regimens of treatment-and-prophylactic immunization are the same for children and adults.

2. The course of treatment-and-prophylactic immunization is prescribed irrespective of the period of treatment of the victim for anti-rabies help, even several months after contact with rabies sick animals suspicious of rabies disease by animals, wild or unknown animals.

3. For individuals who received a previous full course of preventive or preventive vaccinations, from the end of which no more than 1 year has passed, three injections of the vaccine for the prophylaxis of COCAV rabies are prescribed for 1.0 ml at 0, 3, 7 days; if a year or more has passed or an incomplete immunization course has been carried out, vaccinations are carried out in accordance with the above-mentioned "Vaccine preventive vaccination regimen for the prophylaxis of rabies COCAV and anti-rabies immunoglobulin (AIG)",

4. After the course of preventive or preventive immunization, the vaccine is given a certificate (certificate of preventive vaccination), indicating the type and series of drugs, the course of vaccinations and the presence of postvaccinal reactions.

5. The vaccinated must know: it is forbidden to drink any alcohol during the course of vaccination and 6 months after it ends. It should also avoid fatigue, hypothermia, overheating throughout the course of vaccinations.

6. Glucocorticosteroids and immunosuppressants can lead to ineffective vaccine therapy. Therefore, in cases of vaccination against the background of taking corticosteroids and immunosuppressants, the determination of the titer of virus neutralizing antibodies is mandatory.In the absence of virus neutralizing antibodies, an additional course of administration of the vaccine is carried out according to the scheme of 0, 7 and 30 days.

Preventive immunization

The vaccine is injected intramuscularly into the deltoid muscle of the shoulder by 1.0 ml at 0, 7 and 30 days. Revaccination is carried out once, at a dose of 1.0 ml every other year and every three years thereafter.

The scheme of preventive immunization

Primary immunization

Three injections on days 0, 7 and 30 for 1.0 ml

First revaccination in 1 year

One injection, 1.0 ml

Subsequent revaccinations every 3 years

One injection, 1.0 ml


Preventive immunization of contingents of increased risk of infection with rabies is carried out in vaccination rooms of medical and prophylactic institutions, where they fill out and issue a "Certificate of preventive vaccinations", where they bring all the necessary information (names, series, doses, multiplicities and dates of receipt of drugs).


Precautions for use.

The drug is not suitable for use in ampoules with broken integrity, marking, as well as when the color and transparency change, if the expiration date, improper storage.

Opening of ampoules and the vaccination procedure are carried out with strict compliance with aseptic rules.

Vaccinated should be under medical supervision for at least 30 minutes.

Places for vaccination should be equipped with anti-shock therapy.



Side effects:

1. The introduction of a vaccine may be accompanied by a local or general reaction. Local reaction is characterized by a slight swelling, flushing, redness, itching, pain at the injection site, an increase in regional lymph nodes. General information the reaction can be manifested in the form of malaise, headache, weakness, enhancement body temperature, systemic allergic reactions (generalized rash, Quincke's edema). Recommended symptomatic therapy, the use of hyposensitizing agents.Perhaps the development of neurological symptoms, such a patient should be urgently hospitalized.

2. After the introduction of rabies immunoglobulin from the blood serum of the horse, complications may occur: a local allergic reaction occurring 1-2 days after administration; Serum sickness, which occurs most often on day 6-8; anaphylactic shock. When anaphylactic reactions occur, emergency care and follow-up care is required at a specialized institution.In case of anaphylactoid reaction develop a solution of epinephrine, norepinephrine, ephedrine. The multiplicity, the method of application and the dose of injectable drugs depends on the severity of the shock and blood pressure.

When symptoms of serum sickness appear, parenteral administration of N-histamine receptor blockers (antihistamines) of drugs, glucocorticosteroids, and calcium preparations is recommended.

Overdose:

Not installed.

Interaction:

During the course of treatment and preventive vaccination, vaccination with other drugs is prohibited. After the vaccination against rabies vaccination of other vaccines is allowed no earlier than 2 months.

Preventive vaccination is given no earlier than 1 month after vaccination against another infectious disease.

During the course of treatment and prophylactic immunization, the appointment of immunosuppressants and corticosteroids is carried out only according to vital indications.

Effect on the ability to drive transp. cf. and fur:No information.
Form release / dosage:Lyophilizate for the preparation of solution for intramuscular injection.
Packaging:

Lyophilizate for the preparation of a solution for intramuscular injection is included in the kit: 1 ampoule vaccine - 1 dose (at least 2.5 ME) and 1 ampoule solvent (water for injection) - 1 ml each.

For 5 sets together with instructions for use and scarifier ampullum in a pack of cardboard.
Storage conditions:Conditions of transportation. AT according to SP 3.3.2.1248-03 at a temperature of 2 to 8 ° C. It is allowed to transport at a temperature of up to 25 ° C not more than 2 days /

Storage conditions. At a temperature of 2 to 8 ° C out of the reach of children.

Shelf life:

1,5 years. The drug with expired shelf life is not subject to application.

Terms of leave from pharmacies:For hospitals
Registration number:LS-001202
Date of registration:21.09.2011
The owner of the registration certificate:NGO MICROGEN, FSUE NGO MICROGEN, FSUE Russia
Manufacturer: & nbsp
Representation: & nbspMICROGEN FGUP Scientific and Production Association MICROGEN FGUP Scientific and Production Association Russia
Information update date: & nbsp03.03.2013
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