Composition, form of production and packaging
Lyophilizate for the preparation of solution for the / m introduction porous mass of white; is hygroscopic.
vaccine for the prevention of rabies at least 2.5 IU
Excipients: human albumin 5 mg, sucrose 75 mg, gelatin 10 mg.
Solvent: water d / and
2.5 IU ampoules (5) in a kit with a solvent of 1 ml amp. (5 pcs.) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2014.
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.
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 .
- Treatment and prophylactic immunization: contact and bites of people with rabies sick animals, animals with suspected rabies, wild or unknown animals;
- preventive immunization: for prophylactic purposes, immunize persons who are at high risk for rabies (laboratory staff working with street rabies virus, veterinarians, gamekeepers, hunters, foresters, persons engaged in catching and keeping animals and other professional groups).
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. The dissolved vaccine is a clear or slightly opalescent liquid from a colorless to a light yellow color. Storage of dissolved vaccine for more than 5 minutes is not allowed.
Dissolved vaccine is injected slowly intramuscularly into the deltoid muscle of the shoulder, children under 5 years of age - 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 subsequent injection of the vaccine for the prevention of rabies Kokav or, in the presence of indications, combined administration of anti-rabies immunoglobulin (AIG) and vaccine to prevent Koshav's whips. The interval between the introduction of AIG and Kokav is no more than 30 minutes.
Local treatment of wounds Local treatment of wounds (bites, scratches, abrasions) and places of lumbago should begin immediately or as soon as possible after bite or damage. It consists of a large amount of water washed with soap or other detergent (detergent) for several minutes (up to 15 minutes) of the wound surface, 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 in order to stop external bleeding.
In the presence of indications for the use of anti-rabies immunoglobulin, it is used immediately before the application of sutures (see the section Anti-rabies immunoglobulin dose (AIG)).
After the local treatment of injuries (injuries) immediately begin treatment and preventive immunization.
A detailed outline of the treatment and prophylactic immunization and notes to the scheme is presented below in the "Scheme of preventive vaccinations vaccine for the prevention of rabies Kokav and immunoglobulin anti-rabies (AIG)."
Treatment of all people exposed to the risk of infection with rabies is subject to treatment and prophylaxis. If there are indications for combined treatment, first AIG is administered and, no more than 30 minutes after, Kokav is administered.
Immunoglobulin anti-rabies (AIG) is prescribed as soon as possible after contact with a rabid animal or animal with suspected rabies, wild or unknown animals.
Before the introduction of heterologous (horse) immunoglobulin antirabies, 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 blood serum of a horse horse) .The heterologous immunoglobulin antimicrobial is administered no later than 3 days after the bite.
Before the introduction of homologous (human) immunoglobulin anti-rabies individual sensitivity is not checked. Homologous anti-rabies immunoglobulin is administered no later than 7 days after the bite.
The dose of immunoglobulin anti-rabies (AIG). Heterologous (horse) immunoglobulin anti-rabies 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 IU 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 aithirabic vaccine.
Scheme of therapeutic and prophylactic vaccinations with vaccine for the duration of prophylaxis of rabies Kokav and immunoglobulin antirabies (AIG)
Category of damage Nature of contact Data on animal Treatment
1 There is no damage to the skin, no mucus membranes, no mucus membranes. Infectious rabies Not assigned
2 Inflammations of intact skin, abrasions, scratches, superficial bites of the trunk, upper and lower extremities (except the head, face, neck, hand, fingers and toes) caused by domestic and agricultural animals. If, within 10 days of monitoring the animal, it remains healthy, then the treatment is discontinued (ie, after the third injection). If laboratory evidence of the absence of rabies in an animal, the treatment is discontinued 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 with the indicated scheme. Assign immediate treatment: Kokav 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 ravens 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 healthy for 10 days, the treatment is stopped (ie after the third injection). If laboratory evidence of the absence of rabies in an animal, the treatment is discontinued 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 anti-rabies dose (AITO and vaccine for the prevention of rabies: Kokav 1.0 ml in 0,3,7,14,30 and 90 days
Notes to the Scheme of therapeutic and prophylactic vaccinations vaccine for the prevention of rabies Kokav 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 term of treatment of the victim for anti-rabies help, even several months after contact with rabies sick animals suspected of rabies disease by animals, wild or unknown animals.
3. For persons who received a previous complete 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 rabies Kokav for 1.0 ml at 0.3, 7 days are prescribed; 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 "Scheme of therapeutic and prophylactic vaccinations vaccine for the prevention of rabies Kokav and immunoglobulin antirabies (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 grafted person should know: he is not allowed to drink any alcohol during the course of vaccination and 6 months after his graduation. It should also avoid fatigue, hypothermia, overheating throughout the course of vaccinations.
6. Glucocorticosteroids and immunosuppressants can lead to ineffectiveness of 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.
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 at 0, 7 and 30 days of 1.0 ml
First revaccination after 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 preventive institutions, where they fill out and issue a "Certificate of preventive vaccinations", where they make 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.
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. The general 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 anti-rabies immunoglobulin from the blood serum of the horse, complications may occur: 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 H1 blockers of histamine receptors (antihistamines) of drugs, glucocorticosteroids, calcium preparations is recommended.
There are no contra-indications for treatment-and-prophylactic immunization. Pregnancy is not a contraindication.
Contraindications for preventive immunization:
- 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);
- Systemic allergic reactions to the previous administration of the vaccine Kokav (generalized rash, edema, Quincke, etc.);
PREGNANCY AND LACTATION
The use of the drug is possible only with a therapeutic and prophylactic goal for life indications.
During the period of treatment, patients should avoid driving motor vehicles and other activities that require a high concentration of attention and speed of psychomotor reactions.
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.
TERMS OF RELEASE FROM PHARMACY
For treatment and prevention institutions.
TERMS AND CONDITIONS OF STORAGE
At a temperature of 2 to 8 В° C out of the reach of children. Shelf life - 1,5 years.