Composition, form of production and packaging
Liofilizate for the preparation of a solution for the / m introduction in the form of a hygroscopic porous mass of white color.
1 dose (1 ml)
inactivated rabies virus strain Flury LEP * not less than 2.5 IU
[PRING] tris-hydroxymethylaminomethane, sodium chloride, EDTA (titriplex III), potassium L-glutamate, polygelin (poligeline), sucrose; the vaccine does not contain preservatives.
Solvent: water d / and (1 ml).
1 dose - vials of glass (1) complete with a solvent (1 pc.) And sterile syringe tubes with Luer nozzles with separate needles (1 pc.) - packs of cardboard.
* grown on a chicken embryo cell culture, inactivated, purified, lyophilized.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2011.
PHARMACHOLOGIC EFFECT
Vaccine for active immunization against rabies. Allocate pre-exposure and post-exposure immunization.
Pre-exposure immunization is performed routinely by individuals at risk of infection with the rabies virus. Post-exposure immunization is carried out after contact with animals with confirmed or suspected disease of rabies.
INDICATIONS
Pre-exposure immunization for persons at risk of infection with rabies:
- veterinarians;
- students studying veterinary medicine;
- hunters;
- forestry workers;
- workers of slaughterhouses;
- personnel of laboratories working with rabies virus or infected material;
- in cases of planned visits to regions endemic for rabies.
Post-exposure immunization:
- after contact with animals with confirmed or suspected disease of rabies.
DOSING MODE
A single dose for immunization is 1 ml.
Pre-exposure immunization
Immunization according to the scheme: according to 1 ml of the immunizing dose at 0, 7 and 21 or 28 days.
Revaccination
- for persons with a constant risk of infection it is recommended to monitor the level of specific antibodies in the blood every 6 months.
- It is recommended that persons with a frequently occurring risk of infection be tested for antibody levels in the blood 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 В® vaccine provides a strong 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.
Post-exposure vaccination
Begin the vaccination as soon as possible.
Table 1. Relevant post-exposure immunization regimens, depending on the contact category.
Contact category Nature of contact (contact with an animal confirmed or suspected to have rabies, contact at an autopsy) Vaccination schedule
I Touch or feed 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 following scheme: 1.0 ml of Rabipur В® 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, hands, 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 following scheme: 1.0 ml of Rabipur В® at 0, 3, 7, 14, 30 and 90 days. In the case of a bite, an unknown combination or suspicious rabies is assigned immediate combined treatment (active and passive immunization) according to the scheme: rabies immunoglobulin at day 0 and Rabipur В® at 1.0 ml at 0, 3, 7, 14, 30 and 90 days. If the observed pet remains healthy for 10 days, the treatment is stopped *. In other cases, treatment should continue. If the absence of rabies in an animal is proven in laboratory, the treatment is stopped.
III Any mucus 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 damnation and damage caused by wild carnivorous animals, bats and rodents. Immediate combination treatment (active and passive immunization) according to the scheme: rabies immunoglobulin on day 0 and Rabipur В® by 1.0 ml at 0, 3, 7, 14, 30 and 90 days. If the observed pet remains healthy for 10 days, the treatment is stopped *. 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 required.
If it is necessary to carry out a combined course of anti-rabies treatment, first an antirabies immunoglobulin is introduced and, no more than 30 minutes afterwards, the Rabipur В® vaccine is administered. A heterologous antirabic immunoglobulin is administered at a dose of 40 IU per kg of body weight, and a homologous rabies immunoglobulin at a dose of 20 IU 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 the rabies immunoglobulin from the horse's serum (heterologous), and no later than 7 days after the bite for the rabies immunoglobulin from human serum (homologous) .
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 to determine the level of anti-rabies antibodies in the blood. The protective level of antibodies is 0.5 IU / ml.
Depending on the timing of the course of anti-rabies vaccination, the regimens shown in Table 2 should be adhered to.
Table 2. Schemes of vaccination of persons previously immunized after bite.
Interval after vaccination course Vaccination schedule
Less than 1 year (provided the full immunization schedule is received) Vaccination at 0, 3, 7 days to 1.0 ml of Rabipur В®
More than 1 year Full immunization under the scheme of post-exposure prophylaxis (in accordance with the type of injury)
People with immunodeficiency conditions receiving post-exposure anti-rabies treatment are recommended to monitor the protective level of antibodies in the blood 14 days after the end of the vaccination course. Depending on the detectable level of protective antibodies, additional administration of the vaccine may be necessary.If the level of antibodies is lower than the protective level (0.5 IU / ml), an additional three-fold administration of the vaccine is necessary according to scheme 0, 7, 21 or 28 days.
Mode of 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 В® it is necessary to inject IM 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 EFFECT
In assessing the side effects of the drug, the following data on the frequency of their preparation were based on the manufacturer's data: very often (? 10%), often (1% to 10%), infrequently (0.1% to 1%), rarely 0.01% to 0.1%), very rarely (<0.01%, including single 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 field 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 - a tremor.
From the nervous system: very often - headache; very rarely - paresthesia, radicular injuries, polyneuropathy, including Guillain-Barre syndrome, paralysis, visual neuritis.
From the musculoskeletal system: very often - myalgia; very rarely - arthritis.
Other: very often - disruption of the digestive 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.
CONTRAINDICATIONS
Pre-exposure immunization:
- acute infectious diseases or exacerbation of chronic diseases (vaccinations are carried out not earlier than 2 weeks after recovery);
- allergic reactions to antibiotics (neomycin, chlortetracycline and amphotericin B) and components that are part of the Rabipur В® vaccine;
- Complications, incl. systemic allergic reactions that developed after the previous administration of the Rabipur В® vaccine;
- Pregnancy.
Post-exposure immunization:
- As the disease with rabies leads to a fatal outcome, there are no contraindications for post-exposure immunization.
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 В® vaccine into mother's milk is not available.
APPLICATION FOR CHILDREN
Rabipur В® should be injected in / m in the deltoid muscle, or in the anterior lateral surface of the thigh in young children (up to 18 months). You can not inject the vaccine into the gluteus muscle.
SPECIAL INSTRUCTIONS
In case of post-exposure vaccination, persons with clinical symptoms in the form of rash, edema of the lips and / or epiglottis, lagging or bronchospasm, arterial hypotension or shock, in the case of previously observed serious allergic reactions to vaccine components (including polygelin), incl. to antibiotics used in the vaccine manufacturing process (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.
Under no circumstances should the vaccine be administered 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 preliminary treatment of the wound;
- imposition of cutaneous sutures on the wounds of the face;
- stitching of bleeding vessels in order 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 IM in a place different from the place of administration of the vaccine, preferably in the gluteus muscle.
If necessary, prevent tetanus.
OVERDOSE
Data on the overdose of the Rabipur В® vaccine are not available.
DRUG 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.
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.
TERMS OF RELEASE FROM PHARMACY
It is only released to medical and preventive institutions.
TERMS AND CONDITIONS OF STORAGE
The vaccine should be stored in a place inaccessible to children, protected from light at a temperature of 2 В° to 8 В° C; Do not freeze. Shelf life - 4 years. Do not use after the expiration date printed on the package.
