Composition, form of production and packaging
Solution for injection 1 ml
immunoglobulin anti-rabies 150 IU
2 ml - bottles (1) - cardboard boxes.
10 ml - bottles (1) - cardboard boxes.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2013.
Rebinoline is a buffer isotonic solution of a specific human rabies immunoglobulin obtained from a plasma of donors immunized with an inactivated vaccine for the prevention of rabies (prepared from a strain grown on human diploid cell culture) and containing a large number of specific antibodies against the rabies virus.Introduction immediately after infection forms passive immunity to the rabies virus, increases the duration of the incubation period and thereby contributes to effective vaccination in carrying out complex immunoprophylaxis of rabies.
C max antibodies are achieved 2-3 days after intramuscular administration of anti-rabies immunoglobulin.
T 1/2 antibody is between 3 and 4 weeks. Immunoglobulin G and immunoglobulin G-complexes are destroyed in the cells of the reticuloendothelial system.
- treatment and prophylactic immunization against rabies for any damage to the skin (bites, any wounds and scratches) caused by wild or domestic animals, rabies, suspected rabies, under veterinary supervision and beyond, as well as in contact with mucous membranes or damaged skin of the saliva of infected animals.
Intramuscularly, adults and children - 20 IU / kg (0.133 ml / kg), once. Dose should not be exceeded under any circumstances, t. The introduction of an immunoglobulin can partially suppress the production of its own antibodies. If the administration is anatomically possible, the maximum permissible dose of the drug should be administered by infiltration around the wound, and the remainder intramuscularly (in the upper outer quadrant of the buttock). The central part of the gluteal region should be avoided, since there is a risk of damage to the sciatic nerve.
At the same time, the first dose of a vaccine for the prevention of rabies (prepared on human diploid cell culture) is administered to another part of the body, preferably as far from the place of administration of the immunoglobulin as an antirabic (preferably in the deltoid muscle region).
If therapy is postponed for any reason, the drug should be administered no later than the eighth day after the first dose of the vaccine, regardless of the time interval between contact with the virus and the onset of therapy.
The drug can not be administered using the same syringe or in the same anatomical area of вЂ‹вЂ‹the body as the vaccine for the prevention of rabies.
To ensure good infiltration of affected areas of the body in children (especially those with multiple injuries), the dose of the drug can be diluted 2-3 times in 0.9% sodium chloride solution.
Immunoglobulin anti-rabies should be administered exclusively in combination with a vaccine for the prevention of rabies. The only exception is those who have already been vaccinated with a vaccination for rabies prophylaxis and who have confirmed the presence of anti-rabies antibodies. These people should only get the vaccine.
The therapy should be discontinued if the animal remains healthy during the 10-day observation period or if the deceased animal does not have a rabies virus after appropriate laboratory tests.
Local reactions: soreness and discomfort at the injection site.
Systemic reactions: hyperthermia, allergic reactions (skin reactions, anaphylactic shock, angioedema), dizziness, vomiting, lowering of blood pressure, tachycardia.
There is no (100% lethality in the disease with rabies blocks any contraindications).
With caution: in patients with documented allergy to any component of the drug.
PREGNANCY AND LACTATION
The use of this drug during pregnancy in controlled clinical trials has not been studied, so during pregnancy and lactation the drug should be prescribed only in cases where the expected benefit of therapy for the mother exceeds the potential risk to the fetus or infant. The long experience of medical use of immunoglobulins does not allow expecting any harmful effect on the course of pregnancy, as well as on the fetus and the newborn.
It should be borne in mind that immunoglobulins are excreted in breast milk, which can facilitate the transfer of protective antibodies (passive immunity) to the child.
Repeated administration of the drug should not be performed after the initiation of the immunization program with the vaccine for the prevention of rabies; can reduce the maximum immunity.
Do not administer the drug intravenously (risk of anaphylactic shock). Before administration, make sure that the needle does not penetrate into the blood vessel.
Allergic reactions to rabies immunoglobulins of human origin with intramuscular injection are rare. In case of development of shock, to conduct standard therapy. In case of hypersensitivity to blood products (in the anamnesis), antihistamines should be used (with careful monitoring of the patient).
As soon as possible after the bite and regardless of the time that has passed since the contact, surgical and antiseptic treatment of the wound (including extensive washing with water and soap and disinfection using quaternary ammonium salts) should be performed. After the administration of the drug, the patient should be under the supervision of the doctor for at least 20 minutes. After the introduction of immunoglobulin, a temporary increase in the antibody content may cause false positive results in the conduct of serological tests. To avoid possible interactions between several different drugs, you need to inform your doctor about any other ongoing therapy.
In order to avoid the risk of transfer of infectious agents, careful monitoring of the selection of donor blood is carried out by examining each delivered blood volume and total plasma volume, especially with respect to HIV-1, HIV-2, hepatitis B virus, hepatitis C virus, , heat treatment and nanofiltration.
Cases of overdose are not described.
Increases the effect (mutually) of vaccines for the prevention of rabies and is used in combination with them. Especially recommended is the combination with inactivated vaccine for the prevention of rabies, prepared on human diploid cells, because the latter has high immunogenicity and induces active antiviral immunity.
The introduction of immunoglobulins can adversely affect the effectiveness of vaccines containing weakened live measles, rubella, mumps and varicella viruses.Therefore, between the introduction of Rebinoline and attenuated live vaccine, it is necessary to observe the interval for 3 months.
Compatible with antitetanus serum and antibiotics.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
At a temperature of 2 to 8 В° C. Do not freeze. Keep out of the reach of children. Shelf life - 2 years.