Active substanceAntimicrobial immunoglobulinAntimicrobial immunoglobulin
Dosage form: & nbspsolution for intramuscular and subcutaneous administration
Composition:

In 1 ml of solution contains:

active substance: immunoglobulin anti-rabies (human) 150 ME;

Excipients: glycine, water for injection.

Description:

Transparent, slightly opalescent, colorless or pale yellow solution. May contain a small suspended sediment that breaks when shaken.

Pharmacotherapeutic group:MIBP - globulin
ATX: & nbsp

J.06.B.B.05   Immunoglobulin human anti-rabies

Pharmacodynamics:

Rebinolin is a buffer isotonic solution of a specific human rabies immunoglobulin, obtained from donor plasma,immunized with 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.

Pharmacokinetics:

The maximum concentration of antibodies is achieved 2-3 days after intramuscular injection of an antirabic immunoglobulin. The half-life (T1/2) antibodies is from 3 to 4 weeks. Immunoglobulin G and immunoglobulin G-complexes is destroyed in the cells of the reticuloendothelial system.

Indications:

Treatment and prophylactic immunization against rabies for any damage to the skin (bites, any wounds and scratches) inflicted by wild or domestic animals, rabies, with suspicion of rabies, under veterinary supervision and beyond, as well as in contact with mucous membranes or damaged skin of the saliva of infected animals.

Contraindications:

There is no (100% lethality in the disease with rabies blocks any contraindications).

Carefully:Have 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.

Dosing and Administration:

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 introduction is anatomically possible,the maximum permissible part of the dose of the drug should be injected 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 ​​the body as the vaccine for the prevention of rabies.

To ensure good infiltration of the affected parts of the body in children (especially those with multiple injuries), the dose of the drug can be diluted 2-3 times in a 0.9% solution of sodium chloride.

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 vaccine to prevent rabies and tothenryx PThe presence of anti-rabies antibodies has been confirmed. 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.

Side effects:

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.

Overdose:Cases of overdose are not described.
Interaction:

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.

Special instructions:

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 (careful monitoring of the patient is necessary).

As soon as possible after a bite and regardless of the time that has passed since contact,surgical and antiseptic treatment of the wound (including extensive washing with 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.

Form release / dosage:

Solution for intramuscular and subcutaneous administration, 150 IU / ml.

Packaging:

For 2 or 10 ml of the drug in vials of colorless hydrolytic glass (USP) type I, hermetically sealed with rubber stoppers and crimped aluminum caps with a plastic lid (flip-off).

One bottle together with the instruction for use is placed in a cardboard box.

Storage conditions:

At a temperature of 2 to 8 ° C. Do not freeze.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after expiry date.

Terms of leave from pharmacies:On prescription
Registration number:LSR-008016/10
Date of registration:12.08.2010
The owner of the registration certificate:Kamada Co., Ltd.Kamada Co., Ltd. Israel
Manufacturer: & nbsp
Representation: & nbspKAMADA LTD. KAMADA LTD. Israel
Information update date: & nbsp12.10.2015
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