Rebinolin^® (Solution) Instructions for Use

Marketing Authorization Holder

Kamada Ltd. (Israel)

ATC Code

J06BB05 (Human antirabies immunoglobulin)

Dosage Form

Rebinolin®

Solution for intramuscular and subcutaneous injection 150 IU/1 ml: vials 2 ml or 10 ml

Dosage Form, Packaging, and Composition

Solution for intramuscular and subcutaneous injection transparent, slightly opalescent, colorless or light yellow in color; may contain a small amount of suspended sediment that breaks up upon shaking.

Excipients: glycine – 22.5 mg (300 mM), water for injections – up to 1 ml.

2 ml – vials of colorless glass (1) – cardboard boxes.
10 ml – vials of colorless glass (1) – cardboard boxes.

Clinical-Pharmacological Group

Immunological preparation. Immunoglobulin

Pharmacotherapeutic Group

Immunoglobulin

Pharmacological Action

Rebinolin^® is a buffered isotonic solution of specific human antirabies immunoglobulin, obtained from the plasma of donors immunized with an inactivated rabies vaccine (prepared based on a strain grown on human diploid cell culture), and containing a large amount of specific antibodies against the rabies virus.

Administration immediately after infection forms passive immunity to the rabies virus, increases the duration of the incubation period and thereby contributes to effective vaccination during comprehensive immunoprophylaxis of rabies.

Pharmacokinetics

C_max of antibodies is reached 2-3 days after intramuscular administration of antirabies immunoglobulin.

T_1/2 of antibodies is from 3 to 4 weeks. Immunoglobulin G and immunoglobulin G complexes are destroyed in the cells of the reticuloendothelial system.

Indications

• Therapeutic and prophylactic immunization against rabies for any damage to the skin (bites, any wounds and scratches) inflicted by wild or domestic animals with rabies, suspected of having rabies, under veterinary observation and not under observation, as well as when saliva of infected animals gets on mucous membranes or damaged skin.

ICD codes

Dosage Regimen

Intramuscularly, for adults and children – 20 IU/kg (0.133 ml/kg), as a single dose.

The dose should not be exceeded under any circumstances, because the administration of immunoglobulin may partially suppress the production of one’s own antibodies.

If anatomically possible, the maximum allowable part of the drug dose should be administered by infiltration around the wound, and the remainder – intramuscularly (into the upper outer quadrant of the buttock).

The central part of the gluteal region should be avoided, because there is a risk of damage to the sciatic nerve.

Simultaneously, the first dose of rabies vaccine (prepared on human diploid cell culture) is administered into another part of the body, preferably as far as possible from the site of antirabies immunoglobulin administration (preferably into the deltoid muscle area).

If therapy was delayed 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 start of therapy.

The drug should not be administered using the same syringe or into the same anatomical area of the body as the rabies vaccine.

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

Rabies immunoglobulin should be administered exclusively in combination with rabies vaccine.

The only exception is individuals who have already been vaccinated with rabies vaccine and who have confirmed presence of antirabies antibodies.

These individuals should receive only the vaccine.

Therapy should be discontinued if the animal remains healthy during the 10-day observation period or if the rabies virus is not detected in the killed animal after appropriate laboratory tests.

Adverse Reactions

Local reactions pain and discomfort at the injection site.

Systemic reactions hyperthermia, allergic reactions (skin reactions, anaphylactic shock, angioneurotic edema), dizziness, vomiting, decreased blood pressure, tachycardia.

Contraindications

None (100% lethality of rabies disease overrides any contraindications).

Use with caution in patients with documented allergy to any component of the drug.

Use in Pregnancy and Lactation

The use of this drug during pregnancy has not been studied in controlled clinical trials, therefore during pregnancy and lactation the drug should be prescribed only in cases where the expected therapeutic benefit for the mother outweighs the potential risk to the fetus or breastfed infant.

Long-term medical experience with the use of immunoglobulins does not suggest any harmful effects on the course of pregnancy, or on the fetus and newborn.

It should be borne in mind that immunoglobulins are excreted in breast milk, which may contribute to the transfer of protective antibodies (passive immunity) to the child.

Special Precautions

Re-administration of the drug should not be performed after the start of the rabies vaccine immunization program, as it may reduce the maximum immunity.

Do not administer the drug intravenously (risk of anaphylactic shock). Before administration, ensure that the needle has not entered a blood vessel.

Allergic reactions to human antirabies immunoglobulins upon intramuscular administration are rare.

In case of shock development, carry out standard therapy.

In case of hypersensitivity to blood products (in history), antihistamine medications should be used (while carefully monitoring the patient).

Surgical and antiseptic treatment of the wound (including abundant washing with water and soap and disinfection using quaternary ammonium salts) should be performed as soon as possible after the bite and regardless of the time elapsed after contact.

After administration of the drug, the patient should be under medical supervision for at least 20 minutes.

After administration of immunoglobulin, a temporary increase in antibody levels may cause false-positive results in serological tests.

To avoid possible interaction between several different drugs, it is necessary to inform the doctor about any other ongoing therapy.

To prevent the risk of transmission of infectious agents, thorough control of donor blood selection is carried out by testing each donated blood volume and the total plasma volume, especially for HIV-1, HIV-2, hepatitis B virus, hepatitis C virus, in addition, treatment with a detergent solution, heat treatment and nanofiltration are performed.

Overdose

Cases of overdose have not been described.

Drug Interactions

Enhances the effect (mutually) of rabies vaccines and is used in combination with them.

The combination with inactivated rabies vaccine prepared on human diploid cell culture is especially recommended, since the latter has high immunogenicity and induces active antiviral immunity.

Administration of immunoglobulins may adversely affect the efficacy of vaccines containing live attenuated viruses of measles, rubella, mumps, or varicella.

Therefore, an interval of 3 months should be observed between the administration of Rebinolin^® and the attenuated live vaccine.

Compatible with antitetanus serum and antibiotics.

Storage Conditions

At a temperature of 2 to 8°C (46.4°F). Do not freeze. Keep out of reach of children.

Shelf Life

Shelf life – 2 years.

Dispensing Status

The drug is dispensed by prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.