Vinrab
UkraineTable of Contents
INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT VINRAB
Composition:
Active substance: fragments of antirabies immunoglobulin (equine);
1 ml of solution contains not less than 200 IU of antirabies immunoglobulin fragments (equine);
Excipients: cresol (0.25%), glycine (22.5 mg/ml), sodium chloride, water for injections.
Pharmaceutical form. Solution for injection.
Main physicochemical properties: clear solution ranging from pale yellow to light brown in color. Slight turbidity or a small amount of solid particles may occur during storage; a characteristic cresol odor is present.
Pharmacotherapeutic group.
Antimicrobial agents for systemic use. Immune serum.
ATC code J06AA06.
Immunological and biological properties.
Vinrab is a sterile, pyrogen-free solution intended for intramuscular administration, containing antibodies against the rabies virus, obtained from serum of healthy horses immunized with rabies vaccine. Vinrab contains the antimicrobial agent cresol.
Pharmacodynamics. Not applicable.
Pharmacokinetics. Not applicable.
Clinical characteristics.
Indications.
The medicinal product Vinrab is indicated for passive therapeutic and prophylactic immunization of patients suspected of exposure to rabies virus or individuals who have had contact with animals potentially infected with rabies. Vinrab should not be considered as a standalone anti-rabies medicinal product. Vinrab should be administered in combination with rabies vaccine.
The only exception is patients who have previously been vaccinated with anti-rabies vaccine and who can provide documented evidence of vaccination with a cell-culture-derived vaccine (i.e., complete pre-exposure vaccination within the past year, administration of booster doses within the previous 5 years, or complete pre-exposure prophylaxis). Such patients may receive the vaccine alone, without anti-rabies immunoglobulin.
Contraindications.
There are no contraindications to therapeutic and prophylactic immunization, as immunization is performed under life-threatening indications.
Administration to patients with previously documented allergic manifestations or hypersensitivity reactions to equine serum should be carried out with special caution under physician supervision.
Safety precautions.
Unused portions of the injection solution and used vials must be disposed of in accordance with current legislation.
Interaction with other medicinal products and other types of interactions.
In cases of potential exposure to rabies virus, to prevent disease development, the medicinal product Vinrab and rabies vaccine should be administered simultaneously. To minimize possible interference, Vinrab and the rabies vaccine should be injected at different anatomical sites, preferably at opposite sides of the body. The injection solution Vinrab and the rabies vaccine must not be administered using the same syringe.
During the course of therapeutic and prophylactic rabies vaccination, administration of other vaccines is prohibited. After completion of rabies vaccination, administration of other vaccines is permitted no earlier than 2 months later.
Generally, Vinrab should not be administered concurrently with corticosteroids, as they may suppress the immune response.
Special precautions for use
Vinrab must not be administered intravenously due to the risk of shock development.
In patients with known allergy to horse protein, human immunoglobulin should be used. If human rabies immunoglobulin is unavailable, administration of a medicinal product based on anti-rabies (equine) immunoglobulin fragments should be performed immediately, but under strict medical supervision to prevent possible anaphylactic shock. Extreme caution is required when administering the product to patients who have previously exhibited allergic reactions to the drug or who have hypersensitivity to any of its components.
Multiple injections into the wound should be avoided.
Vinrab must not be administered using the same syringe as the vaccine. Whenever possible, the vaccine should be administered at a site opposite to the injection site of Vinrab or any other anti-rabies immunoglobulin-based product.
If allergic or anaphylactic reactions occur, administration of the drug must be stopped immediately. In case of anaphylactic shock, appropriate treatment must be initiated. For hypersensitivity to the drug, symptomatic therapy, desensitizing agents, and antihistamines should be prescribed.
The patient should inform the physician about any known allergies related to animal contact (especially horses), or any history of food allergies.
When clinically indicated, anti-tetanus therapy should be initiated and antibiotics prescribed for the treatment of other infections.
Vinrab should be administered as early as possible after exposure, no later than 3 days post-contact. If Vinrab is not available at the time of the first anti-rabies vaccination, it may be administered within 7 days.
The product contains less than 1 mmol (23 mg)/dose of sodium, i.e., it is practically sodium-free.
Use during pregnancy or breastfeeding
The safety of Vinrab during pregnancy and breastfeeding has not been established in clinical trials involving humans.
Since rabies is a fatal disease, pregnancy is not considered a contraindication for the use of Vinrab. However, if possible, human immunoglobulin should be preferred.
As components of Vinrab may pass into breast milk, breastfeeding should be discontinued during treatment.
The risk-benefit balance of using the drug should always be carefully considered. Pregnant women and breastfeeding mothers should consult a physician before initiating treatment.
Effect on the ability to drive or operate machinery
There are no data indicating negative effects of Vinrab on patient reaction speed or the ability to drive or operate machinery. However, considering the risk of delayed-type allergic reactions (see section "Adverse reactions"), patients are advised to refrain from activities requiring high concentration and rapid reaction, and, if possible, from driving or operating machinery.
Method of Administration and Dosage
First Aid
It is extremely important to perform prompt local wound treatment for bites and scratches that may have been contaminated with rabies virus, regardless of the time elapsed since contact with an animal potentially infected with rabies. Recommended first aid procedures include thorough washing of the wounds with soap and water, or another cleansing agent or antiseptic permitted for human use, or with another substance proven to have a virucidal effect against rabies virus and safe for the patient. Human Rabies Immunoglobulin (HRIG) should be administered as soon as possible after potential exposure to rabies virus.
| Category |
Contact with an animal sick with rabies or suspected of having rabies, or with a wild animal or an animal that is unavailable for observation/examination |
Recommended treatment |
| I |
Touching or feeding animals, licking of intact skin. |
No treatment is required if reliable history is available. |
| II |
Bites on intact skin. Minor scratches or abrasions without bleeding. Licking of damaged skin. |
Immediate vaccination. Treatment should be discontinued if the animal remains healthy throughout the entire observation period (10 days) or if the animal was killed and laboratory testing for rabies using appropriate methods yielded negative results. Administration of WinRab together with rabies vaccine is indicated for patients with impaired immunity (immunosuppression). |
| III |
Single or multiple bites or scratches. Exposure of patient's mucous membranes to saliva from a rabid (or potentially infected) animal. |
WinRab and concomitant rabies vaccination should be initiated immediately. Treatment should be discontinued if the animal remains healthy throughout the entire observation period (10 days) or if the animal was killed and laboratory testing for rabies using appropriate methods yielded negative results. |
For the prevention of rabies development, combined administration of the medicinal product Vinrab and rabies vaccine is recommended. The recommended dose of equine anti-rabies immunoglobulin fragments is 40 IU/kg body weight. If anatomically feasible, as much of the dose as possible should be administered around the wound(s). The remaining dose should be administered once intramuscularly (into the gluteal muscle).
In cases of multiple wounds, the calculated volume of equine anti-rabies immunoglobulin may be insufficient to infiltrate all wounds. Under these conditions, the recommended dose of Vinrab may be diluted with 1/2 or 1/3 of 0.9% sodium chloride solution to achieve sufficient volume and ensure penetration into all wounds. Due to the risk of interference with the antibody production process related to vaccination, the dose should not be increased, nor should repeated doses of anti-rabies immunoglobulin be administered (even if initiation of concurrent prophylaxis is delayed).
Vinrab should be administered simultaneously with the rabies vaccine, but at different body sites, preferably at opposite sides of the body. If indicated, tetanus treatment should be initiated and antibiotics prescribed for the management of other infections.
Infiltration into wounds with specific anatomical locations (fingertips) should be performed with caution to prevent increased tissue pressure (compartment syndrome).
Children.
Children and adults receive the same dose of 40 IU/kg body weight. The medicinal product Vinrab is indicated for use in pediatric practice.
Overdose.
In case of overdose, the active substance of the medicinal product Vinrab may interfere with the ability of live rabies vaccines to induce an immune response.
Side effects
Side effects observed with the use of Vinrab are classified by organ systems and frequency of occurrence: very common: > 1/10; common: > 1/100 – < 1/10; uncommon: > 1/1,000 – < 1/100; rare: > 1/10,000 – < 1/1,000; very rare: < 1/10,000; and unknown (frequency cannot be estimated due to limited available data).
Immune system disorders
Rare – allergic reactions, including immediate-type reactions; anaphylactic reactions, urticaria.
Very rare – anaphylactic shock, angioedema (Quincke's edema).
General disorders
Rare – fever, dyspnea.
Musculoskeletal and connective tissue disorders
Rare – arthralgia.
Injection site reactions
Very rare – allergic reaction (pain, erythema, swelling, pruritus).
Blood and lymphatic system disorders
Rare – adenopathy/lymphadenopathy.
Immediate or delayed-type allergic reactions may occur following administration of equine proteins, including equine rabies immunoglobulin fragments.
Immediate-type allergic reactions include anaphylaxis with hypertension, dyspnea, and urticaria. Delayed-type allergic reactions include inflammatory reactions, fever, pruritus, urticaria, adenopathy, and arthralgia.
Delayed reactions resembling serum sickness (diseases caused by allergic reactions) or angioneurotic edema, reported after administration of heterologous proteins (non-human origin), may occur within six days after initiation of treatment.
Shelf life: 2 years.
After first opening of the vial, the solution should be used immediately.
Storage conditions: Store at a temperature of 2 to 8 °C. Do not freeze. Store in a place protected from light.
Incompatibility: Compatibility studies of the medicinal product Vinrab have not been conducted. Vinrab should not be administered simultaneously with other medicinal products, except those specified in the sections "Method of administration and dosage" and "Special precautions for use".
Packaging: 5 ml in a vial. 1 vial per cardboard box.
Prescription status: Prescription only
Manufacturer: VINS BIOPRODUCTS LIMITED
Manufacturer's address and place of business:
No. 117, Thimmapur, Kothur Mandal, Ranga Reddy District, Telangana State, India.
Marketing authorization holder: VINS BIOPRODUCTS LIMITED
Address of the marketing authorization holder: No. 117, Thimmapur, Kothur Mandal, Ranga Reddy District, Telangana State, India.