Equine antirabies immunoglobulin fragments.
Each mL contains: Equine antirabies immunoglobulin fragments not less than 200 I.U.
Preservative: Cresol B.P. ≤ 0.25% v/v.
Excipients: Sodium Chloride B.P.
Stabilizer: Glycine B.P.
VINRAB 1000 I.U. is a sterile, non-pyrogenic solution for intramuscular administration, containing antiviral substances obtained from the blood serum of healthy equines that have been immunized against rabies by vaccination. In addition, it also contains the antimicrobial agent cresol.
VINRAB 1000 I.U. provides passive immunization against rabies for prevention of rabies in patients at risk of being exposed to rabies after contact with a rabid animal or an animal presumed to be rabid. Antirabies serum itself does not constitute an antirabies treatment and should always be used in conjunction with rabies vaccine.
First-aid treatment: Prompt local treatment of bite wounds and scratches that may be contaminated with rabies virus is important, whatever the time elapsed since the contact. Recommended first-aid procedures are imminent thorough flushing and washing of the wound with soap and water, detergent or other substance of proven lethal effect on rabies virus. The rabies immunoserum should be injected as soon as possible after exposure.
Category-Wise Dosage and Administration:
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For prevention of rabies, combined immunoglobulin vaccine treatment is recommended. The recommended dose is 40 I.U./Kg of body weight. If anatomically feasible, as much as possible of the dose should be infiltrated around the wounds. The remainder should be administered intramuscularly (into the gluteal region) in a single dose.
The first dose of the vaccine should be inoculated at the same time as the immunoglobulin, but in different parts of the body. Children and adults received the same dose of 40 I.U./Kg of body weight. When indicated, begin antitetanus treatment and administer antimicrobial drugs to control infections other than rabies.
Should be used with extreme caution in subjects with a history of allergic symptoms or hypersensitivity to equine serum.
Despite WHO does not recommend to perform the skin test before administration of Equine Rabies Immunoglobulin (WHO Expert Consultation on Rabies, WHO TRS 982), the skin test can still be applied and performed according to the Clinical Practice Guidelines 2012 for Rabies Disease of the Ministry of Public Health. The skin test should be performed as follows: Prepare 1:100 dilution of Vinrab 1000 I.U. with normal saline solution.
Provide the intradermal injection of 0.02 ml of diluted solution to the inside part of the forearm so as to obtain the wheal (3 mm diameter).
An equivalent intradermal injection of normal saline solution at another side of the forearm is used as control.
The observations made 15-20 minutes after the intradermal injection is considered to be positive if: >10 mm diameter of wheal appears with flare surrounded and the control is negative.
The control shows dermal reaction and the sample shows a bigger reaction than the control.
A positive test result is not a formal contra-indication for the use of serotherapy, but it should be considered as a warning. In such cases, Human Rabies Immunoglobulin (HRIG) should be used instead of. If HRIG is not available, VINRAB 1000 I.U. shall be used with caution and under the physicians' observation. Adequate treatment including adrenaline (epinephrine), antihistamine and respirator should be prepared and provided for immediate use. A negative test is not an absolute guarantee for the absence of an immediate allergic type reaction.
Adequate treatment for anaphylaxis reaction should also be prepared even the result is negative.
The safety or rabies immunoserum when used during pregnancy has not been established in clinical trials in human beings. Considering the lethal risk associated with rabies, pregnancy is not a contraindication to the administration of rabies immunoserum subsequence to exposure.
Immediate or delayed hypersensitive type reactions may be developed on administration of rabies immunoserum. The observed immediate reactions are anaphylactoid reactions with hypotension, dyspnea, urticaria. Delayed reactions consist of inflammatory reaction, fever, pruritus, rash or urticaria, adenopathy and arthralgia.
Rabies prevention after contamination risk requires simultaneous administration of antirabies immunoglobulin and vaccine to be inoculated in different parts of the body, contralaterally, if possible, to minimize the interference. The antiserum should not be administered from the same syringe as the vaccine.
Disposal: Left over VINRAB 1000 I.U. and used empty vials should be discarded as Biomedical waste.
Store at a temperature between 2°C to 8°C in a refrigerator.
DO NOT FREEZE.
J06AA06 - rabies serum ; Belongs to the class of immune sera. Used in the treatment of acute infectious diseases caused by toxigenic strains.
Inj (vial) 1,000 IU x 5 mL x 10's.