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Vinrab

Vinrab

rabies immunoglobulin

Manufacturer:

Vins Bioproducts

Distributor:

Ambica
Full Prescribing Info
Contents
Equine anti-rabies immunoglobulin.
Description
Each mL contains: Equine anti-rabies immunoglobulin fragments not less than 200 I.U./mL, Cresol B.P. ≤ 0.25% v/v as preservative, Glycine B.P. 22.50 mg/mL, Sodium chloride B.P. 9 mg/mL, Water for Injection B.P. q.s.
Equine Anti-rabies immunoglobulin (Vinrab) is a sterile 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.
Indications/Uses
Equine Anti-rabies Immunoglobulin (Vinrab) 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. Anti-rabies serum itself doesn't constitute an anti-rabies treatment and should always be used in conjunction with rabies vaccine.
Dosage/Direction for Use
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. (See table.)

Click on icon to see table/diagram/image

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 immunoglobulin, but in different parts of the body. Children and adults receive 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.
Contraindications
Should be used with extreme caution in subjects with a history of allergic symptoms of hypersensitivity to equine serum.
Special Precautions
Despite the high degrees of purification of the serum, it is recommended to perform a skin test before administering ERIG. The skin test consists of an intradermal injection with a 1:10 dilution of ERIG (0.1 mL) on the outside of the forearm so as to obtain an orange ring type appearance (3 mm diameter in duration).
An equivalent intradermal injection of physiological saline solution is used as control. The observations made 15 minutes after intradermal injection is considered to be positive if erythema (>6 mm), local edema or a systemic reaction is observed and this control shows no such dermal reaction. Purified equine rabies immunoglobulin (the active constituent of rabies immunoserum) has been reported to be safe and affordable alternative to human rabies immunoglobulin. (Bulletin WHO 1989, 67 (731-732). A positive test result is not a format contraindication for the use of serotherapy, but it should be considered as a warning. In such cases ERIG should be administered only after ensuring the facility to overcome the anaphylactic shock. A negative test is not an absolute guarantee for the absence of an immediate allergic type reaction.
Use In Pregnancy & Lactation
The safety of rabies immunoserum when used in 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.
Adverse Reactions
Immediate or delayed hypersensitive type reactions may be developed on administration of rabies antiserum. The observed immediate reactions are anaphylactoid reactions with hypotension, dyspnea and urticaria. Delayed reactions consist of inflammatory reaction, fever, pruritus, rash or urticaria, adenopathy and arthralgia.
Drug Interactions
Rabies prevention after contamination risk requires simultaneous 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.
Storage
Store at temperatures between 2°C to 8°C. Do not freeze.
MIMS Class
Vaccines, Antisera & Immunologicals
ATC Classification
J06BB05 - rabies immunoglobulin ; Belongs to the class of specific immunoglobulins. Used in passive immunizations.
Presentation/Packing
Form
Vinrab soln for inj 200 IU/mL
Packing/Price
5 mL x 10 × 1's
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