| ANTI RABIES SERUM I.P. (ARS) |
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useful the treatment of category III bites of dogs, wolves and jackal. Being in liquid form it should be stored at 2oC to 8oC. It a solution of purified antibodies prepared from equine blood.
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| Ingredients : |
Enzyme Refined Equine immunoglbulins . |
| Qty. |
5 ml. Potency not less than 300 IU/Ml |
| Packing : |
1,5,10,20 vials
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| Category : |
Passive immunising agent . |
| Indication : |
Treatment of category III bites of dogs wolves & Jackals. |
| Dosage : |
40 IU/Kg, body weight by 1/M or S/C route. |
| Adverse Drug Reaction : |
Occasional sensitivity reactions acute anaphylactic shock which needs immediate treatment. |
| Precautions : |
- Sensitivity tests should be done whenever possible before administration.
- Antihistamines and treatment for anaphylactic shock should be kept ready.
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| ANTIRABIES SERUM I.P. |
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Equine Refined Equine Rabies Immunoglobulin 1500 I.U. Potency not less than 300 IU/ml.
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| PREAMBLE |
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Antirabies Serum is of equine origin derived from the plasma of the horses, ponies, mules that have been hyperimmunized against rabies. The serum obtained from plasma contains purified, enzyme-refined and concentrated specific immunoglobulins. It is used as a passive immunizing agent and affords protection to the persons suspected of exposure to rabies.
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| COMPOSITION |
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Each ml contains Enzyme-refined Equine Immunoglobulin Not less than 300 I.U. Phenol I.P. Not more than 0.25% w/v.
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| PHARMACEUTICAL FORM |
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Solution for injection by intramuscular or subcutaneous route. 5.0 ml per vial, 1500 I.U.
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| THERAPEUTIC INDICATIONS |
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For the treatment of category III bites for patients at risk being exposed to rabies after contact with confirmed or suspected rabid animal.
(Category III bites -major bites on head, face, neck or finger, single or multiple transdermal bites or scratches. Lacerated wounds on any part of the body. Contamination of mucous membrane with saliva. All jackal and wolf bites,)
It should be given as soon as possible after exposure preferably within 24 to 48 hours as it contains readymade antibodies. These antibodies confer passive immunity against rabies infections.
It must be injected as soon as possible locally to permit direct and rapid in-site neutralization of positive virus. Antirabies serum alone does not guarantee an Antirabies treatment and should always be combined with Antirabies vaccination.
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| PRECAUTIONS |
| Use with caution in subjects with a history of allergic symptoms to serum. In such cases, equine Antirabies serum is administered under medical environment that permits treatment in case there is an eventual dramatic allergic reaction. |
| ADVERSE EFFECTS |
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They are many immediate or delayed allergic type reactions. The observed immediate reactions are anaphylactic reactions with hypotension, dyspoea and unticaria.Delayed reaction consist of inflammatory reaction, fever pruritus rash o urticaria, adenopathy and arthralgias.Anaphylactic reactions can occur during and after the treatment even it the hypersensitivity test is negative. Anaphylactic reaction can occur even with the test.
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| PRECAUTIONS TO BE OBSERVED BEFORE ADMINISTRATION OF ANTIRABIES SERUM. |
- Elicit history of familial allergic disorders such as asthma,
- Eczema, drug all allergy from the patient.
- Whether the patient had received earlier, injection of serum such as ant tetanus serum , Antidiphtheria, serum snake Antivenin or scorpion venom Antiserum etc.
- Carry out the sensitivity test on the patient. Inject subcutaneously 0.1 ml. of the serum diluted 1:10 Observe the patient for 30 minutes for local or general reaction if any.
- Keeps handy injection Adrenaline (Epinephrine) 1 ml of 1:1000 along with antihistanminesand steroids to meet any emergency arising out of sensitivity reactions.
- After administering the full dose of serum the patient should be keep under observation for at latest 30 minutes.
- In sensitivity individual it is advisable to administer Antirabies Serum under the cover of injection Adrenaline (Epinephrine) 1 ml ( 1:1000) intramuscular and Antihistamines.
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| DRUG INTERACTIONS |
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Rabies prevention after contamination risk requires simultaneous administration of Antirabies Serum and vaccine. Antirabies Serum and vaccine must be given in the Separates sites to avoid insite neutralization. Antirabies serum should be administered in the same syringes as the vaccine.
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| PREGNANCY AND LACTATION |
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The use of human AntiRabies immunoglobulin is preferable.
The safety of this medical product when used during Pregnancy has not been established in clinical trials in humans Considering the lethal risk associated with rabies, Pregnancy is not a contraindication to be administration of Antirabies treatment subsequent exposure.
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| DOSE AND ADMINISTRATION |
| First Aid Treatment. |
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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 procedure are immediate through flashing and washing of the would with soap and water, detergent or other substance of proven lethal effect of rabies virus.
Anti Rabies Serum should be injected as soon as possible after exposure.
Anti Rabies Serum should be given to all category III bite cases provide the patient seeks treatment within 7 days of bite.
Recommended dose 40 IU / kg. body weight up to maximum of 3000. I .U.
Maximum possible of the required dose should be infiltrated around the wounds, if anatomically feasible.
The first dose of vaccine should be inculcated at the same time as the immunoglobulin but in a different part of the body (upper part of arms Deltoid region)
In no cases should the dosage of the Antirabies Serum be the exceeded because immunoglobulin may partially suppress active production of antibodies.
Children and adults receive the same dose of 40 IU/Kg of body weight.
When indicated, begin anti-tetanus treatment and administer antimicrobial drugs to control infections other than rabies.
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| Category |
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Type of contact with a suspect or confirmed rabid domestic or wild animal not available observation |
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Recommended Treatment |
| I. |
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Touching or feeding of animal licks on intact skin |
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None, if reliable case history is available |
| II. |
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Rubbing of uncovered skin. Minor scratches or observation without bleeding Licks on broken skin. |
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Administration vaccine immediately. Stop treatment if animal remain healthy throughout an observation period of ten days or if animal is killed humanely and found to be negative for rabies by appropriate laboratory techniques |
| III. |
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Single or myultiple transsdermal bites or scorches Contamination of mucous membrane with saliva (i.e.licks) |
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Administration rabies immunoglobulin and vaccine immediately. Stop treatment if animal remains healthy throughout an observation period of ten days or if animal is killed humanely and found to be negative for rabies by appropriate laboratory techniques |
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| STORAGE : |
| Store at 2 oC to 8 oC in a refrigerator. It should be allowed to freeze |
| EXPIRY : |
| The shelf life the product is 24 months. The expiry date printed on the packing refers to the packed product correctly stored. Do not use beyond Expiry date clearly indicated on the label. |
| References : |
- World Health Organization WHO expert committee on Rabies, 8th
report WHO Tech rep Ser 1992,824, 1-84.
- Wilde H., Purified equine Rabies immunoglobulins. a safe and affordable alternative to human rabies immunoglobulins. Bull. WHO 1989, 67,731-736.
- Meslin F.X., Kaplan M. M. and Koprowsky H. (1996); Laboratory Techniques in rabies, 4th edition WHO Geneva.
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Quantity : Available Rate : Rs. 389.85 (within Maharashtra state)
Rate : Rs. 386.14 (outside Maharashtra state)
(2% CST if FORM 'C' produced)
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