Injection of diphtheria antitoxin in horse-serum-sensitive individual can produce immediate reaction of acute anaphylaxis which could sometimes be fatal unless immediately countered by injecting 1ml of 1:1000 adrenaline intramuscularly. Every care should be taken to prevent this reaction. Before injection of diphtheria antitoxin it is necessary to enquire from the patient
1) Whether he/she has had injections of any serum before
2) Whether there is personal or family history of allergy i.e. asthma, eczema or drug allergy. The sensitivity of the patient to serum is tested by injecting subcutaneously 0.1ml of diphtheria antitoxin diluted 1:10 and the patient is observed for 30 min. for local and general reactions. If the test dose shows either local reaction such as wheal and flare or general anaphylactic reaction such as palor, sweating, nausea, vomiting urticaria or fall of blood pressure, these should be treated with 1ml of 1:1000 adrenaline (which should always be kept handy) before injecting the main dose of diphtheria antitoxin. Half the dose of adrenaline may be repeated 15 min. later if necessary.
In allergic individuals, the diphtheria antitoxin is to be injected 15 to 30 mins. after administration of antihistamines such as injectable Antistine (100mg) and Injectable Hydrocortisone (100mg) intramuscularly. One ml of Adrenaline (1:1000) may be injected intramuscularly at the same time as the antiserums. Administration of hydrocortisone or adrenaline may be repeated if necessary.

COMPOSITION

Each ml contains Enzyme-refined Equine Immunoglobulin Not less than 300 I.U.
Phenol I.P. Not more than 0.25% w/v.

Solution for injection by intramuscular or subcutaneous route. 5.0 ml per vial, 1500 I.U.

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.

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

They are many immediate or delayed allergic type reactions.
The observed immediate reactions are anaphylactic reactions with hypotension, dyspnoea and unticaria.
Delayed reactions consist of inflammatory reaction, fever pruritis rash o urticaria, adenopathy and arthralgias.

Anaphylactic reactions occur during and after the treatment even it the hypersensitivity test is negative.

Anaphylactic reaction can occur even with the test.

• 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 antihistamines and 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.

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.

DOSE AND ADMINISTRATION

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 wound 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.

STORAGE:

Store at 2 oC to 8 oC in a refrigerator. It should be allowed to freeze

EXPIRY:

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