Purified Cobra (Naja kaouthia) antivenom serum (SAV) is a colorless or pale yellow solution, derived from horse plasma containing antibodies against cobra venom.

COMPOSITION: In 1 vial the serum contains:

PHARMACOKINETICS, PHARMACODYNAMICS:

Antivenom serum contains globulins capable of specifically neutralizing snake venom, obtained from healthy horses immunized with that venom (monovalent antivenom) or with several venoms (polyvalent antivenom).
Different types of snake venom depend on the species and geographical distribution. Therefore, a specific antivenom is required for the relevant species.
Cobra venom typically contains neurotoxins that inhibit central nervous system activity.
Various snake antivenoms are produced worldwide. It is important to use the specific antivenom appropriate for the venom of the snake responsible for envenomation.

INDICATIONS:
Treatment of patients bitten by cobra (Naja kaouthia).

CONTRAINDICATIONS:
Due to the life-threatening nature of cobra bites, there are no absolute contraindications; however, measures against anaphylaxis must always be prepared for patients with history of allergy to equine serum.

DOSAGE AND ADMINISTRATION:

– Hypersensitivity test: Prior to injection, dilute the serum to a 1% solution and inject 0.1 ml intradermally. After 15 minutes, if the erythematous wheal is < 1 cm in diameter, the reaction is negative.

– Route: Intramuscular injection or slow intravenous injection. Administer 1 vial every hour until clinical signs of envenomation improve.

– Therapeutic dose: Depends on the severity of envenomation and the patient’s condition. The treating physician determines the appropriate dose (may range from 1 to several vials).

ADVERSE REACTIONS:
Individuals with allergic predisposition or repeated serum exposure may develop allergic reactions such as urticaria, itching, edema, nephritis, or in severe cases, anaphylactic shock.

PRECAUTIONS AND WARNINGS:

– If the hypersensitivity test is positive, apply the Besredka desensitization method: Inject 0.5 ml of 1% diluted serum subcutaneously, observe for 15 minutes. If no reaction, inject 0.1 ml undiluted serum, observe for 15 minutes. If no reaction, administer the remaining dose.
– Antihistamines may be administered before injection if necessary.
– Emergency medicines and equipment must always be available for anaphylaxis management.
– This antivenom is specific only for cobra (Naja kaouthia) venom. It has no or negligible effect against venoms of other snake species.
– Do not overuse purified cobra antivenom once the patient’s vital functions (physiology, biochemistry) have normalized.
– In patients with history of allergy to equine serum, antihistamines and anti-shock drugs must be prepared in advance.
– Do not use cobra antivenom for prophylaxis.
– Delayed hospital admission may reduce efficacy.

♦ Pregnancy: No contraindication when treatment is indicated.
♦ Lactation: No contraindication for use during breastfeeding.

Overdose and management: Report to physician any undesirable effects encountered during use.

DRUG INTERACTIONS:

– Treatment with beta-adrenergic blockers, including cardioselective agents, increases the severity of acute anaphylaxis.
– Anaphylaxis may be prolonged and resistant to conventional therapy in patients on beta-blockers.
– The therapeutic effects of epinephrine and other adrenergic agents may be altered, requiring higher-than-usual doses.

PACKAGING: Box of 10 vials, each vial containing potency equivalent to 1000 LD50.

STORAGE: Store at +2°C to +8°C. Do not freeze.

SHELF LIFE: 2 years.

– Read the package insert carefully before use. Report any undesirable effects to the physician.
– Prescription only medicine.