Type and form of product:
Purified immunoglobulin, clear and injectable liquid
Product compositions:
This product is made from concentrated and purified hyperimmune horse plasma against five types of snakes' venom as follows:
 -VIpera lebetina
-Vipera albicornuta
-Echis carinatus
-Pseudocerastes persicus
-Agkistrodom halys
The active ingredients for this product are included F (ab'), fragments of immunoglobulins; each milliliter has the ability to neutralize more than 50 LD5o of the venom of each above mentioned snakes based on the lethal activity on the mice.
This product contains up to 0.25% phenol as a preservative.
Indication:
For neutralizing the snakes' venom mentioned above.
Administration route and dosage:
Since the amount of venom among the bitten children or adults is the same, they should exactly be taken the same amount of antivenom, regardless of their age and body weight. However, children and weak people are at higher risk. Considering the severity of the symptoms and clinical complications of the person envenomed, it is usually recommended to administer 1 to 2 ampoules via slow intravenous injection or infusion, as an initial dose, to neutralize the venom. In severe cases, especially if there is a delay in treatment, administration of more ampoules will be required. This amount depends on the laboratory test results and clinical examination, and is prescribed* the Physician. The initial dose should be repeated after 1-2 hours in case of persistent or recurrent bleeding, as well as persistence or worsening of the neurological and cardiovascular symptoms. In case of persistence or recurrent of coagulation problems, the initial dose should be repeated after 6 hours.
Appropriate time and bow to use:
This product should be prescribed immediately after the snake bite via intravenous infusion (It should be diluted with 250-500 ml of 0.9% Saline or 5% glucose solution and infused at 250 ml/hr). If there is no available facility for infusion, antivenom could intravenously be injected using a syringe with the rate of 2 ml/min, under a physician's supervision.
How to use during pregnancy and lactation:
There is no information about undesirable effect(s) of this product during pregnancy and lactation.
Contraindications:
-This product cannot be used in cases of scorpion sting.
-Do not use the antivenom if you notice any change(s) in color, opacity and particles- in the ampoule.
-Do not use the antivenom after the expiry date.
Side effects:
It is possible to observe the following side effects due to the fact that this product is made froth horse plasma derivatives and is a heterologous agent for humans.
-Early side effects (anaphylactic) that usually occur 10-180 minutes after injection/ infusion including dry coughs, shortness of breath, heaves, itching, vomiting, nausea, colic, diarrhea, hypotension, tachycardia and anaphylactic shock. • •
-Delayed side effects (caused by endotoxins) that usually occur 1-2 hours after injection/ infusion, including seizure, shaking chills, fever, vasodilation and hypotension.
-Late side effects (serum sickness) that usually occur 1-12 days in 7 days average after injection/ infusion, including fever, nausea, vomiting, diarrhea, itching, rashes or heaves, muscular pain, joint pain, lymphadenopathy; proteinuria associated with nephritis, Mononeuritis multiplex, and encephalopathy in rare cases. 
Note: Individuals who receive antihistamine or corticosteroid are less likely to face with late side effects. 
Therapeutic measures in case of anaphylactic shock:
-Stop the antivenom injection/infusion as soon as noticing signs of anaphylactic shock.
-Inject intramuscularly 0.5-1 ml of adrenaline (1mg/ml) in adults and 0.01 mg/kg in children, if necessary, repeat it every 5-10 minutes until desirable hemodynamic condition is achieved.
-Inject the adrenaline intravenously In case of intensified anaphylactic reactions.
-Prescribe the antihistamine and corticosteroid as complementary treatment.
-Prescribe the oxygen and if necessary give artificial respiration.
-Do Infusion of liquids to compensate for hypotension.
-Continue the antivenom injection/infusion in spite of anaphylactic shock symptoms cured.
Drug interactions:
There has not been yet a comprehensive study concerning the drug interactions of this product.
Precautions and warnings:
-Before injection/infusion of the antivenom, prepare I ml of adrenaline (1mg/m1) in a syringe and keep it available.
-In individuals with severe atopic diseases history, if systematic signs of snakebite exist, prescription of adrenaline, HI &H2 blockers, corticosteroids, and salbutamol, before injection/infusion of antivenom, may prevent the occurrence of bronchospasm. -Antivenom prescription should be immediately stopped in case of any reaction(s) during injection/infusion, and if reactions continued (in spite of injection stopped), symptomatic treatment should be commenced.
-Do not use frozen antivenom.
-Aseptic condition should be followed when injecting/infusing the antivenom.
-As a result of the snakebite, tetanus and microbial infections should possibly be considered and appropriate/necessary measures taken.
-Prescriptions of sedatives such as acetaminophen except morphine are recommended, but avoid drinking alcoholic beverages. 
Notices:
-Keep warm the injured person before and after the antivenom prescription, and supervise him/her for 2 hours after injection. 
-Decrease the anxiety and excitement of the injured person.
-Keep the injured organ fixed, as much as possible.    
-Do not use the tourniquet especially in case of edema.
-To prevent the edema, it is recommended to tie a wide band above the bite area so that it doesn't block the blood flow. 
-Do not reuse the antivenom remained.
-Do not manipulate, cut or suck the bite area.
Safe disposal of waste or partially used product:
Leftover antivenom container and all unused contents must be properly sterilized by autoclave, burning or appropriate chemicals. 
Storage:
Keep the antivenom at 2 to 8 °C away from light. In this condition, it can be used up to the expiry date stated on the product label.
Packaging:
This product is provided in single box, containing 10 milliliters ampule.
Last reviewed:
10.2018
References:
I-David A. Warrel, 2010, guidelines for the management of snake-bites, World Health Organization- regional office for South-East Asia.
2- WHO Technical Report Series 964.