Serum against the venom vipers ordinary horse purified concentrated liquid (Solution) Instructions for Use

Marketing Authorization Holder

Microgen NPO, JSC (Russia)

ATC Code

J06AA03 (Snake venom antiserum)

Dosage Form

Serum against the venom vipers ordinary horse purified concentrated liquid

Solution for injection 150 AU/1 dose: amp. 1 or 5 pcs.

Dosage Form, Packaging, and Composition

Solution for injection transparent or slightly opalescent, colorless or with a yellowish tint, without sediment.

1 dose – ampoules (1) in a set with a sterile syringe – plastic boxes.
1 dose – ampoules (5) – cardboard packs.

Clinical-Pharmacological Group

Immunological preparation. Serum

Pharmacotherapeutic Group

Immune sera and immunoglobulins; immune sera

Pharmacological Action

The preparation is the immunoglobulin fraction of the blood serum of horses immunized with viper venom, purified and concentrated by the method of peptic digestion and salt fractionation, containing specific antibodies.

The antibodies contained in the serum neutralize the venom of the common viper.

Indications

• Treatment of people bitten by a viper.

ICD codes

Dosage Regimen

The serum is administered subcutaneously, intramuscularly, or intravenously as early as possible after the snake bite.

Providing first aid to the bitten person on site. The victim is placed in the shade and given plenty of fluids: tea, coffee, milk, broth, water (consumption of alcoholic beverages is prohibited) and 1 therapeutic dose of serum is administered regardless of the body weight of the bitten person. To avoid anaphylactic shock or other allergic complications, before administering the serum, the victim is given 1-2 tablets of any antihistamine (diphenhydramine, pipolfen, tavegil, etc.) orally. The serum is administered subcutaneously in a fractional manner (according to Bezredka) in any part of the victim’s body: first 0.1 ml, if there is no reaction after 10-15 minutes, 0.25 ml is administered, and then after 15 minutes, if there are no adverse reactions, the entire remaining serum. The opened ampoule should be covered with a sterile bandage or cotton swab.

After providing first aid, it is necessary to ensure the urgent hospitalization of the victim to the nearest medical institution, where treatment will continue. The patient is transported in a lying position. The bitten leg is bandaged to the healthy one, giving it a slightly elevated position. If the bite is on the arm, it is fixed in a bent position with the help of a cloth thrown over the neck.

Assistance in a medical institution. The total administered dose of serum is determined by the doctor depending on the degree of intoxication: for mild degree, 1-2 doses intramuscularly, for severe degree, 4-5 doses, taking into account the dose administered before hospitalization.

In case of particularly severe intoxication, it is recommended to administer the serum intravenously slowly by drip after dilution (1/5-1/10) with sterile, warmed to a temperature of (37±1)°C 0.9% sodium chloride solution for injection. The rate of administration: first 1 ml over 5 minutes, then 1 ml per minute. In exceptional cases, if drip infusion is not possible, slow jet administration of a therapeutic dose of serum without dilution with a syringe is allowed. To avoid possible allergic reactions, before starting the intravenous infusion of serum, 60-90 mg of prednisolone is administered to the patient by jet. Intravenous administration of the serum is permitted only for medical personnel!

In children, the same dosing principle is used as in adults, regardless of weight and age.

In some cases, if the bite site is contaminated with soil, if there are wounds, tissue necrosis of any type, it is necessary to carry out measures for emergency tetanus prophylaxis in accordance with the instructions for tetanus prophylaxis.

Adverse Reactions

The administration of the serum against viper venom may be accompanied by the development of various allergic reactions: immediate, occurring immediately after administration or after a few hours and manifested by symptoms of anaphylactic shock, early – on the 2nd day after administration, and delayed – on days 5-10. The latter are accompanied by a symptom complex of serum sickness (fever, itching and skin rashes, joint pain, etc.). If an anaphylactic reaction occurs, the administration of the serum is suspended. Adrenaline (epinephrine) (0.3-1 ml), cordiamine (1.5-2 ml), prednisolone 25 ml or hydrocortisone (50-100 ml), strophanthin (0.5 ml of 0.04%) with glucose (20 ml of 40% solution) are administered subcutaneously. Given the possibility of shock when administering the serum, each vaccinated person must be provided with medical supervision for 1 hour after the end of the drug administration.

The administration of the serum must be recorded in the established accounting forms with the mandatory indication of the date, method and time of administration, the patient’s reaction, the manufacturer and the batch number of the drug.

Contraindications

The only contraindication to the continued use of the serum is the development of anaphylactic shock upon administration of 0.1-0.25 ml of serum.

Use in Pregnancy and Lactation

During pregnancy, use is possible for vital indications, taking into account the benefit for the mother and the possible risk for the fetus. The lactation period is not a contraindication for use.

Pediatric Use

In children, the same dosing principle is used as in adults, regardless of weight and age

Special Precautions

Precautions for use.

Ampoules with serum should be carefully inspected before opening. The drug should not be used if

• Physical properties have changed (cloudy contents of the ampoule, presence of non-dispersible flakes);
• There is any damage to the integrity of the ampoules (cracks, etc.).

The drug for first aid, stored during expeditions in violation of the temperature regime, is not suitable for use after the expedition.

Effect on the ability to drive vehicles and mechanisms

Absent.

Overdose

Not established.

Drug Interactions

It is necessary to take into account compatibility with other medicinal products containing foreign protein in their composition.

Storage Conditions

Store and transport in accordance with SP 3.3.2.1248-03 at a temperature from 2°C (35.6°F) to 8°C (46.4°F). Keep out of reach of children.

Shelf Life

Shelf life – 2 years.

Dispensing Status

The drug, packaged in plastic boxes of 1 ampoule (1 dose) in a set with a syringe and needle, is dispensed without a prescription.

The drug, packaged in 5 ampoules in cardboard packs (5 doses), is intended for use in medical and preventive institutions.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.