SODIUM THIOSULFATE-BIOLIC

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT SODIUM THIOSULFATE-BIOLIK (SODIUMTHIOSULFATE-BIOLIK)

Composition:

Active substance: sodium thiosulfate;

1 ml of solution contains 300 mg of sodium thiosulfate;

Excipients: sodium bicarbonate, water for injections.

Pharmaceutical form. Solution for injection.

Main physicochemical properties: clear, colorless liquid.

Pharmacotherapeutic group. Antidotes. ATC code V03AB06.

Pharmacological properties.

Pharmacodynamics. Sodium thiosulfate-Biolik exerts an antidotal, anti-inflammatory, and desensitizing effect. When interacting with exogenous compounds of arsenic, mercury, and lead, it forms non-toxic sulfites; with hydrocyanic acid and its salts, it forms less toxic thiocyanate compounds. It neutralizes halogen-containing agents (iodine, bromine).

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Clinical characteristics.

Indications.

Poisoning with arsenic, mercury, and lead compounds, hydrocyanic acid and its salts, iodine, bromine, and their salts.

Contraindications.

Hypersensitivity to the components of the drug.

Interaction with other medicinal products and other forms of interactions.

Concomitant use of medicinal products whose metabolism involves the rhodanation step may reduce the pharmacological effects of these agents.

Medicinal products containing iodides or bromides may fail to exhibit their pharmacological properties when used concurrently with sodium thiosulfate.

Special precautions for use.

Use with caution in patients with arterial hypertension, liver cirrhosis, congestive heart failure, renal insufficiency, or pregnancy toxemia, as worsening of the patient's condition may occur.

In cyanide poisoning, methemoglobin-forming agents (antidote cyanide or amyl nitrite) should be administered first, followed by intravenous administration of sodium thiosulfate.

Before use, inspect the solution in the ampoule. Do not use the preparation if a precipitate is present. For injections, use needles with 5-micron filters; for intravenous infusions, use in-line filters of 0.22 microns.

Patients with impaired renal function. Sodium thiosulfate is primarily excreted by the kidneys, and the risk of developing toxic reactions to the drug is higher in patients with impaired renal function.

Elderly patients. Since decreased renal function is more likely in elderly patients, caution should be exercised when determining dosage, and renal function should be monitored.

Use during pregnancy or breastfeeding. The drug should be administered during pregnancy or breastfeeding only if clearly needed and based on life-threatening indications.

Ability to influence reaction rate while driving or operating machinery. Clinical data are lacking; therefore, during treatment, patients should refrain from driving or operating machinery requiring heightened attention and rapid psychomotor reactions.

Method of administration and dosage.

In cases of poisoning with arsenic, mercury, lead, iodine, bromine and their salts, administer the drug intravenously as a bolus at a dose of 1.5–3 g (5–10 ml of 300 mg/ml injection solution). In cases of poisoning with hydrocyanic acid and its salts, administer the drug slowly intravenously at a dose of 15 g (50 ml of 300 mg/ml injection solution).

The drug should be administered throughout the entire toxicogenic period (from the onset of the first clinical symptoms of poisoning until complete elimination of the toxin from the body).

Children. Do not use in children due to lack of clinical data.

Overdose .

Symptoms: arthralgia, hyperreflexia; seizures; psychotic behavior, including agitation; hallucinations; nausea; vomiting; exacerbation of adverse reactions.

Treatment: hemodialysis; supportive therapy.

Adverse Reactions.

Nervous system disorders: headache, dizziness, impaired consciousness, tinnitus, blurred vision.

Immune system disorders: anaphylactic reactions, arthralgia, fever.

Skin and subcutaneous tissue disorders: pruritus, rash (including maculopapular), urticaria, hyperemia, sensation of heat.

Cardiovascular system disorders: decreased blood pressure up to collapse, tachycardia.

Respiratory, thoracic and mediastinal disorders: dyspnea, labored breathing.

Gastrointestinal disorders: nausea, vomiting.

General disorders and administration site reactions: reactions at the injection site, general weakness, increased diuresis.

Shelf life.

2 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C. Keep out of reach of children.

Incompatibility.

Incompatible with nitrite and nitrate solutions. Do not mix in the same syringe with other drugs.

Packaging.

5 ml in an ampoule; 10 ampoules per pack; 5 ampoules in a blister, 2 blisters per pack.

Prescription status. Prescription only.

Manufacturer.

LLC "BIOLIK PHARMA".

Manufacturer's location and address of its business activity.

Legal entity location:

70 Pomirky Street, Kharkiv, Kharkiv region, 61070, Ukraine.

Address of business activity:

Pomirky-70, building n/a, Kharkiv, Kharkiv region, 61070, Ukraine.