Sodium thiosulfate-Biolic solution for injection 30% ampoule 5 ml No. 10




Composition
active ingredient: sodium thiosulfate;
1 ml of solution contains 300 mg of sodium thiosulfate;
Excipients: sodium bicarbonate, water for injections.
Dosage form
Solution for injection.
Main physicochemical properties: clear colorless liquid.
Pharmacotherapeutic group
Antidotes. ATX code V0ЗА В06.
Pharmacological properties
Pharmacodynamics. Sodium thiosulfate-Biolic has antitoxic, anti-inflammatory and desensitizing effects. When interacting with exogenous compounds of arsenic, mercury, lead, it forms their non-toxic sulfites; with hydrocyanic acid and its salts it forms less toxic compounds of rhodanides. It neutralizes preparations of halides (iodine, bromine).
Pharmacokinetics. After intravenous administration, it quickly enters the extracellular fluid and is excreted unchanged in the urine. The half-life is 0.65 hours.
Indication
Poisoning by compounds of arsenic, mercury, lead, hydrocyanic acid and its salts, iodine, bromine and their salts.
Contraindication
Hypersensitivity to the components of the drug.
Interaction with other medicinal products and other types of interactions
Combined use with drugs whose metabolism passes through the rhodanation stage reduces the pharmacological effects of these drugs.
Medicines that are iodides and bromides may not exhibit their pharmacological properties when used together with sodium thiosulfate.
Application features
Use with caution in patients with arterial hypertension, cirrhosis of the liver, congestive heart failure, renal failure, and toxemia of pregnancy, as the patient's condition may worsen.
In case of cyanide poisoning, it is necessary to initially use methemoglobin-forming agents: anticyanide or amyl nitrite, and then switch to intravenous administration of sodium thiosulfate.
Before use, the contents of the ampoule should be inspected. If a precipitate is present, the drug should not be used. For injections, use needles with 5 micron filters, for intravenous infusions - linear filters of 0.22 micron.
Patients with renal impairment: 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: Elderly patients are more likely to have decreased renal function, so caution should be exercised in determining the dose and renal function should be monitored.
Use during pregnancy or breastfeeding. During pregnancy or breastfeeding, the drug should be prescribed only for vital indications.
The ability to influence the speed of reaction when driving vehicles or other mechanisms. Clinical data are lacking, therefore, during treatment, one should refrain from driving vehicles or working with other mechanisms that require increased concentration of attention and speed of psychomotor reactions.
Method of administration and doses
In case of poisoning with arsenic, mercury, lead, iodine, bromine compounds and their salts, the drug should be administered intravenously as a bolus in a dose of 1.5–3 g (5–10 ml of a 300 mg/ml injection solution). In case of poisoning with hydrocyanic acid and its salts, the drug should be administered intravenously slowly in a dose of 15 g (50 ml of a 300 mg/ml injection solution).
The drug should be administered throughout the entire toxicogenic period (from the appearance of the first clinical symptoms of poisoning until the complete elimination of the toxin from the body).
Children: Do not use in children due to lack of clinical data.
Overdose
Symptoms: arthralgia, hyperreflexia; convulsions; psychotic behavior, including agitation; hallucinations; nausea; vomiting; increased manifestations of adverse reactions.
Treatment: hemodialysis; supportive therapy.
Side effects
From the nervous system: headache, dizziness, impaired consciousness, ringing in the ears, blurred vision.
Immune system disorders: anaphylactic reactions, arthralgia, fever.
Skin and subcutaneous tissue disorders: itching, rash (including maculopapular), urticaria, flushing, feeling of heat.
From the cardiovascular system: decrease in blood pressure up to collapse, tachycardia.
From the respiratory system, chest organs, mediastinum: shortness of breath, difficulty breathing.
Gastrointestinal: nausea, vomiting.
General disorders and administration site conditions: injection site reactions, general weakness, increased diuresis.
Expiration date
2 years.
Storage conditions
Store in original packaging, at a temperature not exceeding 25 ° C. Keep out of the 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 in a pack; 5 ampoules in a blister, 2 blisters in a pack.
Vacation category
According to the recipe.
Producer
LLC "BIOLIK PHARMA".
Location of the manufacturer and address of its place of business.
Location of the legal entity:
Ukraine, 61070, Kharkiv region, Kharkiv city, Pomirky, building 70.
Address of place of business:
Ukraine, 61070, Kharkiv region, Kharkiv city, Pomirky-70, building no.
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