Tobarpin (Concentrate) Instructions for Use

Marketing Authorization Holder

Beijing Tobishi Pharmaceutical Co. Ltd. (China)

ATC Code

B02BX03 (Batroxobin)

Active Substance

Batroxobin (Rec.INN registered by WHO)

Dosage Form

Tobarpin

Concentrate for solution for infusion 10 IU/ml: amp. 0.5 ml 6 pcs.1

Dosage Form, Packaging, and Composition

Excipients: chlorobutanol – 1.49 mg, hydrochloric acid or sodium hydroxide – to adjust pH to 4.8-6.0, water for injection – to 0.5 ml.

0.5 ml – ampoules (6) – blister packs (1) – cardboard packs.

Clinical-Pharmacological Group

Thrombolytic

Pharmacotherapeutic Group

Fibrinolytic agent

Pharmacological Action

It is a monomolecular thrombolytic drug that reduces fibrinogen content and blood viscosity, and improves blood supply to tissues and organs.

Batroxobin is a synthetic analogue of the toxin from the snake Clotalide Bathrops atrox moojeni; it is a solution of a glycopeptide (monomolecular serine proteinase) with a molecular weight of 36,000 Daltons.

Indications

Acute ischemic stroke; ischemic syndrome against the background of obliterating atherosclerosis; peripheral circulation and microcirculation disorders (including acute neurosensory hearing loss, vibration disease).

ICD codes

Dosage Regimen

Intravenous drip.

For acute cerebral infarction – 20 IU within the first 24 hours or 10 IU 24 hours after the onset of the disease; maintenance dose (depending on the patient’s condition) – usually 5-10 IU every other day, a total of 3 injections per course. If necessary, the course can be repeated.

For chronic ischemic disorders and microcirculation disturbances, the initial dose is 10 IU, maintenance dose is 5 IU every other day; it is recommended to conduct 3-6 courses.

Before administration, the drug is diluted in 100 ml of 0.9% sodium chloride solution. The infusion duration should be at least 1 hour.

Adverse Reactions

Headache, dizziness, tinnitus, skin rash, fever; sometimes – local bleeding or mild ecchymosis at the injection site; rarely – nosebleed, nausea, vomiting, unpleasant sensations in the epigastric region, increased activity of liver transaminases, blood urea level, C-reactive protein in the blood, positive reaction for occult blood in urine, anaphylactic shock.

Contraindications

Hypersensitivity (including history); tendency to bleeding (fibrinogen concentration below 1 g/l); gastric and duodenal ulcer (in the acute phase); hemorrhagic stroke (including suspicion of it); concomitant therapy with anticoagulants and thrombolytic drugs; postoperative period; severe hepatic and/or renal failure; rupture of papillary muscles and perforation of the interventricular septum of the heart; cardiogenic shock; multiple organ failure; surgical interventions and invasive procedures and diagnostic methods (including blockade of stellate nerve ganglia, puncture of arteries and deep veins, tooth extraction, etc.); childhood (safety and efficacy have not been studied).

With caution gastric and duodenal ulcer (in history), cerebrovascular diseases (in history), elderly age (over 70 years), tendency to allergic reactions, pregnancy, lactation period.

Use in Pregnancy and Lactation

With caution pregnancy, lactation period.

Use in Hepatic Impairment

Contraindication: severe hepatic insufficiency.

Use in Renal Impairment

Contraindication: severe renal insufficiency.

Pediatric Use

Contraindication: childhood.

Geriatric Use

With caution elderly age (over 70 years).

Special Precautions

During treatment, the fibrinogen level in the blood should be constantly monitored and clinical observation of patients should be carried out. If after a single administration of the drug the fibrinogen concentration is below 1 g/l or if bleeding or suspicion of it appears during treatment, the drug should be discontinued and hemostatic measures should be taken.

A tight bandage should be applied at the site of puncture of small and superficial veins.

In case of necessary surgical interventions (including tooth extraction), doctors should be informed about the use of the drug.

During the treatment period, patients should especially avoid skin damage and injuries.

Storage Conditions

Store at 2°C (36°F) to 8°C (46°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

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.