Tobarpin - instructions for use, dose, side effects, contraindications

Active substanceBatroksobinBatroksobin

Similar drugsTo uncover

Tobarpine

concentrate d / infusion

Beijing Tobishi Pharmaceutical Co., Ltd.

Dosage form: & nbspTOoncentrat for solution for infusion.

Composition:

Active substance:

Batroksobin 5 units

Excipients;

Chlorobutanol 1.49 mg

Hydrochloric acid or sodium hydroxide to pH 4.8 - 6.0

Water for injection up to 0.5 ml

Description:

Colorless, clear liquid.

Pharmacotherapeutic group:Anticoagulant direct action.

ATX: & nbsp

B.02.B.X Other haemostatic drugs for systemic use

Pharmacodynamics:

Anticoagulant of direct action, obtained from the poison of Central and South American rattlesnakes. The main active ingredient of batroxibin is the monomolecular serine protease enzyme, which has an antithrombotic action. It inhibits thrombogenesis processes, activates thrombolysis by stimulating the release of tissue plasminogen, improves the rheological properties of blood (reducing the agglutination of erythrocytes and increasing their deformability), reduces platelet aggregation and the formation of free radicals. Reduces the level of fibrinogen, prolongs the time of bleeding and clotting of blood.

Pharmacokinetics:

The half-life at the first administration is 5.9 hours,in the future, it decreases as the concentration of fibrinogen decreases. In blood batroksobin communicates with α2-macroglobulin, and this complex is excreted by the kidneys. T1 / 2 of which is 3-4 hours; after 24 hours, 2-3% of its activity in the blood remains, 30% of metabolites in the urine are released per day. Penetrates through the blood-brain and placental barriers, into breast milk. Violations of the functions of the liver and kidneys do not significantly affect the pharmacokinetic parameters of batroxobin.

Indications:

Acute (the first 72 hours) stage of ischemic stroke.

Contraindications:

Contraindications

- Violations of the coagulation system of blood, thrombocytopenia (less than 60 thousand / mm³).

- Stomach ulcer and / or duodenal ulcer in the stage of exacerbation.

- Intracerebral haemorrhage, external or internal bleeding.

- Postoperative period

- Admission of other anticoagulants, fibrinolytic or thrombolytic agents (including the period of time after their cancellation lasting less than 14 days).

- The level of fibrinogen of blood is below 1 g / l;

- Severe liver or kidney pathology, cardiogenic shock, multiple organ failure.

- Hypersensitivity.

- Pregnancy and lactation.

- Children's age (due to lack of data).

- Severe hypertension.

Carefully:

Stomach ulcer and / or duodenal ulcer in the stage of exacerbation (in remission or presence in the anamnesis).

Age over 70 years.

Dosing and Administration:

Intravenous drip, slowly (duration of infusion at least 1 hour), every other day. The drug is diluted in 100 ml of saline. The first three infusions of 10 units, then 2 infusions of 5 units. Therapy begins no later than 72 hours from the development of ischemic stroke.

Side effects:

Headache, dizziness, tinnitus, local bleeding or mild echymosis at the injection site, nausea, vomiting, unpleasant sensations in the epigastric region, allergic reactions.

Overdose:

Increased severity of side effects. Treatment: symptomatic. It is not excreted from the body during hemodialysis.

Interaction:

Strengthens the action of anticoagulants and antiaggregants.

Form release / dosage:

Concentrate for the preparation of solution for infusion.

Packaging:0.5 ml (5 AD) per ampoule. 6 ampoules with instructions for use in a pack of cardboard.

Storage conditions:

In a place protected from light and inaccessible to children at a temperature not exceeding 5 ° С (freezing is not allowed!).

Shelf life:1,5 years. Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LS-000892

Date of registration:04.10.2011

The owner of the registration certificate:Beijing Tobishi Pharmaceutical Co., Ltd.Beijing Tobishi Pharmaceutical Co., Ltd.

Manufacturer: & nbsp

Beijing Tobishi Pharmaceutical Co., Ltd. China

Information update date: & nbsp23.04.2012

Illustrated instructions

Instructions

Tobarpine (Tobarpin)