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GASTROTROMBINA® 10000

TRADE NAME OF THE PHARMACEUTICAL PRODUCT

GASTROTROMBINA® 10000
(Thrombinum)

QUALITATIVE AND QUANTITATIVE COMPOSITION OF ACTIVE SUBSTANCE

Bovine thrombin 10000 IU

PHARMACEUTICAL FORM

Freeze dried matter and diluent for preparing solution for oral administration.

CLINICAL PARTICULARS

Indications for use

Gastrotrombina is a homeostatic preparation used in bleeding from the alimentary tract, e.g. in duodenal and gastric ulcer and in bleeding from the oesophagus.

The medicinal product is not a substitute for surgical procedures.

Posology and method of administration

Dilute the contents of the vial with freeze dried thrombin in about 10 ml of diluent (phosphate buffer). Pour the remaining part of the diluent and diluted freeze dried thrombin into a glass and drink after thorough mixing.

In the case of persistent bleeding subsequent doses of the medicinal product should be used within a period of 24-48 hours, in compliance with the recommendations of a physician.

Freeze dried bovine thrombin dissolved in phosphate buffer is unstable and quickly becomes inactive, and for that reason should be used directly after preparation. The medicinal product may be administered with antibiotics or chemotherapeutics.

Contraindications

The medicinal product must not be used in individuals with allergy to protein of bovine origin.

Special warnings and special precautions for use

Gastrotrombina products are intended exclusively for oral administration. Gastrotrombina must not be administered intravenously because of possible intravascular thrombosis.

Interactions with other medicinal products and other forms of interactions

The medicinal product must not be used simultaneously with fibrynolitic medicinal products, such as: tissue plasminogen activator, urokinase, streptokinase, staphylokinase.

Pregnancy and lactation

Gastrotrombina can be used in pregnant and breast feeding women.

Effects on ability to drive and use machines

Medicinal product does affect psychophysical efficiency, and no effects on the ability to drive or use machines have been observed.

Undesirable effects

No undesired side effects of the medicinal product have been found.

Overdose

The consequences of an overdose in humans are not known.

PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: ATC code - B 02 BC

Thrombin, the active component of Gastrotrombina ® 10000, is an enzyme catalyzing the process of blood clotting, i.e. the transformation of fibrinogen into fibrin and the production of a thrombus. The second component of the preparation (diluent phosphate buffer, pH 7.6) neutralizes the acidic stomach environment and creates optimal conditions for thrombin activity. Optimal conditions for specific thrombin activity occur at pH 7.2-7.5.

Pharmacodynamic properties

The activity of Gastrotrombina ® 10000 is relatively fast. The preparation administered properly and in a suitable dose allows the suppression of persistent bleeding, even in individuals with different types of haemorrhagic defects, with the exclusion of individuals with afibrinogenemia.

Pharmacokinetic properties

Gastrotrombina is adsorbed on fibrinogen, besides that it is inactivated by antithrombin present in blood plasma.

Preclinical safety data

No sub-acute or chronic toxicity have been observed in research on laboratory animals (guinea pigs and mice) after the administration of Gastrotrombina ® 10000.

PHARMACEUTICAL PARTICULARS

Composition of the medicinal product and list of excipients

One vial with the freeze dried matter contains:

  • Active substance – freeze dried bovine thrombin 10000 IU
  • Excipient – amino acetic acid – up to 90 mg

One vial with diluent contains:

  • phosphate buffer - 50 ml

Incompatibilities

Gastrotrombina ® 10000 must not be mixed or used simultaneously with fibrynolitic medicinal products, such as:

  1. tissue plazminogen activator,
  2. urokinase,
  3. streptokinase,
  4. staphylokinase.

Shelf life

Stability period of the medicinal product in package - 2 years

Gastrotrombina in phosphate buffer is unstable and becomes gradually inactive, and for that reason should be used directly after preparation.

Special precautions for storage

Medicinal product should be stored at 2°C - 8°C.

Nature and contents of container

2 vials with freeze dried matter 10000 IU each + 2 vials with diluent, 50 ml each. Vials in a cardboard box.

Instructions for use of medicinal product

Dilute the contents of the vial with thrombin freeze dried matter in about 10 ml of diluent (phosphate buffer). Pour the remaining part of the diluent and diluted thrombin into a glass and drink after thorough mixing.