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Trombina 400

TRADE NAME OF THE PHARMACEUTICAL PRODUCT

TROMBINA® 400
(Thrombinum)

QUALITATIVE AND QUANTITATIVE COMPOSITION OF ACTIVE SUBSTANCE

Bovine thrombin 400 IU

PHARMACEUTICAL FORM OF ACTIVE SUBSTANCE

Freeze dried matter and diluent for local administration.

CLINICAL PARTICULARS

Indications for use

Thrombin is used locally to suppress profuse bleeding, mostly external. It is used in:

  1. surgery, in parenchymatous bleeding from internal organs (liver, kidney, lungs);
  2. dentistry, in bleeding from the alveolus after tooth extraction;
  3. laryngology, in nosebleeds, bleeding of mucous membranes of the oral cavity, after extraction of tonsils;
  4. gynaecology.

Thrombin also finds an application as a reagent in the laboratorial determination of congenital defects and congenital disorders of blood clotting.

Posology and method of administration

Dilute the freeze dried matter of Trombina® 400 contained in the ampoule with 2 ml of isotonic solution of sodium chloride. After diluting saturate a sterilized swab or spongostan with the solution and apply it to the wound. The solution of thrombin can be also applied directly on the wound.

Contraindications

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

Special warnings and special precautions for use

The thrombin preparations are intended exclusively for local use. Thrombin must not be administered intravenously, nor for other injections, because of possible intravascular thrombosis.

Interactions with other medicinal products and other forms of interactions

The medicinal product must not be mixed or used simultaneously with fibrynolitic medicinal products, such as:

  1. tissue plasminogen activator (tPA)
  2. urokinase,
  3. streptokinase,
  4. staphylokinase.

Pregnancy and lactation

Thrombin can be used in pregnant and breast feeding women.

Effects on ability to drive and use machines

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 is an enzyme catalyzing the process of blood clotting, which consists of the transformation of fibrinogen into fibrin and the production of a thrombus.

Pharmacodynamic properties

The activity of thrombin is almost immediate. The product administered properly and in a suitable dose allows, in the course of several minutes, the suppression of persistent bleeding, even in individuals with different types of haemorrhagic defects, concerning a defect in the transformation of thrombinogen into the active thrombin (e.g. haemophilia A and B). It is not used in individuals with afibrinogenemia. It does not penetrate to the organism. It does not show any toxic properties.

Pharmacokinetic properties

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

Preclinical safety data

No sub-acute or chronic toxicity have been observed in research on laboratory animals (guinea pigs and mice).

PHARMACEUTICAL PARTICULARS

Composition of the medicinal product and list of excipients

One ampoule with the freeze dried matter contains:

  1. Active substance – freeze dried bovine thrombin 400 IU
  2. Excipient – amino acetic acid – up to 30 mg

One ampoule with diluent contains: isotonic solution of sodium chloride - 2 ml

Incompatibilities

The medicinal product must not be mixed or used simultaneously with fibrynolitic medicinal products, such as:

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

Shelf life

3 years

Trombina® 400 diluted in isotonic solution of sodium chloride is unstable and becomes partially inactive, and for that reason should be used directly after the dissolving of the freeze dried matter.

Special precautions for storage

Store at 2°C - 8°C.

Nature and contents of container

5 ampoules with freeze dried matter + 5 ampoules with diluent, 2 ml each. Glass ampoules in a cardboard box.

Instructions for use of medicinal product

Dilute the contents of the ampoule with thrombin freeze dried matter in 2 ml of diluent (isotonic solution of sodium chloride), and then saturate a sterilized swab or spongostan and apply to the wound. The thrombin solution can be used directly on the bleeding wound.