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HAEMONINE Powder and solvent for solution for injection (2016)

Active ingredients: Coagulation factor IX

Product Name and Form

Haemonine 500.

Haemonine 1000.

Powder and solvent for solution for injection.

Pharmaceutical form

Powder and solvent for solution for injection.

White powder and clear, colourless solvent for solution for injection.

After dissolving the powder in the provided water for injections, the Haemonine solution is clear or slightly opalescent without any visible particles (see section 6.6).

Qualitative and Quantitative Composition

Human plasma derived coagulation factor IX;

Haemonine is presented as a powder and solvent for solution for injection containing either 500 or 1000 IU human coagulation factor IX per vial.

When reconstituted with either 5 ml or 10 ml water for injections, Haemonine contains approximately 100 IU/ml human coagulation factor IX.

The potency (IU) is determined using the European Pharmacopoeia one stage clotting test. The specific activity of Haemonine is ≥70 IU/mg protein.

Excipients with known effect: The reconstituted product contains 0.19 mmol – 0,245 mmol (4.37 mg – 5,63 mg) sodium per ml. For the full list of excipients, see section 6.1.

Chemical substance
Description
Coagulation factor IX

Factor IX is a single chain glycoprotein with a molecular mass of about 68,000 Dalton. It is a vitamin-K dependent coagulation factor and it is synthesised in the liver. Factor IX is activated by factor XIa in the intrinsic coagulation pathway and by the factor VII/tissue factor complex in the extrinsic pathway. Activated factor IX, in combination with activated factor VIII, activates factor X.

List of excipients

Powder:

Arginine
Lysine
Sodium chloride
Sodium citrate

Solvent:

Water for injections.

Pack sizes and Marketing

1 package Haemonine 500 contains:

  • 1 vial with powder, glass type I (Ph.Eur.), closed with chlorobutyl rubber stopper, type I (Ph.Eur.)
  • 1 vial with solvent (5 ml), glass type I (Ph.Eur.), closed with bromobutyl rubber stopper, type I (Ph.Eur.)

The pack also contains: 1 disposable syringe (5 ml), 1 double-filter transfer system, 1 butterfly cannula.

1 package Haemonine 1000 contains:

  • 1 vial with powder, glass type I (Ph.Eur.), closed with chlorobutyl rubber stopper, type I (Ph.Eur.)
  • 1 vial with solvent (10 ml), glass type I (Ph.Eur.), closed with bromobutyl rubber stopper, type I (Ph.Eur.)

The pack also contains: 1 disposable syringe (10 ml), 1 double-filter transfer system, 1 butterfly cannula.

Marketing authorization holder
Authorization dates

Biotest Pharma GmbH, Landsteinerstrasse 5, 63303 Dreieich, Germany, Phone: +49 6103 801-0, Fax: +49 6103 801-150, mail@biotest.de

19/12/2008

Marketing authorization number:

PL 04500/0008