HAEMONINE Powder and solvent for solution for injection (2016)
Βιβλιογραφική αναφορά
Στοιχεία εκδότη
| Εκδότης | Biotest (UK) Ltd |
|---|---|
| Διεύθυνση | 28 Monkspath Business Park,, Highlands Road, Shirley, Solihull, B90 4NZ, UK |
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Περιεχόμενα
Name of the medicinal product
Haemonine 500. Haemonine 1000. Powder and solvent for solution for injection.
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 ...
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 ...
Therapeutic indications
Treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency). Haemonine is indicated in adults, adolescents and children aged 6 years and older.
Posology and method of administration
Treatment should be under the supervision of a physician experienced in the treatment of haemophilia. Treatment monitoring During the course of treatment, appropriate determination of factor IX levels ...
Contraindications
Hypersensitivity to the active substance, to any of the excipients or to heparin.
Special warnings and precautions for use
Hypersensitivity Allergic type hypersensitivity reactions are possible with Haemonine. The product contains traces of human proteins other than factor IX. If symptoms of hypersensitivity occur, patients ...
Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed. No interactions of human coagulation factor IX products with other medicinal products have been reported. Paediatric population The listed interactions apply ...
Fertility, pregnancy and lactation
Fertility data are not available. Animal reproduction studies have not been conducted with factor IX. Based on the rare occurrence of haemophilia B in women, experience regarding the use of factor IX during ...
Effects on ability to drive and use machines
Haemonine has no or negligible influence on the ability to drive and use machines.
Undesirable effects
Summary of the safety profile Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the infusion site, chills, flushing, generalised urticaria, headache, hives, ...
Overdose
No case of overdose has been reported.
Pharmacodynamic properties
Pharmacotherapeutic Group: antihemorrhagics: blood coagulation factor IX ATC code: B02BD04 Factor IX is a single chain glycoprotein with a molecular mass of about 68,000 Dalton. It is a vitamin-K dependent ...
Pharmacokinetic properties
A pharmacokinetic study with 13 patients yielded the following results: Using a biphasic model the mean initial half-life was 2.2 ± 1.9 h at initial visit and 3.1 ± 2.9 h at month 3, respectively. The ...
Preclinical safety data
The preparation contains exclusively human plasma derived proteins, namely high purity coagulation factor IX, which is identical with the endogenous factor IX. Preclinical studies in an Ames test showed ...
List of excipients
Powder: Arginine Lysine Sodium chloride Sodium citrate Solvent: Water for injections.
Incompatibilities
This medicinal product must not be mixed with other medicinal products. Use only the provided injection sets because treatment failure can occur as a consequence of human coagulation factor IX adsorption ...
Shelf life
Shelf life: 2 years. Use immediately after reconstitution.
Special precautions for storage
Do not store above 25°C. Do not freeze. Keep the vials in the outer carton in order to protect from light.
Nature and contents of container
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 ...
Special precautions for disposal and other handling
Absolute sterility is to be ensured in all steps of the procedure ! Dissolution of the concentrate *Bring the unopened vials of the solvent (water for injections) and product to room temperature. If a ...
Marketing authorization holder
Biotest Pharma GmbH, Landsteinerstrasse 5, 63303 Dreieich, Germany, Phone: +49 6103 801-0, Fax: +49 6103 801-150, mail@biotest.de
Marketing authorization number(s)
PL 04500/0008
Date of first authorization / renewal of the authorization
19/12/2008
Date of revision of the text
29/04/2016
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