WILLFACT Powder and solvent for solution for injection (2015)
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Περιεχόμενα
Name of the medicinal product
Willfact 1000 IU Powder and solvent for solution for injection.
Qualitative and quantitative composition
Willfact is presented as powder and solvent for solution for injection containing nominally 1000 IU human von Willebrand factor per vial. The product contains approximately 100 IU/ml human von Willebrand ...
Pharmaceutical form
Powder and solvent for solution for injection. The powder should be white or pale yellow lyophilised powder or friable solid. The solvent should be clear and colourless.
Therapeutic indications
Willfact is indicated in the prevention and treatment of haemorrhages or surgical bleeding in von Willebrand disease when desmopressin (DDAVP) treatment alone is ineffective or contraindicated. Willfact ...
Posology and method of administration
Treatment of von Willebrand disease should be supervised by a physician experienced in the treatment of haemostatic disorders. Posology Generally, 1 IU/kg of von Willebrand factor raises the circulating ...
Contraindications
Hypersensitivity to the active substance or any of the excipients listed in section 6.1.
Special warnings and precautions for use
In actively bleeding patients it is recommended to co-administer a FVIII product with the von Willebrand factor product with a low FVIII content as a first line treatment. Hypersensitivity As with any ...
Interaction with other medicinal products and other forms of interaction
No interactions of human von Willebrand factor products with other medicinal products are known.
Fertility, pregnancy and lactation
Animal studies are insufficient to assess its safety with respect to fertility, reproduction, pregnancy, embryonic/fœtal development or peri- and postnatal development. The safety of Willfact during pregnancy ...
Effects on ability to drive and use machines
No effects on the ability to drive or use machines have been observed.
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 with Willfact has been reported. Thromboembolic events may occur in case of major overdose.
Pharmacodynamic properties
Pharmacotherapeutic group: Anti-haemorrhagics: von Willebrand factor ATC code: B02BD10 Willfact behaves in the same way as endogenous von Willebrand factor. Administration of von Willebrand factor allows ...
Pharmacokinetic properties
A pharmacokinetic study with Willfact was carried out on 8 patients with type 3 von Willebrand disease. It demonstrated that for VWF:RCo: The mean AUC<sub>0-∞</sub> is 3444 IU.h/dl after single dose of ...
Preclinical safety data
Based on data obtained from several preclinical studies using animal models, there is no evidence for other toxic effect of Willfact than those related to the immunogenicity of human proteins in laboratory ...
List of excipients
Powder: Human albumin Arginine hydrochloride Glycine Sodium citrate Calcium chloride dihydrate Solvent: water for injections
Incompatibilities
Willfact must not be mixed with other medicinal products except for plasma-derived coagulation FVIII produced by LFB-BIOMEDICAMENTS, with which a compatibility study was carried out. This FVIII coagulation ...
Shelf life
3 years. Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use ...
Special precautions for storage
Do not store above 25°C. Store in the original package in order to protect from light. Do not freeze. For storage conditions after reconstitution of the medicinal product, see section 6.3.
Nature and contents of container
1 pack contains: powder in a vial (Type I glass) with a bromobutyl stopper, solvent in an injection vial (Type I glass) with a chlorobutyl stopper, and a transfer system.
Special precautions for disposal and other handling
Reconstitution: The currently applicable guidelines for aseptic procedures must be followed. The transfer system is only used to reconstitute the drug, as described below. It is not intended in administering ...
Marketing authorization holder
LFB-BIOMEDICAMENTS, 3, avenue des Tropiques, BP 40305 LES ULIS, 91958 Courtabœuf Cedex, FRANCE
Marketing authorization number(s)
PL 28315/0005
Date of first authorization / renewal of the authorization
Date of first authorisation: 12/01/2011 Date of last renewal: 15/05/2014
Date of revision of the text
12/10/2015
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