REFACTO AF Powder and solvent for solution for injection (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
ReFacto AF 250 IU powder and solvent for solution for injection. ReFacto AF 500 IU powder and solvent for solution for injection. ReFacto AF 1000 IU powder and solvent for solution for injection. ReFacto ...
Qualitative and quantitative composition
ReFacto AF 250 IU powder and solvent for solution for injection: Each vial contains nominally 250 IU* moroctocog alfa**. After reconstitution, each mL of solution contains approximately 62.5 IU moroctocog ...
Pharmaceutical form
ReFacto AF 250 IU, 500 IU, 1000 IU, 2000 IU powder and solvent for solution for injection: Powder and solvent for solution for injection. White to off-white cake/powder. Clear, colourless solvent. ReFacto ...
Therapeutic indications
Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). ReFacto AF is appropriate for use in adults and children of all ages, including newborns. ReFacto ...
Posology and method of administration
Treatment should be initiated under the supervision of a physician experienced in the treatment of haemophilia A. Treatment monitoring During the course of treatment, appropriate determination of factor ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Known allergic reaction to hamster protein.
Special warnings and precautions for use
Traceability In order to improve traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. It is strongly recommended that every ...
Interaction with other medicinal products and other forms of interaction
No interactions of recombinant coagulation factor VIII products with other medicinal products have been reported.
Fertility, pregnancy and lactation
Animal reproduction studies have not been conducted with factor VIII, therefore no data are available on fertility. Because of the rare occurrence of haemophilia A in women, experience regarding the use ...
Effects on ability to drive and use machines
ReFacto AF has no 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 symptoms of overdose have been reported with recombinant coagulation factor VIII products.
Pharmacodynamic properties
Pharmacotherapeutic group: antihaemorrhagics, blood coagulation factor VIII ATC code: B02BD02 ReFacto AF contains B-domain deleted recombinant coagulation factor VIII (moroctocog alfa). It is a glycoprotein ...
Pharmacokinetic properties
Pharmacokinetic properties of ReFacto, derived from a cross-over study of ReFacto and a plasmaderived FVIII concentrate, using the chromogenic substrate assay (see section 4.2), in 18 previously treated ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, and genotoxicity. No investigations on carcinogenic potential or toxicity ...
List of excipients
Powder: Sucrose Calcium chloride dihydrate L-Histidine Polysorbate 80 Sodium chloride Solvent: Sodium chloride Water for injections
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products, including other infusion solutions. Only the provided infusion set is to be used, because ...
Shelf life
3 years. The product may be removed from refrigerated storage for one single period of maximum 3 months at room temperature (up to 25°C). At the end of this period of room temperature storage, the product ...
Special precautions for storage
ReFacto AF 250 IU, 500 IU, 1000 IU, 2000 IU powder and solvent for solution for injection / ReFacto AF 250 IU, 500 IU, 1000 IU, 2000 IU, 3000 IU powder and solvent for solution for injection in pre-filled ...
Nature and contents of container
ReFacto AF 250 IU, 500 IU, 1000 IU, 2000 IU powder and solvent for solution for injection: 250 IU, 500 IU, 1000 IU or 2000 IU powder in a 10 mL vial (type 1 glass) with a stopper (butyl) and a flip-off ...
Special precautions for disposal and other handling
ReFacto AF 250 IU, 500 IU, 1000 IU, 2000 IU powder and solvent for solution for injection: The vial of lyophilised product powder for injection must be reconstituted with the supplied solvent [sodium chloride ...
Marketing authorization holder
Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050, Bruxelles, Belgium
Marketing authorization number(s)
EU/1/99/103/001 EU/1/99/103/002 EU/1/99/103/003 EU/1/99/103/004 EU/1/99/103/009 EU/1/99/103/006 EU/1/99/103/007 EU/1/99/103/008 EU/1/99/103/005
Date of first authorization / renewal of the authorization
Date of first authorisation: 13 April 1999 Date of latest renewal: 15 April 2014
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