BENEFIX Powder and solvent for solution for injection (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
BeneFIX 250 IU powder and solvent for solution for injection. BeneFIX 500 IU powder and solvent for solution for injection. BeneFIX 1000 IU powder and solvent for solution for injection. BeneFIX 1500 IU ...
Qualitative and quantitative composition
BeneFIX 250 IU powder and solvent for solution for injection: Each vial contains nominally 250 IU nonacog alfa (recombinant coagulation factor IX). After reconstitution with the accompanying 5 mL (0.234%) ...
Pharmaceutical form
BeneFIX 250 IU, 500 IU, 1000 IU, 1500 IU, 2000 IU, 3000 IU powder and solvent for solution for injection: Powder and solvent for solution for injection. White/almost white powder and clear and colourless ...
Therapeutic indications
Treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency). BeneFIX can be used for all age groups.
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 or to any of the excipients listed in section 6.1. Known allergic reaction to hamster proteins.
Special warnings and precautions for use
Hypersensitivity Allergic-type hypersensitivity reactions are possible with BeneFIX. The product contains traces of hamster proteins. Potentially life-threatening anaphylactic/anaphylactoid reactions have ...
Interaction with other medicinal products and other forms of interaction
No interactions of human coagulation factor IX (rDNA) products with other medicinal products have been reported.
Fertility, pregnancy and lactation
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 pregnancy and breastfeeding ...
Effects on ability to drive and use machines
BeneFIX has no influence on the ability to drive or 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 IX products.
Pharmacodynamic properties
Pharmacotherapeutic group: Antihaemorrhagics, blood coagulation factor IX ATC code: B02BD04 Mechanism of action BeneFIX contains recombinant coagulation factor IX, (nonacog alfa). Recombinant coagulation ...
Pharmacokinetic properties
In a randomized, cross-over pharmacokinetic study, BeneFIX reconstituted in 0.234% sodium chloride diluent was shown to be pharmacokinetically equivalent to the previously marketed BeneFIX (reconstituted ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of genotoxicity. No investigations on carcinogenicity, fertility impairment and foetal development have been conducted. ...
List of excipients
Powder: Sucrose Glycine L-Histidine Polysorbate 80 Solvent: Sodium chloride solution
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products. Only the provided infusion set should be used. Treatment failure can occur as a consequence ...
Shelf life
2 years. The reconstituted product does not contain a preservative and should be used immediately, but no longer than 3 hours after reconstitution. Chemical and physical in-use stability has been demonstrated ...
Special precautions for storage
Store below 30°C. Do not freeze.
Nature and contents of container
BeneFIX 250 IU, 500 IU, 1000 IU, 1500 IU, 2000 IU, 3000 IU powder and solvent for solution for injection: BeneFIX 250 IU, 500 IU, 1000 IU, 1500 IU, 2000 IU, 3000 IU of powder in a 10 mL vial (type 1 glass) ...
Special precautions for disposal and other handling
BeneFIX is administered by intravenous infusion after reconstitution of the lyophilised powder for injection with the supplied solvent (0.234% w/v sodium chloride solution) in the pre-filled syringe (see ...
Marketing authorization holder
Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050, Bruxelles, Belgium
Marketing authorization number(s)
EU/1/97/047/004 EU/1/97/047/005 EU/1/97/047/006 EU/1/97/047/009 EU/1/97/047/007 EU/1/97/047/008
Date of first authorization / renewal of the authorization
Date of first authorisation: 27 August 1997 Date of latest renewal: 20 July 2012
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