FABRAZYME Powder for concentrate solution (2018)
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Περιεχόμενα
Name of the medicinal product
Fabrazyme 35 mg powder for concentrate for solution for infusion. Fabrazyme 5 mg powder for concentrate for solution for infusion.
Qualitative and quantitative composition
Fabrazyme 35 mg powder for concentrate for solution for infusion: Each vial of Fabrazyme contains a nominal value of 35 mg of agalsidase beta. After reconstitution with 7.2 ml water for injections, each ...
Pharmaceutical form
Powder for concentrate for solution for infusion. White to off-white lyophilised cake or powder.
Therapeutic indications
Fabrazyme is indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry disease (α-galactosidase A deficiency). Fabrazyme is indicated in adults, children and adolescents ...
Posology and method of administration
Fabrazyme treatment should be supervised by a physician experienced in the management of patients with Fabry disease or other inherited metabolic diseases. Posology The recommended dose of Fabrazyme is ...
Contraindications
Life threatening hypersensitivity (anaphylactic reaction) to the active substance or any of the excipients listed in section 6.1.
Special warnings and precautions for use
Immunogenicity Since agalsidase beta (r-hαGAL) is a recombinant protein, the development of IgG antibodies is expected in patients with little or no residual enzyme activity. The majority of patients developed ...
Interaction with other medicinal products and other forms of interaction
No interaction studies and no in vitro metabolism studies have been performed. Based on its metabolism, agalsidase beta is an unlikely candidate for cytochrome P450 mediated drug-drug interactions. Fabrazyme ...
Fertility, pregnancy and lactation
Pregnancy There are no adequate data from the use of agalsidase beta in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to embryonal/foetal development (see ...
Effects on ability to drive and use machines
Fabrazyme may have a minor influence on the ability to drive or use machines on the day of Fabrazyme administration because dizziness, somnolence, vertigo and syncope may occur (see section 4.8).
Undesirable effects
Summary of the safety profile Since agalsidase beta (r-hαGAL) is a recombinant protein, the development of IgG antibodies is expected in patients with little or no residual enzyme activity. Patients with ...
Overdose
In clinical trials doses up to 3 mg/kg body weight were used.
Pharmacodynamic properties
Pharmacotherapeutic group: Other alimentary tract and metabolism products enzymes ATC code: A16AB04 Fabry disease Fabry disease is an inherited heterogeneous and multisystemic progressive disease, that ...
Pharmacokinetic properties
Following an intravenous administration of agalsidase beta to adults at doses of 0.3 mg, 1 mg and 3 mg/kg body weight, the AUC values increased more than dose proportional, due to a decrease in clearance, ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on studies of safety pharmacology, single dose toxicity, repeated dose toxicity and embryonal/foetal toxicity. Studies with regard to other stages ...
List of excipients
Mannitol Sodium phosphate monobasic, monohydrate Sodium phosphate dibasic, heptahydrate
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products in the same infusion.
Shelf life
Shelf life: 3 years. Reconstituted and diluted solutions: From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage and conditions prior to use ...
Special precautions for storage
Store in a refrigerator (2°C–8°C). For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3.
Nature and contents of container
Fabrazyme 35 mg powder for concentrate for solution for infusion: Fabrazyme 35 mg is supplied in clear Type I glass 20 ml vials. The closure consists of a siliconised butyl stopper and an aluminium seal ...
Special precautions for disposal and other handling
The powder for concentrate for solution for infusion has to be reconstituted with water for injections, diluted with 0.9% sodium chloride intravenous solution and then administered by intravenous infusion. ...
Marketing authorization holder
Genzyme Europe B.V., Gooimeer 10, 1411 DD Naarden, The Netherlands
Marketing authorization number(s)
EU/1/01/188/001 Fabrazyme 35 mg 1 vial of powder for concentrate for solution for infusion EU/1/01/188/002 Fabrazyme 35 mg 5 vials of powder for concentrate for solution for infusion EU/1/01/188/003 Fabrazyme ...
Date of first authorization / renewal of the authorization
Date of first authorisation: 03 August 2001 Date of last renewal: 03 August 2006
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