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Βιβλιογραφική αναφορά

Προτάσεις

SPC, UK: Fabrazyme 5 mg, powder for concentrate for solution for infusion (2011)

Εκδότης

Εκδότης Genzyme Therapeutics
Διεύθυνση 4620 Kingsgate, Cascade Way, Oxford Business Park South, Oxford, Oxfordshire, OX4 2SU
Σφάλμα Για την προβολή της πλήρους καταχώρησης χρειάζεται να έχετε συνδρομή σε ισχύ (αγορά συνδρομής).
Ολοκληρώνοντας τη διαδικασία δωρεάν εγγραφής θα αποκτήσετε, χωρίς καμία δέσμευση εκ μέρους σας, συνδρομή διάρκειας 30 ημερών.

Περιεχόμενα

Name of the medicinal product

Fabrazyme 5 mg powder for concentrate for solution for infusion.

Qualitative and quantitative composition

Each vial of Fabrazyme contains a nominal value of 5 mg of agalsidase beta. After reconstitution with ...

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 ...

Posology and method of administration

Fabrazyme treatment should be supervised by a physician experienced in the management of patients with ...

Contraindications

Life threatening hypersensitivity (anaphylactic reaction) to the active substance or any of the excipients ...

Special warnings and precautions for use

Immunogenicity Since agalsidase beta (r-hαGAL) is a recombinant protein, the development of IgG antibodies ...

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, ...

Pregnancy and lactation

Pregnancy There are no adequate data from the use of agalsidase beta in pregnant women. Animal studies ...

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 ...

Undesirable effects

Summary of the safety profile Since agalsidase beta (r-hαGAL) is a recombinant protein, the development ...

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 ...

Pharmacokinetic properties

Following an intravenous administration of agalsidase beta to adults at doses of 0.3 mg, 1 mg and 3 mg/kg ...

Preclinical safety data

Non-clinical data reveal no special hazard for humans based on studies of safety pharmacology, single ...

List of excipients

Mannitol Sodium phosphate monobasic, monohydrate Sodium phosphate dibasic, heptahydrate

Incompatibilities

In the absence of compatibility studies, Fabrazyme must not be mixed with other medicinal products in ...

Shelf life

3 years. Reconstituted and diluted solutions From a microbiological point of view, the product should ...

Special precautions for storage

Store in a refrigerator (2°C – 8°C). For storage conditions after reconstitution and dilution of the ...

Nature and contents of container

Fabrazyme 5 mg is supplied in clear Type I glass 5 ml vials. The closure consists of a siliconised butyl ...

Special precautions for disposal and other handling

The powder for concentrate for solution for infusion has to be reconstituted with water for injections, ...

Marketing authorization holder

Genzyme Europe B.V. Gooimeer 10 NL-1411DD Naarden The Netherlands

Marketing authorization number(s)

EU/1/01/188/004-006

Date of first authorization / renewal of the authorization

Date of first authorisation: 03 August 2001 Date of last renewal: 03 August 2006

Date of revision of the text

11/2011
Απαγορεύεται η αναπαραγωγή και αναδιανομή. Το έργο επεξεργασίας των παραπάνω πληροφοριών αποτελεί πνευματική ιδιοκτησία της Ergobyte Πληροφορική Α.Ε. και προστατεύεται από τη νομοθεσία περί πνευματικών δικαιωμάτων.