NAGLAZYME Concentrate for solution for infusion (2020)
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Περιεχόμενα
Name of the medicinal product
Naglazyme 1 mg/ml concentrate for solution for infusion.
Qualitative and quantitative composition
Each ml of solution contains 1 mg galsulfase. One vial of 5 ml contains 5 mg galsulfase. Galsulfase is a recombinant form of human N-acetylgalactosamine 4-sulfatase and is produced by recombinant DNA technology ...
Pharmaceutical form
Concentrate for solution for infusion. A clear to slightly opalescent, and colourless to pale yellow solution.
Therapeutic indications
Naglazyme is indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of Mucopolysaccharidosis VI (MPS VI; N-acetylgalactosamine 4-sulfatase deficiency; Maroteaux-Lamy ...
Posology and method of administration
As for all lysosomal genetic disorders, it is of primary importance, especially in severe forms, to initiate treatment as early as possible, before appearance of non-reversible clinical manifestations ...
Contraindications
Severe or life-threatening hypersensitivity to the active substance or to any of the excipients, if hypersensitivity is not controllable.
Special warnings and precautions for use
Management of compromised airways Caution must be exercised in the management and treatment of patients with compromised airways by limitation or careful monitoring of antihistamine and other sedative ...
Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
Fertility, pregnancy and lactation
Pregnancy For Naglazyme, no clinical data on exposed pregnancies are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy or embryo-foetal development ...
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed.
Undesirable effects
Due to the low number of patients in clinical trials, adverse event (AE) data from all Naglazyme studies have been pooled and reviewed in a single, clinical trial safety analysis. All patients treated ...
Overdose
Several patients have received their total dose of Naglazyme at approximately twice the recommended infusion rate without apparent adverse events.
Pharmacodynamic properties
Pharmacotherapeutic group: Other alimentary tract and metabolism products, enzymes ATC code: A16AB08 Mucopolysaccharide storage disorders are caused by the deficiency of specific lysosomal enzymes required ...
Pharmacokinetic properties
The pharmacokinetics of galsulfase were evaluated in 13 patients with MPS VI who received 1 mg/kg of galsulfase as a 4 hour infusion. After 24 weeks of treatment the mean (± Standard Deviation [SD]) maximum ...
Preclinical safety data
Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, single-dose toxicity, repeated-dose toxicity or on general reproductive performance or embryo-foetal ...
List of excipients
Sodium chloride Sodium phosphate monobasic, monohydrate Sodium phosphate dibasic, heptahydrate Polysorbate 80 Water for injections
Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Shelf life
Shelf life Unopened vials: 3 years. Diluted solutions: Chemical and physical in-use stability has been demonstrated for up to 4 days at room temperature (23°C-27°C). From a microbiological safety point ...
Special precautions for storage
Store in a refrigerator (2°C-8°C). Do not freeze. For storage conditions of the diluted medicinal product, see section 6.3.
Nature and contents of container
Vial (type I glass) with a stopper (siliconized chlorobutyl rubber) and a seal (aluminium) with a flip-off cap (polypropylene). Pack sizes: 1 and 6 vials. Not all package sizes may be marketed.
Special precautions for disposal and other handling
Each vial of Naglazyme is intended for single use only. The concentrate for solution for infusion has to be diluted with sodium chloride 9 mg/ml (0.9%) solution for infusion using aseptic technique. It ...
Marketing authorization holder
BioMarin International Limited, Shanbally, Ringaskiddy, County Cork, P43 R298, Ireland
Marketing authorization number(s)
EU/1/05/324/001 EU/1/05/324/002
Date of first authorization / renewal of the authorization
Date of first authorisation: 24 January 2006 Date of latest renewal: 26 January 2011
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