ALDURAZYME Concentrate for solution for infusion (2020)
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Περιεχόμενα
Name of the medicinal product
Aldurazyme 100 U/ml concentrate for solution for infusion.
Qualitative and quantitative composition
1 ml contains 100 U (approximately 0.58 mg) of laronidase. Each vial of 5 ml contains 500 U of laronidase. The activity unit (U) is defined as the hydrolysis of one micromole of substrate (4-MUI) per minute. ...
Pharmaceutical form
Concentrate for solution for infusion. A clear to slightly opalescent, and colourless to pale yellow solution.
Therapeutic indications
Aldurazyme is indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of Mucopolysaccharidosis I (MPS I; α-L-iduronidase deficiency) to treat the non-neurological manifestations ...
Posology and method of administration
Aldurazyme treatment should be supervised by a physician experienced in the management of patients with MPS I or other inherited metabolic diseases. Administration of Aldurazyme should be carried out in ...
Contraindications
Severe hypersensitivity (e.g. anaphylactic reaction) to the active substance or to any of the excipients listed in section 6.1 (see sections 4.4 and 4.8).
Special warnings and precautions for use
Infusion-associated reactions Patients treated with Aldurazyme may develop infusion-associated reactions (IARs), defined as any related adverse event occurring during the infusion or until the end of the ...
Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed. Based on its metabolism, laronidase is an unlikely candidate for Cytochrome P450 mediated interactions. Aldurazyme should not be administered simultaneously ...
Fertility, pregnancy and lactation
Pregnancy There are inadequate data on the use of Aldurazyme in pregnant women. Animal studies do not indicate direct or indirect harmful effects on pregnancy, embryonal/foetal development, parturition ...
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
Summary of the safety profile The majority of the related adverse events in the clinical trials were classified as infusion-associated reactions (IARs), experienced by 53% of the patients in the Phase ...
Overdose
No case of overdose has been reported.
Pharmacodynamic properties
Pharmacotherapeutic group: Enzymes ATC code: A16AB05 MPS I disease Mucopolysaccharide storage disorders are caused by the deficiency of specific lysosomal enzymes required for the catabolism of glycosaminoglycans ...
Pharmacokinetic properties
After intravenous administration of laronidase with an infusion time of 240 minutes and at a dose of 100 U/kg body weight pharmacokinetic properties were measured at Weeks 1, 12 and 26. Parameter Infusion ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, single dose toxicity, repeated dose toxicity and toxicity to reproduction. Genotoxic and carcinogenic ...
List of excipients
Sodium chloride Sodium phosphate monobasic, monohydrate Sodium phosphate dibasic, heptahydrate Polysorbate 80 Water for injections
Incompatibilities
In the absence of compatibility studies, 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: From a microbiological safety point of view, the product should be used immediately. If not used immediately, in-use storage should not be longer ...
Special precautions for storage
Store in a refrigerator (2°C–8°C). For storage conditions after dilution of the medicinal product, see section 6.3.
Nature and contents of container
5 ml concentrate for solution in a vial (type I glass) with a stopper (siliconised chlorobutyl rubber) and a seal (aluminium) with a flip-off cap (polypropylene). Pack sizes: 1, 10 and 25 vials. Not all ...
Special precautions for disposal and other handling
Each vial of Aldurazyme 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
Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, The Netherlands
Marketing authorization number(s)
EU/1/03/253/001-003
Date of first authorization / renewal of the authorization
Date of first authorisation: 10 June 2003 Date of latest renewal: 10 June 2008
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