REPLAGAL Concentrate solution for infusion (2018)
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Περιεχόμενα
Name of the medicinal product
Replagal 1 mg/ml concentrate for solution for infusion.
Qualitative and quantitative composition
1 ml of concentrate for solution for infusion contains 1 mg of agalsidase alfa*. Each vial of 3.5 ml of concentrate contains 3.5 mg of agalsidase alfa. * agalsidase alfa is the human protein α-galactosidase ...
Pharmaceutical form
Concentrate for solution for infusion. A clear and colourless solution.
Therapeutic indications
Replagal is indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry Disease (α-galactosidase A deficiency).
Posology and method of administration
Replagal treatment should be supervised by a physician experienced in the management of patients with Fabry Disease or other inherited metabolic diseases. Posology Replagal is administered at a dose of ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Idiosyncratic infusion related reactions 13.7% of adult patients treated with Replagal in clinical trials have experienced idiosyncratic infusion related reactions. Four of 17 (23.5%) paediatric patients ...
Interaction with other medicinal products and other forms of interaction
Replagal should not be co-administered with chloroquine, amiodarone, benoquin or gentamicin since these substances have the potential to inhibit intra-cellular α-galactosidase activity. As α-galactosidase ...
Fertility, pregnancy and lactation
Pregnancy There is very limited data on pregnancies exposed to Replagal. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy or embryonic/fetal development when ...
Effects on ability to drive and use machines
Replagal has no or negligible influence on the ability to drive and use machines.
Undesirable effects
Summary of safety profile The most commonly reported adverse reactions were infusion associated reactions, which occurred in 13.7% of adult patients treated with Replagal in clinical trials. Most undesirable ...
Overdose
In clinical trials doses up to 0.4 mg/kg weekly were used, and their safety profile was not different from the recommended dose of 0.2 mg/kg biweekly.
Pharmacodynamic properties
Pharmacotherapeutic group: Other alimentary tract and metabolism products Enzymes ATC code: A16AB03 Mechanism of action Fabry Disease is a glycosphingolipid storage disorder that is caused by deficient ...
Pharmacokinetic properties
Single doses ranging from 0.007-0.2 mg enzyme per kg body weight were administered to adult male patients as 20-40 minute intravenous infusions while female patients received 0.2 mg enzyme per kg body ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on studies of repeated dose toxicity. Genotoxic and carcinogenic potential are not expected. Reproduction toxicity studies in female rats and ...
List of excipients
Sodium phosphate monobasic, monohydrate Polysorbate 20 Sodium chloride Sodium hydroxide Water for injections
Incompatibilities
In the absence of compatibility studies this medicinal product must not be mixed with other medicinal products.
Shelf life
Shelf life: 2 years. Chemical and physical in use stability has been demonstrated for 24 hours at 25°C. From a microbiological point of view, the product should be used immediately. If not used immediately, ...
Special precautions for storage
Store in a refrigerator (2°C–8°C).
Nature and contents of container
3.5 ml of concentrate for solution for infusion in a 5 ml vial (Type I glass) with a stopper (fluoro-resin coated butyl rubber), a one piece seal (aluminium) and flip-off cap. Pack sizes of 1, 4 or 10 ...
Special precautions for disposal and other handling
Calculate the dose and number of Replagal vials needed. Dilute the total volume of Replagal concentrate required in 100 ml of 9 mg/ml (0.9%) sodium chloride solution for infusion. Care must be taken to ...
Marketing authorization holder
Shire Human Genetic Therapies AB, Vasagatan 7, 111 20, Stockholm, Sweden
Marketing authorization number(s)
EU/1/01/189/001-003
Date of first authorization / renewal of the authorization
Date of first authorisation: 03/08/2001 Date of last renewal: 03/08/2006
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