ELAPRASE Concentrate for solution for infusion (2019)
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Περιεχόμενα
Name of the medicinal product
Elaprase 2 mg/ml concentrate for solution for infusion.
Qualitative and quantitative composition
Each vial contains 6 mg of idursulfase. Each ml contains 2 mg of idursulfase*. Excipient with known effect: Each vial contains 0.482 mmol of sodium. For the full list of excipients, see section 6.1. * ...
Pharmaceutical form
Concentrate for solution for infusion (sterile concentrate). A clear to slightly opalescent, colourless solution.
Therapeutic indications
Elaprase is indicated for the long-term treatment of patients with Hunter syndrome (Mucopolysaccharidosis II, MPS II). Heterozygous females were not studied in the clinical trials.
Posology and method of administration
This treatment should be supervised by a physician or other healthcare professional experienced in the management of patients with MPS II disease or other inherited metabolic disorders. Posology Elaprase ...
Contraindications
Severe or life-threatening hypersensitivity to the active substance or to any of the excipients listed in section 6.1 if hypersensitivity is not controllable.
Special warnings and precautions for use
Infusion-related reactions Patients treated with idursulfase may develop infusion-related reactions (see section 4.8). During clinical trials, the most common infusion-related reactions included cutaneous ...
Interaction with other medicinal products and other forms of interaction
No formal medicinal product interaction studies have been conducted with idursulfase. Based on its metabolism in cellular lysosomes, idursulfase would not be a candidate for cytochrome P450 mediated interactions. ...
Pregnancy and lactation
Pregnancy There are no data or limited amount of data from the use of idursulfase in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity ...
Effects on ability to drive and use machines
Idursulfase has no or negligible influence on the ability to drive and use machines.
Undesirable effects
Summary of the safety profile Adverse reactions that were reported for the 32 patients treated with 0.5 mg/kg idursulfase weekly in the TKT024 phase II/III 52-week placebo-controlled study were almost ...
Overdose
There is no experience with overdoses of Elaprase.
Pharmacodynamic properties
Pharmacotherapeutic group: Other alimentary tract and metabolism products – enzymes ATC code: A16AB09 Mechanism of action Hunter syndrome is an X-linked disease caused by insufficient levels of the lysosomal ...
Pharmacokinetic properties
Idursulfase is taken up by selective receptor-mediated mechanisms involving binding to mannose 6-phosphate receptors. Upon internalization by cells, it is localized within cellular lysosomes, thereby limiting ...
Preclinical safety data
Nonclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, single dose toxicity, repeated dose toxicity, toxicity to reproduction and development and to ...
List of excipients
Polysorbate 20 Sodium chloride Dibasic sodium phosphate heptahydrate Monobasic sodium phosphate monohydrate 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: 3 years. Chemical and physical in-use stability has been demonstrated for 8 hours at 25°C. After dilution: From a microbiological safety point of view, the diluted product should be used immediately. ...
Special precautions for storage
Store in a refrigerator (2°C–8°C). Do not freeze. For storage conditions after dilution of the medicinal product, see section 6.3.
Nature and contents of container
5 ml vial (type I glass) with a stopper (fluoro-resin coated butyl rubber), one piece seal and blue flipoff cap. Each vial contains 3 ml of concentrate for solution for infusion. Pack sizes of 1, 4 and ...
Special precautions for disposal and other handling
Each vial of Elaprase is intended for single use only and contains 6 mg of idursulfase in 3 ml of solution. Elaprase is for intravenous infusion and must be diluted in sodium chloride 9 mg/ml (0.9%) solution ...
Marketing authorization holder
Shire Human Genetic Therapies AB, Vasagatan 7, 111 20, Stockholm, Sweden
Marketing authorization number(s)
EU/1/06/365/001-003
Date of first authorization / renewal of the authorization
Date of first authorisation: 08 January 2007 Date of latest renewal: 09 September 2016
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