GALAFOLD Hard capsule (2019)
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Περιεχόμενα
Name of the medicinal product
Galafold 123 mg hard capsules.
Qualitative and quantitative composition
Each capsule contains migalastat hydrochloride equivalent to 123 mg migalastat. For the full list of excipients, see section 6.1.
Pharmaceutical form
Hard capsule. Size 2 hard capsule (6.4x18.0 mm) with an opaque blue cap and opaque white body with A1001 printed in black, containing white to pale brown powder.
Therapeutic indications
Galafold is indicated for long-term treatment of adults and adolescents aged 16 years and older with a confirmed diagnosis of Fabry disease (α-galactosidase A deficiency) and who have an amenable mutation ...
Posology and method of administration
Treatment with Galafold should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of Fabry disease. Galafold is not intended for concomitant use with enzyme ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
It is advised to periodically monitor renal function, echocardiographic parameters and biochemical markers (every 6 months) in patients initiated on or switched to Galafold. In case of meaningful clinical ...
Interaction with other medicinal products and other forms of interaction
Based upon in vitro data, migalastat is not an inducer of CYP1A2, 2B6, or 3A4. Furthermore, migalastat is not an inhibitor or a substrate of CYP1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, or 3A4/5. Migalastat ...
Fertility, pregnancy and lactation
Women of childbearing potential/Contraception in males and females Galafold is not recommended in women of childbearing potential not using contraception. Pregnancy There are limited data from the use ...
Effects on ability to drive and use machines
Galafold has no or negligible influence on the ability to drive and use machines.
Undesirable effects
Summary of the safety profile The most common adverse reaction was headache, which was experienced by approximately 10% of patients who received Galafold. Tabulated list of adverse reactions Frequencies ...
Overdose
In case of overdose, general medical care is recommended. Headache and dizziness were the most common adverse reactions reported at doses of Galafold of up to 1250 mg and 2000 mg, respectively.
Pharmacodynamic properties
Pharmacotherapeutic group: Various alimentary tract and metabolism products ATC code: A16AX14 Fabry disease is a progressive X-linked lysosomal storage disorder which affects males and females. Fabry disease-causing ...
Pharmacokinetic properties
Absorption The absolute bioavailability (AUC) for a single oral 150 mg migalastat hydrochloride dose or a single 2-hour 150 mg intravenous infusion was approximately 75%. Following a single oral dose of ...
Preclinical safety data
Non-clinical studies suggest no specific hazard for humans on the basis of single-and repeat-dose studies, with the exception of transient and fully reversible infertility in male rats associated with ...
List of excipients
Capsule contents: Pregelatinised starch (maize) Magnesium stearate Capsule shell: Gelatin Titanium dioxide (E171) Indigotine (E132) Printing ink: Shellac Black iron oxide Potassium hydroxide
Incompatibilities
Not applicable.
Shelf life
Shelf life: 4 years.
Special precautions for storage
This medicinal product does not require any special temperature storage conditions. Store in the original package in order to protect from moisture.
Nature and contents of container
PVC / PCTFE / PVC/Al blister. Pack size of 14 capsules.
Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Amicus Therapeutics Europe Limited, Block 1, Blanchardstown Corporate Park, Ballycoolen Road, Blanchardstown, Dublin, D15 AKK1, Ireland Tel: +353 (0) 1 588 6850, Fax: +353 (0) 1 588 6851, e-mail: info@amicusrx.co.uk ...
Marketing authorization number(s)
EU/1/15/1082/001
Date of first authorization / renewal of the authorization
26 May 2016
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