CYSTADANE Oral powder (2017)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Cystadane 1 g oral powder.
Qualitative and quantitative composition
1 g of powder contains 1 g of betaine anhydrous. For the full list of excipients, see section 6.1.
Pharmaceutical form
Oral powder. White crystalline free flowing powder.
Therapeutic indications
Adjunctive treatment of homocystinuria, involving deficiencies or defects in: cystathionine beta-synthase (CBS), 5,10-methylene-tetrahydrofolate reductase (MTHFR), cobalamin cofactor metabolism (cbl). ...
Posology and method of administration
Cystadane treatment should be supervised by a physician experienced in the treatment of patients with homocystinuria. Posology Children and Adult The recommended total daily dose is 100 mg/kg/day given ...
Contraindications
Hypersensitivity to the active substance.
Special warnings and precautions for use
Uncommon cases of severe cerebral oedema associated with hypermethioninemia were reported with betaine anhydrous therapy in patients with CBS deficiency (see section 4.8). Complete recovery was seen after ...
Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed. Based on in vitro data, betaine anhydrous might interact with amino acids mixtures and medicinal products containing vigabatrin and GABA analogues.
Fertility, pregnancy and lactation
Pregnancy Data on a limited number of exposed pregnancies indicate no adverse event of betaine anhydrous on pregnancy or on the health of the foetus/newborn child. To date, no other relevant epidemiologic ...
Effects on ability to drive and use machines
Cystadane has no or negligible influence on the ability to drive and use machines.
Undesirable effects
Summary of the safety profile In general, adverse reactions seen with betaine anhydrous therapy appeared to be not serious and are mainly related to the gastrointestinal system. Gastrointestinal disorders ...
Overdose
No case of overdose has been reported.
Pharmacodynamic properties
Pharmacotherapeutic group: Other alimentary tract and metabolism products ATC code: A16AA06 Mechanism of action Betaine anhydrous was shown to lower plasma homocysteine levels in the three types of homocystinuria, ...
Pharmacokinetic properties
The pharmacokinetic data of homocystinuric patients on long-term betaine anhydrous supplementation are very similar to those of healthy volunteers. This demonstrates that differences in betaine anhydrous ...
Preclinical safety data
At high doses, a CNS depressant effect and irritation of the gastrointestinal tract was seen in rats. Long-term carcinogenicity and reproductive toxicity studies have not been conducted on betaine anhydrous. ...
List of excipients
None.
Incompatibilities
Not applicable.
Shelf life
Unopened bottle: 3 years. After the first opening: 3 months.
Special precautions for storage
Do not store above 25°C. Keep the bottle tightly closed in order to protect from moisture. For storage conditions after first opening of the medicinal product, see section 6.3.
Nature and contents of container
HDPE bottles with a child resistant closure. Each pack contains 1 bottle with 180 g of powder and three measuring spoons.
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
Orphan Europe SARL, Immeuble Le Wilson, 70, Avenue du General de Gaulle, F-92 800 Puteaux, France
Marketing authorization number(s)
EU/1/06/379/001
Date of first authorization / renewal of the authorization
Date of first authorisation: 15 February 2007 Date of latest renewal: 21 November 2016
Date of revision of the text
14 February 2017
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