CHENODEOXYCHOLIC ACID LEADIANT Hard capsule (2017)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Chenodeoxycholic acid Leadiant 250 mg hard capsules.
Qualitative and quantitative composition
Each hard capsule contains 250 mg of chenodeoxycholic acid. For the full list of excipients, see section 6.1.
Pharmaceutical form
Hard capsule. Size 0 capsule, 21.7 mm in length with a yellow body and orange cap, containing a white, compressed powder.
Therapeutic indications
Chenodeoxycholic acid is indicated for the treatment of inborn errors of primary bile acid synthesis due to sterol 27 hydroxylase deficiency (presenting as cerebrotendinous xanthomatosis (CTX)) in infants, ...
Posology and method of administration
Treatment must be initiated and monitored by physicians experienced in the management of CTX or inborn errors of primary bile acid synthesis. During the initiation of therapy and dose adjustment, serum ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Monitoring After the initiation period, cholestanol, urine bile alcohols and liver function should be determined annually, at a minimum, and the dose adjusted accordingly. Additional or more frequent investigations ...
Interaction with other medicinal products and other forms of interaction
In patients with CTX, no interaction studies with chenodeoxycholic acid and concomitantly administered medicinal products have been performed. Colestipol and antacid medicinal products Chenodeoxycholic ...
Fertility, pregnancy and lactation
Women of childbearing potential Women of childbearing potential should use an effective method of contraception. The use of oral contraceptives is not recommended in patients taking chenodeoxycholic acid, ...
Effects on ability to drive and use machines
Chenodeoxycholic acid has no or negligible influence on the ability to drive and use machines.
Undesirable effects
Summary of the safety profile Adverse reactions in patients (both adults and children) receiving Chenodeoxycholic acid are generally mild to moderate in severity; the main reactions observed are given ...
Overdose
The potential for harm from overdose is considered extremely low, as accumulation of chenodeoxycholic acid is unlikely due to an efficient endogenous mechanism of elimination and excretion.
Pharmacodynamic properties
Pharmacotherapeutic group: Alimentary tract and metabolism Bile therapy Bile acid preparations ATC code: A05AA01 Mechanism of action Exogenous chenodeoxycholic acid is used as replacement therapy to ...
Pharmacokinetic properties
Data exists only in the adult population. Chenodeoxycholic acid is an endogenous bile acid in humans, which is tightly regulated by its secretion into bile via exporter pumps and detoxification by sulfation. ...
Preclinical safety data
No formal preclinical safety studies have been conducted however data in the literature reveal no special hazard for humans based on conventional studies of single dose toxicity, repeated dose toxicity, ...
List of excipients
Capsule content: Maize starch Magnesium stearate Silica, colloidal anhydrous Water Capsule shell: Gelatine Titanium dioxide Quinoline yellow Erythrosine
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
Capsules are packed in polyvinyl chloride (PVC) blisters sealed with aluminium foil and packed in cardboard boxes. Packs size: 100 capsules.
Special precautions for disposal and other handling
Patients who are unable to swallow capsules For children, adolescents and adults who cannot swallow capsules and/or need to take a dose below 250 mg, the capsule may be opened, the contents of added to ...
Marketing authorization holder
Leadiant GmbH, Liebherrstr. 22, 80538 Munich, Germany, Telephone: +49 (0)89 5506675 – 0, Fax: +49 (0) 89 55 066 75 25, e-mail: info@leadiantbiosciences.com
Marketing authorization number(s)
EU/1/16/1110/001
Date of first authorization / renewal of the authorization
Date of first authorisation: 10/04/2017
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