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 Περιεχόμενα  Φάρμακα Α - Ζ  Συγχορήγηση

CUPRIOR Film-coated tablet (2020)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Cuprior 150 mg film-coated tablets.

Qualitative and quantitative composition

Each film-coated tablet contains trientine tetrahydrochloride equivalent to 150 mg trientine. For the full list of excipients, see section 6.1.

Pharmaceutical form

Film-coated tablet (tablet). Yellow, 16 mm x 8 mm oblong film-coated tablet with a score line on each side. The tablet can be divided into equal doses.

Therapeutic indications

Cuprior is indicated for the treatment of Wilsons disease in adults, adolescents and children ≥5 years intolerant to D-penicillamine therapy.

Posology and method of administration

Treatment should only be initiated by specialist physicians with experience in the management of Wilsons disease. Posology The starting dose would usually correspond to the lowest dose in the range and ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Special warnings and precautions for use

When switching a patient from another formulation trientine, caution is advised because doses expressed in trientine base may not be equivalent (see section 4.2). Trientine is a chelating agent which has ...

Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed. Trientine has been found to reduce serum iron levels, possibly by reducing its absorption, and iron supplements may be required. Since iron and trientine may ...

Fertility, pregnancy and lactation

Pregnancy There is a limited amount of data from the use of trientine in pregnant women. Studies in animals have shown reproductive toxicity, which was probably a result of trientine-induced copper deficiency ...

Effects on ability to drive and use machines

Cuprior has no or negligible influence on the ability to drive and use machines.

Undesirable effects

Summary of the safety profile The most commonly reported adverse reaction with trientine is nausea. Serious iron deficiency anaemia and severe colitis may occur during treatment. Tabulated list of adverse ...

Overdose

Occasional cases of trientine overdose have been reported. In cases up to 20 g of trientine base there were no apparent adverse effects reported. A large overdose of 40 g of trientine base resulted in ...

Pharmacodynamic properties

Pharmacotherapeutic group: Other alimentary tract and metabolism products, various alimentary tract and metabolism products ATC code: A16AX12 Mechanism of action Trientine is a copper-chelating agent whose ...

Pharmacokinetic properties

Absorption The absorption of trientine following oral administration is low and variable in patients with Wilson disease. The pharmacokinetic profile of Cuprior has been evaluated after a single oral dose ...

Preclinical safety data

Preclinical data obtained with trientine have shown adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to clinical exposure levels and with possible relevance ...

List of excipients

Tablet core: Mannitol Colloidal anhydrous silica Glycerol dibehenate Tablet film-coating: Polyvinyl alcohol Talc Titanium dioxide (E171) Glycerol monocaprylocaprate (Type I) Iron oxide yellow (E172) Sodium ...

Incompatibilities

Not applicable.

Shelf life

30 months.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

OPA/Alu/PVC-Alu blisters, each blister contains 8 film-coated tablets. Pack size: 72 or 96 film-coated tablets. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

gmp-orphan SA, Pépinière Paris Santé Cochin, 27-29 rue du Faubourg Saint-Jacques, 75014, Paris, France

Marketing authorization number(s)

EU/1/17/1199/001

Date of first authorization / renewal of the authorization

Date of first authorisation: 5 September 2017

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