WILZIN Hard capsule (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Wilzin 50 mg hard capsules.
Qualitative and quantitative composition
Each hard capsule contains 50 mg of zinc (corresponding to 167.84 mg of zinc acetate dihydrate). Excipients: Each capsule contains 1.75 mg of sunset yellow FCF (E110) For a full list of excipients, see ...
Pharmaceutical form
Hard capsule. Capsule with orange opaque cap and body, imprinted 93-377.
Therapeutic indications
Treatment of Wilsons disease.
Posology and method of administration
Wilzin treatment should be initiated under the supervision of a physician experienced in the treatment of Wilsons disease (see section 4.4). Wilzin is a life-long therapy. There is no difference in dose ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients.
Special warnings and precautions for use
Zinc acetate dihydrate is not recommended for the initial therapy of symptomatic patients because of its slow onset of action. Symptomatic patients must be initially treated with a chelating agent; once ...
Interaction with other medicinal products and other forms of interaction
Other anti-copper agents Pharmacodynamic studies were conducted in Wilsons disease patients on the combination of Wilzin (50 mg three times daily) with ascorbic acid (1 g once daily), penicillamine (250 ...
Pregnancy and lactation
Pregnancy Data on a limited number of exposed pregnancies in patients with Wilsons disease give no indication of harmful effects of zinc on embryo/foetus and mother. Five miscarriages and 2 birth defects ...
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed.
Undesirable effects
Reported adverse reactions are listed below, by system organ class and by frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 ...
Overdose
Three cases of acute oral overdose with zinc salts (sulphate or gluconate) have been reported in the literature. Death occurred in a 35 year-old woman on the fifth day after ingestion of 6 g of zinc (40 ...
Pharmacodynamic properties
Pharmacotherapeutic group: various alimentary tract and metabolism products ATC code: A16AX05 Wilsons disease (hepatolenticular degeneration) is an autosomal recessive metabolic defect in hepatic excretion ...
Pharmacokinetic properties
Since the mechanism of action of zinc is an effect on copper uptake at the level of the intestinal cell, pharmacokinetic evaluations based on blood levels of zinc do not provide useful information on zinc ...
Preclinical safety data
Preclinical studies have been conducted with zinc acetate and with other zinc salts. Pharmacological and toxicological data available showed large similarities between zinc salts and among animal species. ...
List of excipients
Capsule content: Maize starch Magnesium stearate Capsule shell: Gelatin Titanium dioxide (E171) Sunset yellow FCF (E110) Printing ink: Black iron oxide (E172) Shellac
Incompatibilities
Not applicable.
Shelf life
Shelf life: 3 years.
Special precautions for storage
Do not store above 25°C.
Nature and contents of container
White HDPE bottle with a polypropylene and HDPE closure and contains a filler (cotton coil). Each bottle contains 250 capsules.
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Recordati Rare Diseases, Immeuble Le Wilson, 70, avenue du Général de Gaulle, F-92800 Puteaux, France
Marketing authorization number(s)
EU/1/04/286/002
Date of first authorization / renewal of the authorization
Date of first authorisation: 13 October 2004 Date of latest renewal: 13 October 2009
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