FERRIPROX Film-coated tablet (2020)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Ferriprox 500 mg film-coated tablets. Ferriprox 1000 mg film-coated tablets.
Qualitative and quantitative composition
Ferriprox 500 mg film-coated tablets: Each tablet contains 500 mg deferiprone. Ferriprox 1000 mg film-coated tablets: Each tablet contains 1000 mg deferiprone. For the full list of excipients, see section ...
Pharmaceutical form
Film-coated tablet. Ferriprox 500 mg film-coated tablets: White to off-white, capsule-shaped, film-coated tablets imprinted APO bisect 500 on one side, plain on the other. The tablet is scored. The tablet ...
Therapeutic indications
Ferriprox monotherapy is indicated for the treatment of iron overload in patients with thalassaemia major when current chelation therapy is contraindicated or inadequate. Ferriprox in combination with ...
Posology and method of administration
Deferiprone therapy should be initiated and maintained by a physician experienced in the treatment of patients with thalassaemia. Posology Deferiprone is usually given as 25 mg/kg body weight, orally, ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. History of recurrent episodes of neutropenia. History of agranulocytosis. Pregnancy (see section 4.6). Breast-feeding ...
Special warnings and precautions for use
Neutropenia/Agranulocytosis Deferiprone has been shown to cause neutropenia, including agranulocytosis (see section 4.8 Description of selected adverse reactions). The patients absolute neutrophil count ...
Interaction with other medicinal products and other forms of interaction
Due to the unknown mechanism of deferiprone-induced neutropenia, patients must not take medicinal products known to be associated with neutropenia or those that can cause agranulocytosis (see section 4.3). ...
Fertility, pregnancy and lactation
Pregnancy There are no adequate data from the use of deferiprone in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown. Women ...
Effects on ability to drive and use machines
Not relevant.
Undesirable effects
Summary of the safety profile The most common adverse reactions reported during therapy with deferiprone in clinical trials were nausea, vomiting, abdominal pain, and chromaturia, which were reported in ...
Overdose
No cases of acute overdose have been reported. However, neurological disorders (such as cerebellar symptoms, diplopia, lateral nystagmus, psychomotor slowdown, hand movements and axial hypotonia) have ...
Pharmacodynamic properties
Pharmacotherapeutic group: Iron chelating agents ATC code: V03AC02 Mechanism of action The active substance is deferiprone (3-hydroxy-1,2-dimethylpyridin-4-one), a bidentate ligand which binds iron in ...
Pharmacokinetic properties
Absorption Deferiprone is rapidly absorbed from the upper part of the gastrointestinal tract. Peak serum concentration occurs 45 to 60 minutes following a single dose in fasted patients. This may be extended ...
Preclinical safety data
Non-clinical studies have been conducted in animal species including mice, rats, rabbits, dogs and monkeys. The most common findings in non-iron-loaded animals at doses of 100 mg/kg/day and above were ...
List of excipients
Ferriprox 500 mg film-coated tablets Tablet core: Microcrystalline cellulose Magnesium stearate Colloidal silicon dioxide Coating: Hypromellose Macrogol Titanium dioxide Ferriprox 1000 mg film-coated tablets ...
Incompatibilities
Not applicable.
Shelf life
Ferriprox 500 mg film-coated tablets: 5 years. Ferriprox 1000 mg film-coated tablets: 4 years. After first opening use within 50 days.
Special precautions for storage
Ferriprox 500 mg film-coated tablets: Do not store above 30ºC. Ferriprox 1000 mg film-coated tablets: Do not store above 30ºC. Keep the bottle tightly closed in order to protect from moisture.
Nature and contents of container
Ferriprox 500 mg film-coated tablets: High density polyethylene (HDPE) bottle with a child resistant polypropylene cap. Pack size of 100 tablets. Ferriprox 1000 mg film-coated tablets: High density polyethylene ...
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
Chiesi Farmaceutici S.p.A., Via Palermo 26/A, 43122, Parma, Italy
Marketing authorization number(s)
Ferriprox 500 mg film-coated tablets: EU/1/99/108/001 Ferriprox 1000 mg film-coated tablets: EU/1/99/108/004
Date of first authorization / renewal of the authorization
Date of first authorisation: 25 August 1999 Date of latest renewal: 21 September 2009
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