Ferriprox 100 mg/ml oral solution (2012)
Βιβλιογραφική αναφορά
Στοιχεία εκδότη
| Εκδότης | Swedish Orphan Biovitrum Ltd |
|---|---|
| Διεύθυνση | 1 Fordham House Court, Fordham House Estate, Newmarket Road, Cambridgeshire, CB7 5LL |
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Marketing authorization number(s)
EU/1/99/108/002 EU/1/99/108/003
Special precautions for disposal and other handling
No special requirements.
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, ...
Date of first authorization / renewal of the authorization
Date of first authorisation: 25/08/1999 Date of latest renewal: 25/08/2009
Special precautions for storage
Do not store above 30ºC. Store in the original package in order to protect from light.
List of excipients
Purified water Hydroxyethylcellulose Glycerol Hydrochloric acid, concentrated Artificial cherry flavour Peppermint oil Sunset Yellow (E110) Sucralose (E955)
Name of the medicinal product
Ferriprox 100 mg/ml oral solution.
Qualitative and quantitative composition
Each ml of oral solution contains 100 mg deferiprone (25 g deferiprone in 250 ml and 50 g deferiprone in 500 ml). Excipient: Each ml of oral solution contains 0.4 mg Sunset Yellow (E110). For a full list ...
Marketing authorization holder
Apotex Europe B.V. Darwinweg 20 2333 CR Leiden Netherlands
Therapeutic indications
Ferriprox is indicated for the treatment of iron overload in patients with thalassaemia major when deferoxamine therapy is contraindicated or inadequate.
Nature and contents of container
Amber polyethylene terephthalate (PET) bottles with child resistant closure (polypropylene), and a graduated measuring cup (polypropylene). Each pack contains one bottle of 250 ml or 500 ml oral solution. ...
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 to iron ...
Date of revision of the text
08/2012
Special warnings and precautions for use
Neutropenia/Agranulocytosis Deferiprone has been shown to cause neutropenia, including agranulocytosis. The patients neutrophil count should be monitored every week. In clinical trials, weekly monitoring ...
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 ...
Shelf life
3 years. After first opening use within 35 days.
Undesirable effects
The most common adverse reactions reported during therapy with deferiprone in clinical trials were nausea, vomiting, abdominal pain, and chromaturia, which were reported in more than 10% of patients. The ...
Pharmacokinetic properties
Absorption Deferiprone is rapidly absorbed from the upper part of the gastrointestinal tract. Peak serum concentration is reported to occur 45 to 60 minutes following a single dose in fasted patients. ...
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 ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients. History of recurrent episodes of neutropenia. History of agranulocytosis. Pregnancy (see section 4.6). Breastfeeding (see section 4.6). ...
Incompatibilities
Not applicable.
Pharmaceutical form
Oral solution. Clear, reddish orange coloured liquid.
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 ...
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). ...
Effects on ability to drive and use machines
Not relevant.