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Ιατροφαρμακευτική πληροφόρηση για τον επαγγελματία υγείας

Φάρμακα Δραστικές ουσίες Συμπληρώματα διατροφής Έλεγχος συγχορήγησης Νόσοι ICD-10
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Βιβλιογραφική αναφορά

Προτάσεις

SPC, UK: Ferriprox 100 mg/ml oral solution (2012)

Εκδότης

Εκδότης Swedish Orphan Biovitrum Ltd
Διεύθυνση 1 Fordham House Court, Fordham House Estate, Newmarket Road, Cambridgeshire, CB7 5LL
Σφάλμα Για την προβολή της πλήρους καταχώρησης χρειάζεται να έχετε συνδρομή σε ισχύ (αγορά συνδρομής).
Ολοκληρώνοντας τη διαδικασία δωρεάν εγγραφής θα αποκτήσετε, χωρίς καμία δέσμευση εκ μέρους σας, συνδρομή διάρκειας 30 ημερών.

Περιεχόμενα

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 ...

Pharmaceutical form

Oral solution. Clear, reddish orange coloured liquid.

Therapeutic indications

Ferriprox is indicated for the treatment of iron overload in patients with thalassaemia major when deferoxamine ...

Posology and method of administration

Deferiprone therapy should be initiated and maintained by a physician experienced in the treatment of ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients. History of recurrent episodes of ...

Special warnings and precautions for use

Neutropenia/Agranulocytosis Deferiprone has been shown to cause neutropenia, including agranulocytosis. ...

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 ...

Fertility, pregnancy and lactation

Pregnancy There are no adequate data from the use of deferiprone in pregnant women. Studies in animals ...

Effects on ability to drive and use machines

Not relevant.

Undesirable effects

The most common adverse reactions reported during therapy with deferiprone in clinical trials were nausea, ...

Overdose

No cases of acute overdose have been reported. However, neurological disorders (such as cerebellar symptoms, ...

Pharmacodynamic properties

Pharmacotherapeutic group: Iron chelating agents ATC code: V03AC02 Mechanism of action The active substance ...

Pharmacokinetic properties

Absorption Deferiprone is rapidly absorbed from the upper part of the gastrointestinal tract. Peak serum ...

Preclinical safety data

Non-clinical studies have been conducted in animal species including mice, rats, rabbits, dogs and monkeys. ...

List of excipients

Purified water Hydroxyethylcellulose Glycerol Hydrochloric acid, concentrated Artificial cherry flavour ...

Incompatibilities

Not applicable.

Shelf life

3 years. After first opening use within 35 days.

Special precautions for storage

Do not store above 30ºC. Store in the original package in order to protect from light.

Nature and contents of container

Amber polyethylene terephthalate (PET) bottles with child resistant closure (polypropylene), and a graduated ...

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

Apotex Europe B.V. Darwinweg 20 2333 CR Leiden Netherlands

Marketing authorization number(s)

EU/1/99/108/002 EU/1/99/108/003

Date of first authorization / renewal of the authorization

Date of first authorisation: 25/08/1999 Date of latest renewal: 25/08/2009

Date of revision of the text

08/2012
Απαγορεύεται η αναπαραγωγή και αναδιανομή. Το έργο επεξεργασίας των παραπάνω πληροφοριών αποτελεί πνευματική ιδιοκτησία της Ergobyte Πληροφορική Α.Ε. και προστατεύεται από τη νομοθεσία περί πνευματικών δικαιωμάτων.