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

Προτάσεις

SPC, UK: EXJADE 125 mg, 250mg, 500mg dispersible tablets (2012)

Εκδότης

Εκδότης Novartis Pharmaceuticals UK Ltd
Διεύθυνση Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR
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Περιεχόμενα

Name of the medicinal product

EXJADE® 125 mg dispersible tablets. EXJADE® 250 mg dispersible tablets. EXJADE® 500 mg dispersible tablets. ...

Qualitative and quantitative composition

Each dispersible tablet contains 125 mg deferasirox. Each dispersible tablet contains 250 mg deferasirox. ...

Pharmaceutical form

Dispersible tablet. Off-white, round, flat tablets with bevelled edges and imprints (NVR on one face ...

Therapeutic indications

EXJADE is indicated for the treatment of chronic iron overload due to frequent blood transfusions (≥7 ...

Posology and method of administration

Treatment with EXJADE should be initiated and maintained by physicians experienced in the treatment of ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients. Combination with other iron chelator ...

Special warnings and precautions for use

Renal function EXJADE has been studied only in patients with baseline serum creatinine within the age-appropriate ...

Interaction with other medicinal products and other forms of interaction

The safety of EXJADE in combination with other iron chelators has not been established. Therefore, it ...

Fertility, pregnancy and lactation

Pregnancy No clinical data on exposed pregnancies are available for deferasirox. Studies in animals have ...

Effects on ability to drive and use machines

No studies on the effects of EXJADE on the ability to drive and use machines have been performed. Patients ...

Undesirable effects

Summary of the safety profile The most frequent reactions reported during chronic treatment with EXJADE ...

Overdose

Cases of overdose (2-3 times the prescribed dose for several weeks) have been reported. In one case, ...

Pharmacodynamic properties

Pharmacotherapeutic group: Iron chelating agent ATC code: V03AC03 Mechanism of action Deferasirox is ...

Pharmacokinetic properties

Absorption Deferasirox is absorbed following oral administration with a median time to maximum plasma ...

Preclinical safety data

Preclinical data reveal no special hazard for patients with iron overload, based on conventional studies ...

List of excipients

Lactose monohydrate Crospovidone type A Cellulose, microcrystalline Povidone Sodium laurilsulfate Silica, ...

Incompatibilities

Dispersion in carbonated drinks or milk is not recommended due to foaming and slow dispersion, respectively. ...

Shelf life

3 years.

Special precautions for storage

Store in the original package in order to protect from moisture.

Nature and contents of container

PVC/PE/PVDC/Aluminium blisters. Packs containing 28, 84 or 252 dispersible tablets. Not all pack sizes ...

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

Novartis Europharm Limited Wimblehurst Road Horsham West Sussex, RH12 5AB United Kingdom

Marketing authorization number(s)

Exjade 125mg dispersible tablets: EU/1/06/356/001 EU/1/06/356/002 EU/1/06/356/007 Exjade 250mg dispersible ...

Date of first authorization / renewal of the authorization

Date of first authorisation: 28.08.2006 Date of latest renewal: 28.08.2011

Date of revision of the text

24.10.2012
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.