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

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης :
Novartis Pharmaceuticals UK Ltd
Διεύθυνση :
Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR
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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. Each dispersible tablet contains 500 mg deferasirox. Excipient: Each dispersible tablet contains ...

Pharmaceutical form

Dispersible tablet. Off-white, round, flat tablets with bevelled edges and imprints (NVR on one face and J 125 on the other). Off-white, round, flat tablets with bevelled edges and imprints (NVR on one ...

Therapeutic indications

EXJADE is indicated for the treatment of chronic iron overload due to frequent blood transfusions (≥7 ml/kg/month of packed red blood cells) in patients with beta thalassaemia major aged 6 years and older. ...

Posology and method of administration

Treatment with EXJADE should be initiated and maintained by physicians experienced in the treatment of chronic iron overload due to blood transfusions. Posology It is recommended that treatment be started ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients. Combination with other iron chelator therapies as the safety of such combinations has not been established (see section 4.5). Patients ...

Special warnings and precautions for use

Renal function EXJADE has been studied only in patients with baseline serum creatinine within the age-appropriate normal range. During clinical trials, increases in serum creatinine of >33% on ≥2 consecutive ...

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 must not be combined with other iron chelator therapies (see section 4.3). The concomitant administration ...

Fertility, pregnancy and lactation

Pregnancy No clinical data on exposed pregnancies are available for deferasirox. Studies in animals have shown some reproductive toxicity at maternally toxic doses (see section 5.3). The potential risk ...

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 experiencing the uncommon adverse reaction of dizziness should exercise caution when driving or ...

Undesirable effects

Summary of the safety profile The most frequent reactions reported during chronic treatment with EXJADE in adult and paediatric patients include gastrointestinal disturbances in about 26% of patients (mainly ...

Overdose

Cases of overdose (2-3 times the prescribed dose for several weeks) have been reported. In one case, this resulted in subclinical hepatitis which resolved after a dose interruption. Single doses of 80 ...

Pharmacodynamic properties

Pharmacotherapeutic group: Iron chelating agent ATC code: V03AC03 Mechanism of action Deferasirox is an orally active chelator that is highly selective for iron (III). It is a tridentate ligand that binds ...

Pharmacokinetic properties

Absorption Deferasirox is absorbed following oral administration with a median time to maximum plasma concentration (tmax) of about 1.5 to 4 hours. The absolute bioavailability (AUC) of deferasirox from ...

Preclinical safety data

Preclinical data reveal no special hazard for patients with iron overload, based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity or carcinogenic potential. The main ...

List of excipients

Lactose monohydrate Crospovidone type A Cellulose, microcrystalline Povidone Sodium laurilsulfate Silica, colloidal anhydrous Magnesium stearate

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 may be marketed.

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 tablets: EU/1/06/356/003 EU/1/06/356/004 EU/1/06/356/008 Exjade 500mg dispersible tablets: EU/1/06/356/005 ...

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