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EXJADE Granules in sachet (2022)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

EXJADE 90 mg granules in sachet. EXJADE 180 mg granules in sachet. EXJADE 360 mg granules in sachet.

Qualitative and quantitative composition

<u>EXJADE 90 mg granules:</u> Each sachet contains 90 mg deferasirox. <u>EXJADE 180 mg granules:</u> Each sachet contains 180 mg deferasirox. <u>EXJADE 360 mg granules:</u> Each sachet contains 360 mg ...

Pharmaceutical form

Granules in sachet (granules). White to almost white granules.

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. Posology Transfusional iron overload It is recommended that treatment be started ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Combination with other iron chelator therapies as the safety of such combinations has not been established (see ...

Special warnings and precautions for use

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

Interaction with other medicinal products and other forms of interaction

The safety of deferasirox 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). Interaction with food ...

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

EXJADE has minor influence on the ability to drive and use machines. Patients experiencing the uncommon adverse reaction of dizziness should exercise caution when driving or operating machines (see section ...

Undesirable effects

Summary of the safety profile The most frequent reactions reported during chronic treatment in clinical studies conducted with deferasirox dispersible tablets in adult and paediatric patients include gastrointestinal ...

Overdose

Early signs of acute overdose are digestive effects such as abdominal pain, diarrhoea, nausea and vomiting. Hepatic and renal disorders have been reported, including cases of liver enzyme and creatinine ...

Pharmacodynamic properties

<b>Pharmacotherapeutic group:</b> Iron chelating agents <b>ATC code:</b> V03AC03 Mechanism of action Deferasirox is an orally active chelator that is highly selective for iron (III). It is a tridentate ...

Pharmacokinetic properties

EXJADE granules demonstrate higher bioavailability compared to the EXJADE dispersible tablet formulation. After adjustment of the strength, the granules formulation (4 90 mg strength) was equivalent to ...

Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity or carcinogenic potential. The main findings were kidney ...

List of excipients

Cellulose, microcrystalline Crospovidone Povidone Magnesium stearate Silica, colloidal anhydrous Poloxamer

Incompatibilities

Not applicable.

Shelf life

3 years.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

Sachets of polyethylene terephthalate (PET)/Aluminium/polyethylene (PE) foil. Unit packs containing 30 sachets.

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

Marketing authorization number(s)

EXJADE 90 mg granules: EU/1/06/356/020 EXJADE 180 mg granules: EU/1/06/356/021 EXJADE 360 mg granules: EU/1/06/356/022

Date of first authorization / renewal of the authorization

Date of first authorisation: 28 August 2006 Date of latest renewal: 18 April 2016

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