EXJADE Dispersible tablet (2019)
Βιβλιογραφική αναφορά
Στοιχεία εκδότη
| 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
EXJADE 125 mg dispersible tablets: Each dispersible tablet contains 125 mg deferasirox. Excipient with known effect: Each dispersible tablet contains 136 mg lactose. EXJADE 250 mg dispersible tablets: ...
Pharmaceutical form
Dispersible tablet. EXJADE 125 mg dispersible tablets: White to slightly yellow, round, flat tablets with bevelled edges and imprints (NVR on one face and J 125 on the other). Approximate tablet dimensions ...
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 with deferasirox dispersible tablets in adult and paediatric patients include gastrointestinal disturbances (mainly ...
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
Pharmacotherapeutic group: Iron chelating agents 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 (dispersible tablet formulation) is absorbed following oral administration with a median time to maximum plasma concentration (t<sub>max</sub>) of about 1.5 to 4 hours. The absolute ...
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
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. <u>EXJADE 125 mg dispersible tablets:</u> Packs containing 28, 84 or 252 dispersible tablets. <u>EXJADE 250 mg dispersible tablets:</u> Packs containing 28, 84 or 252 dispersible ...
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 125 mg dispersible tablets: EU/1/06/356/001 EU/1/06/356/002 EU/1/06/356/007 EXJADE 250 mg dispersible tablets: EU/1/06/356/003 EU/1/06/356/004 EU/1/06/356/008 EXJADE 500 mg dispersible tablets: ...
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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