EXJADE Film-coated tablet (2022)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
Name of the medicinal product
EXJADE 90 mg film-coated tablets. EXJADE 180 mg film-coated tablets. EXJADE 360 mg film-coated tablets.
Qualitative and quantitative composition
<b>EXJADE 90 mg film-coated tablets:</b> Each film-coated tablet contains 90 mg deferasirox. <b>EXJADE 180 mg film-coated tablets:</b> Each film-coated tablet contains 180 mg deferasirox. <b>EXJADE 360 ...
Pharmaceutical form
Film-coated tablet. <u>EXJADE 90 mg film-coated tablets:</u> Light blue, ovaloid, biconvex film-coated tablet with bevelled edges and imprints (NVR on one face and 90 on the other). Approximate tablet ...
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 film-coated tablets demonstrate higher bioavailability compared to the EXJADE dispersible tablet formulation. After adjustment of the strength, the film-coated tablet formulation (360 mg strength) ...
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
<u>Tablet core:</u> Cellulose, microcrystalline Crospovidone Povidone Magnesium stearate Silica, colloidal anhydrous Poloxamer <u>Coating material:</u> Hypromellose Titanium dioxide (E171) Macrogol (4000) ...
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
PVC/PVDC/Aluminium blisters. Unit packs containing 30 or 90 film-coated tablets or multipacks containing 300 (10 packs of 30) film-coated tablets. Not all pack sizes may be marketed.
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)
<u>EXJADE 90 mg film-coated tablets:</u> EU/1/06/356/011 EU/1/06/356/012 EU/1/06/356/013 <u>EXJADE 180 mg film-coated tablets:</u> EU/1/06/356/014 EU/1/06/356/015 EU/1/06/356/016 <u>EXJADE 360 mg film-coated ...
Date of first authorization / renewal of the authorization
Date of first authorisation: 28 August 2006 Date of latest renewal: 18 April 2016
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
