Страна: Израиль
Язык: английский
Источник: Ministry of Health
DEFERASIROX
NOVARTIS ISRAEL LTD
V03AC03
TABLETS DISPERSIBLE
DEFERASIROX 250 MG
PER OS
Required
SANDOZ S.R.L., ROMANIA
DEFERASIROX
DEFERASIROX
Exjade is indicated for the treatment of chronic iron overload due to blood transfusions (transfusionalhaemosiderosis) in adult and pediatric patients (aged 2 years and over).Exjade is also indicated for the treatment of chronic iron overload in patients with non-transfusion-dependent thalassemia syndromes aged 10 years and older.Chelation therapy should only be initiated when there is evidence of iron overload (liver iron concentration [LIC] ≥5 mg Fe/g dry weight [dw] or serum ferritin consistently >800 μg/l).LIC is the preferred method of iron overload determination and should be used wherever available
2021-01-31
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 The medicine is dispensed with a doctor’s prescription only EXJADE ® 125 MG DISPERSIBLE TABLETS Each dispersible tablet contains: deferasirox 125 mg EXJADE ® 250 MG DISPERSIBLE TABLETS Each dispersible tablet contains: deferasirox 250 mg EXJADE ® 500 MG DISPERSIBLE TABLETS Each dispersible tablet contains: deferasirox 500 mg INACTIVE AND ALLERGENIC INGREDIENTS: See section 2 “Important information about some of the ingredients of the medicine” and section 6 “Further information”. READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. This medicine has been prescribed for the treatment of your ailment or for the treatment of your child’s ailment. Do not pass it on to others. It may harm them even if it seems to you that their ailment is similar. 1. WHAT IS THE MEDICINE INTENDED FOR? ∙ To treat chronic iron overload caused by blood transfusions, in adults and children (aged 2 years and above). ∙ To treat chronic iron overload in patients with non- transfusion-dependent thalassemia from the age of 10 and above. THERAPEUTIC GROUP: iron chelating agent. Repeated blood transfusions are sometimes necessary in patients suffering from certain types of anemia such as thalassemia, sickle-cell disease and myelodysplastic syndromes (MDS). However, repeated blood transfusions can cause a build-up of excess iron. This is because blood contains iron and the body does not have a natural way to remove the excess iron received with the blood transfusions. In patients with non-transfusion-dependent thalassemia, iron overload may develop over time, mainly due to increased absorption of dietary iron in response to low blood cell counts. Over time, the excess iron can damage vital organs such as the liver and heart. Iron chelator medicines are used to remove the excess iron and red Прочитать полный документ
EXJ API AUG21 V13 EU SmPC Aug 2021 1. NAME OF THE MEDICINAL PRODUCT EXJADE ® 125 mg, 250 mg, 500 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _ _ Exjade 125mg: Each dispersible tablet contains 125 mg deferasirox. Exjade 250mg: Each dispersible tablet contains 250 mg deferasirox. Exjade 500mg: Each dispersible tablet contains 500 mg deferasirox. Excipient with known effect: Exjade 125mg: Each dispersible tablet contains about 136 mg lactose monohydrate. Exjade 250mg: Each dispersible tablet contains about 272 mg lactose monohydrate . Exjade 500mg: Each dispersible tablet contains about 544 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Dispersible tablet Exjade 125mg: 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 12 mm x 3.6 mm. Exjade 250mg: White to slightly yellow, round, flat tablets with bevelled edges and imprints (NVR on one face and J 250 on the other). Approximate tablet dimensions 15 mm x 4.7 mm. Exjade 500mg: White to slightly yellow, round, flat tablets with bevelled edges and imprints (NVR on one face and J 500 on the other). Approximate tablet dimensions 20 mm x 5.6 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS EXJADE is indicated for the treatment of chronic iron overload due to blood transfusions (transfusional haemosiderosis) in adult and paediatric patients (aged 2 years and over). EXJADE is also indicated for the treatment of chronic iron overload in patients with non-transfusion- dependent thalassaemia syndromes aged 10 years and older. Chelation therapy should only be initiated when there is evidence of iron overload (liver iron concentration [LIC] ≥5 mg Fe/g dry weight [dw] or serum ferritin consistently >800 μg/l). LIC is the preferred method of iron overload determination and should be used wherever available. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with EXJADE should be initiated and maintained by physicians e Прочитать полный документ