Šalis: Izraelis
kalba: anglų
Šaltinis: Ministry of Health
DAPAGLIFLOZIN PROPANEDIOL
ASTRAZENECA (ISRAEL) LTD
A10BX09
FILM COATED TABLETS
DAPAGLIFLOZIN PROPANEDIOL 12.30 MG/DOSE
PER OS
Required
ASTRA ZENECA AB., SWEDEN
DAPAGLIFLOZIN
Forxiga is indicated:- in adults aged 18 years and older for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise •as monotherapy when metformin is considered inappropriate due to intolerance. •in addition to other medicinal products for the treatment of type 2 diabetes. - to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure (NYHA class II-IV) with reduced ejection fraction- to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression. Limitations of Use -FORXIGA is not recommended for the treatment of chronic kidney disease in patients with polycystic kidney disease or patients requiring or with a recent history of immunosuppressive therapy for kidney disease. FORXIGA is not expected to be effective in these populations.
2019-07-31
PATIENT PACKAGE LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 The medicine is dispensed with a doctor’s prescription only FORXIGA® 5 MG FORXIGA® 10 MG Film coated tablets Film coated tablets COMPOSITION: Each tablet contains: Each tablet contains: Dapagliflozin 5 mg Dapagliflozin 10 mg For inactive ingredients please see section 2: "Important information regarding some of the medicine ingredients" and Section 6: ‘Further Information’. READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. Keep this leaflet, you may need it again. 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. 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? Forxiga is used to treat type 2 diabetes mellitus in adults (aged 18 years and older), when the diabetes cannot be controlled with other medicines for diabetes, diet and exercise. Your doctor may ask you to take Forxiga on its own, if you are intolerant to metformin, or together with other medicines including insulin. During treatment with Forxiga, it is important to integrate diet and exercise according to the advice of your doctor/medical team. Forxiga is used to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure (NYHA class II‐IV) with reduced ejection fraction. Forxiga is used to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression. Limitations of Use Forxiga is not recommended for the treatment of chronic kidney disease in patients with polycystic kidney disease or patients requiring or with a recent history of immunosuppressive therapy for kidney disease. Forxiga is not expected to be effective in the Perskaitykite visą dokumentą
1 1. NAME OF THE MEDICINAL PRODUCT Forxiga 5 mg film-coated tablets Forxiga 10 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Forxiga 5 mg film-coated tablets : Each tablet contains dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin. _Excipient with known effect: _ Each tablet contains 25 mg of lactose anhydrous. Forxiga 10 mg film-coated tablets: Each tablet contains dapagliflozin propanediol monohydrate equivalent to 10 mg dapagliflozin. _Excipient with known effect: _ Each tablet contains 50 mg of lactose anhydrous. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Forxiga 5 mg film-coated tablets Yellow, biconvex, 0.7 cm diameter round, film-coated tablets with “5” engraved on one side and “1427” engraved on the other side. Forxiga 10 mg film-coated tablets Yellow, biconvex, approximately 1.1 x 0.8 cm diagonally diamond-shaped, film-coated tablets with “10” engraved on one side and “1428” engraved on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Forxiga is indicated in adults aged 18 years and older for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise • as monotherapy when metformin is considered inappropriate due to intolerance. • in addition to other medicinal products for the treatment of type 2 diabetes. For study results with respect to combination of therapies, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1. to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure (NYHA class II-IV) with reduced ejection fraction. to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression. Limitations of Use • FORXIGA is not recommended for the treatment of chronic kidney disease in Perskaitykite visą dokumentą