देश: इसराइल
भाषा: अंग्रेज़ी
स्रोत: Ministry of Health
DAPAGLIFLOZIN PROPANEDIOL; METFORMIN HYDROCHLORIDE
ASTRAZENECA (ISRAEL) LTD
A10BD15
TABLETS EXTENDED RELEASE
METFORMIN HYDROCHLORIDE 502.61 MG; DAPAGLIFLOZIN PROPANEDIOL 12.30 MG
PER OS
Required
BRISTOL-MYERS SQUIBB MANUFACTURING COMPANY, PUERTO RICO
METFORMIN AND DAPAGLIFLOZIN
XIGDUO XR (dapagliflozin and metformin HCl extended-release) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both dapagliflozin and metformin is appropriate.
2017-11-09
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed with a doctor’s prescription only XIGDUO ® XR 5 MG/500 MG EXTENDED-RELEASE TABLETS COMPOSITION: Each tablet contains: Dapagliflozin 5 mg Metformin hydrochloride 500 mg XIGDUO ® XR 5 MG/1000 MG EXTENDED-RELEASE TABLETS COMPOSITION: Each tablet contains: Dapagliflozin 5 mg Metformin hydrochloride 1000 mg XIGDUO ® XR 10 MG/500 MG EXTENDED-RELEASE TABLETS COMPOSITION: Each tablet contains: Dapagliflozin 10 mg Metformin hydrochloride 500 mg XIGDUO ® XR 10 MG/1000 MG EXTENDED-RELEASE TABLETS COMPOSITION: Each tablet contains: Dapagliflozin 10 mg Metformin hydrochloride 1000 mg For inactive ingredients, please see section 6 – “Further Information”. READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. Keep this leaflet, as you may need to read it later. 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. • Xigduo XR may cause serious side effects, including lactic acidosis - please see section 2 “Special warnings regarding use of Xigduo XR”. • Xigduo XR is not intended for type 1 diabetes patients. • Xigduo XR is not intended for patients with diabetic ketoacidosis (increased ketones in blood or urine). • Xigduo XR is not intended for children and adolescents under 18 years of age. 1. WHAT IS THE MEDICINE INTENDED FOR? Xigduo XR is given to treat type 2 diabetes in adults (18 years of age and over), in combination with diet and exercise . Xigduo XR is intended to improve control of blood sugar levels, when treatment with dapagliflozin or metformin alone have not brought to controlled blood sugar levels. THERAPEUTIC GROUP: Dapagliflozin – inhibitor of the SGLT2 sugar carrier in the kidney, which inhibits reuptake of gl पूरा दस्तावेज़ पढ़ें
XIGDUO XR (DAPAGLIFLOZIN AND METFORMIN HCL EXTENDED-RELEASE) TABLETS, FOR ORAL USE XIGDUO XR 5MG/500MG EXTENDED RELEASE TABLETS XIGDUO XR 5MG/1000MG EXTENDED RELEASE TABLETS XIGDUO XR 10MG/500MG EXTENDED RELEASE TABLETS XIGDUO XR 10MG/1000MG EXTENDED RELEASE TABLETS WARNING: LACTIC ACIDOSIS • Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Metformin-associated lactic acidosis was characterized by elevated blood lactate levels (>5 mmol/L), anion gap acidosis (without evidence of ketonuria or ketonemia), an increased lactate/pyruvate ratio; and metformin plasma levels generally >5 mcg/mL [see Warnings and Precautions (5.1)]. • Risk factors for metformin-associated lactic acidosis include renal impairment, concomitant use of certain drugs (e.g., carbonic anhydrase inhibitors such as topiramate), age 65 years old or greater, having a radiological study with contrast, surgery and other procedures, hypoxic states (e.g., acute congestive heart failure), excessive alcohol intake, and hepatic impairment. • Steps to reduce the risk of and manage metformin-associated lactic acidosis in these high risk groups are provided in the full prescribing information [see Dosage and Administration (2.2), Contraindications (4), Warnings and Precautions (5.1), Drug Interactions (7), and Use in Specific Populations (8.6, 8.7)]. • If metformin-associated lactic acidosis is suspected, immediately discontinue XIGDUO XR and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended [see Warnings and Precautions (5.1)]. . 1. THERAPEUTIC INDICATIONS XIGDUO XR (dapagliflozin and metformin HCl extended-release) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitu पूरा दस्तावेज़ पढ़ें