Ország: Ausztrália
Nyelv: angol
Forrás: Department of Health (Therapeutic Goods Administration)
metformin hydrochloride, Quantity: 750 mg
Alphapharm Pty Ltd
Metformin hydrochloride
Tablet
Excipient Ingredients: hypromellose; magnesium stearate; carmellose sodium
Oral
100 tablets, 90 tablets, 120 tablets, 10 tablets, 60 tablets, 30 tablets
(S4) Prescription Only Medicine
Treatment of type 2 diabetes mellitus in adults, particularly in overweight patients, when dietary management and exercise alone does not result in adequate glycaemic control. Diabex XR or Diabex XR 750 may be used as monotherapy or in combination with other oral antidiabetic agents, or with insulin.
Visual Identification: white to off-white, capsule-shaped, biconvex tablet, debossed "750" on one side and "Merck", on the other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 22 Months; Container Temperature: Store below 25 degrees Celsius
Registered
2009-10-28
AUSTRALIAN PRODUCT INFORMATION DIABEX ® XR 500 DIABEX ® XR 750 DIABEX ® XR 1000 _Metformin hydrochloride extended release tablets _ LIFE THREATENING LACTIC ACIDOSIS CAN OCCUR DUE TO ACCUMULATION OF METFORMIN. THE MAIN RISK FACTOR IS RENAL IMPAIRMENT, OTHER RISK FACTORS INCLUDE OLD AGE ASSOCIATED WITH REDUCED RENAL FUNCTION. 1 NAME OF THE MEDICINE Metformin hydrochloride. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Diabex XR contains metformin hydrochloride as the active ingredient and is available in three strengths: Each Diabex XR 500, (500 mg) extended release tablet contains 500 mg of metformin hydrochloride. Each Diabex XR 750, (750 mg) extended release tablet contains 750 mg of metformin hydrochloride. Each Diabex XR 1000, (1000 mg) extended release tablet contains 1000 mg of metformin hydrochloride. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Oral. Extended release tablets. DIABEX XR 500 : Metformin hydrochloride 500 mg extended release tablets: white to off-white, capsule-shaped, biconvex tablet, debossed “500” on one side DIABEX XR 750* : Metformin hydrochloride 750 mg extended release tablets: white to off-white, capsule-shaped, biconvex tablet, debossed “750” on one side and “Merck:” on the other side DIABEX XR 1000 : Metformin hydrochloride 1000 mg extended release tablets: white to off-white, capsule-shaped, biconvex tablet, debossed with ‘1000’ on one face All three tablet strengths are gluten free. The tablet shells may be present in the faeces. Patients should be advised that this is normal. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Metformin is indicated in the treatment of type 2 diabetes mellitus in adults, particularly in overweight patients, when dietary management and exercise alone does not result in adequate glycaemic control. Diabex XR 500, DIABEX ® XR 500, DIABEX ® XR 750 AND DIABEX ® XR 1000 – AUSTRALIAN PRODUCT INFORMATION 2 Diabex XR 750 or Diabex XR 1000 may be used as monotherapy or in combination with oth Olvassa el a teljes dokumentumot