Ülke: Avustralya
Dil: İngilizce
Kaynak: Department of Health (Therapeutic Goods Administration)
metformin hydrochloride, Quantity: 1000 mg; saxagliptin, Quantity: 5 mg
AstraZeneca Pty Ltd
Metformin hydrochloride,Saxagliptin
Tablet, modified release
Excipient Ingredients: hypromellose; carmellose sodium; magnesium stearate; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; indigo carmine aluminium lake; ethanol; Shellac; sulfuric acid; titanium dioxide; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350
Oral
7 tablets (sample pack), 28 tablets (trade pack)
(S4) Prescription Only Medicine
KOMBIGLYZE XR is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both saxagliptin and metformin is appropriate (see Clinical Trials and Dosing and Administration for data on combinations studied).
Visual Identification: Pink, biconvex, capsule shaped, film-coated tablet, with 5/1000 printed on one side and 4223 printed on the other side, in blue ink; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius
Licence status A
2013-10-10
KOMBIGLYZE ® XR _Saxagliptin/metformin hydrochloride modified release_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about KOMBIGLYZE XR. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking KOMBIGLYZE XR against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. Keep this leaflet with the medicine. You may need to read it again. WHAT KOMBIGLYZE XR IS USED FOR KOMBIGLYZE XR is used to lower blood sugar levels in patients with type 2 diabetes mellitus along with diet and exercise. KOMBIGLYZE XR may also be used in combination with other medicines including insulin, a sulfonylurea (such as gliclazide) or a SGLT2 inhibitor (such as dapagliflozin) along with diet and exercise to treat type 2 diabetes. TYPE 2 DIABETES MELLITUS Type 2 diabetes mellitus is a condition in which your body does not make enough insulin and the insulin that your body produces does not work as well as it should. Your body can also make too much sugar. When this happens, sugar (glucose) builds up in the blood and can lead to serious medical problems. The main goal of treating diabetes is to lower your blood sugar to a normal level. Lowering and controlling blood sugar may help prevent or delay complications of diabetes, such as heart disease, kidney disease, blindness and amputation. KOMBIGLYZE XR contains two active ingredients, saxagliptin and metformin hydrochloride (modified release). Saxagliptin is a member of a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors), and metformin belongs to a class of medicines called biguanides. Saxagliptin and metformin work together to lower blood sugar levels in patients with type 2 diabetes mellitus. Your doctor may have prescribed this medicine for another reason. Ask your doctor if you have Belgenin tamamını okuyun
1 of 38 AUSTRALIAN PRODUCT INFORMATION KOMBIGLYZE ® XR (SAXAGLIPTIN/METFORMIN HYDROCHLORIDE) MODIFIED RELEASE TABLETS 1 NAME OF THE MEDICINE Saxagliptin (as hydrochloride)/ metformin hydrochloride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION KOMBIGLYZE XR is available as: • KOMBIGLYZE XR 5/500 tablets containing 5 mg saxagliptin (as hydrochloride) immediate release and 500 mg metformin hydrochloride modified release • KOMBIGLYZE XR 5/1000 tablets containing 5 mg saxagliptin (as hydrochloride) immediate release and 1000 mg metformin hydrochloride modified release • KOMBIGLYZE XR 2.5/1000 tablets containing 2.5 mg saxagliptin (as hydrochloride) immediate release and 1000 mg metformin hydrochloride modified release For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Modified release tablets. • KOMBIGLYZE XR 5/500 modified release tablets are light brown to brown, biconvex, capsule shaped, film-coated tablets, with “5/500” printed on one side and “4221” printed on the other side, in blue ink. • KOMBIGLYZE XR 5/1000 modified tablets are pink, biconvex, capsule shaped, film-coated tablets, with “5/1000” printed on one side and “4223” printed on the other side, in blue ink. • KOMBIGLYZE XR 2.5 /1000 modified tablets are pale yellow to light yellow, biconvex, capsule shaped, film-coated tablets, with “2.5/1000” printed on one side and “4222” printed on the other side, in blue ink. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS KOMBIGLYZE XR is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both saxagliptin and metformin is appropriate ( _see Sections 5.1 Pharmacodynamic properties - Clinical Trials_ and _4.2 Dose and _ _method of administration_ for data on combinations studied). 4.2 DOSE AND METHOD OF ADMINISTRATION LIFE THREATENING LACTIC ACIDOSIS CAN OCCUR DUE TO ACCUMULATION OF METFORMIN. THE MAIN RISK FACTOR IS RENAL IMPAIRMENT, OTHER RISK FACTORS INCLUD Belgenin tamamını okuyun