Australia - English - Department of Health (Therapeutic Goods Administration)

astrazeneca pty ltd - metformin hydrochloride, quantity: 500 mg; saxagliptin, quantity: 5 mg - tablet, modified release - excipient ingredients: microcrystalline cellulose; carmellose sodium; hypromellose; magnesium stearate; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350; iron oxide red; iron oxide yellow; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; indigo carmine aluminium lake; ethanol; shellac; sulfuric acid - 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).

Australia - English - Department of Health (Therapeutic Goods Administration)

astrazeneca pty ltd - metformin hydrochloride, quantity: 1000 mg; saxagliptin, quantity: 5 mg - 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 - 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).

Australia - English - Department of Health (Therapeutic Goods Administration)

astrazeneca pty ltd - metformin hydrochloride, quantity: 1000 mg; saxagliptin, quantity: 2.5 mg - tablet, modified release - excipient ingredients: hypromellose; magnesium stearate; carmellose sodium; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; indigo carmine aluminium lake; ethanol; shellac; sulfuric acid; iron oxide yellow - 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).

United States - English - NLM (National Library of Medicine)

astrazeneca pharmaceuticals lp - saxagliptin hydrochloride (unii: z8j84yix6l) (saxagliptin anhydrous - unii:8i7io46ivq), metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - saxagliptin anhydrous 2.5 mg - kombiglyze xr is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both saxagliptin and metformin is appropriate [see clinical studies (14) ]. kombiglyze xr is not indicated for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis. kombiglyze xr is contraindicated in patients with: limited available data with kombiglyze xr or saxagliptin in pregnant women are not sufficient to determine a drug-associated risk for major birth defects and miscarriage. published studies with metformin use during pregnancy have not reported a clear association with metformin and major birth defect or miscarriage risk [see data ]. no adverse developmental effects independent of maternal toxicity were observed when saxagliptin and metformin were administered separately or in combination to pregnant rats and rabbits during the period of organogenesis [see data ]. the estimated background risk of major birth defects is 6 to 10% in women w

Israel - English - Ministry of Health

astrazeneca (israel) ltd - metformin hydrochloride; saxagliptin - film coated tablets - extended release - saxagliptin 5 mg; metformin hydrochloride 1000 mg - metformin - kombiglyze xr is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both saxagliptin and metformin is appropriate.

Israel - English - Ministry of Health

astrazeneca (israel) ltd - metformin hydrochloride; saxagliptin - film coated tablets - extended release - saxagliptin 2.5 mg; metformin hydrochloride 1000 mg - metformin - kombiglyze xr is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both saxagliptin and metformin is appropriate.

New Zealand - English - Medsafe (Medicines Safety Authority)

astrazeneca limited - metformin hydrochloride 1000mg;  ; saxagliptin 2.5mg (as saxagliptin hydrochloride) - modified release tablet - 2.5mg/1000mg - active: metformin hydrochloride 1000mg   saxagliptin 2.5mg (as saxagliptin hydrochloride) excipient: carmellose sodium hydrochloric acid   hypromellose magnesium stearate opacode blue s-1-10619 opadry ii yellow 85f92209 opadry white 85f18422 purified water     - 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.

New Zealand - English - Medsafe (Medicines Safety Authority)

astrazeneca limited - metformin hydrochloride 1000mg;  ; saxagliptin 5mg (as saxagliptin hydrochloride) - modified release tablet - 5mg/1000mg - active: metformin hydrochloride 1000mg   saxagliptin 5mg (as saxagliptin hydrochloride) excipient: carmellose sodium hydrochloric acid hypromellose magnesium stearate opacode blue s-1-10619 opadry pink 85f14452 opadry white 85f18422 purified water     - 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.

New Zealand - English - Medsafe (Medicines Safety Authority)

astrazeneca limited - metformin hydrochloride 500mg;  ; saxagliptin 5mg (as saxagliptin hydrochloride) - modified release tablet - 5mg/500mg - active: metformin hydrochloride 500mg   saxagliptin 5mg (as saxagliptin hydrochloride) excipient: carmellose sodium hydrochloric acid   hypromellose magnesium stearate microcrystalline cellulose opacode blue s-1-10619 opadry butterscotch 85f17417 opadry white 85f18422 purified water     - 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.

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

astrazeneca sdn. bhd. - metformin hydrochloride; saxagliptin hydrochloride -