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.

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).

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 yellow; iron oxide red; 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).

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.

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.

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

New Zealand - English - Medsafe (Medicines Safety Authority)

astrazeneca limited - metformin hydrochloride 1000mg;  ; saxagliptin 2.5mg - film coated tablet - 2.5mg/1000mg - active: metformin hydrochloride 1000mg   saxagliptin 2.5mg excipient: hydrochloric acid magnesium stearate opacode blue s-1-10619 opadry ii yellow 85f92209 opadry white 85f18422 povidone purified water - kombiglyze is indicated as an adjunct to diet & exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both saxagliptin & metformin is appropriate.

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.

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

astrazeneca pharmaceuticals lp - dapagliflozin (unii: 1ull0qj8uc) (dapagliflozin - unii:1ull0qj8uc), saxagliptin hydrochloride (unii: z8j84yix6l) (saxagliptin anhydrous - unii:8i7io46ivq), metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - qternmet xr (dapagliflozin, saxagliptin, and metformin hydrochloride) extended-release tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. limitations of use qternmet xr is not indicated for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis. qternmet xr initiation is intended only for patients currently taking metformin. qternmet xr is contraindicated in patients with: risk summary based on animal data showing adverse renal effects, from dapagliflozin, qternmet xr is not recommended during the second and third trimesters of pregnancy. the limited available data with qternmet xr or components (dapagliflozin and saxagliptin) in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or 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 ). there are risks to the moth