País: Singapur
Idioma: anglès
Font: HSA (Health Sciences Authority)
SAXAGLIPTIN HYDROCHLORIDE (Anhydrous) 2.79 mg EQV SAXAGLIPTIN
ASTRAZENECA SINGAPORE PTE LTD
A10BH03
2.5 mg
TABLET, FILM COATED
SAXAGLIPTIN HYDROCHLORIDE (Anhydrous) 2.79 mg EQV SAXAGLIPTIN 2.5 mg
ORAL
Prescription Only
AstraZeneca Pharmaceuticals LP
ACTIVE
2010-11-25
ONGLYZA TABLET PHARMACEUTICAL FORM AND STRENGTHS • Each film-coated tablet contains 5.58mg saxagliptin hydrochloride (anhydrous) equivalent to 5mg saxagliptin. ONGLYZA 5 mg tablets are pink, biconvex, round, film- coated tablets with “5” printed on one side and “4215” printed on the reverse side, in blue ink. • Each film-coated tablet contains 2.79mg saxagliptin hydrochloride (anhydrous) equivalent to 2.5mg saxagliptin. ONGLYZA 2.5 mg tablets are pale yellow to light yellow, biconvex, round, film-coated tablets with “2.5” printed on one side and “4214” printed on the reverse side, in blue ink. Each film-coated tablet of ONGLYZA contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, and magnesium stearate. In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, polyethylene glycol, titanium dioxide, talc, and iron oxides. THERAPEUTIC INDICATIONS ONGLYZA is indicated in adult patients with type 2 diabetes mellitus in multiple clinical settings as an adjunct to diet and exercise to improve glycaemic control: as monotherapy; as dual oral therapy in combination with metformin as initial therapy or when metformin alone, with diet and exercise, does not provide adequate glycaemic control; a sulphonylurea, when the sulphonylurea alone, with diet and exercise, does not provide adequate glycaemic control in patients; a thiazolidinedione, when the thiazolidinedione alone with diet and exercise, does not provide adequate glycaemic control in patients; as triple oral therapy in combination with metformin plus a sulphonylurea when this regimen alone, with diet and exercise, does not pr Llegiu el document complet
ONGLYZA TABLET PHARMACEUTICAL FORM AND STRENGTHS Each film-coated tablet contains 5.58mg saxagliptin hydrochloride (anhydrous) equivalent to 5mg saxagliptin. ONGLYZA 5 mg tablets are pink, biconvex, round, film-coated tablets with “5” printed on one side and “4215” printed on the reverse side, in blue ink. Each film-coated tablet contains 2.79mg saxagliptin hydrochloride (anhydrous) equivalent to 2.5mg saxagliptin. ONGLYZA 2.5 mg tablets are pale yellow to light yellow, biconvex, round, film-coated tablets with “2.5” printed on one side and “4214” printed on the reverse side, in blue ink. Each film-coated tablet of ONGLYZA contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, and magnesium stearate. In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, polyethylene glycol, titanium dioxide, talc, and iron oxides. THERAPEUTIC INDICATIONS ONGLYZA is indicated in adult patients with type 2 diabetes mellitus in multiple clinical settings as an adjunct to diet and exercise to improve glycaemic control: As monotherapy; As dual oral therapy in combination with metformin as initial therapy or when metformin alone, with diet and exercise, does not provide adequate glycaemic control; a sulphonylurea, when the sulphonylurea alone, with diet and exercise, does not provide adequate glycaemic control in patients; a thiazolidinedione, when the thiazolidinedione alone with diet and exercise, does not provide adequate glycaemic control in patients; As triple oral therapy in combination with metformin plus a sulphonylurea when this regimen alone, with diet and exercise, does not provide adequate glycaemic control metformin plus an SGLT2 inhibitor when this regimen alone, with diet and exercise, does not provide adequate glycaemic control; As combination therapy with insulin (with or without metformin), when this regimen alone, with diet and exercise, does not provide adequate glycae Llegiu el document complet