MSD-ERTUGLIFLOZIN-SITAGLIPTIN 15/100 ertugliflozin/sitagliptin (as phosphate monohydrate) 15 mg/100 mg film-coated tablet bliste

Country: Ástralía

Tungumál: enska

Heimild: Department of Health (Therapeutic Goods Administration)

Kauptu það núna

Opinber matsskýrsla Opinber matsskýrsla (PAR)
20-10-2022

Virkt innihaldsefni:

sitagliptin phosphate monohydrate, Quantity: 128.5 mg (Equivalent: sitagliptin, Qty 100 mg); ertugliflozin pyroglutamic acid, Quantity: 19.43 mg (Equivalent: ertugliflozin, Qty 15 mg)

Fáanlegur frá:

Merck Sharp & Dohme (Australia) Pty Ltd

Lyfjaform:

Tablet, film coated

Samsetning:

Excipient Ingredients: magnesium stearate; sodium stearylfumarate; microcrystalline cellulose; croscarmellose sodium; calcium hydrogen phosphate; Carnauba Wax; titanium dioxide; hypromellose; hyprolose; iron oxide yellow; iron oxide red; iron oxide black

Stjórnsýsluleið:

Oral

Einingar í pakka:

28, 7

Gerð lyfseðils:

(S4) Prescription Only Medicine

Ábendingar:

MSD-ERTUGLIFLOZIN-SITAGLIPTIN (ertugliflozin and sitagliptin phosphate monohydrate) is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both ertugliflozin and sitagliptin is appropriate. [see 5.1 PHARMACODYNAMIC PROPERTIES, Clinical trials, and 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE]

Vörulýsing:

Visual Identification: Brown, almond-shaped, film-coated tablets debossed with '555' on one side and plain on the other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Leyfisstaða:

Licence status A

Leyfisdagur:

2018-05-17