MSD-ERTUGLIFLOZIN-METFORMIN 2.5/500 ertugliflozin/metformin hydrochloride 2.5 mg/500 mg film-coated tablet blister pack

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

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Prenos Javno poročilo o oceni (PAR)
24-10-2022

Aktivna sestavina:

metformin hydrochloride, Quantity: 500 mg; ertugliflozin pyroglutamic acid, Quantity: 3.238 mg (Equivalent: ertugliflozin, Qty 2.5 mg)

Dostopno od:

Merck Sharp & Dohme (Australia) Pty Ltd

Farmacevtska oblika:

Tablet, film coated

Sestava:

Excipient Ingredients: microcrystalline cellulose; Carnauba Wax; povidone; sodium lauryl sulfate; magnesium stearate; crospovidone; titanium dioxide; hypromellose; hyprolose; iron oxide red

Pot uporabe:

Oral

Enote v paketu:

56, 14

Tip zastaranja:

(S4) Prescription Only Medicine

Terapevtske indikacije:

MSD-ERTUGLIFLOZIN-METFORMIN (ertugliflozin and metformin hydrochloride) 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 metformin is appropriate. [see 5.1 PHARMACODYNAMIC PROPERTIES, Clinical trials and 4.2 DOSE AND METHOD OF ADMINISTRATION]

Povzetek izdelek:

Visual Identification: Pink, oval, film-coated tablets debossed with '2.5/500' 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

Status dovoljenje:

Licence status A

Datum dovoljenje:

2018-05-17