MSD-ERTUGLIFLOZIN-METFORMIN 7.5/500 ertugliflozin/metformin hydrochloride 7.5 mg/500 mg film-coated tablet blister pack

Χώρα: Αυστραλία

Γλώσσα: Αγγλικά

Πηγή: Department of Health (Therapeutic Goods Administration)

Δραστική ουσία:

metformin hydrochloride, Quantity: 500 mg; ertugliflozin pyroglutamic acid, Quantity: 9.713 mg (Equivalent: ertugliflozin, Qty 7.5 mg)

Διαθέσιμο από:

Merck Sharp & Dohme (Australia) Pty Ltd

Φαρμακοτεχνική μορφή:

Tablet, film coated

Σύνθεση:

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

Οδός χορήγησης:

Oral

Μονάδες σε πακέτο:

14, 56

Τρόπος διάθεσης:

(S4) Prescription Only Medicine

Θεραπευτικές ενδείξεις:

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]

Περίληψη προϊόντος:

Visual Identification: Red, oval, film-coated tablets debossed with '7.5/500' 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

Καθεστώς αδειοδότησης:

Licence status A

Ημερομηνία της άδειας:

2018-05-17