MSD-ERTUGLIFLOZIN 5 ertugliflozin 5 mg film-coated tablet blister pack

Држава: Аустралија

Језик: Енглески

Извор: Department of Health (Therapeutic Goods Administration)

Активни састојак:

ertugliflozin pyroglutamic acid, Quantity: 6.48 mg (Equivalent: ertugliflozin, Qty 5 mg)

Доступно од:

Merck Sharp & Dohme (Australia) Pty Ltd

Фармацеутски облик:

Tablet, film coated

Састав:

Excipient Ingredients: sodium starch glycollate type A; lactose monohydrate; microcrystalline cellulose; magnesium stearate; titanium dioxide; hypromellose; triacetin; iron oxide red; macrogol 3350

Пут администрације:

Oral

Јединице у пакету:

7, 28

Тип рецептора:

(S4) Prescription Only Medicine

Терапеутске индикације:

MSD-ERTUGLIFLOZIN (ertugliflozin) is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus as:- - monotherapy when metformin is considered inappropriate due to intolerance; or - in combination with other anti-hyperglycaemic agents,[see 5.1 PHARMACODYNAMIC PROPERTIES, Clinical trials and 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE for available data on different add-on combination therapies].

Резиме производа:

Visual Identification: Pink, triangular-shaped, film-coated tablets debossed with '701' 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

Статус ауторизације:

Licence status A

Датум одобрења:

2018-05-17