MSD-ERTUGLIFLOZIN-SITAGLIPTIN 5/100 ertugliflozin/sitagliptin (as phosphate monohydrate) 5 mg/100 mg film-coated tablet blister

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

지금 구매하세요

공공 평가 보고서 공공 평가 보고서 (PAR)
20-10-2022

유효 성분:

sitagliptin phosphate monohydrate, Quantity: 128.5 mg (Equivalent: sitagliptin, Qty 100 mg); ertugliflozin pyroglutamic acid, Quantity: 6.48 mg (Equivalent: ertugliflozin, Qty 5 mg)

제공처:

Merck Sharp & Dohme (Australia) Pty Ltd

약제 형태:

Tablet, film coated

구성:

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

관리 경로:

Oral

패키지 단위:

7, 28

처방전 유형:

(S4) Prescription Only Medicine

치료 징후:

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]

제품 요약:

Visual Identification: Beige, almond-shaped, film-coated tablets debossed with '554' 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

승인 상태:

Licence status A

승인 날짜:

2018-05-17