VELMETIA XR 50/1000 sitagliptin (as phosphate monohydrate) 50 mg and metformin hydrochloride1000 mg modified release tablet bottle

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

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공공 평가 보고서 공공 평가 보고서 (PAR)
26-11-2017

유효 성분:

metformin hydrochloride, Quantity: 1000 mg; sitagliptin phosphate monohydrate, Quantity: 64.25 mg (Equivalent: sitagliptin, Qty 50 mg)

제공처:

Merck Sharp & Dohme (Australia) Pty Ltd

INN (International Name):

Metformin hydrochloride,sitagliptin phosphate monohydrate

약제 형태:

Tablet, modified release

구성:

Excipient Ingredients: povidone; colloidal anhydrous silica; hypromellose; kaolin; propyl gallate; sodium stearylfumarate; macrogol 3350; Carnauba Wax; titanium dioxide; hyprolose; iron oxide yellow; indigo carmine aluminium lake

관리 경로:

Oral

패키지 단위:

14 tablets - starter pack, 56 tablets

처방전 유형:

(S4) Prescription Only Medicine

치료 징후:

VELMETIA XR (sitagliptin phosphate monohydrate 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 sitagliptin and metformin is appropriate.,[see Sections 5.1 PHARMACODYNAMIC PROPERTIES, Clinical trials and 4.2 DOSE AND METHOD OF ADMINISTRATION].

제품 요약:

Visual Identification: Light green, bi-convex oval, film coated tablet, debossed "80" on one side and plain on the other.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

승인 상태:

Licence status A

승인 날짜:

2014-11-19