Страна: Ізраїль
мова: англійська
Джерело: Ministry of Health
METFORMIN HYDROCHLORIDE; SITAGLIPTIN AS HYDROCHLORIDE
UNIPHARM TRADING LTD, ISRAEL
A10BD07
FILM COATED TABLETS
METFORMIN HYDROCHLORIDE 1000 MG; SITAGLIPTIN AS HYDROCHLORIDE 50 MG
PER OS
Required
LABORATORIOS LICONSA S.A., SPAIN
METFORMIN AND SITAGLIPTIN
Sitar plus is indicated as an adjunct to diet and exercise to improve glycemic control in adult patients with type 2 diabetes mellitus. Important limitations of use: Sitar plus should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings. Sitar plus has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using Sitar plus.
2022-01-13
تاراظنلا عض .ءاود اهيف لوانتت ةرم لك يف يئاودلا رادقملا نم .كلذ رملأا مزل اذإ ةيبطلا رشتسإ ،ءاودلا اذه لامعتسإ لوح ةيفاضإ ةلئسأ كيدل ترفوت اذإ .يلديصلا وأ بيبطلا ةيبناجلا ضارعلأا )4 دنع ةيبناج ً اضارعأ ببسي دق سولپ راتيس لامعتسإ نإ ،ءاود لكب امك لاأ زئاجلا نم .ةيبناجلا ضارعلأا ةمئاق نم شهدنت لا .نيلمعتسملا ضعب .اهنم ً ايأ يناعت :كلذ يف امب ،ةريطخ ةيبناج ً اضارعأ سولپ راتيس ببسي دق دق ،سولپ راتيس يف ةيودلأا دحأ ،نيمروفتيم .ين َ بل ضامح 4.1 10,000 نيب نم 1 ىتح ىدل رهظت نأ نكمي( ةردان ةلاحل يدؤي ) LACTIC ACIDOSIS ( ين َ بل ضامح ىمس ُ ت ةريطخ اهنكل )لمعتسم ين َ بل ضامح .ةافولا ىلإ يدؤي دق يذلاو ،)مدلا يف ضمحلا مكارت( .ىفشتسملا يف ً اجلاع بجوتست ةئراط ةيبط ةلاح وه دحأ كيدل ناك اذإ ، ً اروف كبيبط عم ثدحتو سولپ راتيس لوانت نع فقوت :( lactic acidosis ( ين َ بل ضامحل تاملاع نوكت دق يتلا ،ةيلاتلا ضارعلأا .كيمدق يتحار وأ كيدي يف ةدوربب رعشت تنك ● .ةخودب وأ راودب رعشت تنك ● .مظتنم ريغ وأ ءيطب ضبن كيدل دج ُ و ● .قهرم وأ ً ادج فيعض كنأب رعشت تنك ● .)ةذاش( تلاضعلا يف ةيدايتعإ ريغ ملاآ كيدل تدج ُ و ● .سفنت تابوعص كيدل تدج ُ و ● .مونلا ىلإ ليملاب وأ ساعنلاب رعشت تنك ● .تاؤيقت وأ نايثغ ،نطبلا يف ملاآ كيدل تدج ُ و ● نم نوناعي نيمروفتيم عم ين َ بل ضامح مهيدل ناك نيذلا صاخشلأا ة Прочитайте повний документ
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT50 mg/850 mg film-coated tablets Прочитайте повний документ50 mg/1000 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 50 mg/850 mg film-coated tablets Each tablet contains sitagliptin hydrochloride equivalent to 50 mg sitagliptin and 850 mg of metformin hydrochloride. 50 mg/1000 mg film-coated tablets Each tablet contains sitagliptin hydrochloride equivalent to 50 mg sitagliptin and 1000 mg of metformin hydrochloride. Excipient(s) with known effect Sitagliptin/Metformin 50 mg / 850 mg film-coated tablets Each 50 mg / 850 mg film-coated tablet contains 13.02 mg of lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). 50 mg/850 mg film-coated tablets: Oval-shaped, biconvex, film-coated tablets approximately 20.5 mm x 9.5 mm, pink, debossed with “S476” on one side and plain on the other. 50 mg/1000 mg film-coated tablets: Oval-shaped, biconvex, film-coated tablets approximately 21.5 mm x 10.0 mm, brown, debossed with “S477” on one side and plain on the other. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For adult patients with type 2 diabetes mellitus: is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin. is indicated in combination with a sulphonylurea (i.e., triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea. is indicated as triple combination therapy with a peroxisome proliferator-activated receptor gamma (PPAR γ ) agonist (i.e., a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal to