SITAR PLUS 50850

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

METFORMIN HYDROCHLORIDE; SITAGLIPTIN AS HYDROCHLORIDE

متاح من:

UNIPHARM TRADING LTD, ISRAEL

ATC رمز:

A10BD07

الشكل الصيدلاني:

FILM COATED TABLETS

تركيب:

METFORMIN HYDROCHLORIDE 850 MG; SITAGLIPTIN AS HYDROCHLORIDE 50 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

LABORATORIOS LICONSA S.A., SPAIN

المجال العلاجي:

METFORMIN AND SITAGLIPTIN

الخصائص العلاجية:

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.

تاريخ الترخيص:

2022-01-13

نشرة المعلومات

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

خصائص المنتج

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
50 mg/850 mg film-coated tablets
50 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