GALVUS 50 MG

Maa: Israel

Kieli: englanti

Lähde: Ministry of Health

Aktiivinen ainesosa:

VILDAGLIPTIN

Saatavilla:

NOVARTIS ISRAEL LTD

ATC-koodi:

A10BH02

Lääkemuoto:

TABLETS

Koostumus:

VILDAGLIPTIN 50 MG

Antoreitti:

PER OS

Prescription tyyppi:

Required

Valmistaja:

SIEGFRIED BARBERA, S.L., SPAIN

Terapeuttinen alue:

VILDAGLIPTIN

Käyttöaiheet:

Galvus is indicated as an adjunct to diet and exercise in patients with type 2 diabetes mellitus• As monotherapy, if diet and exercise are not sufficient, or• In combination with metformin, or a sulfonylurea if treatment with these oral antidiabetics does not offer sufficient control of blood glucose.As triple oral therapy in combination with• a sulphonylurea and metformin when diet and exercise plus dual therapy with these agents do not provide adequate glycaemic control. Galvus is also indicated for use in combination with insulin (with or without metformin) when diet and exercise plus a stable dose of insulin do not provide adequate glycaemic control.Galvus is indicated as an adjunct to diet and exercise in patients with type 2 diabetes mellitus• In combination with a thiazolidinedione, in patients with insufficient glycaemic control and for whom the use of a thiazolidinedione is appropriate.

Valtuutus päivämäärä:

2023-11-30

Pakkausseloste

رادقملا صوصخب
ً
اقثاو نكت مل اذإ يلديصلا نم وأ بيبطلا
نم حاضيتسلإا كيلع
.سوڤلاچ ـب جلاعلا ةقيرطو يئاودلا
.طقف بيبطلا لبق نم ناددحي جلاعلا
ةقيرطو يئاودلا رادقملا
:مويلا يف غلم 100 وأ 50 ةداع وه سوڤلاچ نم
ةداع يدايتعلإا يئاودلا رادقملا
غلم 50 وه يدايتعلإا يئاودلا رادقملا نإف
،هدرفمب سوڤلاچ لوانتت تنك اذإ
●
يف غلم 100 وأ ،حابصلا يف ةدحاو ةيئاود
ةعرجب هلوانت متي يذلا مويلا يف
يف غلم 50 -و حابصلا يف غلم 50 اهردق ةيئاود
ةعرجب هلوانت متي يذلا مويلا
ءاسملا
،ايروي لينوفلوس ىلع يوتحي يفاضإ ءاود
ةكراشمب سوڤلاچ لوانتت تنك اذإ
●
ةعرجب هلوانت متي يذلا مويلا يف غلم 50 وه
يدايتعلإا يئاودلا رادقملا نإف
حابصلا يف ةدحاو ةيئاود
وأ نيمروفتيم ىلع يوتحي يفاضإ ءاود
ةكراشمب سوڤلاچ لوانتت تنك اذإ
●
نودب/عم( نيلوسنإ عم وأ ،ايروي
لينوفلوسو نيمروفتيم ةكراشمب
،نوزاتيلچ
متي يذلا مويلا يف غلم 100 وه يدايتعلإا
يئاودلا رادقملا نإف ،)نيمروفتيم
ءاسملا يف غلم 50 -و حابصلا يف غلم 50 اهردق
ةيئاود ةعرجب هلوانت
.هب ىصوملا يئاودلا رادقملا زواجت زوجي
لا
- جلاعلا ةرتف
جلاعلا نوكي دق .كلذب بيبطلا كاصوأ
املاطل موي لك سوڤلاچ لوانت بجي
●
.
ً
لاوطم
لكشلاب رثؤي جلاعلا نأ نم دكأتلل كلذو
مئاد لكشب كتلاح بيبطلا صحفي
●
.بولطملا - لوانتلا ةقيرط
.ءاملا نم سأك عم لماكلا هلكشب صرقلا ع�

Valmisteyhteenveto

GAL API SEP22 V4
1
EU SmPC 07.2022
1.
NAME OF THE MEDICINAL PRODUCT
GALVUS
® 50 MG
tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg of vildagliptin.
Excipient with known effect: Each tablet contains 47.82 mg lactose
anhydrous.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
White to light yellowish, round (8 mm diameter), flat-faced,
bevelled-edge tablet. One side is
debossed with “NVR”, and the other side with “FB”.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Galvus
®
is indicated as an adjunct to diet and exercise in patients with type
2 diabetes
mellitus:

As monotherapy, if diet and exercise are not sufficient, or

In combination with metformin, or a sulfonylurea if treatment with
these oral antidiabetics
does not offer sufficient control of blood glucose.
As triple oral therapy in combination with:

a sulfonylurea and metformin when diet and exercise plus dual therapy
with these
agents do not provide adequate glycaemic control.
Galvus is also indicated for use in combination with insulin (with or
without metformin) when
diet and exercise plus a stable dose of insulin do not provide
adequate glycaemic control.
Galvus is indicated as an adjunct to diet and exercise in patients
with type 2 diabetes mellitus

In combination with a thiazolidinedione, in patients with insufficient
glycaemic control and
for whom the use of a thiazolidinedione is appropriate.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adults
The management of antidiabetic therapy should be individualized.
The recommended dose of Galvus is 50 mg or 100 mg daily for
monotherapy.
The 50 mg dose should be administered once daily in the morning. The
100 mg dose should
be administered as two divided doses of 50 mg given in the morning and
evening.
When used in combination with metformin, in combination with
thiazolidinedione, in
combination with metformin and a SU or in combination with insulin
(with or without
GAL API SEP22 V4
2
EU SmPC 07.2022
metformin), the reco