Galvus

Држава: Нови Зеланд

Језик: Енглески

Извор: Medsafe (Medicines Safety Authority)

Активни састојак:

Vildagliptin 50mg;  ;  

Доступно од:

Novartis New Zealand Ltd

INN (Међународно име):

Vildagliptin 50 mg

Дозирање:

50 mg

Фармацеутски облик:

Tablet

Састав:

Active: Vildagliptin 50mg     Excipient: Lactose Magnesium stearate Microcrystalline cellulose Sodium starch glycolate

Јединице у пакету:

Blister pack, PA/Al/PVC x 7 tablets (starter), 7 tablets

Класа:

Prescription

Тип рецептора:

Prescription

Произведен од:

Novartis Grimsby Limited

Терапеутске индикације:

Galvus is indicated as an adjunct to diet and exercise to improve glycaemic control in patients with type 2 diabetes mellitus · as monotherapy · in dual combination with metformin, a sulphonylurea (SU), or a thiazolidinedione (TZD) when diet, exercise and a single antidiabetic agent do not result in adequate glycaemic control. · in triple combination with a sulphonylurea and metformin when diet and exercise plus dual therapy with these agents do not provide adequate glycaemic control · in combination with insulin (with or without metformin) when diet, exercise, and a stable dose of insulin do not result in adequate glycaemic control.

Резиме производа:

Package - Contents - Shelf Life: Blister pack, PA/Al/PVC (starter) - 7 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, PA/Al/PVC - 28 tablets - 36 months from date of manufacture stored at or below 30°C protect from moisture - Blister pack, PA/Al/PVC - 60 tablets - 36 months from date of manufacture stored at or below 30°C protect from moisture

Датум одобрења:

2006-04-28

Информативни летак

GALVUS
®
1
GALVUS
®
_vildagliptin _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Galvus.
It does not contain all the available
information. It does not take the
place of talking to your doctor,
pharmacist or diabetes educator.
The information in this leaflet was
last updated on the date listed on the
final page. More recent information
on the medicine may be available.
YOU SHOULD ENSURE THAT YOU SPEAK
TO YOUR PHARMACIST OR DOCTOR TO
OBTAIN THE MOST UP TO DATE
INFORMATION ON THE MEDICINE. YOU
CAN ALSO DOWNLOAD THE MOST UP TO
DATE LEAFLET FROM
WWW.MEDSAFE.GOVT.NZ.
Those updates may contain important
information about the medicine and
its use of which you should be aware.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking this medicine
against the benefits they expect it
will provide.
IF YOU HAVE ANY CONCERNS ABOUT THIS
MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT GALVUS IS USED
FOR
Galvus is used to lower blood sugar
levels in patients with type 2 diabetes
mellitus either alone or in
combination with certain other
medicines (metformin, or a
sulfonylurea medicine, or
pioglitazone, or metformin and a
sulfonylurea, or insulin injections),
when diet plus exercise plus the
single or dual medicines do not
provide adequate blood sugar level
control.
_TYPE 2 DIABETES MELLITUS _
Type 2 diabetes develops if the body
does not produce enough insulin, or
where the insulin that your body
makes does not work as well as it
should. It can also develop if the
body produces too much glucagon.
Insulin is a substance which helps to
lower the level of sugar in your
blood, especially after meals.
Glucagon is another substance which
triggers the production of sugar by
the liver, causing the blood sugar to
rise. The pancreas makes both of
these substances.
Galvus is a member of a class of
medicines you take by mouth called
DPP-4 inhibitors (dipeptidyl
peptidase-4 inhibitors) th

Карактеристике производа

1
NEW ZEALAND DATA SHEET
1
GALVUS (50 MG TABLETS)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Vildagliptin:
1-[(3-Hydroxy-adamant-1-ylamino)-acetyl]-pyrrolidine-2(S)-carbonitrile.
One tablet of Galvus® contains 50 mg of vildagliptin.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Galvus 50 mg: white to light yellowish, round (8 mm diameter) flat
faced with beveled edges,
unscored 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 to improve
glycaemic control in patients
with type 2 diabetes mellitus.

as monotherapy.

in dual combination with metformin, a sulphonylurea (SU), or a
thiazolidinedione (TZD)
when diet, exercise and a single antidiabetic agent do not result in
adequate glycaemic
control.

In triple combination with a sulphonylurea and metformin when diet and
exercise plus
dual therapy with these agents do not provide adequate glycaemic
control.

In combination with insulin (with or without metformin) when diet,
exercise and a stable
dose of insulin do not result in adequate glycaemic control.
4.2
DOSAGE AND METHOD OF ADMINISTRATION
Dose
The management of antidiabetic therapy should be individualized.
The recommended dose of Galvus is 50 mg once or twice daily. The
maximum daily dose of
Galvus is 100 mg.
For monotherapy, and for combination with metformin, with a TZD or
with insulin (with or
without metformin), the recommended dose of Galvus is 50 mg or 100 mg
daily.
When used in dual combination with a sulphonylurea, the recommended
dose of vildagliptin
is 50 mg once daily. In this patient population, vildagliptin 100 mg
daily was no more
effective than vildagliptin 50 mg once daily.
For triple combination with metformin and a sulphonylurea, the
recommended dose of Galvus
is 100 mg daily.
2
If tighter glycaemic control is required on the top of the maximum
recommended daily dose
of vildagliptin, the addition of other antidiabetic drugs such a