Galvus Met Tablet 50mg1000mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Metformin Hydrochloride; Vildagliptin

Available from:

NOVARTIS (SINGAPORE) PTE LTD

ATC code:

A10BD08

Dosage:

1000.0 mg

Pharmaceutical form:

TABLET, FILM COATED

Composition:

Metformin Hydrochloride 1000.0 mg; Vildagliptin 50.0 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Novartis Pharma Produktions GmbH

Authorization status:

ACTIVE

Authorization date:

2009-08-11

Patient Information leaflet

    GALVUS MET




     Drugs used
in diabetes, combinations of oral blood glucose lowering drugs 



DESCRIPTION AND COMPOSITION 

PHARMACEUTICAL FORMS 

Three strengths are available. One tablet of Galvus Met contains: 

  50  mg vildagliptin and  500  mg metformin hydrochloride.  Light  yellow,  ovaloid beveled 
edge, film-coated tablet imprinted with “NVR” on one side and “LLO” on the other side. 
  50 mg vildagliptin and 850 mg metformin hydrochloride. Yellow, ovaloid beveled edge, 
film-coated tablet imprinted with "NVR" on
one side and "SEH" on the other side. 
  50 mg vildagliptin and 1,000 mg metformin hydrochloride. Dark yellow, ovaloid beveled 
edge, film-coated tablet imprinted with "NVR" on one side and "FLO" on the other side. 

ACTIVE SUBSTANCES 
Vildagliptin 
Metformin hydrochloride 

ACTIVE MOIETIES 
Vildagliptin and metformin 

Certain dosage strengths and dosage forms may not be available in all countries. 

EXCIPIENTS 

Ferric oxide red, ferric oxide yellow, hypromellose, hydroxypropylcellulose, magnesium 
stearate, polyethylene glycol, and talc. 

Pharmaceutical formulations may vary between countries. 

INDICATIONS 

For patients with Type 2 diabetes mellitus (T2DM): 

Galvus Met is indicated as an adjunct to diet and exercise to improve glycemic control in 
patients  whose  diabetes  is  not  adequately  controlled  on  metformin  hydrochloride  or 
vildagliptin  alone  or  who  are  already treated  with  the  combination of  vildagliptin and 
metformin hydrochloride, as separate tablets. 

Galvus  Met  is  indicated  in  combination  with  a  sulfonylurea  (SU)  (i.e.,  triple  combination 
therapy) as  an  

Summary of Product characteristics

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GALVUS MET

Drugs used in diabetes, combinations of oral blood glucose lowering
drugs
DESCRIPTION
AND COMPOSITION
PHARMACEUTICAL
FORMS
Three strengths are available. One tablet of Galvus Met contains:
•
50 mg vildagliptin and 500 mg metformin hydrochloride. Light yellow,
ovaloid beveled
edge, film-coated tablet imprinted with “NVR” on one side and
“LLO” on the other side.
•
50 mg vildagliptin and 850 mg metformin hydrochloride. Yellow, ovaloid
beveled edge,
film-coated
tablet imprinted with "NVR" on one side and "SEH" on the other side.
•
50 mg vildagliptin and 1,000 mg metformin hydrochloride. Dark yellow,
ovaloid beveled
edge,
film-coated
tablet imprinted with "NVR" on one side and "FLO" on the other side.
ACTIVE SUBSTANCES
Vildagliptin
Metformin hydrochloride
ACTIVE MOIETIES
Vildagliptin and metformin
Certain dosage strengths and dosage forms ma y not be available in all
countries.
EXCIPIENTS
Hydroxypropyl cellulose, hypromellose, iron oxide yellow, iron oxide
red, macrogol, magnesium
stearate, talc and titanium dioxide.
Pharmaceutical formulations may vary between countries.
INDIC
ATIONS
GalvusMet is indicated in adults with type 2 diabetes mellitus as an
adjunct to diet and exercise to
improve glycemic control:
•
as initial therapy when diabetes is not adequately controlled by diet
and exercise alone
•
as
therapy
in
patients
inadequately
controlled
with
metformin
hydrochloride
or
vildagliptin alone or who are already treated with the combination of
vildagliptin and
metformin hydrochloride, as separate tablets
•
as combination therapy- in combination with other medicinal products,
including insulin,
when these do not provide adequate glycemic control (see section on
Warnings and
precautions, section on Interactions and section on Clinical Studies
for available data on
different combinations).
Important limitations of Use
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Galvus Met should not be used in patients with type 1 diabetes or for
the treatment of diabeti