Galvus Met (Vildagliptin, Metformin)

Instructions for Galvus (Vildagliptin, Metformin) pills

English product name
Galvus Met®

Release form
tabletop film sheath, 50 mg+850 mg: 6, 10, 18, 30, 36, 50, 60, 72, 108, 120, 180, 216 or 360 pcs

Description Galvus:

Tablets covered with film sheath yellow with a weak grayish color, oval, with beveled edges; on one side is marked "NVR", on the other side is marked "SEH".

1 tab.
vildagliptin 50 mg
Metformin hydrochloride 850 mg
Auxiliary substances: hyprolose, magnesium stearate, hypromellose (E464), titanium dioxide (E171), macrogol 4000, talc, iron oxide yellow (E172).

ATC codes
A10BD08 Metformin in combination with vildagliptin

Clinical-pharmacological groups / Group affiliation
Oral hypoglycemic preparation

Active substance

• Metformin hydrochloride
• vildagliptin

Pharmacotherapy group Galvus:

Hypoglycemic oral combined agent (dipeptidyl peptidase-4 inhibitor+biguanide)

Testimony Galvus:

• Type 2 diabetes (combined with diet and exercise):
• when monotherapy is insufficiently effective with vildagliptin or metformin; in patients who previously received combination therapy with vildagliptin and metformin in the form of monotherapies; 
• in combination with sulfonyl urea derivatives (triple combination therapy) in patients previously treated with sulfonyl
• urea derivatives and Metformin without achieving adequate glycemia control; 
• in triple combination therapy with insulin in patients who previously received insulin therapy at a stable dose and
• metformin without achieving adequate glycemia control; 
• as an initial therapy in patients with type 2 diabetes with insufficient efficiency of diet therapy,
• exercise and the need to improve glycemia control.

Method of use, course and dosage Galvus:

To be taken inside. The dosing mode is selected individually depending on the effectiveness and tolerability of the therapy. The recommended maximum daily dose of Vildagliptin should not exceed 100 mg.
The recommended initial dose should be selected taking into account the duration of diabetes mellitus and the level of glycemia, the patient's condition and the treatment regimens of vildagliptin and or metformin already used in the patient.

Before starting metformin-containing drugs, SCF should be defined, then this indicator should be monitored at least annually. In patients at risk of deterioration of pre-existing kidney function, as well as in older patients, kidney function should be monitored more often, for example every three to six months.
The maximum daily dose of metformin should be divided into 2 or 3 doses. In patients with SCF <60 ml/min, the factors contributing to the increased risk of lactacidosis should be assessed before starting metformin-containing therapy. In patients with SCF thirty ml/min, the use of this combination is contraindicated due to the presence of metformin in the preparation.

Application for kidney disorders
The use of the preparation is contraindicated in the case of renal insufficiency or a serious kidney failure in the case of a flowerbed filtration rate of <30 ml/min.

Use in liver disorders Vildagliptin
Do not use in patients with liver disease or impaired biochemical indicators of liver function.

Application in elderly patients
Metformin-containing drugs are recommended to be used with caution in patients over sixty years of age when performing hard physical work, due to their increased risk of developing lactacidosis.

Use in children
Contraindication: The age is up to 18 years (effectiveness and safety of use is not established).

• Nosology Galvus (ICD codes)
• E11
• Type 2 diabetes