Buy Galvus (Vildagliptin) anti-diabetic medication
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GALVUS (VILDAGLIPTIN): PRESCRIBING INFORMATION
Name of the medicinal product
Galvus (Vildagliptin) 50 mg tablets
Chemical name: 1-[(3-Hydroxy-adamant-1-ylamino)acetyl]-pyrrolidine-2(S)-carbonitrile
Molecular formula: C17H25N3O2
Molecular weight: 303.40
CAS registry no. 274901-16-5
Qualitative and quantitative composition
Each tablet contains 50 mg of vildagliptin.
Excipient with known effect: Each tablet contains lactose anhydrous, cellulose microcrystalline, sodium starch glycolate (type A), magnesium stearate.
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"
INDICATIONS AND USAGE
Galvus (Vildagliptin) is indicated in the treatment of type 2 diabetes mellitus in adults:
in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance.
As dual oral therapy in combination with
metformin, in patients with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin,
a sulphonylurea, in patients with insufficient glycaemic control despite maximal tolerated dose of a sulphonylurea and for whom metformin is inappropriate due to contraindications or intolerance,
a thiazolidinedione, in patients with insufficient glycaemic control and for whom the use of a thiazolidinedione is appropriate.
As triple oral therapy in combination with
a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.
Vildagliptin (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.
DOSAGE AND ADMINISTRATION
Galvus dosage and administration
Hypersensitivity to the active substance or to any of the excipients.
WARNINGS AND PRECAUTIONS
Galvus warnings and precautions
Galvus drug interactions
USE IN SPECIFIC POPULATIONS
Galvus use in specific populations
Galvus adverse reactions
Information regarding overdose with Galvus (Vildagliptin) is limited.
Information on the likely symptoms of overdose was taken from a rising dose tolerability study in healthy subjects given Galvus for 10 days. At 400 mg, there were three cases of muscle pain, and individual cases of mild and transient paraesthesia, fever, oedema and a transient increase in lipase levels. At 600 mg, one subject experienced oedema of the feet
and hands, and increases in creatine phosphokinase (CPK), aspartate aminotransferase (AST), C-reactive protein (CRP) and myoglobin levels. Three other subjects experienced oedema of the feet, with paraesthesia in two cases. All symptoms and laboratory abnormalities resolved without treatment after discontinuation of the study medicinal product.
In the event of an overdose, supportive management is recommended. Vildagliptin cannot be removed by haemodialysis. However, the major hydrolysis metabolite (LAY 151) can be removed by haemodialysis.
Galvus clinical pharmacology
HOW SUPPLIED / STORAGE AND HANDLING
Galvus (Vildagliptin) is available as a 50 mg tablet.
50 mg: white to light yellowish, round, flat-faced, bevelled edge tablet.
One side is debossed with "NVR" and the other side with "FB".
Galvus is available in blisters packs containing 7, 10, 14, 28, 30, 56, 60 or 112 tablets.
Not all pack sizes may be marketed.
Store below 30°C. Protect from moisture.
Manufactured and distributed by Novartis pharmaceutical company and its divisions.
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