GALVUS NOVARTIS PDF

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Novartis’ Galvus (vildagliptin) is a member of a new class of oral antidiabetic agents known as dipeptidyl peptidase IV inhibitors (DPP-IV) inhibitors or ‘incretin . Galvus Approval Status. FDA Approved: No Brand name: Galvus Generic name: vildagliptin. Previous Name: LAF Company: Novartis Pharmaceuticals. Vildagliptin is an oral anti-hyperglycemic agent (anti-diabetic drug) of the dipeptidyl The European Medicines Agency has also approved a combination of vildagliptin and metformin, vildagliptin/metformin (Eucreas by Novartis) as an oral.

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Vildagliptin – Wikipedia

Marketing authorisation holder 8. Patients should be informed of the characteristic symptom of acute pancreatitis. Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. Opipramol Opipramol may decrease the hypoglycemic activities of Vildagliptin.

Dimetacrine Dimetacrine may decrease the hypoglycemic activities of Vildagliptin. For more information about treatment with Icandra, read the package leaflet also part of the EPAR or contact your doctor or pharmacist. Nitrendipine The risk or severity of hypoglycemia can be increased when Nitrendipine is combined with Vildagliptin.

Celecoxib The therapeutic efficacy of Vildagliptin can be increased when used in combination with Celecoxib. Adverse effects observed glvus clinical trials include nausea, hypoglycemia, tremor, headache and dizziness.

Oxaprotiline Oxaprotiline may decrease the hypoglycemic activities of Vildagliptin. The risk or severity of angioedema can be increased when Ramipril is combined with Vildagliptin. Fluticasone The therapeutic efficacy of Vildagliptin can be decreased when used in combination with Fluticasone.

The therapeutic efficacy of Vildagliptin can be increased when used in combination with Oxolinic acid. The risk or severity of angioedema can be increased when Forasartan is combined with Vildagliptin.

The therapeutic efficacy of Vildagliptin can be decreased when used in combination with Leuprolide. More detail is available in the summary of product characteristics. Novarrtis The risk or severity of angioedema can be increased when Enalapril is combined with Vildagliptin.

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Galvus 50 mg Tablets – Summary of Product Characteristics (SmPC) – (eMC)

Sumatriptan The therapeutic efficacy of Vildagliptin can be increased when used in combination with Sumatriptan. The therapeutic efficacy of Vildagliptin can be increased when used in combination with Celecoxib.

Clorgiline Clorgiline may increase the hypoglycemic activities of Vildagliptin. Sulfathiourea The therapeutic efficacy of Vildagliptin can be increased when used in combination with Sulfathiourea. The risk or severity of hypoglycemia can be increased when Lipoic Acid is combined with Vildagliptin. The risk or severity of angioedema can be increased when Vildagliptin is combined with Carmegliptin. The risk or severity of hypoglycemia can be increased when Vildagliptin novargis combined with Dulaglutide.

The safety and efficacy of vildagliptin as triple oral therapy in combination with metformin and a thiazolidinedione have not been established. Mechanism of action The administration of vildagliptin results in a rapid and complete inhibition of DPP-4 activity, resulting in increased fasting and postprandial endogenous levels of the incretin hormones GLP-1 glucagon-like peptide 1 and GIP glucose-dependent insulinotropic polypeptide.

In clinical trials, weight did not change from baseline when vildagliptin mg daily was administered as monotherapy The therapeutic efficacy of Vildagliptin can be decreased when used in combination with Chlorpromazine. Glucagon The risk or severity of hypoglycemia can be increased when Glucagon recombinant galvys combined with Vildagliptin. Flunarizine The risk or severity of hypoglycemia can be increased when Flunarizine is combined with Vildagliptin.

Ciclesonide The therapeutic efficacy of Vildagliptin can be decreased when used in combination with Ciclesonide.

Vildagliptin

The risk or severity of hypoglycemia can be increased when Dapoxetine is combined with Vildagliptin. Otilonium The risk or severity of hypoglycemia can be increased when Otilonium is combined with Vildagliptin. There are no adequate data from the use of vildagliptin in pregnant women. The risk or severity of hypoglycemia can be increased when Lamotrigine is combined with Vildagliptin. The therapeutic efficacy of Vildagliptin can be decreased when used in combination with Etacrynic acid.

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Icandra (previously Vildagliptin / metformin hydrochloride Novartis)

As monotherapy – in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance. Dotarizine The risk or severity of hypoglycemia can be increased when Dotarizine is combined with Vildagliptin.

Hydroflumethiazide The therapeutic efficacy of Vildagliptin can be decreased when used in combination with Hydroflumethiazide. Mefruside The therapeutic efficacy of Vildagliptin can be increased when used in combination with Mefruside. Pheniprazine Pheniprazine may increase the hypoglycemic activities of Vildagliptin. Tranilast The risk or severity of hypoglycemia can be increased when Tranilast is combined with Vildagliptin.

Liver function should be monitored during treatment with Galvus at three-month intervals during the first year and periodically thereafter. The applicant also presented the results of two studies showing that the active substances in the two strengths of Icandra were absorbed in the body in the same way as when they were taken as separate tablets. Sulfaethoxypyridazine The therapeutic efficacy of Vildagliptin can be increased when used in combination with Sulfaethoxypyridazine.

Dexverapamil The risk or severity of hypoglycemia can be increased when Dexverapamil is combined with Vildagliptin. At study endpoint 2 yearsthe HbA 1c was similar to baseline values in both treatment groups and the body weight changes and hypoglycaemia differences were maintained. The therapeutic efficacy of Vildagliptin can be decreased when used in combination with Hydrocortisone.

Mifepristone The risk or severity of hypoglycemia can be increased when Mifepristone is combined with Vildagliptin. For the full list of restrictions, see the package leaflet. Hypoglycaemia Sulphonylureas are known to cause hypoglycaemia.

Levonorgestrel The therapeutic efficacy of Vildagliptin can be decreased when used in combination with Levonorgestrel.

However, the major hydrolysis metabolite LAY can be removed by haemodialysis.