Country: ইউরোপীয় ইউনিয়ন
ভাষা: ইংরেজি
সূত্র: EMA (European Medicines Agency)
sitagliptin
Merck Sharp and Dohme B.V
A10BH01
sitagliptin
Drugs used in diabetes
Diabetes Mellitus, Type 2
For adult patients with type-2 diabetes mellitus, Januvia is indicated to improve glycaemic control:as monotherapy: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 when diet and exercise plus metformin alone do not provide adequate glycaemic control;a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance;a peroxisome-proliferator-activated-receptor-gamma (PPARγ) agonist (i.e. a thiazolidinedione) when use of a PPARγ agonist is appropriate and when diet and exercise plus the PPARγ agonist alone do not provide adequate glycaemic control;a PPARγ agonist (i.e. a thiazolidinedione) when use of a PPARγ agonist is appropriate and when diet and exercise plus the PPARγ agonist alone do not provide adequate glycaemic control;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;a PPARγ agonist and metformin when use of a PPARγ agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.Januvia is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.
Revision: 32
Authorised
2007-03-20
32 B. PACKAGE LEAFLET 33 PACKAGE LEAFLET: INF ORMATION FOR THE PATIENT JANUVIA 25 MG FILM- COATED TABLETS JANUVIA 50 MG FILM- COATED TABLETS JANUVIA 100 MG FILM- COATED TABLETS sitagliptin READ ALL OF THIS LEAFL ET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONT AINS I MPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have a ny fur ther questions, ask your doctor, pharmacist, or nurse. - This medicine has been prescri bed for you only. Do not pass it on to others. It may harm them, even if their signs of illn ess are the same as yours. - If you get any side effects, talk to your doct or, ph armacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Januvia is and what it is used for 2. What y ou need to know before you take J anuvia 3. How to take Januvia 4. Possible side effects 5. How to store Januvia 6. Contents of the pack and other in formation 1. WHAT JANUVIA IS AND WHAT IT IS USED FOR Januvia contains the a ctive substance sitaglipti n which is a member of a class of med icines called DPP- 4 inhibitors (dipe ptidyl peptidase- 4 inhibitors) that lowers blood sugar levels in adult patients with type 2 diabetes mellitus. This medicine helps to increase the levels of insulin produced after a meal and decreases the amount of suga r made by the body. Your doctor ha s pres cribed this medicine to help lower your blood sugar, which is too high be cause of you r type 2 diabetes. This medicine can be used alone or in combinati on wit h certain other medi cines (insulin, metformin, sulphonylu reas, or glitazones) that lower bloo d suga r, which you may already be taking for your diabetes together with a food and exercise plan. What is type 2 diabetes? Type 2 diabetes is a condition i n whic h your body does not mak e enough insulin, and the insulin that your body produces does not wo rk as well as it should. Your body can also make too much sugar. When this happ ens, sugar ( glucose) bu সম্পূর্ণ নথি পড়ুন
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Januvia 25 mg film- coated tablets Januvia 50 mg film- coated tablets Januvia 100 mg film- coated tablets 2. QUALITATIV E AND QUANTITATIVE COMPOSITION Januvia 25 mg film- coated tablets Each tablet contains sitagliptin phosphate monohydrate, equivalent to 25 mg sitagliptin. Januvia 50 mg film-coated tablets Each tablet conta ins sitagliptin phosphate monohydrate, equivalent to 50 mg sitagliptin . Januvia 100 mg film- coated tablets Each tablet contains sitagliptin phosphate monohydrate, equivalent to 100 mg sitagliptin . F or the full list of excipients, se e section 6.1. 3. PH ARMACEUTICAL FORM Film- coated tablet (tablet). Januvia 25 mg film- coated tablets Rou nd, pink film - coated tablet with “221” on one side. Januvia 50 mg film- coated tablets Round, light beige film - coated table t with “112” on one side . Januvia 100 mg film- coated tablets Round, beige f ilm- coated tablet wi th “277” on one side. 4. CLINICAL PA RTICULARS 4.1 THERAPEUTIC INDICATIONS For adult patients w ith type 2 diabetes mellitus, Januvia is indicated to improve glycaemic control: as monotherapy: • in patient s inadequately controlled by diet and exercise al one and for whom metform in is inapprop riate due to contraindications or intolerance. as dual oral t herapy in combination with : • metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control. • a sulphonylurea when diet and exercise plus maximal t olerated dose of a sulphonylurea alone do not provide adequate glycaemic co nt rol and when metformin is inappropriate due to contraindications or intolerance. 3 • a peroxisome proliferato r- activated receptor gamma (PPAR ) agonist (i.e. a thiazolidinedione) when use of a PPAR agonist is appropriate and when diet and exercise plus the PPAR agonist alone do not provide adequate glycaemic control. as triple oral therap y in combination with : • a sulphonylurea and metformin when diet and সম্পূর্ণ নথি পড়ুন