देश: मलेशिया
भाषा: अंग्रेज़ी
स्रोत: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Canagliflozin hemihydrate
JOHNSON & JOHNSON SDN BHD
Canagliflozin hemihydrate
30tablet Tablets
JANSSEN CILAG SPA
INVOKANA ® FILM-COATED TABLETS Canagliflozin (100mg & 300mg) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What INVOKANA ® is used for 2. How INVOKANA ® works 3. Before you use INVOKANA ® 4. How to use INVOKANA ® 5. While you are using it 6. Side effects 7. Storage and disposal of INVOKANA ® 8. Product description 9. Manufacturer and product registration holder 10. Date of revision 11. Serial number WHAT INVOKANA ® IS USED FOR INVOKANA ® contains the active substance canagliflozin. This belongs to a group of medicines called “oral antihyperglycemics.” INVOKANA ® may also be known as a diabetes medicine. INVOKANA ® is used to lower blood sugar levels in adults with type 2 diabetes. INVOKANA ® can be used alone or together with other medicines that your doctor may prescribe to lower blood sugar. It is also important to keep following your doctor’s advice about diet and exercise. _ _ If you have type 2 diabetes and an increased cardiovascular risk (health problems due to your heart and blood vessels), INVOKANA ® can be used along with diet and exercise to lower your risk of dying from events related to your heart or blood vessels, and to lower your risk from having non-fatal heart attacks and non- fatal strokes. INVOKANA ® is used for type 2 diabetes due to diabetic condition. This is when your kidneys are damaged as a result of your diabetes. INVOKANA ® can be used to slow down the progression rate of your kidney disease and may also reduce death rate relating to cardiovascular disease. _ _ _What is type 2 diabetes? _ Type 2 diabetes is a condition in which your body does not make enough insulin, and the insulin that your body produces does not work as well as it should. Your body can also make too much sugar. When this happens, sugar (glucose) builds up in the blood. This can lead to serious medical conditions such as heart disease, kidney disease, blindness, and amputation. HOW INVOKANA ® WORKS INVOKANA ® works by increasing the amount of sugar removed from t पूरा दस्तावेज़ पढ़ें
1 1. NAME OF THE MEDICINAL PRODUCT Invokana ® 100 mg film-coated tablets Invokana ® 300 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Invokana 100 mg film-coated tablets Each tablet contains canagliflozin hemihydrate, equivalent to 100 mg canagliflozin. _Excipient(s) with known effect _ Each tablet contains 39.2 mg lactose. Invokana 300 mg film-coated tablets Each tablet contains canagliflozin hemihydrate, equivalent to 300 mg canagliflozin. _Excipient(s) with known effect _ Each tablet contains 117.78 mg lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Invokana 100 mg film-coated tablets The tablet is yellow, capsule-shaped, approximately 11 mm in length, immediate-release and film-coated, with “CFZ” on one side and “100” on the other side. Invokana 300 mg film-coated tablets The tablet is white, capsule-shaped, approximately 17 mm in length, immediate-release and film-coated, with “CFZ” on one side and “300” on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Monotherapy INVOKANA (canagliflozin) is indicated as an adjunct to diet and exercise to improve glycemic control in adult patients with type 2 diabetes mellitus for whom metformin is inappropriate due to contraindications or intolerance. _ _ Combination with Metformin or a Sulfonylurea INVOKANA is indicated in combination with metformin or a sulfonylurea in adult patients with type 2 diabetes mellitus to improve glycemic control when diet and exercise plus monotherapy with one of these agents does not provide adequate glycemic control. Combination with Metformin and either a Sulfonylurea or Pioglitazone INVOKANA is indicated in combination with metformin and either a sulfonylurea or pioglitazone in adult patients with type 2 diabetes mellitus to improve glycemic control when diet, exercise, and dual therapy (with metformin plus either a sulfonylurea or pioglitazone) do not provide adequate glycemic control. Combination with Insulin INVOKA पूरा दस्तावेज़ पढ़ें