Country: Малезија
Језик: Енглески
Извор: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
SAXAGLIPTIN HYDROCHLORIDE
ASTRAZENECA SDN. BHD.
SAXAGLIPTIN HYDROCHLORIDE
28Tablet Tablets
AstraZeneca Pharmaceuticals LP.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ ONGLYZA ® TABLET SAXAGLIPTIN (2.5 MG & 5 MG) 1 WHAT IS IN THIS LEAFLET 1. What ONGLYZA is used for 2. How ONGLYZA works 3. Before you use ONGLYZA 4. How to use ONGLYZA 5. While you are using it 6. Side effects 7. Storage and disposal of ONGLYZA 8. Product description 9. Manufacturer 10. Product Registration Holder 11. Date of revision WHAT IS ONGLYZA USED FOR ONGLYZA is a prescription medicine used with diet and exercise to control high blood sugar (hyperglycemia) in adults with type 2 diabetes. _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 problems. The main goal of treating diabetes is to lower your blood sugar so that it is as close to normal as possible. High blood sugar can be lowered by diet and exercise, and by certain medicines when necessary. HOW ONGLYZA WORKS • ONGLYZA lowers blood sugar by helping the body increase the level of insulin after meals. • ONGLYZA is unlikely to cause your blood sugar to be lowered to a dangerous level (hypoglycemia) because it does not work well when your blood sugar is low. However, hypoglycemia may still occur with ONGLYZA. Your risk for getting hypoglycemia is higher if you take ONGLYZA with some other diabetes medicines, such as a sulfonylurea or insulin. BEFORE YOU USE ONGLYZA - _When you must not use it _ _ _ DO NOT TAKE ONGLYZA IF YOU: • are allergic to any ingredients in ONGLYZA. See the end of this Patient Information Leaflet for a complete list of ingredients in ONGLYZA. Symptoms of a serious allergic reaction to ONGLYZA may include : - swelling of your face, lips, throat, and other areas on your skin - difficulty with swallowing or breathing - raised, red areas on your skin (hives) - skin rash, itching, flaking, or peeling If you have these s Прочитајте комплетан документ
ONGLYZA ® saxagliptin tablets INDICATIONS AND USAGE _ _ MONOTHERAPY AND COMBINATION THERAPY _ _ ONGLYZA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see _Clinical Studies_ ]. _ _ LIMITATION OF USE ONGLYZA is not indicated for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings. DOSAGE AND ADMINISTRATION _ _ RECOMMENDED DOSAGE The recommended dosage of ONGLYZA is 2.5 mg or 5 mg once daily taken regardless of meals. ONGLYZA tablets must not be split or cut. _ _ DOSAGE IN PATIENTS WITH RENAL IMPAIRMENT No dosage adjustment for ONGLYZA is recommended for patients with eGFR ≥45 mL/min/1.73 m 2 . The dosage of ONGLYZA is 2.5 mg once daily (regardless of meals) for patients with eGFR <45 mL/min/1.73 m 2 (which includes a subset of moderate or severe renal impairment, or with end- stage renal disease (ESRD) requiring hemodialysis) [see _Clinical Pharmacology _ and _Clinical _ _Studies_ ] . ONGLYZA should be administered following hemodialysis. ONGLYZA has not been studied in patients undergoing peritoneal dialysis. Because the dosage of ONGLYZA should be limited to 2.5 mg based upon renal function, assessment of renal function is recommended prior to initiation of ONGLYZA and periodically thereafter. DOSAGE ADJUSTMENT WITH CONCOMITANT USE OF STRONG CYP3A4/5 INHIBITORS The dosage of ONGLYZA is 2.5 mg once daily when coadministered with strong cytochrome P450 3A4/5 (CYP3A4/5) inhibitors (e.g., ketoconazole, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, and telithromycin) [see _Drug _ _Interactions_ and _Clinical Pharmacology_ ]. CONCOMITANT USE WITH AN INSULIN SECRETAGOGUE (E.G., SULFONYLUREA) OR WITH INSULIN When ONGLYZA is used in combination with an insulin secretagogue (e.g., sulfonylurea) or with insulin, a lower dose of the insulin secretagogue or insulin may be required to minimize the risk of hypoglycemia [see _Warnings and Pr Прочитајте комплетан документ