Valsts: Austrālija
Valoda: angļu
Klimata pārmaiņas: Department of Health (Therapeutic Goods Administration)
alogliptin benzoate, Quantity: 34 mg
Takeda Pharmaceuticals Australia Pty Ltd
Alogliptin benzoate
Tablet, film coated
Excipient Ingredients: iron oxide red; titanium dioxide; mannitol; magnesium stearate; croscarmellose sodium; hypromellose; microcrystalline cellulose; macrogol 8000; hyprolose; Shellac; ethanol absolute; iron oxide black; 1-butanol
Oral
7, 100, 98, 30, 28, 10, 56, 60, 90, 14
(S4) Prescription Only Medicine
NESINA is indicated to improve glycaemic control in adult patients (>= 18 years old) with type 2 diabetes mellitus when diet and exercise do not provide adequate glycaemic control, as add on to metformin, a sulphonylurea, a thiazolidinedione, insulin (with or without metformin), or in combination with metformin and a thiazolidinedione when dual therapy does not provide adequate glycaemic control.
Visual Identification: Light red, oval, biconvex, film-coated tablets with TAK and ALG-25 printed on one side.; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 48 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2013-09-17
NESINA ® _Alogliptin (as benzoate)_ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Nesina. It does not contain all the available information. It does not take the place of talking to your doctor, pharmacist or diabetes educator. The information in this leaflet was last updated on the date listed on the final page. More recent information on the medicine may be available. You should ensure that you speak to your pharmacist or doctor to obtain the most up to date information on this medicine. You can also download the most up to date leaflet from https://takeda.com/en-au/what- we-do/our-products/. Those updates may contain important information about the medicine and its use of which you should be aware. All medicines have risks and benefits. Your doctor has weighed the risks of you taking this medicine against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT NESINA IS USED FOR Nesina is used to lower blood sugar levels in adults with type 2 diabetes mellitus. It must be taken together with other antidiabetic medicines, which your doctor will have prescribed for you, such as sulfonylureas (e.g. glipizide, glimepiride, glibenclamide), metformin and/or thiazolidinediones (e.g. pioglitazone) or insulin with or without metformin. Nesina is used when your blood sugar cannot be adequately controlled by diet, exercise and one or more of these other antidiabetic medicines. It is important that you continue to take your other antidiabetic medication and continue to follow the advice on diet and exercise that your doctor or diabetes educator has given you. TYPE 2 DIABETES MELLITUS Type 2 diabetes is also called non- insulin-dependent diabetes mellitus (NIDDM). Type 2 diabetes develops if the body does not make enough insulin, or if the insulin that your body makes does not work as well as it should. It can also Izlasiet visu dokumentu
_NESINA PI V7.0 (CCDS 6.0)_ _ _ _ _ _1 _ AUSTRALIAN PRODUCT INFORMATION NESINA ® (ALOGLIPTIN BENZOATE) 1 NAME OF THE MEDICINE Alogliptin benzoate. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION NESINA is available for oral use as film-coated tablets containing alogliptin benzoate equivalent to 6.25, 12.5 or 25 mg of free base. Contains benzoates. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM NESINA is available in the following presentations: NESINA 25 mg film-coated tablets: Light red, oval, biconvex, film-coated tablets with “TAK” and “ALG-25” printed on one side. NESINA 12.5 mg film-coated tablets: Yellow, oval, biconvex, film-coated tablets with “TAK” and “ALG-12.5” printed on one side. NESINA 6.25 mg film-coated tablets: Light pink, oval, biconvex, film-coated tablets with “TAK” and “ALG-6.25” printed on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS NESINA is indicated to improve glycaemic control in adult patients (≥ 18 years old) with type 2 diabetes mellitus when diet and exercise do not provide adequate glycaemic control, as add on to metformin, a sulphonylurea, a thiazolidinedione, insulin (with or without metformin), or in combination with metformin and a thiazolidinedione when dual therapy does not provide adequate glycaemic control. 4.2 DOSE AND METHOD OF ADMINISTRATION NESINA should be taken orally once daily with or without food. The tablets should be swallowed whole with water. If a dose is missed, it should be taken as soon as the patient remembers. A double dose should not be taken on the same day. ADULTS (≥ 18 YEARS OLD) The recommended dose of NESINA is 25 mg once daily. NESINA is not indicated for initial combination therapy. _NESINA PI V7.0 (CCDS 6.0)_ _ _ _ _ _2 _ When NESINA is used in combination with metformin and/or a thiazolidinedione, the dose of metformin and/or the thiazolidinedione should be maintained, and NESINA administered concomitantly. When NESINA is used in combination with insulin or an ins Izlasiet visu dokumentu