Χώρα: Αυστραλία
Γλώσσα: Αγγλικά
Πηγή: Department of Health (Therapeutic Goods Administration)
Insulin aspart, Quantity: 100 U/mL
Novo Nordisk Pharmaceuticals Pty Ltd
Insulin aspart
Injection, solution
Excipient Ingredients: glycerol; phenol; metacresol; zinc; dibasic sodium phosphate dihydrate; arginine; hydrochloric acid; sodium hydroxide; water for injections; nicotinamide
Subcutaneous, Intravenous
1 x 3 mL, 5 x 3 mL
(S4) Prescription Only Medicine
Treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above.
Visual Identification: Clear, colourless solution; Container Type: Cartridge; Container Material: Glass Type I Clear; Container Life Time: 30 Months; Container Temperature: Store at 2 to 8 degrees Celsius
Licence status A
2017-07-27
Fiasp ® FlexTouch ® Page 1 of 14 Fiasp Ft cmi2.docx FIASP ® FLEXTOUCH ® _Insulin aspart (rys) _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET WHAT FIASP ® FLEXTOUCH ® IS USED FOR ................................................ 1 BEFORE YOU USE FIASP ® FLEXTOUCH ® ..................................................... 1 HOW TO USE FIASP ® FLEXTOUCH ® 2 WHILE YOU ARE USING FIASP ® FLEXTOUCH ® ................................. 4 THINGS TO BE CAREFUL OF .............. 4 SIDE EFFECTS .................................. 4 AFTER USING FIASP ® FLEXTOUCH ® 5 PRODUCT DESCRIPTION .................. 5 FURTHER INFORMATION .................. 6 This leaflet answers some common questions about Fiasp ® FlexTouch ® . It does not contain all the available information. It does not take the place of talking to your doctor, diabetes education nurse or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you using Fiasp ® FlexTouch ® against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR, DIABETES EDUCATION NURSE OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT FIASP ® FLEXTOUCH ® IS USED FOR The insulin aspart, or “Fiasp ® ”, in Fiasp ® FlexTouch ® is a fast-acting insulin used to treat diabetes mellitus in adults. Diabetes mellitus is a condition where your pancreas does not produce enough insulin to control your blood sugar (glucose) level. Extra insulin is therefore needed. There are two types of diabetes mellitus: type 1 diabetes type 2 diabetes Patients with type 1 diabetes always require insulin to control their blood sugar levels. Some patients with type 2 diabetes may also require insulin after initial treatment with diet, exercise and tablets. _Fiasp_ _®_ _ _ lowers your blood sugar level after injection. When injected under your skin, Fiasp ® has a faster onset of action than NovoRapid ® . Fiasp ® can be injected at the start of a meal, wit Διαβάστε το πλήρες έγγραφο
_Fiasp_pi2.docx_ Page 1 of 22 AUSTRALIAN PRODUCT INFORMATION FIASP ® FLEXTOUCH ® (insulin aspart (rys)) solution for injection FIASP ® (insulin aspart (rys)) solution for injection FIASP ® PENFILL ® (insulin aspart (rys)) solution for injection 1. NAME OF THE MEDICINE Insulin aspart (rys) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Insulin aspart is an analogue of human insulin, differing by the substitution of the amino acid proline by aspartic acid at position 28 on the B-chain. Insulin aspart is produced by recombinant DNA technology in _Saccharomyces cerevisiae_ . 1 mL of the solution contains 100 units of insulin aspart (equivalent to 3.5 mg). FIASP FLEXTOUCH: Each pre-filled pen contains 3 mL equivalent to 300 units. FIASP VIAL: Each vial contains 10 mL equivalent to 1,000 units. FIASP PENFILL: Each cartridge contains 3 mL equivalent to 300 units. For the full list of excipients, see Section 6.1 ‘List of Excipients.’ 3. PHARMACEUTICAL FORM Sterile, clear, colourless, aqueous solution for subcutaneous injection, subcutaneous infusion or intravenous injection. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of diabetes mellitus in adults. 4.2 DOSE AND METHOD OF ADMINISTRATION Dosage Fiasp is an ultra-fast acting insulin for subcutaneous administration. Fiasp administered 0-2 minutes before the start of a meal produced a significantly greater postmeal glucose lowering effect after a standardised meal test compared to NovoRapid. Administration of Fiasp up to 20 minutes after starting a meal was as efficacious as NovoRapid given before a meal (see Section 5.1 ‘Pharmacodynamic Properties’ – ‘Clinical trials’) _._ Fiasp can be used for continuous subcutaneous insulin infusion (CSII) in pumps or be administrated intravenously by healthcare professionals. The potency of insulin analogues, including Fiasp, is expressed in units. One (1) unit of Fiasp corresponds to 1 international unit of human insulin or 1 unit of other fast-acting insulin analogues. _Fiasp_pi2.docx_ Page 2 of 22 Dos Διαβάστε το πλήρες έγγραφο