Nazione: Australia
Lingua: inglese
Fonte: Department of Health (Therapeutic Goods Administration)
Insulin aspart, Quantity: 100 U/mL
Novo Nordisk Pharmaceuticals Pty Ltd
Insulin aspart
Injection, solution
Excipient Ingredients: water for injections; metacresol; glycerol; sodium chloride; dibasic sodium phosphate dihydrate; hydrochloric acid; sodium hydroxide; zinc; phenol
Subcutaneous, Intravenous
1 X 10mL
(S4) Prescription Only Medicine
Treatment of diabetes mellitus.
Visual Identification: A clear colourless solution in 10mL vials closed with a cream septa.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 30 Months; Container Temperature: Store at 2 to 8 degrees Celsius
Licence status A
2006-12-21
NovoRapid® 10mL vial 1 NOVORAPID® 10ML VIAL CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor, diabetes education nurse, or pharmacist. 1. WHY AM I USING NOVORAPID®? NovoRapid® contains the active ingredient insulin aspart. Insulin aspart is a rapid-acting insulin used to treat diabetes mellitus in adults and children. For more information, see Section 1. Why am I using NovoRapid®? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE NOVORAPID®? Do not use if you have ever had an allergic reaction to insulin aspart or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR OR PHARMACIST IF YOU HAVE ANY OTHER MEDICAL CONDITIONS (ESPECIALLY KIDNEY, LIVER OR GLAND PROBLEMS), TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREAST-FEEDING. For more information, see Section 2. What should I know before I use NovoRapid®? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with NovoRapid® and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE NOVORAPID®? • Use immediately (up to 10 minutes) before your meal or carbohydrate snack. Inject into the abdomen, thighs, buttocks or upper arms. • Change your injection site regularly. Carefully follow the advice on how to inject under the skin, or using an insulin pump. Detailed instructions can be found in Section 4. How do I use NovoRapid®? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING NOVORAPID®? THINGS YOU SHOULD DO • Remind any doctor, dentist, pharmacist or diabetes education nurse you visit that you have diabetes and are using insulin. • Measure your blood sugar levels regularly. • Tell your doctor if you often have hypos (low blood sugar levels). • Always carry some sugary food or fruit juice with you. THINGS YOU SHOULD NOT DO • Do not stop using your medicine unless your doctor Leggi il documento completo
_NovoRapid_NovoMix_pi9 _ _ _ _Page 1 of 19 _ AUSTRALIAN PRODUCT INFORMATION NOVORAPID ® (INSULIN ASPART) NOVOMIX ® (SOLUBLE INSULIN ASPART/INSULIN ASPART CRYSTALISED WITH PROTAMINE) 1. NAME OF THE MEDICINE NovoRapid ® (insulin aspart (rys)) 100 U/mL solution for injection 10mL Vial NovoRapid ® Penfill ® (insulin aspart (rys)) 100 U/mL solution for inejction 3mL cartridge NovoRapid ® FlexPen ® (insulin aspart (rys)) 100 U/mL solution for injection 3mL cartridge NovoRapid ® FlexTouch ® (insulin aspart (rys)) 100 U/mL solution for inejction 3mL cartridge NovoMix ® 30 Penfill ® (30% soluble insulin aspart (rys) and 70% insulin aspart (rys) crystallised with protamine) 100 U/mL suspension for inejction 3mL cartridge NovoMix ® 30 FlexPen ® (30% soluble insulin aspart (rys) and 70% insulin aspart (rys) crystallised with protamine) 100 U/mL suspension for injection 3mL cartridge NovoMix ® 50 FlexPen ® (50% soluble insulin aspart (rys) and 50% insulin aspart (rys) crystallised with protamine)100 U/mL suspension for injection 3mL cartridge 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Insulin aspart is a rapid-acting analogue of human insulin that rapidly lowers blood glucose. Insulin aspart is homologous with human insulin with the exception of a substitution of the amino acid proline by aspartic acid at position 28 on the B-chain. The unique structure of insulin aspart increases the rate of absorption from a subcutaneous injection site, giving a faster onset of action, an earlier peak effect and a shorter duration of action than soluble human insulin. Insulin aspart should be given immediately before a meal or, when necessary, after the start of a meal. Insulin aspart is produced by recombinant DNA technology using Saccharomyces cerevisiae. One unit of insulin aspart corresponds to 6 nmol, 0.035 mg salt-free anhydrous insulin aspart. 3. PHARMACEUTICAL FORM NovoRapid is a sterile, clear, colourless, aqueous, neutral solution of insulin aspart (B28 Asp) 100 U/mL. NovoRapid is a solution for injection. NovoMix Leggi il documento completo