البلد: نيوزيلاندا
اللغة: الإنجليزية
المصدر: Medsafe (Medicines Safety Authority)
Insulin aspart 100 IU/mL;
Novo Nordisk Pharmaceuticals Ltd
Insulin aspart 100 IU/mL
100 IU/mL
Suspension for injection
Active: Insulin aspart 100 IU/mL Excipient: Dibasic sodium phosphate dihydrate Glycerol Hydrochloric acid Metacresol Phenol Protamine sulfate Sodium chloride Sodium hydroxide Water for injection Zinc as chloride
Syringe, glass, 3mL, 5 dose units
Prescription
Prescription
Novo Nordisk A/S
The treatment of diabetes mellitus
Package - Contents - Shelf Life: Syringe, glass, 3mL - 5 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 4 weeks not refrigerated stored at or below 25°C
2002-04-03
NovoMix® 30 FlexPen® v15 1 NOVOMIX® 30 FLEXPEN® 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 NOVOMIX® 30 FLEXPEN®? NovoMix® 30 FlexPen® contains the active ingredient insulin aspart in a rapid and longer acting form. NovoMix® 30 FlexPen® is used to treat diabetes mellitus in adults and children. For more information, see Section 1. Why am I using NovoMix® 30 FlexPen®? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE NOVOMIX® 30 FLEXPEN®? 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 NovoMix® 30 FlexPen®? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with NovoMix® 30 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 NOVOMIX® 30 FLEXPEN®? • 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. More instructions can be found in Section 4. How do I use NovoMix® 30? and 8. Instructions for use in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING NOVOMIX® 30 FLEXPEN®? 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 اقرأ الوثيقة كاملة
1 of 15 NEW ZEALAND DATASHEET 1 PRODUCT NAME NovoRapid ® 10ml Vial NovoRapid ® Penfill ® 3ml NovoRapid ® FlexPen ® 3ml 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Insulin Aspart 100 Units/ml Recombinant DNA origin: _Saccharomyces cerevisiae_ 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. 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. 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. 4 CLINICAL PARTICULARS 4.1 Therapeutic indications Treatment of diabetes mellitus. 4.2 Dose and method of administration NovoRapid has a faster onset and a shorter duration of action than soluble human insulin. Due to the faster onset of action, NovoRapid should generally be given immediately before a meal or when necessary, soon after the start of a meal. The dosage of insulin aspart is determined by the physician according to the patient’s individual needs. The individual insulin requirement is usually between 0.5 and 1.0 Units/kg/day in adults and children. In a meal-related treatment 50-70% of this requirement may be provided by NovoRapid and the remainder provided by an intermediate-acting or long-acting insulin given at least once a day. The daily insulin requirement may be higher in patients with insulin resistance (e.g. due to obesity), and low اقرأ الوثيقة كاملة