Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Insulin aspart 100 U/mL (3.5 mg/mL)
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
100 U/mL
Solution for injection
Active: Insulin aspart 100 U/mL (3.5 mg/mL) Excipient: Hydrochloric acid Metacresol Phenol Polysorbate 20 Sodium chloride Sodium hydroxide Water for injection Zinc chloride
Prescription
Treatment of diabetes mellitus
Package - Contents - Shelf Life: Cartridge, fitted into pen device - 1 dose units - 30 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 28 days not refrigerated stored at or below 30°C protect from light. no return to refrigeration, do not freeze - Cartridge, fitted into pen device - 5 dose units - 30 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 28 days not refrigerated stored at or below 30°C protect from light. no return to refrigeration, do not freeze - Cartridge, fitted into pen device - 10 dose units - 30 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 28 days not refrigerated stored at or below 30°C protect from light. no return to refrigeration, do not freeze
2020-11-20
Truvelog SoloStar® 1 TRUVELOG SOLOSTAR® 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 or pharmacist. 1. WHY AM I USING TRUVELOG SOLOSTAR® Truvelog SoloStar®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 Truvelog SoloStar®? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE TRUVELOG SOLOSTAR® 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 BREASTFEEDING. For more information, see Section 2. What should I know while using Truvelog? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Truvelog SoloStar®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 TRUVELOG SOLOSTAR®? • 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 Truvelog SoloStar® and in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING TRUVELOG SOLOSTAR®? 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 te Read the complete document
Property of the Sanofi group - strictly confidential truvelog-ccdsv4-dsv1-15dec22 Page 1 of 21 NEW ZEALAND DATA SHEET 1 PRODUCT NAME Truvelog (insulin aspart) 100 units/mL solution for injection in a 3 mL cartridge Truvelog SoloStar® (insulin aspart) 100 units/ mL solution for injection in a 3 mL pre-filled pen. Truvelog (insulin aspart) 100 units/mL solution for injection in a 10 mL vial Truvelog is a biosimilar medicine to NovoRapid®, NovoRapid® Penfill ® and NovoRapid ® FlexPen ® . The comparability of Truvelog with NovoRapid ® has been demonstrated with regard to physicochemical characteristics and pharmacology, efficacy and safety outcomes. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One mL of the solution contains 100 units (equivalent to 3.5 mg) insulin aspart. Truvelog (insulin aspart) 100 units/mL solution for injection in a 3 mL cartridge – equivalent to 300 units. Truvelog SoloStar® (insulin aspart) 100 units/ mL solution for injection in a 3 mL pre-filled pen – equivalent to 300 units. Truvelog (insulin aspart) 100 units/mL solution for injection in a 10 mL vial – equivalent to 1000 units. For further information regarding the biosimilarity of Truvelog to Novorapid, see Section 5.1. The prescribing physician should be involved in any decision regarding interchangeability. For further information see: www.medsafe.govt.nz/profs/RIss/Biosimilars.asp _ _ For the full list of excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. Truvelog is a clear, colourless aqueous solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of diabetes mellitus. Property of the Sanofi group - strictly confidential truvelog-ccdsv4-dsv1-15dec22 Page 2 of 21 4.2 DOSE AND METHOD OF ADMINISTRATION DOSAGE Truvelog has a faster onset and a shorter duration of action than soluble human insulin. Due to the faster onset of action, Truvelog 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 Read the complete document