Country: Իսրայել
language: անգլերեն
source: Ministry of Health
INSULIN ASPART
NOVO NORDISK LTD., ISRAEL
A10AB05
SOLUTION FOR INJECTION
INSULIN ASPART 100 U/ML
S.C
Required
NOVO NORDISK A/S, DENMARK
INSULIN ASPART
Treatment of patients with diabetes mellitus in adults, adolescents and children aged 2 years and above.
2020-06-30
NovoRapid FLEX IL PIL FEB-2021 Notification Page 1 of 15 Patient leaflet in accordance with the Pharmacists' Regulations (Preparations) - 1986 The dispensing of this medicine requires a doctor’s prescription NovoRapid ® FlexPen ® 100 units/ml Solution for injection in pre-filled pen Active substance: Insulin aspart 100 units/ml Inactive substances and allergens in this medicine: see section 2 “Important information about some of this medicine's ingredients” and section 6 "Additional information". Read all of this leaflet carefully before you start using this medicine. This leaflet contains concise information about this medicine. If you have any further questions, consult your doctor or pharmacist. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if it seems to that their medical condition is similar to yours. This medicine is intended for adults, adolescents, and children over two years old. 1. What is this medicine intended for? NovoRapid is used to reduce high blood sugar level in adults, adolescents and children aged 2 years and above with diabetes. Therapeutic group: Medicines for the treatment of diabetes. Fast-acting insulins and insulin analogs for injection. NovoRapid is a modern insulin (insulin analog) with a rapid-acting effect. Modern insulin products are improved versions of human insulin. Diabetes is a disease where your body does not produce enough insulin to control the level of your blood sugar. Treatment with NovoRapid helps to prevent complications from your diabetes. NovoRapid will start to lower your blood sugar 10–20 minutes after you inject it, a maximum effect occurs between 1 and 3 hours after the injection and the effect lasts for 3–5 hours. Due to this short action NovoRapid should normally be taken in combination with intermediate-acting or long-acting insulin preparations. NovoRapid FLEX IL PIL FEB-2021 Notification Page 2 of 15 2. Before using this medicine Do not use this medicine if: You are sensitive ( read_full_document
NovoRapid IL SPC FEB-2021-NOTIFICATION EMA SmpC Page 1 of 13 1. NAME OF THE MEDICINAL PRODUCT NovoRapid® 100 units/ml solution for injection in vial NovoRapid® Penfill® 100 units/ml solution for injection in cartridge NovoRapid® FlexPen® 100 units/ml solution for injection in pre-filled pen 2. QUALITATIVE AND QUANTITATIVE COMPOSITION NovoRapid vial 1 vial contains 10 ml equivalent to 1,000 units. 1 ml solution contains 100 units insulin aspart* (equivalent to 3.5 mg). NovoRapid Penfill 1 cartridge contains 3 ml equivalent to 300 units. 1 ml solution contains 100 units insulin aspart* (equivalent to 3.5 mg). NovoRapid FlexPen 1 pre-filled pen contains 3 ml equivalent to 300 units. 1 ml solution contains 100 units insulin aspart* (equivalent to 3.5 mg). *Insulin aspart is produced in _Saccharomyces cerevisiae _ by recombinant DNA technology. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. The solution is clear, colourless and aqueous. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of patients with diabetes mellitus in adults, adolescents and children aged 2 years and above. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY The potency of insulin analogues, including insulin aspart, is expressed in units, whereas the potency of human insulin is expressed in international units. NovoRapid dosing is individual and determined in accordance with the needs of the patient. It should normally be used in combination with intermediate-acting or long-acting insulin. Moreover NovoRapid vial can be used for continuous subcutaneous insulin infusion (CSII) in pump systems. NovoRapid vial can also be used if intravenous administration of insulin aspart, by physicians or other healthcare staff, is applicable. NovoRapid IL SPC FEB-2021-NOTIFICATION EMA SmpC Page 2 of 13 Blood glucose monitoring and insulin dose adjustments are recommended to achieve optimal glycaemic control. The individual insulin requirement in adults and children is usually between 0.5 and 1.0 read_full_document