Land: Israel
Sprog: engelsk
Kilde: Ministry of Health
INSULIN ASPART
NOVO NORDISK LTD., ISRAEL
A10AB05
SUSPENSION FOR INJECTION
INSULIN ASPART 100 U/ML
S.C
Required
NOVO NORDISK A/S, DENMARK
INSULIN ASPART
NovoMix 70 is indicated for treatment of diabetes mellitus in adults.
2013-05-31
לע העדוה לע העדוה לע העדוה ( הרמחה ( הרמחה ( הרמחה עדימ עדימ עדימ ל ןולעב )תוחיטב ל ןולעב )תוחיטב ל ןולעב )תוחיטב אפור אפור אפור ןכדועמ( ןכדועמ( ןכדועמ( .102.50 .102.50 .102.50 ) ) ) ךיראת : 7 102/ 20 1 9 / תילגנאב רישכת םש םושירה רפסמו : 00 - 31774 - 76 - 138 – 0 FLEXPEN 7 NOVOMIX םושירה לעב םש : מ"עב קסידרונ ובונ ה טורפל דעוימ הז ספוט דבלב תורמחה ! תושקובמה תורמחהה ןולעב קרפ קט טס יחכונ שדח טסקט INDICATION CONTRAINDICATIONS POSOLOGY, DOSAGE & ADMINISTRATION SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE N/A AVOIDANCE OF ACCIDENTAL MIX-UPS/MEDICATION ERRORS Patients must be instructed to always check the insulin label before each injection to avoid accidental mix-ups between NovoMix and other insulin products. INTERACTION WITH OTHER MEDICAMENTS AND OTHER FORMS OF INTERACTION FERTILITY, PREGNANCY AND LACTATION ADVERSE EVENTS ב"צמ נמוסמ ובש ,ןולעה תו ורמחהה ת שקובמה תו בוהצ עקר לע . ונמוס תורמחה רדגב םניאש םייוניש )ןולעב( םייוניש אלו יתוהמ ןכות קר ןמסל שי .הנוש עבצב .טסקטה םוקימב Læs hele dokumentet
NovoMix 70 FP IL SPC DEC-2020 1 1. NAME OF THE MEDICINAL PRODUCT NovoMix® 70 FlexPen® 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of the suspension contains 100 units soluble insulin aspart*/protamine-crystallised insulin aspart* in the ratio 70/30 (equivalent to 3.5 mg). 1 pre-filled pen contains 3 ml equivalent to 300 units. *Insulin aspart is produced in _Saccharomyces cerevisiae_ by recombinant DNA technology. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension for injection. The suspension is cloudy, white and aqueous. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS NovoMix 70 is indicated for treatment of diabetes mellitus in adults. 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. NovoMix 70 dosing is individual and determined in accordance with the needs of the patient. Blood glucose monitoring and insulin dose adjustments are recommended to achieve optimal glycaemic control. The individual insulin requirement is usually between 0.5 and 1.0 unit/kg/day. NovoMix 70 may fully or partially meet this requirement. In patients with type 2 diabetes, NovoMix 70 can be given as monotherapy or in combination with metformin when the blood glucose is inadequately controlled with metformin alone. Adjustment of dose may be necessary if patients undertake increased physical activity, change their usual diet or during concomitant illness. SPECIAL POPULATIONS NovoMix 70 FP IL SPC DEC-2020 2 In elderly patients (≥65 years old) and in patients with hepatic or renal impairment, glucose monitoring should be intensified and the insulin aspart dose adjusted on an individual basis. Renal or hepatic impairment may reduce the patient’s insulin requirements. _Paediatric population_ The safety and efficacy of NovoMix 70 in children below 18 years of age have not been established. No data are available. TRANSFER FROM OTHER INSULIN Læs hele dokumentet