Riik: Iisrael
keel: inglise
Allikas: Ministry of Health
INSULIN ASPART
NOVO NORDISK LTD, ISRAEL
A10AB05
SUSPENSION FOR INJECTION
INSULIN ASPART 100 IU/ML
S.C
Required
NOVO NORDISK A/S, DENMARK
INSULIN ASPART
INSULIN ASPART
Treatment of diabetes mellitus.
2011-06-30
העדוה העדוה לע לע הרמחה הרמחה ( ( עדימ עדימ ןולעב )תוחיטב ןולעב )תוחיטב ל ל אפור אפור ןכדועמ( ןכדועמ( 05.2013 05.2013 ) ) ךיראת : 07/09/2014 םש רישכת תילגנאב רפסמו םושירה : NOVOMIX 30 FLEXPEN – 127- 24-30599-00 NOVOMIX 30 PENFILL – 122- 67-30240-00 םש לעב םושירה : ובונ קסידרונ מ"עב ספוט הז דעוימ טורפל תורמחהה דבלב ! תורמחהה תושקובמה קרפ ןולעב טסקט יחכונ טסקט שדח INDICATION CONTRAINDICATIONS POSOLOGY, DOSAGE & ADMINISTRATION SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE - Insulin antibodies Insulin administration may cause insulin antibodies to form. In rare cases, the presence of such insulin antibodies may necessitate adjustment of the insulin dose in order to correct a tendency to hyper- or hypoglycaemia. INTERACTION WITH OTHER MEDICAMENTS AND OTHER FORMS OF INTERACTION FERTILITY, PREGNANCY AND LACTATION ADVERSE EVENTS ב"צמ ובש ,ןולעה נמוסמ תו תורמחהה שקובמה תו לע עקר בוהצ . םייוניש םניאש רדגב תורמחה ונמוס )ןולעב( עבצב שי .הנוש ןמסל קר ןכות יתוהמ אלו םייוניש םוקימב .טסקטה רבעוה ראודב ינורטקלא ךיראתב 07/09/2014 Lugege kogu dokumenti
NovoMix 30 FP IL SPC NOV2020 1 1. NAME OF THE MEDICINAL PRODUCT NovoMix® 30 FlexPen® 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of the suspension contains 100 units soluble insulin aspart*/protamine-crystallised insulin aspart* in the ratio 30/70 (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 30 is indicated for treatment of diabetes mellitus in adults, adolescents and children aged 10 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. NovoMix® 30 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. _ _ In patients with type 2 diabetes, NovoMix 30 can be given as monotherapy. NovoMix 30 can also be given in combination with oral antidiabetic medicinal products if the patient's blood glucose is inadequately controlled with oral antidiabetic medicinal products alone. For patients with type 2 diabetes, the recommended starting dose of NovoMix 30 is 6 units at breakfast and 6 units at dinner (evening meal). NovoMix 30 can also be initiated once daily with 12 units at dinner (evening meal). When using NovoMix 30 once daily, it is generally recommended to move to twice daily when reaching 30 units by splitting the dose into equal breakfast and dinner doses. If twice daily dosing with NovoMix® 30 results in recurrent daytime hypoglycaemic episodes, the morning dose can be split into morning and lunchtime doses (thrice daily dosing). NovoMix 30 FP IL SPC NOV2020 2 The following titration Lugege kogu dokumenti