Maa: Israel
Kieli: englanti
Lähde: Ministry of Health
REPAGLINIDE
NOVO NORDISK LTD., ISRAEL
A10BX02
TABLETS
REPAGLINIDE 2 MG
PER OS
Required
NOVO NORDISK A/S, DENMARK
REPAGLINIDE
REPAGLINIDE
Repaglinide is indicated in adults with type 2 diabetes mellitus whose hyperglycaemia can no longer be controlled satisfactorily by diet, weight reduction and exercise. Repaglinide is also indicated in combination with metformin in adults with type 2 diabetes mellitus who are not satisfactorily controlled on metformin alone.Treatment should be initiated as an adjunct to diet and exercise to lower the blood glucose in relation to meals.
2019-06-30
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 ) ) ) רשוא – 61 . 8 ךיראת : 13/07/2016 םושירה רפסמו תילגנאב רישכת םש : NOVONORM 0.5 MG – 114 47 29661 NOVONORM 1 MG -- 114 48 29662 NOVONORM 2 MG -- 114 49 29663 םושירה לעב םש : מ"עב קסידרונ ובונ ימ הז ספוט ! דבלב תורמחהה טורפל דעו תושקובמה תורמחהה ןולעב קרפ יחכונ טסקט שדח טסקט INDICATION CONTRAINDICATIONS POSOLOGY, DOSAGE & ADMINISTRATION SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE INTERACTION WITH OTHER MEDICAMENTS AND OTHER FORMS OF INTERACTION In an interaction study with healthy volunteers, co-administration of _clopidogrel_ (300 mg loading dose), a CYP2C8 inhibitor, increased repaglinide exposure (AUC0–∞) 5.1-fold and continued administration (75 mg daily dose) increased repaglinide exposure (AUC0–∞) 3.9-fold. A small, significant decrease in blood glucose values was observed. In an interaction study with healthy volunteers, co- administration of _clopidogrel_ (300 mg loading dose), a CYP2C8 inhibitor, increased repaglinide exposure (AUC0–∞) 5.1-fold and continued administration (75 mg daily dose) increased repaglinide exposure (AUC0–∞) 3.9-fold. A small, significant decrease in blood glucose values was observed. Since the safety profile of the co- treatment has not been established in these patients, the concomitant use of clopidogrel and repaglinide should be avoided. If concomitant use is necessary, careful monitoring of blood glucose and close clinical monitoring should be performed (see section 4.4). FERTILITY, PREGNANCY AND LACTATION ADVERSE EVENTS ב"צמ נמוסמ ובש ,ןולעה תו תורמחהה שקובמה תו בוהצ עקר לע . ונמוס תורמחה Lue koko asiakirja
1 1. NAME OF THE MEDICINAL PRODUCT NovoNorm ® 0.5 mg tablets NovoNorm ® 1 mg tablets NovoNorm ® 2 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: 0.5 mg of repaglinide 1 mg of repaglinide 2 mg of repaglinide For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet Repaglinide tablets are white (0.5 mg), yellow (1 mg) or peach-coloured (2 mg), round and convex and engraved with Novo Nordisk logo (Apis bull). 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Repaglinide is indicated in adults with type 2 diabetes mellitus whose hyperglycaemia can no longer be controlled satisfactorily by diet, weight reduction and exercise. Repaglinide is also indicated in combination with metformin in adults with type 2 diabetes mellitus who are not satisfactorily controlled on metformin alone. Treatment should be initiated as an adjunct to diet and exercise to lower the blood glucose in relation to meals. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Repaglinide is given preprandially and is titrated individually to optimise glycaemic control. In addition to the usual self-monitoring by the patient of blood and/or urinary glucose, the patient’s blood glucose must be monitored periodically by the physician to determine the minimum effective dose for the patient. Glycosylated haemoglobin levels are also of value in monitoring the patient’s response to therapy. Periodic monitoring is necessary to detect inadequate lowering of blood glucose at the recommended maximum dose level (i.e. primary failure) and to detect loss of adequate blood glucose- lowering response after an initial period of effectiveness (i.e. secondary failure). Short-term administration of repaglinide may be sufficient during periods of transient loss of control in type 2 diabetic patients usually controlled well on diet. Initial dose The dosage should be determined by the physician, according to the patient’s requirements. The recommended starting dose is 0.5 mg. One to two weeks should elapse betw Lue koko asiakirja