NOVONORM 1 MG

Israel - English - Ministry of Health

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Active ingredient:
REPAGLINIDE 1 MG
Available from:
NOVO NORDISK LTD
ATC code:
A10BX02
Pharmaceutical form:
TABLETS
Administration route:
PER OS
Manufactured by:
NOVO NORDISK A/S, DENMARK
Therapeutic group:
REPAGLINIDE
Therapeutic indications:
Treatment of type II diabetes .
Authorization number:
114482966200
Authorization date:
2009-05-01

Documents in other languages

Patient Information leaflet Patient Information leaflet - Arabic

17-01-2021

Patient Information leaflet Patient Information leaflet - Hebrew

17-01-2021

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 רדגב םניאש םייוניש )ןולעב(

.טסקטה םוקימב םייוניש אלו יתוהמ ןכות קר ןמסל שי .הנוש עבצב

ךיראתב ינורטקלא ראודב רבעוה

13/07/2016

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