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קומפטקט 15 מ"ג / 850 מ"ג COMPETACT 15 MG / 850 MG (METFORMIN HYDROCHLORIDE, PIOGLITAZONE AS HYDROCHLORIDE)
תרופה במרשם
תרופה בסל
נרקוטיקה
ציטוטוקסיקה
צורת מתן:
פומי : PER OS
צורת מינון:
טבליות מצופות פילם : FILM COATED TABLETS
עלון לרופא
מינוניםPosology התוויות
Indications תופעות לוואי
Adverse reactions התוויות נגד
Contraindications אינטראקציות
Interactions מינון יתר
Overdose הריון/הנקה
Pregnancy & Lactation אוכלוסיות מיוחדות
Special populations תכונות פרמקולוגיות
Pharmacological properties מידע רוקחי
Pharmaceutical particulars אזהרת שימוש
Special Warning עלון לרופא
Physicians Leaflet
Pregnancy & Lactation : הריון/הנקה
4.6 Fertility, pregnancy and lactation For Competact no preclinical or clinical data on exposed pregnancies or lactation are available. Women of childbearing potential / Contraception in males and females Competact is not recommended in women of childbearing potential not using contraception. If a patient wishes to become pregnant, treatment with Competact should be discontinued. Pregnancy Risk related to pioglitazone There are no adequate human data from the use of pioglitazone in pregnant women. Animal studies have not shown teratogenic effects but have shown foetotoxicity related to the pharmacologic action (see section 5.3). Risk related to metformin Animal studies have not revealed teratogenic effects. Small clinical trials have not revealed metformin to have malformative effects. Competact should not be used during pregnancy. If a pregnancy occurs, treatment with Competact should be discontinued. Breast-feeding Both pioglitazone and metformin have been shown to be present in the milk of lactating rats. It is not known whether breast-feeding will lead to exposure of the infant to the medicinal product. Competact must therefore not be used in women who are breast-feeding (see section 4.3). Fertility In animal fertility studies with pioglitazone, there was no effect on copulation, impregnation or fertility index. Fertility of male or female rats was unaffected by metformin when administered at doses as high as 600 mg/kg/day, which is approximately three times the maximum recommended human daily dose based on body surface area comparisons.
שימוש לפי פנקס קופ''ח כללית 1994
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תאריך הכללה מקורי בסל
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הגבלות
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מידע נוסף
