Quest for the right Drug
אדפרין קרם ADAFERIN CREAM (ADAPALENE)
תרופה במרשם
תרופה בסל
נרקוטיקה
ציטוטוקסיקה
צורת מתן:
חיצוני : TOPICAL
צורת מינון:
קרם : CREAM
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 Orally administered retinoids have been associated with congenital abnormalities. When used in accordance with the prescribing information, topically administered retinoids are generally assumed to result in low systemic exposure due to minimal dermal absorption. However, there could be individual factors (e.g. damaged skin barrier, excessive use) that contribute to an increased systemic exposure Pregnancy: Adaferin is contraindicated (see section 4.3) in pregnancy, or in women planning pregnancy. Animal studies by the oral route have shown reproductive toxicity at high systemic exposure (see section 5.3). Clinical experience with locally applied adapalene in pregnancy is limited but the few available data do not indicate harmful effects on pregnancy or on the health of the foetus exposed in early pregnancy. Due to the limited available data and because a very weak cutaneous passage of adapalene is possible, Adaferin should not be used during pregnancy. In case of unexpected pregnancy, treatment should be discontinued. Breast-feeding: No study on animal or human milk transfer was conducted after cutaneous application of Adaferin. No effects on the suckling child are anticipated since the systemic exposure of the breast-feeding woman to Adaferin is negligible. Adaferin can be used during breastfeeding. To avoid contact exposure of the infant, application of Adaferin to the chest should be avoided when used during breast-feeding.
שימוש לפי פנקס קופ''ח כללית 1994
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תאריך הכללה מקורי בסל
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הגבלות
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רישום
136 13 30260 00
מחיר
0 ₪
מידע נוסף
