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ריאלטריס RYALTRIS (MOMETASONE FUROATE (AS MONOHYDRATE), OLOPATADINE AS HYDROCHLORIDE)
תרופה במרשם
תרופה בסל
נרקוטיקה
ציטוטוקסיקה
צורת מתן:
אפי : NASAL
צורת מינון:
אין פרטים : NASAL SPRAY, SUSPENSION
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 Pregnancy Mometasone Furoate: There are no or limited amount of data from the use of mometasone furoate in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). Olopatadine: There are no or limited amount of data from the use of intranasal olopatadine in pregnant women. Studies in animals have shown reproductive toxicity following systemic administration (see section 5.3). Ryaltris should not be used in pregnancy unless the potential benefit to the mother justifies any potential risk to the mother, foetus or infant. Infants born of mothers who received corticosteroids during pregnancy should be observed carefully for hypoadrenalism. Breast-feeding Mometasone Furoate: It is unknown whether mometasone furoate is excreted in human milk Olopatadine: Available data in animals have shown excretion of olopatadine in milk following oral administration (for details see section 5.3). A risk to the newborn/infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Ryaltris therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman. Fertility There are only limited data with regard to fertility. There are no clinical data concerning the effect of mometasone furoate on fertility. Animal studies have shown reproductive toxicity, but no effects on fertility. There are no clinical data concerning the effect of olopatadine on fertility
שימוש לפי פנקס קופ''ח כללית 1994
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תאריך הכללה מקורי בסל
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