Quest for the right Drug
וקלורי 100 מ"ג אבקה להכנת תמיסה מרוכזת להזלפה VEKLURY 100 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION (REMDESIVIR)
תרופה במרשם
תרופה בסל
נרקוטיקה
ציטוטוקסיקה
צורת מתן:
תוך-ורידי : I.V
צורת מינון:
אבקה להכנת תמיסה מרוכזת לעירוי : POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
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 There is a limited amount of data from the use of remdesivir in pregnant women. (less than 300 pregnancy outcomes). Most of the exposures occurred in the second, third or an unknown trimester and available data do not indicate any risk. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity at exposures of the major metabolite of remdesivir that were around human therapeutic exposures (see section 5.3). Due to very limited experience, remdesivir should not be used during first trimester in pregnancy unless the clinical condition of the woman requires treatment with it. Use in the second and third trimester of pregnancy may be considered. Use of effective contraception during treatment should be considered in women of child-bearing potential. Breast-feeding Remdesivir and its major metabolite are excreted into breast milk in very small amounts after intravenous administration. No clinical effect on the infant, is expected due to low breast milk transfer and poor oral bioavailability. As the clinical experience is limited, a decision about breast-feeding during treatment should be made after a careful individual benefit-risk assessment. Fertility No human data on the effect of remdesivir on fertility are available. In male rats, there was no effect on mating or fertility with remdesivir treatment. In female rats, however, an impairment of fertility was observed (see section 5.3). The relevance for humans is unknown.
שימוש לפי פנקס קופ''ח כללית 1994
לא צוין
תאריך הכללה מקורי בסל
לא צוין
הגבלות
לא צוין
ATC
מידע נוסף
