Quest for the right Drug
קטג'ל עם לידוקאין CATHEJELL WITH LIDOCAINE (CHLORHEXIDINE DIHYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE)
תרופה במרשם
תרופה בסל
נרקוטיקה
ציטוטוקסיקה
צורת מתן:
לצינור השופכה : URETHRAL
צורת מינון:
ג'ל : GEL
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 No controlled clinical studies with pregnant women are available. 50-60% of maternal lidocaine plasma concentrations pass through the placenta. In cases of high systemic exposure, foetal depression may occur. In animal studies, adverse reactions in foetuses were shown only following prenatal exposure to high lidocaine doses (see section 5.3). The potential risk for humans is unknown. With regard to chlorhexidine in Cathejell with Lidocaine, there is virtually no risk, as only very small amounts are absorbed into the maternal circulation. During pregnancy, Cathejell with Lidocaine should only be used after careful consideration of the benefits and risks by a doctor and after establishing the individual dose. Repeated use during pregnancy is not recommended. Breast-feeding Only small amounts of lidocaine are excreted in human milk. If Cathejell with Lidocaine is used correctly (see section 4.2), there are virtually no safety concerns for the child during lactation. There are no data on the excretion of chlorhexidine in human milk. Based on the very low systemic absorption of chlorhexidine following intraurethral instillation, the expected amount in human milk is clinically negligible. During lactation, Cathejell with Lidocaine should be used only if the need and the individual dose have been established, There should be an interval of 12 hours between the instillation of Cathejell with Lidocaine and subsequent breast-feeding. Repeated use during lactation cannot be recommended.
שימוש לפי פנקס קופ''ח כללית 1994
לא צוין
תאריך הכללה מקורי בסל
לא צוין
הגבלות
לא צוין
מידע נוסף
