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עמוד הבית / סינטרדיוס / מידע מעלון לרופא

סינטרדיוס SINTREDIUS (PREDNISOLONE AS SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE)

תרופה במרשם תרופה בסל נרקוטיקה ציטוטוקסיקה

צורת מתן:

פומי : ORAL

צורת מינון:

תמיסה : SOLUTION

Pregnancy & Lactation : הריון/הנקה

4.6   Fertility, pregnancy and lactation
Pregnancy

The ability of glucocorticoids to cross placenta varies between individual drugs, however, 88% of prednisolone is inactivated as it crosses the placenta.
Animal studies indicate that administration of pharmacological doses of glucocorticoids during pregnancy may increase the fetus risk of intrauterine growth retardation, adult cardiovascular and/or metabolic disease and may have an effect on the glucocorticoid receptor density, and neurotransmitter turnover or neurobehavioural development.
Glucocorticoids caused cleft palate formation in animal experiments. There is an ongoing discussion on the possibility of an increased risk of oral cleft formation in the human fetus as a result of the administration of glucocorticoids during the first trimester.
If glucocorticoids are administered towards the end of pregnancy, there is a risk of atrophy of the fetal adrenal cortex, which may necessitate replacement therapy in the newborn, which has to be slowly reduced.
During pregnancy, Sintredius oral solution should only be prescribed when the benefits to the mother and child outweigh the risks. The lowest effective dose of Sintredius oral solution needed to maintain adequate disease control should be used.
Patients with pre-eclampsia or fluid retention require close monitoring.
Breastfeeding
Glucocorticoids are excreted in small amounts in breast milk (up to 0.23% of an individual dose). However doses of up to 40mg daily of prednisolone are unlikely to cause systemic effects in the infant. Infants of mothers taking higher doses than this may have a degree of adrenal suppression but the benefits of breast feeding are likely to outweigh any theoretical risk.
The milk/plasma concentration ratio increases with increasing doses (e.g. 25 % of the serum concentration are found in the breast milk with 80 mg prednisolone daily).
Therefore, when high doses of prednisolone are given, it is recommended to avoid breastfeeding for 4 h after a dose.
Fertility
After high prednisolone doses (30 mg/day for at least 4 weeks) reversible disturbances of spermatogenesis has been observed, which lasted for several months after stop taking the medicine.

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בעל רישום

KAMADA LTD, ISRAEL

רישום

168 82 35801 00

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0 ₪

מידע נוסף

עלון מידע לרופא

08.05.22 - עלון לרופא

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08.05.22 - עלון לצרכן עברית 01.03.23 - עלון לצרכן אנגלית 01.03.23 - עלון לצרכן עברית 01.03.23 - עלון לצרכן ערבית

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