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אגיסטן וי 0.5 גרם טבליה ואגינלית AGISTEN V 0.5 G. VAGINAL TABLET (CLOTRIMAZOLE)
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תרופה בסל
נרקוטיקה
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צורת מתן:
וגינלי : VAGINAL
צורת מינון:
טבליות וגינליות : VAGINAL TABLETS
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
Pharmacological properties : תכונות פרמקולוגיות
Pharmacodynamic Properties
5.1 Pharmacodynamic properties Pharmacotherapeutic group: Gynaecological antiinfectives and antiseptics – imidazole derivatives ATC Code: G01A F02 Mechanism of Action Azoles (e.g. clotrimazole) are usually recommended for the local treatment of vulvovaginal candidosis that is characterized by vulvovaginal symptoms such as itching, burning, discharge, redness, swelling and soreness. Clotrimazole acts against fungi by inhibiting ergosterol synthesis. Inhibition of ergosterol synthesis leads to structural and functional impairment of the fungal cytoplastic membrane. Clotrimazole has a broad antimycotic spectrum of action in vitro and in vivo, which includes dermatophytes, yeasts, moulds, etc. Under appropriate test conditions, the MIC values for these types of fungi are in the region of less than 0.062-8.0 µg/ml substrate. The mode of action of clotrimazole is fungistatic or fungicidal depending on the concentration of clotrimazole at the site of infection. In-vitro activity is limited to proliferating fungal elements; fungal spores are only slightly sensitive. Primarily resistant variants of sensitive fungal species are very rare: the development of secondary resistance by sensitive fungi has so far only been observed in very isolated cases under therapeutic conditions.
Pharmacokinetic Properties
5.2 Pharmacokinetic properties Pharmacokinetic investigations after vaginal application have shown that only a small amount of Clotrimazole (3-10% of the dose) is absorbed. Due to the rapid hepatic metabolisation of absorbed clotrimazole into pharmacologically inactive metabolites the resulting peak plasma concentrations of clotrimazole after vaginal application of a 500mg dose were less than 10 ng/ml., reflecting that clotrimazole applied intravaginally does not lead to measurable systemic effects or side effects.
שימוש לפי פנקס קופ''ח כללית 1994
Vulvovaginal candidiasis & superinfection due to gram positive bacteria
תאריך הכללה מקורי בסל
01/01/1995
הגבלות
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031 74 25210 00
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