Quest for the right Drug
דרונאביר טבע 600 מ"ג DARUNAVIR TEVA 600 MG (DARUNAVIR)
תרופה במרשם
תרופה בסל
נרקוטיקה
ציטוטוקסיקה
צורת מתן:
פומי : PER OS
צורת מינון:
טבליות מצופות פילם : FILM COATED 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
Contraindications : התוויות נגד
4.3 Contraindications Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Patients with severe (Child-Pugh Class C) hepatic impairment. Concomitant treatment with any of the following medicinal products given the expected decrease in plasma concentrations of darunavir, ritonavir and the potential for loss of therapeutic effect (see sections 4.4 and 4.5). - Applicable to darunavir boosted with ritonavir the combination product lopinavir/ritonavir (see section 4.5). - The strong CYP3A inducers rifampicin and herbal preparations containing St John’s wort (Hypericum perforatum). Co-administration is expected to reduce plasma concentrations of darunavir ritonavir, which could lead to loss of therapeutic effect and possible development of resistance (see sections 4.4 and 4.5). Darunavir boosted with ritonavir inhibits the elimination of active substances that are highly dependent on CYP3A for clearance, which results in increased exposure to the co-administered medicinal product. Therefore, concomitant treatment with such medicinal products for which elevated plasma concentrations are associated with serious and/or life-threatening events is contraindicated (applies to darunavir boosted with ritonavir). These active substances include e.g.: - alfuzosin - amiodarone, bepridil, dronedarone, ivabradine, quinidine, ranolazine, - astemizole, terfenadine - colchicine when used in patients with renal and/or hepatic impairment (see section 4.5) - ergot derivatives (e.g. dihydroergotamine, ergometrine, ergotamine, methylergonovine) - elbasvir/grazoprevir - cisapride - dapoxetine - domperidone - naloxegol - lurasidone, pimozide, quetiapine, sertindole (see section 4.5) - triazolam, midazolam administered orally (for caution on parenterally administered midazolam, see section 4.5) - sildenafil - when used for the treatment of pulmonary arterial hypertension, avanafil - simvastatin, lovastatin and lomitapide (see section 4.5) - dabigatan, ticagrelor (see section 4.5).
שימוש לפי פנקס קופ''ח כללית 1994
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תאריך הכללה מקורי בסל
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הגבלות
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רישום
165 06 35798 00
מחיר
0 ₪
מידע נוסף