Quest for the right Drug
דסקובי 10 מ"ג/מ"ג 200 DESCOVY 200 MG/10 MG (EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE)
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
Posology : מינונים
4.2 Posology and method of administration Therapy should be initiated by a physician experienced in the management of HIV infection. Posology Descovy should be administered as shown in Table 1. Table 1: Dose of Descovy according to third agent in the HIV treatment regimen Dose of Descovy Third agent in HIV treatment regimen (see section 4.5) Descovy 200/10 mg once Atazanavir with ritonavir or cobicistat daily Darunavir with ritonavir or cobicistat1 Lopinavir with ritonavir Descovy 200/25 mg once Dolutegravir, efavirenz, maraviroc, daily nevirapine, rilpivirine, raltegravir 1 Descovy 200/10 mg in combination with darunavir 800 mg and cobicistat 150 mg, administered as a fixed-dose combination tablet, was studied in treatment-naive subjects, see section 5.1. Missed doses If the patient misses a dose of Descovy within 18 hours of the time it is usually taken, the patient should take Descovy as soon as possible and resume the normal dosing schedule. If a patient misses a dose of Descovy by more than 18 hours, the patient should not take the missed dose and simply resume the usual dosing schedule. If the patient vomits within 1 hour of taking Descovy another tablet should be taken. Elderly No dose adjustment of Descovy is required in elderly patients (see sections 5.1 and 5.2). Renal impairment No dose adjustment of Descovy is required in adults or adolescents (aged at least 12 years and of at least 35 kg body weight) with estimated creatinine clearance (CrCl) ≥ 30 mL/min. Descovy should be discontinued in patients with estimated CrCl that declines below 30 mL/min during treatment (see section 5.2). No dose adjustment of Descovy is required in adults with end stage renal disease (estimated CrCl < 15 mL/min) on chronic haemodialysis; however, Descovy should generally be avoided but may be used in these patients if the potential benefits are considered to outweigh the potential risks (see sections 4.4 and 5.2). On days of haemodialysis, Descovy should be administered after completion of haemodialysis treatment. Descovy should be avoided in patients with estimated CrCl ≥ 15 mL/min and < 30 mL/min, or < 15 mL/min who are not on chronic haemodialysis, as the safety of Descovy has not been established in these populations. No data are available to make dose recommendations in children less than 18 years with end stage renal disease. Hepatic impairment No dose adjustment of Descovy is required in patients with hepatic impairment. Paediatric population The safety and efficacy of Descovy in children younger than 12 years of age, or weighing < 35 kg, have not yet been established. No data are available. Method of administration Oral use. Descovy should be taken once daily with or without food (see section 5.2). It is recommended that the film-coated tablet is not be chewed or crushed due to the bitter taste and it may impact the absorption of Descovy. For patients who are unable to swallow the tablet whole, the tablet may be split in half and both halves taken one after the other, ensuring that the full dose is taken immediately.
שימוש לפי פנקס קופ''ח כללית 1994
לא צוין
תאריך הכללה מקורי בסל
לא צוין
הגבלות
לא צוין
מידע נוסף
עלון מידע לצרכן
25.11.18 - עלון לצרכן 07.08.22 - עלון לצרכן אנגלית 07.08.22 - עלון לצרכן עברית 07.08.22 - עלון לצרכן ערבית 04.01.23 - עלון לצרכן אנגלית 04.01.23 - עלון לצרכן עברית 08.05.23 - עלון לצרכן אנגלית 16.05.23 - עלון לצרכן אנגלית 08.05.23 - עלון לצרכן עברית 16.05.23 - עלון לצרכן עברית 16.05.23 - עלון לצרכן ערבית 16.05.24 - עלון לצרכן אנגלית 16.05.24 - עלון לצרכן עברית 16.05.24 - עלון לצרכן ערבית 20.11.18 - החמרה לעלון 19.03.19 - החמרה לעלון 07.10.20 - החמרה לעלון 08.03.22 - החמרה לעלון 13.04.22 - החמרה לעלון 04.01.23 - החמרה לעלון 16.05.24 - החמרה לעלוןלתרופה במאגר משרד הבריאות
דסקובי 10 מ"ג/מ"ג 200
