Quest for the right Drug
ארקסיס 100 מ"ג ERAXIS 100 MG (ANIDULAFUNGIN)
תרופה במרשם
תרופה בסל
נרקוטיקה
ציטוטוקסיקה
צורת מתן:
תוך-ורידי : I.V
צורת מינון:
אבקה להכנת תמיסה מרוכזת לעירוי : POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
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
Adverse reactions : תופעות לוואי
4.8 Undesirable effects Summary of the safety profile Infusion-related adverse reactions have been reported with anidulafungin in clinical studies, including rash, pruritus, dyspnoea, bronchospasm, hypotension (common events), flushing, hot flush, and urticaria (uncommon events), summarized in Table 1 (see section 4.4). Tabulated list of adverse reactions The following table includes, the all-causality adverse reactions (MedDRA terms) from 840 subjects receiving 100 mg anidulafungin with frequency corresponding to very common (≥1/10), common (1/100 to <1/10), uncommon (1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and from spontaneous reports with frequency not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Table 1. Table of Adverse Reactions System Organ Very Common Uncommon Rare Very Not Known Class Common ≥ 1/100 ≥ 1/1000 ≥ Rare ≥ 1/10 to to 1/10,000 < < 1/10 <1/100 to 1/10,000 <1/1,000 Blood and Coagulopathy Lymphatic System Disorders Table 1. Table of Adverse Reactions System Organ Very Common Uncommon Rare Very Not Known Class Common ≥ 1/100 ≥ 1/1000 ≥ Rare ≥ 1/10 to to 1/10,000 < < 1/10 <1/100 to 1/10,000 <1/1,000 Immune System Anaphylacti Disorders c shock, anaphylactic reaction* Metabolism and Hypokalaemia Hyperglycaemia Nutrition Disorders Nervous System Convulsion, Disorders headache Vascular Disorders Hypotension, Flushing, hypertension hot flush Respiratory, Bronchospasm, Thoracic and Dyspnoea Mediastinal Disorders Gastrointestinal Diarrhoea, Vomiting Abdominal Disorders nausea pain upper Hepatobiliary Alanine Gamma- Disorders aminotransferase glutamyltrans increased, ferase blood alkaline increased phosphatase increased, aspartate aminotransferase increased, blood bilirubin increased, cholestasis Skin and Rash, Urticaria Subcutaneous pruritus Tissue Disorders Renal and Urinary Blood creatinine Disorders increased General Disorders Infusion site and Administration pain Site Conditions * See section 4.4. Paediatric population The safety of anidulafungin was investigated in 68 paediatric patients (1 month to < 18 years) with ICC in a prospective, open-label, non-comparative paediatric study (see section 5.1). The frequencies of certain hepatobiliary adverse events, including alanine aminotransferase (ALT) increased and aspartate aminotransferase (AST) increased appeared at a higher frequency (7-10%) in these paediatric patients than has been observed in adults (2%). Although chance or differences in underlying disease severity may have contributed, it cannot be excluded that hepatobiliary adverse reactions occur more frequently in paediatric patients compared to adults. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il
פרטי מסגרת הכללה בסל
התרופה תינתן לטיפול בזיהומי קנדידה חודרניים העמידים לטיפול ב-FLUCONAZOLE
מסגרת הכללה בסל
התוויות הכלולות במסגרת הסל
התוויה | תאריך הכללה | תחום קליני | Class Effect | מצב מחלה |
---|---|---|---|---|
התרופה תינתן לטיפול בזיהומי קנדידה חודרניים העמידים לטיפול ב-FLUCONAZOLE | ANIDULAFUNGIN, CASPOFUNGIN, MICAFUNGIN |
שימוש לפי פנקס קופ''ח כללית 1994
לא צוין
תאריך הכללה מקורי בסל
03/01/2010
הגבלות
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