Quest for the right Drug
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פוסקביר 24 מ"ג/מ"ל FOSCAVIR 24 MG/ML (FOSCARNET TRISODIUM HEXAHYDRATE)
תרופה במרשם
תרופה בסל
נרקוטיקה
ציטוטוקסיקה
צורת מתן:
תוך-ורידי : I.V
צורת מינון:
תמיסה לאינפוזיה : 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 The majority of patients who receive Foscavir 24mg/ml are severely immuno- compromised and suffering from serious viral infections. Patients’ physical status, the severity of the underlying disease, other infections and concurrent therapies contribute to adverse events observed during use of Foscavir 24mg/ml. The undesirable effects reported with Foscavir 24mg/ml during clinical trials and post- marketing surveillance are shown in the table below. They are listed by System- Organ Class (SOC) and in order of frequency, using the following convention: 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); not known (cannot be estimated from the available data). Please note that in these clinical trials, hydration and attention to electrolyte balance was not consistently given; the frequency of some adverse events will be lower when current recommendations are followed (see sections 4.2 Posology and method of administration and 4.4 Special warnings and precautions for use). Table 2 - Frequency of adverse events SOC Frequency Event Blood and Very Common Granulocytopenia, anaemia lymphatic system disorders Common Leukopenia, Thrombocytopenia, Neutropenia Uncommon Pancytopenia Immune system Common Sepsis disorders Not known Hypersensitivity (including anaphylactic reactions), anaphylactoid reactions Endocrine Unknown Diabetes insipidus disorders Very Common Decreased Appetite, Hypokalaemia, Hypomagnesaemia, Hypocalcaemia Metabolism and Common Hyperphosphataemia, nutrition Hyponatraemia, disorders Hypophosphataemia, Blood alkaline phosphatase increased, Blood lactate dehydrogenase increased, hypercalcaemia, dehydration Uncommon Acidosis Not known Hypernatraemia Common Aggression,Agitation, Anxiety, Confusional state, Psychiatric Depression, Nervousness disorders Very Common Dizziness, Headache, Paraesthesia Common Coordination abnormal, Nervous system Convulsion, Hypoaesthesia, disorders Muscle contractions involuntary, Neuropathy peripheral, Tremor Common Palpitations, tachycardia Cardiac disorders Not Known Electrocardiogram QT prolonged, Ventricular arrhythmia, torsade de pointes Vascular Common Hypertension, disorders Hypotension, Thrombophlebitisa Very Common Diarrhoea, Nausea, Vomiting Common Abdominal pain, Constipation, Dyspepsia, Gastrointestinal Pancreatitis, gastrointestinal disorders haemorrhage Not Known Oesophageal ulceration Common Hepatic function abnormal Hepato-biliary disorders Very Common Rash Skin and subcutaneous Common Pruritus disorders Uncommon Urticaria, angioedema Not known Erythema multiforme, toxic epidermal necrolysis, Stevens Johnson syndromeb Common Myalgia Musculoskeletal Unknown Muscular weakness, Myopathy, disorders and Myositis, Rhabdomyolysis connective tissue disorders Common Renal impairment, Renal failure acute, Dysuria, Renal and Polyuria, proteinuria urinary disorders Uncommon Glomerulonephritis, nephrotic syndrome Not known Renal pain, renal tubular acidosis, crystal nephropathy, haematuria Reproductive Common Genital discomfort and system and ulcerationc breast disorders Very Common Asthenia, Chills, Fatigue, Pyrexia General disorders and Common Malaise, Oedema, chest paind, administration injection site pain, injection site site conditions inflammation Not known Extravasation Very Common Blood creatinine increased, Haemoglobin decreased Common Creatinine renal clearance Investigations decreased, Electrocardiogram abnormal, gamma- glutamyltransferase increased, alanine aminotransferase increased, aspartate aminotransferase increased, lipase increased Uncommon Amylase increased, blood creatine phosphokinase increased. aThrombophlebitis in peripheral veins following infusion of undiluted foscarnet solution has been observed. bCases of vesiculobullous eruptions including erythema multiforme, toxic epidermal necrolysis, and Stevens Johnson syndrome have been reported. In most cases, patients were taking other medications that have been associated with toxic epidermal necrolysis or Stevens Johnson syndrome. c Foscarnet is excreted in high concentrations in the urine and may be associated with significant irritation and ulceration in the genital area, particularly after prolonged therapy. d Transient chest pain has been reported as part of infusion reactions to foscarnet. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorization 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
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פרטי מסגרת הכללה בסל
התרופה תינתן לטיפול בדלקת ברשתית הנגרמת מ-CMV (Cytomegalo virus) ורק אם המטופל לא הגיב לטיפול בתרופה ganciclovir
שימוש לפי פנקס קופ''ח כללית 1994
לא צוין
תאריך הכללה מקורי בסל
01/01/2000
הגבלות
תרופה מוגבלת לרישום ע'י רופא מומחה או הגבלה אחרת
מידע נוסף