Երկիր: Իսրայել
Լեզու: անգլերեն
Աղբյուրը: Ministry of Health
VORICONAZOLE
K.S.KIM INTERNATIONAL (SK- PHARMA) LTD., ISRAEL
J02AC03
POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
VORICONAZOLE 200 MG/VIAL
I.V
Required
ANFARM HELLAS S.A., GREECE
VORICONAZOLE
Vortimal is a broad spectrum, triazole antifungal agent and is indicated as follows:- Treatment of invasive aspergillosis.- Treatment of candidaemia in non-neutropenic patients.- Treatment of fluconazole-resistant serious invasive Candida infections (including C. krusei).- Treatment of serious fungal infections caused by Scedosporium spp. and Fusarium spp.Vortimal should be administered primarily to immunocompromised patients with progressive, possibly life-threatening infections.Prophylaxis of invasive fungal infections in high risk allogeneic hematopoietic stem cell transplant (HSCT) recipients
2022-10-31
K.S. Kim International Ltd-part of S.K.-Pharma Group Moshe Aviv Tower, Jabotinsky 7, 35 th floor, Ramat Gan, Israel 5252007 Tel.: +972 3 611 4543, Fax: +972 3 751 2601 www.sk-pharma.com רבמטפס 2018 ה/אפור ה/דבכנ , ה/דבכנ ת/חקור , רישכתה :ןודנה – VORTIMAL 200 MG/VIAL ORICONAZOLE V NFUSION I OLUTION FOR S ONCENTRATE FOR C OWDER FOR P ןוכדע לע עידוהל וננוצרב ףדמה ייח ןודנבש רישכתה לש . ל ונכדוע ףדמה ייח - 36 .םישדוח םינוכדע וכרענ ,ףסונב .אפורל ןולעב יוניש השענ םהב םיפיעסל קר תסחייתמ וז העדוה םושירה יאנתב יוניש וא הרמחה הווהמה : שגדומ טסקט בוהצב עמשמ ו חה הרמ . .םיפסונ םיירונימ םינוכדע םימייק :תרשואמה היוותהה Vortimal is a broad spectrum, triazole antifungal agent and is indicated as follows: • Treatment of invasive aspergillosis. • Treatment of candidaemia in non-neutropenic patients. • Treatment of fluconazole-resistant serious invasive Candida infections (including C. krusei). • Treatment of serious fungal infections caused by Scedosporium spp. and Fusarium spp. Vortimal should be administered primarily to immunocompromised patients with progressive, possibly life threatening infections. Prophylaxis of invasive fungal infections in high risk allogeneic hematopoietic stem cell transplant (HSCT) recipients וכדעה םינ יתוהמה םי שענש ו ןולעב ה אפורל םני : 4 .8 UNDESIRABLE EFFECTS […] The most commonly reported adverse reactions were visual disturbances impairments, pyrexia, rash, vomiting, nausea, diarrhoea, headache, peripheral oedema, liver function test abnormal, respiratory distress and abdominal pain. […] _Dermatological reactions _ Dermatological reactions were very common in patients treated with voriconazole in clinical trials, but these patients had serious underlying diseases and were receiving multiple concomit Կարդացեք ամբողջական փաստաթուղթը
1 VORTIMAL 1. NAME OF THE MEDICINAL PRODUCT Vortimal 200 mg powder for solution for infusion 2. QUALITATIVE AN D QUANTITATIVE COMPOSITION Each vial contains 200 mg of voriconazole. After reconstitution each ml contains 10 mg of voriconazole. Once reconstituted further dilution is required before administration. Excipient with known effect Each vial contains 225.6 mg sodium chloride. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for concentrated solution for infusion is a white to off white lyophilized powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Vortimal is a broad spectrum, triazole antifungal agent and is indicated as follows: - Treatment of invasive aspergillosis. - Treatment of candidaemia in non-neutropenic patients. - Treatment of fluconazole-resistant serious invasive _Candida_ infections (including _C. krusei_ ). - Treatment of serious fungal infections caused by _Scedosporium_ spp. and _Fusarium_ spp. Vortimal should be administered primarily to immunocompromised patients with progressive, possibly life-threatening infections. Prophylaxis of invasive fungal infections in high risk allogeneic hematopoietic stem cell transplant 2 (HSCT) recipients. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Electrolyte disturbances such as hypokalaemia, hypomagnesaemia and hypocalcaemia should be monitored and corrected, if necessary, prior to initiation and during voriconazole therapy (see section 4.4). It is recommended that Vortimal is administered at a maximum rate of 3 mg/kg per hour over 1 to 3 hours. Treatment _Adults _ Therapy must be initiated with the specified Intravenous loading dose regimen of Vortimal to achieve adequate plasma concentrations on Day 1. Intravenous treatment should be continued for at least 7 days before switching to oral treatment (see section 5.1). Once the patient is clinically improved and can tolerate medication given by mouth, the oral tablet form or oral suspension form of voriconazole may be utilized. On the basis of the high ora Կարդացեք ամբողջական փաստաթուղթը