Երկիր: Իսրայել
Լեզու: անգլերեն
Աղբյուրը: Ministry of Health
ONDANSETRON AS HYDROCHLORIDE DIHYDRATE
K.S.KIM INTERNATIONAL (SK- PHARMA) LTD., ISRAEL
A04AA01
SOLUTION FOR INJECTION
ONDANSETRON AS HYDROCHLORIDE DIHYDRATE 2 MG/ML
I.V, I.M
Required
KLEVA S.A., GREECE
ONDANSETRON
ONDANSETRON
Adults:Odnatron is indicated for the management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy. Odnatron is indicated for the prevention and treatment of post-operative nausea and vomiting (PONV). Paediatric Population:Odnatron is indicated for the management of chemotherapy-induced nausea and vomiting (CINV) in children aged ≥6 months, and for the prevention and treatment of PONV in children aged ≥ 1 month.
2018-07-31
Page 1 of 4 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 יאמ 2018 KS051 ה/אפור ה/דבכנ , ה/דבכנ ת/חקור , רישכתה :ןודנה – ODNATRON 2MG/ML SOLUTION FOR INJECTION תרבח םיק.סא.ייק מ"עב לנוישנרטניא רשיא תואירבה דרשמ יכ םכעידוהל תדבכתמ ןוכדע ןודנבש רישכתל היוותה . ןוסחאה יאנת ונכדוע םה ףא אפורל ןולעב . ה ןכדועמה ןולע חווד תואירבה דרשמל לולסמב היצקיפיטונ . רישכתל תורשואמה תויוותהה : ADULTS: Odnatron is indicated for the management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy. Odnatron is indicated for the prevention and treatment of post-operative nausea and vomiting (PONV). PAEDIATRIC POPULATION: Odnatron is indicated for the management of chemotherapy-induced nausea and vomiting (CINV) in children aged _ ≥_ 6 months, and for the prevention and treatment of PONV in children aged ≥ 1 month. :הרמחה הווהמה יוניש השענ םהב םיפיעסל קר תסחייתמ וז העדוה שגדומ טסקט בוהצב עמשמ ו חה ו הרמ תנמוסמ טסקט תקיחמ הצוח וקב . .םיפסונ םיירונימ םינוכדע םימייק וכדעה םינ יתוהמה םי שענש ו ןולעב ה אפורל םני : 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS ADULTS: Odnatron is indicated for the management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy. Odnatron is indicated for the prevention and treatment of post-operative nausea and vomiting (PONV). PAEDIATRIC POPULATION: Odnatron is indicated for the management of chemotherapy-induced nausea and vomiting (CINV) in children aged _ ≥_ 6 months, and for the prevention and treatment of PONV in children aged ≥ 2 years 1 month. 4.4. Կարդացեք ամբողջական փաստաթուղթը
ODNATRON 2 MG/ML SOLUTION FOR INJECTION 1. TRADE NAME OF THE MEDICINAL PRODUCT Odnatron 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 2mL glass ampoules each containing 4mg ondansetron (as hydrochloride dihydrate) in aqueous solution for intramuscular or intravenous administration. 4mL glass ampoules each containing 8mg ondansetron (as hydrochloride dihydrate) in aqueous solution for intravenous or intramuscular administration. Excipients with a known effect: This product contains 7 mg of sodium per 4 mg dose (see section 4.4). For the full list of excipients see section 6.1. 3. PHARMACEUTICAL FORM Solution for Injection (aqueous solution). 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS ADULTS: Odnatron is indicated for the management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy. Odnatron is indicated for the prevention and treatment of post-operative nausea and vomiting (PONV). PAEDIATRIC POPULATION: Odnatron is indicated for the management of chemotherapy-induced nausea and vomiting (CINV) in children aged _≥_ 6 months, and for the prevention and treatment of PONV in children aged ≥ 1 month. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY CHEMOTHERAPY AND RADIOTHERAPY INDUCED NAUSEA AND VOMITING (CINV AND RINV) _ADULTS _ The emetogenic potential of cancer treatment varies according to the doses and combinations of chemotherapy and radiotherapy regimens used. The route of administration and dose of Odnatron should be flexible in the range of 8-32mg a day and selected as shown below. _Emetogenic chemotherapy and radiotherapy:_ Odnatron can be given either by intravenous _or intramuscular administration. For most patients receiving emetogenic chemotherapy or radiotherapy, the recommended intravenous (IV) dose of ondansetron is 8mg and should be administered as a slow intravenous injection (in not less than 30 seconds) or intramuscular injection immediately before treatment, followed by 8mg orally twelve hourly. To protect against delayed or prolonged emesis after the first Կարդացեք ամբողջական փաստաթուղթը