Țară: Israel
Limbă: engleză
Sursă: Ministry of Health
ONDANSETRON AS HYDROCHLORIDE DIHYDRATE
NOVARTIS ISRAEL LTD
A04AA01
SOLUTION FOR INJECTION
ONDANSETRON AS HYDROCHLORIDE DIHYDRATE 2 MG/ML
I.M, I.V
Required
GLAXO SMITHKLINE MANUFACTURING S.P.A., ITALY
ONDANSETRON
ONDANSETRON
Adults:Zofran is indicated for the management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy. Zofran is indicated for the prevention and treatment of post-operative nausea and vomiting (PONV). Paediatric Population:Zofran 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.
2013-06-30
אפורל ןולעב )תוחיטב עדימ ( הרמחה לע העדוה אפורל ןולעב )תוחיטב עדימ ( הרמחה לע העדוה ןכדועמ( ןכדועמ( 05.2013 05.2013 ) ) ךיראת 06.2015 םושירה רפסמו תילגנאב רישכת םש ZOFRAN INJECTION 2MG/ML )049-94-26548( םושירה לעב םש GLAXOSMITHKLINE )ISRAEL( LTD : ! דבלב תורמחהה טורפל דעוימ הז ספוט אפורל ןולעב אפורל ןולעב תושקובמה תורמחהה ןולעב קרפ יחכונ טסקט שדח טסקט SPECIAL WARNINGS AND PRECAUTIONS FOR USE There have been post-marketing reports describing patients with serotonin syndrome (including altered mental status, autonomic instability and neuromuscular abnormalities) following the concomitant use of ondansetron and other serotonergic drugs (including selective serotonin reuptake inhibitors (SSRI) and serotonin noradrenaline reuptake inhibitors (SNRIs)). If concomitant treatment with ondansetron and other serotonergic drugs is clinically warranted, appropriate observation of the patient is advised. The development of serotonin syndrome has been reported with 5-HT receptor antagonists alone. Most reports have been associated with concomitant use of serotonergic drugs (e.g., selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors, mirtazapine, fentanyl, lithium, tramadol, and intravenous methylene blue). Some of the reported cases were fatal. Serotonin syndrome occurring with overdose of ZOFRAN alone has also been reported. The majority of reports of serotonin syndrome related to 5- HT receptor antagonist use occurred in a post-anesthesia care unit or an infusion center. … INTERACTIONS WITH OTHER MEDICAMENTS AND OTHER FORMS OF INTERACTION .Caution should be exercised when ondansetron is coadministered with drugs that prolong the QT interval and/or cause electrolyte abnormalities. (see section 4.4) Use of ondansetron with QT prolonging drugs ma Citiți documentul complet
_ _ _ZOF INJ API MAR22 V2.0 _ _UK PI 12Jan2022 _ _ _ _ _ _Page 1 of 14_ 1. NAME OF THE MEDICINAL PRODUCT Zofran ® Injection 2 mg/mL. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Zofran Injection 2 mg/mL: 2 mL glass ampoules each containing 4 mg ondansetron (as hydrochloride dihydrate) in aqueous solution for intramuscular or intravenous administration. 4 mL glass ampoules each containing 8 mg 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: _ Zofran is indicated for the management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy. Zofran is indicated for the prevention and treatment of post-operative nausea and vomiting (PONV). _Paediatric Population: _ Zofran 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 Zofran should be flexible in the range of 8-32 mg a day and selected as shown below. _ _ _Emetogenic chemotherapy and radiotherapy:_ Zofran can be given either by oral (tablets), intravenous or intramuscular administration. For most patients receiving emetogenic chemotherapy or radiotherapy the recommended intravenous (IV) dose of ondansetron is 8 mg and should be administered as a slow intravenous injection (in not less than 30 seconds) or intramuscular injection, immediately before treatment, follow Citiți documentul complet