Страна: Армения
Язык: английский
Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
ondansetron (ondansetron hydrochloride dihydrate)
Pliva Hrvatska d.o.o.
ondansetron (ondansetron hydrochloride dihydrate)
2mg/ml
solution for injection
Prescription
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF MEDICINAL PRODUCT Ondansetron-Teva 2mg/ml Solution for Injection 2. QUALITATIVE UND QUANTITATIVE COMPOSITION Each 2 ml glass ampoule contains 2 ml of aqueous solution containing 4 mg ondansetron (as hydrochloride dihidrate). Each 2 ml glass ampoule contains 4 ml of aqueous solution containing 8 mg ondansetron (as hydrochloride dihidrate). For a complete list of other ingredients see Section 6.1. 3. PHARMACEUTICAL FORM Solution for Injection Ondansetron-Teva 2mg/ml Solution for Injection in a colorless, clear solution for injection. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Adults: _ Ondansetron is indicated for the management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy, and for the prevention and treatment of post-operative nausea and vomitinh (PONV). _Paediatric: _ Ondansetron 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 Chemotherapy and radiotherapy: _ _ _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 ondansetron should be flexible in the range of 8-32 mg a day and selected as shown below. Adults and young people are given 1 ampoule of Metoclopramide 1 – 3 times daily (corresponding to 10 mg Metoclopramide 1 – 3 times daily). _Emetogenic chemotherapy and radiotherapy: _ Ondansetron can be given either by oral (tablets), intravenous or intramuscular administration. For most patients receiving emetogenic chemotherapy or radiotherapy, ondansetron 8 mg should be administered as a slow intravenous or intramuscular injection immediately before treatment, followed by 8 mg orally twelve hourly. To protect against delayed or prolonged emesis after the first 24 hours, oral treatment with ondansetron should be Прочитать полный документ