Ondansetron Accord i/v injection solution, infusion 8mg/4ml ampoule #5

International Nonproprietary Name - Ondansetronum Pharmacological group: Antiemetic preparations Composition The preparation Ppms-Ondansetron (pms- ONDANSETRON) contains ondansetron hydrochloride dihydrate as the active substance. Indications pms-Ondansetron is used for the prophylaxis of nausea and vomiting during anticancer chemotherapy and radiotherapy; as well as for the prophylaxis and treatment of nausea and vomiting in the postoperative period. Dosage and Administration Individual, according to indications and treatment regimen. In adults, after chemotherapy with a high incidence of vomiting, 8mg pms-Ondansetron is prescribed every 8 hours from the second day. Duration of administration up to 5 days. For chemotherapy and radiotherapy with a low incidence of vomiting, 8mg pms-Ondansetron is prescribed 1-2 hours before the start, and after chemotherapy, 8mg twice a day. Duration of administration up to 5 days. For the prophylaxis of nausea and vomiting in the postoperative period, 16mg pms-Ondansetron is prescribed 1 hour before anesthesia. In children (4 to 12 years old), after chemotherapy, 4mg is prescribed every 8 hours. Duration of administration up to 5 days. Side Effects • Headache; rarely transient visual disturbances and dizziness, involuntary movements; • Rarely – chest pain, arrhythmias, bradycardia, arterial hypotension; • Constipation, diarrhea, abdominal pain, transient increase in blood plasma transaminase levels. • Allergic reactions – bronchospasm, angioneurotic edema, urticaria; in isolated cases – anaphylactic reactions. • Sensation of heat and flushing in the head and epigastric region. Contraindications First trimester of pregnancy, hypersensitivity to pms-Ondansetron. Special Instructions In patients with moderate and severe liver dysfunction, exceeding a dose of 8mg/day is not recommended. pms-Ondansetron should be prescribed with caution during abdominal surgery, as its use may mask progressive intestinal obstruction. Storage Conditions and Shelf Life Store at a temperature of 2-3°C, protected from light. Keep out of reach of children. Do not use after the expiry date.