It was found necessary to supplement the instructions for the use of medicinal products with the following information:
1. In the section "Indications for use", the information should be stated in the following edition: "Prevention and treatment of nausea and vomiting caused by cytostatic chemotherapy and radiation therapy in adults, prevention and treatment of nausea and vomiting caused by cytostatic chemotherapy in children, prevention and treatment of postoperative nausea and vomiting adults and children. "
2. Section "Contraindications" supplement: "Children under 6 months of age according to the indication" Prevention and treatment of nausea and vomiting caused by cytostatic chemotherapy in children ", children under 1 month of age according to the indication" Prevention and treatment of postoperative nausea and vomiting in adults and children. "
3. The section "Method of administration and dose" should be presented in accordance with the indications for use: Prevention and treatment of nausea and vomiting,caused by cytostatic chemotherapy and radiotherapy in adults; prevention and treatment of nausea and vomiting caused by cytostatic chemotherapy in children; prevention and treatment of postoperative nausea and vomiting in adults and children. Indicate that in the prevention and treatment of nausea and vomiting caused by cytostatic chemotherapy and radiation therapy in adults, the recommended dose is 8 mg, intravenously or intramuscularly immediately before chemotherapy or radiotherapy.
4. Section "Side effect" is recommended to be presented in the following edition: "The undesirable reactions presented below are listed in accordance with organ and organ system damage and frequency of occurrence.The frequency of occurrence is defined as follows: very often (≥ 1/10), often (≥ 1 / 100 and <1/10), infrequently (≥ 1/1 000 and <1/100), rarely (≥ 1/10 000 and <1/1 000), very rarely (<1/10 000, including individual cases) Unwanted reactions observed "very often," "often," and "infrequently," were usually determined from clinical trials. The adverse reactions observed "rarely" and "very rarely" were determined on the basis of spontaneous reports obtained as part of post-registration follow-up.When the standard recommended doses of ondansetron are taken, the frequency of occurrence is shown below. The profile of adverse reactions in children and adolescents was comparable to the profile observed in adults. Impaired immune system. Rarely: immediate-type hypersensitivity reactions (urticaria, bronchospasm, laryngospasm, angioedema), in a number of severe cases, including anaphylaxis. Violations from the nervous system. Very often: headache. Infrequent: convulsions, motor disorders (including extrapyramidal symptoms such as dystonia, oculogic crisis and dyskinesia) in the absence of persistent clinical consequences. Rarely: dizziness, mainly during rapid intravenous administration. Disorders from the side of the organ of sight. Rarely: transient visual impairment (eg, blurred vision), mainly during intravenous administration. Rarely: transient blindness, mainly during intravenous administration. Violations from the heart. Infrequent: arrhythmia, pain in the chest, both accompanied, and not accompanied by a decrease in the segment ST, bradycardia.Rarely: interval lengthening QT (including ventricular tachycardia of the "pirouette" type). Violations from the vessels. Often: a feeling of hotness or "hot flashes". Infrequent: lowering blood pressure. Disturbances from the respiratory system, chest and mediastinum. Infrequently: hiccough. Disorders from the gastrointestinal tract. Often: constipation. Disorders from the liver and biliary tract. Infrequently: an asymptomatic increase in the activity of "hepatic" enzymes alanine aminotransferase (ALT), aspartate aminotransferase (ACT) (mainly observed in patients receiving cisplatin chemotherapy). Disturbances from the skin and subcutaneous tissues. Very rarely: toxic skin rash, including toxic epidermal necrolysis. General disorders and disorders at the site of administration. Often: local reactions with intravenous administration - burning at the injection site. "
5. In the section "Overdose" information is recommended to be presented in the following edition. "Symptomatology: There is currently insufficient data on overdose with ondansetron.In most cases, the symptoms of an overdose were similar to those reported in patients,receiving the recommended doses. Ondansetron causes dose-dependent lengthening of the interval QT. It is recommended to monitor the ECG in case of an overdose of the drug. In case of an overdose of the drug, when ingested orally, children reported symptoms indicative of serotonin syndrome. Treatment. There is no specific antidote for ondansetron, so if you suspect an overdose, it is recommended that you take appropriate symptomatic and supportive therapy. Further treatment should be based on the clinical situation. It is not recommended to use ipecacuanas for the treatment of drug overdose, since it is unlikely that patients will respond to treatment with ipecacuanas due to the antiemetic effect of ondansetron. "
6. In the section "Special instructions", delete information regarding the use of ondansetron in patients under 1 month of age (according to the indication "Prevention and treatment of postoperative nausea and vomiting") and patients up to 6 months of age (according to "Prevention and treatment of nausea and vomiting caused by cytostatic chemotherapy in children "), since in these groups of patients the drug is contraindicated.