国家: 欧盟
语言: 英文
来源: EMA (European Medicines Agency)
Palonosetron
Accord Healthcare S.L.U.
A04AA05
palonosetron
Antiemetics and antinauseants,
Vomiting; Nausea; Cancer
Palonosetron Accord is indicated in adults for:the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy,the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy.Palonosetron Accord is indicated in paediatric patients 1 month of age and older for:The prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy and prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy.
Revision: 5
Authorised
2016-05-26
22 B. PACKAGE LEAFLET 23 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT PALONOSETRON ACCORD 250 MICROGRAMS SOLUTION FOR INJECTION palonosetron READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist or nurse. - If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Palonosetron Accord is and what it is used for 2. What you need to know before you are given Palonosetron Accord 3. How Palonosetron Accord is given 4. Possible side effects 5. How to store Palonosetron Accord 6. Contents of the pack and other information 1. WHAT PALONOSETRON ACCORD IS AND WHAT IT IS USED FOR Palonosetron Accord belongs to a group of medicines known as serotonin (5HT3) antagonists. These have the ability to block the action of the chemical, serotonin, which can cause nausea and vomiting. Palonosetron Accord is used for the prevention of nausea and vomiting associated with cancer chemotherapy in adults, adolescents and children over one month of age. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN PALONOSETRON ACCORD _ _ DO NOT USE PALONOSETRON ACCORD: - if you are allergic to palonosetron or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist or nurse before using Palonosetron Accord. - if you have acute bowel obstruction or a history of repeated constipation. - if you are using palonosetron accord in addition to other medicines that may induce an abnormal heart rhythm such as amiodarone, nicardipine, quinidine, moxifloxacin, erythromycin, haloperidol, chlorpromazine, quetiapine, thioridazine, domperidone. - if you have a personal or family history of alterations in heart rhythm (QT prolongation): - if you have other heart problems. - if you have an imbala 阅读完整的文件
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Palonosetron Accord 250 micrograms solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution contains 50 micrograms of palonosetron (as hydrochloride). Each vial of 5 ml of solution contains 250 micrograms of palonosetron (as hydrochloride). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. A clear colourless solution, practically free from foreign particles, pH 3.0 to 3.9, osmlolarity 260- 320 mOsm/l. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Palonosetron Accord is indicated in adults for: • the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy, • the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy. Palonosetron Accord is indicated in paediatric patients 1 month of age and older for. • the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy and prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Palonosetron Accord should be used only before chemotherapy administration. This medicinal product should be administered by a healthcare professional under appropriate medical supervision. Posology _ _ _Adults _ 250 micrograms palonosetron administered as a single intravenous bolus approximately 30 minutes before the start of chemotherapy. Palonosetron Accord should be injected over 30 seconds. The efficacy of palonosetron in the prevention of nausea and vomiting induced by highly emetogenic chemotherapy may be enhanced by the addition of a corticosteroid administered prior to chemotherapy. _ _ _Elderly population _ No dose adjustment is necessary for the elderly. _ _ _Hepatic impairment _ No dose adjustment is necessary for patients with impaired hepatic function. _Renal impairment _ No dose adjustment is necessary for patients with impaired 阅读完整的文件