Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
palonosetron hydrochloride
Pfizer Europe MA EEIG
A04AA05
palonosetron
Antiemetics and antinauseants,
Nausea; Vomiting; Cancer
Palonosetron Hospira 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 Hospira 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: 4
Withdrawn
2016-04-08
21 B. PACKAGE LEAFLET Medicinal product no longer authorised 22 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT PALONOSETRON HOSPIRA 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. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Palonosetron Hospira is and what it is used for 2. What you need to know before you are given Palonosetron Hospira 3. How Palonosetron Hospira is given 4. Possible side effects 5. How to store Palonosetron Hospira 6. Contents of the pack and other information 1. WHAT PALONOSETRON HOSPIRA IS AND WHAT IT IS USED FOR Palonosetron Hospira belongs to a group of medicines known as serotonin (5HT 3 ) antagonists. These have the ability to block the action of the chemical, serotonin, which can cause nausea and vomiting. Palonosetron Hospira 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 HOSPIRA YOU MUST NOT BE GIVEN PALONOSETRON HOSPIRA: • 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 or pharmacist before you are given Palonosetron Hospira: • if you have acute bowel obstruction or a history of repeated constipation; • if you are using Palonosetron Hospira 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); Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Palonosetron Hospira250 micrograms solution for injection. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution contains 50 micrograms palonosetron (as hydrochloride). Each vial of 5 ml of solution contains 250 micrograms palonosetron (as hydrochloride). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Clear, colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Palonosetron Hospira 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 Hospira 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 Hospira 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 Hospira should be injected over 30 seconds. The efficacy of Palonosetron Hospira 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. Medicinal product no longer authorised 3 _Paediatric population _ _Children and Adolescents (aged 1 month to 17 years): _ 20 micrograms/kg (the maximum total dose should not exceed 1500 micrograms) palonosetron administered as a Прочетете целия документ