Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
Flumazenil
Cheplapharm Arzneimittel GmbH
V03AB; V03AB25
Flumazenil
500 Micrograms/5ml
Solution for injection/infusion
Product subject to prescription which may not be renewed (A)
Antidotes; flumazenil
Marketed
1988-02-18
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ANEXATE ® 500 MICROGRAMS/5 ML SOLUTION FOR INJECTION OR INFUSION Flumazenil READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 Anexate is and what it is used for 2. What you need to know before you are given Anexate 3. How Anexate will be given 4. Possible side effects 5. How Anexate is stored 6. Contents of the pack and other information 1. WHAT ANEXATE IS AND WHAT IT IS USED FOR Anexate contains a medicine called flumazenil. It is used to wake you up after you have been made sleepy by a medicine called a ‘benzodiazepine’. Anexate reverses the effects of the ‘benzodiazepine’ medicine. It is used to: Wake you up after an operation or medical test. Help you to breathe for yourself and wake up if you have been on a ventilator in intensive care. Reverse any unexpected effects of benzodiazepine treatment Treat benzodiazepine overdose Help find the reason for loss of consciousness in unconscious patients. Anexate is also used in children (more than 1 year old) to wake them up after they have been given a ‘benzodiazepine’ medicine to make them sleepy during a medical procedure. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ANEXATE YOU MUST NOT BE GIVEN ANEXATE IF YOU ARE ALLERGIC (HYPERSENSITIVE) TO: Flumazenil or any of the other ingredients of Anexate (listed in section 6). ‘Benzodiazepine’ medicines. These include diazepam, midazolam and temazepam. You must not be given Anexate if any of the above apply to you. If you are not sure, talk to your doctor or nurse before having Anexate. YOU MUST NOT BE GIVEN ANEXATE IF: You are alre Läs hela dokumentet
Health Products Regulatory Authority 09 December 2020 CRN009ZTK Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Anexate 500 micrograms/5ml, solution for injection or infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5ml ampoule contains 500 micrograms of flumazenil (100 micrograms per ml). Excipient(s) with known effect: Sodium 3.7 mg/ml For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection and infusion. A clear, almost colourless, sterile aqueous solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Anexate is indicated for the complete or partial reversal of the central sedative effects of benzodiazepines. It may therefore be used in the following situations: Termination of general anaesthesia induced and/or maintained with benzodiazepines. Reversal of benzodiazepine sedation in short diagnostic and therapeutic procedures. Reversal of paradoxical reactions due to benzodiazepines. For the diagnosis and/or management of deliberate or accidental benzodiazepine overdosage. As a diagnostic measure in unconsciousness of unknown origin, to differentiate between involvement of benzodiazepines and other aetiologies. For the specific reversal of the central effects of benzodiazepines, to allow return to spontaneous respiration and consciousness, in patients in intensive care. For the reversal of conscious sedation induced with benzodiazepines in children > 1 year of age. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Flumazenil must be administered intravenously by an anaesthetist or a doctor with experience in anaesthesiology and in a unit having the appropriate facilities available. Flumazenil may be administered either undiluted or diluted. For dilution, see section 6.6. It can be administered together with other reanimation measures. _ANAESTHESIOLOGY_ The initial dose is 200 micrograms administered intravenously in 15 seconds. If the desired degree of consciousness is not obtained within 60 seconds, a second dose of 100 micrograms can be Läs hela dokumentet