País: Irlanda
Idioma: inglés
Fuente: HPRA (Health Products Regulatory Authority)
Flumazenil
Fresenius Kabi Deutschland GmbH
V03AB; V03AB25
Flumazenil
0.1 milligram(s)/millilitre
Solution for injection
Antidotes; flumazenil
Not marketed
2007-07-06
1 PACKAGE LEAFLET: INFORMATION FOR THE USER FLUMAZENIL 0.1 MG/ML SOLUTION FOR INJECTION (flumazenil) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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, pharmacist or nurse. - If you get any side effects, talk to your doctor, pharmacist or nurse . This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Flumazenil is and what it is used for 2. What you need to know before you use Flumazenil 3. How to use Flumazenil 4. Possible side effects 5. How to store Flumazenil 6. Contents of the pack and other information 1. WHAT FLUMAZENIL IS AND WHAT IT IS USED FOR Flumazenil is a counteragent (antidote) for the complete or partial reversal of the central sedative effects of benzodiazepines (specific group with sedative, sleep inducing, muscle relaxing and anxiolytic properties). It may therefore be used in anaesthesia to wake you up after certain diagnostic tests or in intensive care if you have been hold under sedative conditions. Flumazenil may also be used for the diagnosis and treatment of intoxications or overdose with benzodiazepines. Flumazenil 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 USE FLUMAZENIL DO NOT USE FLUMAZENIL − if you are ALLERGIC to flumazenil or any of the other ingredients (listed in section 6). − if benzodiazepines have been administered to you to control a POTENTIALLY LIFE- THREATENING SITUATION (for example control of pressure in the brain or a serious epileptic seizure). − in mixed INTOXICATIONS with benzodiazepines and certain types of other antidepressants (so called tricyclic and tetracyclic antidepressants like Imipramin, Clomipramin, Mirtazepine or Mianserin). The toxicity of these antidepres Leer el documento completo
Health Products Regulatory Authority 26 March 2021 CRN009ZPM Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Flumazenil 0.1 mg/ml solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains 0.1 mg flumazenil. 1 ampoule with 5 ml contains 0.5 mg flumazenil. 1 ampoule with 10 ml contains 1 mg flumazenil. Excipients with known effect: Each 10 ml ampoule contains 37 mg of sodium For the full list ofexcipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection Concentrate for solution for infusion Clear colourless solution 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Flumazenil is indicated for the complete or partial reversal of the central sedative effects of benzodiazepines. It may therefore be used in anaesthesia and in the intensive care in the following situations: _In anaesthesia_ -Termination of hypnosedative effects in general anaesthesia induced and/or maintained with benzodiazepines in hospitalized patients. -Reversal of benzodiazepine sedation in short-term diagnostic and therapeutic procedures in ambulatory patients and hospitalized patients. - For the reversal of conscious sedation induced with benzodiazepines in children > 1 year of age _In intensive care situations_ -For the specific reversal of the central effects of benzodiazepines, in order to restore spontaneous respiration. -For diagnosis and treatment of intoxications or overdose with only or mainly benzodiazepines. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Adults: _Anaesthesia_ The recommended starting dose is 0.2 mg administered intravenously over 15 seconds. If the required level of consciousness is not obtained within 60 seconds, a further dose of 0.1 mg can be injected and repeated at 60-second intervals, up to a maximum dose of 1.0 mg. The usual dose required lies between 0.3 and 0.6 mg, but may deviate depending on the patient's characteristics and the benzodiazepine used. _Intensive Care_ The recommended starting dose is 0.3 mg administered intravenously over Leer el documento completo