Valsts: Austrālija
Valoda: angļu
Klimata pārmaiņas: Department of Health (Therapeutic Goods Administration)
flumazenil, Quantity: 0.5 mg
Baxter Healthcare Pty Ltd
Flumazenil
Injection, solution
Excipient Ingredients: water for injections; sodium hydroxide; disodium edetate; glacial acetic acid; sodium chloride
Intravenous
10 ampoules, 5 ampoules
(S4) Prescription Only Medicine
Flumazenil-Baxter is indicated for use in hospitalised patients for the reversal of acute benzodiazepine effects (overdose or therapeutic). Hospitalised patients are patients admitted to hospital, inpatient care and under continued professional observation while under the influence of Flumazenil-Claris. Not to be used in outpatients or short stay patients. Not to be used as a diagnostic.
Visual Identification: Clear colourless solution, practically free from visible particles; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2015-12-02
FLUMAZENIL-CLARIS FLUMAZENIL 0.5 MG/5 ML AND 1 MG/10 ML, SOLUTION FOR INJECTION CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Flumazenil-Claris. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you being given Flumazenil-Claris against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET. You may need to read it again. WHAT FLUMAZENIL-CLARIS IS USED FOR Flumazenil-Claris is used to reverse benzodiazepine overdose, both suspected and known. It is given to arouse people after surgery or benzodiazepine overdose. Your doctor may have prescribed Flumazenil-Claris for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS WHY FLUMAZENIL- CLARIS HAS BEEN PRESCRIBED FOR YOU. BEFORE YOU ARE GIVEN FLUMAZENIL-CLARIS _WHEN YOU MUST NOT BE GIVEN IT _ DO NOT USE FLUMAZENIL-CLARIS IF: • YOU HAVE HAD AN ALLERGIC REACTION TO FLUMAZENIL-CLARIS OR ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET • YOU ARE TAKING A BENZODIAZEPINE FOR CONTROL OF A POTENTIALLY LIFE-THREATENING CONDITION _BEFORE YOU ARE GIVEN IT _ YOUR DOCTOR MUST KNOW ABOUT ALL THE FOLLOWING BEFORE YOU ARE GIVEN FLUMAZENIL-CLARIS. YOU MUST TELL YOUR DOCTOR IF: 1. YOU ARE ALLERGIC TO ANY OTHER MEDICINES OR ANY OTHER SUBSTANCES SUCH AS FOODS, PRESERVATIVES OR DYES 2. YOU SUFFER FROM EPILEPSY 3. YOU HAVE SEVERE LIVER DISEASE 4. YOU SUFFER FROM PANIC DISORDER 5. YOU HAVE BEEN TAKING HIGH DOSES OF BENZODIAZEPINES AND /OR YOU HAVE BEEN TAKING BENZODIAZEPINES FOR A LONG TIME. IF YOU HAVE NOT TOLD YOUR DOCTOR ABOUT ANY OF THE ABOVE, TELL THEM BEFORE YOU ARE GIVEN FLUMAZENIL-CLARIS. _TAKING OTHER MEDICINES _ TELL YOUR DOCTOR IF YOU ARE TAKING ANY OTHER MEDICINES, INCLUDING ANY THAT YOU HAVE BOUGHT FROM A PHARMACY, SUPERMARKET OR HEALTH FOOD SHOP. Some medicines ma Izlasiet visu dokumentu
Flumazenil-Baxter (Flumazenil) Version 2.0 1 of 10 AUSTRALIAN PRODUCT INFORMATION – FLUMAZENIL- BAXTER (FLUMAZENIL) SOLUTION FOR INJECTION 1 NAME OF THE MEDICINE Flumazenil 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active Ingredient: Flumazenil (0.1 mg/mL). For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Solution for injection 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Flumazenil-Baxter is indicated for use in hospitalized patients for the reversal of acute benzodiazepine effects (overdose or therapeutic). Hospitalized patients are patients admitted to hospital, inpatient care and under continued professional observation while under the influence of Flumazenil-Baxter. Not to be used in outpatients or short stay patients. Not to be used as a diagnostic. 4.2 DOSE AND METHOD OF ADMINISTRATION Flumazenil-Baxter should be administered intravenously by an anaesthetist or experienced physician. The use of Flumazenil-Baxter should be balanced against the risk of precipitating withdrawal symptoms (see Section 4.4 Identified precautions). The desirability of retaining a degree of sedation in the early postoperative period should be considered. Flumazenil-Baxter may be diluted in glucose 5% in water or 0.9% NaCl for infusion and may also be used concurrently with other resuscitative procedures. In order to reduce microbial contamination hazards, infusion should be commenced as soon as practicable after preparation. Infusion should be completed within 24 hours of preparation and any residue discarded. Flumazenil-Baxter is for use in one patient only. Discard any remaining contents. Reversal of benzodiazepine effects at therapeutic doses (anaesthesia or sedation) The recommended initial dose is 0.2 mg administered i.v. within 15 seconds. If the desired degree of consciousness is not obtained within 60 seconds following the first i.v. administration, a second dose of 0.1 mg can be injected and this may be repeated at 60 second intervals where necessary, up to a total dose o Izlasiet visu dokumentu