Страна: Австралия
Език: английски
Източник: Department of Health (Therapeutic Goods Administration)
midazolam
Apotex Pty Ltd
Midazolam
Registered
MIDAZOLAM APOTEX SOLUTION FOR INJECTION _Midazolam_ CONSUMER MEDICINE INFORMATION _FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about midazolam. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. ASK YOUR DOCTOR OR PHARMACIST: • if there is anything you do not understand in this leaflet, • if you are worried about being given this medicine, or • to obtain the most up-to-date information. You can also download the most up to date leaflet from www.apotex.com.au. All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you. Pharmaceutical companies cannot give you medical advice or an individual diagnosis. KEEP THIS LEAFLET WITH YOU. You may want to read it again. WHAT THIS MEDICINE IS USED FOR The name of your medicine is MIDAZOLAM APOTEX solution for injection. It contains the active ingredient midazolam. Midazolam may be injected as a sedative during some short medical procedures. Midazolam may be given to you by injection before an operation to produce sleepiness or drowsiness and to relieve anxiety. If you are in an intensive care unit, you may receive an infusion of midazolam over several hours or days as a sedative. _HOW IT WORKS_ Midazolam belongs to a group of medicines called benzodiazepines. Benzodiazepines are thought to work by their action on brain chemicals. Midazolam can cause sedation, hypnosis, amnesia and/or anaesthesia, depending on the dose. Midazolam is only given by a doctor trained to use this medicine. If you will be receiving midazolam during surgery, your doctor will give you the medicine and closely follow your progress. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed this medicine for another reason. This medicine is available only with a doctor's prescription. As with o Прочетете целия документ
1 AUSTRALIAN PRODUCT INFORMATION –MIDAZOLAM APOTEX (MIDAZOLAM) 1 NAME OF THE MEDICINE Midazolam 2 AND 3 QUALITATIVE AND QUANTITATIVE COMPOSITION AND PHARMACEUTICAL FORM Each ampoule contains 1 mg/mL or 5 mg/mL of midazolam as the active ingredient. In addition, each ampoule contains the following inactive ingredients: sodium chloride, hydrochloric acid (to produce hydrochloride) and sodium hydroxide in water for injection to adjust the pH. 1mg/mL Solution for Injection Clear colourless to pale yellow solution. AUST R 217663 5mg/mL Solution for Injection: Clear colourless to pale yellow solution. AUST R 217657, AUST R 217658, AUST R 217659 Not all strengths, pack types and/or pack sizes may be available. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • IV as an agent for conscious sedation prior to short surgical, diagnostic, therapeutic or endoscopic procedures, such as bronchoscopy, gastroscopy, cystoscopy, coronary angiography and cardiac catheterisation, either alone or in conjunction with a narcotic; • IV for induction of anaesthesia, preliminary to administration of other anaesthetic agents. With the use of a narcotic premedicant, induction of anaesthesia can be attained with a narrower dose range and in a shorter period of time. • IV for sedation in intensive care units; intermittent administration or continuous infusion. • IM for preoperative sedation (induction of sleepiness or drowsiness and relief of apprehension) and to impair memory of perioperative events. 4.2 DOSE AND METHOD OF ADMINISTRATION Midazolam APOTEX Solution for Injection is intended for intravenous and intramuscular administration. Dosage should be individualised and drug should be administered slowly. Lower doses may be required in elderly or debilitated patients or in patients with hepatic or renal insufficiency. Because serious and life-threatening cardio-respiratory adverse events have been reported, provision for monitoring, detection and correction of these reactions must be made for every patient to whom midazolam inj Прочетете целия документ