Страна: Австралия
Език: английски
Източник: Department of Health (Therapeutic Goods Administration)
midazolam, Quantity: 50 mg
Alphapharm Pty Ltd
Midazolam
Injection, solution
Excipient Ingredients: sodium chloride; water for injections; hydrochloric acid; sodium hydroxide
Intravenous Infusion, Intravenous, Intramuscular
5 ampoules
(S4) Prescription Only Medicine
Intravenously (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 an opioid . - induction of anaesthesia preliminary to administration of other anaesthetic agents. With the use of an opioid premedicant, induction of anaesthesia can be attained with a narrower dose range and in a shorter period of time. .,Intermittent IV administration or continuous infusion for: . - sedation in intensive care units, intermittent administration or continuous infusion.,Intramuscularly (IM) for: . - preoperative sedation (induction of sleepiness or drowsiness and relief of apprehension) and to impair memory of perioperative events
Visual Identification: Clear, colourless solution; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2011-04-01
MIDAZOLAM VIATRIS _Midazolam_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about MIDAZOLAM VIATRIS. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. Your doctor has weighed the risks of you taking MIDAZOLAM VIATRIS against the benefits expected for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH YOUR MEDICINE. You may need to read it again. WHAT MIDAZOLAM VIATRIS IS USED FOR MIDAZOLAM VIATRIS may be injected as a sedative during some short medical procedures. MIDAZOLAM VIATRIS 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 VIATRIS over several hours or days as a sedative. MIDAZOLAM VIATRIS belongs to a group of medicines known as benzodiazepines. They are thought to work by their action on brain chemicals. MIDAZOLAM VIATRIS can cause sedation, hypnosis, amnesia and/or anaesthesia, depending on the dose. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY MIDAZOLAM VIATRIS HAS BEEN PRESCRIBED FOR YOU. YOUR DOCTOR, HOWEVER, MAY HAVE PRESCRIBED MIDAZOLAM VIATRIS FOR ANOTHER PURPOSE. MIDAZOLAM VIATRIS is only given by a doctor trained to use this medicine. If you will be receiving MIDAZOLAM VIATRIS during surgery, your doctor will give you the medicine and closely follow your progress. This medicine is available only with a doctor's prescription. BEFORE YOU ARE GIVEN MIDAZOLAM VIATRIS _WHEN YOU MUST NOT RECEIVE_ _IT_ DO NOT USE MIDAZOLAM VIATRIS IF YOU HAVE AN ALLERGY TO: • ANY MEDICINE CONTAINING MIDAZOLAM • ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET Some of the symptoms of an allergic reaction may include • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongue or other parts of the body Прочетете целия документ
AUSTRALIAN PRODUCT INFORMATION MIDAZOLAM VIATRIS _midazolam _ 1 NAME OF THE MEDICINE Midazolam 2 QUALITATIVE AND QUANTITATIVE COMPOSITION MIDAZOLAM VIATRIS midazolam solution for injection is available as a 5 mg/ 5 mL, 5 mg/ 1 mL, 15 mg/ 3 mL and 50 mg/ 10 mL solution. MIDAZOLAM VIATRIS 5 mg/5 mL Each mL contains 1 mg of midazolam. One 5 mL ampoule contains 5 mg of midazolam. MIDAZOLAM VIATRIS 5 mg/1 mL Each mL contains 5 mg of midazolam. One 1 mL ampoule contains 5 mg of midazolam. One 3 mL ampoule contains 15 mg of midazolam. One 10 mL ampoule contains 50 mg of midazolam. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Solution for injection. Clear, colourless solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS INTRAVENOUSLY (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 an opioid • induction of anaesthesia preliminary to administration of other anaesthetic agents. With the use of an opioid premedicant, induction of anaesthesia can be attained with a narrower dose range and in a shorter period of time. INTERMITTENT IV ADMINISTRATION OR CONTINUOUS INFUSION FOR: • sedation in intensive care units, intermittent administration or continuous infusion INTRAMUSCULARLY (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 DOSE Dosage should be individualised and drug should be administered slowly. MIDAZOLAM VIATRIS – PRODUCT INFORMATION 2 Lower doses may be required in elderly or debilitated patients or in patients with hepatic or renal insufficiency. Because serious and life-threatening cardiorespiratory adverse events have been reported, provision for monitoring, detection and correction of these reactions must be made for every Прочетете целия документ