Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
midazolam
Accord Healthcare Pty Ltd
Midazolam
Registered
MIDAZOLAM AN Midazolam injection, 5 mg/5 mL, 5 mg/1 mL, 15 mg/3 mL and 50 mg/10 mL CONSUMER MEDICINE INFORMATION Version 3.0 Page 1 of 4 WHAT IS IN THIS LEAFLET This leaflet answers some common questions about MIDAZOLAM AN. 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 using MIDAZOLAM AN 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 MIDAZOLAM AN IS USED FOR MIDAZOLAM AN may be injected as a sedative during some short medical procedures. MIDAZOLAM AN 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 AN over several hours or days as a sedative. MIDAZOLAM AN belongs to a group of medicines called benzodiazepines. They are thought to work by their action on brain chemicals. MIDAZOLAM AN can cause sedation, hypnosis, amnesia and/or anaesthesia, depending on the dose. Your doctor, however, may have prescribed MIDAZOLAM AN for another purpose. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY MIDAZOLAM AN HAS BEEN PRESCRIBED FOR YOU. MIDAZOLAM AN is only given by a doctor trained to use this medicine. If you will be receiving MIDAZOLAM AN 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 RECEIVE MIDAZOLAM AN _DO NOT USE MIDAZOLAM AN _ _if: _ _ _ • YOU HAVE HAD AN ALLERGIC REACTION TO MIDAZOLAM AN, ANY OTHER BENZODIAZEPINE MEDICINE, OR ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET • YOU HAVE SEVERE MUSCLE WEAKNESS, ALSO KNOWN AS MYASTHENIA GRAVIS • YOU HAVE A CONDITION CALLED ACUTE NARROW ANGLE GLAUCOMA • YOU ARE SUFFERING FROM SHOCK, COMA OR ACUTE AL Read the complete document
Page 1 of 15 AUSTRALIAN PRODUCT INFORMATION MIDAZOLAM AN INJECTION 1 NAME OF THE MEDICINE Midazolam 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Midazolam is a benzodiazepine from the imidazobenzodiazepine group. It is a white or yellowish crystalline powder, practically insoluble in water, freely soluble in acetone and alcohol, soluble in methanol. The free base of the active substance of midazolam is a lipophilic substance with low solubility in water. The basic nitrogen in position 2 of the imidazobenzodiazepine ring enables the active substance of midazolam to form water soluble salts with acids. These produce a stable injection solution. Midazolam AN injection contains midazolam 1 mg/mL or 5 mg/mL (as hydrochloride). For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS . 3 PHARMACEUTICAL FORM Midazolam AN injection is a clear, colourless to pale yellow, isotonic solution. The pH of the solution is between 2.9 and 3.7. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC 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 D OSE AND METHOD OF 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 be Read the complete document