Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
midazolam, Quantity: 15 mg
Accord Healthcare Pty Ltd
Midazolam
Injection, solution
Excipient Ingredients: sodium hydroxide; water for injections; sodium chloride; hydrochloric acid
Intramuscular, Intravenous
Pack 10 Ampoules
(S4) Prescription Only Medicine
? 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.
Visual Identification: Clear, colourless to pale yellow, sterile, isotonic, preservative-free solution in clear glass ampoules (type - 1).; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 48 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2014-05-16
Midazolam Accord – version 5 1 MIDAZOLAM ACCORD CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I BEING GIVEN MIDAZOLAM ACCORD? Midazolam Accord contains the active ingredient midazolam. Midazolam Accord can cause sedation, hypnosis, amnesia and/or anaesthesia, depending on the dose, and may be given to you to produce sleepiness or drowsiness, or to relieve anxiety. For more information, see Section 1. Why am I being given Midazolam Accord? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I AM GIVEN MIDAZOLAM ACCORD? Do not use if you have ever had an allergic reaction to an any medicine containing midazolam, any other benzodiazepine medicine, or any of the ingredients listed at the end of this leaflet. You should also not be given it if you have severe muscle weakness (myasthenia gravis), acute narrow angle glaucoma or if you are suffering from shock, coma or acute alcoholic intoxication. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use Midazolam Accord? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Midazolam Accord and affect how it works. See Section 3. What if I am taking other medicines? in the full CMI. 4. HOW WILL I BE GIVEN MIDAZOLAM ACCORD? Midazolam Accord is an injection and will be given to you by your doctor or nurse. More instructions can be found in Section 4. How do I use Midazolam Accord? in the full CMI. 5. WHAT SHOULD I KNOW WHILE BEING GIVEN MIDAZOLAM ACCORD? THINGS YOU SHOULD DO • Tell any other doctors, dentists, and pharmacists who are treating you that you are being treated with Midazolam Accord • Tell your doctor before you take any other medicines - whether they require a prescription or not • Do not drink alcohol for at least 12 hours Read the complete document
Page 1 of 15 AUSTRALIAN PRODUCT INFORMATION MIDAZOLAM ACCORD INJECTION 1 NAME OF THE MEDICINE Midazolam 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Midazolam Accord 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 Accord 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 been reported, provision for monitoring, detection and correction of these reactions must be made for every patient to whom Midazolam Accord injection is administered, regardless of age or health status. The dosage of midazolam administered should be adjusted according to the type and amount of premedication used. INTRAVENOUSLY (IV) Midazolam should be administered slowly. _Conscious Sedation_ _Endoscopic or Cardiovascular Procedures:_ For conscious sedation, midazolam can be used either alo Read the complete document