Երկիր: Ավստրալիա
Լեզու: անգլերեն
Աղբյուրը: Department of Health (Therapeutic Goods Administration)
midazolam, Quantity: 1 mg/mL
Baxter Healthcare Pty Ltd
Midazolam
Injection, solution
Excipient Ingredients: nitrogen; hydrochloric acid; water for injections; sodium chloride; sodium hydroxide
Intramuscular, Intravenous
5 mL, packs of 5 ampoules, 5 mL, packs of 10 ampoules, 5 mL, packs of 25 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 solution; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius
Licence status A
2014-10-08
MIDAZOLAM-CLARIS _Midazolam_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Midazolam-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 using Midazolam-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 MIDAZOLAM-CLARIS IS USED FOR Midazolam-Claris may be injected as a sedative during some short medical procedures. Midazolam-Claris 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-Claris over several hours or days as a sedative. Midazolam belongs to a group of medicines called benzodiazepines. They are thought to work by their action on brain chemicals. Midazolam-Claris can cause sedation, hypnosis, amnesia and/or anaesthesia, depending on the dose. Your doctor, however, may have prescribed Midazolam-Claris for another purpose. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY MIDAZOLAM-CLARIS HAS BEEN PRESCRIBED FOR YOU. Midazolam-Claris is only given by a doctor trained to use this medicine. If you will be receiving Midazolam-Claris 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-CLARIS _DO NOT USE MIDAZOLAM-CLARIS IF_ • YOU HAVE HAD AN ALLERGIC REACTION TO MIDAZOLAM, 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 ALCOHOLIC INTOXICATION IF YOU ARE NOT SURE Կարդացեք ամբողջական փաստաթուղթը
MIDAZOLAM-BAXTER (midazolam) Version 1.1 1 of 23 AUSTRALIAN PRODUCT INFORMATION – MIDAZOLAM- BAXTER (MIDAZOLAM) SOLUTION FOR INJECTION 1 NAME OF THE MEDICINE Midazolam Hydrochloride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active Ingredient: Midazolam Hydrochloride (1 mg/mL or 5 mg/mL) Excipients: Sodium Chloride, Hydrochloric Acid (to produce hydrochloride) and Sodium Hydroxide in water for injection adjusted to pH 3.3. 3 PHARMACEUTICAL FORM Sterile solution for Injection 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Midazolam is a short-acting sleep inducing agent for sedation for short procedures, induction of anaesthesia, and for prolonged sedation in intensive care units. • 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 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, MIDAZOLAM-BAXTER (midazolam) Version 1.1 2 of 23 provision for monitoring, detection and correction of these reactions must be made for every patient to whom Midazolam-Baxter injection is administered, regardless of age or health status. The dosage of Midazolam- Baxter administered should be ad Կարդացեք ամբողջական փաստաթուղթը