Pajjiż: Awstralja
Lingwa: Ingliż
Sors: Department of Health (Therapeutic Goods Administration)
midazolam
Sandoz Pty Ltd
Registered
MIDAZOLAM SANDOZ ® 1 MIDAZOLAM SANDOZ ® _midazolam injection _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Midazolam Sandoz. It does not contain all the available information. It does not take the place of talking to your anaesthetist, surgeon, doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you using Midazolam Sandoz against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT THIS MEDICINE, ASK YOUR ANAESTHETIST, SURGEON, DOCTOR OR PHARMACIST. KEEP THIS LEAFLET AFTER YOUR OPERATION OR HOSPITAL STAY. You may need to read it again. WHAT MIDAZOLAM SANDOZ IS USED FOR Midazolam Sandoz belongs to a group of medicines called benzodiazepines. They are thought to work by their action on brain chemicals. Midazolam Sandoz may be injected as a sedative during some short medical procedures. Midazolam Sandoz may be given to you by injection before an operation to produce sleepiness or drowsiness. If you are in an intensive care unit, you may receive an infusion of Midazolam Sandoz over several hours or days as a sedative. However, your anaesthetist or surgeon may have prescribed Midazolam Sandoz for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY MIDAZOLAM SANDOZ HAS BEEN PRESCRIBED FOR YOU. This medicine is available only with a doctor's prescription. BEFORE YOU ARE GIVEN MIDAZOLAM SANDOZ _WHEN YOU MUST NOT USE IT _ DO NOT USE MIDAZOLAM SANDOZ IF 1. YOU HAVE AN ALLERGY TO: midazolam, or any of the other ingredients listed at the end of this leaflet any other medicine from the benzodiazepine group of medicines. Symptoms of an allergic reaction may include asthma, wheezing or shortness of breath, swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing, hives, itching or skin rash or fainting. 2. YOU HAVE SEVERE MUSCLE WEAKNESS, ALSO KNOWN AS MYASTHENIA GRAVIS. 3. YOU HAVE ACUTE NARROW ANGLE GLAUCOMA (HIGH PRESSURE IN THE EYE). MID Aqra d-dokument sħiħ
Product Information Midazolam Injection Ampoules 05/2016 Version 08 Page 1 PRODUCT INFORMATION MIDAZOLAM SANDOZ ® INJECTION AMPOULE NAME OF THE MEDICINE _ACTIVE_ Midazolam (as hydrochloride) _CHEMICAL NAME: _ 8-chloro-6-(2-fluorophenyl)-1-methyl- 4_H_-imidazo[1,5-_a_][1,4] benzodiazepine _ _ _CHEMICAL STRUCTURE OF MIDAZOLAM _ _MOLECULAR FORMULA_: C 18 H 13 ClFN 3 _MOLECULAR WEIGHT_: 325.8 _CAS_: 59467-70-8 DESCRIPTION _ _ Midazolam is a benzodiazepine from the imidazobenzodiazepine group. 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. The solution is adjusted to a pH of 3.3. _INACTIVE_ Sodium chloride, hydrochloric acid (to produce hydrochloride), sodium hydroxide and water for injections PHARMACOLOGY Midazolam is a short acting central nervous system (CNS) depressant which induces sedation, hypnosis, amnesia and anaesthesia. Pharmacokinetic and pharmacodynamic data in chronic intravenous usage are not available beyond 15 days. _ _ The mechanism of action of the benzodiazepines is under continuous investigation. Benzodiazepines appear to intensify the physiological inhibitory mechanisms mediated by gamma- aminobutyric acid (GABA), the most common inhibitory neurotransmitter in the brain. The effects of midazolam on the CNS are dependent on the dose administered, the route of administration and the presence or absence of other premedications. Onset time of sedative effects Product Information Midazolam Injection Ampoules 05/2016 Version 08 Page 2 after intramuscular administration is 15 minutes, with peak sedation occurring 30 to 60 minutes following injection. When used intravenously as a sedative for endoscopic or other short therapeutic or diagnostic procedures, the end point of slurred speech can be attained within 2.8 to 4.8 minutes, depending on the total dose administ Aqra d-dokument sħiħ