Ország: Ausztrália
Nyelv: angol
Forrás: Department of Health (Therapeutic Goods Administration)
midazolam, Quantity: 5 mg/mL
Pharmaco Australia Ltd
Injection, solution
Excipient Ingredients: hydrochloric acid; sodium chloride; water for injections; sodium hydroxide
Intravenous, Intramuscular
1mL x 10
(S4) Prescription Only Medicine
1. Intravenously as an agent for conscious sedation prior to short surgical, diagnostic, therapeutic or endoscopic procedures, such as bronchoscopy, gastroscopy, cystoscopy, coronary angiography and cardiac cathetherization, either alone or in conjunction with a narcotic; 2. Intravenously 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 narrower dose range and in a shorter period of time; 3. Sedation in intensive care units by intravenous intermittent administration or continuous infusion; 4. Intramuscularly for preoperative sedation (induction of sleepiness or drowsiness and relief of apprehension) and to impair memory of perioperative events.
Visual Identification: clear, colourless liquid; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 5 Years; Container Temperature: Store below 30 degrees Celsius
Registered
1991-08-23
Hypnovel ® 1 HYPNOVEL® 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 USING HYPNOVEL? Hypnovel contains the active ingredient Midazolam. Hypnovel is used as a sedative during some short medical procedures. For more information, see Section 1. Why am I using Hypnovel? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE HYPNOVEL? Do not use if you have ever had an allergic reaction to Hypnovel or any of the ingredients listed at the end of the CMI. 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 Hypnovel? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Hypnovel and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE HYPNOVEL? • Hypnovel may be given to you as an injection into a vein or muscle. It may also be given through an infusion set in an intensive care unit. Other medications may also be given at the same time. • Your doctor will adjust the dose necessary for you. This depends on which medical procedure you will be having, your age, weight and your general health. Elderly patients may need to receive less. More instructions can be found in Section 4. How do I use Hypnovel? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING HYPNOVEL? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using Hypnovel. • Tell your doctor if you are taking any other medicines or have any conditions listed in section 2 of the full CMI prior to taking Hypnovel. THINGS YOU SHOULD NOT DO • Do not take any other medicines whether they require a prescription or not without first telling your doctor. DRIVING OR USING MACHINES • Do not drive or operate machin Olvassa el a teljes dokumentumot
AUSTRALIAN PRODUCT INFORMATION – HYPNOVEL ® (MIDAZOLAM) SOLUTION FOR INJECTION 2020-04 v1.0 1 1. NAME OF THE MEDICINE Midazolam 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Hypnovel 5mg/5mL Each mL contains 1mg of midazolam (as hydrochloride) One 5mL ampoule contains 5mg midazolam Hypnovel 5mg/1mL Each mL contains 5 mg midazolam (as hydrochloride) One 1 mL ampoule contains 5 mg midazolam One 3 mL ampoule contains 15 mg 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 - 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 DOSE 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 Hypnovel injection is administered, regardless of age or health status. The dosage of Hypnovel administered should be adjusted according to the type and amount of premedication used. Intravenously (IV) Hypnovel should be administered slowly. 2020-04 v1. Olvassa el a teljes dokumentumot