Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
midazolam hydrochloride, Quantity: 1.112 mg/mL (Equivalent: midazolam, Qty 1 mg/mL)
B Braun Australia Pty Ltd
midazolam hydrochloride
Injection, solution
Excipient Ingredients: hydrochloric acid; sodium chloride; water for injections
Intramuscular, Intravenous
10 x 5 ml
(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 solution; Container Type: Ampoule; Container Material: LDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2015-06-12
B. BRAUN MIDAZOLAM – CMI – Version 2.1 1 B BRAUN MIDAZOLAM 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 GIVEN B BRAUN MIDAZOLAM? B BRAUN MIDAZOLAM contains the active ingredient midazolam hydrochloride. B BRAUN MIDAZOLAM is used as a sedative during some short medical procedures. For more information, see Section 1. Why am I given B BRAUN MIDAZOLAM? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I AM GIVEN B BRAUN MIDAZOLAM? Do not use if you have ever had an allergic reaction to B BRAUN MIDAZOLAM 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 am given B BRAUN MIDAZOLAM? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with B BRAUN MIDAZOLAM 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 AM I GIVEN B BRAUN MIDAZOLAM? • B. BRAUN MIDAZOLAM 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 receive B BRAUN MIDAZOLAM? in the full CMI. 5. WHAT SHOULD I KNOW WHILE GIVEN B BRAUN MIDAZOLAM? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are receiving B Braun Midazolam. • Tell your doctor if you feel B. BRAUN MIDAZOLAM is not helping you. THINGS YOU SHOULD NOT DO • Do not take any other medicines whether they require Read the complete document
B Braun Midazolam PI – Version 2.0 Page 1 of 18 NAME OF THE MEDICINE A USTRALIAN PRODUCT INFORMATION – B. BRAUN MIDAZOLAM (MIDAZOLAM) 1. NAME OF THE MEDICINE MIDAZOLAM 2. QUALITATIVE AND QUANTITATIVE COMPOSITION B. Braun Midazolam 1 mg/mL 1 ML OF SOLUTION CONTAINS 1 MG OF MIDAZOLAM AS 1.112 MG OF MIDAZOLAM HYDROCHLORIDE EACH AMPOULE WITH 5 ML SOLUTION CONTAINS 5 MG OF MIDAZOLAM AS 5.560 MG OF MIDAZOLAM HYDROCHLORIDE EACH BOTTLE WITH 50 ML SOLUTION CONTAINS 50 MG OF MIDAZOLAM AS 55.60 MG OF MIDAZOLAM HYDROCHLORIDE EACH BOTTLE WITH 100 ML SOLUTION CONTAINS 100 MG OF MIDAZOLAM AS 111.2 MG OF MIDAZOLAM HYDROCHLORIDE For the full list of excipients, see section 6.1 List of excipients. B. Braun Midazolam 5 mg/mL 1 ML OF SOLUTION CONTAINS 5 MG OF MIDAZOLAM AS 5.56 MG OF MIDAZOLAM HYDROCHLORIDE EACH AMPOULE WITH 1 ML SOLUTION CONTAINS 5 MG OF MIDAZOLAM AS 5.56 MG OF MIDAZOLAM HYDROCHLORIDE EACH AMPOULE WITH 3 ML SOLUTION CONTAINS 15 MG OF MIDAZOLAM AS 16.68 MG OF MIDAZOLAM HYDROCHLORIDE EACH AMPOULE WITH 10 ML SOLUTION CONTAINS 50 MG OF MIDAZOLAM AS 55.60 MG OF MIDAZOLAM HYDROCHLORIDE For the full list of excipients, see section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Solution for injection/infusion. 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. B Braun Midazolam PI – Version 2.0 Page 2 of 18 • IM for preoperative sedation (induction of sleepiness or drowsiness and relief of apprehension) Read the complete document