Consumer medicine information

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 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.

5. What should I know while given B BRAUN MIDAZOLAM?

6. Are there any side effects?

Tell your doctor or pharmacist as soon as possible if you do not feel well after you have received B. BRAUN MIDAZOLAM. All medicines can have side effects. Sometimes they are serious, most of the time they are not. All medical procedures which involve the use of an anaesthetic have a very small risk which your doctor will discuss with you. In elderly, or high risk patients, death has resulted rarely due to a slowdown of the heart and lungs.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

1 Name of Medicine

Midazolam.

2 Qualitative and Quantitative Composition

See Tables 1 and 2.
https://stagingapi.mims.com/au/public/v2/images/fulltablegif/BBMIDA01.gif https://stagingapi.mims.com/au/public/v2/images/fulltablegif/BBMIDA02.gif 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

4.9 Overdose

Symptoms. Overdosage of benzodiazepines is usually manifested by degrees of central nervous system depression ranging from drowsiness to coma. Overdose of midazolam is seldom life threatening if the medicine is taken alone, but in mild cases, may lead to symptoms including drowsiness, mental confusion and lethargy. In more serious cases, symptoms may include ataxia, areflexia, apnoea, hypotonia, hypotension, respiratory depression, coma and very rarely death. Coma may be more protracted and cyclical, particularly in elderly patients. Benzodiazepine respiratory depressant effects are more serious in patients with respiratory disease. Benzodiazepines increase the effects of other central nervous system depressants, including alcohol. When combined with other CNS depressants, the effects of overdosage are likely to be severe and may prove fatal.
Treatment. Treatment of overdose is symptomatic; institute supportive measures as indicated by the patient's clinical state. If the overdosage is known to be small, observation of the patient and monitoring of their vital signs only may be appropriate. In adults or children who have taken an overdose of benzodiazepines orally within 1-2 hours, consider activated charcoal with airway protection if indicated.
If CNS depression is severe consider the use of flumazenil, a benzodiazepine antagonist. This should only be administered under closely monitored conditions. It has a short half-life (about an hour), therefore patients administered flumazenil will require monitoring after its effects have worn off. Flumazenil may precipitate seizures and is contraindicated in the presence of medicines that reduce seizure threshold (e.g. tricyclic antidepressants) and epileptic patients who have been treated with benzodiazepines. Refer to the prescribing information for flumazenil for further information on the correct use of this medicine.
Haemoperfusion and haemodialysis are not useful in benzodiazepine intoxication.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Midazolam did not have mutagenic activity in Salmonella typhimurium (5 bacterial strains), Chinese hamster lung cells (V79), human lymphocytes, or in the micronucleus test in mice.
Carcinogenicity. Midazolam maleate was administered with diet in mice and rats for 2 years at dosages of 1, 9 and 80 mg/kg/day. In female mice in the highest dose group there was a marked increase in the incidence of hepatic tumours. In high dose male rats there was a small but statistically significant increase in benign thyroid follicular cell tumours. Dosages of 9 mg/kg/day of midazolam maleate do not increase the incidence of tumours. The pathogenesis of induction of these tumours is not known. These tumours were found after chronic administration, whereas human use is ordinarily single dose or of short duration.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSMIDAZO.gif Molecular formula: C₁₈H₁₃ClFN₃.
Molecular weight: 325.8.
CAS number. 59467-70-8.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription only medicine.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/BBMIDAST.gif