Midazolam

Main information

  • Trade name:
  • Midazolam APOTEX midazolam 5mg/5mL solution for injection ampoule
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Midazolam APOTEX midazolam 5mg/5mL solution for injection ampoule
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217663
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217663

Midazolam APOTEX midazolam 5mg/5mL solution for injection ampoule

ARTG entry for

Medicine Registered

Sponsor

Apotex Pty Ltd

Postal Address

PO Box 280,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

30/10/2014

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. Midazolam APOTEX midazolam 5mg/5mL solution for injection ampoule

Product Type

Single Medicine Product

Effective date

29/03/2016

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific 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.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Ampoule

Glass Type I Clear

36 Months

Store below 30

degrees Celsius

Not recorded

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

5 ampoules

(S4) Prescription Only Medicine

Components

1. Midazolam APOTEX midazolam 5mg/5mL solution for injection ampoule

Dosage Form

Injection, solution

Route of Administration

Intravenous

Intramuscular

Visual Identification

A clear colourless to pale yellow solution.

Active Ingredients

Midazolam

5 mg

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 26.11.2017 at 06:06:35 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Patient Information leaflet

MIDAZOLAM APOTEX

Solution for Injection

Contains the active ingredient midazolam

Consumer Medicine Information

For a copy of a large print leaflet, Ph: 1800 195 055

What is in this leaflet

Read this leaflet for information on

your medicine.

This leaflet answers some common

questions about midazolam. It does

not contain all the available

information. It does not take the

place of talking to your doctor or

pharmacist.

The information in this leaflet was

last updated on the date listed on the

last page. More recent information on

this medicine may be available.

Ask your doctor or pharmacist:

if there is anything you do not

understand in this leaflet,

if you are worried about being

given this medicine, or

to obtain the most up-to-date

information.

You can also download the most up

to date leaflet from

www.apotex.com.au.

All medicines have risks and

benefits. Your doctor has weighed

the risks of you using this medicine

against the benefits they expect it

will have for you.

Pharmaceutical companies cannot

give you medical advice or an

individual diagnosis.

Keep this leaflet with you. You may

want to read it again.

What this medicine is

used for

The name of your medicine is

MIDAZOLAM APOTEX solution

for injection. It contains the active

ingredient midazolam.

Midazolam may be injected as a

sedative during some short medical

procedures.

Midazolam 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 over several hours or

days as a sedative.

Midazolam belongs to a group of

medicines called benzodiazepines.

Midazolam can cause sedation,

hypnosis, amnesia and/or

anaesthesia, depending on the dose.

Your doctor, however, may have

prescribed midazolam for another

purpose.

Ask your doctor if you have any

questions about why this medicine

has been prescribed for you. Your

doctor may have prescribed this

medicine for another reason.

Midazolam is only given by a doctor

trained to use this medicine. If you

will be receiving midazolam during

surgery, your doctor will give you

the medicine and closely follow your

progress.

This medicine is available only with

a doctor's prescription.

How it works

Benzodiazepines are thought to work

by their action on brain chemicals.

As with other benzodiazepines,

midazolam may have the potential to

cause dependence. Benzodiazepines

should be avoided in patients with a

history of alcohol or drug abuse. The

risk of dependence increases with the

duration of treatment; it is also

greater in patients with a medical

history of alcohol and/or drug abuse

Use in children

This medicine should not be used in

children.

Before you are given

this medicine

When you must not be given

it

You must not be given this

medicine 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

MIDAZOLAM APOTEX SOLUTION FOR INJECTION

you are suffering from shock,

coma or acute alcoholic

intoxication

you are hypersensitive to, or

have had an allergic reaction to,

midazolam or any of the

ingredients listed at the end of

this leaflet.

Symptoms of an allergic reaction

may include: cough, shortness of

breath, wheezing or difficulty

breathing; swelling of the face,

lips, tongue, throat or other parts

of the body; rash, itching or hives

on the skin; fainting; or hay

fever-like symptoms.

If you think you are having an

allergic reaction, tell your

doctor immediately or go to the

Accident and Emergency

department at the nearest

hospital.

If you are not sure whether you

should be given midazolam, talk to

your doctor.

Midazolam should not be given to

children.

The safety or effectiveness of

midazolam in children less than eight

years of age has not been established.

Before you are given it

Before you are given this medicine,

tell your doctor if:

You have allergies to:

any other medicines

any other substances, such as

foods, preservatives or dyes.

You have or have had any

medical conditions, especially the

following:

liver, kidney, heart or lung

disease

high or low blood pressure

mental disorders including;

depression, psychosis or

schizophrenia

epilepsy (fits or convulsions)

history of alcohol or drug abuse

If you are pregnant or plan to

become pregnant.

It is not known whether

midazolam is harmful to an

unborn baby when given to a

pregnant woman. If there is a

need to use midazolam when you

are pregnant, your doctor will

discuss the risks and benefits to

you and the unborn baby.

If you are breastfeeding or plan to

breastfeed.

Midazolam may pass into the

breast milk and cause drowsiness

and/or feeding difficulties in the

baby. Midazolam is not

recommended for use while

breastfeeding.

If you drink alcohol regularly.

Be careful when drinking alcohol

before receiving midazolam.

Combining midazolam and

alcohol can make you more

sleepy, dizzy or lightheaded.

Your doctor may suggest that you

avoid alcohol for at least 12 hours

before you receive midazolam.

You are taking or are planning to

take any other medicines. This

includes vitamins and

supplements that are available

from your pharmacy, supermarket

or health food shop.

Some medicines may interact with

midazolam. These include:

other sleeping tablets, sedatives

or tranquillisers

anaesthetics

medicines for depression

medicines to control fits such as

sodium valproate

medicines for allergies or colds

such as antihistamines

pain relievers

muscle relaxants

cimetidine, a medicine used to

treat ulcers

disulfiram a medicine used in

alcohol abuse

erythromycin, a common

antibiotic

diltiazem and verapamil,

medicines used to treat high

blood pressure or heart conditions

verapamil

ketoconazole, fluconazole and

itraconazole, medicines used to

treat fungal infections

ritonavir and saquinavir,

medicines used to treat HIV.

If you have not told your doctor or

nurse about any of the above, tell

them before you receive

midazolam.

If you are taking any of these you

may need a different dose or you

may need to be given a different

medicines.

Other medicines not listed above

may also interact with midazolam.

How this medicine is

given

How much is given

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.

How it is given

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.

How long it is used for

Midazolam may be given once

before a medical procedure, or

continuously by infusion for patients

in an intensive care unit.

Midazolam will be stopped once

there is no further need for sedation.

If you have been given too

much (overdose)

If you think that you or anyone

else may have been given too much

of this medicine, immediately tell a

doctor or nurse, or go to the

Accident and Emergency

MIDAZOLAM APOTEX SOLUTION FOR INJECTION

department at your nearest

hospital.

Do this even if there are no signs of

discomfort or poisoning. You may

need urgent medical attention.

If you have received too much

midazolam, you may feel drowsy,

tired, confused, dizzy, feel weak or

become unconscious.

While you are being

given this medicine

Things you must do

Tell your doctor that you are about to

be given this medicine if:

you are about to be started on any

new medicine

you plan to have any vaccinations

or immunisations

you are pregnant or are planning

to become pregnant

you are breastfeeding or are

planning to breast feed

you are about to have any blood

tests

Do not take any other medicines

whether they require a

prescription or not without first

telling your doctor.

Tell your doctor if you feel

midazolam is not helping you.

Things you must not do

Do not drive or operate machinery

until you know how midazolam

affects you.

Midazolam may cause drowsiness or

dizziness in some people and

therefore may affect alertness. Make

sure you know how your react to

midazolam before you drive a car or

operate machinery, or do anything

else that could be dangerous if you

are drowsy, dizzy or not alert.

Do not have any alcohol for at least

12 hours after you have been given

midazolam.

Things to be careful of

Be careful if you are elderly,

unwell, drinking alcohol or taking

other medicines.

Some people may experience side

effects such as drowsiness,

confusion, dizziness and

unsteadiness, which may increase the

risk of a fall.

Possible side effects

Tell your doctor as soon as possible

if you do not feel well when you

have been given midazolam or if you

have any questions or concerns.

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 risks, 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.

Tell your doctor if you notice any

of the following:

drowsiness, tiredness

dizziness, unsteadiness

loss of memory, inattentiveness,

confusion, lack of concentration

headache, hangover feeling in the

morning

slurred speech

unpleasant dreams

blurred vision

pain, redness or hardness at the

injection site

muscle stiffness or inflammation

of the vein

coughing, hiccups

feeling sick with or without

vomiting

Tell your doctor as soon as possible

if you notice any of the following.

These may be serious side effects and

you may need medical attention:

difficulty breathing

changes in pulse rate and blood

pressure

sudden anxiety or excitation

hallucinations or delusions

severe sleep disturbances

Other side effects not listed above

may occur in some patients.

Allergic reactions

If you think you are having an

allergic reaction to midazolam, tell

your doctor immediately or go to

the Accident and Emergency

department at your nearest

hospital.

Symptoms of an allergic reaction

may include some or all of the

following:

cough, shortness of breath,

wheezing or difficulty breathing

swelling of the face, lips, tongue,

throat or other parts of the body

rash, itching or hives on the skin

fainting

hay fever-like symptoms.

Storage and disposal

Storage

Midazolam will be stored in the

pharmacy or on the ward. It is kept in

a cool dry place where the

temperature stays below 30°C. It

should be protected from light.

Disposal

Midazolam solution for injection is

used for one dose in one patient only.

Any remaining contents should be

discarded.

MIDAZOLAM APOTEX SOLUTION FOR INJECTION

Product description

What MIDAZOLAM APOTEX

solution for injection looks

like

Clear colourless to pale yellow

solution for injection.

Midazolam ampoules 5mg/5mL,

15mg/3mL, 50mg/10mL, come in a

pack size of 5 ampoules.

Midazolam ampoules 5mg/1mL

come in a pack size of 10 ampoules.

* Not all strengths, pack types and/or

pack sizes may be available.

Ingredients

Each ampoule contains 5mg/5mL

and 5mg/1mL of midazolam as the

active ingredient.

It also contains the following inactive

ingredients:

sodium chloride

hydrochloric acid

sodium hydroxide

water for injections

Australian Registration

Numbers

Midazolam-APOTEX 1mg/mL

solution for injection ampoules:

5 mL AUST R 217663.

Midazolam-APOTEX 5mg/5mL

solution for injection ampoules:

1 mL AUST R 217657.

3 mL AUST R 217658.

10 mL AUST R 217659.

Sponsor

Apotex Pty Ltd

16 Giffnock Avenue

Macquarie Park NSW 2113

This leaflet was last updated in:

February 2015.

MIDAZOLAM APOTEX SOLUTION FOR INJECTION

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