MIDAZOLAM

Main information

  • Trade name:
  • MIDAZOLAM ACCORD midazolam (as hydrochloride) 50 mg/10 mL solution for injection ampoules
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • MIDAZOLAM ACCORD midazolam (as hydrochloride) 50 mg/10 mL solution for injection ampoules
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 207225
  • Last update:
  • 10-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

207225

MIDAZOLAM ACCORD midazolam (as hydrochloride) 50 mg/10 mL solution for injection ampoules

ARTG entry for

Medicine Registered

Sponsor

Accord Healthcare Pty Ltd

Postal Address

Level 24 570 Bourke Street,Melbourne, VIC, 3000

Australia

ARTG Start Date

16/05/2014

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 ACCORD midazolam (as hydrochloride) 50 mg/10 mL solution for injection ampoules

Product Type

Single Medicine Product

Effective date

13/09/2016

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

48 Months

Store below 25

degrees Celsius

Neither child resistant

closure nor restricted

flow insert

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

Pack of 10 Ampoules

(S4) Prescription Only Medicine

Components

1. MIDAZOLAM ACCORD midazolam (as hydrochloride) 50 mg/10 mL solution for injection ampoules

Dosage Form

Injection, solution

Route of Administration

Intravenous

Visual Identification

Clear, colourless to pale yellow, sterile, isotonic, preservative-free solution

in clear glass ampoules (type - 1).

Active Ingredients

Midazolam

50 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 28.11.2017 at 12:43:41 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 ACCORD INJECTION

CONSUMER MEDICINE INFORMATION

v 2.0

What is in this leaflet

This leaflet answers some

common questions about

Midazolam Accord. It does not

contain all the available

information.

It does not take the place of

talking to your doctor or

pharmacist.

All medicines have risks and

benefits. Your doctor has

weighed the risks of you using

Midazolam Accord against the

benefits they expect it will have

for you.

If you have any concerns

about being given this

medicine, ask your doctor or

pharmacist.

Keep this leaflet.

You may need to read it again.

What Midazolam

Accord is used for

Midazolam Accord may be

injected as a sedative during

some short medical procedures.

Midazolam Accord 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 Accord

over several hours or days as a

sedative.

Midazolam Accord belongs to a

group of medicines called

benzodiazepines. They are

thought to work by their action

on brain chemicals.

Midazolam Accord can cause

sedation, hypnosis, amnesia

and/or anaesthesia, depending

on the dose.

Your doctor, however, may

have prescribed Midazolam

Accord for another purpose.

Ask your doctor if you have

any questions about why

Midazolam Accord has been

prescribed for you.

Midazolam Accord is only

given by a doctor trained to use

this medicine.

If you will be receiving

Midazolam Accord during

surgery, your doctor will give

you the medicine and closely

follow your progress.

This medicine is available only

with a doctor's prescription.

Before you receive

Midazolam Accord

Do not use Midazolam Accord

if

you have had an allergic

reaction to Midazolam

Accord, 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

you are suffering from

shock, coma or acute

alcoholic intoxication

If you are not sure whether

you should be given

Midazolam Accord, talk to

your doctor.

Do not give Midazolam

Accord to children.

The safety or effectiveness of

Midazolam Accord in children

less than eight years of age has

not been established.

Before you receive it

Your doctor must know about

all the following before you

receive Midazolam Accord.

1)

if you are pregnant or plan

to become pregnant

It is not known whether

Midazolam Accord is harmful

to an unborn baby when given

to a pregnant woman. If there is

a need to use Midazolam

Accord when you are pregnant,

your doctor will discuss the

risks and benefits to you and the

unborn baby.

2)

if you are breastfeeding or

plan to breastfeed

Midazolam Accord may pass

into the breast milk and cause

drowsiness and/or feeding

difficulties in the baby.

Midazolam Accord is not

recommended for use while

breastfeeding.

3)

if you have any other

health problems including:

liver, kidney, heart or

lung disease

high or low blood

pressure

mental disorders

including; depression,

psychosis or

schizophrenia

epilepsy (fits or

convulsions)

4)

if you drink alcohol

regularly

Be careful when drinking

alcohol before receiving

Midazolam Accord.

Combining Midazolam Accord

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 Accord.

5)

if you are allergic to any

other medicines, foods,

dyes or preservatives.

MIDAZOLAM ACCORD INJECTION

CONSUMER MEDICINE INFORMATION

v 2.0

Taking other medicines

Tell your doctor if you are

taking any other medicines

including any that you have

bought without a prescription

from a pharmacy,

supermarket or health food

shop.

Some medicines and

Midazolam Accord may

interfere with each other. These

medicines include:

other sleeping tablets,

sedatives or tranquillisers

anaesthetics

medicines for depression

medicines to control fits e.g.

sodium valproate

medicines for allergies or

colds e.g. antihistamines

pain relievers

muscle relaxants

cimetidine (Tagamet

Magicul

), a medicine used

to treat ulcers

disulfiram (Antabuse

), a

medicine used in alcohol

abuse

erythromycin, a common

antibiotic

diltiazem (Cardizem

verapamil (Isoptin

Anpec

, Cordilox

Veracaps

ketoconazole, fluconazole

and itraconazole

ritonavir and Saquinavir

These medicines may be

affected by Midazolam Accord

or may affect how well

Midazolam Accord works.

Your doctor or pharmacist can

tell you what to do if you are

taking any of these medicines.

They also know of other

medicines to be careful with or

avoid while using Midazolam

Accord.

If you have not told your

doctor about any of the above,

tell them before you receive

Midazolam Accord.

How Midazolam

Accord is given

Midazolam Accord 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.

For how long Midazolam

Accord is given

Midazolam Accord may be

given once before a medical

procedure, or continuously by

infusion for patients in an

intensive care unit. Midazolam

Accord will be stopped once

there is no further need for

sedation.

If you have been given too

much (overdose)

If you have received too much

Midazolam Accord, you may

feel drowsy, tired, confused,

dizzy, feel weak or become

unconscious.

While you are taking

Midazolam Accord

Things you must do

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 Accord is not

helping you.

Things you must not do

Do not drive or operate

machinery until you know

how Midazolam Accord

affects you.

Midazolam Accord may cause

drowsiness or dizziness in some

people and therefore may affect

alertness. Make sure you know

how you react to Midazolam

Accord 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

Accord.

Things to be careful of

Be careful if you are elderly,

unwell 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.

Side effects

Tell your doctor or

pharmacist as soon as possible

if you do not feel well after

you have received Midazolam

Accord.

In addition to the beneficial

effects of Midazolam Accord it

is possible that unwanted effects

will occur during treatment,

even when it is used as

intended. All medicines can

have side effects. Sometimes

they are serious, most of the

time they are not. You may

need medical treatment if you

get some of the side effects.

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,

MIDAZOLAM ACCORD INJECTION

CONSUMER MEDICINE INFORMATION

v 2.0

death has resulted rarely due to

a slowdown of the heart and

lungs.

Tell your doctor if you notice

any of the following and they

worry you:

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 immediately

or go to casualty at your

nearest hospital if you notice

any of the following:

difficulty breathing

changes in pulse rate and

blood pressure

sudden anxiety or excitation

hallucinations or delusions

severe sleep disturbances

These are serious side effects.

You may need urgent medical

attention. Serious side effects

are rare.

This is not a complete list of all

possible side effects. Others

may occur in some people and

there may be some side effects

not yet known.

Tell your doctor if you notice

anything else that is making

you feel unwell, even if it is

not on this list.

Ask your doctor or

pharmacist if you do not

understand anything in this

list.

Do not be alarmed by this list of

possible side effects. You may

not experience any of them.

After taking

Midazolam Accord

Storage

Stored below 25°C. Protect

from Light.

Product description

What Midazolam Accord

looks like

Midazolam Accord is a clear,

colourless to pale yellow,

isotonic solution in clear glass

ampoules (type I).

Ingredients

Active ingredient - midazolam

Midazolam Accord injection

contains, Midazolam 1 mg/mL

or 5 mg/mL.

Inactive ingredients

sodium chloride

hydrochloric acid,

concentrated

sodium hydroxide

water for injection.

Please check with your

pharmacist for the latest

Consumer Medicine

Information.

Australian Register Numbers

AUST R 207239, Midazolam

Accord Injection, 5 mg /5 mL

(sterile) Glass Ampoule (10

ampoule packs).

AUST R 207241, Midazolam

Accord Injection, 5 mg /1 mL

(sterile) Glass Ampoule (10

ampoule packs).

AUST R 207245, Midazolam

Accord Injection, 15 mg /3 mL

(sterile) Glass Ampoule (10

ampoule packs).

AUST R 207225, Midazolam

Accord Injection, 50 mg /10 mL

(sterile) Glass Ampoule (10

ampoule packs).

Name and Address of the

Sponsor

Accord Healthcare Pty Ltd

Lvl 24, 570 Bourke Street

Melbourne, VIC, 3000

Australia

Date of preparation

This leaflet was prepared on 13

September 2016

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