Midazolam-Claris

Main information

  • Trade name:
  • Midazolam-Claris midazolam (as hydrochloride) 5mg/5 mL solution for injection ampoule
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Midazolam-Claris midazolam (as hydrochloride) 5mg/5 mL solution for injection ampoule
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216025
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216025

Midazolam-Claris midazolam (as hydrochloride) 5mg/5 mL solution for injection ampoule

ARTG entry for

Medicine Registered

Sponsor

Claris Lifesciences Australia Pty Ltd

Postal Address

PO Box 1290,BURWOOD, NSW, 1805

Australia

ARTG Start Date

8/10/2014

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-Claris midazolam (as hydrochloride) 5mg/5 mL solution for injection ampoule

Product Type

Single Medicine Product

Effective date

24/08/2017

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

24 Months

Store below 30

degrees Celsius

Not recorded

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

5 mL, packs of 5 ampoules

(S4) Prescription Only Medicine

5 mL, packs of 10 ampoules

(S4) Prescription Only Medicine

5 mL, packs of 25 ampoules

(S4) Prescription Only Medicine

Components

1. Midazolam-Claris midazolam (as hydrochloride) 5mg/5 mL solution for injection ampoule

Dosage Form

Injection, solution

Route of Administration

Intravenous

Intramuscular

Visual Identification

Clear, colourless to pale yellow solution

Active Ingredients

Midazolam

1 mg/mL

© 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 07:47:51 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-Claris

Midazolam

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about Midazolam-Claris.

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-Claris 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-Claris is used for

Midazolam-Claris may be injected as a sedative during some short medical procedures.

Midazolam-Claris 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-Claris over

several hours or days as a sedative.

Midazolam belongs to a group of medicines called benzodiazepines. They are thought to

work by their action on brain chemicals. Midazolam-Claris can cause sedation, hypnosis,

amnesia and/or anaesthesia, depending on the dose.

Your doctor, however, may have prescribed Midazolam-Claris for another purpose. Ask

your doctor if you have any questions about why Midazolam-Claris has been

prescribed for you.

Midazolam-Claris is only given by a doctor trained to use this medicine. If you will be

receiving Midazolam-Claris 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-Claris

Do not use Midazolam-Claris 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

you are suffering from shock, coma or acute alcoholic intoxication

If you are not sure whether you should be given Midazolam-Claris, talk to your doctor.

Do not give Midazolam-Claris to children. The safety or effectiveness of Midazolam-Claris

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-Claris.

if you are pregnant or plan to become pregnant. It is not known whether Midazolam-

Claris is harmful to an unborn baby when given to a pregnant woman. If there is a need

to use Midazolam-Claris 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-Claris may pass into the

breast milk and cause drowsiness and/or feeding difficulties in the baby. Midazolam-

Claris is not recommended for use while breastfeeding.

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)

history of alcohol or drug abuse

if you drink alcohol regularly. Be careful when drinking alcohol before receiving

Midazolam-Claris. Combining Midazolam-Claris 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-Claris.

if you are allergic to any other medicines, foods, dyes or preservatives.

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 healthfood shop.

Some medicines and Midazolam-Claris may interfere with each other. These medicines

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

These medicines may be affected by Midazolam-Claris or may affect how well

Midazolam-

Claris 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.

If you have not told your doctor about any of the above, tell them before you receive

Midazolam-Claris.

How Midazolam-Claris is given

Midazolam-Claris 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-Claris is given

Midazolam-Claris may be given once before a medical procedure, or continuously by

infusion for patients in an intensive care unit.

Midazolam-Claris 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-Claris, you may feel drowsy, tired, confused,

dizzy, feel weak or become unconscious.

While you are taking Midazolam-Claris

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-Claris is not helping you.

Things you must not do

Do not drive or operate machinery until you know how midazolam affects you.

Midazolam-Claris may cause drowsiness or dizziness in some people and therefore may

affect alertness. Make sure you know how you react to Midazolam-Claris 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-

Claris.

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.

Side Effects

Tell your doctor or pharmacist as soon as possible if you do not feel well after you

have received Midazolam-Claris.

In addition to the beneficial effects of Midazolam-Claris 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, 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-Claris

Storage

Midazolam-Claris 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.

Product Description

What Midazolam-Claris looks like

Midazolam-Claris is a clear colourless to yellowish solution.

Ingredients

Active ingredient - midazolam

each ampoule of Midazolam-Claris 5 mg/5 mL and 5 mg/1 mL contains 5 mg

midazolam

each ampoule of Midazolam-Claris 15 mg/3 mL contains 15mg midazolam

each ampoule of Midazolam-Claris 50 mg/10 mL contains 50 mg midazolam

Inactive ingredients

sodium chloride

hydrochloric acid

sodium hydroxide

water for injection

Midazolam Claris is available as:

5 mg/5 mL: packs of 5, 10 and 25 ampoules. AUST R 216025

5 mg/1 mL: packs of 5, 10 and 25 ampoules. AUST R 216024

15 mg/3 mL: packs of 5, 10 and 25 ampoules. AUST R 216026

50 mg/10 mL: packs of 5, 10 and 25 ampoules. AUST R 216027

Distributor

Midazolam-Claris is distributed by:

AFT Pharmaceuticals Pty Ltd

113 Wicks Road

North Ryde

NSW 2113

Date of preparation: 28/07/2015

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