PROPOFOL-LIPURO

Main information

  • Trade name:
  • PROPOFOL-LIPURO 1% propofol 1000 mg/100 mL emulsion for injection bottle
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • PROPOFOL-LIPURO 1% propofol 1000 mg/100 mL emulsion for injection bottle
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220081
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220081

PROPOFOL-LIPURO 1% propofol 1000 mg/100 mL emulsion for injection bottle

ARTG entry for

Medicine Registered

Sponsor

B Braun Australia Pty Ltd

Postal Address

PO Box 6221,BAULKHAM HILLS DC, NSW, 2153

Australia

ARTG Start Date

10/03/2015

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. PROPOFOL-LIPURO 1% propofol 1000 mg/100 mL emulsion for injection bottle

Product Type

Single Medicine Product

Effective date

18/04/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Because of the difficulty in titrating small volumes, Propofol-Lipuro 2% should not be used in children aged from one month to 3 years.,Induction of

General Anaesthesia in Children and Adults

Propofol-Lipuro is a short-acting intravenous anaesthetic agent suitable for induction of general anaesthesia in adults and children aged one month and

older.,Maintenance of General Anaesthesia in Children and Adults

Propofol-Lipuro is a short acting intravenous anaesthetic agent suitable for maintenance of general anaesthesia in adults and children aged 3 years and

older.,Propofol-Lipuro 1% may also be used for maintenance of general anaesthesia in children aged from one month to 3 years for procedures not

exceeding 60 minutes, unless alternative anaesthetic agents should be avoided.,Propofol has no analgesic properties.,Use for Sedation During Intensive

Care in Adults

Propofol-Lipuro may also be used in patients >16 years for sedation of ventilated patients receiving intensive care.,Conscious Sedation for Surgical and

diagnostic Procedures

Propofol-Lipuro may also be used for monitored conscious sedation for surgical and diagnostic procedures in,·Propofol-Lipuro 1%: adults and children

aged one month and older.

·Propofol-Lipuro 2%: adults and children aged 3 years and older.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

Glass Type II Clear

18 Months

Store below 25

degrees Celsius

Neither child resistant

closure nor restricted

flow insert

Protect from Light

Do not Freeze

Pack Size/Poison information

Pack Size

Poison Schedule

10 x 100 mL

(S4) Prescription Only Medicine

Components

1. PROPOFOL-LIPURO 1% propofol 1000 mg/100 mL emulsion for injection bottle

Dosage Form

Injection, emulsion

Route of Administration

Intravenous

Visual Identification

Milky white oil-in-water emulsion in a colourless glass infusion bottle,

sealed with a grey rubber stopper and aluminium seal with blue

polypropylene flip-off insert

Active Ingredients

Propofol

10 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 22.11.2017 at 11:33:25 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

B.Braun Australia Pty Ltd

Page 1

CONSUMER MEDICINE INFORMATION

Propofol-Lipuro 1% and 2%

1. What is in this leaflet

This leaflet contains some common questions about Propofol-Lipuro.

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 or pharmacist has weighed the risk of

you taking this medicine against the benefits they expect it will have for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

2. What is Propofol-Lipuro used for?

It is a short-acting sleep inducing medicinal product used to start and sustain a general

anaesthesia.

It is used to induce sleep or lower your level of consciousness (as a sedative) during intensive

care or during diagnostic or surgical procedures.

3. Before you are given Propofol-Lipuro

When you must not be given Propofol-Lipuro

Do not use Propofol-Lipuro:

if you are allergic (hypersensitive) to Propofol or any of the other ingredients of

Propofol-Lipuro

if you are allergic (hypersensitive) to soya or peanut

Take special care with Propofol-Lipuro if:

you have a disorder in which your body does not handle fat properly

you have any other health problems which require much caution in the use of fat

emulsions

you are very overweight

your blood volume is too low (hypovolaemia)

you are very weak or have heart, circulatory, kidney or liver problems

you have high pressure within in the skull and low blood pressure in the arteries

you have problems with your breathing

you have epilepsy

you are undergoing some procedures where spontaneous movements are particularly,

undesirable.

Please tell your doctor if you have one of these diseases or conditions.

Do not give Propofol-Lipuro in children of one month of age or younger as a general anaesthetic.

B.Braun Australia Pty Ltd

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Do not give Propofol-Lipuro 2% in children under 3 years of age.

Do not give Propofol-Lipuro in children 16 years or younger as a sedation during intensive

care.

The use of Propofol-Lipuro is not recommended in newborn infants

It will not be used when you are receiving electroconvulsive therapy (electric shock treatment in

cases of severe long lasting epileptic attacks.

If you are receiving other lipids by a drip into your vein at the same time your doctor will

pay attention to your total daily fat intake.

Propofol will be administered to you by a physician trained in anaesthesia or intensive

care. You will be constantly monitored during anaesthesia and waking-up time.

If you experience signs of the so called ‘propofol infusion syndrome’ ( a doctor must be

called if the following happen) your doctor will decrease the dosage of propofol or will

switch to an alternative drug.

Taking or using other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,

including medicines obtained without a prescription.

Some medicines may depress your breathing or your blood circulation when combined with

Propofol or prolong the effect of Propofol:

Painkillers, benzodiazepine tranquillisers, narcotic gases, some local anaesthetics, fentanyl, other

medicinal products usually given before operations.

On the other hand, the sedative effect of some of these medicinal products may become stronger.

When given together with Propofol, certain medicines used for muscle relaxation

(suxamethonium) or as antidote (neostigmin) may depress heart function.

Occurrence of a specific organic changes in the brain (leucoencephalopathy) has been reported in

patients having received fat emulsions such as Propofol-Lipuro together with ciclosporin (a

medicine used to suppress rejection reactions after organ transplantation and to suppress

overreactions of the immune system).

Make sure that your doctor knows if you are taking any of these medicinal products.

Using Propofol-Lipuro with food and drink

Alcohol and Propofol make the sedative effects of each other stronger. Therefore you should not

drink alcohol just before or just after you have Propofol-Lipuro.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

Propofol-Lipuro should not be used during pregnancy.

B.Braun Australia Pty Ltd

Page 3

If you are breast-feeding your child you should stop nursing and discard breast milk for 24 hours

after you have received Propofol-Lipuro. Studies in breast-feeding women showed that Propofol

is excreted in small amounts into the milk.

Driving and using machines

You should not drive or operate machinery for a while after you have had an injection or infusion

of Propofol-Lipuro. Your doctor will tell you how long you must wait before you drive or use

machinery again.

Your doctor will advise you

if you should be accompanied when you are leaving.

when you can drive and use machinery again.

on the use of other tranquillizing drugs (e.g. tranquillizers, strong pain killers,

alcohol).

Important information about some of the ingredients of Propofol-Lipuro

This medicinal product contains less than 1 mmol (23 mg) sodium in 100 mL, that is, it is

essentially ‘sodium free’.

4. How to use Propofol-Lipuro

Propofol-Lipuro will only be given by anaesthetists or by specially trained doctors in an intensive

care unit.

Dosage

The dose you are given will vary depending on your age, body weight and physical condition.

The doctor will give the correct dose to start and to sustain anaesthesia or to achieve the required

level of sedation, by carefully watching your responses and vital signs (pulse, blood pressure,

breathing, etc).

The doctor will also observe limits of the time of application, if necessary.

Propofol-Lipuro will usually be given by injection when used to induce general anaesthesia and

by continuous infusion (a slower, longer injection) when used to maintain general anaesthesia. It

may given as an infusion either diluted or undiluted. When used as a sedative it will usually be

given by infusion.

Propofol-Lipuro will only be given for a maximum of 7 days.

Method of administration

You will receive Propofol-Lipuro by intravenous injection or infusion, that is, through a needle or

small tube placed in one of your veins.

Because Propofol

Lipuro does not contain preservatives, an infusion from one vial or bottle of

Propofol

Lipuro will not last longer than 12 hours..

Your circulation and breathing will be constantly monitored while you are being given the

injection or infusion.

Overdose

B.Braun Australia Pty Ltd

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If you received more Propofol-Lipuro then you should

It is unlikely that this occurs because the doses you receive are very carefully controlled.

If you accidentally got an overdose, this could lead to depression of heart function, circulation

and breathing. In this case your doctor will employ any necessary treatment immediately.

If you have any further questions on the use of this product, ask your doctor or pharmacist

5. Possible Side Effects

Like all medicines, Propofol-Lipuro emulsion for injection or infusion can cause side effects,

although not everybody gets them.

Common (may affect up to 1 in 10 people):

Low blood pressure that might occasionally need infusion of fluids and reduction of

the speed of administration of propofol.

Too low heartbeat that might be serious in rare cases.

Rare

(may affect up to 1 in 1,000 people):

Convulsions like in epilepsy

Very rare (may affect up to 1 in 10,000 people):

Allergic reactions including swelling of the face, tongue or throat, wheezing breath,

skin redness and low blood pressure

There have been cases of unconsciousness occurring after operations. You will

therefore be carefully observed during the waking-up time.

Water on lungs (lung oedema) after administration of propofol

Inflammation of the pancreas.

Not known

(frequency cannot be estimated from the available data):

There have been reports of isolated cases of severe adverse reactions presenting as a

combination of the following symptoms: breakdown of muscle tissue, accumulation

of acidic (sour) substances in the blood, abnormally high blood potassium level, high

blood fat levels, abnormalities in the electrocardiogram (Brugada-type ECG), liver

enlargement, irregular heart-beat, kidney failure and heart failure. This has been

called the

“propofol infusion syndrome”

. Some of the affected patients eventually

died. These effects have only been seen in patients in intensive care with doses

higher than 4 mg of propofol per kg body weight per hour. See also section 2,

‘Warnings and precautions’.

Other side effects are:

Very common (affects more than 1 treated patient of 10):

Pain at the injection site occurring during the first injection. The pain may be

reduced by injecting propofol into larger veins of the forearm. Injection of lidocaine

(a local anaesthetic) and propofol at the same time also helps to reduce the pain at the

injection site.

Common (may affect up to 1 in 10 people):

B.Braun Australia Pty Ltd

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Short interruption of breathing

Headache during the time of recovery

Sickness or vomiting during the time of recovery

Uncommon (may affect up to 1 in 100 people):

Blood clots in veins or inflammation of veins

Very rare

(may affect up to 1 in 10,000 people):

Loss of sexual control during the time of recovery

Abnormal colour of urine after longer lasting administration of propofol

Cases of fever after an operation

Not known (frequency cannot be estimated from the available data):

Involuntary movements

Abnormally good mood

Drug abuse

Failure of the heart

Breakdown of muscle tissue has been reported very rarely in cases where propofol

has been given at greater doses than recommanded for sedation in intensive care

units

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any

possible side effects not listed in this leaflet.

6. Storage

Keep out of the reach and sight of children.

Do not use Propofol-Lipuro after the expiry date which is stated on the label and the carton after

EXP. The expiry date refers to the last day of that month.

Keep ampoules in the outer carton in order to protect from light. Store below 25°C. Do not freeze.

Propofol-Lipuro must be used immediately after opening the ampoule, vial or bottle.

Do not use Propofol-Lipuro if two separate layers can be seen after shaking the product.

The following information is intended for medical or healthcare professionals only:

The containers are for single use in one patient only.

Any unused emulsion must be thrown away at the end of administration.

The containers must be shaken before use.

7. Product Description

What

Propofol-Lipuro

looks like

It is a milky-white oil-in water emulsion which comes in the following:

Propofol-Lipuro 1%:

20mL glass ampoule

B.Braun Australia Pty Ltd

Page 6

20mL colourless glass vial, sealed with a grey rubber stopper and aluminium seal with a blue

polypropylene flip

off insert

50mL colourless glass infusion bottles, sealed with a grey rubber stopper and aluminium seal

with a blue polypropylene flip

off insert

100mL colourless glass infusion bottles, sealed with a grey rubber stopper and aluminium seal

with a blue polypropylene flip

off insert

Propofol-Lipuro 2%:

50mL colourless glass infusion bottles, sealed with a grey rubber stopper and aluminium seal

with a red polypropylene flip

off insert

Ingredients:

Propofol-Lipuro 1%

Active ingredient:

Propofol

1 mL contains 10 mg of Propofol.

Inactive ingredients:

Soya oil,

Medium-chain triglycerides,

Egg lecithin,

Glycerol,

Sodium oleate,

Water for injections

Propofol-Lipuro 2%

Active ingredient:

Propofol

1 mL contains 20 mg of Propofol.

Inactive ingredients:

Soya oil,

Medium-chain triglycerides,

Egg lecithin,

Glycerol,

Sodium oleate,

Water for injections

Australian registration number:

Propofol-Lipuro 1%:

20mL ampoule

AUST R 142906

20mL vial

AUST R 220082

50mL bottle

AUST R 220083

Propofol-Lipuro 2%:

50mL bottle

AUST R 220084

100mL bottle

AUST R 220081

8. Sponsor Details

B. Braun Australia Pty Ltd

17 Lexington Drive

Bella Vista NSW 2156

Australia

Toll Free Number: 1800 251 705

9. Date of Information

This leaflet was updated in August 2014