HOSPIRA

Main information

  • Trade name:
  • HOSPIRA PROPOFOL INJECTION propofol 500mg/50mL emulsion for injection vial
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • HOSPIRA PROPOFOL INJECTION propofol 500mg/50mL emulsion for injection vial
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220710
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220710

HOSPIRA PROPOFOL INJECTION propofol 500mg/50mL emulsion for injection vial

ARTG entry for

Medicine Registered

Sponsor

Pfizer Australia Pty Ltd

Postal Address

38-42 Wharf Road,WEST RYDE, NSW, 2114

Australia

ARTG Start Date

16/01/2015

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. HOSPIRA PROPOFOL INJECTION propofol 500mg/50mL emulsion for injection vial

Product Type

Single Medicine Product

Effective date

20/10/2015

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Induction of General Anaesthesia in Children and Adults: ,Hospira™ Propofol Injection 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:

,Hospira™ Propofol Injection is a short-acting intravenous anaesthetic agent suitable for maintenance of general anaesthesia in adults and children aged

3 years and older. ,Hospira™ Propofol Injection may also be used for the 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. ,Hospira™ Propofol Injection has no analgesic

properties. ,Sedation During Intensive Care in Adults: ,Hospira™ Propofol Injection may also be used in adults for sedation of ventilated patients

receiving intensive care. ,Conscious Sedation for Surgical and diagnostic Procedures in Adults: ,Hospira™ Propofol Injection may also be used in adults

for monitored conscious sedation for surgical and diagnostic procedures.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Vial

Glass Type I Clear

2 Years

Store below 25

degrees Celsius

Neither child resistant

closure nor restricted

flow insert

Do not Freeze

Pack Size/Poison information

Pack Size

Poison Schedule

20 vials/pack

(S4) Prescription Only Medicine

Components

1. HOSPIRA PROPOFOL INJECTION propofol 500mg/50mL emulsion for injection vial

Dosage Form

Injection, emulsion

Route of Administration

Intravenous

Visual Identification

An emulsion with a milk-like appearance with no evidence of oiling out.

Active Ingredients

Propofol

500 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 02:13:34 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

Hospira

Propofol Injection CMI

Page 1

Hospira™ Propofol Injection

Propofol (pro-po-fole)

Consumer Medicine Information

Date of dispensing

Consumer name

pharmacy name

Consumer address

pharmacy address

What is in this leaflet

This leaflet answers some

common questions about

Hospira™ Propofol Injection. It

does not contain all the available

information. It does not take the

place of talking to your doctor or

anaesthetist.

All medicines have risks and

benefits. Your doctor or

anaesthetist has weighed the

risks of you being given propofol

against the benefits it is expected

to have for you.

If you have any concerns about

being given this medicine, ask

your doctor or anaesthetist.

Keep this leaflet.

You may need to read it again.

What Hospira™

Propofol Injection is

used for

General anaesthesia

Hospira™ Propofol Injection is

used as a short-acting general

anaesthetic in adults, and

children aged 1 month or older.

A general anaesthetic is a

medicine which produces general

anaesthesia. This is the condition

of heavy sleep needed during

surgery. Propofol is short-acting,

which means that patients go to

sleep quickly, usually within 30

seconds of receiving propofol, but

then wake up quickly as it wears

off.

Propofol can be used for very

short operations when only one

injection is needed.

Propofol can be used throughout

longer operations if more is given

as repeated doses.

Propofol can also be used to start

off anaesthesia (induction

anaesthesia). This means the

anaesthetist may change over to

another anaesthetic once sleep is

induced.

Sedation

Propofol can be given to adults if

they need to be sedated (calm) or

sleepy, but do not need the heavy

sleep of anaesthesia. This type

of sedation may be required

during certain tests or

procedures.

Propofol can also be used in

intensive care wards for adults

who are being ventilated (on a

breathing machine) to keep them

sedated (calm).

Ask your doctor or anaesthetist

if you have any questions

about why this medicine has

been prescribed for you.

Your doctor or anaesthetist may

have prescribed it for another

reason.

This medicine is not addictive.

This medicine is available only

with a doctor’s prescription.

There is not enough information

to recommend the use of this

medicine for children under the

age of 1 month for general

anaesthesia. This medicine must

not be used for children 16 years

of age and under for sedation

during tests or procedures, or for

sedation in the intensive care

ward.

Before you are given

Hospira™ Propofol

Injection

When you must not be

given it

You must not be given Hospira™

Propofol Injection if you have an

allergy to:

any medicine containing

propofol

or any of the other

ingredients; glycerol, soya

oil, egg lecithin or sodium

hydroxide.

Symptoms of an allergic reaction

may include shortness of breath,

wheezing or difficulty breathing;

swelling of the face, lips, tongue

or other parts of the body; rash,

itching or hives on the skin.

Children aged 16 years or under

must not receive propofol for

sedation during tests or

procedures or for sedation in the

intensive care ward.

You must not use this medicine

after the expiry date printed on

the pack or if the packaging is

torn or shows signs of

tampering.

If it has expired or is damaged,

return it to your pharmacist for

disposal.

Hospira

Propofol Injection CMI

Page 2

If you are not sure whether you

should be given this medicine,

talk to your doctor.

Before you are given it

Tell your doctor or anaesthetist

if you have allergies to any

other medicines, foods,

preservatives or dyes.

Tell your doctor or anaesthetist

if you have or have had any of

the following medical

conditions:

epilepsy (fits or convulsions)

heart disease

respiratory (breathing)

problems

liver or kidney disease

very high blood fat levels or

disorders of fat metabolism

(this warning applies to very

rare conditions, not the more

common high blood

cholesterol)

general debility for some time

(feebleness, weakness or loss

of strength).

Tell your doctor or anaesthetist

if you are pregnant or if you

intend to become pregnant or

are breast-feeding.

Hospira™ Propofol Injection is

not recommended for use during

pregnancy or breast-feeding.

Your doctor can discuss with you

the risks and benefits involved.

If you have not told your doctor

or anaesthetist about any of

the above, tell them before you

are given propofol.

Taking other medicines

Tell your doctor, anaesthetist

or pharmacist if you are taking

or using any other medicines,

including any that you buy

without a prescription from

your pharmacy, supermarket or

health food shop.

Some medicines and propofol

may interfere with each other.

These include:

strong pain relievers

heart medication

medicines used to produce

calmness or to help you to

sleep

some anxiety medicines

some medicines used to treat

epilepsy, such as

barbiturates.

Your doctor, anaesthetist or

pharmacist may have information

on medicines to be careful with or

avoid when you are given this

medicine.

How Hospira™

Propofol Injection is

given

How much is given

Your doctor or anaesthetist will

decide how much Hospira™

Propofol Injection you are given.

This will depend on your age and

other factors such as your weight

and the duration of your

procedure. The dose will be

adjusted to keep you at the right

depth of sleep or sedation.

The dose of Hospira™ Propofol

Injection needed for sedation is

less than that needed for

anaesthesia.

How it is given

Hospira™ Propofol Injection is

given by an injection into a vein,

usually in the forearm or the back

of the hand. It must only be given

by a doctor or anaesthetist.

Overdose

As Hospira™ Propofol Injection is

given to you under the

supervision of your doctor or

anaesthetist, it is very unlikely

that you will receive too much.

Your doctor or anaesthetist has

information on how to recognise

and treat an overdose. Symptoms

of an overdose may include low

blood pressure and difficulty in

breathing.

In case of overdose, immediately

contact the Poisons Information

Centre on 131 126 (Australia) or

0800 764 766 (New Zealand).

Ask your doctor or anaesthetist

if you have any concerns.

While you are being

given Hospira™

Propofol Injection

Things to be careful of

Do not drive a car or operate

machinery for at least one day

after you have been given

propofol.

As with other anaesthetics,

propofol may cause impairment of

skilled tasks, such as driving or

operating machinery, for some

time after you have been given it

Make sure you know how you

react to propofol before you

drive a car, operate machinery,

or do anything else that could

be dangerous if you are drowsy

or dizzy.

Ask your doctor when you can

return to work involving

driving, or operating machinery

or heavy equipment.

Side Effects

Tell your doctor or anaesthetist

as soon as possible if you do

not feel well after you have

been given Hospira™ Propofol

Injection.

This medicine helps provide

anaesthesia or sedation for most

people, but it may have unwanted

side effects in a few people. 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.

If you are over 65 years of age

you may have an increased

chance of getting side effects.

Do not be alarmed by the

following lists of side effects.

Hospira

Propofol Injection CMI

Page 3

You may not experience any of

them.

Ask your doctor or anaesthetist

to answer any questions you

may have.

Tell your doctor if you notice

any of the following and they

worry you:

pain, heat or tingling at the

injection site

feeling of extreme excitement

or happiness skin rash or

flushing of the skin

feeling faint

nausea or vomiting, cough,

headache, shivering,

restlessness or mood

changes when you are

waking up from the

anaesthetic

hiccuping or difficulty in

breathing.

The above list includes the more

common side effects of your

medicine. They are usually mild

and short lived.

Tell your doctor as soon as

possible if you notice any of

the following:

slow, fast or irregular heart

beat

convulsions (fitting)

signs of an allergic reaction,

such as shortness of breath,

wheezing or difficulty

breathing; swelling of the

face, lips, tongue or other

parts of the body; rash,

itching or hives on the skin

severe pain in the upper

stomach

temporary paralysis or

weakness of the muscles.

The above list includes serious

side effects. These side effects

are rare.

Some of the side effects of

propofol may occur whilst you are

asleep or sedated. Your doctor or

anaesthetist is trained to manage

these reactions in the unlikely

event that they occur. For

example, if you are sleeping too

deeply and your blood pressure is

too low or you need help

breathing, your anaesthetist may

reduce the dose of propofol. If

your sleep is too light and you

move or wriggle a bit, the dose

may be increased. If your heart

rate becomes too slow or

irregular other medicines may be

needed.

Tell your doctor or anaesthetist

if you notice anything that is

making you feel unwell.

Other side effects not listed

above may also occur in some

patients.

After using Hospira™

Propofol Injection

Storage

Hospira™ Propofol Injection will

be stored in the pharmacy or on

the ward. The injection is kept in

a cool dry place where the

temperature stays below 25

C. It

should not be frozen.

Product Description

What it looks like

Hospira™ Propofol Injection is a

white to slight off-white, oil in

water emulsion containing 10 mg

propofol per 1 mL, which comes

in a glass vial.

Ingredients

Active ingredients:

propofol 10 mg/mL.

Inactive ingredients:

glycerol

soya oil

egg lecithin

sodium hydroxide

water for injection.

Hospira™ Propofol Injection does

not contain lactose, sucrose,

gluten, tartrazine or other azo

dyes.

Sponsor

Australian Sponsor

Hospira Pty Ltd

ABN 13 107 058 328

Level 3

500 Collins St

Melbourne VIC 3000

Australia

New Zealand Sponsor

Hospira NZ Limited

58 Richard Pearse Drive

Airport Oaks, Mangere 2022

Auckland

New Zealand

Hospira™ Propofol Injection vials

are available in the following

sizes:

200mg/20mL

AUST R 217142

500mg/50mL

AUST R 220710

1g/100mL

AUST R 220711

This leaflet was prepared in

January 2015.

13-7-2018

Hospira Issues Voluntary Nationwide Recall of Daptomycin for Injection Lyophilized Powder for Solution, Due to Infusion Reactions

Hospira Issues Voluntary Nationwide Recall of Daptomycin for Injection Lyophilized Powder for Solution, Due to Infusion Reactions

Hospira, Inc., a Pfizer company, is voluntarily recalling 8 lots of Hospira’s Daptomycin for Injection 500 mg, Lyophilized Powder For Solution, Single Dose Vial (NDC 0409-0106-01) to the Hospital/Retail level. The product is being recalled due to adverse event reports indicative of infusion reactions.

FDA - U.S. Food and Drug Administration

4-6-2018

Hospira Issues a Voluntary Nationwide Recall for Two Lots of Naloxone Hydrochloride Injection, USP, in the Carpuject™ Syringe System due to the Potential Presence of Particulate Matter

Hospira Issues a Voluntary Nationwide Recall for Two Lots of Naloxone Hydrochloride Injection, USP, in the Carpuject™ Syringe System due to the Potential Presence of Particulate Matter

Hospira, Inc., a Pfizer company, is voluntarily recalling lots 72680LL and 76510LL of Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL, Carpuject Single-use cartridge syringe system (NDC 0409-1782-69), to the hospital/institution level due to the potential presence of embedded and loose particulate matter on the syringe plunger.

FDA - U.S. Food and Drug Administration

4-6-2018

Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL in the Carpuject™ Single-use Cartridge Syringe System   by Hospira: Recall - Due to the Potential Presence of Particulate Matter

Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL in the Carpuject™ Single-use Cartridge Syringe System by Hospira: Recall - Due to the Potential Presence of Particulate Matter

The patient has a low likelihood of experiencing adverse events ranging from local irritation, allergic reactions, phlebitis, end-organ granuloma, tissue ischemia, pulmonary emboli, pulmonary dysfunction, pulmonary infarction, and toxicity.

FDA - U.S. Food and Drug Administration

1-11-2018

Taxespira (Hospira UK Limited)

Taxespira (Hospira UK Limited)

Taxespira (Active substance: docetaxel) - Centralised - Withdrawal - Commission Decision (2018)7368 of Thu, 01 Nov 2018

Europe -DG Health and Food Safety

22-10-2018

Pemetrexed Hospira (Pfizer Europe MA EEIG)

Pemetrexed Hospira (Pfizer Europe MA EEIG)

Pemetrexed Hospira (Active substance: pemetrexed) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6971 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3970/T/14

Europe -DG Health and Food Safety

8-10-2018

Palonosetron Hospira (Pfizer Europe MA EEIG)

Palonosetron Hospira (Pfizer Europe MA EEIG)

Palonosetron Hospira (Active substance: palonosetron) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6606 of Mon, 08 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4069/T/04

Europe -DG Health and Food Safety

24-9-2018

Topotecan Hospira (Pfizer Europe MA EEIG)

Topotecan Hospira (Pfizer Europe MA EEIG)

Topotecan Hospira (Active substance: topotecan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6238 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1192/T/33

Europe -DG Health and Food Safety

24-9-2018

Zoledronic acid Hospira (Pfizer Europe MA EEIG)

Zoledronic acid Hospira (Pfizer Europe MA EEIG)

Zoledronic acid Hospira (Active substance: zoledronic acid) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6243 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2365/T/33

Europe -DG Health and Food Safety

10-9-2018

Retacrit (Hospira UK Limited)

Retacrit (Hospira UK Limited)

Retacrit (Active substance: epoetin zeta) - Centralised - Yearly update - Commission Decision (2018)5946 of Mon, 10 Sep 2018

Europe -DG Health and Food Safety

10-8-2018

Bortezomib Hospira (Pfizer Europe MA EEIG)

Bortezomib Hospira (Pfizer Europe MA EEIG)

Bortezomib Hospira (Active substance: bortezomib) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5515 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4207/T/10

Europe -DG Health and Food Safety

16-5-2018

Inflectra (Hospira UK Limited)

Inflectra (Hospira UK Limited)

Inflectra (Active substance: Infliximab) - Centralised - Yearly update - Commission Decision (2018)3054 of Wed, 16 May 2018

Europe -DG Health and Food Safety

15-5-2018

Pemetrexed Hospira (Hospira UK Limited)

Pemetrexed Hospira (Hospira UK Limited)

Pemetrexed Hospira (Active substance: pemetrexed) - Centralised - Yearly update - Commission Decision (2018)3059 of Tue, 15 May 2018

Europe -DG Health and Food Safety