PARACETAMOL

Main information

  • Trade name:
  • PARACETAMOL KABI paracetamol 500mg/50mL solution for injection in freeflex bag
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • PARACETAMOL KABI paracetamol 500mg/50mL solution for injection in freeflex bag
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218688
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218688

PARACETAMOL KABI paracetamol 500mg/50mL solution for injection in freeflex bag

ARTG entry for

Medicine Registered

Sponsor

Fresenius Kabi Australia Pty Ltd

Postal Address

Level 2, 2 Woodland Way,Mount Kuring-gai, NSW, 2080

Australia

ARTG Start Date

3/07/2014

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. PARACETAMOL KABI paracetamol 500mg/50mL solution for injection in freeflex bag

Product Type

Single Medicine Product

Effective date

27/03/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Paracetamol 10 mg/mL, solution for infusion is indicated for the relief of mild to moderate pain and the reduction of fever where an intravenous route of

administration is considered clinically necessary.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Plastic

24 Months

Store below 30

degrees Celsius

Neither child resistant

closure nor restricted

flow insert

Do not Refrigerate

Do not Freeze

Pack Size/Poison information

Pack Size

Poison Schedule

20 x 50 mL bags

(S4) Prescription Only Medicine

50 x50 mL bags

(S4) Prescription Only Medicine

60x50 mL bags

(S4) Prescription Only Medicine

Components

1. PARACETAMOL KABI paracetamol 500mg/50mL solution for injection in freeflex bag

Dosage Form

Injection, solution

Route of Administration

Intravenous Infusion

Visual Identification

Colourless to almost colourless solution

Active Ingredients

Paracetamol

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 26.11.2017 at 04:35:47 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

CMI for Paracetamol Kabi

Aug 2016

Filename: ParCMI300816_clean

Paracetamol Kabi

Paracetamol for Injection

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about Paracetamol Kabi.

It does not contain all the available

information. It does not take the

place of talking to your doctor or

pharmacist.

medicines

have

risks

benefits. Your doctor has weighed

the risks of you taking Paracetamol

Kabi

against

benefits

they

expect it will have for you.

If you have any concerns about

taking

this

medicine,

ask

your

doctor or pharmacist.

Keep this leaflet. You may need to

read it again.

What Paracetamol Kabi

is used for

Paracetamol

Kabi

contains

paracetamol

analgesic

medicine which relieves pain and

reduces fever. Paracetamol Kabi is

a solution of paracetamol which is

given by intravenous infusion (IV)

directly into a vein, and is used to

relieve

pain

reduce

fever

following surgery.

This medicine is available only with

a doctor's prescription.

Before you are given

Paracetamol Kabi

When you must not be given it

You

must

not

be

given

Paracetamol Kabi if you have an

allergy to paracetamol or to any

of the ingredients listed at the

end of this leaflet.

Symptoms of an allergic reaction to

Paracetamol Kabi 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

You

must

not

be

given

Paracetamol

Kabi

if

you

have

liver

failure

or

severe

liver

disease.

If you are not sure whether you

should

be

given

Paracetamol

Kabi,

talk

to

your

doctor

or

pharmacist.

Before you start to take it

Tell your doctor or pharmacist if

you have allergies to:

any other medicines

any other substances,

such as foods,

preservatives or dyes

Tell your doctor or pharmacist if

you are pregnant

Paracetamol Kabi may be given to

pregnant women, but your doctor

must be told if you are pregnant.

Tell your doctor or pharmacist if

you are breast-feeding

Paracetamol Kabi may be given

to women who are breast-feeding,

but your doctor must be told if you

are breast-feeding.

Tell your doctor or pharmacist if

you

have

or

have

had

any

medical conditions, especially the

following:

liver disease

kidney disease

alcoholism

suffer

from

malnutrition

(low

reserves of glutathione)

dehydration

eating disorders

(anorexia, bulimia)

a wasting syndrome

including unexplained weight

loss, fatigue, weakness and

loss of appetite (cachexia)

a metabolic condition

called glucose-6-

phosphate

dehydrogenase

deficiency (G6PD)

hypovolaemia (decreased

blood volume)

If you have not told your doctor or

pharmacist

about

any

of

the

above, tell them before you are

given Paracetamol Kabi

Taking other medicines

It

is especially important to tell

your doctor if you are taking any

other

medication,

including

over the counter or pharmacy

medication,

which

contain

paracetamol.

This

may

affect

the dosage of Paracetamol Kabi

which you should receive.

Tell

your

doctor

if

you

drink

alcohol.

CMI for Paracetamol Kabi

Aug 2016

Filename: ParCMI300816_clean

Your doctor may advise you to avoid

alcohol

interfere

with

Paracetamol Kabi.

Some medicines and Paracetamol

Kabi may interfere with each other.

These include:

Pro-Cid (probenecid) – a

medicine used to treat gout or

given with antibiotics

Anticonvulsants – medicines

used to treat epilepsy or fits,

such as Dilantin

(phenytoin),

Tegretol

or Teril

(carbamazepine), amytal

sodium, phenobarbitone

Other forms of paracetamol,

such as tablets, capsules or

liquid preparations

Myleran

or Busulfex

(busulfan) a cancer drug

Dolobid

(diflunisal)

anti-

inflammatory drug

Barbiturates

Retrovir

(zidovudine) – a HIV

drug or other drugs containing

zidovudine

Anticoagulants which are used

to stop blood from clotting

Isoniazid

(isoniazid) a

tuberculosis drug

Antibiotics containing

amoxicillin plus clavulanic acid

such as Clamoxyl

, Clavulin

These medicines may be affected by

Paracetamol Kabi, or may affect how

well Paracetamol Kabi works. You

may need different amounts of your

medicine, or you may need to take

different medicines. Your doctor or

pharmacist will advise you.

Your

doctor

pharmacist may

have more information on medicines

to be careful

with or avoid

while

receiving Paracetamol Kabi.

How Paracetamol Kabi

is given

How much is given

Your doctor will decide what dose

you will be given, and for how long

you will be given Paracetamol Kabi.

Tell your doctor if you have been

taking other forms of paracetamol

(tablets,

capsules,

liquid

preparations) and the quantity that

you have been taking.

How Paracetamol Kabi is given

Paracetamol

Kabi

given

slow

infusion

(drip)

into

vein.

Paracetamol

Kabi

must

only

given by a doctor or nurse.

Overdose

Your doctor has information on how

to recognise and treat an overdose.

your

doctor

nurse

have any concerns.

While you are being

given Paracetamol

Kabi

Things you must do

Tell any other doctors, dentists,

and pharmacists who are treating

you

that

you

are

being

given

Paracetamol Kabi.

If you are about to be started on

any

new

medicine,

tell

your

doctor, dentist or pharmacist that

you are being given Paracetamol

Kabi.

Tell your doctor immediately if

you

develop

a

rash

or

other

symptoms of an allergic reaction.

Symptoms

allergic

reaction

may be:

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

Side effects

Tell your doctor or pharmacist as

soon as possible if you do not

feel

well

while

you

are

being

given Paracetamol Kabi.

Paracetamol

Kabi

helps

most

people with pain and fever, but it

may have unwanted side effects in

some

people.

medicines

have side effects. Sometimes they

are serious, most of the time they

not.

need

medical

treatment if you get some of the

side effects.

Ask your doctor or pharmacist to

answer any questions you may

have.

Tell your doctor or pharmacist

if you notice any of the following

and they worry you.

Feeling unwell

Dizziness, light headedness

Bleeding or bruising more easily

than normal

Vomiting, nausea

Constipation

Faster heart rate

Unusual tiredness or weakness,

fatigue

Redness of the skin

These

side

effects

rare

usually mild.

If any of the following happen, tell

your doctor or nurse immediately.

These

are

very

serious

side

effects.

You

may

need

urgent

medical attention.

Allergic reaction – 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

Yellowing of the skin and/or

eyes also called jaundice

CMI for Paracetamol Kabi

Aug 2016

Filename: ParCMI300816_clean

Other side effects not listed above

may occur in some patients. Tell

your doctor if you notice anything

that is making you feel unwell.

Do not be alarmed by possible side

effects.

You may not experience any of them.

Product Description

What it looks like

Paracetamol

Kabi

solution

infusion

mg/mL

clear

slightly yellowish solution.

Paracetamol

Kabi

available

glass vials containing 50 mL or 100

mL, or in plastic bags (freeflex

containing 50 mL or 100 mL.

Ingredients

Active ingredient: paracetamol 10

mg/mL

vial:

AUST

203625

contains 500 mg paracetamol

vial:

AUST

203624

contains 1 g of paracetamol.

freeflex

bag:

AUST

218687

contains

paracetamol

freeflex

bag:

AUST

218688 contains 1 g paracetamol

Other

ingredients:

mannitol,

cysteine hydrochloride, nitrogen (as

protective gas), water for injections.

Storage

Paracetamol Kabi will be stored in

pharmacy

hospital

ward. The injection should be kept

cool

place

where

temperature stays below 30

C for

the freeflex

bags and below 25°C

for the vials.

Supplier

Paracetamol

Kabi

supplied

Australia by:

Fresenius Kabi Australia Pty

Limited

Level 2, 2 Woodland Way

Mount Kuring-gai NSW 2080

Australia

Telephone: (02) 9391 5555

Paracetamol

Kabi

supplied

New Zealand by:

Fresenius Kabi New Zealand

Limited

60 Pavilion Drive

Airport Oaks, Auckland 2022

New Zealand

Freecall: 0800 144 892

® = Registered Trademark

This leaflet was prepared:

Aug 2016

16-1-2018

Yunnan Feng Shi Ling capsules – counterfeit

Yunnan Feng Shi Ling capsules – counterfeit

Yunnan Feng Shi Ling capsules contain the undeclared substance paracetamol.

Therapeutic Goods Administration - Australia

27-2-2014

Paracetamol use during pregnancy

Paracetamol use during pregnancy

A new Danish study suggests a possible connection between mothers' use of paracetamol painkillers during pregnancy and the risk of developing disorders like ADHD (attention deficit hyperactivity disorder) in children.

Danish Medicines Agency

3-8-2012

Danish Pharmacovigilance Update, 21 June 2012

Danish Pharmacovigilance Update, 21 June 2012

Among the topics covered in this issue of Danish Pharmacovigilance Update are: Decrease in the number of intoxications and suicide attempts using drugs containing acetylsalicylic acid or paracetamol.

Danish Medicines Agency

30-8-2018

Consultation: Referral of proposed amendment to the current Poisons Standard to the meeting of the ACMS, March 2019

Consultation: Referral of proposed amendment to the current Poisons Standard to the meeting of the ACMS, March 2019

Advisory Committee on Medicines Scheduling to consider upscheduling of modified release paracetamol to 'Pharmacist Only'. Closing date 31 October 2018

Therapeutic Goods Administration - Australia

30-8-2018

Modified release paracetamol

Modified release paracetamol

Advisory Committee on Medicines Scheduling to consider upscheduling of modified release paracetamol to 'Pharmacist Only'

Therapeutic Goods Administration - Australia