PARACETAMOL AN paracetamol 1000mg/100mL injection solution vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

paracetamol

Available from:

Medis Pharma Pty Ltd

INN (International Name):

Paracetamol

Authorization status:

Registered

Patient Information leaflet

_Paracetamol AN injection – Consumer Medicine Information_
Paracetamol AN CMI v3.0
Page
1 of 3
PARACETAMOL AN
_Paracetamol _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some
common questions about
Paracetamol AN.
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 risks of you receiving
Paracetamol AN against
the 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 WITH
THE MEDICINE.
You may need to read it
again.
WHAT
PARACETAMOL AN
IS USED FOR
Paracetamol AN contains
paracetamol, an analgesic
medicine which relieves
pain and reduces fever.
Paracetamol AN is a
solution of paracetamol
which is given by IV
infusion directly into a
vein, and is used to
relieve pain or reduce
fever following surgery.
This medicine is
available only with a
doctor's prescription.
BEFORE YOU ARE
GIVEN
PARACETAMOL AN
_WHEN YOU MUST NOT _
_BE GIVEN PARACETAMOL _
_AN _
YOU MUST NOT BE GIVEN
PARACETAMOL AN 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 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 AN IF YOU
HAVE LIVER DISEASE.
IF YOU ARE NOT SURE
WHETHER YOU SHOULD BE
GIVEN PARACETAMOL AN,
TALK TO YOUR DOCTOR OR
PHARMACIST.
_BEFORE YOU ARE GIVEN _
_PARACETAMOL AN _
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 AN 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 AN may be
giv

Summary of Product characteristics

_Paracetamol AN injection Product Information _
_ _
_ Amneal Pharma Australia Pty Ltd_
Paracetamol AN PI v4.0
Page 1 of 18
Paracetamol AN
PRODUCT INFORMATION
NAME OF THE MEDICINE
Paracetamol.
The chemical name for paracetamol is 4-acetamidophenol. Its structural
formula is:
C
8
H
9
NO
2
Molecular weight: 151.2
CAS No.: 103-90-2
DESCRIPTION
Paracetamol is a white, crystalline solid powder which is odourless or
almost odourless and
hygroscopic. It is soluble in water (1 in 70), soluble in alcohol (1
in 7), acetone (1 in 13), glycerol
(1 in 40), propylene glycol (1 in 9) and also soluble in solutions of
the alkali hydoxides.
Paracetamol AN solution for infusion is a clear solution that contains
1000 mg/100 mL of
paracetamol. The solution also contains mannitol, cysteine
hydrochloride monohydrate, dibasic
dihydrate sodium phosphate, sodium hydroxide, hydrochloric acid, water
for injections.
PHARMACOLOGY
PHARMACODYNAMICS
The precise mechanism of the analgesic and antipyretic properties of
paracetamol has yet to be
established; it may involve central and peripheral actions.
Paracetamol 1000 mg/100 mL solution for infusion provides onset of
pain relief within five to ten
minutes after the start of administration. The peak analgesic effect
is obtained in one hour and
the duration of this effect is usually four to six hours.
Paracetamol 1000 mg/100 mL solution for infusion reduces fever within
30 minutes after the start
of administration with a duration of the antipyretic effect of at
least 6 hours.
PHARMACOKINETICS
_ADULTS _
Absorption
Paracetamol pharmacokinetics are linear after a single administration
of up to 2 g and after
repeated administration during 24 hours.
_Paracetamol AN injection Product Information _
_ _
_ Amneal Pharma Australia Pty Ltd_
Paracetamol AN PI v4.0
Page 2 of 18
The bioavailability of paracetamol following infusion of paracetamol
1000 mg/100 mL is similar to
that observed following infusion of propacetamol 2 g (containing
paracetamol 1 g). For both
these products, peak plasma concentration is ob