PARACETAMOL KABI paracetamol 500mg/50mL solution for injection in freeflex bag
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
24-08-2020
Summary of Product characteristics
(SPC)
08-10-2020
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
paracetamol, Quantity: 10 mg/mL
Available from:
Fresenius Kabi Australia Pty Ltd
INN (International Name):
Paracetamol
Pharmaceutical form:
Injection, solution
Composition:
Excipient Ingredients: cysteine hydrochloride monohydrate; mannitol; water for injections; nitrogen
Administration route:
Intravenous Infusion
Units in package:
50 x50 mL bags, 60x50 mL bags, 20 x 50 mL bags
Prescription type:
(S4) Prescription Only Medicine
Therapeutic 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.
Product summary:
Visual Identification: Colourless to almost colourless solution; Container Type: Bag; Container Material: Plastic; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Authorization status:
Licence status A
Authorization date:
2014-07-03
Patient Information leaflet
1
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.
All
medicines
have
risks
and
benefits. Your doctor has weighed
the risks of you taking Paracetamol
Kabi
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. You may need to
read it again.
WHAT PARACETAMOL KABI
IS USED FOR
Paracetamol Kabi is used to relieve
pain
and
reduce
fever
following
surgery.
This medicine belongs to a group of
medicines called analgesics.
ASK YOUR DOCTOR IF YOU HAVE ANY
CONCERNS
ABOUT
WHY
THIS
MEDICINE
HAS
BEEN
PRESCRIBED
FOR YOU.
Your doctor may have prescribed it
for another reason.
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 THE
FOLLOWING MEDICAL CONDITIONS.
liver failure
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 IF YOU HAVE
ALLERGIES TO ANY OTHER MEDICINES,
FOODS, PRESERVATIVES OR DYES.
TELL YOUR DOCTOR OR PHARMACIST IF
YOU
HAVE
OR
HAVE
HAD
ANY
MEDICAL CONDITIONS:
liver
disease
(including
Gilbert’s syndrome)
kidney disease
alcoholism
dehydration
eating disorders
(anorexia, bulimia)
a wasting syndrome
including unexplained weight
loss, fatigue,
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Summary of Product characteristics
AUSTRALIAN PRODUCT INFORMATION- PARACETAMOL KABI
(PARACETAMOL)
1. NAME OF MEDICINE
Paracetamol
2. QUALITATIVE AND QUANTATIVE COMPOSITION
Paracetamol Kabi solution for infusion contains 10 mg/mL of
paracetamol (50 mL vial/
bag contains 500 mg of paracetamol, 100 mL vial/bag contains 1 g of
paracetamol).
Paracetamol
Kabi
solution
for
infusion
contains
the
excipients
mannitol,
cysteine
hydrochloride, nitrogen (as protective gas), water for injections.
For the full list of excipients, see Section 6.1 List of excipients.
3. PHARMACEUTICAL FORM
Paracetamol solution for infusion 10 mg/mL is a clear to slightly
yellowish solution.
Paracetamol
is
a
white
crystalline
solid
or
powder
chemically
described
as
4
–
acetamidophenol. 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
hydroxides.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC 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.
4.2 DOSE AND METHOD OF ADMINISTRATION
THE PRESCRIBED DOSE MUST BE BASED ON THE PATIENT’S WEIGHT.
UNINTENTIONAL OVERDOSE CAN LEAD TO SERIOUS LIVER DAMAGE AND DEATH (SEE
SECTION
4.9 OVERDOSE).
Healthcare providers are reminded that it is essential to follow both
the weight-related
dose recommendations and to consider individual patient risk factors
for hepatotoxicity
including
hepatocellular
insufficiency,
chronic
alcoholism,
chronic
malnutrition
(low
reserves of hepatic glutathione), and dehydration (see section 4.2
DOSE METHOD AND
ADMINISTRATION – HEPATIC IMPAIRMENT).
It is recommended that suitable oral analgesic treatment be
substituted for Paracetamol
solution for infusion as soon as the patient can be treated by the
oral route (see section
4.3 CONTRAINDICATIONS).
INTRAVENOUS ROUTE
Paracetamol solution for infusion 10 mg/mL should not be mixed with
other medic
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