Paracetamol 10 mg/ml solution for infusion

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

PARACETAMOL

Available from:

Baxter Holding B.V. Kobaltweg 49, 3542CE Utrecht, Netherlands

ATC code:

N02BE01

INN (International Name):

PARACETAMOL 10 mg/ml

Pharmaceutical form:

SOLUTION FOR INFUSION

Composition:

PARACETAMOL 10 mg/ml

Prescription type:

POM

Therapeutic area:

ANALGESICS

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2021-06-28

Patient Information leaflet

Page 1 of 9
PACKAGE LEAFLET: INFORMATION FOR THE USER
PARACETAMOL 10 MG/ML SOLUTION FOR INFUSION
PARACETAMOL
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4
WHAT IS IN THIS LEAFLET
1. What Paracetamol Baxter is and what it is used for
2. What you need to know before you use Paracetamol Baxter
3. How to use Paracetamol Baxter
4. Possible side effects
5. How to store Paracetamol Baxter
6. Contents of the pack and other information
1. WHAT PARACETAMOL BAXTER IS AND WHAT IT IS USED FOR
This medicine contains the active substance paracetamol, and it is an
analgesic (it relieves pain) and an
antipyretic (it lowers fever). The medicine is restricted to adults,
adolescents and children weighing
more than 33 kg.
It is indicated for the short-term treatment of moderate pain,
especially following surgery, and for the
short-term treatment of fever.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE PARACETAMOL BAXTER
DO NOT USE PARACETAMOL BAXTER
•
if you are allergic to paracetamol or to any of the other ingredients
of this medicine (listed in
section 6).
•
if you are allergic to propacetamol hydrochloride. This is another
painkiller that the body
converts to paracetamol.
•
if you have a severe liver disease.
Page 2 of 9
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR OR PHARMACIST BEFORE USING PARACETAMOL BAXTER, IF
ANY OF THESE APPLY TO
YOU:
•
if you could take painkillers through the mouth (orally) instead,
since that is the recommended
administration route.
•
if you have reduced liver or kidney function, or if you drink too much
alcohol.
•
if you are taking other medicines that have paracetamol in them.
•
in cases of malnutrition or dehydration.
•
If you have a glucose-6-phos

Summary of Product characteristics

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1
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9
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Paracetamol 10 mg/ml solution for infusion
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml contains 10 mg paracetamol
Each bag of 100 ml contains 1000 mg paracetamol
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Solution for infusion.
The solution is clear, colourless to slightly yellowish and free from
visible particles.
pH: 5.0 – 6.5
Osmolality 270 to 310 mOsm/kg
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Paracetamol Baxter is indicated for the short-term treatment of
moderate pain,
especially
following
surgery
and
for
the
short-term
treatment
of
fever,
when
administration by intravenous route is clinically justified by an
urgent need to treat
pain or hyperthermia and/or when other routes of administration are
not possible.
This medicinal product is indicated in adults, adolescents and
children weighing more
than 33 kg.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Intravenous use.
This medicinal product is restricted to adults, adolescents and
children weighing more
than 33 kg.
POSOLOGY:
Dosing based on patient weight (please see the dosing table here
below)
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9
Patient weight
Dose per
administration
Volume per
administration
Maximum
volume
of
Paracetamol
Baxter
(10
mg/mL)
per
administration based on
upper
weight
limits
of
group (mL)**
Maximum
Daily
Dose *
>
33
kg
to
≤50kg
15 mg/kg
1.5mL/kg
75 mL
60mg/kg
not
exceeding
3g
>50
kg
with
additional
risk
factors
for
hepatotoxicity
1g
100mL
100mL
3g
> 50 kg and no
additional
risk
factors
for
hepatotoxicity
1g
100mL
100mL
4g
*
MAXIMUM DAILY DOSE:
The maximum daily dose as presented in the table above is
for patients that are not receiving other paracetamol containing
products and should
be adjusted accordingly taking such products into account.
** Patients weighing less will require smaller volumes.
The minimum interval between each administration must be at least 4
hours. No more
than 4 doses to be given in 24 hours
.
The minimum interval between