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In this leaflet:
1 W
hat Paracetamol 10mg/ml Solution for
Infusion is and what it is used for
2 Before you take
3 H
ow to take
4 P
ossible side effects
5 How to store
6 Further information
U
se a suitable oral pain killer as soon as possible.
If you suffer from a liver disease, severe kidney disease or
from alcohol abuse.
If you are taking other medicines containing
paracetamol.
In cases of nutrition problems (malnutrition) or
dehydration.
Inform your doctor before treatment if any of the above
mentioned conditions apply to you.
Dosage
AAAE5332
Dosage
Dose per
administration
Volume per
administration
Maximum volume of
Maximum Daily
Paracetamol (10mg/
Dose **
mL) per administration
based on upper weight
limits of group (mL)***
75mL
60mg/kg
not exceeding 3g
Children weighing
more than 33kg
(approximately 11 years
old), adolescents and
adults weighing up
to 50kg
>50kg with additional
risk factors for
hepatotoxicity
>50kg and no
additional risk factors
for hepatotoxicity
15mg/kg
1.5mL/kg
1g
100mL
100mL
3g
1g
100mL
100mL
4g
AAAE5332
pharmacode:
1. Black
2.
3.
4.
5.
6.
originated by: NM
approved for print/date
colours/plates:
Technical Approval
revised by: SA
supplier: Diaco
The dose you will be given will decided by the doctor and will
depend on your weight, liver and kidney function.
Only for patients weighing more than 33kg.
Body Weight
Dosage
>50kg
1g up to 4 times a day
Also you can help to make sure that medicines remain as safe
as possible by reporting any unwanted side effects via the
internet at www.mhra.gov.uk/yellowcard. Alternatively you
can call Freephone 0808 100 3352 (available from 10 a.m. to 2
p.m. Mondays to Fridays) or fill in a paper form available from
your local pharmacy.
5 How to store
Keep out of the sight and reach of children.
Do not use Paracetamol 10mg/ml Solution for Infusion after
the expiry date which is stated on the blister and carton after
EXP. The expiry date refers to the last day of that month.
Store below 30C. Protect from light. Store in the original
package. Do not refrigerate or freeze.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.
6 Further information
Kidney disease:
Method of administration
RISK OF MEDICATION ERRORS
Take care to avoid dosing errors due to confusion between
milligram (mg) and millilitre (mL), which could result in
accidental overdose and death.
The paracetamol solution is administered as a 15-minute
intravenous infusion (injection into a vein).
As for all solutions for infusion presented in glass vials, it should be
remembered that close monitoring is needed notably at the end
of the infusion, regardless of administration route. This monitoring
at the end of the infusion applies particularly for central route
infusions, in order to avoid air embolism.
Do not use Paracetamol 10mg/ml Solution for Infusion if you
notice any particulate matter and discolouration.
For single use only. The product should be used immediately after
opening. Any unused solution should be discarded.
For the 100ml vials, a 0.8mm needle (21 gauge needle) has to be
used and the stopper vertically perforated at the spot specifically
indicated.
It can also be diluted in 0.9% sodium chloride or 5% glucose up to
one tenth (one volume paracetamol into nine volumes diluent).
AAAE5332
pharmacode:
1. Black
2.
3.
4.
5.
6.
originated by: NM
approved for print/date
colours/plates:
Technical Approval
revised by: SA
supplier: Diaco