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PARACETAMOL 10MG/ML SOLUTION FOR INFUSION

Active substance(s): PARACETAMOL / PARACETAMOL / PARACETAMOL

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Paracetamol 10mg/ml Solution for Infusion

Read all of this leaflet carefully before you are given this
medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, nurse or
pharmacist.
• This medicine has been prescribed for you. Do not pass it on
to others. It may harm them, even if their symptoms are the
same as yours.
• If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor or
pharmacist.

In this leaflet:
1 W
 hat Paracetamol 10mg/ml Solution for Infusion is
and what it is used for
2 B
 efore you use
3 H
 ow to use
4 P
 ossible side effects
5 H
 ow to store
6  F
 urther information
1 What Paracetamol 10mg/ml Solution for Infusion is

and what it is used for

Paracetamol 10mg/ml Solution for Infusion is used as an analgesic
(relieves pain) and an antipyretic (lowers fever).
It is used for:
• short-term treatment of moderate pain, especially following surgery
• short-term treatment of fever.

2 Before you use
Do not use Paracetamol 10mg/ml Solution for Infusion
if you:

• are allergic (hypersensitive) to paracetamol or any of the other
ingredients of Paracetamol 10mg/ml Solution for Infusion. An
allergic reaction may include a rash, itching, difficulty breathing or
swelling of the face, lips, throat or tongue.
• are allergic (hypersensitive) to propacetamol (another analgesic
similar to paracetamol).
• suffer from severe liver disease.

Take special care with Paracetamol 10mg/ml Solution for
Infusion
• Use 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.

Taking other medicines

Please tell your doctor, nurse or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without a prescription or herbal medicines and natural products.
Take particular care if you are taking the following medicines while
under treatment with Paracetamol 10mg/ml Solution for Infusion:
• other paracetamol-containing products, in order not to exceed the
recommended daily dose.
• probenecid.
• oral anticoagulants. More check-ups to look at the effect of the
anticoagulant might be needed.

Pregnancy and breastfeeding

Inform your doctor or nurse if you are pregnant, may be pregnant or
are breast feeding. Paracetamol 10mg/ml Solution for Infusion may
be used during pregnancy, however, the doctor must evaluate if the
treatment is advisable.
Ask your doctor, nurse or pharmacist for advice before taking any
medicine.

Important information about some of the ingredients of
Paracetamol 10mg/ml Solution for Infusion

This medicinal product contains 4.32 mmol sodium per dose. To be
taken into consideration by patients on a controlled sodium diet.

3 How to use

For intravenous use (injection into a vein).
The 50ml vial is restricted to term newborn infants, infants, toddlers
and children weighing less than 33kg.
The 100ml vial is restricted to adults, adolescents and children
weighing more than 33kg.

Dosage

Do not give anything else containing paracetamol while
using this medicine.
The dose you will be given will be decided by the doctor and will
depend on your weight, liver and kidney function.

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Continued over page

BBBA0819

The following information is intended for medical or healthcare professionals only:

Paracetamol 10mg/ml Solution for Infusion
The 50ml vial is restricted to term newborn infants, infants, toddlers and children weighing less than 33kg.
The 100ml vial is restricted to adults, adolescents and children weighing more than 33kg.

Dosage

Dosing based on patient weight (please see table below):
Patient weight

Dose per
administration

Volume per
administration

≤10kg *
> 10kg to ≤33kg

7.5mg/kg
15mg/kg

0.75mL/kg
1.5mL/kg

Maximum volume of
Maximum Daily Dose **
paracetamol, solution
for infusion (10mg/
mL) per administration
based on upper weight
limits of group (mL)***
75mL
30mg/kg
49.5mL
60mg/kg not exceeding 2g

1.5mL/kg
100mL

75mL
100mL

60mg/kg not exceeding 3g
3g

100mL

100mL

4g

> 33kg to ≤50kg
15mg/kg
>50kg with additional 1g
risk factors for
hepatotoxicity
> 50kg and no
1g
additional risk factors
for hepatotoxicity
Continued top of next column

Continued over page

BBBA0819

Paracetamol IV 10mg/ml Solution for Infusion PIL - UK
approved for print/date

Proof Round

2

UK-Eire-Artwork-Support@Actavis.com

Item no:

BBBA0819

Originator:
Origination Date:
Revision Date:
Revised By:

Technical
Approval

S.Anson
16.05.17
19.06.17
S.Anson

Date sent:
16.05.17
Date received: 29.05.17

Dimensions:
150 x 315
Min Body Text Size: 7pt
Supplier:
Neogen

Colours

Non Printing Colours

1. Black

1.

2.

2.

3.

3.

4.
5.
6.

* Please note that only Artwork Studio is permitted to make changes to the above artwork.
No changes are permitted by any 3rd party other than added notes and mark ups for required changes.

Patient
weight

Dose per Volume
adminis- per
tration administration

Maximum volume of
paracetamol, solution for infusion (10
mg/mL) per administration based on
upper weight limits
of group (mL)***
≤10 kg * 7.5 mg/kg 0.75 mL/kg 7.5mL
> 10 kg to 15 mg/kg 1.5mL/kg 49.5mL
≤33kg

Maximum
Daily
Dose **

> 33 kg to 15 mg/kg 1.5mL/kg
≤50kg

75 mL

>50kg with 1g
additional
risk factors
for hepatotoxicity
> 50 kg
1g
and no
additional
risk factors
for hepatotoxicity

100mL

100mL

30 mg/kg
60mg/kg
not exceeding 2g
60mg/kg
not exceeding 3g
3g

100mL

100mL

4g

Tell your doctor or nurse if you experience the following side effects:
Rare (occurs in less than 1 in 1,000 patients):
• a general feeling of being unwell (malaise)
• a drop in blood pressure
• changes in liver enzymes found during blood checks. Should this
occur, inform your doctor as regular blood checks may be required
later.
Very Rare (occurs in less than 1 in 10,000 patients):
• very rare cases of serious skin reactions have been reported.
Not Known (cannot be estimated from available data):
• other changes in laboratory test results which may result in regular
blood checks: abnormally low levels of some types of blood cells
(platelets, white cells) can occur, possibly leading to bleeding from
the nose or gums.
If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor or
pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card Scheme Website: www.
mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the
safety of this medicine.

* Pre-term newborn infants: No safety and efficacy data are available
for pre-term newborn infants.
**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.
The minimum interval between each administration in patients
with severe renal insufficiency must be at least 6 hours.
No more than 4 doses to be given in 24 hours.
In patients weighing 50kg or less or with risk factors, you will be
given a maximum dose of 3g per day.
If you are given more Paracetamol 10mg/ml Solution for Infusion
than you should
Talk to a doctor at once if you are given too much of this medicine
even if you feel well. This is because too much paracetamol can
cause delayed, serious liver damage. Contact your doctor, nurse or
pharmacist immediately if you experience the following symptoms of
an overdose within the first 24 hours: feeling or being sick, weight loss,
pale skin (pallor) or abdominal pain.
If you forget to use Paracetamol 10mg/ml Solution for Infusion
If you forget to use Paracetamol 10mg/ml Solution for Infusion, pain
or fever is likely to return. Do not take a double dose to make up for
forgotten individual doses.
If you have any further questions on the use of Paracetamol 10mg/ml
Solution for Infusion, ask your doctor, nurse or pharmacist.

4 Possible side effects
Like all medicines, Paracetamol 10mg/ml Solution for Infusion can
cause side effects, although not everybody gets them.
Contact your doctor or nurse and stop treatment immediately
if you experience an allergic reaction with symptoms such as
swelling of the face, lips, tongue and throat, difficulty breathing or
swallowing or a skin rash.

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 30ºC. 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
What Paracetamol 10mg/ml Solution for Infusion contains
• The active substance is paracetamol.
• One ml contains 10mg paracetamol.
• Each 50ml vial contains 500mg paracetamol.
• Each 100ml vial contains 1000mg paracetamol in 100ml.
• The other ingredients are: cysteine hydrochloride monohydrate,
disodium phosphate dihydrate, hydrochloric acid (1M) (for pHadjustment), sodium hydroxide (1M) (for pH-adjustment), mannitol,
water for injections.

What Paracetamol 10mg/ml Solution for Infusion looks
like and contents of the pack
Vials 50ml and 100ml.
Paracetamol 10mg/ml Solution for Infusion is a clear solution.
The vials are packed in carton boxes. Each box contains:
50ml: 10 vials
100ml: 10 vials
Marketing Authorisation Holder
Accord Healthcare Limited, Sage House , 319 Pinner Road,
North Harrow, Middlesex, HA1 4HF, United Kingdom
Manufacturer
Neogen Developments N.V., Square Marie Curie , 50 Anderlecht ,
1070 Belgium
This leaflet was last revised in May 2017

If you would like a
leaflet with larger
text, please contact
01271 385257.
Accord Healthcare Ltd, North Harrow, HA1 4HF, UK

Continued top of next column

* Pre-term newborn infants: No safety and efficacy data are
available for pre-term newborn infants.
**Maximum daily dose: The maximum daily dose as presented
in the table overleaf is for patients that are not receiving other
paracetamol containing products and should be adjusted
accordingly taking such products into account.

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.

***Patients weighing less will require smaller volumes.

The paracetamol solution is administered as a 15-minute
intravenous infusion (injection into a vein).

The minimum interval between each administration must be
at least 4 hours.
The minimum interval between each administration in patients
with severe renal insufficiency must be at least 6 hours.
No more than 4 doses to be given in 24 hours.

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 exceed the stated dose.

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 50ml and 100ml vials, a 0.8mm needle (21 gauge needle)
has to be used and the stopper vertically perforated at the spot
specifically indicated.

Kidney disease:

It is recommended when giving paracetamol to patients with
severe renal impairment (creatinine clearance ≤ 30mL/min), to
increase the minimum interval between each administration to 6
hours.

For the 50ml vial, it can also be diluted in 0.9% sodium chloride or
5% glucose up to one tenth (one volume paracetamol into nine
volumes diluent).
Continued top of next column

Accord Healthcare Ltd, North Harrow, HA1 4HF, UK

BBBA0819

Paracetamol IV 10mg/ml Solution for Infusion PIL - UK
approved for print/date

Proof Round

2

UK-Eire-Artwork-Support@Actavis.com

Item no:

BBBA0819

Originator:
Origination Date:
Revision Date:
Revised By:

Technical
Approval

S.Anson
16.05.17
19.06.17
S.Anson

Date sent:
16.05.17
Date received: 29.05.17

Dimensions:
150 x 315
Min Body Text Size: 7pt
Supplier:
Neogen

Colours

Non Printing Colours

1. Black

1.

2.

2.

3.

3.

4.
5.
6.

* Please note that only Artwork Studio is permitted to make changes to the above artwork.
No changes are permitted by any 3rd party other than added notes and mark ups for required changes.

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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