Paracetamol 10 mg/ml Solution for Infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

PARACETAMOL

Available from:

MACO PHARMA

ATC code:

N02BE; N02BE01

INN (International Name):

PARACETAMOL

Dosage:

10 milligram(s)/millilitre

Pharmaceutical form:

Solution for infusion

Therapeutic area:

Anilides; paracetamol

Authorization status:

Not marketed

Authorization date:

2011-04-01

Patient Information leaflet

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.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
•
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 10 mg/ml Solution for Infusion is and what it is used
for
2.
What you need to know before you use Paracetamol 10 mg/ml Solution for
Infusion
3.
How to use Paracetamol 10 mg/ml Solution for Infusion
4.
Possible side effects
5.
How to store Paracetamol 10 mg/ml Solution for Infusion
6.
Contents of the pack and other information
1. WHAT PARACETAMOL 10 MG/ML SOLUTION FOR INFUSION IS AND WHAT IT IS
USED
FOR
Paracetamol is an analgesic agent (it relieves pain) and an
antipyretic agent (it reduces body
temperature).
The
100-ml
bag
is
for
use
in
adults,
adolescents
and
children
weighing
more
than
33
kg
(approximately 11 years of age) only.
The 50-ml bag is for use in full-term newborns, infants and children
weighing less than 33 kg. The
10 ml bag is adapted for use in full-term newborns, infants and
children weighing less than 10 kg.
It is indicated in the short-term treatment of moderate pain,
particularly post-surgery pain, and in the
short-term treatment of fever.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE PARACETAMOL 10 MG/ML
SOLUTION FOR INFUSION
DO NOT USE PARACETAMOL 10 MG/ML SOLUTION FOR INFUSION:

if you are allergic (hypersensitive) to paracetamol or to any of the
other ingredients.

if you are allergic (hypersensitive) to propacetamol (another
analgesic agent used for
infusions, a precursor of paracetamol).

if you suffer fro

Summary of Product characteristics

Health Products Regulatory Authority
09 June 2020
CRN009MW8
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Paracetamol 10 mg/ml Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Paracetamol 10.00 mg for 1 ml of solution for infusion:
One 100-ml bag contains 1000 mg paracetamol.
One 50-ml bag contains 500 mg paracetamol.
One 10-ml bag contains 100 mg paracetamol.
Excipients-contains Sodium 25.2 mg/10 ml, 126 mg/50 ml and 252 mg/100
ml.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion.
Clear solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Paracetamol is indicated in the short-term treatment of moderate pain,
particularly post-surgery pain, and in the short-term
treatment of fever, when the intravenous route is clinically justified
by the urgent need to treat pain or hyperthermia and/or
when other routes of administration cannot be used.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Intravenous use.
100-ml bag: for use in adults, adolescents and children weighing more
than 33 kg only.
50-ml bag: for use in newborns, infants and children weighing less
than 33 kg.
10-ml bag: for use in newborns, infants and children weighing less
than 10 kg.
POSOLOGY:
Dosing based on patient weight (please see the dosing table here
below)
PATIENT WEIGHT
DOSE PER
ADMINISTRATION
VOLUME PER
ADMINISTRATION
MAXIMUM VOLUME
OF PARACETAMOL
(10 MG/ML) PER
ADMINISTRATION
BASED ON UPPER
WEIGHT LIMITS OF
GROUP (ML)***
MAXIMUM
DAILY
DOSE**
≤10 KG*
7.5 mg/kg
0.75 ml/kg
7.5 ml
30 mg/kg
>10KG TO ≤33 KG
15 mg/kg
1.5 ml/kg
49.5 ml
60 mg/kg
not
exceeding
2 g
Health Products Regulatory Authority
09 June 2020
CRN009MW8
Page 2 of 7
>33 KG TO ≤50 KG
15 mg/kg
1.5 ml/kg
75 ml
60 mg/kg
not
exceeding
3 g
>50 KG WITH ADDITIONAL RISK FACTORS FOR
HEPATOTOXICITY
1g
100 ml
100 ml
3 g
>50 KG AND NO ADDITIONAL RISK FACTORS FOR
HEPATOTOXICITY
1g
100 ml
100 ml
4 g
* PRE-TERM NEWBORN INFANTS:No safety and efficacy data are available
for pre-term newborn infants (see s