PARACETAMOL 10 Mg/Ml Solution for Infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

PARACETAMOL

Available from:

Fresenius Kabi Limited

ATC code:

N02BE01

INN (International Name):

PARACETAMOL

Dosage:

10 Mg/Ml

Pharmaceutical form:

Solution for Infusion

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Analgesics and antipyretics

Authorization status:

Authorised

Authorization date:

2013-06-28

Patient Information leaflet

M088864/05 UK
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  of  the  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 Infusion is and what it is
used for
2.  What you need to know before you use
Paracetamol Infusion
3.  How to use Paracetamol Infusion
4.  Possible side effects
5.  How to store Paracetamol Infusion
6.  Contents of the pack and other information
1.  WHAT PARACETAMOL INFUSION IS AND WHAT IT IS     
 USED FOR
This medicine is an analgesic (it relieves pain) and
an antipyretic (it lowers fever).
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 INFUSION
DO NOT USE PARACETAMOL INFUSION
-
if  you  are
 ALLERGIC (hypersensitive)  TO 
PARACETAMOL or any of the other ingredients of
Paracetamol Infusion (listed in section 6)
-
if  you  are
ALLERGIC  (hypersensitive)  TO 
PROPACETAMOL  (another  pain  killer  and  a
precursor of paracetamol).
- 
if you suffer from a
SEVERE LIVER DISEASE.
WARNING AND PRECAUTIONS
Talk to your doctor before using Paracetamol Infusion
TAKE SPECIAL CARE WITH PARACETAMOL INFUSION
- 
if you suffer from a
LIVER OR KIDNEY DISEASE, or
from 
ALCOHOL ABUSE.
- 
if  you  suffer  from  an  inherited  liver  function
disor

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Paracetamol 10 mg/ml solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains 10 mg paracetamol.
Each 50 ml bag contains 500 mg paracetamol.
Each 100 ml bag contains 1000 mg paracetamol.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion
Clear and slightly yellowish solution.
The solution is iso-osmotic and its pH is between 5.0 and 7.0.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Paracetamol is indicated for:
the short-term treatment of moderate pain, especially following surgery,
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.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Intravenous use.
The 100 ml vial or bag is restricted to adults, adolescents and children weighing more than 33 kg.
The 50 ml vial or bag is restricted to term newborn infants, infants, toddlers and children weighing up to 33 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
10MG/ML SOLUTION FOR
INFUSION 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
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 14/10/2015_
_CRN 2156311_
_page number: 1_
*PRE-TERM NEWBORN INFANTS: No safety and efficacy data are available for pre-term newborn infants (see section 5.2).
**MAXIMUM DAILY DOSE: The maximum daily dose as presented in the