Paracetamol 10 mg/ml solution for infusion

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

Paracetamol

Commercializzato da:

Rowex Ltd

Codice ATC:

N02BE; N02BE01

INN (Nome Internazionale):

Paracetamol

Dosaggio:

10 milligram(s)/millilitre

Forma farmaceutica:

Solution for infusion

Tipo di ricetta:

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

Area terapeutica:

Anilides; paracetamol

Stato dell'autorizzazione:

Not marketed

Data dell'autorizzazione:

2012-09-07

Foglio illustrativo

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
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, pharmacist or
nurse.
•
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, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Paracetamol is and what it is used for
2.
What you need to know before you use Paracetamol
3.
How to use Paracetamol
4.
Possible side effects
5.
How to store Paracetamol
6.
Contents of the pack and other information
1.
WHAT PARACETAMOL IS AND WHAT IT IS USED FOR
Paracetamol contains the active substance paracetamol, an analgesic
(it relieves pain) and an
antipyretic (it lowers fever).
This medicine is given by intravenous infusion directly into a vein.
It is used for
•
short-term treatment of moderate pain, especially following surgery
•
short-term treatment of fever.
The 100 ml vial is restricted to adults, adolescents and children
weighing more than 33 kg.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE PARACETAMOL
DO NOT USE PARACETAMOL
•
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 (another analgesic and related to
paracetamol)
•
if you suffer from severe liver disease.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Paracetamol
•
Do not exceed the recommended dose. Doses higher than those
recommended entail the risk of
very serious liver damage. Symptoms of liver damage are not usually
seen until 2 days, and up to a
maximum of 4-6 days, after administration.
•
Take care not to exceed the maximum

Scheda tecnica

Health Products Regulatory Authority
13 November 2019
CRN009C4M
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
Each ml solution for infusion contains 10 mg of paracetamol.
Each 100 ml vial contains 1000 mg of paracetamol.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion.
Clear colorless to slightly yellowish, particle-free solution.
pH: 5.5
Osmolarity: 295 mOsm/L
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS

Short-term treatment of moderate pain, especially following surgery,

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 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)
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
*
> 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
1 g
100 ml
100 ml
3 g
> 50 KG AND NO ADDITIONAL RISK FACTORS FOR
HEPATOTOXICITY
1 g
100 ml
100 ml
4 g
Health Products Regulatory Authority
13 November 2019
CRN009C4M
Page 2 of 7
*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 EACH ADMINISTRATION IN PATIE