Paracetamol 10 mg/ml solution for infusion

País: Irlanda

Língua: inglês

Origem: HPRA (Health Products Regulatory Authority)

Ingredientes ativos:

Paracetamol

Disponível em:

Baxter Holding B.V.

Código ATC:

N02BE01

DCI (Denominação Comum Internacional):

Paracetamol

Dosagem:

10 milligram(s)/millilitre

Forma farmacêutica:

Solution for infusion

Área terapêutica:

paracetamol

Status de autorização:

Marketed

Data de autorização:

2021-12-03

Folheto informativo - Bula

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.
•
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 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
This medicine contains the active substance paracetamol, and it is an
analgesic (it relieves pain)
and an antipyretic (it lowers fever).
NEWBORN INFANTS, INFANTS, TODDLERS AND CHILDREN (LESS THAN OR EQUAL TO
33 KG)
Use 50 ml fill vial.
ADULTS, ADOLESCENTS AND CHILDREN (ABOVE 33 KG)
Use 100 ml fill vial.
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
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 hydrochloride. This is another
painkiller that the
body converts to paracetamol.
•
if you have a severe liver disease.
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR OR PHARMACIST BEFORE USING PARACETAMOL, IF ANY OF
THESE APPLY TO
YOU:
•
if you could take painkillers through the mouth (orally) instead,
since that is the
recommended administration route.
•
if you have reduced liver or kidney function, or if you drink too much
alcohol.
•
if you are taking other medicines that have paracetamol in them.
•
in cases of malnutrition or dehydration.
•
If you have a glucose-6-pho

Características técnicas

Health Products Regulatory Authority
27 February 2023
CRN00D8FW
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
1 ml contains 10 mg paracetamol.
Each vial of 50 ml contains 500 mg paracetamol.
Each vial of 100 ml contains 1000 mg paracetamol.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion.
The solution is clear, colourless to slightly yellowish and free from
visible particles.
Osmolality 270 to 310 mOsm/kg
pH: 4.5 – 6.5
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Paracetamol is indicated for the short-term treatment of moderate
pain, especially following surgery and for 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.
NEWBORN INFANTS, INFANTS, TODDLERS AND CHILDREN (LESS THAN OR EQUAL TO
33 KG)
Use 50 ml fill vial.
ADULTS, ADOLESCENTS AND CHILDREN (ABOVE 33 KG)
Use 100 ml fill vial.
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
7.5mL
30 mg/kg
> 10 kg to ≤33 kg
15 mg/kg
1.5 mL/kg
49.5mL
60 mg/kg not
exceeding 2g
> 33 kg to ≤50 kg
15 mg/kg
1.5 mL/kg
75 mL
60 mg/kg not
exceeding 3g
Patient weight
Dose per
administration
Volume per
administration
Maximum volume per
administration **
Maximum Daily
Dose ***
>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
27 February 2023
CRN00D8FW
Page 2 of 7
* PRE-TERM NEWBORN INFANTS: No safety a