Paracetamol 10 mg/ml solution for infusion

País: Malta

Língua: inglês

Origem: Medicines Authority

Ingredientes ativos:

PARACETAMOL

Disponível em:

Accord Healthcare Ireland Ltd Euro House, Euro Business Park, Little Island Cork, T45 K857, Ireland

Código ATC:

N02BE01

DCI (Denominação Comum Internacional):

PARACETAMOL 10 mg/ml

Forma farmacêutica:

SOLUTION FOR INFUSION

Composição:

PARACETAMOL 10 mg/ml

Tipo de prescrição:

POM

Área terapêutica:

ANALGESICS

Status de autorização:

Withdrawn

Data de autorização:

2017-11-17

Folheto informativo - Bula

Page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE USER
PARACETAMOL 10 MG/ML SOLUTION FOR INFUSION
PARACETAMOL
For children and adults from 33 kg up
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.
-
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
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.
The 100 ml container is restricted to adults, adolescents and children
weighing more than 33 kg
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE PARACETAMOL
YOU SHOULD NOT BE GIVEN PARACETAMOL:
-
If you are allergic to paracetamol or any of the other ingredients of
this medicine (listed in
section 6) or to propacetamol hydrochloride (prodrug of paracetamol).
-
If you are allergic to propacetamol (another analgesic and a precursor
of paracetamol)
-
If you suffer from a severe liver disease
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before taking Paracetamol
-
If you suffer from a liver or kidney disease, or from alcohol abuse,
-
If you are taking other medicines containing paracetamol,
-
In cases of nutrition problems (malnutrition) or dehydration.
It is recommended that a suitable analgesic oral treatment be used as
soon as this route of
administration is possible.
Page 2 of 6
OTHER MEDICINES AND PARACETAMOL
Tell your doctor or pharmacist if you a

Características técnicas

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1
of
10
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Paracetamol 10 mg/ml solution for infusion
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each container contains 1000 mg paracetamol.
One ml contains 10 mg paracetamol
Excipients with known effect: Sodium 0.02 mg/ml
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Solution for infusion.
The solution is clear , free from visible particles and colourless to
slightly brownish.
pH: 5.0-6.5
Theoretical Osm: 270-300 mOsm
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.
The product 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
15 mg/kg
1.5 ml/kg
75 ml
60 mg/kg not
Page
2
of
10
kg
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
*
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 T