Paracetamol 10mg/ml Solution for Infusion - 10ml ampoule

Land: Malta

Språk: engelsk

Kilde: Medicines Authority

Aktiv ingrediens:

PARACETAMOL

Tilgjengelig fra:

B Braun Melsungen AG Carl-Braun-Strasse 1, D34212 Melsungen, Germany

ATC-kode:

N02BE01

INN (International Name):

PARACETAMOL 10 mg/ml

Legemiddelform:

SOLUTION FOR INFUSION

Sammensetning:

PARACETAMOL 10 mg/ml

Resept typen:

POM

Terapeutisk område:

ANALGESICS

Autorisasjon status:

Authorised

Autorisasjon dato:

2018-04-06

Informasjon til brukeren

07817.1MM1620G22
1
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 is an analgesic (it relieves pain) and an antipyretic
(it lowers fever).
It is used for
•
short-term treatment of moderate pain, especially following surgery.
•
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 (hypersensitive) to propacetamol (another
analgesic, being converted to
paracetamol in your body)
●
if you suffer from a severe liver disease.
WARNINGS AND PRECAUTIONS
Talk to your doctor before you receive Paracetamol B. Braun
Take special care with Paracetamol
●
if you suffer from liver or severe kidney disease, or from chronic
alcohol abuse
●
if you are taking other medicines containing paracetamol. In this case
your doctor will adjust
your dose
●
in cases of nutrition problems (states of underfeeding, malnutrition)
or dehydration
●
if
you
suffer from a genetically caused disorder of the enzyme glucose-6-
phosphatedehydrogenase (favism)
Inform your doctor before treatment if any of the above mentioned
conditions apply to you.
Prolonged or frequent use of paracetamol is discouraged. It is
reco

Preparatomtale

07817.1MM1620G22
Page 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
One ml solution for infusion contains 10 mg paracetamol.
Each 10 ml ampoule contains 100 mg paracetamol
Each 50 ml bottle contains 500 mg paracetamol.
Each 100 ml bottle contains 1 000 mg paracetamol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for infusion.
The solution is clear and colourless to slightly pinkish-orangish.
Perception may vary.
Theoretical Osmolarity 305 mOsm/l
pH
4.5 – 5.5
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Paracetamol is indicated for:
●
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 hy-
perthermia and/or when other routes of administration are not
possible.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The 100 ml bottle is restricted to adults, adolescents and children
weighing more than 33 kg.
The 50 ml bottle is restricted to toddlers and children weighing more
than 10 kg and up to 33 kg.
The 10 ml ampoule is restricted to term newborn infants, infants and
toddlers weighing up to 10 kg.
_POSOLOGY: _
_ _
THE DOSE TO BE ADMINISTERED AND THE BOTTLE SIZE TO BE USED DEPEND
EXCLUSIVELY ON THE PATIENT`S
WEIGHT. THE VOLUME TO BE ADMINISTERED MUST NOT EXCEED THE DETERMINED
DOSE. IF APPLICABLE THE
DESIRED VOLUME MUST BE DILUTED IN A SUITABLE SOLUTION FOR INFUSION
PRIOR TO ADMINISTRATION (SEE
SECTION 6.6) OR A SYRINGE DRIVER MUST BE USED.
07817.1MM1620G22
Page 2 of 10
Dosing based on patient weight (please see the dosing table here
below)
10 ML AMPOULE
PATIENT WEIGHT
DOSE
PER ADMINISTRATION
VOLUME PER ADMIN-
ISTRATION
MAXIMUM VOLUME OF
PARACETA-
MOL(10 MG/ML) PER AD-
MINISTRATION 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
100 ML BOTTLE
PATIE