Paracetamol 10mg/ml solution for infusion

Land: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Paracetamol

Fáanlegur frá:

B. Braun Melsungen AG

ATC númer:

N02BE; N02BE01

INN (Alþjóðlegt nafn):

Paracetamol

Skammtar:

10 milligram(s)/millilitre

Lyfjaform:

Solution for infusion

Gerð lyfseðils:

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

Lækningarsvæði:

Anilides; paracetamol

Leyfisstaða:

Marketed

Leyfisdagur:

2012-03-09

Upplýsingar fylgiseðill

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
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.
2
Prolonged or frequent use of paracetamol is discouraged. It is
recommended that this medici

Vara einkenni

Health Products Regulatory Authority
06 September 2022
CRN00CXWQ
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Paracetamol 10mg/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 hyperthermia 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.
Dosing based on patient weight (please see the dosing table here
below)
10 ML AMPOULE
PATIENT WEIGHT
DOSE
PER ADMINISTRATION
VOLUME PER ADMINISTRATION
MAXIMUM VOLUME OF
PARACETAMOL B. BRAUN (10
MG/ML) PER ADMINISTRATION
BASED ON UPPER WEIGHT
MAXIMUM DAILY DOSE**
Health Products Regulatory Authority
06 September 2022
CRN00CXWQ
Page 2 of 8
LIMITS