Paracetamol 10 mg/ml solution for infusion

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

Paracetamol

Dostopno od:

Fresenius Kabi Deutschland GmbH

Koda artikla:

N02BE; N02BE01

INN (mednarodno ime):

Paracetamol

Odmerek:

10 milligram(s)/millilitre

Farmacevtska oblika:

Solution for infusion

Tip zastaranja:

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

Terapevtsko območje:

Anilides; paracetamol

Status dovoljenje:

Marketed

Datum dovoljenje:

2010-12-21

Navodilo za uporabo

1.3.1 SPC, LABELLING AND PACKAGE LEAFLET
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.
-
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 of the 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 infusion is and what it is used for
2.
What you need to know before you use Paracetamol infusion
3.
How to use Paracetamol infusion
4.
Possible side effects
5.
How to store Paracetamol infusion
6.
Contents of the pack and other information
1.
WHAT PARACETAMOL INFUSION 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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE PARACETAMOL INFUSION
DO NOT USE PARACETAMOL INFUSION
-
if you are
ALLERGIC
(hypersensitive)
TO PARACETAMOL
or any of the other ingredients of
Paracetamol infusion (listed in section 6).
-
if you are
ALLERGIC
(hypersensitive)
TO PROPACETAMOL
(another pain killer and a precursor of
Paracetamol).
-
if you suffer from a
SEVERE LIVER DISEASE
.
WARNINGS AND PRECAUTIONS
Talk to your doctor before using Paracetamol infusion .
TAKE SPECIAL CARE WITH PARACETAMOL INFUSION
-
if you suffer from a
LIVER OR KIDNEY DISEASE
, or from
ALCOHOL ABUSE
.
-
if you suffer from a inherited liver function disorder called
MEULENGRACHT GILBERT'S
SYNDROME
.
-
if you suffer from
GLUCOSE-6-PHOSPHATE DEHYDROGENASE DEFICIENCY.
-
if you are taking
OTHER MEDICINES CONTAINING

Lastnosti izdelka

Health Products Regulatory Authority
12 July 2022
CRN008LQR
Page 1 of 9
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 10 ml ampoule contains 100 mg paracetamol.
Each 50 ml vial contains 500 mg paracetamol.
Each 100 ml vial contains 1000 mg paracetamol.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion
Clear and slightly yellowish solution.
The solution is iso-osmotic and its pH is between 5.0 and 7.0.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Paracetamol is indicated for:

the short-term treatment of moderate pain, especially following
surgery,

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 100 ml vial or bag is restricted to adults, adolescents and
children weighing more than 33 kg.
The 10 ml ampoule and the 50 ml vial or bag is restricted to term
newborn infants, infants, toddlers and children weighing up
to 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
SOLUTION FOR
INFUSION PER
ADMINISTRATION
BASED ON
UPPER WEIGHT
LIMITS OF GROUP
(ML)***
MAXIMUM
DAILY
DOSE**
Health Products Regulatory Authority
12 July 2022
CRN008LQR
Page 2 of 9
≤ 10 KG*
7.5 mg/kg
0.75 mL/kg
7.5 mL
30 mg/kg
> 10 KG TO ≤ 33 KG
15 mg/kg
1.5 mL/kg
49.5 mL
60 mg/kg,
not
exceeding
2 g
> 33 KG TO ≤ 50 KG
15 mg/kg
1.5 mL/kg
75 mL
60 mg/kg,
not
exceeding
3 g
> 50 KG AND 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
*PRE-TERM NEWBORN INFANTS: No safety and efficacy data are ava