Paracetamol 10 mg/ml solution for infusion

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

Paracetamol

Dostopno od:

Actavis Group PTC ehf

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:

2010-10-01

Navodilo za uporabo

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
PARACETAMOL 10MG/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. 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 Paracetamol is administered to you
3.
How Paracetamol is administered to you
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
Paracetamol contains the active substance paracetamol, an analgesic
(it relieves pain) and an
antipyretic (it lowers fever). This medicine is given by intravenous
infusion directly into a vein. It is
used for
-
short-term treatment of moderate pain, especially following surgery
-
short-term treatment of fever.
The 100 ml vial is restricted to adults, adolescents and children
weighing more than 33 kg.
The 50 ml vial is restricted to term newborn infants, infants,
toddlers and children weighing less than
33 kg. 2.
WHAT YOU NEED TO KNOW BEFORE PARACETAMOL IS ADMINISTERED TO YOU
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 (another analgesic and related to
paracetamol)
-
if you suffer from severe liver disease
WARNINGS AND PRECAUTIONS
-
Use a suitable analgesic for oral use (via the mouth) as soon as this
is possible.
-
Tell your doctor if you are using other medicines containing
paracetamol (see section 2 “Using
other medicines”).
-
If you have a serious infection such as blood poisoning, this may
increase the risk of so called
metabolic acidosis. Signs of metabolic acidosis include: deep, fast,
strai

Lastnosti izdelka

Health Products Regulatory Authority
16 September 2019
CRN0095PY
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Paracetamol 10 mg/ml solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml contains 10 mg paracetamol
One 50 ml vial contains 500 mg paracetamol.
One 100ml vial contains 1000 mg paracetamol.
Excipient with known effect: Sodium 0.076 mg/ml
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion.
The solution is clear, slightly yellowish and particle free.
pH 5.5
Osmolarity 295 mOsm/litre
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 50 ml vial is restricted to term newborn infants, infants,
toddlers and children weighing less than 33 kg
The 100 ml vial 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,
SOLUTION FOR
INFUSION (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 ≤33KG
15 mg/kg
1.5mL/kg
49.5mL
60mg/kg
not
exceeding
Health Products Regulatory Authority
16 September 2019
CRN0095PY
Page 2 of 8
PATIENT WEIGHT
DOSE PER
ADMINISTRATION
VOLUME PER
ADMINISTRATION
MAXIMUM
VOLUME OF
PARACETAMOL,
SOLUTION FOR
INFUSION (10
MG/ML) PER
ADMINISTRATION
BASED ON
UPPER WEIGHT
LIMITS OF GROUP
(ML)***
MAXIMUM
DAILY DOSE
**
2g
> 33 KG TO ≤50KG
15 mg/kg
1.5mL/kg
75 mL
60mg/kg
not
exceeding
3g
>50KG WITH ADDITIONAL RISK FACTORS FOR HEPATOTOXICI