Perfalgan 1g/100ml solution for infusion vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Paracetamol

Available from:

Bristol-Myers Squibb Pharmaceuticals Ltd

ATC code:

N02BE01

INN (International Name):

Paracetamol

Dosage:

10mg/1ml

Pharmaceutical form:

Solution for infusion

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04070100; GTIN: 5012712003533

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
PERFALGAN 10 MG/ML, SOLUTION FOR INFUSION Paracetamol
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
• 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. Do not pass it on to
others. It may harm them, even if their
symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your
doctor or pharmacist.
IN THIS LEAFLET:
1. What PERFALGAN 10 mg/ml, solution for infusion is and what it is
used for
2. Before you use PERFALGAN 10 mg/ml, solution for infusion
3. How to use PERFALGAN 10 mg/ml, solution for infusion
4. Possible side effects
5. How to store PERFALGAN 10 mg/ml, solution for infusion
6. Further information
1.
WHAT PERFALGAN 10 MG/ML, SOLUTION FOR INFUSION IS AND WHAT IT IS USED
FOR
This medicine is an analgesic (it relieves pain) and an antipyretic
(it lowers fever).
The 100 ml vial is restricted to adults, adolescents and children
weighing more than 33 kg.
The 50 ml vial is adapted to term newborn infants, infants, toddlers
and children weighing less than 33 kg.
It is indicated for the short-term treatment of moderate pain,
especially following surgery, and for the short-term
treatment of fever.
2.
BEFORE YOU USE PERFALGAN 10 MG/ML, SOLUTION FOR INFUSION
DO NOT USE PERFALGAN 10 MG/ML, SOLUTION FOR INFUSION
• if you are allergic (hypersensitive) to paracetamol or to any of
the other ingredients of Perfalgan.
• if you are allergic (hypersensitive) to propacetamol (another
analgesic for infusion and a precursor of
paracetamol).
• if you suffer from a severe liver disease.
TAKE SPECIAL CARE WITH PERFALGAN 10 MG/ML, SOLUTION FOR INFUSION
• use a suitable analgesic oral treatment as soon as this
administration route is possible.
• if you suffer from a liver or kidney disease, or from alcohol
abuse.
• if you are taking other medici

Summary of Product characteristics

OBJECT 1
PERFALGAN 10MG/ML SOLUTION FOR INFUSION
Summary of Product Characteristics Updated 05-Apr-2017 | Bristol-Myers
Squibb Pharmaceuticals
limited
1. Name of the medicinal product
PERFALGAN 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 100 ml vial contains 1000 mg paracetamol
Excipients: Sodium 0.04 mg/ml
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for infusion.
The solution is clear and slightly yellowish.
4. Clinical particulars
4.1 Therapeutic indications
Perfalgan 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 route.
The 100 ml vial is restricted to adults, adolescents and children
weighing more than 33 kg.
The 50 ml vial is adapted to term newborn infants, infants, toddlers
and children weighing less 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
PERFALGAN (10 MG/ML)
PER ADMINISTRATION
BASED ON UPPER WEIGHT
LIMITS OF GROUP
MAXIMUM DAILY
DOSE ***
(ML)**
≤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 2g
> 33 KG TO ≤50KG
15 mg/kg
1.5mL/kg
75 mL
60mg/kg not
exceeding 3g
PATIENT WEIGHT
Dose per
administration
Volume per
administration
Maximum volume per
administration **
Maximum Daily
Dose ***
>50KG WITH
ADDITIONAL RISK
FACTORS FOR
HEPATOTOXICITY
1g
100mL
100mL
3g
> 50 KG AND NO
ADDITIONAL RISK
FACTORS FOR
HEPATOTOXICITY
1 g
100mL
100mL
4g
* PRE-TERM NEWBORN INFANTS: No safety and efficacy data are available
for pre-term newborn infants (see
section 5.2).
** Pati