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PERFALGAN 10MG/ML SOLUTION FOR INFUSION

Active substance(s): PARACETAMOL

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0122549402

PACKAGE LEAFLET: INFORMATION FOR THE USER
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.

3g

100mL

100mL

4g

* Pre-term newborn infants: No safety and efficacy data are available for pre-term newborn.
** Maximum daily dose: The maximum daily dose as presented in the table above is for patients that are not receiving other paracetamol
containing products and should be adjusted accordingly taking such products into account.
***Patients weighing less will require smaller volumes.
The minimum interval between each administration must be at least 4 hours.
The minimum interval between each administration in patients with severe renal insufficiency must be at least 6 hours.
No more than 4 doses to be given in 24 hours.
The paracetamol solution is administered in intravenous infusion over 15 minutes.
If you have the impression that the effect of PERFALGAN 10 mg/ml, solution for infusion is too strong or too weak, talk to your doctor.

0122549402

INFORMATION FOR HEALTH PROFESSIONALS
Below is a summary of the dosage, dilution, administration and storage details for Perfalgan 10 mg/ml, solution for infusion. Reference
should be made to the Summary of Product Characteristics for full prescribing information.
For the 50ml and 100ml vial, close monitoring is needed before the end of infusion.
Dosage
Dosing based on patient weight (please see the dosing table here below)
Patient weight

Dose per
administration

Volume per
administration

≤10 kg*

7.5 mg/kg

0.75 mL/kg

Maximum volume of
Maximum Daily
Perfalgan (10 mg/mL) per Dose **
administration based on
upper weight limits of
group (mL)***
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

100mL

100mL

3g

100mL

100mL

4g

>50kg with additional risk 1g
factors for hepatotoxicity
> 50 kg and no additional 1 g
risk factors for hepatotoxicity

* Pre-term newborn infants: No safety and efficacy data are available for pre-term newborn.
** Maximum daily dose: The maximum daily dose as presented in the table above is for patients that are not receiving other paracetamol

Pollutri

100mL

10 pt
07.04.2014

100mL

>50kg with additional risk 1g
factors for hepatotoxicity
> 50 kg and no additional 1 g
risk factors for hepatotoxicity

Min. Font Size Text:
Proof No.: 2
Braille:

60mg/kg not exceeding 3g

Diecut

75 mL

1225494A2
(2/5) 0122549402
200 x 400 mm

1.5mL/kg

Product Code:
Barcode Type:
Format/Dimension:
Tech. Drawing No.:

15 mg/kg

Pantone 072
Pantone 347

> 33 kg to ≤50kg

PERFALGAN SINJ1G

60mg/kg not exceeding 2g

Product Name:

49.5mL

Anagni
Della Vecchia

1.5mL/kg

Production Site:
CTM:
Printing Colours:

15 mg/kg

No

> 10 kg to ≤33kg

£

0.75 mL/kg

Yes /

7.5 mg/kg

S

≤10 kg*

Maximum volume of
Maximum Daily
Perfalgan (10 mg/mL) per Dose **
administration based on
upper weight limits of
group (mL)***
7.5mL
30 mg/kg

20%

GB

Volume per
administration

RETINO - SCREENED

Live Text:
Country:

Dose per
administration

Phone contact: +39 0692708387
e-mail contact: artwork@grafimed.it
www.grafimed.it

Patient weight

P347

Technical Colours:

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 or 100 ml bag 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.
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 medicines containing paracetamol,
• in cases of nutrition problems (malnutrition) or dehydration.
Inform your doctor before treatment if any of the above mentioned conditions apply to you.
Taking or using other medicines
Do not give anything else containing paracetamol while giving this medicine. This medicine contains paracetamol and this must be taken into
account if other medicines containing paracetamol or propacetamol are taken, in order not to exceed the recommended daily dose (see following
section). Inform your doctor if you are taking other medicines containing paracetamol or propacetamol as your doctor may need to change your
dose.
A dose reduction should be considered for concomitant treatment with Probenecid.
Please inform your doctor or pharmacist if you are taking oral anticoagulants. Closer check-ups of the effect of the anticoagulant might be
necessary.
Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.
Pregnancy and breast-feeding
Pregnancy
Inform your doctor if you are pregnant. PERFALGAN may be used during pregnancy. However, in this case the doctor must evaluate if the treatment
is advisable.
Ask your doctor or pharmacist for advice before taking any medicine.
Breast-feeding
PERFALGAN may be used during breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Important information about some of the ingredients of PERFALGAN 10 mg/ml, solution for infusion
This medicinal product contains less than 1 mmol sodium (23mg) per 100 ml of Perfalgan, i.e. essentially "sodium free".
3. HOW TO USE PERFALGAN 10 mg/ml, solution for infusion
You should not be given more medicine than the label says. Do not exceed the stated dose.
Intravenous use.
The 100 ml vial or 100 ml bag 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.
Dosage
Dosing based on patient weight (please see the dosing table here below)

1225494A2

Technical Colours:

Diecut

Pantone 072
Pantone 347

Pollutri

Production Site:
CTM:
Printing Colours:

Anagni
Della Vecchia

20%

PERFALGAN SINJ1G

1225494A2
(2/5) 0122549402
200 x 400 mm

10 pt
07.04.2014

Product Name:

Product Code:
Barcode Type:
Format/Dimension:
Tech. Drawing No.:

Min. Font Size Text:
Proof No.: 2
Braille:

No

£
Yes /

S

Phone contact: +39 0692708387
e-mail contact: artwork@grafimed.it
www.grafimed.it

RETINO - SCREENED

GB

containing products and should be adjusted accordingly taking such products into account.
***Patients weighing less will require smaller volumes.
The minimum interval between each administration must be at least 4 hours.
The minimum interval between each administration in patients with severe renal insufficiency must be at least 6 hours.
No more than 4 doses to be given in 24 hours.
Method of administration
RISK OF MEDICATION ERRORS
Take care to avoid dosing errors due to confusion between milligram (mg) and milliliter (mL), which could result in
accidental overdose and death.
The paracetamol solution is administered in intravenous infusion over 15 minutes.
Patients weighing ≤ 10 kg:
• The glass vial/bag of Perfalgan should not be hung as an infusion due to the small volume of the medicinal product to be ad ministered in
this population.
• The volume to be administered should be withdrawn from the vial/bag and diluted in a 0.9% sodium chloride solution or 5% glucose
solution up to one tenth (one v lume Perfalgan into nine volumes diluent) and administered over 15 minute.
• A 5 or 10 ml syringe should be used to measure the dose as appropriate for the weight of the child and the desired volume. However,
this should never exceed 7.5ml per dose
• The user should be referred to the product information for dosing guidelines.
For the 50ml and 100ml vials, a 0.8 mm needle (21 gauge needle) has to be used and the stopper vertically perforated at the spot
specifically indicated.
It can also be diluted in 0.9% sodium chloride or 5% glucose up to one tenth (one volume Perfalgan into nine volumes diluent).
The diluted solution should be visually inspected and must not be used if opalescence, visible particulate matter or precipitate are found.

P347

Live Text:
Country:

0122549402

5. HOW TO STORE PERFALGAN 10 mg/ml, solution for infusion
Keep out of the reach and sight of children.
Do not use PERFALGAN 10 mg/ml, solution for infusion after the expiry date which is stated on the packaging after EXP.
The expiry date refers to the last day of that month.
Do not store above 30°C. Do not refrigerate or freeze.
For the 100 ml bag, keep the immediate packaging in the outer, aluminium over-packaging.
For the 50ml vial, after dilution in 0.9% sodium chloride or 5% glucose : do not store for more than 1 hour (infusion time included).
Before administration, the product should be inspected visually. Do not use PERFALGAN if you notice any particulate matter and
discoloration. For the 100ml bag, note that there is a potential presence of moisture between the bag and the outer sachet due to the sterilization
process, the quality of the product is not impacted.
For single use only. The product should be used immediately after opening. Any unused solution should be discarded.
6. FURTHER INFORMATION
What PERFALGAN 10 mg/ml, solution for infusion contains
• The active substance is paracetamol. One ml contains 10 mg paracetamol.
• The other ingredients are mannitol, cysteine hydrochloride monohydrate, disodium phosphate dihydrate, sodium hydroxide, hydrochloric acid,
water for injections.
What PERFALGAN 10 mg/ml, solution for infusion looks like and contents of the pack
Vials of 50 ml and 100 ml
Bags of 100 ml.
PERFALGAN 10 mg/ml solution for infusion is a clear and slightly yellowish solution.
PERFALGAN 10 mg/ml solution for infusion vials are supplied in packs of 12 vials.
PERFALGAN 10 mg/ml solution for infusion bags are supplied in cartons of 50 bags.
Not all pack sizes or presentation may be marketed.
Marketing Authorisation Holder
Bristol-Myers Squibb Pharmaceuticals Ltd
BMS House
Uxbridge Business Park
Sanderson Road
Uxbridge
Middlesex UB8 1DH
United Kingdom
Manufacturer
BRISTOL MYERS SQUIBB
304, avenue du Docteur Jean Bru
47000 AGEN, France
or
BRISTOL MYERS SQUIBB
Loc. Fontana del Ceraso
Anagni, Italy
or
Laboratoire RENAUDIN
Z.A. Errobi
64250 ITXASSOU, France
or
BIEFFE MEDITAL S.p.A.
Via Nuova Provinciale, nc
23034 GROSOTTO-SO, Italy
or
LABORATORIOS GRIFOLS, S.A.
Passeig Fluvial, 24
Poligono Industrial Autopista
08150 Parets del Vallès
BARCELONA
(Spain)
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in April 2014.

0122549402

If you or your child use more PERFALGAN 10mg/ml, solution for infusion than if you or your child use should, talk to a doctor at
once if you or your child take too much of this medicine even if you or your child seem feel well. This is because too much
paracetamol can cause delayed, serious liver damage.
In overdose cases, symptoms generally appear within the first 24 hours and comprise: nausea, vomiting, anorexia, pallor, abdominal pain
and a risk of liver injury.
If you have any further questions on the use of this product ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, PERFALGAN 10 mg/ml, solution for infusion can cause side effects, although not everybody gets them.
• In very rare cases (less than 1 out of 10,000 persons, including isolated reports), a serious skin rash or allergic reaction may occur. Stop the
treatment immediately and inform your doctor.
• In rare cases (more than 1 out of 10,000 persons and less than 1 out of 1,000 persons), the following may occur : a malaise, a drop in blood
pressure or changes in laboratory test results : abnormally high levels of hepatic enzymes found during blood checks. Should this occur,
inform your doctor as regular blood checks may be required later.
• In isolated cases, other changes in laboratory test results have been observed which have necessitated regular blood checks : abnormally
low levels of some types of blood cells (platelets, white cells), possibly leading to bleeding from the nose or gums. Should this occur, inform
your doctor.
• Cases of redness of the skin, flushing, itching and abnormally rapid beating of the heart have been reported.
• Cases of pain and burning sensation at injection site have been reported.
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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.

0122549402

PACKAGE LEAFLET: INFORMATION FOR THE USER
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 or 100 ml bag 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.
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 medicines containing paracetamol,
• in cases of nutrition problems (malnutrition) or dehydration.
Inform your doctor before treatment if any of the above mentioned conditions apply to you.
Taking or using other medicines
Do not give anything else containing paracetamol while giving this medicine. This medicine contains paracetamol and this must be taken into
account if other medicines containing paracetamol or propacetamol are taken, in order not to exceed the recommended daily dose (see following
section). Inform your doctor if you are taking other medicines containing paracetamol or propacetamol as your doctor may need to change your
dose.
A dose reduction should be considered for concomitant treatment with Probenecid.
Please inform your doctor or pharmacist if you are taking oral anticoagulants. Closer check-ups of the effect of the anticoagulant might be
necessary.
Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.
Pregnancy and breast-feeding
Pregnancy
Inform your doctor if you are pregnant. PERFALGAN may be used during pregnancy. However, in this case the doctor must evaluate if the treatment
is advisable.
Ask your doctor or pharmacist for advice before taking any medicine.
Breast-feeding
PERFALGAN may be used during breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Important information about some of the ingredients of PERFALGAN 10 mg/ml, solution for infusion
This medicinal product contains less than 1 mmol sodium (23mg) per 100 ml of Perfalgan, i.e. essentially "sodium free".
3. HOW TO USE PERFALGAN 10 mg/ml, solution for infusion
You should not be given more medicine than the label says. Do not exceed the stated dose.
Intravenous use.
The 100 ml vial or 100 ml bag 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.
Dosage
Dosing based on patient weight (please see the dosing table here below)

100mL

100mL

4g

* Pre-term newborn infants: No safety and efficacy data are available for pre-term newborn.
** Maximum daily dose: The maximum daily dose as presented in the table above is for patients that are not receiving other paracetamol
containing products and should be adjusted accordingly taking such products into account.
***Patients weighing less will require smaller volumes.
The minimum interval between each administration must be at least 4 hours.
The minimum interval between each administration in patients with severe renal insufficiency must be at least 6 hours.
No more than 4 doses to be given in 24 hours.
The paracetamol solution is administered in intravenous infusion over 15 minutes.
If you have the impression that the effect of PERFALGAN 10 mg/ml, solution for infusion is too strong or too weak, talk to your doctor.

0122549402

INFORMATION FOR HEALTH PROFESSIONALS
Below is a summary of the dosage, dilution, administration and storage details for Perfalgan 10 mg/ml, solution for infusion. Reference
should be made to the Summary of Product Characteristics for full prescribing information.
For the 50ml and 100ml vial, close monitoring is needed before the end of infusion.
Dosage
Dosing based on patient weight (please see the dosing table here below)
Patient weight

Dose per
administration

Volume per
administration

≤10 kg*

7.5 mg/kg

0.75 mL/kg

Maximum volume of
Maximum Daily
Perfalgan (10 mg/mL) per Dose **
administration based on
upper weight limits of
group (mL)***
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

100mL

100mL

3g

100mL

100mL

4g

>50kg with additional risk 1g
factors for hepatotoxicity
> 50 kg and no additional 1 g
risk factors for hepatotoxicity

* Pre-term newborn infants: No safety and efficacy data are available for pre-term newborn.
** Maximum daily dose: The maximum daily dose as presented in the table above is for patients that are not receiving other paracetamol

Pollutri

3g

10 pt
07.04.2014

100mL

Min. Font Size Text:
Proof No.: 2
Braille:

100mL

>50kg with additional risk 1g
factors for hepatotoxicity
> 50 kg and no additional 1 g
risk factors for hepatotoxicity

Diecut

60mg/kg not exceeding 3g

Technical Colours:

75 mL

1225494A2
(2/5) 0122549402
200 x 400 mm

1.5mL/kg

Product Code:
Barcode Type:
Format/Dimension:
Tech. Drawing No.:

15 mg/kg

Pantone 072
Pantone 347

> 33 kg to ≤50kg

PERFALGAN SINJ1G

60mg/kg not exceeding 2g

Product Name:

49.5mL

Anagni
Della Vecchia

1.5mL/kg

Production Site:
CTM:
Printing Colours:

15 mg/kg

No

> 10 kg to ≤33kg

£

0.75 mL/kg

Yes /

7.5 mg/kg

S

≤10 kg*

Maximum volume of
Maximum Daily
Perfalgan (10 mg/mL) per Dose **
administration based on
upper weight limits of
group (mL)***
7.5mL
30 mg/kg

GB

Volume per
administration

Live Text:
Country:

Dose per
administration

RETINO - SCREENED

20%

Phone contact: +39 0692708387
e-mail contact: artwork@grafimed.it
www.grafimed.it

Patient weight

P347

0122549402

PACKAGE LEAFLET: INFORMATION FOR THE USER
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 or 100 ml bag 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.
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 medicines containing paracetamol,
• in cases of nutrition problems (malnutrition) or dehydration.
Inform your doctor before treatment if any of the above mentioned conditions apply to you.
Taking or using other medicines
Do not give anything else containing paracetamol while giving this medicine. This medicine contains paracetamol and this must be taken into
account if other medicines containing paracetamol or propacetamol are taken, in order not to exceed the recommended daily dose (see following
section). Inform your doctor if you are taking other medicines containing paracetamol or propacetamol as your doctor may need to change your
dose.
A dose reduction should be considered for concomitant treatment with Probenecid.
Please inform your doctor or pharmacist if you are taking oral anticoagulants. Closer check-ups of the effect of the anticoagulant might be
necessary.
Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.
Pregnancy and breast-feeding
Pregnancy
Inform your doctor if you are pregnant. PERFALGAN may be used during pregnancy. However, in this case the doctor must evaluate if the treatment
is advisable.
Ask your doctor or pharmacist for advice before taking any medicine.
Breast-feeding
PERFALGAN may be used during breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Important information about some of the ingredients of PERFALGAN 10 mg/ml, solution for infusion
This medicinal product contains less than 1 mmol sodium (23mg) per 100 ml of Perfalgan, i.e. essentially "sodium free".
3. HOW TO USE PERFALGAN 10 mg/ml, solution for infusion
You should not be given more medicine than the label says. Do not exceed the stated dose.
Intravenous use.
The 100 ml vial or 100 ml bag 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.
Dosage
Dosing based on patient weight (please see the dosing table here below)

100mL

100mL

4g

* Pre-term newborn infants: No safety and efficacy data are available for pre-term newborn.
** Maximum daily dose: The maximum daily dose as presented in the table above is for patients that are not receiving other paracetamol
containing products and should be adjusted accordingly taking such products into account.
***Patients weighing less will require smaller volumes.
The minimum interval between each administration must be at least 4 hours.
The minimum interval between each administration in patients with severe renal insufficiency must be at least 6 hours.
No more than 4 doses to be given in 24 hours.
The paracetamol solution is administered in intravenous infusion over 15 minutes.
If you have the impression that the effect of PERFALGAN 10 mg/ml, solution for infusion is too strong or too weak, talk to your doctor.

0122549402

INFORMATION FOR HEALTH PROFESSIONALS
Below is a summary of the dosage, dilution, administration and storage details for Perfalgan 10 mg/ml, solution for infusion. Reference
should be made to the Summary of Product Characteristics for full prescribing information.
For the 50ml and 100ml vial, close monitoring is needed before the end of infusion.
Dosage
Dosing based on patient weight (please see the dosing table here below)
Patient weight

Dose per
administration

Volume per
administration

≤10 kg*

7.5 mg/kg

0.75 mL/kg

Maximum volume of
Maximum Daily
Perfalgan (10 mg/mL) per Dose **
administration based on
upper weight limits of
group (mL)***
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

100mL

100mL

3g

100mL

100mL

4g

>50kg with additional risk 1g
factors for hepatotoxicity
> 50 kg and no additional 1 g
risk factors for hepatotoxicity

* Pre-term newborn infants: No safety and efficacy data are available for pre-term newborn.
** Maximum daily dose: The maximum daily dose as presented in the table above is for patients that are not receiving other paracetamol

Pollutri

3g

10 pt
07.04.2014

100mL

Min. Font Size Text:
Proof No.: 2
Braille:

100mL

>50kg with additional risk 1g
factors for hepatotoxicity
> 50 kg and no additional 1 g
risk factors for hepatotoxicity

Diecut

60mg/kg not exceeding 3g

Technical Colours:

75 mL

1225494A2
(2/5) 0122549402
200 x 400 mm

1.5mL/kg

Product Code:
Barcode Type:
Format/Dimension:
Tech. Drawing No.:

15 mg/kg

Pantone 072
Pantone 347

> 33 kg to ≤50kg

PERFALGAN SINJ1G

60mg/kg not exceeding 2g

Product Name:

49.5mL

Anagni
Della Vecchia

1.5mL/kg

Production Site:
CTM:
Printing Colours:

15 mg/kg

No

> 10 kg to ≤33kg

£

0.75 mL/kg

Yes /

7.5 mg/kg

S

≤10 kg*

Maximum volume of
Maximum Daily
Perfalgan (10 mg/mL) per Dose **
administration based on
upper weight limits of
group (mL)***
7.5mL
30 mg/kg

GB

Volume per
administration

Live Text:
Country:

Dose per
administration

RETINO - SCREENED

20%

Phone contact: +39 0692708387
e-mail contact: artwork@grafimed.it
www.grafimed.it

Patient weight

P347

1225494A2

RETINO - SCREENED

Technical Colours:

Diecut

Pantone 072
Pantone 347

Anagni
Della Vecchia

Pollutri

Production Site:
CTM:
Printing Colours:
PERFALGAN SINJ1G

1225494A2
(2/5) 0122549402
200 x 400 mm

10 pt
07.04.2014

Product Name:

Product Code:
Barcode Type:
Format/Dimension:
Tech. Drawing No.:

Min. Font Size Text:
Proof No.: 2
Braille:

No

£
Yes /

S

Phone contact: +39 0692708387
e-mail contact: artwork@grafimed.it
www.grafimed.it

20%

GB

containing products and should be adjusted accordingly taking such products into account.
***Patients weighing less will require smaller volumes.
The minimum interval between each administration must be at least 4 hours.
The minimum interval between each administration in patients with severe renal insufficiency must be at least 6 hours.
No more than 4 doses to be given in 24 hours.
Method of administration
RISK OF MEDICATION ERRORS
Take care to avoid dosing errors due to confusion between milligram (mg) and milliliter (mL), which could result in
accidental overdose and death.
The paracetamol solution is administered in intravenous infusion over 15 minutes.
Patients weighing ≤ 10 kg:
• The glass vial/bag of Perfalgan should not be hung as an infusion due to the small volume of the medicinal product to be ad ministered in
this population.
• The volume to be administered should be withdrawn from the vial/bag and diluted in a 0.9% sodium chloride solution or 5% glucose
solution up to one tenth (one v lume Perfalgan into nine volumes diluent) and administered over 15 minute.
• A 5 or 10 ml syringe should be used to measure the dose as appropriate for the weight of the child and the desired volume. However,
this should never exceed 7.5ml per dose
• The user should be referred to the product information for dosing guidelines.
For the 50ml and 100ml vials, a 0.8 mm needle (21 gauge needle) has to be used and the stopper vertically perforated at the spot
specifically indicated.
It can also be diluted in 0.9% sodium chloride or 5% glucose up to one tenth (one volume Perfalgan into nine volumes diluent).
The diluted solution should be visually inspected and must not be used if opalescence, visible particulate matter or precipitate are found.

P347

Live Text:
Country:

0122549402

5. HOW TO STORE PERFALGAN 10 mg/ml, solution for infusion
Keep out of the reach and sight of children.
Do not use PERFALGAN 10 mg/ml, solution for infusion after the expiry date which is stated on the packaging after EXP.
The expiry date refers to the last day of that month.
Do not store above 30°C. Do not refrigerate or freeze.
For the 100 ml bag, keep the immediate packaging in the outer, aluminium over-packaging.
For the 50ml vial, after dilution in 0.9% sodium chloride or 5% glucose : do not store for more than 1 hour (infusion time included).
Before administration, the product should be inspected visually. Do not use PERFALGAN if you notice any particulate matter and
discoloration. For the 100ml bag, note that there is a potential presence of moisture between the bag and the outer sachet due to the sterilization
process, the quality of the product is not impacted.
For single use only. The product should be used immediately after opening. Any unused solution should be discarded.
6. FURTHER INFORMATION
What PERFALGAN 10 mg/ml, solution for infusion contains
• The active substance is paracetamol. One ml contains 10 mg paracetamol.
• The other ingredients are mannitol, cysteine hydrochloride monohydrate, disodium phosphate dihydrate, sodium hydroxide, hydrochloric acid,
water for injections.
What PERFALGAN 10 mg/ml, solution for infusion looks like and contents of the pack
Vials of 50 ml and 100 ml
Bags of 100 ml.
PERFALGAN 10 mg/ml solution for infusion is a clear and slightly yellowish solution.
PERFALGAN 10 mg/ml solution for infusion vials are supplied in packs of 12 vials.
PERFALGAN 10 mg/ml solution for infusion bags are supplied in cartons of 50 bags.
Not all pack sizes or presentation may be marketed.
Marketing Authorisation Holder
Bristol-Myers Squibb Pharmaceuticals Ltd
BMS House
Uxbridge Business Park
Sanderson Road
Uxbridge
Middlesex UB8 1DH
United Kingdom
Manufacturer
BRISTOL MYERS SQUIBB
304, avenue du Docteur Jean Bru
47000 AGEN, France
or
BRISTOL MYERS SQUIBB
Loc. Fontana del Ceraso
Anagni, Italy
or
Laboratoire RENAUDIN
Z.A. Errobi
64250 ITXASSOU, France
or
BIEFFE MEDITAL S.p.A.
Via Nuova Provinciale, nc
23034 GROSOTTO-SO, Italy
or
LABORATORIOS GRIFOLS, S.A.
Passeig Fluvial, 24
Poligono Industrial Autopista
08150 Parets del Vallès
BARCELONA
(Spain)
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in April 2014.

0122549402

If you or your child use more PERFALGAN 10mg/ml, solution for infusion than if you or your child use should, talk to a doctor at
once if you or your child take too much of this medicine even if you or your child seem feel well. This is because too much
paracetamol can cause delayed, serious liver damage.
In overdose cases, symptoms generally appear within the first 24 hours and comprise: nausea, vomiting, anorexia, pallor, abdominal pain
and a risk of liver injury.
If you have any further questions on the use of this product ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, PERFALGAN 10 mg/ml, solution for infusion can cause side effects, although not everybody gets them.
• In very rare cases (less than 1 out of 10,000 persons, including isolated reports), a serious skin rash or allergic reaction may occur. Stop the
treatment immediately and inform your doctor.
• In rare cases (more than 1 out of 10,000 persons and less than 1 out of 1,000 persons), the following may occur : a malaise, a drop in blood
pressure or changes in laboratory test results : abnormally high levels of hepatic enzymes found during blood checks. Should this occur,
inform your doctor as regular blood checks may be required later.
• In isolated cases, other changes in laboratory test results have been observed which have necessitated regular blood checks : abnormally
low levels of some types of blood cells (platelets, white cells), possibly leading to bleeding from the nose or gums. Should this occur, inform
your doctor.
• Cases of redness of the skin, flushing, itching and abnormally rapid beating of the heart have been reported.
• Cases of pain and burning sensation at injection site have been reported.
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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.

1225494A2

RETINO - SCREENED

Technical Colours:

Diecut

Pantone 072
Pantone 347

Anagni
Della Vecchia

Pollutri

Production Site:
CTM:
Printing Colours:
PERFALGAN SINJ1G

1225494A2
(2/5) 0122549402
200 x 400 mm

10 pt
07.04.2014

Product Name:

Product Code:
Barcode Type:
Format/Dimension:
Tech. Drawing No.:

Min. Font Size Text:
Proof No.: 2
Braille:

No

£
Yes /

S

Phone contact: +39 0692708387
e-mail contact: artwork@grafimed.it
www.grafimed.it

20%

GB

containing products and should be adjusted accordingly taking such products into account.
***Patients weighing less will require smaller volumes.
The minimum interval between each administration must be at least 4 hours.
The minimum interval between each administration in patients with severe renal insufficiency must be at least 6 hours.
No more than 4 doses to be given in 24 hours.
Method of administration
RISK OF MEDICATION ERRORS
Take care to avoid dosing errors due to confusion between milligram (mg) and milliliter (mL), which could result in
accidental overdose and death.
The paracetamol solution is administered in intravenous infusion over 15 minutes.
Patients weighing ≤ 10 kg:
• The glass vial/bag of Perfalgan should not be hung as an infusion due to the small volume of the medicinal product to be ad ministered in
this population.
• The volume to be administered should be withdrawn from the vial/bag and diluted in a 0.9% sodium chloride solution or 5% glucose
solution up to one tenth (one v lume Perfalgan into nine volumes diluent) and administered over 15 minute.
• A 5 or 10 ml syringe should be used to measure the dose as appropriate for the weight of the child and the desired volume. However,
this should never exceed 7.5ml per dose
• The user should be referred to the product information for dosing guidelines.
For the 50ml and 100ml vials, a 0.8 mm needle (21 gauge needle) has to be used and the stopper vertically perforated at the spot
specifically indicated.
It can also be diluted in 0.9% sodium chloride or 5% glucose up to one tenth (one volume Perfalgan into nine volumes diluent).
The diluted solution should be visually inspected and must not be used if opalescence, visible particulate matter or precipitate are found.

P347

Live Text:
Country:

0122549402

5. HOW TO STORE PERFALGAN 10 mg/ml, solution for infusion
Keep out of the reach and sight of children.
Do not use PERFALGAN 10 mg/ml, solution for infusion after the expiry date which is stated on the packaging after EXP.
The expiry date refers to the last day of that month.
Do not store above 30°C. Do not refrigerate or freeze.
For the 100 ml bag, keep the immediate packaging in the outer, aluminium over-packaging.
For the 50ml vial, after dilution in 0.9% sodium chloride or 5% glucose : do not store for more than 1 hour (infusion time included).
Before administration, the product should be inspected visually. Do not use PERFALGAN if you notice any particulate matter and
discoloration. For the 100ml bag, note that there is a potential presence of moisture between the bag and the outer sachet due to the sterilization
process, the quality of the product is not impacted.
For single use only. The product should be used immediately after opening. Any unused solution should be discarded.
6. FURTHER INFORMATION
What PERFALGAN 10 mg/ml, solution for infusion contains
• The active substance is paracetamol. One ml contains 10 mg paracetamol.
• The other ingredients are mannitol, cysteine hydrochloride monohydrate, disodium phosphate dihydrate, sodium hydroxide, hydrochloric acid,
water for injections.
What PERFALGAN 10 mg/ml, solution for infusion looks like and contents of the pack
Vials of 50 ml and 100 ml
Bags of 100 ml.
PERFALGAN 10 mg/ml solution for infusion is a clear and slightly yellowish solution.
PERFALGAN 10 mg/ml solution for infusion vials are supplied in packs of 12 vials.
PERFALGAN 10 mg/ml solution for infusion bags are supplied in cartons of 50 bags.
Not all pack sizes or presentation may be marketed.
Marketing Authorisation Holder
Bristol-Myers Squibb Pharmaceuticals Ltd
BMS House
Uxbridge Business Park
Sanderson Road
Uxbridge
Middlesex UB8 1DH
United Kingdom
Manufacturer
BRISTOL MYERS SQUIBB
304, avenue du Docteur Jean Bru
47000 AGEN, France
or
BRISTOL MYERS SQUIBB
Loc. Fontana del Ceraso
Anagni, Italy
or
Laboratoire RENAUDIN
Z.A. Errobi
64250 ITXASSOU, France
or
BIEFFE MEDITAL S.p.A.
Via Nuova Provinciale, nc
23034 GROSOTTO-SO, Italy
or
LABORATORIOS GRIFOLS, S.A.
Passeig Fluvial, 24
Poligono Industrial Autopista
08150 Parets del Vallès
BARCELONA
(Spain)
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in April 2014.

0122549402

If you or your child use more PERFALGAN 10mg/ml, solution for infusion than if you or your child use should, talk to a doctor at
once if you or your child take too much of this medicine even if you or your child seem feel well. This is because too much
paracetamol can cause delayed, serious liver damage.
In overdose cases, symptoms generally appear within the first 24 hours and comprise: nausea, vomiting, anorexia, pallor, abdominal pain
and a risk of liver injury.
If you have any further questions on the use of this product ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, PERFALGAN 10 mg/ml, solution for infusion can cause side effects, although not everybody gets them.
• In very rare cases (less than 1 out of 10,000 persons, including isolated reports), a serious skin rash or allergic reaction may occur. Stop the
treatment immediately and inform your doctor.
• In rare cases (more than 1 out of 10,000 persons and less than 1 out of 1,000 persons), the following may occur : a malaise, a drop in blood
pressure or changes in laboratory test results : abnormally high levels of hepatic enzymes found during blood checks. Should this occur,
inform your doctor as regular blood checks may be required later.
• In isolated cases, other changes in laboratory test results have been observed which have necessitated regular blood checks : abnormally
low levels of some types of blood cells (platelets, white cells), possibly leading to bleeding from the nose or gums. Should this occur, inform
your doctor.
• Cases of redness of the skin, flushing, itching and abnormally rapid beating of the heart have been reported.
• Cases of pain and burning sensation at injection site have been reported.
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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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