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Bristol-Myers Squibb Pharmaceutical Limited
Bristol-Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex, UB8 1DH , UK
Telephone: +44 (0)1895 523 000
Fax: +44 (0)1895 523 010
Medical Information Direct Line: +44 (0)1895 523 740
Medical Information e-mail: medical.information@bms.com
Medical Information Fax: +44 (0)1895 523 677

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Summary of Product Characteristics last updated on the eMC: 26/07/2010
SPC Perfalgan 10mg/ml Solution for Infusion

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 26/07/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 6 - Instructions for use, handling and disposal
Date of revision of text on the SPC:   29-Apr-2009
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company



Section 4.2 , 4.4, 6.3,6.4  6.5  and 6,6 have been updated with text for the 50ml and 100ml vials


Section  4.8 has been updated with the word frequent

 

 

 

 

 
Updated on 30/11/2009 and displayed until 26/07/2010
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   02-Jul-2009
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 4.2 add: In adults with hepatocellular insufficiency, chronic alcoholism, chronic malnutrition (low reserves of hepatic glutathione), dehydration: The maximum daily dose must not exceed 3g (see section 4.4).

Section 4.4 amend: In order to avoid the risk of overdose, check that no other medicines administered to not contain either paracetamol or propacetamol.

Doses higher than those recommended entail the risk of very serious liver damage. Clinical signs and symptoms of liver damage (including fulminant hepatitis, hepatic failure, cholestatic hepatitis, cytolytic hepatitis) are not usually first seen after two days of drug administration with a peak seen, usually after 4-6 days. Treatment with antidote should be given as soon as possible (See section 4.9 Overdose).

Section 4.8 add: Cases of erythema, flushing, pruritus and tachycardia have been reported.

Section 4.9 amend first sentence: There is a risk of liver injury (including fulminant hepatitis, hepatic failure, cholestatic hepatitis, cytolytic hepatitis), particularly in elderly subjects, in young children, in patients with liver disease, in cases of chronic alcoholism, in patients with chronic malnuturition and in patients receiving enzyme inducers.

Section 10. Date of Revision of Text: November 2009
Updated on 03/07/2007 and displayed until 30/11/2009
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 02/07/2007 and displayed until 03/07/2007
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   06/2007
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 4.2:
 
The 50 ml vial is restricted to term newborn infants, infants, toddlers and children weighing less than 33 kg.

Term newborn infants, infants, toddlers and children weighing less than 10kg (up to approximately 1 year old):

Paracetamol 7.5mg/kg per administration i.e. 0.75ml solution per kg up to four times a day.

The minimum interval between each administration must be 4 hours.

The maximum daily dose must not exceed 30mg/kg.

No safety and efficacy data are available for premature neonates (see also section 5.2)

 
Section 5.2:
 

Total excretion of paracetamol and its metabolites is the same at all ages.

 

Table - Age related pharmacokinetic values (standardised clearance, *CLstd/Foral (L.h-1 70kg-1)

 

Age

Weight (kg)

CLstd/Foral (L.h-1 70kg-1)

40 weeks PCA

3.3

5.9

3 months PNA

6

8.8

6 months PNA

7.5

11.1

1 year PNA

10

13.6

2 years PNA

12

15.6

5 years PNA

20

16.3

8 years PNA

25

16.3

 

*CLstd is the population estimate for CL

Section 10:
Changed to June 2007
Updated on 20/03/2007 and displayed until 02/07/2007
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   03/2007
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 4.2 - Addition of:
As for all solutions for infusion presented in glass vials, it should be remember that close monitoring is needed notably at the end of the infusion, regardless of administration route.  This monitoring at the end of the infusiion applies particularly for central route infusions, in order to avoid air embolism.
 
Section 4.5 - Addition of:
Concomitant use of paracetamol (4g per day for at least 4 days) with oral anticoagulants may lead to slight variations of INR values.  In this case, increased monitoring of INR values should be conducted during the period of concomitant use, as well as for 1 week after paracetamol treatment has been discontinued.
Updated on 19/01/2007 and displayed until 20/03/2007
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 17/01/2007 and displayed until 19/01/2007
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   12/2006
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 2 now includes:
Excipients: Sodium 0.04mg/ml
For the full list of excipients, see section 6.1
 
Section 4.2 now includes under method of administration:
Perfalgan 50ml vial can also be diluted in a 0.9% sodium chloride solution or 5% glucose solution up to one tenth.  In this case, use the diluted solution within the hour following its preparation (infusion time included).
 
Section 4.4 now includes:
This medicinal product contains less than 1mmol sodiuk (23mg) per 100ml of Perfalgan i.e. essentially sodium free.
 
Section 4.8:
Within the table detailing the frequency of undesirable effects, the column stating isolated reports has been deleted with thrombocytopenia, leucopenia and neutorpenia being moved into the column headed 'very rare'.  The sentence 'Isolated reports of thrombocytopenia have been observed' has been deleted.
 
Section 6.3 now includes:
If diluted in 0.9% sodium chloride or 5% glucose, the solution should also be used immediately.  However, if the solution is not used immediately, do not store for more than 1 hour (infusion time included).
 
Section 6.6 now includes:
The diluted solution should be visually inspected and should not be used in the presence of opalescence, visible particulate matter or precipitate.
 
Updated on 03/03/2006 and displayed until 17/01/2007
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 01/12/2005 and displayed until 03/03/2006
Reasons for adding or updating:
  • No reasons supplied
Updated on 20/08/2004 and displayed until 01/12/2005
Reasons for adding or updating:
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 2 - qualitative and quantitative composition
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 10 (date of (partial) revision of the text
Updated on 28/05/2004 and displayed until 20/08/2004
Reasons for adding or updating:
  • Addition of Black Triangle
Updated on 08/04/2004 and displayed until 28/05/2004
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics

 
  paracetamol