Updated on 24/04/2012 and displayed until Current
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Improved Electronic Presentation
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| Date of revision of text on the SPC: 29-Apr-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| None provided |
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Updated on 26/07/2010 and displayed until 24/04/2012
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Updated on 30/11/2009 and displayed until 26/07/2010
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Change to section 4.2 - Posology and method of administration
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.8 - Undesirable Effects
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Change to section 10 date of revision of the text
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| 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
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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
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Updated on 03/07/2007 and displayed until 30/11/2009
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Correction of spelling/typing errors
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Updated on 02/07/2007 and displayed until 03/07/2007
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Change to section 4.2 - Posology and method of administration
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Change to section 5.2 - Pharmacokinetic Properties
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Change to section 10 date of revision of the text
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| 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
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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)
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Age
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Weight (kg)
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CLstd/Foral (L.h-1 70kg-1)
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40 weeks PCA
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3.3
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5.9
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3 months PNA
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6
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8.8
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6 months PNA
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7.5
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11.1
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1 year PNA
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10
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13.6
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2 years PNA
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12
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15.6
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5 years PNA
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20
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16.3
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8 years PNA
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25
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16.3
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*CLstd is the population estimate for CL
Section 10:
Changed to June 2007
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Updated on 20/03/2007 and displayed until 02/07/2007
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Change to section 4.2 - Posology and method of administration
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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Change to section 10 date of revision of the text
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| 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
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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.
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Updated on 19/01/2007 and displayed until 20/03/2007
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Improved Electronic Presentation
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Updated on 17/01/2007 and displayed until 19/01/2007
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Change to section 2 - Qualitative and quantitative composition
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Change to section 4.2 - Posology and method of administration
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.8 - Undesirable Effects
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Change to section 6. 3 - Shelf Life
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Change to section 6. 6 - Instructions for use, handling and disposal
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Change to section 9 - Date of first Authorisation/renewal of the Authorisation
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Change to section 10 date of revision of the text
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| 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
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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.
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Updated on 03/03/2006 and displayed until 17/01/2007
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Improved Electronic Presentation
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Updated on 01/12/2005 and displayed until 03/03/2006
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Updated on 20/08/2004 and displayed until 01/12/2005
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Change to section 4.2 - Posology and Method of Administration
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Change to section 2 - qualitative and quantitative composition
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Change to section 4.8 - Undesirable Effects
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Change to section 5.2 - Pharmacokinetic Properties
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Change to section 6. 5 - Nature and Contents of Container
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Change to section 10 (date of (partial) revision of the text
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Updated on 28/05/2004 and displayed until 20/08/2004
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Addition of Black Triangle
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Updated on 08/04/2004 and displayed until 28/05/2004
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