Summary of Product Characteristics
last updated on the eMC:
27/01/2012
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 27/01/2012 and displayed until Current
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Reasons for adding or updating:
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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: 12-Jan-2012 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section
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Summary of change
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4.4
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Update to Section 4.4 Special Warnings and Precautions for Use with regards to QT prolongation
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4.8
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Update to include Undesirable Effects to include additional information on QT prolongation, including Torsades de Pointes.
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10
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Updated date
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Updated on 18/10/2011 and displayed until 27/01/2012
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Reasons for adding or updating:
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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 4.5 - Interaction with other medicinal products and other forms of interaction
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Change to section 4.8 - Undesirable Effects
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Change to section 4.9 - Overdose
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Change to section 5.1 - Pharmacodynamic 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: 10-Oct-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Sections changed:
4.2 Updated with information on administration and dosage
4.4 Updated with information adenotonsillar surgery
4.5 Updated with information on interactions
4.8Updated withd efinitions for adverse reactions
4.9 Updated with information on the use of the ipecacuanha
5.1 Updated with information on paediatric population
10 Updated with new date of revision of text
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Updated on 03/08/2011 and displayed until 18/10/2011
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Reasons for adding or updating:
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Change to section 4.7 - Effects on Ability to Drive and Use Machines
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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-Feb-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Sections Amended:
4.7 Section updated to provide clearer guidance regarding lack of or negligible effect of ondansetron on ability to drive and use machines
10. Updated with new date of revision of text
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Updated on 20/01/2010 and displayed until 03/08/2011
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Reasons for adding or updating:
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Change to section 5.2 - Pharmacokinetic Properties
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| Date of revision of text on the SPC: 14-Oct-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 5.2 - Addition of the following sentence: "Mean bioavailability in healthy male subjects, following the oral administration of a single 8 mg tablet, is approximately 55 to 60%".
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Updated on 29/10/2009 and displayed until 20/01/2010
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Reasons for adding or updating:
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Change to section 4.1 - Therapeutic indications
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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 4.5 - Interaction with other medicinal products and other forms of interaction
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Change to section 4.8 - Undesirable Effects
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Change to section 5.1 - Pharmacodynamic Properties
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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: 14-Oct-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 4.1 - Adults:
Zofran is indicated for the management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy. Zofran is indicated for the prevention of post-operative nausea and vomiting (PONV).
Paediatric Population:
Zofran is indicated for the management of chemotherapy-induced nausea and vomiting (CINV) in children aged =6 months, and for the prevention and treatment of PONV in children aged =1 month.
Section 4.2 - entire section
Section 4.4 - Respiratory events should be treated symptomatically and clinicians should pay particular attention to them as precursors of hypersensitivity reactions.
Paediatric Population:
Paediatric patients receiving ondansetron with hepatotoxic chemotherapeutic agents should be monitored closely for impaired hepatic function.
CINV:
When calculating the dose on an mg/kg basis and administering three doses at 4-hourly intervals, the total daily dose will be higher than if one single dose of 5mg/m2 followed by an oral dose is given. The comparative efficacy of these two different dosing regimens has not been investigated in clinical trials. Cross-trial comparison indicates similar efficacy for both regimens (section 5.1).
Section 4.5 -Use of Zofran with QT prolonging drugs may result in additional QT prolongation. Concomitant use of Zofran with cardiotoxic drugs (e.g. anthracyclines) may increase the risk of arrhythmias (section 4.4).
Section 4.8 - Paediatric population
The adverse event profile in children and adolescents was comparable to that seen in adults.
Section 5.1 - entire section
Section 5.2 - entire section
Section 10 - 14-Oct-2009
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Updated on 30/04/2007 and displayed until 29/10/2009
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Reasons for adding or updating:
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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: 10/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 10: Reformatted date of revision
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Updated on 31/10/2006 and displayed until 30/04/2007
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Reasons for adding or updating:
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Change to section 4.4 - Special warnings and precautions for Use
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| Date of revision of text on the SPC: 10/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| To add special warning 'very rarely and predominantly with intravenous Zofran, transient ECG changes including QT interval prolongation have been reported'.
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Updated on 26/10/2006 and displayed until 31/10/2006
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Reasons for adding or updating:
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Change to section 4.4 - Special warnings and precautions for Use
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| Date of revision of text on the SPC: 10/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| To add special warning “transient ECG changes including QT interval prolongation” to section 4.4 Special Warnings & Precautions for Use.
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Updated on 24/04/2006 and displayed until 26/10/2006
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 21/04/2006 and displayed until 24/04/2006
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Reasons for adding or updating:
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Addition of separate SPCs covering individual presentations
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