Summary of Product Characteristics
last updated on the eMC:
14/05/2012
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 14/05/2012 and displayed until Current
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Reasons for adding or updating:
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Change to section 2 - Qualitative and quantitative composition
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Change to section 4.3 - Contraindications
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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. 6 - Instructions for use, handling and disposal
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| Date of revision of text on the SPC: 30-Apr-2012 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| UPDATE OF THE QRD TEMPLATE
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Updated on 11/08/2011 and displayed until 14/05/2012
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Reasons for adding or updating:
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Change to section 2 - Qualitative and quantitative composition
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| Date of revision of text on the SPC: 30-Jun-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| change of the year for annual strain
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Updated on 22/03/2011 and displayed until 11/08/2011
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Reasons for adding or updating:
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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 4.3 - Contraindications
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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 4.6 - Pregnancy and Lactation
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Change to section 4.7 - Effects on Ability to Drive and Use Machines
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Change to section 4.8 - Undesirable Effects
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Change to section 6. 5 - Nature and Contents of Container
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| Date of revision of text on the SPC: 24-Feb-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| update of the SmpC to be in line with the new guidelines
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Updated on 31/08/2010 and displayed until 22/03/2011
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Reasons for adding or updating:
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Change to section 2 - Qualitative and quantitative composition
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| Date of revision of text on the SPC: 24-Feb-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| Anuual Strain change
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Updated on 18/05/2010 and displayed until 31/08/2010
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Reasons for adding or updating:
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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 8 - MARKETING AUTHORISATION NUMBER(S)
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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: 19-Feb-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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4.8 Undesirable effects.
Adverse reactions observed from clinical trials
The safety of INTANZA has been assessed in 3 open-label randomised clinical trials, 3,372 vaccinees received an injection of INTANZA.
Safety evaluation was performed for all subjects during the first 3 weeks following vaccination and serious adverse reactions were collected during six months of follow-up for 2,974 subjects (population of two out of the three clinical trials).
The most common reactions occurring after vaccine administration were local reactions at injection site.
Apparent local reactions after intradermal administration were more frequent than after the intramuscular administration of an adjuvanted or non-adjuvanted comparator vaccine administered intramuscularly.
Most reactions resolved spontaneously within 1 to 3 days after onset.
Systemic safety profile of INTANZA is similar to the comparator vaccine, adjuvanted or non-adjuvanted, administered intramuscularly.
5.1 Pharmacodynamic properties
In a randomised comparative phase III trial, 398 subjects over 65 years of age received, 0.1 ml of INTANZA by intradermal route and 397 subjects over 65 years of age received 0.5 ml of a trivalent inactivated adjuvanted (MF-59 containing) influenza vaccine at the same dosage administered by intramuscular route.
INTANZA is as immunogenic as the comparator trivalent adjuvanted (MF-59 containing) vaccine in terms of GMT for each of the 3 influenza strains with the SRH method and for 2 strains with the HI method
Section 8 - Marketing Authorisation Numbers have been revised.
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Updated on 21/05/2009 and displayed until 18/05/2010
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Reasons for adding or updating:
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| Date of revision of text on the SPC: |
| 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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