Influvac Sub-unit, suspension for injection
- Name:
Influvac Sub-unit, suspension for injection
- Company:
Mylan IRE Healthcare Limited
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 05/11/18
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Mylan IRE Healthcare Limited
Company Products
When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
Updated on 5 November 2018 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
Updated on 5 November 2018 SmPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 2 August 2018 PIL
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 2 August 2018 SmPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 27 July 2017 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 27 July 2017 SmPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Influenza virus surface antigens (haemagglutinin and neuraminidase) of the following strains*:
- A/
(A/Singapore/GP1908/2015, IVR-180) 15 micrograms HA **
- A/Hong Kong/4801/2014 (H3N2)-like strain
(A/Hong Kong/4801/2014, NYMC X-263B) 15 micrograms HA **
- B/Brisbane/60/2008-like strain
(B/Brisbane/60/2008, wild type) 15 micrograms HA **
per 0.5 ml dose
* propagated in fertilised hens’ eggs from healthy chicken flocks
** haemagglutinin.
This vaccine complies with the World Health Organisation (WHO) recommendation (northern hemisphere) and EU recommendation for the
10. DATE OF REVISION OF THIS TEXT
Updated on 26 July 2017 PIL
Reasons for updating
- New PIL for new product
Updated on 26 July 2017 PIL
Reasons for updating
- Change to section 6 - what the product contains
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 9 February 2017 SmPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 9 February 2017 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
- Change to section 6 - date of revision
Updated on 8 December 2016 PIL
Reasons for updating
- Change to section 6 - date of revision
Updated on 9 August 2016 SmPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
|
- A/California/7/2009 (H1N1)pdm09-like strain (A/California/7/2009, X-181) |
15 micrograms HA ** |
|
- A/Hong Kong/4801/2014 (H3N2)-like strain (A/Hong Kong/4801/2014, X-263B) |
15 micrograms HA **
|
|
- B/Brisbane/60/2008-like strain (B/Brisbane/60/2008, wild type) |
15 micrograms HA ** |
|
|
per 0.5 ml dose |
|
* propagated in fertilised hens’ eggs from healthy chicken flocks ** haemagglutinin. |
|
Updated on 8 August 2016 PIL
Reasons for updating
- Change of active ingredient
- Change to further information section
- Change to date of revision
Updated on 21 June 2016 SmPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
"Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation or stress-related reactions can occur following, or even before, any vaccination as a psychogenic response to the needle injection. This can be accompanied by several neurological signs such as transient visual disturbance, paraesthesia and tonic-clonic limb movements during recovery. It is important that procedures are in place to avoid injury from faints."
Updated on 20 June 2016 PIL
Reasons for updating
- Change to further information section
- Change to date of revision
- Change to warnings or special precautions for use
Updated on 7 August 2015 SmPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 4 August 2015 PIL
Reasons for updating
- Change to further information section
- Change to date of revision
Updated on 30 March 2015 SmPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.6 - Pregnancy and lactation
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 6.5 - Nature and contents of container
- Change to section 8 - MA number
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Main changes affecting the Influvac labelling include the text for reporting of suspected adverse reactions, together with a reference to the local center for reporting AEs.
Updated on 26 March 2015 PIL
Reasons for updating
- Change to further information section
- Change to date of revision
- Addition of information on reporting a side effect.
Updated on 10 February 2015 PIL
Reasons for updating
- Change of licence holder
- Change to further information section
- Change to date of revision
Updated on 9 February 2015 SmPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - MA number
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 7 August 2014 SmPC
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
season 2: update of vaccine strains
section 9: update of renewal date as result of recent renewal
section 10; update date of revision
Updated on 5 August 2014 PIL
Reasons for updating
- Change to further information section
- Change to date of revision
- Change to product name
Updated on 1 August 2014 PIL
Reasons for updating
- Change to MA holder contact details
Updated on 20 June 2014 SmPC
Reasons for updating
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
- Change to MA holder contact details
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Update contact details of MAH address
Updated on 27 February 2014 SmPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
4.2. Posology and method of administration
For detailed instructions on administering a 0.25 ml or 0.5 ml dose, see section 6.6.6.6 Special precautions for disposal and other handling
For the administration of a 0.25 ml dose from a single dose 0.5 ml syringe, push the front side of the plunger exactly to the edge of the mark so that half the volume is eliminated; a volume of 0.25 ml of the vaccine remains in the syringe, suitable for administration. See also section 4.2.
10. DATE OF REVISION OF THIS TEXT
February 2014
Updated on 21 February 2014 PIL
Reasons for updating
- Change to date of revision
- Change to dosage and administration
Updated on 17 September 2013 SmPC
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 2 - Update strains of Influenza virus for the new season
Updated on 17 September 2013 PIL
Reasons for updating
- Change to further information section
- Addition of information on reporting a side effect.
Updated on 25 July 2013 SmPC
Reasons for updating
- Change to section 1 - Name of medicinal product
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 23 July 2013 PIL
Reasons for updating
- Change of trade or active ingredient name
Updated on 12 September 2012 SmPC
Reasons for updating
- New individual SPC (was previously included in combined SPC)
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 7 September 2012 PIL
Reasons for updating
- New individual PIL (was previously included in a combined PIL)