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Influvac Sub-unit, suspension for injection

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 05/11/18

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Summary of Product Characteristics last updated on medicines.ie: 5/11/2018

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Mylan IRE Healthcare Limited

Mylan IRE Healthcare Limited

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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 SPC

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 SPC

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 SPC

Reasons for updating

  • New SPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 27 July 2017 SPC

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

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Influenza virus surface antigens (haemagglutinin and neuraminidase) of the following strains*:

- A/California/7/2009 (H1N1)pdm09-like strain (A/California/7/2009, X-181) Michigan/45/2015 (H1N1)pdm09-like strain
(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 20162017/20172018 season.

10. DATE OF REVISION OF THIS TEXT
February 2017 July 2017

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 SPC

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

Change to MAH, PA no. as a result of Transfer of MAH

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 SPC

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

The influenza strains for 2016-2017 seasone have been registered as follows:

- 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 SPC

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

The following wording was added to section 4.4:
 

 

"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 SPC

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

Annual Update 2015-2016 NH influenza season.  Change in the influenza strains registered, change in date of revision of SPC.

Updated on 4 August 2015 PIL

Reasons for updating

  • Change to further information section
  • Change to date of revision

Updated on 30 March 2015 SPC

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

Type IB variation approved to align labelling with the QRD template (minor editorial changes).

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 SPC

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

Transfer of MAH from Abbott Healthcare Products Ltd. to BGP Products Ltd with change in PA number also.


Updated on 7 August 2014 SPC

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

section 1: deletion of season year 2014/2015
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 SPC

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

Renewal (repeat use) approval: change in Renewal date
Update contact details of MAH address

Updated on 27 February 2014 SPC

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 SPC

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 1 -  Change'Season 2012/2013' to 'Season 2013/2014'
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 SPC

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

Update SPC section 1 to remove the season (year) from the name of the product. Same change where name is mentioned throughout the document

Updated on 23 July 2013 PIL

Reasons for updating

  • Change of trade or active ingredient name

Updated on 12 September 2012 SPC

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

Update of the SPC in accordance with the annual update 2012/2013.

Updated on 7 September 2012 PIL

Reasons for updating

  • New individual PIL (was previously included in a combined PIL)