Xultophy 100 units/ml + 3.6 mg/ml solution for injection

  • Name:

    Xultophy 100 units/ml + 3.6 mg/ml solution for injection

  • Company:
    info
  • Active Ingredients:

    Insulin degludec, liraglutide

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 15/05/20

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Summary of Product Characteristics last updated on medicines.ie: 15/5/2020

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Novo Nordisk Limited

Novo Nordisk Limited

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1 - 0 of 40 items.Total: Infinity pages

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 15 May 2020 PIL

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 4 - how to report a side effect

Free text change information supplied by the pharmaceutical company

Section 1

Subsection updated as follows:

"If you use basal insulin

You should stop your basal insulin treatment prior to starting on Xultophy."

 

Section 4

HPRA reporting details shortened to 'HPRA Pharmacovigilance, Website: www.hpra.ie"

Updated on 15 May 2020 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.2:

Transfer from any basal insulin regimen that includes a basal insulin component

Therapy with other basal insulin regimens should be discontinued prior to initiation of Xultophy. When transferring from basal any other insulin therapy that includes a basal insulin component, the recommended starting dose of Xultophy is 16 dose steps (16 units insulin degludec and 0.6 mg liraglutide) (see section 4.4 and 5.1). The recommended starting dose should not be exceeded, but may be reduced to avoid hypoglycaemia in selected cases. Close glucose monitoring is recommended during the transfer and in the following weeks.

 

Section 4.8, how to report a side effect

Reporting details for the HPRA reduces as per QRD Appendix V.

 

Section 5.1

Figure 7 replaced to correct minor change

 

Updated on 4 October 2019 SmPC

Reasons for updating

  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Removal of Black Inverted Triangle

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Black triangle removed

Section 9 updated to include "Date of latest renewal: 08 July 2019"

Updated on 4 October 2019 PIL

Reasons for updating

  • Removal of Black Inverted Triangle

Free text change information supplied by the pharmaceutical company

Black triangle removed

 

Updated on 22 July 2019 PIL

Reasons for updating

  • Change to section 6 - what the product contains

Updated on 22 July 2019 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.3 - Shelf life

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.4:

Sentence update: "In case of discontinuation of Xultophy, ensure that instruction for initiation of alternative antidiabetic medication treatment is followed"

Section 4.8:

Text update in Table 1. 'Adverse Drug Reaction' updated to 'Adverse reaction'

Reporting of side effects: reporting of adverse event to the MHRA deleted. Reporting to the HPRA remains.

Section 6.3:

Text updates: "After first opening, the medicinal product can be stored for 21 days at a maximum temperature of 30°C. The medicinal product should be discarded 21 days after first opening"

Updated on 26 June 2019 PIL

Reasons for updating

  • New PIL for new product

Updated on 25 June 2019 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)