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: 04/10/19

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Summary of Product Characteristics last updated on medicines.ie: 4/10/2019

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Novo Nordisk Limited

Novo Nordisk Limited

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Medicine Name Fiasp 100 units-mL solution for injection in Cartridge Penfill Active Ingredients Insulin aspart
Medicine Name Fiasp 100 units-mL solution for injection in pre-filled FlexTouch pen Active Ingredients Insulin aspart
Medicine Name Fiasp 100 units-mL solution for injection in vial Active Ingredients Insulin aspart
Medicine Name GlucaGen HypoKit 1 mg powder and solvent for solution for injection Active Ingredients Glucagon hydrochloride
Medicine Name Insulatard 10 ml Vial Active Ingredients Human Insulin
Medicine Name Insulatard InnoLet Active Ingredients Human Insulin
Medicine Name Insulatard Penfill Active Ingredients Human Insulin
Medicine Name Insulatard, Insulatard Penfill, Insulatard InnoLet Active Ingredients Human Insulin
Medicine Name Kliogest 2 mg/1 mg film-coated tablets Active Ingredients Estradiol Hemihydrate, Norethisterone acetate
Medicine Name Levemir FlexPen (Insulin detemir) 100 units/ml solution for injection in pre-filled pen Active Ingredients insulin detemir
Medicine Name Levemir InnoLet (Insulin detemir) 100 units/ml solution for injection in pre-filled pen Active Ingredients insulin detemir
Medicine Name Levemir Penfill (Insulin detemir) 100 units/ml solution for injection in cartridge Active Ingredients insulin detemir
Medicine Name Norditropin FlexPro 10 mg/1.5 ml solution for injection in pre-filled pen Active Ingredients Somatropin
Medicine Name Norditropin FlexPro 15 mg/1.5 ml solution for injection in pre-filled pen Active Ingredients Somatropin
Medicine Name Norditropin FlexPro 5 mg/1.5 ml solution for injection in pre-filled pen Active Ingredients Somatropin
Medicine Name Norditropin SimpleXx 10 mg/1.5 ml, solution for injection Active Ingredients Somatropin
Medicine Name Norditropin SimpleXx 15 mg/1.5 ml, solution for injection Active Ingredients Somatropin
Medicine Name Norditropin SimpleXx 5 mg/1.5 ml, solution for injection in cartridge Active Ingredients Somatropin
Medicine Name Novofem film-coated tablets Active Ingredients Estradiol Hemihydrate, Norethisterone acetate
Medicine Name NovoMix 30 FlexPen Active Ingredients Insulin aspart
Medicine Name NovoMix 30 Penfill Active Ingredients Insulin aspart
Medicine Name NovoNorm 0.5 mg, 1 mg and 2 mg tablets Active Ingredients Repaglinide
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 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)