Bydureon 2 mg powder and solvent for prolonged-release suspension for injection in pre-filled pen

  • Name:

    Bydureon 2 mg powder and solvent for prolonged-release suspension for injection in pre-filled pen

  • Company:
    info
  • Active Ingredients:

    Exenatide

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 02/05/19

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Summary of Product Characteristics last updated on medicines.ie: 11/4/2019

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AstraZeneca Pharmaceuticals (Ireland) DAC

AstraZeneca Pharmaceuticals (Ireland) DAC

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Medicine Name Bydureon 2 mg powder and solvent for prolonged-release suspension for injection in pre-filled pen Active Ingredients Exenatide
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1 - 0 of 56 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 1 August 2019 Ed-HCP

Reasons for updating

  • Replace document

Free text change information supplied by the pharmaceutical company

slight amendment to some diagrams and layout to facilitate readability.

Updated on 26 June 2019 Ed-Ptnt

Reasons for updating

  • Add New Doc

Free text change information supplied by the pharmaceutical company

Upload to replace Instructions for use Category from "HCPs" to "Patient"

Updated on 2 May 2019 PIL

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 11 April 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink

Updated on 11 April 2019 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.2 – Addition of wording related to Diabetic ketoacidosis.

Section 4.4 – Addition of wording related to Diabetic ketoacidosis.

Section 10 – Date of revision.

Updated on 27 February 2019 PIL

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 6 - date of revision

Updated on 27 February 2019 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.6 - Special precautions for disposal and other handling

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

Free text change information supplied by the pharmaceutical company

Section 4.8 - footnote to Table 1 has been corrected with updated data for Study 7.

Section 5.1 - data corrected with the data from updated CSR/CO for study 7.

Section 5.3 – Deletion of ‘exenatide’.

Section 6.6 – Addition of text for instructions of use.

Updated on 2 October 2018 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

Section 4.1 – refer to sections 4.4, 4.5 and 5.1 for information on glycaemic control and cardiovascular events

Section 4.2 – removal of text on limited information available on renal patients over 75 years

Section 5.1 – additional information on clinical trial on Type 2 diabetes patients with any level of CV risk

Section 10 – date of revision of the text 20th September 2018

Updated on 6 September 2018 PIL

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 3 - dose and frequency
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 6 September 2018 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text

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

Updated on 16 April 2018 Ed-HCP

Reasons for updating

  • Add New Doc

Updated on 27 November 2017 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

$0Section 4.1 – Addition ofcombination with basal insulin to indication.$0$0Section 4.2 – Addition ofinstructions for use when used with insulin.$0$0Section 4.4 – Update toconcomitant medicinal product section to remove insulin as a medicinal productthat has not been studied.$0$0Section 4.8 – Update toinformation regarding clinical trials, addition of hypoglycaemia (with insulin)as a side effect. Editorial changes to the table footnote numbering. Additionof information regarding use of insulin with exenatide.$0$0Section 5.1 – Update to reflectadditional clinical studies completed. Addition of new clinical data forexenatide in combination with insulin glargine.$0$0Section 10 – Update to revisiondate.$0$0 $0

Updated on 27 November 2017 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 23 November 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 23 November 2017 PIL

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 3 - how to take/use
  • Change to section 6 - date of revision

Updated on 6 September 2017 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

Section 4.1- Indication re written to state use in combination with other glucose-loweing medicinal products when the therapy in use together with diet and exercise does not provide adequate glycaemic control.

Section 4.4- minor editorial changes

Section 4.8-minor editorial changes and update to UK reporting details

Section 5.1-Information on clinical efficacy and safety information updated with new figures, information and result data from clinical study on combination of prolonged-release exenatide and dapagliflozin added and minor editorial changes.

Section 5.2 minor editorial changes

Section 5.3 minor editorial changes

Section 9- error in date of first authorisation corrected

Section 10- date of revision updated

Updated on 5 September 2017 PIL

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
  • Correction of spelling/typing errors
  • Improved presentation of PIL

Updated on 4 August 2017 SmPC

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

section 5.1 Update to ATC code and Pharmacotherapeutic group.
section 10 Update to revision date

Updated on 28 November 2016 SmPC

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

Section 5.1 Updated information within the Glycaemic control section, data on uncontrolled study extension updated to reflect final data of study

Section 10 revision date amended

Updated on 8 March 2016 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 2 – editorial

Secton 4.2 – editorial

Section 4.3 – editorial

Section 4.4 – editorial

Section 4.5 – editorial

Section 4.6 – editorial

Section 4.7 – editorial

Section 4.8 – editorial

Section 4.9 – editorial

Section 5.1 – editorial

Section 5.2 – editorial

Section 5.3 – editorial

Section 6.1 – editorial

Section 6.3 – editorial

Section 6.4 – editorial

Section 6.6 – editorial

Section 9 – editorial

Section 10 – date of revision

Updated on 7 March 2016 PIL

Reasons for updating

  • Change to date of revision
  • Change to improve clarity and readability
  • Addition of information on reporting a side effect.

Updated on 11 January 2016 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company



Section 4.2 – editorial updates.  

Section 4.4 – reported frequencies updated for renal impairment, acute pancreatitis and interaction with warfarin.

Section 4.5 – reported frequencies updated for interaction with warfarin.

Section 4.8 – frequency of adverse events updated

Section 5.2 – editorial updates.

Section 10 – Date of revision updated.

Updated on 8 January 2016 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 4 February 2015 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 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

- Section 4.4 adding cholelithiasis as example of rapid weight loss.
- Section 4.8 Combine side effects into one table namely moving the following from one table to another; dehydration, dysgeusia,   hyperhidrosis, alopecia, asthenia, feeling jittery and
International normalised ratio investgation.

- Section 4.8 updating Malta adverse event reporting information.

- Section 10 Change to date of revision

Updated on 3 February 2015 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 2 February 2015 PIL

Reasons for updating

  • New PIL for new product

Updated on 2 February 2015 SmPC

Reasons for updating

  • New SPC for new product

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

Free text change information supplied by the pharmaceutical company

None provided