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

  • Company:

    AstraZeneca Pharmaceuticals (Ireland) DAC
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)
  • Active Ingredient(s):

    *Additional information is available within the SPC or upon request to the company

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 January 2021

File name

20210111 Package Leaflet IE MT Bydureon DCP PRAC CV 21 0002_1610712256.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Green = added text

Possible side effects

...

Uncommon side effects

  • a delay in the emptying of the stomach

...

Date of revision updated to 01/2021

 

Updated on 15 January 2021

File name

20210111 SPC IE MT Bydureon DCP PRAC CV 21 0001_1610711780.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • 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

Green = Added text

Red = Deleted text
 

4.8 Undesirable effects

Table 1: Adverse reactions of prolonged-release exenatide identified from clinical studies and spontaneous reports

...

Delayed gastric emptying 

...

Rate based on sixteen prolonged-release exenatide completed long term efficacy and safety studies n = 4086 total

...

10. DATE OF REVISION OF THE TEXT

30th January 2020 11th January 2021

 

 

 

Updated on 31 January 2020

File name

20200130 SPC IE MT Bydureon DCP DITP CV 20 0005_1580489360.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • 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 31 January 2020

File name

20200130 Pakage Leaflet IE MT Bydureon DCP DITP CV 20 0004_1580489223.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 27 January 2020

File name

20200123-SmPC-IE-MT-Bydureon DCP-Renal Update-CV 19 0032_1580125076.pdf

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 5.1 - Pharmacodynamic properties
  • 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 January 2020

File name

20200123-Package Leaflet-IE-MT-Bydureon DCP-Renal update-CV 19 0033_1580124832.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

EDM Updated on 01 August 2019

File name

2018-11-27 IFU Bydureon DCP 2mg UIM CV 18 0121_1544044168.pdf

Reasons for updating

  • Replace File

Free text change information supplied by the pharmaceutical company

slight amendment to some diagrams and layout to facilitate readability.

EDM Updated on 26 June 2019

File name

2016-02-18 User manual Bydureon DCP 2mg CV 16 0037 No Footer_1539808459.pdf

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 02 May 2019

File name

20190424-uim-pl-bydureon-dcp brexit brs update CV 19 0066_1556792711.pdf

Reasons for updating

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

Updated on 11 April 2019

File name

20190405_uim_pl_bydureon_dcp_prac_update_CV_19_0045_1554978315.pdf

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

File name

20190405_uim_spc_bydureon_dcp_prac_update_CV_19_0044_1554978243.pdf

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 not be renewed (A)

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

File name

2019-02-14_PIL_Bydureon_DCP_2_mg_UIM_CV_19_0030_1551279602.pdf

Reasons for updating

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

Updated on 27 February 2019

File name

2019-02-14_SmPC_Bydureon_DCP_2_mg_UIM_CV_19_0029_1551279928.pdf

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 not be renewed (A)

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 02 October 2018

File name

2018-09-20 SmPC Bydureon DCP 2 mg UIM CV 18 0063_1538475004.pdf

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 not be renewed (A)

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 06 September 2018

File name

2018-08-27 PIL Bydureon DCP 2 mg UIM CV 18 0055_1536225948.pdf

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 06 September 2018

File name

2018-08-27 SmPC Bydureon DCP 2 mg UIM CV 18 0054_1536226151.pdf

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 not be renewed (A)

EDM Updated on 16 April 2018

File name

Bydureon 2mg PFP user manual.pdf

Reasons for updating

  • Add New Doc

Updated on 27 November 2017

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 not be renewed (A)

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

Reasons for updating

  • New SPC for new product

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

Updated on 23 November 2017

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 23 November 2017

File name

PIL_16223_343.pdf

Reasons for updating

  • New PIL for new product

Updated on 06 September 2017

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 not be renewed (A)

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 05 September 2017

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 04 August 2017

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 not be renewed (A)

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

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 not be renewed (A)

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 08 March 2016

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 not be renewed (A)

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 07 March 2016

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

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 not be renewed (A)

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 08 January 2016

Reasons for updating

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

Updated on 04 February 2015

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 not be renewed (A)

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 03 February 2015

Reasons for updating

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

Updated on 02 February 2015

Reasons for updating

  • New SPC for new product

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

Free text change information supplied by the pharmaceutical company

None provided

Updated on 02 February 2015

Reasons for updating

  • New PIL for new product