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:
AstraZeneca Pharmaceuticals (Ireland) DAC
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may be renewed (B)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 15/01/21
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AstraZeneca Pharmaceuticals (Ireland) DAC
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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 15 January 2021 PIL
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 SPC
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 be renewed (B)
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 SPC
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 be renewed (B)
Updated on 31 January 2020 PIL
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 27 January 2020 SPC
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 be renewed (B)
Updated on 27 January 2020 PIL
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
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 SPC
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 SPC
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 SPC
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 SPC
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 SPC
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
Updated on 27 November 2017 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
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 23 November 2017 PIL
Reasons for updating
- New PIL for new product
Updated on 6 September 2017 SPC
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 SPC
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 10 Update to revision date
Updated on 28 November 2016 SPC
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 SPC
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 SPC
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 SPC
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 SPC
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
Updated on 2 February 2015 PIL
Reasons for updating
- New PIL for new product
Bydureon 2 mg Pre Filled Pen User ManualInstructions for use
(Click to Download)
Educational Materials for Medicines
Educational Materials for Medicines
Bydureon 2 mg Pre Filled Pen User ManualInstructions for use
(Click to Download)
Educational Materials for Medicines
Educational Materials for Medicines