Caverject 10 micrograms, Powder and Solvent for Solution for Injection
*Company:
Pfizer Healthcare IrelandStatus:
No Recent UpdateLegal 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
Updated on 13 February 2023
File name
DEC202086665_Reg SPC CJ 15_0 10mcg IE_clean.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 05 January 2021
File name
DEC202086665_Reg PIL 10 20 mcg CJ 19_1 IE_clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- 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 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 05 January 2021
File name
DEC202086665_Reg SPC CJ 15_0 10mcg IE_clean.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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 - how to report a side effect
- Change to section 6.1 - List of excipients
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
|
The SPC has been updated as follows for Caverject vials:
Section 2 – update to amount of Benzyl alcohol 4.1 – Administrative change to include Benzyl alcohol. 4.4 – Addition of Sodium and Benzyl alcohol as excipient information. Update to section 4.8 - update IE reporting details. 6.1 - Addition of (E1519) to Benzyl alcohol |
Updated on 12 November 2020
File name
DEC202075780_Reg SPC CJ 14_2 10mcg IE_clean.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 05 June 2018
File name
PIL_10768_549.pdf
Reasons for updating
- New PIL for new product
Updated on 03 March 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 03 March 2017
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows:
Section 4.4 - Alprostadil should be used with caution in patients with cardiovascular and cerebrovascular risk factors
Section 4.8 – addition of adverse drug reactions myocardial ischaemia and cerebrovascular accident, frequency not knownUpdated on 03 March 2017
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows:
Section 4.4 - Alprostadil should be used with caution in patients with cardiovascular and cerebrovascular risk factors
Section 4.8 – addition of adverse drug reactions myocardial ischaemia and cerebrovascular accident, frequency not knownUpdated on 19 January 2016
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
The SPC has been updated as follows:
4.8 – frequency of Erythema updated to Common, duplicate event Hypasthesia deleted, ADRs listed in order of decreasing medical seriousness within each frequency category and MedDRA System Organ Class
10 – date last updated revisedUpdated on 19 January 2016
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows:
4.8 – frequency of Erythema updated to Common, duplicate event Hypasthesia deleted, ADRs listed in order of decreasing medical seriousness within each frequency category and MedDRA System Organ Class
10 – date last updated revisedUpdated on 27 November 2015
Reasons for updating
- 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
The SPC has been updated as follows:
Section 4.4 – text added regarding the possibility of needle breakage and advising patients not to straighten a bent needle
Section 10 – date last updated revisedUpdated on 27 November 2015
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows:
Section 4.4 – text added regarding the possibility of needle breakage and advising patients not to straighten a bent needle
Section 10 – date last updated revisedUpdated on 05 June 2015
Reasons for updating
- Change to section 6.5 - Nature and contents of container
- 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
The SPC has been updated as follows
Section 6.5 – updated with a description of the needles
Section 10 – date of revision updated
Updated on 05 June 2015
Reasons for updating
- Change to section 6.5 - Nature and contents of container
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows
Section 6.5 – updated with a description of the needles
Section 10 – date of revision updated
Updated on 11 December 2014
Reasons for updating
- 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
The SPC has been updated as follows
Section 4.8 – Reporting of suspected adverse reactions updated from IMB to HPRA
Section 10 – date last revised updatedUpdated on 11 December 2014
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows
Section 4.8 – Reporting of suspected adverse reactions updated from IMB to HPRA
Section 10 – date last revised updatedUpdated on 05 September 2014
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.1 - Therapeutic indications
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- 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
2 – reworded in line with QRD
4.1 – specifies not indicated for paediatric use
4.3 – typo corrected
4.4 – additional benzyl alcohol text
4.8 – addition of details for reporting suspected adverse reactions
10 – date of revision of text
Updated on 05 September 2014
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.1 - Therapeutic indications
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
2 – reworded in line with QRD
4.1 – specifies not indicated for paediatric use
4.3 – typo corrected
4.4 – additional benzyl alcohol text
4.8 – addition of details for reporting suspected adverse reactions
10 – date of revision of text
Updated on 28 August 2014
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.1 - Therapeutic indications
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- 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
Update to sections 2, 4.1, 4.3, 4.4, 4.8 & 10
Updated on 28 August 2014
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.1 - Therapeutic indications
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
Update to sections 2, 4.1, 4.3, 4.4, 4.8 & 10
Updated on 26 February 2014
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - MA number
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 26 February 2014
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - MA number
Free text change information supplied by the pharmaceutical company
Updated on 12 September 2013
Reasons for updating
- Change to section 6.1 - List of excipients
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
SPC
Section 6.1 addition of α-Cyclodextrine to list of excipients
Section 6.5 removal of flurocoated rubber stopper and replaced with bromobutyl rubber stopper
Updated on 12 September 2013
Reasons for updating
- Change to section 6.1 - List of excipients
- Change to section 6.5 - Nature and contents of container
Free text change information supplied by the pharmaceutical company
SPC
Section 6.1 addition of α-Cyclodextrine to list of excipients
Section 6.5 removal of flurocoated rubber stopper and replaced with bromobutyl rubber stopper
Updated on 27 February 2013
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 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 6.6 - Special precautions for disposal and other handling
- 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
2: administrative update in line with QRD template to state excipients with known effect
4.2 – administrative update to cross references
4.3 – rewritten in bullet points in line with QRD template
4.4 – to minimize risk select lowest effective dose, treatment of priapism should be according to local medical practice, use with care in patients who have experienced TIA or other unstable cardiac disorders, not intended for co-administration with other agents for treatment of erectile dysfunction, potential for abuse should be considered in patients with a history of psychiatric disorders or addiction, use with care in patients with heart disease/failure/pulmonary disease – these patients should engage in sexual activity with caution, properly discard device and any unused solution, contains less than 1 mmol sodium (essentially sodium free)
4.5 – effects of combination with other treatments for erectile dysfunction have not been studied, sympathomimetics may reduce the effect of alprostadil. Alprostadil may enhance the effects of antihypertensives, vasodilative agents, anticoagulants and platelet aggregation inhibitors
4.7 - Alprostadil would not be expected to have an influence on the ability to drive or operate machines
4.8 – rewritten to include a frequency table and text on clinical trial data. Adverse reactions updated in line with latest system organ class definitions and additional events added
4.9 - Overdosage was not observed in clinical trials with alprostadil. If intracavernous overdose of alprostadil occurs, the patient should be placed under medical supervision until any systemic effects have resolved and/or until penile detumescence has occurred. Symptomatic treatment of any systemic symptoms would be appropriate.
6.6 - Caverject is not intended to be mixed or coadministered with any other products (correction to SmPC in line with IMB Schedule).
10 – update to date of revision of text
Updated on 27 February 2013
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 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
2: administrative update in line with QRD template to state excipients with known effect
4.2 – administrative update to cross references
4.3 – rewritten in bullet points in line with QRD template
4.4 – to minimize risk select lowest effective dose, treatment of priapism should be according to local medical practice, use with care in patients who have experienced TIA or other unstable cardiac disorders, not intended for co-administration with other agents for treatment of erectile dysfunction, potential for abuse should be considered in patients with a history of psychiatric disorders or addiction, use with care in patients with heart disease/failure/pulmonary disease – these patients should engage in sexual activity with caution, properly discard device and any unused solution, contains less than 1 mmol sodium (essentially sodium free)
4.5 – effects of combination with other treatments for erectile dysfunction have not been studied, sympathomimetics may reduce the effect of alprostadil. Alprostadil may enhance the effects of antihypertensives, vasodilative agents, anticoagulants and platelet aggregation inhibitors
4.7 - Alprostadil would not be expected to have an influence on the ability to drive or operate machines
4.8 – rewritten to include a frequency table and text on clinical trial data. Adverse reactions updated in line with latest system organ class definitions and additional events added
4.9 - Overdosage was not observed in clinical trials with alprostadil. If intracavernous overdose of alprostadil occurs, the patient should be placed under medical supervision until any systemic effects have resolved and/or until penile detumescence has occurred. Symptomatic treatment of any systemic symptoms would be appropriate.
6.6 - Caverject is not intended to be mixed or coadministered with any other products (correction to SmPC in line with IMB Schedule).
10 – update to date of revision of text
Updated on 30 July 2008
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 6.1 - List of excipients
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 30 July 2008
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 6.1 - List of excipients
Free text change information supplied by the pharmaceutical company
Updated on 17 June 2008
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 17 June 2008
Reasons for updating
- New SPC for medicines.ie