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  • Caverject 20 micrograms, Powder and Solvent for Solution for Injection;

Caverject 20 micrograms, Powder and Solvent for Solution for Injection;

*
Pharmacy Only: Prescription

  • Company:

    Pfizer Healthcare Ireland Unlimited Company

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    Alprostadil

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

Updated on 16 October 2024

File name

Reg SPC CJ 17_0 20mcg IE_clean.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

Updated on 16 October 2024

File name

Reg PIL 10 20 mcg CJ 20_0 IE_clean.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision
  • Change to MA holder contact details

Updated on 13 February 2023

File name

DEC202086665_Reg SPC CJ 16_0 20mcg 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 - excipient warnings
  • 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 16_0 20mcg 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 15_2 20mcg 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 24 February 2017

Reasons for updating

  • New SPC for new product

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

Updated on 24 February 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 known

Updated on 24 February 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 known

Updated 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 revised

Updated 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 revised

Updated on 27 November 2015

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • Change to section 4.4 - Special warnings and precautions for use

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 revised

Updated on 27 November 2015

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • Change to section 4.4 - Special warnings and precautions for use

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 revised

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

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 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 27 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

Update to sections 7 & 8

Updated on 27 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

Update to sections 7 & 8

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

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

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 18 June 2008

Reasons for updating

  • New individual SPC (was previously included in combined SPC)

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

Free text change information supplied by the pharmaceutical company

Three seperate SPCs for Caverject 5, 10 & 20 have now been introduced to the EMC. 

Updated on 18 June 2008

Reasons for updating

  • New individual SPC (was previously included in combined SPC)

Free text change information supplied by the pharmaceutical company

Three seperate SPCs for Caverject 5, 10 & 20 have now been introduced to the EMC. 

Updated on 18 April 2006

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 7 - Marketing authorisation holder
  • 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 18 April 2006

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Updated on 30 June 2003

Reasons for updating

  • New SPC for medicines.ie

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

Updated on 30 June 2003

Reasons for updating

  • New SPC for medicines.ie