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Boehringer Ingelheim Limited

The Crescent Building, , Northwood, Santry, Dublin 9,
Telephone: +353 1 295 9620
Fax: : +353 1 816 3642
Medical Information e-mail: Medinfo@dbl.boehringer-ingelheim.com
Summary of Product Characteristics last updated on medicines.ie: 04/01/2016
SPC Actilyse Cathflo 2 mg

When a pharmaceutical company changes an SPC or PIL, 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 04/01/2016 and displayed until Current
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
Date of revision of text on the SPC:   01-Oct-2015
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

Sections 1, 2, 3, 6.1, 6.5 and 6.6 of the SPC have been updated to include changes associated with the removal of the solvent vial from the pack.
Updated on 15/10/2015 and displayed until 04/01/2016
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • 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 6.6 - Special precautions for disposal and other handling
  • Change to section 7 - Marketing authorisation holder
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01-Oct-2015
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



Actilyse Cathflo 2 mg SPC changes

Following renewal, sections 2, 3, 4.1, 4.2, 4.4, 4.5, 4.6, 4.8 (including the addition of Reporting of Suspected Adverse Reactions details), 4.9, 5.1, 6.1, 6.2, 6.3, 6.4, 6.5, 6.6, 7, 9 and 10 (Date of Revision amended from October 2013 to October 2015) have been updated.  If further information is required, please do not hesitate to contact the company.

Updated on 25/10/2013 and displayed until 15/10/2015
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • 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 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 7 - Marketing authorisation holder
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01-Oct-2013
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



Section 1 Name of the Medicinal Product

Minor editorial change made to the word powder i.e. p changed from upper to lower case.

 

Section 4.1 Therapeutic Indications

Minor editorial change made to the section heading i.e. indications changed to Indications.

 

Section 4.3 Contraindications

This section has had new text including when Actilyse Cathflo should not be administered and reference to gentamicin added to it and now reads: Actilyse Cathflo should not be administered to patients with known hypersensitivity to the active substance alteplase, gentamicin (a trace residue from the manufacturing process) or to any of the excipients listed in section 6.1.

 

Section 4.4 Special Warnings and Precautions for Use

The previous sub-heading title of Re-administration has been replaced with that of Hypersensitivity and new text (from second sentence onwards) has been added to the first paragraph of this sub-heading text.

 

A new final paragraph regarding anaphylactoid reaction has been added to the Hypersensitivity sub-heading of this section.

 

Section 4.6 Fertility, Pregnancy and Lactation

The section heading has been amended from Pregnancy and lactation to Fertility, pregnancy and lactation.

 

Section 4.8 Undesirable Effects

Minor editorial changes have been made to the final paragraph of this section i.e. 10, 20, 50 mg has been amended to 10mg, 20mg, 50mg and 2 mg has been amended to 2mg.

 

Section 7 Marketing Authorisation Holder

The commas and full stops have been deleted from the end of each address sentence in this section.

 

Section 9 Date of First Authorisation/Renewal of the Authorisation

The text Date of last renewal has been deleted from this section.

 

Section 10 Date of Revision of the Text

The date has been updated from July 2010 to October 2013.
 

The legal category text (LEGAL CATEGORY, POM) has been deleted from the end of the SPC document.

Updated on 06/06/2011 and displayed until 25/10/2013
Reasons for adding or updating:
  • New SPC for new product
Date of revision of text on the SPC:  
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

None provided

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Active Ingredients

 
   Alteplase