Actilyse Cathflo 2 mg
*Company:
Boehringer Ingelheim LimitedStatus:
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 14 April 2023
File name
Cropped 319883-01 dated 05.08.2022 PIP055409-001 TPA-05.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 4 - how to report a side effect
- Change to section 6 - what the product contains
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 14 April 2023
File name
A1;2mg-E-SPC-11.pdf
Reasons for updating
- 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 4.6 - 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 5.2 - Pharmacokinetic properties
- Change to section 6.6 - Special precautions for disposal and other handling
- 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)
Free text change information supplied by the pharmaceutical company
The following sections of the SmPC have been updated:
- Section 4.2: Minor editorial changes and moving of Paediatric population section
- Section 4.3: Minor editorial changes and removal of information referring to gentamicin
- Section 4.4: Minor editorial changes and addition of new subheadings plus removal of information mentioning the stopper contains natural rubber (a derivatives of latex) and gentamicin
- Section 4.6: Inclusion/update to advice on the use of Actilyse Cathflo during Pregnancy and Breastfeeding plus addition of new section related to ‘Fertility’
- Section 4.8: Minor editorial changes and update to AE reporting details
- Section 4.9: Addition of new subheadings ‘Symptoms’ and ‘Therapy’
- Section 5.2: Minor editorial changes and update to pharmacokinetics properties of alteplase
- Section 6.6: Inclusion of detailed label instructions for the product reconstitution in order to improve the guidance provided and to help on preventing handling errors along with minor editorial changes
- Section 7: Removal of ‘D-’ from MA Holder address
- Section 10: Date of revision has been updated to September 2022
Updated on 02 March 2023
File name
A1;2mg-E-SPC-8.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 18 February 2020
File name
Cropped - 316393-02 dated 06.09.2019 PIP046183-002.pdf
Reasons for updating
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Section 6: ‘What Actilyse Cathflo contains’ section updated - information added on how Alteplase is produced.
Updated on 31 May 2019
File name
A1;2mg-E-SPC-8.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
- 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 SmPC has been updated in section 7 (Marketing Authorisation Holder), section 8 (Marketing Authorisation Number) with new MAH details and section 10 date of revision of the text.
Updated on 07 May 2019
File name
316393-01 PIP046183-001 21.12.2018 AMT 88073 Cropped.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
- Change to section 6 - date of revision
Updated on 08 November 2018
File name
PIL 307972-02 07.08.18 PIP035389-002 AMT 88972 cropped.pdf
Reasons for updating
- Change to section 5 - how to store or dispose
- Change to section 6 - date of revision
Updated on 07 November 2018
File name
A1;2mg-E-SPC-7.pdf
Reasons for updating
- 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 5.1 - Pharmacodynamic properties
- Change to section 6.2 - Incompatibilities
- Change to section 6.3 - Shelf life
- 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
- Section 4.4: Update to Special warnings and precautions for use; specifically the addition of information relating to traceability of biological medicinal products.
- Section 4.5 and 5.1: Additional subheadings added, no content change.
- Section 6.2 and 6.6: Additional information regarding turbidity of reconstituted solution and minor editorial changes.
- Section 6.3: Administrative clarification to reconstitution shelf life statement.
- Section 10: Date of revision has been updated to October 2018.
Updated on 23 May 2018
File name
A1-2mg-E-SPC-6.docx
Reasons for updating
- 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 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 04 January 2016
File name
PIL_15007_956.pdf
Reasons for updating
- New PIL for new product
Updated on 04 January 2016
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 04 January 2016
Reasons for 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
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 04 January 2016
Reasons for updating
- Change of trade or active ingredient name
- Change of inactive ingredient
- Change to further information section
- Change to date of revision
- Change to appearance of the medicine
- Change to product name
Updated on 15 October 2015
Reasons for 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
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 15 October 2015
Reasons for updating
- Change to, or new use for medicine
- Change to warnings or special precautions for use
- Change of contraindications
- Change to side-effects
- Change to information about pregnancy or lactation
- Change to further information section
- Change to date of revision
- Change to appearance of the medicine
- Change to dosage and administration
- Addition of information on reporting a side effect.
Updated on 06 November 2013
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to date of revision
Updated on 25 October 2013
Reasons for 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
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 05 July 2013
Reasons for updating
- Improved electronic presentation
Updated on 07 June 2011
Reasons for updating
- New PIL for new product
Updated on 06 June 2011
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)