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Metalyse 10,000 units

*
Pharmacy Only: Prescription

  • Company:

    Boehringer Ingelheim Limited

  • Status:

    Updated

  • Legal Category:

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

  • Active Ingredient(s):

    Tenecteplase

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

Updated on 27 November 2024

File name

M10;50mg-EU-SPC-20 - medicines.ie.pdf

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

  • Section 6.5: the description of the vial stopper has been updated from ‘a coated (B2-42) grey rubber stopper’ to ‘a silicone coated grey rubber stopper’.
  • Section 10: date of revision has been updated to October 2024. 


Updated on 30 January 2024

File name

Metalyse 50mg PIL Text -II-0070.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
  • Correction of spelling/typing errors
  • Change to product name

Updated on 29 January 2024

File name

M10;50mg-EU-SPC-19 medicines.ie.pdf

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 4.2 - Posology and method of administration
  • 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: Update to the name of the medicinal product to include 50 mg
  • Section 4.2: Addition of the text ‘The appropriate presentation of tenecteplase product should be chosen carefully and in line with the indication. The 40 mg and 50 mg presentations are only intended for use in acute myocardial infarction.’
  • Administrative and format changes throughout the SmPC e.g. ml to mL, addition/replacement of spaces/hard spaces, hyphens, symbols (please refer to the annotated SmPC). In addition, the font size and format of the SmPC has been fully aligned with the Commission Decision Annexes
  • Section 10: Date of revision of the SmPC has also been updated to January 2024


Updated on 17 March 2023

File name

Metalyse 10,000 Units PIL Text -IB-0065.pdf

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents

Updated on 17 March 2023

File name

M10;10000-EU-SPC-18.pdf

Reasons for updating

  • 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

  • Section 6.5 & 6.6: Removal of the information related to needle


Updated on 02 February 2023

File name

Metalyse 10,000 Units PIL Text -IB-0067.pdf

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 1 - what the product is used for
  • 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 6 - what the product contains
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 02 February 2023

File name

M10;10000-EU-SPC-17.pdf

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • 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 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • 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 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 3: Removal of statement regarding the reconstituted solution
  • Section 4.2: Section regarding Method of administration updated and moved to end of the section
  • Section 4.3: Update to Contraindications wording
  • Section 4.4: Addition of new subsection regarding Traceability plus update to subsection regarding Arrhythmias
  • Section 4.5: Addition of new subheading ‘Drugs affecting coagulation/platelet function’
  • Section 4.6: Update to subsection on Breast-feeding 
  • Section 4.8: Update to Table 1 ‘Uncommon Adverse reaction’
  • Section 4.9: Addition of Subheadings ‘Symptoms’ and ‘Therapy’
  • Section 6.5: Addition of the word 'contains'
  • Section 6.6: Update to Instructions for reconstitution
  • Section 7: Removal of ‘D-’ from MA Holder address
  • Section 10: Date of revision has been updated to January 2023 

Updated on 26 September 2022

File name

M10;10000-EU-SPC-15.pdf

Reasons for updating

  • Change to section 6.3 - Shelf life
  • 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 6.3: Updated to increase the shelf life from 2 years to 3 years
  • Section 10: Date of revision has been updated to September 2022

Updated on 30 June 2022

File name

Metalyse 10,000 Units PIL Text - medicines.ie.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Section 4: AE details updated to include “United Kingdom (Northern Ireland)”

Updated on 30 June 2022

File name

M10;10000-EU-SPC-13 - med.ie.pdf

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


•           SmPC Heading: Updated to include “United Kingdom (Northern Ireland)”

•           Section 4.8: AE details updated to include “United Kingdom (Northern Ireland)”

•           Section 10: Date of revision of the SmPC updated to 07/2021


Updated on 08 February 2021

File name

Metalyse 10k - TypeIAin manufacturer Feb 2021.pdf

Reasons for updating

  • Change to date of revision

Free text change information supplied by the pharmaceutical company

Date of approval of PIL updated to 12/2020

Updated on 07 December 2020

File name

Metalyse 10k - TypeIAin manufacturer.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 25 September 2018

File name

Metalyse 10k - EMEA-H-C-000306-N-0056.pdf

Reasons for updating

  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 14 February 2018

File name

PIL_8959_286.pdf

Reasons for updating

  • New PIL for new product

Updated on 14 February 2018

Reasons for updating

  • Change to other sources of information section
  • Improved presentation of PIL

Updated on 26 October 2017

Reasons for updating

  • New SPC for new product

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

Updated on 26 October 2017

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 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 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 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

·        Updates to sections 1, 2, 3, 4.2, 4.4, 4.8, 5.1, 6.1, 6.2, 6.3, 6.4, 6.5 & 6.6 of the SPCs in line with the latest version of the SPC QRD template, including other editorial changes.

·        Section 10: Date of revision updated to October 2017.

Updated on 26 October 2017

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 4 - how to report a side effect
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Updated on 13 November 2015

Reasons for updating

  • Change to date of revision
  • Change to MA holder contact details

Updated on 30 October 2014

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 4.5 - 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 - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • 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

Sections 4.2, 4.3, 4.4, 4.5, 4.6, 4.8, 5.1, 5.2 and 6.5 have been revised to implement changes associated with the revised Company Core Data Sheet and QRD9 template revisions including the addition of Adverse Event reporting contact details.

Additional minor/editorial updates have been made to align with the final, approved texts.

The date of revision of the text (Section 10) has been updated from February 2013 to October 2014.

Updated on 29 October 2014

Reasons for updating

  • Change to side-effects
  • Change to date of revision
  • Change to MA holder contact details
  • Change to improve clarity and readability
  • Addition of information on reporting a side effect.

Updated on 12 April 2013

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to storage instructions
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to further information section
  • Change to date of revision
  • Change to dosage and administration
  • Change of special precautions for disposal

Updated on 22 March 2013

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

Previously, one SPC included details for both 8,000 U and 10,000 U.  However, it has since been necessary to split this into two separate documents (one SPC each for 8,000 U and 10,000 U).  Consequently, minor updates have been made to sections 1, 2, 6.5 and 8 to facilitate this.

 

The main change was to section 5.2, where text has been split into the following sub-sections: Absorption, Distribution, Metabolism and Elimination.  

 

In addition, minor word revisions have been made sections 4.2, 4.4, 4.6 and 6.6, along with changes to section headings 4.2, 4.6, 4.8, 5.1 and 6.5. 

 

Additional minor formatting changes have also been made throughout.

 

Section 10 has been updated to February 2013.

Updated on 28 November 2012

Reasons for updating

  • Correction of spelling/typing errors

Updated on 12 July 2010

Reasons for updating

  • Change of contraindications
  • Change to side-effects
  • Change to MA holder contact details

Updated on 06 May 2010

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to dosage and administration

Updated on 22 March 2007

Reasons for updating

  • Improved electronic presentation

Updated on 13 June 2006

Reasons for updating

  • Improved electronic presentation

Updated on 17 September 2004

Reasons for updating

  • New PIL for medicines.ie