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Metalyse 8,000 units

  • Name:

    Metalyse 8,000 units

  • Company:
    info
  • Active Ingredients:

    Tenecteplase

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 25/09/18

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Summary of Product Characteristics last updated on medicines.ie: 25/10/2017
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Boehringer Ingelheim Limited

Boehringer Ingelheim Limited

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Medicine Name Giotrif 50 mg film-coated tablets Active Ingredients Afatinib dimaleate
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Medicine Name Metalyse 10,000 units Active Ingredients Tenecteplase
Medicine Name Metalyse 8,000 units Active Ingredients Tenecteplase
Medicine Name Micardis 20 mg Tablets Active Ingredients Telmisartan
Medicine Name Micardis 40 mg Tablets Active Ingredients Telmisartan
Medicine Name Micardis 80 mg Tablets Active Ingredients Telmisartan
Medicine Name MicardisPlus 40 mg/12.5 mg tablets Active Ingredients Hydrochlorothiazide, Telmisartan
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1 - 0 of 48 items.Total: Infinity pages

When a pharmaceutical company changes any document, 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 25 September 2018 PIL

Reasons for updating

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

Updated on 14 February 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 14 February 2018 PIL

Reasons for updating

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

Updated on 26 October 2017 PIL

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 25 October 2017 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 25 October 2017 SmPC

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 10 November 2015 PIL

Reasons for updating

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

Updated on 30 October 2014 SmPC

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 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • 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 PIL

Reasons for updating

  • 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
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to storage instructions
  • Change to side-effects
  • Change to drug interactions

Updated on 22 March 2013 SmPC

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 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 12 July 2010 PIL

Reasons for updating

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

Updated on 6 May 2010 PIL

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 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 13 June 2006 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 17 September 2004 PIL

Reasons for updating

  • New PIL for medicines.ie