Actilyse

  • Name:

    Actilyse

  • Company:
    info
  • Active Ingredients:

    Alteplase

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 20/11/19

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Summary of Product Characteristics last updated on medicines.ie: 20/11/2019

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Boehringer Ingelheim Limited

Boehringer Ingelheim Limited

Company Products

Medicine NameActive Ingredients
Medicine Name Actilyse Active Ingredients Alteplase
Medicine Name Actilyse Cathflo 2 mg Active Ingredients Alteplase
Medicine Name APTIVUS 100 mg/ml oral solution Active Ingredients Tipranavir
Medicine Name Aptivus 250 mg soft capsules Active Ingredients Tipranavir
Medicine Name Atrovent 250 UDVs, 250 micrograms/1ml Nebuliser Solution Active Ingredients ipratropium bromide monohydrate
Medicine Name Atrovent 500 UDVs, 500 micrograms/2ml Nebuliser Solution Active Ingredients ipratropium bromide monohydrate
Medicine Name Atrovent Inhaler CFC-Free Active Ingredients ipratropium bromide monohydrate
Medicine Name Catapres Ampoules Active Ingredients Clonidine hydrochloride
Medicine Name Catapres Tablets 100 micrograms Active Ingredients Clonidine hydrochloride
Medicine Name Giotrif 20 mg film-coated tablets Active Ingredients Afatinib dimaleate
Medicine Name Giotrif 30 mg film-coated tablets Active Ingredients Afatinib dimaleate
Medicine Name Giotrif 40 mg film-coated tablets Active Ingredients Afatinib dimaleate
Medicine Name Giotrif 50 mg film-coated tablets Active Ingredients Afatinib dimaleate
Medicine Name Glyxambi 10 mg/5 mg film-coated tablets Active Ingredients Empagliflozin, Linagliptin
Medicine Name Glyxambi 25 mg/5 mg film-coated tablets Active Ingredients Empagliflozin, Linagliptin
Medicine Name Jardiance 10 mg and 25 mg Film-Coated Tablets Active Ingredients Empagliflozin
Medicine Name Jentadueto 2.5 mg/850 mg film-coated tablets and Jentadueto 2.5 mg/1,000 mg film-coated tablets Active Ingredients Linagliptin, Metformin Hydrochloride
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
Medicine Name MicardisPlus 80 mg/12.5 mg tablets Active Ingredients Hydrochlorothiazide, Telmisartan
Medicine Name MicardisPlus 80 mg/25 mg Active Ingredients Hydrochlorothiazide, Telmisartan
1 - 0 of 50 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 20 November 2019 PIL

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Minor clarifications; correction of spelling errors

Updated on 20 November 2019 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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 5.1 - Pharmacodynamic properties
  • 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

Sections 4.1, 4.2, 4.3, 4.5, 4.6, 4.9, 5.1, 6.6:  Administrative / clarifications and the product information has been updated in line with excipient guidelines

Sections 4.2, 4.3, 4.4, 4.8, 4.9, 6.6:  Traceability statement added regarding recording batch number and sections updated with extensive changes.

Specifically, section 4.2 updated to introduce a structure to specify more clearly which recommended or maximum dosage applies to which registered indication and patient body weight and to add a dosing table for alteplase use in the indication acute ischaemic stroke. Section 4.4 updated to cluster already existing safety information broken down by indication. Section 4.4 updated to include a statement that the name and batch number of the administered product should be clearly recorded in the patient file to improve traceability. Section 4.8 update to reword the side effect "Bleeding" (MedDRA Lowest Level Term) to its corresponding MedDRA preferred term "Haemorrhage" (MedDRA Version 21.0). Section 4.9 updated to include the information regarding the symptoms occurring in case of an overdose.

Section 10 Date of Revision has been updated

Updated on 25 July 2019 SmPC

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

Section 7:  Marketing Authorisation Holder updated

Section 8:  Marketing Authorisation Number updated

Section 10, date of revision updated

Updated on 7 May 2019 PIL

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 3 October 2018 PIL

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision
  • Change to information for healthcare professionals

Updated on 3 October 2018 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 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.1 - List of excipients
  • 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: Minor update to the sub-heading from ‘Pulmonary embolism’ to ‘Acute massive pulmonary embolism’.
  • Sections 4.3: Deletion of ‘Use in elderly patients’ section to remove reference regarding Actilyse not indicated for the treatment of acute stroke in adults over 80 years and minor update to the sub-headings from ‘acute pulmonary embolism’ to ‘acute massive pulmonary embolism’ .
  • Section 4.4: Update to the information in the ‘Additional special warnings and precautions in acute ischaemic stroke’ section, addition of cross-references to section 4.3, and update to the sub-headings as section 4.3.
  • Section 4.8: Minor wording update to the description of Table 1.
  • Section 5.1: Addition of information in the ‘Elderly (>80 years)’ section regarding nine randomised trials to assess benefit-risk of alteplase in patients > 80 years and addition of multiple sub-headings.
  • Section 6.1: Editorial update to the excipient  ‘Phosphoric acid, dilute to ‘Phosphoric acid (for pH-adjustment)’
  • Section 10: Date of revision has been updated to September 2018

Updated on 21 August 2018 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision
  • Change to information for healthcare professionals

Updated on 21 August 2018 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 5.1 - Pharmacodynamic properties
  • 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

 

  • Sections 4.2: Wording update in the ‘Paediatric population’ section to specify inclusion of 16 - 17 years in the adolescents group.
  • Sections 4.3: Wording update in the ‘Use in children and adolescents’ section to specify inclusion of 16 - 17 years in the adolescents group.
  • Section 4.4: Addition of information in the ‘Paediatric population’ section with cross-reference to section 5.1.
  • Section 5.1: Addition of information in the ‘Paediatric population’ section regarding Observational non-randomised and non-comparative data in stroke patients of 16 – 17 years.
  • Section 6.3: Editorial update to align with RMS annex text.
  • Section 10: Date of revision has been updated to August 2018 to align with the HPRA approval date of 13-Aug-2018. For reference, the RMS approval date was 23-Apr-2018.
  • Other editorial changes within the SmPCs to align with the HPRA approved versions of the SmPC, where relevant.

Updated on 17 August 2018 SmPC

Reasons for updating

  • Previous version of SmPC reinstated

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

Free text change information supplied by the pharmaceutical company

Previous version of SmPC reinstated

Updated on 17 August 2018 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 5.1 - Pharmacodynamic properties
  • Change to section 6.3 - Shelf life

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: Wording update in the ‘Paediatric population’ section to specify inclusion of 16 - 17 years in the adolescents group.
  • Sections 4.3: Wording update in the ‘Use in children and adolescents’ section to specify inclusion of 16 - 17 years in the adolescents group.
  • Section 4.4: Addition of information in the ‘Paediatric population’ section with cross-reference to section 5.1.
  • Section 5.1: Addition of information in the ‘Paediatric population’ section regarding Observational non-randomised and non-comparative data in stroke patients of 16 – 17 years.
  • Section 6.3: Editorial update to align with RMS annex text.

Updated on 16 May 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 8 May 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 8 May 2018 SmPC

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 25 May 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 25 May 2017 PIL

Reasons for updating

  • Change to section 6 - date of revision

Updated on 12 May 2017 PIL

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision

Updated on 8 May 2017 SmPC

Reasons for updating

  • 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 6.3 Shelf Life (clarification / editorial / wording changes –  actual shelf life not changed).

-        Section 6.6 Special precautions for disposal and other handling (includes substantial changes to Instructions for reconstituting Actilyse).

-        Section 10 (Revision date updated).  The date of revision of the text has updated to align with the RMS approval dated 25Apr17.

Updated on 8 May 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 31 March 2015 PIL

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 appearance of the medicine
  • Change to dosage and administration
  • Change to improve clarity and readability
  • Addition of information on reporting a side effect.

Updated on 24 March 2015 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 4.3 - 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 5.1 - 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

Further to receipt of renewal approval, the following are updated:


Sections 1, 2 and 7 (with minor typographical changes)

Sections 3 (re appearance), 4.2, 4.3, 4.4, 4.6, 4.8, 4.9, 5.1, 6.1, 6.2, 6.3, 6.4, 6.5, 6.6 and 9 (with significant changes)

Section 10 (revision date updated from August 2013 to March 2015) 

Updated on 12 November 2013 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to further information section
  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 1 November 2013 SmPC

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • 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 4.3 Contraindications

This section has been updated to include warnings for latex and gentamicin.

This section has been updated to include additional anticoagulation statements.

 

Section 4.4 Special Warnings and Precautions for Use

This section has been updated to include warnings for latex and gentamicin.

This section has been updated to include additional anticoagulation statements.

 

Section 6.6 Special Precautions for Disposal and Other Handling

The section header has been updated to now read Special precautions for disposal and other handling i.e. … of a used medicinal product or waste materials derived from such medicinal product and … of the product have been deleted.


Section 10 Date of Revision of the Text

The date has been updated from October 2011 to August 2013.

Updated on 16 April 2012 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to date of revision
  • Changes to therapeutic indications

Updated on 16 April 2012 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • 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 4.1 Therapeutic Indications

The final paragraph (regarding fibrinolytic treatment of acute ischaemic stroke) has had text both added to and deleted from.  The text … as early as possible …,

… 4.5 …, … after … and all that after … imaging techniques … is new.

 

Section 4.2 Posology and Method of Administration

The Acute ischaemic stroke sub-heading of this section has had both text added to and deleted from. 

 

The text … only …, … under the responsibility and follow-up of …, … trained and experienced …, and … neurovascular … is new in the first paragraph.

 

The text … as early as possible …, … 4.5 … and the complete final sentence of the third paragraph is new.

 

Section 4.3 Contraindications

The second paragraph of this section has been added as new text.

 

The first bullet point of the Additional contraindications in acute ischaemic stroke sub-heading has been amended.  The text … 4.5 …, … symptoms for which the …, … time … and … and could potentially be more than 4.5 hours ago (see section 5.1) has been added.

 

A new sub-heading entitled Use in elderly patients, together with corresponding text, has been added.

 

Section 4.4 Special Warnings and Precautions for Use

A new first paragraph has been added to this section.

 

The sub-heading Additional special warnings and precautions in acute ischaemic stroke has had both text added to and deleted from.  The text … only …, … under the responsibility and follow-up of a … and … neurovascular … has been added.

 

A new third bullet point has been added to the Special warnings/conditions with a decreased benefit/risk ratio sub-heading.

 

A new penultimate paragraph (regarding data available from ECASS III) has been added to this section.

 

Section 4.5 Interaction with Other Medicinal Products and Other Forms of Interaction

The text … active substances which interfere with … has replaced the text … other agents inhibiting … in the second paragraph of this section.

 

Section 4.8 Undesirable Effects

The first paragraph of this section (regarding adverse reactions frequency and system organ class) has had text both added to and deleted from.

 

The text … and without any relevant increase in overall mortality and severe disability combined, i.e. mRS of 5 and 6 … has been added to the common category of the Haemorrhage sub-heading.

 

The text … ear haemorrhage … has been added to the uncommon category of the Haemorrhage sub-heading.

 

Section 4.9 Overdose

The text … severe bleeding results, the infusion of fresh frozen plasma or fresh blood is recommended and if necessary, synthetic antifibryinolytics may be administered … has been added to the first paragraph of this section.

 

Section 5.1 Pharmacodynamic Properties

The text … iv… and … s.c… has been replaced with the text … intravenous … and … subcutaneous … in the fourth paragraph of this section.

 

The Acute stroke sub-heading of this section has had both text added to and deleted from, including the addition of a new second paragraph regarding the ECASS III trial and the addition of a new third paragraph regarding the safety and efficacy of Actilyse for acute ischaemic stroke treatment.

 

Section 6.6 Special Precautions for Disposal and Other Handling

Minor editorial changes have been made to this section.

 

Section 10 Date of Revision of the Text

The date has been amended from November 2009 to October 2011.

Updated on 11 May 2010 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.3 - Contraindications
  • 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 5.2 - Pharmacokinetic properties
  • 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

Section 2 Qualitative and Quantitative Composition

The text Active ingredient: has been deleted as the first paragraph of this section.

 

Section 4.3 Contraindications

A new second paragraph for this section has been inserted i.e. paragraph commencing with the text: Additional contraindications in acute myocardial infarction, …

 

Section 4.4 Special Warnings and Precautions for Use

A new first paragraph for this section has been inserted i.e. paragraph commencing with the text: Special warnings and precautions in acute myocardial infarction, …

 

The word oedama has been corrected to spell oedema in the first sentence of the last paragraph of this section i.e. the one entitled Other special warnings.


Section 4.8 Undesirable Effects

The first paragraph of this section has been completely reworded i.e. the one regarding adverse reactions according to frequency and system organ class.  Text has both been deleted from and added to this paragraph.

 

The word arrythmias has been corrected to spell arrhythmias in the very common paragraph of the Cardiac disorders heading of this section.

 

Section 5.1 Pharmacodynamic Properties

A new third paragraph has been added to this section i.e. one commencing with the text: Due to its relative fibrin-specificity alteplase at a dose of 100 mg leads to a modest decrease …

 

This paragraph was originally the first paragraph in section 5.2 (Pharmacokinetic Properties) and has moved location.  No changes to the text itself have taken place.

 

Section 5.2 Pharmacokinetic Properties

What was originally the first paragraph of this section has been deleted and moved to section 5.1 (Pharmacodynamic Properties) where it has become the third paragraph of this section.

 

Section 6.3 Shelf-Life

The text 10 mg, 20 mg and 50 mg pack sizes has been added to now come before the text 3 years.

 

Section 6.4 Special Precautions for Storage

The text Do not store above 25ºC has been relocated to become the second sentence of the second paragraph of this section.

 

The text For 10 mg, 20 mg and 50 mg pack sizes: has been added as the first sentence of the second paragraph of this section.

 

Section 6.5 Nature and Contents of Container

The text For the 10 mg. 20 mg and 50 mg pack sizes, t has been added to and the capital T of the word the deleted from the beginning of the first sentence under the Solvent heading of this section. 

 

The words injection and have been added to the first sentences of each strength pack size details in this section.

 

Section 6.6 Special Precautions for Disposal and Other Handling

A new fourth paragraph has been added to this section i.e. one commencing with the text When reconstituting the product from the respective amount of powder and solvent, …

 

Section 10 Date of Revision of the Text

The date March 2007 has been replaced with the date April 2010.

Updated on 2 September 2009 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 6 February 2009 SmPC

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 29 January 2008 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 7 December 2007 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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

Free text change information supplied by the pharmaceutical company

Correction of error in Section 4.8 Undesirable effects

Updated on 2 August 2007 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 5.3 - Preclinical safety data
  • 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

Changes to section 4.2 - Posology and method of administration, Change to section 4.3 – Contraindications, Change to section 4.4 – Special warnings and special 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 details:

Section 4.2 Posology and method of administration.

The section on adjunctive therapy has been updated to incorporate current recommendations.  It now states “Antithrombotic adjunctive therapy is recommended according to the current international guidelines for the management of patients with ST-elevation myocardial infarction”

 

Section 4.3 Contraindications

Acitylase is contraindicated in cases where there is a high risk of haemorrhage in a number of situations; this now includes patients with a “significant bleeding disorder at present or within the past 6 months”.

An additional contraindication for use in acute myocardial infarction and acute pulmonary embolism was any history of stroke.  This has now been changed to include

“any known history of haemorrhagic stroke or stroke of unknown origin”

and “any known history of ischaemic stroke if transient ischaemic attack in the preceding 6 months, except current acute ischaemic stroke in the last 3 hours”.

 

Section 4.4 Special warnings and special precautions for use

This section now notes that the concomitant use of GPIIb/IIIa antagonists increases the risk of bleeding.

 

Section 4.5 Interaction with other medicinal products and other forms of interaction

This section now notes that the concomitant use of GPIIb/IIIa antagonists increases the risk of bleeding.

 

Section 4.8 – Undesirable effects

Corrections in the frequency classification of some undesirable effects.  The following effects have been reclassified from uncommon to common:

Respiratory tract haemorrhage (such as pharyngeal haemorrhage, epistaxis, haemoptysis)

Gastrointestinal haemorrhage (such as gastric haemorrhage, gastric ulcer haemorrhage, haemorrhage rectum, haematemesis, melaena, mouth haemorrhage)

 

As with other thrombolytic agents some cardiac disorders have been reported as sequelae of myocardial infarction and / or thrombolytic treatment. Reperfusion arrythmias are now classified as a very common undesirable effect.

 

Gastrointestinal disorders: Nausea and vomiting have been reclassified from a rare to a common undesirable effect.

 

The following effect has been added

Injury and poisoning and procedural complications:

rare:     fat embolism (cholesterol crystal embolisation), which may lead to corresponding consequences in the organs concerned

Updated on 18 April 2007 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 22 March 2007 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 14 February 2006 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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 5.1 - Pharmacodynamic properties
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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)

Updated on 19 May 2005 SmPC

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 14 September 2004 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 20 August 2003 SmPC

Reasons for updating

  • Improved electronic presentation

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

Updated on 25 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

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