Meronem I.V. 1g

  • Name:

    Meronem I.V. 1g

  • Company:
    info
  • Active Ingredients:

    Meropenem Trihydrate

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 10/12/19

files-icon(Click to Download)
Summary of Product Characteristics last updated on medicines.ie: 10/12/2019

Click on this link to Download PDF directly

Pfizer Healthcare Ireland

Pfizer Healthcare Ireland

Company Products

Medicine NameActive Ingredients
Medicine Name Accupro 10 mg Film - Coated tablets Active Ingredients Quinapril hydrochloride
Medicine Name Accupro 20 mg Film - Coated tablets Active Ingredients Quinapril hydrochloride
Medicine Name Accupro 40 mg Film - Coated tablets Active Ingredients Quinapril hydrochloride
Medicine Name Accupro 5 mg Film - Coated tablets Active Ingredients Quinapril hydrochloride
Medicine Name Accuretic 20 mg/12.5 mg Tablets Active Ingredients Hydrochlorothiazide, Quinapril hydrochloride
Medicine Name Aciclovir 25 mg/ml Concentrate for Solution for Infusion. Active Ingredients Aciclovir sodium
Medicine Name Aldactone 100mg film coated tablets Active Ingredients Spironolactone
Medicine Name Aldactone 25mg film-coated tablets Active Ingredients Spironolactone
Medicine Name Aldactone 50 mg Film-coated tablets. Active Ingredients Spironolactone
Medicine Name Amlodipine Pfizer 10 mg Tablets Active Ingredients Amlodipine besilate
Medicine Name Amlodipine Pfizer 5 mg Tablets Active Ingredients Amlodipine besilate
Medicine Name Anugesic HC Cream Active Ingredients Balsam Peru, Benzyl Benzoate, Bismuth Oxide, Hydrocortisone Acetate, Pramocaine Hydrochloride, Zinc Oxide
Medicine Name ARICEPT 10 mg film coated tablets Active Ingredients Donepezil Hydrochloride
Medicine Name ARICEPT 5 mg film coated tablets Active Ingredients Donepezil Hydrochloride
Medicine Name Aromasin 25 mg coated tablets Active Ingredients Exemestane
Medicine Name Arthrotec 50 Active Ingredients Diclofenac Sodium, Misoprostol
Medicine Name Arthrotec 75 modified-release tablets Active Ingredients Diclofenac Sodium, Misoprostol
Medicine Name Ativan 1mg Tablets Active Ingredients Lorazepam
Medicine Name ATIVAN INJECTION Active Ingredients Lorazepam
Medicine Name BeneFIX Active Ingredients nonacog alfa
Medicine Name BESPONSA 1 mg powder for concentrate for solution for infusion Active Ingredients Inotuzumab ozogamicin
Medicine Name Bosulif 100 mg, 400 mg & 500 mg film-coated tablets Active Ingredients Bosutinib monohydrate
Medicine Name Cabaser 1mg Tablet Active Ingredients Cabergoline
Medicine Name Cabaser 2mg Tablet Active Ingredients Cabergoline
Medicine Name CAMPTO 20 mg/ml, concentrate for solution for infusion Active Ingredients Irinotecan hydrochloride trihydrate
1 - 0 of 227 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 10 December 2019 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties

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

Updated on 10 December 2019 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 13 March 2019 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.4 - Special precautions for storage

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

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:
section 4.4: addition of
Severe cutaneous adverse reactions (SCAR), and update to sodium content. Section 4.8 ADR table updated accordingly. Section 6.4 updated with:  storage condition for reconstituted product.

Updated on 13 February 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - excipient warnings
  • Change to section 4 - possible side effects
  • Change to information for healthcare professionals

Updated on 8 November 2018 PIL

Reasons for updating

  • Change to name of medicinal product
  • Removal of one or more presentations from joint PIL

Updated on 10 November 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 9 November 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 9 November 2017 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows: update of the MAH details to Pfizer Healthcare Ireland.

Updated on 9 November 2017 PIL

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows: update of the MAH details to Pfizer Healthcare Ireland.

Updated on 8 November 2017 PIL

Reasons for updating

  • Improved presentation of SPC

Free text change information supplied by the pharmaceutical company

removal of footer - improved presentation

Updated on 8 November 2017 SmPC

Reasons for updating

  • Improved presentation of SPC

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

Free text change information supplied by the pharmaceutical company

removal of footer - improved presentation

Updated on 1 September 2017 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text
  • Transfer of marketing authorisation holder

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

Free text change information supplied by the pharmaceutical company

Section 2 - QRD update with regards to excipients
Section 4.1 – clarification of age in treatment of children and management of neutropenic patients
Section 4.2 – Addition of sub-headings ‘Posology’ and ‘Method of administration’
Section 4.4 – deletion of information relating to paediatric population
Section 4.5 – Addition of information relating to paediatric population
Section 4.6 – Amendment to ‘Breast-feeding’ section
Section 5.1 – QRD update: change to sub-heading ‘Mechanism of action’
Section 5.2 - QRD update: change to sub-heading ‘Biotransformation’ and ‘paediatric population’
Section 10 – update to date of revision

Updated on 1 September 2017 PIL

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text
  • Transfer of marketing authorisation holder

Free text change information supplied by the pharmaceutical company

Section 2 - QRD update with regards to excipients
Section 4.1 – clarification of age in treatment of children and management of neutropenic patients
Section 4.2 – Addition of sub-headings ‘Posology’ and ‘Method of administration’
Section 4.4 – deletion of information relating to paediatric population
Section 4.5 – Addition of information relating to paediatric population
Section 4.6 – Amendment to ‘Breast-feeding’ section
Section 5.1 – QRD update: change to sub-heading ‘Mechanism of action’
Section 5.2 - QRD update: change to sub-heading ‘Biotransformation’ and ‘paediatric population’
Section 10 – update to date of revision

Updated on 17 March 2017 PIL

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 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

Section 4.1: movement of information with regards to treatment of patients with bacteraemia to ease readability.  

Section 4.2: editorial update – correction of word section to sections.

Section 4.3: editorial update – correction of betalactam to beta-lactam

Section 4.8: Addition of DRESS syndrome to ‘not known’ frequency of Skin and subcutaneous tissue disorders and spelling correction of pruritus.

Section 5.1: Editorial correction of ‘antibacterials’ to ‘antibacterial’.

Section 5.3: Editorial correction of ‘that’ to ‘than’.

Section 10: updated date of revision

Updated on 17 March 2017 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 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data
  • 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: movement of information with regards to treatment of patients with bacteraemia to ease readability.  

Section 4.2: editorial update – correction of word section to sections.

Section 4.3: editorial update – correction of betalactam to beta-lactam

Section 4.8: Addition of DRESS syndrome to ‘not known’ frequency of Skin and subcutaneous tissue disorders and spelling correction of pruritus.

Section 5.1: Editorial correction of ‘antibacterials’ to ‘antibacterial’.

Section 5.3: Editorial correction of ‘that’ to ‘than’.

Section 10: updated date of revision

Updated on 14 March 2016 SmPC

Reasons for updating

  • Change to section 5.3 - Preclinical safety data
  • Change to section 4.7 - Effects on ability to drive and use machines
  • 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 4.7 – spelling correction of paraesthesiae.

Section 5.3 – deleting statement regarding Monkey’s abortion.

Section 10 – date of revision

Updated on 14 March 2016 PIL

Reasons for updating

  • Change to section 5.3 - Preclinical safety data
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

Section 4.7 – spelling correction of paraesthesiae.

Section 5.3 – deleting statement regarding Monkey’s abortion.

Section 10 – date of revision

Updated on 6 October 2015 PIL

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

Section 4.4 – paediatric information added

Section 4.7 – Driving warning statement added

Section 4.8 – paediatric information added

Section 10 – revision date updated.

Updated on 6 October 2015 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.7 - Effects on ability to drive and use machines
  • 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)

Free text change information supplied by the pharmaceutical company

Section 4.4 – paediatric information added

Section 4.7 – Driving warning statement added

Section 4.8 – paediatric information added

Section 10 – revision date updated.

Updated on 13 April 2015 PIL

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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

Free text change information supplied by the pharmaceutical company

- Section 4.8 editorial edits to adverse reaections table.

- Section 4.8 update to AE reporting wording.

- Section 6.3 storage conditions updated.

- Section 6.6 glucose reference replaced with dextrose.

- Section 10 Date of revision of text updated.

Updated on 13 April 2015 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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 4.8 editorial edits to adverse reaections table.

- Section 4.8 update to AE reporting wording.

- Section 6.3 storage conditions updated.

- Section 6.6 glucose reference replaced with dextrose.

- Section 10 Date of revision of text updated.

Updated on 29 September 2014 PIL

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

- Section 4.4 Relevant subtitles added to each paragraph section.

- Section 4.8 Subtitles added to side effects section. Frequency classification changed from ‘Not known’ to ‘Uncommon’ for Bloody and Lymphatic system disorders, Immune system disorders, GI disorders, Skin and subcutaneous tissue disorders and General disorders and administration site conditions
- section 10 updated date of revision

Updated on 29 September 2014 SmPC

Reasons for updating

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

Free text change information supplied by the pharmaceutical company

- Section 4.4 Relevant subtitles added to each paragraph section.

- Section 4.8 Subtitles added to side effects section. Frequency classification changed from ‘Not known’ to ‘Uncommon’ for Bloody and Lymphatic system disorders, Immune system disorders, GI disorders, Skin and subcutaneous tissue disorders and General disorders and administration site conditions
- section 10 updated date of revision

Updated on 30 April 2014 PIL

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 - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

- Section 4.1

·         First bullet point has been changed to: Severe pneumonia, including hospital and ventilator-associated pneumonia.

·         Following statement has been added: Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above.


- Section 4.2

·         Addition of: .....less susceptible bacterial species (e.g. Enterobacteriaceae,……) or very severe infections. or very severe infections.

·         In the first table the statement about pneumonia has been changed to: Severe pneumonia, including hospital and ventilator-associated pneumonia.

·         In the third table the statement about pneumonia has been changed to: Severe pneumonia, including hospital and ventilator-associated pneumonia.

 

- Section 4.3

·         Addition of: listed in section 6.1.

 

 

- Section 4.4

·         Addition of: Resistance to penems of Enterobacteriaceae, Pseudomonas aeruginosa, Acinetobacter spp. varies across the European Union. Prescribers are advised to take into account the local prevalence of resistance in these bacteria to penems.

·         Addition of: …….valpromide is not recommended (see section 4.5).

 

 

- Section 4.5

·         Addition of: sodium valproate/valpromide in paragraph 4.

 

- Section 4.8

·         Addition of AE reporting statement

 

- Section 5.1

·         Reformatting of EUCAST table and further clarification in footnotes

·         Addition of: Glanders and melioidosis: Use of meropenem in humans is based on in vitro B.mallei and B. pseudomallei susceptibility data and on limited human data. Treating physicians should refer to national and/or international consensus documents regarding the treatment of glanders and melioidosis.

 

- Section 9

·         Addition of: Date of last renewal: 30 April 2012

 

- Section 10

·         Revision date

Updated on 30 April 2014 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 - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • 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 4.1

·         First bullet point has been changed to: Severe pneumonia, including hospital and ventilator-associated pneumonia.

·         Following statement has been added: Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above.


- Section 4.2

·         Addition of: .....less susceptible bacterial species (e.g. Enterobacteriaceae,……) or very severe infections. or very severe infections.

·         In the first table the statement about pneumonia has been changed to: Severe pneumonia, including hospital and ventilator-associated pneumonia.

·         In the third table the statement about pneumonia has been changed to: Severe pneumonia, including hospital and ventilator-associated pneumonia.

 

- Section 4.3

·         Addition of: listed in section 6.1.

 

 

- Section 4.4

·         Addition of: Resistance to penems of Enterobacteriaceae, Pseudomonas aeruginosa, Acinetobacter spp. varies across the European Union. Prescribers are advised to take into account the local prevalence of resistance in these bacteria to penems.

·         Addition of: …….valpromide is not recommended (see section 4.5).

 

 

- Section 4.5

·         Addition of: sodium valproate/valpromide in paragraph 4.

 

- Section 4.8

·         Addition of AE reporting statement

 

- Section 5.1

·         Reformatting of EUCAST table and further clarification in footnotes

·         Addition of: Glanders and melioidosis: Use of meropenem in humans is based on in vitro B.mallei and B. pseudomallei susceptibility data and on limited human data. Treating physicians should refer to national and/or international consensus documents regarding the treatment of glanders and melioidosis.

 

- Section 9

·         Addition of: Date of last renewal: 30 April 2012

 

- Section 10

·         Revision date

Updated on 4 July 2011 PIL

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

Section 6.3
Change to storage conditions.


Section 10
Revision date of text 13th May 2011

Updated on 4 July 2011 SmPC

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

Section 6.3
Change to storage conditions.


Section 10
Revision date of text 13th May 2011

Updated on 6 August 2010 SmPC

Reasons for updating

  • 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 the entire document due to harmonisation

Updated on 6 August 2010 PIL

Reasons for updating

  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

Changes to the entire document due to harmonisation

Updated on 18 March 2009 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • 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 3
change of  text regarding colour of powder:
A white to light yellow powder.
 
Section 10
new revision date of text: 11 March 2009

Updated on 18 March 2009 PIL

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

Section 3
change of  text regarding colour of powder:
A white to light yellow powder.
 
Section 10
new revision date of text: 11 March 2009

Updated on 2 January 2009 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • 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

Following new sentence added:

Meronem may reduce serum valproic acid levels.  Subtherapeutic levels may be  reached in some patients.

 

 

Section 4.8

Text is now in-line with MedDRA frequency descriptor table, aligning frequency with system order class and MedDRA terminology.

 

New text added to table under common frequency Abdominal Pain

New text also added under not known frequency Haemolytic anaemia

 

Following new sentence added to end of table:

2 For convulsions, the incidence is calculated on exposures in patients with infections other than meningitis.

 

Section 4.9

Following first sentence deleted: Intentional overdosing with Meronem is unlikely.

 

Following sentence deleted: Limited post-marketing experience indicates that if adverse events occur following overdosage, they are consistent with the adverse event profile described in section 4.8, are generally mild in severity and resolve on withdrawal or dose reduction. 

And replaced with following new text: Limited post-marketing experience indicates that adverse events following overdosage are consistent with the adverse event profile described in section 4.8.

 

Section 10

Date changed to 30th January 2008

Updated on 2 January 2009 PIL

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

Section 4.4

Following new sentence added:

Meronem may reduce serum valproic acid levels.  Subtherapeutic levels may be  reached in some patients.

 

 

Section 4.8

Text is now in-line with MedDRA frequency descriptor table, aligning frequency with system order class and MedDRA terminology.

 

New text added to table under common frequency Abdominal Pain

New text also added under not known frequency Haemolytic anaemia

 

Following new sentence added to end of table:

2 For convulsions, the incidence is calculated on exposures in patients with infections other than meningitis.

 

Section 4.9

Following first sentence deleted: Intentional overdosing with Meronem is unlikely.

 

Following sentence deleted: Limited post-marketing experience indicates that if adverse events occur following overdosage, they are consistent with the adverse event profile described in section 4.8, are generally mild in severity and resolve on withdrawal or dose reduction. 

And replaced with following new text: Limited post-marketing experience indicates that adverse events following overdosage are consistent with the adverse event profile described in section 4.8.

 

Section 10

Date changed to 30th January 2008

Updated on 8 February 2008 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • 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 8 February 2008 PIL

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text

Updated on 22 December 2005 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
  • Change from the BAN of the active substance to the rINN

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

Updated on 22 December 2005 PIL

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
  • Change from the BAN of the active substance to the rINN

Updated on 23 February 2005 PIL

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text

Updated on 23 February 2005 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • 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 18 August 2003 PIL

Reasons for updating

  • New SPC for medicines.ie

Updated on 18 August 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

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

Updated on 23 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

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

Updated on 23 June 2003 PIL

Reasons for updating

  • New SPC for medicines.ie