Meronem I.V. 1g
*Company:
Pfizer Healthcare IrelandStatus:
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 24 January 2024
File name
REG PIL MR 71 1g IV IE.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 14 February 2023
File name
DEC201964941_REG SPC MR 1g 3_1 IE.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 08 February 2021
File name
DEC202108123_REG PIL MR 6_0 1g IV IE.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 10 December 2019
File name
DEC201964941_REG SPC MR 1g 3_1 IE.pdf
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
File name
DEC201964941_REG PIL MR 5_1 1g IV IE.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 13 March 2019
File name
clean REG SPC MR 1g 2_2 IE.pdf
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
File name
clean PIL MR 4_0 1g IV IE_1.pdf
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 08 November 2018
File name
Reg HCP MR 1_1 PIL MR 3_1 1g IV IE clean.pdf
Reasons for updating
- Change to name of medicinal product
- Removal of one or more presentations from joint PIL
Updated on 10 November 2017
File name
PIL_8134_498.pdf
Reasons for updating
- New PIL for new product
Updated on 09 November 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 09 November 2017
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
Updated on 09 November 2017
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Free text change information supplied by the pharmaceutical company
Updated on 08 November 2017
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
Updated on 08 November 2017
Reasons for updating
- Improved presentation of SPC
Free text change information supplied by the pharmaceutical company
Updated on 01 September 2017
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 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 01 September 2017
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 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
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 17 March 2017
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 14 March 2016
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
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 06 October 2015
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 06 October 2015
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 13 April 2015
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 13 April 2015
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 29 September 2014
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 29 September 2014
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 30 April 2014
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 30 April 2014
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 04 July 2011
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 04 July 2011
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 06 August 2010
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
Updated on 06 August 2010
Reasons for updating
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
Updated on 18 March 2009
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
Updated on 18 March 2009
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
Updated on 02 January 2009
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
Updated on 02 January 2009
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
Updated on 08 February 2008
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 08 February 2008
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
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
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
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 23 February 2005
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 18 August 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 18 August 2003
Reasons for updating
- New SPC for medicines.ie
Updated on 23 June 2003
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
Reasons for updating
- New SPC for medicines.ie