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AstraZeneca Pharmaceuticals (Ireland) DAC

College Park House, 20 Nassau Street, Dublin 2,
Telephone: +353 1 609 7100
Fax: +353 1 679 6650
Medical Information Direct Line: 1800 800 899 Freephone
Medical Information e-mail: medical.informationuk@astrazeneca.com
Customer Care direct line: +353(0)1 609 7100 Supply & non-medical enquiries
Medical Information Facsimile: +44 (0)1582 838 003
Summary of Product Characteristics last updated on medicines.ie: 17/03/2017
SPC Meronem I.V. 500mg & 1g

When a pharmaceutical company changes an SPC or PIL, 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 17/03/2017 and displayed until Current
Reasons for adding or 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
Date of revision of text on the SPC:   07-Mar-2017
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 14/03/2016 and displayed until 17/03/2017
Reasons for adding or 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
Date of revision of text on the SPC:   02-Mar-2016
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 06/10/2015 and displayed until 14/03/2016
Reasons for adding or 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
Date of revision of text on the SPC:   22-Sep-2015
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 13/04/2015 and displayed until 06/10/2015
Reasons for adding or 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
Date of revision of text on the SPC:   24-Mar-2015
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 29/09/2014 and displayed until 13/04/2015
Reasons for adding or 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
Date of revision of text on the SPC:   15-Sep-2014
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 30/04/2014 and displayed until 29/09/2014
Reasons for adding or 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
Date of revision of text on the SPC:   09-Jan-2014
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 04/07/2011 and displayed until 30/04/2014
Reasons for adding or updating:
  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   13-May-2011
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 06/08/2010 and displayed until 04/07/2011
Reasons for adding or updating:
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   22-Jul-2010
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 18/03/2009 and displayed until 06/08/2010
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   03/2009
Legal Category:   prescription only

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 02/01/2009 and displayed until 18/03/2009
Reasons for adding or 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
Date of revision of text on the SPC:   01/2008
Legal Category:   prescription only

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 08/02/2008 and displayed until 02/01/2009
Reasons for adding or 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 22/12/2005 and displayed until 08/02/2008
Reasons for adding or 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 23/02/2005 and displayed until 22/12/2005
Reasons for adding or 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 18/08/2003 and displayed until 23/02/2005
Reasons for adding or updating:
  • New SPC for medicines.ie
Updated on 23/06/2003 and displayed until 18/08/2003
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
   Meropenem Trihydrate