INVANZ
*Company:
MSD Ireland (Human Health) LimitedStatus:
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 16 February 2023
File name
INVANZ-H-C-0389-IB-066-SPC-IE-en-Feb2022.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
SPC document format updated to html
Updated on 30 June 2022
File name
QRD-IE-MT-UKNI-INVANZ-LFT-BRX-NIP-IB0066-v2-27May2022.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to other sources of information section
Free text change information supplied by the pharmaceutical company
Addition of United Kingdom (Northern Ireland) details to section 4 and section 6 of the PIL.
Updated on 01 March 2022
File name
INVANZ-H-C-0389-IB-066-SPC-IE-en-Feb2022.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 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 & 4.8 – updated to include the signal of toxic encephalopathy in patients with renal impairment.
Section 10 – The last revision date is updated.
Note: minor editorial change in section 4.4 & 4.8 ‘Clostridioides difficile’, and align to the latest QRD Template.
Updated on 03 March 2021
File name
QRD-IE-MT-INVANZ-LFT-IAIN-XXX-FAREVA-CRT-Feb2021-V2 (002).pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Change in the name of the Manufacturer .
Updated on 18 January 2021
File name
QRD-IE-MT-INVANZ-LFT-II-0062-CRT-Dec2020 (002).pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 2 - excipient warnings
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
PIL change to section 2- update for sodium statement and pregnancy and breast-feeding wording; Change to section 4- a new rare adverse event at the site of injection.
Updated on 18 January 2021
File name
INVANZ-H-C-0389-II-0062-SPC-IE-en-CRT-Dec2020 (002).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 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
SPC section 4.4, update for sodium statement to align with revised EU guideline; section 4.8, a new post-marketing adverse reaction, hypersensitivity vasculitis.
Updated on 20 November 2019
File name
IE_MT_QRD_Invanz_ PIL_II060_CRT.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
- Change to further information section
Updated on 20 November 2019
File name
INVANZ-H-C-0389-II-060-SPC-IE-en-CRT-October 2019.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- 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
In section 4.8, a new post-marketing adverse reaction term, acute generalized exanthematous pustulosis, section 5.1 update with the breakpoints as published in the EUCAST
Updated on 18 June 2019
File name
INVANZ-H-C-0389-T-058-SPC-IE-en-CRT.pdf
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
Converted the SPC from word document to pdf file format
Updated on 18 September 2018
File name
IE_QRD_Invanz_ PIL_MA transfer Brexit_CRT (2).pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 05 June 2018
File name
INVANZ-H-C-0389-T-058-SPC-IE-en-CRT.docx
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- 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
Change to Section 7 –Marketing Authorisation Holder; Change to Section 10 - Date of revision of the text
Updated on 05 June 2018
File name
QRD - INVANZ PIL.IVZ.18.UK.6366.T-058 FT 25-May-18 clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 18 February 2016
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 18 February 2016
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
- 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
Change to Section 5.1 - Section 5.1 of the SPC has been updated to recategorize Bacteroides fragilis group from "commonly susceptible species" to "Species for which acquired resistance may be a problem”
Change to Section 10 - Date of revision of the text
Updated on 17 February 2016
File name
PIL_9216_715.pdf
Reasons for updating
- New PIL for new product
Updated on 17 February 2016
Reasons for updating
- Change to storage instructions
- Change to further information section
Updated on 17 December 2014
Reasons for updating
- Change to side-effects
Updated on 15 December 2014
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
4.8 - Undesirable effects- New side-effect: Addition of tooth staining.
6.5 - Nature and contents of container
Updated on 20 January 2014
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
4.8 Undesirable effects- new side-effect: depressed level of consciousness. There is also a new statement in section 4.8 of the SPC is to encourage reporting of suspected adverse reactions by healthcare professionals and patients/consumers:
Updated on 15 January 2014
Reasons for updating
- Change to side-effects
Updated on 07 August 2012
Reasons for updating
- Change to side-effects
Updated on 16 July 2012
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
Updated on 13 January 2012
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 4.3 - 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 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- 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 6.6 - Special precautions for disposal and other handling
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 September 2010
Reasons for updating
- Change to warnings or special precautions for use
Updated on 17 August 2010
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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
4.4 Special warnings and precautions for use
Before initiating therapy with ertapenem, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, other beta-lactams and other allergens (see section 4.3).
4.8 Undesirable effects
Post Marketing Experience:
Skin and subcutaneous tissue disorders: Drug Rash with Eosinophilia and Systemic Symptoms (DRESS syndrome)
Updated on 09 November 2009
Reasons for updating
- Change to warnings or special precautions for use
Updated on 02 November 2009
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
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
4.4 Special warnings and precautions for use
The concomitant use of ertapenem and valproic acid/sodium valproate is not recommended (see section 4.5).
4.5 Interaction with other medicinal products and other forms of interaction Decreases in valproic acid levels that may fall below the therapeutic range have been reported when valproic acid was co-administered with carbapenem agents. The lowered valproic acid levels can lead to inadequate seizure control; therefore, concomitant use of ertapenem and valproic acid/sodium valproate is not recommended and alternative antibacterial or anti-convulsant therapies should be considered.
Updated on 05 October 2009
Reasons for updating
- Change to side-effects
Updated on 30 September 2009
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
Updated on 19 March 2009
Reasons for updating
- Change to side-effects
Updated on 19 January 2009
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
The change relates to section 4.8 i.e. the addition of 'Altered mental status' under Psychiatric Disorders in Post Marketing Experience section.
Updated on 12 September 2007
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
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 August 2007
Reasons for updating
- Change to improve clarity and readability
Updated on 10 April 2007
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 30 January 2007
Reasons for updating
- Changes to therapeutic indications
Updated on 14 November 2006
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
Updated on 11 October 2006
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 4.3 - Contraindications
- 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 5.3 - Preclinical safety data
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
- Change to section 6.6 - Special precautions for disposal and other handling
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 February 2006
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 31 January 2006
Reasons for updating
- Change to, or new use for medicine
Updated on 28 September 2005
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 28 September 2005
Reasons for updating
- Change to, or new use for medicine
- Change to warnings or special precautions for use
- Change to side-effects
- Change to dosage and administration
Updated on 28 June 2005
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 16 November 2004
Reasons for updating
- New PIL for medicines.ie
Updated on 21 January 2004
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 19 June 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)