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INVANZ

*
Pharmacy Only: Prescription

  • Company:

    MSD Ireland (Human Health) Limited

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    Ertapenem

    *Additional information is available within the SPC or upon request to the company

Updated on 08 July 2024

File name

QRD-IE-MT-UKNI-INVANZ-LFT-Art61.3-0071-24062024.pdf

Reasons for updating

  • Change to section 6 - date of revision
  • Change to further information section

Free text change information supplied by the pharmaceutical company

Change to Local Representative email address.

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

Update to  4.8: Undesirable effects

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


Sections updated: Section 2; 4.1; 4.2; 4.3;4.4; 4.6; 4.8; 4.9; 5.1; 5.2; 5.3; 6.2; 6.3; 6.4; 6.6

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

Update section 4.8 - post marketing Psychiatric and nervous systems disorders.

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

Update section 5.1: Break point details

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

No significant changes-changes relate to re-phrasing or moving of text.

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

Update to Sections 4.4 and 4.8 following assessment of PSUR

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

Sections 2 and 4.4 amended to add information on the quantity of sodium.
 
Section 4.1 amended to include indication for prophylaxis of surgical site infection following elective colorectal surgery.
Sections 4.2, 4.4 and 4.8 amended as a result of the additional indication in Section 4.1.
 
Sections 4.3, 4.7, 5.3, 6.6 amended to new EMEA/QRD template.

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)