INVANZ

  • Name:

    INVANZ

  • Company:
    info
  • Active Ingredients:

    Ertapenem

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 20/11/19

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Summary of Product Characteristics last updated on medicines.ie: 20/11/2019

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MSD Ireland (Human Health) Limited

MSD Ireland (Human Health) Limited

Company Products

Medicine NameActive Ingredients
Medicine Name Adempas Film Coated Tablets Active Ingredients Riociguat
Medicine Name Arcoxia 30 60 90 120 film-coated tablets Active Ingredients Etoricoxib
Medicine Name Atozet 10mg/10mg, 10mg/20mg, 10mg/40mg and 10mg/80mg film-coated tablets Active Ingredients Atorvastatin calcium trihydrate, ezetimibe
Medicine Name Bridion Active Ingredients Sugammadex sodium
Medicine Name Cancidas 50mg Powder for concentrate for solution for infusion Active Ingredients caspofungin acetate
Medicine Name Cancidas 70mg Powder for concentrate for solution for infusion Active Ingredients caspofungin acetate
Medicine Name Cerazette 75 microgram film-coated tablet Active Ingredients Desogestrel
Medicine Name Cozaar 12.5mg, 50mg & 100mg Film-coated Tablets Active Ingredients Losartan potassium
Medicine Name Cozaar 2.5mg/ml Powder and Solvent for Oral Suspension Active Ingredients Losartan potassium
Medicine Name Cozaar COMP 50 mg/12.5 mg, 100 mg/12.5 mg, 100 mg/25 mg film-coated tablets Active Ingredients Hydrochlorothiazide, Losartan potassium
Medicine Name Cubicin 350mg Powder for Solution for injection or infusion Active Ingredients Daptomycin
Medicine Name Cubicin 500mg powder for solution for injection or infusion Active Ingredients Daptomycin
Medicine Name Delstrigo 100 mg/300 mg/245 mg film-coated tablets Active Ingredients Lamivudine, Tenofovir disoproxil fumarate, Doravirine
Medicine Name Diprosalic Scalp Application Active Ingredients Betamethasone dipropionate, Salicylic Acid
Medicine Name Elocon Cream Active Ingredients Mometasone Furoate
Medicine Name Elocon Ointment Active Ingredients Mometasone Furoate
Medicine Name Elocon Scalp Lotion Active Ingredients Mometasone Furoate
Medicine Name EMEND 125 mg hard capsules Active Ingredients Aprepitant
Medicine Name EMEND 80 mg hard capsules Active Ingredients Aprepitant
Medicine Name EMEND 80mg, 125mg hard Capsules Active Ingredients Aprepitant
Medicine Name Esmeron Active Ingredients Rocuronium Bromide
Medicine Name EZETROL 10 mg Tablets Active Ingredients ezetimibe
Medicine Name FOSAMAX Once Weekly 70 mg Tablets Active Ingredients Alendronate Sodium Trihydrate
Medicine Name FOSAVANCE Active Ingredients Alendronate Sodium Trihydrate, Colecalciferol (Vitamin D3)
Medicine Name GARDASIL Active Ingredients human papillomavirus vaccine
1 - 0 of 84 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 20 November 2019 PIL

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 SmPC

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 SmPC

Reasons for updating

  • Improved presentation of SmPC

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 PIL

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 5 June 2018 SmPC

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 5 June 2018 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 18 February 2016 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 18 February 2016 SmPC

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 PIL

Reasons for updating

  • New PIL for new product

Updated on 17 February 2016 PIL

Reasons for updating

  • Change to storage instructions
  • Change to further information section

Updated on 17 December 2014 PIL

Reasons for updating

  • Change to side-effects

Updated on 15 December 2014 SmPC

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 SmPC

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 PIL

Reasons for updating

  • Change to side-effects

Updated on 7 August 2012 PIL

Reasons for updating

  • Change to side-effects

Updated on 16 July 2012 SmPC

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 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 4.3 - 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 6 September 2010 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 17 August 2010 SmPC

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 9 November 2009 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 2 November 2009 SmPC

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 5 October 2009 PIL

Reasons for updating

  • Change to side-effects

Updated on 30 September 2009 SmPC

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 PIL

Reasons for updating

  • Change to side-effects

Updated on 19 January 2009 SmPC

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 SmPC

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 9 August 2007 PIL

Reasons for updating

  • Change to improve clarity and readability

Updated on 10 April 2007 SmPC

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 PIL

Reasons for updating

  • Changes to therapeutic indications

Updated on 14 November 2006 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

Update to Sections 4.4 and 4.8 following assessment of PSUR

Updated on 11 October 2006 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 4.3 - 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 6 February 2006 SmPC

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 PIL

Reasons for updating

  • Change to, or new use for medicine

Updated on 28 September 2005 SmPC

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 PIL

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 SmPC

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 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 21 January 2004 SmPC

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 SmPC

Reasons for updating

  • New SPC for medicines.ie

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