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Lasix 20mg/2ml Solution for Injection or Infusion

*
Pharmacy Only: Prescription

  • Company:

    SANOFI

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    Furosemide

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

Updated on 03 March 2023

File name

1.2.2 Lasix Inj IE S21 617 Clean text sodium excipient PIL.pdf

Reasons for updating

  • Change to section 2 - excipient warnings

Updated on 03 March 2023

File name

1.3.1 SPC Lasix IE S21 617 sodium excipient clean.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 02 September 2021

File name

1.3.1.1 Lasix PIL Mock up 706951 v1.pdf

Reasons for updating

  • Change to section 3 - dose and frequency
  • Change to section 3 - use in children/adolescents
  • Change to section 3 - how to take/use
  • Change to section 3 - duration of treatment
  • Change to section 3 - overdose, missed or forgotten doses

Updated on 02 September 2021

File name

1.3.1 SPC Lasix IE S21 234 clean.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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 12 September 2018

File name

Lasix PIL CCDS V12 WSP 702140 V2.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 17 August 2018

File name

1.3.1 Lasix Injection SPC clean.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • 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

Section 4.8

Skin and subcutaneous tissue disorders

 

Uncommon: pruritus, urticaria, rashes, dermatitis bullous, erythema multiforme, pemphigoid, dermatitis exfoliative, purpura, photosensitivity reaction

Not known: Stevens-Johnson syndrome, toxic epidermal necrolysis, AGEP (acute generalized exanthematous pustulosis) and DRESS (Drug Rash with Eosinophilia and Systemic Symptoms).

Not Known: acute generalised exanthematous pustulosis (AGEP), lichenoid reactions

Updated on 28 July 2017

Reasons for updating

  • New SPC for new product

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

Updated on 28 July 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

correct attached SPC for Lasix Injection

Updated on 13 April 2017

File name

PIL_12306_649.pdf

Reasons for updating

  • New PIL for new product

Updated on 13 April 2017

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 15 December 2016

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 09 August 2016

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

General disorders and administration site conditions

 

Not known: following intramuscular injection, local reactions such as pain.

Rare: fever.

 

Musculoskeletal and connective tissue disorders

 

Not known: cases of rhabdomyolysis have been reported, often in the context of severe hypokalaemia (see section 4.3)

Updated on 25 February 2016

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-

Symptomatic hypotension leading to dizziness, fainting or loss of consciousness can occur in patients treated with furosemide, particularly in the elderly, patients on other medications which can cause hypotension and patients with other medical conditions that are risks for hypotension.



4.8
Uncommon- deafness (sometimes irreversible)

Updated on 11 February 2016

Reasons for updating

  • 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

Levothyroxine: High doses of furosemide may inhibit binding of thyroid hormones to carrier proteins and thereby lead to an initial transient increase in free thyroid hormones, followed by an overall decrease in total thyroid hormone levels. Thyroid hormone levels should be monitored.

Updated on 10 February 2016

Reasons for updating

  • Change to drug interactions
  • Change to date of revision

Updated on 04 November 2015

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- Special warnings and precautions

There is a possibility of exacerbation or activation of systemic lupus erythematosus. Therefore, caution should be taken when administring the drug to patients with a history of SLE.

Updated on 29 October 2015

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision

Updated on 18 October 2013

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

Type II.C.I.4 variation to update section 4.8 of the Summary of Product Characteristics in line with the Company Core Safety Data, version 7, for Furosemide, following a Global Labelling Review.

Updated on 17 October 2013

Reasons for updating

  • Change to side-effects

Updated on 14 August 2013

Reasons for updating

  • Change to marketing authorisation holder

Updated on 05 March 2013

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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

Bulk Type II variation to update sections 4.5 and 4.8 of the SPC in line with CCDS v6.

Updated on 01 March 2013

Reasons for updating

  • Change to side-effects
  • Change to drug interactions

Updated on 05 February 2013

Reasons for updating

  • Change to section 6.3 - Shelf life

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

Free text change information supplied by the pharmaceutical company

Type IB No. B.II.f.1.a variation to reduce the shelf life of the above product from 60 months to 36 months.

Updated on 03 January 2013

Reasons for updating

  • Improved electronic presentation

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

Free text change information supplied by the pharmaceutical company

Update for IE audit

Updated on 18 October 2012

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

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

Free text change information supplied by the pharmaceutical company

Type IB variation to update SPC sections 4.2 and 4.5 in line with CCSI version 5 and Type II variation to update SPC section 4.8 in line with CCSI version 6 (CRN: 2100177).

Updated on 23 March 2012

Reasons for updating

  • Addition of manufacturer

Updated on 14 May 2010

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

Addition of SJS & TEN to Section 4.8.

Updated on 24 September 2009

Reasons for updating

  • Change due to user-testing of patient information

Updated on 21 July 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

Update section 4.4 and 4.5 of SPC to include warning on concurrent use with risperidone.

Updated on 24 July 2008

Reasons for updating

  • Improved electronic presentation

Updated on 13 May 2008

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 17 August 2007

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

Update
Section 4.4 - statement on use in patients with partial obstruction of urinary output
Seciton 4.8 - additional undesirable effects and reformatting of section

Updated on 13 August 2007

Reasons for updating

  • New PIL for medicines.ie

Updated on 23 January 2007

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

Update Section 7 - MAH changed to sanofi-aventis Ireland Ltd.
Section 10 - Date of revision of text

Updated on 05 January 2007

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 3 - Pharmaceutical form
  • 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

Update Section-
1 - Change name to Lasix 20mg/2ml Solution for Injection or Infusion
3 - Description included.
8 - Renewal date.
10 - Date of revision

Updated on 05 July 2006

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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 - 
4.2 - addition of statement that lowest dose sufficient should be used to achieve desired effect.
4.5 - addition of statement regarding antihypertensive agents, diuretics or other drugs with blood pressure lowering potential, given with furosemide could cause fall in blood pressure.  Addition of statement regarding concomitant use with cyclosporin, ACE inhibitors, patients receiving radiocontrast.
 

Updated on 16 August 2005

Reasons for updating

  • Improved electronic presentation

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

Updated on 30 June 2003

Reasons for updating

  • Improved electronic presentation

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

Updated on 10 June 2003

Reasons for updating

  • New SPC for medicines.ie

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