Suprane Inhalation vapour, solution

*
Pharmacy Only: Prescription
  • Company:

    Baxter Holding B.V.
  • Status:

    No Recent Update
  • Legal 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 02 August 2023

File name

Suprane BE-30-03-253_12AUG19_P01.pdf

Reasons for updating

  • New PIL for new product

Updated on 26 January 2023

File name

ie-spc-2019-05-suprane-clean.pdf

Reasons for updating

  • Document format updated

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

Updated on 28 May 2019

File name

ie-spc-2019-05-suprane-clean.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

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

Updated on 03 May 2018

File name

ie-2018-04-spc-suprane-c.docx

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text

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

Updated on 03 May 2017

Reasons for updating

  • New SPC for new product

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

Updated on 03 May 2017

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.3 - Contraindications
  • 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

4.1 – Removal of ‘recommended’

4.3 – changes to bullet points – add section 4.4 and change Section 4.4 to 4.1  - add text to final paragraph ‘See also Section 4.4 – Paediatric Inhalation Induction

4.4 – addition of text   QT Prolongation

QT prolongation, very rarely associated with torsade de pointes, has been reported (see section 4.8). Caution should be exercised when administering desflurane to susceptible patients.

4.8 – addition of Electrocardiogram QT prolonged in Adverse Reactions table in section Cardian Disorders

Updated on 03 May 2017

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Free text change information supplied by the pharmaceutical company

4.1 – Removal of ‘recommended’

4.3 – changes to bullet points – add section 4.4 and change Section 4.4 to 4.1  - add text to final paragraph ‘See also Section 4.4 – Paediatric Inhalation Induction

4.4 – addition of text   QT Prolongation

QT prolongation, very rarely associated with torsade de pointes, has been reported (see section 4.8). Caution should be exercised when administering desflurane to susceptible patients.

4.8 – addition of Electrocardiogram QT prolonged in Adverse Reactions table in section Cardian Disorders

Updated on 01 September 2016

Reasons for updating

  • New SPC for medicines.ie

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

Free text change information supplied by the pharmaceutical company

None provided

Updated on 01 September 2016

Reasons for updating

  • New SPC for medicines.ie

Free text change information supplied by the pharmaceutical company

None provided