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Rapamune 1 mg/ml oral solution

*
Pharmacy Only: Prescription

  • Company:

    Pfizer Healthcare Ireland

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    Sirolimus

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

Updated on 25 July 2022

File name

AdvSPCRA170tabletsoralsolIEclean.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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 25 July 2022

File name

AdvPILRA180oralsolIENIclean.pdf

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision

Updated on 23 February 2022

File name

Adv PIL RA 17_0 oral sol IE NI clean.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to other sources of information section
  • Individual PILs superseded by joint PIL

Updated on 16 November 2021

File name

Adv SPC RA 16_0 tablets & oral sol IE clean.pdf

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

The SPC has been updated as follows: update of section 6.3 shelf life of Rapamune coated tablets 0.5 mg from 2 to 3 years.

Updated on 16 November 2021

File name

Adv PIL RA 16_0 oral sol IE clean.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision
  • Improved presentation of PIL

Updated on 20 July 2021

File name

DEC202149057_Adv SPC RA 15_0 tablets & oral sol IE clean.pdf

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)

Updated on 20 July 2021

File name

DEC202149057_Adv PIL RA 15_0 oral sol IE clean.pdf

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision

Updated on 18 February 2021

File name

DEC202110953_Adv PIL RA 14_0 oral sol IE clean.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 19 November 2020

File name

Adv SPC RA 14_0 tablets oral sol IE clean.pdf

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)

Updated on 19 November 2020

File name

Adv PIL RA 13_0 oral sol IE clean.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to MA holder contact details

Updated on 21 June 2019

File name

DEC201932722_Adv PIL RA 12_0 Oral Sol UK IE_clean.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Updated on 21 June 2019

File name

DEC201932722_Adv SPC RA 13_0 tablet and Oral Sol UK IE_clean.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 6.2 - Incompatibilities

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

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows: Correction of the amount of ethanol for the oral solution and update to the ammonium hydroxide information in Sections 2 and 6.2, repositioning of the sentence in Section 4.2 that treatment should be initiated by and remain under the guidance of an appropriately qualified specialist in transplantation, and minor correction regarding the excipient concentrated ammonium solution in section 6.2

Updated on 16 January 2019

File name

Adv PIL RA 11_0 Oral Sol UK IE clean.pdf

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 6 - date of revision

Updated on 23 October 2018

File name

Adv PIL RA 10_0 oral UK_IE-clean.pdf

Reasons for updating

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

Updated on 22 October 2018

File name

Adv SPC RA 12_0 tablet & oral sol UK_IE-clean.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows.

SPC section 7: Marketing authorisation holder change to Pfizer EEIG.

Updated on 03 October 2018

File name

Adv PIL RA 9_0 oral UK_IE-clean.pdf

Reasons for updating

  • Change to section 6 - date of revision

Updated on 03 October 2018

File name

Adv SPC RA 11_0 tablet & oral sol UK_IE-clean.pdf

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

The SPC has been updated as follows:

Section 6.3 – Shelf life.

Updated on 14 August 2018

File name

Adv PIL RA 8_0 oral UK_IE-clean corrected.pdf

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 09 August 2018

File name

Adv SPC RA 10_0 tablet_oral sol UK_IE-clean.pdf

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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 4.8 – Undesirable effects - how to report a side effect
  • 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)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

Section

Section 4.1 Indication. – New indication for the treatment of patients with sporadic lymphangioleiomyomatosis with moderate lung disease or declining lung function

Section 2 Posology patients with sporadic lymphangioleiomyomatosis

Section 4.4 clarification on warnings relating to only renal transplant patients

Section 4.8 Clarification on undesirable effects observed with prophylaxis of organ rejection in renal transplantation

Section 4.8 Undesirable effects observed with patients with S-LAM

Section 5..1 and 5.2 Clinical data on treatment of sporadic lymphangioleiomyomatosis

Updated on 08 August 2018

File name

Adv PIL RA 8_0 oral UK_IE-clean.pdf

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 08 August 2018

File name

Adv SPC RA 10_0 tablet_oral sol UK_IE-clean.pdf

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 SPC has been updated as follows:

Section

Section 4.8 AE reporting details for UK.

Updated on 05 June 2018

File name

Adv_SPC_RA_9_0_oral_sol_UK_IE_clean.docx

Reasons for updating

  • New SPC for new product

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

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

Section 2, 3, 4.2, 4.4, 4.8, 5.2, 6.1, 6.2, 6.3, 6.4, 6.5, 6.6, and 8.

Updated on 27 March 2017

File name

PIL_10399_483.pdf

Reasons for updating

  • New PIL for new product

Updated on 27 March 2017

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision
  • Correction of spelling/typing errors

Updated on 23 October 2015

Reasons for updating

  • Change of inactive ingredient

Updated on 26 June 2015

Reasons for updating

  • Change to side-effects
  • Change to date of revision
  • Change to MA holder contact details

Updated on 05 August 2013

Reasons for updating

  • Change to marketing authorisation holder

Updated on 02 August 2013

Reasons for updating

  • Change to marketing authorisation holder

Updated on 21 January 2013

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change to storage instructions
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to information about driving or using machinery
  • Change to further information section
  • Change to date of revision
  • Change to MA holder contact details

Updated on 17 February 2012

Reasons for updating

  • Change of manufacturer

Updated on 04 August 2011

Reasons for updating

  • Change to marketing authorisation holder

Updated on 08 April 2011

Reasons for updating

  • Change to name of manufacturer

Updated on 01 February 2011

Reasons for updating

  • Change to MA holder contact details

Updated on 19 January 2011

Reasons for updating

  • Change of active ingredient
  • Change to packaging
  • Change of contraindications
  • Change to storage instructions
  • Change to dosage and administration

Updated on 11 August 2010

Reasons for updating

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

Updated on 08 February 2010

Reasons for updating

  • Change to side-effects
  • Change to MA holder contact details

Updated on 12 May 2008

Reasons for updating

  • Change to side-effects

Updated on 10 December 2007

Reasons for updating

  • Correction of spelling/typing errors
  • Change to side-effects
  • Change to dosage and administration
  • Change to information about pregnancy or lactation
  • Change to storage instructions
  • Change to date of revision

Updated on 04 September 2007

Reasons for updating

  • Change to side-effects

Updated on 13 August 2007

Reasons for updating

  • Change to side-effects
  • Change to further information section

Updated on 19 April 2007

Reasons for updating

  • Change to side-effects
  • Change to further information section

Updated on 21 September 2006

Reasons for updating

  • Change of manufacturer
  • Change to side-effects
  • Change to date of revision

Updated on 26 July 2006

Reasons for updating

  • Change of inactive ingredient
  • Change of manufacturer
  • Change to date of revision

Updated on 19 May 2006

Reasons for updating

  • Correction of spelling/typing errors

Updated on 29 March 2006

Reasons for updating

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

Updated on 13 February 2006

Reasons for updating

  • Change to side-effects

Updated on 02 February 2006

Reasons for updating

  • Change to side-effects

Updated on 04 November 2005

Reasons for updating

  • New PIL for medicines.ie