Trazimera - 150mg & 420mg powder for solution for infusion *
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):

    This medicinal product is subject to additional monitoring.

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

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 30 November 2021

File name

Adv SPC bTR 9_0 IE clean_1638273545.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.6 - Pregnancy and lactation
  • 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 30 November 2021

File name

Adv PIL bTR 12_0 IE & NI clean_1638273390.pdf

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
  • Change to information for healthcare professionals

Updated on 11 October 2021

File name

Adv PIL bTR 11_0 IE & NI clean_1633967646.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
  • Joint PIL superseded by individual PILs
  • Change of distributor details

Updated on 15 April 2021

File name

DEC202122959_Adv SPC bTR 8_0 IE clean_1618475212.pdf

Reasons for updating

  • 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 15 April 2021

File name

DEC202122959_Adv PIL bTR 10_0 IE clean_1618475168.pdf

Reasons for updating

  • Change to section 6 - date of revision
  • Change to information for healthcare professionals

Updated on 26 February 2021

File name

DEC202113099_Adv PIL bTR 9_0 IE clean_1614337326.pdf

Reasons for updating

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

Updated on 21 January 2021

File name

DEC202103518_Adv SPC bTR 7_0 IE_1611226571.pdf

Reasons for updating

  • Change to section 4.7 - Effects on ability to drive and use machines
  • 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 21 January 2021

File name

DEC202103518_Adv PIL bTR 8_0 IE_1611226353.pdf

Reasons for updating

  • Change to section 2 - driving and using machines
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
  • Change of distributor details

Updated on 21 January 2021

File name

DEC202103854_Adv PIL bTR 8_0 NI_1611226272.pdf

Reasons for updating

  • Change to section 2 - driving and using machines
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
  • Change of distributor details

Updated on 18 February 2020

File name

DEC202008059_Adv SPC bTR 6_0 UK & IE_1582012261.pdf

Reasons for updating

  • 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

The SPC has been updated as follows:

 

1. Update to section 6.3 shelf life:

addition of aseptic reconstitution and dilution activities.

Change from "24 hours at temperatures not exceeding 30°C." to "up to 30 days at 2°C – 8°C and 24 hours at temperatures not exceeding 30°C."

2. Update to section 6.4 to clarify storage conditions of unopened vial

3. Update to section 6.6 with additional aseptic preparation, handling and storage activities

Updated on 18 February 2020

File name

DEC202008059_Adv PIL bTR 7_0 IE_1582012201.pdf

Reasons for updating

  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision

Updated on 06 December 2019

File name

DEC201968577_Adv PIL bTR 6_0 IE_1575627283.pdf

Reasons for updating

  • Change to section 6 - date of revision

Updated on 08 August 2019

File name

DEC201938984_clean Adv PIL bTR 5_1 IE_1_1565168313.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 07 August 2019

File name

DEC201938984_clean Adv SPC bTR 5_1 UK & IE_1565168360.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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

Updated on 01 May 2019

File name

clean Adv PIL bTR 4_0 IE_1556706760.pdf

Reasons for updating

  • New PIL for new product

Updated on 01 May 2019

File name

clean Adv SPC bTR 4_0 UK & IE_1_1556706804.pdf

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

Product launched in Ireland on 01/05/2019