Methotrexate 1 g/10 ml Injection *
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):

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

Updated on 03 February 2022

File name

RegSPCIEgxME140Inj1g10mlclean_1643898734.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)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

Section 2 & 4.4 updated for the excipient sodium

Updated on 03 February 2022

File name

RegPILIEgxME170Inj1g10ml5g5mlclean_1643898593.pdf

Reasons for updating

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

Updated on 29 November 2021

File name

Reg SPC IE gxME 12_0 Inj 1g-10ml clean_1638202903.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

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 to section 4.4 to add the warning of progressive multifocal leukoencephalopathy (PML) in line with PRAC recommended text

Updated on 29 November 2021

File name

Reg PIL IE gxME 15_0 Inj 1g-10ml & 5g-5 ml clean_1638202372.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Updated on 01 March 2021

File name

DEC202113658_Reg PIL IE gxME 14_0 Inj 1g-10ml & 5g-5 ml-clean_1614602259.pdf

Reasons for updating

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

Updated on 28 September 2020

File name

Reg SPC IE gxME 11_1 Inj 1g-10ml-clean_1601284137.pdf

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)

Updated on 28 September 2020

File name

Reg PIL IE gxME 12_1 Inj 1g-10ml & 5g-5 ml-clean_1601284040.pdf

Reasons for updating

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

Updated on 20 December 2019

File name

DEC201972132_Reg SPC IE gxME 10_2 Inj 1g-10ml_clean_1576854669.pdf

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)

Updated on 20 December 2019

File name

DEC201972132_Reg PIL IE gxME 11_1 Inj 1g-10ml & 5g-5 ml_clean_1576854497.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 3 - dose and frequency
  • Change to section 6 - date of revision

Updated on 14 November 2019

File name

Reg SPC IE gxME 9_1 Inj 1g-10ml-c_1573741182.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)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

To update section 4.5 of the SmPC as per PRAC recommendations (EMEA/H/C/PSUSA/00002014/201810). To update the interaction of methotrexate with nitrous oxide

Updated on 14 November 2019

File name

Reg PIL IE gxME 10_1 Inj 1g-10ml 5g-5 ml-c_1573740584.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 6 - date of revision

Updated on 01 November 2018

File name

Reg PIL IE gxME 8_0 Inj 1g-10ml & 5g-5 ml_clean_1541060633.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects

Updated on 01 November 2018

File name

Reg SPC IE gxME 7_0 Inj 1g-10ml_clean_1541060722.pdf

Reasons for updating

  • 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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose

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

Free text change information supplied by the pharmaceutical company

Please update eMC / medicines.ie

The SPC has been updated as per the PRAC recommendations. The following sections have been updated: 4.2, 4.3, 4.4, 4.5, 4.6, 4.8 and 4.9

 

Updated on 01 October 2018

File name

Reg SPC IE gxME 6_1 Inj 1g-10ml_clean_1538391446.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)

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 7 has been updated from Current MAH to Pfizer Healthcare Ireland, 9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24, Ireland. Subsequently section 8 has also been updated with the HPRA newly appointed Marketing Authorisation number.

Updated on 28 September 2018

File name

Reg PIL IE gxME 7_0 Inj 1g-10ml 5g-5 ml_clean_1538141934.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 28 September 2018

File name

Reg SPC IE gxME 6_1 Inj 1g-10ml_clean_1538141384.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: Section 7 has been updated from Current MAH to Pfizer Healthcare Ireland, 9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24, Ireland. Subsequently section 8 has also been updated with the HPRA newly appointed Marketing Authorisation number.

Updated on 18 September 2018

File name

Reg PIL IE gxME 6_0 Inj 1g-10ml & 5g-5 ml_clean_1537170484.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 09 August 2018

File name

Reg SPC IE gxME 5_0 Inj 1g-10ml_clean_1533807094.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

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

Free text change information supplied by the pharmaceutical company

SPC impacted only.

Section 4.4 – updated to include reference to Thoracic pain

Updated on 14 May 2018

File name

Reg_SPC_IE_gxME_3_0_Inj_1g-10ml_clean.docx

Reasons for updating

  • New SPC for new product

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

Updated on 26 April 2018

File name

Reg PIL IE gxME 3_0 Inj 1g-10ml & 5g-5 ml_clean.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 24 April 2018

File name

Reg_SPC_IE_gxME_3_0_Inj_1g-10ml_clean.docx

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 and 4.8 updates with details of pulmonary alveolar haemorrhage

Section 10-  update date of revision of text to 04/2018 to reflect submission date and internal reference number updated.

Updated on 23 February 2018

Reasons for updating

  • New SPC for new product

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

Updated on 23 February 2018

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

Please update eMC / medicines.ie

Section 7 – Marketing Authorisation Holder – address updated.

Section 10 – Date of revision of text updated to 02/2018 and Reference number updated.

Updated on 21 February 2018

File name

PIL_17058_832.pdf

Reasons for updating

  • New PIL for new product

Updated on 21 February 2018

Reasons for updating

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

Updated on 25 January 2017

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 19 January 2017

Reasons for updating

  • New PIL for medicines.ie