Diflucan 2mg/ml Solution for Infusion
*Company:
Pfizer Healthcare Ireland Unlimited CompanyStatus:
UpdatedLegal 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 15 October 2024
File name
Reg PIL DF 26_0 2mg-ml IV IE-clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 15 October 2024
File name
Reg SPC DF 40_0 2mg-ml IV (vials) 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)
Updated on 22 February 2024
File name
Reg SPC DF 39_0 2mgml IV vials IE clean.pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 22 February 2024
File name
Reg PIL DF 25_0 2mgml IV IE clean.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 6 - date of revision
Updated on 17 November 2022
File name
RegSPCDF3812mgmlIVvialsIEclean.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:
Section 4.5: all formulation
Addition of Abrocitinib and instruction to adjust dose if co-administered with fluconazole.
Updated on 17 November 2022
File name
RegPILDF2412mgmlIVIEclean.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 11 April 2022
File name
RegSPCDF3712mgmlIVvialsIEclean.pdf
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 06 April 2022
File name
RegSPCDF3712mgmlIVvialsIEclean.pdf
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
- 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)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows:
Section 4.4: Capsules only-
Updated Excipients- replace Lapp with total
Section 4.5: all formulation
Update HMG- CoA reductase inhibitors
Updated-ivacaftor
Spelling correction- Immunosuppressors
Addition of Lurasidone
Section 4.6: all formulation
Under Pregnancy
Added-Before becoming pregnant a washout period of approximately 1 week (corresponding to 5-6 half-lives) is recommended after a single-dose or discontinuation of a course of treatment (see section 5.2).
Section 6.6: POS only
Update to Reconstitution instructions
Updated on 06 April 2022
File name
RegPILDF2302mgmlIVIEclean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 3 - how to take/use
- Change to section 6 - date of revision
- Change to other sources of information section
- Change to information for healthcare professionals
Updated on 02 August 2021
File name
DEC202151340_Reg SPC DF 35_1 2mg-ml IV (vials) IE-clean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic 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 4.4: Drug reaction with eosinophilia and systemic symptoms (DRESS). Infections with Candida species other than C. albicans. Section 4.6-under pregnancy addition of data when pregnant women treated with a cumulative dose of ≤ 150 mg of fluconazole, administered in the first trimester. Section 4.8- Drug reaction with eosinophilia and systemic symptoms (DRESS). Section 5.1: Susceptibility in vitro updated. Superinfection with Candida species updated under subcategory Mechanisms of resistance. |
Updated on 02 August 2021
File name
DEC202151340_Reg PIL DF 21_2 2mg-ml IV IE-clean.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 4 - possible side effects
- Change to section 6 - date of revision
- Correction of spelling/typing errors
Updated on 01 February 2021
File name
DEC202106264_Reg SPC DF 34_1 2mg-ml IV (vials) IE-clean.pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic 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 5.1 Addition under subsection Susceptibility in vitro: C. krusei is intrinsically resistant to fluconazole. The wild-type population of C. glabrata is of intermediate susceptibility (I) to fluconazole. The MICs and epidemiological cut-off value (ECOFF) of fluconazole for C. guilliermondiishows a wide range of are higher than for C. albicans susceptibility while C. krusei is resistant to fluconazole. The recently emerging species C. auris tends to be relatively resistant to fluconazole. Addition under subsection Mechanisms of resistance: In usually susceptible species of Candida, the most commonly encountered mechanism of resistance development involves the target enzymes of the azoles, which are responsible for the biosynthesis of ergosterol. Resistance may be caused by mutation, increased production of an enzyme, drug efflux mechanisms, or the development of compensatory pathways. and The resistance mechanisms have not been completely elucidated in some intrinsically resistant (C. krusei) or emerging (C. auris) species of Candida. Addition under EUCAST Breakpoints European Committee on Antimicrobial Susceptibility Testing, Antifungal Agents, Breakpoint tables for interpretation of MICs, Version 10.0, valid from 2020-02-04). and Candida dubliniensis to the table under ‘Species-related breakpoints’ column and update to the footer of the table |
Updated on 10 December 2020
File name
DEC202082514_Reg SPC DF 33_1 2mg-ml IV (vials) IE-clean.pdf
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 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 10 December 2020
File name
DEC202082514_Reg PIL DF 20_1 2mg-ml IV IE-clean.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 4 - how to report a side effect
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 10 November 2020
File name
DEC202075209_Reg SPC DF 32_2 2mg-ml IV (vials) IE-clean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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 10 November 2020
File name
DEC202075209_Reg PIL DF 19_5 2mg-ml IV IE-clean.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 4 - how to report a side effect
- Change to section 6 - what the product contains
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
- Correction of spelling/typing errors
Updated on 14 May 2020
File name
DEC202031354_Reg PIL DF 17_3 2mgml IV 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 14 May 2020
File name
DEC202031354_Reg SPC DF 2mg-ml IV 29_2 (vials) IE-clean.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 October 2019
File name
DEC201953268_Reg PIL DF 15_0 2mgml IV IE-clean.pdf
Reasons for updating
- Change to other sources of information section
Free text change information supplied by the pharmaceutical company
| List of authorised countries changed. |
Updated on 11 October 2018
File name
Reg PIL DF 14_0 2mgml IV IE Clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 11 October 2018
File name
Reg SPC DF 2mg-ml IV 28_0 (vials) IE Clean.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 Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK to Pfizer Healthcare Ireland, 9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24, Ireland.
Section 8 has also been updated with the HPRA newly appointed Marketing Authorisation number.
Updated on 28 August 2018
File name
Reg_SPC_DF_2mg_ml_IV_27_1_(vials)_IE_clean.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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
SmPC: updated
Addition of Drug-Drug Interaction information between fluconazole and tofacitinib in section 4.5 of the Summary of Product Characteristics (SmPC) in line with the company's Core Data Sheet (CDS) following approval of the Marketing Authorisation Application for Xeljanz (tofacitinib) in Europe on 22nd March 2017. Also section 2 of SmPC has been updated to include a statement regarding prescription of most appropriate pharmaceutical form and strength according to age.
Updated on 18 May 2018
File name
Reg_SPC_DF_2mg_ml_IV_27_1_(vials)_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
SmPC: updated
Addition of Drug-Drug Interaction information between fluconazole and tofacitinib in section 4.5 of the Summary of Product Characteristics (SmPC) in line with the company's Core Data Sheet (CDS) following approval of the Marketing Authorisation Application for Xeljanz (tofacitinib) in Europe on 22nd March 2017. Also section 2 of SmPC has been updated to include a statement regarding prescription of most appropriate pharmaceutical form and strength according to age.
Updated on 18 May 2018
File name
Reg PIL DF 13_1 2mgml IV 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 04 December 2017
File name
PIL_8761_426.pdf
Reasons for updating
- New PIL for new product
Updated on 04 December 2017
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 07 November 2017
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 4 - possible side effects
Updated on 18 May 2017
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 4 - possible side effects
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
- Submitted in error
Updated on 03 March 2017
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 4 - possible side effects
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 05 November 2015
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to side-effects
- Change to drug interactions
- Change to date of revision
Updated on 27 October 2015
Reasons for updating
- Change to information about pregnancy or lactation
- Change to date of revision
Updated on 20 January 2015
Reasons for updating
- Change to drug interactions
- Change to information about pregnancy or lactation
- Change to date of revision
- Change to improve clarity and readability
Updated on 06 October 2014
Reasons for updating
- Change to date of revision
- Change to name of manufacturer
Updated on 03 June 2014
Reasons for updating
- Change to storage instructions
- Change to information about pregnancy or lactation
- Change to further information section
- Change to date of revision
Updated on 09 May 2014
Reasons for updating
- Introduction of new pack/pack size
Updated on 12 July 2012
Reasons for updating
- Change to packaging
- Change to storage instructions
- Change to date of revision
- Introduction of new pack/pack size
Updated on 08 May 2012
Reasons for updating
- Correction of spelling/typing errors
Updated on 28 March 2012
Reasons for updating
- Change of active ingredient
- Change of inactive ingredient
- Change to warnings or special precautions for use
- Change of contraindications
- Change to instructions about missed dose
- Change to instructions about overdose
- 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 how the medicine works
- Change to further information section
- Change to date of revision
- Change to appearance of the medicine
- Change to dosage and administration
- Changes to therapeutic indications
- Change of special precautions for disposal
- Change due to harmonisation of PIL
- Addition of joint PIL covering all presentations
Updated on 06 January 2012
Reasons for updating
- Change of trade or active ingredient name
- Change to warnings or special precautions for use
- Change of contraindications
- 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 how the medicine works
- Change to further information section
- Change to date of revision
- Change to dosage and administration
- Changes to therapeutic indications
- Change to product name
Updated on 24 May 2011
Reasons for updating
- Change to date of revision
- Correction of spelling/typing errors
Updated on 16 March 2011
Reasons for updating
- Change of contraindications
- Change to side-effects
- Change to drug interactions
- Change to information about driving or using machinery
- Change to date of revision
Updated on 14 February 2011
Reasons for updating
- Change to date of revision
- Change due to user-testing of patient information
Updated on 27 March 2008
Reasons for updating
- Change to warnings or special precautions for use
- Change to drug interactions
- Change to date of revision
Updated on 18 May 2007
Reasons for updating
- Change of inactive ingredient
- Change of special precautions for disposal
Updated on 16 August 2005
Reasons for updating
- Change of active ingredient
- Change to storage instructions
- Change to further information section
- Change to date of revision
Updated on 22 September 2004
Reasons for updating
- New PIL for medicines.ie