Folinic Acid (as Calcium Folinate) 7.5mg/mL Solution for Injection * Pharmacy Only: Prescription
Company:
Pfizer Healthcare IrelandStatus:
No Recent UpdateLegal 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 10 September 2021
File name
DEC202160619_Reg SPC gxFO 5_0 7.5mg-ml IE clean_1631276218.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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)
Free text change information supplied by the pharmaceutical company
|
The SPC has been updated as follows: Section 2 – update to excipient information. Section 4.4 update to excipient warning. Section 4.8 update to HPRA contact details |
Updated on 10 September 2021
File name
DEC202160619_Reg PIL gxFO 10_0 7.5mg-ml inj IE clean_1631268889.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 03 March 2021
File name
DEC202114575_Reg PIL gxFO 9_0 7.5mg-ml inj IE - clean_1614768671.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 29 January 2021
File name
DEC202106242_Reg SPC gxFO 4_1 7.5mg-ml IE - CLEAN_1611910682.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- 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 29 January 2021
File name
DEC202106242_Reg PIL gxFO 6_1 7.5mg-ml inj IE - CLEAN_1611910603.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 25 March 2020
File name
DEC202019081_Reg SPC gxFO 3_2 7.5mg-ml IE-clean_1585160839.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.1 - Therapeutic indications
- 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 - how to report a side effect
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.1 - List of excipients
- Change to section 6.3 - Shelf life
- Change to section 6.6 - Special precautions for disposal and other handling
- 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
The SPC has been updated and including QRD updates as follows:
Injections: sections 2, 4.1, 4.2 (added method of administration), 4.3, 4.4 (added monitoring patients and sodium excipient quanitities), 4.5 (added other antibiotics, methotrexate, fluoropyrimidine and chloramphenicol), 4.6 (added fertility), 4.8 (added blood disorders, neurological disorders and HPRA ADR reporting), 4.9, 5.1, 6.1 (added pH adjustors), 6.3, 6.6 (added diluents), 10.
Updated on 25 March 2020
File name
DEC202019081_Reg PIL gxFO 5_2 7.5mg-ml inj IE-clean_1585160697.pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - contraindications
- 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 2 - driving and using machines
- Change to section 2 - excipient warnings
- Change to section 3 - dose and frequency
- Change to section 3 - how to take/use
- Change to section 3 - overdose, missed or forgotten doses
- 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 - what the product looks like and pack contents
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Updated on 05 October 2018
File name
Reg PIL gxFO 4_0 7.5mg-ml inj IE - clean_1538732188.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 05 October 2018
File name
Reg SPC gxFO 2_0 7.5mg-ml IE - clean_1538732226.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 14 September 2018
File name
Reg PIL gxFO 3-0 7.5mg-ml inj IE - clean_1536923209.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 21 August 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 17 August 2017
File name
PIL_17262_370.pdf
Reasons for updating
- New PIL for new product