Depo-Medrone 40 mg/ml 1ml vial
*Company:
Pfizer Healthcare Ireland Unlimited CompanyStatus:
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 24 October 2024
File name
c Reg HCP leaflet DM 22_1 PIL DM 27_0 IE - Copy.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Free text change information supplied by the pharmaceutical company
The PIL has been updated to reflect the SPC changes
Updated on 24 October 2024
File name
c Reg SPC DM 26_0 1ml IE - Copy.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:
Thyrotoxic Periodic Paralysis warning in section 4.4
Updated on 24 October 2024
File name
c Reg SPC DM 26_0 1ml IE - Copy.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:
Thyrotoxic Periodic Paralysis warning in section 4.4
Updated on 21 October 2024
File name
c Reg SPC DM 26_0 1ml IE - Copy.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 Change of MAH name and address.
Updated on 21 October 2024
File name
c Reg SPC DM 26_0 1ml IE - Copy.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
- Change to MA holder contact details
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 18 October 2024
File name
c Reg HCP leaflet DM 22_1 PIL DM 27_0 IE - Copy.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
- Change to MA holder contact details
Updated on 16 July 2024
File name
Clean Reg SPC DM 25_0 1ml IE - Copy.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:
Update section 4.8 to add (Flushing and injection pain flare)
Updated on 16 July 2024
File name
clean Reg HCP leaflet DM 22_1 PIL DM 26_0 IE - Copy.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 26 September 2023
File name
CleanRegSPC DM 241 1ml IE.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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:
Updated section 4.4 (TLS warning) AND 4.8 following CDS update.
Updated on 26 September 2023
File name
CleanRegHCPleafletDM221 PIL DM 252 IE1.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 13 February 2023
File name
DEC202109158_Reg SPC DM 23_1 1ml IE clean.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 12 February 2021
File name
DEC202109158_Reg HCP leaflet DM 22_1 PIL DM 24_1 IE clean.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 6 - date of revision
- Change to information for healthcare professionals
- Correction of spelling/typing errors
Updated on 11 February 2021
File name
DEC202109158_Reg SPC DM 23_1 1ml IE clean.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 10 December 2020
File name
DEC202082814_Reg SPC DM 22_1 1ml IE clean.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)
Updated on 10 December 2020
File name
DEC202082814_Reg HCP leaflet DM 21_1 PIL DM 23_1 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 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 21 November 2019
File name
DEC201964950_Reg HCP leaflet DM 21_1 PIL DM 22_2 IE clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 21 November 2019
File name
DEC201964950_Reg SPC DM 21_2 1ml 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 5.3 - Preclinical safety data
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 more information about peritonitis; s
ection 4.6 to add information on low birth weight, relationship to dose and impairment of fertility;
section 4.8 to add peritonitis and anaphylactoid reaction as well as PT updates;
5.3 to add information concerning impairment of fertility, carcinogenesis, mutagenesis, embryo-foetal lethality, and details from animal studies.
Updated on 14 May 2019
File name
DEC201925046_Reg HCP leaflet DM 20_1 PIL DM 21_1 IE clean.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 27 November 2018
File name
Reg SPC DM 20_1 1ml IE.pdf
Reasons for updating
- Improved presentation of SPC
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Improved presentation of SPC uploaded
Updated on 28 August 2018
File name
Reg_SPC_DM_20_1_1ml_IE_cl.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 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- 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 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
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:
IE DM 025 - CDS revised to align with the information across the corticosteroid CDSs, and to fulfil PSUR commitment (to update the SPC with reference to Kaposi’s Sarcoma and to reformat section 4.8 of the SPCs.)
IE DM 029 - CDS revised to align with the information across the corticosteroid CDSs.
IE DM 031 - CDS was revised to include a warning for Pheochromocytoma.
IE DM 033 - CDS was updated to include warnings for benzyl alcohol.
IE DM 036 – CDS was updated to add statement re discouraging use of high doses of corticosteroids to treat traumatic brain injury.
IE DM 037 – CDS was updated to add warning concerning thrombosis including venous thromboembolism and to add thrombosis and pulmonary embolism as new ADRs.
IE DM 042 – SPC was updated in line with PRAC updates: methylprednisolone PSUSA-00002026-201411
IE DM 048 - CDS was updated to add a cautionary statement about use in patients with systemic sclerosis because an increased incidence of scleroderma renal crisis has been observed with corticosteroids, including methylprednisolone.
IE DM 049 - SPC was updated in line with PRAC updates: methylprednisolone PSUSA-00000449-201604
Updated on 11 July 2018
File name
Reg_SPC_DM_20_1_1ml_IE_cl.docx
Reasons for updating
- 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 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- 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 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
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:
IE DM 025 - CDS revised to align with the information across the corticosteroid CDSs, and to fulfil PSUR commitment (to update the SPC with reference to Kaposi’s Sarcoma and to reformat section 4.8 of the SPCs.)
IE DM 029 - CDS revised to align with the information across the corticosteroid CDSs.
IE DM 031 - CDS was revised to include a warning for Pheochromocytoma.
IE DM 033 - CDS was updated to include warnings for benzyl alcohol.
IE DM 036 – CDS was updated to add statement re discouraging use of high doses of corticosteroids to treat traumatic brain injury.
IE DM 037 – CDS was updated to add warning concerning thrombosis including venous thromboembolism and to add thrombosis and pulmonary embolism as new ADRs.
IE DM 042 – SPC was updated in line with PRAC updates: methylprednisolone PSUSA-00002026-201411
IE DM 048 - CDS was updated to add a cautionary statement about use in patients with systemic sclerosis because an increased incidence of scleroderma renal crisis has been observed with corticosteroids, including methylprednisolone.
IE DM 049 - SPC was updated in line with PRAC updates: methylprednisolone PSUSA-00000449-201604
Updated on 11 July 2018
File name
Reg HCP leaflet DM 20_1 PIL DM 20_1 IE cl.pdf
Reasons for updating
- 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 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
- Change to information for healthcare professionals
- Correction of spelling/typing errors
Updated on 06 April 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 06 April 2017
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
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 SmPC s4.4 warning of increased risk of systemic side effects when co-administered with CYP3A inhibitors, including cobicistat. SmPC s4.5 interaction when corticosteroids (including methylprednisolone acetate) are co-administered with CYP3A inhibitors, including cobicistat. |
Updated on 05 April 2017
File name
PIL_10820_294.pdf
Reasons for updating
- New PIL for new product
Updated on 05 April 2017
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Updated on 04 April 2017
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Updated on 16 April 2012
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - MA number
- 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
Updated on 13 April 2012
Reasons for updating
- Change of licence holder
- Change to date of revision
- Change to marketing authorisation holder
Updated on 17 October 2011
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
Updated on 13 October 2011
Reasons for updating
- Change to marketing authorisation holder
Updated on 15 June 2011
Reasons for updating
- Change due to user-testing of patient information
Updated on 26 July 2010
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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
Section 4.4
Warning added concerning potentially severe psychiatric adverse reactions may occur with systemic steroids, normally within a few days or weeks of starting treatment.
Section 4.8
Inclusion of psychiatric reactions including irritability, depression, psychological dependence and suicidal thoughts.
Updated on 23 July 2010
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
Updated on 07 February 2007
Reasons for updating
- Change from the BAN of the active substance to the rINN
Updated on 26 April 2006
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- 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 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
- 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)
Updated on 26 April 2006
Reasons for updating
- New PIL for medicines.ie
Updated on 08 July 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)