Depo-Medrone 40 mg/ml 1ml vial
- Name:
Depo-Medrone 40 mg/ml 1ml vial
- Company:
Pfizer Healthcare Ireland
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 21/11/19
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Pfizer Healthcare Ireland
Company Products
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 21 November 2019 PIL
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 21 November 2019
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
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 PIL
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 27 November 2018
Reasons for updating
- Improved presentation of SmPC
Free text change information supplied by the pharmaceutical company
Improved presentation of SPC uploaded
Updated on 28 August 2018
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
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
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 PIL
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 6 April 2017 SPC
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 6 April 2017
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 5 April 2017 PIL
Reasons for updating
- New PIL for new product
Updated on 5 April 2017 PIL
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 4 April 2017 PIL
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 SPC
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 PIL
Reasons for updating
- Change of licence holder
- Change to date of revision
- Change to marketing authorisation holder
Updated on 17 October 2011 SPC
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 PIL
Reasons for updating
- Change to marketing authorisation holder
Updated on 15 June 2011 PIL
Reasons for updating
- Change due to user-testing of patient information
Updated on 26 July 2010 SPC
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 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
Updated on 7 February 2007 PIL
Reasons for updating
- Change from the BAN of the active substance to the rINN
Updated on 26 April 2006 SPC
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 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 8 July 2003 SPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may not be renewed (A)