Depo-Medrone 40mg/ml with Lidocaine 10mg/ml Suspension for Injection, 2ml Vial
- Name:
Depo-Medrone 40mg/ml with Lidocaine 10mg/ml Suspension for Injection, 2ml 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: 16/01/20
(Click to Download)Click on this link to Download PDF directly
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 16 January 2020 PIL
Reasons for updating
- Change to section 4 - possible side effects
Updated on 16 January 2020 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
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- 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 following changes to the labelling have been approved. Please refer to attached copy/copies of labelling documentation for full details.
|
The SPC has been updated as follows: Sections 4.4 to add information about peritonitis; section 4.6 to add information on low birth weight, relationship to dose and impairment of fertility; 4.5 to remove a cautionary statement about the use of aspirin and corticosteroids in patients with hypoprothrombinemia; 4.8 to add peritonitis and anaphylactoid reaction as well as PT updates; 5.2 to add PK information pertaining to lidocaine; and 5.3 to add information concerning impairment of fertility, carcinogenesis, mutagenesis, embryo-foetal lethality, and details from animal studies. Changes in line with CDS. |
Updated on 10 April 2019 PIL
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 26 September 2018 SPC
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 4.9 - 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 DML 027 - CDS revised to align with the information across the corticosteroid CDSs
IE DML 029 - CDS revised to include a warning for Epidural lipomatosis & Central serous chorioretinopathy. Updates also regarding use of intrathecal/epidural routes of administration and to align with the information across the corticosteroid CDSs.
IE DML 031 - CDS was revised to include a warning for Pheochromocytoma.
IE DML 034 - CDS was updated to include warnings for benzyl alcohol and to separate information for methylprednisolone acetate and lidocaine throughout SPC
IE DML 037 – CDS was updated to add statement re discouraging use of high doses of corticosteroids to treat traumatic brain injury and impairment of fertility. Also to add information re pharmacokinetic properties and pre-clinical safety data.
IE DM 042 – CDS was updated to add warning concerning thrombosis including venous thromboembolism and to add thrombosis and pulmonary embolism as new ADRs. Also to remove the term ‘high doses’ from the statement regarding treatment of traumatic brain injury.
IE DM 047 – SPC was updated in line with PRAC updates: methylprednisolone PSUSA-00002026-201411. Update was included in IE DML 034 and 037 updates.
IE DML 053 - SPC was updated in line with PRAC updates: methylprednisolone PSUSA-00000449-201604
Updated on 29 August 2018 SPC
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 4.9 - 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 9 August 2018 PIL
Reasons for updating
- Change to Section 1 - what the product is
- 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 3 - dose and frequency
- Change to section 3 - duration of treatment
- 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 looks like and pack contents
- Change to section 6 - date of revision
Updated on 9 August 2018 SPC
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
|
VAR II CDS update (s4.2, 4.3, 4.4, 5.4, 4.6, 4.7, 4.8, 4.9, 5.1, 5.2, 5.3); 2012-0001342
VAR II CDS update (s4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 5.2, 5.3); 2013-001977, 2013-0002862
VAR II CDS update (s4.4); 2013-0003195
VAR II CDS update (s4.2, 4.4, 4.6, 4.8, 4.9, 5.1, 5.2); 3013-0004235
VAR II CDS update (s4.4, 4.6, 5.2, 5.3); 2014-0005478, 2014-0005532, 2014-0005135
VAR II CDS update (s4.4, 4.8); 2014-0007607, 2014-0007608
VAR IB PRAC update (s4.4, 4.8); 2015-0013452
VAR II CDS update (s4.4, 4.8); 2018-0036511 |
Updated on 6 June 2018 SPC
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
Change to section 4.4 - Special warnings and precautions for use
Updated on 30 April 2018 SPC
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:
s4.4 Special warnings and precautions for use
Addition of a cautionary statement about use in patients with systemic sclerosis as increased incidence of scleroderma renal crisis observed with corticosteroids, including methylprednisolone
Updated on 26 April 2018 PIL
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - date of revision
- Change to information for healthcare professionals
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 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 16 October 2012 PIL
Reasons for updating
- Change of licence holder
- Change to date of revision
- Change to marketing authorisation holder
Updated on 18 October 2011 PIL
Reasons for updating
- Change to marketing authorisation holder
Updated on 10 August 2011 PIL
Reasons for updating
- Change to date of revision
- Correction of spelling/typing errors
Updated on 15 June 2011 PIL
Reasons for updating
- Change due to user-testing of patient information
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 July 2006 PIL
Reasons for updating
- New PIL for medicines.ie