Depo-Medrone 40mg/ml with Lidocaine 10mg/ml Suspension for Injection, 2ml Vial
*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 19 November 2024
File name
Clean Reg SPC DML 26_0 2ml IE .pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- 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 19 November 2024
File name
Clean Reg HCP leaflet DML 22_0 & PIL DML 28_0 IE .pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 17 October 2024
File name
Clean Reg HCP leaflet DML 22_0 & PIL DML 27_0 IE .pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - manufacturer
- Change to MA holder contact details
Updated on 17 October 2024
File name
Clean Reg SPC DML 25_0 2ml IE .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 16 July 2024
File name
Clean Reg SPC DML 24_0 2ml IE_.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 DML 22_0 & PIL DML 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 October 2023
File name
CleanRegHCPleafletDML220PILDML251IECopy.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 6 - what the product looks like and pack contents
Updated on 14 July 2023
File name
Clean Reg SPC DML 23_0 2ml IE Copy.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 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 14 July 2023
File name
Clean Reg HCP leaflet DML 22_0 PIL DML 24_0 IE.pdf
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 2 - driving and using machines
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 4 - possible side effects
- Change to information for healthcare professionals
Updated on 20 March 2023
File name
Clean Reg SPC DML 22_1 2ml IE.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 20 March 2023
File name
Clean Reg SPC DML 22_1 2ml IE.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 20 March 2023
File name
Clean Reg HCP leaflet DML 21_1 PIL DML 23_1 IE.pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 1 - what the product is used for
Updated on 13 February 2023
File name
Reg SPC DML 19_2 2ml IE clean.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 01 December 2021
File name
Reg HCP leaflet DML 18_1 & PIL DML 20_2 IE clean.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- 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 - date of revision
- Improved presentation of PIL
Updated on 01 December 2021
File name
Reg SPC DML 19_2 2ml IE clean.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 4.6 - Pregnancy and lactation
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 6.1 - List of excipients
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: Sections 2, 4.4, 4.6 and 6.1 with information regarding the excipients benzyl alcohol and sodium, and update of ADR reporting contacts in section 4.8.
Updated on 12 February 2021
File name
DEC202002474_Reg HCP leaflet DML 18_1 & PIL DML 19_2 IE clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 11 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 16 January 2020
File name
DEC202002474_Reg HCP leaflet DML 18_1 & PIL DML 19_2 IE clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 16 January 2020
File name
DEC202002474_Reg SPC DML 18_3 2ml IE clean.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 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.
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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
File name
DEC201918654_Reg HCP leaflet DML 17_1 & PIL DML 18_1 IE clean.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 26 September 2018
File name
Reg SPC DML 17_1 2ml 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 4.9 - 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
File name
Reg SPC DM 20_1 2ml 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 4.9 - 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 09 August 2018
File name
Reg HCP leaflet DML 17_1 PIL DML 17_1 IE cl.pdf
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 09 August 2018
File name
Reg SPC DML 17_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
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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 06 June 2018
File name
Red_SPC_DML_2ml_15_1_IE_clean.docx
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
File name
Red_SPC_DML_2ml_15_1_IE_clean.docx
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
File name
Reg HCP leaflet DML 15_1 & PIL DML 15_1 IE clean.pdf
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 05 April 2017
File name
PIL_11140_874.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
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 16 October 2012
Reasons for updating
- Change of licence holder
- Change to date of revision
- Change to marketing authorisation holder
Updated on 18 October 2011
Reasons for updating
- Change to marketing authorisation holder
Updated on 10 August 2011
Reasons for updating
- Change to date of revision
- Correction of spelling/typing errors
Updated on 15 June 2011
Reasons for updating
- Change due to user-testing of patient information
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 July 2006
Reasons for updating
- New PIL for medicines.ie