Solu-Medrone 40mg

  • Name:

    Solu-Medrone 40mg

  • Company:
    info
  • Active Ingredients:

    Methylprednisolone sodium succinate

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 12/12/19

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Summary of Product Characteristics last updated on medicines.ie: 28/11/2018

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Pfizer Healthcare Ireland

Pfizer Healthcare Ireland

Company Products

Medicine NameActive Ingredients
Medicine Name Accupro 10 mg Film - Coated tablets Active Ingredients Quinapril hydrochloride
Medicine Name Accupro 20 mg Film - Coated tablets Active Ingredients Quinapril hydrochloride
Medicine Name Accupro 40 mg Film - Coated tablets Active Ingredients Quinapril hydrochloride
Medicine Name Accupro 5 mg Film - Coated tablets Active Ingredients Quinapril hydrochloride
Medicine Name Accuretic 20 mg/12.5 mg Tablets Active Ingredients Hydrochlorothiazide, Quinapril hydrochloride
Medicine Name Aciclovir 25 mg/ml Concentrate for Solution for Infusion. Active Ingredients Aciclovir sodium
Medicine Name Aldactone 100mg film coated tablets Active Ingredients Spironolactone
Medicine Name Aldactone 25mg film-coated tablets Active Ingredients Spironolactone
Medicine Name Aldactone 50 mg Film-coated tablets. Active Ingredients Spironolactone
Medicine Name Amlodipine Pfizer 10 mg Tablets Active Ingredients Amlodipine besilate
Medicine Name Amlodipine Pfizer 5 mg Tablets Active Ingredients Amlodipine besilate
Medicine Name Anugesic HC Cream Active Ingredients Balsam Peru, Benzyl Benzoate, Bismuth Oxide, Hydrocortisone Acetate, Pramocaine Hydrochloride, Zinc Oxide
Medicine Name ARICEPT 10 mg film coated tablets Active Ingredients Donepezil Hydrochloride
Medicine Name ARICEPT 5 mg film coated tablets Active Ingredients Donepezil Hydrochloride
Medicine Name Aromasin 25 mg coated tablets Active Ingredients Exemestane
Medicine Name Arthrotec 50 Active Ingredients Diclofenac Sodium, Misoprostol
Medicine Name Arthrotec 75 modified-release tablets Active Ingredients Diclofenac Sodium, Misoprostol
Medicine Name Ativan 1mg Tablets Active Ingredients Lorazepam
Medicine Name ATIVAN INJECTION Active Ingredients Lorazepam
Medicine Name BeneFIX Active Ingredients nonacog alfa
Medicine Name BESPONSA 1 mg powder for concentrate for solution for infusion Active Ingredients Inotuzumab ozogamicin
Medicine Name Bosulif 100 mg, 400 mg & 500 mg film-coated tablets Active Ingredients Bosutinib monohydrate
Medicine Name Cabaser 1mg Tablet Active Ingredients Cabergoline
Medicine Name Cabaser 2mg Tablet Active Ingredients Cabergoline
Medicine Name CAMPTO 20 mg/ml, concentrate for solution for infusion Active Ingredients Irinotecan hydrochloride trihydrate
1 - 0 of 227 items.Total: Infinity pages

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 12 December 2019 PIL

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 28 November 2018 SmPC

Reasons for updating

  • Improved presentation of SmPC

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 SmPC

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:

Sections 4.4 and 4.8 updated to include “blurred vision” warnings

Updated on 30 May 2018 SmPC

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:

Sections 4.4 and 4.8 updated to include “blurred vision” warnings

Updated on 21 May 2018 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Updated on 2 May 2018 SmPC

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:

In section 4.4 detail of scleroderma has been added to the section on Renal and urinary disorders

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

Updated on 13 March 2018 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 13 March 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 13 March 2018 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 6.1 - List of excipients
  • Change to section 6.3 - Shelf life

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: reference to benzyl alcohol removed
4.2: the solvent is identified as water for injection. Following reconstitution the solution should now be used immediately. Information on the new formulation has been added.
6.1 reference to benzyl alcohol removed
6.3 Following reconstitution the solution should now be used immediately

Updated on 13 March 2018 PIL

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 6.1 - List of excipients
  • Change to section 6.3 - Shelf life

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:
Sections
2: reference to benzyl alcohol removed
4.2: the solvent is identified as water for injection. Following reconstitution the solution should now be used immediately. Information on the new formulation has been added.
6.1 reference to benzyl alcohol removed
6.3 Following reconstitution the solution should now be used immediately

Updated on 28 November 2017 PIL

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

4.3 Contraindications – the warning concerning cow’s milk allergy has been strengthened

4.4 Special Warnings – Specific discussion of allergy to bovine derived lactose has been added

Updated on 28 November 2017 SmPC

Reasons for updating

  • Change to section 4.3 - Contraindications
  • 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:

4.3 Contraindications – the warning concerning cow’s milk allergy has been strengthened

4.4 Special Warnings – Specific discussion of allergy to bovine derived lactose has been added

Updated on 28 March 2017 SmPC

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

Updates to sections 4.4 and 4.5 of the Summary of Product Characteristics (SmPC)

arising from PRAC recommendation 10 November 2016 EMA/PRAC/700146/2016. The updates concern increased risk of systemic side effects when corticosteroids are co-administered with CYP3A inhibitors, including cobicistat containing products.

Updated on 28 March 2017 PIL

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

Free text change information supplied by the pharmaceutical company

Updates to sections 4.4 and 4.5 of the Summary of Product Characteristics (SmPC)

arising from PRAC recommendation 10 November 2016 EMA/PRAC/700146/2016. The updates concern increased risk of systemic side effects when corticosteroids are co-administered with CYP3A inhibitors, including cobicistat containing products.

Updated on 19 January 2017 SmPC

Reasons for updating

  • Change to section 4.3 - Contraindications

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: 4.3 Contradictions
•           for use by the epidural route of administration.>

Updated on 19 January 2017 PIL

Reasons for updating

  • Change to section 4.3 - Contraindications

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows: 4.3 Contradictions
•           for use by the epidural route of administration.>

Updated on 2 December 2016 SmPC

Reasons for updating

  • Change to section 4.3 - Contraindications

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: 4.3 Contradictions
•           for use by the epidural route of administration.>

Updated on 2 December 2016 PIL

Reasons for updating

  • Change to section 4.3 - Contraindications

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows: 4.3 Contradictions
•           for use by the epidural route of administration.>

Updated on 20 September 2016 PIL

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 4.6 - 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

Free text change information supplied by the pharmaceutical company

Updates to sections 4.3, (40mg only), 4.4, 4.6, 4.8, 5.2 & 5.3 following CDS update.

Updates to section 4.2 to correct Act-o-Vial usage instructions.

Updated on 20 September 2016 SmPC

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 4.6 - 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

Updates to sections 4.3, (40mg only), 4.4, 4.6, 4.8, 5.2 & 5.3 following CDS update.

Updates to section 4.2 to correct Act-o-Vial usage instructions.

Updated on 11 February 2016 SmPC

Reasons for updating

  • 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:

Sections 4.4 and 4.8 have been updated in line with recommended PRAC wording.

Updated on 11 February 2016 PIL

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

Sections 4.4 and 4.8 have been updated in line with recommended PRAC wording.

Updated on 20 August 2015 PIL

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Free text change information supplied by the pharmaceutical company

Section 4.8 Undesirable effects

Updated with Thrombosis and Pulmonary embolism

Updated on 20 August 2015 SmPC

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

Section 4.8 Undesirable effects

Updated with Thrombosis and Pulmonary embolism

Updated on 4 June 2015 PIL

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

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

Section 4.2 Posology and method of administration

Updated with paediatric population and benzyl alcohol warning

Section 4.3 Contraindications

Removal of epidural contraindication

Section 4.4 Special warnings and precautions for use: 

Removal of warnings concerning corticosteroids and addition of warning for Pheochromocytoma crisis

Section 4.5 Interaction with other medicinal products and other forms of interaction

Interactions updated

Section 4.6 Fertility, pregnancy and lactation

Benzyl alcohol update

Section 4.7 Effects on ability to drive and use machines

Updated warning

Section 4.8 Undesirable effects:

Table updated

Section 4.9 Overdose:

Updated information

Section 5.1

Update to ATC code and therapeutic group

Section 5.2

Update to pharmacodynamics data

Section 5.3

Update to preclinical data

 

Updated on 4 June 2015 SmPC

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:

Section 4.2 Posology and method of administration

Updated with paediatric population and benzyl alcohol warning

Section 4.3 Contraindications

Removal of epidural contraindication

Section 4.4 Special warnings and precautions for use: 

Removal of warnings concerning corticosteroids and addition of warning for Pheochromocytoma crisis

Section 4.5 Interaction with other medicinal products and other forms of interaction

Interactions updated

Section 4.6 Fertility, pregnancy and lactation

Benzyl alcohol update

Section 4.7 Effects on ability to drive and use machines

Updated warning

Section 4.8 Undesirable effects:

Table updated

Section 4.9 Overdose:

Updated information

Section 5.1

Update to ATC code and therapeutic group

Section 5.2

Update to pharmacodynamics data

Section 5.3

Update to preclinical data

 

Updated on 26 May 2015 PIL

Reasons for updating

  • Improved electronic presentation

Free text change information supplied by the pharmaceutical company

change of version code

Updated on 26 May 2015 SmPC

Reasons for updating

  • Improved electronic presentation

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

change of version code

Updated on 19 May 2015 PIL

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

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

Section 4.2 Posology and method of administration

Updated with paediatric population and benzyl alcohol warning

Section 4.3 Contraindications

Removal of epidural contraindication

Section 4.4 Special warnings and precautions for use: 

Removal of warnings concerning corticosteroids and addition of warning for Pheochromocytoma crisis

Section 4.5 Interaction with other medicinal products and other forms of interaction

Interactions updated

Section 4.6 Fertility, pregnancy and lactation

Benzyl alcohol update

Section 4.7 Effects on ability to drive and use machines

Updated warning

Section 4.8 Undesirable effects:

Table updated

Section 4.9 Overdose:

 

Section 5.1

Update to ATC code and therapeutic group

Section 5.2

Update to pharmacodynamics data

Section 5.3

Update to preclinical data

Updated on 19 May 2015 SmPC

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:

Section 4.2 Posology and method of administration

Updated with paediatric population and benzyl alcohol warning

Section 4.3 Contraindications

Removal of epidural contraindication

Section 4.4 Special warnings and precautions for use: 

Removal of warnings concerning corticosteroids and addition of warning for Pheochromocytoma crisis

Section 4.5 Interaction with other medicinal products and other forms of interaction

Interactions updated

Section 4.6 Fertility, pregnancy and lactation

Benzyl alcohol update

Section 4.7 Effects on ability to drive and use machines

Updated warning

Section 4.8 Undesirable effects:

Table updated

Section 4.9 Overdose:

 

Section 5.1

Update to ATC code and therapeutic group

Section 5.2

Update to pharmacodynamics data

Section 5.3

Update to preclinical data

Updated on 8 January 2015 PIL

Reasons for updating

  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

Please note that the only differences are the version numbers and revision dates.

Updated on 8 January 2015 SmPC

Reasons for updating

  • 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

Please note that the only differences are the version numbers and revision dates.

Updated on 6 November 2014 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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

Addition of statement to section 4.4 regarding discouraging the use of high doses of corticosteroids to treat traumatic brain injury and correction in section 4.2 from Pneumocystis carinii to Pneumocystis jiroveci

Updated on 6 November 2014 PIL

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use

Free text change information supplied by the pharmaceutical company

Addition of statement to section 4.4 regarding discouraging the use of high doses of corticosteroids to treat traumatic brain injury and correction in section 4.2 from Pneumocystis carinii to Pneumocystis jiroveci

Updated on 30 July 2012 SmPC

Reasons for updating

  • 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

SPC Section 8 & 10

Updated on 30 July 2012 PIL

Reasons for updating

  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

SPC Section 8 & 10

Updated on 20 March 2012 SmPC

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

Update to Section 4.4 to update ophthalmic warning

Updated on 20 March 2012 PIL

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

Free text change information supplied by the pharmaceutical company

Update to Section 4.4 to update ophthalmic warning

Updated on 17 October 2011 SmPC

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

SmPC changes to sections 7 & 10

Updated on 17 October 2011 PIL

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

SmPC changes to sections 7 & 10

Updated on 1 July 2010 SmPC

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 1 July 2010 PIL

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

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 April 2009 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Reduction of shelf-life for Solu-Medrone 125 mg Act-o-vial to 2 years

Updated on 23 April 2009 PIL

Reasons for updating

  • Change to section 6.3 - Shelf life

Free text change information supplied by the pharmaceutical company

Reduction of shelf-life for Solu-Medrone 125 mg Act-o-vial to 2 years

Updated on 14 November 2007 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

6.3 Shelf life - Solu-MedroneÔ Powder and Solvent for solution for injection or concentrate for solution for infusion 40 mg / vial has been reduced to 2 years

Updated on 14 November 2007 PIL

Reasons for updating

  • Change to section 6.3 - Shelf life

Free text change information supplied by the pharmaceutical company

6.3 Shelf life - Solu-MedroneÔ Powder and Solvent for solution for injection or concentrate for solution for infusion 40 mg / vial has been reduced to 2 years

Updated on 8 December 2006 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.3 - Contraindications
  • 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 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.2 - Incompatibilities

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.2 Revision of the posology of the product
Section 4.4 adding warnings concerning Measles, cataracts, glaucoma, Kaposi’s sarcoma and a warning concerning use on people with head injuries
Section 4.8 Additional undesirable effects added.

Section 4.1, 4.3, 4.5, 4.6, 4.7, 5.1, 5.2, 6.2 formatting changes

Updated on 8 December 2006 PIL

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.3 - Contraindications
  • 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 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.2 - Incompatibilities

Free text change information supplied by the pharmaceutical company

Section 4.2 Revision of the posology of the product
Section 4.4 adding warnings concerning Measles, cataracts, glaucoma, Kaposi’s sarcoma and a warning concerning use on people with head injuries
Section 4.8 Additional undesirable effects added.

Section 4.1, 4.3, 4.5, 4.6, 4.7, 5.1, 5.2, 6.2 formatting changes

Updated on 26 July 2006 PIL

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 6.6 - Special precautions for disposal and other handling
  • Change to section 7 - Marketing authorisation holder
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

Section 1
Addition of Pharmaceutical form - Powder and Solvent for solution for injection or concentrate for solution for infusion - to trade name
 
Section 2
Addition of - The powder also contains sodium and the solvent contains benzyl alcohol.
 
Section 3
Addition of - Sterile lyophilised  powder and 1ml of the diluent presented in a upper compartment.
 
Section 4.4
Section heading updated as per new SPC guidelines
 
Section 4.5
Section heading updated as per new SPC guidelines
 
Section 6.3
Update to text (Shelf life not changed)
 
Section 6.6
Section heading updated as per new SPC guidelines
 
Section 7
Address of MAH updated to 9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24. 
 
Section 9
Date of last renewal updated to 28th January 2006
 
Section 10
Date of last revision updated
 
 
 
 

Updated on 26 July 2006 SmPC

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 6.6 - Special precautions for disposal and other handling
  • Change to section 7 - Marketing authorisation holder
  • Change to section 9 - Date of renewal of authorisation
  • 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

Section 1
Addition of Pharmaceutical form - Powder and Solvent for solution for injection or concentrate for solution for infusion - to trade name
 
Section 2
Addition of - The powder also contains sodium and the solvent contains benzyl alcohol.
 
Section 3
Addition of - Sterile lyophilised  powder and 1ml of the diluent presented in a upper compartment.
 
Section 4.4
Section heading updated as per new SPC guidelines
 
Section 4.5
Section heading updated as per new SPC guidelines
 
Section 6.3
Update to text (Shelf life not changed)
 
Section 6.6
Section heading updated as per new SPC guidelines
 
Section 7
Address of MAH updated to 9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24. 
 
Section 9
Date of last renewal updated to 28th January 2006
 
Section 10
Date of last revision updated
 
 
 
 

Updated on 7 July 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 7 July 2003 PIL

Reasons for updating

  • New SPC for medicines.ie