Updated on 12/12/2011 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.2 - Posology and method of administration
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 01-Nov-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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In section 4.2. (Posology and method of administration) Addition of home infusion
In section 4.8. (Undesirable effects) addition of summary of safety profile
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Updated on 17/06/2011 and displayed until 12/12/2011
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Reasons for adding or updating:
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 08-Jun-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Changes to section 5.1 Pharmacodynamic properties - addition of the paragraph
"In the postmarketing setting, experience was gained in patients who initiated treatment at a dose of 1 mg/kg every 2 weeks and subsequently received a reduced dose for an extended period. In some of these patients, an increase of some of the following symptoms was spontaneously reported: pain, paraesthesia and diarrhoea, as well as cardiac, central nervous system and renal manifestations. These reported symptoms resemble the natural course of Fabry disease"
Change to Date of Revision
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Updated on 09/02/2010 and displayed until 17/06/2011
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Reasons for adding or updating:
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 25-Jan-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 5.1 Pharmacodynamic properties - Additions to the table. In the "Frequency Unknown" column Hypoxia has been added against "System organ class" - Respiratory, thoracic and mediastinal disorders. Also and additional row has been added at the bottom of the table. Investigations has been added under the "System organ class" with Oxygen saturation decreased in the "Frequency Unknown" column. In the second paragraph beneath the table, "hypoxia (oxygen saturation decreased)" was also added.
Section 10 Date of revision of the text - changed.
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Updated on 11/04/2008 and displayed until 09/02/2010
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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Change to section 5.1 - Pharmacodynamic Properties
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| Date of revision of text on the SPC: 02/2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.8
The number of patients in clinical trials has increased form 121 to 168 patient and that also has changed the frequency for some events:
a. Flushing changed from very common into common
b. Dyspnea exacerbated, stomach discomfort, hypoaesthesia oral, angioneurotic oedema, muscle tightness and musculoskeletal stiffness changed from uncommon to common.
c. Muscle spasms were added with frequency common and leucoclastic vasculitis as well as anaphylactoid reaction were added with frequency unknown as these are based on post-marketing data.
d. The table was re-formatted.
Section 5.1 was revised:
a. Deletion of the sentence “approval under exceptional circumstances”.
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Updated on 13/11/2007 and displayed until 11/04/2008
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Reasons for adding or updating:
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Change to section 4.2 - Posology and method of administration
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Change to section 5.1 - Pharmacodynamic Properties
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| Date of revision of text on the SPC: 11/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.2: The following text was added: "Alternative dosing regimens have been used in clinical studies. In one of these studies, after an initial dose of 1.0 mg/kg every 2 weeks for 6 months, 0.3 mg/kg every 2 weeks may maintain clearance of GL-3 in certain cell types in some patients; however, the long term clinical relevance of these findings has not been established (see section 5.1)".
Section 5.1: The following text was added: In an additional study, 21 male patients were enrolled to follow GL3 clearance in kidney and skin tissues at an alternative dosing regimen. Following treatment with 1 mg/kg every other week for 24 weeks, a dose regimen of 0.3 mg/kg every 2 weeks for 18 months was able to maintain the clearance of cellular GL-3 in the capillary endothelium of the kidney, other kidney cell types and skin (superficial skin capillary endothelium) in the majority of patients. However, at the lower dose, IgG antibodies may play a role with respect to GL-3 clearance in some patients. Due to the limitations of the study design (small number of patients), no definitive conclusion regarding the dose maintenance regimen can be drawn, but these findings suggest that, after an initial debulking dose of 1.0 mg/kg every 2 weeks, 0.3 mg/kg every 2 weeks may be sufficient in some patients to maintain clearance of GL-3.
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Updated on 03/05/2007 and displayed until 13/11/2007
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Reasons for adding or updating:
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Change to section 4.2 - Posology and method of administration
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.8 - Undesirable Effects
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 5.2 - Pharmacokinetic Properties
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Change to section 6. 6 - Instructions for use, handling and disposal
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 02/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Inclusion of paediatric posology, pharmacodynamics and pharmacokinetics.
Inclusion of additional safety, pharmacodynamics and pharmacokinetics information on adults.
Inclusion of MedDRA adverse events terminology. Inclusion of standard EU adverse events frequency convention.
Additional instructions regarding dilution after reconstitution.
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Updated on 20/11/2006 and displayed until 03/05/2007
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Reasons for adding or updating:
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Change to section 6. 3 - Shelf Life
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Change to section 6. 6 - Instructions for use, handling and disposal
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| Date of revision of text on the SPC: 09/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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6.3 Shelf life
Shelf life has changed from 2 to 3 years.
6.6 Instructions for use, handling and disposal
Clarified the instructions for reconstitution and dilution. Added a recommendation to administer the diluted solution through an in-line low protein binding 0.2 µm filter.
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Updated on 10/07/2006 and displayed until 20/11/2006
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Reasons for adding or updating:
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New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
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