Summary of Product Characteristics
last updated on the eMC:
11/08/2009
When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.
Updated on 11/08/2009 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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| Date of revision of text on the SPC: 06-Aug-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 4.2 has been updated to bring dosage recommendations in line with guidelines on the Emergency treatment of anaphylactic reactions published by the Working Group of the Resuscitation Council (UK).
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Updated on 24/03/2009 and displayed until 11/08/2009
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Reasons for adding or updating:
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Change to section 4.3 - Contraindications
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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Change to section 4.8 - Undesirable Effects
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Change to section 4.9 - Overdose
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Change to section 5 - Pharmacological Properties
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| Date of revision of text on the SPC: 24-Feb-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.3
– Contraindications – The following sentence was added “Hypersensitivity
to adrenaline, sodium metabisulphite or any of the other
ingredients.” and “1 in 1000” after Adrenaline in 2nd paragraph.
Section 4.4
- Special warnings and precautions for use – Additional warnings and
precautions for use added.
Section 4.5
– Interactions with other medicinal products and other forms of interactions
- General rewrite of section, grouping it into drug classes and other
interactions. With addition of “Antidepressants agents, Antihypertensive
agents, Other drugs, Hypokalaemia and Hyperglycaemia”.
Section 4.8 – Undesirable effects – Rewritten to group
into system organ classes.
Section 4.9 – Overdose – Added that “Pulmonary oedema
may occur” as one of the symptoms of overdosage and a subsection “Treatment” to
manage overdosage.
Section 5 - Pharmacological Properties – General
rewrite of this section.
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Updated on 09/06/2008 and displayed until 24/03/2009
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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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| Date of revision of text on the SPC: |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| None provided |
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