Summary of Product Characteristics
last updated on the eMC:
04/11/2010
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 04/11/2010 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.9 - Overdose
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| Date of revision of text on the SPC: 01-Jun-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.4: Additional warning for sleep apnoea included
Section 4.9: Warning that death may occur in cases of severe hypotension with circulatory failure, rhabdomyolosis progressing to renal failure.
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Updated on 24/06/2010 and displayed until 04/11/2010
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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 4.6 - Pregnancy and Lactation
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 20-May-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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4.3 - additional contraindication in patients with acute diarrhoea caused b poisoning or invasive pathogens.
4.4 - Caution advised for patients with a history of drug abuse, asthma, hypotension, urethral stricture. Warning of tolerance to opioid analgesic effects and increase in abdominal pain.
4.5 - Sedative replaces the word deppressant when describing effects. Also anxiolytics added to the list of drugs which may potentiate the effects of morphine.
4.6 - Rewording of recommendations for breastfeeding.
4.8 - Side-effects ordered according to Meddra system organ class (SOC).
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Updated on 19/05/2010 and displayed until 24/06/2010
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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 4.6 - Pregnancy and Lactation
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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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| Date of revision of text on the SPC: 01-May-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Changes to section:
4.3- contraindication for patients with acute diarrhoea caused by poisoning.
4.4- complete change of format and information on special warning and speacial precaution for use.
4.6- clarification of advice for pregnant and lactating women.
4.8- reordering og AEs into Meddra Systems Organ Class.
4.9- additional advice given for management of overdose.
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Updated on 13/07/2006 and displayed until 19/05/2010
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Reasons for adding or updating:
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Change to section 1 - trade name
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| Date of revision of text on the SPC: 02/2005 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Removal of Rapijet presentation.
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Updated on 30/11/2005 and displayed until 13/07/2006
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Reasons for adding or updating:
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Change to section 4.3 - Contra-indications
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Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
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Change to section 4.6 - Pregnancy and Lactation
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Change to section 4.8 - Undesirable Effects
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Change to section 10 (date of (partial) revision of the text
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Updated on 03/12/2003 and displayed until 30/11/2005
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 20/11/2003 and displayed until 03/12/2003
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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Updated on 28/06/2001 and displayed until 20/11/2003
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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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