Summary of Product Characteristics
last updated on the eMC:
27/04/2012
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 27/04/2012 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.1 - Therapeutic indications
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Change to section 4.2 - Posology and method of administration
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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: 07-Feb-2012 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section
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Summary of change
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1.
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2.
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3.
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4.
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4.1
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Ventolin Nebules are indicated in adults, adolescents and children aged 4 to 11 years,. For babies and children under 4 years of age, see Section 4.2
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4.2
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Children aged 12 years and over: Dose as per adult population.
Infants under 18 months old: Clinical efficacy of nebulised salbutamol in infants under 18 months is uncertain.
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4.3
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4.4
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4.5
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4.6
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4.7
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4.8
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4.9
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5.
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5.1
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5.2
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5.3
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6.
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6.1
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6.2
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6.3
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6.4
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6.5
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6.6
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7.
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8.
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9.
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10.
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Updated with new date of revision of text
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Updated on 27/08/2009 and displayed until 27/04/2012
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Reasons for adding or updating:
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Change to section 4.9 - Overdose
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| Date of revision of text on the SPC: 02-Jul-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| 4.9 - Lactic Acidosis
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Updated on 20/07/2009 and displayed until 27/08/2009
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Reasons for adding or updating:
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Change to section 4.9 - Overdose
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| Date of revision of text on the SPC: 02-Jul-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.9 - The preferred antidote for overdosage with salbutamol is a cardioselective -blocking agent, but -blocking drugs should be used with caution in patients with a history of bronchospasm.
The most common signs and symptoms of overdose with salbutamol are transient beta agonist pharmacologically mediated events, including tachycardia, tremor, hyperactivity and metabolic effects including hypokalaemia (see sections 4.4 and 4.8). (see section 4.8)
Hypokalaemia may occur following overdose with salbutamol. Serum potassium levels should be monitored.
Consideration should be given to discontinuation of treatment and appropriate symptomatic therapy such as cardio-selective beta-blocking agents in patients presenting with cardiac symptoms (e.g. tachycardia, palpitations). Beta-blocking drugs should be used with caution in patients with a history of bronchospasm.
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Updated on 09/03/2009 and displayed until 20/07/2009
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Reasons for adding or updating:
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Change to section 4.9 - Overdose
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| Date of revision of text on the SPC: 15-Aug-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.9
The preferred antidote to overdosage with salbutamol is a cardioselective -blocking agent, but -blocking drugs should be used with caution in patients with a history of bronchospasm.
Hypokalaemia may occur following overdose with salbutamol. Serum potassium levels should be monitored.
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Updated on 24/09/2008 and displayed until 09/03/2009
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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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Change to section 4.9 - Overdose
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Change to section 7 - Marketing Authorisation Holder
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Change to section 4.4 - Special warnings and precautions for Use
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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: 15-Aug-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.2 - whole section
Section 4.4 - whole section
Section 4.8 - whole section
Section 4.9 - whole section
Section 7 - trading as Allen & Hanburys
Section 10 - 15 August 2008
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Updated on 29/06/2007 and displayed until 24/09/2008
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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 4.8 - Undesirable Effects
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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: 06/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.3, 4.4 and 4.8: Updates for presentations with obstetric and respiratory indications
Section 4.4 and 4.8: Updates for presentations with respiratory only indications to include additional wording regarding myocardial ischaemia.
Section 10: Now 05/06/2007
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Updated on 19/04/2006 and displayed until 29/06/2007
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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 10 (date of (partial) revision of the text
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Updated on 27/06/2003 and displayed until 19/04/2006
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Reasons for adding or updating:
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Change to section 9 - Date of Renewal of Authorisation
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Updated on 16/08/2001 and displayed until 27/06/2003
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Reasons for adding or updating:
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Transferred from eMC version 1
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Updated on 06/09/1999 and displayed until 16/08/2001
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Reasons for adding or updating:
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