Summary of Product Characteristics
last updated on the eMC:
03/01/2012
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 03/01/2012 and displayed until Current
|
Reasons for adding or updating:
|
-
Change to section 4.1 - Therapeutic indications
-
Change to section 4.2 - Posology and method of administration
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 13-Dec-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
|
Section
|
Summary of change
|
|
1.
|
|
|
2.
|
|
|
3.
|
|
|
4.
|
|
|
4.1
|
We are now stating that “Ventolin Injection is indicated in adults and adolescents”.
We are now stating that “Ventolin Infusion is indicated in adults and adolescents”
|
|
4.2
|
New wording added on Paediatric Population
|
|
4.3
|
|
|
4.4
|
|
|
4.5
|
|
|
4.6
|
|
|
4.7
|
|
|
4.8
|
|
|
4.9
|
|
|
5.
|
|
|
5.1
|
|
|
5.2
|
|
|
5.3
|
|
|
6.
|
|
|
6.1
|
|
|
6.2
|
|
|
6.3
|
|
|
6.4
|
|
|
6.5
|
|
|
6.6
|
|
|
7.
|
|
|
8.
|
|
|
9.
|
|
|
10.
|
Updated with new date of revision of text
|
|
|
Updated on 12/11/2009 and displayed until 03/01/2012
|
Reasons for adding or updating:
|
-
Change to section 4.3 - Contraindications
-
Change to section 4.4 - Special warnings and precautions for Use
|
| Date of revision of text on the SPC: 31-Jul-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| section 4.3 - Addition to text:
Salbutamol should not be used as a tocolytic agent in patients with pre-existing ischaemic heart disease or those patients with significant risk factors for ischaemic heart disease
section 4.4 - addition to text:
Cardiovascular effects may be seen with sympathomimetic drugs, including salbutamol. There is some evidence from post-marketing data and published literature of myocardial ischaemia associated with salbutamol.
Tocolysis
Salbutamol should be used with caution in tocolysis and supervision of cardiorespiratory function, including ECG monitoring, should be considered. Treatment should be discontinued if signs of myocardial ischaemia (such as chest pain or ECG changes) develop. Salbutamol should not be used as a tocolytic agent in patients with significant risk factors for or pre-existing heart disease (see section 4.3).
Respiratory indications
Patients with underlying severe heart disease (e.g. ischaemic heart disease, arrhythmia or severe heart failure) who are receiving salbutamol should be warned to seek medical advice if they experience chest pain or other symptoms of worsening heart disease. Attention should be paid to assessment of symptoms such as dyspnoea and chest pain, as they may be of either respiratory or cardiac origin.
|
|
Updated on 10/08/2009 and displayed until 12/11/2009
|
Reasons for adding or updating:
|
-
Change to section 4.9 - Overdose
|
| Date of revision of text on the SPC: 31-Jul-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
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 and lactic acidosis (see sections 4.4 and 4.8).
Nausea, vomiting and hyperglycaemia have been reported, predominantly in children and when salbutamol overdose has been taken via the oral route.
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.
|
|
Updated on 09/03/2009 and displayed until 10/08/2009
|
Reasons for adding or updating:
|
-
Change to section 4.9 - Overdose
|
| 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
|
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.
|
|
Updated on 22/09/2008 and displayed until 09/03/2009
|
Reasons for adding or updating:
|
-
Change to section 4.9 - Overdose
-
Change to section 7 - Marketing Authorisation Holder
-
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 10 date of revision of the text
|
| 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
|
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
|
|
Updated on 02/08/2007 and displayed until 22/09/2008
|
Reasons for adding or updating:
|
-
Change to section 4.3 - Contraindications
-
Change to section 4.4 - Special warnings and precautions for Use
-
Change to section 4.8 - Undesirable Effects
|
| 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
|
Section 4.3
statement added regarding tocolytic agent
Section 4.4
additional wording added mycocardial ischaemia
Section 4.8
Frequencies updated
Section 10
updated
|
|
Updated on 17/11/2003 and displayed until 02/08/2007
|
Reasons for adding or updating:
|
-
Change to section 4.2 - Posology and Method of Administration
-
Change to section 6. 4 - Special Precautions for Storage
-
Change to section 10 (date of (partial) revision of the text
|
|
Updated on 25/03/2002 and displayed until 17/11/2003
|
Reasons for adding or updating:
|
-
Correction of spelling/typing errors
|
|
Updated on 12/02/2002 and displayed until 25/03/2002
|
Reasons for adding or updating:
|
-
Change to section 6. 5 - Nature and Contents of Container
|
|
Updated on 11/08/2001 and displayed until 12/02/2002
|
Reasons for adding or updating:
|
-
Transferred from eMC version 1
|
|
Updated on 06/09/1999 and displayed until 11/08/2001
|
Reasons for adding or updating:
|
|
|
|
