Summary of Product Characteristics
last updated on the eMC:
22/12/2011
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 22/12/2011 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 syrup is indicated in adults, adolescents and children aged 2 to 12 years.”
|
|
4.2
|
We changed sub-header from “Children” to “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 07/08/2009 and displayed until 22/12/2011
|
Reasons for adding or updating:
|
-
Change to section 6. 6 - Instructions for use, handling and disposal
-
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).
Hypokalaemia may occur following overdose with salbutamol. Serum potassium levels should be monitored.
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.
Section 6.6 - No special instructions.
Ventolin syrup may be diluted with Purified Water BP (50%v/v). The resulting mixture should be protected from light and used within 28 days.
A 50% v/v dilution of Ventolin syrup has been shown to be adequately preserved against microbial contamination.
Admixture of Ventolin syrup with other liquid preparation is not recommended.
|
|
Updated on 11/07/2007 and displayed until 07/08/2009
|
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
-
Change to section 10 date of revision of the text
|
| 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, 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
|
|
Updated on 04/08/2006 and displayed until 11/07/2007
|
Reasons for adding or updating:
|
-
Change to section 4.8 - Undesirable Effects
-
Change to section 10 (date of (partial) revision of the text
|
| Date of revision of text on the SPC: 08/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
|
For further information, please contact GlaxoSmithKline on +44 (0)800 221 441
|
|
Updated on 02/11/2005 and displayed until 04/08/2006
|
Reasons for adding or updating:
|
-
Change to section 9 - Date of Renewal of Authorisation
|
|
Updated on 04/08/2005 and displayed until 02/11/2005
|
Reasons for adding or updating:
|
-
Improved Electronic Presentation
|
|
Updated on 28/04/2005 and displayed until 04/08/2005
|
Reasons for adding or updating:
|
-
Change to section 4.8 - Undesirable Effects
|
|
Updated on 05/08/2001 and displayed until 28/04/2005
|
Reasons for adding or updating:
|
|
|
|
Updated on 21/11/2000 and displayed until 05/08/2001
|
Reasons for adding or updating:
|
|
|
|
Updated on 12/07/2000 and displayed until 21/11/2000
|
Reasons for adding or updating:
|
|
|
|
Updated on 06/09/1999 and displayed until 12/07/2000
|
Reasons for adding or updating:
|
|
|
|
