Updated on 09/12/2011 and displayed until Current
|
Reasons for adding or updating:
|
-
Change to section 2 - Qualitative and quantitative composition
-
Change to section 3 - Pharmaceutical form
-
Change to section 4.2 - Posology and method of administration
-
Change to section 4.4 - Special warnings and precautions for Use
-
Change to section 4.6 - Pregnancy and Lactation
-
Change to section 4.7 - Effects on Ability to Drive and Use Machines
-
Change to section 4.8 - Undesirable Effects
-
Change to section 5.1 - Pharmacodynamic Properties
-
Change to section 6.2 - Incompatibilities
-
Change to section 6. 3 - Shelf Life
-
Change to section 6. 4 - Special Precautions for Storage
-
Change to section 6. 6 - Instructions for use, handling and disposal
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 01-Nov-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
Section 2 Refers now to section 6.1 for a full list of excipients
Section 3 Additional physico-chemical details; solution is clear and colourless with pH = 2.2 - 2.8
Section 4.2 Refers to Section 6.6 for dilution instructions
Section 4.4 Warnings added or re-worded on use in patients with severe hypotension or markedly reduced systemic vascular resistance; also for benign or serious arrhythmias and excessive tachycardia; also in patients with marked reduction in systemic vascular resistance; also in patients with a history ischaemic heart disease; likewise in patients with hypokalaemia or hyperkalaemia
Section 4.6 Strengthened recommendation not to use in pregnant or lactating women
Section 4.7 No studies have been performed on ability to drive or use machines added
Section 4.8 Addition that careful titration may minimise incidence of AEs; clarification of hypertension and tachycardia events; inclusion of post-marketing event frequencies; tabulation of adverse reactions by patients from all HF studies and also by patients in cardiac surgery studies
Section 5.1 Addition of pharmacotherapeutic group
Section 6.2 Clarification of diluents to be used and warning not to mix with other medicinal products except those mentioned in Section 6.6
Section 6.3 Clarification and extension of microbiological patency if diluted material not used immediately; not normally longer than 24h at 2°C - 8°C unless dilution in controlled and validated aseptic conditions
Section 6.4 Store below 25°C and protect from both light and moisture by keeping in outer carton; also refers to Section 6.3 recommendations if products have been opened or diluted
Section 6.6 Tabulation of dilution scheme replaces previous instructions; options therein now given of using one 5ml ampoule with 100ml diluent or two 5ml ampoules with 250ml to give a final concentration of 500µg/ml and 400µg/ml respectively. Additional warning that care should be taken in HF patients to restrict sodium load and volume administered.
Section 10 Date of revision now changed to November 2011
|
|
Updated on 29/06/2011 and displayed until 09/12/2011
|
Reasons for adding or updating:
|
-
Change to section 4.9 - Overdose
|
| Date of revision of text on the SPC: 23-Jun-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
In Section 4.9 (Overdose)
To the effects of overdosage have been added bradycardia, myocardial infarction, arrythmias, headache, sweating and shortness of breath.
Substituted in place of 'Treatment should be supportive and directed towads these symptoms' is 'Management should be symptomatic and supportive' and appended to this, 'Stop the dopexamine infusion until symptoms settle and heart rate and blood pressure return to normal. In asymptomatic patients monitor heart rate and blood pressure for at least 30 minutes. Consider esmolol, metoprolol, or other beta-adrenergic blocking agents for cardiac dysrhythmias.'
|
|
Updated on 14/04/2010 and displayed until 29/06/2011
|
Reasons for adding or updating:
|
-
Change to section 7 - Marketing Authorisation Holder
-
Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
-
Change to section 9 - Date of first Authorisation/renewal of the Authorisation
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 22-Mar-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| Sections 7, 8, 9 and 10 of the SmPC have been updated as follows:
Section 7: Marketing Authorisation Holder has been changed to Cephalon UK Limited, 1 Albany Place, Hyde Way, Welwyn Garden City, Hertfordshire
Section 8: Marketing Authorisation Number(s) has been changed from PL 21799/0009 to PL 16260/0023
Section 9: Date of First Authorisation/Renewal of the Authorisation
Section 10: Date of Revision of Text
|
|
Updated on 10/03/2008 and displayed until 14/04/2010
|
Reasons for adding or updating:
|
-
Change to MA holder contact details
|
| Date of revision of text on the SPC: 10/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
Section 7: MAH contact address changed from The Magdalen centre, Oxford science park, Oxford, OX4 4GA, UK to 1 Albany Place, Hyde way, Welwyn Garden City, Hertfordshire, AL7 3BT
|
|
Updated on 13/06/2007 and displayed until 10/03/2008
|
Reasons for adding or updating:
|
-
Change to section 7 - Marketing Authorisation Holder
|
| Date of revision of text on the SPC: 12/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
Section 7 - Marketing Authorisation Holder changed from:
Zeneus Pharma Limited
The Magdalen Centre
Oxford Science Park
Oxford
OX4 4GA
United Kingdom
to:
Cephalon Limited
The Magdalen Centre
Oxford Science Park
Oxford
OX4 4GA
United Kingdom
|
|
Updated on 12/06/2007 and displayed until 13/06/2007
|
Reasons for adding or updating:
|
-
Change to section 7 - Marketing Authorisation Holder
|
| Date of revision of text on the SPC: 12/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
|
Section 7 - Marketing Authorisation Holder changed from:
Zeneus Pharma Limited
The Magdalen Centre
Oxford Science Park
Oxford
OX4 4GA
United Kingdom
to:
Cephalon Limited
The Magdalen Centre
Oxford Science Park
Oxford
OX4 4GA
United Kingdom
|
|
Updated on 28/09/2005 and displayed until 12/06/2007
|
Reasons for adding or updating:
|
-
Change to section 7 - Marketing Authorisation Holder
-
Change to section 8 - MA number
-
Change to section 10 (date of (partial) revision of the text
|
|
Updated on 15/09/2005 and displayed until 28/09/2005
|
Reasons for adding or updating:
|
-
Change to section 1 - trade name
-
Change to section 4.2 - Posology and Method of Administration
-
Change to section 4.4 - Special Warnings and Precautions for Use
-
Change to section 6. 4 - Special Precautions for Storage
-
Change to section 10 (date of (partial) revision of the text
|
|
Updated on 28/05/2004 and displayed until 15/09/2005
|
Reasons for adding or updating:
|
-
Company name change or merger
|
|
Updated on 24/07/2001 and displayed until 28/05/2004
|
Reasons for adding or updating:
|
-
Transferred from eMC version 1
|
|
Updated on 18/01/2000 and displayed until 24/07/2001
|
Reasons for adding or updating:
|
|
|
|
