r reconstituted see section 6.3.
6.5 Nature and contents of container
Box of 10 clear Type 1 glass ampoules each containing 5 ml of 1% (w/v) solution of dopexamine hydrochloride (50 mg per ampoule).
6.6 Special precautions for disposal and other handling
Dopacard should only be diluted with 0.9% Sodium Chloride Injection, 5% Dextrose Injection, Hartmann's Solution (Compound Sodium Lactate Intravenous Infusion) or Dextrose 4%/Saline 0.18% Injection.
The appropriate volume of diluent solution should be aseptically extracted from the infusion bag, or the metering chamber of the administration set, before adding the contents of the Dopacard ampoule(s) to arrive at the final concentration - see table below.
Care should be exercised in heart failure to restrict the sodium load and volume being administered.
|
Volume of diluent solution (ml)
|
Volume to be extracted (ml)
|
No. of 5 ml Dopacard ampoules to be added
|
Final Concentration μ g/ml)
|
|
100
|
5
|
1
|
500
|
|
250
|
10
|
2
|
400
|
|
500
|
20
|
4
|
400
|
|
250
|
20
|
4
|
800
|
Dopacard, in common with other catecholamines, may turn slightly pink in prepared solutions. There is no significant loss of potency associated with this change.
7. MARKETING AUTHORISATION HOLDER
Cephalon Limited
1 Albany Place
Hyde Way
Welwyn Garden City
Hertfordshire
AL7 3BT
UK
8. MARKETING AUTHORISATION NUMBER(S)
PA 1260/4/1
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 14 June 1999
Date of last renewal: 14th June 2009
10. DATE OF REVISION OF THE TEXT
March 2010
