Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Janssen-Cilag Limited, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG, UK
VELETRI 0.5 mg, Powder for Solution for Infusion.
VELETRI 1.5 mg, Powder for Solution for Infusion.
| Pharmaceutical Form |
|---|
|
Powder for solution for infusion. White to off-white powder. For the pH of the diluted solution see section 4.4. |
Each vial contains 0.531 mg epoprostenol sodium equivalent to 0.5 mg epoprostenol
One mL of reconstituted solution contains 0.1 mg epoprostenol (as epoprostenol sodium) (0.5 mg epoprostenol in 5 mL of solvent).
Each vial contains 1.593 mg epoprostenol sodium equivalent to 1.5 mg epoprostenol
One mL of reconstituted solution contains 0.3 mg epoprostenol (as epoprostenol sodium) (1.5mg epoprostenol in 5 mL of solvent).
Excipient(s) with known effect: sodium, (0.03 mg for 0.5 mg/vial and 0.09 mg for 1.5 mg/vial)
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Epoprostenol |
Epoprostenol sodium, the monosodium salt of epoprostenol, a naturally occurring prostaglandin produced by the intima of blood vessels. Epoprostenol is the most potent inhibitor of platelet aggregation known. It is also a potent vasodilator. |
| List of Excipients |
|---|
|
Sucrose |
10 mL colourless glass type I vial closed with a rubber stopper and an aluminium flip-off cap (with a white disc for the 0.5 mg/vial strength, and a red disc for the 1.5 mg/vial strength).
Pulmonary Arterial Hypertension:
There are 2 presentations available for use in the treatment of pulmonary arterial hypertension, as follows:
Renal Dialysis:
There is 1 presentation available for use in the treatment of renal dialysis, as follows:
Not all pack sizes may be marketed.
Janssen-Cilag Limited, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG, UK
PL 00242/0645
PL 00242/0646
Date of first authorisation: 26 April 2013
| Drug | Countries | |
|---|---|---|
| VELETRI | Australia, Spain, France, Hong Kong, Ireland, Netherlands, New Zealand, Poland, Singapore, Turkey, United Kingdom, United States |
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