VELETRI Powder for solution for infusion Ref.[9383] Active ingredients: Epoprostenol

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

Product name and form

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.

Qualitative and quantitative composition

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
Arginine
Sodium hydroxide (for pH adjustment)

Pack sizes and marketing

Powder for solution for infusion

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).

Pack presentations

Pulmonary Arterial Hypertension:

There are 2 presentations available for use in the treatment of pulmonary arterial hypertension, as follows:

  • One 0.5 mg powder vial.
  • One 1.5 mg powder vial.

Renal Dialysis:

There is 1 presentation available for use in the treatment of renal dialysis, as follows:

  • One 0.5 mg powder vial.

Not all pack sizes may be marketed.

Marketing authorization holder

Janssen-Cilag Limited, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG, UK

Marketing authorization dates and numbers

PL 00242/0645
PL 00242/0646

Date of first authorisation: 26 April 2013

Drugs

Drug Countries
VELETRI Australia, Spain, France, Hong Kong, Ireland, Netherlands, New Zealand, Poland, Singapore, Turkey, United Kingdom, United States

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.