ILOPROST Concentrate for solution for infusion Ref.[9900] Active ingredients: Iloprost

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Colonis Pharma Ltd, Quantum House, Hobson Industrial Estate, Burnopfield, County Durham, NE16 6EA, United Kingdom

Product name and form

Iloprost 100 micrograms/ml concentrate for solution for infusion.

Pharmaceutical Form

Concentrate for solution for infusion.

Clear colourless solution, free of visible particles.

Qualitative and quantitative composition

Each 1 ml concentrate for solution for infusion contains 100 micrograms iloprost (equivalent to 134 micrograms iloprost trometamol).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Iloprost

Iloprost is a synthetic prostacyclin analogue. After inhalation of iloprost direct vasodilatation of the pulmonary arterial bed occur with consecutive significant improvement of pulmonary artery pressure, pulmonary vascular resistance and cardiac output as well as mixed venous oxygen saturation.

List of Excipients

Trometamol
Ethanol 96% (v/v)
Sodium chloride
Hydrochloric acid
Water for injection

Pack sizes and marketing

Glass ampoules from glass type I (Type I hydrolytic class glass).

Iloprost 100 micrograms/ml Concentrate for solution for infusion is available in the following pack sizes:

  • Box of 1 or 5 ampoules, each with 0.5 ml concentrate for solution for infusion.
  • Box of 1 or 5 ampoules, each with 1 ml concentrate for solution for infusion.

Not all pack sizes may be marketed.

Marketing authorization holder

Colonis Pharma Ltd, Quantum House, Hobson Industrial Estate, Burnopfield, County Durham, NE16 6EA, United Kingdom

Marketing authorization dates and numbers

PL 41344/0046

15/01/2019

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