TIROFIBAN Solution for infusion Ref.[8520] Active ingredients: Tirofiban

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Aspire Pharma Ltd, Unit 4 Rotherbrook Court, Bedford Road, Petersfield, Hampshire, GU32 3QG, United Kingdom

Product name and form

Tirofiban *50 micrograms/mL Solution for infusion.

* in the following document the abbreviated terms detailed below are used.

*Tirofiban means Tirofiban Solution for Infusion

* Tirofiban Solution will be used when referring to Tirofiban Solution for Infusion i.e. the 250 ml infusion bag.

Pharmaceutical Form

Tirofiban Solution: Solution for Infusion (250 ml bag)

A clear, colourless solution.

Qualitative and quantitative composition

Tirofiban Solution: 1 ml of solution for infusion contains 56 micrograms of tirofiban hydrochloride monohydrate which is equivalent to 50 micrograms tirofiban.

This medicinal product contains 31 mmol (or 715 mg) sodium per bag (250 ml). To be taken into consideration by patients on a controlled sodium diet.

For excipients, see section 6.1.

Active Ingredient Description
Tirofiban

Tirofiban is a non-peptidal antagonist of the GP IIb/IIIa receptor, an important platelet surface receptor involved in platelet aggregation. Tirofiban prevents fibrinogen from binding to the GP IIb/IIIa receptor, thus blocking platelet aggregation.

List of Excipients

Sodium dihydrogen phosphate dihydrate
Mannitol (E421)
Sodium chloride
Water for injection
Sodium hydroxide and/or Hydrochloric acid for pH adjustment

Pack sizes and marketing

250 ml flexible plastic IV bag with Twist-off port stopper, colourless, 3-layer polypropylene film. It is packed in a pre-printed foil overpouch.

Marketing authorization holder

Aspire Pharma Ltd, Unit 4 Rotherbrook Court, Bedford Road, Petersfield, Hampshire, GU32 3QG, United Kingdom

Marketing authorization dates and numbers

PL 35533/0058

19/10/2019

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