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SPC, UK: TIROFIBAN Solution for infusion (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Tirofiban *50 micrograms/mL Solution for infusion. * in the following document the abbreviated terms detailed below are used. <sup>*</sup>Tirofiban means Tirofiban Solution for Infusion * Tirofiban 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 ...

Pharmaceutical form

Tirofiban Solution: Solution for Infusion (250 ml bag) A clear, colourless solution.

Therapeutic indications

Tirofiban is indicated for the prevention of early myocardial infarction in adult patients presenting with acute coronary syndromes without ST elevation (NSTE-ACS) with the last episode of chest pain occurring ...

Posology and method of administration

This product is for hospital use only, by specialist physicians experienced in the management of acute coronary syndromes. Tirofiban should be administered with unfractionated heparin and oral antiplatelet ...

Contraindications

Tirofiban is contraindicated in patients who are hypersensitive to the active substance or to any of the excipients of the preparation listed in section 6.1 or who developed thrombocytopenia during earlier ...

Special warnings and precautions for use

The administration of Tirofiban alone without unfractionated heparin is not recommended. There is limited experience with concomitant administration of Tirofiban with enoxaparin (see section 5.1 and section ...

Interaction with other medicinal products and other forms of interaction

The use of several platelet aggregation inhibitors increases the risk of bleeding, likewise their combination with heparin, warfarin and thrombolytics. Clinical and biological parameters of haemostasis ...

Fertility, pregnancy and lactation

Pregnancy There are no or limited amount of data from the use of tirofiban hydrochloride in pregnant women. Animal studies are insufficient with respect to the reproductive toxicity (see section 5.3). ...

Effects on ability to drive and use machines

No data are available on whether Tirofiban impairs the ability to drive or use machines.

Undesirable effects

a. Summary of safety profile The most common adverse reaction reported during therapy with tirofiban hydrochloride when used concomitantly with heparin, aspirin and other oral anti-platelet agents, was ...

Overdose

Inadvertent overdose with tirofiban hydrochloride occurred in the clinical studies, up to 50 microgram/kg as a three minute bolus or 1.2 microgram/kg/min as an initial infusion. Overdose with up to 1.47 ...

Pharmacodynamic properties

Pharmacotherapeutic group: Blood and blood forming organs – antithrombotic agents – antithrombotic agents Platelet aggregation inhibitors excl. heparin ATC-Code: B01AC17 Mechanism of action Tirofiban ...

Pharmacokinetic properties

Distribution Tirofiban is not strongly bound to plasma protein, and protein binding is concentration-independent in the range of 0.01–25 microgram/ml. The unbound fraction in human plasma is 35%. The distribution ...

Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity and genotoxicity. Fertility and reproductive performance were not affected ...

List of excipients

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

Incompatibilities

Incompatibility has been found with diazepam. Therefore, Tirofiban and diazepam should not be administered in the same intravenous line. No incompatibilities have been found with tirofiban and the following ...

Shelf life

Shelf life: 36 months.

Special precautions for storage

Do not freeze. Keep infusion bag in foil overpouch to protect from light.

Nature and contents of container

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.

Special precautions for disposal and other handling

Some opacity of the plastic due to moisture absorption during the sterilisation process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. ...

Marketing authorization holder

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

Marketing authorization number(s)

PL 35533/0058

Date of first authorization / renewal of the authorization

19/10/2019

Date of revision of the text

19/10/2019

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