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INTEGRILIN Solution for infusion (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

INTEGRILIN 0.75 mg/ml solution for infusion.

Qualitative and quantitative composition

Each ml of solution for infusion contains 0.75 mg of eptifibatide. One vial of 100 ml of solution for infusion contains 75 mg of eptifibatide. For the full list of excipients, see section 6.1.

Pharmaceutical form

Solution for infusion. Clear, colourless solution.

Therapeutic indications

INTEGRILIN is intended for use with acetylsalicylic acid and unfractionated heparin. INTEGRILIN is indicated for the prevention of early myocardial infarction in adults presenting with unstable angina ...

Posology and method of administration

This product is for hospital use only. It should be administered by specialist physicians experienced in the management of acute coronary syndromes. INTEGRILIN solution for infusion must be used in conjunction ...

Contraindications

INTEGRILIN must not be used to treat patients with: hypersensitivity to the active substance or to any of the excipients listed in section 6.1 evidence of gastrointestinal bleeding, gross genitourinary ...

Special warnings and precautions for use

Bleeding INTEGRILIN is an antithrombotic agent that acts by inhibition of platelet aggregation; therefore the patient must be observed carefully for indications of bleeding during treatment (see section ...

Interaction with other medicinal products and other forms of interaction

Warfarin and dipyridamole INTEGRILIN did not appear to increase the risk of major and minor bleeding associated with concomitant use of warfarin and dipyridamole. INTEGRILIN-treated patients who had a ...

Pregnancy and lactation

Pregnancy There are no adequate data from the use of eptifibatide in pregnant women. Animal studies are insufficient with respect to effects on pregnancy, embryonal/foetal development, parturition or postnatal ...

Effects on ability to drive and use machines

Not relevant, as INTEGRILIN is intended for use only in hospitalised patients.

Undesirable effects

The majority of adverse reactions experienced by patients treated with eptifibatide were generally related to bleeding or to cardiovascular events that occur frequently in this patient population. Clinical ...

Overdose

The experience in humans with overdose of eptifibatide is extremely limited. There was no indication of severe adverse reactions associated with administration of accidental large bolus doses, rapid infusion ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antithrombotic agent (platelet aggregation inhibitors excl. heparin) ATC code: B01AC16 Mechanism of action Eptifibatide, a synthetic cyclic heptapeptide containing six amino ...

Pharmacokinetic properties

The pharmacokinetics of eptifibatide are linear and dose proportional for bolus doses ranging from 90 to 250 microgram/kg and infusion rates from 0.5 to 3.0 microgram/kg/min. For a 2.0 microgram/kg/min ...

Preclinical safety data

Toxicology studies conducted with eptifibatide include single and repeated dose studies in the rat, rabbit and monkey, reproduction studies in the rat and rabbit, in vitro and in vivo genetic toxicity ...

List of excipients

Citric acid monohydrate Sodium hydroxide Water for injections

Incompatibilities

INTEGRILIN is not compatible with furosemide. In the absence of compatibility studies, INTEGRILIN must not be mixed with other medicinal products except those mentioned in 6.6.

Shelf life

3 years.

Special precautions for storage

Store in a refrigerator (2°C-8°C). Store in the original package in order to protect from light.

Nature and contents of container

One 100 ml Type I glass vial, closed with a butyl rubber stopper and sealed with a crimped aluminium seal.

Special precautions for disposal and other handling

Physical and chemical compatibility testing indicate that INTEGRILIN may be administered through an intravenous line with atropine sulfate, dobutamine, heparin, lidocaine, meperidine, metoprolol, midazolam, ...

Marketing authorization holder

GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

Marketing authorization number(s)

EU/1/99/109/001

Date of first authorization / renewal of the authorization

Date of first authorisation: 01.07.1999 Date of latest renewal: 09.07.2009

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