Aggrastat

Main information

  • Trade name:
  • Aggrastat 0.25 mg/mL Concentrate for infusion
  • Dosage:
  • 0.25 mg/mL
  • Pharmaceutical form:
  • Concentrate for infusion
  • Units in package:
  • Vial, glass, 50 mL
  • Class:
  • Prescription
  • Prescription type:
  • Prescription
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug
  • Manufactured by:
  • Cadila Healthcare Ltd

Documents

Localization

  • Available in:
  • Aggrastat 0.25 mg/mL Concentrate for infusion
    New Zealand
  • Language:
  • English

Other information

Status

  • Source:
  • Medsafe - Medicines Safety Authority - New Zealand
  • Authorization number:
  • 6853
  • Authorization date:
  • 18-11-1997
  • Last update:
  • 27-09-2017

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

Consumer MedicineInformation

INFORMATIONFORCONSUMERS

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Singledosevial

tirofiban hydrochloride

Whatisinthisleaflet

ThisleafletanswerssomecommonquestionsaboutAGGRASTAT.Itdoesnotcontainalltheavailable

information.

Itdoesnottaketheplaceoftalkingto yourdoctororpharmacist.

All medicineshaverisksandbenefits.YourdoctorhasweighedtherisksofyouusingAGGRASTATagainst

thebenefitstheyexpectitwillhave foryou.

Ifyouhaveanyconcernsaboutbeinggiventhismedicine,askyourdoctororpharmacist.

Keep thisleaflet.Youmayneedto readitagain.

WhatAGGRASTATisusedfor

AGGRASTAT,incombination withheparin(anothermedicineusedtopreventbloodclots),isusedto prevent

complicationsthatmayoccurin peoplewhohaveunstable angina(atype ofchestpain)orarehavingaheart

attack.

AGGRASTATbelongstoagroupofmedicinescalledplateletaggregationinhibitors.

Itworksbypreventing cellsin theblood,calledplatelets,fromstickingtogethertoformbloodclots.Ifblood

clotsarenottreatedorprevented,theycanblockbloodvessels.Thiscan leadtocomplicationssuchas

anginaorheartattacks.

BeforeyouaregivenAGGRASTAT

When you must notbegiven it

Do notuseAGGRASTATifyou have an allergytoAGGRASTAToranyoftheingredientslistedattheendof

thisleaflet.

DonotuseAGGRASTATifyouhaveanyofthefollowingmedicalconditions:

bleedinginsideyourbody

a historyofbleedinginthebrain

a historyofbraintumour

a historyofabnormalordeformedarteriesorveins

a historyofswellingandweakeningofapartofa bloodvessel,also calledaneurysm

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month

l ahistory,symptomsorsignsoraorticdisection,a diseaseofalargebloodvessel

l severe,uncontrolledhighbloodpressure

l pericarditis,acondition whichinvolvesswellingofthe lining thatsurroundstheheart.

Do notuseAGGRASTATifyou have receivedAGGRASTATbeforeanddevelopedalowplateletcount.

IfyouarenotsurewhetheryouhavereceivedAGGRASTATbefore anddevelopedalowplateletcount,ask

yourdoctor.

Donotuse AGGRASTATifhave conditionsthatrequiretreatmentwithmedicinestodissolvebloodclots.

Do notuseAGGRASTATifyou arebreast-feedingorintendtobreast-feed.

AGGRASTATisnotrecommendedforusewhilebreast-feeding.Itisnotknown whetheritpassesintobreast

milk.

Do notuseAGGRASTATin children.

Thesafetyandeffectivenessinchildrenhavenotbeen established.

IfyouarenotsurewhetheryoushouldstartreceivingAGGRASTAT,talktoyourdoctor.

Before you are given it

Tellyourdoctorif:

you arepregnant

Likemostmedicines,AGGRASTATisgenerallynotrecommendedduringpregnancy.However,ifthere

isaneedtoconsiderusing AGGRASTATduring pregnancy,yourdoctorwilldiscussthepossiblerisks

andbenefitsto you andyourunborn baby.

you haveorhavehadanymedicalconditions,especiallythefollowing:

anybleedingproblems,includingstomachbleeding,orbloodinyoururineorstools,withinthe

lastyear

bloodclottingproblemsorplateletdiseases,includinglowplateletcount

diseaseofthebloodvesselsofthebrain,includingstroke,withinthe lastyear

problemswiththebloodvesselsinthebackofyoureye/s

kidneydisease

a recentspinal/epiduralprocedure.

ifyouhaveanyallergiestoanyothermedicinesoranyothersubstances,suchasfoods,preservatives

ordyes.

Ifyouhavenottoldyourdoctoraboutanyoftheabove,tell thembefore youaregivenAGGRASTAT.

Taking othermedicines

Tellyourdoctorifyou aretakinganyothermedicines,includingmedicinesthatyoubuywithoutaprescription

fromyourpharmacy,supermarketorhealthfoodshop.SomemedicinesandAGGRASTATmayinterferewith

each other.Thisincludesmedicinesusedtodissolveorpreventbloodclots,includingwarfarin.

ThesemedicinesmaybeaffectedbyAGGRASTAT,ormayaffecthowwell itworks.Youmayneeddifferent

amountsofyourmedicine,oryou mayneedtotakedifferentmedicines.

Yourdoctororpharmacisthasmoreinformationonmedicinestobecarefulwith orto avoidwhilebeinggiven

AGGRASTAT.

HowAGGRASTATisgiven

AGGRASTATisgivenasa slowinjectionintoa vein.

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Yourdoctorwilldecide whatdoseandhowlongyou willreceiveAGGRASTAT.Thisdependsonyour

condition,theprocedure you'rehavingandotherfactors,suchasyourweightandkidneyfunction.

AdverseEffects

Tellyourdoctor,nurse,orpharmacistassoonaspossibleifyoudonotfeelwell whileyouarebeinggiven

AGGRASTAT.

AGGRASTAThelpsmostpeople,butitmayhaveunwantedadverseeffectsin afewpeople.Allmedicines

can haveadverseeffects.Sometimestheyareserious,mostofthetime theyarenot.You mayneedmedical

treatmentifyougetsomeoftheadverseeffects.

Askyourdoctororpharmacisttoansweranyquestionsyoumayhave.

Tellyourdoctorornurseimmediatelyifyou noticeanyunusual bleedingorbruising.

Thisincludesbleeding gums,nosebleeds,bloodinyoururine,bloodyorblack,tarrystools,coughingup

blood,vomiting bloodormaterial thatlookslike coffeegrounds.

Thesemaybe seriousadverseeffectsofAGGRASTAT.Youmayneedurgentmedicalattention.

Tellyourdoctorornurseifyounoticeanyofthefollowingandtheyworryyou:

fever

nausea

headache

rashorallergicreaction.

TheseareusuallymildadverseeffectsofAGGRASTAT.

Otheradverseeffectsnotlistedabovemayalso occurinsomepatients.Tellyourdoctorifyounoticeany

othereffects.

Do notbealarmedbythislistofpossibleadverse effects.Youmaynotexperience anyofthem.

Storage

AGGRASTATwillbe storedinthe pharmacyorontheward.

Thesolutioniskeptinacool,dryplacewhere thetemperaturestaysbelow30°Candwhere itisprotected

fromlight.

ProductDescription

What itlooks like

AGGRASTATConcentrateforInfusioncomesin aglassvial,containing 50 mLofsolution.

Ingredients

Activeingredients:

AGGRASTATConcentrateforInfusion-0.25mgoftirofibanpermL.

Inactiveingredients:

citricacidanhydrous

sodiumcitrate dihydrate

sodiumchloride

waterforinjections

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AGGRASTATissuppliedinNewZealandby:

MerckSharp &Dohme(NewZealand)Limited

POBox99851

Newmarket

Auckland

Tel:0800500673

Thisleafletwaspreparedon 13 November2001

CP-ARS-1001-(131101)

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12-6-2018

EU/3/10/811 (Celgene Europe B.V.)

EU/3/10/811 (Celgene Europe B.V.)

EU/3/10/811 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3809 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/092/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/10/810 (Celgene Europe B.V.)

EU/3/10/810 (Celgene Europe B.V.)

EU/3/10/810 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3808 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/084/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/10/794 (Celgene Europe B.V.)

EU/3/10/794 (Celgene Europe B.V.)

EU/3/10/794 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3803 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/069/10/T/03

Europe -DG Health and Food Safety