natgillin/translations-raw huggingface dataset:
• diltiazem, verapamil, nifedipin, nisoldipin eller andre “calciumblokkere” (anvendes til behandling af højt blodtryk)
which are given with ritonavir) - midazolam, triazolam, alprazolam or other “benzodiazepines” (used as sedatives or muscle relaxants) - diltiazem, verapamil, nifedipine, nisoldipine or other “calcium channel blockers” (used to treat high blood pressure) - digoxin (used to treat heart failure) - Glipizide or other “sulfonylureas” (used to treat high blood sugar).
I forebyggelsesstudiernevarmiddelværdien ved steady-state for den gennemsnitlige koncentration af posaconazol (Cav) blandt tiunge (13-17år)ligeledessammenlignelig med Cav opnået hos voksne (≥18 år).
was comparable among ten adolescents (13-17 years of age) to Cav achieved in adults (≥ 18 years of age).
FARMACEUTISKEOPLYSNINGER
PHARMACEUTICAL PARTICULARS
Titandioxid(E171)
Polyvinyl alcohol-part hydrolyzed Titanium dioxide (E171) Macrogol
Posaconazole Accord tabletter og Posaconazole Accord oral suspension kan ikke udskiftes med hinanden
Non-Interchangeability between Posaconazole Accord tablets and posaconazole oral suspension
Fortæl lægen, apotekspersonalet eller sundhedspersonalet, hvis du opdager en eller flere af følgende bivirkninger:
Tell your doctor, pharmacist or nurse if you notice any of the side effects listed above.
Studie 316 var et randomiseret, dobbeltblindet studie af posaconazol oral suspension (200 mgtregange dagligt) versus fluconazolkapsler (400 mg en gang dagligt) til patienter medgraft versus hostsygdom(GVHD), der havde gennemgået allogen HSCT.Detprimærevirkningsendepunkt varforekomstafverificeret/sandsynligIFI16ugerefterrandomiseringbestemtafetuafhængigt,blindeteksternt ekspertpanel.
Study 316 was a randomised, double-blind trial of posaconazole oral suspension (200 mg three times a day) versus fluconazole capsules (400 mg once daily) in allogeneic hematopoietic stem cell transplant recipients with graft-versus-host disease (GVHD).
Gentagen administration af posaconazol oral suspension (400 mg to gange dagligt i 16 dage) øgedeCmaxogAUCforsirolimus(2mgenkeltdosis) med henholdsvis et gennemsnit på6,7 gangeog 8,9 gange (interval 3,1 til 17,5 gange) hos raske forsøgspersoner.
Repeat dose administration of posaconazole oral suspension (400 mg twice daily for 16 days) increased the Cmax and AUC of sirolimus (2 mg single dose) an average of 6.7-fold and 8.9-fold (range 3.1 to 17.5-fold), respectively, in healthy subjects.
Coccidioidomykose
Coccidioidomycosis
Samtidig administration med sekalealkaloider (se pkt.
Co-administration with ergot alkaloids (see section 4.5).
Behandling med posaconazol blev givet med en medianvarighed på 28 dage.20 patienter fik en daglig dosis på 200 mg, og 210 patienterfik en daglig dosis på 300 mg (efter dosering,to gange dagligt på dag 1i hver kohorte).
Twenty patients received 200 mg daily dose and 210 patients received 300 mg daily dose (following twice daily dosing on Day 1 in each cohort).
LÆGEMIDLETS NAVN Posaconazole Accord 100 mg gastroresistente tabletter
NAME OF THE MEDICINAL PRODUCT Posaconazole Accord 100 mg gastro-resistant tablets
Ikkeallepakningsstørrelserernødvendigvismarkedsført.
Not all pack sizes may be marketed.
Hvis samtidig administration er nødvendig, tilrådes nøje monitorering for tilbagevendendesvampeinfektioner.Gentagnedoseraffosamprenavir(700mgto gange dagligt i 10dage)nedsatte Cmaxog AUC for posaconazoloral suspension (200 mgengang dagligtpå dag 1, 200 mgto gangedagligtpådag2,derefter400 mgto gange dagligt i8 dage) med henholdsvis 21 %og 23 %.
Repeat dose administration of fosamprenavir (700 mg twice daily x 10 days) decreased the Cmax and AUC of posaconazole oral suspension (200 mg once daily on the 1st day, 200 mg twice daily on the 2nd day, then 400 mg twice daily x 8 Days) by 21% and 23%,
Posaconazol kan øge plasmakoncentrationen af sekalealkaloider (ergotamin og dihydroergotamin), somkanmedføreergotisme.Samtidigadministrationafposaconazologsekalealkaloidererkontraindiceret (se pkt.
Posaconazole may increase the plasma concentration of ergot alkaloids (ergotamine and dihydroergotamine), which may lead to ergotism.
Ingenkliniskrelevantvirkningblevobserveret,daposaconazoltabletterblevanvendtsammenmedsyreneutralis erendemidler, H2-receptorantagonisterogprotonpumpehæmmere.Dosisjusteringerafposaconazol tabletter er ikke nødvendige, når posaconazol tabletter anvendes sammen syreneutraliserendemidler, H2receptorantagonisterogprotonpumpehæmmere.
H2 receptor antagonists and proton pump inhibitors No clinically relevant effects were observed when posaconazole tablets are concomitantly used with antacids, H2-receptor antagonists and proton pump inhibitors.
Hepatocellulær ødelæggelse, hepatitis, gulsot, hepatomegali, kolestase, levertoksicitet, unormal leverfunktion
hepatocellular damage, hepatitis, jaundice, hepatomegaly, cholestasis, hepatic toxicity, hepatic function abnormal
• hvis du har haft en allergisk reaktion over for et andet svampemiddel såsom ketoconazol,
Talk to your doctor or pharmacist before taking Posaconazole Accord - if you have had an allergic reaction to another antifungal medicine such as ketoconazole,
Initialdosis på 300 mg (tre 100 mgtabletter)togangedagligtpåden første dag, herefter 300 mg (tre 100 mg tabletter) en gangdagligt.
Loading dose of 300 mg (three 100 mg tablets) twice a day on the first day, then 300 mg (three 100 mg tablets) once a day thereafter.
PosaconazolerenpotenthæmmerafCYP3A4.SamtidigadministrationafposaconazologCYP3A4-substrater kan resultere i en stor stigning i eksponering for CYP3A4-substrater som eksemplificeretnedenfor ved virkningenpåtacrolimus,sirolimus,atazanavirogmidazolam.Forsigtighedbørudvisesunder samtidig administration af posaconazol og CYP3A4-substrater administreret intravenøst, og derkanværebehovfor,atdosisafCYP3A4-substratet reduceres.
Co-administration of posaconazole with CYP3A4 substrates may result in large increases in exposure to CYP3A4 substrates as exemplified by the effects on tacrolimus, sirolimus, atazanavir and midazolam below.
Iet ikke-sammenlignende studie med salvage-behandling (studie 0041) blev posaconazol oralsuspension 800 mg dagligt fordelt på flere doser vurderet som behandling af invasiv aspergillose hos patienter,somvarsygdomsrefraktæreoverforbehandlingmedamphotericin B (inklusiveliposomformuleringer) eller itraconazol eller hos patienter, der havde intolerans over for disse lægemidler.
Oral posaconazole suspension 800 mg/day in divided doses was evaluated for the treatment of invasive aspergillosis in patients with disease refractory to amphotericin B (including liposomal formulations) or itraconazole or in patients who were intolerant of these medicinal products in a noncomparative salvage therapy trial (Study 0041).
Opkastning, abdominalsmerte, diarré, dyspepsi, mundtørhed, flatulens, obstipation, anorektale gener
vomiting, abdominal pain, diarrhoea, dyspepsia, dry mouth, flatulence, constipation, anorectal discomfort
Som følge af risikoen for forlænget sedering og mulig respirationsdepression bør samtidig administrationafposaconazologbenzodiazepiner,sommetaboliseresafCYP3A4(f.eks.midazolam,triazolam,
Due to the risk of prolonged sedation and possible respiratory depression co-administration of posaconazole with any benzodiazepines metabolised by CYP3A4 (e.g. midazolam, triazolam, alprazolam) should only be considered if clearly necessary.
Plasmakoncentrationen af posaconazolergenerelthøjereefteradministration af posaconazol tabletterend efter posaconazol oral suspension.
Posaconazole plasma concentrations following administration of posaconazole tablets are generally higher than those obtained with posaconazole oral suspension.
Hæmmere (f.eks. verapamil, ciclosporin, quinidin,chlarithromycin,erythromycin osv.)eller induktorer (f.eks. rifampicin, rifabutin, visse antiepileptikaosv.)
Therefore, inhibitors (e.g. verapamil, ciclosporin, quinidine, clarithromycin, erythromycin, etc.) or inducers (e.g. rifampicin, rifabutin, certain anticonvulsants, etc.) of these clearance pathways may increase or decrease posaconazole plasma concentrations, respectively.
Azolantimykotika, inklusive posaconazol, bør kun anvendes til patienter,der fårvinkaalkaloider,inklusivevincristin, ogsom ikke har andre muligheder for behandling med antimykotika (se pkt.
Reserve azole antifungals, including posaconazole, for patients receiving a vinca alkaloid, including vincristine, who have no alternative antifungal treatment options (see section 4.5).
Posaconazol oral suspension 200 mg en gang dagligt øgede koncentrationerne af ciclosporin hos hjertetransplanteredepatienterpåenstabildosisafciclosporin, hvilketmedførtebehovfordosisnedsættelser.
In heart transplant patients on stable doses of ciclosporin, posaconazole oral suspension 200 mg once daily increased ciclosporin concentrations requiring dose reductions.
Gastroresistenttablet
Gastro-resistant tablet
Farmakokinetikkenforposaconazoltabletterersammenlignelighosungeogældreforsøgspersoner.Der blev ikke observeret nogen generelle forskelle i sikkerheden hos de ældre patienter og de yngrepatienter.
No overall differences in safety were observed between the geriatric patients and younger patients; therefore, no dosage adjustment is recommended for geriatric patients.
Lad derfor være med at give medicinentilandre.
Do not pass it on to others.
Efter samtidig administration af posaconazol oral suspension (400 mg to gange dagligt) og atazanavir (300 mg en gang dagligt) i 7 dage hos raske forsøgspersoner øgedesCmaxogAUCforatazanavirmedetgennemsnit påhenholdsvis2,6gange og 3,7gange(interval 1,2til26 gange).
Following co-administration of posaconazole oral suspension (400 mg twice daily) with atazanavir (300 mg once daily) for 7 days in healthy subjects Cmax and AUC of atazanavir increased by an average of 2.6-fold and 3.7-fold (range 1.2 to 26-fold respectively.
Efter samtidig administration af posaconazol oral suspension (400 mgtogangedagligt) ogatazanavirog ritonavir (300/100 mg en gangdagligt) i 7 dage hos raskeforsøgspersoner øgedes CmaxogAUCforatazanavirmedetgennemsnitpåhenholdsvis1,5gange og 2,5gange (interval 0,9til 4,1 gange).
Following co-administration of posaconazole oral suspension (400 mg twice daily) with atazanavir and ritonavir (300/100 mg once daily) for 7 days in healthy subjects Cmax and AUC of atazanavir increased by an average of 1.5-fold and 2.5-fold (range 0.9 to 4.1-fold), respectively.
Amning skal ophøre ved påbegyndelse af behandling medposaconazol.
Breast-feeding must be stopped on initiation of treatment with posaconazole.
Invasivaspergillose
Invasive aspergillosis
Se også nedenfor vedrørende virkningenafposaconazolpåplasmaniveauerafrifabutin.
See also below regarding the effect of posaconazole on rifabutin plasma levels.
Posaconazole Accord 100 mg gastroresistente tabletter posaconazol
Posaconazole Accord 100 mg gastro-resistant tablets posaconazole
Calciumantagonister metaboliseret via CYP3A4 (f.eks. diltiazem, verapamil, nifedipin, nisoldipin) Der anbefales hyppig monitorering for bivirkninger og toksicitet relateret til calciumantagonister ved administration sammen med posaconazol.
Calcium channel blockers metabolised through CYP3A4 (e.g. diltiazem, verapamil, nifedipine, nisoldipine)
Hvis du har taget for meget Posaconazole Accord Kontakt lægen, skadestuen eller apoteket, hvis du har tagetmere af Posaconazole Accord, end der står i denne information, eller mere end lægen har foreskrevet (og du føler dig utilpas).
If you take more Posaconazole Accord than you should If you think that you may have taken too much Posaconazole Accord, talk to a doctor or go to the hospital straight away.
Posaconazol var ikke genotoksisk iinvitro-og invivo-studier.Karcinogenicitetsstudier viste ingenspeciel risiko for mennesker.
Posaconazole was not genotoxic in in vitro and in vivo studies.
Efter administration af tabletterne elimineres posaconazol langsomt med en gennemsnitlighalveringstid(t½) på 29 timer (26-31 timer) og en gennemsnitlig tilsyneladende udskillelsei intervallet7,5 til 11 l/time.Efter administration af 14C-posaconazol blev radioaktiviteten hovedsagelig genfundet i fæces (77 % af den radioaktivt mærkede dosis) heraf hovedparten som uforandret lægemiddel (66 % af den radioaktivt mærkede dosis).
After administration of 14C-posaconazole, radioactivity was predominantly recovered in the faeces (77% of the radiolabelled dose) with the major component being parent compound (66% of the radiolabelled dose).
Fra 173 raske mandlige og kvindelige forsøgspersoner i alderen 18til85 år blev der før og under administration af posaconazol oral suspension (400 mg to gange dagligt med et fedtrigt måltid)indsamletfleretidsmæssigtsammenligneligeekg'eroverenperiodepå12 timer.
Multiple, time-matched ECGs collected over a 12 hour period were obtained before and during administration of posaconazole oral suspension (400 mg twice daily with high fat meals) from 173 healthy male and female volunteers aged 18 to 85 years.
Tal straks med lægen, apotekspersonalet eller sundhedspersonalet, hvis du får alvorlig diarré eller kaster op, mens du tager Posaconazole Accord, da dette kan medføre, at det ikke virker ordentligt.
If you develop severe diarrhoea or vomiting (being sick) while taking Posaconazole Accord, talk to your doctor, pharmacist or nurse straight away, as this may stop it from working properly.
Rygsmerter, nakkesmerter, muskuloskeletale smerter, ekstremitetssmerter
back pain, neck pain, musculoskeletal pain, pain in extremity
Øjne Ikke almindelig
Eye disorders Uncommon:
ProfylakseforAML og HSCT
Prophylaxis in AML and HSCT Study 5615
6.6 Reglerforbortskaffelse
6.6 Special precautions for disposal
Luftveje, thorax og mediastinum Ikke almindelig
pulmonary embolism, deep vein thrombosis Respiratory, thoracic and mediastinal disorders Uncommon:
Kombinationsbehandling med antimykotika bør ikke nedsætte virkningen af hverken posaconazol eller de andre lægemidler.
The use of combination antifungal therapies should not decrease the efficacy of either posaconazole or the other therapies; however, there is currently no clinical evidence that combination therapy will provide an added benefit.
Pædiatrisk population Der foreligger ingen erfaring med posaconazol-tabletter til børn.
There is no paediatric experience for posaconazole tablets.
Fusarium-arter
Fusarium spp.
Tabel4.
Table 4.
HMG-CoA reduktasehæmmere metaboliseret via CYP3A4 (f.eks. simvastatin, lovastatin ogatorvastatin) PosaconazolkanøgeplasmaniveauerneafHMG-CoA reduktasehæmmere, som metaboliseres afCYP3A4,betydeligt.BehandlingmeddisseHMG-CoAreduktasehæmmere bør seponeres underbehandling med posaconazol, da forhøjede niveauer har været forbundet med rhabdomyolyse (sepkt.
Treatment with these HMG-CoA reductase inhibitors should be discontinued during treatment with posaconazole as increased levels have been associated with rhabdomyolysis (see section 4.3).
Nedsat leverfunktion, kolestatisk hepatitis, hepatosplenomegali, leverømhed, asterixis
hepatic failure, hepatitis cholestatic, hepatosplenomegaly, liver tenderness, asterixis Skin and subcutaneous tissue disorders Common:
Tag altid lægemidletnøjagtigt efter lægens ellerapotekspersonalets anvisning.Erdu i tvivl,såspørglægen eller apotekspersonalet.
Always take this medicine exactly as your doctor or pharmacist has told you.
Rifamycin antibakterielle midler (rifampicin, rifabutin), visse antiepileptika (phenytoin,carbamazepin, phenobarbital, primidon) og efavirenz Koncentrationenafposaconazolkanværebetydeligtnedsatvedkombination.Samtidigbehandlingmed posaconazol bør derfor undgås, medmindre fordelen for patienten opvejer risikoen (se pkt.4.5).
Rifamycin antibacterials (rifampicin, rifabutin), certain anticonvulsants (phenytoin, carbamazepine, phenobarbital, primidone), and efavirenz
Ødem, smerte, kuldegysninger, utilpashed, ubehag i brystet, lægemiddeloverfølsomhed, rastløshed, slimhindebetændelse
oedema, pain, chills, malaise, chest discomfort, drug intolerance, feeling jittery, mucosal inflammation
Af hensyn til miljøet må du ikkesmide medicinresteriafløbet,toilettetellerskraldespanden.
Do not throw away any medicines via wastewater or household waste.
Hoste, næseblod, hikke, tilstoppet næse, pleurale smerter, hurtig vejrtrækning
cough, epistaxis, hiccups, nasal congestion, pleuritic pain, tachypnoea
Plasmakoncentrationen af posaconazolkanmedtidenstigehosnogle patienter, der får posaconazol tabletter (se pkt.
Posaconazole plasma concentrations following administration of posaconazole tablets may increase over time in some patients (see section 5.2).
Blødning i mave/tarm, ileus
gastrointestinal haemorrhage, ileus
Hvis der er kliniske tegn og symptomer på udvikling af leversygdom, bør seponeringaf Posaconazole Accord overvejes.
Discontinuation of Posaconazole Accord should be considered if clinical signs and symptoms are consistent with development of liver disease.
NydiagnosticeretAML var denhyppigsteunderliggende sygdom(435/602, [72 %]).Den gennemsnitligebehandlingsvarighed var 29 dageforposaconazolog25 dage forfluconazol/itraconazol.
The mean duration of therapy was 29 days for posaconazole and 25 days for fluconazole/itraconazole.
• endetarmsgener.
Fixed-time periodc
- Kontakt lægen, apotekspersonalet eller sundhedspersonalet, hvis du får bivirkninger,
Other side effects Tell your doctor, pharmacist or nurse if you notice any of the following side effects:
Tungeødem, ansigtsødem
Hepatic impairment
De hyppigst rapporterede alvorlige bivirkningererkvalme,opkastning,diarré, pyreksi og øgetbilirubinniveau.Sikkerheden af posaconazol tabletter er vurderet hos 336 patienter og raske frivillige forsøgspersoner i kliniske studier.
The safety of posaconazole tablet has been assessed in 336 patients and healthy volunteers enrolled in clinical trials.
Posaconazole Accord kan anvendes hos voksne til behandling af følgende svampeinfektioner, når andre svampemidlerikkeharvirket,ellerduvarnødt til at stoppe med at tage dem:
Posaconazole Accord can increase the amount of these medicines in the blood which may lead to very serious changes to your heart rhythm: - any medicines that contain “ergot alkaloids” such as ergotamine or dihydroergotamine used to treat migraines.
Dette lægemiddel kan også anvendes til at forebygge svampeinfektioner hos voksne,som har en højrisiko for at få en svampeinfektion, f.eks.:
This medicine can also be used to prevent fungal infections in adults who are at high risk of getting a fungal infection, such as: - patients who have a weak immune system due to having chemotherapy for “acute myelogenous leukemia” (AML) or “myelodysplastic syndromes” (MDS) - patients having “high- dose immunosuppressive therapy” after “hematopoietic stem cell transplant” (HSCT).
Posaconazole Accord indeholder:
What Posaconazole Accord is and what it is used for
• anæmiogetlavthæmoglobinniveau(fremgårafdineblodprøver) - tegnpådettekanværehovedpine, træthed eller svimmelhed,åndenødellerbleghed
- inability to sleep (insomnia) - being completely or partially unable to talk - swelling of the mouth - abnormal dreams, or difficulty sleeping - problems with co-ordination or balance - mucosal inflammation - stuffy nose - difficulty breathing - chest discomfort - feeling bloated - mild to severe nausea, vomiting, cramps and diarrhoea, usually caused by a virus, stomach pain - belching - feeling jittery
- Integrilin er ikke beregnet til anvendelse hos børn eller unge under 18 år.
− Integrilin is not intended for use in children or adolescents less than 18 years of age.
INTEGRILIN bør ikke anvendes under graviditet, medmindre det er klart nødvendigt.
INTEGRILIN should not be used during pregnancy unless clearly necessary.
INTEGRILIN er ikke forligeligt med furosemid.
INTEGRILIN is not compatible with furosemide.
Integrilin anbefales normalt ikke til brug under graviditet.
Integrilin is not usually recommended for use during pregnancy.
0,034a a: Pearson's chi-square test af difference mellem placebo og eptifibatid.
0.034a a: Pearson's chi-square test of difference between placebo and eptifibatide.
Hyppigheden af dødsfald/CEC-vurderede MI (“Behandlet som randomiseret” population)
Incidence of Death/CEC-Assessed MI («Treated as Randomised» Population)
Graden af eptifibatid binding til humant plasmaprotein er omkring 25 %.
The extent of eptifibatide binding to human plasma protein is about 25 %.
Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent published on the European medicines web-portal.
- Under brugen af Integrilin vil du blive omhyggeligt undersøgt for tegn på usædvanlig eller uventet blødning.
− During use of Integrilin, you will be checked carefully for any signs of unusual or unexpected bleeding.
INTEGRILIN-behandlede patienter, der havde en protrombintid (PT) > 14,5 sekunder og fik warfarin samtidig, syntes ikke at have øget risiko for blødning.
INTEGRILIN-treated patients who had a prothrombin time (PT) > 14.5 seconds and received warfarin concomitantly did not appear to be at an increased risk of bleeding.
Tabel 1.
Table 1
GUSTO svær/livstruende blødning var ikke almindelig og sammenlignelig i de to behandlingsgrupper (0,8 %).
GUSTO severe/life threatening bleeding was uncommon and comparable in both treatment groups (0.8%).
Lægen vil opveje fordelene for dig ved at få Integrilin, mens du er gravid, op mod risikoen for dit ufødte barn.
Your doctor will weigh up the benefit to you against the risk to your baby of using Integrilin while you are pregnant.
Der er ingen erfaringer med INTEGRILIN og lavmolekylære hepariner.
There is no experience with INTEGRILIN and low molecular weight heparins.
Hvis der forekommer alvorlig blødning, der ikke kan kontrolleres med tryk, skal infusionen med INTEGRILIN og eventuel ufraktioneret heparin, der gives samtidig, stoppes øjeblikkeligt.
If serious bleeding occurs that is not controllable with pressure, the INTEGRILIN infusion should be stopped immediately and any unfractionated heparin that is given concomitantly.
En øget risiko for blødning kan også observeres hos patienter, som får tidlig administration af INTEGRILIN (f.eks. ved diagnosticeringen) sammenlignet med patienter, som får det umiddelbart før PCI, som set i EARLY ACS-forsøget.
An increased risk of bleeding may also be observed in patients who receive early administration of INTEGRILIN (e.g. upon diagnosis) compared to receiving it immediately prior to PCI, as seen in the Early ACS trial.
INTEGRILIN er også beregnet til anvendelse samtidig med acetylsalicylsyre, idet dette er en del af standardbehandlingen af patienter med akutte koronarsyndromer, medmindre anvendelse er kontraindiceret.
INTEGRILIN is also intended for concurrent use with acetylsalicylic acid, as it is part of standard management of patients with acute coronary syndromes, unless its use is contraindicated.
Meget almindelig (≥1/10), Almindelig (≥1/100 til <1/10), Ikke almindelig (≥1/1000 til <1/100), Sjælden (≥1/10.000 til <1/1000), Meget sjælden (<1/10.000), Ikke kendt (kan ikke estimeres ud fra tilgængelige data).
Frequencies are defined as very common (≥1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000).
Trombocytopeni, der opstår efter første eksponering for en GP-IIb/IIIa-hæmmer, kan måske forklares ved det faktum, at antistoffer er naturligt til stede hos nogle normale individer.
Thrombocytopaenia occurring after first exposure to a GPIIb/IIIa inhibitor may be explained by the fact that antibodies are naturally present in some normal individuals.
- Før og under din behandling med Integrilin, vil du få taget blodprøver, der skal undersøges, for at begrænse risikoen for en uventet blødning.
− Before and during your treatment with Integrilin, samples of your blood will be tested as a safety measure to limit the possibility of unexpected bleeding.