natgillin/translations-raw huggingface dataset:
Patienterne rådes til ikke at køre bil eller betjene maskiner, medens de tager Xagrid, hvis de oplever svimmelhed.
Patients are advised not to drive or operate machinery while taking Xagrid if dizziness is experienced.
Sikkerheden for anagrelid er undersøgt i 4 kliniske open- label forsøg.
The safety of anagrelide has been examined in 4 open label clinical studies.
2 mg/ dag, vurderet for sikkerhed.
In 3 of the studies 942 patients who received anagrelide at a mean dose of approximately 2mg/ day were assessed for safety.
2 mg/ dag, vurderet for sikkerhed.
In the later study 3660 patients who received anagrelide at a mean dose of approximately 2mg/ day were assessed for safety.
6%, og diare forekom med 5%.
The most commonly reported drug related adverse reactions were headache occurring at approximately 14%, palpitations occurring at approximately 9%, fluid retention and nausea both occurring at approximately 6%, and diarrhoea occurring at 5%.
Disse negative lægemiddelreaktioner forventes på basis af anagrelids farmakologi (hæmning af PDE III).
These adverse drug reactions are expected based on the pharmacology of anagrelide (inhibition of PDE III).
Gradvis dosistitrering kan måske være med til at formindske disse virkninger (se pkt.
Gradual dose titration may help diminish these effects (see section 4.2).
Følgende konvention blev brugt for hyppigheden af negative lægemiddelreaktioner: meget almindelige (> 1/ 10); almindelige (> 1/ 100, < 1/ 10); ualmindelige (> 1/ 1, 000, < 1/ 100), sjældne (> 1/ 10, 000, < 1/ 1, 000); ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
The following convention was used for frequency of adverse drug reactions: very common (> 1/ 10); common (> 1/ 100 ,< 1/10); uncommon (> 1/1 ,000, < 1/100); rare (> 1/10,000, < 1/ 1,000); not known (cannot be estimated from the available data).
Lidelser i blod og lymfesystem Almindelige:
Blood and lymphatic system disorders Common:
Anæmi Ualmindelige:
Uncommon:
Trombocytopeni, pancytopeni, ecchymose, blødning
Anaemia Thrombocytopenia, pancytopenia, ecchymosis, haemorrhage
Metabolisme og ernæringslidelser Almindelige:
Metabolism and nutrition disorders Common:
Væskeophobning Ualmindlige:
Uncommon:
Ødemer, vægttab Sjældne:
Rare:
Vægtforøgelse
Fluid retention Oedema, weight loss Weight gain
Lidelser i nervesystemet Meget almindelige:
Nervous system disorders Very common:
Hovedpine Almindelige:
Headache Common:
Svimmelhed Ualmindelige:
Uncommon:
Paræstesi, søvnløshed, depression, forvirring, hypoæstesi, nervøsitet, tør mund, amnesi Sjældne:
Dizziness Paraesthesia, insomnia, depression, confusion, hypoaesthesia, nervousness, dry mouth, amnesia
Somnolens, unormal koordination, dysartri, migræne
Somnolence, abnormal coordination, dysarthria, migraine
Særlige sanser
Special senses
Synsforstyrrelser, tinnitus, diplopi
Vision abnormal, tinnitus, diplopia
Hjertelidelser
Cardiac disorders Common:
Almindelige:
Palpitations, tachycardia
Hjertebanken, takykardi Ualmindelige:
5 Uncommon:
Angina pectoris, myokardial infarkt, kardiomegali, kardiomyopati, perikardial effusion, vasodilatation, postural hypotension
Congestive heart failure, hypertension, arrhythmia, atrial fibrillation, supraventricular tachycardia, ventricular tachycardia, syncope
5
Rare:
Lidelser i åndedræt og thorax Ualmindelige:
Angina pectoris, myocardial infarction, cardiomegaly, cardiomyopathy, pericardial effusion, vasodilatation, postural hypotension
Dyspnø, epitaksis, pleural effusion, lungebetændelse Sjældne:
Rare:
Pulmonal hypertension, pulmonal infiltration Allergisk alveolitis
Dyspnoea, epistaxis, pleural effusion, pneumonia Pulmonary hypertension, pulmonary infiltrates Allergic alveolitis
Gastrointestinale lidelser Almindelige:
Gastrointestinal disorders Common:
Kvalme, diare, mavesmerter, flatulens, opkastning Ualmindelige:
Uncommon:
Dyspepsi, anorexi, pancreatitis, konstipation, gastrointestinal blødning, gastrointestinal lidelse Sjældne:
Nausea, diarrhoea, abdominal pain, flatulence, vomiting Dyspepsia, anorexia, pancreatitis, constipation, gastrointestinal haemorrhage, gastrointestinal disorder
Colitis, gastritis, gingival blødning
Colitis, gastritis, gingival bleeding
Sygdomme i lever og galdeveje Ualmindelige:
Hepatobiliary disorders Uncommon:
Hud og subkutant væv Almindelige:
Skin and subcutaneous tissue Common:
Udslæt Ualmindelige:
Rare:
Alopecia, misfarvning af huden, pruritus Sjældne:
Rash Alopecia, skin discoloration, pruritus Dry skin
Tør hud
Musculoskeletal and connective tissue disorders Uncommon:
Musculoskeletale lidelser og bindevævslidelser Ualmindelige:
Myalgia, arthralgia, back pain
Myalgi, arthralgi, rygsmerter
Urogenital
Urogenitale lidelser Ualmindelige:
Uncommon:
Impotens Sjældne:
Rare:
Nocturia, nyresvigt
Impotence Nocturia, renal failure
Sjældne:
Investigations Rare:
Generelle lidelser og tilstande på indgivelsesstedet Almindelige:
General disorders and administration site conditions Common:
Træthed Ualmindelige:
Uncommon:
Brystsmerter, svaghed, kuldegysninger, utilpashed, feber Sjældne:
Rare:
Astæni, smerte, influenzalignende symptomer
Fatigue Chest pain, weakness, chills, malaise, fever Asthenia, pain, flu-like syndrome
Der er efter markedsføringen rapporteret om et lille antal tilfælde af tilsigtet overdosering af anagrelide.
There have been a small number of post-marketing case reports of intentional overdose with anagrelide.
Doseringen bør nedsættes eller afbrydes efter behov, til blodpladetallet er tilbage i det normale interval.
Dosage should be decreased or stopped, as appropriate, until the platelet count returns to within the normal range.
Xagrid givet ved højere doser end de anbefalede har fremkaldt fald i blodtryk med lejlighedsvise tilfælde af hypotension.
Xagrid, at higher than recommended doses, has been shown to produce reductions in blood pressure with occasional instances of hypotension.
En enkelt 5 mg dosis anagrelid kan føre til et fald i blodtrykket, normalt ledsaget af svimmelhed.
A single 5mg dose of anagrelide can lead to a fall in blood pressure usually accompanied by dizziness.
L01XX35 (Andre antineoplastiske midler)
L01XX35 (Other Antineoplastic Agents)
Den specifikke måde, hvorpå anagrelid reducerer antallet af blodplader, er ikke fuldt forstået, men det er bekræftet, at anagrelid er et blodplade selektiv på basis af oplysninger fra in vitro og in vivo undersøgelser.
The specific mechanism of action by which anagrelide reduces platelet count is not yet fully understood although it has been confirmed that anagrelide is platelet selective from in vitro and in vivo study information.
In vitro undersøgelser af human megakaryocytopoiese har fastslået, at anagrelids hæmmende virkning på dannelsen af blodplader hos mennesker fremkaldes via forsinkelse af modningen af megakaryocytter, og ved at reducere deres størrelse og ploidi.
In vitro studies of human megakaryocytopoiesis established that anagrelide’ s inhibitory actions on platelet formation in man are mediated via retardation of maturation of megakaryocytes, and reducing their size and ploidy.
Anagrelids sikkerhed og virkning som et middel til reduktion af blodpladerne er vurderet i fire open - label, ikke- kontrollerede kliniske undersøgelser (undersøgelsesnummer 700- 012, 700- 014, 700- 999 og 13970- 301), der omfattede mere end 4000 patienter med myeloproliferative sygdomme (MPD).
The safety and efficacy of anagrelide as a platelet lowering agent have been evaluated in four open- label, non-controlled clinical trials (study numbers 700-012, 700-014, 700-999 and 13970-301) including more than 4000 patients with myeloproliferative disorders (MPDs).
Hos patienter med essentiel trombocytæmi blev komplet respons defineret som et fald i blodpladetallet til ≤600 x109/ l eller en ≥50% reduktion i forhold til baseline og opretholdelse af reduktionen i mindst 4 uger.
In patients with essential thrombocythaemia complete response was defined as a decrease in platelet count to ≤ 600 x 109/ l or a ≥ 50% reduction from baseline and maintenance of the reduction for at least 4 weeks.
I undersøgelserne 700- 012, 700- 014, 700- 999 og undersøgelse 13970- 301 varierede tiden til komplet respons fra 4 til 12 uger.
In studies 700- 012, 700-014, 700-999 and study 13970-301 the time to complete response ranged from 4 to 12 weeks.
Et klinisk open- label forsøg med en 3 måneders behandlingsperiode gav ikke anledning til bekymring med hensyn til sikkerheden af anagrelid hos 17 børn/ yngre patienter med ET (i alderen 7- 14 år) sammenlignet med 18 voksne patienter.
An open label clinical study with a 3 month treatment period did not raise any safety concerns for anagrelide in 17 children/ adolescent patients with ET (age range 7-14 years) compared to 18 adult patients.
På et tidligere trin i den kliniske udvikling blev et begrænset antal (12) børn (i alderen 5- 17 år) med essentiel trombocytæmi behandlet med anagrelid.
Earlier during clinical development a limited number (12) of children (age range 5 - 17 years) with essential thrombocythaemia were treated with anagrelide.
1, 3 time.
In fasted subjects, peak plasma levels occur about 1 hour after a 0.5mg dose; the plasma half- life is short, approximately 1.3 hours.
Dosisproportionalitet er fundet i dosisintervallet 0, 5 mg til 2 mg.
Dose proportionality has been found in the dose range 0.5mg to 2mg.
Anagrelid metaboliseres primært ved CYP1A2; under 1% genfindes i urinen som anagrelid.
Anagrelide is primarily metabolised by CYP1A2; less than 1% is recovered in the urine as anagrelide.
Der er identificeret to vigtige urin metabolitter, 2- amino- 5, 6- dichloro- 3, 4- dihydroquinazolin og N - (5, 6 - dichloro- 3, 4- dihydroquinazalin- 2- yl) - 2- oxoacetamid.
Two major urinary metabolites, 2-amino-5, 6-dichloro-3, 4-dihydroquinazoline and N-(5,6-dichloro- 3,4-dihydroquinazalin-2-yl)-2-oxoacetamide have been identified.
18- 35% af den indgivne dosis.
The mean recovery of 2-amino-5, 6-dichloro-3, 4-dihydroquinazoline in urine is approximately 18-35% of the administered dose.
Farmakokinetiske data fra raske personer viste, at føde reducerer Cmax for anagrelid med 14%, men øger AUC med 20%.
Pharmacokinetic data from healthy subjects established that food decreases the Cmax of anagrelide by 14%, but increases the AUC by 20%.
Føde havde en mere signifikant virkning på den aktive metabolit og reducerede Cmax med 29%, skønt det ikke havde nogen virkning på AUC.
Food had a more significant effect on the active metabolite and decreased the Cmax by 29%, although it had no effect on the AUC.
Som forventet ud fra halveringstiden er der ingen tegn på ophobning af anagrelid i plasma.
As expected from its half-life, there is no evidence for anagrelide accumulation in the plasma.
Desuden viser disse resultater ingen tegn på auto- induktion af anagrelid clearance.
Additionally these results show no evidence of auto-induction of the anagrelide clearance.
7 aktive metabolit.
7 Special populations
Disse observationer kan være en afspejling af mere effektiv metabolisk clearance hos yngre patienter.
These observations may be a reflection of more efficient metabolic clearance in younger subjects.
Ældre patienter Farmakokinetiske data fra fastende ældre patienter med ET (i alderen 65- 75 år) sammenlignet med fastende voksne patienter (i alderen 22- 50 år) viser, at Cmax og AUC for anagrelid var henholdsvis 36% og 61% højere hos ældre patienter, hvorimod Cmax og AUC for den aktive metabolit 2- amino - 5, 6- dichlor- 3, 4- dihydroquinazolin var henholdsvis 42% og 37% lavere hos ældre patienter.
Elderly Pharmacokinetic data from fasting elderly patients with ET (age range 65-75 years) compared to fasting adult patients (age range 22-50 years) indicate that the Cmax and AUC of anagrelide were 36% and 61% higher respectively in elderly patients, but that the Cmax and AUC of the active metabolite, 2- amino-5, 6-dichloro-3, 4-dihydroquinazoline, were 42% and 37% lower respectively in the elderly patients.
Disse forskelle skyldtes sandsynligvis en lavere præsystemisk metabolisme af anagrelid end af 2- amino- 5, 6 - dichlor- 3, 4- dihydroquinazolin hos ældre patienter.
These differences were likely to be caused by lower presystemic metabolism of anagrelide to 2-amino-5, 6-dichloro-3, 4-dihydroquinazoline in the elderly patients.
Toksicitet ved gentagne doser:
Repeated dose toxicity.
Efter gentagen indgivelse af anagrelid i doser på 1 mg/ kg/ dag eller derover forekom subendocardial blødning og fokal myocardial nekrose hos hunde.
Following repeated administration of anagrelide, at doses of 1mg/ kg/ day or higher, subendocardial haemorrhage and focal myocardial necrosis occurred in dogs.
Reproduktiv toksikologi:
Reproductive toxicology.
Toksiske doser af anagrelid (60 mg/ kg/ dag og derover) til moderdyr hos rotter og kaniner blev sat i forbindelse med øget fosterresorption og fosterdødelighed.
Maternally toxic doses of anagrelide (60 mg/ kg/ day and above) in rats and rabbits were associated with increased embryo resorption and foetal mortality.
Mutagent og carcinogent potentiale:
Mutagenic and carcinogenic potential.
I et to- årigt studie af carcinogenitet hos rotter blev der gjort ikke- neoplastiske og neoplastiske observationer, som kunne føres tilbage til en udtalt farmakologisk virkning.
In a two-year rat carcinogenicity study, non-neoplastic and neoplastic findings were observed and related or attributed to an exaggerated pharmacological effect.
Blandt disse var en forøget forekomst af fæokromocytomer i binyrerne hos hanrotter sammenlignet med kontrollen på alle dosisniveauer (≥ 3 mg/ kg/ dag) og hos hunrotter, som modtog 10 mg/ kg/ dag og derover.
Among them, the incidence of adrenal phaeochromocytomas was increased relative to control in males at all dose levels (≥ 3 mg/ kg/ day) and in females receiving 10 mg/ kg/ day and above.
Den laveste dosis hos hanrotter (3 mg/ kg/ dag) svarer til 37 gange den humane AUC- eksponering efter en dosis på 1 mg to gange dagligt.
The lowest dose in males (3 mg/ kg/ day) corresponds to 37 times the human AUC exposure after a 1 mg twice daily dose.
Uterine adenocarcinomer med epigenetisk ophav var forbundet med en enzym - induktion af CYP1- familien.
Uterine adenocarcinomas, of epigenetic origin, could be related to an enzyme induction of CYP1 family.
De blev observeret hos hunrotter, som modtog 30 mg/ kg/ dag svarende til 572 gange den humane AUC- eksponering efter en dosis på 1 mg to gange dagligt.
They were observed in females receiving 30 mg/ kg/ day, corresponding to 572 times the human AUC exposure after a 1 mg twice daily dose.
I øjeblikket er der ikke klinisk bevis på, at disse virkninger har relevans ved klinisk brug.
Currently, there is no clinical evidence that these findings are of relevance to human use.
Kapslens indhold Povidon (E1201) Vandfri laktose Laktose monohydrat Mikrokrystallin cellulose (E460) Crospovidon Magnesium stearat
Capsule contents Povidone (E1201) Anhydrous lactose Lactose monohydrate Microcrystalline cellulose (E460) Crospovidone Magnesium stearate
Indkapsling Gelatine Titanium dioxid (E171)
Capsule shell Gelatin Titanium dioxide (E171)
8 Sort jernoxid (E172)
8 Printing ink Shellac Strong ammonium solution Potassium hydroxide (E525) Black iron oxide (E172)
6. 2 Uforligneligheder
6.2 Incompatibilities
Ingen særlige forholdsregler vedrørende opbevaringen
No special precautions for storage
Glas af high- density polyethylen (HDPE), der indeholder tørremiddel, med børnesikret lukning og 100 kapsler
High-density polyethylene (HDPE) bottles containing desiccant with child-resistant closures containing 100 capsules
Shire Pharmaceutical Contracts Ltd Hampshire International Business Park Chineham Basingstoke Hampshire RG24 8EP Storbritannien
Shire Pharmaceutical Contracts Ltd Hampshire International Business Park Chineham Basingstoke Hampshire RG24 8EP United Kingdom
DATO FOR ÆNDRINGAF TEKSTEN
DATE OF REVISION OF THE TEXT
Wasdell Packaging Limited, Upper Mills Estate, Bristol Road, Stonehouse, Gloucestershire, GL10 2BJ, Storbritannien
Wasdell Packaging Limited, Upper Mills Estate, Bristol Road, Stonehouse, Gloucestershire, GL10 2BJ, United Kingdom
Shire gennemfører en sikkerhedsundersøgelse efter markedsføringstilladelsen (PASS) SPD422- 401 En ikke- interventionel sikkerhedsundersøgelse efter markedsføringstilladelse til løbende overvågning af sikkerheds - og graviditetsresultater hos en gruppe risikopatienter med Essential Trombocytæmi (ET), der eksponeres for Xagrid sammenlignet med andre, traditionelle cytoreduktive behandlinger.
Shire will conduct a Post Authorisation Safety Study (PASS) Study SPD422-401 A non- interventional, post authorisation safety study, to continuously monitor safety and pregnancy outcomes in a cohort of at-risk Essential Thrombocythaemia (ET) subjects exposed to Xagrid compared to other conventional cytoreductive treatments.
Primært Løbende at overvåge sikkerheds - og graviditetsresultater hos en gruppe risikopatienter med ET, der eksponeres for Xagrid, sammenlignet med andre, traditionelle cytoreduktive behandlinger.
Primary To continuously monitor safety and pregnancy outcomes in a cohort of at-risk ET subjects exposed to Xagrid compared to other conventional cytoreductive treatments.
Sekundært Virkning (reduktion af trombocyttal, forekomst af trombohæmoragiske hændelser).
Secondary Efficacy (platelet reduction, incidence of thrombohaemorrhagic events).
Anvendelse af lægemidler (lægemiddeltype, lægemiddeldosis, eksponeringens varighed).
Drug utilisation (drug type, drug dose, duration of exposure).
Opdateringer og rapporter om udviklingen leveres med 6 måneders mellemrum i 5 år efter godkendelsen vedrørende patienter, der behandles med Xagrid.
Updates and progress reports will be provided at 6 monthly intervals for 5 years post-approval on patients treated with Xagrid.
Efter vurderingen efter 5 år kan undersøgelsen eventuelt fortsættes i yderligere 5 år for at indhente specifikke oplysninger om:
Following the 5 year review the study may be continued for an additional 5 years to obtain specific information on:
Resultater af graviditeter og opfølgning af kvinder i den fødedygtige alder, hæmatologiske ændringer.
Pregnancy outcomes and follow-up in women of childbearing potential, Haematological transformations.
Rekruttering til undersøgelsen blev igangsat i løbet af maj måned 2005.
Study recruitment was initiated during May 2005.
Den sjette og syvende halvårlige sikkerhedsopdateringsrapport forventes henholdsvis i maj 2008 og november 2008.
The sixth and seventh 6-monthly safety update reports are expected in May 2008 and November 2008, respectively.
Shire gennemfører en randomiseret, komparativ undersøgelse af patienter med ET.
Shire will conduct a randomised, comparative study in patients with ET.
Undersøgelse SPD422- 403.
Study SPD422-403.
En randomiseret fase IIIb undersøgelse til sammenligning af virkning, tolerans og sikkerhed for anagrelid hydroklorid vs hydroxyurea hos højrisikopatienter med essentiel trombocytæmi.
A Phase IIIb, randomised study to compare the efficacy, tolerability and safety of anagrelide hydrochloride versus hydroxyurea in high-risk patients with essential thrombocythaemia.
Primært:
11 Primary:
At sammenligne sikkerheden for anagrelid og hydroxyurea ved kort - og langsigtet anvendelse i indtil tre år med særligt henblik på kardiovaskulær sikkerhed (vurderet ved ekkografi).
To compare the safety of anagrelide and hydroxyurea in short and long term usage of up to three years with particular reference to cardiovascular safety (as assessed by echocardiography).
Sekundært:
Secondary:
At sammenligne virkningen af anagrelid og hydroxyurea med hensyn til trombocyttal efter 6 måneders behandling.
To compare the efficacy of anagrelide and hydroxyurea in terms of the platelet count after 6 months of treatment.
At sammenligne virkningen af anagrelid og hydroxyurea med hensyn til trombocyttal efter 3 måneders behandling.
To compare the efficacy of anagrelide and hydroxyurea in terms of the platelet count after 3 months of treatment.
At sammenligne virkningen af anagrelid og hydroxyurea med hensyn til det antal patienter, der opnår fuldstændig respons.
To compare the efficacy of anagrelide and hydroxyurea in terms of the number of patients achieving a complete response.
At sammenligne den cytoreduktive virkning af anagrelid og hydroxyurea på hvide blodceller og røde blodceller.
To compare the cytoreductive impact of anagrelide and hydroxyurea on white blood cell and red blood cell lines.
At undersøge toleransen for anagrelid og hydroxyurea ved kort - og langvarig brug i op til 3 år.
To investigate the tolerability of anagrelide and hydroxyurea in short and long term usage of up to three years.
At undersøge virkningerne af anagrelid og hydroxyurea på forekomsten af sygdomsrelaterede trombotiske og hæmoragiske hændelser.
To investigate the effects of anagrelide and hydroxyurea on incidence of disease related thrombotic and haemorrhagic events.
At sammenligne den gennemsnitlige periode til respons efter behandling med anagrelid eller hydroxyurea.
To compare the average time to response following treatment with anagrelide or hydroxyurea.
Undersøgelsen vil omfatte en centraliseret og blindet vurdering af ekkokardiografier som led i vurderingen af virkningen af begge behandlinger på LVEF.
The study will include a centralized and blinded review of the echocardiographs as part of the assessment of the effect of both treatments on LVEF.
Foreløbige sikkerhedsrapporter hver 6. måned.
Interim safety reports every 6 months.
Forløbs - og rekrutteringsopdateringer leveres sammen med standard PSUR.
Progress and recruitment updates will be provided alongside the standard PSURs.
Den endelige undersøgelsesrapport afgives 4 måneder efter databaselåsning.
The final study report will be provided 4 months after data base lock.
Rekruttering til undersøgelsen blev igangsat i løbet af januar måned 2006.
Study recruitment was initiated during January 2006.
Shire vil gennemføre en farmakokinetisk undersøgelse hos unge og ældre patienter med ET.
Shire will conduct a pharmacokinetic study in young and elderly patients with ET.
En open- label, multicenter, fase II, farmakokinetisk, farmakodynamisk undersøgelse og sikkerhedsundersøgelse af anagrelid hydroklorid hos unge (18- 50 år) og ældre (≥ 65 år) patienter med essentiel trombocytæmi.
Study SPD422-203 A phase II, open label, multi centre, pharmacokinetic, pharmacodynamic and safety study of anagrelide hydrochloride in young (18-50 years) and elderly (≥ 65 years) patients with essential thrombocythaemia.
Primært:
Primary:
At sammenligne steady- state farmakokinetisk profil for anagrelid og dets aktive metabolit hos unge (18- 50 år) vs. ældre (≥ 65 år) patienter med essentiel trombocytæmi (ET).
To compare the steady state pharmacokinetic profile of anagrelide and its active metabolite in young (18-50 years) versus elderly (≥ 65 years) essential thrombocythaemia (ET) patients.
At vurdere en eventuel sammenhæng mellem anagrelid i daglig dosis og de deraf følgende plasmakoncentrationer af anagrelid i plasma og ændringer fra baseline i trombocyttal hos unge (18- 50 år) og ældre (≥ 65 år) patienter med ET.
To evaluate the correlation, if any, between anagrelide daily dose, resultant anagrelide plasma concentrations and changes from baseline in platelet count in young (18-50 years) and elderly (≥ 65 years) ET patients.
At vurdere en eventuel sammenhæng mellem plasmakoncentrationer af anagrelid og dets aktive metabolit og hjertefrekvens og blodtryk hos unge (18- 50 år) og ældre (≥ 65 år) patienter med ET.
To evaluate the correlation, if any, between plasma concentration of anagrelide and its active metabolite and heart rate and blood pressure in young (18-50 years) and elderly (≥ 65 years) ET patients.
At vurdere sikkerhed og tolerans for anagrelid hos unge (18- 50 år) og ældre (≥ 65 år) patienter med ET.
To assess the safety and tolerability of anagrelide in young (18-50 years) and elderly (≥ 65 years) ET patients.
12 24 patienter (12 pr. aldersgruppe) optages i undersøgelsen.
24 patients (12 per age group) will be enrolled into the study.
Shire vil sørge for farmakokinetiske data fra en gruppe ældre patienter.
Shire will provide pharmacokinetic data from a cohort of elderly patients.
Forløbs - og rekrutteringsdata vil blive leveret sammen med standard PSUR.
Progress and recruitment updates will be provided alongside the standard PSURs.