natgillin/translations-raw huggingface dataset:
This medicinal product is contraindicated in patients with severe preexisting cardiovascular disease or patients who had recently suffered from a stroke or myocardial infarction (see section 4.3).
Ovaj lijek je kontraindiciran u bolesnika s teškom postojećom kardiovaskularnom bolesti ili bolesnika koji su nedavno pretrpjeli moždani udar ili infarkt miokarda (vidjeti dio 4.3).
The use of Besremi is not recommended during pregnancy.
Primjena lijeka Besremi ne preporučuje se tijekom trudnoće.
Then, tap the pen (cartridge holder) gently with your fingers to allow any air bubbles to rise to the top of the cartridge holder.
Potom blago lupkajte brizgalicu (nosač uloška) prstima kako biste omogućili da se svi mjehurići zraka podignu u vrh nosača uloška.
Ropeginterferon alfa-2b may inhibit the activity of CYP1A2 and CYP2D6 and thus may increase the blood concentrations of these medicinal products.
Ropeginterferon alfa-2b može inhibirati aktivnost CYP1A2 i CYP2D6 i tako povećati koncentracije tih lijekova u krvi.
Besremi contains benzyl alcohol.
Besremi sadrži benzilni alkohol.
The recommended injection site is the abdominal skin around but not within 5 cm of the navel or the thigh.
Preporučeno mjesto davanja injekcije je koža u području abdomena oko, ali ne unutar, 5 cm od pupka ili koža bedra.
Abbreviations: CTCAE, common terminology criteria for adverse events; n.r., not reported; ADR, adverse drug reaction; PT, preferred term; IR, incidence rate of mean adverse events per 100 patients per year; N: number of patients.
Kratice: CTCAE, zajednički terminološki kriteriji za nuspojave; n.z., nije zabilježeno; IR (engl, incidence rate), stopa incidencije srednje vrijednosti broja štetnih događaja na 100 bolesnika po godini; N, broj bolesnika.
What you need to know before you use Besremi 3.
Što morate znati prije nego počnete primjenjivati Besremi
Besremi is indicated as monotherapy in adults for the treatment of polycythaemia vera without symptomatic splenomegaly.
Besremi je indiciran kao monoterapija u odraslih za liječenje policitemije vere bez simptomatske splenomegalije.
Interferon alfa belongs to the class of type I interferons which exhibit their cellular effects by binding to a transmembrane receptor termed interferon alfa receptor (IFNAR).
Interferon alfa pripada interferonima skupine tip I koji iskazuju svoje stanične učinke vezivanjem na transmembranski receptor koji sadrži receptor za interferon alfa (IFNAR).
Adverse reactions are listed by system organ class and frequency (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) or not known (cannot be estimated from available data).
<1/100), rijetko (≥1/10 000 i <1/1000), vrlo rijetko (<1/10 000) ili nepoznato (ne može se procijeniti iz dostupnih podataka)).
The dose should be gradually increased by 50 micrograms every two weeks (in parallel, other cytoreductive therapy should be decreased gradually, as appropriate) until stabilisation of the haematological parameters is achieved (haematocrit <45%, platelets <400 x 109/L and leukocytes <10 x 109/L).
Dozu treba postupno povećavati za 50 mikrograma svaka dva tjedna (istodobno, drugu citoreduktivnu terapiju treba postupno smanjivati prema potrebi) dok se ne postigne stabilizacija hematoloških parametara (hematokrit <45%, trombociti <400 x 109/l i leukociti <10 x 109/l).
Other CNS effects,
Učinci na SŽS,
Women of childbearing potential/Contraception in females Women of childbearing potential have to use effective contraception during the treatment with ropeginterferon alfa-2b, unless otherwise discussed with the physician.
Žene reproduktivne dobi/kontracepcija u žena Žene reproduktivnog potencijala moraju koristiti učinkovitu kontracepciju tijekom liječenja ropeginterferonom alfa-2b, osim ako se ne dogovore drugačije s liječnikom.
• Hold the pen with the needle pointing upwards.
• Držite brizgalicu s iglom usmjerenom prema gore.
Thus, other products (e.g. hydroxycarbamide) may be preferred in patients for whom an early reduction in elevated blood counts is necessary to prevent thrombosis and bleeding.
Stoga, drugi lijekovi (npr. hidroksikarbamid) mogu biti poželjni u bolesnika za koje je potrebna rana redukcija u povišenoj razini krvnih stanica za sprječavanje tromboze i krvarenja.
n.r.
n.z.
Reuse of the pen:
Ponovna uporaba brizgalice:
• If you are using your pen for the first time, prepare the pen for injection by turning the dose knob until you see the symbol of a “drop”.
• Ako svoju brizgalicu upotrebljavate po prvi put, pripremite brizgalicu za injekciju tako što ćete okretati kotačić za odabir doze dok ne ugledate simbol „kapljice“.
Each pre-filled pen contains a cartridge (type 1 colourless glass) with a grey plunger (bromobutyl rubber) and a flanged cap (aluminium) with a stopper (bromobutyl rubber).
Jedna napunjena brizgalica sadrži uložak (bezbojno staklo tipa 1), sa sivim klipom (od bromobutilne gume) i kapicom s prirubnicama (od aluminija) s čepom (od bromobutilne gume).
Cases of pulmonary arterial hypertension (PAH) have been reported with interferon alfa, notably in patients with risk factors for PAH (such as portal hypertension, HIV infection, cirrhosis).
Slučajevi plućne arterijske hipertenzije (PAH) uočeni su kod primjene interferona alfa, posebice u bolesnika s čimbenicima rizika za PAH (poput portalne hipertenzije, infekcije virusom HIV-a te ciroze).
If a certain dose cannot be set, an insufficient quantity of medicinal product may be left in the pen and a new pen must be used.
Ako se određena doza ne može podesiti, možda je u brizgalici preostala nedostatna količina lijeka te se mora upotrijebiti nova brizgalica.
• Check the solution through the inspection windows along the sides of the cartridge holder.
• Provjerite otopinu kroz prozorčić za provjeru smješten na nosaču uloška.
Mean Cmax was 2.4 ng/mL (with a dose of 5080 micrograms) to 49 ng/mL (with a dose of 450 micrograms) and AUC0-t ranged from 28.5 ng.h/mL (with a dose of 50 - 80 micrograms) to 552.6 ng.h/mL (with a dose of 450 micrograms) in patients after subcutaneous multiple dose administration.
Srednja vrijednost Cmax iznosila je 2,4 ng/ml (s dozom od 50 - 80 mikrograma) do 49 ng/ml (s dozom od 450 mikrograma) te je AUC0-t bio u rasponu od 28,5 ng.h/ml (s dozom od 50 - 80 mikrograma) do 552,6 ng.h/ml (s dozom od 450 mikrograma) u bolesnika nakon višekratnog supkutanog doziranja.
not known retinal detachment#
nepoznato ablacija mrežnice#
A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from ropeginterferon alfa-2b therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Potrebno je odlučiti da li prekinuti dojenje ili prekinuti liječenje/suzdržati se od liječenja ropeginterferonom alfa-2b, uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu.
It may only be used if the solution is clear, colourless to pale yellow, with no particles visible.
Otopina se može koristiti samo ako je bistra, bezbojna do blijedožuta te bez vidljivih čestica.
Besremi is presented as a solution for injection (injection) in a pre-filled pen.
Besremi je dostupan kao otopina za injekciju (injekcija) u napunjenoj brizgalici.
Read them before you start using Besremi.
Pročitajte ih prije nego počnete primjenjivati lijek Besremi.
The instructions for use in the package leaflet should be followed.
Potrebno je pridržavati se uputa za uporabu u uputi o lijeku.
You should see a droplet of liquid appearing at the needle tip.
Morali biste vidjeti kako se na vrhu igle pojavljuje kapljica tekućine.
The Besremi pre-filled pen comes with two needles.
Besremi napunjena brizgalica isporučuje se s dvije igle.
The mean dose after 12 months of treatment was 382 (±141) micrograms for ropeginterferon alfa-2b.
Srednja doza nakon 12 mjeseci liječenja bila je 382 (± 141) mikrograma za ropeginterferon alfa-2b.
It is available in packs containing 1 pre-filled pen and 2 injection needles.
Dostupan je u pakiranjima koja sadrže 1 napunjenu brizgalicu i 2 igle za injekciju.
• Click the needle onto the pen and make sure that it is firmly attached.
• Nataknite iglu na brizgalicu i pazite da je dobro pričvršćena.
One patient who experienced serious acute stress disorder (0.6%; incidence rate: 0.2 events/100 patients per year) with moderate intensity recovered completely after the dose of ropeginterferon alfa-2b was reduced.
Jedan bolesnik u kojeg se javio ozbiljni, akutni stresni poremećaj (0,6%; stopa incidencije: 0,2 događaja/100 bolesnika na godinu) s umjerenim intenzitetom u potpunosti se je oporavio nakon smanjenja doze ropeginterferona alfa-2b.
- if you have a liver or kidney disease.
- ako imate bolest jetre ili bubrega.
While holding the pre-filled pen with the needle pointing upwards, tap the pre-filled pen gently with the fingers so that any air bubbles rise up towards the needle.
Dok držite napunjenu brizgalicu s iglom usmjerenom prema gore, lagano lupkajte prstima napunjenu brizgalicu tako da se svi mjehurići zraka podignu prema igli.
There are no or limited amount of data from the use of interferon alfa in pregnant women.
Nema podataka ili su podaci o primjeni interferona alfa u trudnica ograničeni.
Patients showed a statistically significant difference in the JAK2V617F allele burden (19.7%) and JAK2V617F allele change from baseline (-22.9%).
Bolesnici su pokazali statistički značajnu razliku u opterećenju alelom JAK2V617F (19,7%) te promjeni alela JAK2V617F u odnosu na početnu vrijednost (-22,9%).
The pen can be adjusted to administer doses in 50 microgram intervals in the range of 50 to 250 micrograms or 50 to 500 micrograms.
Brizgalica se može prilagoditi za primjenu doza u intervalima od 50 mikrograma, u rasponu od 50 do 250 mikrograma ili 50 do 500 mikrograma.
• Set the dose your doctor told you by turning the dose knob.
• Namjestite dozu koju Vam je liječnik odredio okretanjem kotačića za odabir doze.
Interferon alfa was shown to be abortifacient in primates and ropeginterferon alfa-2b is expected to have a similar effect.
Pokazano je da interferon alfa ima abortivan učinak u primata te se očekuje da će i ropeginterferon alfa-2b imati sličan učinak.
No dose adaptions for ropeginterferon alfa-2b should be necessary when concomitantly administered with medicinal products metabolised via CYP2C9/19, CYP3A4 or by N-acetyltransferase.
Neće biti potrebna prilagodba doze ropeginterferona alfa-2b kod istodobne primjene s lijekovima koji se metaboliziraju putem CYP2C9/19, CYP3A4 ili N-acetiltransferazom.
Ropeginterferon alfa-2b treatment was continued and the patients received appropriate medicinal products to treat these events.
Terapija ropeginterferonom alfa-2b se nastavila, a bolesnici su primili odgovarajuće lijekove za liječenje tih događaja.
Treatment with ropeginterferon alfa-2b should be discontinued when, despite dose reduction, the increase in liver enzyme levels is progressive and clinically significant.
Liječenje ropeginterferonom alfa-2b treba prekinuti kada je unatoč smanjenju doze, porast razine jetrenih enzima progresivan te klinički značajan.
Over a dose range of 24 to 270 micrograms, ropeginterferon alfa-2b Cmax increased proportionally with dose in a pharmacokinetic study with healthy subjects.
Za raspon doza od 24 do 270 mikrograma, Cmax ropeginterferona alfa-2b povećavao se proporcionalno s dozom u farmakokinetičkom ispitivanju u zdravih ispitanika.
Likewise, caution is recommended with CYP2D6 substrates (e.g. vortioxetine, risperidone) combined with ropeginterferon alfa-2b.
Slično tome, preporučuje se oprez sa supstratima CYP2D6 (npr. vortioksetinom, risperidonom) u kombinaciji s ropeginterferonom alfa-2b.
Caution must be exercised when administering ropeginterferon alfa-2b in combination with other potentially myelosuppressive/chemotherapeutic agents.
Potreban je oprez kada se ropeginterferon alfa-2b primjenjuje u kombinaciji s drugim potencijalno mijelosupresivnim/kemoterapijskim agensima.
If you need a dose of more than 250 micrograms, you require two Besremi 250 microgram pre-filled pens.
Ako Vam je potrebna doza viša od 250 mikrograma, trebat će Vam dvije napunjene brizgalice lijeka Besremi 250 mikrograma.
Find a well-lit area without significant distraction for the injection.
Nađite dobro osvijetljeno i mirno okruženje gdje možete neometano primijeniti injekciju.
Further, it was demonstrated that interferon alfa is able to decrease the mutated JAK2V617F allele burden in patients with polycythaemia vera (a V617F point mutation in the JAK2 kinase is a hallmark of polycythaemia vera and is present in approximately 95% of patients).
Nadalje, dokazano je da interferon alfa može smanjiti opterećenje mutiranim alelom JAK2V617F kod bolesnika s policitemijom verom (točkasta mutacija V617F kod JAK2 kinaze je obilježje policitemije vere te je prisutna u približno 95% bolesnika).
Administration of 180 micrograms of pegylated interferon alfa-2a once weekly for 4 weeks in healthy male subjects did not show any effect on mephenytoin, dapsone, debrisoquine and tolbutamide pharmacokinetics profiles, suggesting that pegylated interferon alfa-2a has no effect on in vivo metabolic activity of cytochrome P450 (CYP) 3A4, 2C9, 2C19 and 2D6 isozymes.
Primjena 180 mikrograma pegiliranog interferona alfa-2a jedanput na tjedan tijekom 4 tjedna u zdravih muških ispitanika nije pokazala nikakav učinak na farmakokinetičke profile mefenitoina, dapsona, debrizokina i tolbutamida, ukazujući da pegilirani interferon alfa-2a nema učinka na in vivo metaboličku aktivnost izoenzime (CYP) 3A4, 2C9, 2C19 i 2D6 citokroma P450 . U istom ispitivanju,
If adverse events develop during therapy, the administered dose should be reduced or treatment discontinued temporarily until adverse events abate; further, treatment should be re-initiated with a lower dose than the dose that caused adverse events.
Ako se tijekom terapije razviju štetni događaji, primijenjenu dozu treba smanjiti ili privremeno prekinuti liječenje dok se štetni događaji ne povuku.
Besremi contains benzyl alcohol
Besremi sadrži benzilni alkohol
This medicine contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially ‘sodiumfree'.
Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) po ml, tj. zanemarive količine natrija.
19 (10.7) 6.0 n.r.
19 (10,7) 6,0 n.z.
Based on single dose data, clearance was similar in patients with severe renal impairment not on haemodialysis and in patients who received haemodialysis.
Na temelju podataka o jednokratnoj dozi, klirens je bio sličan u bolesnika s teškim oštećenjem bubrega koji nisu na hemodijalizi te u bolesnika koji su primili hemodijalizu.
Correct the dose if necessary by turning the dose knob.
Ako je potrebno, ispravite dozu okretanjem kotačića za odabir doze.
The use of ropeginterferon alfa-2b is associated with skin disorders (pruritus, alopecia, rash, erythema, psoriasis, xeroderma, dermatitis acneiform, hyperkeratosis, hyperhydrosis).
Uporaba ropeginterferon alfa-2b povezana je s kožnim poremećajima (pruritus, alopecija, osip, eritem, psorijaza, kseroderma, akneiformni dermatitis, hiperkeratoza, hiperhidroza).
Raynaud's phenomenon, hypertension, haematoma, flushing
Raynaudov fenomen, hipertenzija, hematom, navale crvenila
The disease response (defined as haematocrit <45% without phlebotomy [at least 3 months since last phlebotomy], platelets <400 x 109/L and leukocytes <10 x 109/L after 12 months of treatment) was 43.1% [53/123 of patients] in the ropeginterferon alfa-2b arm after 12 months of treatment.
Odgovor na bolest (definiran kao vrijednost hematokrita < 45% bez flebotomije [barem 3 mjeseca od posljednje flebotomije], trombociti <400 x 109/l i leukociti <10 x 109/l nakon 12 mjeseci liječenja uključivao je 43,1% [53/123 bolesnika] u skupini koja je primala ropeginterferon alfa-2b (43,1%
Arthralgia 23 (12.9) 8.5 1 (4.3)* 4 (17.4) 4 (17.4) Fatigue
Trombocitopenija 33 (18,5) 15,0 4 (12,1%)* 13 (39,4) 3 (9,1) Artralgija
Ropeginterferon alfa-2b is found mainly in the bloodstream and extracellular fluid as seen by the volume of distribution at steady-state (Vd) of 6.6 to 17 litres in patients after subcutaneous administration (dose range 50 - 450 micrograms).
Ropeginterferon alfa-2b nalazi se uglavnom u krvotoku i izvanstaničnoj tekućini što se može vidjeti prema volumenu distribucije u stanju dinamičke ravnoteže (Vd) od 6,6 do 17 litara u bolesnika nakon supkutane primjene (raspon doze 50 - 450 mikrograma).
Only limited pharmacokinetic data are available from the use of ropeginterferon alfa-2b in the elderly.
Dostupni su samo ograničeni farmakokinetički podaci o uporabi ropeginterferona alfa-2b u starijih osoba.
Adjustments in the recommended dose for ropeginterferon alfa-2b are not necessary when starting therapy in elderly patients (see section 5.2).
Prilagodbe u preporučenoj dozi ropeginterferona alfa-2b nisu potrebne kada se počinje s terapijom u starijih bolesnika (vidjeti dio 5.2).
After subcutaneous multiple dose administration (dose range 50 - 450 micrograms), the terminal halflife of ropeginterferon alfa-2b in patients is approximately 6 to 10 days and the clearance of ropeginterferon alfa-2b is 0.023 to 0.061 L/h.
Nakon višekratnog supkutanog doziranja (raspon doza od 50 do 450 mikrograma), terminalni poluvijek ropeginterferona alfa-2b u bolesnika iznosi približno 6 do 10 dana, a klirens ropeginterferona alfa-2b je 0,023 do 0,061 l/sat.
In the clinical development program of ropeginterferon alfa-2b, two cases of serious depression (1.1%; incidence rate: 0.4 events/100 patients per year) occurred.
U programu kliničkog razvoja ropeginterferona alfa-2b dogodila su se dva slučaja ozbiljne depresije (1,1%; stopa incidencije: 0,4 događaja/100 bolesnika po godini).
The recommended posology for the titration phase of ropeginterferon alfa-2b (see section 4.2) results in a prolonged time to reach the individual optimal dose compared to hydroxycarbamide.
Preporučeno doziranje za fazu titracije ropeginterferona alfa-2b (vidjeti dio 4.2) rezultira u produljenom vremenu dostizanja individualne optimalne doze u usporedbi s hidroksikarbamidom.
If the pre-filled pen is used for the first time, the pen is prepared for injection by turning the dose knob until the symbol of a “drop” in the display window is seen.
Ako se napunjena brizgalica koristi po prvi put, brizgalica se priprema za injekciju okretanjem kotačića za odabir doze dok se ne uoči simbol „kapljice“ na prozorčiću za prikaz doze.
Besremi 250 micrograms/0.5 mL
Besremi 250 mikrograma/0,5 ml
Patients should have eye examinations before and during ropeginterferon alfa-2b therapy, specifically in those patients with retinopathy associated disease such as diabetes mellitus or hypertension.
Bolesnicima treba pregledati oči prije i tijekom terapije ropeginterferonom alfa-2b, posebice kod onih bolesnika s retinopatijom povezanom s bolestima poput dijabetesa melitusa ili hipertenzije.
In addition, dry mouth could have a damaging effect on teeth and mucous membranes of the mouth during long-term treatment with ropeginterferon alfa-2b.
Osim toga, suha usta mogu imati štetan učinak na zube i sluznicu usta tijekom dugotrajnog liječenja ropeginterferonom alfa-2b.
**e.g. urticaria, angioedema, bronchoconstriction or anaphylaxis.
**npr. urtikarija, angioedem, bronhokonstrikcija ili anafilaksija.
• Unscrew the needle and dispose of it appropriately.
• Odvijte iglu i zbrinite je na odgovarajući način.
Keep the pre-filled pen in the outer carton in order to protect from light.
Napunjenu brizgalicu čuvati u vanjskoj kutiji radi zaštite od svjetlosti.
Your doctor will tell you where you have to inject it. Possible injection sites are the belly (more than five centimeters away from the belly button) or the thigh.
Moguća mjesta injiciranja su trbuh (mjesto mora biti udaljeno više od 5 cm od pupka) ili na bedru.
Studies with a similar interferon alfa medicinal product (pegylated interferon alfa-2a) indicated that the kidney is a major organ for excretion of radiolabelled metabolic products (study in rats) and that the systemic clearance of pegylated interferon alfa-2a in humans is about 100-fold lower compared to the native, unpegylated interferon alfa-2a.
Ispitivanja sa sličnim lijekom koji sadrži interferon alfa (pegilirani interferon alfa-2a) ukazala su na to da je bubreg glavni organ za izlučivanje radio označenih metaboličkih produkata (ispitivanje na štakorima) i da je sistemski klirens pegiliranog interferona alfa-2a u ljudi otprilike 100 puta niži u usporedbi s nativnim nepegeiliranim interferonom alfa-2a.
The dose can be set in steps of 50 micrograms by rotating the dose knob.
Doza se može podesiti u koracima od 50 mikrograma rotiranjem kotačića za odabir doze.
Interferon alfa has shown to influence the activity of cytochrome P450 (CYP) isozymes CYP1A2 and CYP2D6.
Interferon alfa je pokazao utjecaj na aktivnosti citokroma P450 (CYP) izoenzima CYP1A2 i CYP2D6.
An abortifacient effect was reported in primates receiving other interferon alfa medicinal products.
Abortivni učinak zabilježen je u primata koji primaju druge lijekove koji sadrže interferon alfa.
not known
nepoznato
The attachment of interferon alfa-2b to a high molecular weight (40 kDa) branched polyethylene glycol moiety is considered as the main reason for the differences in the elimination compared to unpegylated interferons.
Dodavanje interferona alfa-2b razgranatom polietilenglikolnom dijelu molekule s visokom molekularnom težinom (40 kDa) smatra se glavnim razlogom za razlike u eliminaciji u usporedbi s nepegiliranim interferonima.
Please read this leaflet carefully before using the Besremi 500 micrograms pre-filled pen.
Pažljivo pročitajte ovu uputu prije nego počnete koristiti Besremi 500 mikrograma napunjenu brizgalicu.
Ropeginterferon alfa-2b must not be administered in patients with existence of or history of severe psychiatric disorders, particularly severe depression, suicidal ideation or suicide attempt (see section 4.3).
Ropeginterferon alfa-2b ne smije se primjenjivati u bolesnika koji trenutno ili u anamnezi imaju teške psihijatrijske poremećaje, posebice tešku depresiju, suicidalnu ideaciju ili pokušaj samoubojstva (vidjeti dio 4.3).
Hydroxycarbamide treatment-naïve (n=160) or hydroxycarbamide treated (n=94) patients were randomised to receive ropeginterferon alfa-2b or hydroxycarbamide.
Bolesnici koji nisu prethodno primali hidroksikarbamid (n=160) ili bolesnici koji su liječeni hidroksikarbamidom (n=94) bili su randomizirani za primanje ropeginterferona alfa-2b ili hidroksikarbamida.
• Alcohol wipe
• alkoholnu maramicu
Interferon alfa was shown to have an inhibitory effect on the proliferation of hematopoietic and bone marrow fibroblast progenitor cells and antagonised the action of growth factors and other cytokines that have a role in the development of myelofibrosis.
Dokazano je da interferon alfa ima inhibitorni učinak na proliferaciju hematopoetskih te progenitorskih stanica fibroblasta koštane srži te antagonistički djelovanju čimbenika rasta i drugih citokina koji imaju ulogu u razvoju mijelofibroze.
The absorption of ropeginterferon alfa-2b is sustained in patients with peak serum concentrations reached after 3 to 6 days.
Apsorpcija ropeginterferona alfa-2b održana je u bolesnika, a vršne serumske koncentracije se postižu nakon 3 do 6 dana.
Inspect the solution before use.
Prije uporabe pregledajte otopinu.
An open-label, phase IIIb extension study (CONTINUATION-PV) enrolled 171 adult polycythaemia vera patients who previously completed the PROUD-PV Study to evaluate the long-term efficacy and safety of ropeginterferon alfa-2b.
Otvoreni produžetak ispitivanja faze IIIb (CONTINUATION-PV) uključivao je 171 odraslog bolesnika s policitemijom verom koji su prethodno dovršili ispitivanje PORUD-PV za procjenu dugotrajne djelotvornosti i sigurnosti ropeginterferona alfa-2b.
An open label, randomised phase III study (PROUD-PV) evaluated the efficacy and safety of ropeginterferon alfa-2b in comparison to hydroxycarbamide in 254 adult polycythaemia vera patients (randomisation 1:1).
U otvorenom, randomiziranom kliničkom ispitivanju faze III (PROUD-PV) procjenjivala se djelotvornost i sigurnost ropeginterferona alfa-2b u usporedbi s hidroksikarbamidom u 254 odrasla bolesnika s policitemijom verom (randomizacija 1:1).