natgillin/translations-raw huggingface dataset:
Because the dose is < 23 mcg, dilution is required to ensure accurate dosing.
Ker je odmerek < 23 µg, je potrebno redčenje za zagotovitev natančnega odmerjanja.
The composite bleeding episode was defined as clinically significant bleeding events or the use of a rescue medication to prevent a clinical significant bleeding event during weeks 2 through 25 of the treatment period.
Sestavljena pojavnost krvavitev je bila definirana kot klinično pomembna krvavitev ali uporaba rešilnega zdravila za preprečitev klinično pomembne krvavitve med 2. in 25. tednom zdravljenja.
Do not use Nplate:
Ne uporabljajte zdravila Nplate:
Once Nplate has been dissolved, inject immediately.
Ko je zdravilo Nplate raztopljeno, ga takoj injicirajte.
In addition the reactions listed below have been deemed to be related to romiplostim treatment.
Poleg tega je bilo tudi za spodaj naštete učinke ocenjeno, da so povezani z zdravljenjem z romiplostimom.
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) and not known (cannot be estimated from the available data).
Pogostnosti so opredeljene takole: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000) in neznani (ni mogoče oceniti iz razpoložljivih podatkov).
Nplate should be reconstituted in accordance with good aseptic practice.
Zdravilo Nplate je treba pripraviti skladno z dobro aseptično prakso.
Using: 2 alcohol swab packages, 1 vial, and 1 vial adapter package.
Uporabite: 2 pakiranji alkoholnih zložencev, 1 vialo in 1 pakiranje z nastavkom za vialo.
Study 1 non-splenectomised patients
Študija 1 Nesplenektomirani bolniki
• Do not open items until directed in instructions.
• Materiala ne odpirajte, dokler ni v navodilih navedeno, da ga odprite.
Dilution (required when the calculated individual patient dose is less than 23 mcg)
Redčenje (potrebno, ko je izračunan odmerek za posameznega bolnika nižji od 23 µg)
Increased reticulin may be suggested by morphological changes in the peripheral blood cells and can be detected through bone marrow biopsy.
Zvišanje retikulina lahko nakazujejo morfološke spremembe celic v periferni krvi in ga je mogoče ugotoviti z biopsijo kostnega mozga.
Nplate will be given under the direct supervision of your doctor, who will closely control the amount of Nplate given to you.
Zdravilo Nplate boste prejeli pod nadzorom svojega zdravnika, ki bo natančno kontroliral dano količino zdravila Nplate.
• changes in some blood tests (increase in transaminase; blood lactate dehydrogenase increased);
• spremembe nekaterih preiskav krvi (zvišanje transaminaz, zvišanje laktat-dehidrogenaze v krvi),
Please read the instructions at the end of this leaflet on how to inject Nplate, as discussed with your doctor.
Prosimo, preberite navodila za injiciranje zdravila Nplate na koncu tega navodila, kot ste se dogovorili z vašim zdravnikom.
Note: To prevent contamination of the product, do not touch the vial adapter spike or Luer lock.
Opomba: Da boste preprečili onesnaženje zdravila, se ne smete dotakniti konice nastavka za vialo ali nastavka Luer.
If you have any questions about storage, contact your healthcare professional for further instructions.
Če imate vprašanja o shranjevanju, se za dodatna navodila obrnite na zdravstvenega delavca.
All subjects were negative for neutralising activity to TPO.
Vsi bolniki so bili negativni na nevtralizirajočo aktivnost proti TPO.
Water must flow slowly onto powder.
Voda mora na prašek teči počasi.
Your doctor will ensure that you receive the right amount of Nplate.
Vaš zdravnik bo poskrbel, da boste dobili pravo količino zdravila Nplate.
Vial Content:
Vsebina viale:
The safety and efficacy of romiplostim have been evaluated for up to 3 years of continuous treatment.
Varnost in učinkovitost romiplostima so ocenjevali med neprekinjenim zdravljenjem, ki je trajalo do 3 leta.
The serum concentrations varied among patients and did not correlate with the dose administered.
Koncentracija v serumu se je med bolniki razlikovala in ni bila v sorazmerju z uporabljenim odmerkom.
The injection device and Nplate vial must NEVER be reused.
Pripomočka za injiciranje in viale zdravila Nplate ne smete NIKOLI ponovno uporabiti.
Patients received single subcutaneous weekly injections for 24 weeks.
Bolniki so 24 tednov enkrat na teden prejemali posamezne subkutane injekcije.
If the use of romiplostim is deemed necessary, platelet count should be closely monitored to minimise the risk of thromboembolic complications.
Če je uporaba romiplostima potrebna, je treba število trombocitov natančno kontrolirati, da bi zmanjšali tveganje za tromboembolične zaplete.
The mild form of these bone marrow changes is called “increased reticulin” and has been observed in Nplate clinical trials.
Blago obliko takšnih sprememb kostnega mozga imenujemo "zvišanje retikulina" in so jo opazili v kliničnih preskušanjih zdravila Nplate.
No formal clinical trials have been conducted in these patient populations.
Pri bolnikih te starostne skupine niso opravili uradnih kliničnih preskušanj.
If you forget to use Nplate
Če ste pozabili uporabiti zdravilo Nplate
Summary of key efficacy results from placebo-controlled studies
Povzetek ključnih rezultatov o učinkovitosti iz študij, kontroliranih s placebom
After the first month of self-injecting Nplate, you will need to show that you can still prepare and inject Nplate correctly.
Ko bo minil prvi mesec, odkar si zdravilo Nplate injicirate sami, boste morali pokazati, da še vedno pravilno pripravite in si injicirate zdravilo Nplate.
• Note: If there is any colour or particles in the liquid, contact your healthcare professional.
• Opomba: Če je tekočina kakor koli obarvana ali so v njej delci, se posvetujte z zdravstvenim delavcem.
• Push the vial adapter down onto the vial until it is firmly in place and you can't push down any more.
• Potisnite nastavek za vialo navzdol na vialo, dokler ni trdno nameščen in ga ne morete več pritisniti navzdol.
Pharmacotherapeutic group: Antihaemorrhagics, other systemic haemostatics, ATC code: B02BX04
Farmakoterapevtska skupina: antihemoragiki, drugi hemostatiki za sistemsko zdravljenje, oznaka ATC: B02BX04
b Overall platelet response is defined as achieving durable or transient platelet responses.
Celotni odziv trombocitov je opredeljen kot doseganje trajnega ali prehodnega odziva trombocitov.
After suitable training, your doctor may also allow you to inject Nplate yourself.
Po ustreznem usposabljanju vam bo zdravnik morda dovolil, da si zdravilo Nplate injicirate sami.
• Do not touch vial stopper after cleaning it.
• Ne dotikajte se zamaška viale, potem ko ste ga očistili.
In pre-clinical and clinical trials no anti-romiplostim antibodies cross reacted with endogenous TPO.
V predkliničnih in kliničnih preskušanjih nobeno protitelo proti romiplostimu ni navzkrižno reagiralo z endogenim TPO.
The safety and efficacy of romiplostim was evaluated in two placebo-controlled, double-blind studies in adults with ITP who had completed at least one treatment prior to study entry and are representative of the entire spectrum of such ITP patients.
Varnost in učinkovitost romiplostima so ocenili v dveh s placebom kontroliranih, dvojno slepih študijah odraslih bolnikov z ITP, ki so pred vključitvijo v študijo zaključili vsaj eno zdravljenje in so vzorčni za celotni spekter podobnih bolnikov z ITP.
Time to reach the maximum effect on platelet count is approximately 10-14 days, and is independent of the dose.
Največji učinek na število trombocitov je dosežen v času od 10 do 14 dni, in ni odvisen od odmerka.
In some paediatric patients, accurate dosing relies on an additional dilution step after reconstitution which may increase the risk for medication errors (see section 4.2).
Pri nekaterih pediatričnih bolnikih natančno odmerjanje temelji na dodatnem koraku redčenja po pripravi, ki lahko zviša tveganje za napake pri uporabi zdravila (glejte poglavje 4.2).
Loss of response to romiplostim
Izguba odziva na romiplostim
After the platelet count has fallen to < 150 x 10
Potem ko število trombocitov upade na < 150 x 10
Nplate is supplied as a 1 pack or multipack comprising 4 packs.
Zdravilo Nplate je na voljo kot 1 pakiranje ali multipakiranje, ki vsebuje 4 pakiranja.
Patients should be clinically evaluated periodically and continuation of treatment should be decided on an individual basis by the treating physician, and in non-splenectomised patients this should include evaluation relative to splenectomy.
Bolnike je treba redno klinično spremljati, lečeči zdravnik se mora o nadaljevanju zdravljenja odločiti za vsakega bolnika posamezno, odločitev pa mora pri nesplenektomiranih bolnikih vključevati oceno glede splenektomije.
Slowly push the plunger up to force the air bubbles out of the syringe.
Počasi potisnite bat navzgor, da boste zračne mehurčke iztisnili iz brizge.
Within each MedDRA system organ class and frequency grouping, undesirable effects are presented in order of decreasing incidence.
V razvrstitvah po organskih sistemih po MedDRA in po pogostnosti so neželeni učinki navedeni po padajoči incidenci.
• a rare disorder characterised by periods of burning pain, redness and warmth in the feet and hands (erythromelalgia).
• redka motnja, za katero so značilna obdobja pekoče bolečine, pordelosti in topline v stopalih in dlaneh (eritromelalgija).
Caution should be used during preparation of Nplate in calculating the dose and reconstitution with the correct volume of sterile water for injection.
Med pripravo zdravila Nplate je potrebna previdnost pri izračunu odmerka in pri pripravi s pravilno količino sterilne vode za injekcije.
• if you are allergic to other medicines that are produced by DNA technology using the micro-organism Escherichia coli (E. coli).
• če ste alergični na druga zdravila, pridobljena s tehnologijo DNA in uporabo mikroorganizmov
Multiple dose romiplostim toxicology studies were conducted in rats for 4 weeks and in monkeys for up to 6 months.
Toksikološke študije z večimi odmerki romiplostima so opravili pri podganah (4 tedne) in opicah (do 6 mesecev).
Study S1 (212) evaluated patients who were non-splenectomised and had an inadequate response or were intolerant to prior therapies.
Študija S1 (212) je ocenjevala nesplenektomirane bolnike, ki se na predhodne terapije niso primerno odzvali ali jih niso prenesli.
• Make sure all other materials are discarded into proper containers.
• Poskrbite, da boste tudi drug material zavrgli v ustrezne vsebnike.
Elimination half-life of romiplostim in ITP patients ranged from 1 to 34 days (median, 3.5 days).
Razpolovni čas izločanja romiplostima pri bolnikih z ITP je bil od 1 do 34 dni (mediana 3,5 dni).
How to use Nplate
Kako uporabljati zdravilo Nplate
The potential interactions of romiplostim with co-administered medicinal products due to binding to plasma proteins remain unknown.
Možna medsebojna delovanja romiplostima med sočasno uporabo drugih zdravil zaradi vezave na plazemske beljakovine ostajajo neznana.
Thrombocytosis in paediatric subjects occurred uncommonly (≥ 1/1,000 to < 1/100), with a subject incidence of 1 (0.4%).
Pediatrični bolniki je do trombocitoze prišlo redko (≥ 1/1.000 do < 1/100), z incidenco 1 (0,4 %).
Gastroenteritis Pharyngitis*** Conjunctivitis*** Ear infection*** Sinusitis***
gastroenteritis faringitis*** konjuktivitis*** vnetje ušesa*** sinusitis***
Doses were adjusted to maintain (50 to 200 x 10
Odmerki so bili prilagojeni za vzdrževanje števila trombocitov (od 50 do 200 x 10
Long-term use of Nplate may cause changes in your bone marrow.
Dolgotrajna uporaba zdravila Nplate lahko povzroči spremembe v kostnem mozgu.
If formation of neutralising antibodies is suspected, contact the local representative of the Marketing Authorisation Holder (see section 6 of the Package Leaflet) for antibody testing.
Če obstaja sum na nastajanje nevtralizirajočih protiteles, se za testiranje protiteles obrnite na lokalnega predstavnika imetnika dovoljenja za promet (glejte poglavje 6: Navodila za uporabo).
If you are also taking medicines which prevent blood clots (anticoagulants or antiplatelet therapy) there is a greater risk of bleeding.
Če jemljete tudi zdravila za preprečevanje nastanka krvnih strdkov (antikoagulantna ali antiagregacijska zdravila), obstaja večje tveganje za krvavitve.
Dose adjustment guidelines should be followed (see section 4.2).
Upoštevati je treba smernice za prilagajanje odmerka (glejte poglavje 4.2).
9/L during weeks 18 through 25 of treatment.
9/l na teden med 18. in 25. tednom zdravljenja.
Your doctor will take regular blood samples to measure how your platelets are responding and may adjust your dose as necessary.
Zdravnik vam bo redno jemal kri za meritve, ki bodo pokazale, kako dobro se trombociti odzivajo, in bo odmerek morda po potrebi prilagodil.
Any excess dissolved Nplate must be thrown away immediately after completing the injection process.
Ves preostanek raztopljenega zdravila Nplate morate zavreči takoj po koncu injiciranja.
The diagnosis of ITP in adults and elderly patients should have been confirmed by the exclusion of other clinical entities presenting with thrombocytopenia, in particular the diagnosis of MDS must be excluded.
Diagnoza ITP pri odraslih in starejših bolnikih mora biti potrjena z izključitvijo drugih kliničnih stanj, povezanih s trombocitopenijo, še zlasti je treba izključiti diagnozo MDS.
Bone marrow changes (increased reticulin and possible bone marrow fibrosis)
Spremembe kostnega mozga (zvišanje retikulina in možna fibroza kostnega mozga)
• dizziness or a spinning sensation (vertigo);
• omotica ali vrtoglavica (vertigo),
Pharmacokinetics of romiplostim in patients with renal and hepatic impairment has not been investigated.
Farmakokinetika romiplostima pri bolnikih z okvaro ledvic ali jeter ni raziskana.
• Slowly push back on the plunger to leave only the amount prescribed by your healthcare professional.
• Počasi potisnite nazaj na bat, da v brizgi pustite le količino, ki vam jo je predpisal zdravnik.
A bone marrow aspirate and biopsy should normally have been done over the course of the disease and treatment, particularly in patients over 60 years of age, for those with systemic symptoms or abnormal signs such as increased peripheral blast cells.
V teku bolezni in med zdravljenjem je običajno potrebno izvesti aspiracijo in biopsijo kostnega mozga, predvsem pri bolnikih, starejših od 60 let, pri bolnikih s sistemskimi simptomi ali z nenormalnimi znaki, kot je povečanje števila perifernih blastnih celic.
A. Push air into vial.
A. Potisnite zrak v vialo.
• bleeding beneath the surface of the skin or bruising under the skin (purpura);
• krvavitev pod površino kože ali podkožne podplutbe (purpura),
If you have missed a dose of Nplate, your doctor will discuss with you when you should have your next dose.
Če ste izpustili odmerek zdravila Nplate, se bo zdravnik z vami pogovoril o tem, kdaj morate prejeti naslednji odmerek.
Using: New alcohol swab.
Uporabite: Nov alkoholni zloženec.
Stop and contact your healthcare professional.
Prenehajte s postopkom in se posvetujte z zdravstvenim delavcem.
Possible side effects in children with ITP
Možni neželeni učinki pri otrocih z ITP
Therefore, the risk of potential carcinogenicity of romiplostim in humans remains unknown.
Tveganje o možni kancerogenosti romiplostima pri človeku tako ni znano.
• Withdraw the full amount of liquid into the syringe.
• Izvlecite celotno količino tekočine v brizgo.
e Stable dose defined as dose maintained within ± 1 mcg/kg during the last 8 weeks of treatment.
e Stabilni odmerek je opredeljen kot odmerek, ki je bil v zadnjih 8 tednih zdravljenja znotraj ± 1 µg/kg.
Nplate is a sterile but unpreserved medicinal product and is intended for single use only.
Zdravilo Nplate je sterilno zdravilo, vendar ne vsebuje konzervansov in je namenjeno samo za enkratno uporabo.
Adjust the amount to your prescribed dose
Odmerite količino tako, da bo ustrezala vašemu predpisanemu odmerku
Your doctor may decide to take a bone marrow biopsy if they decide it is necessary to ensure that you have ITP, and not another condition such as Myelodysplastic Syndrome (MDS).
Zdravnik se lahko odloči za biopsijo kostnega mozga, če je treba potrditi, da imate ITP in ne kakšne druge bolezni kot npr. mielodisplastičnega sindroma (MDS).
Dextrose (5%) in water or sterile water for injection should not be used for the dilution.
Za redčenje ne smete uporabiti dekstroze (5 %) v vodi ali sterilne vode za injekcije.
There were no antibodies detected to TPO.
Protiteles proti TPO niso zaznali.
Left over Nplate in vial must NEVER be re-used for another injection.
Preostanka zdravila Nplate v viali ne smete NIKOLI ponovno uporabiti za še eno injekcijo.
In the paediatric studies, 282 paediatric ITP subjects were treated with romiplostim in 2 controlled and 3 uncontrolled clinical trials.
V preskušanjih pediatrične populacije je bilo 282 pediatričnih bolnikov z ITP zdravljenih z romiplostimom v 2 kontroliranih in 3 nekontroliranih kliničnih preskušanjih.
Paediatric subjects who had completed a prior romiplostim study (including study S4) were allowed to enroll in study S6 (340), an open-label extension study evaluating the safety and efficacy of long-term dosing of romiplostim in thrombocytopenic paediatric subjects with ITP.
Pediatrični bolniki, ki so zaključili prejšnjo klinično preskušanje z romiplostimom (vključno s študijo S4), so se smeli vključiti v študijo S6 (340), podaljšano preskušanje odprtega tipa, ki je ocenjevalo varnost in učinkovitost dolgoročnega odmerjanja romiplostima pri trombocitopeničnih pediatričnih bolnikih z ITP.
• Take the Nplate self injection kit out of the refrigerator.
• Vzemite komplet za samoinjiciranje zdravila Nplate iz hladilnika.
In embryo-foetal development studies in mice and rats, reductions in maternal body weight were found only in mice.
V študijah embrio-fetalnega razvoja pri miših in podganah so samo pri miših ugotovili zmanjšanje telesne mase samic-mater.
In these cases, if clinically appropriate, higher cut-off levels of platelet count for dose reduction (200 x 10
V takšnih primerih, če je klinično primerno, se lahko v skladu z zdravniško presojo upošteva višjo mejno raven števila trombocitov za zmanjšanje odmerka (200 x 10
Nplate works by stimulating the bone marrow (part of the bone which makes blood cells) to produce more platelets.
Zdravilo Nplate spodbuja kostni mozeg (del kosti, v katerem nastajajo krvne celice) k tvorbi več trombocitov.
The safety and efficacy of romiplostim 250/500 mcg powder and solvent for solution for injection, also used for self-administration in eligible adult patients, have not been established in patients aged under 18 years.
Varnost in učinkovitost romiplostima 250/500 µg praška in vehikla za raztopino za injiciranje, ki ga uporabljajo tudi odrasli bolniki, ki izpolnjujejo pogoje za samoinjiciranje, pri bolnikih, starih do 18 let, nista bili dokazani.
Patients requiring rescue medicinal products were not considered for durable platelet response.
Bolniki, ki so potrebovali rešilna zdravila, niso prišli v poštev za trajen odziv trombocitov.
Additional medical management may include cessation of anticoagulant and/or antiplatelet therapy, reversal of anticoagulation, or platelet support.
Dodatni možni zdravstveni ukrepi so prenehanje antikoagulantnega in/ali antiagregacijskega zdravljenja, odprava antikoagulacije ali trombocitna podpora.
There was also a stimulatory effect on leukocyte production, as peripheral blood counts for neutrophils, lymphocytes, monocytes, and eosinophils were mildly increased.
Ugotovili so tudi stimulacijski učinek na nastajanje levkocitov, ker se je število nevtrofilcev, limfocitov, monocitov in eozinofilcev v periferni krvi rahlo povečalo.
A total of 2.2% (4/184) adult patients developed binding, non-neutralising antibody against TPO.
Celokupno je 2,2 % (4/184) odraslih bolnikov razvilo vezavna, ne -nevtralizirajoča protitelesa proti TPO.
Hypersensitivity** Angioedema
Bolezni imunskega sistema preobčutljivost** angioedem
• Remove red (250 micrograms) or blue (500 micrograms) plastic cap from vial.
• Odstranite rdečo (250 mikrogramska viala) ali modro (500 mikrogramska viala) plastično zaporko z viale.
Of the 157 subjects randomised to the romiplostim group, three subjects did not receive romiplostim.
Med 157 bolniki, ki so bili randomizirani v skupino z romiplostimom, trije bolniki niso prejeli romiplostima.
Rescue therapies allowed in the study were IVIG, platelet transfusions, anti-D immunoglobulin, and corticosteroids.
V študiji dovoljena rešilna zdravila so bila IVIG, transfuzije trombocitov, anti-D imunoglobulin in kortikosteroidi.
If reconstituted product is not used immediately, the syringe should not be removed from the vial adapter to maintain microbiological integrity.
Če pripravljeno zdravilo ni uporabljeno takoj, brizge z zdravilom ne smete odpeti z nastavka za vialo; tako bo ostalo mikrobiološko nedotaknjeno.
Reduction in permitted concurrent ITP medical therapies
Zmanjšanje dovoljenih sočasnih zdravil za ITP
If you stop taking Nplate your platelet count will have to be monitored, and your doctor will discuss appropriate precautions with you.
Če nehate jemati zdravilo Nplate, vam bo treba spremljati število trombocitov in zdravnik se bo z vami pogovoril o ustreznih previdnostnih ukrepih.
The Nplate self injection kit must be kept in the original package until use in order to protect the Nplate vial from light.
Komplet za samoinjiciranje zdravila Nplate je treba do uporabe hraniti v originalni ovojnini za zagotovitev zaščite viale zdravila Nplate pred svetlobo.
Of the 271 patients who received romiplostim in ITP clinical trials, 55 (20%) were age 65 and over, and 27 (10%) were 75 and over.
271 bolnikov, ki so romiplostim prejemali v kliničnih preskušanjih ITP, je bilo 55 (20 %) starejših od 65 let in 27 (10 %) starejših od 75 let.
If you are taking corticosteroids, danazol, and/or azathioprine, which you may be receiving to treat your ITP, these may be reduced or stopped when given together with Nplate.
Če jemljete kortikosteroide, danazol in/ali azatioprin, ki jih morda dobivate za zdravljenje ITP, vam bodo njihov odmerek med hkratno uporabo zdravila Nplate morda zmanjšali ali jih bodo celo povsem opustili.
• Note: After injecting the water into the vial it is common for the plunger to move back up.
• Opomba: Po injiciranju vode v vialo se bat pogosto premakne nazaj gor.
9/L in the absence of rescue medication) was 93.8% (n = 61) and was similar across age groups.
9/l enkrat ali večkrat brez uporabe rešilnega zdravila) znašala 93,8 % (n = 61) in je bila podobna med starostnimi skupinami.
It is recommended that, if treatment with romiplostim is discontinued, ITP treatment be restarted according to current treatment guidelines.
V primeru prenehanja zdravljenja z romiplostimom je priporočljivo ITP znova začeti zdraviti skladno z veljavnimi terapevtskimi smernicami.
If you stop using Nplate
Če ste prenehali uporabljati zdravilo Nplate
Patients who have a stable platelet count ≥ 50 x 10
Bolniki, ki imajo stabilno število trombocitov ≥ 50 x 10
• Step 3b: Holding the syringe with one hand, bend the tip of the white plastic cover downward with your other hand.
• Korak 3b: Z eno roko držite brizgo, z drugo roko pa upognite konico belega plastičnega pokrovčka navzdol.
In a prenatal and postnatal development study in rats an increase of the duration of gestation and a slight increase in the incidence of peri-natal pup mortality was found.
V študiji predporodnega in poporodnega razvoja pri podganah so ugotovili podaljšanje gestacije in nekoliko večjo incidenco perinatalne umrljivosti mladičev.
The median average weekly dose for splenectomised patients was 3 mcg/kg and for non-splenectomised patients was 2 mcg/kg.
Mediani povprečni tedenski odmerek pri splenektomiranih bolnikih je bil 3 µg/kg in pri nesplenektomiranih 2 µg/kg.
In these studies, myelofibrosis was not observed in animals after a 4-week post-treatment recovery period, indicating reversibility.
V teh študijah po koncu 4-tedenskega okrevanja po zdravljenju pri živalih niso ugotovili mielofibroze, kar nakazuje reverzibilnost.