FrancophonIA/ELRC3.0 huggingface dataset:
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) PUREGON EPAR summary for the public
Slovenian: EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) PUREGON Povzetek EPAR za javnost
English: The Committee recommended that Puregon be given marketing authorisation.
Slovenian: Odbor je priporočil, da se za zdravilo Puregon odobri dovoljenje za promet.
English: Puregon was studied in 172 anovulatory women, measuring how many cycles of treatment were needed for these women to ovulate.
Slovenian: Zdravilo Puregon so proučevali pri 172 ženskah brez ovulacije, merili pa so, koliko ciklov zdravljenja so potrebovale do pojava ovulacije.
English: • women who are anovulatory (do not produce eggs) and do not respond to treatment with clomiphene citrate (another medicine that stimulates ovulation).
Slovenian: • pri ženskah z anovulacijo (ki ne proizvajajo jajčec) in ženskah, ki se niso odzvale na zdravljenje s klomifen citratom (drugim zdravilom, ki spodbuja ovulacijo);
English: Puregon's use in women undergoing fertility treatment has been studied in 981 patients.
Slovenian: Uporaba zdravila Puregon pri ženskah, ki se zdravijo zaradi neplodnosti, je bila raziskana pri 981 bolnicah.
English: Puregon should not be used in people who may be hypersensitive (allergic) to follitropin beta or any of the other ingredients.
Slovenian: Zdravila Puregon ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) na folitropin beta ali katero koli drugo sestavino zdravila.
English: What is the risk associated with Puregon?
Slovenian: Kakšna tveganja so povezana z uporabo zdravila Puregon?
English: • women who are undergoing fertility treatment (assisted reproductive techniques, such as in vitro fertilisation).
Slovenian: • pri ženskah, ki se zdravijo zaradi neplodnosti (postopki asistirane reprodukcije, kot je in vitro oploditev).
English: Puregon can also be used to stimulate sperm production in men who have hypogonadotrophic hypogonadism (a rare hormone deficiency disease).
Slovenian: Zdravilo Puregon se prav tako lahko uporablja za spodbujanje proizvajanja semenčic pri moških, ki imajo hipogonadotropni hipogonadizem (redka bolezen pomanjkanja hormonov).
English: Puregon is given as a ‘subcutaneous' injection (under the skin) or into a muscle.
Slovenian: Zdravilo Fertavid se daje s subkutano injekcijo (pod kožo) ali v mišico.
English: Puregon can only be obtained with a prescription.
Slovenian: Zdravilo Puregon se dobi samo na recept.
English: In all of the studies, Puregon was compared to the natural FSH hormone that was extracted from urine.
Slovenian: Pri vseh študijah so zdravilo Puregon primerjali z naravnim hormonom FSH, pridobljenim iz urina.
English: In 4 % of the women treated with Puregon in clinical studies, signs and symptoms related to ovarian hyperstimulation syndrome (e.g. feeling sick, weight gain, and diarrhoea) have been reported.
Slovenian: Pri 4 % žensk, ki so v kliničnih študijah prejemale zdravilo Puregon, so poročali o znakih in simptomih, podobnih sindromu hiperstimulacije jajčnikov (kot so občutek slabosti, povečanje telesne mase in driska).
English: In the body, FSH regulates the reproductive function: in women, it stimulates the production of eggs, and in men, it stimulates the production of sperm by the testicles.
Slovenian: V telesu FSH uravnava funkcijo reprodukcije: pri ženskah spodbuja nastajanje jajčec, pri moških pa nastajanje semenčic v modih.
English: The powder should be mixed with the solvent provided just before use.
Slovenian: Prašek se zmeša s priloženim vehiklom neposredno pred uporabo.
English: The follitropin beta in Puregon is produced by a method known as ‘recombinant DNA technology'.
Slovenian: Folitropin beta, ki ga vsebuje zdravilo Puregon, je pridobljen z metodo, znano kot „tehnologija rekombinantne DNK“.
English: Puregon must not be used in patients with tumours of the ovary, breast, womb, testicle, pituitary gland or hypothalamus.
Slovenian: Zdravila Puregon ne smejo uporabljati bolniki s tumorji jajčnikov, dojk, maternice, testisov, hipofize ali hipotalamusa.
English: It is also available as a solution for injection in a vial or a cartridge.
Slovenian: Na razpolago je tudi v obliki raztopine za injiciranje v viali ali vložku.
English: Puregon is administered to stimulate the ovaries to produce more than one egg at a time
Slovenian: Zdravilo Puregon se daje za spodbujanje delovanja jajčnikov, da bi v njih nastalo več kot eno jajčece hkrati.
English: In men, Puregon was studied to see its effect on sperm production in 49 patients.
Slovenian: Pri moških so vpliv zdravila Puregon na proizvajanje sperme proučevali pri 49 bolnikih.
English: Puregon should only be administered by people who have been trained by the doctor and have access to expert advice.
Slovenian: Zdravilo Puregon lahko dajejo samo osebe, ki jih je za to usposobil zdravnik in ki imajo možnost posvetovati se s strokovnjakom.
English: Puregon is used to treat infertility in women in the following situations:
Slovenian: Zdravilo Puregon se uporablja za zdravljenje neplodnosti v naslednjih primerih:
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Puregon's benefits are greater than its risks in the female for the treatment of infertility, and in the male for deficient spermatogenesis due to hypogonadotrophic hypogonadism.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Puregon pri zdravljenju neplodnosti pri ženskah in nezadostne spermatogeneze zaradi hipogonadotropnega hipogonadizma pri moških, večje od z njim povezanih tveganj.
English: Why has Puregon been approved?
Slovenian: Zakaj je bilo zdravilo Puregon odobreno?
English: Puregon is a powder and solvent to be made up into a solution for injection.
Slovenian: Zdravilo Puregon sestavljata prašek in topilo za pripravo raztopine za injiciranje.
English: Puregon contains the active substance follitropin beta.
Slovenian: Zdravilo Puregon vsebuje zdravilno učinkovino folitropin beta.
English: The full EPAR for Puregon is available here.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Puregon je na voljo tukaj.
English: The active substance in Puregon, follitropin beta, is a copy of the natural hormone follicle stimulating hormone (FSH).
Slovenian: Zdravilna učinkovina zdravila Puregon, folitropin beta je posnetek naravnega folikle stimulirajočega hormona (FSH).
English: Puregon was as effective as the comparator in all of the studies.
Slovenian: V vseh študijah je bilo zdravilo Puregon enako učinkovito kot primerjalno zdravilo.
English: For a full list of all side effects reported with Puregon, see the Package Leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Puregon, glejte navodilo za uporabo.
English: Puregon was as effective as urinary FSH as a fertility treatment, in producing ovulation and in producing sperm.
Slovenian: Zdravilo Puregon je bilo pri zdravljenju neplodnosti, spodbujanju ovulacije in nastajanju sperme enako učinkovito kot FSH, pridobljen iz urina.
English: What is Puregon used for?
Slovenian: Za kaj se zdravilo Puregon uporablja?
English: How has Puregon been studied?
Slovenian: Kako je bilo zdravilo Puregon raziskano?
English: What is Puregon?
Slovenian: Kaj je zdravilo Puregon?
English: How does Puregon work?
Slovenian: Kako zdravilo Puregon deluje?
English: How is Puregon used?
Slovenian: Kako se zdravilo Puregon uporablja?
English: For a full description of the doses, please see the Package Leaflet.
Slovenian: Celoten opis odmerjanja najdete v navodilu za uporabo.
English: EU/1/19/1399/001 XOSPATA
Slovenian: EU/1/19/1399/001
English: Oral use blister (OPA/aluminium/PVC/ aluminium)
Slovenian: mg filmsko obložena tableta peroralna uporaba pretisni omot (OPA/aluminij/PVC/aluminij)
English: Pack size
Slovenian: XOSPATA
English: Film-coated tablet
Slovenian: Stična ovojnina
English: Content Package size
Slovenian: Način uporabe Pakiranje Vsebina Velikost pakiranja
English: Both studies were similarly designed.
Slovenian: Obe študiji sta bili podobno zasnovani.
English: Adult and children (1 to 17 years):
Slovenian: Odrasli in otroci (1 leto do 17 let):
English: Date of first authorisation: 4 February 2009 Date of latest renewal: 20 December 2013
Slovenian: Datum prve odobritve: 4. februar 2009 Datum zadnjega podaljšanja: 20. december 2013
English: Before you begin
Slovenian: Preden začnete
English: IMMEDIATELY continue to step 7.
Slovenian: NEMUDOMA nadaljujte s 7. korakom.
English: Perform step 3a before step 3b.
Slovenian: Opravite korak 3a pred korakom 3b.
English: Combined studies 1 & 2
Slovenian: Kombinirani študiji 1 in 2
English: A summary of the key efficacy endpoints is presented below.
Slovenian: Spodaj je prikazan povzetek ključnih končnih točk učinkovitosti.
English: The injection volume may be very small.
Slovenian: Količina za injiciranje je lahko zelo majhna.
English: One Amgen Center Drive Thousand Oaks, CA 91320 USA
Slovenian: One Amgen Center Drive Thousand Oaks, CA 91320 ZDA
English: The overall safety profile was similar to that seen in adults.
Slovenian: Celokupen varnostni profil je bil podoben kot pri odraslih.
English: Component of a multipack, not to be sold separately.
Slovenian: Sestavine multipakiranja, ki se ne prodajajo ločeno.
English: The median duration of exposure was 65.4 weeks.
Slovenian: Mediana trajanja izpostavljenosti je bila 65,4 tedna.
English: Overall survival was similar to placebo.
Slovenian: Celokupno preživetje je bilo podobno kot pri placebu.
English: Patient may not have a weekly response within 8 weeks after receiving any rescue medicinal products.
Slovenian: Bolnik lahko nima tedenskega odziva v 8 tednih po prejetju kakršnekoli rešilne terapije.
English: As with all therapeutic proteins, there is a potential for immunogenicity.
Slovenian: Tako kot pri vseh terapevtskih beljakovinah obstaja možnost imunogenosti.
English: Do the following:
Slovenian: Naredite naslednje:
English: > 150 for two consecutive weeks
Slovenian: > 150 dva tedna zapored
English: • allergic reaction;
Slovenian: • alergična reakcija,
English: Effects of romiplostim on red and white blood cells
Slovenian: Učinki romiplostima na rdeče in bele krvne celice
English: Do not use if frozen.
Slovenian: Zdravila ne uporabite, če je zmrznjeno.
English: • protein in the urine.
Slovenian: • beljakovine v urinu.
English: Before continuing:
Slovenian: Pred nadaljevanjem:
English: • Wash your hands with soap and warm water.
Slovenian: • Umijte si roke z milom in toplo vodo.
English: Other pharmaceutical forms/strengths may be more appropriate for administration to this population.
Slovenian: Za uporabo pri tej populaciji so morda bolj primerne druge farmacevtske oblike/jakosti.
English: • if you are allergic to romiplostim or any of the other ingredients of this medicine (listed in section 6).
Slovenian: • če ste alergični na romiplostim ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: • Select a well lit, flat work surface, such as a table.
Slovenian: • Izberite dobro osvetljeno, ravno delovno površino, kot je na primer miza.
English: Reassessment of body weight is recommended every 12 weeks.
Slovenian: Priporočljivo je, da se telesna masa ponovno oceni vsakih 12 tednov.
English: If necessary push liquid back into the vial to achieve the desired dose.
Slovenian: Če je treba, potisnite tekočino nazaj v vialo, da boste dosegli želeni odmerek.
English: Worsening of blood cancers
Slovenian: Poslabšanje krvnih rakov
English: • Do check your dose before starting this step.
Slovenian: • Pred začetkom tega koraka preverite svoj odmerek.
English: Children (1 to 17 years old): in addition to adjusting your dose based on platelet counts, your doctor will also regularly reassess your body weight in order to adjust your dose.
Slovenian: Otroci (stari 1 leto do 17 let): vaš zdravnik bo poleg prilagajanja vašega odmerka na osnovi števila trombocitov redno ocenjeval tudi vašo telesno težo in tako prilagajal vaš odmerek.
English: ITP is a disease in which your body's immune system destroys its own platelets.
Slovenian: ITP je bolezen, pri kateri telesni imunski sistem uničuje svoje lastne trombocite.
English: • Do dissolve slowly and carefully.
Slovenian: • Zdravilo raztopite počasi in pazljivo.
English: Romiplostim should be used with caution in these populations.
Slovenian: Romiplostim je treba pri teh populacijah uporabljati previdno.
English: Do not try to inject yourself if you have not been trained.
Slovenian: Ne poskušajte si injicirati zdravila, če se za to niste usposobili.
English: Push slowly and gently
Slovenian: Potisnite počasi in previdno
English: The European Medicines Agency has waived the obligation to submit data for children < 1 year.
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev podatkov za otroke, mlajše od enega leta.
English: Progression of existing Myelodysplastic Syndromes (MDS)
Slovenian: Napredovanje obstoječih mielodisplastičnih sindromov (MDS)
English: This is a protein product and proteins can be easily damaged by improper mixing and excessive shaking.
Slovenian: To je zdravilo, ki vsebuje beljakovine, beljakovine pa se med nepravilnim mešanjem in prekomernim stresanjem zlahka poškodujejo.
English: Multipack: comprising 4 packs Each pack contains:
Slovenian: Multipakiranje: obsega 4 pakiranja Vsako pakiranje vsebuje:
English: In general, effects observed during these studies were related to the thrombopoietic activity of romiplostim and were similar regardless of study duration.
Slovenian: Na splošno so bili učinki, ugotovljeni v teh študijah, povezani s trombopoetskim delovanjem romiplostima in so bili podobni ne glede na trajanje študije.
English: If the expiry date has passed, do not use.
Slovenian: Če je rok uporabnosti že potekel, zdravila ne uporabite.
English: Although high doses were tested in the animal studies, due to differences between the laboratory species and humans with regard to the sensitivity for the pharmacodynamic effect of romiplostim and the effect of neutralising antibodies, safety margins cannot be reliably estimated.
Slovenian: V študijah na živalih so sicer preizkusili velike odmerke, vendar zaradi razlik med laboratorijskimi vrstami in človekom, kar zadeva občutljivost na farmakodinamične učinke romiplostima in učinek nevtralizirajočih protiteles, meje varnosti ni mogoče zanesljivo oceniti.
English: 9/L for at least 4 weeks without dose adjustment) has been achieved.
Slovenian: 9/l vsaj 4 tedne brez prilagoditve odmerka).
English: Your doctor will tell you how much you must take.
Slovenian: Zdravnik vam bo povedal, koliko zdravila morate dobivati.
English: • Note: The Nplate liquid is highly potent which is why accuracy and dose measurement are important.
Slovenian: • Opomba: Tekočina zdravila Nplate je izredno močna, zato sta točnost in odmerjanje odmerka pomembna.
English: However, the data are insufficient to draw any meaningful conclusion relating to the impact of dose and age on the pharmacokinetics of romiplostim.
Slovenian: Vendar pa so podatki nezadostni za podajanje pomembnih zaključkov o vplivu odmerka in starosti na farmakokinetiko romiplostima.
English: Before you begin Step 3 please note the following:
Slovenian: Preden začnete s 3. korakom, bodite pozorni na sledeče:
English: Before you begin Step 4 please note the following:
Slovenian: Preden začnete s 4. korakom, bodite pozorni na sledeče:
English: Treatment should remain under the supervision of a physician who is experienced in the treatment of haematological diseases.
Slovenian: Zdravljenje mora ves čas potekati pod nadzorom zdravnika, izkušenega v zdravljenju hematoloških bolezni.
English: No other diluents have been tested.
Slovenian: Druga redčila niso bila preizkušena.
English: You do not have to maintain pressure on the plunger for the rest of Step 4.
Slovenian: Bata vam ni treba ves preostanek 4. koraka držati pritisnjenega.
English: • anaemia.
Slovenian: • anemija.
English: With the other hand, hold the syringe (like a pencil) at a 45-degree angle to the skin.
Slovenian: Z drugo roko držite brizgo (kot svinčnik) pod kotom 45 stopinj glede na kožo.
English: • Make sure you have the following items: Alcohol swab package x4
Slovenian: • Preverite, da imate naslednji material: 4 x pakiranje alkoholnih zložencev
English: • trouble sleeping (insomnia);
Slovenian: • težave s spanjem (nespečnost),
English: What you need to know before you use Nplate
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Nplate
English: 9/L for at least 4 weeks without dose adjustment may, at the discretion of the supervising physician, self-administer Nplate solution for injection.
Slovenian: 9/l vsaj 4 tedne brez prilagoditve odmerka, si lahko po presoji nadzornega zdravnika sami injicirajo zdravilo Nplate raztopina za injiciranje.
English: Study 2 splenectomised patients
Slovenian: Študija 2 Splenektomirani bolniki
English: = Amount to inject in mL
Slovenian: = količina za injiciranje v ml
English: Generally, dissolution of Nplate takes less than 2 minutes.
Slovenian: Praviloma traja raztapljanje zdravila Nplate manj kot 2 minuti.
English: What Nplate is and what it is used for
Slovenian: Kaj je zdravilo Nplate in za kaj ga uporabljamo
English: Read all instructions for use thoroughly.
Slovenian: Natančno in v celoti preberite navodila za uporabo.
English: • Note: If your healthcare professional has instructed you that your Nplate dose requires more than one injection of Nplate, you will need to use more than one self injection kit.
Slovenian: • Opomba: Če vam je zdravstveni delavec dal navodila, da za svoj odmerek zdravila Nplate potrebujete več kot eno injekcijo zdravila Nplate, boste morali uporabiti več kot le en komplet za samoinjiciranje.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Slovenian: Če ste noseči ali dojite, menite, da ste noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden vzamete to zdravilo.
English: • The product is now ready for injection.
Slovenian: • Zdravilo je zdaj pripravljeno za injiciranje.
English: See table 2 below for dose adjustment and monitoring.
Slovenian: Tabelo 2 za prilagajanje odmerkov in spremljanje.
English: Toxicokinetic studies showed no interaction of the antibodies with the measured concentrations.
Slovenian: Toksikokinetične študije niso pokazale interakcije protiteles z merjenimi koncentracijami.
English: No overall differences in safety or efficacy have been observed in patients < 65 and ≥ 65 years of age (see section 5.1).
Slovenian: Gledano v celoti se varnost in učinkovitost pri bolnikih, starih < 65 in ≥ 65 let nista razlikovali (glejte poglavje 5.1).
English: • flu like symptoms (influenza like illness);
Slovenian: • gripi podobni bolezenski znaki (gripi podobna bolezen),
English: • If you are at risk of blood clots or if blood clots are common in your family.
Slovenian: • Če imate tveganje za nastajanje krvnih strdkov ali če so krvni strdki v vaši družini pogosti.
English: Your doctor, nurse or pharmacist will show you how to inject yourself with Nplate.
Slovenian: Vaš zdravnik, medicinska sestra ali farmacevt vam bodo pokazali, kako si morate injicirati zdravilo Nplate.
English: • pain in your hands and feet;
Slovenian: • bolečine v rokah in nogah,
English: Although based on these data no adjustment of the dosing regimen is required for older patients, care is advised considering the small number of elderly patients included in the clinical trials so far.
Slovenian: Čeprav starejšim bolnikom glede na te podatke ni treba prilagoditi odmerne sheme, je glede na majhno število starejših bolnikov, ki so bili doslej vključeni v klinična preskušanja, vseeno priporočljiva previdnost.
English: In all developmental studies neutralising antibodies were formed, which may have inhibited romiplostim effects.
Slovenian: V vseh razvojnih študijah so nastajala nevtralizirajoča protitelesa, ki so morda zavrla učinke romiplostima.
English: The safety and efficacy of romiplostim in children under the age of one year has not been established.
Slovenian: Varnost in učinkovitost romiplostima pri otrocih, mlajših od 1 leta, nista bili dokazani.
English: This section contains information on how to give yourself an injection of Nplate.
Slovenian: To poglavje vsebuje informacije o tem, kako si sami injicirate zdravilo Nplate.
English: In the post-marketing registry study, 19 confirmed paediatric patients were included.
Slovenian: V študijo v obliki registra v obdobju po začetku trženja zdravila je bilo vključenih 19 potrjenih pediatričnih bolnikov.
English: Once your platelet count is under control, your doctor will continue to regularly check your blood.
Slovenian: Ko bo število trombocitov pod nadzorom, vam bo zdravnik še naprej redno kontroliral kri.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or to E. coli derived proteins.
Slovenian: Preobčutljivost na zdravilno učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1, ali beljakovine pridobljene iz E. coli.
English: Air bubbles: Incorrect
Slovenian: Zračni mehurčki: Nepravilno
English: In both studies, efficacy was determined by an increase in the proportion of patients who achieved a durable platelet response.
Slovenian: V obeh študijah so učinkovitost ugotavljali s povečanjem deleža bolnikov, ki so dosegli trajen odziv trombocitov.
English: Follow the steps as described in this leaflet and use as many self injection kits as necessary to complete your prescribed dose of Nplate.
Slovenian: Sledite korakom, ki so opisana v tem navodilu, in uporabite toliko kompletov za samoinjiciranje, kot je potrebno, da boste dobili predpisani odmerek zdravila Nplate.
English: This medicinal product must not be mixed with other medicinal products, except those mentioned in section 6.6.
Slovenian: Zdravila ne smemo mešati z drugimi zdravili, razen s tistimi, ki so omenjena v poglavju 6.6. 6.3 Rok uporabnosti
English: Similar to adults with ITP, romiplostim pharmacokinetics are highly variable in paediatric subjects with ITP and are not reliable and predictive.
Slovenian: Podobno kot pri odraslih z ITP je bila farmakokinetika romiplostima pri pediatričnih bolnikih z ITP zelo variabilna in ni zanesljiva in napovedljiva.
English: 4 alcohol swabs.
Slovenian: 4 alkoholne zložence.
English: • Keep filled syringe in your hand and do not touch syringe tip.
Slovenian: • Napolnjeno brizgo držite v roki in se ne dotikajte konice brizge.
English: Your doctor will decide if you should stop using Nplate.
Slovenian: Zdravnik bo odločil, ali morate nehati uporabljati zdravilo Nplate.
English: Study S2 (105) evaluated patients who were splenectomised and continued to have thrombocytopenia.
Slovenian: Študija S2 (105) je ocenjevala splenektomirane bolnike, ki so še naprej imeli trombocitopenijo.
English: Subject incidence was 1 (0.4%) for either grade ≥ 3 or serious thrombocytosis.
Slovenian: Incidenca je bila 1 (0,4 %) za trombocitozo stopnje 3 ali več ali za resno trombocitozo.
English: • Do not pull plunger back to more than 1 mL.
Slovenian: • Ne izvlecite bata za več kot 1 ml.
English: 1 pack containing:
Slovenian: 1 pakiranje vsebuje:
English: Romiplostim had no observed effect on the fertility of rats.
Slovenian: Romiplostim ni opazno vplival na plodnost podgan.
English: Romiplostim is not recommended during pregnancy and in women of childbearing potential not using contraception.
Slovenian: Romiplostima ni priporočljivo uporabljati pri nosečnicah in pri ženskah v rodni dobi, ki ne uporabljajo kontracepcije.
English: • Do not re-use items.
Slovenian: • Materiala ne uporabite ponovno.
English: It is very important the product is prepared correctly and the correct dose is taken.
Slovenian: Zelo pomembno je, da zdravilo pravilno pripravite in da uporabite pravilen odmerek.
English: Of these, 65 subjects (98.5%) received at least 1 dose of romiplostim.
Slovenian: 65 bolnikov (98,5 %) je prejelo vsaj 1 odmerek romiplostima.
English: The carcinogenic potential of romiplostim has not been evaluated.
Slovenian: Kancerogenega potenciala romiplostima niso ocenjevali.