FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Slovenian: 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.
English: • Take the Nplate self injection kit out of the refrigerator.
Slovenian: • Vzemite komplet za samoinjiciranje zdravila Nplate iz hladilnika.
English: In embryo-foetal development studies in mice and rats, reductions in maternal body weight were found only in mice.
Slovenian: V študijah embrio-fetalnega razvoja pri miših in podganah so samo pri miših ugotovili zmanjšanje telesne mase samic-mater.
English: In these cases, if clinically appropriate, higher cut-off levels of platelet count for dose reduction (200 x 10
Slovenian: 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
English: Nplate works by stimulating the bone marrow (part of the bone which makes blood cells) to produce more platelets.
Slovenian: Zdravilo Nplate spodbuja kostni mozeg (del kosti, v katerem nastajajo krvne celice) k tvorbi več trombocitov.
English: 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.
Slovenian: 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.
English: Patients requiring rescue medicinal products were not considered for durable platelet response.
Slovenian: Bolniki, ki so potrebovali rešilna zdravila, niso prišli v poštev za trajen odziv trombocitov.
English: Additional medical management may include cessation of anticoagulant and/or antiplatelet therapy, reversal of anticoagulation, or platelet support.
Slovenian: Dodatni možni zdravstveni ukrepi so prenehanje antikoagulantnega in/ali antiagregacijskega zdravljenja, odprava antikoagulacije ali trombocitna podpora.
English: There was also a stimulatory effect on leukocyte production, as peripheral blood counts for neutrophils, lymphocytes, monocytes, and eosinophils were mildly increased.
Slovenian: Ugotovili so tudi stimulacijski učinek na nastajanje levkocitov, ker se je število nevtrofilcev, limfocitov, monocitov in eozinofilcev v periferni krvi rahlo povečalo.
English: A total of 2.2% (4/184) adult patients developed binding, non-neutralising antibody against TPO.
Slovenian: Celokupno je 2,2 % (4/184) odraslih bolnikov razvilo vezavna, ne -nevtralizirajoča protitelesa proti TPO.
English: Hypersensitivity** Angioedema
Slovenian: Bolezni imunskega sistema preobčutljivost** angioedem
English: • Remove red (250 micrograms) or blue (500 micrograms) plastic cap from vial.
Slovenian: • Odstranite rdečo (250 mikrogramska viala) ali modro (500 mikrogramska viala) plastično zaporko z viale.
English: Of the 157 subjects randomised to the romiplostim group, three subjects did not receive romiplostim.
Slovenian: Med 157 bolniki, ki so bili randomizirani v skupino z romiplostimom, trije bolniki niso prejeli romiplostima.
English: Rescue therapies allowed in the study were IVIG, platelet transfusions, anti-D immunoglobulin, and corticosteroids.
Slovenian: V študiji dovoljena rešilna zdravila so bila IVIG, transfuzije trombocitov, anti-D imunoglobulin in kortikosteroidi.
English: If reconstituted product is not used immediately, the syringe should not be removed from the vial adapter to maintain microbiological integrity.
Slovenian: Če pripravljeno zdravilo ni uporabljeno takoj, brizge z zdravilom ne smete odpeti z nastavka za vialo; tako bo ostalo mikrobiološko nedotaknjeno.
English: Reduction in permitted concurrent ITP medical therapies
Slovenian: Zmanjšanje dovoljenih sočasnih zdravil za ITP
English: If you stop taking Nplate your platelet count will have to be monitored, and your doctor will discuss appropriate precautions with you.
Slovenian: Če nehate jemati zdravilo Nplate, vam bo treba spremljati število trombocitov in zdravnik se bo z vami pogovoril o ustreznih previdnostnih ukrepih.
English: The Nplate self injection kit must be kept in the original package until use in order to protect the Nplate vial from light.
Slovenian: Komplet za samoinjiciranje zdravila Nplate je treba do uporabe hraniti v originalni ovojnini za zagotovitev zaščite viale zdravila Nplate pred svetlobo.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: • Note: After injecting the water into the vial it is common for the plunger to move back up.
Slovenian: • Opomba: Po injiciranju vode v vialo se bat pogosto premakne nazaj gor.
English: 9/L in the absence of rescue medication) was 93.8% (n = 61) and was similar across age groups.
Slovenian: 9/l enkrat ali večkrat brez uporabe rešilnega zdravila) znašala 93,8 % (n = 61) in je bila podobna med starostnimi skupinami.
English: It is recommended that, if treatment with romiplostim is discontinued, ITP treatment be restarted according to current treatment guidelines.
Slovenian: V primeru prenehanja zdravljenja z romiplostimom je priporočljivo ITP znova začeti zdraviti skladno z veljavnimi terapevtskimi smernicami.
English: If you stop using Nplate
Slovenian: Če ste prenehali uporabljati zdravilo Nplate
English: Patients who have a stable platelet count ≥ 50 x 10
Slovenian: Bolniki, ki imajo stabilno število trombocitov ≥ 50 x 10
English: • Step 3b: Holding the syringe with one hand, bend the tip of the white plastic cover downward with your other hand.
Slovenian: • Korak 3b: Z eno roko držite brizgo, z drugo roko pa upognite konico belega plastičnega pokrovčka navzdol.
English: 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.
Slovenian: V študiji predporodnega in poporodnega razvoja pri podganah so ugotovili podaljšanje gestacije in nekoliko večjo incidenco perinatalne umrljivosti mladičev.
English: The median average weekly dose for splenectomised patients was 3 mcg/kg and for non-splenectomised patients was 2 mcg/kg.
Slovenian: Mediani povprečni tedenski odmerek pri splenektomiranih bolnikih je bil 3 µg/kg in pri nesplenektomiranih 2 µg/kg.
English: In these studies, myelofibrosis was not observed in animals after a 4-week post-treatment recovery period, indicating reversibility.
Slovenian: V teh študijah po koncu 4-tedenskega okrevanja po zdravljenju pri živalih niso ugotovili mielofibroze, kar nakazuje reverzibilnost.
English: In Study S6 (340), intensive romiplostim concentrations were available from 4 subjects (2 at 7 mcg/kg and 2 at 9 mcg/kg).
Slovenian: V študiji S6 (340) so bile intenzivne koncentracije romiplostima pridobljene od 4 bolnikov (2 pri 7 µg/kg in 2 pri 9 µg/kg).
English: Patients eligible for self-administration of Nplate should be trained in these procedures.
Slovenian: Bolnike, ki izpolnjujejo pogoje za samoinjiciranje zdravila Nplate, morate usposobiti za te postopke.
English: Nplate is not recommended for use in children below age 18.
Slovenian: Zdravila Nplate ni priporočljivo uporabljati pri otrocih, mlajših od 18 let.
English: A total of 3.2% (9/282) subjects had binding antibodies to TPO at any time during romiplostim treatment.
Slovenian: Celokupno je 3,2 % (9/282) bolnikov imelo vezavna protitelesa na TPO kadar koli med zdravljenjem z romiplostimom.
English: • painful swollen joints caused by uric acid (food breakdown product) (gout);
Slovenian: • boleča oteklost sklepov zaradi sečne kisline (razgradnega produkta hrane) (protin),
English: Due to the formation of neutralising antibodies pharmacodynamic effects of romiplostim in rats were often decreasing at prolonged duration of administration.
Slovenian: Zaradi nastajanja nevtralizirajočih protiteles so se farmakodinamičnimi učinki romiplostima pri podganah med dolgotrajno uporabo pogosto zmanjševali.
English: The vial should not be shaken or vigorously agitated.
Slovenian: Viale ne smete tresti ali močno stresati.
English: In 6 additional patients reticulin was observed upon bone marrow biopsy (see section 4.4).
Slovenian: Pri 6 nadaljnjih bolnikih so retikulin ugotovili z biopsijo kostnega mozga (glejte poglavje 4.4).
English: If available, comparison to a prior bone marrow biopsy should be made.
Slovenian: Narediti je treba primerjavo s predhodno biopsijo kostnega mozga, če je na voljo.
English: Possible side effects in adults with ITP
Slovenian: Možni neželeni učinki pri odraslih bolnikih z ITP
English: • Pull back on the pink safety cover (toward the syringe and away from the needle).
Slovenian: • Potegnite nazaj rožnati varnostni pokrovček (proti brizgi in proč od igle).
English: Pharmacokinetic data of romiplostim were collected from two studies in 21 paediatric subjects with ITP.
Slovenian: Podatki o farmakokinetiki romiplostima so bili pridobljeni v dveh preskušanjih 21 pediatričnih bolnikov z ITP.
English: Dose in mcg x
Slovenian: Odmerek v µg x
English: The elimination of serum romiplostim is in part dependent on the TPO receptor on platelets.
Slovenian: Odstranjevanje romiplostima v serumu je deloma odvisno od receptorjev TPO na trombocitih.
English: Among the 154 subjects who received romiplostim, the total median exposure to romiplostim was 52.0 weeks and ranged from 2 to 53 weeks.
Slovenian: Med 154 bolniki, ki so prejeli romiplostim, je bila celotna mediana izpostavljenosti romiplostimu 52,0 tednov in je segala od 2 do 53 tednov.
English: The most common adverse reactions observed include hypersensitivity reactions (including cases of rash, urticaria and angioedema) and headache.
Slovenian: Najpogosteje opaženi neželeni učinki vključujejo preobčutljivostne reakcije (vključno s primeri izpuščaja, urtikarije in angioedema) in glavobol.
English: If your doctor has allowed you to self-inject, you should follow up with your doctor every month to have the doctor determine if Nplate is working for you or if another treatment needs to be considered.
Slovenian: Če vam je zdravnik dovolil, da si zdravilo injicirate sami, ga morate vsak mesec obiskati, da bo preveril, ali je zdravilo Nplate pri vas učinkovito ali pa je treba razmisliti o kakšnem drugem zdravljenju.
English: GENTLY swirl the vial until all of the powder has dissolved and the liquid in the vial is clear and colourless.
Slovenian: PREVIDNO vrtite vialo, dokler se ves prašek ne raztopi ter je tekočina v viali bistra in brezbarvna.
English: In study S5 (195), romiplostim concentrations were available from 17 subjects at doses ranging from 1 to 10 mcg/kg.
Slovenian: V študiji S5 (195) so bile koncentracije romiplostima pridobljene od 17 bolnikov v odmerkih od 1 do 10 µg/kg.
English: The volume of romiplostim to administer is calculated based on body weight, dose required, and concentration of product.
Slovenian: Količina za apliciranje se izračuna na podlagi telesne tesne mase, zahtevanega odmerka in koncentracije zdravila.
English: Reinitiate treatment with Nplate in accordance with dosing and administration recommendations.
Slovenian: Zdravljenje z zdravilom Nplate znova začnite v skladu s priporočili za odmerjanje in dajanje.
English: • Make sure the top of the plunger head lines up with the syringe marking that matches your prescribed dose.
Slovenian: • Preverite, da je vrh glave bata v isti liniji kot tista oznaka na brizgi, ki ustreza vašemu predpisanemu odmerku.
English: • Do not inject into areas where the skin is tender, bruised and hard.
Slovenian: • Ne injicirajte v predele, kjer je koža občutljiva, podpluta ali zatrdela.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Nplate in one or more subsets of the paediatric population in the treatment of immune thrombocytopenia (idiopathic thrombocytopenic purpura) (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Nplate za eno ali več podskupin pediatrične populacije za zdravljenje imunske trombocitopenije (idiopatične trombocitopenične purpure) (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: If you have MDS and receive Nplate you may have an increase in your blast cell counts and your MDS condition may worsen to become an acute myeloid leukaemia, which is a type of cancer of the blood.
Slovenian: Če imate bolezen MDS in prejemate zdravilo Nplate, se vam število blastnih celic lahko poveča in stanje bolezni MDS se lahko poslabša, tako da preide v akutno mieloično levkemijo, ki je vrsta raka krvi.
English: • Do remove the clear needle shield before injecting.
Slovenian: • Prozorni ščitnik igle odstranite pred injiciranjem.
English: The median (Q1, Q3) duration of treatment was 138.0 weeks (91.1 weeks, 186.0 weeks).
Slovenian: Mediana (Q1, Q3) trajanja zdravljenja je bila 138,0 tednov (91,1 tednov, 186,0 tednov).
English: Very slowly and gently expel all water into powder vial.
Slovenian: Zelo počasi in previdno iztisnite vodo v vialo s praškom.
English: • pain in the mouth and throat (oropharyngeal pain);
Slovenian: • bolečina v ustih in grlu (orofaringealna bolečina),
English: Do not re-use Nplate!
Slovenian: Zdravila Nplate ne uporabite ponovno!
English: What Nplate is and what it is used for What you need to know before you use Nplate How to use Nplate
Slovenian: Kaj je zdravilo Nplate in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Nplate Kako uporabljati zdravilo Nplate Možni neželeni učinki
English: Reoccurrence of thrombocytopenia and bleeding after cessation of treatment
Slovenian: Ponoven pojav trombocitopenije in krvavitev po prenehanju zdravljenja
English: You can press a cotton ball or gauze over the injection site for 10 seconds.
Slovenian: S kosmom vate ali z gazo lahko 10 sekund pritiskate na mesto injiciranja.
English: Platelet counts should be monitored in patients receiving Nplate (see sections 4.2, 4.4 and 4.9).
Slovenian: Bolnikom, ki prejemajo zdravilo Nplate, je treba kontrolirati število trombocitov (glejte poglavja 4.2, 4.4 in 4.9).
English: The paediatric adverse reactions are derived from each of the paediatric ITP randomised safety set (2 controlled clinical trials) and paediatric ITP safety set (2 controlled and 3 uncontrolled clinical trials) where the subject incidence was at least 5% higher in the romiplostim arm compared to placebo and at least a 5% subject incidence in romiplostim-treated subjects.
Slovenian: Neželeni učinki pri pediatrični populaciji so pridobljeni iz vsakega pediatričnega ITP randomiziranega varnostnega sklopa (2 kontrolirani klinični preskušanji) in pediatričnega ITP varnostnega sklopa (2 kontrolirani klinični preskušanji in 3 nekontrolirana klinična preskušanja), v katerih je bila incidenca v skupini, zdravljeni z romiplostimom, vsaj 5 % višja v primerjavi s placebom in incidenca bolnikov, zdravljenih z romiplostimom, vsaj 5 %.
English: Study S4 (279) was a phase 3 study with 24 weeks of romiplostim treatment and study S5 (195) was a phase 1/2 study with 12 weeks of romiplostim treatment (up to 16 weeks for eligible responders who enter a 4-week pharmacokinetic assessment period).
Slovenian: Študija S4 (279) je bilo klinično preskušanje faze 3, v katerem je zdravljenje z romiplostimom trajalo 24 tednov, v študiji S5 (195), preskušanju faze 1/2, pa 12 tednov (do 16 tednov za izbrane osebe, ki so dosegle odziv na zdravljenje, in so bile vključene v nadaljnjo 4 tedne trajajočo oceno farmakokinetike).
English: In the placebo group, 0% to 7% of patients were able achieve a platelet count response during the 6 months of treatment.
Slovenian: V skupini s placebom je med 6-mesečno uporabo doseglo odziv števila trombocitov od 0 % do 7 % bolnikov.
English: Guidelines for calculating individual patient dose and volume of romiplostim to administer
Slovenian: Tabela 1: Smernice za izračun odmerka za posameznega bolnika in količine romiplostima za apliciranje
English: The most frequently used weekly dose was 3-10 mcg/kg and the maximum allowed dose on study was 10 mcg/kg.
Slovenian: Najpogosteje uporabljen tedenski odmerek je znašal 3-10 µg/kg, najvišji dovoljen odmerek v preskušanju pa je znašal 10 µg/kg.
English: 184 confirmed adult patients were included in this study; for these patients, the incidence of binding antibody post treatment was 3.8% (7/184) to romiplostim, of which 0.5% (1/184) was positive for neutralising antibodies to romiplostim.
Slovenian: 184 potrjenih odraslih bolnikov je bilo vključenih v to študijo; za te bolnike je bila incidenca vezavnih protiteles po zdravljenju 3,8 % (7/184) proti romiplostimu, od katerih je bilo 0,5 % (1/184) pozitivnih za nevtralizirajoča protitelesa proti romiplostimu.
English: • Physicians who express an interest in initiating self-administration for specific patients are provided with a HAT pack for those patients.
Slovenian: • Zdravnikom, ki imajo interes, da bi pri določenih bolnikih uvedli samoinjiciranje zdravila, je za takšne bolnike na voljo paket za usposabljanje za samoinjiciranje doma.
English: In an ongoing paediatric clinical trial, of the subjects with an evaluable on-study bone marrow biopsy, 5 out of 27 subjects (18.5%) developed increased reticulin in cohort 1 and 2 out of 4 subjects (50.0%) developed increased reticulin in cohort 2.
Slovenian: V kliničnem preskušanju pediatričnih bolnikov, ki še poteka, je od 27 bolnikov z ocenljivo biopsijo kostnega mozga, izvedeno med študijo, 5 bolnikov (18,5 %) razvilo zvišan retikulin v kohorti 1 in 2 bolnika od 4 (50,0 %) sta razvila zvišan retikulin v kohorti 2.
English: This study evaluated non-splenectomised patients with ITP and platelet counts < 50 x 10
Slovenian: Ta študija je ocenjevala nesplenektomirane bolnike z ITP in s številom trombocitov < 50 x 10
English: • a rare type of anaemia in which the red blood cells, white blood cells and platelets are all reduced in number (aplastic anaemia);
Slovenian: • redka vrsta anemije, pri kateri je zmanjšano število rdečih in belih krvnih celic ter krvnih ploščic (aplastična anemija),
English: Romiplostim should not be used in patients with moderate to severe hepatic impairment (Child-Pugh score ≥ 7) unless the expected benefit outweighs the identified risk of portal venous thrombosis in patients with thrombocytopenia associated to hepatic insufficiency treated with thrombopoietin (TPO) agonists (see section 4.4).
Slovenian: Romiplostima se ne sme uporabljati pri bolnikih z zmerno ali hudo okvaro jeter (stopnja ≥ 7 po Child-Pughu), razen če pričakovana korist odtehta ugotovljeno tveganje za portalno vensko trombozo pri bolnikih s trombocitopenijo, povezano z insuficienco jeter in zdravljeno s trombopoetinskimi (TPO) agonisti (glejte poglavje 4.4).
English: The incidence of pre-existing antibodies to romiplostim and TPO was 8.0% and 5.4%, respectively.
Slovenian: Incidenca že obstoječih protiteles proti romiplostimu je bila 8,0 % in proti TPO 5,4 %.
English: The incidence of thrombotic/thromboembolic events observed in clinical trials was 6.0% with romiplostim and 3.6% with placebo.
Slovenian: V kliničnih preskušanjih je bila incidenca trombotičnih/tromboemboličnih dogodkov med uporabo romiplostima 6,0 % in med uporabo placeba 3,6 %.
English: However, no subject showed any bone marrow abnormalities that were inconsistent with an underlying diagnosis of ITP at baseline or on-treatment.
Slovenian: Vendar pa noben od bolnikov ni kazal kakršnih koli nepravilnosti kostnega mozga, ki bi bile neskladne z osnovno diagnozo ITP na začetku ali med zdravljenjem.
English: • weight decreased; weight increased; intolerance of alcohol; loss of appetite (anorexia or decreased appetite); dehydration;
Slovenian: • zmanjšanje telesne mase, povečanje telesne mase, neprenašanje alkohola, izguba apetita (neješčnost ali zmanjšan apetit), dehidracija,
English: Medicinal products used in the treatment of ITP in combination with romiplostim in clinical trials included corticosteroids, danazol, and/or azathioprine, intravenous immunoglobulin (IVIG), and anti-D immunoglobulin.
Slovenian: Med zdravili, ki so jih v kliničnih preskušanjih uporabljali za zdravljenje ITP v kombinaciji z romiplostimom, so bili kortikosteroidi, danazol in/ali azatioprin, intravenski imunoglobulin (IVIG) in anti-D imunoglobulin.
English: Instructions for preparing and giving an injection of Nplate
Slovenian: Navodila za pripravo in injiciranje zdravila Nplate
English: As a result for a given dose, patients with high platelet counts are associated with low serum concentrations and vice versa.
Slovenian: Zato je pri določenem odmerku koncentracija v serumu pri bolnikih z velikim številom trombocitov nizka in obratno.
English: Concurrent anaemia and leucocytosis (within a 4-week window) may occur in patients regardless of splenectomy status, but have been seen more often in patients who have had a prior splenectomy.
Slovenian: Ne glede na status splenektomije se pri bolnikih lahko (v obdobju 4 tednov) sočasno pojavita anemija in levkocitoza, vendar sta bili pogosteje opaženi pri bolnikih, ki so pred tem imeli splenektomijo.
English: Using: A new 1 mL syringe package and the vial of dissolved, clear Nplate.
Slovenian: Uporabite: Novo pakiranje z 1 ml brizgo ter vialo raztopljenega, bistrega zdravila Nplate.
English: • In paediatric patients, future dose adjustments are based on changes in platelet counts and changes in body weight.
Slovenian: • Pri pediatričnih bolnikih nadaljnje prilagoditve odmerka temeljijo na spremembi števila trombocitov in spremembah telesne mase.
English: • Very slowly and gently push down on plunger rod to inject all water in the syringe into the vial.
Slovenian: • Zelo počasi in previdno pritisnite na držalo bata, da boste vso vodo iz brizge injicirali v vialo.
English: Doses were increased in increments of 2 mcg/kg every 2 weeks and the target platelet count was ≥ 50 x 10
Slovenian: Odmerki so bili postopoma povečani za 2 µg/kg vsaka 2 tedna, ciljno število trombocitov je znašalo ≥ 50 x 10
English: Your initial dose is 1 microgram of Nplate per kilogram of your body weight once a week.
Slovenian: Začetni odmerek bo 1 mikrogram zdravila Nplate na kilogram telesne mase enkrat na teden.
English: Self-administration of romiplostim is not allowed for paediatric patients.
Slovenian: Samoinjiciranje romiplostima pri pediatričnih bolnikih ni dovoljeno.
English: Additionally, 2.5% (7/282) developed neutralising antibodies to romiplostim.
Slovenian: Dodatno je 2,5 % (7/282) bolnikov razvilo nevtralizirajoča protitelesa proti romiplostimu.
English: Note: Remove all air bubbles from syringe to ensure precise solution amount is in syringe.
Slovenian: Opomba: Iz brizge odstranite vse zračne mehurčke, da boste zagotovili natančno količino raztopine v brizgi.
English: A clinically significant bleeding event was defined as a Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 grade ≥ 2 bleeding event.
Slovenian: Klinično pomembna krvavitev je bila definirana kot krvavitev 2. stopnje ali več po terminološko poenotenih kriterijih za neželene učinke (CTCAE - Common Terminology Criteria for Adverse Events), verzija 3.0.