FrancophonIA/ELRC3.0 huggingface dataset:
English: 9/L, 77 subjects received SOC treatment according to standard institutional practice or therapeutic guidelines.
Slovenian: 9/l, 77 bolnikov pa je prejelo standardno zdravstveno oskrbo v skladu z običajno prakso ustanove ali s terapevtskimi smernicami.
English: In paediatric studies, the incidence of binding antibodies to romiplostim at any time was 7.8% (22/282).
Slovenian: V pediatričnih preskušanjih je bila incidenca vezavnih protiteles proti romiplostimu kadar koli v času 7,8 % (22/282).
English: A total of 66 subjects were enrolled in this study, including 54 subjects (82%) who had completed study S4.
Slovenian: Celokupno je bilo v preskušanje vključenih 66 bolnikov, vključno s 54 bolniki (82 %), ki so zaključili preskušanje S4.
English: This will break the seal of the white plastic cover.
Slovenian: Tako boste prelomili zapečateni del belega plastičnega pokrovčka.
English: The safety and efficacy of romiplostim was evaluated in two placebo-controlled, double-blind studies.
Slovenian: Varnost in učinkovitost romiplostima sta bili ocenjeni v dveh s placebom kontroliranih, dvojno slepih preskušanjih.
English: Other medicines and Nplate
Slovenian: Druga zdravila in zdravilo Nplate
English: There is no data available on fertility.
Slovenian: Podatkov o plodnosti ni.
English: Administer subcutaneous injection following local protocols and good aseptic technique.
Slovenian: Zdravilo injicirajte subkutano, upoštevaje lokalne protokole in pravilen aseptičen postopek.
English: • As self-administration of Nplate is not allowed for paediatric patients, the HAT pack is intended for use with adult patients and not with paediatric patients.
Slovenian: • Ker samoinjiciranje zdravila Nplate ni dovoljeno za pediatrične bolnike, je pakt za usposabljanje za samoinjiciranje doma namenjen za uporabo pri odraslih bolnikih in ne pri pediatričnih bolnikih.
English: This should help to prevent bruising and bleeding associated with ITP.
Slovenian: To pomaga preprečiti podplutbe in krvavitve, ki spremljajo ITP.
English: Adjust the dose as follows:
Slovenian: Odmerek prilagajajte takole:
English: Only patients who demonstrate the ability to reconstitute and self-administer Nplate are allowed to continue doing so.
Slovenian: Samo tisti bolniki, ki pokažejo, da lahko pripravijo in si sami injicirajo zdravilo Nplate, lahko s tem nadaljujejo.
English: • Physicians involved in the prescribing of romiplostim are provided with a dosing calculator to simplify the calculation of the correct dose and as a guide to the correct reconstitution, dilution (if required) and administration procedures.
Slovenian: • Zdravnikom, ki predpisujejo romiplostim, je na voljo kalkulator odmerka za enostavnejši izračun pravilnega odmerka in kot vodilo za pravilen postopek priprave, redčenja (če je potrebno) in dajanja zdravila.
English: Always cover the needle with the pink safety cover before disposal.
Slovenian: Iglo vedno pokrijte z rožnatim varnostnim pokrovčkom, preden jo zavržete.
English: Nplate has moderate influence on the ability to drive and use machines.
Slovenian: Zdravilo Nplate ima zmeren vpliv na sposobnost vožnje in upravljanja s stroji.
English: All the 63 subjects received at least 1 dose of romiplostim.
Slovenian: Vseh 63 bolnikov je prejelo vsaj 1 odmerek romiplostima.
English: • With one hand, gently pinch the cleaned area of skin and hold it firmly.
Slovenian: • Z eno roko rahlo stisnite očiščeni predel kože in ga trdno držite.
English: • There may be a little bleeding at the injection site.
Slovenian: • Na mestu injiciranja se lahko pojavi rahla krvavitev.
English: Initial or subsequent once weekly dose:
Slovenian: Izračun odmerka Začetni in nadaljnji odmerek enkrat na teden:
English: Twenty-one non-splenectomised and 18 splenectomised patients received on-study ITP medical treatments (primarily corticosteroids) at the start of study.
Slovenian: Enaindvajset nesplenektomiranih in 18 splenektomiranih bolnikov je dodatna zdravila za ITP prejelo na začetku študije (v glavnem kortikosteroide).
English: • depression; abnormal dreams;
Slovenian: • depresija, nenormalne sanje,
English: These instructions are for patients who are already trained by their healthcare professional, such as your doctor, nurse, or pharmacist, in self injection.
Slovenian: Ta navodila so namenjena bolnikom, ki so jih njihovi zdravstveni delavci, kot na primer zdravnik, medicinska sestra ali farmacevt, že naučili, kako si zdravilo injicirajo sami.
English: These changes may lead to abnormal blood cells or your body making less blood cells.
Slovenian: Posledica teh sprememb so lahko nenormalne krvne celice ali zmanjšano nastajanje krvnih celic v telesu.
English: (SD) p-value No. (%) patients requiring rescue therapies d
Slovenian: (std. odklon) vrednost p Št. (%) bolnikov, ki so potrebovali rešilno terapijo d
English: • Do a final check to ensure the correct amount of liquid for your dose is in the syringe and all air bubbles have been removed.
Slovenian: • Opravite končno preverjanje, da se boste prepričali, da je v brizgi pravilna količina tekočine za vaš odmerek in da so vsi zračni mehurčki odstranjeni.
English: Because the dose is < 23 mcg, dilution is required to ensure accurate dosing.
Slovenian: Ker je odmerek < 23 µg, je potrebno redčenje za zagotovitev natančnega odmerjanja.
English: 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.
Slovenian: 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.
English: Do not use Nplate:
Slovenian: Ne uporabljajte zdravila Nplate:
English: Once Nplate has been dissolved, inject immediately.
Slovenian: Ko je zdravilo Nplate raztopljeno, ga takoj injicirajte.
English: In addition the reactions listed below have been deemed to be related to romiplostim treatment.
Slovenian: Poleg tega je bilo tudi za spodaj naštete učinke ocenjeno, da so povezani z zdravljenjem z romiplostimom.
English: 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).
Slovenian: 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).
English: Nplate should be reconstituted in accordance with good aseptic practice.
Slovenian: Zdravilo Nplate je treba pripraviti skladno z dobro aseptično prakso.
English: Using: 2 alcohol swab packages, 1 vial, and 1 vial adapter package.
Slovenian: Uporabite: 2 pakiranji alkoholnih zložencev, 1 vialo in 1 pakiranje z nastavkom za vialo.
English: Study 1 non-splenectomised patients
Slovenian: Študija 1 Nesplenektomirani bolniki
English: • Do not open items until directed in instructions.
Slovenian: • Materiala ne odpirajte, dokler ni v navodilih navedeno, da ga odprite.
English: Dilution (required when the calculated individual patient dose is less than 23 mcg)
Slovenian: Redčenje (potrebno, ko je izračunan odmerek za posameznega bolnika nižji od 23 µg)
English: Increased reticulin may be suggested by morphological changes in the peripheral blood cells and can be detected through bone marrow biopsy.
Slovenian: Zvišanje retikulina lahko nakazujejo morfološke spremembe celic v periferni krvi in ga je mogoče ugotoviti z biopsijo kostnega mozga.
English: Nplate will be given under the direct supervision of your doctor, who will closely control the amount of Nplate given to you.
Slovenian: Zdravilo Nplate boste prejeli pod nadzorom svojega zdravnika, ki bo natančno kontroliral dano količino zdravila Nplate.
English: • changes in some blood tests (increase in transaminase; blood lactate dehydrogenase increased);
Slovenian: • spremembe nekaterih preiskav krvi (zvišanje transaminaz, zvišanje laktat-dehidrogenaze v krvi),
English: Please read the instructions at the end of this leaflet on how to inject Nplate, as discussed with your doctor.
Slovenian: Prosimo, preberite navodila za injiciranje zdravila Nplate na koncu tega navodila, kot ste se dogovorili z vašim zdravnikom.
English: Note: To prevent contamination of the product, do not touch the vial adapter spike or Luer lock.
Slovenian: Opomba: Da boste preprečili onesnaženje zdravila, se ne smete dotakniti konice nastavka za vialo ali nastavka Luer.
English: If you have any questions about storage, contact your healthcare professional for further instructions.
Slovenian: Če imate vprašanja o shranjevanju, se za dodatna navodila obrnite na zdravstvenega delavca.
English: All subjects were negative for neutralising activity to TPO.
Slovenian: Vsi bolniki so bili negativni na nevtralizirajočo aktivnost proti TPO.
English: Water must flow slowly onto powder.
Slovenian: Voda mora na prašek teči počasi.
English: Your doctor will ensure that you receive the right amount of Nplate.
Slovenian: Vaš zdravnik bo poskrbel, da boste dobili pravo količino zdravila Nplate.
English: Vial Content:
Slovenian: Vsebina viale:
English: The safety and efficacy of romiplostim have been evaluated for up to 3 years of continuous treatment.
Slovenian: Varnost in učinkovitost romiplostima so ocenjevali med neprekinjenim zdravljenjem, ki je trajalo do 3 leta.
English: The serum concentrations varied among patients and did not correlate with the dose administered.
Slovenian: Koncentracija v serumu se je med bolniki razlikovala in ni bila v sorazmerju z uporabljenim odmerkom.
English: The injection device and Nplate vial must NEVER be reused.
Slovenian: Pripomočka za injiciranje in viale zdravila Nplate ne smete NIKOLI ponovno uporabiti.
English: Patients received single subcutaneous weekly injections for 24 weeks.
Slovenian: Bolniki so 24 tednov enkrat na teden prejemali posamezne subkutane injekcije.
English: If the use of romiplostim is deemed necessary, platelet count should be closely monitored to minimise the risk of thromboembolic complications.
Slovenian: Če je uporaba romiplostima potrebna, je treba število trombocitov natančno kontrolirati, da bi zmanjšali tveganje za tromboembolične zaplete.
English: The mild form of these bone marrow changes is called “increased reticulin” and has been observed in Nplate clinical trials.
Slovenian: Blago obliko takšnih sprememb kostnega mozga imenujemo "zvišanje retikulina" in so jo opazili v kliničnih preskušanjih zdravila Nplate.
English: No formal clinical trials have been conducted in these patient populations.
Slovenian: Pri bolnikih te starostne skupine niso opravili uradnih kliničnih preskušanj.
English: If you forget to use Nplate
Slovenian: Če ste pozabili uporabiti zdravilo Nplate
English: Summary of key efficacy results from placebo-controlled studies
Slovenian: Povzetek ključnih rezultatov o učinkovitosti iz študij, kontroliranih s placebom
English: After the first month of self-injecting Nplate, you will need to show that you can still prepare and inject Nplate correctly.
Slovenian: Ko bo minil prvi mesec, odkar si zdravilo Nplate injicirate sami, boste morali pokazati, da še vedno pravilno pripravite in si injicirate zdravilo Nplate.
English: • Note: If there is any colour or particles in the liquid, contact your healthcare professional.
Slovenian: • Opomba: Če je tekočina kakor koli obarvana ali so v njej delci, se posvetujte z zdravstvenim delavcem.
English: • Push the vial adapter down onto the vial until it is firmly in place and you can't push down any more.
Slovenian: • Potisnite nastavek za vialo navzdol na vialo, dokler ni trdno nameščen in ga ne morete več pritisniti navzdol.
English: Pharmacotherapeutic group: Antihaemorrhagics, other systemic haemostatics, ATC code: B02BX04
Slovenian: Farmakoterapevtska skupina: antihemoragiki, drugi hemostatiki za sistemsko zdravljenje, oznaka ATC: B02BX04
English: b Overall platelet response is defined as achieving durable or transient platelet responses.
Slovenian: Celotni odziv trombocitov je opredeljen kot doseganje trajnega ali prehodnega odziva trombocitov.
English: After suitable training, your doctor may also allow you to inject Nplate yourself.
Slovenian: Po ustreznem usposabljanju vam bo zdravnik morda dovolil, da si zdravilo Nplate injicirate sami.
English: • Do not touch vial stopper after cleaning it.
Slovenian: • Ne dotikajte se zamaška viale, potem ko ste ga očistili.
English: In pre-clinical and clinical trials no anti-romiplostim antibodies cross reacted with endogenous TPO.
Slovenian: V predkliničnih in kliničnih preskušanjih nobeno protitelo proti romiplostimu ni navzkrižno reagiralo z endogenim TPO.
English: 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.
Slovenian: 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.
English: Time to reach the maximum effect on platelet count is approximately 10-14 days, and is independent of the dose.
Slovenian: Največji učinek na število trombocitov je dosežen v času od 10 do 14 dni, in ni odvisen od odmerka.
English: 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).
Slovenian: 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).
English: Loss of response to romiplostim
Slovenian: Izguba odziva na romiplostim
English: After the platelet count has fallen to < 150 x 10
Slovenian: Potem ko število trombocitov upade na < 150 x 10
English: Nplate is supplied as a 1 pack or multipack comprising 4 packs.
Slovenian: Zdravilo Nplate je na voljo kot 1 pakiranje ali multipakiranje, ki vsebuje 4 pakiranja.
English: 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.
Slovenian: 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.
English: Slowly push the plunger up to force the air bubbles out of the syringe.
Slovenian: Počasi potisnite bat navzgor, da boste zračne mehurčke iztisnili iz brizge.
English: Within each MedDRA system organ class and frequency grouping, undesirable effects are presented in order of decreasing incidence.
Slovenian: V razvrstitvah po organskih sistemih po MedDRA in po pogostnosti so neželeni učinki navedeni po padajoči incidenci.
English: • a rare disorder characterised by periods of burning pain, redness and warmth in the feet and hands (erythromelalgia).
Slovenian: • redka motnja, za katero so značilna obdobja pekoče bolečine, pordelosti in topline v stopalih in dlaneh (eritromelalgija).
English: Caution should be used during preparation of Nplate in calculating the dose and reconstitution with the correct volume of sterile water for injection.
Slovenian: Med pripravo zdravila Nplate je potrebna previdnost pri izračunu odmerka in pri pripravi s pravilno količino sterilne vode za injekcije.
English: • if you are allergic to other medicines that are produced by DNA technology using the micro-organism Escherichia coli (E. coli).
Slovenian: • če ste alergični na druga zdravila, pridobljena s tehnologijo DNA in uporabo mikroorganizmov
English: Multiple dose romiplostim toxicology studies were conducted in rats for 4 weeks and in monkeys for up to 6 months.
Slovenian: Toksikološke študije z večimi odmerki romiplostima so opravili pri podganah (4 tedne) in opicah (do 6 mesecev).
English: Study S1 (212) evaluated patients who were non-splenectomised and had an inadequate response or were intolerant to prior therapies.
Slovenian: Študija S1 (212) je ocenjevala nesplenektomirane bolnike, ki se na predhodne terapije niso primerno odzvali ali jih niso prenesli.
English: • Make sure all other materials are discarded into proper containers.
Slovenian: • Poskrbite, da boste tudi drug material zavrgli v ustrezne vsebnike.
English: Elimination half-life of romiplostim in ITP patients ranged from 1 to 34 days (median, 3.5 days).
Slovenian: Razpolovni čas izločanja romiplostima pri bolnikih z ITP je bil od 1 do 34 dni (mediana 3,5 dni).
English: How to use Nplate
Slovenian: Kako uporabljati zdravilo Nplate
English: The potential interactions of romiplostim with co-administered medicinal products due to binding to plasma proteins remain unknown.
Slovenian: Možna medsebojna delovanja romiplostima med sočasno uporabo drugih zdravil zaradi vezave na plazemske beljakovine ostajajo neznana.
English: Thrombocytosis in paediatric subjects occurred uncommonly (≥ 1/1,000 to < 1/100), with a subject incidence of 1 (0.4%).
Slovenian: Pediatrični bolniki je do trombocitoze prišlo redko (≥ 1/1.000 do < 1/100), z incidenco 1 (0,4 %).
English: Gastroenteritis Pharyngitis*** Conjunctivitis*** Ear infection*** Sinusitis***
Slovenian: gastroenteritis faringitis*** konjuktivitis*** vnetje ušesa*** sinusitis***
English: Doses were adjusted to maintain (50 to 200 x 10
Slovenian: Odmerki so bili prilagojeni za vzdrževanje števila trombocitov (od 50 do 200 x 10
English: Long-term use of Nplate may cause changes in your bone marrow.
Slovenian: Dolgotrajna uporaba zdravila Nplate lahko povzroči spremembe v kostnem mozgu.
English: 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.
Slovenian: 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).
English: If you are also taking medicines which prevent blood clots (anticoagulants or antiplatelet therapy) there is a greater risk of bleeding.
Slovenian: Če jemljete tudi zdravila za preprečevanje nastanka krvnih strdkov (antikoagulantna ali antiagregacijska zdravila), obstaja večje tveganje za krvavitve.
English: Dose adjustment guidelines should be followed (see section 4.2).
Slovenian: Upoštevati je treba smernice za prilagajanje odmerka (glejte poglavje 4.2).
English: 9/L during weeks 18 through 25 of treatment.
Slovenian: 9/l na teden med 18. in 25. tednom zdravljenja.
English: Your doctor will take regular blood samples to measure how your platelets are responding and may adjust your dose as necessary.
Slovenian: Zdravnik vam bo redno jemal kri za meritve, ki bodo pokazale, kako dobro se trombociti odzivajo, in bo odmerek morda po potrebi prilagodil.
English: Any excess dissolved Nplate must be thrown away immediately after completing the injection process.
Slovenian: Ves preostanek raztopljenega zdravila Nplate morate zavreči takoj po koncu injiciranja.
English: 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.
Slovenian: 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.
English: Bone marrow changes (increased reticulin and possible bone marrow fibrosis)
Slovenian: Spremembe kostnega mozga (zvišanje retikulina in možna fibroza kostnega mozga)
English: • dizziness or a spinning sensation (vertigo);
Slovenian: • omotica ali vrtoglavica (vertigo),
English: Pharmacokinetics of romiplostim in patients with renal and hepatic impairment has not been investigated.
Slovenian: Farmakokinetika romiplostima pri bolnikih z okvaro ledvic ali jeter ni raziskana.
English: • Slowly push back on the plunger to leave only the amount prescribed by your healthcare professional.
Slovenian: • Počasi potisnite nazaj na bat, da v brizgi pustite le količino, ki vam jo je predpisal zdravnik.
English: 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.
Slovenian: 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.
English: A. Push air into vial.
Slovenian: A. Potisnite zrak v vialo.
English: • bleeding beneath the surface of the skin or bruising under the skin (purpura);
Slovenian: • krvavitev pod površino kože ali podkožne podplutbe (purpura),
English: If you have missed a dose of Nplate, your doctor will discuss with you when you should have your next dose.
Slovenian: Če ste izpustili odmerek zdravila Nplate, se bo zdravnik z vami pogovoril o tem, kdaj morate prejeti naslednji odmerek.
English: Using: New alcohol swab.
Slovenian: Uporabite: Nov alkoholni zloženec.
English: Stop and contact your healthcare professional.
Slovenian: Prenehajte s postopkom in se posvetujte z zdravstvenim delavcem.
English: Possible side effects in children with ITP
Slovenian: Možni neželeni učinki pri otrocih z ITP
English: Therefore, the risk of potential carcinogenicity of romiplostim in humans remains unknown.
Slovenian: Tveganje o možni kancerogenosti romiplostima pri človeku tako ni znano.
English: • Withdraw the full amount of liquid into the syringe.
Slovenian: • Izvlecite celotno količino tekočine v brizgo.
English: e Stable dose defined as dose maintained within ± 1 mcg/kg during the last 8 weeks of treatment.
Slovenian: e Stabilni odmerek je opredeljen kot odmerek, ki je bil v zadnjih 8 tednih zdravljenja znotraj ± 1 µg/kg.
English: Nplate is a sterile but unpreserved medicinal product and is intended for single use only.
Slovenian: Zdravilo Nplate je sterilno zdravilo, vendar ne vsebuje konzervansov in je namenjeno samo za enkratno uporabo.
English: Adjust the amount to your prescribed dose
Slovenian: Odmerite količino tako, da bo ustrezala vašemu predpisanemu odmerku
English: 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).
Slovenian: 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).
English: Dextrose (5%) in water or sterile water for injection should not be used for the dilution.
Slovenian: Za redčenje ne smete uporabiti dekstroze (5 %) v vodi ali sterilne vode za injekcije.
English: There were no antibodies detected to TPO.
Slovenian: Protiteles proti TPO niso zaznali.
English: Left over Nplate in vial must NEVER be re-used for another injection.
Slovenian: Preostanka zdravila Nplate v viali ne smete NIKOLI ponovno uporabiti za še eno injekcijo.
English: In the paediatric studies, 282 paediatric ITP subjects were treated with romiplostim in 2 controlled and 3 uncontrolled clinical trials.
Slovenian: V preskušanjih pediatrične populacije je bilo 282 pediatričnih bolnikov z ITP zdravljenih z romiplostimom v 2 kontroliranih in 3 nekontroliranih kliničnih preskušanjih.