FrancophonIA/ELRC3.0 huggingface dataset:
English: Eporatio should not be used in people who may be hypersensitive (allergic) to epoetin theta, to any other epoetins or substances derived from them, or to any of the other ingredients of Eporatio.
Slovenian: Zdravila Eporatio ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) epoetin theta, na katere koli druge epoetine ali iz njih izpeljane snovi ali na katero koli drugo sestavino zdravila Eporatio.
English: The most common side effects with Eporatio (seen in between 1 and 10 patients in 100) are shunt thrombosis (clots that can form in blood vessels of patients on dialysis, a blood clearance technique), headache, hypertension (high blood pressure), hypertensive crisis (sudden, dangerously high blood pressure), skin reactions, arthralgia (joint pain) and influenza (flu)-like illness.
Slovenian: Najpogostejši neželeni učinki zdravila Eporatio (opaženi pri 1 do 10 bolnikih izmed 100) so tromboza spoja (strdki, ki lahko nastanejo v krvnih žilah pri bolnikih na dializi, tj. tehnika čiščenja krvi), glavobol, hipertenzija (visok krvni tlak), hipertenzivna kriza (nenaden, nevarno visok krvni tlak), kožne reakcije, artralgija (bolečine v sklepih) in gripi podobna bolezen.
English: In the four renal failure studies, patients were given either Eporatio (under the skin or into a vein) or epoetin beta (another erythropoietin-like medicine used for anaemia).
Slovenian: V štirih študijah ledvične odpovedi so bolnikom dali zdravilo Eporatio (pod kožo ali v veno) ali pa epoetin beta (drugo eritropoetinu podobno zdravilo, uporabljeno pri anemiji).
English: What is the risk associated with Eporatio?
Slovenian: Kakšna tveganja so povezana z zdravilom Eporatio?
English: The main measure of effectiveness in two of these studies was based on whether increasing the dose of Eporatio from 20 or 40 IU per kg body weight to 120 IU per kg body weight led to improvements in haemoglobin levels during the correction phase.
Slovenian: Glavno merilo učinkovitosti v dveh od teh študij je temeljilo na tem, ali je povišanje odmerka zdravila Eporatio z 20 ali 40 i.e. na kilogram telesne mase na 120 i.e. na kilogram telesne mase povzročilo izboljšanje ravni hemoglobina v korekcijski fazi.
English: Eporatio is a solution for injection.
Slovenian: Zdravilo Eporatio je raztopina za injiciranje.
English: Patients who receive Eporatio by injection under the skin may inject themselves once they have been trained appropriately.
Slovenian: Bolniki, ki prejemajo zdravilo Eporatio s podkožnim injiciranjem, si lahko zdravilo po ustreznem usposabljanju injicirajo sami.
English: Eporatio is used to treat anaemia (low levels of red blood cells or haemoglobin) that is causing symptoms.
Slovenian: Zdravilo Eporatio se uporablja za zdravljenje anemije (nizke koncentracije rdečih krvničk ali hemoglobina), ki povzroča simptome.
English: For the full list of all side effects reported with Eporatio, see the Package Leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Eporatio, glejte navodilo za uporabo.
English: In chronic renal failure patients, the correction phase showed that increasing the starting dose of Eporatio leads to improvements in haemoglobin levels.
Slovenian: Pri bolnikih s kronično ledvično odpovedjo je korekcijska faza pokazala, da povišanje začetnega odmerka zdravila Eporatio povzroči izboljšanje ravni hemoglobina.
English: The weekly dose of Eporatio should not at any time be more than 700 IU per kg body weight.
Slovenian: Tedenski odmerek zdravila Eporatio ne sme nikoli preseči 700 i.e. na kilogram telesne mase.
English: Average weekly increases in haemoglobin were 0.73 and 0.58 g/dl in patients receiving the higher dose of Eporatio compared with 0.20 and 0.26 g/dl in patients receiving the lower dose of Eporatio.
Slovenian: Povprečna tedenska zvišanja hemoglobina so bila 0,73 in 0,58 g/dl pri bolnikih, ki so prejemali višji odmerek zdravila Eporatio, v primerjavi z 0,20 in 0,26 g/dl pri bolnikih, ki so prejemali nižji odmerek zdravila Eporatio.
English: The epoetin theta in Eporatio works in the body in the same way as the natural hormone to stimulate red blood cell production.
Slovenian: Epoetin theta v zdravilu Eporatio deluje v telesu enako kot naravni hormon in vzpodbuja tvorbo rdečih krvničk.
English: The other two renal failure studies showed that during the maintenance stage the change in haemoglobin levels was similar in patients receiving Eporatio and patients receiving epoetin beta.
Slovenian: Drugi dve študiji ledvične odpovedi sta pokazali, da je bila v vzdrževalni fazi sprememba ravni hemoglobina pri bolnikih, ki so prejemali zdravilo Eporatio, in pri bolnikih, ki so prejemali epoetin beta, podobna.
English: The active substance in Eporatio, epoetin theta, is a copy of a human hormone called erythropoietin that stimulates the production of red blood cells from the bone marrow.
Slovenian: Zdravilna učinkovina v zdravilu Eporatio, epoetin theta, je kopija človeškega hormona, imenovanega eritropoetin, ki spodbuja tvorbo rdečih krvničk v kostnem mozgu.
English: In the cancer studies, between 64 and 73% of patients who received Eporatio had an increase in haemoglobin of 2 g/dl compared with between 20 and 26% of patients who were given placebo.
Slovenian: V študijah raka se je pri 64 do 73 % bolnikov, ki so prejemali zdravilo Eporatio, raven hemoglobina povišala za 2 g/dl, v primerjavi z 20 do 26 % bolnikov, ki so prejemali placebo.
English: Why has Eporatio been approved?
Slovenian: Zakaj je bilo zdravilo Eporatio odobreno?
English: The other two studies compared Eporatio with epoetin beta during the maintenance phase.
Slovenian: V drugih dveh študijah so v vzdrževalni fazi zdravilo Eporatio primerjali z epoetinom beta.
English: In the cancer studies, the main measure of effectiveness was the number of patients receiving either Eporatio or placebo (a dummy treatment) with an increase in haemoglobin of 2 g/dl over 12 or 16 weeks.
Slovenian: V študijah raka je bilo glavno merilo učinkovitosti število bolnikov, ki so prejemali zdravilo Eporatio ali placebo (zdravilo brez zdravilne učinkovine), ki se jim je po 12 ali 16 tednih hemoglobin povišal za 2 g/dl.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Eporatio's benefits are greater than its risks for the treatment of symptomatic anaemia in adults with chronic renal failure and adults with non-myeloid cancers who are receiving chemotherapy.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Eporatio za zdravljenje simptomatske anemije pri odraslih s kronično ledvično odpovedjo in pri odraslih z nemieloidnim rakom, ki prejemajo kemoterapijo, večje od z njim povezanih tveganj.
English: Eporatio was effective at treating anaemia in patients with chronic renal failure and patients with nonmyeloid cancer who were receiving chemotherapy.
Slovenian: Zdravilo Eporatio je bilo učinkovito za zdravljenje anemije pri bolnikih s kronično ledvično odpovedjo in pri bolnikih z nemielodnim rakom, ki so prejemali kemoterapijo.
English: Patients with cancer should continue to receive treatment for up to four weeks after they stop receiving chemotherapy.
Slovenian: Tedenski odmerek zdravila Eporatio ne sme biti višji od 60 000 i.e. Bolniki z rakom naj zdravljenje nadaljujejo do štiri tedne po prenehanju zdravljenja s kemoterapijo.
English: Eporatio treatment should be started by a doctor experienced in treating symptomatic anaemia in patients with chronic renal failure and non-myeloid cancer.
Slovenian: Zdravljenje z zdravilom Eporatio sme uvesti zdravnik, ki ima izkušnje z zdravljenjem simptomatske anemije pri bolnikih s kronično odpovedjo ledvic in nemieloidnim rakom.
English: How does Eporatio work?
Slovenian: Kako zdravilo Eporatio deluje?
English: The full EPAR for Eporatio can be found here.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Eporatio je na voljo tukaj.
English: How has Eporatio been studied?
Slovenian: Kako je bilo zdravilo Eporatio raziskano?
English: What is Eporatio used for?
Slovenian: Za kaj se zdravilo Eporatio uporablja?
English: What is Eporatio?
Slovenian: Kaj je zdravilo Eporatio?
English: How is Eporatio used?
Slovenian: Kako se zdravilo Eporatio uporablja?
English: Long-term safety evaluations are ongoing.
Slovenian: Dolgoročna ocenjevanja varnosti še potekajo.
English: (fatal)1, 2 ,3
Slovenian: (smrtna)1, 2, 3
English: Clean your hands
Slovenian: Umijte si roke
English: 50 to 100
Slovenian: 50 do 100
English: Important Information:
Slovenian: Pomembne informacije:
English: • The injection may take up to 10 seconds.
Slovenian: • Injiciranje lahko traja do 10 sekund.
English: Date of last renewal: 25 September 2013
Slovenian: Datum zadnjega podaljšanja: 25. september 2013
English: The interval between consecutive doses should be at least 8 hours.
Slovenian: Interval med zaporednimi odmerki mora biti najmanj 8 ur.
English: Not included in the box:
Slovenian: Vključeno v škatlo:
English: Unopened vial: 30 months
Slovenian: Neodprta viala: 30 mesecev
English: These instructions do not replace training from your healthcare provider.
Slovenian: Navodila ne nadomeščajo usposabljanja s strani vašega zdravstvenega delavca.
English: Be alert for the first signs of infection such as:
Slovenian: Bodite pozorni na prve znake okužb, kot so:
English: Of these 3 patients, 1 subsequently withdrew from the study.
Slovenian: Od teh 3 bolnikov je 1 pozneje izstopil iz študije.
English: - to address the risk of allergic reactions.
Slovenian: - da opozori na tveganje alergijskih reakcij.
English: Genentech Inc. One Antibody Way Oceanside CA 92056
Slovenian: One Antibody Way Oceanside CA 92056
English: This includes medicines obtained without a prescription.
Slovenian: To vključuje zdravila, ki jih dobite brez recepta.
English: • If you are opening the box for the first time, check to make sure that it is properly sealed.
Slovenian: • Če škatlo odpirate prvič, preverite, ali je pravilno zapečatena.
English: Study I AMBITION
Slovenian: Študija I AMBITION
English: Call your healthcare provider for help.
Slovenian: Za pomoč pokličite zdravstvenega delavca.
English: There may be local or state laws about how to throw away used syringes.
Slovenian: Morda obstaja lokalni ali državni zakon o odstranjevanju uporabljenih injekcijskih brizg.
English: • if you have an active, severe infection.
Slovenian: • če imate aktivno, hudo okužbo.
English: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Slovenian: Za izboljšanje sledljivosti bioloških zdravil je treba zaščiteno ime in številko serije uporabljenega zdravila jasno zabeležiti.
English: In addition, some previous infections may reappear.
Slovenian: Dodatno opozori, da se lahko nekatere predhodne okužbe ponovno pojavijo;
English: No data are available
Slovenian: Podatkov ni na voljo.
English: Dispose of the syringe and do not use if:
Slovenian: Zavrzite injekcijsko brizgo in je ne uporabite, če:
English: This remained consistent following 2 years of treatment (83%; n=353).
Slovenian: To se je ohranilo po 2 letih zdravljenja (83 %; n = 353).
English: • The needle-shield may not have locked.
Slovenian: • Zaščita za iglo se morda ni zaklenila.
English: Stevens-JohnsonSyndrome3
Slovenian: StevensJohnsonov sindrom3
English: A “click” sound indicates the start of the injection.
Slovenian: Zvok "klik" označuje začetek injiciranja.
English: Patients should be managed according to local clinical guidelines for management of hyperlipidaemia.
Slovenian: Bolnike je treba obravnavati v skladu z lokalnimi kliničnimi smernicami za vodenje hiperlipidemije.
English: • If you have persistent headaches.
Slovenian: • Če imate trdovratne glavobole.
English: A decrease to the lower limit of normal occurred in 15 patients at some point in the study.
Slovenian: Znižanje na spodnjo mejo normale se je pojavilo pri 15 bolnikih v določenem trenutku med študijo.
English: • Look in the clear Window area.
Slovenian: • Dobro si oglejte območje okenca.
English: • Write the date, time, and specific part of your body where you injected yourself.
Slovenian: • Zapišite datum, čas in določen del telesa, kamor ste si injicirali zdravilo.
English: These decreases occurred without associated bleeding events.
Slovenian: Ta znižanja so se pojavila brez spremljajočih krvavitev.
English: Active, severe infections (see section 4.4).
Slovenian: Aktivne, hude okužbe (glejte poglavje 4.4).
English: > 1 to 3 x Upper Limit of Normal (ULN)
Slovenian: > 1- do 3-kratna zgornja meja normalne vrednosti (ZMN)
English: p-value(a)
Slovenian: p-vrednost(a)
English: Cmax increased dose-proportionally.
Slovenian: Cmax je naraščala sorazmerno odmerku.
English: Efficacy results from Study WA28119
Slovenian: Rezultati učinkovitosti v študiji WA28119
English: ANC 0.5 to 1
Slovenian: ANC 0,5 do 1
English: If you feel dizzy, do not drive or use machines.
Slovenian: Če ste omotični, ne vozite ali upravljajte strojev.
English: Call your doctor and seek medical attention without delay if you think you might be developing an infection.
Slovenian: Pokličite svojega zdravnika in poiščite zdravniško pomoč brez odlašanja, če mislite, da se je pojavila okužba.
English: The control period in 4 of the studies was 6 months and in 1 study was up to 2 years.
Slovenian: Obdobje kontrole je v štirih študijah trajalo 6 mesecev, v eni študiji pa do 2 leti.
English: Time to onset was rapid (as early as week 2) and the magnitude of response continued to improve with duration of treatment.
Slovenian: Čas do začetka odziva je bil hiter (že 2. teden), stopnja odziva pa se je v nadaljevanju zdravljenja še naprej izboljševala.
English: You will find detailed “Instructions for administration” at the end of this leaflet.
Slovenian: Podrobna navodila za dajanje zdravila boste našli na koncu tega navodila.
English: Study IV TOWARD
Slovenian: Študija IV TOWARD
English: This is important to ensure that the syringe and medicine are safe to use.
Slovenian: To je pomembno za zagotovitev varne uporabe injekcijske brizge in zdravila.
English: • the medicine contains particles
Slovenian: • zdravilo vsebuje delce,
English: These differences occur due to unknown reasons.
Slovenian: Razlogi za te razlike niso znani.
English: From a microbiological point of view, the prepared solution for infusion should be used immediately.
Slovenian: Z mikrobiološkega stališča je treba pripravljeno raztopino za infundiranje uporabiti takoj.
English: Component of a multipack, can't be sold separately.
Slovenian: Sestavnih delov skupnega pakiranja ni mogoče prodati posebej.
English: In particular, there was no impairment of skeletal growth, immune function and sexual maturation.
Slovenian: Še posebno niso bili okrnjeni skeletna rast, imunska funkcija in spolno dozorevanje.
English: It is important to read, understand and follow these instructions so that you or your caregiver uses the RoActemra syringe correctly.
Slovenian: Pomembno je, da preberete, razumete in upoštevate ta navodila, da boste vi ali vaš skrbnik pravilno uporabljali napolnjeno injekcijsko brizgo z zdravilom RoActemra.
English: They will dilute the solution, set up the intravenous infusion and monitor you during and after the treatment.
Slovenian: Raztopino bodo razredčili, pripravili intravensko infuzijo in vas med zdravljenjem ter po njem nadzirali.
English: • If you have any kind of infection, short- or long-term, or if you often get infections.
Slovenian: • Če imate kakršno koli okužbo, kratkotrajno ali dolgotrajno, ali če se vam pogosto pojavljajo okužbe.
English: The first injection should be performed under the supervision of a qualified health care professional.
Slovenian: Prvo injiciranje je treba opraviti pod nadzorom usposobljenega zdravstvenega delavca.
English: The treatment effect was similar in patients independent of rheumatoid factor status, age, gender, race, number of prior treatments or disease status.
Slovenian: Učinek zdravljenja je bil pri bolnikih podoben, neodvisno od prisotnosti revmatoidnega faktorja, starosti, spola, rase, števila predhodnih zdravljenj ali stanja bolezni.
English: - modified Total Sharp Score
Slovenian: modified mean total Sharp score).
English: Signs of serious infections:
Slovenian: Znaki resnih okužb:
English: Immunoglobulin G
Slovenian: Imunoglobulin G
English: The once every week dosing interval should be followed.
Slovenian: Upoštevati je treba odmerjanje enkrat na teden.
English: Renal function should be monitored closely in these patients.
Slovenian: Delovanje ledvic je treba pri teh bolnikih skrbno nadzorovati.
English: • You may see a drop of liquid at the end of the needle.
Slovenian: • Morda boste videli kapljico tekočine na koncu injekcijske igle.
English: • Let the skin dry for approximately 10 seconds.
Slovenian: • Počakajte približno 10 sekund, da se koža osuši.
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: TCZ = tocilizumab a = Per Protocol Population
Slovenian: TCZ = tocilizumab a = populacija po protokolu
English: These events were not treatment limiting.
Slovenian: Ti učinki niso omejili zdravljenja.
English: • You may not have received your full dose of RoACTEMRA.
Slovenian: • Morda niste prejeli celotnega odmerka zdravila RoACTEMRA.
English: • Reference to the Summary of Product Characteristics (e.g., link to EMA website)
Slovenian: • napotilo na povzetek glavnih značilnosti zdravila (npr. povezava na spletno stran EMA),
English: Parents and carers will get training on how to inject RoActemra for patients who cannot inject themselves, such as children.
Slovenian: Starše in skrbnike bodo poučili, kako injicirati zdravilo RoActemra bolnikom, ki se ga ne morejo injicirati sami, kot so otroci.
English: Reporting suspected adverse reactions after authorization of the medicinal product is important.
Slovenian: Poročanje o domnevnih neželenih učinkih zdravila po izdaji dovoljenja za promet je pomembno.
English: Possible serious side effects: tell a doctor straight away.
Slovenian: Možni resni neželeni učinki: nemudoma obvestite zdravnika.
English: • If needed, you may cover the injection site with a small bandage.
Slovenian: • Če je potrebno, lahko mesto injiciranja prekrijete z majhnim povojem.
English: This protein is involved in inflammatory processes of the body, and blocking it can reduce the inflammation in your body.
Slovenian: Ta beljakovina je vpletena v vnetna dogajanja v telesu in njeno blokiranje lahko zmanjša vnetje.
English: These proportions were statistically significantly different (p=0.0024).
Slovenian: Ta deleža sta bila statistično signifikantno različna (p = 0,0024).
English: The total patient exposure was 184.4 patient years.
Slovenian: Skupna izpostavljenost bolnikov je bila 184,4 bolnik-let.
English: • This medicine has been prescribed for you only.
Slovenian: • Zdravilo je bilo predpisano vam osebno.
English: Carcinogenicity studies were not performed because IgG1 monoclonal antibodies are not deemed to have intrinsic carcinogenic potential.
Slovenian: Študije kancerogenosti s tocilizumabom niso bile izvedene, ker se za monoklonska protitelesa IgG1 ne smatra, da imajo intrinzični kancerogeni potencial.
English: (cells x 109/ L )
Slovenian: (celic x 109/l )
English: This is an inflammatory disease that causes pain and swelling in one or more joints.
Slovenian: To je vnetna bolezen, ki povzroči bolečino in otekanje enega ali več sklepov.
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Slovenian: V odsotnosti študij kompatibilnosti zdravila ne smemo mešati z drugimi zdravili.
English: This should be a final volume of 50 mL.
Slovenian: To mora biti končni volumen (50 ml).
English: • The product may lessen signs and symptoms of acute infection delaying the diagnosis
Slovenian: • Zdravilo lahko oslabi znake in simptome akutne okužbe in podaljša čas do diagnoze;
English: RoActemra can reduce your body's ability to respond to infections and may make an existing infection worse or increase the chance of getting a new infection.
Slovenian: Zdravilo RoActemra lahko zmanjša sposobnost telesa za odziv na okužbe ter lahko poslabša obstoječo okužbo ali poveča možnost za pojav nove okužbe.
English: • if you or a child patient you look after have an active, severe infection.
Slovenian: • če imate vi ali otrok (bolnik), za katerega skrbite, aktivno, hudo okužbo.
English: During the open-label period of Study II, the improvement in physical function has been maintained for up to 2 years.
Slovenian: Med odprto, podaljšano fazo študije II je bilo izboljšanje funkcijske zmogljivosti ohranjeno do 2 leti.
English: Duration of Corticosteroid Therapy During Screening in Study WA28119
Slovenian: Trajanje zdravljenja s kortikosteroidi med presejanjem v študiji WA28119
English: IgG levels decrease during therapy.
Slovenian: Vrednosti IgG se med zdravljenjem znižajo.
English: Women of childbearing potential must use effective contraception during and up to 3 months after treatment.
Slovenian: Ženske v rodni dobi morajo uporabljati učinkovito kontracepcijo med zdravljenjem in do 3 mesece po njem.
English: The nonlinear part of RoActemra elimination leads to an increase in exposure that is more than dose-proportional.
Slovenian: Nelinearni del izločanja zdravila RoActemra povzroči povečanje izpostavljenosti, ki je več kot sorazmerno odmerku.
English: The results from study VII are shown in Table 6.
Slovenian: Rezultati iz študije VII so prikazani v preglednici 6.
English: Laboratory Value
Slovenian: Laboratorijska vrednost
English: It may also be helpful to write any questions or concerns about the injection so you can ask your healthcare provider.
Slovenian: Morda vam bo v pomoč tudi pisanje vprašanj ali pomislekov glede injiciranja, s katerimi se lahko obrnete na zdravstvenega delavca.
English: Quality of Life Outcomes
Slovenian: Izidi kakovosti življenja
English: • low fibrinogen levels in the blood (a protein involved in blood clotting).
Slovenian: • nizke vrednosti fibrinogena v krvi (beljakovine, vključene v strjevanje krvi).
English: This should be a final volume of 100 mL.
Slovenian: To mora biti končni volumen (100 ml).
English: Week 52
Slovenian: 52. teden
English: Ninety three percent (93%; n=271) of patients had no progression between week 52 and week 104.
Slovenian: Pri 93 % (n = 271) bolnikov ni bilo napredovanja med 52. in 104. tednom.
English: Study V RADIATE
Slovenian: Študija V RADIATE
English: DATE OF FIRST AUTHORISATION/DATE OF LATEST RENEWAL Date of first authorisation: 16 January 2009
Slovenian: Datum prve odobritve: 16. januar 2009
English: If appropriate, the dose of concomitant MTX and/or other medications should be modified or dosing stopped and tocilizumab dosing interrupted until the clinical situation has been evaluated.
Slovenian: Če je primerno, je treba odmerek sočasno uporabljenega metotreksata in/ali drugih zdravil prilagoditi ali uporabo ustaviti ter odmerjanje tocilizumaba prekiniti, dokler klinično stanje ni ocenjeno.
English: The TNF antagonist therapy was discontinued prior to randomisation.
Slovenian: Zdravljenje z zaviralcem TNF je bilo prekinjeno pred randomizacijo.
English: • Do not inject through clothing covering the skin
Slovenian: • Ne uporabljate je skozi obleko, ki prekriva kožo.
English: Depending on your response, your doctor may decrease your dose to 4 mg/kg then increase back to 8 mg/kg when appropriate.
Slovenian: Odvisno od vašega odziva vam lahko zdravnik zmanjša odmerek na 4 mg/kg in ga nato spet poveča na 8 mg/kg, ko je primerno.
English: Glucocorticoids should be given according to medical judgement and practice guidelines.
Slovenian: Uporabiti je treba glukokortikoide v skladu z zdravnikovo presojo in smernicami za zdravljenje.
English: L-Histidine
Slovenian: L-histidin
English: • red swollen areas in the mouth
Slovenian: • rdeči, otekli predeli v ustih,