FrancophonIA/ELRC3.0 huggingface dataset:
English: To reduce the risk of infusion-related reactions, patients may be given other medicines before or during treatment with Remsima or the infusion may be slowed down.
Slovenian: Za zmanjšanje tveganja za pojav reakcij, povezanih z infundiranjem, lahko bolniki pred zdravljenjem z zdravilom Remsima ali med njim prejemajo druga zdravila ali pa se hitrost infundiranja upočasni.
English: Remsima is an anti-inflammatory medicine that contains the active substance infliximab.
Slovenian: Remsima je protivnetno zdravilo, ki vsebuje učinkovino infliksimab.
English: Remsima can only be obtained with a prescription and treatment should be started and supervised by a specialised doctor who has experience in the diagnosis and treatment of the diseases that Remsima can be used to treat.
Slovenian: Predpisovanje in izdaja zdravila Remsima je le na recept, zdravljenje z njim pa lahko uvede in nadzoruje le zdravnik specialist, ki ima izkušnje z diagnosticiranjem in zdravljenjem bolezni, za katere se zdravilo Remsima uporablja.
English: It is usually used when other medicines or treatments have failed, in adults with the following immune-system diseases:
Slovenian: Navadno se uporablja pri odraslih z naslednjimi boleznimi imunskega sistema, kadar druga zdravila ali zdravljenja niso bila učinkovita:
English: • Crohn's disease (a disease causing inflammation of the digestive tract), when the disease is moderate to severe or fistulising (with the formation of fistulas, abnormal passageways between the gut and other organs);
Slovenian: • Crohnova bolezen (obolenje, ki povzroča vnetje prebavnega trakta), kadar je obolenje zmerno do močno izraženo ali pa prihaja do fistulizacije (s pojavljanjem fistul, tj. nenormalnih prehodov med črevesjem in drugimi organi);
English: A study was also carried out in 250 patients with ankylosing spondylitis to show that Remsima given by infusion into a vein produces levels of the active substance in the body that are comparable to the reference medicine, Remicade.
Slovenian: Izvedli so tudi študijo z 250 bolniki z ankilozirajočim spondilitisom, s katero so dokazali, da zdravilo Remsima, ki se daje z infuzijo v veno, dosega primerljive ravni učinkovine v telesu kot referenčno zdravilo Remicade.
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Remsima has a highly similar structure, purity and biological activity to Remicade and is distributed in the body in the same way.
Slovenian: Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU glede podobnih bioloških zdravil dokazano, da je zdravilo Remsima po zgradbi, čistosti in biološkem delovanju zelo podobno zdravilu Remicade in da se po telesu enako prenaša.
English: This messenger is involved in causing inflammation and is found at high levels in patients with the diseases that Remsima is used to treat.
Slovenian: Ta prenašalec sodeluje pri povzročanju vnetja in ga je mogoče v velikih koncentracijah najti pri bolnikih z obolenji, za zdravljenje katerih se uporablja zdravilo Remsima.
English: In addition, studies in rheumatoid arthritis and ankylosing spondylitis have shown that the safety and effectiveness of Remsima are equivalent to those of Remicade in the conditions.
Slovenian: Poleg tega so s študijami pri revmatoidnem artritisu in ankilozirajočem spondilitisu dokazali, da sta varnost in učinkovitost zdravila Remsima pri teh boleznih enakovredni varnosti in učinkovitosti zdravila Remicade.
English: Patients received Remsima by infusion twice, two weeks apart and subsequent treatments were given either by infusion or injection under the skin.
Slovenian: Bolniki so prejeli zdravilo Remsima v obliki infuzije dvakrat v razmaku dveh tednov, nadaljnje zdravljenje pa je potekalo v obliki infuzije ali injekcije v podkožje.
English: The reference medicine for Remsima is Remicade.
Slovenian: Referenčno zdravilo za zdravilo Remsima je zdravilo Remicade.
English: Patients received either Remsima or Remicade in addition to methotrexate for 30 weeks.
Slovenian: Bolniki so 30 tednov prejemali bodisi zdravilo Remsima bodisi zdravilo Remicade skupaj z metotreksatom.
English: Therefore, the Agency's view was that, as for Remicade, the benefits of Remsima outweigh the identified risks and it can be authorised for use in the EU.
Slovenian: Agencija je menila, da koristi zdravila Remsima, enako kot pri zdravilu Remicade, odtehtajo znana tveganja in da se zdravilo lahko odobri za uporabo v EU.
English: Remsima given by injection under the skin for rheumatoid arthritis is as effective as Remsima given by infusion and the safety profile is acceptable.
Slovenian: Zdravilo Remsima, ki se za zdravljenje revmatoidnega artritisa daje v obliki injekcije v podkožje, je enako učinkovito kot zdravilo Remsima, ki se daje v obliki infuzije, varnostni profil pa je sprejemljiv.
English: Remsima is a ‘biosimilar' medicine.
Slovenian: Zdravilo Remsima je „podobno biološko zdravilo“.
English: How is Remsima used?
Slovenian: Kako se zdravilo Remsima uporablja?
English: For treatment of rheumatoid arthritis, Remsima is also available as a solution for injection under the skin in a pre-filled syringe or pen.
Slovenian: Za zdravljenje revmatoidnega artritisa je zdravilo Remsima na voljo tudi v obliki raztopine za injiciranje pod kožo v napolnjeni injekcijski brizgi ali peresniku.
English: • psoriasis (a disease causing red, scaly patches on the skin).
Slovenian: • psoriaza (bolezen, ki povzroča rdeče, luskaste zaplate na koži).
English: For rheumatoid arthritis, after two treatments with infliximab have been given by infusion, Remsima can be given by injection under the skin for subsequent treatments.
Slovenian: Pri zdravljenju revmatoidnega artritisa se po dveh zdravljenjih z infliksimabom v obliki infuzije zdravilo Remsima za nadaljnje zdravljenje lahko daje v obliki injekcije v podkožje.
English: Patients can inject Remsima themselves once they have been trained.
Slovenian: Bolniki si lahko po ustreznem usposabljanju zdravilo Remsima injicirajo sami.
English: For the full list of all side effects of Remsima, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Remsima, glejte navodilo za uporabo.
English: • rheumatoid arthritis (a disease causing inflammation of the joints).
Slovenian: • revmatoidni artritis (bolezen, ki povzroča vnetje sklepov).
English: Remsima is available as a powder to be made up into a solution for infusion (drip) into a vein.
Slovenian: Zdravilo Remsima je na voljo v obliki praška za pripravo raztopine za infundiranje (kapalne infuzije) v veno.
English: • ankylosing spondylitis (a disease causing inflammation and pain in the joints of the spine);
Slovenian: • ankilozirajoči spondilitis (bolezen, ki povzroča vnetje in bolečine v sklepih v hrbtenici);
English: Laboratory studies comparing Remsima with Remicade have shown that the active substance in Remsima is highly similar to that in Remicade in terms of structure, purity and biological activity.
Slovenian: Laboratorijske študije, v katerih so zdravilo Remsima primerjali z zdravilom Remicade, so pokazale, da je učinkovina v zdravilu Remsima po zgradbi, čistosti in biološkem delovanju zelo podobna učinkovini v zdravilu Remicade.
English: In addition, Remsima and Remicade given by infusion into a vein were compared in one main study involving 606 adults with rheumatoid arthritis.
Slovenian: Poleg tega so v eni glavni študiji s 606 odraslimi bolniki z revmatoidnim artritisom primerjali zdravili Remsima in Remicade, ki so ju dajali v obliki infuzije v veno.
English: • ulcerative colitis (a disease causing inflammation and ulcers in the lining of the gut);
Slovenian: • ulcerozni kolitis (bolezen, ki povzroča vnetje in razjede v črevesni sluznici);
English: • psoriatic arthritis (a disease causing red, scaly patches on the skin and inflammation of the joints);
Slovenian: • psoriatični artritis (bolezen, ki povzroča nastajanje rdečih in luskinastih zaplat na koži in vnetje sklepov);
English: How does Remsima work?
Slovenian: Kako zdravilo Remsima deluje?
English: Remsima is given as an infusion into a vein lasting one or two hours.
Slovenian: Zdravilo Remsima se daje v obliki eno- ali dveurne infuzije v veno.
English: Remsima injection to be given under the skin was shown to be as effective as Remsima given by infusion into a vein in a study involving 343 patients with rheumatoid arthritis.
Slovenian: V študiji s 343 bolniki z revmatoidnim artritisom so dokazali, da je zdravilo Remsima v obliki injekcije, ki se daje v podkožje, enako učinkovito kot zdravilo Remsima v obliki infuzije v veno.
English: This usually takes between 15 and 30 minutes.
Slovenian: Običajno to traja od 15 do 30 minut.
English: At the final analysis, 1 653 deaths were reported.
Slovenian: Ob končni analizi so poročali o 1.653 smrtih.
English: Date of first authorisation: 18 December 2007 Date of latest renewal: 15 November 2012
Slovenian: Datum prve odobritve: 18. december 2007 Datum zadnjega podaljšanja: 15. november 2012
English: Make the next injection as soon as you remember.
Slovenian: Naslednjo injekcijo uporabite takoj, ko se spomnite.
English: This requires urgent treatment.
Slovenian: To zahteva nujno zdravljenje.
English: Adults donating their own blood
Slovenian: Odrasli, ki darujejo lastno kri
English: • anaemia from other causes
Slovenian: • anemijo iz drugih vzrokov
English: Thus, the volume of distribution is slightly greater than the plasma space.
Slovenian: Volumen porazdelitve je torej nekoliko večji kot plazemski prostor.
English: The recommended dosing regimen is described in the following diagram*:
Slovenian: Priporočeni režim odmerjanja je opisan v spodnjem diagramu*:
English: It may affect other treatments or test results.
Slovenian: To lahko vpliva na druga zdravljenja ali izvide preiskav.
English: • Skin rashes, which may result from an allergic reaction.
Slovenian: • Kožni izpuščaji, ki je lahko posledica alergijske reakcije.
English: • if you know, or think that it may have been accidentally frozen, or
Slovenian: • če veste ali mislite, da bi lahko bilo po pomoti zamrznjeno, ali
English: • if the seal is broken,
Slovenian: • če je pečat pretrgan,
English: 1316 BN Almere The Netherlands
Slovenian: 1316 BN Almere Nizozemska
English: Influenza-like illness may occur especially at the start of treatment.
Slovenian: Gripi podobna bolezen se lahko pojavi zlasti na začetku zdravljenja.
English: • if there has been a refrigerator failure.
Slovenian: • če je prišlo do okvare hladilnika.
English: • porphyria (a rare blood disorder)
Slovenian: • porfirijo (redko krvno bolezen)
English: • Or under the skin (subcutaneously).
Slovenian: • bodisi pod kožo (subkutano).
English: Overall, these studies have methodological limitations but treatment was associated with positive trends towards higher haemoglobin levels.
Slovenian: Na splošno imajo te študije metodološke omejitve, vendar je bilo zdravljenje povezano s pozitivnimi trendi proti višjim ravnem hemoglobina.
English: Treatment with Retacrit is divided into two stages - correction and maintenance phase.
Slovenian: Zdravljenje z zdravilom Retacrit poteka v dveh stopnjah - korekcijska in vzdrževalna faza.
English: Frequency estimate: 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), not known (cannot be estimated from the available data).
Slovenian: Ocenjena pogostnost: 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), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: Patients should only be switched from one ESA to another under appropriate supervision.
Slovenian: Prehod z enega ESA na drugega mora potekati pod ustreznim nadzorom.
English: Your doctor or nurse may have shown you how to do this.
Slovenian: Zdravnik ali medicinska sestra vam bosta pokazala, kako.
English: No unexpected adverse events were reported (see section 4.2).
Slovenian: O nepričakovanih neželenih učinkih niso poročali (glejte poglavje 4.2).
English: Administer over at least one to five minutes, depending on the total dose.
Slovenian: Odmerek injicirajte najmanj 1 do 5 minut, odvisno od celotnega odmerka.
English: • Take a syringe out of the refrigerator.
Slovenian: • Brizgo vzemite iz hladilnika.
English: The pharmacokinetic profile of erythropoietins in children and adolescents appears to be similar to that of adults.
Slovenian: Kaže, da je farmakokinetični profil eritropoetina pri otrocih in mladostnikih podoben kot pri odraslih.
English: EPO is involved in all phases of erythroid development, and has its principal effect at the level of erythroid precursors.
Slovenian: EPO sodeluje v vseh fazah eritroidnega razvoja, njegov glavni učinek pa je na ravni eritroidnih prekurzorjev.
English: The dose of Retacrit you receive is based on your bodyweight in kilograms.
Slovenian: Odmerek zdravila Retacrit, ki ga dobivate, temelji na vaši telesni masi v kilogramih.
English: Currently available data for subcutaneous use of epoetin alfa in these populations are described in section 5.1 but no recommendation on posology can be made.
Slovenian: Trenutno razpoložljivi podatki o subkutani uporabi epoetina alfa pri teh populacijah so opisani v poglavju 5.1, vendar priporočil o odmerjanju ni mogoče dati.
English: The median age of patients enrolled in the study was 11.6 years (range 0.5 to 20.1 years).
Slovenian: Mediana starost bolnikov, ki so jih vključili v študijo, je bila 11,6 leta (razpon od 0,5 do 20,1 leta).
English: Generally, children under 30 kg require higher maintenance doses than children over 30 kg and adults.
Slovenian: Na splošno potrebujejo otroci, lažji od 30 kg, večje vzdrževalne odmerke kot otroci, težji od 30 kg, in odrasli.
English: If you are a patient with hepatitis C and you receive interferon and ribavirin
Slovenian: Če ste bolnik s hepatitisom C ter prejemate interferon in ribavirin
English: • If blood tests show your haemoglobin is too high before the operation, the treatment will be stopped.
Slovenian: • Če krvne preiskave pokažejo, da je vaša vrednost hemoglobina pred operacijo previsoka, bo zdravljenje ustavljeno.
English: As with all growth factors, there is a concern that epoetins could stimulate the growth of tumours.
Slovenian: Kot pri vseh rastnih dejavnikih obstaja tudi pri epoetinih skrb, da lahko stimulirajo rast tumorjev.
English: Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Slovenian: Pred začetkom uporabo zdravila natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
English: Depending on your individual situation a blood transfusion may be preferable.
Slovenian: Glede na vašo individualno situacijo je lahko priporočljivejša transfuzija krvi.
English: In order to improve the traceability of ESAs, the trade name and the batch number of the administered ESA should be clearly recorded (or stated) in the patient file.
Slovenian: Da bi zagotovili sledljivost ESA, morata biti trgovsko ime in številka serije uporabljenega ESA jasno zapisana (ali navedena) v bolnikovi kartoteki.
English: • Never put used syringes into your normal household waste bin.
Slovenian: • Nikdar uporabljenih brizg ne odlagajte med običajne gospodinjske odpadke.
English: • Only use Retacrit if it has been stored correctly - see section 5, How to Store Retacrit.
Slovenian: • Zdravilo Retacrit uporabljajte samo, če je bilo ustrezno hranjeno - glejte poglavje 5, Kako shranjevati zdravilo Retacrit.
English: A.LABELLING
Slovenian: A. OZNAČEVANJE
English: The cause of your anaemia is also a factor in your doctor deciding the correct dose.
Slovenian: Vzrok vaše anemije je ravno tako dejavnik, ki ga zdravnik uporablja pri določanju pravega odmerka.
English: • Problem with the blood that may cause pain, dark coloured urine or increased sensitivity of the skin to sunlight (porphyria).
Slovenian: • Težava s krvjo, ki lahko povzroči bolečino, temno obarvan urin ali zvečanje občutljivosti kože na sončno svetlobo (porfirija).
English: If the product has been shaken vigorously, don't use it.
Slovenian: Če je bilo zdravilo izpostavljeno močnemu stresanju, ga ne uporabite.
English: Do not use this medicine if you notice that the seal is broken or if the liquid is coloured or you can see particles floating in it.
Slovenian: Ne uporabljajte tega zdravila, če opazite, da je pečat pretrgan ali če je tekočina obarvana ali v njej videti plavati delce.
English: Surgery patients who for any reason cannot receive adequate antithrombotic prophylaxis.
Slovenian: Kirurški bolniki, ki iz kakršnegakoli razloga ne morejo prejemati ustrezne profilakse proti trombozi.
English: If you are within a day of your next injection, forget the missed one and carry on with your normal schedule.
Slovenian: Če je do vaše naslednje injekcije še en dan ali manj, pozabite na izpuščeno injekcijo in nadaljujte po svojem običajnem urniku.
English: Retacrit may not be suitable for you.
Slovenian: Zdravilo Retacrit za vas morda ni primerno.
English: The liquid needs to come to room temperature.
Slovenian: Tekočina se mora ogreti na sobno temperaturo.
English: • Once your anaemia has been corrected, your doctor will continue to check your blood regularly.
Slovenian: • Ko je anemija odpravljena, bo zdravnik še naprej redno preverjal vašo kri.
English: ESAs are not indicated for use in this patient population,
Slovenian: Zdravila ESA niso indicirana za uporabo pri tej populaciji bolnikov;
English: Push it slowly and evenly, keeping the skin fold pinched.
Slovenian: Potiskajte enakomerno in počasi, kožna guba naj bo ves čas pridvignjena.
English: • Your doctor will order regular blood tests to see how your anaemia is responding and may adjust the dose, usually no more frequently than every four weeks.
Slovenian: • Vaš zdravnik bo redno opravljal preiskave krvi, da vidi, kako se vaša anemija odziva, ter lahko odmerek prilagodi, običajno ne pogosteje kot na vsake 4 tedne.
English: • If you have high blood pressure not properly controlled with medicines.
Slovenian: • če imate visok krvni tlak, ki ga z zdravili ni možno kontrolirati.
English: Factors that should be considered in this assessment should include the type of tumour and its stage; the degree of anaemia; life-expectancy; the environment in which the patient is being treated; and patient preference (see section 5.1).
Slovenian: Dejavnike, ki bi jih morali upoštevati pri tej oceni, morajo vključevati tip tumorja in njegov stadij, stopnjo anemičnosti, pričakovano življenjsko dobo, okolje v katerem se bolnika zdravi in prednosti za bolnika (glejte poglavje 5.1).
English: Monitoring of the blood pressure should be performed, particularly at the start of therapy (see section 4.4).
Slovenian: Krvni tlak je treba redno spremljati, še posebej na začetku zdravljenja (glejte poglavje 4.4).
English: • For patients on peritoneal dialysis Retacrit may be given twice a week.
Slovenian: • Pri bolnikih na peritonealni dializi se lahko zdravilo Retacrit daje dvakrat tedensko.
English: The apparent molecular weight of erythropoietin is 32 000 to 40 000 dalton.
Slovenian: Navidezna molekulska masa eritropoetina je med 32.000 in 40.000 daltoni.
English: • Do not remove the needle cover from the pre-filled syringe until you are ready to inject your medicine.
Slovenian: • Ne odstranite pokrovčka igle z napolnjene injekcijske brizge, dokler niste pripravljeni na injiciranje zdravila.
English: All special warnings and special precautions associated with autologous predonation programmes, especially routine volume replacement, should be respected.
Slovenian: Upoštevati je treba vsa posebna opozorila in previdnostne ukrepe, povezane z avtolognimi preddonorskimi programi, zlasti rutinsko nadomeščanje tekočine.
English: • Choose an injection site.
Slovenian: • Izberite mesto za injiciranje.
English: Patients from the group treated with epoetin alfa were also enrolled in an open-label extension study which demonstrated improvements in their quality of life that were maintained for an additional 12 months.
Slovenian: Bolnike iz skupine, ki se je zdravila z epoetinom alfa, so vključili tudi v odprto podaljšano študijo, s katero so dokazali izboljšanje kakovosti njihovega življenja, ki so jo ohranjali še 12 mesecev.
English: Your doctor will help you to decide if Retacrit is suitable for you.
Slovenian: Zdravnik vam bo pomagal pri odločitvi, ali je zdravilo Retacrit primerno za vas.
English: After EPO binds to its cell surface receptor, it activates signal transduction pathways that interfere with apoptosis and stimulates erythroid cell proliferation.
Slovenian: Ko se EPO veže na svoj površinski receptor, aktivira poti prenosa signalov, ki motijo apoptozo in spodbujajo proliferacijo eritroidnih celic.
English: After 52 weeks, 57% of patients remained in the study, receiving a median dose of 200 IU/kg/week.
Slovenian: Po 52 tednih je v študiji ostalo še 57 % bolnikov, ki so prejemali mediani odmerek 200 i.e./kg/teden.
English: In the four placebo-controlled studies the hazard ratios for overall survival ranged between 1.25 and 2.47 in favour of controls.
Slovenian: V štirih s placebom nadzorovanih študijah so bila razmerja tveganj za skupno preživetje v razponu od 1,25 in 2,47 v prid kontrolam.
English: If blood pressure cannot be controlled, epoetin zeta treatment should be discontinued.
Slovenian: Če krvnega tlaka ni mogoče obvladati, je treba zdravljenje z epoetinom zeta prekiniti.
English: If you can't take medicines that prevent blood clotting, you must not have Retacrit.
Slovenian: Če ne smete jemati zdravil, ki preprečujejo strjevanje krvi, zdravila Retacrit ne smete jemati.
English: Consequently, epoetin zeta should be used in pregnancy only if the potential benefit outweighs the potential risk to the foetus.
Slovenian: Zato se med nosečnostjo epoetin zeta sme uporabljati le, če možne koristi odtehtajo možna tveganja za plod.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any subsequent updates of the RMP.
Slovenian: Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
English: Usually the injections will be given to you by a doctor, nurse or other health care professional.
Slovenian: Običajno vam bo injekcije dajal zdravnik, medicinska sestra ali drug zdravstveni delavec.
English: This risk may be higher if you have other risk factors for developing blood clots (for example, if you have had a blood clot in the past or are overweight, have diabetes, have heart disease or you are off your feet for a long time because of surgery or illness).
Slovenian: To tveganje je lahko večje, če imate druge dejavnike tveganja za nastanek krvnih strdkov (če ste na primer imeli krvni strdek v preteklosti ali imate prekomerno telesno težo, sladkorno bolezen, bolezen srca ali morate ležati zaradi kirurškega posega ali bolezni).
English: • Always use Retacrit exactly as instructed by your doctor or nurse.
Slovenian: • Vedno zdravilo Retacrit uporabite natančno tako, kot sta vas naučila zdravnik ali medicinska sestra.
English: Epoetin zeta should be used with caution in the presence of untreated, inadequately treated or poorly controllable hypertension.
Slovenian: Epoetin zeta je treba previdno uporabljati pri nezdravljeni, nezadostno zdravljeni ali slabo obvladljivi hipertenziji.
English: • To stimulate the production of your red blood cells (so that doctors can take more blood from you) if you cannot have transfusions with your own blood during or after surgery.
Slovenian: • za spodbujanje tvorbe vaših rdečih krvnih celic (tako da vam lahko zdravniki odvzamejo več krvi), če med operacijami ali po njih ne morete prejeti transfuzij svoje lastne krvi.