FrancophonIA/ELRC3.0 huggingface dataset:
English: Assemble all of the supplies you will need for an injection on a clean, well-lit flat surface such as a table.
Slovenian: Zberite vse potrebno, kar potrebujete za injiciranje, na čisti ravni površini, kot je miza.
English: Push the plunger up slowly to the remove all air,, as shown to you by a healthcare professional.
Slovenian: Bat počasi potisnite navzgor, da odstranite ves zrak, kot vam je pokazal zdravstveni delavec.
English: Also, ulcers of mouth, throat, nose, genitals and eyes (red and swollen eyes) can occur.
Slovenian: Lahko se pojavijo tudi razjede v ustih, grlu, nosu, genitalijah in očeh (rdeče in otekle oči).
English: In clinical studies 24% of patients treated with MIRCERA were aged 65 to 74 years, while 20% were aged 75 years and over.
Slovenian: V kliničnih preskušanjih je bilo 24 % bolnikov, zdravljenih z zdravilom MIRCERA, starih od 65 do 74 let, 20 % pa 75 let in več.
English: The average molecular mass is approximately 60 kDa of which the protein moiety plus the carbohydrate part constitutes approximately 30 kDa.
Slovenian: Povprečna molekulska masa je 60 kDa, od tega prispevata proteinski in karbohidratni del približno 30 kDa.
English: · Read the packaging and ensure you have the dose prescribed by your healthcare professional.
Slovenian: · Preberite navodila in se prepričajte, da imate odmerek, ki vam ga je predpisal zdravstveni delavec.
English: Do not attempt to administer an injection until you are sure that you understand how to use the pre-filled syringe.
Slovenian: Ne poskušajte si dati injekcije, dokler niste popolnoma prepričani, da razumete, kako uporabljati napolnjeno injekcijsko brizgo.
English: Stevens-Johnson syndrome / toxic epidermal necrolysis*
Slovenian: Stevens-Johnsonov sindrom / toksična epidermalna nekroliza*
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Slovenian: Zaradi pomanjkanja študij o kompatibilnosti tega zdravila ne smemo mešati z drugimi zdravili.
English: The target haemoglobin concentration in two studies was >13 g/dl; in the remaining three studies it was 1214 g/dl.
Slovenian: Ciljne koncentracije hemoglobina so bile v dveh študijah > 13 g/dl, v preostalih treh pa 12-14 g/dl.
English: Two controlled clinical studies in which epoetins were administered to patients with various cancers including head and neck cancers, and breast cancer, have shown an unexplained excess mortality.
Slovenian: Dve kontrolirani klinični študiji, v katerih so epoetine dajali bolnikom z različnimi vrstami raka, vključno z rakom glave in vratu ter rakom dojk, sta pokazali nerazložljivo povečanje smrtnosti.
English: Keep the syringe dry.
Slovenian: Injekcijska brizga mora ostati suha.
English: These serious skin rashes are often preceded by fever and/or flu-like symptoms.
Slovenian: Pred temi hudimi kožnimi izpuščaji se pogosto pojavijo zvišana telesna temperatura in/ali gripi podobni simptomi.
English: · Do not warm up the syringe in any other way.
Slovenian: · Injekcijske brizge ne segrevajte na kakršen koli drug način.
English: If you have these symptoms please contact your doctor immediately to receive treatment.
Slovenian: Če imate te simptome, prosimo nemudoma obiščite zdravnika, da boste prejeli ustrezno zdravljenje.
English: Controlled clinical trials have not shown significant benefits attributable to the administration of epoetins when haemoglobin concentration is increased beyond the level necessary to control symptoms of anaemia and to avoid blood transfusion.
Slovenian: Kontrolirana klinična preskušanja niso pokazala pomembnih koristi, ki bi jih pripisali dajanju epoetinov, če so koncentracije hemoglobina povečane nad raven, ki je potrebna za kontrolo simptomov anemije in izognitev transfuzijam krvi.
English: Deficiencies of iron, folic acid or vitamin B12 reduce the effectiveness of ESAs and should therefore be corrected.
Slovenian: Pomanjkanje železa, folne kisline ali vitamina B12 zmanjša učinkovitost zdravil za stimulacijo eritropoeze, zato je treba ta stanja popraviti.
English: • If your doctor suspects or confirms that you have these antibodies in your blood, you must not be treated with MIRCERA.
Slovenian: · Če vaš zdravnik sumi ali potrdi, da imate ta protitelesa v krvi, se ne smete zdraviti z zdravilom
English: MIRCERA has no or negligible influence on the ability to drive and use machines.
Slovenian: Zdravilo MIRCERA nima ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: Dose adjustments should not be made more frequently than once a month.
Slovenian: Odmerka naj ne bi prilagajali pogosteje kot enkrat na mesec.
English: You should discuss options for anemia treatment with your doctor.
Slovenian: O možnostih zdravljenja anemije se posvetujte z zdravnikom.
English: The sterile pre-filled syringe does not contain any preservative and is to be used for a single injection only.
Slovenian: Sterilna napolnjena injekcijska brizga ne vsebuje konzervansov in je namenjena le za enkratno injiciranje.
English: Pure red cell aplasia*
Slovenian: neznana čista aplazija rdečih krvnih celic*
English: Studies in animals have shown no evidence of impaired fertility (see section 5.3).
Slovenian: Študije na živalih niso pokazale škodljivih vplivov na plodnost (glejte poglavje 5.3).
English: Frequency categories are defined using the following convention: very common (³1/10); common (³1/100 to <1/10); uncommon (³1/1,000 to <1/100); rare (³1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Slovenian: Za razvrstitev pogostnosti je uporabljen naslednji dogovor: zelo pogosti (³ 1/10), pogosti (³ 1/100 do < 1/10), občasni (³ 1/1.000 do < 1/100), redki (³ 1/10.000
English: Individual responsiveness must be considered when treatment is initiated.
Slovenian: Pri uvajanju zdravljenja je treba upoštevati individualni odziv.
English: As with all growth factors, there is a concern that ESAs could stimulate the growth of any type of malignancy.
Slovenian: Kot pri vseh rastnih dejavnikih obstaja bojazen, da zdravila, ki spodbujajo eritropoezo, lahko spodbujajo tudi rast katerekoli malignosti.
English: Treatment with MIRCERA is normally long-term.
Slovenian: Zdravljenje z zdravilom MIRCERA je običajno dolgotrajno.
English: Follow the recommendations of your healthcare professional about how you should inject MIRCERA.
Slovenian: Sledite navodilom vašega zdravstvenega delavca, kako si naj bi injicirali zdravilo MIRCERA.
English: · Do not touch the needle or let it touch any surface, as the needle may become contaminated and may cause injury and pain if touched.
Slovenian: · Igle se ne dotikajte in ne pustite, da se dotakne katere koli površine, ker se lahko okuži in lahko povzroči poškodbo in bolečino, če se jo dotaknemo.
English: What MIRCERA is and what it is used for What you need to know before you use MIRCERA How to use MIRCERA
Slovenian: Kaj je zdravilo MIRCERA in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo MIRCERA Kako uporabljati zdravilo MIRCERA
English: Now, the tear-off label can be removed, if necessary.
Slovenian: Če je potrebno, lahko sedaj odstranite nalepko.
English: Treatment with MIRCERA must be started under the supervision of a healthcare professional.
Slovenian: Zdravljenje z zdravilom MIRCERA je treba začeti pod nadzorom zdravstvenega delavca.
English: Examine the syringe and check the expiration date on the syringe and box.
Slovenian: Preglejte injekcijsko brizgo in preverite rok uporabnosti na injekcijski brizgi in škatli.
English: Further injections can be given by a healthcare professional or, after you have been trained, you can inject MIRCERA yourself (see instructions at the end of this leaflet.)
Slovenian: Naslednje injekcije vam lahko daje zdravstveni delavec ali pa si zdravilo MIRCERA injicirate sami potem, ko so vas o tem ustrezno poučili (glejte napotke na koncu tega navodila za uporabo).
English: There are no data from the use of MIRCERA in pregnant women.
Slovenian: Ni podatkov o uporabi zdravila MIRCERA pri nosečnicah.
English: · Do not touch the release clips (see diagram below) as this may damage the syringe and make it unusable.
Slovenian: · Ne dotikajte se sprostitvene sponke (glejte sliko spodaj), ker to lahko poškoduje injekcijsko brizgo in jo naredi neuporabno.
English: What MIRCERA is and what it is used for
Slovenian: Kaj je zdravilo MIRCERA in za kaj ga uporabljamo
English: It can, however, be stopped on the advice of your doctor at any time.
Slovenian: Po nasvetu zdravnika ga lahko kadar koli prekinete.
English: Supplementary iron therapy is recommended for all patients with serum ferritin values below 100 microgram/l or with transferrin saturation below 20%.
Slovenian: Jemanje železovih pripravkov je priporočljivo za vse bolnike, ki imajo serumsko koncentracijo feritina pod 100 mikrogramov/l ali nasičenost transferina pod 20 %.
English: Haemoglobin concentration: In patients with chronic kidney disease, maintenance haemoglobin concentration should not exceed the upper limit of the target haemoglobin concentration recommended in section 4.2.
Slovenian: Koncentracija hemoglobina: Pri bolnikih s kronično ledvično odpovedjo vzdrževana koncentracija hemoglobina ne sme preseči zgornje meje ciljne koncentracije hemoglobina, priporočene v poglavju 4.2.
English: Since the treatment experience is limited in patients on peritoneal dialysis, regular haemoglobin monitoring and strict adherence to dose adjustment guidance are recommended in these patients.
Slovenian: Ker so izkušnje z zdravljenjem pri bolnikih na peritonealni dializi omejene, je pri teh bolnikih priporočljivo redno spremljanje koncentracij hemoglobina in dosledno upoštevanje navodil za prilagajanje odmerkov.
English: MIRCERA pre-filled syringe Instructions For Use
Slovenian: MIRCERA napolnjena injekcijska brizga Navodila za uporabo
English: This medicine is prescribed to you because you have anaemia caused by your chronic kidney disease and associated whith typical symptoms, such as tiredness, weakness and shortness of breath.
Slovenian: Zdravilo so vam predpisali, ker imate anemijo, ki jo je povzročila kronična bolezen ledvic in je povezana s tipičnimi simptomi, kot so utrujenost, oslabelost in pojemanje sape.
English: To ensure effective erythropoiesis, iron status has to be evaluated for all patients prior to and during treatment.
Slovenian: Za zagotovitev učinkovite eritropoeze je treba vsem bolnikom pred začetkom zdravljenja in med samim zdravljenjem kontrolirati status železa.
English: In a six-month rat toxicity study no tumorigenic or unexpected mitogenic responses were observed in non-haematological tissues.
Slovenian: V šestmesečni študiji toksičnosti pri podganah v nehematoloških tkivih niso opazili tumorogenega ali nepričakovanega mitogenega odziva.
English: During clinical studies patients had a slight decrease in their platelet blood counts.
Slovenian: Med kliničnimi študijami so bolniki imeli malenkostno znižano število trombocitov v krvi.
English: A common side effect (may affect up to 1 in 10 people) is hypertension (high blood pressure).
Slovenian: Pogost neželeni učinek (pojavi se pri manj kot 1 od 10 ljudi) je hipertenzija (visok krvni tlak).
English: Misuse of MIRCERA by healthy people may lead to an excessive increase in haemoglobin.
Slovenian: Zloraba zdravila MIRCERA pri zdravih osebah lahko povzroči čezmerno povečanje koncentracij hemoglobina.
English: The safety and efficacy of MIRCERA therapy has not been established in patients with haemoglobinopathies, seizures, bleeding or a recent history of bleeding requiring transfusions or with platelet levels greater than 500 x 109/l.
Slovenian: Varnosti in učinkovitosti zdravljenja z zdravilom MIRCERA niso raziskali pri bolnikih s hemoglobinopatijami, epileptičnimi napadi, krvavitvami ali nedavno krvavitvijo, ki je zahtevala transfuzijo, ter pri koncentracijah trombocitov, večjih od 500 x 109/l.
English: If you do not respond adequately to MIRCERA, your doctor will check your dose and will inform you if you need to change doses of MIRCERA.
Slovenian: Če se ne boste ustrezno odzvali na zdravilo MIRCERA, bo zdravnik preveril vaš odmerek in vam povedal, če boste morali spremeniti odmerke zdravila MIRCERA.
English: · Do not remove the needle shield until you are ready to perform an injection.
Slovenian: · Ne odstranite igelne zaščite, dokler niste pripravljeni za dajanje injekcije.
English: Adverse reactions in Table 2 are listed according to MedDRA system organ class and frequency category.
Slovenian: Neželeni učinki v preglednici 2 so navedeni po organskih sistemih MedDRA in pogostnosti.
English: Treatment with MIRCERA is not recommended in children and adolescents, because it has not been studied in these patients.
Slovenian: Zdravljenje z zdravilom MIRCERA ni priporočljivo za bolne otroke in mladostnike, saj pri njih ni bilo raziskano.
English: Erythropoietin is a growth factor that primarily stimulates red cell production.
Slovenian: Eritropoetin je rastni dejavnik, ki primarno stimulira tvorbo rdečih krvnih celic.
English: Do not allow the medicine to freeze, and protect the medicine from light.
Slovenian: Zdravilo ne sme zmrzniti in zaščititi ga morate pred svetlobo.
English: Disinfect your hands well with soap and warm water or hands sanitizer.
Slovenian: Roke si skrbno umijte z milom in toplo vodo ali dezinficirajte z razkužilom za roke.
English: Overdose can result in manifestations of an exaggerated pharmacodynamic effect, e.g. excessive erythropoiesis.
Slovenian: Preveliko odmerjanje se lahko izrazi s pretiranim farmakodinamičnim učinkom, na primer s čezmerno eritropoezo.
English: Physical, cognitive, or sexual developments in the offspring of mothers receiving methoxy polyethylene glycol-epoetin beta during gestation and lactation were not affected.
Slovenian: Telesni, kognitivni ali spolni razvoj potomcev samic, ki so prejemale metoksipolietilenglikol epoetin beta med gestacijo in laktacijo, ni bil prizadet.
English: To be sure the needle can be inserted correctly under the skin, use your free hand to pinch a fold of loose skin at the clean injection site.
Slovenian: Da boste sigurni, da lahko iglo pravilno vstavite pod kožo, s prosto roko naredite kožno gubo na očiščenem mestu injiciranja.
English: During this period when you have stored MIRCERA at a room temperature not above 30 °C you may not put MIRCERA back in the refrigerator before use.
Slovenian: V tem času, ko ste zdravilo hranili pri sobni temperaturi do 30 °C, pred uporabo zdravila ne smete vrniti nazaj v hladilnik.
English: · You should use a different injection site each time you administer an injection, at least three centimeters from the area you used for the previous injection.
Slovenian: · Vsakič, ko si dajate injekcijo, si izberite drugo mesto injiciranja, ki je oddaljeno vsaj tri centimetre od prejšnjega mesta injiciranja.
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 agreed subsequent updates of the RMP.
Slovenian: Imetnik dovoljenja za promet z zdravilom bo izvedel farmakovigilančne aktivnosti, podrobno opisane v načrtu farmakovigilance, sprejetem v RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnih posodobitvah RMP v soglasju z Odborom za zdravila za uporabo v humani medicini (CHMP).
English: Take the needle out of the skin WITHOUT releasing the plunger.
Slovenian: Iglo odstranite iz kože, BREZ da bi sprostili bat.
English: A reticulocyte count should be considered as part of the evaluation.
Slovenian: Kot del ocenjevanja pride v poštev določanje števila retikulocitov.
English: Your doctor will decide to treat you with MIRCERA administered as a single injection once a month.
Slovenian: Odločil se bo, ali vas bo zdravil z zdravilom MIRCERA v eni injekciji enkrat na mesec.
English: No patients treated with MIRCERA were included in this data analysis.
Slovenian: Bolniki zdravljeni z zdravilom MIRCERA niso bili vključeni v analizo podatkov.
English: As primary growth factor for erythroid development, the natural hormone erythropoietin is produced in the kidney and released into the bloodstream in response to hypoxia.
Slovenian: Kot primarni rastni dejavnik za razvoj eritrocitov nastaja naravni hormon eritropoetin v ledvicah in se sprošča v krvni obtok kot odgovor na hipoksijo.
English: The carcinogenic potential of methoxy polyethylene glycol-epoetin beta has not been evaluated in long-term animal studies.
Slovenian: Kancerogenega potenciala metoksipolietilenglikol epoetina beta v dolgoročnih raziskavah na živalih niso ocenjevali.
English: Data from correction studies with patients treated once every two weeks and once every four weeks show that the haemoglobin response rates in the MIRCERA group at the end of the correction period were high and comparable to comparators.
Slovenian: Podatki iz študij, ki so proučevale fazo korekcije pri bolnikih, ki so prejemali zdravilo enkrat na dva tedna in enkrat na štiri tedne, kažejo, da so bili na koncu faze korekcije deleži povečanja hemoglobina v skupini, ki je prejemala zdravilo MIRCERA, visoki in primerljivi z deleži v primerjalni skupini.
English: · Dispose of the full container as instructed by your healthcare provider or pharmacist.
Slovenian: · Poln vsebnik zavrzite, kot vam je naročil vaš zdravstveni delavec ali farmacevt.
English: Your doctor will advise if you should stop or continue breast-feeding and stop or continue your treatment.
Slovenian: Vaš zdravnik vam bo svetoval, če morate dojenje prekiniti oziroma lahko z njim nadaljujete in ali morate zdravljenje nadaljevati ali ga prekiniti.
English: Take special care with other products that stimulate red blood cell production: MIRCERA is one of a group of products that stimulate the production of red blood cells like the human protein erythropoietin does.
Slovenian: Bodite posebno pozorni pri uporabi drugih zdravil, ki spodbujajo nastajanje rdečih krvnih celic: zdravilo MIRCERA je eno izmed skupine zdravil, ki spodbujajo nastajanje rdečih krvnih celic na enak način kot humana beljakovina eritropoetin.
English: The potency of methoxy polyethene glycol-epoetin beta should not be compared to the potency of another pegylated or non-pegylated protein of the same therapeutic class.
Slovenian: Jakosti metoksipolietilenglikol epoetina beta ne smete primerjati z jakostjo drugih pegiliranih ali nepegiliranih beljakovin iz istega terapevtskega razreda.
English: Once your anaemia is corrected your doctor may change your dosing to once a month administration.
Slovenian: Ko se bo vaša anemija popravila, vam zdravnik lahko spremeni odmerjanje na enkrat na mesec.
English: · Do not rub the injection site with dirty hand or cloth.
Slovenian: · Ne drgnite mesta injiciranja z umazano roko ali krpo.
English: HOW TO GIVE THE INJECTION Step 1: Allow the syringe to adjust to room temperature
Slovenian: Korak 1: Injekcijska brizga se naj prilagodi na sobno temperaturo
English: See leaflet for further information.
Slovenian: Za nadaljnje informacije glejte priloženo navodilo.
English: · Only handle the syringe by the body, because any contact with the release clips could cause premature release of the safety device.
Slovenian: · Injekcijsko brizgo prijemajte le za telo, ker lahko pritisk na sprostitveno sponko sproži predčasno sprostitev varnostnega mehanizma.
English: · Never re-use a syringe.
Slovenian: · Nikoli ne uporabite injekcijske brizge ponovno.
English: Once you have removed your medicine from the refrigerator you must use it within this period of one month.
Slovenian: Ko zdravilo vzamete iz hladilnika, ga morate porabiti v tekočem mesecu.
English: An analysis in 126 CKD patients showed no pharmacokinetic difference between patients on dialysis and patients not on dialysis.
Slovenian: Analiza izsledkov 126 bolnikov s kronično ledvično boleznijo ni pokazala razlik v farmakokinetiki med dializnimi in nedializnimi bolniki.
English: The most frequent reported adverse reaction was hypertension (common).
Slovenian: Neželeni učinek, o katerem so najpogosteje poročali, je bila hipertenzija
English: At the evaluation period (week 29-36), the mean and median level of haemoglobin in patients treated with MIRCERA was virtually identical to their baseline haemoglobin level.
Slovenian: V obdobju evalvacije (v tednih od 29 do 36) sta bili srednja koncentracija hemoglobina in mediana koncentracije hemoglobina pri bolnikih, zdravljenih z zdravilom MIRCERA, skoraj identični s tistimi pred začetkom zdravljenja.
English: Blood pressure should be adequately controlled in all patients before, at initiation of, and during treatment with MIRCERA.
Slovenian: Krvni tlak mora biti ustrezno urejen pri vseh bolnikih pred zdravljenjem z zdravilom MIRCERA, na začetku zdravljenja in med njim.
English: • Contact your doctor if you feel tired, weak or have shortness of breath, because this could mean that your MIRCERA treatment is not effective.
Slovenian: · Če se počutite utrujeni, oslabeli ali imate kratko sapo, obvestite zdravnika, ker to lahko pomeni, da zdravljenje z zdravilom MIRCERA ni učinkovito.
English: The starting dose of MIRCERA is based on the calculated previous weekly dose of darbepoetin alfa or epoetin at the time of substitution as described in Table 1.
Slovenian: Začetni odmerek zdravila MIRCERA je izračunan na osnovi prejšnjega tedenskega odmerka darbepoetina alfa ali epoetina ob času zamenjave, kot je opisano v preglednici 1.
English: A post-authorisation safety study showed similar incidence rate of stroke between MIRCERA (6.3%) and reference ESAs groups (epoetin alfa, darbepoetin alfa and epoetin beta) (7%).
Slovenian: V varnostni študiji po prihodu zdravila na trg so opazili podobno pogostnost kapi pri skupini, zdravljeni z zdravilom MIRCERA (6,3 %), in skupini, zdravljeni z referenčnimi zdravili za stimulacijo eritropoeze (epoetinom alfa, darbepoetinom alfa in epoetinom beta) (7 %).
English: The end-user may remove the medicinal product from refrigeration for storage at a room temperature not above 30°C for one single period of 1 month.
Slovenian: Končni uporabnik lahko zdravilo vzame iz hladilnika in ga hrani pri temperaturi do 30 °C za enkratno obdobje 1 meseca.
English: Blood pressure monitoring: As with other ESAs, blood pressure may rise during treatment with MIRCERA.
Slovenian: Kontrola krvnega tlaka: Kot pri drugih zdravilih za stimulacijo eritropoeze se lahko krvni tlak zviša tudi med zdravljenjem z zdravilom MIRCERA.
English: These can appear as reddish target-like macules or circular patches often with central blisters on the trunk, skin peeling, ulcers of mouth, throat, nose, genitals and eyes and can be preceded by fever and flu-like symptoms.
Slovenian: Lahko se pojavijo kot rdečkaste, tarčam podobne makule ali okrogle lise po telesu, pogosto z mehurjem v sredini, lupljenje kože, razjede v ustih, žrelu, nosu, spolovilih in očeh, pred njimi pa lahko do zvišane telesne temperature in gripi podobnih simptomov.
English: Your doctor will calculate your MIRCERA starting dose based on the last dose of your previous medicine.
Slovenian: MIRCERA na osnovi zadnjega odmerka vašega prejšnjega zdravila.
English: If high blood pressure is difficult to control by medical treatment or dietary measures, the dose must be reduced or administration discontinued (see section 4.2).
Slovenian: Če je krvni tlak težko obvladovati z zdravljenjem ali dieto, odmerek znižamo ali dajanje zdravila prekinemo (glejte poglavje 4.2).
English: Traceability of MIRCERA: In order to improve the traceability of ESAs, the trade name of the administered ESA should be clearly recorded (or stated) in the patient file.
Slovenian: Sledljivost zdravila MIRCERA: za izboljšanje sledljivosti zdravil za stimulacijo eritropoeze (ESA) je treba zaščiteno ime danega zdravila ESA v bolnikovi kartoteki jasno izpisati (oz. navesti).