FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not use this medicine after the expiry date which is stated on the outer carton and pre-filled syringe label after ‘EXP'.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in napolnjeni injekcijski brizgi poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: No adjustments of the starting dose nor of the dose modification rules are required in patients with hepatic impairment (see section 5.2).
Slovenian: Pri bolnikih z okvaro jeter začetnega odmerka ali smernic za prilagajanje odmerkov ni potrebno spreminjati (glejte poglavje 5.2).
English: This includes any possible side effects not listed in this leaflet.
Slovenian: Posvetujte se tudi, če opazite katere koli neželeni učinke, ki niso navedeni v tem navodilu.
English: It did not induce a proliferative response in non-haematological tumor cell lines in vitro.
Slovenian: Zdravilo in vitro ni vplivalo na proliferacijo nehematoloških tumorskih celičnih linij.
English: 4.2 Posology and method of administration.
Slovenian: 4.2 Odmerjanje in način uporabe
English: You may remove your MIRCERA pre-filled syringe from the refrigerator and store it at a room temperature not above 30 °C for a single period of one month.
Slovenian: Napolnjeno injekcijsko brizgo zdravila MIRCERA lahko vzamete iz hladilnika samo enkrat in jo shranite pri sobni temperaturi do 30 °C za obdobje enega meseca.
English: In case PRCA is diagnosed, therapy with MIRCERA must be discontinued, and patients should not be switched to another recombinant erythropoietic protein (see section 4.4).
Slovenian: Če je diagnosticirana čista aplazija rdečih krvnih celic, je treba terapijo z zdravilom MIRCERA prekiniti, bolnika pa se ne sme prevesti na drugo rekombinantno eritropoetično beljakovino (glejte poglavje 4.4).
English: Slowly push the plunger with the thumb while holding the syringe with the forefinger and the middle finger against the finger grips until all the medicine is injected.
Slovenian: Bat počasi s palcem potiskajte navznoter, medtem ko injekcijsko brizgo držite s konicami kazalca in sredinca, dokler ne injicirate celotnega odmerka zdravila.
English: Name and address of the manufacturer responsible for batch release for the pre-filled syringes
Slovenian: Ime in naslov proizvajalca, odgovornega za sproščanje serij napolnjenih injekcijskih brizg Roche Pharma AG
English: The first MIRCERA dose will be given on the planned injection day of your previous medicine.
Slovenian: boste prejeli na dan, kot je bilo načrtovano dajanje vašega prejšnjega zdravila.
English: Stop using Mircera if you develop these symptoms and contact your doctor or seek medical attention immediately, see also section 2.
Slovenian: Če se pojavijo ti simptomi, prenehajte uporabljati zdravilo Mircera in nemudoma obvestite zdravnika ali poiščite zdravniško pomoč; glejte tudi poglavje 2.
English: The absolute bioavailability of methoxy polyethylene glycol-epoetin beta after subcutaneous administration was 54%.
Slovenian: Absolutna biološka uporabnost metoksipolietilenglikol epoetina beta je bila po subkutanem dajanju 54 %.
English: You will not receive another ESA and your doctor will treat you for this condition.
Slovenian: Drugih zdravil za spodbujanje eritropoeze ne boste prejeli, vaš zdravnik pa bo zdravil to stanje.
English: · Never attempt to take the syringe apart.
Slovenian: · Nikoli ne poskušajte injekcijske brizge razstaviti.
English: If you are on dialysis, the recommended starting dose is 0.6 micrograms for every kilogram of your body weight.
Slovenian: Če ste dializni bolnik, potem je priporočeni začetni odmerek 0,6 mikrograma na kilogram telesne mase.
English: No dose adjustment is required in patients aged 65 years or older.
Slovenian: Za bolnike, stare 65 let in več, prilagajanje odmerka ni potrebno.
English: Pulmonary embolism*
Slovenian: redki pljučni embolizem*
English: It can be injected subcutaneously in the abdomen, arm or thigh.
Slovenian: Lahko ga injiciramo sukbutano v trebuh, roko ali stegno.
English: Prefilled syringes 30, 50, 75 micrograms are available in pack size of 1 or 3 pre-filled syringe(s).
Slovenian: 30-, 50- in 75-mikrogramske napolnjene injekcijske brizge so na voljo v pakiranjih z 1 ali 3 napolnjenimi injekcijskimi brizgami.
English: During treatment with MIRCERA
Slovenian: Med zdravljenjem z zdravilom MIRCERA
English: How to use MIRCERA
Slovenian: Kako uporabljati zdravilo MIRCERA
English: More severe cases have been observed with long-acting epoetins.At the time of prescription patients should be advised of the signs and symptoms and monitored closely for skin reactions.
Slovenian: Ob predpisu zdravila je treba bolnike seznaniti z znaki in simptomi kožnih reakcij in jih pozorno spremljati.
English: Peel back the protective film from the plastic tray and remove the needle and the syringe, holding the syringe by the middle of the body without touching the release clips.
Slovenian: Odlepite zaščitno folijo s plastičnega omota in vzemite ven injekcijsko brizgo ter iglo tako, da držite injekcijsko brizgo na sredini, brez da bi se dotaknili sprostitvenih sponk.
English: Do not inject into moles, scars, bruises, or areas where the skin is tender, red, hard or not intact.
Slovenian: brazgotine ali mesta, kjer je koža nežna, rdeča, trda ali poškodovana.
English: Grasp the packaged needle firmly in both hands.
Slovenian: Z obema rokama trdno primite iglo.
English: In patients with a poor haemoglobin response to epoetins, alternative explanations for the poor response should be considered (see section 4.2 and 5.1).
Slovenian: Pri bolnikih s slabim odzivom hemoglobina na epoetine je treba razmisliti o drugih razlagah za slab odziv (glejte poglavji 4.2 in 5.1).
English: In addition, using a panel of human tissues, the in vitro binding of methoxy polyethylene glycol-epoetin beta was only observed in target cells (bone marrow progenitor cells).
Slovenian: Pri uporabi plošče s humanimi tkivi so in vitro vezavo metoksipolietilenglikol epoetina beta opazili le pri tarčnih celicah (progenitorne matične celice kostnega mozga).
English: Your doctor may increase or decrease your dose or temporarily stop your treatment to adjust your haemoglobin to an appropriate level for you.
Slovenian: Zdravnik lahko poveča ali zmanjša odmerek ali pa začasno prekine zdravljenje, tako prilagodi koncentracijo hemoglobina, kot je za vas primerno.
English: MIRCERA should be administered either subcutaneously or intravenously.
Slovenian: Zdravilo MIRCERA dajemo subkutano ali intravensko.
English: • Your doctor will check the amount of iron in your blood before and during MIRCERA treatment.
Slovenian: · Zdravnik bo pred in med zdravljenjem z zdravilom MIRCERA preverjal količino železa v vaši krvi.
English: If a dose adjustment is required to maintain the target haemoglobin concentration above 10 g/dl (6.21 mmol/l), the monthly dose may be increased by approximately 25%.
Slovenian: Če je za vzdrževanje koncentracije hemoglobina nad 10 g/dl (6,21 mmol/l) potrebna prilagoditev odmerka, lahko mesečni odmerek povečate za približno 25 %.
English: Remove the needle shield and prepare for injection
Slovenian: Korak 5: Odstranite igelno zaščito in se pripravite na injiciranje
English: · Do not throw away used syringes or the puncture-resistant container in household trash and do not recycle them.
Slovenian: · Ne zavrzite uporabljenih injekcijskih brizg ali vsebnika za odpadni material, ki je odporen proti vbodom, med gospodinjske odpadke in jih ne reciklirajte.
English: Platelet counts below 100 x 109/l were observed in 7% of patients treated with MIRCERA and 4% of patients treated with other ESAs during clinical development.
Slovenian: Število trombocitov pod 100 x 109/l so opazili pri 7 % bolnikov, zdravljenih z zdravilom MIRCERA, in pri 4 % bolnikov, ki so se zdravili z drugimi zdravili za stimulacijo eritropoeze.
English: The first injection should start at the next scheduled dose of the previously administered darbepoetin alfa or epoetin.
Slovenian: S prvo injekcijo začnemo ob predvidenem naslednjem odmerku darbepoetina alfa ali epoetina, ki ga je bolnik prejemal prej.
English: Blood and lymphatic system disorders
Slovenian: Bolezni krvi in limfatičnega sistema občasni trombocitopenija*
English: Your doctor may increase or decrease your dose or temporarily stop your treatment to adjust your haemoglobin level, as appropriate for you.
Slovenian: Zdravnik lahko poveča ali zmanjša odmerek ali začasno prekine vaše zdravljenje, dokler koncentracija hemoglobina ne bo prilagojena, kot je za vas primerno.
English: Only solutions which are clear, colourless to slightly yellowish and free of visible particles must be injected.
Slovenian: Uporabimo lahko le raztopine, ki so bistre, brezbarvne do rahlo rumenkaste in brez vidnih delcev.
English: Push the plunger with the thumb while holding the syringe with the forefinger and the middle finger against the finger grips until all the medicine is injected.
Slovenian: Pritiskajte na bat s palcem, medtem ko držite injekcijsko iglo s konicami kazalca in sredinca, dokler ne injicirate celotnega odmerka.
English: MIRCERA stimulates erythropoiesis by interaction with the erythropoietin receptor on progenitor cells in the bone marrow.
Slovenian: Zdravilo MIRCERA spodbuja eritropoezo preko interakcije z eritropoetinskim receptorjem, ki se nahaja na progenitornih matičnih celicah v kostnem mozgu.
English: A tendency towards increased risk estimates for all-cause mortality, cardiovascular and cerebrovascular events associated with higher cumulative ESA doses independent of the diabetes or dialysis status was observed (see section 4.2 and section 4.4).
Slovenian: Opazili so težnjo k povišanju ocene tveganja za splošno umrljivost, srčnožilne in možganskožilne dogodke, povezane z večjimi kumulativnimi odmerki zdravil za stimulacijo eritropoeze neodvisno od prisotnosti sladkorne bolezni ali zdravljenja z dializo (glejte poglavji 4.2 in
English: MATERIALS Included in the pack: A pre-filled syringe of MIRCERA and a separate injection needle
Slovenian: Napolnjena injekcijska brizga zdravila MIRCERA in ločena injekcijska igla
English: Approximately 6% of patients treated with MIRCERA are expected to experience adverse reactions.
Slovenian: Neželeni učinki so se pojavili pri približno 6 % bolnikov, ki so se zdravili z zdravilom MIRCERA.
English: Dispose of the syringe: · Throw away used syringes in a sharps/ puncture-resistant container.
Slovenian: Odstranjevanje injekcijske brizge: · Odvrzite uporabljene injekcijske brizge v vsebnik za odpadni material, ki je odporen proti vbodom.
English: MIRCERA has not shown evidence of impaired fertility in animals.
Slovenian: Vpliv zdravilo MIRCERA na plodnost pri živalih ni bil dokazan.
English: · Never pull on or handle the syringe by its plunger.
Slovenian: · Nikoli ne vlecite ali držite injekcijske brizge za bat.
English: During the study, platelet counts below 100 x 109/l were observed yearly in 1.5% to 3.0% of patients treated with MIRCERA and 1.6% to 2.5% of patients treated with other ESAs.'
Slovenian: Med študijo so letno opazili število trombocitov pod 100 x 109/l pri 1,5 % do 3,0 % bolnikov, zdravljenih z zdravilom MIRCERA, in pri 1,6 % do 2,5 % bolnikov, ki so se zdravili z drugimi zdravili za stimulacijo eritropoeze.
English: Remove the pre-filled syringe from the venous port WITHOUT releasing the plunger.
Slovenian: Odstranite napolnjeno injekcijsko brizgo iz venskega dostopa, BREZ da bi sprostili bat.
English: As with other ESAs, cases of thrombosis, including pulmonary embolism, have been reported in the post-marketing setting (see section 4.4).
Slovenian: Tako kot pri drugih zdravilih za stimulacijo eritropoeze (ESA) so po prihodu zdravila na trg poročali o primerih tromboze, vključno s pljučnim embolizmom (glejte poglavje 4.4).
English: Your doctor will use the lowest effective dose to control the symptoms of your anaemia.
Slovenian: Za nadzor simptomov anemije bo zdravnik uporabil najmanjši učinkovit odmerek.
English: Intercurrent infections, inflammatory or traumatic episodes, occult blood loss, haemolysis, severe aluminium toxicity, underlying haematologic diseases, or bone marrow fibrosis may also compromise the erythropoietic response.
Slovenian: Eritropoetski odziv lahko poslabšajo tudi sočasne okužbe, vnetja ali poškodbe, prikrito izgubljanje krvi, hemoliza, zastrupitev z aluminijem, obstoječe hematološke bolezni ali fibroza kostnega mozga.
English: What MIRCERA looks like and contents of the pack MIRCERA is a solution for injection in pre-filled syringe.
Slovenian: Izgled zdravila MIRCERA in vsebina pakiranja Napolnjena injekcijska brizga za injiciranje zdravila MIRCERA.
English: Hold the syringe firmly with one hand and pull off the needle shield with the other hand.
Slovenian: Odstranite zaščito na igli, tako da z eno roko trdno primete injekcijsko brizgo, z drugo roko pa močno povlecite zaščito z igle.
English: • If you are not currently treated with an ESA If you are not on dialysis, the recommended starting dose of MIRCERA is 1.2 micrograms for every kilogram of your body weight to be administered under the skin once every month as a single injection.
Slovenian: · Če se trenutno ne zdravite z zdravili, ki spodbujajo eritropoezo Če niste dializni bolnik, potem je priporočeni začetni odmerek zdravila MIRCERA 1,2 mikrograma na kilogram telesne mase.
English: Each pre-filled syringe contains 0.3 ml or 0.6 ml.
Slovenian: Vsaka napolnjena injekcijska brizga vsebuje 0,3 ali 0,6 ml raztopine.
English: Pharmacotherapeutic group: Other antianemic preparations, ATC code: B03XA03
Slovenian: Oznaka ATC: B03XA03.
English: In patients with a poor haemoglobin response to MIRCERA, alternative explanations for the poor response should be considered (see section 4.4 and 5.1).
Slovenian: Pri bolnikih s slabim odzivom hemoglobina na zdravilo Mircera je treba razmisliti o drugih razlagah za slab odziv (glejte poglavji 4.4 in 5.1).
English: Following subcutaneous administration to CKD patients on dialysis, the maximum serum concentrations of methoxy polyethylene glycol-epoetin beta were observed 72 hours (median value) after administration.
Slovenian: Po subkutanem dajanju dializnim bolnikom s kronično ledvično boleznijo so največjo koncentracijo metoksipolietilenglikol epoetina beta v serumu zasledili po 72 urah (mediana).
English: The observed terminal elimination half-life was 142 hours in CKD patients not on dialysis.
Slovenian: Ugotovljeni končni razpolovni čas izločanja pri nedializnih bolnikih s kronično ledvično boleznijo je bil 142 ur.
English: If one dose of MIRCERA is missed, the missed dose is to be administered as soon as possible and administration of MIRCERA is to be restarted at the prescribed dosing frequency.
Slovenian: Izpuščeni odmerek Če je izpuščen en odmerek zdravila MIRCERA, ga je treba dati takoj, ko je mogoče, nato pa odmerjanje nadaljevati po predpisani shemi.
English: Keep the pre-filled syringe in the outer carton in order to protect from light
Slovenian: Napolnjeno injekcijsko brizgo shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo
English: Table 2: Adverse reactions attributed to the treatment with MIRCERA in CKD patients .
Slovenian: Preglednica 2: Neželeni učinki, povezani z zdravljenjem z zdravilom MIRCERA pri bolnikih s kronično ledvično boleznijo.
English: As with other ESAs, cases of thrombosis, including pulmonary embolism, have been reported in the post-marketing setting.
Slovenian: Tako kot pri drugih zdravilih za spodbujanje eritropoeze so po prihodu zdravila na trg poročali o primerih tromboze, vključno s pljučnim embolizmom.
English: Prefilled syringes 40, 60, 100, 120, 150, 200, 250 and 360 micrograms are available in pack size of 1 pre-filled syringe.
Slovenian: 40-, 60- in 100-, 120-, 150-, 200-, 250- in 360-mikrogramske napolnjene injekcijske brizge so na voljo v pakiranjih z 1 napolnjeno injekcijsko brizgo.
English: There is no evidence that MIRCERA alters the metabolism of other medicinal products.
Slovenian: Dokazov o tem, da bi zdravilo MIRCERA spremenilo presnovo drugih zdravil, ni.
English: Prefilled syringes 30, 40, 50, 60, 75, 100, 120, 150, 200 and 250 micrograms contain 0.3 ml solution.
Slovenian: 30-, 40-, 50-, 60-, 75-, 100-, 120-, 150-, 200- in 250-mikrogramske napolnjene injekcijske brizge vsebujejo 0,3 ml raztopine.
English: Tap the syringe gently to bring any bubbles to the top.
Slovenian: da se bodo mehurčki dvignili proti vrhu.
English: A condition called Pure Red Cell Aplasia (PRCA, stopped or reduced production of red blood cells) due to anti-erythropoietin antibodies was observed in some patients treated with ESAs, including MIRCERA.
Slovenian: Stanje imenovano čista aplazija rdečih krvnih celic (prekinjeno ali zmanjšano nastajanje rdečih krvnih celic), ki je posledica protiteles proti eritropoetinu, so opazili pri nekaterih bolnikih zdravljenih z zdravili za spodbujanje eritropoeze, vključno z zdravilom MIRCERA.
English: Alternatively, a starting dose of 0.6 microgram/kg bodyweight may be administered once every two weeks as a single intravenous or subcutaneous injection in patients on dialysis or not on dialysis.
Slovenian: Dializni ali nedializni bolniki lahko prejmejo tudi začetni odmerek 0,6 mikrograma/kg telesne mase enkrat na dva tedna v obliki ene intravenske ali subkutane injekcije.
English: Meta-analysis of overall survival data produced a hazard ratio point estimate of 1.06 in favour of controls (95% CI: 1.00, 1.12; 53 trials and 13,933 patients) and for the cancer patients receiving chemotherapy, the overall survival hazard ratio was 1.04 (95% CI: 0.97, 1.11; 38 trials and 10,441 patients).
Slovenian: Meta analiza podatkov o celokupnem preživetju je podala oceno razmerja ogroženosti 1,06 v dobro kontrolne skupine (95-% interval zaupanja: 1,00, 1,12; 53 preskušanj in 13.933 bolnikov).
English: • if you are allergic to methoxy polyethylene glycol-epoetin beta or to any of the other ingredients of this medicine (listed in section 6)
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo MIRCERA Ne uporabljajte zdravila MIRCERA · če ste alergični na metoksipolietilenglikol epoetin beta ali katero koli sestavino tega zdravila (navedeno v poglavju 6);
English: MIRCERA 30 micrograms/0.3 ml solution for injection in pre-filled syringe MIRCERA 40 micrograms/0.3 ml solution for injection in pre-filled syringe MIRCERA 50 micrograms/0.3 ml solution for injection in pre-filled syringe MIRCERA 60 micrograms/0.3 ml solution for injection in pre-filled syringe MIRCERA 75 micrograms/0.3 ml solution for injection in pre-filled syringe MIRCERA 100 micrograms/0.3 ml solution for injection in pre-filled syringe MIRCERA 120 micrograms/0.3 ml solution for injection in pre-filled syringe MIRCERA 150 micrograms/0.3 ml solution for injection in pre-filled syringe MIRCERA 200 micrograms/0.3 ml solution for injection in pre-filled syringe MIRCERA 250 micrograms/0.3 ml solution for injection in pre-filled syringe MIRCERA 360 micrograms/0.6 ml solution for injection in pre-filled syringe
Slovenian: MIRCERA 30 mikrogramov/0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi MIRCERA 40 mikrogramov/0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi MIRCERA 50 mikrogramov/0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi MIRCERA 60 mikrogramov/0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi MIRCERA 75 mikrogramov/0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi MIRCERA 100 mikrogramov/0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi MIRCERA 120 mikrogramov/0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi MIRCERA 150 mikrogramov/0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi MIRCERA 200 mikrogramov/0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi MIRCERA 250 mikrogramov/0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi MIRCERA 360 mikrogramov/0,6 ml raztopina za injiciranje v napolnjeni injekcijski brizgi
English: Meta-analyses also indicate consistently a significantly increased relative risk of thromboembolic events in cancer patients receiving recombinant human erythropoietin (see section 4.4).
Slovenian: Meta analize so pri bolnikih z rakom, ki prejemajo rekombinantni humani eritropetin, pokazale značilno povečano relativno tveganje za trombembolične dogodke (glejte poglavje 4.4).
English: Clean the chosen injection site area using an alcohol pad to reduce the risk of infection; carefully follow the instructions of the alcohol pad.
Slovenian: Z alkoholnim zložencem očistite mesto injiciranja, da zmanjšate tveganje okužbe.
English: Alternatively, your doctor may decide to administer a starting dose of MIRCERA of 0.6 micrograms for every kilogram of your body weight.
Slovenian: Vaš zdravnik se lahko odloči tudi za začetni odmerek zdravila MIRCERA 0,6 mikrograma/kg telesne mase.
English: Step 3: Unpack and visually inspect the pre-filled syringe
Slovenian: Korak 3: Vzemite napolnjeno injekcijsko brizgo iz škatle in jo vizualno preglejte
English: • If you are currently being treated with another ESA Your doctor may replace your current medicine with MIRCERA.
Slovenian: Zdravnik lahko zamenja vaše dosedanje zdravilo z zdravilom MIRCERA.
English: MIRCERA should be administered either subcutaneously or intravenously in order to increase haemoglobin to not greater than 12 g/dl (7.45 mmol/l).
Slovenian: Zdravilo MIRCERA dajemo subkutano ali intravensko, da bi povečali koncentracijo hemoglobina do največ 12 g/dl (7,45 mmol/l).
English: • If you are a patient with chronic kidney disease and anemia treated with an ESA and are also a cancer patient you should be aware that ESAs, might have a negative impact on your condition.
Slovenian: · Če za zdravljenje kronične bolezni ledvic in anemije prejemate zdravila za spodbujanje eritropoeze in imate obenem tudi raka, bodite pozorni na podatek, da lahko zdravila za spodbujanje eritropoeze negativno vplivajo na vašo bolezen.
English: Following subcutaneous administration to CKD patients not on dialysis, the maximum serum concentrations of methoxy polyethylene glycol-epoetin beta were observed 95 hours (median value) after administration.
Slovenian: Po subkutanem dajanju nedializnim bolnikom s kronično ledvično boleznijo so največjo koncentracijo metoksipolietilenglikol epoetina beta v serumu zasledili po 95 urah (mediana).
English: If the rate of rise in haemoglobin is greater than 2 g/dl (1.24 mmol/l) in one month or if the haemoglobin level is increasing and approaching 12 g/dl (7.45 mmol/l), the dose is to be reduced by approximately 25%.
Slovenian: Če se je koncentracija hemoglobina v enem mesecu povečala za več kot 2 g/dl (1,24 mmol/l) ali če se koncentracija hemoglobina povečuje in približuje 12 g/dl (7,45 mmol/l), odmerek zmanjšajte za približno 25 %.
English: Hypersensitivity reactions, including cases of anaphylactic reaction and serious skin rashes including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis have been reported in association with epoetin treatement.
Slovenian: V povezavi z zdravljenjem z epoetini so poročali o preobčutljivostnih reakcijah, vključno s primeri anafilaktične reakcije in hudih kožnih izpuščajev, vključno s Stevens-Johnsonovim sindromom (SJS) in toksično epidermalno nekrolizo.