FrancophonIA/ELRC3.0 huggingface dataset:
English: • Evidence of iron overload
Slovenian: • dokazani preobremenitvi z železom
English: No drug-drug interaction studies have been performed.
Slovenian: Študij medsebojnega delovanja z zdravili niso izvedli.
English: The major study outcomes assessed the change in haemoglobin from Baseline to Day 35.
Slovenian: Glavni izidi študije so ocenjevali spremembo hemoglobina od izhodišča do 35. dne.
English: No studies regarding effects on the ability to drive or operate machines have been performed.
Slovenian: Študij o vplivu na sposobnost vožnje in upravljanja s stroji niso izvedli.
English: Please immediately tell the doctor or nurse if you start to feel unwell.
Slovenian: Takoj obvestite zdravnika ali medicinsko sestro, če se vaše počutje poslabša.
English: During the post-marketing phase, several patients received an overdose of Rienso ranging from 1 g in 1 day to 2.5 g over 21 days.
Slovenian: V obdobju trženja je več bolnikov prejelo prevelik odmerek zdravila Rienso v razponu od 1 g v 1 dnevu do 2,5 g v 21 dneh.
English: However, the MAH acknowledges that Rostoker and Cohen recommend a minimum of 6 months between ferumoxytol's administration, which they base on the study with 6 healthy volunteers published by Storey et al.
Slovenian: Vendar pa imetnik dovoljenja za promet z zdravilom priznava, da Rostoker in Cohen priporočata, da naj mine vsaj 6 mesecev od dajanja ferumoksitola, kar utemeljujeta na študiji s 6 zdravili prostovoljci, ki jo je objavil Storey et al.
English: Incompatibilities • Rienso must not be mixed with other medicinal products, with the exception of the infusion
Slovenian: Inkompatibilnosti • Zdravila Rienso se ne sme mešati z drugimi zdravili, z izjemo zgoraj navedenih infuzijskih
English: Within the limitations inherent to post-marketing reporting, the following reporting rate can be calculated: As of 30 June 2014, the cumulative overall post-marketing reporting rate of hypersensitivity based on 2 g per person per year is: 527/266,914 × 100 = 0.20 %.
Slovenian: V okviru omejitev povezanih s poročanjem v obdobju trženja, je bilo možno izračunati naslednjo stopnjo poročanja: Do 30. junija 2014 je kumulativna celokupna stopnja poročanja preobčutljivosti v obdobju trženja na podlagi 2 g na osebo na leto: 527/266.914 × 100 = 0,20 %.
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING
Slovenian: A. IZDELOVALEC ODGOVOREN ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE
English: Treatment with Rienso should be confined to second and third trimester if the benefit is judged to outweigh the potential risk for both the mother and the foetus.
Slovenian: Zdravljenje z zdravilom Rienso je treba omejiti na drugo in tretje trimesečje nosečnosti, če se oceni, da koristi odtehtajo možna tveganja tako za mater kot za plod.
English: Patients should be re-assessed at least one month after the completion of a course of Rienso and this should include laboratory testing of haematologic and blood iron parameters.
Slovenian: Bolnike je treba ponovno oceniti vsaj en mesec po zaključku zdravljenja z zdravilom Rienso, kar mora vključevati tudi laboratorijske preiskave hematoloških parametrov in parametrov železa v krvi.
English: • Patients with any known history of drug allergy including hypersensitivity to other parenteral iron products
Slovenian: • bolnikih s katero koli znano alergijo na zdravila v preteklosti, vključno s preobčutljivostjo na druga parenteralna zdravila, ki vsebujejo železo
English: The maximum dose is 1020 mg (2 vials) and the two doses of Rienso must not be administered at the same time.
Slovenian: Največji odmerek je 1.020 mg (2 viali), pri čemer dveh odmerkov zdravila Rienso ni dovoljeno dati hkrati.
English: Therefore Rienso should not be administered to children and adolescents below the age of 18 years (see section 5.1).
Slovenian: Zato se zdravila Rienso ne sme dajati otrokom in mladostnikom, mlajšim od 18 let (glejte poglavje 5.1).
English: • Information regarding the increased risk of serious including fatal hypersensitivity reactions: contraindications, special patient populations (e.g. pregnant women, elderly), warnings, symptoms of hypersensitivity reactions, monitoring by health care professionals during 30 minutes after administration, warning on late onset of allergic reactions.
Slovenian: • Informacije glede večjega tveganja resnih preobčutljivostnih reakcij, vključno s smrtnimi: kontraindikacije, posebne populacije bolnikov (npr. nosečnice, starejši), opozorila, simptome preobčutljivostnih reakcij, spremljanje, ki ga izvajajo zdravstveni delavci 30 minut po dajanju zdravila, opozorilo o zapoznelem pojavu alergijskih reakcij.
English: No change in dosage is recommended from Table 1.
Slovenian: Spremembe odmerjanja, odstopajoč od preglednice 1, se ne priporočajo.
English: Other side effects that you should tell your doctor, pharmacist or nurse about if they become serious:
Slovenian: Drugi neželeni učinki, o katerih morate obvestiti svojega zdravnika, farmacevta ali medicinsko sestro, če postanejo resni:
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Rienso in one or more subsets of the paediatric population in the treatment of iron deficiency anaemia (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je začasno odložila obvezo za predložitev rezultatov študij z zdravilom Rienso za eno ali več podskupin pediatrične populacije za zdravljenje pediatrične populacije z anemijo zaradi pomanjkanja železa (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Elderly patients (> 65 years of age) or patients with multiple co-morbidities who experience a serious hypersensitivity reaction may have more severe outcomes.
Slovenian: Pri starejših bolnikih (> 65 let starosti) ali pri bolnikih z več sočasnimi obolenji, je ob pojavu resne preobčutljivostne reakcije lahko izid bolj resen.
English: - if you have iron overload (too much iron in your body).
Slovenian: - če imate preobremenjenost z železom (preveč železa v svojem telesu).
English: If you become pregnant during treatment, you must ask your doctor for advice.
Slovenian: Če med zdravljenjem zanosite, vprašajte zdravnika za nasvet.
English: A risk to breastfeeding newborns/infants cannot be excluded.
Slovenian: Tveganja za dojenčka ne moremo izključiti.
English: Post-Marketing Data from Dialysis Clinics in the United States
Slovenian: Podatki iz obdobja trženja, pridobljeni v dializnih klinikah v Združenih državah Amerike
English: Special population - patients receiving haemodialysis
Slovenian: Posebna populacija - bolniki na hemodializi
English: It is not known whether the active substance in this medicine can pass into breast milk.
Slovenian: Ni znano, ali se zdravilna učinkovina tega zdravila izloča v materino mleko.
English: During this PSUR covering period, 45 new cases of hypersensitivity reactions have been reported: 24 serious including one fatal case already reported as part of the previous PSUR as late-breaking information and 21 non-serious cases.
Slovenian: V obdobju, ki ga pokriva ta PSUR, so poročali o 45 novih primerih preobčutljivosti: 24 resnih, vključno z enim smrtnim primerom, o katerem so že poročali v prejšnjem PSUR, kot o najnovejši informaciji, in 21 primerih, ki niso bili resni.
English: Prior to the use of Rienso in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Slovenian: Pred uporabo zdravila Rienso v vsaki državi članici se bo imetnik dovoljenja za promet z zdravilom z nacionalnim pristojnim organom dogovoril o obliki in vsebini izobraževalnega programa, vključno z mediji preko katerih bo tekla komunikacija, načinom razdeljevanja in drugimi vidiki programa.
English: As with all parenteral iron preparations the absorption of oral iron is reduced when administered concomitantly.
Slovenian: Kot pri vseh parenteralnih zdravilih z železom se absorpcija peroralnega železa zmanjša, če se daje sočasno.
English: Retrospective observational data from three large haemodialysis clinics in the US over a 1 year period included the treatment of over 8,600 patients with more than 33,300 administered doses of Rienso; nearly 50% of patients received repeat dosing with 4 or more doses.
Slovenian: Retrospektivni opazovalni podatki iz treh velikih hemodializnih klinik v ZDA, pridobljeni v obdobju 1 leta, so vključevali zdravljenje več kot 8.600 bolnikov z več kot 33.300 uporabljenih odmerkov zdravila Rienso; skoraj 50 % bolnikov je prejelo ponovne odmerke, in sicer 4 ali več.
English: The safety and efficacy of Rienso in children and adolescents below the age of 18 years has not been established.
Slovenian: Varnost in učinkovitost zdravila Rienso pri otrocih in mladostnikih, mlajših od 18 let, nista bili dokazani.
English: For the same reason also talk to your doctor or radiographer if you have been given Rienso within the past 6 months and an MRI is subsequently arranged.
Slovenian: Zaradi tega se z zdravnikom ali radiologom posvetujte tudi, če ste zdravilo Rienso prejeli v zadnjih 6 mesecih in ste se naknadno dogovorili za MR-slikanje.
English: Your doctor will monitor iron levels to avoid iron accumulation.
Slovenian: Vaš zdravnik bo spremljal vaše ravni železa, da prepreči kopičenje.
English: Only one case of minor rash was observed.
Slovenian: Opazili so le en primer manjšega izpuščaja.
English: Rienso will not interfere with X-ray, computed tomography (CT), positron emission tomography (PET), single photon emission computed tomography (SPECT), ultrasound or nuclear medicine imaging.
Slovenian: Zdravilo Rienso ne vpliva na rentgenske žarke, računalniško tomografijo (CT), pozitronsko emisijsko tomografijo (PET), računalniško tomografijo emisije posameznih fotonov (SPECT), ultrazvok ali nuklearno medicinsko slikanje.
English: Severe adverse reactions of clinically significant hypotension have been reported.
Slovenian: Poročali so o hudih neželenih reakcijah klinično pomembne hipotenzije.
English: To maintain the target haemoglobin value, re-treatment with Rienso may be given after the patient has been re-assessed and confirmed to be iron deficient.
Slovenian: Da se ohrani ciljna vrednost hemoglobina, se lahko ponovi zdravljenje z zdravilom Rienso potem, ko se bolnika ponovno oceni in je potrjeno pomanjkanje železa.
English: Iron is an essential element required to make haemoglobin, a molecule in red blood cells that enables oxygen to be carried around the body.
Slovenian: Železo je bistven element pri nastajanju hemoglobina, molekule v rdečih krvnih celicah, ki omogoča prenos kisika po telesu.
English: The safety and efficacy of Rienso (cumulative dose of 1.02 grams) for the treatment of iron deficiency in CKD patients with IDA were assessed in three randomized, open-label, controlled clinical studies (Studies 1, 2 and 3).
Slovenian: Varnost in učinkovitost zdravila Rienso (kumulativni odmerek 1,02 grama) za zdravljenje pomanjkanja železa pri bolnikih s kronično ledvično boleznijo z anemijo zaradi pomanjkanja železa so ocenili v treh randomiziranih, odprtih, kontroliranih kliničnih študijah (študije 1, 2 in 3).
English: If you are able to become pregnant, you must use birth control during treatment.
Slovenian: Če ste v rodni dobi, morate med zdravljenjem uporabljati kontracepcijo.
English: 2 × 510 mg iron (2 vials)
Slovenian: 2 × 510 mg železa (2 viali)
English: Parenteral iron should be used with caution in cases of immunologic disease or acute or chronic infection.
Slovenian: Pri parenteralnem dajanju železa je potrebna previdnost v primerih imunološke bolezni oz. akutne ali kronične okužbe.
English: What you need to know before you receive Rienso
Slovenian: Kaj morate vedeti, preden boste dobili zdravilo Rienso
English: Rienso is supplied in glass vials containing 17 ml.
Slovenian: Zdravilo Rienso je na voljo v steklenih vialah, ki vsebujejo 17 ml.
English: Chemical and physical in-use stability has been demonstrated for 96 hours at 25 °C.
Slovenian: Dokazano je bilo, da je raztopina, pripravljena za uporabo, kemijsko in fizikalno stabilna 96 ur pri temperaturi 25 °C.
English: Volume of distribution (Vd) was consistent with plasma volume, and the mean maximum observed plasma concentration (Cmax) and terminal half-life (t1/2) values increased with dose.
Slovenian: Volumen porazdelitve (Vd) se je ujemal s plazemskim volumnom, povprečne največje vrednosti koncentracije v plazmi (Cmax) in končnega razpolovnega časa (t1/2), ki so jih opazili, pa so se z odmerkom večale.
English: The study will also have to be reflected in the updated RMP submission.
Slovenian: Študija se bo morala odražati tudi v posodobljenem načrtu za obvladovanje tveganja (RMP).
English: The treatment you will receive can be 1 or 2 vials of Rienso (510 mg each) by infusion and each dose will be infused into a vein.
Slovenian: Zdravljenje, ki ga boste prejeli, sta lahko 1 ali 2 viali zdravila Rienso (510 mg vsaka) z infuzijo, pri čemer se vsak odmerek infundira v veno.
English: Cumulatively, since the granting of the marketing authorisation up to the data lockpoint (DLP) of the current PSUR, a total of 527 reported post-marketing cases of hypersensitivity reactions of which more than 50 % were serious including life threatening allergic reactions (264 serious, 263 non-serious).
Slovenian: Kumulativno so od pridobitve dovoljenja za promet z zdravilom do datum zaključka zbiranja podatkov trenutnega PSUR poročali o skupaj 527 primerih preobčutljivnostih iz obdobja trženja zdravila, med katerimi je bilo več kot 50 % resnih, vključno z življenjsko nevarnimi alergijskimi reakcijami (264 resnih, 263 primerov, ki niso bili resni).
English: Please see the iron overload section 4.4 and for dosing guidance, see section 4.2.
Slovenian: Za preobremenitev z železom glejte poglavje 4.4 in za smernice glede odmerjanja poglavje 4.2.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 510 mg/17 ml
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 510 mg / 17 ml
English: Rienso may have a minor influence on the ability to drive and use machines.
Slovenian: Zdravilo Rienso ima lahko blag vpliv na sposobnost vožnje in upravljanja s stroji.
English: Rienso should be administered as an intravenous infusion into a new or existing venous access site.
Slovenian: Zdravilo Rienso je treba dati v obliki intravenske infuzije v nov ali obstoječ venski dostop.
English: Each 510 mg dose is administered as an intravenous infusion for at least 15 minutes.
Slovenian: Odmerek 510 mg se da v obliki intravenske infuzije, ki traja najmanj 15 minut.
English: Rienso exhibited dose-dependent, capacity-limited elimination from plasma with a half life of approximately 16 hours in humans.
Slovenian: Zdravilo Rienso je pokazalo od odmerka odvisno izločanje iz plazme z omejeno stopnjo z razpolovnim časom približno 16 ur, pri ljudeh.
English: Overdose can cause accumulation of iron in your body.
Slovenian: Prevelik odmerek lahko povzroči kopičenje železa v telesu.
English: A decision must be made whether to discontinue breast-feeding or to discontinue Rienso therapy, taking into account the benefit of breast-feeding for the child and the benefit of the therapy for the mother.
Slovenian: Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z zdravilom Rienso, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
English: reactions to other injectable iron preparations.
Slovenian: reakcijo na druga zdravila za injiciranje, ki vsebujejo železo.
English: As seen from clinical data there is no evidence that these effects seen in female rats are relevant for humans.
Slovenian: Na podlagi kliničnih podatkov ni dokazov, da bi imeli opisani učinki pri podganjih samicah povezavo s človekom.
English: Interference with Magnetic Resonance Imaging (MRI) No spontaneous post-marketing reports of MRI interference have been received to date.
Slovenian: Vpliv na magnetnoresonančno slikanje (MRI- Magnetic Resonance Imaging) Do danes ni bilo prejeto nobeno spontano poročilo iz obdobja trženja zdravila o vplivu na MRI.
English: Iron Overload
Slovenian: Preobremenitev z železom
English: If you receive more Rienso than you should
Slovenian: Če ste prejeli večji odmerek zdravila Rienso, kot bi smeli
English: In patients with liver dysfunction, parenteral iron should only be administered after careful risk/benefit assessment.
Slovenian: Bolnikom z jetrno disfunkcijo se lahko železo parenteralno daje samo po skrbni presoji razmerja med koristmi in tveganji.
English: • Anaemia not caused by iron deficiency
Slovenian: • anemiji, ki ni posledica pomanjkanja železa.
English: The risk is enhanced for patients with known allergies including drug allergies, including patients with a history of severe asthma, eczema or other atopic allergy (see section 4.3).
Slovenian: Tveganje je večje pri bolnikih z znanimi alergijami, vključno z alergijami na zdravila, in pri bolnikih s hudo astmo, ekcemom ali drugo atopično alergijo v anamnezi (glejte poglavje 4.3).
English: Limited clinical study data is available regarding re-treatment with Rienso and no clinical study data is available for repeated long term use.
Slovenian: V zvezi s ponovnim zdravljenjem z zdravilom Rienso so razpoložljivi omejeni podatki iz kliničnih študij, podatkov iz kliničnih študij za večkratno dolgotrajno uporabo ni na voljo.
English: For patients receiving two vials, the second one will be infused two to eight days after the first infusion.
Slovenian: Bolnikom, ki bodo prejeli dve viali, se druga infundira dva ali osem dni po prvi infuziji.
English: In a placebo-controlled, cross-over trial, 713 patients with CKD received a single 510 mg dose of Rienso and placebo.
Slovenian: V križnem, s placebom kontroliranem preskušanju, je 713 bolnikov s kronično ledvično boleznijo prejelo en odmerek 510 mg zdravila Rienso in placebo.
English: Available pharmacokinetic data in animals have shown excretion of Rienso in milk (see section 5.3).
Slovenian: Razpoložljivi farmakokinetični podatki pri živalih kažejo na izločanje zdravila Rienso v mleko (glejte poglavje 5.3).
English: Mean haemoglobin increased (0.5-0.9 g/dl) post-treatment and stabilised in the range of 11-11.7 g/dl over the 10 month post-dose period; no new safety signals were identified with repeat dosing.
Slovenian: Povprečni hemoglobin se je po zdravljenju povečal (0,5-0,9 g/dl) in stabiliziral v razponu med 11-11,7 g/dl v 10 mesecih po odmerjanju; novih varnostnih signalov po ponovnem odmerjanju niso opazili.
English: Periodic monitoring of laboratory parameters of iron storage, such as serum ferritin and transferrin saturation, enables recognition of iron accumulation.
Slovenian: Obdobno spremljanje laboratorijskih parametrov zalog železa, kot so feritin v serumu in nasičenost transferina, omogoča prepoznavanje kopičenja železa.
English: When there is insufficient iron in the body, haemoglobin cannot be formed, resulting in anaemia (low levels of haemoglobin).
Slovenian: Zaradi pomankjanja železa v telesu ne more nastajati hemoglobin, kar ima za posledico slabokrvnost (nizka raven hemoglobina).
English: SCIENTIFIC CONCLUSIONS AND GROUNDS RECOMMENDING THE VARIATION TO THE TERMS OF THE MARKETING AUTHORISATIONS
Slovenian: ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA PRIPOROČENO SPREMEMBO POGOJEV
English: Facilities for cardio respiratory resuscitation and equipment for handling acute anaphylactic/anaphylactoid reactions should be available, including an injectable 1:1000 adrenaline solution.
Slovenian: Na voljo morajo biti ustrezni pripomočki in oprema za kardiopulmonalno oživljanje in za ravnanje z akutnimi anafilaktičnimi/anafilaktoidnimi reakcijami, vključno z injekcijo raztopine adrenalina v razmerju 1:1.000.
English: On the basis of the scientific conclusions for Rienso, the CHMP is of the opinion that the benefit-risk balance of the medicinal product containing the active substance ferumoxytol is favourable subject to the proposed changes to the product information.
Slovenian: Na podlagi znanstvenih zaključkov za zdravilo Rienso odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravila, ki vsebuje zdravilno učinkovino ferumoksitol, ugodno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
English: Children and adolescents Rienso should not be given to children and adolescents under 18 years old.
Slovenian: Otroci in mladostniki Zdravilo Rienso se ne sme uporabljati pri otrocih in mladostnikih, mlajših od 18 let.
English: Rienso will be administered in an environment where any allergic event can receive appropriate and prompt treatment.
Slovenian: Zdravilo Rienso boste prejeli v okolju, kjer je ob alergijski reakciji na voljo ustrezno in takojšnje zdravljenje.
English: Baseline at Day 35 (mean ± SD, ng/ml) * p≤0.001 for main efficacy endpoint
Slovenian: SD, ng/ml) * p ≤ 0,001 za glavni cilj učinkovitosti
English: Following completion of the controlled phase of each of the Phase 3 trials, patients who were iron deficient and anaemic could be optionally retreated and receive two additional 510 mg intravenous injections of Rienso for a total cumulative dose of 2.04 g. Overall, 69 patients received a total cumulative dose of 2.04 g. Adverse reactions following this repeat Rienso dosing were similar in character and frequency to those observed following the first two intravenous injections.
Slovenian: Po zaključku kontrolirane faze vsakega od preskušanj 3. faze so imeli bolniki s pomanjkanjem železa in anemijo možnost ponovnega zdravljenja in prejetja dveh dodatnih 510 mg intravenskih injekcij zdravila Rienso do skupnega kumulativnega odmerka 2,04 g. Na splošno je 69 bolnikov prejelo skupni kumulativni odmerek 2,04 g. Neželeni učinki po tej ponovni uporabi odmerkov zdravila Rienso so bili po značaju in pogostnosti podobni učinkom, ki so jih opazili po prvih dveh intravenskih injekcijah.
English: In addition, patients should be placed in a reclining or semi-reclining position during infusion and for at least 30 minutes thereafter (see section 4.4).
Slovenian: Poleg tega morajo biti bolniki med infundiranjem in še najmanj 30 minut po njem nameščeni v ležeč ali polležeč položaj (glejte poglavje 4.4).
English: The shell isolates the bioactive iron from plasma components until the iron-carbohydrate complex enter reticuloendothelial system macrophages of the liver, spleen and bone marrow.
Slovenian: Ovojnica izolira biološko aktivno železo pred sestavinami plazme, dokler kompleks železo-ogljikov hidrat ne vstopi v makrofage retikuloendotelijskega sistema jeter, vranice in kostnega mozga.
English: One patient had a prior history of drug allergy.
Slovenian: En bolnik je imel alergijo na zdravilo v anamnezi.
English: What is in this leaflet What Rienso is and what it is used for What you need to know before you receive Rienso
Slovenian: Kaj je zdravilo Rienso in za kaj ga uporabljamo Kaj morate vedeti, preden boste dobili zdravilo Rienso
English: Administration should be performed as follows:
Slovenian: Dajanje se opravi kot sledi:
English: Therefore, in view of available data regarding hypersensitivity reactions and interference with Magnetic Resonance Imaging (MRI), the PRAC considered that changes to the product information were warranted.
Slovenian: V luči razpoložljivih podatkov v zvezi s preobčutljivostnimi reakcijami in vplivom na magnetnoresonančno slikanje (MRI) je zato odbor PRAC presodil, da so spremembe informacij o zdravilu utemeljene.
English: The MAH shall conduct a study to investigate the mechanism of hypersensitivity associated with the exposure to ferumoxytol, according to a protocol agreed by the CHMP.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora izvesti študijo za preučitev mehanizma preobčutljivosti, povezanega z izpostavljenostjo ferumoksitolu, v skladu s protokolom, dogovorjenim z odborom CHMP.