FrancophonIA/ELRC3.0 huggingface dataset:
English: Within the on-going clinical studies only two serious adverse reactions have been reported.
Slovenian: V potekajočih kliničnih študijah so poročali o samo dveh resnih neželenih reakcijah.
English: In about one third of the total cases (223/846), the patients recovered after drug withdrawal.
Slovenian: Približno ena tretjina vseh bolnikov (223/846) si je po odtegnitvi zdravila opomogla.
English: When outcome is known, most patients recovered without sequelae (94.8%).
Slovenian: Kjer je bil izid znan, si je večina bolnikov opomogla brez posledic (94,8 %).
English: In approximately 90% of the cases in which the time to onset was reported the reaction occurred within the first 10 minutes of administration, and in about one third it occurred during the test dose.
Slovenian: Pri približno 90 % primerov, pri katerih so poročali o času do pojava, se je reakcija pojavila v prvih 10 minutah po dajanju, pri približno eni tretjini pa med testnim odmerkom.
English: So the CHMP conclusions are applicable to all the iron complexes assessed in this referral.
Slovenian: Zaključki CHMP zato veljajo za vse komplekse železa, ocenjene v tej napotitvi.
English: In summary, there is only very limited data on safety from clinical studies.
Slovenian: Povzamemo lahko, da so iz kliničnih študij na voljo le zelo omejeni podatki o varnosti.
English: In later stages of pregnancy the intravenous iron preparations may be given but after careful consideration of the risks involved for the mother and foetus.
Slovenian: V poznih fazah nosečnosti se pripravki intravenskega železa lahko dajejo, vendar po skrbnem premisleku tveganj za mater in zarodek.
English: The majority of cases were classified as grade III (53%) followed by grade II (32%).
Slovenian: Večina primerov je bila razvrščena kot stopnja III (53 %), ki ji je sledila stopnja II (32 %).
English: As the conclusions of this assessment were mainly drawn from the post-marketing data, differentiation between these iron complexes in terms of hypersensitivity reactions could not be identified.
Slovenian: Ker so bili zaključki te ocene večinoma izpeljani iz podatkov v obdobju trženja, razlik med temi kompleksi železa glede preobčutljivostnih reakcij ni bilo mogoče določiti.
English: 19 pregnant women presented at least one anaphylactic reaction.
Slovenian: 19 nosečnic je doživelo vsaj eno anafilaktično reakcijo.
English: A total of 236 cases of hypersensitivity reactions were reported (mainly grade I and II).
Slovenian: Zabeleženih je bilo skupno 236 primerov preobčutljivostnih reakcij (v glavnem stopnje I in II).
English: A fatal case was also reported.
Slovenian: Poročali so tudi o enem primeru s smrtnim izidom.
English: Hypersensitivity (also called allergic reactions) refers to undesirable reactions produced by the normal immune system, including allergies and autoimmunity.
Slovenian: Preobčutljivost (imenovana tudi alergijske reakcije) se nanaša na neželene reakcije, ki jih sproži normalni imunski sistem, vključno z alergijami in avtoimunsko boleznijo.
English: However the discussion of the existing preclinical data did not clear the immunogenic point, therefore the existing pre-clinical data do not allow for any firm conclusions; the CHMP conclusions were reached based on clinical and pharmacovigilance data.
Slovenian: Ker pa v razpravi o obstoječih predkliničnih podatkih vprašanja imunogenosti niso bila pojasnjena, obstoječi predklinični podatki ne omogočajo izpeljave nobenih zanesljivih zaključkov; CHMP je svoje zaključke zato podal na osnovi kliničnih in farmakovigilančnih podatkov.
English: In conclusion, regarding post-marketing data, 317 cases of hypersensitivity were reported (frequency rate 0.0022%).
Slovenian: Skratka, v podatkih v obdobju trženja so zabeležili 317 primerov preobčutljivosti (stopnja pogostnosti 0,0022 %).
English: The majority of cases were reported as serious and five cases were reported with a primary event within the immune system disorders.
Slovenian: Večina primerov je bila zabeležena kot resnih in pri petih primerih so zabeležili primarni dogodek znotraj motenj imunskega sistema.
English: The Committee concluded that there was need for further risk minimisation measures such as information to patients and healthcare professionals.
Slovenian: • Odbor je zaključil, da so potrebni dodatni ukrepi za zmanjšanje tveganja, na primer informacije za bolnike in zdravstvene delavce.
English: In two cases, no symptoms were reported and it was not reported whether treatment of the reaction was provided nor was the time to onset other than the day of the event reported, making it difficult to classify these events.
Slovenian: Pri dveh primerih niso zabeležili nobenih simptomov in niso zabeležili, ali je bilo zagotovljeno zdravljenje reakcije in ali je bil čas do pojava drugačen od dneva, ko je bil dogodek zabeležen, zato je bilo te dogodke težko razvrstiti.
English: In view of the above, on 7 December 2011 France requested the CHMP under Article 31 of Directive 2001/83/EC to assess the above concerns regarding hypersensitivity and its impact on the benefit-risk balance for iron intravenous containing medicinal products, and to give its opinion on measures necessary to ensure the safe and effective use, and on whether the marketing authorisation for these products should be maintained, varied, suspended or withdrawn.
Slovenian: Na podlagi zgoraj navedenega je Francija 7. decembra 2011 v skladu s členom 31 Direktive 2001/83/ES zaprosila CHMP, naj prouči zgoraj omenjene zadržke glede preobčutljivosti in njen vpliv na razmerje med tveganji in koristmi za intravenska zdravila, ki vsebujejo železo, ter poda mnenje glede ukrepov, potrebnih za zagotovitev varne in učinkovite uporabe, in o tem, ali bi bilo treba dovoljenje za promet s temi zdravili ohraniti, spremeniti, začasno umakniti ali preklicati.
English: Instead caution should be exercised in each iron administration even in the cases of repeated administrations.
Slovenian: Namesto tega je pri dajanju železa potrebna previdnost, tudi pri primerih ponovljenih odmerkov.
English: Thirty-two of 88 patients experienced a reaction at injection site.
Slovenian: Pri dvaintridesetih od 88 bolnikov so zabeležili reakcijo na mestu injiciranja.
English: In only one case, the onset was reported as a late-occurring event (onset after one day).
Slovenian: Pri enem primeru so pojav zabeležili kot pozno pojavljeni dogodek (ki se je pojavil po enem dnevu).
English: A total of 168 cases were reported with a primary event within the System Organ Class (SOC) of immune system disorders (28.6%) including 147 serious.
Slovenian: Poročali so o skupno 168 primerih s primarnim dogodkom znotraj organskega sistema motenj imunskega sistema (28,6 %), vključno s 147 resnimi primeri.
English: In conclusion the post-marketing data are in accordance with the known safety profile of ferric carboxymaltose.
Slovenian: Podatki v obdobju trženja so v skladu z znanim varnostnim profilom železove karboksimaltoze.
English: One of these cases was an anaphylactoid reaction, and another was a probable serious allergic reaction.
Slovenian: Eden od teh je bila anafilaktoidna reakcija, druga pa verjetna resna alergijska reakcija.
English: The CHMP concluded that the information on test dose is not appropriate as it may give false reassurance to the healthcare professionals.
Slovenian: CHMP je zaključil, da informacije o testnem odmerku niso ustrezne, saj lahko dajejo zdravstvenim delavcem napačno zagotovilo.
English: Of these, one was reported as non-serious and four as serious.
Slovenian: Od teh so zabeležili en primer, ki ni bil resen, in štiri resne primere.
English: For one patient, the event of hypersensitivity occurred after the first and the second injection.
Slovenian: Pri enem bolniku se je preobčutljivost pojavila po prvem in drugem injiciranju.
English: All five patients made full recovery.
Slovenian: Vseh pet bolnikov si je v celoti opomoglo.
English: Analysis on the severity of the hypersensitivity post marketing cases showed 33 cases of the 178 serious cases required hospitalization, 31 cases of the 178 serious cases were of a life-threatening nature, from which 6 patients presented with a history of allergy.
Slovenian: Analize resnosti primerov preobčutljivosti v obdobju trženja so pokazale, da je bila v 33 primerih od 178 resnih primerov potrebna hospitalizacija in da je bilo 31 primerov od 178 resnih primerov življenjsko ogrožajoče narave, od katerih je imelo 6 bolnikov alergijo v anamnezi.
English: In addition the CHMP stressed that these products should not be given to pregnant women in the first trimester of pregnancy; treatment should be confined to second or third trimester, if the benefit is clearly judged to outweigh the potential risks for both the mother and the foetus.
Slovenian: CHMP je prav tako poudaril, da teh zdravil ni dovoljeno dajati nosečnicam v prvem trimesečju nosečnosti; zdravljenje je treba omejiti na drugo ali tretje trimesečje, če so po skrbnem premisleku koristi večje od potencialnih tveganj za mater in zarodek;
English: A total of 1649 cases including 546 serious and 1103 non-serious cases corresponding to 6179 ADRs were recorded.
Slovenian: Zabeležili so skupno 1 649 primerov, vključno s 546 resnimi primeri in 1 103 primeri, ki niso bili resni, kar ustreza 6 179 neželenim reakcijam.
English: Among 20 patients who presented a reaction of grade IV, six (6) patients died.
Slovenian: Od 20 bolnikov, pri katerih so zabeležili reakcijo stopnje IV, jih je šest (6) umrlo.
English: In conclusion the CHMP recommended that no test dose is administered for any of the intravenous containing iron products.
Slovenian: CHMP je zato priporočil, da se testni odmerek ne daje za nobena intravenska zdravila, ki vsebujejo železo.
English: Over all studies, 36 hypersensitivity events occurring in 35 patients were reported.
Slovenian: V vseh študijah so poročali o skupno 36 preobčutljivostnih dogodkih pri 35 bolnikih.
English: The CHMP discussed the potential that patients with allergies (notably type 1-allergies) may have an increased risk of serious allergic reactions to intravenous iron.
Slovenian: CHMP je razpravljal o morebitnem potencialu bolnikov z alergijami (zlasti alergijami tipa 1) za povečano tveganje resnih alergijskih reakcij na intravensko železo.
English: Out of these 6 patients, 5 patients died from a non-allergic reaction a few days after the last injection (e.g. complications of amputation, septic shock, bronchopulmonary disease complication, rhabdomyolysis and pulmonary embolism).
Slovenian: Od teh 6 bolnikov jih je 5 umrlo zaradi nealergijske reakcije nekaj dni po zadnjem injiciranju (npr. zapleti pri amputaciji, septični šok, zapleti pri bronhopulmonarni bolezni, rabdomioliza in pljučna embolija).
English: Some of the assessed parenteral iron containing products have a recommendation for a test dose to be administered prior to the final administration.
Slovenian: Pri nekaterih ocenjenih parenteralnih zdravilih, ki vsebujejo železo, se pred končnim dajanjem priporoča dajanje testnega odmerka.
English: A total of 34 grade III (14.4%) and 2 grade IV (0.8%) were reported.
Slovenian: Zabeleženih je bilo skupno 34 primerov stopnje III (14,4 %) in 2 primera stopnje IV (0,8 %).
English: Of note, hypotension, nausea, vomiting and cramps are often symptoms associated with haemodialysis.
Slovenian: Opomnimo, da so hipotenzija, navzeja, bruhanje in krči pogosto simptomi, povezani s hemodializo.
English: Further, a test-dose might give the prescriber a feeling of false assurance that an allergic reaction is unlikely to happen.
Slovenian: Poleg tega lahko daje testni odmerek zdravniku, ki predpiše zdravilo, napačno zagotovilo, da se alergijska reakcija verjetno ne bo pojavila.
English: The most frequent AEs experienced by patients in all treatment groups were hypotension (48.7%), nausea (31.9%), vomiting (22.1%) and cramps.
Slovenian: Najpogostejši neželeni učinki, ki so jih zabeležili pri bolnikih v vseh zdravljenih skupinah, so bili hipotenzija (48,7 %), navzeja (31,9 %), bruhanje (22,1 %) in krči.
English: In 8 cases of the total 51 life-threatening cases (15.7%; 8/51 cases, one graded as Grade IV), the patient presented with a history of allergy.
Slovenian: V 8 primerih od skupno 51 življenjsko ogrožajočih primerov (15,7 %; 8/51 primerov, eden razvrščen kot stopnja IV) so imeli bolniki alergijo v anamnezi.
English: Among the 846 cases with allergic reaction, 55 patients (6.5%) received a dose-test of sodium ferric gluconate prior to the first IV infusion.
Slovenian: Med 846 primeri z alergijskimi reakcijami je 55 bolnikov (6,5 %) prejelo testni odmerek natrijevega železovega glukonata pred prvo i.v.
English: According to the MAH, of 9 fatal cases of hypersensitivity reactions reported, six (1.9%, 6/317) were considered to be related.
Slovenian: Po podatkih imetnika dovoljenja za promet z zdravilom so od 9 zabeleženih smrtnih primerov preobčutljivostnih reakcij menili, da jih je bilo šest (1,9 %, 6/317) povezanih.
English: In iron deficiency anaemia there were three publications with no anaphylactoid reactions reported.
Slovenian: O anemiji zaradi pomanjkanja železa so govorile tri publikacije, v katerih niso poročali o nobenih anafilaktoidnih reakcijah.
English: Other groups of patients included home total parenteral nutrition, those unable to tolerate or respond to oral iron, children with inflammatory bowel disease (IBD), patients with cancer, and pregnant women.
Slovenian: Med druge skupine bolnikov so spadali bolniki s popolno parenteralno prehrano na domu, bolniki, ki peroralnega železa niso prenašali ali se nanj niso odzivali, otroci z vnetno boleznijo črevesja, bolniki z rakom ter nosečnice.
English: Of these all patients recovered.
Slovenian: Od teh so se vsi bolniki opomogli.
English: All serious cases reported with a primary event other than within the immune system disorders has been reviewed according to the common terminology criteria for adverse events (CTCAE) grade III-V in order not to oversee any severe potential allergic reactions (n=219 additional cases).
Slovenian: Vse resne primere s primarnim dogodkom, ki ni spadal med motnje imunskega sistema, so pregledali po enotnih terminoloških merilih neželenih dogodkov (CTCAE) stopnje III−V, da ne bi spregledali nobenih morebitnih resnih alergijskih reakcij (n = 219 dodatnih primerov).
English: One of the ways to classify the hypersensitivity reactions is according to Ring and Messmer1 definition.
Slovenian: Eden od načinov razvrščanja preobčutljivostnih reakcij je razvrščanje po definiciji Ring in Messmer1.
English: Over 8,000 patients have been included/treated across all arms in these clinical trials, of whom almost half (N=4,048) received iron sucrose either as the test product or as the reference (comparator) therapy.
Slovenian: V teh kliničnih preskušanjih je bilo v vseh krakih vključenih/zdravljenih več kot 8 000 bolnikov, od katerih jih je skoraj polovica (N = 4 048) prejela železov saharat kot testno zdravilo ali kot referenčno (primerjalno) zdravljenje.
English: Iron(III) isomaltoside 1000
Slovenian: Železov (III) izomaltozid 1000
English: This is out of around 260 patients being included in clinical studies regarding iron (III) isomaltoside 1000 (studies that also assessed safety parameters).
Slovenian: To je bilo med približno 260 bolniki, ki so sodelovali v kliničnih študijah glede železovega (III) izomaltozida 1000 (v študijah so ocenili tudi varnostne parametre).
English: However, due to very limited exposure in utero to sodium ferric gluconate the risk for neonates of developing any abnormality seems unlikely.
Slovenian: Vendar je zaradi zelo omejene izpostavljenosti in utero natrijevemu železovemu glukonatu tveganje novorojenčkov za razvoj kakršnih koli anomalij malo verjetno.
English: Six cases were classified as grade V and all led to a fatal outcome due to cardiac arrest, hypotension, or circulatory failure.
Slovenian: Šest primerov je bilo razvrščenih kot stopnja V in so se končali s smrtnim izidom zaradi zastoja srca, hipotenzije ali cirkulatorne odpovedi.
English: In the 3% of cases where sodium ferric gluconate was re-administered, the patients experienced the same type of ADRs, mainly allergic reactions without aggravation of the symptoms.
Slovenian: Pri 3 % primerov, ki so prejeli ponovni odmerek natrijevega železovega glukonata, so bolniki doživeli enako vrsto neželenih reakcij, v glavnem alergijske reakcije brez poslabšanja simptomov.
English: For pregnancy specifically, as oral iron may be well tolerated in the first trimester of the pregnancy, the CHMP advised that the intravenous iron complexes are not given to pregnant women in the early stages.
Slovenian: Ker se v nosečnosti peroralno železo dobro prenaša v prvem trimesečju, je CHMP glede nosečnosti predlagal, da se kompleksov intravenskega železa ne uporablja pri nosečnicah v zgodnjih fazah.
English: Different regimens were employed from 100 mg maintenance doses in HD to high accelerated total dose infusions (TDIs).
Slovenian: Uporabili so različne režime zdravljenja, od vzdrževalnega odmerka 100 mg v visokem odmerku do visokopospešenih infuzij celotnega odmerka.
English: Until 31 December 2011, a total of 236 hypersensitivity associated cases were identified, for a total exposure of 393,160 patient-years.
Slovenian: Do 31. decembra 2011 je bilo identificiranih 236 primerov, povezanih s preobčutljivostjo, za skupno izpostavljenost 393 160 bolnikov-let.
English: These 19 patients recovered at sodium ferric gluconate withdrawal with or without corrective treatment.
Slovenian: Teh 19 bolnic si je po odtegnitvi natrijevega železovega glukonata opomoglo z ali brez korektivnega zdravljenja.
English: Sodium ferric gluconate was mainly prescribed for the treatment of iron deficiency anaemia and rarely for the treatment of anaemia in pregnancy.
Slovenian: Natrijev železov glukonat so večinoma predpisali za zdravljenje anemije zaradi pomanjkanja železa in redko za zdravljenje anemije v nosečnosti.
English: All administrations of these iron complexes should be given in an environment with staff able to recognise and treat hypersensitivity reactions and where resuscitation facilities are available.
Slovenian: Vse te komplekse železa se lahko daje samo v okolju z osebjem z izkušnjami v prepoznavanju in zdravljenju preobčutljivostnih reakcij in kjer je na voljo oprema za oživljanje.
English: The CHMP also agreed on the need of an updated risk management plan to be submitted for the products which have a risk management plan already; for the medicinal products which do not have an EU risk minimisation plan the CHMP is requesting the MAHs to submit one.
Slovenian: CHMP se je prav tako strinjal, da je treba predložiti posodobljen načrt za obvladovanje tveganja za zdravila, za katere je že izdelan načrt za obvladovanje tveganja; za zdravila, za katere načrt EU za obvladovanje tveganja še ni izdan, pa je CHMP imetnike dovoljenj za promet z zdravili pozval, da ga predložijo.
English: A systematic review of the relevant published literature has been performed and randomised clinical study and other study designs including uncontrolled retrospective and prospective studies have been included if they reported on ADRs associated with the use of low molecular weight iron dextran (LMWID) complex.
Slovenian: Izveden je bil sistematični pregled ustrezne objavljene literature, vanj pa so bile vključene randomizirana klinična študija ter druge oblike študij, vključno z nenadzorovanimi retrospektivnimi in prospektivnimi študijami, če so v njih poročali o neželenih reakcijah, povezanih z uporabo kompleksa železovega dekstrana z nizko molekulsko maso (LMWID).
English: However, no skin reactions were seen when ferric carboxymaltose or iron sucrose was administered.
Slovenian: Vendar pa nobenih kožnih reakcij niso zabeležili pri dajanju železove karboksimaltoze ali železovega saharata.
English: The dose immediately prior to events, in both clinical trial database and post marketing safety database varies widely.
Slovenian: Odmerek takoj pred dogodki se v zbirki podatkov kliničnih preskušanj in v zbirki podatkov o varnosti v obdobju trženja precej razlikuje.
English: Furthermore the CHMP agreed on other changes to the product information, additional pharmacovigilance activities and risk minimisation measures to address the risk of hypersensitivity events to all patients including administration in pregnancy.
Slovenian: Nadalje se je CHMP strinjal glede drugih sprememb informacij o zdravilu, dodatnih dejavnosti farmakovigilance ter ukrepov za zmanjšanje tveganja, namenjenih oceni tveganja za preobčutljivostne dogodke za vse bolnike, vključno z dajanjem v nosečnosti.
English: As data from the post marketing reporting showed that a successful test dose may give false assurance to the professionals dealing with the product administration, no test dose should be applied.
Slovenian: Ker so podatki iz poročanja v obdobju trženja pokazali, da lahko daje uspešni testni odmerek napačno zagotovilo zdravstvenim delavcem, ki se ukvarjajo z dajanjem zdravila, testnega odmerka ni dovoljeno uporabiti.
English: In the pivotal controlled study a total of 88 patients received sodium ferric gluconate.
Slovenian: V kontrolirani ključni študiji je skupno 88 bolnikov prejelo natrijev železov glukonat.
English: Of these, 3 were classified as anaphylactoid reactions.
Slovenian: Od teh so bili 3 razvrščeni kot anafilaktoidne reakcije.
English: Other control patients have been grouped into those receiving other IV iron preparations (N=3,364), oral iron (N=887), placebo (N=256) or standard medical care [(SMC), N=159].
Slovenian: pripravke železa (N = 3 364), peroralno železo (N = 887), placebo (N = 256) ali standardno zdravniško oskrbo (N = 159).
English: Some studies were iron sucrose only, some studies included a placebo or standard medical care arm, and some studies had another active substance as comparator.
Slovenian: Nekatere študije so vključevale samo železov saharat, druge so vključevale tudi krak placeba ali standardne zdravniške oskrbe, nekatere študije pa so zdravilo primerjale z drugo zdravilno učinkovino.
English: Six cases (4%) were classified as grade IV (2 reported anaphylactic shock leading to a fatal outcome and 4 anaphylactic shock leading to cardiac arrest (all patients made full recovery).
Slovenian: Šest primerov (4 %) je bilo razvrščenih kot stopnja IV (2 zabeležena anafilaktična šoka s smrtnim izidom in 4 anafilaktični šoki z zastojem srca (vsi bolniki so v celoti okrevali)).
English: The CHMP endorsed a Direct healthcare professional communication (DHPC), to communicate the outcome of the present review and to communicate to the healthcare professionals the updated method of administration for these products in an environment where trained staff and facilities for resuscitation exist and to highlight the risk of the hypersensitivity reactions.
Slovenian: CHMP je odobril neposredno obvestilo zdravstvenim delavcem (Direct Healthcare Professional Communication - DHPC), da se jih seznani z izidom tega pregleda in s posodobljenim načinom dajanja teh zdravil v okolju, kjer so na voljo usposobljeno osebje in pripomočki za oživljanje, in da se opozori na tveganje za preobčutljivostne reakcije.
English: According to this definition Grade I show skin symptoms and or mild fever reaction; Grade II show measurable symptoms, but not life threatening, cardiovascular reaction (tachycardia, hypotension), gastrointestinal disturbance (nausea) and respiratory; Grade III symptoms show shock, life threatening spams of smooth muscles (bronchi, uterus); and Grade IV show cardiac and/or respiratory arrest.
Slovenian: Po tej definiciji v stopnjo I spadajo kožni simptomi in/ali blažja vročinska reakcija; v stopnjo II spadajo simptomi, ki jih je mogoče izmeriti, vendar niso življenjsko ogrožajoči, srčnožilne reakcije (tahikardija, hipotenzija), prebavne motnje (navzeja) in motnje dihanja; med simptome v stopnji III spadajo šok, življenjsko ogrožajoči krči gladkih mišic (sapnic, maternice); v stopnjo IV pa spadata zastoj srca in/ali dihanja.