FrancophonIA/ELRC3.0 huggingface dataset:
English: All studies have been performed applying a protocol not including a test dose.
Croatian: Sva su ispitivanja provedena primjenom protokola koji nije uključivao probnu dozu.
English: The far majority of cases could not be assessed as potential serious allergic reactions.
Croatian: Velika većina slučajeva nije se mogla procijniti kao potencijalne ozbiljne alergijske reakcije.
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.
Croatian: U približno 90% slučajva u kojima je vrijeme do nastupa bilo prijavljeno reakcija se dogodila unutar prvih 10 minuta primjene te se kod otprilike jedne trećine dogodila tijekom doze testiranja.
English: A total of 34 grade III (14.4%) and 2 grade IV (0.8%) were reported.
Croatian: Ukupno su prijavljene 34 reakcije stupnja III (14,4%) i 2 stupnja IV (0,8%).
English: In about one third of the total cases (223/846), the patients recovered after drug withdrawal.
Croatian: U otprilike jedne trećine ukupnih slučajeva (223 od 846 slučajeva) bolesnici su se oporavili nakon prekida liječenja.
English: For some cases (108 out of 168) the time-to-onset of the reaction was reported.
Croatian: Za neke slučajeve (108 od 168 slučajeva) prijavljeno je vrijeme do nastupa događaja.
English: In summary, there is only very limited data on safety from clinical studies.
Croatian: Sažetak je da postoje vrlo ograničeni podaci o sigurnosti iz kliničkih ispitivanja.
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.
Croatian: Ukupno je prijavljeno 168 slučaja s primarnim događajem unutar Klasifikacije organskih sustava (SOC) poremećaja imunološkog sustava (28,6%) uključujući 147 ozbiljnih slučajeva.
English: Of these, one was reported as non-serious and four as serious.
Croatian: Od ovih slučajeva, jedan je prijavljen kao neozbiljan slučaj, a četiri kao ozbiljni slučajevi.
English: In only one case, the onset was reported as a late-occurring event (onset after one day).
Croatian: U samo jednom slučaju nastup reakcije prijavljen je kao kasni događaj (nastup nakon jednog dana).
English: Hypersensitivity (also called allergic reactions) refers to undesirable reactions produced by the normal immune system, including allergies and autoimmunity.
Croatian: Preosjetljivost (također zvana alergijske reakcije) odnosi se na neželjene reakcije koje uzrokuje normalni imunološki sustav uključujući alergije i autoimunitet.
English: Three patients experienced allergic reactions leading to product discontinuation.
Croatian: Tri su bolesnika iskusili alergijske reakcije koje su uzrokovale prekid liječenja proizvodom.
English: When outcome is known, most patients recovered without sequelae (94.8%).
Croatian: Uz poznati ishod, većina bolesnika se oporavila bez posljedica (94,8%).
English: Data provided regarding safety in pregnancy and intestinal absorption disorder was very limited.
Croatian: Podaci koji su dobiveni s obzirom na sigurnost prilikom primjene u trudnoći i poremećajima crijevne apsorpcije bili su vrlo ograničeni.
English: The Committee concluded that there was need for further risk minimisation measures such as information to patients and healthcare professionals.
Croatian: Povjerenstvo je zaključilo da je postojala potreba za daljnjim mjerama minimizacije rizika poput informacija za bolesnike i zdravstvene djelatnike.
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.
Croatian: Pored toga CHMP je naglasio da se ti lijekovi ne smiju davati trudnicama u prvom tromjesečju trudnoće; liječenje treba ograničiti na drugo ili treće tromjesečje ako se jasno procijeni da dobrobit premašuje potencijalne rizike za majku i za dijete.
English: Of these, 17 were considered serious, of which five within the immune system disorder, as mentioned above.
Croatian: Od toga 17 je smatrano ozbiljnim od kojih je pet pripadalo poremećajima imunološkog sustava kako je to navedeno u prethodnom tekstu.
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.
Croatian: U dva slučaja nisu prijavljeni nikakvi simptomi te nije prijavljeno je li u vrijeme nastupa reakcije bolesniku bilo pruženo liječenje niti je zabilježeno vrijeme do nastupa reakcije drugačije od dana prijave događaja, što otežava klasifikaciju ovih događaja.
English: Two of these 3 anaphylactoid reactions occurred in patients with Crohn's disease.
Croatian: Dvije od te 3 anafilaktoidne reakcije pojavile su u bolesnika s Crohnovom bolešću.
English: When classifying all cases that were not reported as immune reactions, according to CTCAE approximately 20% were classified as grade III.
Croatian: Prilikom klasifikacije svih slučajeva koji nisu bili prijavljeni kao reakcije u imunološkom sustavu, u skladu s CTCAE približno 20% bilo ih je klasificirano kao stupanj III.
English: The majority of cases were reported as serious and five cases were reported with a primary event within the immune system disorders.
Croatian: Većina slučajeva prijavljena je kao ozbiljni slučajevi, a pet slučajeva prijavljeno je s primarnim događajem unutarn skupine poremećaja imunološkog sustava.
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.
Croatian: Međutim, rasprava o postojećim nekliničkim podacima nije razjasnila pitanje imunogenosti pa stoga postojećeni neklinički podaci ne omogućavaju nikakve čvrste zaključke; CHMP zaključci doneseni su na temelju kliničkih i farmakovigilancijskih podataka.
English: Cytotoxicity is mediated throughout the formation of reactive oxygen species (ROS).
Croatian: Citotoksičnost je posredovana stvaranjem reaktivnih vrsta kislika (ROS).
English: A total of 1649 cases including 546 serious and 1103 non-serious cases corresponding to 6179 ADRs were recorded.
Croatian: Ukupno 1649 slučajeva uključivalo je 546 ozbiljnih i 1103 neozbiljna slučaja koji su odgovarali brojci od 6179 zabilježenih nuspojava.
English: Predisposition to an allergy or known asthma may result in a more severe reaction.
Croatian: Predispozicija za alergije ili dijagnosticirna astma mogu uzrokovati ozbiljnije reakcije.
English: Further, a test-dose might give the prescriber a feeling of false assurance that an allergic reaction is unlikely to happen.
Croatian: Nadalje, probna doza mogla bi dati propisivaču lažni osjećaj sigurnosti da pojava alergijske reakcije nije vjerojatna.
English: Among 20 patients who presented a reaction of grade IV, six (6) patients died.
Croatian: Između 20 bolesnika koji su iskazali reakciju stupnja IV, šestoro (6) ih je umrlo.
English: A total of 236 cases of hypersensitivity reactions were reported (mainly grade I and II).
Croatian: Ukupno je zabilježeno 236 slučaja reakcija preosjetljivosti (uglavnom stupanj I i stupanj II).
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).
Croatian: Od ovih 6 bolesnika, 5 ih je umrlo od nealergijskih reakcija nekoliko dana nakon posljednje injekcije (primjerice, komplikacije od amputacije, septički šok, komplikacije bronhopulmonarne bolesti, rabdomiliza i plućna embolija).
English: Twenty-two clinical studies were submitted.
Croatian: Predani su rezultati 22 klinička ispitivanja.
English: So the CHMP conclusions are applicable to all the iron complexes assessed in this referral.
Croatian: Stoga su zaključci CHMP primjenjivi na sve željezove komplekse koji su obuhvaćeni ovom procjenom.
English: For reports classified as grade III, the most commonly reported term was “anaphylactic shock” and the outcome of these cases was either recovered, not recovered (1 case only) or unknown (8 cases).
Croatian: Za izvješća klasificirana kao stupanj III, najčešeć prijavljeni termin bio je „anafilaktički šok”, a ishod ovih slučajeva bio je ili oporavak ili se bolesnik nije oporavio (samo 1 slučaj) ili nije bio poznat (8 slučajeva).
English: Regarding allergic reactions, a total of 846 cases / 1524 ADRs/AEs were identified of which approximately half cases were serious and half were non-serious.
Croatian: Što se tiče alergijskih reakcija, ukupno je identificirano 846 slučajeva/1524 nuspojave/štetna događaja od kojih je približno polovica bila ozbiljna, a druga polovica ne.
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.
Croatian: Analize ozbiljnosti reakcija preosjetljivosti nakon stavljanja lijeka u promet pokazale su da su 33 slučaja od 178 ozbiljnih slučajeva zahtijevali hospitalizaciju, a 31 slučaj od njih 178 ozbiljnih bio je po život opasan dok je 6 bolesnika imalo anamnezu alergije.
English: The majority of cases were classified as grade III (53%) followed by grade II (32%).
Croatian: Većina slučajeva klasificirana je kao stupanj III (53%), a ostatak kao stupanj II (32%).
English: One of these cases was an anaphylactoid reaction, and another was a probable serious allergic reaction.
Croatian: Jedan od tih slučajeva bile su anafilaktoidne reakcije, a drugi je vjerojatno bio ozbiljna alergijska reakcija.
English: In iron deficiency anaemia there were three publications with no anaphylactoid reactions reported.
Croatian: Kod anemije manjka željeza objavljene su tri publikacije koje nisu prijavljivale anafilaktoidne reakcije.
English: The most frequent AEs experienced by patients in all treatment groups were hypotension (48.7%), nausea (31.9%), vomiting (22.1%) and cramps.
Croatian: Najčešće nuspojave koje su iskusili bolesnici u svim skupinama liječenja bile su hipotenzija (48,7%), mučnina (31,9%), povraćanje (22,1%) i grčevi.
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.
Croatian: Od 846 slučajeva s alergijskim reakcijama, 55 bolesnika (6,5%) primilo je probnu dozu natrijeva željezova glukonata prije prve intravenske infuzije.
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.
Croatian: CHMP je raspravljao mogućnost da bolesnici s alergijama (prvenstveno s alergijama tipa 1) mogu biti pod povećanim rizikom od ozbiljnih alergijskih reakcija na intravensko željezo.
English: Over all studies, 36 hypersensitivity events occurring in 35 patients were reported.
Croatian: Tijekom svih ispitivanja prijavljeno je 36 reakcija preosjetljivosti u 35 bolesnika.
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).
Croatian: Svi ozbiljni slučajevi koji su kao primarni događaj imali neki drugi događaj osim poremećaja imunološkog sustava pregledani su u skladu sa Zajedničkim terminološkim kriterijima za nuspojave (CTCAE) stupnja III-V kako se ne bi predvidjele nikakve teške potencijalne alergijske reakcije (n=219 dodatnih slučajeva).
English: In these patients, intravenous iron products should only be used if the benefit is clearly judged to outweigh the potential risk.
Croatian: U ovih bolesnika intravenske lijekove koji sadrže željezo treba upotrebljavati samo ako dobrobit jasno premašuju mogući rizik.
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.
Croatian: U kasnijim stadijima trudnoće mogu se davati intravenski pripravci željeza ali nakon pomne procjene rizika za majku i dijete.
English: This corresponds to a hypersensitivity events frequency rate of 0.060%, which is lower than the frequency rate found in clinical trials.
Croatian: To odgovara stopi učestalosti događaja preosjetljivosti od 0,060% što je niže od stope učestalosti otkrivene u kliničkim ispitivanjima.
English: The test-dose does not seem to prevent the occurrence of severe reactions.
Croatian: Ne čini se da probna doza sprječava pojavu teških reakcija.
English: Cytotoxicity of various iron complexes has been documented in the literature.
Croatian: Citotoksičnost različitih kompleksa željeza dokumentirana je u literaturi.
English: The dose immediately prior to events, in both clinical trial database and post marketing safety database varies widely.
Croatian: Doza neposredno prije događaja u obje baze podataka kliničkih ispitivanja i u sigurnosnoj bazi podataka nakon stavljanja lijeka u promet uvelike se razlikuje.
English: The CHMP concluded that the information on test dose is not appropriate as it may give false reassurance to the healthcare professionals.
Croatian: CHMP je zaključilo da informacije o probnoj dozi nisu odgovarajuće te da mogu dati lažni osjećaj sigurnosti zdravstvenim djelatnicima.
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.
Croatian: S obzirom da su zaključci iz ove procjene doneseni uglavnom na temelju podataka nakon stavljanja lijeka u promet, nije moguće razlikovati navedene komplekse željeza u smislu reakcija preosjetljivosti.
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.
Croatian: U 3% slučajeva gdje je natrijev željezov glukonat ponovno uveden u liječenje, bolesnici su iskusili istu vrstu nuspojava, uglavnom alergijske reakcije bez pogoršavanja simptoma.
English: In inflammatory bowel disease population, according to Khalil et al (2011), 6% of IBD patients experienced anaphylactoid reactions (Ring and Messmer grade I-II).
Croatian: Kod populacije s upalnom bolesti crijeva u skladu s Khalilom et al (2011), 6% bolesnika s IBD iskusilo je anafilaktoidne reakcije (Ring i Messmerov stupanj I-II).
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.
Croatian: U 8 slučajeva od ukupno 51 po život opasnih slučajeva (15,7%; 8 od 51 slučajeva, jedan je bio stupnja IV), bolesnici su imali anamnezu alergije.
English: In conclusion, regarding post-marketing data, 317 cases of hypersensitivity were reported (frequency rate 0.0022%).
Croatian: Kao zaključak, u svezi s podacima nakon stavljanja lijeka u promet, prijavljeno je 317 slučajeva preosjetljivosti (stopa učestalosti 0,0022%).
English: Of these, 3 were classified as anaphylactoid reactions.
Croatian: Od toga tri su slučaja bila klasificirana kao aanfilaktoidne reakcije.
English: Nevertheless, there was one grade IV (cardiac arrest) reported in Fishbane and colleagues (1996) publication and a total of fifteen hypersensitivity (7.3%) mainly grade II-III, reported in HD population (Haddad et al, 2009), all occurring during the test dose.
Croatian: Međutim, bila je jedna reakcija stupnja IV (srčani arest) prijavljena kod u publikaciju Fishbane-a i kolega (1996) te ukupno 15 reakcija preosjetljivosti (7,3%) uglavnom stupnja II-III, prijavljenih u HD populaciju (Haddad et al, 2009), a sve su se dogodile pri testnoj dozi.
English: Since the time of authorisation until 29 February 2012, a total of 587 case reports have been received yielding an ADR reporting rate of 0.003 % (which corresponds to 1093 case reports for 100,000 patients-days).
Croatian: Od vremena odobrenja pa sve do 29. veljače 2012. godine, ukupno je prijavljeno 587 slučajev koji su doprinijeli stopi nuspojava od 0,003% (što odgovara 1093 slučaja za 1 000 000 bolesnikovih dana).
English: A total of 317 cases of hypersensitivity were identified from the MAH database, which occurred in 13,824,369 patient years (cut-off date 31 December 2011).
Croatian: Ukupno je 317 slučajeva preosjetljivosti identificirano u bazi podataka nositelja odobrenja koji su se dogodili u 13 824 369 bolesnikovih godina (datum prestanka prikupljanja podataka 31. prosinca 2011. godine).
English: One of the ways to classify the hypersensitivity reactions is according to Ring and Messmer1 definition.
Croatian: Jedan od načina klasifikacije reakcija preosjetljivosti je u skladu s definicijom Ringa i Messmera1.
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.
Croatian: Druge skupine bolesnika uključivale su totalnu kućnu parenteralnu prehranu, osobe koje nisu podnosile peroralne pripravke željeza ili koje nisu reagirale na njih, djecu s upalnim bolestima crijeva (IBD), bolesnike s karcinomom i trudnice.
English: Pregnant women were among the cases with hypersensitivity reactions.
Croatian: Trudne žene bile su među slučajima reakcija preosjetljivosti.
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.
Croatian: U skladu s ovom definicijom stupanj I pokazuje simptome kože i/ili blage vrućice; Stupanj II pokazuje mjerljive simptome ali koji nisu opasni po život, kardiovaskularne reakcije (tahikardiju, hipotenziju), probavne poremećaje (mučninu) i poremećaje dišnog sustava; Simptomi 3. stupnja prikazuju šok, po život opasne spazme glatkih mišića (bronhije, maternica) dok simptomi Stupnja IV prikazuju srčani i/ili respiratorni arest
English: This is out of around 260 patients being included in clinical studies regarding iron (III) isomaltoside 1000 (studies that also assessed safety parameters).
Croatian: To je otprilike 260 bolesnika koji su bili uključeni u klinička ispitivanja željezova (III) izomaltozida 1000 (ispitivanja koja su također procjenjivala sigurnosne parametre).
English: Until 31 December 2011, a total of 236 hypersensitivity associated cases were identified, for a total exposure of 393,160 patient-years.
Croatian: Do 31. prosinca 2011. godine ukupno je identificirano 236 reakcija preosjetljivosti, za ukupnu izloženost od 393 160 bolesnikovih godina.
English: According to the MAH, of 9 fatal cases of hypersensitivity reactions reported, six (1.9%, 6/317) were considered to be related.
Croatian: U skladu s nositeljem odobrenja, od 9 prijavljenih reakcija preosjetljivosti, šest ih se smatralo povezanim s lijekom (1,9%, 6 od 317).
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].
Croatian: Drugi kontrolni bolesnici bili su grupirani u skupine koje su primale druge intravenske pripravke željeza (N=3,364), peroralne pripravke željeza (N=887), placebo (N=256) ili standardnu medicinsku skrb [(SMC), N=159].
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.
Croatian: CHMP se također složio o potrebi za ažuriranim planom upravljanja rizicima koji treba predati za lijekove koji već imaju plan upravljanja rizicima; za lijekove koji nemaju EU plan upravljanja rizicima, CHMP traži od nositelja odobrenja da pripravi i preda plan upravljanja rizicima.
English: The vast majority of these concerned patients in chronic kidney disease (CKD) and treatment in patients undergoing chronic haemodialysis (HD).
Croatian: Velika većina dotičnih bolesnika s kroničnom bolesti bubrega (CKD) i u liječenju bolesnika koji se podrgavaju kroničnoj dijalizi (HD).
English: Iron(III) isomaltoside 1000
Croatian: Željezov (III) izomaltozid 1000
English: Six cases were classified as grade V and all led to a fatal outcome due to cardiac arrest, hypotension, or circulatory failure.
Croatian: Šest slučajeva bilo je prijavljeno kao stupanj V i svi su imali smrtni ishod zbog srčanog aresta, hipotenzije i zatajenja krvotoka.
English: The main safety data which were used in the CHMP assessment and conclusions were post-marketing data for all complexes.
Croatian: Glavni podaci o sigurnosti koji su korišteni u procjeni CHMP i zaključci potjecali su nakon stavljanja u promet svih kompleksa.
English: In conclusion the CHMP recommended that no test dose is administered for any of the intravenous containing iron products.
Croatian: Kao zaključak CHMP je preporučio da se probna doza ne primjenjuje ni kod jednog intravenskog lijeka koji sadrži željezo.
English: For iron gluconate (sodium ferric gluconate) an overview of the toxicology program performed between 1970's and 1996 to support the registration of sodium ferric gluconate complex was submitted.
Croatian: Za željezo glukonat (natrijev željezov glukonat) predan je pregled toksikološkog programa proveden između 1970. i 1996. godine kako bi podržao odobravanje kompleksa natrijeva željezova glukonata.
English: The frequency of hypersensitivity related events reported with iron sucrose in the analysed clinical trials (0.27%) was considerably less than the hypersensitivity event risk for the respective background populations (1.2
Croatian: Učestalost događaja povezanih s preosjetljivosti koji su bili prijavljeni s kompleksom željeza i saharoze u analiziranim kliničkim ispitivanjima (0,27%) bila je znatno manja od događaja rizika kod preosjetljivosti za respektivne pozadinske populacije (1,2
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.
Croatian: Francuska je zatražila od CHMP u skladu sa člankom 31 Direktive 2001/83/EZ kako bi se procijenili prethodno spomenuti rizici u vezi preosjetljivosti i njenog utjecaja na omjer dobrobiti i rizika za intravenske lijekove koji sadrže željezo te dobilo mišljenje mjerama koje su potrebne za osiguravanje sigurne i djelotvorne upotrebe te o tome da li odobrenja za stavljanje u promet tih lijekova treba održati, promijeniti, suspendirati ili povući.
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).
Croatian: Šest slučajeva (4%) bilo je klasificirano kao stupanj IV (2 prijavljena anafilaktička šoka uzrokovala su smrtni ishod i 4 anafilaktička šoka uzrokovala su srčani arest (svi su se bolesnici potpuno oporavili),
English: It might be of interest to note, that these patients had penicillin allergy and latex allergy, respectively.
Croatian: Zanimljivo je napomenuti da su ti bolesnici bili alergični na penicilin odnosna na lateks.