natgillin/translations-raw huggingface dataset:
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.
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.
Of these all patients recovered.
Od teh so se vsi bolniki opomogli.
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).
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).
One of the ways to classify the hypersensitivity reactions is according to Ring and Messmer1 definition.
Eden od načinov razvrščanja preobčutljivostnih reakcij je razvrščanje po definiciji Ring in Messmer1.
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.
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.
Iron(III) isomaltoside 1000
Železov (III) izomaltozid 1000
This is out of around 260 patients being included in clinical studies regarding iron (III) isomaltoside 1000 (studies that also assessed safety parameters).
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).
However, due to very limited exposure in utero to sodium ferric gluconate the risk for neonates of developing any abnormality seems unlikely.
Vendar je zaradi zelo omejene izpostavljenosti in utero natrijevemu železovemu glukonatu tveganje novorojenčkov za razvoj kakršnih koli anomalij malo verjetno.
Six cases were classified as grade V and all led to a fatal outcome due to cardiac arrest, hypotension, or circulatory failure.
Šest primerov je bilo razvrščenih kot stopnja V in so se končali s smrtnim izidom zaradi zastoja srca, hipotenzije ali cirkulatorne odpovedi.
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.
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.
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.
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.
Different regimens were employed from 100 mg maintenance doses in HD to high accelerated total dose infusions (TDIs).
Uporabili so različne režime zdravljenja, od vzdrževalnega odmerka 100 mg v visokem odmerku do visokopospešenih infuzij celotnega odmerka.
Until 31 December 2011, a total of 236 hypersensitivity associated cases were identified, for a total exposure of 393,160 patient-years.
Do 31. decembra 2011 je bilo identificiranih 236 primerov, povezanih s preobčutljivostjo, za skupno izpostavljenost 393 160 bolnikov-let.
These 19 patients recovered at sodium ferric gluconate withdrawal with or without corrective treatment.
Teh 19 bolnic si je po odtegnitvi natrijevega železovega glukonata opomoglo z ali brez korektivnega zdravljenja.
Sodium ferric gluconate was mainly prescribed for the treatment of iron deficiency anaemia and rarely for the treatment of anaemia in pregnancy.
Natrijev železov glukonat so večinoma predpisali za zdravljenje anemije zaradi pomanjkanja železa in redko za zdravljenje anemije v nosečnosti.
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.
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.
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.
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.
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.
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).
However, no skin reactions were seen when ferric carboxymaltose or iron sucrose was administered.
Vendar pa nobenih kožnih reakcij niso zabeležili pri dajanju železove karboksimaltoze ali železovega saharata.
The dose immediately prior to events, in both clinical trial database and post marketing safety database varies widely.
Odmerek takoj pred dogodki se v zbirki podatkov kliničnih preskušanj in v zbirki podatkov o varnosti v obdobju trženja precej razlikuje.
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.
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.
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.
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.
In the pivotal controlled study a total of 88 patients received sodium ferric gluconate.
V kontrolirani ključni študiji je skupno 88 bolnikov prejelo natrijev železov glukonat.
Of these, 3 were classified as anaphylactoid reactions.
Od teh so bili 3 razvrščeni kot anafilaktoidne reakcije.
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].
pripravke železa (N = 3 364), peroralno železo (N = 887), placebo (N = 256) ali standardno zdravniško oskrbo (N = 159).
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.
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.
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).
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)).
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.
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.
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.
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.
This cytotoxicity is proper to various iron complexes nevertheless the effect is related to the stability of the complex and therefore of the
Ta citotoksičnost je značilna za različne komplekse železa, vendar pa je njen učinek povezan s stabilnostjo kompleksa in se zato za oblogo uporablja ogljikov hidrat.
The main safety data which were used in the CHMP assessment and conclusions were post-marketing data for all complexes.
Glavni podatki o varnosti, ki jih je CHMP uporabil v svoji oceni in zaključkih, so bili podatki iz obdobja, ko je bilo zdravilo na trgu, za vse komplekse.
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.
Vendar so v publikaciji Fishbane in sodelavci (1996) zabeležili eno reakcijo stopnje IV (zastoj srca) ter skupno petnajst preobčutljivostnih reakcij (7,3 %), v glavnem stopnje II−III, pri populaciji z visokim odmerkom (Haddad in sod., 2009), pri čemer so se vse pojavile med testnim odmerkom.
All these patients recovered after product withdrawal.
Vsi ti bolniki so si po odtegnitvi zdravila opomogli.
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).
Pri poročilih, razvrščenih kot stopnja III, so najpogosteje poročali o „anafilaktičnem šoku“ in bolniki so si po njem opomogli ali ne (samo 1 primer) ali podatki o tem niso znani (8 primerov).
As part of the risk minimisation measures the CHMP considered there was a need to ensure that all relevant information for the safe use of these products should be applied across authorised products and therefore agreed on the wording for all relevant sections dealing with the risk of hypersensitivity reactions including the sections on pregnancy.
Kot del ukrepov za zmanjšanje tveganja je CHMP menil, da je treba zagotoviti, da se pri vseh odobrenih zdravilih navedejo vse pomembne informacije o varni uporabi teh zdravil, zato je določil besedila za vsa poglavja, ki obravnavajo tveganje za preobčutljivostne reakcije, vključno s poglavji o nosečnosti.
The iron complexes involved in this procedure are iron gluconate (sodium ferric gluconate), iron sucrose, iron dextran, iron carboxymaltose, and iron (III) isomaltoside 1000.
Kompleksi železa, vključeni v tem postopku, so železov glukonat (natrijev železov glukonat), železov saharat, železov dekstran, železova karboksimaltoza in železov (III) izomaltozid 1000.
The MAH reported that 25 events were related to ferrix carboxymaltose (20 grade I, 2 grade II, 2 grade III and 1 grade IV), 2 events were unlikely related to ferrix carboxymaltose (1 grade II and 1 grade IV), 9 events were not related to ferrix carboxymaltose (6 grade I, 1 grade II and 2 grade III).
Imetnik dovoljenja za promet z zdravilom je zabeležil, da je bilo 25 dogodkov povezanih z železovo karboksimaltozo (20 stopnje I, 2 stopnje II, 2 stopnje III in 1 stopnje IV), 2 dogodka najverjetneje nista bila povezana z železovo karboksimaltozo (1 stopnje II in 1 stopnje IV), 9 dogodkov pa ni bilo povezanih z železovo karboksimaltozo (6 stopnje I, 1 stopnje II in 2 stopnje III).
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).
Od izdaje dovoljenja do 29. februarja 2012 je bilo predloženih skupno 587 poročil o posameznih primerih, kar je povzročilo 0,003-odstotno stopnjo poročanja o neželenih učinkih (kar ustreza 1 093 poročilom o posameznih primerih za 100 000 bolnikov-dni).
There are only three completed studies involving iron (III) isomaltoside 1000 and eleven are still ongoing.
Zaključene so le tri študije z železovim (III) izomaltozidom 1000, enajst pa jih še poteka.
Three patients experienced allergic reactions leading to product discontinuation.
Pri treh bolnikih so zabeležili alergijske reakcije, zaradi katerih je bilo jemanje zdravila prekinjeno.
According to the Ring and Messmer classification reports twenty patients recovered without sequelae and one case (Grade I, 1 patient) was ongoing at time of last follow-up.
V skladu s klasifikacijo Ring in Messmer so poročali o dvajsetih bolnikih, ki so okrevali brez posledic, in o enem primeru (stopnja I, 1 bolnik) v teku v času zadnjega sledenja.
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).
V zbirki podatkov imetnika dovoljenja za promet z zdravilom je bilo identificiranih skupno 317 primerov preobčutljivosti, do katere je prišlo pri 13 824 369 bolnikov-let (presečni datum je 31. december 2011).
It might be of interest to note, that these patients had penicillin allergy and latex allergy, respectively.
Morda je primerno zabeležiti, da je imel prvi bolnik alergijo na penicilin, drugi pa alergijo na lateks.
The latter should also be included in the risk management plan, highlighting the risks and warnings of hypersensitivity reactions.
Gradivo naj bo vključeno tudi v načrt za obvladovanje tveganja, v njem pa naj bodo izpostavljena tveganja in opozorila glede preobčutljivostnih reakcij.
In most publications the majority of anaphylactoid reactions reported with LMWID were classified as grade I-II of severity according to Ring and Messmer classification.
V večini publikacij so večino anafilaktoidnih reakcij, o katerih so poročali pri LMWID, razvrstili kot resnost stopnje I−II po klasifikaciji Ring in Messmer.
The CHMP endorsed a Dear healthcare professional communication (DHPC), to communicate the outcome of the present review.
CHMP je odobril neposredno obvestilo zdravstvenim delavcem (DHPC), da se jim sporoči izid tega pregleda.
A total of 13,134 patients have been included in 29 MAH sponsored Phase 1 to 3 studies in different therapeutic areas (nephrology, gynaecology, gastroenterology, neurology, cardiology and iron deficiency anaemia), of which 6,608 have received ferric carboxymaltose and compared with those receiving other parenteral irons.
V 29 študij od 1. do 3. faze na različnih terapevtskih področjih (nefrologija, ginekologija, gastroenterologija, nevrologija, kardiologija in anemija zaradi pomanjkanja železa), ki jih je sponzoriral imetnik dovoljenja za promet z zdravilom, je bilo vključenih skupno 13 134 bolnikov, od katerih jih je 6 608 prejelo železovo karboksimaltozo, primerjali pa so jih z bolniki, ki so prejemali druga parenteralna železa.
This risk was particularly of concern with low molecular-weight iron-dextran (LMWID) containing products, particularly in pregnant women for whom uterine hypertonia was observed.
Tveganje je bilo zlasti zaskrbljujoče pri zdravilih, ki vsebujejo železov dekstran z nizko molekulsko maso (low molecular-weight iron-dextran − LMWID), zlasti pri nosečnicah z opaženo hipertonijo maternice.
In 2011 the French medicines agency (ANSM) had concerns with regards to the risk of hypersensitivity reactions of intravenous iron containing products indicated in iron deficiency situations when the oral route is insufficient or poorly tolerated especially in chronic kidney disease (CKD) patients (haemodialysis), but also in pre- or post-operative situations, or in case of intestinal absorption disorders.
Francoska agencija za zdravila (ANSM) je leta 2011 izrazila zadržke glede tveganja za preobčutljivostne reakcije intravenskih zdravil, ki vsebujejo železo, indiciranih za zdravljenje pomanjkanja železa, kadar peroralna pot ni zadostna ali v primeru slabega prenašanja, zlasti pri bolnikih s kronično boleznijo ledvic (na hemodializi), ter tudi v situacijah pred operacijami ali po operacijah in v primeru motenj absorpcije v črevesju.
The majority of hypersensitivity associated events (15.1%) occurred between 1 hour and 24 hours after treatment with iron sucrose, closely followed by hypersensitivity associated events which occurred between 5 and 30 minutes (13.9%)
Večina dogodkov, povezanih s preobčutljivostjo (15,1 %), se je pojavila od 1 ure do 24 ur po zdravljenju z železovim saharidom, čemur so tesno sledili dogodki, povezani s preobčutljivostjo, ki so se pojavili med 5 in 30 minutami (13,9 %).
Patients with known allergies and with immune or inflammatory conditions (e.g. systemic lupus erythematosus, rheumatoid arthritis) may enhance their risk when given these products as their condition may worsen unless it is deemed that the benefit outweighs the risks for these patients.
Pri bolnikih z znanimi alergijami in imunskimi ali vnetnimi boleznimi (npr. sistemski eritematozni lupus, revmatoidni artritis) se lahko pri prejemu teh zdravil tveganje za preobčutljivost poveča, saj se lahko njihovo stanje poslabša, razen v primeru, ko so pri teh bolnikih koristi večje od z njimi povezanih tveganj.
All patients recovered from the hypersensitivity event.
Vsi bolniki so po preobčutljivostnem dogodku okrevali.
As of 29 February 2012 a total of 26 case reports regarding hypersensitivity have been received yielding an ADR reporting rate of 0.02 %.
Od 29. februarja 2012 je bil prejetih skupno 26 poročil o posameznih primerih preobčutljivosti, kar je povzročilo 0,02-odstotno stopnjo poročanja o neželenih učinkih.
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.
V zvezi z alergijskimi reakcijami so identificirali skupno 846 primerov neželenih reakcij od 1 524 primerov neželenih dogodkov, od katerih je bila približno polovica resnih, polovica pa ne.
Only a few preclinical studies with low molecular weight iron dextrans (LMWID), iron(III) isomaltoside 1000 have been carried out and only studies with safety findings relevant to immunogenicity were referenced in the data submission by the MAHs.
Izvedenih je bilo le nekaj predkliničnih študij z železovimi dekstransi z nizko molekulsko maso (LMWID) in železovim (III) izomaltozidom 1000, v podatkih, ki so jih predložili imetniki dovoljenj za promet z zdravili, pa so bile navedene samo študije z ugotovitvami o varnosti, pomembnimi za imunogenost.
In these patients, intravenous iron products should only be used if the benefit is clearly judged to outweigh the potential risk.
Pri teh bolnikih se lahko intravenska zdravila, ki vsebujejo železo, daje samo, kadar so po skrbnem premisleku njihove koristi večje od potencialnega tveganja;
Furthermore the CHMP requested that a PASS will be conducted to further evaluate the safety concern of the hypersensitivity reactions, as well as adequate educational materials to be developed for patients and prescribers.
Nadalje je CHMP zahteval, da se izvede PASS, namenjen nadaljnji oceni zadržkov glede varnosti v zvezi s preobčutljivostnimi reakcijami, ter izdela ustrezno izobraževalno gradivo za bolnike in zdravnike, ki predpisujejo zdravilo;
A higher incidence of total adverse events (AEs) per patient and exposure within LMWID compared to iron sucrose group was identified but no difference between iron sucrose and iron gluconate (Ganguli et al 2008) in CKD population was observed.
Zabeležili so večjo pojavnost vseh neželenih dogodkov na bolnika in izpostavljenost znotraj LMWID v primerjavi s skupino z železovim saharatom, vendar pri populaciji s kronično boleznijo ledvic niso zabeležili nobene razlike med železovim saharatom in železovim glukonatom (Ganguli in sod.
According to the Ring & Messmer algorithm, 15 non-serious cases were all coded as either Grade I or II cases.
V skladu z algoritmom Ring in Messmer je bilo vseh 15 primerov, ki niso bili resni, razvrščenih kot stopnja I ali II.
This supports the conclusion that in patients with known allergies and with immune or inflammatory conditions (e.g. systemic lupus erythematosus, rheumatoid arthritis) the risk of hypersensitivity reactions is enhanced.
To podpira zaključek, da je pri bolnikih z znanimi alergijami ter imunskimi ali vnetnimi stanji (npr. sistemski eritematozni lupus, revmatoidni artritis) tveganje za preobčutljivostne reakcije povečano.
Pregnant women were among the cases with hypersensitivity reactions.
Med primere s preobčutljivostnimi reakcijami so spadale tudi nosečnice.
One study showed that slow administration of sodium ferric gluconate resulted in less allergic reactions than if this was done during a shorter period of time.
V eni študiji so ugotovili, da se je pri počasnem dajanju natrijevega železovega glukonata pojavilo manj alergijskih reakcij kot pri hitrejšem dajanju.
According to the Ring and Messmer classification, three cases were classified as grade II anaphylactoid reactions and one case as grade III.
Po klasifikaciji Ring in Messmer so bili trije primeri razvrščeni kot stopnja II anafilaktoidnih reakcij in eden kot stopnja III.
The MAHs were requested by the CHMP to provide a detailed analysis classified according to Ring and Messmer for the purpose of the review of the risk of allergic reactions.
CHMP je imetnike dovoljenj za promet z zdravili pozval, da predložijo podrobno analizo z razvrstitvijo po definiciji Ring in Messmer, za namene pregleda tveganja alergijskih reakcij.
Between the 20 patients who presented an anaphylactic reaction grade IV, 35% (7/20) patients had a medical history of hypersensitivity reactions.
Od 20 bolnikov, pri katerih so zabeležili anafilaktično reakcijo stopnje IV, je imelo 35 % (7/20) bolnikov preobčutljivostne reakcije v anamnezi.
When classifying all cases that were not reported as immune reactions, according to CTCAE approximately 20% were classified as grade III.
Pri razvrščanju vseh primerov, ki niso bili zabeleženi kot imunske reakcije, jih je bilo v skladu s CTCAE približno 20 % razvrščenih kot stopnja III. Velike večine primerov ni bilo mogoče oceniti kot potencialno resnih alergijskih reakcij.