FrancophonIA/ELRC3.0 huggingface dataset:
English: FULFIL (CTT116853) was a 24-week study (N=1,810), with an extension up to 52 weeks in a subset of subjects (n=430), that compared Temybric Ellipta (92/55/22 micrograms) with budesonide/formoterol 400/12 micrograms (BUD/FOR) administered twice-daily.
Croatian: Ispitivanje FULFIL (CTT116853) bilo je 24-tjedno ispitivanje (N = 1810) koje je u jednoj podskupini ispitanika (n = 430) bilo produženo do 52 tjedna i u kojem se Temybric Ellipta (92/55/22 mikrograma) uspoređivao se s budezonidom/formoterolom u dozi od 400/12 mikrograma (BUD/FOR) primijenjenim dvaput na dan.
English: In IMPACT, over 52 weeks, Temybric Ellipta significantly reduced (p<0.001) the annual rate of moderate/severe exacerbations by 15% (95% CI:10, 20) compared with FF/VI (rate; 0.91 vs 1.07 events per patient year) and by 25% (95% CI: 19, 30) compared with UMEC/VI (rate; 0.91 vs 1.21 events per patient year).
Croatian: U ispitivanju IMPACT, Temybric Ellipta je tijekom 52 tjedna značajno smanjio (p < 0,001) godišnju stopu umjerenih/teških egzacerbacija za 15% (95% CI: 10; 20) u odnosu na FF/VI (stopa: 0,91 naspram 1,07 događaja po bolesnik-godini) te za 25% (95% CI: 19; 30) u odnosu na UMEK/VI (stopa: 0,91 naspram 1,21 događaj po bolesnik-godini).
English: In a 52-week study, with a total of 10,355 patients with COPD and a history of moderate or severe exacerbations within the prior 12 months (mean post-bronchodilator screening FEV1 46% of predicted, SD 15%) (study CTT116855), the incidence of pneumonia was 8% (317 patients) for Temybric Ellipta (n = 4,151), 7% (292 subjects) for fluticasone furoate/vilanterol (n = 4,134), and 5% (97 subjects) for umeclidinium/vilanterol (n = 2,070).
Croatian: U 52-tjednom ispitivanju koje je obuhvatilo ukupno 10 355 bolesnika s KOPB-om i umjerenim ili teškim egzacerbacijama unutar proteklih 12 mjeseci (srednja vrijednost FEV1 nakon primjene bronhodilatatora pri probiru: 46% predviđene vrijednosti; standardno odstupanje: 15%) (ispitivanje CTT116855), incidencija pneumonije iznosila je 8% (317 bolesnika) uz Temybric Ellipta (n = 4151), 7% (292 ispitanika) uz flutikazonfuroat/vilanterol (n = 4134) te 5% (97 ispitanika) uz umeklidinij/vilanterol (n = 2070).
English: IMPACT (CTT116855) was a 52-week study (N=10,355) that compared Temybric Ellipta (92/55/22 micrograms) with fluticasone furoate/vilanterol 92/22 micrograms (FF/VI) and umeclidinium/vilanterol 55/22 micrograms (UMEC/VI).
Croatian: Ispitivanje IMPACT (CTT116855) bilo je 52-tjedno ispitivanje (N = 10 355) u kojem se Temybric Ellipta (92/55/22 mikrograma) uspoređivao s flutikazonfuroatom/vilanterolom u dozi od 92/22 mikrograma (FF/VI) i umeklidinijem/vilanterolom u dozi od 55/22 mikrograma (UMEK/VI).
English: In IMPACT, Temybric Ellipta prolonged the time to first moderate/severe exacerbation and significantly decreased (p<0.001) the risk of a moderate/severe exacerbation, as measured by time to first exacerbation, compared with both FF/VI (14.8%; 95% CI: 9.3, 19.9) and UMEC/VI (16.0%; 95% CI: 9.4, 22.1).
Croatian: U ispitivanju IMPACT, Temybric Ellipta produljio je vrijeme do prve umjerene/teške egzacerbacije te je značajno smanjio (p < 0,001) rizik od umjerene/teške egzacerbacije, mjeren vremenom do prve egzacerbacije, i u odnosu na FF/VI (14,8%; 95% CI: 9,3; 19,9) i u odnosu na UMEK/VI (16,0%; 95% CI: 9,4; 22,1).
English: In FULFIL, Temybric Ellipta improved daily symptoms of COPD as assessed by E-RS: COPD total score, compared with BUD/FOR (≥2 unit decrease from baseline).
Croatian: Evaluating Respiratory Symptoms in COPD, E-RS:COPD) u odnosu na BUD/FOR (smanjenje početnog rezultata za ≥ 2 jedinice).
English: Temybric Ellipta should be used with caution in patients with narrow-angle glaucoma or urinary retention.
Croatian: Temybric Ellipta treba primjenjivati uz oprez u bolesnika s glaukomom uskog kuta ili retencijom mokraće.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/19/1378/003
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/19/1378/003
English: In FULFIL the proportion of responders according to TDI (defined as at least 1 unit) was significantly higher (p<0.001) for Temybric Ellipta compared with BUD/FOR (61% vs 51%; OR 1.61; 95% CI: 1.33, 1.95).
Croatian: U ispitivanju FULFIL, udio bolesnika koji su postigli odgovor prema TDI rezultatu (koji se definirao kao najmanje 1 jedinica) bio je značajno veći (p < 0,001) uz Temybric Ellipta nego uz BUD/FOR (61% naspram 51%; OR 1,61; 95% CI: 1,33; 1,95).
English: NAME OF THE MEDICINAL PRODUCT Temybric Ellipta 92 micrograms/55 micrograms/22 micrograms inhalation powder, pre-dispensed
Croatian: NAZIV LIJEKA Temybric Ellipta 92 mikrograma/55 mikrograma/22 mikrograma prašak inhalata, dozirani
English: In IMPACT, Temybric Ellipta statistically significantly reduced the mean number of nighttime awakenings due to COPD compared with FF/VI (-0.05; 95% CI: -0.08, -0.01; p=0.005) and with UMEC/VI (-0.10; 95% CI: -0.14, -0.05; p<0.001) at weeks 49 to 52.
Croatian: Buđenje noću U ispitivanju IMPACT, Temybric Ellipta statistički je značajno smanjio srednju vrijednost broja buđenja noću zbog KOPB-a u odnosu na FF/VI (-0,05; 95% CI: -0,08; -0,01; p = 0,005) i UMEK/VI (-0,10; 95% CI: -0,14; -0,05; p < 0,001) između 49. i 52. tjedna.
English: Temybric Ellipta significantly improved (p<0.001) Health Related Quality of Life (as measured by the St George's Respiratory Questionnaire [SGRQ] total score) in both FULFIL (week 24) when compared with BUD/FOR (-2.2 units; 95% CI: -3.5, -1.0) and IMPACT (week 52) when compared with FF/VI (-1.8 units; 95% CI: -2.4, -1.1) and UMEC/VI (-1.8 units; 95% CI: -2.6, -1.0).
Croatian: St. George's Respiratory Questionnaire, SGRQ]) i u ispitivanju FULFIL (24. tjedan) u usporedbi s kombinacijom BUD/FOR (-2,2 jedinice; 95% CI: -3,5; -1,0) i u ispitivanju IMPACT (52. tjedan) u usporedbi s kombinacijom FF/VI (-1,8 jedinica; 95% CI: -2,4; -1,1) i UMEK/VI (-1,8 jedinica; 95% CI: -2,6; -1,0).
English: What Temybric Ellipta is used for
Croatian: Za što se Temybric Ellipta koristi
English: There is no relevant use of Temybric Ellipta in the paediatric population (under 18 years of age) for the indication of COPD.
Croatian: Nema relevantne primjene lijeka Temybric Ellipta u pedijatrijskoj populaciji (bolesnici mlađi od
English: Don't use Temybric Ellipta: - if you are allergic to fluticasone furoate, umeclidinium, vilanterol or any of the other ingredients of this medicine (listed in section 6).
Croatian: - ako ste alergični na flutikazonfuroat, umeklidinij, vilanterol ili neki drugi sastojak ovoga lijeka
English: Temybric Ellipta 92 micrograms/55 micrograms/22 micrograms inhalation powder, pre-dispensed fluticasone furoate/umeclidinium/vilanterol
Croatian: Temybric Ellipta 92 mikrograma/55 mikrograma/22 mikrograma prašak inhalata, dozirani flutikazonfuroat/umeklidinij/vilanterol
English: Comparison Temybric vs. UMEC/VI
Croatian: Temybric u odnosu na UMEK/VI
English: In the subset of 430 patients treated for up to 52 weeks, the incidence of pneumonia events reported in both Temybric
Croatian: U podskupini od 430 bolesnika liječenih tijekom najviše 52 tjedna, prijavljena incidencija događaja pneumonije bila je jednaka u skupini liječenoj lijekom Temybric Ellipta i u onoj koja je primala budezonid/formoterol (2%).
English: The proportion of responders during weeks 21-24 was significantly higher (p<0.001) for patients treated with Temybric Ellipta compared with BUD/FOR (47% and 37% respectively; OR 1.59; 95% CI: 1.30, 1.94).
Croatian: Udio bolesnika s odgovorom tijekom razdoblja od 21. do 24. tjedna bio je značajno veći (p < 0,001) uz Temybric Ellipta nego uz BUD/FOR (47% odnosno 37%; OR 1,59; 95% CI:
English: What Temybric Ellipta is
Croatian: Što je Temybric Ellipta
English: Comparison Temybric vs. FF/VI
Croatian: (95% CI) Temybric u odnosu na FF/VI
English: NAME OF THE MEDICINAL PRODUCT Temybric Ellipta 92/55/22 mcg inhalation powder fluticasone furoate/umeclidinium/vilanterol
Croatian: Temybric Ellipta 92/55/22 µg prašak inhalata Fluticasone furoate/Umeclidinium/Vilanterol
English: Temybric Ellipta significantly improved (p<0.001) lung function (as defined by mean change from baseline in trough FEV1 at week 24) (see Table 1) and the improvement was maintained in the subset of patients who continued treatment to week 52.
Croatian: Temybric Ellipta značajno je poboljšao (p < 0,001) plućnu funkciju (definirano srednjom vrijednošću promjene najniže vrijednosti FEV1 od početka ispitivanja do 24. tjedna) (vidjeti
English: What Temybric Ellipta contains The active substances are fluticasone furoate, umeclidinium bromide and vilanterol.
Croatian: Djelatne tvari su flutikazonfuroat, umeklidinijev bromid i vilanterol.
English: Package leaflet: Information for the patient Temybric Ellipta 92 micrograms/55 micrograms/22 micrograms inhalation powder, pre-dispensed fluticasone furoate/umeclidinium/vilanterol
Croatian: Uputa o lijeku: Informacije za bolesnika Temybric Ellipta 92 mikrograma/55 mikrograma/22 mikrograma prašak inhalata, dozirani flutikazonfuroat/umeklidinij/vilanterol
English: No dosage adjustment is required in patients with renal impairment (see section 5.2).
Croatian: Oštećenje bubrežne funkcije Nije potrebno prilagođavati dozu u bolesnika s oštećenjem bubrežne funkcije (vidjeti dio 5.2).
English: Laboratori Guidotti S.p.A. Tel: + 39 050 971011
Croatian: Tel: +39 050 971011
English: other long-acting medicines similar to this medicine that are used to treat breathing problems, e.g.
Croatian: - lijekove koji smanjuju količinu kalija u krvi, poput nekih diuretika (tableta za izmokravanje) - druge dugodjelujuće lijekove slične ovom lijeku koji se koriste za liječenje dišnih tegoba, npr.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Temybric Ellipta 92 /55 /22 mcg inhalation powder fluticasone furoate/umeclidinium/vilanterol
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Temybric Ellipta 92/55/22 µg prašak inhalata Fluticasone furoate/Umeclidinium/Vilanterol
English: • blurred vision
Croatian: • upala sinusa
English: Once the tray is opened Temybric Ellipta is ready to use.
Croatian: Temybric Ellipta spreman je za uporabu odmah nakon otvaranja podloška.
English: medicines called beta blockers (such as propranolol), to treat high blood pressure or other heart problems ketoconazole or itraconazole, to treat fungal infections clarithromycin or telithromycin, to treat bacterial infections ritonavir or cobicistat, to treat HIV infection medicines that lower the amount of potassium in your blood, such as some diuretics (water tablets)
Croatian: - lijekove koji se zovu beta blokatori (poput propranolola), a koriste se za liječenje visokog krvnog tlaka ili drugih srčanih tegoba
English: How to store Temybric Ellipta
Croatian: Kako čuvati Temybric Ellipta
English: What Temybric Ellipta looks like and contents of the pack The Ellipta inhaler consists of a light grey plastic body, a beige coloured mouthpiece cover and a dose counter.
Croatian: Inhalator Ellipta sastoji se od svijetlosivog plastičnog tijela, bež poklopca nastavka za usta i brojača doza.
English: Treatment with Temybric Ellipta should be discontinued immediately if paradoxical bronchospasm occurs.
Croatian: U slučaju paradoksalnog bronhospazma potrebno je odmah prekinuti liječenje lijekom
English: What you need to know before you use Temybric Ellipta 3.
Croatian: Što morate znati prije nego počnete primjenjivati Temybric Ellipta Nemojte primjenjivati Temybric Ellipta:
English: If you get tightness of the chest, coughing, wheezing or breathlessness immediately after using your Temybric Ellipta inhaler:
Croatian: Ako se neposredno nakon primjene lijeka Temybric Ellipta jave stezanje u prsnom košu, kašalj, piskanje pri disanju ili nedostatak zraka:
English: Talk to your doctor before using Temybric Ellipta - if you have asthma (Don't use Temybric Ellipta to treat asthma) - if you have heart problems or high blood pressure - if you have liver problems - if you have tuberculosis (TB) of the lung, or any long standing or untreated infections - if you have an eye problem called narrow-angle glaucoma - if you have an enlarged prostate, difficulty passing urine or a blocking in your bladder - if you suffer from epilepsy - if you have thyroid gland problems - if you have low potassium in your blood - if you have a history of diabetes - if you experience blurred vision or other visual disturbances
Croatian: - ako imate astmu (ne smijete primjenjivati Temybric Ellipta za liječenje astme) - ako imate srčane tegobe ili visok krvni tlak - ako imate tegoba s jetrom
English: No clinically relevant effects of hypokalaemia were observed in clinical studies with Temybric Ellipta at the recommended therapeutic dose.
Croatian: U kliničkim ispitivanjima nisu primijećeni klinički značajni učinci hipokalijemije kod primjene lijeka
English: Study 200812 was a 24-week, non-inferiority study (N=1,055) that compared Temybric Ellipta (92/55/22 micrograms) with FF/VI (92/22 micrograms) + UMEC (55 micrograms), co-administered once daily as a multi-inhaler therapy in patients with a history of moderate or severe exacerbations within the prior 12 months.
Croatian: Ispitivanje 200812 bilo je 24-tjedno ispitivanje neinferiornosti (N = 1055) u kojem se Temybric Ellipta (92/55/22 mikrograma) uspoređivao s flutikazonfuroatom/vilanterolom (92/22 mikrograma) +
English: How to use Temybric Ellipta
Croatian: Kako primjenjivati Temybric Ellipta
English: Nasopharyngitis Candidiasis of mouth and throat Urinary tract infection
Croatian: - ritonavir ili kobicistat, koji se koriste za liječenje HIV infekcije
English: Time (days) to event
Croatian: Vrijeme (dani) do događaja
English: • Grounds for one additional renewal
Croatian: • Osnova za jednu dodatnu obnovu
English: It can be removed the day after the last infusion.
Croatian: Može se ukloniti dan nakon posljednje infuzije.
English: The overall treatment period should not exceed 20 days.
Croatian: Ukupno trajanje liječenja ne bi smjelo biti dulje od 20 dana.
English: If such symptoms occur, please inform your doctor as soon as possible.
Croatian: Ako se takvi simptomi pojave, molimo obavijestite svog liječnika što je prije moguće.
English: For each syringe a new cannula is used.
Croatian: Za svaku štrcaljku koristi se nova cjevčica.
English: Talk to your doctor or nurse before using Removab.
Croatian: Obratite se svom liječniku ili medicinskoj sestri prije nego primijenite Removab.
English: These reactions resolved under symptomatic treatment.
Croatian: Ove su reakcije riješene simptomatskim liječenjem.
English: Material and equipment required
Croatian: Potreban materijal i oprema
English: 95% CI for HR
Croatian: 95% CI za HR
English: Children and adolescents Removab should not be used in children and adolescents under 18 years of age.
Croatian: Djeca i adolescenti Removab se ne bi trebao primjenjivati djece i adolescenata mlađih od 18 godina.
English: What Removab is and what it is used for
Croatian: Što je Removab i za što se koristi
English: N: number of patients in a treatment group.
Croatian: N: broj bolesnika u liječenoj grupi.
English: The concentrations increased with the number of infusions and the doses applied in most patients.
Croatian: Koncentracije su rasle s porastom broja infuzija i porastom primjenjivanih doza u većine bolesnika.
English: Date of latest renewal: 18 December 2013
Croatian: Datum prvog odobrenja: 20 travnja 2009 Datum posljednje obnove: 18 prosinac 2013
English: For the first of the four doses an infusion time of 6 hours may be considered depending on the patient's health condition.
Croatian: Za prvu od četiri doze, trajanje infuzije od 6 sati može se razmotriti ovisno o zdravstvenom stanju bolesnika.
English: This results in destruction of tumour cells.
Croatian: To rezultira uništavanjem tumorskih stanica.
English: Trion Pharma GmbH Frankfurter Ring 193a DE-80807 Munich Germany
Croatian: Trion Pharma GmbH Frankfurter Ring 193a DE-80807 München
English: Final volume for administration
Croatian: Konačan volumen za primjenu
English: Disposal No special requirements.
Croatian: Nema posebnih zahtjeva.
English: Percentage of EpCAM positive effusions
Croatian: Postotak izljeva pozitivnih na EpCAM
English: Other medicines and Removab Tell your doctor if you are taking, have recently taken or might take any other medicines.
Croatian: Drugi lijekovi i Removab Obavijestite svog liječnika ako uzimate ili ste nedavno uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: Estimated Probability of Being Puncture-free (%)
Croatian: Procijenjena vjerojatnost da neće biti korištena punkcija (%)
English: Subsequently, the catheter can be removed.
Croatian: Posljedično, kateter se može ukloniti.
English: In the pivotal study IP-REM-AC-01 98.1% of patients were hospitalised for a median of 11 days.
Croatian: U pivotalnom ispitivanju IP-REM-AC-01 98,1% bolesnika hospitalizirano je s medijanom trajanja od 11 dana.
English: Only in case of clinically relevant or persisting increase further diagnostics or therapy should be considered.
Croatian: Samo u slučaju klinički značajnog ili perzistirajućeg porasta vrijednosti potrebno je razmotriti daljnje dijagnostičke metode ili liječenje.
English: After the Removab infusion you will be observed as decided by your doctor.
Croatian: Nakon infuzije Removaba ostat ćete na promatranju ako tako odluči Vaš liječnik.
English: The median puncture-free survival time was 47.5 days, median time to first therapeutic puncture 60.0 days and median overall survival 406.5 days.
Croatian: Medijan vremena preživljenja bez punkcije bio je 47,5 dana, medijan vremena do prve terapijske punkcije 60,0 dana i medijan ukupnog preživljenja 406,5 dana.
English: Special populations No studies have been conducted.
Croatian: Posebne populacije Nisu provedena ispitivanja.
English: Endometrial *= lobular breast cancer
Croatian: Endometrij *= lobularni karcinom dojke
English: The outer surface of the pre-filled syringe is not sterile.
Croatian: Vanjska površina napunjene štrcaljke nije sterilna.
English: • The catheter is kept closed until the next infusion.
Croatian: • Kateter se drži zatvorenim do sljedeće infuzije.
English: Some of these side effects may require medical treatment.
Croatian: Neke od ovih nuspojava možda će biti potrebno liječiti.
English: Figure 3 Schematic illustration of the infusion system
Croatian: Slika 3 Shematska ilustracija infuzijskog sustava
English: If such symptoms occur, speak to a doctor immediately, as these side effects require immediate attention and treatment.
Croatian: Ako se ovakvi simptomi pojave, odmah obavijestite svog liječnika, budući da ovakve nuspojave zahtijevaju neodgodivu pozornost i liječenje.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Croatian: Ako se ne primijeni odmah, vrijeme čuvanja i uvjeti čuvanja prije primjene odgovornost su korisnika, a to ne bi trebalo biti duže od 24 sata na 2°C do 8°C, osim ako je razrjeđivanje provedeno u kontroliranim i validiranim aseptičkim uvjetima.
English: Do not use Removab - if you are allergic to catumaxomab or any of the other ingredients of this medicine (listed in section 6) - if you are allergic to murine proteins (from rat and / or mouse)
Croatian: Nemojte primjenjivati Removab - ako ste alergični na katumaksomab ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.) - ako ste alergični na mišje proteine (štakora i/ili miša)
English: Frequency groupings are defined as follows: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100).
Croatian: Skupine učestalosti definirane su na sljedeći način: vrlo često (≥1/10), često (≥1/100 do <1/10), manje često (≥1/1000 do <1/100).
English: In presence of factors interfering with the immune system, in particular acute infections, the administration of Removab is not recommended.
Croatian: U prisutnosti čimbenika koji utječu na rad imunološkog sustava, posebno akutnih infekcija, ne preporučuje se primjena Removaba.
English: In the pivotal study patients were monitored for 24 h after each infusion.
Croatian: U ključnom ispitivanju bolesnici su bili nadzirani 24 sata nakon svake infuzije.
English: Before starting and during treatment, you will be given other medicines to reduce fever, pain or inflammation caused by Removab.
Croatian: Prije početka i tijekom liječenja dobit ćete druge lijekove kako bi se smanjila vrućica, bol ili upala izazvana Removabom.
English: The EpCAM antigen is overexpressed on most carcinomas (Table 2).
Croatian: EpCAM antigen pojačano je izražen u većine karcinoma (Tablica 2).
English: During and after infusion with Removab more than 1 in 10 patients (very common) will probably experience infusion-related side effects.
Croatian: Tijekom i nakon infuzije Removaba više od 1 na 10 bolesnika (vrlo često) vjerojatno će imati nuspojave vezane uz infuziju.
English: • The day after the last infusion a drainage of ascites until stop of spontaneous flow is performed.
Croatian: • Dan nakon posljednje infuzije učini se drenaža ascitesa do prestanka spontanog istjecanja.
English: A decision must be made whether to discontinue breast-feeding or to discontinue / abstain from Removab therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Croatian: Potrebno je odlučiti treba li prekinuti dojenje ili prekinuti liječenje/odgoditi liječenje lijekom Removabom uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu.
English: The variability between subjects was high.
Croatian: Postojala je velika raznolikost među ispitanicima.
English: Altogether 45 out of 88 (51%) patients in the control arm crossed-over to achieve active treatment with catumaxomab.
Croatian: Sveukupno 45 od 88 (51%) bolesnika u kontrolnoj skupini prešlo je na liječenje katumaksomabom.
English: 6 Catheter
Croatian: 6 Kateter
English: In clinical studies infusion times of 3 hours and 6 hours were investigated.
Croatian: U kliničkim ispitivanjima primjenjivane su infuzije od 3 i 6 sati.
English: Repeated-dose toxicity, genotoxicity, carcinogenicity, reproductive and developmental toxicity studies have not been performed.
Croatian: Nisu provedena ispitivanja toksičnosti kod ponavljane primjene doze, genotoksičnosti, karcinogenosti, reproduktivne i razvojne toksičnosti.
English: Anxiety, insomnia.
Croatian: Anksioznost, nesanica
English: The patient population was comparable to the pivotal study.
Croatian: Populacija bolesnika bila je usporediva s onom u pivotalnom ispitivanju.
English: These symptoms reflect the mechanism of action of catumaxomab and are in general fully reversible.
Croatian: Ovi simptomi posljedica su mehanizma djelovanja katumaksomaba i općenito su potpuno reverzibilni.
English: Current data on catumaxomab derived from the pivotal study show that only 5.6% of patients (7/124 patients) were HAMA positive before the 4th infusion.
Croatian: Postojeći podaci o katumaksomabu koji potječu iz pivotalnog ispitivanja pokazuju da je samo 5,6% bolesnika (7/124) bilo HAMA pozitivno prije 4. infuzije.
English: In general, the changes in laboratory parameters were not clinically relevant and mostly returned to baseline after end of treatment.
Croatian: Općenito, promjene laboratorijskih parametara nisu bile klinički značajne i većinom su se nakon završetka liječenja vratile na vrijednosti od prije početka liječenja.
English: This transient effect is considered partially a consequence of the intraperitoneal route of administration.
Croatian: Ovaj se prolazni učinak djelomično smatra posljedicom intraperitonealnog puta primjene.
English: However, these findings are of limited value due to the high species-specificity of catumaxomab.
Croatian: Međutim, ovi rezultati imaju ograničenu vrijednost zbog specifičnosti vezane za vrstu kod katumaksomaba.
English: Adequate monitoring of the patient after end of Removab infusion is recommended.
Croatian: Preporučuje se odgovarajući nadzor bolesnika nakon završetka infuzije Removaba.
English: Plasma levels tended to decline after achieving a maximum after each dose.
Croatian: Vrijednosti u plazmi smanjivale su se nakon postizanja maksimuma nakon primjene pojedine doze.