FrancophonIA/ELRC3.0 huggingface dataset:
English: • Serious skin problems such as toxic epidermal necrolysis, Stevens-Johnson syndrome and acute generalised exanthematous pustulosis
Croatian: • ozbiljne kožne bolesti kao što su toksična epidermalna nekroliza, Stevens-Johnsonov sindrom i akutna generalizirana egzantematozna pustuloza
English: • Tell your doctor if you think you might be at risk of contracting hepatitis B.
Croatian: • Obavijestite svog liječnika ako mislite da postoji rizik da se zarazite hepatitisom B.
English: The required total volume of reconstituted Inflectra solution has to be calculated.
Croatian: Morate izračunati ukupni potrebni volumen rekonstituirane otopine lijeka Inflectra.
English: In ACT 1 and ACT 2, infliximab improved quality of life, confirmed by statistically significant improvement in both a disease specific measure, IBDQ, and by improvement in the generic 36-item short form survey SF-36.
Croatian: U ispitivanjima ACT 1 i ACT 2 infliksimab je doveo do poboljšanja kvalitete života, što je potvrđeno statistički značajnim poboljšanjem mjerila specifičnog za bolest (IBDQ) kao i poboljšanjem rezultata generičkog kratkog upitnika SF-36, s 36 pitanja.
English: If inactive (‘latent') tuberculosis is diagnosed, treatment for latent tuberculosis must be started with antituberculosis therapy before the initiation of infliximab, and in accordance with local recommendations.
Croatian: Ako se dijagnosticira neaktivna ("latentna") tuberkuloza, prije uvođenja infliksimaba mora se započeti liječenje latentne tuberkuloze antituberkuloznom terapijom sukladno lokalnim preporukama.
English: Concurrent administration with other biological therapeutics
Croatian: Istodobna primjena s drugim biološkim lijekovima
English: This patient reminder card contains important safety information that you need to be aware of before and during treatment with Inflectra.
Croatian: Ova kartica s podsjetnikom za bolesnika sadrži važne sigurnosne informacije, kojih morate biti svjesni prije i tijekom liječenja lijekom Inflectra.
English: • Medicines that affect your immune system.
Croatian: • lijekove koji djeluju na imunološki sustav.
English: The combination of infliximab and abatacept is not recommended.
Croatian: Ne preporučuje se kombinirana primjena infliksimaba i abatacepta.
English: All patients administered infliximab are to be observed for at least 1-2 hours post-infusion for acute infusion-related reactions.
Croatian: Svi bolesnici koji primaju infliksimab moraju biti pod nadzorom najmanje 1 - 2 sata nakon infuzije, za slučaj akutne reakcije vezane uz infuziju.
English: Placebo (Week 24)
Croatian: Placebo (24. tjedan)
English: Results from week 54 (ACR20, total van der Heijde-modified Sharp score and HAQ) are shown in Table 3.
Croatian: Rezultati nakon 54 tjedana (ACR20, HAQ i ukupan rezultat prema van der Heijdeovoj modifikaciji Sharpove bodovne skale) prikazani su u Tablici
English: What Inflectra is and what it is used for What you need to know before you use Inflectra How Inflectra will be given Possible side effects
Croatian: Što je Inflectra i za što se koristi Što morate znati prije nego počnete primjenjivati lijek Inflectra Kako primjenjivati lijek Inflectra Moguće nuspojave
English: In the REACH study, infections were reported in 56.3% of randomised subjects treated with infliximab.
Croatian: U ispitivanju REACH infekcije su prijavljene u 56,3% randomiziranih ispitanika liječenih infliksimabom.
English: Table 1 Adverse reactions in clinical studies and from post-marketing experience Infections and infestations Very common:
Croatian: Tablica 1 Nuspojave u kliničkim ispitivanjima i nakon stavljanja lijeka u promet Infekcije i infestacije Vrlo često:
English: Based on an observational study from Northern Europe, an increased risk (OR, 95% CI; p-value) for C-section (1.50, 1.14-1.96; p = 0.0032), preterm birth (1.48, 1.05-2.09; p = 0.024), small for gestational age (2.79, 1.54-5.04; p = 0.0007), and low birth weight (2.03, 1.41-2.94; p = 0.0002) was observed in women exposed during pregnancy to infliximab (with or without immunomodulators/corticosteroids, 270 pregnancies) as compared to women exposed to immunomodulators and/or corticosteroids only (6,460 pregnancies).
Croatian: Na temelju opservacijskog ispitivanja provedenog u sjevernoj Europi, opažen je povećan rizik (OR, 95% CI; p-vrijednost) za carski rez (1,50; 1,14-1,96; p = 0,0032), prijevremeni porođaj (1,48; 1,052,09; p = 0,024), malu veličinu ploda za gestacijsku dob (2,79; 1,54-5,04; p = 0,0007) i novorođenče niske porođajne težine (2,03; 1,41-2,94; p = 0,0002) u žena koje su tijekom trudnoće bile izložene infliksimabu (u kombinaciji s imunomodulatorima/kortikosteroidima ili bez njih, 270 trudnoća) u usporedbi sa ženama koje su bile izložene samo imunomodulatorima i/ili kortikosteroidima (6460 trudnoća).
English: • A reminder to patients to show the patient reminder card to all treating HCPs, including in conditions of emergency, and a message for HCPs that the patient is using Inflectra
Croatian: • podsjetnik bolesnicima da pokažu karticu s podsjetnikom za bolesnika svim zdravstvenim radnicima koji ih liječe, ujedno i u hitnim situacijama, te poruku za zdravstvene radnike da bolesnik uzima lijek Inflectra
English: Amnesia, agitation, confusion, somnolence, nervousness.
Croatian: amnezija, agitiranost, konfuzija, somnolencija, nervoza
English: Almost all patients had received treatment with AZA or 6-MP concomitantly with or immediately prior to a TNF-blocker.
Croatian: Gotovo svi bolesnici su primili terapiju azatioprinom (AZA) ili 6-MP istodobno ili neposredno prije primjene TNF-blokatora.
English: Additionally, closure of all fistulae was achieved in 55% of infliximab-treated patients compared with 13% of placebo-treated patients (p=0.001).
Croatian: Uz to, zatvaranje svih fistula postignuto je u 55% bolesnika liječenih infliksimabom, u odnosu na 13% bolesnika koji su primali placebo (p = 0,001).
English: Sustained Steroid-Free Remission b a Reduction in CDAI ≥ 25% and ≥ 70 points.
Croatian: Smanjenje CDAI ≥ 25% i ≥ 70 bodova.
English: Infliximab is a monoclonal antibody - a type of protein that attaches to a specific target in the body called TNF (tumour necrosis factor) alpha.
Croatian: Infliksimab je monoklonsko protutijelo - vrsta bjelančevine koja se veže na određeno ciljno mjesto u tijelu koje se zove TNF-alfa (faktor nekroze tumora alfa).
English: Any unused portion of the infusion solution should not be stored for reuse.
Croatian: Neiskorišteni dio otopine za infuziju ne smije se čuvati za kasniju primjenu.
English: However, if the solution is prepared in germ-free conditions, it can be stored in a refrigerator at 2 °C - 8 °C up to 28 days and for an additional 24 hours at 25 °C after removal from the refrigerator.
Croatian: Međutim, ako se otopina pripremila u sterilnim uvjetima, može se čuvati u hladnjaku na temperaturi od 2°C do 8°C do 28 dana i tijekom dodatna 24 sata nakon vađenja iz hladnjaka na temperaturi od 25°C.
English: Concomitant stable doses of oral aminosalicylates, corticosteroids, and/or immunomodulatory agents were permitted.
Croatian: Dozvoljena je bila istodobna primjena stabilnih doza peroralnih aminosalicilata, kortikosteroida i/ili imunomodulatora.
English: e HAQ = Health Assessment Questionnaire; greater values indicate less disability.
Croatian: Health Assesment Questionnaire); veće vrijednosti označavaju manji stupanj onesposobljenosti.
English: 3 Number of patients evaluated for ALT. 4 Median follow-up is based on patients treated.
Croatian: 4 Medijan praćenja temelji se na broju liječenih bolesnika.
English: The European Medicines Agency has waived the obligation to submit the results of studies with the reference medicinal product containing infliximab in all subsets of the paediatric population in rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, psoriasis and Crohn's disease (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja referentnog lijeka koji sadrži infliksimab u svim podskupinama pedijatrijske populacije u reumatoidnom artritisu, juvenilnom idiopatskom artritisu, psorijatičnom artritisu, ankilozantnom spondilitisu, psorijazi i Crohnovoj bolesti (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Immunogenicity Antibodies to infliximab were detected in 4 (7.7%) patients through week 54.
Croatian: Imunogenost Protutijela protiv infliksimaba su do kraja 54. tjedna otkrivena u 4 bolesnika (7,7%).
English: Approximately half of infliximab-treated patients in clinical studies who were ANA negative at baseline developed a positive ANA during the study compared with approximately one fifth of placebo-treated patients.
Croatian: Otprilike polovica bolesnika liječenih infliksimabom u kliničkim ispitivanjima koji su na početku ispitivanja bili negativni na ANA postali su pozitivni na ANA tijekom ispitivanja, u odnosu na približno jednu petinu bolesnika koji su primali placebo.
English: Of the infliximab-treated patients who received at least one shortened infusion, infusion-related reactions occurred in 15% of patients and serious infusion reactions occurred in 0.4% of patients.
Croatian: Među bolesnicima liječenima infliksimabom koji su primili barem jednu infuziju u skraćenom trajanju, reakcije vezane uz infuziju javile su se u njih 15%, dok su se ozbiljne reakcije na infuziju javile u 0,4% bolesnika.
English: • Tell your surgeon or dentist that you are having treatment with Inflectra by showing them your patient reminder card.
Croatian: • Obavijestite svog kirurga ili stomatologa da uzimate lijek Inflectra i pokažite im svoju karticu s podsjetnikom za bolesnika.
English: Anaphylactic reaction, lupus-like syndrome, serum sickness or serum sickness-like reaction.
Croatian: anafilaktička reakcija, sindrom nalik lupusu, serumska bolest ili reakcije nalik serumskoj bolesti
English: Patients who develop a new infection while undergoing treatment with infliximab, should be monitored closely and undergo a complete diagnostic evaluation.
Croatian: Bolesnike koji tijekom liječenja infliksimabom razviju novu infekciju treba pažljivo nadzirati i podvrgnuti cjelovitom dijagnostičkom postupku.
English: Due to methodological limitations, a negative assay did not exclude the presence of antibodies to infliximab.
Croatian: Zbog ograničenja metode negativni rezultati testa ne isključuju prisutnost protutijela protiv infliksimaba.
English: The following adverse reactions were reported more commonly in paediatric Crohn's disease patients in the REACH study (see section 5.1) than in adult Crohn's disease patients: anaemia (10.7%), blood in stool (9.7%), leukopenia (8.7%), flushing (8.7%), viral infection (7.8%), neutropenia (6.8%), bacterial infection (5.8%), and respiratory tract allergic reaction (5.8%).
Croatian: Sljedeće nuspojave prijavljene su češće u djece s Crohnovom bolešću uključene u kliničko ispitivanje REACH (vidjeti dio 5.1) nego u odraslih bolesnika s Crohnovom bolešću: anemija (10,7%), krv u stolici (9,7%), leukopenija (8,7%), crvenilo praćeno osjećajem užarenosti (8,7%), virusne infekcije (7,8%), neutropenija (6,8%), bakterijske infekcije (5,8%) i alergijske reakcije dišnog sustava (5,8%).
English: The required volume of reconstituted Inflectra solution should slowly be added to the 250-mL infusion bottle or bag and gently be mixed.
Croatian: Potrebni volumen rekonstituirane otopine lijeka Inflectra treba se polako dodavati u 250-mililitarsku infuzijsku bocu ili vrećicu te lagano promiješati.
English: In the 3 mg/kg infliximab group, 4 out of 60 patients had a serious infusion reaction and 3 patients reported a possible anaphylactic reaction (2 of which were among the serious infusion reactions).
Croatian: U skupini koja je primala dozu od 3 mg/kg infliksimaba, 4 od 60 bolesnika imala su ozbiljnu reakciju na infuziju dok su 3 bolesnika prijavila moguću anafilaktičku reakciju (od kojih su 2 bile među ozbiljnim reakcijama na infuziju).
English: The educational programme consists of a patient reminder card to be held by the patient.
Croatian: Edukacijski program obuhvaća karticu s podsjetnikom za bolesnika koju će bolesnik nositi sa sobom.
English: If active tuberculosis is diagnosed, infliximab therapy must not be initiated (see section 4.3).
Croatian: Ako se dijagnosticira aktivna tuberkuloza, ne smije se započeti liječenje infliksimabom (vidjeti dio 4.3).
English: Hepatosplenic T-cell lymphoma (primarily in adolescents and young adult males with Crohn's disease and ulcerative colitis), Merkel cell carcinoma.
Croatian: hepatosplenički limfom T-stanica (prvenstveno u adolescenata i mlađih odraslih muškaraca s Crohnovom bolešću i ulceroznim kolitisom), karcinom Merkelovih stanica
English: • If you received Inflectra while you were pregnant, your baby may also be at higher risk for getting an infection with live vaccines for up to six months after birth.
Croatian: • Ako ste primali lijek Inflectra za vrijeme trudnoće, u Vašeg djeteta može također postojati veći rizik za razvoj infekcije živim cjepivom u razdoblju do šest mjeseci nakon rođenja.
English: Table 1 lists the ADRs based on experience from clinical studies as well as adverse reactions, some with fatal outcome, reported from post-marketing experience.
Croatian: Tablici 1 navedene su nuspojave koje se temelje na iskustvu iz kliničkih ispitivanja kao i nuspojave prijavljene nakon stavljanja lijeka u promet, od kojih su neke imale smrtni ishod.
English: The safety and efficacy of re-administration after an infliximab-free interval of more than 16 weeks has not been established.
Croatian: Nisu utvrđene sigurnost i djelotvornost ponovne primjene ako je razdoblje u kojemu se infliksimab nije davao bilo dulje od 16 tjedana.
English: • Infection due to a live vaccine because of a weakened immune system.
Croatian: • infekcija nastala zbog živog cjepiva i oslabljenog imunološkog sustava.
English: Analysis of lamina propria mononuclear cells obtained by biopsy of the intestinal mucosa showed that infliximab treatment caused a reduction in the number of cells capable of expressing TNFα and interferon .
Croatian: Analiza mononuklearnih stanica u lamini propriji, dobivenih biopsijom sluznice crijeva, pokazala je da je liječenje infliksimabom dovelo do smanjenja broja stanica koje mogu izraziti TNFα i interferon γ.
English: In this situation, infliximab should be re-initiated as a single dose followed by the maintenance dose recommendations described above.
Croatian: U tom slučaju treba započeti terapiju davanjem jedne doze infliksimaba, a zatim nastaviti s dozama održavanja, prema gore opisanim preporukama.
English: • These infections may be serious and include tuberculosis, infections caused by viruses, fungi, bacteria or other organisms in the environment and sepsis that may, be life-threatening.
Croatian: • Te infekcije mogu biti ozbiljne, a uključuju tuberkulozu, virusne infekcije, gljivične infekcije, bakterijske infekcije ili infekcije uzrokovane drugim organizmima u okolini te sepsu, koja može ugroziti život.
English: • Patients with COPD and patients who are heavy smokers may have a higher risk of developing cancer with Inflectra treatment.
Croatian: • Bolesnici s KOPB-om i bolesnici koji su teški pušači mogu imati povećan rizik za razvoj raka pri liječenju lijekom Inflectra.
English: Table 6 Percent of patients achieving corticosteroid-free clinical remission at Week 26, SONIC AZA Monotherapy
Croatian: Tablica 6 Postotak bolesnika koji su postigli kliničku remisiju bez kortikosteroida u 26. tjednu, SONIC
English: If jaundice and/or ALT elevations ≥ 5 times the upper limit of normal develop(s), infliximab should be discontinued, and a thorough investigation of the abnormality should be undertaken.
Croatian: Ako se razvije žutica i/ili je koncentracija ALT ≥ 5 puta veća od gornje granice normale, liječenje infliksimabom treba prekinuti te provesti temeljite pretrage i utvrditi razlog poremećaja.
English: Brand name: Batch number:
Croatian: Zaštićeni naziv: Broj serije:
English: Patients with fistulising Crohn's disease with acute suppurative fistulas must not initiate infliximab therapy until a source for possible infection, specifically abscess, has been excluded (see section 4.3).
Croatian: Bolesnici s fistulirajućim oblikom Crohnove bolesti s akutnim, gnojnim fistulama ne smiju započeti liječenje infliksimabom dok se ne otkloni izvor moguće infekcije, osobito apsces (vidjeti dio 4.3).
English: In patients who develop HBV reactivation, infliximab should be stopped and effective antiviral therapy with appropriate supportive treatment should be initiated.
Croatian: U bolesnika u kojih se ponovno aktivira HBV treba prekinuti primjenu infliksimaba te uvesti učinkovite antivirusne lijekove uz odgovarajuće suportivno liječenje.
English: A reduction in the rate of the progression of structural joint damage (erosions and joint space narrowing) was observed in all infliximab groups at 54 weeks (Table 3).
Croatian: Smanjenje brzine napredovanja strukturnog oštećenja zglobova (erozije i sužavanje zglobnog prostora) primijećeno je nakon 54 tjedana u svim skupinama bolesnika koji su primali infliksimab (Tablica 3).
English: If you were using Inflectra during pregnancy, tell your baby's doctor and other healthcare professionals caring for your baby about your Inflectra use before the baby receives any vaccines.
Croatian: Ako ste uzimali lijek Inflectra tijekom trudnoće, obavijestite pedijatra Vašeg djeteta ili druge zdravstvene radnike koji skrbe za Vaše dijete da ste uzimali lijek Inflectra prije nego što dijete primi bilo koje cjepivo.
English: • Possible signs of cancer including but not limited to swelling of lymph nodes, weight loss, fever, unusual skin nodules, changes in moles or skin colouring, or unusual vaginal bleeding.
Croatian: • Mogući znakovi raka uključuju no nisu ograničeni na oticanje limfnih čvorova, gubitak tjelesne težine, vrućicu, neuobičajene čvoriće na koži, promjene na madežima ili u boji kože ili neuobičajeno krvarenje iz rodnice.
English: • Some children and teenage patients who have received TNF-blockers such as infliximab have developed cancers, including unusual types, which sometimes resulted in death.
Croatian: • U neke djece i mladih bolesnika koji su primali TNF-blokatore kakav je infliksimab razvio se rak, uključujući neuobičajene vrste raka koje su ponekad imale smrtni ishod.
English: Almost all patients had also received medicines containing azathioprine or mercaptopurine in addition to TNF-blockers.
Croatian: Gotovo svi bolesnici također su uzimali i lijekove koji sadrže azatioprin ili merkaptopurin s TNF-blokatorima.
English: Re-administration for Crohn's disease and rheumatoid arthritis If the signs and symptoms of disease recur, infliximab can be re-administered within 16 weeks following the last infusion.
Croatian: Ako se ponovno pojave znakovi i simptomi bolesti, infliksimab se može ponovno primijeniti unutar 16 tjedana od zadnje infuzije.
English: Cases of malignancies, including lymphoma, have also been reported in the post-marketing setting (see section 4.4).
Croatian: Slučajevi zloćudnih bolesti, uključujući limfom, prijavljeni su i nakon stavljanja lijeka u promet (vidjeti dio 4.4).
English: • If your doctor feels that you are at risk for TB, you may be treated with medicines for TB before you are given Inflectra.
Croatian: • Ako liječnik misli da u Vas postoji rizik od razvoja TBC-a, prije nego primite lijek Inflectra možda ćete dobiti lijekove za liječenje TBC-a.
English: N/A 60 N/A 49.4 N/A 6.7% N/A 1.7%
Croatian: N/P 6,7% N/P 1,7%
English: More signs of allergic side effects that may happen up to 12 days after your injection include pain in the muscles, fever, joint or jaw pain, sore throat or headache.
Croatian: Više znakova alergijske nuspojave koje se mogu javiti i do 12 dana nakon infuzije su bol u mišićima, vrućica, bol u zglobovima ili čeljusti,
English: Cases of TB have been reported in patients treated with infliximab, even in patients who have already been treated with medicines for TB.
Croatian: U bolesnika liječenih infliksimabom prijavljeni su slučajevi tuberkuloze, čak i u bolesnika koji su već liječeni lijekovima protiv TBC-a.
English: Nervous system disorders Very common:
Croatian: apatija Poremećaji živčanog sustava Vrlo često:
English: In a subset of 90 adult patients with rheumatoid arthritis from the ASPIRE study a similar proportion of patients in each treatment group (methotrexate plus: placebo [n = 17], 3 mg/kg [n = 27] or 6 mg/kg infliximab [n = 46]) mounted an effective two-fold increase in titres to a polyvalent pneumococcal vaccine, indicating that infliximab did not interfere with T-cell independent humoral immune responses.
Croatian: U podskupini od 90 odraslih bolesnika s reumatoidnim artritisom iz ispitivanja ASPIRE, sličan je udio bolesnika u svim liječenim skupinama (metotreksat plus: placebo [n = 17], infliksimab u dozi od 3 mg/kg [n = 27] ili infliksimab u dozi od 6 mg/kg [n = 46]) ostvario učinkovito dvostruka povećanja titra kao odgovor na polivalentno pneumokokno cjepivo, što ukazuje na to da infliksimab nije utjecao na humoralne imunološke odgovore neovisne o T-stanicama.
English: Number of patients
Croatian: Indikacija Broj bolesnika
English: In clinical studies using single and multiple infliximab doses ranging from 1 to 20 mg/kg, antibodies to infliximab were detected in 14% of patients with any immunosuppressant therapy, and in 24% of patients without immunosuppressant therapy.
Croatian: U kliničkim ispitivanjima primjene jednokratnih i višekratnih doza infliksimaba od 1 do 20 mg/kg, protutijela protiv infliksimaba otkrivena su u 14% bolesnika koji su primali neku imunosupresivnu terapiju te u 24% bolesnika koji nisu primali imunosupresivnu terapiju.
English: ACR 20 response* ACR 50 response* ACR 70 response* PASI response (% of patients)b
Croatian: Odgovor ACR 20* 5 (10%) Odgovor ACR 50* 0 (0%) Odgovor ACR 70* 0 (0%) PASI odgovor (% bolesnika)
English: • Narrowed airway in the lungs, causing difficulty breathing
Croatian: • suženi dišni putevi u plućima koji uzrokuju otežano disanje
English: c a control = All patients had active RA despite treatment with stable methotrexate doses for 6 months prior to enrolment and were to remain on stable doses throughout the study.
Croatian: kontrolna skupina = svi su bolesnici imali aktivni reumatoidni artritis usprkos liječenju ustaljenim dozama metotreksata tijekom 6 mjeseci prije uključenja u ispitivanje i trebali su nastaviti s uzimanjem istih doza tijekom čitavog ispitivanja.
English: Concurrent use of stable doses of conventional therapies was permitted, and 92% of patients continued to receive these therapies.
Croatian: Bila je dozvoljena istodobna primjena konvencionalne terapije u ustaljenoj dozi, koju je nastavilo primati 92% bolesnika.
English: Use of TNF-blocking agents, including infliximab, has been associated with cases of new onset or exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disorders, including multiple sclerosis, and peripheral demyelinating disorders, including Guillain-Barré syndrome.
Croatian: Primjena lijekova koji inhibiraju TNF, uključujući infliksimab, dovodi se u vezu sa slučajevima nastajanja novih ili egzacerbacijom postojećih kliničkih simptoma i/ili radioloških nalaza demijelinizacijskih bolesti središnjeg živčanog sustava, uključujući multiplu sklerozu te demijelinizacijskih poremećaja perifernog živčanog sustava, uključujući Guillain-Barréov sindrom.
English: Although comparative data are lacking, limited data in patients who initially responded to 5 mg/kg but who lost response indicate that some patients may regain response with dose escalation (see section 5.1).
Croatian: Premda nema usporednih podataka, ograničeni podaci u bolesnika koji su inicijalno odgovorili na dozu od 5 mg/kg, ali se odgovor potom izgubio, ukazuju na to da se u nekih bolesnika povećanjem doze može ponovno uspostaviti terapijski odgovor (vidjeti dio 5.1).
English: Some patients who developed high titres of antibodies to infliximab had evidence of reduced efficacy.
Croatian: U nekih bolesnika koji su razvili visoki titar protutijela protiv infliksimaba bilo je dokaza smanjene djelotvornosti lijeka.