FrancophonIA/ELRC3.0 huggingface dataset:
English: On 22 September 2016, Hospira UK Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Pemetrexed (as ditromethamine) Hospira, for the treatment of malignant pleural mesothelioma and non-small-cell lung cancer.
Croatian: Dana 22. rujna 2016., tvrtka Hospira UK Limited službeno je obavijestila Odbor za lijekove za humanu uporabu (CHMP) kako želi povući svoj zahtjev za odobrenje za stavljanje u promet lijeka Pemetrexed (u obliku ditrometamina) Hospira, za liječenje malignog pleuralnog mezotelioma i raka pluća nemalih stanica.
English: Pemetrexed (as ditromethamine) Hospira was expected to be used to treat two types of lung cancer: malignant pleural mesothelioma (a cancer of the lining of the lungs usually caused by exposure to asbestos) and advanced non-small-cell lung cancer of the kind known as ‘non-squamous'.
Croatian: Pemetrexed (u obliku ditrometamina) Hospira trebao se koristiti za liječenje dvaju tipova raka pluća: malignog pleuralnog mezotelioma (raka ovojnice pluća koji je obično uzrokovan izlaganjem azbestu) i uznapredovalog raka pluća nemalih stanica koje su poznate pod nazivom „neskvamozne stanice”.
English: Because Pemetrexed (as ditromethamine) Hospira was developed as a generic medicine, the company presented the results of studies to show the quality of the medicine.
Croatian: Budući da je lijek Pemetrexed (u obliku ditrometamina) Hospira razvijen kao generički lijek, tvrtka je predstavila rezultate ispitivanja kojima se dokazuje kvaliteta lijeka.
English: The CHMP thought that the company could have addressed these questions and was of the provisional opinion that Pemetrexed (as ditromethamine) Hospira could have been approved for the treatment of malignant pleural mesothelioma and nonsmall-cell lung cancer.
Croatian: CHMP je smatrao da je tvrtka mogla odgovoriti na ta pitanja i bio je privremenog mišljenja da je moguće dati odobrenje za Pemetrexed (u obliku ditrometamina) Hospira za liječenje malignog pleuralnog mezotelioma i raka pluća nemalih stanica.
English: No further studies were carried out because Pemetrexed (as ditromethamine) Hospira is a generic medicine that is given by infusion into a vein and contains the same active substance as the reference medicine, Alimta.
Croatian: Nisu provedena dodatna ispitivanja jer je Pemetrexed (u obliku ditrometamina) Hospira generički lijek koji se daje intravenskom infuzijom i koji sadrži istu djelatnu tvar kao i referentni lijek Alimta.
English: Pemetrexed (as ditromethamine) Hospira was developed as a ‘generic medicine'.
Croatian: Pemetrexed (u obliku ditrometamina) Hospira razvijen je kao „generički lijek”.
English: Pemetrexed (as ditromethamine) Hospira is a cancer medicine that contains the active substance pemetrexed.
Croatian: Pemetrexed (u obliku ditrometamina) Hospira je lijek za liječenje raka koji sadrži djelatnu tvar pemetreksed.
English: Pemetrexed (as ditromethamine) Hospira is expected to work in the same way as the reference medicine, Alimta.
Croatian: Lijek Pemetrexed (u obliku ditrometamina) Hospira trebao je djelovati na isti način kao i referentni lijek Alimta.
English: What is Pemetrexed (as ditromethamine) Hospira?
Croatian: Što je Pemetrexed (u obliku ditrometamina) Hospira?
English: What was Pemetrexed (as ditromethamine) Hospira expected to be used for?
Croatian: Za što se lijek Pemetrexed (u obliku ditrometamina) Hospira trebao koristiti?
English: Further information on Enurev Breezhaler can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Više informacija o lijeku Enurev Breezhaler nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: the main measure of effectiveness was improvement in patients' forced expiratory volumes (FEV1, the maximum volume of air a person can breathe out in one second).
Croatian: U oba ispitivanja glavno mjerilo učinkovitosti lijeka bilo je poboljšanje forsiranog izdisajnog volumena bolesnika (FEV1, maksimalni volumen zraka koji osoba može izdahnuti u sekundi).
English: Enurev Breezhaler (glycopyrronium bromide) EMA/326865/2018
Croatian: Enurev Breezhaler (glikopironijev bromid) EMA/326865/2018
English: The most common side effects with Enurev Breezhaler (seen in more than 1 patient in 100) are dry mouth, nasopharyngitis (inflammation of the nose and throat), insomnia (difficulty sleeping), muscle and bone pain and gastroenteritis (diarrhoea and vomiting).
Croatian: Najčešće nuspojave lijeka Enurev Breezhaler (zabilježene u više od 1 na 100 bolesnika) jesu suhoća usta, nazofaringitis (upala nosa i grla), insomnija (nesanica), bolovi u mišićima i kostima te gastroenteritis (proljev i povraćanje).
English: After 12 weeks of treatment, Enurev Breezhaler increased FEV1 by 97 ml more than with placebo in the first study, and by 108 ml more in the second study.
Croatian: U prvom ispitivanju, nakon 12 tjedana terapije lijekom Enurev Breezhaler FEV1 povećao se za 97 ml više nego uz primjenu placeba, a u drugom ispitivanju za 108 ml više.
English: Enurev Breezhaler received a marketing authorisation valid throughout the EU on 28 September 2012.
Croatian: Lijek Enurev Breezhaler dobio je odobrenje za stavljanje u promet koje je na snazi u Europskoj uniji od 28. rujna 2012.
English: Enurev Breezhaler capsules, which contain a powder for inhalation, are only used with the Enurev Breezhaler inhaler and must not be swallowed.
Croatian: Kapsule lijeka Enurev Breezhaler, koje sadrže prašak inhalata, primjenjuju se samo s inhalatorom za Enurev Breezhaler i ne smiju se progutati.
English: Side effects reported with Enurev Breezhaler are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Enurev Breezhaler pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Enurev Breezhaler have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Enurev Breezhaler nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: The European Medicines Agency noted that Enurev Breezhaler had a modest but relevant benefit for patients in terms of improving lung function, and also improved the symptoms of COPD.
Croatian: Europska agencija za lijekove smatrala je da Enurev Breezhaler ima skromnu, ali važnu korist za bolesnike jer poboljšava plućnu funkciju te ublažava simptome KOPB-a.
English: Enurev Breezhaler is a medicine that is used to relieve the symptoms of chronic obstructive pulmonary disease (COPD) in adults.
Croatian: Enurev Breezhaler je lijek koji se primjenjuje za ublažavanje simptoma kronične opstruktivne plućne bolesti (KOPB) u odraslih osoba.
English: In addition, there were no major safety concerns with Enurev Breezhaler, with side effects similar to other muscarinic receptor antagonist medicines.
Croatian: Osim toga, nisu postojali ozbiljni razlozi za zabrinutost pri primjeni lijeka Enurev Breezhaler, a nuspojave su slične onima kod drugih antagonista muskarinskih receptora.
English: What measures are being taken to ensure the safe and effective use of Enurev Breezhaler?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Enurev Breezhaler?
English: For more information about using Enurev Breezhaler, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Enurev Breezhaler pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: What is Enurev Breezhaler and what is it used for?
Croatian: Što je Enurev Breezhaler i za što se koristi?
English: Enurev Breezhaler (glycopyrronium bromide)
Croatian: Enurev Breezhaler (glikopironijev bromid)
English: Therefore, the Agency decided that Enurev Breezhaler's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Agencija je stoga zaključila da koristi lijeka Enurev Breezhaler nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: An overview of Enurev Breezhaler and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Enurev Breezhaler i zašto je odobren u EU-u
English: As for all medicines, data on the use of Enurev Breezhaler are continuously monitored.
Croatian: Kao za sve lijekove, podatci o primjeni lijeka Enurev Breezhaler kontinuirano se prate.
English: Other information about Enurev Breezhaler
Croatian: Ostale informacije o lijeku Enurev Breezhaler
English: Why is Enurev Breezhaler authorised in the EU?
Croatian: Zašto je lijek Enurev Breezhaler odobren u EU-u?
English: Enurev Breezhaler is used for maintenance (regular) treatment.
Croatian: Enurev Breezhaler primjenjuje se kao (redovita) terapija održavanja.
English: The active substance in Enurev Breezhaler, glycopyrronium bromide, is a muscarinic receptor antagonist.
Croatian: Djelatna tvar lijeka Enurev Breezhaler, glikopironijev bromid, antagonist je muskarinskih receptora.
English: Enurev Breezhaler contains the active substance glycopyrronium bromide.
Croatian: Enurev Breezhaler sadrži djelatnu tvar glikopironijev bromid.
English: What are the risks associated with Enurev Breezhaler?
Croatian: Koji su rizici povezani s lijekom Enurev Breezhaler?
English: Enurev Breezhaler can only be obtained with a prescription.
Croatian: Lijek Enurev Breezhaler izdaje se samo na liječnički recept.
English: How does Enurev Breezhaler work?
Croatian: Kako djeluje Enurev Breezhaler?
English: For the full list of side effects and restrictions with Enurev Breezhaler, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja pri primjeni lijeka Enurev Breezhaler potražite u uputi o lijeku.
English: How is Enurev Breezhaler used?
Croatian: Kako se Enurev Breezhaler koristi?
English: What benefits of Enurev Breezhaler have been shown in studies?
Croatian: Koje su koristi od lijeka Enurev Breezhaler utvrđene u ispitivanjima?
English: Enurev Breezhaler was found to be more effective than placebo (a dummy treatment) at relieving symptoms of COPD in two main studies involving a total of 1,888 patients with COPD.
Croatian: U dvama glavnim ispitivanjima kojima je bilo obuhvaćeno ukupno 1 888 osoba oboljelih od KOPB-a utvrđeno je da je lijek Enurev Breezhaler učinkovitiji od placeba (prividnog liječenja) pri ublažavanju
English: • ringing in the ears
Croatian: • zvonjenje u ušima
English: For all indications
Croatian: Za sve indikacije
English: Please read the instructions carefully and follow them step by step.
Croatian: Pažljivo pročitajte upute te ih slijedite korak po korak.
English: Your doctor can provide advice.
Croatian: Liječnik Vam može dati savjet o tome.
English: For each injection you will need:
Croatian: Za svaku ćete injekciju trebati:
English: There is no need to rush your injection - 5 minutes gives you enough time.
Croatian: Ne morate žuriti s injiciranjem, 5 minuta je dovoljno vremena.
English: - If you have ever had an allergic reaction to latex.
Croatian: - ako ste ikad imali alergijsku reakciju na lateks.
English: Some cases have had a fatal outcome.
Croatian: Neki slučajevi imali su fatalni ishod.
English: However, the available clinical experience is too limited to,
Croatian: Međutim, dostupno kliničko iskustvo je previše ograničeno da bi se,
English: (d) Full Analysis Set
Croatian: (d) Set potpune analize
English: The value of these data to the evaluation of human risk may be limited.
Croatian: Vrijednost tih podataka u evaluaciji rizika u ljudi može biti ograničena.
English: - anakinra - abatacept
Croatian: - anakinru - abatacept
English: - Certain vaccinations may cause infections.
Croatian: - Određena cjepiva mogu uzrokovati infekcije.
English: • antibody directed against normal tissue
Croatian: • antitijela usmjerena protiv normalnog tkiva
English: This can take up to 15 seconds.
Croatian: To može trajati 15 sekundi.
English: Elderly patients (≥ 65 years old)
Croatian: Stariji bolesnici (≥ 65 godina starosti)
English: This will make sure you are giving the injection correctly.
Croatian: Tako ćete biti sigurni da pravilno primjenjujete injekciju.
English: Date of latest renewal: 16 May 2014
Croatian: Datum posljednje obnove odobrenja: 16 svibnja 2014.
English: • general physical health deterioration.
Croatian: • pogoršanje općeg fizičkog zdravlja.
English: The time left is shown on screen.
Croatian: Preostalo vrijeme prikazivat će se na zaslonu.
English: Paediatric population (< 18 years old)
Croatian: Pedijatrijska populacija (< 18 godina starosti)
English: Do not inject until the skin is dry.
Croatian: Nemojte injicirati dok koža nije suha.
English: • increased iron levels in the body
Croatian: • povišena razina željeza u tijelu
English: As this medecine is being given by your doctor or nurse, it is unlikely that you will be given too much.
Croatian: Budući da Vam ovaj lijek daje Vaš liječnik ili medicinska sestra, malo je vjerojatno da ćete dobiti previše lijeka.
English: • Find a comfortable position and sit down for your injection.
Croatian: • Pronađite udoban položaj i sjednite da biste primijenili injekciju.
English: • AutoClicks pre-filled pen is designed to work accurately and safely.
Croatian: • Napunjena brizgalica (AutoClicks) dizajnirana je tako da radi točno i sigurno.
English: The terminal elimination phase half-life (t1/2) was approximately 14 days for all doses tested.
Croatian: Terminalni poluvijek faze eliminacije (t1/2) bio je oko 14 dana za sve testirane doze.
English: - Try to relax as this will make the injection more comfortable.
Croatian: - Pokušajte se opustiti jer će Vam tada injekcija biti ugodnija.
English: •The needle safety device will not activate unless the entire dose is given.
Croatian: • Sigurnosni uređaj za iglu se neće aktivirati dok ne bude dana čitava doza.
English: It is very important that you tell your doctor if you have ever had tuberculosis, or if you have been in close contact with someone who has had tuberculosis.
Croatian: Vrlo je važno da svom liječniku kažete ako ste prije imali tuberkulozu ili ako ste bili u bliskom kontaktu s osobom koja je imala tuberkulozu.
English: Periodic skin examination is recommended, particularly for patients with risk factors for skin cancer.
Croatian: Preporučuje se periodički pregled kože, osobito za bolesnike s rizičnim faktorima za rak kože.
English: • after 16 weeks if you have plaque psoriasis.
Croatian: • nakon 16 tjedana ako imate plak psorijazu.
English: The C-EARLY trial met its primary and key secondary endpoints.
Croatian: C-EARLY ispitivanje ispunilo je svoje primarne i ključne sekundarne mjere ishoda.
English: - The medication contains 1ml of Cimzia and is not completely full - this is normal.
Croatian: - Uložak sadrži 1 ml Cimzije i nije posve pun - to je normalno.
English: Radiographic set with linear extrapolation.
Croatian: Radiografski set s linearnom ekstrapolacijom.
English: - Repeat the injection process starting at Step 2.
Croatian: - Ponovite postupak injiciranja od 2. koraka.
English: In rare occasions tuberculosis can develop during therapy even if you have received preventive treatment for tuberculosis.
Croatian: U rijetkim se slučajevima može razviti tuberkuloza tijekom terapije čak i ako ste dobili preventivno liječenje za tuberkulozu.
English: The CIMPACT study evaluated 559 patients.
Croatian: U ispitivanju CIMPACT procijenjeno je 559 bolesnika.
English: Cimzia has not been studied in these patient populations.
Croatian: Cimzia nije ispitivana u ovim populacijama bolesnika.
English: If the viewing window turns orange and you hear a second click this means the injection has been completed.
Croatian: Ako prozorčić za gledanje postane narančast i čujete drugi klik, to znači da je injiciranje dovršeno.
English: PASI 90 at Week 16 was a key secondary endpoint in all 3 studies.
Croatian: PASI 90 u 16. tjednu bila je ključna sekundarna mjera ishoda u sva 3 ispitivanja.
English: For details on therapeutic effects, see section 5.1.
Croatian: Za detalje o terapijskim učincima, vidjeti dio 5.1.
English: • feeling faint, including loss of consciousness
Croatian: • osjećaj nesvjestice, uključujući gubitak svijesti
English: You may see air bubbles - this is normal.
Croatian: Možda ćete vidjeti mjehuriće zraka - to je normalno.
English: • Take your thumb off the plunger head.
Croatian: • Maknite palac s glave klipa.
English: ASDAS-MI Week 52
Croatian: ASDAS-MI 52. tjedan
English: * Hodges-Lehmann point estimate of shift and 95% asymptotic (Moses) confidence interval.
Croatian: * Procjena pomaka prema Hodges-Lehmannu i 95%-tni asimptotski (Moses) interval pouzdanosti.
English: Hepatitis B virus (HBV) reactivation
Croatian: Reaktivacija virusa hepatitisa B (HBV)
English: Take care not to touch the needle or let the needle touch any surface.
Croatian: Pazite da pritom ne dotaknete iglu ili da igla ne dotakne neku površinu.
English: • multiple sclerosis*
Croatian: • multipla skleroza*
English: The results at week 34 are shown in Table 7.
Croatian: Rezultati u 34. tjednu prikazani su u tablici 7.
English: At this time, the injection will be complete.
Croatian: U tom trenutku, postupak injiciranja će biti dovršen.
English: • swollen face, hands, feet (angioedema)
Croatian: • otečeno lice, ruke, stopala (angioedem)
English: Frequency categories are defined as follows: Very common (≥ 1/10); Common (≥ 1/100 to < 1/10); Uncommon (≥ 1/1000 to < 1/100); Rare (≥ 1/10,000 to < 1/1000); Very rare (< 1/10,000), not known (cannot be estimated from the available data).
Croatian: Kategorije učestalosti definirane su kao: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ /10 000 i < 1/1000), vrlo rijetko (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: The maximum duration of the study was 204 weeks.
Croatian: Maksimalno trajanje istraživanja bilo je 204 tjedna.
English: • serious skin rashes.
Croatian: • ozbiljni kožni osipi.
English: A dose of 400 mg every 2 weeks can be considered in patients with insufficient response (see section 5.1).
Croatian: Doza od 400 mg svaka 2 tjedna može se razmotriti u bolesnika s nedovoljnim odgovorom (vidjeti dio 5.1).
English: This medicinal product is for single use only.
Croatian: Ovaj lijek je namijenjen samo za jednokratnu uporabu.
English: • muscle problems including increased muscle enzymes
Croatian: • problemi s mišićima uključujući povišene razine mišićnih enzima
English: RA-I (52 weeks)
Croatian: RA-I (52 tjedna)
English: Concomitant use with other biologics
Croatian: Istodobna primjena s drugim biološkim lijekovima
English: These data are reasonably in agreement with observed data.
Croatian: Ti su podaci u skladu sa zabilježenim podacima.
English: What Cimzia is and what it is used for
Croatian: Što je Cimzia i za što se koristi
English: All patients had a history of heavy smoking.
Croatian: Svi su bolesnici prije bili teški pušači.
English: • The needle will automatically move back into the empty pen.
Croatian: • Igla će se automatski vratiti natrag u praznu brizgalicu.
English: PGA clear or almost clearb)
Croatian: PGA čista ili gotovo čistab)
English: What Cimzia looks like and contents of the pack
Croatian: Kako Cimzia izgleda i sadržaj pakiranja
English: Check that the red “medication level indicator” is at the top of the cartridge.
Croatian: Provjerite nalazi li se crveni „indikator razine lijeka” u vrhu uloška.
English: Cimzia will be given to you by your doctor or nurse, in hospital or clinic.
Croatian: Cimziju će Vam dati Vaš liječnik ili medicinska sestra, u bolnici ili klinici.
English: CH-1630 Bulle Switzerland
Croatian: CH-1630 Bulle
English: Results are from the Randomized Set.
Croatian: Prikazani rezultati su iz randomiziranog skupa.
English: • fistula (tract from one organ to another) (any site)
Croatian: • fistula (kanal koji povezuje jedan organ s drugim) (različite lokacije)
English: OTHER SPECIAL WARNING(S), IF NECESSARY For healthcare professionals only.
Croatian: DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO Samo za zdravstvene radnike.
English: ASDAS-MI response was defined as an ASDAS reduction (improvement) ≥ 2.0 relative to baseline or as reaching the lowest possible score.
Croatian: ASDAS-MI odgovor definirao se kao smanjenje (poboljšanje) ASDAS-a ≥ 2,0 u odnosu na početno stanje ili dostizanje najnižeg mogućeg rezultata.
English: • ava then shows: - Your current dose and how often you need to inject it, - This is then followed by the message, “Inspect and then insert medication”.
Croatian: • Uređaj „ava” će zatim prikazati: - Vašu trenutnu dozu i koliko je često trebate injicirati, - Nakon toga će prikazati poruku „Pregledajte i umetnite uložak“.
English: - If you are at risk of or are a carrier of or have active HEPATITIS B VIRUS (HBV) infection, Cimzia may increase the risk of reactivation in people who carry this virus.
Croatian: - ako imate rizik ili ste nosilac ili imate aktivnu infekciju VIRUSOM HEPATITISA B (HBV), Cimzia može povećati rizik reaktivacije u ljudi koji su nosioci tog virusa.
English: The injection begins when a first “click” is heard and the orange band at the bottom of the pre-filled pen disappears.
Croatian: Injiciranje započinje kad čujete prvi “klik”, a narančasta vrpca na dnu napunjene brizgalice nestane.
English: Because the elimination of certolizumab pegol may take up to 5 months, monitoring should be continued throughout this period (see section 4.3).
Croatian: Budući da eliminacija certolizumabpegola može trajati i do 5 mjeseci, praćenje treba nastaviti i tijekom tog razdoblja (vidjeti dio 4.3).
English: Responses were maintained through Weeks 52 (RA-I) and 24 (RA-II).
Croatian: Odgovori su održavani kroz 52 tjedna (RA-I), odnosno 24 tjedna (RA-II).
English: Some of these events have been fatal.
Croatian: Neki od tih slučajeva bili su s fatalnim ishodom.
English: Response rates and p-values based on a logistic regression model.
Croatian: Stope odgovora i p-vrijednosti na osnovi modela logističke regresije.
English: If you received Cimzia while you were pregnant, your baby may be at higher risk for getting such an infection for up to approximately five months after the last dose you received during pregnancy.
Croatian: Ako ste primali Cimziju dok ste bili trudni Vaše dijete može imati povišeni rizik od dobivanja takve infekcije do otprilike pet mjeseci od zadnje doze koju ste primili u trudnoći.
English: This rare type of T-cell lymphoma has a very aggressive disease course and is usually fatal.
Croatian: Ovaj rijetki tip limfoma T-stanica ima vrlo agresivan tijek bolesti i često je fatalan.
English: Contact with natural rubber latex may cause severe allergic reactions in individuals sensitive to latex.
Croatian: Kontakt s lateksom prirodne gume može izazvati teške alergijske reakcije u osoba koje su osjetljive na lateks.
English: Do not attempt to self-inject until you are sure that you understand how to prepare and give the injection.
Croatian: Nemojte si pokušavati injicirati lijek dok niste sigurni da razumijete kako pripremiti i dati injekciju.
English: 87.7% of patients received concomitant NSAIDs.
Croatian: 87,7% bolesnika je istodobno primalo NSAIL-e.
English: Study AS0006, performed in subjects without radiographic signs of inflammation in the SI joints, confirmed the effect previously demonstrated in this subgroup in the AS001 study.
Croatian: Ispitivanje AS0006, provedeno na ispitanicima bez radiografskih znakova upale sakroilijačnih zglobova, potvrdilo je učinak prethodno dokazan u ovoj podskupini u ispitivanju AS001.
English: RA-II (24 weeks)
Croatian: RA-II (24 tjedna)
English: Patients had ≥ 3 swollen and tender joints and increased acute phase reactants.
Croatian: Bolesnici su imali ≥ 3 otečenih i bolnih zglobova i povišene reaktante akutne faze.
English: Information screen
Croatian: Zaslon s informacijama
English: The maximum duration of the study was 216 weeks.
Croatian: Maksimalno trajanje istraživanja bilo je 216 tjedana.