FrancophonIA/ELRC3.0 huggingface dataset:
English: Olumiant 2 mg film-coated tablets Olumiant 4 mg film-coated tablets
Croatian: Olumiant 2 mg filmom obložene tablete Olumiant 4 mg filmom obložene tablete
English: The recommended dose is 2 mg once daily in patients with creatinine clearance between 30 and 60 mL/min.
Croatian: U bolesnika kojima je klirens kreatinina između 30 i 60 ml/min, preporučena doza iznosi 2 mg jedanput na dan.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTONS FOR 2 MG FILM-COATED TABLETS
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA ZA FILMOM OBLOŽENE TABLETE OD 2 MG
English: A dose relationship was observed with CPK elevations ≥ 5 x ULN of normal reported in 1.5 %, 0.8 % and 0.6 % of patients at 16 weeks in the 4 mg, 2 mg and placebo groups, respectively.
Croatian: Primijećena je povezanost s dozom, pri čemu je porast vrijednosti CPK-a ≥ 5 x GGN tijekom razdoblja do 16 tjedana prijavljen u 1,5% bolesnika koji su primali dozu od 4 mg, 0,8% onih liječenih dozom od 2 mg te 0,6% bolesnika koji su primali placebo.
English: In studies which included both doses, infections were reported in 31.9%, 28.8% and 24.1% of patients up to 16 weeks in the 4 mg, 2 mg and placebo groups, respectively.
Croatian: 31,9% bolesnika koji su primali dozu od 4 mg, 28,8% onih liječenih dozom od 2 mg te 24,1% bolesnika koji su primali placebo.
English: In clinical pharmacology studies there were no clinically meaningful effects on exposure when baricitinib was coadministered with digoxin (Pgp substrate) or methotrexate (substrate of several transporters).
Croatian: U ispitivanjima kliničke farmakologije nisu zabilježeni klinički značajni učinci na izloženost kada se baricitinib primjenjivao istodobno s digoksinom
English: Hepatic Impairment
Croatian: Zloćudna bolest
English: Week 24 0.61 0.39 0.29*
Croatian: 24. tjedan 0,61 0,39 0,29* 52. tjedan 1,02 0,80 0,40**
English: RA-BEACON TNF-IR patients
Croatian: RA-BEACON Bolesnici s nedovoljno dobrim odgovorom na inhibitor TNF-a
English: • At week 48: 57/73 (78 %) continuing 4 mg vs. 51/86 (59 %) reduced to 2 mg (p ≤ 0.05)
Croatian: • U 48. tjednu: 57/73 (78%) bolesnika koji su nastavili liječenje dozom od 4 mg naspram
English: NAME OF THE MEDICINAL PRODUCT Olumiant 4 mg tablets baricitinib
Croatian: NAZIV LIJEKA Olumiant 4 mg tablete baricitinib
English: NAME OF THE MEDICINAL PRODUCT Olumiant 2 mg tablets baricitinib
Croatian: NAZIV LIJEKA Olumiant 2 mg tablete baricitinib
English: On background cDMARDs5
Croatian: • Placebo kDMARD-ovi kao osnovna terapija5
English: The proportion of patients with no radiographic progression (mTSS change ≤ 0) was significantly higher with Olumiant 4 mg compared to placebo at weeks 24 and 52.
Croatian: rezultata za ≤ 0) u 24. i 52. tjednu bio je značajno veći uz Olumiant u dozi od 4 mg nego uz placebo.
English: In patients with rheumatoid arthritis, decreases in serum C-reactive protein (CRP) were observed as early as 1 week after starting treatment with Olumiant and were maintained throughout dosing.
Croatian: U bolesnika s reumatoidnim artritisom, pad serumske vrijednosti C-reaktivnog proteina (CRP)
English: Screening for viral hepatitis should be performed in accordance with clinical guidelines before starting therapy with Olumiant.
Croatian: Prije početka liječenja lijekom Olumiant potrebno je provesti probir na virusni hepatitis u skladu s kliničkim smjernicama.
English: Metabolism and nutrition disorders
Croatian: Poremećaji metabolizma i prehrane hiperkolesterolemijac hipertrigliceridemijac
English: Week 12 59 % 79 %*** 77 %*** 40 % 70 %***† 61 %*** 39 % 66 %*** 62 %*** 27 % 49 %*** 55 %*** Week 24 62 % 77 %** 78 %*** 37 % 74 %***† 66 %*** 42 % 61 %*** 65 %*** 27 % 45 %*** 46 %*** Week 52 56 % 73 %*** 73 %***
Croatian: 12. tjedan 59% 79%*** 77%*** 40% 70%***† 61%*** 39% 66%*** 62%*** 27% 49%*** 55%*** 24. tjedan 62% 77%** 78%*** 37% 74%***† 66%*** 42% 61%*** 65%*** 27% 45%*** 46%*** 52. tjedan 56% 73%*** 73%***
English: Olumiant is for oral use.
Croatian: Olumiant se primjenjuje kroz usta.
English: What Olumiant looks like and contents of the pack Olumiant 2 mg film-coated tablets are light pink, oblong tablets, with “Lilly” on one side and “2” on the other.
Croatian: Olumiant 2 mg filmom obložene tablete su svjetloružičaste ovalne tablete s oznakom „Lilly” s jedne strane i '2' s druge strane.
English: Week 12 30 % 47 %*** 56 %*** 14 % 44 %***†† 35 %*** 17 % 36 %*** 39 %*** 9 % 24 %*** 32 %*** Week 24 38 % 57 %*** 60 %*** 19 % 52 %*** 48 %*** 24 % 46 %*** 52 %*** 11 % 20 %* 33 %*** Week 52 38 % 57 %*** 63 %***
Croatian: 12. tjedan 30% 47%*** 56%*** 14% 44%***†† 35%*** 17% 36%*** 39%*** 9% 24%*** 32%*** 24. tjedan 38% 57%*** 60%*** 19% 52%*** 48%*** 24% 46%*** 52%*** 11% 20%* 33%*** 52. tjedan 38% 57%*** 63%***
English: Patients should be screened for tuberculosis (TB) before starting Olumiant therapy.
Croatian: Prije početka liječenja lijekom Olumiant u bolesnika treba provesti probir na tuberkulozu (TBC).
English: • At week 24: 163/191 (85 %) continuing 4 mg vs. 144/189 (76 %) reduced to 2 mg (p ≤ 0.05)
Croatian: 144/189 (76%) bolesnika kojima je doza smanjena na 2 mg (p ≤ 0,05)
English: Possible side effects
Croatian: Ti učinci mogu
English: The proportion of patients achieving a clinically significant improvement (HAQ-DI ≥ 0.30) was also higher with Olumiant compared to placebo or MTX at week 12 (Table 4).
Croatian: Udio bolesnika koji su ostvarili klinički značajno poboljšanje (HAQ-DI ≥ 0,30) u 12. tjednu također je bio veći uz
English: The pattern and incidence of increases in platelet counts remained stable at a higher value than baseline over time including in the long term extension study.
Croatian: Obrazac i incidencija rasta broja trombocita bili su stabilni tijekom vremena i zadržavali su se na vrijednosti višoj od početne, uključujući i dugoročni produžetak ispitivanja.
English: In clinical pharmacology studies, coadministration of baricitinib with ketoconazole (strong CYP3A inhibitor) resulted in no clinically meaningful effect on the PK of baricitinib.
Croatian: Istodobna primjena baricitiniba i ketokonazola (snažnog inhibitora CYP3A)
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS CALENDAR BLISTERS NON-PERFORATED FOR 4 MG FILM-COATED TABLETS
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP NEPERFORIRANI KALENDARSKI BLISTERI ZA FILMOM OBLOŽENE TABLETE OD 4 MG
English: Deep Vein Thrombosis
Croatian: Krvožilni poremećaji duboka venska tromboza
English: Swelling of the face, Urticaria
Croatian: Poremećaji imunološkog sustava oticanje lica urtikarija
English: Radiographic Changes
Croatian: Tablica 5. Radiografske promjene Ispitivanje
English: Olumiant 4 mg film-coated tablets
Croatian: Olumiant 4 mg filmom obložene tablete
English: In controlled studies, for up to 16 weeks, increases in platelet counts above 600 x 109 cells/L occurred in 2.0 % of patients treated with Olumiant 4 mg and 1.1 % of patients treated with placebo.
Croatian: U kontroliranim su ispitivanjima porasti broja trombocita iznad 600 x 109 stanica/l tijekom razdoblja do 16 tjedana zabilježeni u 2,0% bolesnika liječenih lijekom Olumiant u dozi od 4 mg, u usporedbi s
English: In RA-BEAM, treatment with Olumiant resulted in significant improvement in patient and physician global assessments, HAQ-DI, pain assessment and CRP at Weeks 12, 24 and 52 compared to adalimumab.
Croatian: HAQ-DI rezultata, ocjene boli i razine CRP-a u 12., 24. i 52. tjednu u odnosu na adalimumab.
English: Information for Patients about OLUMIANT® (baricitinib)
Croatian: Informacije o lijeku OLUMIANT® (baricitinib) za bolesnike
English: Upper respiratory tract infectionsa
Croatian: Stopa ozbiljnih infekcija uz
English: Hepatic transaminase elevations
Croatian: Povišenja vrijednosti jetrenih transaminaza
English: Week 12 33 % 55 %*** 60 %*** 17 % 45 %***†† 35 %*** 13 % 33 %*** 34 %*** 8 % 20 %** 28 %*** Week 24 43 % 60 %** 63 %*** 19 % 51 %*** 45 %*** 21 % 41 %*** 44 %*** 13 % 23 %* 29 %*** Week 52 38 % 57 %*** 62 %***
Croatian: 12. tjedan 33% 55%*** 60%*** 17% 45%***†† 35%*** 13% 33%*** 34%*** 8% 20%** 28%*** 24. tjedan 43% 60%** 63%*** 19% 51%*** 45%*** 21% 41%*** 44%*** 13% 23%* 29%*** 52. tjedan 38% 57%*** 62%***
English: • Olumiant 2 mg QD
Croatian: • Olumiant 2 mg jedanput na dan
English: • A painful skin rash with blisters.
Croatian: - bolan kožni osip praćen mjehurićima i vrućicom
English: Week 12 6 % 14 %* 20 %*** 2 % 8 %*** 7 %*** 1 % 9 %*** 9 %*** 2 % 2 % 5 % Week 24 10 % 22 %** 23 %*** 3 % 16 %*** 14 %*** 4 % 17 %*** 15 %*** 2 % 5 % 9 %** Week 52 13 % 25 %** 30 %***
Croatian: 24. tjedan 10% 22%** 23%*** 3% 16%*** 14%*** 4% 17%*** 15%*** 2% 5% 9%** 52. tjedan 13% 25%** 30%***
English: Olumiant 2 mg film-coated tablets
Croatian: Olumiant 2 mg filmom obložene tablete
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS CALENDAR BLISTERS NON-PERFORATED FOR 2 MG FILM-COATED TABLETS
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP NEPERFORIRANI KALENDARSKI BLISTERI ZA FILMOM OBLOŽENE TABLETE OD 2 MG
English: Respiratory, thoracic, mediastinal disorders
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja plućna embolija
English: In 43.1 % (95 % CI: 34.0 %, 52.8 %) of the patients, a satisfactory IgG immune response to tetanus vaccination was achieved.
Croatian: Zadovoljavajući imunološki odgovor IgG-a na cijepljenje protiv tetanusa postignut je u 43,1% (95% CI: 34,0%; 52,8%) bolesnika.
English: B. PACKAGE LEAFLET
Croatian: Tablica 2. Nuspojave
English: In controlled studies, for up to 16 weeks, decreases in neutrophil counts below 1 x 109 cells/L occurred in 0.3 % of patients treated with Olumiant compared to 0 % of patients treated with placebo.
Croatian: 16 tjedana zabilježen u 0,3% bolesnika liječenih lijekom Olumiant, u usporedbi s 0% onih koji su primali placebo.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTERS PERFORATED UNIT DOSE FOR 2 MG FILM-COATED TABLETS
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP PERFORIRANI BLISTERI DJELJIVI NA POJEDINAČNE DOZE ZA FILMOM OBLOŽENE TABLETE OD 2 MG
English: Olumiant 4 mg vs. 2 mg
Croatian: Olumiant 4 mg u odnosu na 2 mg
English: • croscarmellose sodium
Croatian: • karmelozanatrij, umrežena
English: Week 12 16 % 31 %*** 34 %*** 5 % 19 %***† 13 %*** 3 % 18 %*** 18 %*** 2 % 13 %*** 11 %** Week 24 21 % 42 %*** 40 %*** 8 % 30 %***† 22 %*** 8 % 25 %*** 24 %*** 3 % 13 %*** 17 %*** Week 52 25 % 42 %*** 46 %***
Croatian: 12. tjedan 16% 31%*** 34%*** 5% 19%***† 13%*** 3% 18%*** 18%*** 2% 13%*** 11%** 24. tjedan 21% 42%*** 40%*** 8% 30%***† 22%*** 8% 25%*** 24%*** 3% 13%*** 17%*** 52. tjedan 25% 42%*** 46%***
English: Week 12 15 % 21 % 34 %*** 7 % 24 %*** 21 %*** 7 % 21 %*** 22 %*** 4 % 13 %** 12 %** Week 24 23 % 36 %** 39 %*** 10 % 32 %*** 34 %*** 10 % 29 %*** 32 %*** 7 % 11 % 17 %** Week 52 27 % 36 % 45 %***
Croatian: 12. tjedan 15% 21% 34%*** 7% 24%*** 21%*** 7% 21%*** 22%*** 4% 13%** 12%** 24. tjedan 23% 36%** 39%*** 10% 32%*** 34%*** 10% 29%*** 32%*** 7% 11% 17%** 52. tjedan 27% 36% 45%***
English: Hepatobiliary disorders
Croatian: Odstupanja hematoloških vrijednosti
English: • Olumiant 4 mg QD
Croatian: • Olumiant 4 mg jedanput na dan
English: • Primary endpoint: ACR20 at week 12
Croatian: • Primarna mjera ishoda: ACR20
English: Absolute Lymphocyte Count (ALC)
Croatian: Apsolutni broj limfocita (ABL)
English: Week 12 7 % 14 %* 19 %*** 2 % 8 %*** 7 %** 2 % 10 %*** 9 %*** 2 % 3 % 6 % Week 24 11 % 21 %** 22 %** 4 % 16 %*** 12 %*** 4 % 15 %*** 15 %*** 3 % 5 % 9 %* Week 52 16 % 25 %* 28 %**
Croatian: 24. tjedan 11% 21%** 22%** 4% 16%*** 12%*** 4% 15%*** 15%*** 3% 5% 9%* 52. tjedan 16% 25%* 28%**
English: RA-BEAM MTX-IR patients
Croatian: Bolesnici prethodno neliječeni MTX-om
English: Joint Space Narrowing Score, mean change from baseline:
Croatian: Rezultat za suženje zglobnog prostora, srednja vrijednost promjene od početne vrijednosti:
English: Lipid elevations
Croatian: Porast vrijednosti lipida
English: Lymphocytes
Croatian: Trombocitoza
English: The presence of at least 6 tender and 6 swollen joints was required at baseline.
Croatian: Bolesnici su na početku ispitivanja morali imati najmanje 6 osjetljivih i
English: Malignancy
Croatian: - mučnina
English: Fri.
Croatian: Limfociti
English: Ofev is available as capsules (100 and 150 mg).
Croatian: Ofev je dostupan kao kapsule (100 i 150 mg).
English: This summary was last updated in 01-2015.
Croatian: Ovaj sažetak je posljednji put ažuriran u 01.2015.
English: Other information about Ofev
Croatian: Ostale informacije o lijeku Ofev
English: The European Commission granted a marketing authorisation valid throughout the European Union for Ofev on 15 January 2015.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Ofev na snazi u Europskoj uniji od 15. siječnja 2015.
English: The recommended dose is 150 mg taken twice a day with food, approximately 12 hours apart.
Croatian: Preporučena doza iznosi 150 mg dva puta na dan s hranom, u razmaku od 12 sati.
English: What measures are being taken to ensure the safe and effective use of Ofev?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Ofev?
English: The average FVC of patients before treatment was between 2600 and 2700 millilitre (ml).
Croatian: Prosječni FVC bolesnika prije terapije iznosio je između 2600 i 2700 mililitara (ml).
English: In patients who do not tolerate this dose, the dose should be reduced to 100 mg twice a day or treatment should be interrupted.
Croatian: U bolesnika koji ne podnose ovu dozu, dozu treba smanjiti na 100 mg dva puta na dan ili terapiju treba prekinuti.
English: It is not intended to provide practical advice on how to use Ofev.
Croatian: Svrha sažetka nije davati praktične savjete o korištenju lijeka Ofev.
English: Ofev must not be used in patients who are hypersensitive (allergic) to nintedanib, peanut or soya, or any of the other ingredients.
Croatian: Ofev se ne smije koristiti u bolesnika koji su preosjetljivi (alergični) na nintedanib, kikiriki ili soju, ili bilo koji drugi sastojak.
English: What is Ofev and what is it used for?
Croatian: Što je Ofev i za što se koristi?
English: The most common side effects with Ofev (which may affect more than 1 in 10 people) are diarrhoea, nausea (feeling sick), abdominal pain (stomach ache) and raised levels of liver enzymes in the blood (a sign of liver problems); vomiting, decreased appetite and weight loss are also common.
Croatian: Najčešće nuspojave lijeka Ofev (mogu se javiti u više od 1 na 10 osoba) su proljev, mučnina (osjećaj slabosti), abdominalna bol (bol u trbuhu) i povišene razine jetrenih enzima u krvi (znak problema s jetrom); također su uobičajeni povraćanje, smanjenje apetita i gubitak težine.
English: Why is Ofev approved?
Croatian: Zašto je Ofev odobren?
English: Because the number of patients with IPF is low, the disease is considered ‘rare', and Ofev was designated an ‘orphan medicine' (a medicine used in rare diseases) on 26 April 2013.
Croatian: Budući da je broj bolesnika s IPF-om nizak, bolest se smatra „rijetkom” te se Ofev označava kao lijek za liječenje rijetkih bolesti od 26. travnja 2013.
English: This is a summary of the European public assessment report (EPAR) for Ofev.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Ofev.
English: Ofev has been compared with placebo (a dummy treatment) in two main studies involving a total of 1,066 patients with IPF.
Croatian: Ofev je uspoređen s placebom (lažnim liječenjem) u dva glavna ispitivanja koja su obuhvatila 1066 bolesnika s IPF-om.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Ofev's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji odlučilo je da koristi od lijeka Ofev nadmašuju s njim povezane rizike te je preporučilo njegovo odobrenje za korištenje u Europskoj uniji.
English: These enzymes are present in certain receptors (such as VEGF, FGF and PDGF receptors) in cells in the lungs, where they activate several processes involved in the generation of fibrous tissue seen in IPF.
Croatian: Ovi se enzimi nalaze u određenim receptorima (poput receptora VEGF, FGF i PDGF) na površini stanica pluća, gdje aktiviraju nekoliko postupaka uključenih u generiranje fibroznog tkiva uočeno u IPF-u.
English: A risk management plan has been developed to ensure that Ofev is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Ofev.
English: FVC is the maximum amount of air the patient can breathe out forcefully after taking in a deep breath and this decreases as the condition gets worse.
Croatian: FVC je maksimalna količina zraka koju bolesnik može forsirano izdahnuti nakon što je duboko udahnuo, a ovo se smanjuje kako se stanje pogoršava.
English: In the second study, the average decrease was 114 ml for Ofev compared with 207 ml for placebo.
Croatian: U drugom ispitivanju, prosječno smanjenje iznosilo je 114 ml za Ofev u usporedbi sa 207 ml za placebo.
English: Ofev can only be obtained with a prescription, and treatment should be started by a doctor experienced in the diagnosis and treatment of IPF.
Croatian: Ofev se izdaje samo na liječnički recept, a liječenje mora započeti liječnik s iskustvom u dijagnosticiranju i liječenju IPF-a.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Ofev can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Croatian: Sažetak mišljenja Odbora za lijekove za rijetke bolesti za lijek Ofev dostupan je na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: The full EPAR and risk management plan summary for Ofev can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR kao i sažetak plana upravljanja rizikom za lijek Ofev nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: In both studies, the main measure of effectiveness was the decline in the functioning of the patients' lungs over the course of 1 year of treatment, measured by their forced vital capacity (FVC).
Croatian: U oba ispitivanja, glavna mjera djelotvornosti bilo je smanjenje u funkciji pluća bolesnika tijekom razdoblja 1 godine liječenja, izmjereno njihovim forsiranim vitalnim kapacitetom (FVC).
English: What are the risks associated with Ofev?
Croatian: Koji su rizici povezani s lijekom Ofev?
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Ofev, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi o lijeku za lijek Ofev nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: By blocking these enzymes, nintedanib helps to reduce the formation of fibrous tissue in the lungs, thereby helping to prevent the symptoms of IPF from getting worse.
Croatian: Inhibirajući ove enzime, nintedanib pomaže u smanjivanju formiranja fibroznog tkiva u plućima, te tako pomaže u sprječavanju pogoršavanja IPF-a.
English: A further analysis of the results of the 2 main studies, which took into account that some patients stopped treatment, confirmed the benefits of Ofev over placebo, although the difference in FVC between the two was less pronounced.
Croatian: Daljnja analiza rezultata 2 glavna ispitivanja, koja je uzela u obzir da su pojedini bolesnici prekinuli terapiju, potvrdila je koristi lijeka Ofev u odnosu na placebo, iako je razlika u FVC-u između oboje bila manje izražena.
English: Regarding safety, the side effects associated with Ofev were considered manageable with dose interruptions or reductions.
Croatian: Vezano uz sigurnost, nuspojave povezane s lijekom Ofev smatraju se upravljivima s prekidima ili smanjenjima u dozi.
English: The active substance in Ofev, nintedanib, blocks the activity of some enzymes known as tyrosine kinases.
Croatian: Djelatna tvar lijeka Ofev, nintedanib, inhibira djelovanje pojedinih enzima poznatih pod nazivom tirozin kinaza.
English: Ofev is a medicine used to treat adults with idiopathic pulmonary fibrosis (IPF).
Croatian: Ofev je lijek za liječenje idiopatske plućne fibroze (IPF) u odraslih osoba.
English: The CHMP considered that Ofev has been shown to be effective at slowing down the worsening of lung function in patients with IPF.
Croatian: CHMP je zaključio kako je dokazana djelotvornost lijeka Ofev za usporavanje pogoršanja funkcije pluća u bolesnika s IPF-om.
English: For more information about treatment with Ofev, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Ofev pročitajte u uputi o lijeku (također dio EPAR-a), ili se obratite svom liječniku ili ljekarniku.
English: In the first study, the average decrease in FVC over 1 year was 115 ml in patients taking Ofev compared with a decrease of 240 ml in patients taking placebo.
Croatian: U prvom ispitivanju, prosječno smanjenje u FVC-u tijekom 1 godine iznosilo je 115 ml u bolesnika koji su uzimali Ofev u usporedbi sa smanjenjem od 240 ml u bolesnika koji su uzimali placebo.
English: Ofev contains the active substance nintedanib.
Croatian: Ofev sadrži djelatnu tvar nintedanib.
English: In both studies, patients taking Ofev had a smaller decline in FVC than patients taking placebo, meaning that Ofev slowed down the worsening of the condition.
Croatian: U oba ispitivanja, bolesnici koji su uzimali lijek Ofev imali su manje smanjenje u vrijednostima FVC-a u odnosu na bolesnike koji su uzimali placebo, što znači da je Ofev usporio pogoršavanje stanja.
English: What benefits of Ofev have been shown in studies?
Croatian: Koje su koristi lijeka Ofev utvrđene u ispitivanjima?
English: How does Ofev work?
Croatian: Kako djeluje Ofev?
English: IPF is a long-term disease in which hard fibrous tissue continuously forms in the lungs, causing persistent cough and severe shortness of breath.
Croatian: IPF je dugoročna bolest uslijed koje se tvrdo fibrozno tkivo kontinuirano formira u plućima, uzrokujući kontinuirani kašalj i ozbiljnu zadihanost. „Idiopatski“ označava da uzrok bolesti nije poznat.
English: For practical information about using Ofev, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju lijeka Ofev pročitajte u uputi o lijeku, odnosno obratite se svom liječniku ili ljekarniku.
English: How is Ofev used?
Croatian: Kako se Ofev koristi?
English: For the full list of all side effects reported with Ofev, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Ofev potražite u uputi o lijeku.
English: It may be given with or without food.
Croatian: Može se uzimati s hranom ili bez nje.
English: See section 4. .
Croatian: Pogledajte dio 4.
English: The absolute risk for cardiovascular malformation was increased from less than 1%, up to approximately 1.5%.
Croatian: Apsolutni rizik od kardiovaskularnih malformacija povećan je s manje od 1% na do oko 1,5%.
English: • If you are in your last trimester of pregnancy
Croatian: • ako ste u zadnjem tromjesečju trudnoće.
English: • breathing difficulties sometimes associated with cough
Croatian: • teškoće pri disanju, ponekad povezane s kašljem
English: The risk is believed to increase with dose and duration of therapy.
Croatian: Vjeruje se da se taj rizik povećava s dozom i trajanjem liječenja.
English: • worsening of food allergies.
Croatian: • pogoršanje alergije na hranu.
English: Pliva Croatia Ltd Prilaz baruna Filipovica 25 10 000 Zagreb Croatia
Croatian: Pliva Croatia Ltd Prilaz baruna Filipovica 25 10 000 Zagreb Hrvatska
English: The tablets have a length of 14.0 mm and a width of 6.8 mm.
Croatian: Tablete su dugačke 14,0 mm i široke 6,8 mm.
English: • Adults and elderly population
Croatian: • Odrasli i starija populacija