FrancophonIA/ELRC3.0 huggingface dataset:
English: For patients with tumour of adenocarcinoma histology, 15.8 % had disease stage < IIIB/IV, 15.2 %, had disease stage IIIB and 69.0 % had disease stage IV. 5.8 % of the adenocarcinoma patients entered the trial with locally recurrent disease stage as had been evaluated at baseline.
Croatian: U bolesnika s tumorom adenokarcinomske histologije, 15,8 % je imalo stadij bolesti < IIIB/IV, 15,2 % je imalo stadij bolesti IIIB i 69,0 % je imalo stadij bolesti IV.
English: After treatment interruption and recovery of transaminase-values to ≤ 2.5 x ULN in conjunction with bilirubin to normal, dose reduction from 200 mg twice daily to 150 mg twice daily and - if a 2
Croatian: Nakon prekida liječenja i povrata vrijednosti transaminaza na ≤ 2,5 x GGN zajedno s normalizacijom nalaza bilirubina, smanjenje doze s 200 mg dvaput dnevno na 150 mg dvaput dnevno i, ako se 2. smanjenje doze smatra neophodnim, sa 150 mg dvaput dnevno na 100 mg dvaput dnevno.
English: Unless there is an alternative cause established, Vargatef should be permanently discontinued (see section 4.2).
Croatian: Ukoliko nije utvrđen drugi uzrok, primjena Vargatefa se mora trajno prekinuti (vidjeti dio 4.2).
English: Unless there is an alternative cause established, Vargatef should be permanently discontinued (see also section 4.4).
Croatian: Ukoliko nije utvrđen drugi uzrok, liječenje Vargatefom se mora trajno prekinuti (vidjeti također dio 4.4).
English: PHARMACEUTICAL FORM AND CONTENTS 60 x 1 soft capsule.
Croatian: OBLIK I SADRŽAJ 60 x 1 meka kapsula.
English: Number of Deaths, n (%) Median OS [months] HR (95 % CI)
Croatian: Medijan OS [mjeseci] HR (95 % CI)
English: Drug-induced liver injury
Croatian: oštećenje jetre uzrokovano lijekovima
English: In addition, 2 patients had an overdose of maximum 600 mg twice daily (b.i.d.)
Croatian: Pored toga, kod 2 bolesnika je došlo do predoziranja od maksimalno 600 mg dvaput dnevno u trajanju do osam dana.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON (150 mg)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA (150 mg)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAPPER (100 mg - multipack of 120 capsules - contains Blue Box)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA (100 mg - višestruko pakiranje sa 120 kapsula - sadrži plavi okvir)
English: In order to investigate suitable bio-/tumour markers (including VEGF) to allow identification and selection of a more targeted population of patients most likely to benefit from the treatment of nintedanib, the Applicant will conduct and submit results from a Biomarkers research programme including: 1.
Croatian: Da bi se ispitali prikladni bio-/tumorski markeri (uključujući VEGF) kako bi se omogućila identifikacija i odabir više ciljane populacije bolesnika koja će najvjerojatnije imati koristi od liječenja nintedanibom, podnositelj zahtjeva će provesti istraživački program za biomarkere i predati rezultate uključujući sljedeće: 1. Prikupljeni uzorci krvi iz studija LUME-Lung 1 i LUME-Lung 2 bit će procijenjeni na genetičku varijabilnost klica u angiogenim čimbenicima, uključujući VEGF ili njegove niže receptore.
English: This daily dose should be split into two doses of one capsule about 12 hours apart, for example one capsule in the morning and one capsule in the evening.
Croatian: Ova dnevna doza se mora podijeliti na dvije doze od po jednu kapsulu u razmaku od približno 12 sati u primjerice jednu kapsulu ujutro i jednu kapsulu navečer.
English: Vomiting ≥ grade 2
Croatian: Povraćanje ≥ stupnja 2 I/ILI
English: Mucositis (including stomatitis), Rash, Alopecia
Croatian: Poremećaji kože i potkožnog tkiva mukozitis (uključujući stomatitis), osip, alopecija pruritus
English: PHARMACEUTICAL FORM AND CONTENTS 60 x 1 soft capsule
Croatian: OBLIK I SADRŽAJ 60 x 1 meka kapsula
English: Do not use this medicine after the expiry date which is stated on the carton and blisters.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisterima iza oznake „EXP“.
English: Frequent monitoring of complete blood counts should be performed at the beginning of each treatment cycle and around the nadir for patients receiving treatment with nintedanib in combination with docetaxel, and as clinically indicated after the administration of the last combination cycle.
Croatian: Učestalo praćenje kompletne krvne slike treba izvoditi na početku svakog ciklusa liječenja, oko najniže točke pada krvne slike tijekom kombiniranog liječenja nintedanibom i docetakselom, te prema kliničkoj indikaciji nakon primjene zadnjeg ciklusa kombiniranog liječenja.
English: Not all pack-sizes of Vargatef 100 mg soft capsules may be marketed.
Croatian: Na tržištu se ne moraju nalaziti sve veličine pakiranja Vargatef 100 mg mekih kapsula.
English: Increased liver enzyme values (alanine aminotransferase, aspartate aminotransferase, blood alkaline phosphatase) in the blood as seen from blood tests Hair loss (alopecia)
Croatian: - Porast vrijednosti jetrenih enzima (alanin aminotransferaze, aspartat aminotransferaze, alkalne fosfataze) u krvi vidljiv iz krvnih pretraga.
English: Do not use this medicine after the expiry date which is stated on the carton, wrapper and blisters.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji, omotu i blisterima iza oznake „EXP“.
English: Pharmacokinetic/pharmacodynamic relationship(s) In exploratory pharmacokinetic adverse event analyses, higher exposure to nintedanib tended to be associated with liver enzyme elevations, but not with gastrointestinal adverse events.
Croatian: U istraživačkim farmakokinetičkim analizama štetnih događaja, veća izloženost nintedanibu bila je povezana s porastom vrijednosti jetrenih enzima, ali nije bila povezana s gastrointestinalnim štetnim događajima.
English: One box contains 60 capsules (6 aluminium blisters of 10 capsules each).
Croatian: Jedna kutija sadrži 60 kapsula (6 aluminijskih blistera od kojih svaki sadrži 10 kapsula).
English: Perforation
Croatian: Perforacija
English: The safety, efficacy and pharmacokinetics of nintedanib have not been investigated in patients with severe hepatic impairment (Child Pugh C).
Croatian: Sigurnost, djelotvornost i farmakokinetika nintedaniba nisu ispitani u bolesnika s teškim oštećenjem funkcije jetre (Child Pugh C).
English: There are no human or animal data on potential effects of nintedanib on female fertility available.
Croatian: Nema podataka o potencijalnim učincima nintedaniba na žensku plodnost u ljudi ili životinja.
English: If co-administered with nintedanib, potent P-gp inhibitors (e.g. ketoconazole or erythromycin) may increase exposure to nintedanib.
Croatian: P-gp-a (npr. ketokonazol ili eritromicin) mogu povećati izloženost nintedanibu.
English: One box containing 120 capsules (12 aluminium blisters of 10 capsules each).
Croatian: - Jedna kutija koja sadrži 120 kapsula (12 aluminijskih blistera od kojih svaki sadrži 10 kapsula).
English: Cases of gastrointestinal perforations, some of which were fatal, have been reported in the post-marketing period.
Croatian: U razdoblju nakon stavljanja lijeka u promet prijavljeni su slučajevi gastrointestinalnih perforacija, od kojih su neki imali smrtni ishod.
English: In clinical trials the frequency was not increased in patients treated with nintedanib plus docetaxel as compared to placebo plus docetaxel.
Croatian: U kliničkim ispitivanjima, učestalost se nije povećala u bolesnika liječenih kombinacijom nintedaniba i docetaksela u usporedbi s liječenjem kombinacijom placebo i docetaksel.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON (100 mg)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA (100 mg)
English: Table 3 provides a summary of the adverse reactions by System Organ Class (SOC).
Croatian: Tablica 3 daje sažetak nuspojava prema klasifikaciji organskih sustava.
English: Stratified by baseline ECOG PS (0 versus 1), brain metastases at baseline (yes versus no) and prior treatment with bevacizumab (yes versus no).
Croatian: Stratificirano prema početnoj vrijednosti ECOG PS (0 naspram 1), metastazama u mozgu na početku ispitivanja (da naspram ne) i prethodnom liječenju bevacizumabom (da naspram ne).
English: Elevation of AST and/or ALT values to > 3 x ULN in conjunction with an increase of total bilirubin to ≥ 2 x ULN and ALKP < 2 x ULN
Croatian: Povećanje vrijednosti AST-a i/ili ALT-a > 3 x GGN zajedno s povećanjem vrijednosti ukupnog bilirubina ≥ 2 x GGN i AP < 2 x GGN
English: How to store Vargatef
Croatian: Kako čuvati Vargatef
English: After treatment interruption and recovery to grade 1 or baseline, dose reduction from 200 mg twice daily to 150 mg twice daily and - if a 2
Croatian: Nakon prekida liječenja i oporavka do stupnja 1 ili početne vrijednosti, smanjenje doze s 200 mg dvaput dnevno na 150 mg dvaput dnevno i, ako se 2. smanjenje doze smatra potrebnim, sa 150 mg dvaput dnevno na 100 mg dvaput dnevno.
English: Perforation Pancreatitis
Croatian: perforacija pankreatitis kolitis
English: Vargatef should be discontinued in patients with life-threatening venous thromboembolic reactions.
Croatian: Primjenu Vargatefa se mora trajno prekinuti u bolesnika sa životno ugrožavajućim rizikom venske tromboembolije.
English: OS analysis and follow-up PFS-analysis performed when 1121 death cases had been observed in the overall ITT population (535 events in adenocarcinoma patients).
Croatian: OS analiza i PFS analiza praćenja provedene su kada je opaženo 1121 smrtnih slučajeva u ukupnoj ITT populaciji (535 događaja u bolesnika s adenokarcinomom) + Omjer šansi i p-vrijednosti dobiveni su modelom logističke regresije prilagođenim za početnu vrijednost općeg stanja bolesnika prema ECOG-u (0 naspram 1).
English: In this case your doctor will prescribe Vargatef 100 mg soft capsules for your treatment.
Croatian: U tom slučaju liječnik će Vam propisati liječenje Vargatef 100 mg mekim kapsulama.
English: Vargatef 100 mg soft capsules
Croatian: Vargatef 100 mg meke kapsule
English: AUCτ,ss decreased by 16 % for a 45-year old patient (5
Croatian: AUCτ,ss se smanjio za 16 % u 45-godišnjeg bolesnika (5. percentila), a povećao za 13 % u 76-godišnjeg bolesnika (95. percentila) u odnosu na bolesnika s medijanom dobi od 62 godine.
English: Febrile neutropenia, Abscesses, Sepsis
Croatian: Infekcije i infestacije febrilna neutropenija, apscesi, sepsa
English: Brain metastasis
Croatian: Metastaze u mozgu
English: Bleeding (see section 4.4)
Croatian: Krvožilni poremećaji krvarenje (vidjeti dio 4.4)
English: Vargatef 150 mg soft capsules
Croatian: Vargatef 150 mg meke kapsule
English: Capsule shell: Gelatin, glycerol (85 %), titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172)
Croatian: želatina, glicerol (85%), titanijev dioksid (E171), crveni željezov oksid (E172), žuti željezov oksid (E172)
English: performance status was 0 (28.6 %) or 1 (71.3 %); one patient had a baseline ECOG performance status of 2.
Croatian: Većina bolesnika su bili neazijati (81,6 %), medijan dobi je iznosi 60,0 godina, početna vrijednost statusa općeg stanja bolesnika prema ECOG-u je bila 0 (28,6 %) ili 1 (71,3 %); jedan bolesnik je imao početnu vrijednost 2 statusa općeg stanja bolesnika prema ECOG-u.
English: Decreased appetite, Electrolyte imbalance
Croatian: uključujući stomatitis) - Osip - Smanjeni apetit - Poremećaj ravnoteže elektrolita
English: Women who can become pregnant must use an effective combination of birth control methods, including barrier methods as a second form of contraception, while they are taking Vargatef and for at least 3 months after stopping treatment.
Croatian: Tijekom uzimanja Vargatefa te najmanje 3 mjeseca nakon prestanka liječenja žene koje mogu zatrudnjeti moraju primjenjivati učinkovite metode kontracepcije, uključujući metode mehaničke kontracepcije kao dodatni oblik kontracepcije, kako bi spriječile trudnoću.
English: AUCτ,ss increased by 25 % for a 50 kg patient (5
Croatian: AUCτ,ss se povećao za 25 % u bolesnika s 50 kg (5. percentil), a smanjio za 19 % u bolesnika sa 100 kg (95. percentil) u odnosu na bolesnike s medijanom težine od 71,5 kg.
English: Marketing Authorisation Holder Boehringer Ingelheim International GmbH Binger Strasse 173
Croatian: Nositelj odobrenja za stavljanje lijeka u promet Boehringer Ingelheim International GmbH Binger Strasse 173
English: Iron oxide black (E172) Propylene glycol (E1520)
Croatian: Željezov oksid, crni (E172) Propilenglikol (E1520)
English: If relevant liver enzyme elevations are measured, interruption, dose reduction or discontinuation of the therapy with Vargatef may be required (see section 4.2).
Croatian: Ako se izmjeri značajno povišenje vrijednosti jetrenih enzima, može biti potrebno privremeno prekinuti, smanjiti dozu ili trajno prekinuti terapiju Vargatefom (vidjeti dio 4.2).
English: A multipack containing 120 capsules (2 boxes of 60 capsules each, bundled together by a wrapping foil).
Croatian: - Višestruko pakiranje koje sadrži 120 kapsula (2 kutije od kojih svaka sadrži 60 kapsula,
English: Fluid loss (dehydration)
Croatian: - Gubitak kose (alopecija)
English: Plasma levels of electrolytes should be monitored, if relevant gastrointestinal adverse events occur.
Croatian: Pri pojavi svakog značajnog gastrointestinalnog poremećaja, potrebno je nadzirati razine elektrolita u plazmi.
English: Active brain metastasis
Croatian: Aktivne metastaze u mozgu
English: Neutropenia (includes febrile neutropenia)
Croatian: Poremećaji krvi i limfnog sustava neutropenija (uključuje febrilnu neutropeniju)
English: What Vargatef looks like and contents of the pack Vargatef 150 mg soft capsules (capsules) are brown-coloured, opaque, oblong capsules imprinted on one side in black with the Boehringer Ingelheim company symbol and the figure “150”.
Croatian: Vargatef 150 mg meke kapsule (kapsule) su smeđe boje, neprozirne, duguljaste kapsule koje na jednoj strani imaju u crnoj boji utisnute logo tvrtke Boehringer Ingelheim i oznaku „150“.
English: Uncommon side effects (may affect up to 1 in 100 people) Occurrence of holes in the wall of your gut (gastrointestinal perforation) Serious liver problems
Croatian: Manje česte nuspojave (mogu se javiti u do 1 na 100 osoba) - Pucanje stijenke crijeva (gastrointestinalna perforacija) - Ozbiljne tegobe s jetrom - Upala gušterače (pankreatitis) - Srčani udar - Zatajenje bubrega
English: In the pivotal trial 1199.13, 85 patients (12.9 % of the patients with adenocarcinoma histology) were ≥ 70 years of age (median age: 72 years, range: 70 - 80 years) (see section 5.1).
Croatian: ≥ 70 godina (medijan dobi: 72 godine, raspon: od 70 do 80 godina) (vidjeti dio 5.1).
English: th
Croatian: Dob
English: Interruption, dose reduction or discontinuation of therapy with Vargatef may be required (see section 4.2).
Croatian: Može biti potrebno privremeno prekinuti, smanjiti dozu ili trajno prekinuti terapiju Vargatefom (vidjeti dio 4.2).
English: 55216 Ingelheim am Rhein GERMANY
Croatian: 55216 Ingelheim am Rhein Njemačka
English: 55216 Ingelheim am Rhein Germany
Croatian: 55216 Ingelheim am Rhein NJEMAČKA
English: Limited safety data are available in 9 patients with hepatocellular carcinoma and moderate hepatic impairment classified as Child Pugh B. Although no unexpected safety findings were reported in these patients, the data are insufficient to support a recommendation for treatment of patients with moderate hepatic impairment.
Croatian: Iako u ovih bolesnika nisu bili prijavljeni nikakvi neočekivani nalazi o sigurnosti primjene lijeka, podaci nisu dovoljni da podrže preporuku za liječenje bolesnika s umjerenim oštećenjem funkcije jetre.
English: Package leaflet: Information for the patient Vargatef 150 mg soft capsules nintedanib
Croatian: Uputa o lijeku: Informacije za bolesnika Vargatef 150 mg meke kapsule nintedanib
English: What Vargatef looks like and contents of the pack Vargatef 100 mg soft capsules (capsules) are peach-coloured, opaque, oblong capsules imprinted on one side in black with the Boehringer Ingelheim company symbol and the figure “100”.
Croatian: Vargatef 100 mg meke kapsule (kapsule) su boje breskve, neprozirne, duguljaste kapsule koje na jednoj strani imaju u crnoj boji utisnute logo tvrtke Boehringer Ingelheim i oznaku „100“.
English: You should take one capsule of this strength twice daily approximately 12 hours apart with food (for example in the morning and in the evening) at about the same time of the day.
Croatian: Uzmite po jednu kapsulu ove jačine dvaput dnevno u razmaku od približno 12 sati (primjerice jednu kapsulu ujutro i jednu kapsulu navečer) i odvojeno od obroka.
English: Serious cases of diarrhoea leading to dehydration and electrolyte disturbances have been reported with nintedanib in the post-marketing period.
Croatian: U razdoblju nakon stavljanja lijeka u promet, uz nintedanib prijavljeni su ozbiljni slučajevi proljeva koji je doveo do dehidracije i poremećaja elektrolita.
English: Package leaflet: Information for the patient Vargatef 100 mg soft capsules nintedanib
Croatian: Uputa o lijeku: Informacije za bolesnika Vargatef 100 mg meke kapsule nintedanib
English: Shellac, iron oxide black (E172),propylene glycol (E1520)
Croatian: Tinta za označivanje: šelak, crni željezov oksid (E172), propilenglikol (E1520)
English: NAME OF THE MEDICINAL PRODUCT Vargatef 100 mg soft capsules nintedanib
Croatian: NAZIV LIJEKA Vargatef 100 mg meke kapsule nintedanib
English: Brown-coloured, opaque, oblong soft-gelatin capsule imprinted on one side in black with the Boehringer Ingelheim company symbol and “150”.
Croatian: Neprozirne, duguljaste, meke želatinske kapsule smeđe boje, koje na jednoj strani imaju u crnoj boji utisnut logo tvrtke Boehringer Ingelheim i oznaku „150“.
English: NAME OF THE MEDICINAL PRODUCT Vargatef 150 mg soft capsules nintedanib
Croatian: NAZIV LIJEKA Vargatef 150 mg meke kapsule nintedanib
English: Each soft capsule contains100 mg nintedanib (as esilate).
Croatian: Jedna meka kapsula sadrži 100 mg nintedaniba (u obliku nintedanibesilata).
English: Pruritus
Croatian: Proljev
English: Decrease in the number of white blood cells (neutropenia) Inflammation of the mucous membranes lining the digestive tract includingsoresand ulcers in the mouth(mucositis,including stomatitis)
Croatian: - Smanjenje broja bijelih krvnih stanica praćeno vrućicom (febrilna neutropenija) - Krvni ugrušci u venama (venska tromboembolija), osobito u nogama (simptomi uključuju bol,
English: No increased frequency of impaired wound healing was observed in the LUME-Lung 1 trial.
Croatian: Nije opažena povećana učestalost usporenog cijeljenja rane u ispitivanju LUME-Lung 1. Nisu provedena ciljana ispitivanja za istraživanje učinka nintedaniba na cijeljenje rana.
English: Management of adverse reactions may require interruption, dose reduction, or discontinuation of therapy with Vargatef (see section 4.2).
Croatian: Zbrinjavanje nuspojava može zahtijevati privremeni prekid, smanjenje doze ili trajni prekid terapije Vargatefom (vidjeti dio 4.2).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/954/001
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/14/954/001
English: Printing ink
Croatian: Tinta za označavanje Šelak
English: Venous thromboembolism Hypertension
Croatian: venska tromboembolija hipertenzija aneurizme i disekcije arterije
English: Peach-coloured, opaque, oblong soft-gelatin capsules imprinted on one side in black with the Boehringer Ingelheim company symbol and “100”.
Croatian: Neprozirne, duguljaste, meke želatinske kapsule boje breskve, koje na jednoj strani imaju u crnoj boji utisnut logo tvrtke Boehringer Ingelheim i oznaku „100“.
English: Decrease in the number of white blood cells accompanied by fever (febrileneutropenia) Blood clots in the veins (venous thromboembolism), especially in the legs (symptoms include pain, redness, swelling, and warmth of a limb), which may travel through blood vessels to the lungs causing chest pain and difficulty in breathing (if you notice any of these symptoms, seek medical advice immediately)
Croatian: crvenilo, oticanje i toplinu udova), koji se mogu kretati krvnim žilama do pluća i uzrokovati bol u prsnom košu i otežano disanje (ako osjetite bilo koji od ovih simptoma, odmah potražite liječničku pomoć) - Visoki krvni tlak (hipertenzija) - Gubitak tekućine (dehidracija) - Lokalizirane gnojne upale (apscesi) - Nizak broj krvnih pločica (trombocitopenija) - Žutica (hiperbilirubinemija)
English: It was not clearly dose dependent, but most responses were seen at doses of ≥ 200 mg. Logistic regression revealed a statistically significant association of the anti-angiogenic effect to nintedanib exposure.
Croatian: Taj učinak nije bio jasno ovisan o dozi, ali većina odgovora je bila viđena pri dozama ≥ 200 mg.
English: Each soft capsule contains150mg nintedanib (as esilate).
Croatian: Jedna meka kapsula sadrži 150 mg nintedaniba (u obliku nintedanibesilata).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/954/004
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/14/954/004
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/954/003
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/14/954/003
English: Glycerol (85 %) Titanium dioxide (E171)
Croatian: želatina, glicerol (85 %), titanijev dioksid (E171), crveni željezov oksid (E172), žuti željezov oksid (E172)
English: Iron oxide red (E172) Iron oxide yellow (E172)
Croatian: Glicerol (85 %) Titanijev dioksid (E171) Željezov oksid, crveni (E172) Željezov oksid, žuti (E172)
English: Vascular disorders
Croatian: trombocitopenija
English: As the company had supplied the additional information requested, the ‘exceptional circumstances' ended on 19 March 2012.
Croatian: Budući da je tvrtka dostavila dodatne zatražene informacije, „iznimne okolnosti” su ukinute dana 19. ožujka 2012.
English: This summary was last updated in 01-2015.
Croatian: Sažetak je posljednji put ažuriran 01.2015.
English: The following is a list of main benefits shown in these studies:
Croatian: Niže u tekstu slijedi popis glavnih koristi utvrđenih u ovim ispitivanjima:
English: Velcade must not be given by other routes.
Croatian: Velcade se ne smije davati drugim putovima.
English: At least 72 hours must pass between two consecutive doses of Velcade.
Croatian: Mora proći najmanje 72 sata između dvije uzastopne doze lijeka Velcade.
English: The full EPAR for Velcade can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Cjelovito Europsko javno izvješće o procjeni (EPAR) lijeka Velcade nalazi se na internetskim stranicama Agencije ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Other information about Velcade:
Croatian: Ostale informacije o lijeku Velcade:
English: The recommended starting dose is 1.3 mg per square metre body surface area (calculated using the patient's height and weight).
Croatian: Preporučena doza iznosi 1,3 mg po kvadratnom metru tjelesne površine (izračunato temeljem visine i tjelesne težine bolesnika).
English: It must not be given to patients with acute diffuse infiltrative pulmonary disease or pericardial disease (disease affecting the sac that surrounds the heart).
Croatian: Ne smije se davati bolesnicima s akutnim difuznim infiltrativnim plućnim poremećajem ili perikardnom bolesti (bolesti koja utječe na vrećicu koja okružuje srce).
English: If a patient develops severe side effects after a treatment cycle, the treatment must be suspended, delayed or the dose adjusted.
Croatian: Ako se u bolesnika pojave ozbiljne nuspojave nakon ciklusa liječenja, liječenje se mora prekinuti, odgoditi ili se doza mora prilagoditi.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Velcade on 26 April 2004.
Croatian: Europska komisija izdaje odobrenje za stavljanje u promet koje za lijek Velcade vrijedi na prostoru Europske unije od 26. travnja 2004.
English: When the proteins in the cancer cells, such as the proteins that control the growth of the cells, are not broken down, the cells are affected and they eventually die.
Croatian: Ako se proteini u stanicama raka, poput proteina koji kontroliraju rast stanica, ne razgrade, stanice su zaražene te naposljetku umiru.