FrancophonIA/ELRC3.0 huggingface dataset:
English: Most patients were FIGO stage III (both 68%) followed by FIGO stage IV (13% and 14%), FIGO stage II (10% and 11%) and FIGO stage I (9% and 7%).
Croatian: Većina bolesnica bila je u FIGO stadiju III bolesti (68% u obje skupine), nakon čega je najčešći bio FIGO stadij IV (13% odnosno 14%), FIGO stadij II (10% odnosno 11%) te FIGO stadij I (9% odnosno 7%).
English: The pharmacokinetics of bevacizumab was well characterised by the paediatric population PK model for 70 paediatric patients in study BO20924 (1.4 to 17.6 years; 11.6 to 77.5 kg) and 59 patients in study BO25041 (1 to 17 years; 11.2 to 82.3 kg).
Croatian: Farmakokinetika bevacizumaba dobro je okarakterizirana pedijatrijskim populacijskim farmakokinetičkim modelom za 70 pedijatrijskih bolesnika u ispitivanju BO20924 (1,4 - 17,6 godina; 11,6 - 77,5 kg) te 59 bolesnika u ispitivanju BO25041 (1 - 17 godina; 11,2 - 82,3 kg).
English: Results from the primary analysis and the follow-up analysis are presented by bevacizumab treatment and by trial treatment in table 24 and 25, respectively.
Croatian: Rezultati primarne analize i analize nakon praćenja su prikazani prema terapiji bevacizumabom i prema ispitivanom liječenju u Tablici 24 odnosno Tablici 25.
English: Individual cases and clusters of serious ocular adverse reactions have been reported following unapproved intravitreal use of bevacizumab compounded from vials approved for intravenous administration in cancer patients.
Croatian: Prijavljeni su pojedinačni slučajevi i skupine ozbiljnih očnih nuspojava nakon neodobrene intravitrealne primjene lijeka bevacizumab pripremljenog iz bočica odobrenih za intravensku primjenu u bolesnika s malignom bolešću.
English: • MVASI may cause bleeding, especially tumour-related bleeding.
Croatian: • MVASI može izazvati krvarenje, naročito ono povezano s tumorom.
English: Most patients in both the CP arm (80.4%) and the CPB arm (78.9%) were white.
Croatian: Većina bolesnica i u skupini CP (80,4%) i u skupini CPB (78,9%) bila je bijele rase.
English: MVASI has been developed and made to treat cancer by injecting it into the bloodstream.
Croatian: MVASI je razvijen i proizveden za liječenje raka primjenom u krvotok.
English: Patients should be monitored for signs and symptoms of CNS bleeding, and MVASI treatment discontinued in cases of intracranial bleeding.
Croatian: Bolesnike treba nadzirati kako bi se uočili eventualni znakovi i simptomi krvarenja u SŽS-u te u slučaju intrakranijalnog krvarenja obustaviti liječenje lijekom MVASI.
English: The overall rates of discontinuation due to adverse events were 8.8% in the CT arm and 43.6% in the CT + BV arm (mostly due to grade 2-3 adverse events) and the median time to discontinuation in the CT + BV arm was 5.2 months compared with 2.4 months in the CT arm.
Croatian: Ukupna stopa prekida ispitivanja zbog nuspojava iznosila je 8,8% u skupini KT te 43,6% u skupini KT+BV (uglavnom zbog nuspojava stupnja 2-3), a medijan vremena do prekida ispitivanja u skupini KT+BV bio je 5,2 mjeseca u usporedbi s 2,4 mjeseca u skupini KT.
English: MVASI will be administered in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy.
Croatian: MVASI će se davati u kombinaciji s paklitakselom i cisplatinom ili, alternativno, paklitakselom i topotekanom u bolesnica koje ne mogu primiti terapiju platinom.
English: Secondary PFS analyses, based on ‘on-treatment'-based response assessments, confirmed the significantly superior clinical benefit for patients treated with bevacizumab (analyses shown in table 7), consistent with the statistically significant benefit observed in the pooled analysis.
Croatian: Sekundarne analize preživljenja bez progresije bolesti, na temelju procjene odgovora tijekom liječenja, potvrdile su značajno superiorniju kliničku korist za bolesnike liječene lijekom bevacizumab (analize prikazane u Tablici 7), što je u skladu sa statistički značajnom koristi opaženom u analizi objedinjenih podataka.
English: • The other ingredients are trehalose dihydrate, sodium phosphate, polysorbate 20 and water for injections.
Croatian: - Drugi sastojci su trehaloza dihidrat, natrijev fosfat, polisorbat 20 i voda za injekcije.
English: Efficacy results for trial E3200
Croatian: Rezultati djelotvornosti za ispitivanje E3200
English: The primary endpoint was PFS based on investigator's assessment of disease progression based on radiological scans or CA-125 levels, or symptomatic deterioration per protocol.
Croatian: Primarna mjera ishoda bilo je preživljenje bez progresije bolesti, prema ispitivačevoj procjeni progresije bolesti na temelju radioloških snimaka, razine CA-125 ili simptomatskog pogoršanja po protokolu.
English: Patients may be at risk of developing infusion/hypersensitivity reactions.
Croatian: Bolesnici mogu biti izloženi riziku za razvoj infuzijskih reakcija odnosno reakcija preosjetljivosti.
English: The administration of MVASI should be temporarily discontinued
Croatian: Primjenu lijeka MVASI treba privremeno prekinuti
English: The 649 randomised patients (641 treated) had Karnofsky Performance Status (KPS) of ≥ 70%, no CNS metastases and adequate organ function.
Croatian: Randomizirano je 649 bolesnika (od kojih je 641 liječen) funkcionalnog statusa po Karnofskom ≥ 70%, bez metastaza u središnjem živčanom sustavu i sa zadovoljavajućom funkcijom organa.
English: Severe side effects, which may be very common (may affect more than 1 in 10 people), include:
Croatian: Teške nuspojave koje mogu biti vrlo česte (mogu se javiti u više od 1 na 10 osoba) uključuju:
English: • allergic reactions (the signs may include difficulty breathing, facial redness, rash, low blood pressure or high blood pressure, low oxygen in your blood, chest pain, or nausea/vomiting),
Croatian: • alergijske reakcije (znakovi mogu uključivati otežano disanje, crvenilo lica, osip, visok ili nizak krvni tlak, niske razine kisika u krvi, bol u prsištu ili mučninu/povraćanje),
English: In published literature reports, cases of non-mandibular osteonecrosis have been observed in patients under the age of 18 years treated with bevacizumab.
Croatian: U izvješćima objavljenima u literaturi zabilježeni su slučajevi osteonekroze koja nije zahvaćala čeljust u bolesnika mlađih od 18 godina liječenih bevacizumabom.
English: If a dose of MVASI is missed
Croatian: Ako ste propustili dozu lijeka MVASI
English: In this trial, there were two primary objectives: to show that XELOX was non-inferior to FOLFOX-4 and to show that bevacizumab in combination with FOLFOX-4 or XELOX chemotherapy was superior to chemotherapy alone.
Croatian: Ovo je ispitivanje imalo dva primarna cilja: pokazati neinferiornost protokola XELOX u odnosu na protokol FOLFOX-4 te pokazati da je liječenje lijekom bevacizumab u kombinaciji s kemoterapijskim protokolima FOLFOX-4 ili XELOX superiornije od liječenja samo kemoterapijom.
English: FOLFOX-4 or
Croatian: FOLFOX-4 ili
English: • MVASI can increase the risk of bleeding or increase the risk of problems with wound healing after surgery.
Croatian: • MVASI može povećati rizik od krvarenja ili problema sa zacjeljivanjem rana poslije operacije.
English: • a hole in the cartilage wall separating the nostrils of the nose,
Croatian: • otvor u nosnom septumu - koštanoj pregradi koja razdvaja nosnice,
English: In terms of safety, there was a higher overall incidence of grade 3-5 AEs in study E3200 relative to study ML18147.
Croatian: Što se tiče sigurnosti primjene, u ispitivanju E3200 ukupna incidencija nuspojava stupnja 3-5 bila je veća nego u ispitivanju ML18147.
English: • PLD 40 mg/m2 as a 1 mg/min IV infusion on day 1 only every 4 weeks.
Croatian: PLD 40 mg/m2 u obliku i.v. infuzije brzinom od 1 mg/min samo 1. dana svaka 4 tjedna.
English: • reduction in the number of white cells in the blood, and cells that help the blood clot,
Croatian: • smanjenje broja bijelih krvnih stanica i stanica koje pomažu u zgrušavanju krvi,
English: Decreased neutrophil count, decreased white blood cell count and presence of urine protein may be associated with MVASI treatment.
Croatian: Smanjen broj neutrofila, smanjen broj leukocita i prisutnost proteina u mokraći mogu biti povezani s liječenjem lijekom MVASI.
English: Bevacizumab may adversely affect the wound healing process.
Croatian: Bevacizumab može imati nepovoljan utjecaj na proces zacjeljivanja rana.
English: IFN alfa-2a was given up to 52 weeks or until disease progression at a recommended starting dose of 9 MIU three times a week, allowing a dose reduction to 3 MIU three times a week in 2 steps.
Croatian: Interferon alfa2a se primjenjivao najdulje 52 tjedna ili do progresije bolesti u preporučenoj početnoj dozi od 9 milijuna IU tri puta tjedno, uz mogućnost postupnog (u dva koraka) smanjenja doze na 3 milijuna IU tri puta tjedno.
English: In an exploratory retrospective analysis of data from 13 completed randomised trials in patients with various tumour types, 3 patients out of 91 (3.3%) with brain metastases experienced CNS bleeding (all grade 4) when treated with bevacizumab, compared to 1 case (grade 5) out of 96 patients (1%) that were not exposed to bevacizumab.
Croatian: U eksploracijskoj retrospektivnoj analizi podataka iz 13 završenih randomiziranih ispitivanja u bolesnika s različitim vrstama tumora, 3 bolesnika od njih 91 (3,3%) s metastazama na mozgu imala su krvarenja u SŽS-u (svi stupnja 4) kada su liječeni bevacizumabom, u usporedbi s 1 bolesnikom (stupanj 5) od njih 96 (1%) koji nisu bili izloženi bevacizumabu.
English: Do not stop treatment with MVASI unless you have discussed this with your doctor.
Croatian: Nemojte prekinuti liječenje lijekom MVASI bez prethodnog savjetovanja s liječnikom.
English: Bevacizumab may impair female fertility (see sections 4.6 and 4.8).
Croatian: Bevacizumab može narušiti plodnost u žena (vidjeti dijelove 4.6 i 4.8).
English: The overall incidence of NCI-CTC grade 3 and 4 hypertension in patients receiving bevacizumab ranged from 0.4% to 17.9%.
Croatian: Ukupna incidencija hipertenzije stupnja 3 i 4 prema NCI-CTC kriterijima u bolesnika koji su primali bevacizumab kretala se od 0,4% do 17,9%.
English: You may be advised to have a dental check-up before you start treatment with MVASI.
Croatian: Možda će Vam biti preporučeno da prije početka liječenja lijekom MVASI obavite stomatološki pregled.
English: The frequency of GI-vaginal fistulae in the group treated with bevacizumab + chemotherapy was higher in patients with recurrence within the field of prior radiation (16.7%) compared with patients with no prior radiation and/or no recurrence inside the field of prior radiation (3.6%).
Croatian: Učestalost gastrointestinalno-vaginalnih fistula u skupini liječenoj bevacizumabom + kemoterapijom bila je viša u bolesnica s recidivom unutar područja koje je prethodno bilo zračeno (16,7%) nego u onih koje prethodno nisu primale zračenje i/ili onih bez recidiva unutar područja koje je prethodno bilo zračeno (3,6%).
English: • It is possible that MVASI can increase the risk of bleeding in your lungs, including coughing or spitting blood.
Croatian: • MVASI može povećati rizik od krvarenja u plućima, uključujući iskašljavanje krvi ili krvavi ispljuvak.
English: MVASI is not formulated for intravitreal use.
Croatian: MVASI nije namijenjen za intravitrealnu primjenu.
English: In study BO25041, bevacizumab exposure was similar compared to a typical adult at the same dose.
Croatian: U ispitivanju BO25041, izloženost bevacizumabu bila je slična onoj u tipičnog odraslog bolesnika pri istoj dozi.
English: Bevacizumab has no or negligible influence on the ability to drive and use machines.
Croatian: Bevacizumab ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: • problems with wound healing after surgery,
Croatian: • problemi sa zacjeljivanjem rana nakon operacije,
English: assessment)** Median overall survival* Hazard ratio (97.5% CI) * Overall survival analysis at clinical cut-off 31 January 2007.
Croatian: Ukupna stopa odgovora (procjena ispitivača)** Medijan ukupnog preživljenja* Omjer hazarda (97,5% CI) * analiza ukupnog preživljenja prema podacima do 31. siječnja 2007. ** primarna analiza prema podacima do 31. siječnja 2006.
English: • serious infections of the skin or deeper layers under the skin, especially if you had holes in the gut wall or problems with wound healing,
Croatian: • ozbiljne infekcije kože ili dubljih potkožnih slojeva, osobito ako ste imali napuknuća u stijenci crijeva ili probleme sa zacjeljivanjem rana,
English: Cases of foetal abnormalities in women treated with bevacizumab alone or in combination with known embryotoxic chemotherapeutics have been observed (see section 4.6) * If specified, the frequency has been derived from clinical trial data.
Croatian: Primijećeni su slučajevi poremećaja fetusa u žena liječenih bevacizumabom samostalno ili u kombinaciji s poznatim embriotoksičnim kemoterapeuticima (vidjeti dio 4.6) * ako je učestalost navedena, preuzeta je iz podataka prikupljenih tijekom kliničkih ispitivanja.
English: These results suggest that close clinical observation with appropriate cardiac assessments should be considered for patients exposed to cumulative doxorubicin doses greater than 300 mg/m2 when combined with bevacizumab.
Croatian: Ovi rezultati upućuju na potrebu pomnog kliničkog nadzora uz odgovarajuću procjenu srčane funkcije u bolesnika izloženih kumulativnim dozama doksorubicina višima od 300 mg/m2 u kombinaciji s bevacizumabom.
English: The rates of discontinuation due to adverse events in the subgroup of patients > 65 years old were 8.8% in the CT arm and 50.0% in the CT + BV arm.
Croatian: Stope prekida ispitivanja zbog nuspojava u podskupini bolesnica starijih od 65 godina iznosile su 8,8% u skupini KT te 50,0% u skupini KT+BV.
English: In study JO25567, all grade hypertension was observed in 77.3% of the patients who received bevacizumab in combination with erlotinib as first-line treatment for non-squamous NSCLC with EGFR activating mutations, compared to 14.3% of patients treated with erlotinib alone.
Croatian: U ispitivanju JO25567, hipertenzija svih stupnjeva primijećena je u 77,3% bolesnika koji su primali bevacizumab u kombinaciji s erlotinibom kao prvu liniju liječenja neskvamoznog NSCLC-a s aktivirajućim mutacijama EGFR-a u usporedbi s 14,3% bolesnika liječenih samo erlotinibom.
English: The majority of patients included in the study were white (87% in all three arms); the median age was 60 years in CPP and CPB15 arms and 59 years in CPB15+ arm; and 29% of patients in CPP or CPB15 and 26% in CPB15+ were over 65 years of age.
Croatian: Većina bolesnica obuhvaćenih ispitivanjem bile su bijele rase (87% u sve tri skupine), medijan dobi iznosio je 60 godina u skupinama CPP i CPB15, a 59 godina u skupini CPB15+, dok je 29% bolesnica u skupinama CPP i CPB15 te 26% u skupini CPB15+ bilo starije od 65 godina.
English: • feeling of numbness or tingling in hands or feet,
Croatian: • osjećaj utrnulosti ili trnce u šakama ili stopalima,
English: There were neither statistically significant nor clinically relevant differences in bevacizumab clearance in patients receiving bevacizumab monotherapy compared to patients receiving bevacizumab in combination with interferon alfa-2a, erlotinib or chemotherapies (IFL, 5-FU/LV, carboplatin/paclitaxel, capecitabine, doxorubicin or cisplatin/gemcitabine).
Croatian: Nije bilo ni statistički ni klinički značajnih razlika u klirensu bevacizumaba između bolesnika koji su primali samo bevacizumab i bolesnika koji su primali bevacizumab u kombinaciji s interferonom alfa-2a, erlotinibom ili kemoterapeuticima (IFL, 5-FU/LV, karboplatin/paklitaksel, kapecitabin, doksorubicin ili cisplatin/gemcitabin).
English: Censored for NPT Median PFS (months)
Croatian: Cenzurirano za terapiju izvan protokola Medijan PFS (mjeseci)
English: No significant difference was observed in the duration of overall survival between patients who received bevacizumab monotherapy compared to patients treated with FOLFOX-4.
Croatian: Nije opažena značajna razlika u duljini ukupnog preživljenja između bolesnika koji su primali bevacizumab u monoterapiji i bolesnika liječenih protokolom FOLFOX-4.
English: Gall bladder perforation (not known)
Croatian: Perforacija žučnog mjehura (nepoznato)
English: Follow-up analysis was performed with a data cut-off date of 07 March 2014. p-value displayed for descriptive purpose only.
Croatian: Analiza nakon praćenja provedena je na temelju podataka prikupljenih do 7. ožujka 2014. p-vrijednost navedena je samo u ilustrativne svrhe.
English: Median PFS (months) HR (95% CI) p-value Response rates (for patients with measurable disease) Investigator assessment
Croatian: Medijan PFS-a (mjeseci) HR (95% CI) p-vrijednost Stope odgovora na liječenje (za bolesnike s mjerljivom bolešću) Procjena ispitivača
English: First-line treatment of non-squamous NSCLC in combination with platinum-based chemotherapy
Croatian: Prva linija liječenja neskvamoznog NSCLC-a u kombinaciji s kemoterapijom na bazi platine
English: The safety of reinitiating bevacizumab therapy in patients previously experiencing PRES is not known.
Croatian: Nije poznata sigurnost ponovnog uvođenja bevacizumaba u bolesnika koji su prethodno imali PRES.
English: In bevacizumab clinical trials, gastrointestinal fistulae (all grade) have been reported with an incidence of up to 2% in patients with metastatic colorectal cancer and ovarian cancer, but were also reported less commonly in patients with other types of cancer.
Croatian: U kliničkim ispitivanjima bevacizumaba prijavljena incidencija gastrointestinalnih fistula (svih stupnjeva) iznosila je do 2% u bolesnika s metastatskim kolorektalnim karcinomom i karcinomom jajnika, no one su prijavljene manje često i u bolesnika s drugim oblicima karcinoma.
English: Prior radiation is a major risk factor for the development of GI-vaginal fistulae and all patients with GI-vaginal fistulae had a history of prior radiation.
Croatian: Prethodno zračenje značajan je čimbenik rizika za razvoj gastrointestinalno-vaginalne fistule, a sve bolesnice s gastrointestinalno-vaginalnom fistulom prethodno su bile liječene zračenjem.
English: The side effects listed below were seen when MVASI was given together with chemotherapy.
Croatian: Niže navedene nuspojave uočene su kada se MVASI primjenjivao zajedno s kemoterapijom.
English: Treatment of platinum-resistant recurrent disease: MVASI is administered in combination with one of the following agents - paclitaxel, topotecan (given weekly) or pegylated liposomal doxorubicin.
Croatian: Liječenje rekurentne bolesti rezistentne na platinu: MVASI se primjenjuje u kombinaciji s jednim od sljedećih lijekova - paklitakselom, topotekanom (primijenjenim jednom tjedno) ili pegiliranim liposomalnim doksorubicinom.
English: In clinical trials, with the exception of study JO25567, the overall incidence of hypertension (all grades) ranged up to 42.1% in the bevacizumab-containing arms compared with up to 14% in the control arms.
Croatian: U kliničkim ispitivanjima, osim u ispitivanju JO25567, ukupna incidencija hipertenzije (svih stupnjeva), dosezala je do 42,1% u skupinama čije je liječenje uključivalo bevacizumab, u usporedbi s najviše 14% u kontrolnim skupinama.
English: The European Medicines Agency has waived the obligation to submit the results of studies, in all subsets of the paediatric population, in breast carcinoma, adenocarcinoma of the colon and rectum, lung carcinoma (small cell and non-small cell carcinoma), kidney and renal pelvis carcinoma (excluding nephroblastoma, nephroblastomatosis, clear cell sarcoma, mesoblastic nephroma, renal medullary carcinoma and rhabdoid tumour of the kidney), ovarian carcinoma (excluding rhabdomyosarcoma and germ cell tumours), fallopian tube carcinoma (excluding rhabdomyosarcoma and germ cell tumours), peritoneal carcinoma (excluding blastomas and sarcomas) and cervix and corpus uteri carcinoma.
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka u svim podskupinama pedijatrijske populacije u indikacijama karcinoma dojke, adenokarcinoma kolona i rektuma, karcinoma pluća (malih i nemalih stanica), karcinoma bubrega i bubrežne zdjelice (izuzev nefroblastoma, nefroblastomatoze, svjetlostaničnog sarkoma, mezoblastičnog nefroma, medularnog karcinoma bubrega i rabdoidnog tumora bubrega), karcinoma jajnika (izuzev rabdomiosarkoma i tumora germinativnih stanica), karcinoma jajovoda (izuzev rabdomiosarkoma i tumora germinativnih stanica), peritonealnog karcinoma (izuzev blastoma i sarkoma) te karcinoma vrata i tijela uterusa.
English: In cases of internal fistula not arising in the gastrointestinal tract, discontinuation of MVASI should be considered.
Croatian: U slučajevima razvoja unutarnje fistule izvan gastrointestinalnog trakta, potrebno je razmotriti prestanak primjene lijeka MVASI.
English: No clinically relevant interaction of bevacizumab was observed on the pharmacokinetics of co-administered interferon alfa 2a, erlotinib (and its active metabolite OSI-420), or the chemotherapies irinotecan (and its active metabolite SN38), capecitabine, oxaliplatin (as determined by measurement of free and total platinum), and cisplatin.
Croatian: Nije primijećena klinički značajna interakcija bevacizumaba na farmakokinetiku istodobno primijenjenog interferona alfa-2a, erlotiniba (i njegova aktivnog metabolita OSI-420) ni kemoterapeutika irinotekana (i njegova aktivnog metabolita SN38), kapecitabina, oksaliplatina (što je utvrđeno određivanjem slobodne platine i ukupne platine) i cisplatina.
English: Difference in response rates 95% CI for difference in response rates4
Croatian: 95% CI za razliku u stopama odgovora4
English: The primary efficacy endpoint was overall survival (OS).
Croatian: Primarna mjera ishoda za djelotvornost bilo je ukupno preživljenje (OS).
English: • AVF2107g: A weekly schedule of irinotecan/bolus 5-fluorouracil/folinic acid (IFL) for a total of 4 weeks of each 6 week-cycle (Saltz regimen).
Croatian: • AVF2107g: tjedna primjena protokola irinotekan/bolus 5-fluorouracila/folne kiseline (IFL) kroz ukupno 4 tjedna tijekom svakog šestotjednog ciklusa (Saltzov protokol).
English: • muscle and joint pain, muscular weakness,
Croatian: • bol u mišićima i zglobovima, slabost mišića,
English: Infections and infestations Necrotising fasciitis, usually secondary to wound healing complications, gastrointestinal perforation or fistula formation (rare) (see also section 4.4)
Croatian: Nekrotizirajući fasciitis, obično kao posljedica komplikacija pri zacjeljivanju rana, gastrointestinalne perforacije ili stvaranja fistule (rijetko) (vidjeti i dio 4.4)
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 100 mg/4 mL
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 100 mg/4 ml
English: Patients with central nervous system metastases, including previously-treated or resected brain lesions, were excluded.
Croatian: U ispitivanje nisu bili uključeni bolesnici s metastazama u središnjem živčanom sustavu, uključujući prethodno liječene ili odstranjene lezije mozga.
English: It is recommended that treatment be continued until progression of the underlying disease or until unacceptable toxicity (see section 5.1).
Croatian: Liječenje se preporučuje nastaviti do progresije osnovne bolesti ili do pojave neprihvatljive toksičnosti (vidjeti dio 5.1).
English: Information on foetal malformations observed in the post-marketing setting are provided in sections 4.6 and 4.8.
Croatian: Informacije o malformacijama fetusa primijećenima nakon stavljanja lijeka u promet navode se u dijelovima 4.6 i
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 400 mg/16 mL
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 400 mg/16 ml
English: • if you have problems with wound healing following surgery,
Croatian: • u slučaju problema sa zacjeljivanjem rana nakon operacije,