FrancophonIA/ELRC3.0 huggingface dataset:
English: In postmarketing experience, rare cases of ARN have been observed in patients receiving TYSABRI.
Croatian: Nakon stavljanja lijeka u promet zabilježeni su rijetki slučajevi akutne retinalne nekroze u bolesnika koji su primali TYSABRI.
English: virus granule cell neuronopathy) is also caused by JC virus and has occurred in some patients who have been given TYSABRI.
Croatian: Stanje koje se naziva neuronopatija granularnih stanica uzrokovana JC virusom (JCV GCN) pojavilo se u nekih bolesnika koji su primali TYSABRI.
English: ARN has been observed in patients being administered TYSABRI and can be potentially blinding.
Croatian: Akutna retinalna nekroza je zapažena u bolesnika u kojih se primijenjuje TYSABRI te može potencijalno izazvati sljepoću.
English: LIST OF EXCIPIENTS
Croatian: Skupine ispitanika
English: When diluted, the solution for infusion contains approximately 2.6 mg/ml of natalizumab.
Croatian: Kada je razrijeđena, otopina za infuziju sadrži otprilike 2,6 mg/ml natalizumaba.
English: Severe sequelae can occur including coma and death.
Croatian: Moguće su i teške posljedice, uključujući komu i smrt.
English: Biogen Hungary Kft. Tel.: +36 (1) 899 9883
Croatian: Tel.: +36 (1) 899 9883
English: In patients with PML a reaction known as IRIS (Immune Reconstitution Inflammatory Syndrome) is likely to occur after treatment for PML, as TYSABRI is removed from your body.
Croatian: U bolesnika s PML-om, nakon liječenja PML-a, zbog uklanjanja TYSABRIJA iz tijela vjerojatno će se javiti reakcija poznata kao upalni sindrom imunološke rekonstitucije (IRIS).
English: Natalizumab is a selective adhesion-molecule inhibitor and binds to the α4-subunit of human integrins, which is highly expressed on the surface of all leukocytes, with the exception of neutrophils.
Croatian: Natalizumab selektivno inhibira adhezijske molekule vezanjem za α4-podjedinicu ljudskih integrina,
English: Patients who have all three risk factors for PML (i.e., are anti-JCV antibody positive and have received more than 2 years of TYSABRI therapy, and have received prior immunosuppressant therapy) have a higher risk of PML.
Croatian: Bolesnici koji imaju sva tri faktora rizika za PML (tj. pozitivni su na anti-JCV antitijela, primaju terapiju lijekom TYSABRI više od 2 godine te su primili prethodnu terapiju imunosupresivima) imaju viši rizik od PML-a.
English: • Reminder to read the package leaflet carefully before starting Tysabri
Croatian: • Podsjetnik na to da pokažu karticu svakom liječniku koji ih liječi • Podsjetnik na to da pažljivo pročitaju uputu u lijeku prije nego što počnu uzimati Tysabri
English: Physicians must discuss the benefits and risks of TYSABRI therapy with the patient and provide them with a Patient Alert Card.
Croatian: Liječnici moraju razgovarati s bolesnikom o koristima i rizicima terapije TYSABRIJEM te im dati
English: A Complete Blood Count (CBC, including lymphocytes) is recommended prior to initiating TYSABRI to ensure that immune effects of the previous therapy (i.e. cytopenia) have resolved.
Croatian: Kako bi se osiguralo da su nestali imunološki učinci prethodne terapije (tj. citopenija), prije početka liječenja lijekom TYSABRI preporučuje se kontrola kompletne krvne slike (KKS, uključujući limfocite).
English: • After the infusion is complete, flush the intravenous line with sodium chloride 9 mg/ml (0.9%) solution for injection.
Croatian: • Po završetku infuzije isperite intravensku liniju 0,9%-tnom (9 mg/ml) otopinom natrijevog klorida za injekcije.
English: Although JC viral load in the CSF might be expected to decline in the setting of IRIS, it is also possible that due to the breakdown of the blood brain barrier (BBB) and release of JCV from cells lysed during IRIS, it can be increased.
Croatian: Iako bi se moglo očekivati da će se opterećenje JC virusa u CST-u smanjiti u prisutnosti IRIS-a,
English: • Visually inspect the diluted medicinal product for particles or discolouration prior to administration.
Croatian: • Prije primjene vizualno provjerite da li razrijeđeni lijek sadrži čestice ili je promijenio boju.
English: Persistent anti-natalizumab antibodies (one positive test reproducible on retesting at least
Croatian: Perzistirajuća anti-natalizumab protutijela (pozitivan test na protutijela reproducibilan i kod ponovnog testiranja najmanje 6 tjedana kasnije) razvila su se u oko 6% bolesnika.
English: In some instances, the reaction reoccurred when TYSABRI was reintroduced.
Croatian: U nekim slučajevima, reakcija se može ponovo pojaviti kod ponovljene primjene
English: • The diluted solution is to be infused intravenously over 1 hour at a rate of approximately 2 ml/minute.
Croatian: • Razrijeđena otopina daje se putem intravenske infuzije tijekom 1 sata brzinom od oko
English: Patients who have all three risk factors for PML (i.e., are anti-JCV antibody positive and have received more than 2 years of TYSABRI therapy, and have received prior immunosuppressant therapy) have a significantly higher risk of PML.
Croatian: Kod bolesnika koji imaju sva tri čimbenika rizika za PML (npr. koji su pozitivni na anti-JCV protutijela i primali su TYSABRI više od 2 godine, i liječeni su imunosupresivima prije primanja TYSABRIJA), rizik za PML je znatno viši.
English: • Yellowing of your skin or the whites of your eyes • Unusual darkening of the urine.
Croatian: • žuta boja kože ili bjeloočnica
English: The reactions are reported as MedDRA preferred terms under the MedDRA primary system organ class.
Croatian: Nuspojave su navedene u skladu s MedDRA nazivljem i klasifikacijom organskih sustava prema
English: Concurrent treatment with immunosuppressants
Croatian: Istovremeno liječenje imunosupresivima
English: Sodium chloride Polysorbate 80 (E433) Water for injections
Croatian: 6.1 Popis pomoćnih tvari natrijev dihidrogenfosfat hidrat natrijev hidrogenfosfat heptahidrat natrijev klorid polisorbat 80 (E433) voda za injekcije
English: Randomised
Croatian: Sljedivost
English: − Severe diarrhoea
Croatian: − teški proljev
English: Diluted solution After dilution with sodium chloride 9 mg/ml (0.9%) solution for injection, immediate use is recommended.
Croatian: Preporučuje se primijeniti otopinu odmah nakon razrjeđivanja 0,9%-tnom (9 mg/ml) otopinom natrijevog klorida za injekciju.
English: Biogen Slovakia s.r.o.
Croatian: Biogen Hungary Kft.
English: concentrate for solution for infusion 1 x 15 ml vial
Croatian: 1 x 15 ml bočica
English: Tél/Tel: +32 2 219 12 18
Croatian: Biogen Belgium N.V./S.A. Tél/Tel: +32 2 219 12 18
English: Combination with other DMTs.
Croatian: Kombinacija s drugim terapijama koje mijenjaju tijek bolesti.
English: Patient alert card
Croatian: Karticu s upozorenjem za bolesnika.
English: o Management of PML o Monitoring strategy after discontinuation of TYSABRI treatment o The need to inform patients about the benefits and risk of TYSABRI and provide them with:
Croatian: o Liječenje PML-a o Strategija praćenja nakon prekida liječenja lijekom TYSABRI
English: Hepatic events
Croatian: Farmakodinamički učinci
English: MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE
English: Unopened vial 4 years
Croatian: Neotvorena bočica
English: • Tiredness
Croatian: Urtikarija
English: • Reminder of PML symptoms • When MRI imaging may be warranted
Croatian: • Podsjetnik na simptome PML-a
English: 1 ≥106.3 and ≤ 108.3 CFU of live Bordetella bronchiseptica bacteria strain B-C2 per dose
Croatian: 1 ≥106.3 I ≤ 108.3 CFU žive Bordetella bronchiseptica bakterije soj B-C2 po dozi
English: Vial (type I glass) in carton box
Croatian: Bočice (staklene tip I) u kartonskoj kutiji
English: Vial (type I glass) in plastic box
Croatian: Bočice (staklene tip I) u plastičnoj kutiji
English: Pack size l t o r
Croatian: Veličina pakovanja k i
English: EMA Number
Croatian: EMA broj postupka (Zaštićeno) name
English: • you are pregnant.
Croatian: • ako ste trudni.
English: Kaplan-Meier estimates.
Croatian: Kaplan-Meierove procjene.
English: The results of these pre-specified analyses are as follows:
Croatian: Rezultati tih unaprijed određenih analiza su sljedeći:
English: • problems with the eyes (including increased production of tears),
Croatian: • probleme s očima (uključujući pojačano stvaranje suza),
English: Currently available data are described in sections 4.8, 5.1 and 5.2, but no recommendation on a posology can be made.
Croatian: Trenutno dostupni podaci opisani su u dijelovima 4.8, 5.1 i 5.2, međutim nije moguće dati preporuku o doziranju.
English: • or through an evaluation of individual case reports.
Croatian: • ili ocjenom izvješća o pojedinačnim slučajevima.
English: • changes in speech,
Croatian: • promjene govora,
English: • lack of energy,
Croatian: • nedostatak energije,
English: • epidemiological studies/non-interventional or observational studies,
Croatian: • iz epidemioloških ispitivanja odnosno neintervencijskih ili opservacijskih ispitivanja,
English: Blinded independent review (protocol-defined primary analysis).
Croatian: Blinded independent review) (protokolom definirana primarna analiza).
English: You will be treated with MVASI once every 2 or 3 weeks.
Croatian: MVASI ćete primati jedanput svaka 2 ili 3 tjedna.
English: There were no objective (partial or complete) radiological responses (MacDonald criteria).
Croatian: Nije bilo objektivnog (parcijalnog ili potpunog) radiološkog odgovora (kriterij po MacDonaldu).
English: What MVASI is and what it is used for
Croatian: Što je MVASI i za što se koristi
English: Subject to a p-value boundary of 0.0116.
Croatian: Ovisno o graničnoj p-vrijednosti od 0,0116.
English: • your doctor will decide when you should be given your next dose of MVASI.
Croatian: • Vaš će liječnik odlučiti kada trebate dobiti sljedeću dozu lijeka MVASI.
English: • loss of body weight,
Croatian: • gubitak tjelesne težine,
English: 6 - 12 months (n = 202) Median
Croatian: 6 - 12 mjeseci (n = 202) Medijan
English: Overall survival (final analysis)***
Croatian: Ukupno preživljenje (završna analiza)***
English: Observed in paediatric population only.
Croatian: Zabilježena samo u pedijatrijskoj populaciji.
English: Patients older than 65 years have an increased risk of experiencing the following side effects:
Croatian: Bolesnici stariji od 65 godina imaju povećani rizik od sljedećih nuspojava:
English: • spontaneous reporting,
Croatian: • iz spontanih prijava,
English: Patients included in analysis
Croatian: Bolesnici obuhvaćeni analizom
English: Key efficacy results for the superiority analysis (ITT population, trial NO16966)
Croatian: Ključni rezultati djelotvornosti za analizu superiornosti (ITT populacija, ispitivanje NO16966)
English: This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Croatian: Ovaj se lijek ne smije miješati s drugim lijekovima, osim onih navedenih u dijelu 6.6.
English: Tumour assessments and response evaluations were determined by the investigators using the GOG RECIST criteria (Revised RECIST guideline (version 1.1).
Croatian: Ocjene tumora i procjene odgovora provodili su ispitivači na temelju GOG RECIST kriterija (Revidirana RECIST smjernica (verzija 1.1).
English: Best overall response - Primary analysis6
Croatian: Najbolji ukupni odgovor - Primarna analiza6
English: Some of these reactions have resulted in various degrees of visual loss, including permanent blindness.
Croatian: Neke od ovih reakcija imale su za posljedicu gubitak vida različitog stupnja, uključujući i trajnu sljepoću.
English: Do not use MVASI if:
Croatian: Nemojte primati MVASI:
English: If you have high blood pressure which is not well controlled with blood pressure medicines, please consult your doctor as it is important to make sure that your blood pressure is under control before starting MVASI treatment.
Croatian: Ako imate visok krvni tlak koji nije dobro reguliran lijekovima, posavjetujte se sa svojim liječnikom jer je važno osigurati da Vam je krvni tlak reguliran prije početka liječenja lijekom MVASI.
English: What MVASI looks like and contents of the pack
Croatian: Kako MVASI izgleda i sadržaj pakiranja
English: The adverse reactions listed in this section fall into the following frequency categories: Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).
Croatian: Nuspojave navedene u ovom dijelu mogu se svrstati u sljedeće kategorije učestalosti: vrlo često (≥ 1/10); često (≥ 1/100 i < 1/10); manje često (≥ 1/1000 i < 1/100); rijetko (≥ 1/10 000 i < 1/1000); vrlo rijetko (< 1/10 000); nepoznato (ne može se procijeniti iz dostupnih podataka).
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA PC
Croatian: JEDINSTVENI IDENTIFIKATOR - PODACI ČITLJIVI LJUDSKIM OKOM PC:
English: Other medicines and MVASI
Croatian: Drugi lijekovi i MVASI
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 15 January 2018
Croatian: Datum prvog odobrenja: 15. siječnja 2018.
English: Terms represent a group of events that describe a medical concept rather than a single condition or MedDRA (Medical Dictionary for Regulatory Activities) preferred term.
Croatian: Pojmovi označavaju skup događaja koji opisuju određeni medicinski koncept, a ne pojedinačno stanje ili preporučeni pojam prema Medicinskom rječniku za regulatorne poslove (MedDRA).
English: MVASI use is not recommended in children and adolescents under the age of 18 years because the safety and benefit have not been established in these patient populations.
Croatian: MVASI se ne preporučuje za primjenu u djece i adolescenata mlađih od 18 godina jer sigurnost i korist liječenja nisu ustanovljeni u toj populaciji bolesnika.
English: p-value (Chi-squared test)
Croatian: p-vrijednost (hi-kvadrat test)
English: Final analysis
Croatian: Završna analiza.
English: MVASI may also cause changes in laboratory tests carried out by your doctor.
Croatian: MVASI može uzrokovati i promjene u rezultatima laboratorijskih testova na koje Vas šalje liječnik.
English: Severe side effects of unknown frequency (frequency cannot be estimated from the available data), include:
Croatian: Teške nuspojave nepoznate učestalosti (učestalost se ne može procijeniti iz dostupnih podataka) uključuju:
English: The dose of MVASI needed depends on your body weight and the kind of cancer to be treated.
Croatian: Potrebna doza lijeka MVASI ovisi o Vašoj tjelesnoj težini i vrsti raka koji se liječi.
English: The incidence of adverse events, including grade ≥ 3 adverse events and serious adverse events, was similar between the two treatment arms.
Croatian: Incidencija štetnih događaja, uključujući štetne događaje stupnja ≥ 3 i ozbiljne štetne događaje, bila je slična u obje liječene skupine.
English: When bevacizumab is injected directly into the eye (unapproved use), the following side effects may occur:
Croatian: Kada se bevacizumab injicira izravno u oko (neodobrena primjena), mogu se javiti sljedeće nuspojave:
English: Name and address of the manufacturer of the biological active substance Amgen Inc
Croatian: Naziv i adresa proizvođača biološke djelatne tvari Amgen Inc
English: *** The final analysis of overall survival was performed when 266 deaths, which account for 73.7% of enrolled patients, were observed.
Croatian: *** Završna analiza ukupnog preživljenja provedena je nakon što je umrlo 266 bolesnica, što predstavlja 73,7% uključenih bolesnica.
English: It rarely resulted in discontinuation of bevacizumab treatment or hospitalisation.
Croatian: Rijetko je došlo do prekida liječenja bevacizumabom ili hospitalizacije.
English: If not used immediately, in-use storage times and conditions are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Croatian: Ako se ne primijeni odmah, za trajanje i uvjete čuvanja do primjene lijeka odgovoran je korisnik te ono obično ne smije biti dulje od 24 sata na temperaturi od 2°C do 8°C, osim ako je razrjeđivanje provedeno u kontroliranim i validiranim aseptičkim uvjetima.
English: However two of the randomised patients discontinued the study before receiving any study treatment.
Croatian: Međutim, dva su randomizirana bolesnika prekinula sudjelovanje u ispitivanju prije nego što su primila bilo koju ispitivanu terapiju.
English: Based on a substudy from NSABP C-08 with 295 patients.
Croatian: Na temelju podataka iz podispitivanja u okviru ispitivanja NSABP C-08 s 295 bolesnica.
English: You should discuss this with your doctor.
Croatian: Porazgovarajte o tome sa svojim liječnikom.
English: Primary analysis was performed with a data cut-off date of 12 December 2012 and is considered the final analysis.
Croatian: Primarna analiza provedena je na temelju podataka prikupljenih do 12. prosinca 2012. i smatra se završnom analizom.
English: The addition of bevacizumab to FOLFOX-4 resulted in a statistically significant prolongation of survival.
Croatian: Dodatak bevacizumaba protokolu FOLFOX-4 rezultirao je statistički značajnim produljenjem preživljenja.
English: • Bleeding in the eye.
Croatian: • krvarenje u oku.
English: • you are allergic (hypersensitive) to bevacizumab or to any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični (preosjetljivi) na bevacizumab ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: • abnormally high blood pressure in the blood vessels of the lungs which makes the right side of the heart work harder than normal,
Croatian: • abnormalno visok krvni tlak u krvnim žilama pluća zbog čega desna strana srca mora raditi više nego inače,
English: The population pharmacokinetics were analysed in adult and paediatric patients to evaluate the effects of demographic characteristics.
Croatian: U odraslih i pedijatrijskih bolesnika analizirana je populacijska farmakokinetika kako bi se procijenili učinci demografskih karakteristika.
English: • you may develop a severe migraine.
Croatian: • možete dobiti jaku migrenu.
English: • The risk of developing blood clots in your arteries (a type of blood vessel) can increase if you are over 65 years old, if you have diabetes, or if you have had previous blood clots in your arteries.
Croatian: • Rizik od nastanka krvnih ugrušaka u arterijama (vrsta krvnih žila) može se povećati ako ste stariji od 65 godina, ako imate šećernu bolest ili ako ste u prošlosti imali krvne ugruške u arterijama.
English: Objective response rate (ORR)
Croatian: Stopa objektivnog odgovora (ORR)
English: Interferon alfa-2a 9 MIU 3x/week.
Croatian: Interferon alfa-2a 9 milijuna IU 3 puta tjedno.
English: MVASI is a biosimilar medicinal product.
Croatian: MVASI je biosličan lijek.
English: The incidence varied between 10% (4/40) and 20%
Croatian: Incidencija je varirala između 10% (4/40) i 20% (3/15).
English: MVASI may cause damage to your unborn baby as it may stop the formation of new blood vessels.
Croatian: MVASI može naškoditi nerođenom djetetu jer može zaustaviti stvaranje novih krvnih žila.
English: The safety and efficacy of concomitant administration of radiotherapy and bevacizumab has not been established.
Croatian: Nisu ustanovljene sigurnost i djelotvornost istodobne primjene radioterapije i bevacizumaba.
English: • It is possible that MVASI can cause hypersensitivity and/or infusion reactions (reactions related to your injection of the medicine).
Croatian: • MVASI može prouzročiti reakcije preosjetljivosti i/ili infuzijske reakcije (reakcije povezane s injiciranjem lijeka).
English: • change in the sense of taste,
Croatian: • promjene osjeta okusa,
English: MVASI should be permanently discontinued if medically significant hypertension cannot be adequately controlled with antihypertensive therapy, or if the patient develops hypertensive crisis or hypertensive encephalopathy.
Croatian: MVASI treba trajno obustaviti ako se medicinski značajna hipertenzija ne može odgovarajuće kontrolirati antihipertenzivima, ili ako se u bolesnika razvije hipertenzivna kriza ili hipertenzivna encefalopatija.
English: In Part II, treatment assignment was double-blind with respect to bevacizumab.
Croatian: U dijelu II je randomizacija bolesnika bila dvostruko slijepa s obzirom na bevacizumab.
English: CT + BV
Croatian: KT+BV
English: • infection, and in particular infection in the blood or bladder,
Croatian: • infekcije, a osobito infekcije krvi ili mokraćnog mjehura,
English: Your doctor should advise you about using contraception during treatment with MVASI and for at least 6 months after the last dose of MVASI.
Croatian: Liječnik bi Vas trebao savjetovati o uporabi kontracepcije tijekom liječenja lijekom MVASI i najmanje 6 mjeseci nakon posljednje doze lijeka MVASI.
English: MVASI is for single-use only, as the product contains no preservatives.
Croatian: MVASI je namijenjen samo za jednokratnu primjenu jer ne sadrži konzervanse.
English: There is no information on the effect of bevacizumab in patients with uncontrolled hypertension at the time of initiating therapy.
Croatian: Nema informacija o učinku bevacizumaba na bolesnike s nekontroliranom hipertenzijom u vrijeme početka liječenja.
English: No adverse events leading to death occurred in either treatment arm; all deaths were attributed to disease progression.
Croatian: Niti u jednoj skupini nisu nastupili štetni događaji koji bi doveli do smrti; svi smrtni ishodi pripisani su progresiji bolesti.
English: Common (may affect up to 1 in 10 people) side effects, which were not severe, include: • voice changes and hoarseness.
Croatian: Česte (mogu se javiti u do 1 na 10 osoba) nuspojave koje nisu bile teške uključuju: • promjene glasa i promuklost.
English: The median age of patients was 61.0 (range: 25-84) years.
Croatian: Medijan dobi bolesnica bio je 61,0 godinu (raspon 25-84 godine).
English: XELOX or
Croatian: XELOX ili
English: • MVASI increases the risk of having protein in your urine especially if you already have high blood pressure.
Croatian: • MVASI povećava rizik od pojave proteina u mokraći, posebno ako već imate visok krvni tlak.
English: In one clinical trial, the incidence of hypertension of grade ≥ 3 was two fold higher in patients aged > 65 years than in the younger age group (< 65 years).
Croatian: U jednom je kliničkom ispitivanju incidencija hipertenzije stupnja ≥ 3 bila dvostruko veća u bolesnika starijih od 65 godina nego u mlađoj dobnoj skupini (< 65 godina).
English: • shortness of breath or low levels of oxygen in the blood,
Croatian: • nedostatak zraka ili nisku razinu kisika u krvi,
English: 95% CI for one sample binomial using Pearson-Clopper method.
Croatian: 95% CI za binomski test na jednom uzorku primjenom Pearson-Clopperove metode.
English: Your doctor will prescribe a dose of MVASI that is right for you.
Croatian: Liječnik će propisati dozu lijeka MVASI koja je primjerena za Vas.
English: MVASI is not approved for use in patients under the age of 18 years.
Croatian: MVASI nije odobren za primjenu u bolesnika mlađih od 18 godina.
English: A doctor or nurse will give you this diluted MVASI solution by intravenous infusion (a drip into your vein).
Croatian: Liječnik ili medicinska sestra će Vam tu razrijeđenu otopinu lijeka MVASI dati intravenskom infuzijom (kapanjem u venu).
English: What you need to know before you use MVASI
Croatian: Što morate znati prije nego počnete primati MVASI
English: There is insufficient information to determine the safety and efficacy of bevacizumab in children with newly diagnosed high-grade glioma.
Croatian: Nema dovoljno informacija na temelju kojih bi se utvrdila sigurnost i djelotvornost bevacizumaba u djece s novodijagnosticiranim gliomom visokog stupnja malignosti.
English: A total of 484 patients with measurable disease were randomised 1:1 to either:
Croatian: Ukupno je randomizirano 484 bolesnica s mjerljivom bolešću u omjeru 1:1 da primaju:
English: Objective response rate**
Croatian: Stopa objektivnog odgovora**
English: For further information on proteinuria see section 4.4 and Proteinuria in section 4.8
Croatian: Za dodatne informacije o proteinuriji vidjeti dio 4.4 i Proteinurija u dijelu 4.8