FrancophonIA/ELRC3.0 huggingface dataset:
English: • Decreased or increased blood pressure
Croatian: • sniženi ili povišeni krvni tlak
English: Over 99% of patients had an ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1.
Croatian: Više od 99% bolesnika imalo je status općeg zdravlja prema ECOG-u (Eastern Cooperative Oncology Group) 0 ili 1.
English: The primary efficacy endpoint was overall survival (OS).
Croatian: Primarni ishod djelotvornosti bilo je sveukupno preživljenje (OS).
English: The reconstituted dispersion should be milky and homogenous without visible precipitates.
Croatian: Rekonstituirana disperzija treba biti mliječne boje i homogena, bez vidljivih taloga.
English: If you are given other medicines as part of your treatment, you should ask your doctor for advice on driving and using machines.
Croatian: Ako ste dobili druge lijekove kao dio svog liječenja, trebate pitati svog liječnika za savjet u vezi s vožnjom i rukovanjem strojevima.
English: Reconstitution of 100 mg:
Croatian: Rekonstitucija 100 mg:
English: Seventy-seven percent of the patients had been previously exposed to anthracyclines.
Croatian: Sedamdeset sedam posto bolesnika bilo je prethodno izloženo antraciklinima.
English: Rare: Extravasation
Croatian: Rijetko: ekstravazacija
English: Gemcitabine (N=430)
Croatian: Gemcitabin (N = 430)
English: Your doctor or pharmacist is responsible for disposing of any unused Pazenir correctly.
Croatian: Vaš liječnik ili ljekarnik odgovoran je za pravilno zbrinjavanje neupotrijebljenog lijeka Pazenir.
English: 2 Year
Croatian: 2 godine
English: This includes medicines obtained without a prescription, including herbal medicines.
Croatian: To se odnosi i na lijekove koje ste nabavili bez recepta, uključujući biljne pripravke.
English: Febrile Neutropenia:
Croatian: Febrilna neutropenija:
English: What Pazenir looks like and contents of the pack
Croatian: Kako Pazenir izgleda i sadržaj pakiranja
English: 1The frequency of hypersensitivity reactions is calculated based on one definitely related case in a population of 789 patients.
Croatian: 1 Učestalost reakcija preosjetljivosti izračunata je na temelju jednog jasno povezanog slučaja u populaciji od 789 bolesnika.
English: This stability results in the inhibition of the normal dynamic reorganisation of the microtubule network that is essential for vital interphase and mitotic cellular functions.
Croatian: Ta stabilnost rezultira inhibicijom normalne dinamičke reorganizacije mreže mikrotubula koja je ključna za vitalnu interfazu i mitotske funkcije stanice.
English: This is because Pazenir can affect the way some other medicines work.
Croatian: Tako je zbog toga što Pazenir može utjecati na način djelovanja nekih drugih lijekova.
English: This means that other chemicals that can cause side effects that can be life threatening are not needed.
Croatian: To znači da nisu potrebne druge kemijske tvari koje mogu izazvati nuspojave, a koje bi mogle ugroziti život.
English: • Depression, sleep problems
Croatian: • depresija, teškoće sa spavanjem
English: Pazenir is used to treat the following types of cancer:
Croatian: Pazenir koristi se za liječenje ovih vrsta raka:
English: Limiting the infusion of Pazenir to 30 minutes, as directed, reduces the likelihood of infusion-related reactions.
Croatian: Ograničavanje trajanja infuzije lijeka Pazenir na 30 minuta, kao što je preporučeno, smanjuje vjerojatnost reakcija povezanih s infuzijom.
English: A non-inferiority analysis was conducted for PFS and OS, with a pre-specified non-inferiority margin of 15%.
Croatian: Provedena je analiza neinferiornosti za PFS i OS uz prethodno određenu granicu neinferiornosti od 15%.
English: In addition, elimination of paclitaxel shows an inverse correlation with total bilirubin and a positive correlation with serum albumin.
Croatian: Osim toga, eliminacija paklitaksela pokazuje obrnutu korelaciju s ukupnim bilirubinom, a pozitivnu korelaciju sa serumskim albuminom.
English: Patients should be advised not to drive and use machines if they feel tired or dizzy.
Croatian: Bolesnike treba savjetovati da ne upravljaju vozilima i ne rade na strojevima ako osjete umor ili omaglicu.
English: • A disorder of the electrical conduction system of the heart (atrioventricular block)
Croatian: • poremećaj sustava električne provodljivosti srca (atrioventrikularni blok).
English: Based on findings in animals, male and female fertility may be compromised.
Croatian: Na temelju nalaza u životinja, moguće je smanjenje muške i ženske plodnosti.
English: Lymphopenia was observed in 45% of the patients.
Croatian: Limfopenija je opažena u 45% bolesnika.
English: Most of the individuals were previously exposed to cardiotoxic medicinal products such as anthracyclines, or had underlying cardiac history.
Croatian: Većina tih osoba bila je prethodno izložena kardiotoksičnim lijekovima, kao što su antraciklini, ili je imala već postojeću anamnezu bolesti srca.
English: Patients were treated without steroid pre-treatment or planned G-CSF support.
Croatian: Bolesnici su liječeni bez premedikacije steroidima ili planiranom potpornom primjenom G-CSF-a (engl. granulocyte colony stimulating factor).
English: If a patient becomes febrile (regardless of neutrophil count), initiate treatment with broad spectrum antibiotics.
Croatian: Ako bolesnik razvije vrućicu (bez obzira na broj neutrofila), treba započeti liječenje antibioticima širokog spektra.
English: Given the possibility of extravasation, it is advisable to closely monitor the infusion site for possible infiltration during administration of the medicinal product.
Croatian: S obzirom na mogućnost ekstravazacije, savjetuje se pomno nadziranje mjesta infuzije zbog moguće infiltracije tijekom primjene lijeka.
English: Treatment was administered until disease progression or development of an unacceptable toxicity.
Croatian: Liječenje se provodilo do progresije bolesti ili razvoja neprihvatljive toksičnosti.
English: The generation of foam must be avoided.
Croatian: Mora se izbjeći stvaranje pjene.
English: • Difficulty in breathing
Croatian: • poteškoće u disanju
English: Delay doses until recovery
Croatian: Odgoda doza do oporavka
English: Overall Response Rate (independent review)
Croatian: Ukupna stopa odgovora (neovisna procjena)
English: For the other subscale (oedema), there was no difference in the treatment arms.
Croatian: Za drugu podljestvicu (edem) nije bilo razlike između liječenih skupina.
English: Talk to your doctor or nurse if you experience any of these conditions whilst being treated with Pazenir, your doctor may wish to stop treatment or reduce the dose:
Croatian: Obratite se liječniku ili medicinskoj sestri ako tijekom liječenja lijekom Pazenir opazite bilo koje od ovih stanja; liječnik će možda htjeti prekinuti liječenje ili smanjiti dozu:
English: Paclitaxel and gemcitabine do not share a common metabolic pathway.
Croatian: Paklitaksel i gemcitabin nemaju zajednički metabolički put.
English: Use of filters with a pore size less than 15 µm may result in blockage of the filter.
Croatian: Uporaba filtara s otvorima veličine manje od 15 µm može za posljedicu imati začepljenje filtra.
English: Like all medicines, this medicine can cause side effects, although not everyone gets them.
Croatian: Moguće nuspojave Kao i svi lijekovi, ovaj lijek može uzrokovati nuspojave iako se one neće javiti kod svakoga.
English: Then, the vial should gently and slowly be swirled and/or inverted for at least 2 minutes until complete redispersion of any powder occurs.
Croatian: Potom bočicu treba nježno i polako okretati i/ili prevrtati najmanje 2 minute sve do potpune redisperzije praška.
English: Randomised comparative study
Croatian: Randomizirano komparativno ispitivanje
English: Patients with pre-existing neuropathy of Grade ≥ 2 or serious medical risk factors involving any of the major organ systems were excluded.
Croatian: Bolesnici s postojećom neuropatijom ≥ 2. stupnja ili ozbiljnim medicinskim čimbenicima rizika koji su uključivali bilo koji od glavnih organskih sustava, bili su isključeni.
English: 2D bar code carrying the unique identifier
Croatian: Sadrži 2D barkod s jedinstvenim identifikatorom.
English: Powder for dispersion for infusion.
Croatian: Prašak za disperziju za infuziju.
English: Do not breast feed when taking Pazenir as it is not known if the active ingredient paclitaxel passes into the mother's milk.
Croatian: Nemojte dojiti za vrijeme primjene lijeka Pazenir jer nije poznato prelazi li djelatna tvar paklitaksel u majčino mlijeko.
English: • if you have severe liver problems;
Croatian: • ako imate teške probleme s jetrom;
English: Very rare: Stevens-Johnson syndrome2, toxic epidermal necrolysis2
Croatian: Vrlo rijetko: Stevens-Johnsonov sindrom2, toksična epidermalna nekroliza2
English: Post-marketing experience
Croatian: Postmarketinško razdoblje
English: Myelosuppression events, peripheral neuropathy events, and arthralgia were more frequent in patients 65 years or older compared to patients younger than 65 years of age.
Croatian: Događaji mijelosupresije, periferne neuropatije i artralgije bili su češći u bolesnika u dobi od 65 ili više godina u usporedbi s bolesnicima mlađim od 65 godina.
English: Pazenir is for intravenous use.
Croatian: Pazenir je za intravensku primjenu.
English: Paclitaxel may cause serious birth defects and should therefore not be used if you are pregnant.
Croatian: Paklitaksel može uzrokovati ozbiljne urođene mane te ga stoga ne smijete uzimati ako ste trudni.
English: Teva Nederland B.V. (additional entity) Swensweg 5
Croatian: Teva Nederland B.V. (dodatna tvrtka) Swensweg 5
English: Pharmacokinetic interactions between Pazenir and gemcitabine have not been evaluated in humans.
Croatian: Farmakokinetičke interakcije između lijeka Pazenir i gemcitabina nisu procijenjene u ljudi.
English: Take care and speak to your doctor when taking Pazenir at the same time as any of the following:
Croatian: Budite oprezni i posavjetujte se s liječnikom kada primjenjujete Pazenir istodobno s nekim od sljedećih lijekova:
English: Neutropenia was the most notable important haematological toxicity (reported in 79% of patients), and was rapidly reversible and dose dependent; leukopenia was reported in 71% of patients.
Croatian: Neutropenija je bila najuočljivija važna hematološka toksičnost (prijavljena u 79% bolesnika) te je bila lako reverzibilna i ovisna o dozi; leukopenija je prijavljena u 71% bolesnika.
English: • medicines for treating infections (i.e. antibiotics such erythromycin, rifampicin, etc.; ask your doctor, nurse or pharmacist if you are unsure whether the medicine you are taking is an antibiotic), and including medicines for treating fungal infections (e.g. ketoconazole)
Croatian: • lijekovi za liječenje infekcija (tj. antibiotici kao što su eritromicin, rifampicin, itd.; provjerite s liječnikom, medicinskom sestrom ili ljekarnikom ako niste sigurni je li lijek koji uzimate antibiotik), uključujući lijekove za liječenje gljivičnih infekcija (npr. ketokonazol)
English: Pazenir will be given to you by a doctor or nurse into a vein from an intravenous drip.
Croatian: Pazenir davat će Vam liječnik ili medicinska sestra u venu putem infuzije.
English: Gloves, goggles and protective clothing should be used.
Croatian: Moraju se koristiti rukavice, zaštitne naočale i zaštitna odjeća.
English: • if you have poor kidney function;
Croatian: • ako imate oslabljenu funkciju bubrega;
English: Your doctor will arrange a pregnancy test before starting treatment with Pazenir.
Croatian: Vaš će liječnik dogovoriti testiranje na trudnoću prije početka liječenja lijekom Pazenir.
English: Complications due to the underlying pancreatic cancer, especially biliary obstruction or presence of biliary stent, were identified as significant contributing factors.
Croatian: Komplikacije zbog osnovnog karcinoma pankreasa, osobito bilijarna opstrukcija ili prisutnost bilijarnog stenta, ustanovljene su kao značajan dodatni čimbenik.
English: 2Maximum of 7 days post scheduled Day 1 dose of next cycle.
Croatian: 2Najviše 7 dana poslije predviđenog 1. dana sljedećeg ciklusa.
English: Use of a 15 µm filter removes strands and does not change the physical or chemical properties of the reconstituted product.
Croatian: Uporabom filtra od 15 µm postiže se uklanjanje vlakana, a fizikalna ili kemijska svojstva rekonstituiranog lijeka nisu promijenjena.
English: Day 15
Croatian: 15. dan
English: • Dehydration, taste disturbance, weight loss
Croatian: • dehidracija, poremećaj okusa, gubitak težine
English: Fifty-nine percent received study medicinal product as second or greater than second-line therapy.
Croatian: Pedeset i devet posto primilo je ispitivani lijek kao drugu ili sljedeću po redu liniju liječenja.
English: Following recurrence of severe neutropenia or severe sensory neuropathy, additional dose reduction should be made to 180 mg/m2.
Croatian: U slučaju ponavljanja teške neutropenije ili teške senzorne neuropatije potrebno je dodatno smanjiti dozu na 180 mg/m2.
English: The occurrence of Grade 1 or 2 sensory neuropathy does not generally require dose reduction.
Croatian: Pojava senzorne neuropatije 1. ili 2. stupnja obično ne zahtijeva smanjenje doze.
English: If precipitates or settling are visible, the vial should be gently inverted again to ensure complete redispersion prior to use.
Croatian: Ako su nakupine ili talozi vidljivi, bočicu treba ponovno nježno preokrenuti da bi se osigurala potpuna redisperzija prije primjene.
English: Pazenir should not be used in pregnancy, and in women of childbearing potential not using effective contraception, unless the clinical condition of the mother requires treatment with paclitaxel.
Croatian: Pazenir se ne smije primjenjivati tijekom trudnoće kao ni u žena reproduktivne dobi koje ne koriste učinkovitu kontracepciju, osim ako kliničko stanje trudnice ne zahtijeva liječenje paklitakselom.
English: Reduce doses 1 dose level
Croatian: Smanjenje doza za 1 razinu
English: Neutropenia is dose-dependent and a dose-limiting toxicity.
Croatian: Neutropenija je toksičnost ovisna o dozi, ali isto tako toksičnost koja uvjetuje ograničenje doze.
English: Other medicines and Pazenir
Croatian: Drugi lijekovi i Pazenir
English: If not used immediately, in-use storage times and conditions are the responsibility of the user.
Croatian: Ako se ne primijeni odmah, za vrijeme i uvjete čuvanja disperzije u primjeni odgovoran je korisnik.
English: Patients received a median of 6 cycles of treatment in both study arms.
Croatian: U obje skupine bolesnici su primili medijan od 6 ciklusa liječenja.
English: Patients with high cardiovascular risk, history of peripheral artery disease and/or of connective tissue disorders and/or interstitial lung disease were excluded from the study.
Croatian: Bolesnici u kojih postoji visoki rizik od kardiovaskularnih bolesti, bolest perifernih arterija u anamnezi, i/ili poremećaji vezivnog tkiva i/ili intersticijska bolest pluća, bili su isključeni iz ispitivanja.
English: For patients of 75 years and older, no benefit for the combination treatment of Pazenir and gemcitabine in comparison to gemcitabine monotherapy has been demonstrated.
Croatian: Za bolesnike u dobi od 75 i više godina nije dokazana korist od liječenja kombinacijom lijeka Pazenir i gemcitabina, u usporedbi s monoterapijom gemcitabinom.
English: Paclitaxel may cause adverse reactions such as tiredness (very common) and dizziness (common) that may affect the ability to drive and use machinery.
Croatian: Paklitaksel može uzrokovati nuspojave kao što su umor (vrlo često) i omaglica (često) koji mogu utjecati na sposobnost vožnje i rada na strojevima.
English: a P-value is based on a chi-square test.
Croatian: P-vrijednost se temelji na hi-kvadrat testu
English: Figure 1: Kaplan-Meier curve of overall survival (intent-to-treat population)
Croatian: Slika 1: Kaplan-Meierova krivulja sveukupnog preživljenja (populacija s namjerom liječenja)
English: This medicine has not been studied in children and adolescents, as breast cancer, pancreatic cancer and lung cancer do not occur in these age groups.
Croatian: Ovaj lijek nije ispitan u djece i adolescenata jer se rak dojke, rak gušterače i rak pluća ne javljaju u tim dobnim skupinama.
English: Because these events have been reported voluntarily during clinical practice, true estimates of frequency cannot be made and a causal relationship to the events has not been established.
Croatian: Budući da su ti događaji prijavljeni spontano tijekom kliničke prakse, nije bilo moguće uspostaviti uzročnu povezanost s događajima te procijeniti stvarnu učestalost.
English: Gastrointestinal disorders Nausea occurred in 29% of the patients and diarrhoea in 25% of the patients.
Croatian: Gastrointestinalni poremećaji Mučnina se javila u 29% bolesnika, a proljev u 25% bolesnika.
English: • Very slow pulse, heart attack
Croatian: • jako usporeni puls, srčani udar
English: Overall Response Rate
Croatian: Stopa sveukupnog odgovora
English: Cycles were administered at 3 week intervals.
Croatian: Ciklusi su primjenjivani u trotjednim vremenskim intervalima.
English: • Small bleedings in your skin due to blood clots
Croatian: • mala krvarenja u koži zbog krvnih ugrušaka
English: The non-inferiority criterion was met for both PFS and OS with the upper bound of the 95% confidence interval for the associated hazard ratios being less than 1.176 (Table 13).
Croatian: Kriterij neinferiornosti ispunjen je i za PFS i OS, s tim da je gornja granica intervala pouzdanosti od 95% za povezane omjere hazarda iznosila manje od 1,176 (tablica 13).
English: • Reduction in all blood cell counts
Croatian: • smanjenje broja svih krvnih stanica
English: CNS metastases are generally not well controlled by systemic chemotherapy.
Croatian: Metastaze u središnjem živčanom sustavu obično se ne mogu dobro kontrolirati primjenom sistemske kemoterapije.
English: 16% had a Karnofsky Performance Status of 100; 42% had a KPS of 90; 35% had a KPS of 80; 7% had a KPS of 70; and <1% of patients had a KPS of below 70.
Croatian: U 16% bolesnika funkcionalni status prema Karnofskyju (KPS) iznosio je 100; 42% imalo je KPS od 90; 35% KPS od 80; 7% KPS od 70; a < 1% bolesnika imalo je KPS manji od 70.
English: Pharmacotherapeutic group: Antineoplastic agents, plant alkaloids and other natural products, taxanes, ATC Code: L01CD01
Croatian: Farmakoterapijska skupina: antineoplastici, biljni alkaloidi i drugi prirodni pripravci, taksani, ATK oznaka: L01CD01
English: Patients with hepatic impairment may be at increased risk of toxicity, particularly from myelosuppression; such patients should be closely monitored for development of profound myelosuppression.
Croatian: U bolesnika s oštećenjem jetrene funkcije može postojati povećani rizik za razvoj toksičnosti, osobito mijelosupresije; takve bolesnike treba pomno nadzirati zbog mogućeg razvoja izrazite mijelosupresije.
English: There is no known antidote for paclitaxel overdose.
Croatian: Nije poznat antidot za predoziranje paklitakselom.
English: Instructions for use, handling and disposal Preparation and administration precautions
Croatian: Upute za uporabu, rukovanje i zbrinjavanje Priprema i mjere opreza kod primjene
English: • Loss of hair (the majority of cases of hair loss happened less than one month after starting paclitaxel.
Croatian: • gubitak kose (u većini slučajeva gubitak kose pojavio se za manje od mjesec dana od početka uzimanja paklitaksela, a kada se dogodi, gubitak kose je izrazit (više od 50%) u većine bolesnika)
English: The reconstituted dispersion has a pH of 6-7.5 and an osmolality of 300-360 mOsm/kg.
Croatian: Rekonstituirana disperzija ima pH od 6 do 7,5 te osmolalnost od 300 do 360 mOsm/kg.
English: • medicines used to help you stabilize your mood also sometimes referred to as anti-depressants (e.g. fluoxetine)
Croatian: • lijekovi koji pomažu stabilizirati raspoloženje poznati kao antidepresivi (npr. fluoksetin)
English: 30 minutes on Days 1, 8 and 15 of each 21-day cycle.
Croatian: 1., 8. i 15. dana svakog 21-dnevnog ciklusa.
English: • A condition involving destruction of red blood cells and acute kidney failure
Croatian: • stanje koje uključuje uništavanje crvenih krvnih stanica i akutno zatajenje bubrega.
English: Although limited data is available, no clear benefit in terms of prolonged overall survival has been demonstrated in pancreatic adenocarcinoma patients with normal CA 19-9 levels prior to start of treatment with Pazenir and gemcitabine (see section 5.1).
Croatian: Iako postoje ograničeni podaci, nije dokazana jasna korist s obzirom na produljeno opće preživljenje u bolesnika s adenokarcinomom pankreasa i normalnim razinama CA 19-9 prije početka terapije lijekom Pazenir i gemcitabinom (vidjeti dio 5.1).
English: The response rates in all patients were 39.5% (95% CI: 24.9%54.2%) and 47.6% (95% CI: 35.3%-60.0%), respectively.
Croatian: Stope odgovora u svih bolesnika iznosile su 39,5% (95% CI: 24,9%-54,2%) i 47,6% (95% CI: 35,3%-60,0%).
English: Rare occurrences of severe hypersensitivity reactions, including very rare events of anaphylactic reactions with fatal outcome, have been reported.
Croatian: Prijavljene su rijetke pojave teških reakcija preosjetljivosti, uključujući vrlo rijetke anafilaktičke reakcije sa smrtnim ishodom.
English: • Increased liver function tests
Croatian: • povišene vrijednosti pretraga funkcije jetre
English: Because of potential serious adverse reactions in breast-feeding infants, Pazenir is contraindicated during lactation.
Croatian: S obzirom na moguće ozbiljne nuspojave u dojenčadi na majčinom mlijeku, Pazenir je kontraindiciran tijekom laktacije.
English: There was no evidence for accumulation of paclitaxel with multiple treatment courses.
Croatian: Nije bilo dokaza akumulacije paklitaksela tijekom više ciklusa liječenja.
English: Do not administer the reconstituted dispersion if particulate matter is observed in the vial.
Croatian: Nemojte primijeniti rekonstituiranu disperziju ako u bočici primijetite čestice.
English: Patients weighing 50 kg had paclitaxel AUC approximately 25% lower than those weighing 75 kg.
Croatian: U bolesnika težine 50 kg vrijednosti AUC-a paklitaksela bile su približno 25% niže nego u bolesnika težine 75 kg.
English: • Pazenir is used in non-small cell lung cancer where surgery or radiotherapy would not be suitable to treat the disease.
Croatian: • Pazenir koristi se za liječenje raka pluća nemalih stanica kada kirurški zahvat ili radioterapija ne bi bili pogodni za liječenje bolesti.
English: Pancreatic adenocarcinoma (Pazenir administered in combination with gemcitabine)
Croatian: Adenokarcinom pankreasa (Pazenir primijenjen u kombinaciji s gemcitabinom)
English: • Leaking of drug outside the vein
Croatian: • istjecanje lijeka izvan vene
English: The primary efficacy endpoint was overall response rate defined as the percentage of patients who achieved an objective confirmed complete response or partial response based on an independent, central, blinded radiological review using RECIST (Version 1.0).
Croatian: Primarna mjera ishoda djelotvornosti bila je ukupna stopa odgovora definirana kao postotak bolesnika koji su postigli objektivno potvrđen potpuni odgovor ili djelomični odgovor prema slijepoj neovisnoj središnjoj radiološkoj procjeni na temelju smjernica RECIST (verzija 1.0).
English: Also, some other medicines can affect the way Pazenir works.
Croatian: Osim toga, drugi lijekovi mogu utjecati na način na koji djeluje Pazenir.
English: Paclitaxel is suspected to cause serious birth defects when administered during pregnancy.
Croatian: Postoji sumnja da paklitaksel uzrokuje ozbiljne urođene mane kada se primjenjuje tijekom trudnoće.
English: Death or progression, n (%)
Croatian: Broj smrti, n (%)
English: Treat with same dose
Croatian: Primijeniti istu dozu
English: The median time to disease progression was 5.3 months (175 mg/m2; 95% CI: 4.6-6.2 months) and 6.1 months (300 mg/m2; 95% CI: 4.2-9.8 months).
Croatian: Medijan vremena do progresije bolesti iznosio je 5,3 mjeseca (175 mg/m2;95% CI: 4,6-6,2 mjeseca) i 6,1 mjesec (300 mg/m2; 95% CI: 4,2-9,8 mjeseci).
English: Contents of the pack and other information What Pazenir contains
Croatian: Sadržaj pakiranja i druge informacije Što Pazenir sadrži
English: Withhold doses until improves to ≤ Grade 1;
Croatian: Obustava doza do poboljšanja na ≤ 1. stupnja;