FrancophonIA/ELRC3.0 huggingface dataset:
English: The analysis on the global population included (64 patients) showed that the majority had remained at least stable (i.e., without deterioration) based on non-paediatric-specific WHO functional class assessment (97% twice daily, 100% three times daily) and physician's global clinical impression (94% twice daily, 93% three times daily) during the treatment period.
Croatian: Analiza cijele uključene populacije (64 bolesnika) pokazala je da je većina ostala barem stabilna (tj. bez pogoršanja) temeljeno na procjeni WHO funkcionalnog stupnja nespecifičnog za djecu (97% za doziranje dvaput dnevno, 100% za doziranje triput dnevno) i kliničkom općem dojmu liječnika (94% za doziranje dvaput dnevno, 93% za doziranje triput dnevno) tijekom razdoblja liječenja.
English: Your doctor will advise you on your dosing.
Croatian: Liječnik će Vam propisati doziranje.
English: Similar effects would be expected with other ritonavir-boosted protease inhibitors (see section 4.4).
Croatian: Slični učinci očekuju se i s ostalim inhibitorima proteaza pojačanim ritonavirom (vidjeti dio 4.4).
English: In an animal model of pulmonary fibrosis, bosentan reduced collagen deposition in the lungs.
Croatian: Na životinjskom modelu plućne fibroze, bosentan je smanjio odlaganje kolagena u plućima.
English: Re-introduction of treatment with STAYVEER should only be considered if the potential benefits of treatment with STAYVEER outweigh the potential risks and when liver aminotransferase levels are within pre-treatment values.
Croatian: Ponovno liječenje STAYVEEROM treba razmotriti samo ako moguće koristi od liječenja STAYVEEROM nadmašuju moguće rizike te kada su vrijednosti jetrenih aminotransferaza unutar vrijednosti prije liječenja.
English: In patients with mildly impaired liver function (Child-Pugh class A) no relevant changes in the pharmacokinetics have been observed.
Croatian: U bolesnika s blagim smanjenjem jetrene funkcije (Child-Pugh stadij A) nisu primijećene značajne promjene u farmakokinetici.
English: No drug-drug interaction data are available with the other sulfonylureas.
Croatian: Podaci o interakcijama s drugim sulfonilurejama nisu dostupni.
English: Your monthly liver blood test schedule:
Croatian: Raspored Vaših mjesečnih krvnih nalaza jetre:
English: • Monthly pregnancy tests are recommended during treatment to allow early detection of pregnancy
Croatian: • Preporučuje se mjesečno testiranje na trudnoću kako bi se trudnoća rano otkrila
English: In BREATHE-3, the most frequent adverse reactions were flushing (21%), headache, and abnormal liver function test (each 16%).
Croatian: U BREATHE-3, najčešće nuspojave bile su crvenilo uz osjećaj vrućine (21%), glavobolja i poremećaj nalaza funkcije jetre (svaka po 16%).
English: The patient's response to treatment and need for continued therapy should be re-evaluated on a regular basis.
Croatian: Potrebno je redovito procjenjivati odgovor bolesnika na liječenje i potrebu za dugotrajnom terapijom.
English: • Pregnancy (see sections 4.4 and 4.6)
Croatian: • Trudnoća (vidjeti dijelove 4.4 i 4.6)
English: For children aged 1 year and older, treatment with STAYVEER is usually started with 2 mg per kg bodyweight twice daily (morning and evening).
Croatian: Za djecu u dobi od 1 godine i stariju liječenje STAYVEEROM se obično započinje dozom od 2 mg po kg tjelesne težine dva puta dnevno (ujutro i navečer).
English: If these results are abnormal, your doctor may decide to reduce your dose or stop treatment with STAYVEER and to perform further tests to investigate the cause.
Croatian: Ako ti rezultati nisu uredni, liječnik će odlučiti da li smanjiti dozu ili prekinuti liječenje STAYVEEROM te će možda provesti dodatne nalaze kako bi ispitao moguće razloge.
English: After a single intravenous dose of 250 mg, the clearance was 8.2 L/h.
Croatian: Nakon jedne intravenske doze od 250 mg, klirens je bio 8,2 l/h.
English: The mechanism of this adverse effect is unclear.
Croatian: Mehanizam te nuspojave nije jasan.
English: • if you are taking cyclosporine A (a medicine used after a transplant or to treat psoriasis)
Croatian: • ako uzimate ciklosporin A (lijek koji se koristi nakon transplantacije ili za liječenje psorijaze)
English: As STAYVEER may render hormonal contraceptives ineffective, and taking into account the risk that pulmonary hypertension deteriorates with pregnancy as well as the teratogenic effects observed in animals:
Croatian: Budući da STAYVEER može smanjiti učinkovitost hormonskih kontraceptiva te uzimajući u obzir rizik od pogoršanja plućne hipertenzije u trudnoći i teratogene učinke uočene u životinja:
English: STAYVEER has no or negligible influence on the ability to drive and use machines.
Croatian: STAYVEER ima zanemariv ili nikakav utjecaj na sposobnost upravljanja vozilima i rada sa strojevima.
English: The possibility of altered efficacy of medicinal products metabolised by these isoenzymes should be considered.
Croatian: Treba uzeti u obzir mogućnost promijenjene učinkovitosti lijekova koje metaboliziraju ovi izoenzimi.
English: • Hormonal contraceptives cannot be the sole method of contraception during treatment with STAYVEER
Croatian: • Hormonski kontraceptivi ne mogu biti jedina kontracepcija tijekom liječenja STAYVEEROM
English: There was no evidence of any clinical benefit with 2 mg/kg three times daily as compared to 2 mg/kg twice daily dosing.
Croatian: Nije bilo dokaza nikakve kliničke koristi primjene doze od 2 mg/kg triput dnevno u usporedbi s doziranjem od 2 mg/kg dvaput dnevno.
English: In both studies, patients on bosentan were less likely to develop multiple new digital ulcers during the study and took longer to develop each successive new digital ulcer than did those on placebo.
Croatian: U obje studije u bolesnika koji su dobivali bosentan bila je manja vjerojatnost za razvoj novih ulceracija prstiju tijekom studije i trebalo im je dulje da razviju svaku novu ulceraciju nego u bolesnika koji su dobivali placebo.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON WITH 56 AND 112 TABLETS
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU PAKIRANJE S 56 I 112 TABLETA
English: STAYVEER is used to treat patients with class III PAH to improve exercise capacity (the ability to carry out physical activity) and symptoms.
Croatian: STAYVEER se koristi u liječenju bolesnika s III. stupnjem plućne arterijske hipertenzije (PAH) kako bi se poboljšalo podnošenje fizičkog opterećenja (mogućnost izvođenja fizičke aktivnosti) i simptomi.
English: Study performed in neonates with persistent pulmonary hypertension of the newborn (PPHN):
Croatian: Studija provedena na novorođenčadi s perzistentnom plućnom hipertenzijom novorođenčeta (PPHN):
English: • glibenclamide (a diabetes medicine), rifampicin (a tuberculosis medicine), fluconazole (a medicine against fungal infections), ketoconazole (a medicine used to treat Cushing's syndrome), or nevirapine (an HIV medicine), as these medicines are not recommended to be used together with STAYVEER.
Croatian: • glibenklamid (lijek za dijabetes), rifampicin (lijek za tuberkulozu), flukonazol (lijek za gljivične infekcije), ketokonazol (lijek za liječenje Cushingovog sindroma) ili nevirapin (za liječenje HIV infekcije) budući da nije preporučljivo uzimati te lijekove zajedno sa STAYVEEROM
English: In fertility studies in male and female rats, no effects on sperm count, motility and viability, or on mating performance or fertility were observed at exposures that were 21 and 43 times the expected therapeutic level in humans, respectively; nor was there any adverse effect on the development of the pre-implantation embryo or on implantation.
Croatian: U studijama plodnosti u mužjaka i ženki štakora nije primijećen utjecaj na broj, pokretljivost ili održivost spermija, kao ni na parenje ili plodnost, pri izloženosti 21 odnosno 43 puta većoj od očekivane terapijske razine u ljudi te nisu primijećeni štetni učinci na razvoj embrija prije implantacije ili na samu implantaciju.
English: In this study there was an increasedincidence of hospitalisation due to CHF during the first 4-8 weeks of treatment with bosentan, which could have been the result of fluid retention.
Croatian: U toj studiji učestalost hospitalizacije zbog kroničnog zatajenja srca tijekom prvih 4-8 tjedana liječenja bosentanom bila je povećana, što je možda bio rezultat zadržavanja tekućine.
English: At adult age (Day 69 post partum), no effects of bosentan were detected at 1.3 (males) and 2.6 (females) times the therapeutic exposure in children with PAH.
Croatian: U odrasloj dobi (69. postpartalni dan) nisu zabilježeni učinci bosentana pri izloženosti 1,3 puta (mužjaci) i 2,6 puta (ženke) većoj od terapijske izloženosti u djece s PAH-om.
English: In adult patients, the exposure to the active metabolite is greater than in healthy subjects.
Croatian: Izloženost aktivnom metabolitu veća je kod odraslih bolesnika nego kod zdravih osoba.
English: An increased long-term risk of hepatic toxicity and haematological adverse events cannot be excluded when bosentan is used in combination with antiretroviral medicinal products.
Croatian: Povećan dugoročan rizik od hepatotoksičnosti i hematoloških nuspojava ne može se isključiti kod istodobne primjene bosentana i antiretrovirusnih lijekova.
English: Elevations in liver aminotransferases, i.e., aspartate and alanine aminotransferases (AST and/or ALT), associated with bosentan are dose dependent.
Croatian: Povišenje razine jetrenih aminotransferaza, tj. aspartat- i alanin-aminotransferaze (AST i/ili ALT) ovisno je o dozi bosentana.
English: No specific studies have been conducted to assess the direct effect of STAYVEER on the ability to drive and use machines.
Croatian: Nisu provedene specifične studije za procjenu direktnog utjecaja STAYVEERA na sposobnost upravljanja vozilima i rada sa strojevima.
English: Because of possible hormonal contraception failure during STAYVEER treatment, and also bearing in mind the risk that pulmonary hypertension severely deteriorates with pregnancy, monthly pregnancy tests during treatment with STAYVEER are recommended to allow early detection of pregnancy.
Croatian: Zbog mogućeg zatajenja hormonske kontracepcije tijekom liječenja STAYVEEROM te uzimajući u obzir da u trudnoći dolazi do teškog pogoršanja plućne hipertenzije, preporučuju se mjesečni testovi na trudnoću tijekom liječenja STAYVEEROM kako bi se trudnoća rano otkrila.
English: If you stop taking STAYVEER
Croatian: Ako prestanete uzimati STAYVEER
English: An interaction study between bosentan and lopinavir+ritonavir in healthy subjects showed increased plasma concentrations of bosentan, with the maximum level during the first 4 days of treatment (see section 4.5).
Croatian: Studija interakcije između bosentana i lopinavira te ritonavira na zdravim dobrovoljcima je pokazala povišene koncentracije bosentana u plazmi s maksimalnom razinom tijekom prva 4 dana terapije (vidjeti dio 4.5).
English: Consequently, bosentan is not expected to increase the plasma concentrations of medicinal products metabolised by these isoenzymes.
Croatian: Stoga se ne očekuje da bosentan povećava koncentracije u plazmi lijekova koje metaboliziraju ti izoenzimi.
English: After co-administration of bosentan for 9.5 days, the plasma exposures to lopinavir and ritonavir decreased to a clinically non-significant extent (by approximately 14% and 17%, respectively).
Croatian: Nakon istodobne primjene bosentana kroz 9,5 dana, izloženost lopinaviru i ritonaviru u plazmi se smanjila u klinički neznačajnom opsegu (približno 14% odnosno 17%).
English: For the same reason, concomitant administration of both a potent CYP3A4 inhibitor (such as ketoconazole, itraconazole or ritonavir) and a CYP2C9 inhibitor (such as voriconazole) with STAYVEER is not recommended.
Croatian: Iz istog razloga ne preporučuje se istodobna primjena jakog inhibitora CYP3A4 (poput ketokonazola, itrakonazola ili ritonavira) i inhibitora CYP2C9 (poput vorikonazola) sa STAYVEEROM.
English: These effects are mediated by endothelin binding to ETA and ETB receptors located in the endothelium and vascular smooth muscle cells.
Croatian: Do tih učinaka dolazi uslijed vezanja endotelina za receptore ETA i ETB koji se nalaze u endotelu i glatkim mišićnim stanicama krvnih žila.
English: This is most likely due to induction of CYP3A4 by bosentan.
Croatian: To je najvjerojatnije posljedica indukcije CYP3A4 uz pomoć bosentana.
English: Plasma concentrations of bosentan metabolites increased about 2-fold in these patients as compared with subjects with normal renal function.
Croatian: Koncentracije metabolita bosentana u plazmi povećale su se otprilike dvostruko u tih bolesnika u odnosu na bolesnike s normalnom bubrežnom funkcijom.
English: In the event of associated clinical symptoms of liver injury, i.e., nausea, vomiting, fever, abdominal pain, jaundice, unusual lethargy or fatigue, flu-like syndrome (arthralgia, myalgia, fever), treatment must be stopped and re-introduction of STAYVEER is not to be considered.
Croatian: U slučaju drugih kliničkih simptoma oštećenja jetre, tj. mučnine, povraćanja, vrućice, bolova u abdomenu, žutice, neuobičajene slabosti ili umora, simptoma sličnih gripi (artralgija, mialgija, vrućica), liječenje treba prekinuti bez razmatranja ponovnog liječenja STAYVEEROM.
English: At study start, less than half of the patients included (45.3% [29/64]) had bosentan treatment alone not combined with other PAH medication.
Croatian: Na početku studije manje od polovice uključenih bolesnika (45,3% [29/64]) liječeno je bosentanom u monoterapiji, bez kombinacije s drugim lijekovima za PAH.
English: Treatment with bosentan led to a WHO functional class improvement in 42.4% of patients (placebo 30.4%).
Croatian: Liječenje bosentanom dovelo je do poboljšanja WHO funkcionalnog stupnja u 42,4% bolesnika (i u 30,4% bolesnika koji su dobivali placebo).
English: • Elevated liver function tests with hepatitis (inflammation of the liver) including possible exacerbation of underlying hepatitis and/or jaundice (yellowing of the skin or the whites of the eyes)
Croatian: • Povišene vrijednosti testova jetrene funkcije s hepatitisom (upala jetre), uključujući i moguće pogoršanje podležećeg hepatitisa, i/ili žuticom (žutilo kože ili bjeloočnica)
English: There is no specific clinical experience in patients undergoing dialysis.
Croatian: Nema kliničkog iskustva za bolesnike na dijalizi.
English: Concomitant use of STAYVEER with glibenclamide, fluconazole and rifampicin is not recommended.
Croatian: Istodobna primjena STAYVEERA s glibenklamidom, flukonazolom i rifampicinom se ne preporučuje.
English: These will be done every month for the duration of treatment with STAYVEER.
Croatian: Ove pretrage provodit će se svakog mjeseca tijekom liječenja STAYVEEROM.
English: No dose adjustment is needed for warfarin and similar oral anticoagulant agents when bosentan is initiated, but intensified monitoring of INR is recommended, especially during bosentan initiation and the up-titration period.
Croatian: Prilagođavanje doze varfarina i sličnih oralnih antikoagulansa nije potrebno u početku primjene bosentana, no ipak se preporuča intenzivno praćenje INR-a, osobito u početku liječenja bosentanom i kod povećanja doze.
English: The study was primarily designed as a pharmacokinetic study (see section 5.2), and efficacy endpoints were only exploratory.
Croatian: Studija je prvenstveno zamišljena kao farmakokinetička studija (vidjeti dio 5.2) i mjere ishoda djelotvornosti bile su samo eksploratorne.
English: For white high-density polyethylene bottles:
Croatian: Za bijele boce od polietilena visoke gustoće:
English: During treatment with STAYVEER, your doctor will arrange for regular blood tests to check for changes in your liver function.
Croatian: Tijekom liječenja STAYVEEROM liječnik će zakazati redovite krvne pretrage kako bi provjerio promjene u funkciji jetre.
English: ((Inside 2))
Croatian: ((Unutarnja str. 2))
English: The same recommendations apply to reintroduction of STAYVEER after treatment interruption (see section 4.4).
Croatian: Iste preporuke vrijede i pri ponovnom uvođenju liječenja STAYVEEROM nakon prekida terapije (vidjeti dio 4.4).
English: STAYVEER 125 mg film-coated tablets EU/1/13/832/002
Croatian: STAYVEER 125 mg filmom obložene tablete EU/1/13/832/002
English: The film-coat contains hypromellose, glycerol triacetate, talc, titanium dioxide (E171), iron oxide yellow (E172), iron oxide red (E172) and ethylcellulose.
Croatian: Film ovojnica sadrži hipromelozu, gliceroltriacetat, talk, titanijev diokisid (E171), željezov oksid žuti (E172), željezov oksid crveni (E172) i etilcelulozu.
English: When administered concomitantly with lopinavir+ritonavir, or other ritonavir-boosted protease inhibitors, the patient's tolerability of STAYVEER should be monitored.
Croatian: Kada se STAYVEER primjenjuje u kombinaciji sa lopinavirom + ritonavirom ili nekim drugim inhibitorima proteaza pojačanih ritonavirom, treba pratiti bolesnikovu podnošljivost
English: In a study investigating the effects of bosentan on testicular function in male PAH patients, 8 out of 24 patients showed a decreased sperm concentration from baseline of at least 42% after 3 or 6 months of treatment with bosentan.
Croatian: U ispitivanju koje je istraživalo učinke bosentana na funkciju testisa muških bolesnika s PAH-om, u 8 od 24 bolesnika zabilježeno je smanjenje koncentracije spermija od početne vrijednosti od najmanje 42% nakon 3 ili 6 mjeseci liječenja bosentanom.
English: Patients were in WHO functional class I (n = 19, 29 %), class II (n = 27, 42%) or class III (n = 18, 28%) at start of study treatment.
Croatian: Bolesnici su prema WHO funkcionalnom stupnju klasificirani u stupanj I (n = 19, 29%), stupanj II (n = 27, 42%) ili stupanj III (n = 18, 28%) na početku ispitivanog liječenja.
English: However, STAYVEER can induce hypotension (decrease of your blood pressure) which can make you feel dizzy, affect your vision and affect your ability to drive and use machines.
Croatian: Ipak, STAYVEER može uzrokovati hipotenziju (pad krvnog tlaka) što može uzrokovati osjećaj omaglice, utjecati na vaš vid i utjecati na vašu sposobnost upravljanja vozilima i rada sa strojevima.
English: In animal models of pulmonary hypertension, chronic oral administration of bosentan reduced pulmonary vascular resistance and reversed pulmonary vascular and right ventricular hypertrophy.
Croatian: Na životinjskim modelima plućne hipertenzije, kronična oralna primjena bosentana smanjila je plućni krvožilni otpor i zaustavila hipertrofiju plućnih žila i desnog ventrikula.
English: Epoprostenol: Limited data obtained from a study (AC-052-356 [BREATHE-3]) in which 10 paediatric patients received the combination of bosentan and epoprostenol indicate that after both single- and multiple-dose administration, the Cmax and AUC values of bosentan were similar in patients with or without continuous infusion of epoprostenol (see section 5.1).
Croatian: Epoprostenol: ograničeni podaci dobiveni iz studije (AC-052-356 [BREATHE-3]) u kojoj je 10 pedijatrijskih bolesnika dobilo kombinaciju bosentana i epoprostenola pokazuju da su i nakon primjene jednokratnih i višekratnih doza vrijednosti Cmax i AUC bosentana bile slične u bolesnika sa ili bez kontinuirane infuzije epoprostenola (vidjeti dio 5.1).
English: Dyspnoea measurement during walk tests showed an improvement in bosentan-treated patients.
Croatian: Mjerenje dispneje tijekom testova hodanja pokazalo je poboljšanje u bolesnika koji su dobivali bosentan.
English: In study AC-052-391 (FUTURE 4) conducted in neonates, bosentan concentrations increased slowly and continuously over the first dosing interval, resulting in low exposure (AUC0-12 in whole blood:
Croatian: U studiji AC-052-391 (FUTURE 4) provedenoj na novorođenčadi, koncentracije bosentana rasle su polako i neprekidno tijekom prvog intervala doziranja dovodeći do niske izloženosti (AUC0-12 u punoj krvi: 164 ng•h/mL, n = 11).
English: Abnormal liver function test (see section 4.4)
Croatian: Poremećaj nalaza funkcije jetre (vidjeti dio 4.4)
English: • hormonal contraceptives, which are not effective as the sole method of contraception when you take STAYVEER.
Croatian: • hormonske kontraceptive koji nisu učinkoviti kao jedina metoda kontracepcije kod uzimanja STAYVEERA.
English: ((Inside 1))
Croatian: ((Unutarnja str. 1))
English: Aminotransferase elevations associated with hepatitis (including possible exacerbation of underlying hepatitis) and/or jaundice1 (see section 4.4)
Croatian: Povišene razine aminotransferaze povezane s hepatitisom (uključujući moguću egzacerbaciju podležećeg hepatitisa) i/ili žuticom1 (vidjeti dio 4.4)
English: The average exposure to bosentan in these paediatric patients was about half the exposure in adult patients at the 125 mg twice daily maintenance dose but showed a large overlap with the exposures in adults.
Croatian: Prosječna izloženost bosentanu ovih pedijatrijskih bolesnika iznosila je oko polovicu izloženosti odraslih bolesnika koji su dobivali dozu održavanja od 125 mg dvaput dnevno te je pokazalo veliko preklapanje sa izloženostima u odraslih.
English: However, long-term vital status was recorded for all 235 patients who were treated with bosentan in the two pivotal placebo-controlled studies (AC-052-351 and AC-052-352) and/or their two uncontrolled, open-label extensions.
Croatian: Dugoročna vitalnost zabilježena je za svih 235 bolesnika koji su dobivali bosentan u sklopu dvije placebom kontrolirane studije (AC-052-351 i AC-052-352) i/ili njihova dva nekontrolirana, otvorena produženja.
English: Liver dysfunction risk may also be increased when medicinal products that are inhibitors of the bile salt export pump, e.g., rifampicin, glibenclamide and cyclosporine A (see sections 4.3 and 4.5), are co-administered with bosentan, but limited data are available.
Croatian: Rizik od poremećaja funkcije jetre može biti povećan kod istodobne primjene inhibitora crpke za izlučivanje žučnih soli, poput rifampicina, glibenklamida i ciklosporina A (vidjeti dijelove 4.3 i 4.5), s tim da su dostupni samo ograničeni podaci.
English: Treatment must be stopped and re-introduction of STAYVEER is not to be considered.
Croatian: Liječenje treba prekinuti bez razmatranja ponovnog liječenja
English: A careful benefit/risk assessment should be made, taking into consideration that the liver toxicity is dose dependent (see sections 4.4 and 5.1).
Croatian: Potrebno je pažljivo procijeniti omjer koristi i rizika, uzimajući u obzir da je toksično djelovanje na jetru ovisno o dozi (vidjeti dijelove 4.4 i 5.1).
English: Pregnancy tests
Croatian: Testovi na trudnoću
English: Bosentan has been administered as a single dose of up to 2,400 mg to healthy subjects and up to 2,000 mg/day for 2 months in patients with a disease other than pulmonary hypertension.
Croatian: Bosentan je primijenjen jednokratno u dozi do 2400 mg u zdravih osoba te do 2000 mg dnevno tijekom 2 mjeseca u bolesnika s bolešću izuzev plućne hipertenzije.
English: However, STAYVEER may induce hypotension, with symptoms of dizziness, blurred vision or syncope that could affect the ability to drive or use machines.
Croatian: Ipak, STAYVEER može uzrokovati hipotenziju sa simptomima omaglice, zamagljenog vida ili sinkope koji mogu utjecati na sposobnost upravljanja vozilima ili rada sa strojevima.
English: In the post-marketing period rare cases of liver cirrhosis and liver failure have been reported.
Croatian: Tijekom postmarketinškog razdoblja zabilježeni su rijetki slučajevi ciroze jetre i zatajenja jetre.
English: The similarities of the pattern of malformations observed with other ET receptor antagonists and in ET knock-out mice indicate a class effect.
Croatian: Sličnost u malformacijama koje su primijećene u drugih antagonista ET-receptora i u miševa bez ET-receptora (knock-out) ukazuje da je riječ o učinku iste klase.
English: The effect of bosentan on reduction of the number of new digital ulcers was more pronounced in patients with multiple digital ulcers.
Croatian: Učinak bosentana na smanjenje broja novih ulceracija prstiju bio je više izražen u bolesnika s brojnim ulceracijama prstiju.
English: No evidence for acute rebound has been observed.
Croatian: Nije primijećena pojava akutnog pogoršanja (rebounda).