FrancophonIA/ELRC3.0 huggingface dataset:
English: A difference in FEV1 response by age was noted.
Croatian: Uočena je razlika u odgovoru FEV1 prema dobi.
English: 4 capsules = 1 dose
Croatian: 4 kapsule = 1 doza
English: Missed doses
Croatian: Propuštena doza
English: Take TOBI Podhaler twice a day, every day for 28 days
Croatian: Uzimajte TOBI Podhaler dvaput na dan, svaki dan tijekom 28 dana
English: If you forget to take TOBI Podhaler and there are at least 6 hours to your next dose, take your dose as soon as you can.
Croatian: Ako zaboravite uzeti TOBI Podhaler, a do sljedeće doze je ostalo najmanje 6 sati, uzmite dozu čim možete.
English: TOBI Podhaler is administered by inhalation using the Podhaler device (see section 6.6 for detailed instructions for use).
Croatian: TOBI Podhaler se primjenjuje inhalacijom korištenjem uređaja Podhaler (vidjeti dio 6.6 za detaljne upute za uporabu).
English: No other inhaler may be used.
Croatian: Ne smije se koristiti nijedan drugi inhalator.
English: The variability in pharmacokinetic parameters was higher in sputum as compared to serum.
Croatian: Varijabilnost farmakokinetičkih parametara bila je viša u sputumu nego u serumu.
English: If it is empty, discard the capsule.
Croatian: Ako je prazna, uklonite kapsulu.
English: However, subcutaneous administration of tobramycin during organogenesis was not teratogenic nor embryotoxic.
Croatian: Međutim, potkožna primjena tobramicina tijekom organogeneze nije bila teratogena ili embriotoksična.
English: Otherwise, the patient should wait for the next dose and not inhale more capsules to make up for the missed dose.
Croatian: U suprotnom, bolesnik treba čekati sljedeću dozu i ne inhalirati više kapsula kako bi nadoknadio propuštenu dozu.
English: Tear the perforations along the length then width: see Figures (a) and (b).
Croatian: Otkinite po perforacijama prvo po dužini, a zatim po širini: vidjeti Slike (a) i (b).
English: Not all pack sizes may be available in your country.
Croatian: Na tržištu se ne moraju nalaziti sve veličine pakiranja.
English: The safety and efficacy of TOBI Podhaler in children aged under 6 years have not been established.
Croatian: Sigurnost i djelotvornost TOBI Podhalera u djece u dobi ispod 6 godina nisu ustanovljene.
English: It must not be administered by any other route or using any other inhaler.
Croatian: Ne smije se primjenjivati nikakvim drugim putem ili korištenjem bilo kojeg drugog inhalatora.
English: Each inhaler is only used for 7 days.
Croatian: Svaki se inhalator koristi samo 7 dana.
English: However, aminoglycosides can cause foetal harm (e.g. congenital deafness) when high systemic concentrations are achieved in a pregnant woman.
Croatian: Međutim, aminoglikozidi mogu uzrokovati oštećenje ploda (npr. kongenitalnu gluhoću) kad se u trudnice postigne visoka sistemska koncentracija lijeka.
English: Use this if your weekly inhaler is not functioning correctly, is wet, or has dropped on the ground.
Croatian: Upotrijebiti ga ako Vaš tjedni inhalator ne radi ispravno, ako je mokar ili ako je pao na pod.
English: Patients in this study had no exposure to inhaled tobramycin for at least 4 months prior to study start.
Croatian: Bolesnici u ovom ispitivanju nisu bili izloženi inhalacijskom tobramicinu najmanje 4 mjeseca prije početka ispitivanja.
English: However, no association was observed in either clinical study between the incidence of bronchospasm and cough events.
Croatian: Međutim, nije bila uočena nikakva povezanost u bilo kojem kliničkom ispitivanju između incidencije bronhospazma i kašlja.
English: Data in different age groups
Croatian: Podaci za različite dobne skupine
English: Once removed from the capsule card (blister), a capsule should be used immediately.
Croatian: Nakon što se izvadi iz kartice s kapsulama (blistera), kapsulu treba odmah upotrijebiti.
English: In the open label extensions, each additional 6 months of treatment resulted in incremental increases similar in magnitude to that observed in the 6 months of placebo-controlled studies.
Croatian: U otvorenim produžecima, svakih dodatnih 6 mjeseci liječenja rezultiralo je postupnih povećanjima, po veličini sličnim onima koja su primijećena u 6mjesečnim placebom kontroliranim ispitivanjima.
English: See also section 4.2.
Croatian: Vidjeti također dio 4.2.
English: It acts primarily by disrupting protein synthesis leading to altered cell membrane permeability, progressive disruption of the cell envelope and eventual cell death.
Croatian: Djeluje prvenstveno tako da ometa sintezu proteina, što dovodi do promjene propusnosti stanične membrane, progresivnog prekida stanične ovojnice i konačno do smrti stanice.
English: • if you are allergic to tobramycin, to any type of aminoglycoside antibiotic, or to any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na tobramicin, na bilo koju vrstu aminoglikozidnih antibiotika, ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: Although the magnitude of improvements in lung function was smaller in this study, this is explained by the previous exposure of this patient population to treatment with inhaled tobramycin.
Croatian: Iako su poboljšanja plućne funkcije u ovom ispitivanju bila manja, to se objašnjava prethodnom izloženošću ove populacije bolesnika liječenju s inhalacijskim tobramicinom.
English: It is a very common bacterium that infects the lungs of nearly everyone with cystic fibrosis at some time during their lives.
Croatian: To je vrlo česta bakterija koja zarazi pluća gotovo svih oboljelih od cistične fibroze u nekom trenutku njihovog života.
English: The main resistance mechanisms are drug efflux and drug inactivation by modifying enzymes.
Croatian: Glavni mehanizmi rezistencije su izbacivanje lijeka i inaktivacija lijeka modificirajućim enzimima.
English: FEV1 should be measured before and after inhalation of TOBI Podhaler.
Croatian: FEV1 se treba mjeriti prije i nakon inhalacije TOBI Podhalera.
English: You should not take the following medicines while you are taking TOBI Podhaler:
Croatian: Ne smijete uzimati sljedeće lijekove dok uzimate TOBI Podhaler:
English: • Furosemide or ethacrynic acid, diuretics
Croatian: • Furosemid ili etakrinsku kiselinu, diuretike
English: The development of antibiotic-resistant P. aeruginosa and superinfection with other pathogens represent potential risks associated with antibiotic therapy.
Croatian: Razvoj P. aeruginosa rezistentnog na antibiotike i superinfekcija s drugim patogenima predstavljaju potencijalne rizike povezane s antibiotskom terapijom.
English: Basic instructions for use are given below, more detailed instructions are available from the patient leaflet.
Croatian: Osnovne upute za uporabu navedene su u nastavku, a podrobnije upute dostupne su u uputi o lijeku.
English: Tear along the perforations of the capsule card lengthwise then widthwise, as indicated in pictures (1) and (2).
Croatian: Odvojite po perforiranim crtama karticu s kapsulama po duljini i po širini, kako je prikazano na slikama (1) i (2).
English: • Vomiting, nausea
Croatian: • Povraćanje, mučninu
English: Each Podhaler device is only used for 7 days.
Croatian: Svaki se uređaj Podhaler koristi samo 7 dana.
English: Monthly pack.
Croatian: Mjesečno pakiranje.
English: Briefly inspect the inhaler to make sure it is not damaged or dirty.
Croatian: Kratko pregledajte inhalator kako biste provjerili da nije oštećen ili prljav.
English: • Store in the original packaging in order to protect from moisture.
Croatian: • Čuvati u originalnom pakiranju radi zaštite od vlage.
English: Based on available data from animals a risk of toxicity (e.g. ototoxicity) at prenatal exposure levels cannot be excluded.
Croatian: Na temelju podataka prikupljenih u ispitivanjima na životinjama, rizik od toksičnosti (npr. ototoksičnosti) za vrijeme prenatalne izloženosti lijeku ne može se isključiti.
English: Pharmacotherapeutic group: Antibacterials for systemic use, Aminoglycoside antibacterials, ATC Code: J01GB01
Croatian: Farmakoterapijska skupina: Antibakterijski lijekovi za sistemsku primjenu, Aminoglikozidni antibakterijski lijekovi, ATK oznaka: J01GB01
English: Inhale the powder deeply with a single breath.
Croatian: Duboko udahnite prašak jednim udisajem.
English: In case of missed dose with at least 6 hours until the next dose, the patient should take the dose as soon as possible.
Croatian: U slučaju propuštene doze pri čemu je do sljedeće doze ostalo najmanje 6 sati, bolesnik treba uzeti dozu čim bude moguće.
English: 3 years Discard the Podhaler device and its case 1 week after first use.
Croatian: 3 godine Bacite uređaj Podhaler i njegov spremnik tjedan dana nakon prve uporabe.
English: Non-clinical data reveal that the main hazard for humans, based on studies of safety pharmacology, repeated dose toxicity, genotoxicity, or toxicity to reproduction, consists of renal toxicity and ototoxicity.
Croatian: Neklinički podaci ukazuju da glavnu opasnost za ljude, na temelju ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti ili reproduktivne toksičnosti, predstavljaju bubrežna toksičnost i ototoksičnost.
English: Development of resistance during inhaled tobramycin therapy could limit treatment options during acute exacerbations; this should be monitored.
Croatian: Razvoj rezistencije tijekom inhalacijske terapije tobramicinom mogao bi ograničiti mogućnosti liječenja tijekom akutnih egzacerbacija; to se mora pratiti.
English: Do not use each inhaler and its case for longer than 1 week.
Croatian: Ne koristiti pojedini inhalator i njegov spremnik dulje od 1 tjedan.
English: • Look at the inhaler to make sure it is not damaged or dirty.
Croatian: • Pregledajte inhalator kako biste bili sigurni da nije oštećen ili prljav.
English: For safety results see section 4.8
Croatian: Za rezultate sigurnosti vidjeti 4.8.
English: The following medicines can increase the chances of harmful effects occurring if they are given to you while you are also receiving injections of tobramycin or other aminoglycoside antibiotic:
Croatian: Sljedeći lijekovi mogu povećati mogućnost pojave štetnih učinaka ako ih uzimate dok primate injekcije tobramicina ili drugog aminoglikozidnog antibiotika:
English: • It is not harmful if these pieces are swallowed or inhaled.
Croatian: • Neće Vam naškoditi ako te komadiće progutate ili udahnete.
English: • Each capsule card contains 8 capsules (corresponding to a daily dose: content of 4 capsules to be inhaled in the morning and content of 4 capsules to be inhaled in the evening).
Croatian: • Svaka kartica s kapsulama sadrži 8 kapsula (što odgovara dnevnoj dozi: sadržaj 4 kapsule koji se inhalira ujutro i sadržaj 4 kapsule koji se inhalira uvečer).
English: • blood in your sputum (the substance you cough up)
Croatian: • krv u iskašljaju (sadržaju koji iskašljavate)
English: In both studies, there was a trend for a recovery of P. aeruginosa density after the 28 days off-treatment period, which was reversed after a further 28 days on-treatment.
Croatian: U oba ispitivanja postojao je trend oporavka gustoće P. aeruginosa nakon razdoblja od 28 dana neuzimanja terapije, koji se obrnuo nakon dodatnih 28 dana uzimanja terapije.
English: Aminoglycosides may aggravate muscle weakness because of a potential curare-like effect on neuromuscular function.
Croatian: Aminoglikozidi mogu pogoršati mišićnu slabost zbog potencijalnog učinka na neuromuskularnu funkciju poput onog što ga izaziva kurare.
English: Remove the inhaler from your mouth, and hold your breath for about 5 seconds.
Croatian: Izvadite inhalator iz usta i zadržite dah oko 5 sekundi.
English: Tobramycin is an aminoglycoside antibiotic produced by Streptomyces tenebrarius.
Croatian: Tobramicin je aminoglikozidni antibiotik proizveden pomoću Streptomyces tenebrarius.
English: If the infection is not properly fought, it will continue to damage your lungs, causing further problems to your breathing.
Croatian: Ako se infekcija primjereno ne liječi, ona će nastaviti oštećivati Vaša pluća i uzrokovati daljnje poteškoće s disanjem.
English: Please also refer to nephrotoxicity information in section 4.4.
Croatian: Molimo vidjeti i informacije o nefrotoksičnosti u dijelu 4.4.
English: Ask your pharmacist how to dispose of medicines and inhalers no longer required.
Croatian: Upitajte svog ljekarnika kako baciti lijek i inhalatore koje više ne trebate.
English: Inhale the content of 4 capsules twice a day (4 capsules in the morning and 4 capsules in the evening), using the Podhaler device.
Croatian: Inhalirajte sadržaj 4 kapsule dvaput na dan (4 kapsule ujutro i 4 kapsule uvečer), koristeći uređaj Podhaler.
English: Use capsule immediately after removal from blister.
Croatian: Kapsulu upotrijebiti odmah nakon što se izvadi iz blistera.
English: See also section 5.1 for the profile of response of TOBI Podhaler compared to tobramycin nebuliser solution.
Croatian: Vidjeti također dio 5.1 za profil odgovora na TOBI Podhaler u usporedbi s tobramicin otopinom za nebulizator.
English: • Remove the capsule from the card.
Croatian: • Izvadite kapsulu iz kartice.
English: TOBI Podhaler contains a medicine called tobramycin which is an antibiotic.
Croatian: TOBI Podhaler sadrži lijek koji se naziva tobramicin i koji je antibiotik.
English: Tinnitus may be a sentinel symptom of ototoxicity, and therefore the onset of this symptom warrants caution.
Croatian: Tinitus može biti simptom koji upozorava na ototoksičnosti te stoga pojava ovog simptoma zahtijeva oprez.
English: • Decreasing hearing (ringing in the ears is a potential warning sign of hearing loss), noises (such as hissing) in the ears (common).
Croatian: • Slabljenje sluha (zvonjava u ušima je potencijalni znak upozorenja za gubitak sluha), zvukovi
English: See also information on previous and concomitant use of systemic aminoglycosides and diuretics in section 4.4.
Croatian: Vidjeti također informacije o prethodnoj i istodobnoj primjeni sistemskih aminoglikozida i diuretika u dijelu 4.4.
English: common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare
Croatian: Uz to, za svaku je nuspojavu navedena i odgovarajuća kategorija učestalosti prema sljedećem načelu (CIOMS III): 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: učestalost se ne može procijeniti iz dostupnih podataka.
English: • Anticholinesterases such as neostigmine and pyridostigmine (used to treat muscle weakness), or botulinum toxin.
Croatian: • Antikolinesteraze poput neostigmina i piridostigmina (koji se koriste za liječenje slabosti mišića), ili botulinum toksin.
English: Not known (frequency cannot be estimated from the available data)
Croatian: Nepoznato (učestalost se ne može procijeniti iz dostupnih podataka) • Opće loše osjećanje
English: In general, toxicity is seen at higher systemic tobramycin levels than are achievable by inhalation at the recommended clinical dose.
Croatian: Toksičnost se općenito opaža pri višim sistemskim razinama tobramicina od onih koje se postižu inhalacijom u preporučenoj kliničkoj dozi.
English: • Other medicines which may harm your kidneys or hearing.
Croatian: • Druge lijekove koji mogu naštetiti Vašim bubrezima ili sluhu.
English: Your doctor may ask you to use other appropriate medicines before taking TOBI Podhaler.
Croatian: Liječnik će Vas možda zamoliti da uzmete druge odgovarajuće lijekove prije nego što uzmete TOBI Podhaler.
English: If you have questions about how long to take TOBI Podhaler for, talk to your doctor or your pharmacist.
Croatian: Ako imate pitanja o tome koliko dugo uzimati TOBI Podhaler, obratite se svom liječniku ili ljekarniku.
English: Capsule card
Croatian: Kartica s kapsulama
English: Caregivers should provide assistance to children starting TOBI Podhaler treatment, particularly those aged 10 years or younger, and should continue to supervise them until they are able to use the Podhaler device properly without help.
Croatian: Pružatelji skrbi trebaju pomoći djeci koja započinju liječenje TOBI Podhalerom, osobito onoj u dobi od 10 ili manje godina, i trebaju ih nastaviti nadzirati dok ne mogu pravilno koristiti Podhaler uređaj bez pomoći.
English: If you experience any of these, tell your doctor straight away.
Croatian: Ako osjetite bilo što od toga, odmah se obratite svom liječniku.
English: Sputum concentrations
Croatian: Koncentracije u sputumu
English: The proportions of patients requiring hospitalisation for respiratory events were 24.4% with TOBI Podhaler and 22.0% with TOBI nebuliser solution.
Croatian: Udjeli bolesnika kojima je bila potrebna hospitalizacija zbog respiratornih događaja bili su 24,4% s TOBI Podhalerom i 22,0% s TOBI otopinom za nebulizator.
English: Such coumpounds can enhance aminoglycoside toxicity by altering antibiotic concentrations in serum and tissue.
Croatian: Takvi spojevi mogu pojačati toksičnost aminoglikozida time što povisuju koncentracije antibiotika u serumu i tkivima.
English: TOBI Podhaler significantly improved lung function compared with placebo, as shown by the relative increase in percent predicted FEV1 of about 13% after 28 days of treatment.
Croatian: TOBI Podhaler je značajno poboljšao plućnu funkciju u usporedbi s placebom, što je bilo vidljivo iz relativnog povećanja u postotku predviđenog FEV1 za oko 13% nakon 28 dana liječenja.
English: The unique characteristics of chronic P. aeruginosa infections in CF patients, such as anaerobic conditions and high frequency of genetic mutations, may also be important factors for reduced susceptibility of P. aeruginosa in CF patients.
Croatian: Jedinstvene karakteristike kroničnih infekcija P. aeruginosa u bolesnika s CF-om, kao što su anaerobni uvjeti i visoka učestalost genetskih mutacija, također bi mogle biti važni čimbenici za smanjenu osjetljivost P. aeruginosa u bolesnika s
English: No effect on male or female fertility was observed in animal studies after subcutaneous administration (see section 5.3).
Croatian: Nije uočen nikakav utjecaj na plodnost mužjaka ili ženki u ispitivanjima na životinjama nakon supkutane primjene (vidjeti dio 5.3).
English: Tobramycin showed no genotoxic potential in a battery of genotoxicity tests.
Croatian: Tobramicin nije pokazao genotoksičan potencijal u nizu testova genotoksičnosti.
English: Inhale the powder deeply with a single continuous inhalation.
Croatian: Duboko udahnite prašak jednim kontinuiranim udisajem.
English: • So for each remaining capsule, repeat steps 5,6, 7, 8, 9,
Croatian: • Za svaku preostalu kapsulu ponovite korake 5, 6, 7, 8, 9, 10 i 11.
English: 224 capsules + 5 inhalers
Croatian: 224 kapsule + 5 inhalatora
English: The two doses (of 4 capsules each) should be inhaled as close as possible to 12 hours apart and not less than 6 hours apart.
Croatian: 4 kapsule) treba inhalirati u razmaku koji iznosi što je bliže moguće 12 sati te nije manji od 6 sati.
English: There are no adequate data on the use of tobramycin via inhalation in pregnant women.
Croatian: Nema odgovarajućih podataka o uporabi tobramicina primjenjenog putem inhalacije u trudnica.
English: Animal studies with tobramycin do not indicate a teratogenic effect (see section 5.3).
Croatian: Ispitivanja tobramicina na životinjama nisu pokazala teratogene učinke (vidjeti dio 5.3).
English: The inhaler should never be washed with water.
Croatian: Inhalator se nikada ne smije prati vodom.
English: • Other medicines with diuretic properties such as urea or intravenous mannitol
Croatian: • Druge lijekove s diuretičkim svojstvima kao što su urea ili manitol primijenjen u venu
English: Put the pierced side of the capsule in first.
Croatian: Umetnite prvo probušenu stranu kapsule.
English: If clinical deterioration of pulmonary status is evident, additional or alternative anti-pseudomonal therapy should be considered.
Croatian: Ako je kliničko pogoršanje stanja pluća očito, potrebno je razmotriti dodatnu ili drugu antipseudomonalnu terapiju.
English: The vast majority of adverse reactions reported with TOBI Podhaler were mild or moderate, and severity did not appear to differ between cycles or between the entire study and on-treatment periods.
Croatian: Velika većina nuspojava zabilježenih s TOBI Podhalerom bila je blaga ili umjerena, a njihova težina nije se razlikovala između ciklusa ili između cijelog razdoblja ispitivanja i razdoblja inhalacije lijeka.
English: Patients with serum creatinine 2 mg/dl or more and blood urea nitrogen (BUN) 40 mg/dl or more have not been included in clinical studies and there are no data in this population to support a recommendation for or against dose adjustment with TOBI Podhaler.
Croatian: Bolesnici koji imaju serumski kreatinin 2 mg/dl ili više i dušik iz uree u krvi (BUN) 40 mg/dl ili više nisu bili uključeni u klinička ispitivanja pa nema podataka za ovu populaciju na temelju kojih bi se mogla donijeti preporuka za ili protiv prilagođavanja doze s TOBI Podhalerom.
English: If you are aged 65 years or older, your doctor may perform additional tests to decide if TOBI Podhaler is right for you.
Croatian: Ako imate 65 ili više godina, liječnik će možda obaviti dodatne pretrage kako bi odlučio je li TOBI
English: monthly multipack
Croatian: mjesečno višestruko pakiranje
English: Caution should be exercised when prescribing TOBI Podhaler to patients with known or suspected neuromuscular disorders such as myasthenia gravis or Parkinson's disease.
Croatian: Mora se oprezno postupati prilikom propisivanja TOBI Podhalera bolesnicima s poznatim ili suspektnim neuromuskularnim poremećajima kao što su mijastenija gravis ili Parkinsonova bolest.
English: After this if the capsule is still full and appears to be unpunctured, replace the inhaler with the reserve inhaler and try again.
Croatian: Nakon toga, ako je kapsula još uvijek puna i izgleda kao da nije probušena, zamijenite inhalator rezervnim i pokušajte ponovo.
English: • Platinum compounds such as carboplatin and cisplatin (used to treat some forms of cancer).
Croatian: • Spojevi s platinom kao što su karboplatin i cisplatin (koriste se za liječenje nekih oblika raka).
English: Each TOBI Podhaler capsule should be inhaled with two breath-hold manoeuvres and checked to ensure it is empty.
Croatian: Svaku TOBI Podhaler kapsulu potrebno je inhalirati u dva udisaja sa zadržavanjem daha i provjeriti da je prazna.
English: In addition, all patients were infected with P. aeruginosa as demonstrated by a positive sputum or throat culture (or bronchoalveolar lavage) within 6 months prior to screening, and also in a sputum culture taken at the screening visit.
Croatian: Uz to, svi su bolesnici bili zaraženi bakterijom P. aeruginosa što je dokazano pozitivnom kulturom sputuma ili grla (ili bronhoalveolarnom lavažom) u roku od 6 mjeseci prije probira, te u kulturi sputuma uzetoj na posjetu za probir.
English: Look at the used capsule.
Croatian: Pogledajte iskorištenu kapsulu.
English: The frequencies in Table 1 are based on the reporting rates from the active-controlled study.
Croatian: Učestalosti u Tablici 1 temelje se na stopi prijava iz aktivno kontroliranog ispitivanja.
English: Severely maternally toxic doses to female rabbits (i.e. nephrotoxicity) lead to spontaneous abortions and death.
Croatian: Vrlo toksične doze za majku kod ženki kunića (tj. nefrotoksičnost) vode do spontanih pobačaja i smrti.
English: Serum concentrations greater than 12 µg/ml are associated with tobramycin toxicity and treatment should be discontinued if concentrations exceed this level.
Croatian: Koncentracija u serumu veća od 12 µg/ml povezana je s toksičnošću tobramicina pa je liječenje potrebno prekinuti ako koncentracija prijeđe tu razinu.
English: Sputum from cystic fibrosis exhibits an inhibitory action on the local biological activity of inhaled aminoglycosides.
Croatian: Sputum kod cistične fibroze pokazuje inhibitorno djelovanje na lokalnu biološku aktivnost inhalacijskih aminoglikozida.
English: This antibiotic belongs to a class called aminoglycosides.
Croatian: Ovaj antibiotik pripada skupini koja se naziva aminoglikozidi.
English: Cough was the most frequently reported adverse reaction in both clinical studies.
Croatian: Kašalj je bio najučestalije zabilježena nuspojava u oba klinička ispitivanja.