FrancophonIA/ELRC3.0 huggingface dataset:
English: The estimated formoterol Vc/F (volume of the central compartment), and Vp1/F (volume of the peripheral compartment) are 1030 L, and 647 L, respectively, via population pharmacokinetic analysis.
Croatian: Na temelju populacijske farmakokinetičke analize, procijenjeni Vc/F (volumen središnjeg odjeljka) formoterola iznosi 1030 l, dok njegov procijenjeni Vp1/F (volumen perifernog odjeljka) iznosi 647 l.
English: o Take the Bevespi Aerosphere inhaler out of the foil pouch.
Croatian: o Izvadite inhalator lijeka Bevespi Aerosphere iz vrećice od folije.
English: This will release a puff of medicine from the mouthpiece (See Figure 5).
Croatian: Tako ćete iz nastavka za usta otpustiti količinu lijeka za jedan udisaj (pogledajte Sliku 5).
English: Do not pierce the pressurised container.
Croatian: Ne probijati spremnik pod tlakom.
English: No pharmacokinetic studies have been performed with Bevespi Aerosphere in patients with hepatic impairment.
Croatian: Nisu provedena ispitivanja farmakokinetike lijeka Bevespi Aerosphere kod bolesnika s oštećenjem funkcije jetre.
English: Immediate breathing difficulties If you get tightness of the chest, coughing, wheezing or breathlessness immediately after using Bevespi Aerosphere: Stop using this medicine and seek medical help immediately, as you may have a serious condition called paradoxical bronchospasm.
Croatian: Prestanite primjenjivati ovaj lijek i odmah potražite liječničku pomoć, jer možda imate ozbiljno stanje koje se zove paradoksalni bronhospazam.
English: Bevespi Aerosphere 7.2 micrograms/5 micrograms pressurised inhalation, suspension
Croatian: Bevespi Aerosphere 7,2 mikrograma/5 mikrograma stlačeni inhalat, suspenzija
English: The mean bronchodilator effect derived from serial FEV1 measurements at Day 1 and Week 12 from PINNACLE 1 are shown in Figure 1.
Croatian: Na Slici 1 prikazana je srednja vrijednost bronhodilatacijskog učinka, izračunata na temelju vrijednosti FEV1 mjerenog serijski 1. dana i 12. tjedna u ispitivanju PINNACLE 1. Rezultati iz ispitivanja PINNACLE 2 slični su onima opaženima u ispitivanju PINNACLE 1.
English: Figure 16
Croatian: Slika 16
English: This corresponds to a metered dose of glycopyrronium bromide 10.4 micrograms equivalent to 8.3 micrograms of glycopyrronium, and formoterol fumarate dihydrate 5.8 micrograms.
Croatian: To odgovara odmjernoj dozi od 10,4 mikrograma glikopironijeva bromida, što odgovara količini od 8,3 mikrograma glikopironija, i 5,8 mikrograma formoterolfumarat dihidrata.
English: Other pharmacodynamic interactions
Croatian: Druge farmakodinamičke interakcije
English: Before you use Bevespi Aerosphere for the first time, you must prime the inhaler.
Croatian: Prije prve primjene lijeka Bevespi Aerosphere morate pripremiti inhalator.
English: If you have any further questions on the use of this medicine, talk to your doctor or pharmacist.
Croatian: U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se liječniku ili ljekarniku.
English: The largest mean (90% upper confidence bound) differences from placebo in baseline- and individually corrected QT was 3.1 (4.7) ms for Bevespi Aerosphere (14.4 /10 micrograms) and 7.6 (9.2) ms for glycopyrronium/formoterol with eight times the recommended dose of glycopyrronium and four times the recommended dose of formoterol.
Croatian: Najveća srednja vrijednost (gornja granica intervala pouzdanosti od 90%) razlike u odnosu na placebo s obzirom na početni ili individualno korigirani QT interval iznosila je 3,1 (4,7) ms uz Bevespi Aerosphere (14,4/10 mikrograma) te 7,6 (9,2) ms uz
English: Figure 18
Croatian: Slika 18
English: This means that there are 100 puffs of medicine left in the pressurised container (See Figure 2c).
Croatian: To znači da je u spremniku pod tlakom preostala količina lijeka dovoljna za 100 udisaja (pogledajte Sliku 2c).
English: In patients with severe hepatic impairment, Bevespi Aerosphere should be used only if the expected benefit outweighs the potential risk (see section 5.2).
Croatian: Kod bolesnika s teškim oštećenjem jetrene funkcije Bevespi Aerosphere smije se primjenjivati samo ako očekivana korist nadmašuje potencijalni rizik (vidjeti dio 5.2).
English: If you stop using Bevespi Aerosphere
Croatian: Ako prestanete primjenjivati Bevespi Aerosphere
English: If you forget to use Bevespi Aerosphere
Croatian: Ako ste zaboravili primijeniti Bevespi Aerosphere
English: The other ingredients are norflurane, 1,2- distearoyl-sn-glycero-3-phosphocholine and calcium chloride.
Croatian: Drugi sastojci su norfluran, 1,2-distearoil-sn-glicero-3-fosfokolin i kalcijev klorid.
English: Musculoskeletal and connective tissue disorders
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva mišićni grčevi često
English: Norflurane 1,2-distearoyl-sn-glycero-3-phosphocholine and calcium chloride.
Croatian: Norfluran 1,2-distearoil-sn-glicero-3-fosfokolin i kalcijev klorid.
English: Agitation Restlessness Insomnia
Croatian: Psihijatrijski poremećaji anksioznost često agitacija nemir nesanica manje često
English: • you have an eye problem called narrow-angle glaucoma (also called angle-closure glaucoma)
Croatian: • ako imate bolest oka koja se zove glaukom uskog kuta (ili glaukom zatvorenog kuta)
English: How to clean your Bevespi Aerosphere inhaler:
Croatian: Kako čistiti inhalator lijeka Bevespi Aerosphere:
English: Clinical drug-drug interaction studies have not been conducted with Bevespi Aerosphere, however, the potential for metabolic interactions is considered to be low based on in-vitro studies (see section 5.2).
Croatian: Međutim, na temelju podataka iz ispitivanja in vitro, smatra se da je potencijal za metaboličke interakcije malen (vidjeti dio 5.2).
English: If you find it difficult breathing in and pressing the inhaler at the same time talk to your doctor or pharmacist.
Croatian: Primjena lijeka Bevespi Aerosphere uz pomoć komore za inhaliranje Ako Vam je teško istodobno udahnuti i pritisnuti inhalator, obratite se svom liječniku ili ljekarniku.
English: The terminal elimination half-life of glycopyrronium following oral inhalation derived via population pharmacokinetics analysis was 15 hours.
Croatian: Prema populacijskoj farmakokinetičkoj analizi, terminalno poluvrijeme eliminacije glikopironija nakon peroralne inhalacije iznosilo je 15 sati.
English: Step 2: Take the cap off the mouthpiece.
Croatian: 2. korak: Skinite zatvarač s nastavka za usta.
English: • Remove the cap from the mouthpiece (See Figure 3).
Croatian: • Skinite zatvarač s nastavka za usta (pogledajte Sliku 3).
English: Figure 15
Croatian: Slika 15
English: However, these animal experimental results have little relevance to man. A slight increase in the incidence of uterine leiomyomas has been observed in rats and mice treated with formoterol; an effect which is considered to be a class-effect in rodents after long-term exposure to high doses of β2-adrenoreceptor agonists.
Croatian: Kod štakora i miševa izloženih formoterolu opaženo je blago povećanje incidencije leiomioma maternice, koje se smatra učinkom skupine kod glodavaca nakon dugotrajnog izlaganja visokim dozama agonista β2-adrenoreceptora.
English: Bevespi Aerosphere can be used at the recommended dose in patients with mild to moderate hepatic impairment.
Croatian: Bevespi Aerosphere može se primjenjivati u preporučenoj dozi kod bolesnika s blagim do umjerenim oštećenjem bubrežne funkcije.
English: The estimated glycopyrronium Vc/F (volume of the central compartment), and Vp1/F (volume of the peripheral compartment) are 741 L, and 2990 L, respectively, via population pharmacokinetic analysis.
Croatian: Na temelju populacijske farmakokinetičke analize, procijenjeni Vc/F (volumen središnjeg odjeljka) glikopironija iznosi 741 l, dok njegov procijenjeni Vp1/F (volumen perifernog odjeljka) iznosi 2990 l.
English: number in Intent to Treat population primary endpoint in all studies PINNACLE 1 and PINNACLE 2 used SAC-TDI.
Croatian: U ispitivanjima PINNACLE 1 i PINNACLE 2 koristio se SAC-TDI.
English: • Your Bevespi Aerosphere inhaler comes in a foil pouch that contains a drying packet (desiccant).
Croatian: • Inhalator lijeka Bevespi Aerosphere dolazi u vrećici od folije koja sadrži pakiranje sredstva za sušenje.
English: • you have prostate problems, or difficulty passing urine
Croatian: • ako imate tegoba s prostatom ili otežano mokrite
English: In-vitro glycopyrronium is a substrate for the renal transporters OCT2 and MATE1/2K.
Croatian: Glikopironij je supstrat bubrežnih prijenosnika OCT2 i MATE1/2K in vitro.
English: Do not store above 30 oC.
Croatian: Ne čuvati na temperaturi iznad 30°C.
English: CYP2D6 was found to be the predominant enzyme involved in the metabolism of glycopyrronium.
Croatian: Utvrđeno je da u metabolizmu glikopironija pretežno sudjeluje enzim CYP2D6.
English: Figure 12 Step 8: Replace the cap over the mouthpiece right away after use (See Figure 13).
Croatian: 8. korak: Odmah nakon uporabe vratite zatvarač na nastavak za usta (pogledajte Sliku 13).
English: Figure 13
Croatian: Slika 13
English: • The pointer points between 100 and 120 after you use 10 more puffs.
Croatian: • Nakon sljedećih 10 udisaja indikator pokazuje između 100 i 120.
English: Check inside the mouthpiece before you use the inhaler to make sure it is clear.
Croatian: Prije uporabe inhalatora provjerite da se ništa ne nalazi u nastavku za usta.
English: In studies PINNACLE 1, PINNACLE 2 and PINNACLE 4, Bevespi Aerosphere showed improvements in trough FEV1 over 24 weeks relative to placebo, glycopyrronium and formoterol (p<0.0001) [see Table 2].
Croatian: U ispitivanjima PINNACLE 1, PINNACLE 2 i PINNACLE 4 Bevespi Aerosphere pokazao je poboljšanja najniže vrijednosti FEV1 tijekom 24 tjedna u odnosu na placebo, glikopironij i formoterol (p<0,0001) [vidjeti Tablicu 2]. Bronhodilatacijski učinak nije oslabio tijekom vremena.
English: 120 actuations
Croatian: 120 potisaka
English: SAC-TDI was a primary endpoint in PINNACLE 1 and PINNACLE 2 only From the Rescue Ventolin User Population in PINNACLE 4 A hierarchical statistical testing procedure was used in this study and this comparison was below a comparison that did not achieve statistical significance.
Croatian: SAC-TDI rezultat bio je primarna mjera ishoda samo u ispitivanjima PINNACLE 1 i PINNACLE 2 Podaci prikupljeni u populaciji bolesnika iz ispitivanja PINNACLE 4 koji su primjenjivali Ventolin za hitno ublažavanje simptoma
English: Gastrointestinal disorders Dry mouth 2, Nausea
Croatian: Poremećaji probavnog sustava suha usta
English: Figure 11
Croatian: Slika 11
English: Aerosphere (N=551) vs placebo (N=235)
Croatian: Aerosphere (N=551) u odnosu na placebo (N=235)
English: Mouthpiece
Croatian: • mučnina
English: The pharmacokinetics of formoterol was best described by a two compartment disposition model with a first-order rate constant of absorption and linear elimination.The typical clearance (CL/F) of formoterol was 99 L/h.
Croatian: Farmakokinetika formoterola najbolje je opisana modelom raspoloživosti s dva odjeljka, s konstantom apsorpcije prvog reda i linearnom eliminacijom.
English: Aerosphere (N=526) vs placebo (N=219)
Croatian: Aerosphere (N=526) u odnosu na placebo (N=219)
English: Aerosphere (N=510) vs placebo (N=223)
Croatian: Aerosphere (N=510) u odnosu na placebo (N=223)
English: Bevespi Aerosphere is for inhalation use.
Croatian: Bevespi Aerosphere primjenjuje se udisanjem (inhaliranjem).
English: Each single puff delivers a dose of 9 micrograms glycopyrronium bromide (equivalent to 7.2 micrograms of glycopyrronium), and 5 micrograms of formoterol fumarate dihydrate.
Croatian: Jednim udisajem isporučuje se doza od 9 mikrograma glikopironijeva bromida (što odgovara količini od 7,2 mikrograma glikopironija) i 5 mikrograma formoterolfumarat dihidrata.
English: The effect of renal impairment on the exposure to glycopyrronium and formoterol for up to 12 weeks was evaluated in a population pharmacokinetic analysis.
Croatian: U populacijskoj farmakokinetičkoj analizi ocjenjivao se utjecaj oštećenja funkcije bubrega na izloženost glikopironiju i formoterolu tijekom razdoblja u trajanju do 12 tjedana.
English: Bevespi Aerosphere (N=551) vs glycopyrronium (N=474)
Croatian: Bevespi Aerosphere (N=551) u odnosu na glikopironij (N=474)
English: The active substances are glycopyrronium and formoterol fumarate dihydrate.
Croatian: Što Bevespi Aerosphere sadrži Djelatne tvari su glikopironij i formoterolfumarat dihidrat.
English: Bevespi Aerosphere, 7.2 micrograms / 5 micrograms pressurised inhalation, suspension glycopyrronium / formoterol fumarate dihydrate
Croatian: Bevespi Aerosphere 7,2 mikrograma/5 mikrograma stlačeni inhalat, suspenzija glikopironij/formoterolfumarat dihidrat
English: The mouthpiece is covered with an orange protective cap. Bevespi Aerosphere is supplied in a foil pouch that contains a drying packet (desiccant) and packed into a carton.
Croatian: Bevespi Aerosphere isporučuje se u vrećici od folije, koja sadrži vrećicu sa sredstvom za sušenje, i dolazi zapakiran u kutiji.
English: Dose indicator
Croatian: Pokazivač doze
English: In PINNACLE 1, PINNACLE 2 and PINNACLE 4, Bevespi Aerosphere provided an improvement in disease-specific health-related quality of life, as indicated by a reduction in the St George's Respiratory Questionnaire (SGRQ) total score over 24 weeks compared to placebo and glycopyrronium [see Table 2].
Croatian: U ispitivanjima PINNACLE 1, PINNACLE 2 i PINNACLE 4 Bevespi Aerosphere ostvario je poboljšanje kvalitete života vezane uz zdravlje specifične za ovu bolest, što je pokazalo smanjenje ukupnog rezultata upitnika o bolestima dišnih putova „St. George's“ (engl.
English: Each single actuation (delivered dose, ex-actuator) contains glycopyrronium bromide 9 micrograms equivalent to 7.2 micrograms of glycopyrronium, and 5 micrograms of formoterol fumarate dihydrate.
Croatian: Jednim potiskom primjenjuje se doza (isporučena doza, doza oslobođena iz aktivatora) koja sadrži 9 mikrograma glikopironijeva bromida, što odgovara količini od 7,2 mikrograma glikopironija, i 5 mikrograma formoterolfumarat dihidrata.
English: On actuation of Bevespi Aerosphere, a volume of the suspension is expelled from the pressurised container at high velocity.
Croatian: Aktivacijom inhalatora lijeka Bevespi Aerosphere iz spremnika pod tlakom velikom se brzinom oslobađa određeni volumen suspenzije.
English: SIDE VIEW
Croatian: BOČNI PRIKAZ
English: NAMES OF THE MARKETING AUTHORISATION HOLDER
Croatian: NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
English: How to store Bevespi Aerosphere
Croatian: Kako čuvati Bevespi Aerosphere
English: Bevespi Aerosphere (N=551) vs formoterol fumarate (N=480)
Croatian: Aerosphere (N=551) u odnosu na formoterolfumarat (N=480)
English: How to use Bevespi Aerosphere
Croatian: Kako primjenjivati Bevespi Aerosphere
English: Cardiovascular effects, such as cardiac arrhythmias e.g. atrial fibrillation and tachycardia, may be seen after the administration of muscarinic receptor antagonists and sympathomimetics, including glycopyrronium or formoterol.
Croatian: Nakon primjene antagonista muskarinskih receptora i simpatomimetika, uključujući glikopironij ili formoterol, mogu nastupiti kardiovaskularni učinci poput srčanih aritmija, npr. fibrilacije atrija i tahikardije.
English: Pointer
Croatian: Indikator
English: Priming your Bevespi Aerosphere inhaler:
Croatian: Priprema inhalatora lijeka Bevespi Aerosphere:
English: Bevespi Aerosphere (N=526) vs formoterol fumarate (N=449)
Croatian: Aerosphere (N=526) u odnosu na formoterolfumarat (N=449)
English: Bevespi Aerosphere (N=510) vs formoterol fumarate (N=437)
Croatian: Aerosphere (N=510) u odnosu na formoterolfumarat (N=437)
English: • you have thyroid gland problems (called ‘thyrotoxicosis')
Croatian: • ako imate tegoba sa štitnjačom (tireotoksikozu)
English: Do not clean the pressurised container or let it get wet.
Croatian: Nemojte čistiti ni močiti spremnik pod tlakom.
English: Bevespi Aerosphere 7.2 mcg/5 mcg pressurised inhalation glycopyrronium/formoterol fumarate dihydrate Inhalation use
Croatian: Bevespi Aerosphere 7,2 μg/5 μg stlačeni inhalat glikopironij/formoterolfumarat dihidrat
English: FOIL POUCH
Croatian: • suha usta
English: 6.1 List of excipients
Croatian: 6.1 Popis pomoćnih tvari norfluran
English: Shake the inhaler well before each priming puff.
Croatian: Prije svakog otpuštanja lijeka radi pripreme inhalatora dobro protresite inhalator.
English: Glycopyrronium
Croatian: Blokatori β-adrenoreceptora
English: In PINNACLE 1 and PINNACLE 2, Bevespi Aerosphere provided improvements in breathlessness as demonstrated by Self-administered Computerised Transitional Dyspnoea Index (SAC TDI) focal score over 24 weeks compared to placebo and glycopyrronium (see Table 2).
Croatian: Self-administered Computerised Transitional Dyspnoea Index, SAC TDI) tijekom 24 tjedna u usporedbi s placebom i glikopironijem (vidjeti Tablicu 2).
English: Drug-induced hypokalaemia
Croatian: Hipokalijemija uzrokovana djelovanjem lijeka
English: A puff of medicine is released each time you press the centre of the dose indicator.
Croatian: Svakim pritiskom na središnji dio pokazivača doze oslobađa se količina lijeka za jedan udisaj.
English: • The pointer points to 100 after you take 10 more puffs.
Croatian: • Nakon sljedećih 10 udisaja indikator pokazuje 100.
English: Anxiety
Croatian: Doziranje
English: Each single actuation contains glycopyrronium bromide equivalent to 7.2 micrograms of glycopyrronium, and 5 micrograms of formoterol fumarate dihydrate.
Croatian: Jednim potiskom primjenjuje se glikopironijev bromid u dozi koja odgovara 7,2 mikrograma glikopironija te 5 mikrograma formoterolfumarat dihidrata.
English: Norflurane
Croatian: Glikopironij
English: This means that there are 120 puffs of medicine left in the pressurised container (See Figure 2a).
Croatian: 120 udisaja (pogledajte Sliku 2a).
English: • dry mouth
Croatian: Nastavak za usta
English: Do not use Bevespi Aerosphere if:
Croatian: Nemojte primjenjivati Bevespi Aerosphere
English: • anxiety
Croatian: • nemir
English: In PINNACLE 4, Bevespi Aerosphere provided improvements in breathlessness as demonstrated by TDI focal score over 24 weeks compared to placebo and glycopyrronium (see Table 2).
Croatian: Transition Dyspnoea Index, TDI) tijekom 24 tjedna u usporedbi s placebom i glikopironijem (vidjeti Tablicu 2).
English: COPD exacerbations:
Croatian: Egzacerbacije KOPB-a:
English: • Talk to your doctor or pharmacist if you have any questions about the use of your inhaler.
Croatian: • Ako imate bilo kakvih pitanja o uporabi inhalatora, obratite se liječniku ili ljekarniku.
English: Table 1Adverse reactions by frequency and system organ class (SOC)
Croatian: Nuspojave prema učestalosti i klasifikaciji organskih sustava Klasifikacija organskih sustava
English: Common conditions adverse reaction relates to formoterol adverse reaction relates to glycopyrronium
Croatian: Opći poremećaji i reakcije na mjestu primjene bol u prsištu često nuspojava povezana s formoterolom nuspojava povezana s glikopironijem
English: The recommended dose is:
Croatian: Preporučena doza jest:
English: Menstruation is no contraindication.
Croatian: Menstruacija nije kontraindikacija.
English: After first opening: use within 45 days.
Croatian: Nakon prvog otvaranja: upotrijebiti u roku od 45 dana.
English: No further interaction studies have been performed.
Croatian: Nisu provedena daljnja ispitivanja interakcija.
English: Date of first authorisation: 2 June 2017
Croatian: Datum prvog odobrenja: 02. lipnja 2017.
English: In such situations, treatment cessation should be considered.
Croatian: U tim situacijama potrebno je razmotriti prekid liječenja.
English: Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Croatian: Pažljivo pročitajte ovu uputu prije nego što počnete uzimati ovaj lijek jer sadrži Vama važne podatke.
English: Your doctor will discuss with you whether the treatment should be continued.
Croatian: Liječnik će s Vama razgovarati o tome trebate li nastaviti s liječenjem.
English: • ringing or buzzing in the ears
Croatian: • zvonjenje ili zujanje u ušima
English: In three studies, the observed difference was clearly statistically significant.
Croatian: U trima ispitivanjima primijećena razlika bila je jasno statistički značajna.
English: This leaflet was last revised in <{MM/YYYY}>.
Croatian: Ova uputa zadnji je put revidirana: <{MM/YYYY}>.
English: Not known: frequency cannot be estimated from the available data
Croatian: Nepoznato: učestalost se ne može procijeniti na temelju dostupnih podataka
English: Keep the bottle tightly closed in order to protect from moisture.
Croatian: Držite bočicu čvrsto zatvorenom radi zaštite od vlage.
English: Open date: ……………………
Croatian: Datum otvaranja: ……………………
English: The capsules should be taken with water at least 1 hour before meals or 2 hours after meals.
Croatian: Kapsule treba uzimati s vodom najmanje 1 sat prije obroka ili 2 sata nakon obroka.
English: In addition positive effects were observed on the voiding profile, although the observed differences were not statistically significant:
Croatian: Osim toga, primijećeni su pozitivni učinci na profil mokrenja, iako primijećene razlike nisu bile statistički značajne:
English: Always take this medicine exactly as your doctor or pharmacist has told you.
Croatian: Uvijek uzmite ovaj lijek točno onako kako vam je savjetovao vaš liječnik ili ljekarnik.
English: 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 available data).
Croatian: 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: Take the capsules whole with one glass of water, at least 1 hour before or 2 hours after meals.
Croatian: Uzmite cijelu kapsulu s jednom čašom vode barem 1 sat prije ili 2 sata nakon obroka.
English: For storage conditions after first opening of the bottle, see section 6.3.
Croatian: Uvjete čuvanja nakon prvog otvaranja bočice vidjeti u dijelu 6.3.
English: • allergic reactions, increased sensitivity to light
Croatian: • alergijske reakcije, povećana osjetljivost na svjetlo
English: PVC/Aclar-Aluminium blister with 90 (9x10) capsules.
Croatian: PVC/Aclar-aluminijski blister s 90 (9 x 10) kapsula.
English: GRA (95% CI) Pain (95% CI) Urgency (95% CI)
Croatian: (95 % CI) Urgencija (95 % CI)
English: • The other ingredients are microcrystalline cellulose, magnesium stearate, gelatin, titanium dioxide (E171).
Croatian: • Drugi sastojci su mikrokristalična celuloza, magnezijev stearat, želatina, titanijev dioksid (E171).
English: • ever had a reduced number of blood platelets caused by the medicine called heparin
Croatian: • ste ikad imali smanjen broj trombocita uzrokovan lijekom koji se zove heparin
English: Participants who reported either of the latter two categories were defined as treatment responders.
Croatian: Ispitanici koji su prijavili bilo koju od zadnje dvije kategorije definirani su kao ispitanici koji odgovaraju na liječenje.
English: Other medicines and elmiron
Croatian: Drugi lijekovi i elmiron
English: Dispose any remaining capsules after this period.
Croatian: Nakon tog razdoblja bacite sve preostale kapsule.
English: Talk to your doctor or pharmacist before taking elmiron if you have:
Croatian: Obratite se svom liječniku ili ljekarniku prije nego što uzmete lijek elmiron ako:
English: White opaque capsules size 2.
Croatian: Bijele neprozirne kapsule veličine 2.
English: • lack of blood platelets, red or white blood cells
Croatian: • manjak trombocita, crvenih ili bijelih krvnih stanica