FrancophonIA/ELRC3.0 huggingface dataset:
English: For more information about treatment with Optimark, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Optimark pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: In all of the studies, the effects of Optimark were compared with those of gadopentetate dimeglumine (another contrast agent containing gadolinium).
Croatian: U svim su se ispitivanjima učinci lijeka Optimark uspoređivali s učincima gadopentetat dimeglumina (drugo kontrastno sredstvo koje sadrži gadolinij).
English: In all of the studies, Optimark was as effective as the comparator contrast agent in improving the ability to see abnormalities on the scans.
Croatian: Lijek Optimark u svim se ispitivanjima pokazao jednako učinkovitim kao usporedno kontrastno sredstvo u poboljšanju mogućnosti uočavanja abnormalnosti na prikazima.
English: A repeated dose is not recommended in children, in patients with kidney problems or in elderly patients.
Croatian: Ponovljena doza ne preporučuje se u djece, u bolesnika s oštećenjem bubrega ii u bolesnika starije dobi.
English: It is available in prefilled syringes and in vials.
Croatian: Dostupan je u obliku napunjenih štrcaljki i u bočicama.
English: In the two studies of brain and spine abnormalities taken together, scans taken with Optimark had a score increase of 0.63 points on average from a ‘baseline' of 1.58 points without Optimark.
Croatian: U okviru dvaju ispitivanja abnormalnosti mozga i kralježnice koja su provedena zajedno, prikazi snimljeni uz primjenu lijeka Optimark pokazali su prosječno povećanje rezultata od 0,63 boda u odnosu na osnovnu vrijednost od 1,58 bodova bez primjene lijeka Optimark.
English: The main measure of effectiveness was the difference in the ability to see the abnormalities on MRI scans taken with and without the contrast agent.
Croatian: Glavno mjerilo djelotvornosti bila je razlika u mogućnosti uočavanja abnormalnosti pri pregledima magnetskom rezonancijom pomoću kontrastnog sredstva ili bez njega.
English: Optimark should only be given by a doctor who has experience in using MRI.
Croatian: Optimark smije primjenjivati samo liječnik s iskustvom u magnetskoj rezonanciji.
English: Patients who have moderate problems with their kidneys should only receive Optimark if their doctor has carefully balanced the benefits and risks of using it.
Croatian: U bolesnika s umjerenim oštećenjem bubrega lijek Optimark smije se primjenjivati samo ako je liječnik pažljivo razmotrio omjer koristi i rizika njegove primjene.
English: Why has Optimark been approved?
Croatian: Zašto je Optimark odobren?
English: Gadolinium is used as a ‘contrast agent' to help obtain better images with MRI scans.
Croatian: Gadolinij se koristi kao kontrastno sredstvo pomoću kojega se dobivaju jasnije slike pri magnetskoj rezonanciji.
English: The active substance in Optimark, gadoversetamide, contains gadolinium, a ‘rare-earth' metal element.
Croatian: Djelatna tvar u lijeku Optimark, gadoversetamid, sadrži gadolinij, rijetki zemni metal.
English: What is the risk associated with Optimark?
Croatian: Koji su rizici povezani s lijekom Optimark?
English: What is Optimark?
Croatian: Što je Optimark?
English: Optimark is a solution for injection that contains the active substance gadoversetamide.
Croatian: Optimark je otopina za injekciju koja sadrži djelatnu tvar gadoversetamid.
English: The most common side effects with Optimark (seen in between 1 and 10 patients in 100) are headache, dysgeusia (taste disturbances) and feeling hot. For the full list of all side effects reported with Optimark, see the package leaflet.
Croatian: Najčešće su nuspojave lijeka Optimark (zabilježene u između 1 i 10 na 100 bolesnika) glavobolja, dizguezija (poremećaj okusa) i osjećaj vrućine.
English: What benefit has Optimark shown during the studies?
Croatian: Koje su koristi lijeka Optimark utvrđene u ispitivanjima?
English: What is Optimark used for?
Croatian: Za što se Optimark koristi?
English: How is Optimark used?
Croatian: Kako se Optimark koristi?
English: How does Optimark work?
Croatian: Kako djeluje Optimark?
English: How has Optimark been studied?
Croatian: Kako je lijek Optimark ispitivan?
English: EU (MA) Number
Croatian: Broj (EU) odobrenja (Novoizumljeno) ime
English: Strength Pharmaceutical Form Route of Administration
Croatian: Jačina Farmaceutski oblik
English: MA (EU) number Invented name Strength Pharmaceutical form
Croatian: Zaštićeno ime Doza Farmaceutski oblik Put primjene
English: Route of administration
Croatian: Broj (EU) odobrenja
English: White suspension.
Croatian: Bijela suspenzija.
English: It is important to instruct the patient to:
Croatian: Važno je uputiti bolesnika da:
English: Date of first authorisation: 18 December 2018
Croatian: Datum prvog odobrenja: 18. prosinca 2018.
English: You may need medical attention.
Croatian: Možda će Vam trebati medicinska pomoć.
English: Always tell your doctor about other health problems.
Croatian: Uvijek obavijestite svog liječnika o drugim zdravstvenim tegobama.
English: These symptoms may be signs of an allergic reaction which may become serious.
Croatian: Ti simptomi mogu biti znakovi alergijske reakcije, koja može postati ozbiljna.
English: Take it as soon as you remember.
Croatian: Uzmite dozu čim se sjetite.
English: Therefore, statistical significance on this comparison cannot be inferred.
Croatian: Stoga se statistički značaj ove usporedbe ne može utvrditi.
English: It will help to reduce the effects of COPD on your everyday life.
Croatian: Pomoći će smanjiti utjecaj KOPB-a na Vaš svakodnevni život.
English: • medicines which can prolong ‘QT interval' (a change in the electrical activity of the heart).
Croatian: • lijekove koji mogu produljiti 'QT interval' (promjena u električnoj aktivnosti srca).
English: Clean the inhaler once each week for the first 3 weeks.
Croatian: Inhalator čistite jednom tjedno tijekom prva 3 tjedna.
English: Treatment difference (95% confidence intervals, p-value)
Croatian: Razlika između liječenja (intervali pouzdanosti od 95%, p-vrijednost)
English: • When the arrow reaches ‘0', you must stop using your inhaler.
Croatian: • Kad strelica dođe do '0', morate prestati koristiti inhalator.
English: If there is any built-up medicine, repeat Steps 3 to 5 in the section.
Croatian: Ako i dalje ima nakupljenog lijeka, ponovite korake 3 - 5 iz ovog dijela.
English: If you want to stop treatment, first talk to your doctor.
Croatian: Ako želite prekinuti liječenje, najprije razgovarajte sa svojim liječnikom.
English: • you have asthma.
Croatian: • ako imate astmu.
English: If a dose is missed, it should be taken as soon as possible and the next dose should be taken at the usual time.
Croatian: Ako bolesnik propusti dozu, treba je uzeti što je prije moguće, a sljedeću dozu treba uzeti u uobičajeno vrijeme.
English: There were no major differences in total systemic exposure (AUC) for both compounds between healthy Japanese and Western subjects.
Croatian: Nije bilo značajnih razlika u ukupnoj sistemskoj izloženosti (AUC) objema sastavnicama između zdravih ispitanika iz Japana i zapadnih zemalja.
English: Note: Patients should be instructed on the correct inhalation technique.
Croatian: Napomena: Bolesnike treba poučiti pravilnoj tehnici inhaliranja.
English: These patients should be monitored for potential adverse reactions.
Croatian: Te bolesnike treba nadzirati zbog potencijalnih nuspojava.
English: Other antimuscarinics and sympatomimetics
Croatian: Ostali antimuskarinici i simpatomimetici
English: Your inhaler is now ready to use.
Croatian: Inhalator je sada spreman za uporabu.
English: However, if it is nearly time for your next dose, skip the missed dose.
Croatian: Međutim, ako je uskoro vrijeme za sljedeću dozu, preskočite propuštenu dozu.
English: The recommended dose is two inhalations twice daily (two inhalations in the morning and two inhalations in the evening).
Croatian: Preporučena doza je dvije inhalacije dvaput na dan (dvije inhalacije ujutro i dvije inhalacije navečer).
English: These belong to a group of medicines called long-acting bronchodilators.
Croatian: One pripadaju skupini lijekova koji se zovu dugodjelujući bronhodilatatori.
English: Do not use this medicine for asthma
Croatian: Nemojte koristiti ovaj lijek za liječenje astme
English: Then stop pressing the dose indicator.
Croatian: Zatim prestanite pritiskati pokazivač doze.
English: Hold your breath as long as you comfortably can, up to 10 seconds (See Figure 11).
Croatian: Zadržite dah koliko možete, do 10 sekundi (pogledajte Sliku 11).
English: • fast or irregular heart beat
Croatian: • brzi ili nepravilni otkucaji srca
English: Date pouch opened:__________
Croatian: Datum otvaranja vrećice:__________
English: It is important to use Bevespi Aerosphere every day, even if you have no COPD symptoms at the time.
Croatian: Važno je da Bevespi Aerosphere primjenjujete svakodnevno, čak i ako trenutno nemate simptome KOPB-a.
English: • high blood sugar levels
Croatian: • visoke razine šećera u krvi
English: It will only be effective as long as you are using it. Do not stop unless your doctor tells you to, even if you feel better, as your symptoms may get worse.
Croatian: Nemojte prestati primjenjivati lijek osim ako Vam to ne kaže liječnik, čak i ako se osjećate bolje, jer se simptomi mogu pogoršati.
English: If this occurs, do not drive or use machines.
Croatian: Ako se te nuspojave pojave, nemojte upravljati vozilima i raditi sa strojevima.
English: Non-clinical data reveal no specific hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti i kancerogenog potencijala.
English: Step 3: Hold the actuator under the tap and run warm water through it for about 30 seconds.
Croatian: 3. korak: Držite aktivator pod slavinom i pustite da topla voda prolazi kroz njega približno 30 sekundi.
English: Patients with clinically significant uncontrolled cardiovascular disease were excluded from clinical studies.
Croatian: Bolesnici s klinički značajnom nekontroliranom kardiovaskularnom bolešću nisu bili uključeni u klinička ispitivanja.
English: WEEK 12
Croatian: 12. TJEDAN
English: Step 4: Shake off as much water from the actuator as you can.
Croatian: 4. korak: Otresite vodu s aktivatora najbolje što možete.
English: It is unlikely that this medicine will affect your ability to drive and use machines.
Croatian: Nije vjerojatno da će ovaj lijek utjecati na Vašu sposobnost upravljanja vozilima i rada sa strojevima.
English: Please read the instructions for use at the end of this leaflet.
Croatian: Pročitajte upute za uporabu na kraju ove upute o lijeku.
English: Your inhaler may not feel empty and it may seem as though it still works.
Croatian: Možda će Vam se činiti da inhalator nije prazan i da još uvijek radi.
English: Figure 2d
Croatian: Slika 2d
English: - you are allergic to glycopyrronium, formoterol fumarate dihydrate or any of the other ingredients of this medicine (listed in section 6).
Croatian: - ako ste alergični na glikopironij, formoterolfumarat dihidrat ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: Stop using Bevespi Aerosphere and seek immediate medical care if you notice any of the following symptoms:
Croatian: Prestanite primjenjivati Bevespi Aerosphere i odmah potražite liječničku pomoć ako primijetite bilo koji od navedenih simptoma:
English: Press here
Croatian: Pritisnuti ovdje
English: Insufficient pharmacokinetic data are available to compare exposure for other ethnicities or races.
Croatian: Nije dostupno dovoljno farmakokinetičkih podataka za usporedbu izloženosti u drugim etničkim skupinama ili rasama.
English: You may notice that your heart is beating faster than usual, you feel shaky, you have visual disturbances, have a dry mouth, or have a headache or feel nauseous (sick).
Croatian: Možda ćete primijetiti da Vam srce kuca brže nego inače, da se tresete, da imate smetnje vida, suha usta ili glavobolju ili da osjećate mučninu.
English: This could cause a puff of medicine to be released.
Croatian: To bi moglo dovesti do otpuštanja lijeka.
English: INNER CARTON, MULTIPACK - WITH NO BLUE BOX
Croatian: UNUTARNJA KUTIJA, VIŠESTRUKO PAKIRANJE - BEZ PLAVOG OKVIRA
English: Concurrent use of either non-selective or selective β-adrenergic blockers should be avoided unless there are compelling reasons for their use.
Croatian: Treba izbjegavati istodobnu primjenu kako neselektivnih tako i selektivnih blokatora β-adrenoreceptora, osim ako ne postoje uvjerljivi razlozi za njihovu primjenu.
English: Step 6: When you have finished breathing in, remove the mouthpiece from your mouth.
Croatian: 6. korak: Kad završite s udisanjem, izvadite nastavak iz usta.
English: The frequency of adverse reactions is defined using the following convention: 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) and not known (cannot be estimated from available data).
Croatian: Učestalost nuspojava definirana je kao: 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) i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: SAC-TDI / TDI Focal Score
Croatian: Ukupan SAC-TDI / TDI rezultat
English: Do not put the pressurised container back into the actuator if it is still wet.
Croatian: Nemojte vraćati spremnik pod tlakom u aktivator ako je još uvijek mokar.
English: Secondary metabolic pathways include deformylation and sulfate conjugation.
Croatian: Sekundarni metabolički putovi uključuju deformilaciju i sulfokonjugaciju.
English: Repeat steps 2 to 7 to take your second puff of Bevespi Aerosphere.
Croatian: Ponovite korake 2 - 7 za primjenu drugog udisaja lijeka Bevespi Aerosphere.
English: • The colour in the dose indicator display window will change to red, as shown in the shaded area, when there are only 20 puffs of medicine left in your inhaler (See Figure 2d).
Croatian: • Boja prozorčića za prikaz doze promijenit će se u crvenu, kako je prikazano osjenčanim dijelom, kada u inhalatoru preostane količina lijeka dovoljna za samo 20 udisaja (pogledajte Sliku 2d).
English: Bevespi Aerosphere has no or negligible influence on the ability to drive and use machines.
Croatian: Bevespi Aerosphere ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: • medicines that lower potassium in your blood.
Croatian: • lijekove koji smanjuju razinu kalija u krvi.
English: • Use Bevespi Aerosphere exactly as your doctor tells you to.
Croatian: • Primjenjujte Bevespi Aerosphere točno onako kako Vam je rekao liječnik.
English: 2 years To be used within 3 months of opening the pouch.
Croatian: 2 godine Upotrijebiti u roku od 3 mjeseca nakon otvaranja vrećice.
English: Patients should be advised not to take more than 2 inhalations twice daily.
Croatian: Bolesnike je potrebno uputiti da ne primjenjuju više od 2 inhalacije dvaput na dan.
English: Do not take more than two puffs twice a day.
Croatian: Nemojte primijeniti više od dva udisaja dvaput na dan.
English: Warning: Do not break, puncture or burn the pressurised container, even when apparently empty.
Croatian: Upozorenje: Nemojte lomiti, probijati ni paliti spremnik pod tlakom, čak ni kada je naizgled prazan.
English: • Carefully read the instructions for use in the patient information leaflet, which is packed together with each inhaler.
Croatian: • pažljivo pročita upute za uporabu u uputi o lijeku koja je priložena u pakiranju svakog inhalatora.
English: Read this instructions for use and the package leaflet before you start using Bevespi Aerosphere and each time you get a new inhaler.
Croatian: Pročitajte ove upute za uporabu i uputu o lijeku prije nego počnete primjenjivati Bevespi Aerosphere i svaki put kad dobijete novi inhalator.
English: The most common adverse reactions reported in the clinical development program (comprised of 1,588 patients receiving Bevespi Aerosphere) were headache (1.9%), nausea (1.4%), muscle spasms (1.4%), and dizziness (1.3%).
Croatian: Najčešće prijavljene nuspojave u programu kliničkog razvoja (koji je uključivao 1588 bolesnika koji su primali Bevespi Aerosphere) bile su glavobolja (1,9%), mučnina (1,4%), mišićni grčevi (1,4%) i omaglica (1,3%).
English: • Hold the inhaler upright, away from your face and shake it well (See Figure 4).
Croatian: • Držite inhalator uspravno, podalje od lica i dobro ga protresite (pogledajte Sliku 4).
English: Hypersensitivity to the active substances or any of the excipients listed in section 6.1.
Croatian: Preosjetljivost na djelatne tvari ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: However, you will not get the right amount of medicine if you keep using it.
Croatian: Međutim, ako ga nastavite koristiti, nećete primiti odgovarajuću količinu lijeka.
English: Elderly No dose adjustments are required in elderly patients (see section 5.2).
Croatian: Nije potrebno prilagođavati dozu kod starijih bolesnika (vidjeti dio 5.2).
English: If overdose occurs, the patient should be treated supportively with appropriate monitoring as necessary.
Croatian: Ako dođe do predoziranja, bolesnika treba liječiti potporno te prema potrebi uvesti odgovarajući nadzor.
English: The number in the dose indicator display window will change after every 20 puffs.
Croatian: Broj na prozorčiću za prikaz doze promijenit će se nakon svakih 20 udisaja.
English: The pressurised container should not be broken, punctured or burnt, even when apparently empty.
Croatian: Spremnik pod tlakom ne smije se lomiti, probijati ni paliti, čak ni kada je naizgled prazan.
English: Glycopyrronium did not cause any adverse effects on fertility in rats.
Croatian: Glikopironij nije imao štetnih učinaka na plodnost kod štakora.
English: The combination of these substances with different mechanisms of action results in additive efficacy compared to use with either component alone.
Croatian: Kombinacijom ovih tvari s različitim mehanizmima djelovanja postiže se aditivna djelotvornost u usporedbi s onom kod primjene jedne od sastavnica samostalno.
English: If paradoxical bronchospasm does occur, treatment with the medicinal product should be stopped and other treatments considered.
Croatian: Ako se paradoksalni bronhospazam ipak razvije, treba prekinuti liječenje ovim lijekom i razmotriti druge terapije.
English: Bevespi Aerosphere is not for use in children or adolescents below 18 years of age.
Croatian: Bevespi Aerosphere ne smije se primjenjivati u djece i adolescenata mlađih od 18 godina.
English: For pharmacokinetic purposes each component can therefore be considered separately.
Croatian: Stoga se za farmakokinetičke potrebe svaka sastavnica može razmotriti zasebno.
English: Do not use this medicine to treat a sudden attack of breathlessness or wheezing.
Croatian: Nemojte primjenjivati ovaj lijek za liječenje iznenadnog napadaja nedostatka zraka ili piskanja pri disanju.
English: In that study, 62% of the radiolabelled formoterol was excreted in the urine while 24% was eliminated in the faeces.
Croatian: U tom se ispitivanju 62% radioaktivno označenog formoterola izlučilo u mokraću, dok se 24% eliminiralo kroz feces.
English: • any medicines that work in the same way as Bevespi Aerosphere, such as medicines containing active substances such as tiotropium, ipratropium, aclidinium, umeclidinium, salmeterol, vilanterol, olodaterol, or indacaterol.
Croatian: • bilo koje lijekove koji djeluju na isti način kao Bevespi Aerosphere, poput lijekova koji sadrže djelatne tvari kao što su tiotropij, ipratropij, aklidinij, umeklidinij, salmeterol, vilanterol, olodaterol ili indakaterol.
English: France or
Croatian: Francuska ili
English: The inhaler can be used for up to 3 months after first opening the pouch.
Croatian: Inhalator možete koristiti najviše 3 mjeseca nakon prvog otvaranja vrećice.
English: Do not expose to temperatures higher than 50°C.
Croatian: Ne izlažite temperaturama iznad 50°C.
English: A placebo- and active-controlled (moxifloxacin) thorough QT study in 69 healthy subjects did not demonstrate a clinically relevant effect on the QT interval, using a threshold of 10 ms.
Croatian: U temeljitom, placebom i aktivnim lijekom (moksifloksacinom) kontroliranom ispitivanju učinaka na QT interval provedenom kod 69 zdravih ispitanika nije utvrđen klinički značajan učinak na QT interval; korišten je prag od 10 ms.
English: • you have low levels of potassium in the blood
Croatian: • ako imate niske razine kalija u krvi
English: OUTER CARTON, MULTIPACK - WITH BLUE BOX
Croatian: VANJSKA KUTIJA, VIŠESTRUKO PAKIRANJE - UKLJUČUJUĆI PLAVI OKVIR
English: COPD is a long-term disease of the airways in the lungs, which is often caused by smoking.
Croatian: KOPB je dugotrajna bolest dišnih putova u plućima, koju često uzrokuje pušenje.
English: Both central and peripheral deposition were observed.
Croatian: Opažena je depozicija i u središnjim i u perifernim dišnim putovima.
English: • shaking or tremor
Croatian: • tresenje ili nevoljno drhtanje
English: Bevespi Aerosphere should only be used during pregnancy if the expected benefits outweigh the potential risks.
Croatian: Bevespi Aerosphere smije se primjenjivati tijekom trudnoće samo ako očekivana korist nadmašuje potencijalne rizike.
English: You may be able to use a ‘spacer' with your inhaler.
Croatian: Možda ćete moći koristiti svoj inhalator s ‘komorom za inhaliranje'.
English: The recommended dose is two puffs twice a day.
Croatian: Preporučena doza je dva udisaja dvaput na dan.
English: The dose indicator display window shows how many puffs of medicine you have left.
Croatian: U prozorčiću za prikaz doze prikazuje se koliko Vam je udisaja lijeka preostalo.
English: This information should be used alongside a discussion with your doctor about your medical condition and treatment.
Croatian: Ove informacije dopuna su razgovoru s liječnikom o Vašoj bolesti ili njezinu liječenju.
English: Step 5: Look into the actuator and the mouthpiece to make sure any medicine build-up has been completely washed away.
Croatian: 5. korak: Pogledajte u aktivator i nastavak za usta kako biste se uvjerili da je voda potpuno isprala sav nakupljeni lijek.
English: There is no relevant use of Bevespi Aerosphere in children and adolescents (under 18 years of age) for the indication of COPD.
Croatian: Nema relevantne primjene lijeka Bevespi Aerosphere kod djece i adolescenata (mlađih od 18 godina) za indikaciju KOPB-a.
English: Pharmacotherapeutic group: Drugs for obstructive airway diseases: adrenergics in combination with anticholinergics, ATC code: R03AL07.
Croatian: Farmakoterapijska skupina: Lijekovi za liječenje opstruktivnih bolesti dišnih putova: kombinacije adrenergika s antikolinergicima, ATK oznaka: R03AL07.
English: Step 2: Shake the inhaler well before each use (See Figure 7).
Croatian: 2. korak: Prije svake uporabe dobro protresite inhalator (pogledajte Sliku 7).
English: This medicine is for long-term use.
Croatian: Ovaj je lijek namijenjen za dugotrajnu primjenu.
English: The active ingredients are present in a pressurised suspension inside the pressurised container.
Croatian: Djelatne tvari nalaze se u stlačenoj suspenziji unutar spremnika pod tlakom.
English: • Prime the inhaler by shaking it and actuating into the air four times before first use or two times when the inhaler has not been used for more than seven days, has been exposed to low temperatures, or has been dropped.
Croatian: • pripremi inhalator tako da ga protrese i ispusti u zrak četiri doze prije prve uporabe ili dvije doze ako inhalator nije bio korišten dulje od sedam dana, ako je bio izložen niskim temperaturama ili ako je pao na pod.
English: • you have heart problems
Croatian: • ako imate srčanih tegoba