FrancophonIA/ELRC3.0 huggingface dataset:
English: - you have heart problems.
Croatian: - ako imate problema sa srcem.
English: In case such effects occur with this medicinal product, treatment may need to be discontinued.
Croatian: Ako se pojave ovi učinci s ovim lijekom, možda se liječenje treba prekinuti.
English: If you forget to inhale a dose at the usual time, inhale one as soon as possible that day.
Croatian: Ako zaboravite inhalirati dozu u uobičajeno vrijeme, inhalirajte je čim bude moguće toga dana.
English: This medicine blocks the tightening of these muscles in the lungs, making it easier for air to get in and out of the lungs.
Croatian: Ovaj lijek blokira stezanje tih mišića u plućima, zbog čega zrak lakše ulazi i izlazi iz pluća.
English: Remove empty capsule Put the empty capsule in your household waste.
Croatian: Izvadite praznu kapsulu Odložite praznu kapsulu u kućanski otpad.
English: Place the mouthpiece in your mouth and close your lips firmly around it.
Croatian: Stavite nastavak u usta i usnama ga čvrsto obujmite.
English: Patients should be instructed on how to administer the medicinal product correctly.
Croatian: Bolesnici moraju biti upućeni kako pravilno primjenjivati lijek.
English: You may taste the medicine as you inhale.
Croatian: Mogli biste osjetiti okus lijeka dok inhalirate.
English: Reproduction studies and other data in animals do not indicate a concern regarding fertility in either males or females.
Croatian: Ispitivanja reprodukcije i drugi podaci u životinja ne upućuju na zabrinutost oko plodnosti u žena ili muškaraca.
English: The effect remains constant over the whole 24-h dosing interval.
Croatian: Učinak je ostao postojan tijekom cijelog razdoblja doziranja od 24 h.
English: This medicine contains lactose (23.5 mg per capsule).
Croatian: Ovaj lijek sadrži laktozu (23,5 mg po kapsuli).
English: Not to be sold separately.
Croatian: Nije za zasebnu prodaju.
English: A further 5% of the dose was found in the bile.
Croatian: Dodatnih 5% doze pronađeno je u žuči.
English: You should hear a noise as the capsule is pierced.
Croatian: Trebate čuti zvuk kad se probuši kapsula.
English: Supportive and symptomatic treatment is indicated.
Croatian: Indicirana je primjena suportivnog i simptomatskog liječenja.
English: • voice alteration (hoarseness).
Croatian: • promjena glasa (promuklost).
English: • Do not press the side buttons more than once.
Croatian: • Ne pritišćite bočne tipke više od jedanput.
English: What should I do if there is powder left inside the capsule?
Croatian: Što trebam napraviti ako je ostalo praška u kapsuli?
English: In addition, the corresponding frequency category for each adverse reaction is based on the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000, <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Croatian: Osim toga, odgovarajuća kategorija učestalosti za svaku nuspojavu temelji se na sljedećem načelu: 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: If there is powder left in the capsule:
Croatian: Ako je ostalo praška u kapsuli:
English: If a dose is missed, it should be taken as soon as possible on the same day.
Croatian: Ako se preskoči doza, potrebno ju je uzeti čim prije istoga dana.
English: Ask your doctor or pharmacist for advice before using any medicine.
Croatian: Obratite se svom liječniku ili ljekarniku za savjet prije uzimanja bilo kojeg lijeka.
English: A hydroxylated derivative was the most prominent metabolite in serum.
Croatian: Hidroksilirani derivat bio je najvažniji metabolit u serumu.
English: Lean body weight (which is a function of weight and height) was identified as a covariate.
Croatian: Čista tjelesna težina (funkcija tjelesne težine i visine) bila je identificirana kao kovarijata.
English: However, this medicine may cause dizziness (see section 4).
Croatian: Međutim, ovaj lijek može uzrokovati omaglicu (pogledajte dio 4).
English: Ask your pharmacist how to dispose of medicines and inhalers that are no longer required.
Croatian: Upitajte svog ljekarnika kako odložiti lijekove i inhalatore koje više ne trebate.
English: Blister card
Croatian: Blister kartica
English: The maximal effect on blood glucose was 0.67 mmol/l.
Croatian: Najveći učinak na glukozu u krvi bio je 0,67 mmol/l.
English: • swollen hands, ankles and feet.
Croatian: • otečene šake, gležnjevi i stopala.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development.
Croatian: Neklinički podaci ne ukazuju na posebnu opasnost za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti, kancerogenog potencijala, reproduktivne i razvojne toksičnosti.
English: Also contains: lactose and magnesium stearate.
Croatian: Također sadrži: laktozu i magnezijev stearat.
English: I coughed after inhaling - does this matter?
Croatian: Zakašljao/la sam nakon inhaliranja - je li to važno?
English: Pierce capsule by firmly pressing both side buttons at the same time.
Croatian: Probušite kapsulu čvrstim pritiskom na bočne tipke s obje strane istovremeno.
English: The apparent volume of distribution in the terminal phase following inhalation was almost 20-fold larger, which reflects the much slower elimination after inhalation.
Croatian: Prividni volumen distribucije u terminalnoj fazi nakon inhalacije bio je gotovo 20 puta veći, što odražava puno sporiju eliminaciju nakon inhalacije.
English: Shortening of electrocardiograph intervals and decreased systolic and diastolic blood pressure were also apparent.
Croatian: Skraćenje elektrokardiografskih intervala i sniženi sistolički i dijastolički krvni tlak također su bili uočljivi.
English: Do not use this medicine to treat a sudden attack of breathlessness or wheezing.
Croatian: Ne koristite ovaj lijek za liječenje iznenadnog napada nedostatka zraka ili piskanja.
English: Rare (may affect up to 1 in 1000 people) • tingling or numbness.
Croatian: Rijetke (mogu se javiti u do 1 na 1000 osoba) • trnci ili utrnulost.
English: However, the occurrence of dizziness may influence the ability to drive and use machines (see section 4.8).
Croatian: Međutim, pojava omaglice može utjecati na sposobnost upravljanja vozilima i rada sa strojevima (vidjeti dio 4.8).
English: There was no attenuation of the bronchodilator effect over time.
Croatian: Nije bilo slabljenja bronhodilatacijskog učinka tijekom vremena.
English: The safety profile is characterised by typical anticholinergic and beta-adrenergic symptoms related to the individual components of the combination.
Croatian: Sigurnosni profil karakteriziran je tipičnim antikolinergičkim i beta-adrenergičkim simptomima povezanima s pojedinačnim komponentama kombinacije.
English: No evidence of carcinogenicity was seen in mice.
Croatian: Nije bila zapažena karcinogenost u miševa.
English: Then, inhale the next dose as usual the next day.
Croatian: Zatim inhalirajte sljedeću dozu prema uobičajenom rasporedu sljedeći dan.
English: The chances of the capsule breaking into small pieces will be increased if the capsule is pierced more than once.
Croatian: Vjerojatnost da će se kapsula zdrobiti veća je ako se kapsula probuši više od jedanput.
English: Close the inhaler.
Croatian: Zatvorite inhalator.
English: It is unlikely that this medicine will affect your ability to drive and use machines.
Croatian: Malo je vjerojatno da će ovaj lijek utjecati na Vašu sposobnost upravljanja vozilima i strojevima.
English: Carcinogenicity was assessed in a two-year rat study and a six-month transgenic mouse study.
Croatian: Karcinogenost je bila procijenjena u dvogodišnjem ispitivanju u štakora i šestomjesečnom transgeničnom ispitivanju u miševa.
English: COPD is a long-term disease and you should use Ultibro Breezhaler every day and not only when you have breathing problems or other symptoms of COPD.
Croatian: KOPB je dugoročna bolest i trebate primijeniti Ultibro Breezhaler svaki dan, a ne samo kada imate poteškoće s disanjem ili druge simptome KOPB-a.
English: A negative correlation between systemic exposure and lean body weight (or body weight) was observed; however, no dose adjustment is recommended due to the magnitude of the change or the predictive precision of lean body weight.
Croatian: Uočena je negativna korelacija između sistemske izloženosti i čiste tjelesne težine (ili tjelesne težine); međutim, ne preporučuje se prilagođavanje doze zbog razmjera promjene prediktivne preciznosti čiste tjelesne težine.
English: - Tell your doctor immediately if your COPD symptoms such as breathlessness, wheezing or cough do not improve or get worse.
Croatian: - Odmah se obratite svom liječniku ako Vam se simptomi KOPB-a kao što su nedostatak zraka, piskanje ili kašalj nisu popravili ili ako su se pogoršali.
English: The in vitro human serum and plasma protein binding was about 95%.
Croatian: In vitro vezanje na ljudske proteine seruma i plazme bilo je oko 95%.
English: The capsule may be stuck in the capsule chamber.
Croatian: Moguće je da je kapsula zapela u komori za kapsulu.
English: Glycopyrronium bromide (including its metabolites) was excreted into the milk of lactating rats and reached up to 10-fold higher concentrations in the milk than in the blood of the dam.
Croatian: Glikopironijev bromid (uključujući njegove metabolite) izlučivao se u mlijeku štakora u laktaciji i dosegao do 10 puta veće koncentracije u mlijeku nego u krvi matične životinje.
English: A greater than 4-fold selectivity for the human M3 receptors over the human M2 receptor has been demonstrated using radioligand binding studies.
Croatian: Dokazana je više od 4 puta veća selektivnost za humane M3 receptore od one za humani M2 receptor u ispitivanjima vezanja radioaktivnog liganda.
English: The mean bronchodilator effect derived from serial FEV1 measurements over 24 h was 320 ml after 26 weeks of treatment.
Croatian: Srednji bronhodilatacijski učinak izveden iz serijskih mjerenja FEV1 tijekom 24 h bio je 320 ml nakon 26 tjedana liječenja.
English: Ultibro Breezhaler is recommended to be administered at the same time of the day each day.
Croatian: Preporučuje se da se Ultibro Breezhaler primjenjuje u isto vrijeme svakoga dana.
English: Repeat steps 3a to 3c.
Croatian: Ponovite korake 3a do 3c.
English: Inhale the medicine again by repeating steps 3a to 3c.
Croatian: Ponovo inhalirajte lijek ponavljajući korake 3a do 3c.
English: Up to 23% of the delivered dose was found in urine as parent drug.
Croatian: Do 23% isporučene doze bilo je pronađeno u mokraći kao ishodišni lijek.
English: There are no data on the use of this medicine in pregnant women and it is not known whether the active substances of this medicine pass into human milk.
Croatian: Nema podataka o primjeni ovog lijeka u trudnica i nije poznato izlučuje li se djelatna tvar ovog lijeka u majčino mlijeko.
English: Reports received from post-marketing experience; frequencies calculated, however, on the basis of clinical trial data.
Croatian: Izvješća zaprimljena nakon stavljanja lijeka u promet; međutim učestalost je izračunata na temelju podataka iz kliničkih ispitivanja.
English: Mild irritancy or adaptive changes in the respiratory tract were seen in rats.
Croatian: Blaga nadraženost ili adaptivne promjene u dišnom sustavu bile su uočene u štakora.
English: If you have questions about how long to continue your treatment with this medicine, talk to your doctor or pharmacist.
Croatian: Ako imate pitanja o tome koliko dugo trebate nastaviti liječenje ovim lijekom, obratite se svom liječniku ili ljekarniku.
English: - In this pack, you will find an inhaler and capsules (in blisters) that contain the medicine as inhalation powder.
Croatian: - U ovom pakiranju naći ćete inhalator i kapsule (u blisterima) koje sadrže lijek kao prašak inhalata.
English: • dental caries.
Croatian: • zubni karijes.
English: Pharmacotherapeutic group: Drugs for obstructive airway diseases, adrenergics in combination with anticholinergics, ATC code: R03AL04
Croatian: Farmakoterapijska skupina: Lijekovi za liječenje opstruktivnih bolesti dišnih puteva, adrenergici u kombinaciji s antikolinergicima, ATK oznaka: R03AL04
English: The mean terminal elimination half-life was much longer after inhalation (33 to 57 hours) than after intravenous (6.2 hours) and oral (2.8 hours) administration.
Croatian: Srednji terminalni poluvijek eliminacije bio je puno dulji nakon inhalacije (33 do 57 sati) nego nakon intravenske (6,2 sata) i peroralne primjene (2,8 sata).
English: If this happens, carefully loosen the capsule by tapping the base of the inhaler.
Croatian: Ako se to dogodi, pažljivo oslobodite kapsulu tapkanjem po donjem dijelu inhalatora.
English: Talk to your doctor, pharmacist or nurse before using Ultibro Breezhaler if any of the following applies to you: - you have asthma - this medicine should not be used as a treatment for asthma.
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego uzmete Ultibro Breezhaler ako se bilo što od navedenoga odnosi na Vas: - ako imate astmu - ovaj lijek se ne smije koristiti za liječenje astme.
English: Although beta2-adrenergic receptors are the predominant adrenergic receptors in bronchial smooth muscle and beta1-adrenergic receptors are the predominant receptors in the human heart, there are also beta2-adrenergic receptors in the human heart comprising 10% to 50% of the total adrenergic receptors.
Croatian: Premda su beta2-adrenergički receptori predominantni adrenergički receptori u bronhijalnim glatkim mišićima, a beta1-adrenergički receptori predominantni receptori u ljudskom srcu, u ljudskom srcu postoje i beta2- adrenergički receptori koji čine 10-50% ukupnih adrenergičkih receptora.
English: Patients should be informed about the signs and symptoms of acute narrow-angle glaucoma and should be informed to stop using Ultibro Breezhaler should any of these signs or symptoms develop.
Croatian: Bolesnike treba obavijestiti o znakovima i simptomima akutnog glaukoma uskog kuta i uputiti ih da prestanu koristiti Ultibro Breezhaler ako se pojavi bilo koji od tih znakova i simptoma.
English: Their presence in the heart raises the possibility that even highly selective beta2-adrenergic agonists may have cardiac effects.
Croatian: Njihova prisutnost u srcu povećava mogućnost da čak i visoko selektivni beta2-adrenergički agonisti mogu imati srčane učinke.
English: The in vitro human plasma protein binding of glycopyrronium was 38% to 41% at concentrations of 1 to 10 nanograms/ml.
Croatian: In vitro vezanje glikopironija za ljudske proteine plazme bilo je 38% do 41% pri koncentracijama od 1 do 10 nanograma/ml.
English: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity at clinically relevant exposures (see section 5.3).
Croatian: Ispitivanja na životinjama ne ukazuju na izravan ili neizravan štetan učinak na reprodukcijsku toksičnost pri klinički značajnoj izloženosti (vidjeti dio 5.3).
English: In this pack, you will find a device called an inhaler together with capsules in blister strips.
Croatian: U ovom pakiranju pronaći ćete napravu koja se naziva inhalator, zajedno s kapsulama u blisterima.
English: The inhaler provided with each new prescription should be used.
Croatian: Treba koristiti inhalator koji se dobije sa svakim novim receptom.
English: Hydroxylation resulting in a variety of mono- and bis-hydroxylated metabolites and direct hydrolysis resulting in the formation of a carboxylic acid derivative (M9) were seen.
Croatian: Uočena je hidroksilacija koja je rezultirala raznim mono- i bis-hidroksiliranim metabolitima te direktna hidroliza koja je rezultirala stvaranjem derivata karboksilne kiseline (M9).
English: After intravenous infusion the volume of distribution of indacaterol during the terminal elimination phase was 2557 litres indicating an extensive distribution.
Croatian: Nakon intravenske infuzije volumen distribucije indakaterola tijekom završne faze eliminacije bio je 2557 litara ukazujući na ekstenzivnu distribuciju.
English: • crushing chest pain with increased sweating - this may be a serious heart problem (ischaemic heart disease).
Croatian: • pritiskajuća bol u prsnom košu s pojačanim znojenjem - to bi mogao biti ozbiljan srčani problem (ishemijska bolest srca).
English: Indacaterol serum concentrations declined in a multi-phasic manner with an average terminal half-life ranging from 45.5 to 126 hours.
Croatian: Koncentracije indakaterola u serumu padale su na multifazni način, uz prosječni poluvijek u rasponu od 45,5 do 126 sati.
English: There is no relevant use of Ultibro Breezhaler in the paediatric population (under 18 years) in the indication COPD.
Croatian: Nema relevantne primjene Ultibro Breezhalera u pedijatrijskoj populaciji (mlađih od 18 godina) u indikaciji KOPB-a.
English: The magnitude of exposure increases due to interactions does not raise any safety concerns given the safety experience of treatment with indacaterol in clinical studies of up to one year at doses up to twice the maximum recommended indacaterol dose.
Croatian: Razmjer povećanja izloženosti zbog interakcija ne uzrokuje nikakva sigurnosna pitanja s obzirom na iskustvo sa sigurnošću liječenja indakaterolom u kliničkim ispitivanjima u trajanju do jedne godine pri dozama koje su do dva puta veće od najviše preporučene doze indakaterola.
English: A thorough QT (TQT) study in healthy volunteers with high doses of inhaled indacaterol (up to twice the maximum recommended therapeutic dose) did not demonstrate a clinically relevant effect on the QT interval.
Croatian: Temeljito ispitivanje QT-a (TQT) u zdravih dobrovoljaca s visokim dozama inhaliranog indakaterola (do dvaput većim od preporučene terapijske doze) nije pokazalo klinički značajan učinak na QT interval.
English: As it contains indacaterol and glycopyrronium, the type and severity of adverse reactions associated with each of these components may be expected in the combination.
Croatian: Budući da sadrži indakaterol i glikopironij, vrsta i težina nuspojava povezanih sa svakom od tih komponenti može se očekivati i u kombinaciji.
English: - you have diabetes.
Croatian: - ako imate šećernu bolest.
English: An overdose could lead to exaggerated effects typical of beta2-adrenergic stimulants, i.e. tachycardia, tremor, palpitations, headache, nausea, vomiting, drowsiness, ventricular arrhythmias, metabolic acidosis, hypokalaemia and hyperglycaemia or could induce anticholinergic effects such as increased intraocular pressure (causing pain, vision disturbances or reddening of the eye), obstipation or difficulties in voiding.
Croatian: Predoziranje može dovesti do pretjeranih učinaka karakterističnih za beta2-adrenergičke stimulatore, tj. tahikardije, tremora, palpitacija, glavobolje, mučnine, povraćanja, omamljenosti, ventrikularnih aritmija, metaboličke acidoze, hipokalijemije i hiperglikemije ili može izazvati antikolinergične učinke kao što su povišeni intraokularni tlak (koji uzrokuje bol, poremećaje vida ili crvenilo očiju), opstipacija ili poteškoće s pražnjenjem.
English: Breathe out fully Do not blow into the inhaler.
Croatian: Izdahnite do kraja Nemojte puhati u inhalator.
English: PA/Alu/PVC - Alu perforated unit-dose blister.
Croatian: PA/Al/PVC - Aluminijski perforirani blister s jediničnim dozama.
English: Inhalation powder, hard capsule
Croatian: Prašak inhalata, tvrda kapsula
English: In Phase III studies, bronchodilator effects were seen within 5 minutes after the first dose and were maintained over the 24-hour dosing interval from the first dose.
Croatian: U ispitivanjima faze III bronhodilatacijski učinci bili su zapaženi u roku od 5 minuta nakon prve doze i održali su se tijekom 24-satnog intervala doziranja od prve doze.
English: Insufficient pharmacokinetic data is available for other ethnicities or races.
Croatian: Dostupni farmakokinetički podaci za druge etničke ili rasne skupine su nedostatni.
English: When inhaled, indacaterol acts locally in the lung as a bronchodilator.
Croatian: Kada se udahne, indakaterol djeluje lokalno u plućima kao bronhodilator.
English: Other most common adverse reactions related to the medicinal product (at least 3% of patients for Ultibro Breezhaler and also greater than placebo) were cough, nasopharyngitis and headache.
Croatian: Druge najčešće nuspojave povezane s lijekom (u najmanje 3% bolesnika za Ultibro Breezhaler i uz to češće nego za placebo) bile su kašalj, nazofaringitis i glavobolja.
English: The recommended dose is the inhalation of the content of one capsule once daily using the Ultibro Breezhaler inhaler.
Croatian: Preporučena doza je inhalacija sadržaja jedne kapsule jedanput na dan korištenjem Ultibro Breezhaler inhalatora.
English: Glycopyrronium bromide and its metabolites did not significantly cross the placental barrier of pregnant mice, rabbits and dogs.
Croatian: Glikopironijev bromid i njegovi metaboliti nisu značajno prešli placentarnu barijeru skotnih miševa, zečeva i pasa.
English: Close the inhaler and repeat steps 3a to 3c.
Croatian: Zatvorite inhalator i ponovite korake 3a do 3c.
English: • Do not handle capsules with wet hands.
Croatian: • Ne dirajte kapsule mokrim rukama.
English: Systemic exposure to indacaterol increased with increasing (delivered) dose (120 micrograms to 480 micrograms) in a dose proportional manner.
Croatian: Sistemska izloženost indakaterolu povećala se s povećanom (isporučenom) dozom (120 mikrograma do 480 mikrograma) proporcionalno dozi.
English: If any of the above applies to you (or you are not sure), talk to your doctor, pharmacist or nurse before using this medicine.
Croatian: Ako se bilo što od navedenoga odnosi na Vas (ili ako niste sigurni), obavijestite svog liječnika, ljekarnika ili medicinsku sestru prije nego uzmete ovaj lijek.
English: Ultibro Breezhaler should be used with caution in these patient groups.
Croatian: Ultibro Breezhaler treba koristiti s oprezom u tih skupina bolesnika.
English: Therefore Ultibro Breezhaler should not be given together with beta-adrenergic blockers (including eye drops) unless there are compelling reasons for their use.
Croatian: Zbog toga Ultibro Breezhaler ne treba primjenjivati istodobno s beta-adrenergičkim blokatorima (uključujući kapi za oči), osim ako za to ne postoje uvjerljivi razlozi.
English: Remove capsule Separate one of the blisters from the blister card.
Croatian: Odvojite jedan od blistera od blister kartice.
English: • swelling mainly of the tongue, lips, face or throat (possible signs of angioedema).
Croatian: • oticanje uglavnom jezika, usana, lica ili grla (mogući znakovi angioedema).
English: OUTER CARTON OF MULTIPACK (INCLUDING BLUE BOX)
Croatian: VANJSKA KARTONSKA KUTIJA VIŠESTRUKOG PAKIRANJA (UKLJUČUJUĆI PLAVI OKVIR)
English: Where required, cardioselective beta-adrenergic blockers should be preferred, although they should be administered with caution.
Croatian: Kada je potrebno, prednost treba dati kardioselektivnim beta-adrenergičkim blokatorima, iako ih treba primjenjivati s oprezom.
English: • pain that affects the muscles, ligaments, tendons, joints and bones.
Croatian: • bol koja zahvaća mišiće, ligamente, tetive, zglobove i kosti.
English: You may notice that your heart is beating faster than usual, or you may have a headache, feel drowsy, feel nauseous or have to vomit, or you may notice visual disturbances, feel constipated or have difficulty when passing urine.
Croatian: Možda ćete primijetiti da su otkucaji srca brži nego inače, ili imate glavobolju, osjećate se omamljeno, osjećate mučninu ili povraćate ili možete primijetiti vizualne poremećaje, osjećate zatvor ili imate poteškoća s otežanim mokrenjem.
English: - Peel the backing away from the blister to open it - do not push the capsule through the foil.
Croatian: - Odlijepite foliju s blistera da biste ga otvorili - ne gurajte kapsulu kroz foliju.