FrancophonIA/ELRC3.0 huggingface dataset:
English: Concomitant use of antipsychotics should be monitored carefully for worsening of Parkinson's motor symptoms especially when D2-receptor antagonists are used (see section 4.5).
Croatian: Istodobnu primjenu antipsihotika mora se pažljivo nadzirati zbog pogoršanja motoričkih simptoma Parkinsonove bolesti, osobito kada se primjenjuju antagonisti D2-receptora (vidjeti dio 4.5).
English: Somnolence and episodes of sudden sleep onset
Croatian: Somnolencija i epizode iznenadnog nastupa sna
English: Cardiovascular ischaemic events
Croatian: Kardiovaskularni ishemijski događaji
English: No notable differences between placebo and Inbrija were observed in forced expiratory volume in 1 second (FEV1) following the first dose.
Croatian: Nije primijećena vidljiva razlika između placeba i Inbrije u forsiranom ekspiratornom volumenu u prvoj sekundi (FEV1) nakon primjene prve doze.
English: b A responder was defined as a subject that changed from OFF to ON within 60 minutes post dose and who remained ON at 60 minutes post dose.
Croatian: b Ispitanik s odgovorom definiran je kao ispitanik koji je iz OFF-razdoblja prešao u ON-razdoblje unutar 60 minuta nakon primljene doze i koji se je zadržao u ON-razdoblju 60 minuta nakon primljene doze.
English: Euphoric mood, Libido increased, Bruxism,
Croatian: euforično raspoloženje, pojačan libido, bruksizam,
English: Pharmacotherapeutic group: Anti-Parkinson drugs, dopaminergic agents, ATC code: N04BA01 Mechanism of action
Croatian: Farmakoterapijska skupina: Antiparkinsonici, dopaminergici, ATK oznaka: N04BA01 Mehanizam djelovanja
English: Then breathe out.
Croatian: Zatim izdahnite.
English: There are no data on the effects of levodopa on human fertility.
Croatian: Nema podataka o učincima levodope na plodnost ljudi.
English: You should continue taking your main medicine for Parkinson's disease and use Inbrija to control worsening of symptoms (such as inability to move) during off periods.
Croatian: Morate nastaviti uzimati svoj glavni lijek za liječenje Parkinsonove bolesti, a Inbriju koristiti za kontrolu pogoršanja simptoma (poput nemogućnosti izvođenja pokreta) tijekom off razdoblja.
English: Central Nervous System (CNS) effects and mental disturbances
Croatian: Učinci na središnji živčani sustav (SŽS) i mentalne poremećaje
English: Blue Handle Capsule Chamber White Mouthpiece Blue Cap
Croatian: Plavi držak Komora za kapsulu Bijeli usnik
English: The European Medicines Agency has waived the obligation to submit the results of studies with Inbrija in all subsets of the paediatric population in the treatment of idiopathic Parkinson's disease (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka Inbrija u svim podskupinama pedijatrijske populacije za liječenje idiopatske Parkinsonove bolesti (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Potassium chloride Carnauba wax Maize starch
Croatian: karagenan kalijev klorid karnauba vosak kukuruzni škrob
English: Levodopa is associated with somnolence and has been associated very rarely with excessive daytime somnolence and sudden sleep onset episodes.
Croatian: Levodopa je udružena sa somnolencijom, a povezuje je se vrlo rijetko s prekomjernom somnolencijom preko dana i epizodama iznenadnog nastupa sna.
English: After correcting the parameters for body weight, the gender difference after each treatment was no longer significant: the body-weight adjusted Cmax and AUC0-24 h after a dose of Inbrija in women were 9.7% and 15.1% higher than men.
Croatian: Nakon korekcije parametara za tjelesnu težinu, razlika po spolu nakon svake primjene više nije bila značajna: nakon korekcije za tjelesnu težinu, Cmax nakon doze Inbrije bio je 9,7% a AUC0-24 h 15,1% viši u žena nego u muškaraca.
English: The hard capsules are supplied in Aluminium / PVC / Aluminium peel-off blisters.
Croatian: Tvrde kapsule isporučuju se u aluminij/PVC/aluminijskim blisterima s odvojivom pokrovnom folijom.
English: Dopamine D2 receptor antagonists and isoniazid
Croatian: Antagonisti dopaminskih D2 receptora i izoniazid
English: In a subpopulation of the 12-week study, serial spirometry measurements were performed at 15, 30 and 60 minutes following the first dose of Inbrija 66 mg or placebo.
Croatian: U subpopulaciji ispitanika tijekom ispitivanja u trajanju od 12 tjedana provedena su serijska spirometrijska mjerenja 15, 30 i 60 minuta nakon primjene prve doze od 66 mg Inbrije ili placeba.
English: Acorda Therapeutics Ireland Limited 10 Earlsfort Terrace Dublin 2, D02 T380
Croatian: 10 Earlsfort Terrace Dublin 2, D02 T380
English: - It is important to advise the patient that if they do not hear or feel the capsule “whirl” while inhaling they may need to take a deeper, longer breath, breathing in again using the same capsule.
Croatian: - Važno je savjetovati bolesnika da, ako nije čuo ili osjetio da se kapsula „zavrtjela“ tijekom inhalacije, može biti potrebno primijeniti dublji i duži udah koristeći ponovno istu kapsulu.
English: This is because other medicines can affect the way Inbrija works.
Croatian: To je zato što drugi lijekovi mogu utjecati na djelovanje Inbrije.
English: Puncturing tines and springs are made from stainless steel.
Croatian: Šiljci za probijanje kapsule i opruge načinjene su od nehrđajućeg čelika.
English: 97 months
Croatian: 97 mjeseci
English: Peptic ulcer disease
Croatian: Peptički ulkus
English: Most cough reported in the clinical studies with Inbrija were mild to moderate in intensity, and usually reported within the first 30 days of the treatment.
Croatian: Kašalj koji je zabilježen tijekom kliničkih ispitivanja s Inbrijom bio je većinom blag do umjeren po intenzitetu i obično prijavljen unutar prvih 30 dana liječenja.
English: 96 months
Croatian: 96 mjeseci
English: Sudden sleep onset
Croatian: Iznenadni nastup sna
English: Drop 1 capsule into the opening of the capsule chamber.
Croatian: Spustite jednu kapsulu u otvor komore za kapsulu.
English: Intercurrent respiratory infection
Croatian: Interkurentna respiratorna infekcija
English: The acute symptoms of levodopa overdose can be expected to arise from dopaminergic overstimulation.
Croatian: Za akutne simptome predoziranja levodopom može se očekivati da proizlaze iz prekomjerne dopaminergične stimulacije.
English: Line up the white arrows on the handle and mouthpiece.
Croatian: Poravnajte bijele strelice na dršku i usniku.
English: The physician or other healthcare professional should instruct the patient how to administer the product correctly.
Croatian: Liječnik ili drugo medicinsko osoblje moraju podučiti bolesnika kako ispravno primjenjivati lijek.
English: - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Croatian: - Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1
English: The recommended dose of Inbrija is 2 hard capsules up to 5 times per day each delivering 33 mg levodopa.
Croatian: Preporučena doza Inbrije je 2 tvrde kapsule primijenjene do 5 puta dnevno, pri čemu svaka isporučuje 33 mg levodope.
English: Adjustment of levodopa therapy or other medicinal products used for the treatment of Parkinson's disease may be considered.
Croatian: Može se razmotriti prilagodba terapije levodopom ili drugim lijekovima za liječenje Parkinsonove bolesti.
English: No effects were seen on male or female reproductive organs in repeat dose toxicology studies in mice, rats or monkeys with levodopa alone.
Croatian: Nisu opaženi učinci na muške ili ženske reproduktivne organe u ispitivanju toksičnosti ponovljenih doza u miševa, štakora i majmuna nakon primjene samo levodope.
English: Place the mouthpiece and inhaler on a clean and dry surface.
Croatian: Usnik i inhalator položite na čistu i suhu površinu.
English: Adverse reactions in clinical trials with Inbrija
Croatian: Nuspojave u kliničkim ispitivanjima s Inbrijom
English: It is not recommended to take more than 2 capsules per OFF period.
Croatian: Ne preporučuje se uzeti više od 2 kapsule po jednom OFF razdoblju.
English: The following side effects may happen with this medicine: Very common (may affect more than 1 in 10 people): - cough
Croatian: Sljedeće nuspojave mogu se javiti kod primjene ovog lijeka: Vrlo često (može se javiti u više od 1 na 10 osoba):
English: When experiencing an OFF period, subjects could use inhaled levodopa on demand up to five times a day.
Croatian: Kada su prepoznali OFF razdoblje, ispitanici su smjeli inhalirati levodopu po potrebi do pet puta dnevno.
English: Levodopa may cause increased intraocular pressure in patients with glaucoma.
Croatian: Levodopa može uzrokovati porast intraokularnog tlaka u bolesnika s glaukomom.
English: Whether the increased risk observed was due to Parkinson's disease or other factors, such as medicinal products used to treat Parkinson's disease, is unclear.
Croatian: Nije jasno je li taj povećani rizik posljedica same Parkinsonove bolesti ili drugih faktora, poput lijekova za liječenje Parkinsonove bolesti.
English: If this happens start again at Step 4 using a new capsule.
Croatian: Ako se to dogodi, vratite se na 4. korak i upotrijebite novu kapsulu.
English: EU/1/19/1390/001 60 hard capsules EU/1/19/1390/002 92 hard capsules
Croatian: EU/1/19/1390/002 92 tvrde kapsule
English: Levodopa has caused visceral and skeletal malformations in rabbits.
Croatian: Levodopa uzrokovala je visceralne i skeletne malformacije u kunića.
English: Patients who are taking these medicinal products should be monitored for worsening Parkinson's symptoms (see section 4.4).
Croatian: Bolesnici koji uzimaju ove lijekove moraju se nadzirati zbog mogućeg pogoršanja simptoma Parkinsonove bolesti (vidjeti dio 4.4).
English: There is only limited data available in very elderly patients (≥75 years).
Croatian: Za bolesnike još starije životne dobi (≥75 godina) dostupni su samo ograničeni podaci.
English: 2 doses
Croatian: 2 doze
English: The maximum dose of Inbrija is 10 capsules per day.
Croatian: Maksimalna doza Inbrije je 10 kapsula na dan.
English: Animal studies indicated no effect on fertility (see section 5.3).
Croatian: Ispitivanja na životinjama nisu pokazala učinke na plodnost (vidjeti dio 5.3).
English: Certain side effects such as sleepiness and dizziness, that have been reported with other forms of levodopa medicinal products, may affect some patients' ability to drive or use machines.
Croatian: Neke nuspojave, poput somnolencije i omaglice, zabilježene pri liječenju drugim oblicima lijekova koji sadrže levodopu, mogu u nekih bolesnika utjecati na njihovu sposobnost upravljanja vozilima ili rada sa strojevima.
English: Do not use Inbrija if you have taken medicines called non-selective MAO inhibitors for treating depression in the last 14 days.
Croatian: Nemojte primijeniti Inbriju ako ste u zadnjih 14 dana uzeli lijekove za liječenje depresije koji se nazivaju neselektivni MAO inhibitori.
English: If you need to have surgery, tell your doctor that you are using Inbrija.
Croatian: Morate li biti podvrgnuti kirurškom zahvatu, recite liječniku da uzimate Inbriju.
English: Abnormalities in laboratory tests may include elevations of liver function tests such as alkaline phosphatase, aspartate aminotransferase (AST), alanine aminotransferase (ALT), lactic dehydrogenase (LDH), and bilirubin.
Croatian: Abnormalnosti laboratorijskih nalaza mogu uključivati povišene vrijednosti testova jetrene funkcije, poput alkalne fosfataze, aspartat aminotransferaze (AST), alanin aminotransferaze (ALT), laktat dehidrogenaze (LDH) i bilirubina.
English: These medicines include isocarboxazid and phenelzine.
Croatian: Ovi lijekovi uključuju izokarboksazid i fenelzin.
English: Then, remove the used capsule and load a second capsule into the inhaler.
Croatian: Zatim uklonite iskorištenu kapsulu i umetnite drugu kapsulu u inhalator.
English: Levodopa can cause orthostatic hypotension.
Croatian: Levodopa može uzrokovati ortostatsku hipotenziju.
English: If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using Inbrija.
Croatian: Ako niste sigurni odnosi li se nešto od gore navedenoga na Vas, obratite se svom liječniku ili ljekarniku prije nego što primijenite Inbriju.
English: Step 1: Gather supplies
Croatian: 1. korak: Prikupite potreban pribor
English: Pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists and/or other dopaminergic treatments containing levodopa (see section 4.4).
Croatian: Patološko kockanje, povećani libido, hiperseksualnost, kompulzivno trošenje ili kupovanje, prejedanje i kompulzivno jedenje mogu se pojaviti u bolesnika liječenih agonistima dopamina i/ili drugim dopaminergičkim lijekovima koji sadrže levodopu (vidjeti dio 4.4).
English: Patients who have experienced somnolence and/or an episode of sudden sleep onset must refrain from driving or operating machines.
Croatian: Bolesnici koji su imali somnolenciju i/ili iznenadne nastupe sna moraju se suzdržati od upravljanja vozilima i rada sa strojevima.
English: Psychotic reactions have been observed in patients receiving amantadine and levodopa.
Croatian: Zabilježene su psihotične reakcije u bolesnika koji su primali amantadin i levodopu.
English: Alanine aminotransferase increased,
Croatian: povišena vrijednost alanin aminotransferaze,
English: There is insufficient information on the effects of levodopa in newborns/infants.
Croatian: Nema dovoljno podataka o učincima levodope na novorođenčad/dojenčad.
English: UPDRS-III was assessed before and 30 minutes post dose administration.
Croatian: Procjena ljestvicom UPDRS-III provedena je prije i 30 minuta poslije primjene doze.
English: Cardiac function should be monitored with particular care in such patients during the initiation of treatment with Inbrija.
Croatian: U tih bolesnika srčana se funkcija mora osobito pažljivo nadzirati tijekom započinjanja liječenja Inbrijom.
English: Prepare and use a total of 2 capsules.
Croatian: Pripremite i primijenite ukupno 2 kapsule.
English: 64 years
Croatian: 64 godine
English: Inbrija should be used with caution in case of concomitant use of medicinal products that may cause orthostatic hypotension, e.g. anti-hypertensive medicinal products.
Croatian: Inbrija se mora primjenjivati s oprezom u slučaju istodobne primjene lijekova koji mogu uzrokovati ortostatsku hipotenziju, npr. antihipertenzivnih lijekova.
English: This abnormal thinking and behaviour can consist of one or more of a variety of manifestations including anxiety, depression, paranoid ideation, delusions, hallucinations, confusion, psychotic-like behaviour, disorientation, aggressive behaviour, agitation, and delirium.
Croatian: Ovo abnormalno razmišljanje i ponašanje može se sastojati od jedne ili više različitih manifestacija, uključujući anksioznosti, depresiju, paranoidnu ideaciju, deluzije, halucinacije, konfuziju, ponašanja nalik psihotičnom, dezorijentaciju, agresivno ponašanje, agitaciju i delirij.
English: Patients being treated with levodopa medicinal products and presenting with somnolence and/or sudden sleep episodes must be informed to refrain from driving or engaging in activities where impaired alertness may put themselves or others at risk of serious injury or death (e.g. use machines), until such recurrent episodes and somnolence have resolved (see also section 4.4).
Croatian: Bolesnike koji se liječe lijekovima koji sadrže levodopu a kod kojih se javljaju somnolencija i/ili iznenadne epizode sna mora se obavijestiti da se suzdrže od upravljanja vozilima ili aktivnosti kod kojih oslabljena pažnja može njih ili druge dovesti u opasnost od ozbiljne ozljede ili smrti (npr. upravljanje strojevima), sve dok te ponavljajuće epizode i somnolencija ne nestanu (vidjeti također dio 4.4).
English: The use of selective MAO-B inhibitors (e.g. rasagiline, selegiline, and safinamide) with levodopa may be associated with orthostatic hypotension.
Croatian: Primjena selektivnih MAO-B inhibitora (npr. razagilina, selegilina i safinamida) s levodopom može biti povezana s ortostatskom hipotenzijom.
English: Inbrija should be inhaled when symptoms, motor or non-motor, of an OFF period start to return.
Croatian: Inbriju je potrebno inhalirati kada se motorički i nemotorički simptomi OFF razdoblja počnu vraćati.
English: Your doctor will monitor you closely during start of treatment; - an ulcer in your stomach or intestines; - an eye condition called glaucoma, because the pressure in your eyes may need to be monitored; - severe problems with your kidneys; - severe problems with your liver.
Croatian: Liječnik će Vas pažljivo nadzirati tijekom početka liječenja. - vrijed (čir) na želucu ili crijevu - stanje očiju koje se naziva glaukom, jer može biti potrebno kontrolirati očni tlak - izraziti problemi s bubrezima
English: The addition of entacapone to a levodopa/dopa-decarboxylase inhibitor has been demonstrated to increase the levodopa bioavailability by 30%.
Croatian: Pokazalo se da dodavanje entakapona levodopi / inhibitoru dopa-dekarboksilaze povećava bioraspoloživost levodope za 30%.
English: Review of treatment is recommended if such symptoms develop.
Croatian: Ako se razviju takvi simptomi, preporučuje se revizija liječenja.
English: There is limited data available on the use of Inbrija during a respiratory infection.
Croatian: Dostupni su ograničeni podaci o primjeni Inbrije tijekom respiratorne infekcije.
English: Important information before you use Inbrija: - Inbrija capsules must not be swallowed.
Croatian: Važna informacija prije nego što primijenite Inbriju: - Kapsule Inbrije ne smiju se gutati.
English: Patients selected for treatment with Inbrija should be able to recognize the onset of their 'OFF' symptoms and be capable of preparing the inhaler or else have a responsible care giver able to prepare the inhaler for them when required.
Croatian: Bolesnici odabrani za liječenje Inbrijom moraju biti sposobni prepoznati početak OFF simptoma i u stanju pripremiti inhalator ili imati na raspolaganju njegovatelja koji umjesto njih može pripremiti inhalator kada je to potrebno.
English: A dose adjustment of levodopa may be required.
Croatian: Može biti potrebno prilagoditi dozu levodope.
English: Get urgent medical help if you have an allergic oedema with symptoms including hives (nettle rash), itching, rash, swelling of your face, lips, tongue, or throat.
Croatian: Potražite hitnu medicinsku pomoć ako imate alergijski edem sa simptomima koji uključuju urtikariju (koprivnjaču), svrbež, osip, otok lica, usana, jezika ili grla.
English: Henoch-Schonlein purpura, Urticaria,
Croatian: Henoch-Schonleinova purpura, urtikarija, alopecija,
English: Each perforated unit-dose blister strip contains 4 hard capsules.
Croatian: Svaki perforirani blister s jediničnim dozama sadrži 4 tvrde kapsule.
English: For use only with the inhaler provided in the pack.
Croatian: Za primjenu samo pomoću inhalatora priloženog u pakiranju.
English: These behaviours are called impulse control disorders and can include addictive gambling, excessive eating or spending, an abnormally high sex drive or an increase in sexual thoughts or feelings.
Croatian: Ta se ponašanja nazivaju poremećaji kontrole impulsa i mogu uključivati ovisnost o kockanju, pretjerano jedenje ili rastrošnost, neuobičajeno jaki seksualni poriv ili učestale seksualne misli ili osjećaje.
English: Store in the original package in order to protect from light and moisture and remove immediately before use.
Croatian: Čuvati u originalnom pakiranju radi zaštite od svjetlosti i vlage i izvaditi neposredno prije primjene.
English: Sudden onset of sleep (see section 4.4),
Croatian: iznenadna epizoda sna (vidjeti dio 4.4),
English: Apparent volume of distribution (Vz/F) was 168 L for Inbrija 66 mg (2 x 33 mg capsules).
Croatian: Prividni volumen distribucije (Vz/F) iznosio je 168 l za dozu Inbrije od 66 mg (2 kapsule od 33 mg).
English: If an OFF period emerged subjects received placebo or inhaled levodopa.
Croatian: Ako bi nastupilo OFF razdoblje, ispitanici bi primili placebo ili inhalirali levodopu.
English: • Load 1 capsule into the Inbrija inhaler, close your lips firmly around the mouthpiece, then breathe in (inhale) and hold that breath for 5 seconds.
Croatian: • Umetnite 1 kapsulu u Inbrija inhalator, usne čvrsto stisnite oko usnika inhalatora i zatim udahnite (inhalirajte) i zadržite dah 5 sekundi.
English: Take in a deep, comfortable breath until your lungs feel full.
Croatian: Duboko udahnite bez naprezanja dok potpuno ne ispunite pluća.
English: Antihypertensives
Croatian: Antihipertenzivi
English: Abnormalities in blood urea nitrogen (BUN) and positive Coombs test have also been reported.
Croatian: Također su zabilježene povećane vrijednosti ureje u krvi (BUN) i pozitivni Coombsov test.
English: The UPDRS part III is designed to assess the severity of the cardinal motor findings (e.g. tremor, rigidity, bradykinesia, postural instability) in patients with Parkinson's disease.
Croatian: Dio III ljestvice UPDRS osmišljen je za ocjenu težine glavnih motoričkih nalaza (npr. tremora, rigiditeta, bradikinezije, posturalne nestabilnosti) u bolesnika s Parkinsonovom bolesti.
English: Exceeding the recommended dose may lead to increased levodopa associated adverse reactions.
Croatian: Prekoračenje preporučene doze može dovesti do povećanja nuspojava povezanih s primjenom levodope.
English: Interactions of Inbrija with local or systemic pulmonary medicinal products were not investigated because Inbrija is not recommended in patients with asthma, chronic obstructive pulmonary disease (COPD), or other chronic underlying lung disease (see section 4.4).
Croatian: Interakcija Inbrije s lokalnim ili sistematski lijekovima za pluća nije ispitana, jer se primjena Inbrije ne preporučuje u bolesnika s astmom, kroničnom opstruktivnom bolesti pluća (KOBP) ili drugim podležećim kroničnim bolestima pluća (vidjeti dio 4.4).
English: - The patient should load 1 capsule into the Inbrija inhaler, breathe in and hold their breath for 5 seconds.
Croatian: - Bolesnik mora staviti 1 kapsulu u Inbrija inhalator, udahnuti i zadržati dah 5 sekundi.
English: Detailed instructions for use for the patients are included in the package leaflet.
Croatian: Detaljne upute za primjenu za bolesnike uključene su u uputu o lijeku.
English: At baseline, patients had at least 2 hours of OFF time per day, and the levodopa/dopa-decarboxylase inhibitor medicines did not exceed 1,600 mg levodopa per day.
Croatian: Na početku ispitivanja bolesnici su imali najmanje 2 sata OFF razdoblja na dan, a liječenje lijekovima s levodopom / inhibitorom dopa-dekarboksilaze nije prekoračivalo dozu od 1600 mg levodope na dan.
English: Urinary retention, Chromaturia, Urinary incontinence
Croatian: Poremećaji bubrega i mokraćnog sustava retencija urina, kromaturija, inkontinencija urina
English: If you stop using Inbrija
Croatian: Ako prestanete primjenjivati Inbriju
English: Patients should receive electrocardiographic monitoring for the development of arrhythmias; if needed, appropriate antiarrhythmic therapy should be given.
Croatian: Moraju se nadzirati elektrokardiografski za slučaj pojava aritmija, i ako je potrebno, moraju primiti odgovarajuću antiaritmijsku terapiju.
English: Do not use this medicine after the expiry date which is stated on the blisters and carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na blisteru i kutiji iza oznake „EXP“.
English: In this pack, you will find an inhaler together with peel-off blisters containing 4 hard capsules each.
Croatian: U pakiranju ćete naći inhalator s blisterima koji imaju odvojivu pokrovnu foliju,a od kojih svaki sadrži 4 tvrde kapsule.
English: The dose that leaves the mouthpiece of the inhaler (delivered dose) is 33 mg of levodopa.
Croatian: Doza koja izađe iz usnika inhalatora (isporučena doza) sadrži 33 mg levodope.