FrancophonIA/ELRC3.0 huggingface dataset:
English: Children and adolescents ADASUVE is not for use in children and adolescents under 18 years.
Croatian: Djeca i adolescenti ADASUVE nije namijenjen za primjenu u djece i adolescenata mlađih od 18 godina.
English: Treatment with ADASUVE may have to be stopped if this occurs.
Croatian: Možda će se liječenje ADASUVE morati prekinuti u tim slučajevima.
English: ADASUVE has major influence on the ability to drive and use machines.
Croatian: ADASUVE značajno utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: • A clear recommendation not to start ADASUVE treatment in patients with a respiratory medical history
Croatian: • Jasnu preporuku o tome da se ne započinje liječenje lijekom ADASUVE u bolesnika s anamnezom respiratornih bolesti
English: EU/1/13/823/001 (5 single-dose inhalers) EU/1/13/823/003 (1 single-dose inhaler)
Croatian: EU/1/13/823/001 (5 jednodoznih inhalatora) EU/1/13/823/003 (1 jednodozni inhalator)
English: Women in the schizophrenia trial were scarcely represented (26.5%), and about half of the patients were male (49.7%) in Study 004-302.
Croatian: Žene su bile vrlo malo zastupljene u ispitivanju shizofrenije (26,5%), a oko polovice bolesnika u Ispitivanju 004-302 su bili muškarci (49,7%).
English: A population pharmacokinetic analysis that compared exposures in smokers versus non-smokers indicated that smoking, which induces CYP1A2, had a minimal effect on the exposure to ADASUVE.
Croatian: Farmakokinetička analiza populacije u kojoj je uspoređena izloženost pušača naspram nepušačima pokazala je da pušenje, koje inducira CYP1A2, ima minimalni utjecaj na izloženost lijeku ADASUVE.
English: ADASUVE works by blocking certain chemicals in the brain (neurotransmitters) such as dopamine and serotonin thus causing calming effects and relieving aggressive behaviour.
Croatian: ADASUVE djeluje tako da blokira određene kemijske spojeve u mozgu (zvane neurotransmiteri) kao što su dopamin i serotonin što uzrokuje umirujuće djelovanje i smanjuje agresivno ponašanje.
English: These can be associated with a severe condition called neuroleptic malignant syndrome (NMS)
Croatian: To može biti povezano s teškim stanjem koje se zove maligni neuroleptički sindrom (MNS)
English: EU/1/13/823/002 (5 single-dose inhalers) EU/1/13/823/004 (1 single-dose inhaler)
Croatian: EU/1/13/823/002 (5 jednodoznih inhalatora) EU/1/13/823/004 (1 jednodozni inhalator)
English: The white inhaler (housing) is molded from a medical-grade polycarbonate.
Croatian: Bijeli inhalator (kućište) je oblikovano od polikarbonata medicinske kakvoće.
English: Inclusion in Study 004-302 required a diagnosis of bipolar disorder (current episode manic or mixed).
Croatian: Uključenje u Ispitivanje 004-302 je zahtijevalo dijagnozu bipolarnog poremećaja (trenutne manične ili miješane epizode).
English: ADASUVE is for inhalation use.
Croatian: ADASUVE je za inhaliranje.
English: What ADASUVE is and what it is used for
Croatian: Što je ADASUVE i za što se koristi
English: When it occurred, it was typically reported within 25 minutes after dosing.
Croatian: Kada bi se dogodio, obično se prijavio u roku od 25 minuta od uzimanja lijeka.
English: A majority of the patients in both Phase 3 studies were smokers with about 82% of the patients with schizophrenia and 74% of the patients with bipolar disorder currently smoking.
Croatian: Većina bolesnika u oba ispitivanja Faze III su bili pušači; 82% bolesnika oboljelih od shizofrenije i 74% bolesnika oboljelih od bipolarnog poremećaja su bili pušači u vrijeme ispitivanja.
English: Hypersensitivity to the active substance, or to amoxapine.
Croatian: Preosjetljivost na djelatnu tvar ili na amoksapin.
English: The efficacy of loxapine is proposed to be mediated through high affinity antagonism of dopamine D2 receptors and serotonin 5-HT2A receptors.
Croatian: Smatra se da je djelotvornost loksapina posredovana putem visoke sklonosti antagonizma receptora dopamina D2 i serotonina 5-HT2A.
English: After the first dose, a second dose was administered at least 2 hours later if the agitation had not subsided sufficiently.
Croatian: Nakon prve doze dana je druga doza najmanje 2 sata kasnije u slučajevima kad se agitacija nije povukla u dovoljnoj mjeri.
English: ADASUVE may have limited effectiveness when patients are on concomitant medicinal products, predominantly other antipsychotics.
Croatian: ADASUVE može imati ograničenu učinkovitost kad bolesnici istodobno uzimaju druge lijekove, posebno druge antipsihotike.
English: If your baby develops any of these symptoms you may need to contact your doctor.
Croatian: Ako Vaše dijete razvije bilo koji od navedenih simptoma, obratite se svom liječniku.
English: ADASUVE should only be administered in a hospital-setting under the supervision of a healthcare professional.
Croatian: ADASUVE se isključivo treba primjenjivati u zdravstvenoj ustanovi pod nadzorom zdravstvenog radnika.
English: Once the pull-tab is removed, a green light turns on, indicating the product is ready for use (Note: the product must be used within 15 minutes of pulling the tab).
Croatian: Nakon što se trakica za povlačenje ukloni, upali se zeleno svjetlo koje označava da je inhalator spreman za upotrebu (Napomena: inhalator je potrebno upotrijebiti u roku od 15 minuta od povlačenja trakice).
English: Patients had significant and long-standing psychiatric disease (Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV)), based on years since diagnosis and previous hospitalizations.
Croatian: Bolesnici su bolovali od dugoročne psihijatrijske bolesti (prema Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) ), računajući godine od dijagnoze i prethodne hospitalizacije.
English: The safety and efficacy of ADASUVE in children (less than 18 years of age) have not been established.
Croatian: Sigurnost i djelotvornost ADASUVE u djece (u dobi do 18 godina) nisu još ustanovljene.
English: In vitro studies indicated that loxapine was not a substrate for P-glycoprotein (P-gp), but does inhibit P-gp.
Croatian: In vitro ispitivanja su pokazala da loksapin nije supstrat P-glikoproteina (P-gp), ali ga inhibira.
English: Concomitant administration of benzodiazepines or other hypnosedatives or respiratory depressants may be associated with excessive sedation and respiratory depression or respiratory failure.
Croatian: Istodobna primjena benzodiazepina ili drugih hipnosedativa ili respiratornih depresora može biti povezana s pretjeranom sedacijom i respiratornom depresijom ili zatajenjem disanja.
English: A third dose was administered if needed after at least 4 hours after dose 2.
Croatian: Treća doza je dana po potrebi nakon najmanje 4 sata nakon 2. doze.
English: Firmly pull the plastic tab from the rear of the inhaler.
Croatian: Čvrsto povucite plastičnu trakicu na stražnjoj strani inhalatora.
English: The safety and efficacy of ADASUVE has not been evaluated in patients with agitation due to intoxication or physical disease (delirium).
Croatian: Sigurnost i djelotvornost lijeka ADASUVE nije ispitana u bolesnika s agitacijom kao posljedicom intoksikacije ili fizičke bolesti (delirij).
English: Ferrer Internacional, S.A. Gran Vía Carlos III, 94 08028- Barcelona España
Croatian: Ferrer Internacional, S.A. Gran Vía Carlos III, 94 08028- Barcelona
English: Extrapyramidal symptoms (including acute dystonia) are known class effects for antipsychotics.
Croatian: Ekstrapiramidalni simptomi (uključujući akutnu distoniju) su poznati učinak skupine za antipsihotike.
English: Clinically relevant QT prolongation does not appear to be associated with single and repeat doses of ADASUVE.
Croatian: Klinički relevantno produljenje QT intervala čini se nije povezano s jednokratnom i višekratnim dozama lijeka ADASUVE.
English: • light-headedness or fainting, as these could mean that the medicine is lowering your blood pressure (uncommon occurrence);
Croatian: • laganu ošamućenost ili nesvjesticu, jer to može značiti da Vam lijek snižava krvni tlak (manje česta pojava);
English: Read the following 5 steps before administering ADASUVE to a patient:
Croatian: Pročitajte sljedećih 5 koraka prije primjene lijeka ADASUVE bolesniku:
English: The potential risk of QTc prolongation due to interaction with medicinal products known to prolong QTc interval is unknown.
Croatian: Potencijalni rizik produljenja QTc intervala zbog interakcija s lijekovima za koje je poznato da produljuju QTc interval nije poznat.
English: What you need to know before you use ADASUVE
Croatian: Što morate znati prije nego počnete primjenjivati ADASUVE
English: Joan Buscalla, 1-9, 08173 Sant Cugat del Vallès Barcelona, Spain
Croatian: Joan Buscalla, 1-9, 08173 Sant Cugat del Vallès Barcelona, Španjolska
English: Consequently, patients receiving ADASUVE should be observed as appropriate following dosing.
Croatian: Stoga se bolesnike koji primaju ADASUVE treba motriti na odgovarajući način nakon uzimanja lijeka.
English: Animal studies following oral administration suggest an initial preferential distribution in the lungs, brain, spleen, heart and kidney.
Croatian: Ispitivanja na životinjama nakon oralnog davanja lijeka su pokazala početnu preferencijalnu distribuciju u plućima, mozgu, slezeni, srcu i bubrezima.
English: • have or had heart problems or stroke
Croatian: • imate ili ste imali problema sa srcem ili moždani udar
English: • medicines like fluvoxamine, propranolol, and enoxacin and other medicines that inhibit a certain liver enzyme called “CYP450 1A2.”
Croatian: • lijekove kao što su fluvoksamin, propranolol, enoksacin i duge lijekove koji sprječavaju rad jetrenih enzima pod nazivom „CYP450 1A2“.
English: No cases of overdosage of ADASUVE were reported in clinical studies.
Croatian: Nisu prijavljeni slučajevi predoziranja lijekom ADASUVE u kliničkim ispitivanjima.
English: # Doses Needed
Croatian: Br. potrebnih doza
English: Rescue medication was administered in respectively 32.6%, 11.1 % and 14.6 % of patients.
Croatian: Po skupinama, simptomatski lijek je primijenjen na 32,6%, 11,1% odnosno na 14,6% bolesnika.
English: • medicines that may put you at a risk for seizures (for example, clozapine, tricyclics or SSRIs,
Croatian: • lijekove kod kojih postoji rizik epileptičkih napadaja (npr. klozapin, triciklici ili SSRI, tramadol,
English: • Availabilty of rescue medications (short acting beta agonist bronchodilator) during treatment
Croatian: • Dostupnost lijeka za hitno ublažavanje simptoma (brzodjelujući beta-agonistički bronhodilatator) za vrijeme liječenja
English: If benzodiazepine therapy is deemed necessary in addition to loxapine, patients should be monitored for excessive sedation and for orthostatic hypotension.
Croatian: Ako se terapija benzodiazepinom smatra potrebnom dodatno uz loksapin, bolesnike je potrebno motriti u pogledu pretjerane sedacije i ortostatske hipotenzije.
English: AUC0-2h, AUCinf, and Cmax increased in a dose-dependent manner.
Croatian: AUC0-2 h, AUCinf i Cmax su bili povišeni ovisno o dozi.
English: Directions for use
Croatian: Upute za uporabu
English: Non-clinical safety data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeat-dose toxicity, and genotoxicity, except for changes to reproductive tissues related to the extended pharmacology of loxapine.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, i genotoksičnosti, osim kod promjena reproduktivnog tikva povezanih s proširenom farmakologijom loksapina.
English: The possibility of occurrence of extrapyramidal symptoms and/or convulsive seizures should be kept in mind.
Croatian: Potrebno je imati na umu mogućnost pojave ekstrapiramidalnih simptoma i/ili konvulzivnih epileptičkih napada.
English: Do not use in patients with asthma or COPD or acute respiratory symptoms
Croatian: Nemojte primjenjivati u bolesnika s astmom ili KOPB-om ili u bolesnika s akutnim respiratornim simptomima.
English: Do not drive or use any tools or machines after using ADASUVE until you know how ADASUVE affects you since dizziness, sedation, and sleepiness have been reported as a potential side effect of ADASUVE.
Croatian: Nemojte upravljati vozilima ili strojevima nakon uzimanja lijeka ADASUVE sve dok ne saznate kako ADASUVE utječe na Vas budući da su kao nuspojave lijeka ADASUVE prijavljene omaglica, sedacija i pospanost.
English: MedDRA system organ classification Nervous system disorders
Croatian: MedDRA klasifikacija organskih sustava Poremećaji živčanog sustava
English: The effects of the combination on sedation appeared to be additive.
Croatian: Čini se da su učinci kombinacije tih lijekova na sedaciju aditivni.
English: Loxapine is 96.6% bound to human plasma proteins.
Croatian: Loksapin se veže na proteine plazme u ljudi u iznosu od 96,6%.
English: • have or had breathing problems like asthma or other chronic lung diseases such as bronchitis or emphysema
Croatian: • imate ili ste imali problema s disanjem kao što su astma ili druge kronične bolesti pluća kao što su bronhitis ili efizem
English: Elderly patients with dementia-related psychosis
Croatian: Stariji bolesnici oboljeli od psihoze povezane s demencijom
English: • have or had glaucoma (increased pressure in the eye)
Croatian: • imate ili ste imali glaukom (povišen očni tlak)
English: Note: If the green light stays on after the patient inhales, instruct the patient to repeat steps 3 to 5.
Croatian: Napomena: Ako zeleno svjetlo ostane upaljeno nakon što bolesnik udahne, uputite bolesnika da ponovi korake 3 do 5.
English: Changes in the level of excitability of subcortical inhibitory areas have been observed in several animal species, associated with calming effects and suppression of aggressive behaviour.
Croatian: Promjene u razinama pobuđenosti subkortikalnih inhibicijskih područja, povezane s umirujućim učincima i supresijom agresivnog ponašanja, su opažene kod nekoliko životinjskih vrsta.
English: Do not use ADASUVE after the expiry date which is stated on the product label.
Croatian: ADASUVE se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na označavanju lijeka.
English: • The indicator light turns on (green) when the tab is pulled out.
Croatian: • Svjetlo se pali (zeleno) kad se izvuče trakica.
English: A second dose can be given after 2 hours, if necessary.
Croatian: Ako je potrebno, druga doza se može dati nakon 2 sata.
English: • medicines to treat a breathing problem
Croatian: • lijekove za liječenje dišnih tegoba
English: Correct use of ADASUVE inhaler is important for administration of the full dose of loxapine.
Croatian: Ispravna upotreba inhalatora ADASUVE je važna radi primjene pune doze loksapina.
English: • Treatment with ADASUVE to be limited to a hospital setting
Croatian: • Liječenje lijekom ADASUVE je potrebno ograničiti na zdravstvene ustanove
English: At therapeutic concentrations, however, it is not expected to inhibit P-gp-mediated transport of other medicinal products in a clinically significant manner.
Croatian: Pri terapijskim koncentracijama se, međutim, ne očekuje inhibicija prijenosa drugih lijekova pomoću P-gp-a na klinički značajan način.
English: Loxapine is metabolised extensively in the liver, with multiple metabolites formed.
Croatian: Loksapin se ekstenzivno metabolizira u jetri, s višestruko formiranim metabolitima.
English: After the doctor or nurse has prepared ADASUVE for you to use, you will be asked to take the device in your hand, exhale and then put the mouthpiece in your mouth, inhale the medicine through the device and then hold your breath briefly.
Croatian: Nakon što su Vam liječnik ili medicinska sestra pripremili ADASUVE, zamolit će Vas da uzmete uređaj u ruku, izdahnete i da stavite nastavak za usta u usta, udahnete lijek iz uređaja i nakratko zadržite dah.
English: If vasopressor therapy is required, noradrenaline or phenylephrine is preferred.
Croatian: Ako je potrebna vazopresorna terapija, prednost se daje noradrenalinu ili fenilefrinu.
English: Mean peak plasma concentrations were similar after the first and third dose of ADASUVE, indicating minimal accumulation during the 4-hour dosing interval.
Croatian: Prosječne vršne vrijednosti koncentracija plazme su bile slične nakon prve i treće doze lijeka ADASUVE, što pokazuje minimalnu akumulaciju za vrijeme intervala doziranja od 4 sata.
English: For complete instructions on how to use ADASUVE see information for the healthcare professional section of the package leaflet.
Croatian: Za potpune upute o tome kao upotrijebiti ADASUVE, vidjeti informaciju u uputi o lijeku u dijelu za zdravstvene djelatnike.
English: Metabolites are excreted in the urine in the form of conjugates and in the faeces unconjugated.
Croatian: Metaboliti se izlučuju u obliku konjugata urinom, a u nekonjugiranom obliku stolicom.
English: Patients with acute respiratory signs/symptoms (e.g., wheezing) or with active airways disease (such as patients with asthma or chronic obstructive pulmonary disease [COPD] (see section 4.4).
Croatian: Bolesnici s akutnim respiratornim znakovima/simptomima (npr. piskanje) ili s aktivnom bolesti dišnih putova (poput bolesnika oboljelih od astme ili kronične opstruktivne plućne bolesti [KOPB] (vidjeti dio 4.4).
English: Read the following 5 steps before administering ADASUVE to a patient.
Croatian: Pročitajte sljedećih 5 koraka prije davanja lijeka ADASUVE bolesniku.
English: Female rats did not mate due to persistent diestrus after oral treatment with loxapine.
Croatian: Ženke štakora se nisu parile zbog stalnog diestrusa nakon oralnog liječenja loksapinom.
English: • already used ADASUVE and you developed symptoms of wheezing or shortness of breath
Croatian: • ste već upotrebljavali ADASUVE i razvili simptome piskanja ili nedostatka zraka
English: Loxapine should be used with caution in patients with a history of convulsive disorders since it lowers the convulsive threshold.
Croatian: Loksapin bi se trebao koristiti s oprezom kod bolesnika s povijesti konvulzija, obzirom da snižava konvulzivni prag.
English: The following symptoms may occur in newborn babies of mothers that have repeatedly used antipsychotic medicines in the last three months of their pregnancy: shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding.
Croatian: Sljedeći simptomi se mogu pojaviti kod novorođenčadi majki koji su opetovano uzimale antipsihotičke lijekove tijekom posljednja tri mjeseca trudnoće: drhtanje, ukočenost mišića i/ili slabost, pospanost, uznemirenost, problemi s disanjem i poteškoće u hranjenju.
English: Do not use ADASUVE if you notice an open or torn pouch or any signs of physical damage to the medicine.
Croatian: ADASUVE se ne smije upotrijebiti ako primijetite da je vrećica otvorena ili potrgana ili bilo kakve znakove fizičkog oštećenja inhalatora.
English: The recommended initial dose is 9.1 mg. After 2 hours, your doctor may prescribe a second dose after carefully considering your condition and your dose may be reduced to 4.5 mg if your doctor believes that this is a more appropriate dose to treat your condition.
Croatian: Nakon 2 sata, Vaš liječnik Vam može propisati drugu dozu nakon pažljivog razmatranja Vašeg stanja te može smanjiti dozu na 4,5 mg ako vjeruje da je to prikladnija doza za liječenje Vašeg stanja.
English: ADASUVE contains the active substance loxapine, which belongs to a group of medicines called antipsychotics.
Croatian: ADASUVE sadrži djelatnu tvar pod nazivom loksapin, koja pripada skupini lijekova pod nazivom antipsihotici.
English: There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, or feeding disorder.
Croatian: Prijavljeni su slučajevi agitacije, hipertonije, hipotonije, tremora, pospanosti, respiratornog distresa i poremećaja hranjenja.
English: Caution should be used in patients receiving concomitant treatment with other medicinal products that are either inhibitors or inducers of these enzymes, particularly if the concomitant medicinal product is known to inhibit or induce several of the enzymes involved in loxapine metabolism.
Croatian: Potreban je oprez kod bolesnika koji se istodobno liječe drugim lijekovima koji su ili inhibitori ili induktori tih enzima, posebno ako je istodobni lijek poznat kao inhibitor ili induktor nekoliko enzima uključenih u metabolizam loksapina.
English: The most commonly reported adverse reactions during treatment with ADASUVE were dysgeusia, sedation/somnolence and dizziness (dizziness was more common after placebo treatment than loxapine treatment).
Croatian: Najčešće prijavljene nuspojave za vrijeme liječenja lijekom ADASUVE su bile disgeuzija, sedacija/somnolencija i omaglica (omaglica je bila češća nakon liječenja placebom naspram liječenja loksapinom).
English: • Antipsychotic medicines like ADASUVE can cause movements that you may not be able to control including making faces, sticking out your tongue, smacking or puckering your lips, blinking rapidly, or moving your legs, arms or fingers rapidly.
Croatian: • Antipsihotici kao što je ADASUVE mogu uzrokovati radnje koje možda nećete moći kontrolirati kao što su pravljenje grimasa, plaženje jezika, cmoktanje, nabiranje usana, brzo treptanje ili brzo pomicanje nogu, ruku ili prstiju.
English: If you are concerned that you are given more ADASUVE than you feel necessary, tell your doctor or nurse of your concern.
Croatian: Ako ste zabrinuti da uzimate više lijeka ADASUVE nego što mislite da je potrebno, obratite se svom liječniku ili medicinskoj sestri.
English: Potential for other medicinal products to affect ADASUVE
Croatian: Potencijal utjecaja ostalih lijekova na ADASUVE
English: A lower dose of 4.5 mg may be given if the 9.1 mg dose was not previously tolerated by the patient or if the physician decides a lower dose is more appropriate.
Croatian: Niža doza od 4,5 mg se može dati ako bolesnik nije prethodno dobro podnio dozu od 9,1 mg ili ako liječnik odluči da je niža doza primjerena.
English: What ADASUVE contains
Croatian: Što ADASUVE sadrži
English: In female smokers exposure (AUCinf) to ADASUVE and its active metabolite 7-OH-loxapine is lower than in female non-smokers (84% vs 109% 7-OH-loxapine/Loxapine Ratio), which is probably due to an increase in loxapine clearance in smokers.
Croatian: Kod žena pušača, izloženost (AUCinf) lijeku ADASUVE i njegovom aktivnom metabolitu 7-OHloksapinu je niža nego kod žena nepušača (84% nasuprot 109% 7-OH-loksapin/loksapin omjer), što je vjerojatno uzrokovano povišenim klirensom loksapina kod pušača.
English: If you get any of the following side effects, talk to your doctor immediately and stop taking the medicine:
Croatian: Ako primijetite bilo koju od sljedećih nuspojava, obavijestite liječnika ili medicinsku sestru bez odlaganja i prestanite uzimati lijek:
English: In short-term (24-hour), placebo-controlled trials in patients with agitation associated with schizophrenia or bipolar disorder without active airways disease, bronchospasm (which includes reports of wheezing, shortness of breath or cough) was uncommon in patients treated with ADASUVE.
Croatian: U kratkoročnim (24 sata), placebom kontroliranim ispitivanjima u bolesnika s agitacijom povezanom sa shizofrenijom ili bipolarnim poremećajem bez aktivne bolesti dišnih putova, bronhospazam (što uključuje i slučajeve piskanja, nedostatka zraka ili kašlja) je bio manje čest kod bolesnika liječenih lijekom ADASUVE.
English: Read all instructions before use.
Croatian: Prije primjene pročitajte cijelu uputu.
English: No data are available on the use of ADASUVE in patients with underlying cardiovascular diseases.
Croatian: Nema podataka o upotrebi lijeka ADASUVE u bolesnika s osnovnim kardiovaskularnim bolestima.
English: Patient should be observed during the first hour after each dose for signs and symptoms of bronchospasm.
Croatian: Bolesnika se mora promatrati za vrijeme prvog sata nakon svake doze radi znakova i simptoma bronhospazma.
English: A short-acting beta-agonist bronchodilator should be available for treatment of possible bronchospasm.
Croatian: Brzodjelujući beta-agonistički bronhodilator mora biti dostupan za liječenje mogućeg bronhospazma.