FrancophonIA/ELRC3.0 huggingface dataset:
English: In the event of accidental overdosage, signs and symptoms will depend on the number of units taken and individual patient tolerance.
Croatian: Kod slučajnog predoziranja, znakovi i simptomi će ovisiti o broju primljenih jedinica kao i o individualnoj toleranciji bolesnika.
English: ADASUVE should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Croatian: ADASUVE se može uzimati u trudnoći samo ako potencijalna korist uzimanja opravdava potencijalni rizik po plod.
English: Intoxication or physical disease (delirium)
Croatian: Intoksikacija ili fizička bolest (delirij)
English: • The indicator light automatically turns off again when the medicine is inhaled.
Croatian: • Svjetlo indikatora se automatski ponovno gasi kad se lijek udahne.
English: The medicinal product has been delivered when the green light turns off.
Croatian: Lijek je isporučen kad se ugasi zeleno svjetlo.
English: • Neuroleptic Malignant Syndrome (NMS) is a set of symptoms that can occur if you are taking antipsychotic medicines, including ADASUVE.
Croatian: • Maligni neuroleptički sindrom (MNS) je skup simptoma koji se mogu pojaviti ako uzimate antipsihotičke lijekove, uključujući i ADASUVE.
English: Inclusion in Study 004-301 required a diagnosis of schizophrenia.
Croatian: Uključenje u Ispitivanje 004-301 je zahtijevalo dijagnozu shizofrenije.
English: • if you are allergic to loxapine or amoxapine;
Croatian: • ako ste alergični na loksapin ili amoksapin;
English: The adverse reactions listed below are categorized 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).
Croatian: Dolje navedene nuspojave su kategorizirane prema sljedećim pravilima: 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
English: You will use ADASUVE under the supervision of a doctor or nurse.
Croatian: Upotrijebit ćete ADASUVE pod nadzorom liječnika ili medicinske sestre.
English: Prior to launch in each Member State the Marketing Authorisation Holder (MAH) shall agree an educational programme with the National Competent Authority.
Croatian: Prije stavljanja lijeka u promet u svakoj državi članici, nositelj odobrenja će dogovoriti program edukacije zajedno s nadležnim nacionalnim tijelom.
English: White device with a mouthpiece on one end and a pull-tab protruding from the other end.
Croatian: Bijeli uređaj s nastavkom za usta na jednom kraju i trakicom za povlačenje na drugom.
English: Not all pack-sized may be marketed.
Croatian: Na tržištu se ne moraju nalaziti sve veličine pakiranja.
English: If you use more ADASUVE than you should
Croatian: Ako uzmete više ADASUVE nego što ste trebali
English: These are diseases characterised by symptoms such as:
Croatian: Te bolesti karakteriziraju sljedeći simptomi:
English: It is known that in humans, long-term treatment with antipsychotics may lead to loss of libido and amenorrhoea.
Croatian: Poznato je da dugotrajno liječenje kod ljudi može uzrokovati gubitak libida i amenoreju.
English: Therefore, the risk of metabolic interactions caused by an effect on an individual isoform is limited.
Croatian: Prema tome, rizik metaboličkih interakcija uzrokovanih djelovanjem pojedinih izoformi je ograničen.
English: Date of first authorisation: 20 February 2013 Date of latest renewal:
Croatian: Datum prvog odobrenja: 20. veljače 2013.
English: Do not use ADASUVE
Croatian: Nemojte uzimati ADASUVE
English: Do not open pouch until ready to use.
Croatian: Ne otvarajte vrećicu dok niste spremni za primjenu lijeka.
English: Very common: dysgeusia
Croatian: Vrlo često: disgeuzija
English: PEC Change
Croatian: PEC promjena
English: In female rats, reproductive effects have been observed (see section 5.3).
Croatian: Kod ženki štakora je opažen utjecaj na reprodukciju (vidjeti dio 5.3).
English: Similar changes, e.g., gynecomastia, are known in humans, but only after long-term administration of medicines causing hyperprolactinaemia.
Croatian: Slične promjene (npr. ginekomastija) su poznate kod ljudi, ali samo nakon dugotrajne primjene lijekova koji uzrokuju hiperprolaktinemiju.
English: • When ADASUVE is removed from the pouch, the indicator light is off.
Croatian: • Kad se ADASUVE izvadi iz vrećice, svjetlo indikatora je ugašeno.
English: Neuroleptic malignant syndrome (NMS)
Croatian: Maligni neuroleptički sindrom (MNS)
English: • Observation of patients for 1 hour after each dose of ADASUVE
Croatian: • Zapažanja o bolesnicima 1 sat nakon davanja svake doze lijeka ADASUVE
English: Use within 15 minutes after removing the tab (or until the green light turns off) to prevent automatic deactivation of the inhaler.
Croatian: Upotrijebite u roku od 15 minuta nakon uklanjanja trakice (ili dok se ne ugasi zeleno svjetlo) kako biste spriječili automatsku deaktivaciju inhalatora.
English: Loxapine binds with noradrenergic, histaminergic, and cholinergic receptors, and its interaction with these systems may influence the spectrum of its pharmacological effects.
Croatian: Loksapin se veže na noradrenergičke, histaminergičke i kolinergičke receptore i njegove interakcije s ovim sustavima mogu utjecati na široki spektar njegovih farmakoloških učinaka.
English: The terminal elimination half-life (T½) ranged from 6 to 8 hours.
Croatian: Konačno vrijeme poluživota eliminacije (T½) iznosilo je između 6 i 8 sati.
English: Loxapine excretion occurs mainly in the first 24 hours.
Croatian: Loksapin se u najvećoj mjeri izlučuje tijekom prva 24 sata.
English: • Addtional risk minimisation measures
Croatian: • Dodatne mjere minimizacije rizika
English: • adrenaline
Croatian: • adrenalin
English: The inhaler is then ready for use.
Croatian: Inhalator je tada spreman za upotrebu.
English: Healthcare professionals should ensure the patient will use the inhaler properly.
Croatian: Zdravstveni radnici trebaju osigurati da bolesnik ispravno koristi inhalator.
English: Before treatment with ADASUVE, tell your doctor or nurse if you:
Croatian: Prije liječenja lijekom ADASUVE, obratite se svom liječniku ili medicinskoj sestri ako:
English: • have or had urinary retention (incomplete emptying of the bladder)
Croatian: • imate ili ste imali urinarnu retenciju (nepotpuno pražnjenje mokraćnog mjehura)
English: Rescue medication (intramuscular lorazepam) was given if medically required.
Croatian: Simptomatski lijek (lorazepam intramuskularno) je primijenjen po potrebi.
English: About 35% of the patients with schizophrenia were taking concomitant antipsychotics at the time of dosing while approximately 13% of the patients with bipolar disorder were taking these drugs.
Croatian: Oko 35% bolesnika oboljelih od shizofrenije su istodobno uzimali antipsihotike u vrijeme uzimanja lijeka, dok je otprilike 13% bolesnika oboljelih od bipolarnog poremećaja uzimalo ove lijekove.
English: • (Schizophrenia) Hearing, seeing, or sensing things which are not there, suspiciousness, mistaken beliefs, incoherent speech and behaviour and emotional flatness.
Croatian: • (Shizofrenija) Osluškivanje, viđenje ili osjećanje stvari koje se stvarno ne događaju, sumnjičavost, pogrešne predodžbe, nepovezan govor i ponašanje i emocionalna ravnodušnost.
English: The MAH shall ensure that, following discussion and agreement with the National Competent Authorities in each Member State where ADASUVE is marketed, at launch and after launch, all healthcare professionals who are expected to use ADASUVE are provided with an information pack containing the following items:
Croatian: Nositelj odobrenja će osigurati da, nakon rasprave i dogovora s nadležnim nacionalnim tijelom u svakoj državi članici gdje se ADASUVE stavlja u promet, za vrijeme stavljanje lijeka u promet i nakon toga, svi zdravstveni djelatnici za koje se očekuje da će koristiti ADASUVE, dobiju informativni paket koji sadrži sljedeće:
English: Pharmacokinetics in special patient populations
Croatian: Farmakokinetika kod posebnih populacije bolesnika
English: • if you have symptoms of wheezing or shortness of breath;
Croatian: • ako imate simptome piskanja ili nedostatka zraka;
English: The mean age of randomized patients was 43.1 years in Study 004-301 and 40.8 years in Study 004-302: young adults (18-25 years old) were scarcely (7.3%) represented in either trial.
Croatian: Prosječna dob randomiziranih bolesnika je bila 43,1 godinu u Ispitivanju 004-301 i 40,8 godina u Ispitivanju 004-302: mlađe odrasle osobe (u dobi od 18-25 godina) su bile vrlo malo zastupljene (7,3%) u oba ispitivanja.
English: Very common (may affect more than 1 in 10 people): bad taste in the mouth or sleepiness.
Croatian: Vrlo često (može se javiti kod više od 1 na 10 osoba): loš okus u ustima ili pospanost.
English: Clinical studies with both atypical and conventional antipsychotic medicinal products have demonstrated that elderly patients with dementia-related psychosis are at an increased risk of death compared to placebo.
Croatian: Klinička ispitivanja izvršena i s atipičnim i konvencionalnim antipsihoticima su pokazala da starije osobe oboljele od psihoze povezane s demencijom imaju povećani rizik smrti u usporedbi s placebom.
English: However, loxapine and its metabolites have been shown to be transported into the milk of lactating dogs.
Croatian: Međutim, pokazalo se da se loksapin i njegovi metaboliti prenose u mlijeko ženki pasa u laktaciji.
English: • (Bipolar disorder) Feeling “high”, having excessive amounts of energy, needing much less sleep than usual, talking very quickly with racing ideas, and sometimes severe irritability.
Croatian: • (Bipolarni poremećaj) Osjećaj „ushićenosti“, višak energije, potreba za puno manje sna nego je to uobičajeno, vrlo brzi govor uz bujicu misli i ponekad visoka razdražljivost.
English: IMPORTANT: Check that the green light turns off after the patient inhales.
Croatian: VAŽNO: Provjerite je li se ugasilo zeleno svjetlo nakon što je bolesnik udahnuo.
English: The safety and efficacy of ADASUVE in patients older than 65 years of age have not been established.
Croatian: Sigurnost i djelotvornost lijeka ADASUVE u bolesnika u dobi iznad 65 godina nisu utvrđene.
English: Store in the original pouch until ready for use in order to protect from light and moisture.
Croatian: Čuvati u originalnoj vrećici do uporabe radi zaštite od svjetlosti i vlage.