FrancophonIA/ELRC3.0 huggingface dataset:
English: SPECIAL STORAGE CONDITIONS Dry powder:
Croatian: Suhi prašak:
English: Amoxil 1 g powder for solution for injection or infusion is packaged in a clear Ph.Eur.
Croatian: Amoxil 1 g prašak za otopinu za injekciju ili infuziju dolazi u prozirnoj staklenoj bočici (staklo tipa
English: Powder for 40 ml oral suspension Powder for 60 ml oral suspension Powder for 80 ml oral suspension Powder for 100 ml oral suspension Powder for 120 ml oral suspension
Croatian: Prašak za 120 ml oralne suspenzije.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER [To be completed nationally]
Croatian: 11. IME I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
English: Amoxil 250 mg powder for solution for injection or infusion is a white to off-white sterile powder filled into a clear glass 25 ml vial, with a chlorobutyl rubber stopper closure and a tamper evident sealing ring.
Croatian: Kako Amoxil izgleda i sadržaj pakiranja Amoxil 250 mg prašak za otopinu za injekciju ili infuziju je bijeli do bjelkasti sterilni prašak u prozirnoj staklenoj bočici od 25 ml s klorobutilnim gumenim čepom i prstenom na zatvaraču s evidencijom otvaranja.
English: Chlamydia spp.
Croatian: Vrste roda Chlamydia
English: 1 g powder for solution for injection or infusion Powder for solution for injection or infusion Vials containing a white to off-white sterile powder.
Croatian: 1 g prašak za otopinu za injekciju ili infuziju Prašak za otopinu za injekciju ili infuziju
English: The patient fully recovered the same day.
Croatian: Bolesnik se isti dan u potpunosti oporavio.
English: The primary outcome of the study was time to relapse.
Croatian: Primarni ishod ispitivanja bilo je vrijeme do relapsa.
English: This can appear after short or long term use.
Croatian: Ovo se može pojaviti nakon kratkotrajne ili dugotrajne primjene.
English: Some of these patients had confounding factors.
Croatian: Neki od ovih bolesnika imali su ometajuće faktore.
English: This is because the medicine will stay in your body for some time after the last dose was taken.
Croatian: Razlog za to je što će se lijek zadržati u Vašem tijelu još neko vrijeme nakon što ste uzeli zadnju dozu.
English: The mechanism for this increased risk is not known.
Croatian: Mehanizam koji dovodi do tog povećanja rizika nije poznat.
English: Therefore close monitoring in the first phase of treatment is important.
Croatian: Stoga je strogi nadzor važan u prvoj fazi liječenja.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 13 July 2017
Croatian: DATUM PRVOG ODOBRENJA / DATUM OBNOVE ODOBRENJA 13. srpnja 2017.
English: Consumption of grapefruit juice should be avoided.
Croatian: Treba izbjegavati konzumiranje soka od grejpa.
English: Of the 2,844 patients 933 were female (see section 4.2).
Croatian: Od 2844 bolesnika, 933 bile su žene (vidjeti dio 4.2).
English: Ask your doctor about appropriate choices of contraception.
Croatian: Upitajte svog liječnika o izboru odgovarajuće kontracepcije.
English: Do not take this medicine during pregnancy unless your doctor has told you to do so.
Croatian: Nemojte uzimati ovaj lijek tijekom trudnoće, osim ako Vaš liječnik ne kaže da to učinite.
English: Your doctor will carefully select the appropriate dose for your needs.
Croatian: Vaš liječnik će pažljivo odabrati odgovarajuću dozu u skladu s Vašim potrebama.
English: What Reagila is and what it is used for
Croatian: Što je Reagila i za što se koristi
English: Talk to your doctor.
Croatian: Razgovarajte sa svojim liječnikom.
English: An increased risk cannot be excluded for other antipsychotics or other patient populations.
Croatian: Povećan rizik ne može se isključiti ni kod drugih antipsihotika ili drugih populacija bolesnika.
English: 86% of patients were less than 55 years old, 54% of them were male.
Croatian: Osamdeset i šest posto (86%) bolesnika bilo je mlađe od 55 godina, a 54% njih bili su muškarci.
English: The safety and efficacy of cariprazine in children and adolescents aged less than 18 years have not been established.
Croatian: Sigurnost i djelotvornost kariprazina u djece i adolescenata mlađih od 18 godina nisu ustanovljene.
English: Consequently, newborns should be monitored carefully.
Croatian: Zbog toga novorođenčad treba pomno nadzirati.
English: This medicine is not recommended for children and adolescents under 18 years due to the lack of data in these patients.
Croatian: Ovaj se lijek ne preporučuje za primjenu u djece i adolescenata mlađih od 18 godina zbog nedostatka podataka o primjeni u tih bolesnika.
English: 95%CI
Croatian: 95% CI p-vrijednost
English: Close medical supervision and monitoring should continue until the patient recovers.
Croatian: Strog liječnički nadzor i praćenje treba provoditi sve dok se bolesnik ne oporavi.
English: Tell your doctor immediately if you notice any signs of a stroke.
Croatian: Odmah obavijestite svog liječnika ako primijetite bilo kakve znakove moždanog udara.
English: This analysis included 2,844 patients of different races, involving 536 patients between the ages of 50 and 65.
Croatian: Analiza je uključivala 2844 bolesnika različitih rasa, uključujući 536 bolesnika u dobi između 50 i 65 godina.
English: If your doctor decides that you should take this medicine during pregnancy, your doctor will monitor your baby closely after birth.
Croatian: Ako Vaš liječnik odluči da morate uzimati ovaj lijek tijekom trudnoće, pažljivo će pratiti Vaše dijete nakon rođenja.
English: Even if you feel better, do not alter or stop your daily dose of Reagila unless told to do so by your doctor as your symptoms may return.
Croatian: Čak i ako se osjećate bolje, nemojte mijenjati ili prestati uzimati svoju dnevnu dozu lijeka Reagila, osim ako Vam liječnik kaže da to učinite, jer se simptomi mogu vratiti.
English: Do not drive or use any tools or machines until you know that this medicine does not affect you in a negative way.
Croatian: Nemojte voziti ni koristiti bilo kakve alate ili strojeve dok se ne uvjerite da lijek ne utječe na Vas na negativan način.
English: Contact your doctor for advice.
Croatian: Obratite se svom liječniku za savjet.
English: Cariprazine can be administered with or without food.
Croatian: Kariprazin se može primjenjivati s hranom ili bez nje.
English: The effect of food on the exposure of the metabolites DCAR and DDCAR was also minimal.
Croatian: Učinak hrane na izloženost metabolitima DCAR i DDCAR također je bio minimalan.
English: Treatment difference versus placebo (95% CI)
Croatian: Razlika liječenja naspram placeba (95% CI)
English: Suicidal thoughts and behaviours are more likely at the beginning of the treatment.
Croatian: Samoubilačke misli i ponašanja češća su na početku liječenja.
English: Take Reagila at the same time each day with or without food.
Croatian: Uzmite lijek Reagila u isto vrijeme svaki dan, s hranom ili bez nje.
English: UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included.
Croatian: 17. JEDINSTVENI IDENTIFIKATOR - 2D BARKOD Sadrži 2D barkod s jedinstvenim identifikatorom.*
English: Do not breast-feed if you are taking Reagila because a risk for the baby cannot be excluded.
Croatian: Nemojte dojiti ako uzimate lijek Reagila jer se rizik za bebu ne može isključiti.
English: Other medicines and Reagila
Croatian: Drugi lijekovi i Reagila
English: Pharmacotherapeutic group: Psycholeptics, other antipsychotics, ATC code: N05AX15
Croatian: Farmakoterapijska skupina: Psiholeptici, ostali antipsihotici, ATK oznaka: N05AX15
English: Allura red AC is a coloring agent, which may cause allergic reactions.
Croatian: Allura red AC je sredstvo za bojenje koje može izazvati alergijske reakcije.
English: None of the cariprazine treated patients had any liver damage.
Croatian: Niti jedan od bolesnika liječenih kariprazinom nije imao oštećenje jetre.
English: Table 2 Summary of results in study RGH-188-005
Croatian: Tablica 2. Sažetak rezultata ispitivanja RGH-188-005
English: Your doctor will need to check your blood sugar regularly since it may be increased by Reagila.
Croatian: Vaš će Vam liječnik morati redovito provjeravatirazinu šećera u krvi budući da je lijek Reagila može povećati.
English: Reproductive performance of the first generation pups was unaffected; however, second generation pups also had similar clinical signs and lower body weight.
Croatian: Nije bilo učinka na reproduktivne sposobnosti prve generacije mladunčadi; međutim, druga generacija mladunčadi također je imala slične kliničke znakove i manju tjelesnu težinu.
English: Your doctor will need to check your blood pressure regularly.
Croatian: Vaš će Vam liječnik morati redovito provjeravati krvni tlak.
English: If you take more Reagila than you should
Croatian: Ako uzmete više lijeka Reagila nego što ste trebali
English: Cariprazine has not been studied in elderly patients with dementia and is not recommended to treat elderly patients with dementia due to increased risk of overall mortality.
Croatian: Kariprazin se nije ispitivao u starijih bolesnika s demencijom i ne preporučuje se za liječenje starijih bolesnika s demencijom uslijed povećanog rizika od ukupne smrtnosti.
English: The blisters are packed in a folded carton box.
Croatian: Blisteri su zapakirani u kartonsku kutiju.
English: Reagila contains the active substance cariprazine and belongs to a group of medicines called antipsychotics.
Croatian: Reagila sadrži djelatnu tvar kariprazin i pripada skupini lijekova koji se nazivaju antipsihotici.
English: Your doctor will advise you to visit an ophthalmologist.
Croatian: Vaš liječnik će Vas posavjetovati da posjetite specijalista za oči (oftalmologa).
English: If you have taken more Reagila than your doctor has recommended or if, for example, a child has taken it by mistake, contact your doctor or go to the nearest hospital right away and take the pack of the medicine with you.
Croatian: Ako ste uzeli više lijeka Reagila nego što Vam je preporučio liječnik ili ako je na primjer dijete slučajno uzelo lijek, odmah o tome obavijestite svog liječnika ili otiđite u najbližu bolnicu i ponesite pakiranje lijeka sa sobom.
English: You cannot take certain medicines together with Reagila (see section “Do not take Reagila”).
Croatian: Ne smijete uzimati određene lijekove zajedno s lijekom Reagila (vidjeti dio „Nemojte uzimati lijek Reagila“).
English: The mechanism of action of cariprazine is not fully known.
Croatian: Mehanizam djelovanja kariprazina nije u potpunosti poznat.
English: Neuroleptic malignant syndrome (NMS)
Croatian: Neuroleptički maligni sindrom (NMS)
English: Your doctor will also inform you how to act if you switch from Reagila to another medicine.
Croatian: Liječnik će Vas također uputiti kako djelovati ako prelazite s lijeka Reagila na drugi lijek.
English: Cardiovascular monitoring should commence immediately, including continuous electrocardiographic monitoring for possible arrhythmias.
Croatian: Treba odmah započeti s kardiovaskularnim nadzorom, uključujući kontinuirano elektrokardiografsko praćenje kako bi se otkrile moguće aritmije.
English: Thereafter, the dose may be slowly adjusted by your doctor, in steps of 1.5 mg, depending on how the treatment works for you.
Croatian: Nakon toga, Vaš liječnik može polako prilagođavati dozu u koracima od 1,5 mg, ovisno o tome kako liječenje dijeluje na Vas.
English: For the management of patients treated with cariprazine, the effective half-life is more relevant than the terminal half-life.
Croatian: Za liječenje bolesnika koji uzimaju kariprazin, efektivni poluvijek važniji je od terminalnog poluvijeka.
English: It should be considered that plasma concentration of cariprazine and its active metabolites will decline by 50% in ~1 week (see section 5.2).
Croatian: Potrebno je uzeti u obzir da će se plazmatska koncentracija kariprazina i njegovih aktivnih metabolita smanjiti za 50% za ~1 tjedan (vidjeti dio 5.2).
English: - The active substance is cariprazine.
Croatian: - Djelatna tvar je kariprazin.
English: Reagila may cause significant weight increase which may affect your health.
Croatian: Lijek Reagila može uzrokovati značajno povećanje tjelesne težine koje može ugroziti Vaše zdravlje.
English: Reagila is indicated for the treatment of schizophrenia in adult patients.
Croatian: Reagila je indicirana za liječenje shizofrenije u odraslih bolesnika.
English: ° abnormal amount of lipids (e.g. cholesterol and/or fat) in the blood
Croatian: ° abnormalne količine lipida (npr. kolesterola i/ili masti) u krvi
English: Because cariprazine is not a substrate for CYP1A2, smoking is not expected to have an effect on the pharmacokinetics of cariprazine.
Croatian: Budući da kariprazin nije supstrat za CYP1A2, ne očekuje se da će pušenje utjecati na farmakokinetiku kariprazina.
English: Reagila is for oral use, to be taken once daily at the same time of the day with or without food.
Croatian: Reagila je namijenjena za peroralnu primjenu i uzima se jedanput na dan u isto doba dana, s hranom ili bez nje.
English: Physicians should, therefore, weigh the risks versus the benefits when prescribing cariprazine to patients with Parkinson's disease.
Croatian: Liječnici stoga trebaju procijeniti rizike u odnosu na koristi kada kariprazin propisuju bolesnicima s Parkinsonovom bolešću.
English: What Reagila looks like and contents of the pack
Croatian: Kako Reagila izgleda i sadržaj pakiranja
English: The European Medicines Agency has deferred the obligation to submit the results of studies with cariprazine in paediatric population.
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja kariprazina u pedijatrijskoj populaciji.
English: The possibility of suicidality (suicidal ideation, suicide attempt and completed suicide) is inherent in psychotic illnesses and, generally, it is reported early after initiation or switch of antipsychotic therapy.
Croatian: Moguća pojava suicidalnosti (suicidalne ideje, pokušaj samoubojstva i izvršenje samoubojstva) svojstvena je psihičkim bolestima i uglavnom se prijavljuje rano nakon započinjanja ili promjene terapije antipsihoticima.
English: Patients should be cautioned about operating hazardous machinery, including motor vehicles, until they are reasonably certain that therapy with Reagila does not affect them adversely.
Croatian: Bolesnike treba upozoriti da ne upravljaju opasnim strojevima, uključujući motorna vozila, dok se ne uvjere da liječenje lijekom Reagila ne utječe negativno na njih.
English: Because of the long half-life of cariprazine and its active metabolites, changes in dose will not be fully reflected in plasma for several weeks.
Croatian: Zbog dugog poluvijeka kariprazina i njegovih aktivnih metabolita, promjene doze neće se u potpunosti reflektirati u plazmi još nekoliko tjedana.
English: The effective (functional) half-life is ~ 2 days for cariprazine and DCAR, 8 days for DDCAR and is ~1 week for total cariprazine.
Croatian: Efektivni (funkcionalni) poluvijek iznosi ~ 2 dana za kariprazin i DCAR, 8 dana za DDCAR i ~ 1 tjedan za ukupni kariprazin.
English: There is no specific antidote to cariprazine.
Croatian: Nema specifičnog protulijeka za kariprazin.
English: The lowest effective dose should be maintained according to the clinical judgement of the treating physician.
Croatian: Najnižu učinkovitu dozu treba održavati prema kliničkoj procjeni liječnika.
English: These can be the signs of the so-called neuroleptic malignant syndrome.
Croatian: To mogu biti znakovi takozvanog neuroleptičkog malignog sindroma.
English: Risk of cerebrovascular accidents (CVA)
Croatian: Rizik od cerebrovaskularnog inzulta (CVI)
English: Cariprazine and its major active metabolites are highly bound (96 to 97% for CAR, 94% to 97% for DCAR and 92% to 97% for DDCAR) to plasma proteins.
Croatian: Kariprazin i njegovi glavni aktivni metaboliti u velikoj se mjeri vežu (96 - 97% za CAR, 94 - 97% za DCAR i 92 - 97% za DDCAR) za proteine u plazmi.
English: These symptoms may occur early during treatment with Reagila.
Croatian: Ovi simptomi se mogu javiti rano tijekom liječenja lijekom Reagila.
English: Blood pressure changes
Croatian: Promjene krvnog tlaka
English: Nevertheless, patients who would develop symptoms potentially related to cataract should be advised to ophthalmologic examination and re-evaluated for treatment continuation.
Croatian: Ipak, bolesnike kod kojih bi došlo do razvoja simptoma potencijalno povezanih s kataraktom treba savjetovati da obave oftalmološki pregled i treba ih se ponovno procijeniti za nastavak liječenja.
English: The effect of cariprazine on human fertility has not been evaluated.
Croatian: Učinak kariprazina na plodnost ljudi nije se ocjenjivala.
English: Results for the secondary outcome parameter (CGI) and additional endpoints were supportive of the primary endpoint.
Croatian: Rezultati parametara sekundarnog ishoda (CGI) i dodatnih mjera ishoda podržavaju mjeru primarnog ishoda.
English: The clinical consequences of this effect is not fully understood, however the use of P-gp substrates with narrow therapeutic index such as dabigatran and digoxin could require extra monitoring and dose adjustment.
Croatian: Iako kliničke posljedice tog učinka nisu posve jasne, primjena supstrata P-gp-a s uskim terapijskim indeksom, poput dabigatrana i digoksina, mogla bi zahtijevati dodatno praćenje i prilagodbu doze.
English: The dose can be modified based on individual response and tolerability (see section 4.8).
Croatian: Doza se može prilagođavati prema individualnom odgovoru i podnošljivosti (vidjeti dio 4.8).
English: Cariprazine is a P-gp inhibitor in vitro at its theoretical maximum intestinal concentration.
Croatian: Kariprazin je inhibitor P-gp-a in vitro pri svojoj teoretski maksimalnoj koncentraciji u crijevima.
English: People with this condition may also feel depressed, guilty, anxious, tense, or not being able to start or keep up planned activities, unwillingness to speak, lack of emotional response to a situation that would normally stimulate feelings in others.
Croatian: Osobe s ovom bolešću također mogu osjećati depresiju, krivnju, tjeskobu, napetost ili nedostatak sposobnosti za započinjanje i održavanje planiranih aktivnosti, nespremnost da govore te nedostatak emocionalnog odgovora na situaciju koja uobičajeno izaziva emocije kod drugih.
English: Reagila with food, drink and alcohol You should not drink grapefruit juice during treatment with Reagila.
Croatian: Reagila s hranom, pićem i alkoholom Tijekom liječenja lijekom Reagila ne smijete piti sok od grejpa.
English: Talk to your doctor or pharmacist before taking Reagila, or during treatment if you have: - ever experienced or start to experience restlessness and inability to sit still.
Croatian: Obratite se svom liječniku ili ljekarniku prije nego što uzmete lijek Reagila ili tijekom liječenja: - ako ste ikada osjećali ili ste počeli osjećati nemir i nesposobnost da mirno sjedite.
English: It is used to treat adults with schizophrenia.
Croatian: Koristi se za liječenje odraslih sa shizofrenijom.
English: Your doctor will therefore check your weight regularly.
Croatian: Stoga će Vaš liječnik redovito kontrolirati Vašu tjelesnu težinu.
English: If you have serious kidney or liver problems Reagila may not be appropriate for you.
Croatian: Ako imate ozbiljne probleme s bubrezima ili jetrom, lijek Reagila možda nije prikladan za Vas.
English: If prescribed to patients with Parkinson's disease, antipsychotic medicinal products may exacerbate the underlying disease and worsen symptoms of Parkinson's disease.
Croatian: Ako se propisuju bolesnicima s Parkinsonovom bolešću, antipsihotici mogu pogoršati osnovnu bolest i simptome Parkinsonove bolesti.
English: There is a minor or moderate risk that the medicine could affect the ability to drive and use machines.
Croatian: Postoji manji ili umjeren rizik da bi lijek mogao utjecati na sposobnost upravljanja vozilima i rada sa strojevima.
English: Estimated Treatment Difference
Croatian: Procijenjena razlika između liječenja
English: This patient experienced orthostasis and sedation.
Croatian: U tog su se bolesnika javili ortostaza i sedacija.
English: The plasma concentration of total cariprazine will gradually decline following dose discontinuation or interruption.
Croatian: Plazmatska koncentracija ukupnog kariprazina postupno će se smanjivati nakon trajnog ili privremenog prekida primjene.
English: The most commonly reported ocular adverse event was blurred vision (placebo: 1/683; 0.1%, cariprazine: 22/2048; 1.1%).
Croatian: Najčešće prijavljivana očna nuspojava bila je zamagljen vid (placebo: 1/683; 0,1%, kariprazin: 22/2048; 1,1%).
English: These complications have varied in severity; while in some cases symptoms have been self-limited, in other cases, neonates have required intensive care unit support and prolonged hospitalization.
Croatian: Težina tih komplikacija je varirala; dok su u nekim slučajevima simptomi bili samoograničavajući, u drugima je novorođenčadi bilo potrebno potporno liječenje u jedinici intenzivnog liječenja i produljena hospitalizacija.
English: The maximum dose should not exceed 6 mg once a day.
Croatian: Ne smije se prekoračiti maksimalna dnevna doza od 6 mg jedanput na dan.
English: - high or low blood pressure, cardiovascular disease.
Croatian: - ako imate visok ili nizak krvni tlak ili bolest srca i krvnih žila.
English: If a patient develops signs and symptoms indicative of NMS, or presents with unexplained high fever without additional clinical manifestations of NMS, cariprazine must be discontinued immediately.
Croatian: Ako se kod bolesnika pojave znakovi i simptomi koji ukazuju na NMS ili neobjašnjivo visoka tjelesna temperatura bez dodatnih kliničkih manifestacija NMS-a, odmah se mora prekinuti primjena kariprazina.
English: Patients with kidney or liver problems
Croatian: Bolesnici koji imaju probleme s bubrezima ili jetrom
English: Since cariprazine is highly bound to plasma proteins, haemodialysis is unlikely to be useful in the management of overdose.
Croatian: Budući da se kariprazin u velikoj mjeri veže za proteine u plazmi, nije vjerojatno da bi hemodijaliza bila korisna u liječenju predoziranja.
English: Tell your doctor immediately if you have: - a severe allergic reaction seen as fever, swollen mouth, face, lip or tongue, shortness of breath, itching, skin rash and sometimes a drop in blood pressure.
Croatian: Odmah obavijestite svog liječnika ako imate: - jaku alergijsku reakciju koja se očituje kao vrućica, oticanje usta, lica, usana ili jezika, nedostatak zraka, svrbež, kožni osip i ponekad pad krvnog tlaka.
English: - ever experienced or start to experience abnormal, involuntary movements, most commonly of the tongue or face.
Croatian: - ako ste ikada imali ili počinjete imati neuobičajene, nevoljne pokrete, najčešće jezika ili lica.
English: Absolute bioavailability of cariprazine is unknown.
Croatian: Apsolutna bioraspoloživost kariprazina je nepoznata.
English: Detailed and updated information on this medicine is available by scanning the QR code below and the outer carton with a smartphone.
Croatian: Detaljne i ažurirane informacije o ovom lijeku dostupne su skeniranjem QR koda navedenog u nastavku i na vanjskom pakiranju uz pomoć pametnog telefona.
English: What you need to know before you take Reagila
Croatian: Što morate znati prije nego počnete uzimati lijek Reagila
English: Available data in elderly patients aged ≥65 years treated with cariprazine are not sufficient to determine whether or not they respond differently from younger patients (see section 5.2).
Croatian: Dostupni podaci o primjeni kariprazina u bolesnika u dobi od ≥ 65 godina nisu dovoljni da bi se utvrdilo reagiraju li drugačije od mlađih bolesnika (vidjeti dio 5.2).
English: Tardive dyskinesia is a syndrome consisting of potentially irreversible, rhythmical, involuntary movements, predominantly of the tongue and/or face that can develop in patients treated with antipsychotics.
Croatian: Tardivna diskinezija je sindrom koji se sastoji od potencijalno ireverzibilnih, ritmičkih, nevoljnih pokreta, pretežno jezika i/ili lica, koji se mogu razviti u bolesnika liječenih antipsihoticima.
English: Blood pressure should be monitored.
Croatian: Potrebno je pratiti krvni tlak.