FrancophonIA/ELRC3.0 huggingface dataset:
English: Aripiprazole is thought to act mainly by being a ‘partial agonist' at the receptors for the neurotransmitters dopamine and 5-hydroxytryptamine (also called serotonin).
Croatian: Smatra se da aripiprazol djeluje uglavnom kao „parcijalni agonist” za receptore neurotransmitera dopamina i 5-hidroksitriptamina (također zvani serotonin).
English: The dose should be adjusted in patients who are taking other medicines that affect the way Aripiprazole Sandoz is broken down in the body.
Croatian: Dozu treba prilagoditi u bolesnika koji uzimaju druge lijekove, koji mogu utjecati na način razgradnje lijeka Aripiprazole Sandoz u tijelu.
English: This means that it is similar to a ‘reference medicine', but it contains aripiprazole at a new strength in addition to existing strengths: while the reference medicine, Abilify, is available as 5, 10, 15 and 30 mg, Aripiprazole Sandoz is also available as 20 mg tablets.
Croatian: To znači da je sličan "referentnom lijeku", no sadrži aripiprazol u novoj jačini uz već postojeće jačine: dok je referetni lijek, Abilify, dostupan u jačinama 5, 10, 15 i 30 mg, Aripiprazole
English: Aripiprazole Sandoz aripiprazole
Croatian: Aripiprazole Sandoz aripiprazol
English: Aripiprazole Sandoz is used in patients with the following mental illnesses:
Croatian: Aripiprazole Sandoz koristi se u bolesnika sa sljedećim mentalnim bolestima:
English: The company provided data from the published literature on aripiprazole.
Croatian: Tvrtka je priložila podatke o aripiprazolu iz objavljene literature.
English: This is a summary of the European public assessment report (EPAR) for Aripiprazole Sandoz.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Aripiprazole Sandoz.
English: What is Aripiprazole Sandoz and what is it used for?
Croatian: Što je Aripiprazole Sandoz i za što se koristi?
English: Aripiprazole Sandoz is available as tablets and can only be obtained with a prescription.
Croatian: Aripiprazole Sandoz dostupan je kao tablete i izdaje se samo na recept.
English: Because Aripiprazole Sandoz is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Croatian: Sandoz bioekvivalent referentnom lijeku, smatra se da su njegove koristi i rizici isti kao i oni referentnog lijeka.
English: Aripiprazole Sandoz is used in patients aged 15 years or over;
Croatian: Aripiprazole Sandoz koristi se u bolesnika u dobi od 15 godina ili starijih;
English: Aripiprazole Sandoz is used in adults to treat moderate to severe manic episodes and to prevent new manic episodes in adults whose illness has improved with the medicine in the past.
Croatian: Aripiprazole Sandoz koristi se u odraslih osoba za liječenje umjerenih do ozbiljnih maničnih epizoda i za sprječavanje novih maničnih epizoda u odraslih osoba koje su odgovorile na lijek u prošlosti.
English: It is not intended to provide practical advice on how to use Aripiprazole Sandoz.
Croatian: Svrha sažetka nije davati praktične savjete o korištenju lijeka Aripiprazole Sandoz.
English: Aripiprazole Sandoz is also used for up to 12 weeks to treat moderate to severe manic episodes in patients aged 13 years or over.
Croatian: Aripiprazole Sandoz se također koristi u razdoblju do 12 tjedana za liječenje umjerenih do ozbiljnih maničnih epizoda u bolesnika u dobi od 13 godina i starijih.
English: What measures are being taken to ensure the safe and effective use of Aripiprazole Sandoz?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Aripiprazole Sandoz?
English: A risk management plan has been developed to ensure that Aripiprazole Sandoz is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Aripiprazole Sandoz.
English: The Committee recommended that Aripiprazole Sandoz be approved for use in the EU.
Croatian: Povjerenstvo je preporučilo izdavanje odobrenja za stavljanje u promet lijeka Aripiprazole Sandoz u EU-u.
English: What are the benefits and risks of Aripiprazole Sandoz?
Croatian: Koje su koristi i rizici lijeka Aripiprazole Sandoz?
English: For schizophrenia, the recommended starting dose is 10 or 15 mg by mouth per day in adults, followed by a ‘maintenance' dose of 15 mg once a day.
Croatian: U slučaju shizofrenije preporučena početna doza iznosi 10 ili 15 mg peroralno na dan za odrasle osobe, nakon čega slijedi doza "održavanja" od 15 mg jednom na dan.
English: Other information about Aripiprazole Sandoz
Croatian: Ostale informacije o lijeku Aripiprazole Sandoz
English: Aripiprazole Sandoz contains the active substance aripiprazole and is a ‘generic' and a ‘hybrid' medicine.
Croatian: Sandoz sadrži djelatnu tvar aripiprazol te je "generički" i "hibridni" lijek.
English: For treating manic episodes in patients aged between 13 and 17 years, the starting dose is 2 mg a day (using an aripiprazole product available in liquid form), which is gradually increased to the recommended dose of 10 mg once a day.
Croatian: Za potrebe liječenja maničnih epizoda u bolesnika u dobi između 13 i 17 godina, početna doza iznosi 2 mg na dan (primjenom lijeka koji sadrži aripiprazol dostupnog u tekućem obliku), koji se postepeno povećava do preporučene doze od 10 mg jednom na dan.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Aripiprazole Sandoz has been shown to have comparable quality and to be bioequivalent to Abilify.
Croatian: Povjerenstvo za lijekove za primjenu kod ljudi (CHMP) pri Agenciji zaključilo je kako je, u skladu s preduvjetima EU-a, potvrđeno kako Aripiprazole
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Aripiprazole Sandoz, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Sandoz uključene su sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: The full EPAR and risk management plan summary for Aripiprazole Sandoz can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Sandoz nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports Više informacija o terapiji lijekom Aripiprazole Sandoz pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
English: For practical information about using Aripiprazole Sandoz, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Sandoz pročitajte u uputi o lijeku, odnosno obratite se svojem liječniku ili ljekarniku.
English: How is Aripiprazole Sandoz used?
Croatian: Kako se koristi Aripiprazole Sandoz?
English: How does Aripiprazole Sandoz work?
Croatian: Kako djeluje Aripiprazole Sandoz?
English: The company carried out ‘bioequivalence' studies to show that Aripiprazole Sandoz is bioequivalent to the reference medicine, Abilify.
Croatian: Tvrtka je provela ispitivanja "bioekvivaletnosti" kako bi dokazala da je Aripiprazole
English: Why is Aripiprazole Sandoz approved?
Croatian: Sandoz odobren?
English: Then carry on as normal, sticking to your usual injection day.
Croatian: Zatim nastavite po normalnom rasporedu, pridržavajući se svog uobičajenog dana injekcije.
English: If you experience any of the following, contact your doctor immediately:
Croatian: Ako primijetite bilo što od sljedećeg, odmah se obratite svom liječniku:
English: Daclizumab beta pharmacokinetics are well described by a two-compartment model with first-order absorption and elimination.
Croatian: Farmakokinetika daklizumaba beta dobro je opisana modelom s dva odjeljka s apsorpcijom i eliminacijom prvog reda.
English: (Uncommon - may affect up to 1 in 100 people) • Severe inflammation of the liver which might be life-threatening or result in death
Croatian: (Manje često - mogu se javiti u manje od 1 na 100 osoba) • teška upala jetre koja može biti opasna za život ili imati za posljedicu smrtni ishod
English: Daclizumab beta had no effect on peri- and post-natal development from birth to up to 6 months in the offspring.
Croatian: Daklizumab beta nije imao utjecaja na peri- i postnatalni razvoj mladunčadi od rođenja do 6 mjeseci života.
English: Do not share the pen with anyone else to avoid giving an infection to them or getting an
Croatian: Nemojte dijeliti brizgalicu ni s kim drugim kako bi se izbjeglo da svoju infekciju prenesete na druge ili da se infekcija s drugih prenese na Vas.
English: Table 3: Study design and baseline characteristics for SELECT study and DECIDE study Study name
Croatian: Tablica 3: Dizajn ispitivanja i početne značajke ispitivanja SELECT i DECIDE Naziv ispitivanja
English: Chronic administration of daclizumab beta at all doses increased the incidence of skin findings (compared to those observed in control animals).
Croatian: Kronična primjena daklizumaba beta pri svim dozama povećala je incidenciju nalaza na koži (u odnosu na one opažene kod kontrolnih životinja).
English: Four new serious cases of colitis confirmed by health-care professionals have been received during this period.
Croatian: Tijekom ovoga razdoblja prijavljena su četiri nova ozbiljna slučaja kolitisa koja su potvrdili zdravstveni radnici.
English: In the DECIDE study (see section 5.1), patients were tested for anti-drug (daclizumab beta) antibodies at week 4 and approximately every 3 months thereafter.
Croatian: U ispitivanju DECIDE (vidjeti dio 5.1), bolesnici su testirani na protutijela na lijek (daklizumab beta) u 4. tjednu i otprilike svaka 3 mjeseca nakon toga.
English: • Recommended storage is controlled refrigeration 2°C to 8°C in the closed original carton to
Croatian: • Preporučeno čuvanje je kontrolirano rashlađivanje od 2°C do 8°C u zatvorenoj originalnoj kutiji radi zaštite od svjetlosti.
English: Do not try to treat any side effects yourself, but contact your doctor or nurse.
Croatian: Nemojte pokušati sami liječiti nijednu nuspojavu, nego se obratite svom liječniku ili medicinskoj sestri.
English: Low red blood cell counts (autoimmune haemolytic anaemia): (Uncommon - may affect up to 1 in 100 people)
Croatian: Nizak broj crvenih krvnih stanica (autoimuna hemolitična anemija): (Manje često - mogu se javiti u manje od 1 na 100 osoba)
English: Using one hand, hold the syringe by the glass barrel.
Croatian: Jednom rukom držite štrcaljku za stakleni cilindar.
English: Daclizumab beta was detected in the milk of 11/14 lactating monkeys at levels that were <0.122% of the maternal serum levels, with no adverse reactions observed in the off-spring.
Croatian: Daklizumab beta je otkriven u mlijeku 11/14 ženki majmuna u laktaciji na razinama koje su bile <0,122% od razina u serumu majke, bez nuspojava opaženih u mladunčadi.
English: Step 4: Firmly remove the needle cover
Croatian: 4. korak: Snažnim pokretom uklonite pokrov igle
English: In vitro investigative studies suggest that microglial aggregates are not due to a direct effect of daclizumab beta on microglial cells but are likely to be attributable to an increase in local IL-2 bioavailability.
Croatian: In vitro istražna ispitivanja upućuju na to da agregati mikroglije nisu posljedica izravnog učinka daklizumaba beta na stanice mikroglije, nego su vjerojatno posljedica povećanja lokalne bioraspoloživosti IL-2.
English: Daclizumab beta did not affect reproductive capacity in female and male cynomolgus monkeys (AUC in females and males up to 85 and 100 times higher than the exposure at the clinical dose respectively).
Croatian: Daklizumab beta nije utjecao na reproduktivni kapacitet ženki i mužjaka makaki majmuna (AUC u ženki i mužjaka do 85 odnosno 100 puta veći od izloženosti pri kliničkoj dozi).
English: Based on the cross-study population pharmacokinetic analysis, daclizumab beta pharmacokinetics were not influenced by age (range: 18 to 66 years; n=1670) or gender (n = 567 males and 1103 females).
Croatian: Na temelju analize populacijske farmakokinetike između ispitivanja, na farmakokinetiku daklizumaba beta nisu utjecali dob (raspon: 18 do 66 godina; n=1670) niti spol (n = 567 muškaraca i 1103 žena).
English: Do not use Zinbryta - if you have previously had a serious allergic reaction to any form of daclizumab, or any of the other ingredients of this medicine listed in section 6.
Croatian: Nemojte primjenjivati Zinbrytu - ako ste imali ozbiljnu alergijsku reakciju na bilo koji oblik daklizumaba ili neki drugi sastojak ovog lijeka naveden u dijelu 6. - ako imate tegobe s jetrom.
English: Available toxicology data in lactating cynomolgus monkeys have shown excretion of daclizumab beta in milk (for details see section 5.3).
Croatian: Dostupni toksikološki podaci u makaki majmuna u laktaciji pokazali su izlučivanje daklizumaba beta u mlijeko (za detalje vidjeti dio 5.3).
English: This small volume of distribution indicates that daclizumab beta is primarily confined to the vascular and interstitial spaces.
Croatian: Taj mali volumen distribucije pokazuje da je daklizumab beta prvenstveno ograničen na krvožilni i intersticijski prostor.
English: Check the medicine window and make sure the Zinbryta medicine is colourless to
Croatian: Provjerite prozorčić za lijek i provjerite je li lijek Zinbryta bezbojan do blago žut.
English: Following subcutaneous administration of daclizumab beta, the median time to reach maximum serum concentrations (Tmax) ranged from 5 to 7 days.
Croatian: Nakon supkutane primjene daklizumaba beta, medijan vremena do postizanja maksimalne koncentracije u serumu (Tmax) kretao se u rasponu od 5 do 7 dana.
English: • Patients with 2 or more relapses in 1 year, and with 1 or more Gd-enhancing lesions on brain
Croatian: • Bolesnici s 2 ili više relapsa u 1 godini, i s 1 ili više lezija imbibiranih gadolinijem na MR snimci mozga, ili
English: Preclinical safety studies were conducted in cynomolgus monkeys due to species specificity of daclizumab beta binding only to human or primate CD25.
Croatian: Neklinička ispitivanja sigurnosti su provedena u makaki majmuna zbog specifičnosti vezanja daklizumaba beta samo na ljudski ili primatski CD25.
English: • If you do forget a dose, and it is within 2 weeks of your missed dose, inject as soon as you can.
Croatian: • Ako zaboravite primijeniti dozu, a prošlo je manje od 2 tjedna od propuštene doze, injicirajte je čim prije možete.
English: • The recommendation not to initiate treatment in patients with autoimmune disorders (other than
Croatian: • preporuku da ne započinju liječenje u bolesnika s autoimunim poremećajima (osim multiple skleroze)
English: It should include the following elements:
Croatian: Obrazac mora uključivati sljedeće:
English: There was no apparent correlation of anti-drug antibodies or neutralising antibodies development to clinical response, adverse reactions, or pharmacodynamic profile of daclizumab beta.
Croatian: Nije bilo vidljive korelacije između razvoja protutijela na lijek ili neutralizirajućih protutijela i kliničkog odgovora, nuspojava ili farmakodinamičkog profila daklizumaba beta.
English: No risk factors or alternative aetiology have been reported in any of these cases.
Croatian: Ni u jednom od tih slučajeva nisu zabilježeni čimbenici rizika ili neka druga etiologija.
English: Consistent with results from individual studies, a cross-study population pharmacokinetic analysis indicated that daclizumab beta exposure is more than dose-proportional in the 50 mg to 100 mg subcutaneous dose range and is dose proportional in the 100 mg to 300 mg subcutaneous dose range.
Croatian: U skladu s rezultatima iz pojedinačnih ispitivanja, analiza populacijske farmakokinetike između ispitivanja pokazala je da je izloženost daklizumabu beta više nego proporcionalna dozi u rasponu supkutanih doza od 50 mg do 100 mg, a proporcionalna je dozi u rasponu supkutanih doza od 100 mg do 300 mg.
English: Daclizumab beta is produced in a mammalian cell line (NS0) by recombinant DNA technology.
Croatian: Daklizumab beta je proizveden tehnologijom rekombinantne DNK u staničnoj liniji sisavaca (NS0).
English: These findings (dry, red raised patchy areas of the skin, as compared to controls, that correlated microscopically with acanthosis/hyperkeratosis and subacute to chronic inflammation) were characterised predominantly as mild to moderate, with one case assessed as severe.
Croatian: Ti nalazi (suhe, crvene uzdignute mrlje na koži, u usporedbi s kontrolama, koje koreliraju mikroskopski s akantozom/hiperkeratozom i subakutnim do kroničnim upalama) uglavnom su karakterizirani kao blagi do umjereni, s jednim slučajem ocijenjenim kao teškim.
English: Together, these immunomodulatory effects of daclizumab beta are believed to reduce CNS pathology in MS and thereby reduce the occurrence of relapses and disability progression.
Croatian: Smatra se da ovi imunomodulirajući učinci daklizumaba beta zajedno smanjuju patologiju SŽS-a u MS-u te time smanjuju pojavu relapsa i napredovanja onesposobljenosti.
English: Do not inject into an area of your body where the skin is irritated, red, bruised, tattooed, infected, or scarred.
Croatian: Nemojte injicirati u područja na kojima je koža nadražena, crvena, s modricama, tetovirana, zaražena ili s ožiljcima.
English: Key effects of this IL-2 pathway modulation potentially related to the therapeutic effects of daclizumab beta in MS include selective antagonism of activated T-cell responses, and expansion of immunoregulatory CD56bright natural killer (NK) cells, which have been shown to selectively decrease activated T-cells.
Croatian: Ključni učinci ove modulacije signalnog puta IL-2 potencijalno povezani s terapijskim učincima daklizumaba beta u multiploj sklerozi uključuju selektivni antagonizam odgovora aktiviranih T-stanica i ekspanziju imunoregulatornih CD56bright stanica prirodnih ubojica (NK), za koje je pokazano da selektivno smanjuju broj aktiviranih T-stanica.
English: • The need to screen for hepatitis B and C prior to treatment initiation and to recommend patients who test positive for HBV or HCV infection to consult with a physician with expertise in the
Croatian: • potrebu testova na hepatitis B i C prije početka liječenja i potrebu da se bolesnicima koji su pozitivni na infekciju HBV-om ili HCV-om preporuči zatražiti savjet liječnika specijalista za liječenje tih bolesti
English: The absolute bioavailability of daclizumab beta 150 mg subcutaneously administered was approximately 90% based on a cross-study population pharmacokinetic analysis of subcutaneous and intravenous dosing.
Croatian: Apsolutna bioraspoloživost supkutano primijenjenog daklizumaba beta od 150 mg bila je otprilike 90% na osnovi analize populacijske farmakokinetike između ispitivanja supkutanog i intravenskog doziranja.
English: As an IgG1 monoclonal antibody, daclizumab beta is expected to undergo catabolism to peptides and amino acids in the same manner as endogenous IgG.
Croatian: Budući da je IgG1 monoklonsko protutijelo, za daklizumab beta se očekuje katabolizam na peptide i aminokiseline na isti način kao i za endogeni IgG.
English: Twelve cases of sarcoidosis confirmed by health-care professionals were reported from clinical trials cumulatively.
Croatian: Iz kliničkih ispitivanja kumulativno je prijavljeno dvanaest slučajeva sarkoidoze koje su potvrdili zdravstveni radnici.
English: Potential adverse reactions beyond this level are expected to be consistent with the safety profile for daclizumab beta in MS patients.
Croatian: Očekuje se da će potencijalne nuspojave iznad te razine biti u skladu sa sigurnosnim profilom za daklizumab beta u bolesnika s MS-om.
English: Based on the cross-study population pharmacokinetic analysis, the clearance of daclizumab beta is 0.212 L/day with a terminal half-life value of approximately 21 days.
Croatian: Na temelju analize populacijske farmakokinetike između ispitivanja, klirens daklizumaba beta iznosi 0,212 l/dan s vrijednošću terminalnog poluvijeka od oko 21 dana.
English: - at least monthly blood tests during treatment, as close as possible before each dose of Zinbryta, and more often if your doctor decides this is necessary - tests for up to 6 months after stopping treatment.
Croatian: - najmanje jednom mjesečno testiranje krvi tijekom liječenja, i to što bliže prije primjene svake doze Zinbryte, a češće ako liječnik odluči da je to potrebno - testiranje do 6 mjeseci nakon prestanka liječenja.
English: Based on the cross-study population pharmacokinetic analysis, the steady-state volume of distribution of daclizumab beta is 6.34 L in a patient with a body weight of 68 kg (approximate median of evaluated patients).
Croatian: Na temelju analize populacijske farmakokinetike između ispitivanja, volumen distribucije daklizumaba beta u stanju dinamičke ravnoteže je 6,34 l u bolesnika s tjelesnom težinom od 68 kg (približan medijan procijenjenih bolesnika).
English: Daclizumab beta is a humanised IgG1 monoclonal antibody that binds to CD25 (IL-2Rα), and prevents IL-2 binding to CD25.
Croatian: Daklizumab beta je humanizirano IgG1 monoklonsko protutijelo koje se veže na CD25 (IL-2Rα), te sprječava vezanje IL-2 na CD25.
English: • You do not see the green stripes in the
Croatian: • ne vidite zelene trake u prozorčiću stanja
English: Based on the cross-study population pharmacokinetic analysis, body weight accounted for less than 40% of the inter-patient variability in daclizumab beta clearance.
Croatian: Na temelju analize populacijske farmakokinetike između ispitivanja, tjelesna težina bila je uzrok za manje od 40% varijabilnosti između bolesnika u klirensu daklizumaba beta.
English: On the basis of the scientific conclusions for daclizumab beta the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing daclizumab beta is unchanged subject to the proposed changes to the product information
Croatian: Na temelju znanstvenih zaključaka za daklizumab beta, CHMP smatra da je omjer koristi i rizika lijeka(ova) koji sadrži(e) daklizumab beta nepromijenjen, uz predložene izmjene informacija o lijeku.
English: Do not inject directly into your belly
Croatian: Nemojte injicirati izravno u pupak.
English: • Immune disorder that can affect the lungs, skin and lymph nodes (sarcoidosis)
Croatian: • poremećaj imunološkog sustava koji može zahvatiti pluća, kožu i limfne čvorove (sarkoidoza)
English: Daclizumab beta clearance in patients who developed neutralising antibodies was, on average, 19% higher (see section 4.8 Immunogenicity).
Croatian: Klirens daklizumaba beta u bolesnika koji su razvili neutralizirajuća protutijela bio je u prosjeku 19% viši (vidjeti dio 4.8
English: In two 9 month studies conducted in cynomolgus monkeys daclizumab beta was subcutaneously administered at bi-weekly doses of 10-200 mg/kg.
Croatian: U dva 9-mjesečna ispitivanja provedena u makaki majmuna, daklizumab beta je primijenjen supkutano u dvotjednim dozama od 10-200 mg/kg.
English: Zinbryta is contraindicated in patients with a history of severe hypersensitivity (e.g. anaphylaxis or anaphylactoid reactions) to all forms of daclizumab or to any of the excipients in Zinbryta (see section
Croatian: Zinbryta je kontraindicirana u bolesnika s anamnezom teške preosjetljivosti (npr. anafilaksija ili anafilaktoidna rekcija) na sve oblike daklizumaba ili na neku od pomoćnih tvari u Zinbryti (vidjeti dio
English: • If some areas are too difficult for you to reach, ask a carer who has been trained to
Croatian: • Ako Vam je teško doprijeti do nekih područja, zamolite za pomoć njegovatelja koji je prošao obuku kako bi Vam mogao pomoći.
English: Daclizumab beta modulates IL-2 signalling by blocking CD25dependent, high-affinity IL-2 receptor signalling, resulting in higher levels of IL-2 available for signalling through the intermediate-affinity IL-2 receptor.
Croatian: Daklizumab beta modulira signaliziranje IL-2 blokiranjem signaliziranja putem receptora visokog afiniteta za IL-2 ovisnog o CD25, što dovodi do viših razina IL-2 na raspolaganju za signaliziranje putem receptora intermedijarnog afiniteta za IL-2.