FrancophonIA/ELRC3.0 huggingface dataset:
English: Its exact mechanism of action is unknown, but it attaches to several receptors on the surface of nerve cells in the brain.
Croatian: Njegov točan mehanizam djelovanja nije poznat, ali poznato je da se veže na nekoliko receptora na površini živčanih stanica u mozgu.
English: The full EPAR for Abilify Maintena can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Abilify Maintena nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: In one main study involving adults whose disease had already been stabilised on treatment with aripiprazole taken by mouth, 22 out of the 265 patients (8.3%) treated with Abilify Maintena had symptoms coming back within 26 weeks, compared with 21 out of 266 (7.9%) patients treated with aripiprazole taken by mouth.
Croatian: U glavnom ispitivanju koje je uključivalo odrasle bolesnike čija je bolest već stabilizirana peroralnim aripiprazolom, 22 od 265 bolesnika (8,3 %) liječenih lijekom Abilify Maintena imali su povrat simptoma unutar 26 tjedana u usporedbi s 21 od 266 bolesnika (7,9 %) liječenih oralnim aripiprazolom.
English: Schizophrenia is a mental illness with a number of symptoms, including disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (false beliefs).
Croatian: Shizofrenija je mentalna bolest koja se očituje nizom simptoma, uključujući neorganizirano razmišljanje i govor, halucinacije (bolesnici čuju ili vide nešto čega nema), sumnje i iluzije (pogrešna vjerovanja).
English: This disrupts signals transmitted between brain cells by ‘neurotransmitters', chemicals that allow nerve cells to communicate with each other.
Croatian: To prekida signale koje između moždanih stanica prenose „neurotransmiteri”, kemikalije koje omogućavaju međusobnu komunikaciju živčanih stanica.
English: After the first injection, daily treatment with 10 to 20 mg aripiprazole by mouth should be continued for 2 weeks.
Croatian: Nakon prve injekcije moguće je nastaviti dnevnu terapiju od 10 do 20 mg peroralnog aripiprazola tijekom 2 tjedna.
English: Abilify Maintena aripiprazole
Croatian: Abilify Maintena aripiprazol
English: The dose may also need to be lowered in patients who are taking certain other medicines that slow the breakdown of aripiprazole in the body.
Croatian: Doza se također može smanjiti kod bolesnika koji uzimaju određene druge lijekove koji usporavaju razgradnju aripiprazola u tijelu.
English: Abilify Maintena is available as a powder (300 mg and 400 mg) and solvent to be made into a prolonged-release suspension for injection.
Croatian: Abilify Maintena dostupan je u obliku praška (300 mg i 400 mg) kao i otapala za pripravu suspenzije za injekciju s produljenim oslobađanjem.
English: Aripiprazole is thought to act mainly by being a ‘partial agonist' for 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 most common side effects with Abilify Maintena (which may affect 5 or more people in 100) are increased weight, akathisia (a constant urge to move), insomnia (difficulty sleeping) and injection site pain.
Croatian: Najčešće nuspojave lijeka Abilify Maintena (koje mogu zahvatiti 5 ili više osoba na uzorku od 100 osoba) jesu povećana tjelesna težina, akatizija (neprekidna potreba za kretanjem), insomnija (poteškoće sa spavanjem) i bol na mjestu injekcije.
English: Since dopamine and 5hydroxytryptamine are involved in schizophrenia, aripiprazole helps to normalise the activity of the brain, reducing psychotic symptoms and preventing them from returning.
Croatian: S obzirom na to da su dopamin i 5-hidroksitriptamin uključeni u shizofreniju, aripiprazol pomaže u normalizaciji moždane aktivnosti smanjujući psihotičke simptome i sprečavajući njihov povratak.
English: This means that aripiprazole acts like dopamine and 5-hydroxytryptamine by activating these receptors, but less strongly than the neurotransmitters.
Croatian: To znači da aripiprazol djeluje kao dopamin i 5-hidroksitriptamin aktivacijom ovih receptora, ali manje snažno od neurotransmitera.
English: This is a summary of the European public assessment report (EPAR) for Abilify Maintena.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Abilify Maintena.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Abilify Maintena on 15 November 2013.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Abilify Maintena na snazi u Europskoj uniji od 15. studenog 2013.
English: It is used for the maintenance treatment of schizophrenia in adults whose disease has already been stabilised on treatment with aripiprazole taken by mouth.
Croatian: Koristi se za terapiju održavanja kod odraslih bolesnika sa shizofrenijom čija je bolest već stabilizirana na terapiji peroralnim aripiprazolom.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Abilify Maintena's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji odlučio je da koristi od lijeka Abilify Maintena nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za korištenje u Europskoj uniji.
English: What is Abilify Maintena and what is it used for?
Croatian: Što je Abilify Maintena i za što se koristi?
English: It is not intended to provide practical advice on how to use Abilify Maintena.
Croatian: Svrha sažetka nije davati praktične savjete o načinu korištenja lijeka Abilify Maintena.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Abilify Maintena, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi za lijek Abilify Maintena nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: Treatment beyond 2 weeks with medicines that speed up the breakdown of aripiprazole should be avoided.
Croatian: Mora se izbjegavati liječenje duže od 2 tjedna lijekovima koji usporavaju razgradnju aripiprazola u tijelu.
English: What measures are being taken to ensure the safe and effective use of Abilify Maintena?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Abilify Maintena?
English: The medicine is given once a month by slow injection into the buttock or deltoid (shoulder) muscle by a doctor or nurse.
Croatian: Liječnik ili medicinska sestra daju lijek jednom mjesečno sporom injekcijom u mišić stražnjice ili deltoidno područje (rame).
English: The CHMP noted that Abilify Maintena is as effective as aripiprazole taken by mouth, and has a similar safety profile with the exception of injection pain, which was considered manageable.
Croatian: CHMP je napomenuo da je lijek Abilify Maintena jednako djelotvoran i kao peroralni aripiprazol te da ima sličan profil sigurnosti uz iznimku boli kod injektiranja što se smatra rješivim problemom.
English: Other information about Abilify Maintena
Croatian: Ostale informacije o lijeku Abilify Maintena
English: Why is Abilify Maintena approved?
Croatian: Zašto je Abilify Maintena odobren?
English: A risk management plan has been developed to ensure that Abilify Maintena is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Abilify Maintena.
English: For more information about treatment with Abilify Maintena, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Abilify Maintena pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: The active substance in Abilify Maintena, aripiprazole, is an antipsychotic medicine.
Croatian: Djelatna tvar lijeka Abilify Maintena, aripiprazol, je antipsihotik.
English: Abilify Maintena is a medicine that contains the active substance aripiprazole.
Croatian: Abilify Maintena je lijek koji sadrži djelatnu tvar aripiprazol.
English: What are the risks associated with Abilify Maintena?
Croatian: Koji su rizici povezani s lijekom Abilify Maintena?
English: Abilify Maintena was shown to be as effective as aripiprazole taken by mouth at preventing symptoms of schizophrenia from returning.
Croatian: Dokazano je da je Abilify Maintena jednako djelotvoran i kao peroralni aripiprazol u sprječavanju povratka simptoma shizofrenije.
English: For practical information about using Abilify Maintena, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju lijeka Abilify Maintena pročitajte u uputi o lijeku, odnosno obratite se svom liječniku ili ljekarniku.
English: For the full list of all side effects reported with Abilify Maintena, see the package leaflet.
Croatian: Potpuni popis svih nuspojava zabilježenih pri primjeni lijeka Abilify Maintena potražite u uputi o lijeku.
English: How is Abilify Maintena used?
Croatian: Kako se Abilify Maintena koristi?
English: What benefits of Abilify Maintena have been shown in studies?
Croatian: Koje su koristi lijeka Abilify Maintena utvrđene u ispitivanjima?
English: How does Abilify Maintena work?
Croatian: Kako djeluje Abilify Maintena?
English: This summary was last updated in 09/2014.
Croatian: Sažetak je posljednji put obnovljen u 09.2014.
English: Other information about Fortacin
Croatian: Druge informacije o Fortacin
English: Doses should not be repeated more frequently than every 4 hours, and no more than three doses should be used in 24 hours.
Croatian: Doze se ne smiju ponavljati češće od svaka 4 sata te se u 24 sata ne smije primijeniti više od tri doze.
English: What is Fortacin and what is it used for?
Croatian: Što je Fortacin i za što se koristi?
English: A risk management plan has been developed to ensure that Fortacin is used as safely as possible.
Croatian: Razvijen je plan upravljanja rizikom kako bi se osiguralo da se Fortacin koristi što je sigurnije moguće.
English: The full EPAR for Fortacin can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjelovito Europsko javno izvješće o ocjeni dokumentacije o lijeku (EPAR) za Fortacin može se naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It is not intended to provide practical advice on how to use Fortacin.
Croatian: Svrha sažetka nije davati praktične savjete o načinu korištenja Fortacin.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Fortacin on 15 November 2013.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje za Fortacin vrijedi na prostoru Europske unije od 15. studenog 2013.
English: This reduces sensitivity to stimulation, helping to increase the time taken to ejaculate.
Croatian: To smanjuje osjetljivost na stimulaciju te pomaže u povećanju vremena koje je potrebno da bi se postigla ejakulacija.
English: Some patients were monitored for up to 9 months in an extension of the initial studies and continued to show similar benefit.
Croatian: Neki bolesnici praćeni su do 9 mjeseci kao produžetak početnih ispitivanja te su nastavili iskazivati sličnu korist od liječenje.
English: Why is Fortacin approved?
Croatian: Zašto je Fortacin odobren?
English: This is a summary of the European public assessment report (EPAR) for Fortacin.
Croatian: Ovo je sažetak Europskoga javnog izvješća o ocjeni (EPAR) za Fortacin.
English: What measures are being taken to ensure the safe and effective use of Fortacin?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Fortacin?
English: It is used to treat men with primary (lifelong) premature ejaculation (when ejaculation regularly occurs before, or too early during, penetration).
Croatian: Koristi se za liječenje muškaraca s primarnom (doživotnom) preuranjenom ejakulacijom (kad se ejakulacija redovito događa prije ili prerano tijekom penetracije).
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Croatian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom uspoređivala su lijek sa sprejem placeba tijekom 12 tjedana.
English: Fortacin must also not be used in patients whose partners are hypersensitive to these substances.
Croatian: Fortacin ne smije se koristiti u bolesnika čiji su partneri preosjetljivi na te tvari.
English: What are the risks associated with Fortacin?
Croatian: Koji su rizici povezani s Fortacin?
English: Fortacin lidocaine / prilocaine
Croatian: Lidokain/prilokain
English: In the first study, the average time to ejaculation in patients treated with Fortacin was 2.6 minutes, compared with 0.8 minutes in those using placebo; in the second study, average ejaculation time in patients using the medicine was 3.8 minutes compared with 1.1 minutes in the placebo group.
Croatian: U prvom ispitivanju prosječno vrijeme do ejakulacije u bolesnika liječenih s Fortacin iznosilo je 2,6 minuta u usporedbi s osam minuta u onih koji su primali placebo; u drugom ispitivanju prosječno vrijeme ejakulacije u bolesnika koji su primali lijek iznosilo je 3,8 minuta u usporedbi sa 1,1 minute u skupini koja je primala placebo.
English: The most common side effects with Fortacin (which may affect up to 1 in 10 people) are hypoaesthesia (reduced sensation) and a burning sensation in the genital area in both men and their female sexual partners, and erectile dysfunction (inability to maintain a normal erection) in men.
Croatian: Najčešće nuspojave s Fortacin (koje mogu zahvatiti do 1 na 10 osoba) su hipoestezija (smanjen prag senzacije) i osjećaj žarenja u području genitalija i kod muških i kod ženskih seksualnih partnera te erektilna disfunkcija (nesposobnost održavanja normalne erekcije) u muškaraca.
English: Fortacin can only be obtained with a prescription and is available as a spray-on solution that supplies 7.5 mg of lidocaine and 2.5 mg of prilocaine per spray.
Croatian: Fortacin može se dobiti samo na recept i dostupan je kao otopina, sprej za kožu koja sadrži 7,5 mg lidokaina i 2,5 mg prilokaina po spreju.
English: There were positive psychological benefits to patients and their partners, and side effects were local and generally manageable.
Croatian: Zabilježene su pozitivne fiziološke koristi za bolesnike i njihove partnere, a nuspojave su bile lokalne i općenito su ih bolesnici dobro podnosili.
English: The recommended dose is three sprays onto the head (glans) of the penis before intercourse.
Croatian: Preporučena doza je tri spreja na glavić penisa prije snošaja.
English: The active substances in the medicine, lidocaine and prilocaine, are local anaesthetics that temporarily numb the contact area by reversibly blocking the transmission of signals in the nerves.
Croatian: Djelatne tvari u lijeku, lidokain i prilokain su lokalni anestetici koji privremeno otupljuju područje kontakta reverzibilnom blokadom transmisije signala u živcima.
English: Fortacin must not be used in patients who are hypersensitive (allergic) to any of the ingredients of the medicine or to other local anaesthetics with a structure related to the active ingredients (amide-type local anaesthetics).
Croatian: Fortacin ne smije se koristiti u bolesnika koji su preosjetljivi (alergični) na bilo koji sastojak lijeka ili na druge lokalne anestetike sa strukturom sličnom strukturi djelatnih sastojaka (lokalni anestetici amidnog tipa).
English: The main measures of effectiveness were the time taken to ejaculate after penetration and the amount of control over ejaculation, sexual satisfaction and distress reported by the patients.
Croatian: Glavne mjere djelotvornosti bile su vrijeme potrebno za ejakulaciju nakon penetracije i količina kontrole nad ejakulacijom, seksualno zadovoljstvo i distres koji su prijavili bolesnici.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Fortacin, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju ovog plana sigurnosne informacije uključene su u Sažetak opisa svojstava lijeka i Uputu o lijeku za Fortacin uključujući i odgovarajuće mjere opreza kojih se trebaju pridržavati zdravstveni djelatnici i bolesnici.
English: What benefits of Fortacin have been shown in studies?
Croatian: Koje koristi lijeka Fortacin su dokazane u ispitivanjima?
English: Fortacin is a medicine containing the active substances lidocaine and prilocaine.
Croatian: Fortacin je lijek koji sadrži djelatne tvari lidokain i prilokain.
English: How is Fortacin used?
Croatian: Kako se koristi Fortacin?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) considered that the active ingredients are a well-known local anaesthetic combination, and the use of a local spray minimises the amount of active substance absorbed and hence the risk of side effects affecting the body as a whole.
Croatian: Povjerenstvo Agencije za lijekove za primjenu kod ljudi (CHMP) smatralo je da su djelatne tvari dobro poznata kombinacija anestetika i da uporaba lokalnog spreja smanjuje apsorbiranu količinu djelatne tvari te na taj način i nuspojave koje zahvaćaju cijelo tijelo.
English: In both studies, patients given the medicine reported substantially greater improvements in reported control, sexual satisfaction and distress than patients given the placebo.
Croatian: U oba ispitivanja bolesnici koji su primili lijek prijavili su znatno veća poboljšanja u zabilježenoj kontroli, seksualnom zadovoljstvu i distresu od bolesnika koji su primali placebo.
English: For more information about treatment with Fortacin, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju s Fortacin pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: For practical information about using Fortacin, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju Fortacin bolesnici trebaju pročitati u uputi o lijeku ili se obratiti svom liječniku ili ljekarniku.
English: The CHMP therefore decided that Fortacin's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Povjerenstvo za lijekove za primjenu kod ljudi (CHMP) pri Agenciji odlučilo je da koristi od Fortacin nadmašuju s njim povezane rizike te je preporučila njegovo odobrenje za korištenje u Europskoj uniji
English: The effectiveness of Fortacin has been shown in two main studies involving a total of 256 and 300 heterosexual adult men with premature ejaculation, respectively; both studies compared the medicine with a placebo (dummy) spray over 12 weeks.
Croatian: Djelotvornost lijeka Fortacin dokazana je u dva glavna ispitivanja koja su uključivala ukupno 256 odnosno 300 heteroseksualnih odraslih muškaraca s preranom ejakulacijom; oba ispitivanja
English: How does Fortacin work?
Croatian: Kako Fortacin djeluje?
English: For the full list of all side effects reported with Fortacin, see the package leaflet.
Croatian: Potpuni popis nuspojava koje su zabilježene s Fortacin potražite u uputi o lijeku.
English: 21months
Croatian: 21 mjeseci
English: Always take these capsules exactly as your doctor has told you.
Croatian: Uvijek uzmite ove kapsule točno onako kako Vam je rekao Vaš liječnik.
English: Adults (18 years and over in age)
Croatian: Odrasle osobe (u dobi od 18 i više godina)
English: Each bottle contains 56 capsules.
Croatian: Svaka boca sadrži 56 kapsula.
English: Do not take a double dose to make up for a forgotten capsule.
Croatian: Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu kapsulu.
English: This leaflet was last revised in xxx <Other sources of information>
Croatian: Ova je uputa zadnji put revidirana u xxx <Drugi izvori informacija>
English: • Patients receiving repeated blood transfusions.
Croatian: • Bolesnici koji primaju ponovljene transfuzije krvi.
English: NN: {number}>
Croatian: NN: {broj} >
English: Absorption and elimination
Croatian: Apsorpcija i eliminacija
English: Do not use this medicine for more than 45 days after first opening the bottle.
Croatian: Ne upotrebljavajte ovaj lijek nakon 45 dana od prvog otvaranja boce.
English: No dose adjustment is needed in elderly patients
Croatian: Prilagodba doze nije potrebna u starijih bolesnika.
English: Treatment duration will depend on the severity of iron deficiency but generally at least 12-weeks treatment is required.
Croatian: Trajanje liječenja ovisi o težini manjka željeza, no uglavnom je potrebno liječenje u trajanju od najmanje 12 tjedana.
English: Supportive and symptomatic measures reflecting best standard medical care should be implemented.
Croatian: Potrebno je provesti suportivne i simptomatske mjere u skladu s najboljim standardima medicinske skrbi.
English: The vomit and stools may be grey or black.
Croatian: Izbljuvak i stolica mogu biti sive ili crne boje.
English: No data are available (see section 4.4).
Croatian: Nema dostupnih podataka (vidjeti dio 4.4).
English: No clinical studies are available to date.
Croatian: Do sada nisu bila dostupna klinička ispitivanja o tome.
English: Make sure that you take this leaflet and any remaining capsules with you to show to the doctor.
Croatian: Pobrinite se da sa sobom uzmete ove upute o lijeku i preostale kapsule kako biste ih pokazali liječniku.
English: Swallow the capsules whole.
Croatian: Progutajte cijelu kapsulu.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 18 February 2016
Croatian: Datum prvog odobrenja: 18. veljače 2016.
English: You should leave at least 2 hours between taking Feraccru and taking:
Croatian: Morate ostaviti najmanje dva sata razmaka između uzimanja Feraccrua i:
English: Low iron causes anaemia (too few red blood cells).
Croatian: Niska razina željeza uzrokuje anemiju (premalo crvenih krvnih stanica).
English: Shelf-life after first opening container: 45 days.
Croatian: Rok valjanosti nakon prvog otvaranja spremnika: 45 dana.
English: If you are pregnant or breast-feeding, think you may be pregnant or planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku ili ljekarniku za savjet prije nego uzmete ovaj lijek.
English: A possible potential genotoxic potential for maltol could not be fully ruled out.
Croatian: Mogući potencijalni genotoksični potencijal za maltol nije moguće u potpunosti isključiti.
English: • Supplements or medicines that contain magnesium or calcium.
Croatian: • nadomjestaka ili lijekova koji sadrže magnezij ili kalcij;
English: Red capsule (19 mm long x 7 mm diameter).
Croatian: Crvena kapsula (dugačka 19 mm x 7 mm promjera).
English: The results for the other key efficacy endpoints are shown in Table 2.
Croatian: Rezultati drugih ključnih mjera ishoda djelotvornosti prikazani su u tablici 2.
English: The recommended dose is one capsule (30 mg) taken twice a day, morning and evening.
Croatian: Preporučena doza je jedna kapsula (30 mg) dva puta dnevno, jedna ujutro i jedna navečer.
English: • Sodium laurilsulfate
Croatian: • Natrijev laurilsulfat
English: • Mycophenolate (used with other medicines to prevent the body rejecting transplanted organs).
Croatian: • mikofenolata (koji se upotrebljava s drugim lijekovima kako bi se spriječilo da tijelo odbaci presađene organe)