FrancophonIA/ELRC3.0 huggingface dataset:
English: Reporting suspected adverse reactions after authorisation of the medicinal product is important.
Croatian: Nakon dobivanja odobrenja lijeka važno je prijavljivanje sumnji na nuspojave.
English: Rare side effects (may affect up to 1 in 1000 people): - Loss of appetite, increased appetite - Abnormal behaviour, confusional state, depressed mood, excitability, feelings of emotional and mental discomfort, feeling of seeing or hearing things that are not really there when you sleep - Loss of consciousness, tension headache, , trouble of the memory, poor sleep quality - Abdominal discomfort, difficulty or pain in swallowing, flatulence, inflammation of the digestive tract - Infection of the skin, abnormally high sensitivity to sunlight - Neck pain, chest pain - Spontaneous abortion - Pain, night sweats, sense of oppression
Croatian: Rijetke nuspojave (mogu se javiti u do 1 na 1000 osoba) - gubitak apetita, povećani apetit - abnormalno ponašanje, stanje smetenosti, depresivno raspoloženje, uzbuđenost, osjećaj emocionalne i mentalne nelagode, priviđanje stvari koje ne postoje ili umišljanje zvukova koji ne postoje tijekom sna - gubitak svijesti, tenzijska glavobolja, problemi s pamćenjem, loša kvaliteta sna - nelagoda u trbuhu, otežano ili bolno gutanje, vjetrovi, upala probavnog sustava - infekcija kože, abnormalna preosjetljivost na sunčevo svjetlo - bol u vratu, bol u prsištu - spontani pobačaj
English: Asthenia Chest Pain Feeling Abnormal Malaise Oedema Peripheral oedema
Croatian: Astenija Bol u prsištu Abnormalno osjećanje Malaksalost Edem Periferni edem
English: Figure 1: Changes in Epworth Sleepiness Scale Score (ESS) (mean ± SEM) from Baseline to week 8 in Harmony 1 study
Croatian: Slika 1: Promjene rezultata na Epworthovoj ljestvici pospanosti (ESS) (srednja vrijednost ± standardna pogreška) od početka do 8. tjedna u ispitivanju Harmony 1
English: Erythema Pruritus Rash Hyperhidrosis Sweating
Croatian: Eritem Svrbež Osip Hiperhidroza Znojenje
English: Figure 2: Changes in weekly cataplexy episodes (geometric mean) from Baseline to week 7 in Harmony CTP study
Croatian: Slika 2: Promjene učestalosti tjednih epizoda katapleksije (geometrijska sredina) od početka do 7. tjedna u ispitivanju Harmony CTP
English: Agitation Hallucination Hallucination visual, auditory Affect lability Abnormal dreams Dyssomnia Middle insomnia Initial insomnia Terminal insomnia Nervousness Tension Apathy Nightmare Restlessness Panic Attack Libido decreased Libido increased
Croatian: Agitacija Halucinacije Vizualne i auditivne halucinacije Labilnost afekta Abnormalni snovi Disomnija Nesanica s buđenjem tijekom noći Nesanica s otežanim usnivanjem Nesanica s ranim buđenjem Nervoza Napetost Apatija Noćne more Nemir Napadaj panike Smanjenje libida Povećanje libida
English: Visual acuity reduced Blepharospasm
Croatian: Smanjena oštrina vida Blefarospazam
English: How to store Wakix
Croatian: Kako čuvati Wakix
English: Uncommon side effects (may affect up to 1 in 100 people): - Sweating - Decrease or increase of appetite - Oedema - Feeling jittery, nervousness, seeing or hearing things that are not really there - Changing emotions - Abnormal dreams - Tension - Difficulty in falling asleep at the beginning of the night or in the middle of the night or at the end of the night, difficulty in staying asleep, excessive sleepiness, somnolence - State of indifference with lack of emotion - Nightmare - Feeling restless and unable to keep still - Panic reaction - Altered or increased sexual interest - Sudden and transient episode of muscle weakness, uncontrollable muscle spasms or movement of one leg - Disturbance in attention - Migraine - Epilepsy - Weakness - Movement disturbance, slow body movement - Sensation of tingling, tickling, pricking, or burning of the skin - Sudden and unpredictable phases of mobility and immobility - Feeling unsteady - Reduced visual acuity, abnormal contraction or twitch of the eyelid - Hearing of sound when no external sound is present - Abnormal heart beat, slow or fast heart rate, raised or decrease blood pressure , hot flush - Yawning - Dry mouth - Diarrhoea, abdominal pain, discomfort or pain in the belly (abdomen), constipation, heartburn,
Croatian: Manje česte nuspojave (mogu se javiti u do 1 na 100 osoba) - znojenje - smanjenje ili povećanje apetita - edem - uznemirenost, nervoza, vidite ili čujete stvari koje nisu stvarne - promjenjivi osjećaji - abnormalni snovi - napetost - poteškoće s usnivanjem na početku noći ili usred noći ili na kraju noći, poteškoće pri održavanju sna, pretjerana pospanost, izrazita pospanost - stanje ravnodušnosti uz nedostatak emocija - noćne more - osjećaj nemira i nemogućnost mirovanja - panična reakcija - izmijenjen ili povećani seksualni interes - iznenadna i prolazna epizoda mišićne slabosti, nekontroliranih mišićnih grčeva ili pokreta jedne noge - poremećaj pažnje - migrena - epilepsija - slabost - poremećaj kretanja, sporo kretanje tijela - osjećaj mravinjanja, škakljanja, bockanja ili peckanja kože - iznenadne i nepredvidive faze pokretljivosti i nepokretljivosti - osjećaj nestabilnosti - smanjena oštrina vida, abnormalne kontrakcije ili trzaji kapka - čujete zvukove, iako ne postoje vanjski zvukovi - abnormalni otkucaji srca, usporeni ili ubrzani otkucaji srca, povišen ili snižen krvni tlak, navala vrućine - zijevanje - suha usta - proljev, bol u trbuhu, nelagoda ili bol u trbuhu (abdomen), zatvor, žgaravica, bol i nelagoda u želucu, gastritis, pretjerana kiselost probavnog sustava - svrbež, poremećaji kože lica uz neuobičajeno crvenilo na području nosa i obraza, pretjerano znojenje - bol u zglobovima, bol u leđima, ukočenost mišića, slabost mišića, bol u mišićima i kostima, bol u nožnim prstima i prstima - abnormalno mokrenje - neredovita krvarenja iz maternice - gubitak snage ili izraziti umor, bol u prsištu, malaksalost, edem - povećanje težine, smanjenje težine, abnormalna očitavanja (EKG) srca, abnormalne krvne vrijednost povezane s funkcijom jetre.
English: Pitolisant induces CYP3A4, CYP1A2 and CYP2B6 in vitro.
Croatian: Pitolizant in vitro inducira CYP3A4, CYP1A2 i CYP2B6.
English: The combination of pitolisant with substrates of CYP3A4 and having a narrow therapeutic margin should be avoided (see section 4.5).
Croatian: Treba izbjegavati kombiniranje pitolizanta i supstrata CYP3A4 te onih s uskom terapijskom širinom (vidjeti dio 4.5).
English: Arthralgia Back pain Muscle rigidity Muscular weakness Musculoskeletal pain Myalgia Pain in extremity
Croatian: Artralgija Bol u leđima Ukočenost mišića Slabost mišića Mišićno-koštani bol Mialgija Bol u ekstremiteta
English: Talk to your doctor before taking Wakix if any of the situations mentioned below apply to you:
Croatian: Obratite se svom liječniku prije nego što uzmete Wakix ako se bilo koja od sljedećih situacija odnosi na Vas: - ako ste ikada patili od tjeskobe ili depresije sa suicidalnim mislima.
English: Abnormal behaviour Confusional state Depressed mood Excitability Obsessive thoughts Dysphoria Hypnopompic hallucination Depressive symptom Hypnagogic hallucination Mental impairment
Croatian: Opsesivne misli Disforija Hipnopompne halucinacije Simptomi depresije Hipnagogne halucinacije Mentalno oštećenje
English: Figure 3: Changes in Epworth Sleepiness Scale Score (ESS) (mean ± SEM) from Baseline to week 7 in Harmony CTP study
Croatian: Slika 3: Promjene rezultata Epworthove ljestvice pospanosti (ESS) (srednja vrijednost ± standardna pogreška) od početka do 7. tjedna u ispitivanju Harmony CTP
English: Weight increased Weight decreased Hepatic enzymes increased
Croatian: Povećanje tjelesne težine Smanjenje tjelesne težine
English: The active substance is pitolisant.
Croatian: Djelatna tvar je pitolizant.
English: Nutrition disorders
Croatian: Poremećaji prehrane
English: On liver microsomes, pitolisant and its major metabolites do not significantly inhibit the activities of the cytochromes CYP1A2, CYP2C9, CYP2C19, CYP2C8, CYP2B6, CYP2E1 or CYP3A4 and of uridine diphosphate glucuronosyl transferases isoforms UGT1A1, UGT1A4, UGT1A6, UGT1A9 and UGT2B7 up to the concentration of 13.3 µM, a level considerably higher than the levels achieved with therapeutic dose.
Croatian: ‑difosfat‑glukuroniltransferaze UGT1A1, UGT1A4, UGT1A6, UGT1A9 i UGT2B7 do koncentracije od 13,3 µM, razine koja je znatno viša od razina koje se postižu terapijskom dozom.
English: What you need to know before you take Wakix
Croatian: Što je Wakix i za što se koristi Što morate znati prije nego počnete uzimati Wakix Kako uzimati Wakix
English: Bioprojet Pharma contact@bioprojet.com
Croatian: Pharma contact@bioprojet.com
English: Wakix 18 mg comes in a white, round, film-coated tablet of 7.5 mm, biconvex marked with “20” on one side.
Croatian: Wakix od 18 mg je bijela, okrugla, filmom obložena bikonveksna tableta od 7,5 mm, s oznakom “20” na jednoj strani.
English: No dosage adjustment is required in patients with mild hepatic impairment.
Croatian: U bolesnika s blagim oštećenjem jetre nije potrebna prilagodba doze.
English: At baseline, the geometric mean of WRC was 7.31 (median=6.5 [4.5; 12]) and 9.15 (median=8.5 [5.5; 15.5]) in the placebo and pitolisant groups respectively.
Croatian: Na početku liječenja, geometrijska sredina WRC-a iznosila je 7,31 (medijan=6,5 [4,5; 12]) za placebo i 9,15 (medijan=8,5 [5,5; 15,5]) za pitolizant.
English: Wakix 4.5 mg comes in a white, round, film-coated tablet of 3.7 mm, biconvex marked with “5” on one side.
Croatian: Wakix od 4,5 mg je bijela, okrugla, filmom obložena bikonveksna tableta od 3,7 mm, s oznakom “5” na jednoj strani.
English: Wakix 18 mg film-coated tablet
Croatian: Wakix 18 mg filmom obložena tableta
English: White, round, biconvex film-coated tablet, 3.7 mm diameter, marked with “5” on one side.
Croatian: Bijela, okrugla, bikonveksna filmom obložena tableta, promjera 3,7 mm, s oznakom “5” na jednoj strani.
English: Tri or tetracyclic antidepressants (e.g. imipramine, clomipramine, mirtazapine) may impair the efficacy of pitolisant because they display histamine H1-receptor antagonist activity and possibly cancel the effect of endogenous histamine released in brain by the treatment.
Croatian: Triciklični ili tetraciklični antidepresivi (npr. imipramin, klomipramin, mirtazapin) mogu smanjiti djelotvornost pitolizanta, jer pokazuju aktivnost antagonista
English: Pitolisant/metabolites were shown to cross the placenta barrier in animals.
Croatian: Utvrđeno je da u životinja pitolizant/metaboliti prolaze kroz posteljicu.
English: - Have severe liver problems, as pitolisant is normally broken down in the liver and excess levels may build up in patients whose liver function is severely reduced.
Croatian: - ako ste alergični na pitolizant ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.). - ako imate teške probleme s jetrom, budući da se pitolizant obično razgrađuje u jetri, pa bi u bolesnika s izrazito smanjenom funkcijom jetre moglo doći do nakupljanja prekomjernih razina.
English: In the pitolisant group, ESS decreased significantly between baseline and the end of treatment compared to placebo with an observed mean change of -1.9 ± 4.3 and -5.4 ± 4.3 (mean ± sd) for placebo and pitolisant respectively, (p<0.0001) (Figure 3).
Croatian: U skupini koja je primala pitolizant, ESS se značajno smanjio od početka do kraja liječenja u odnosu na skupinu koja je primala placebo, uz opaženu srednju vrijednost promjene od -1,9 ± 4,3 za placebo
English: White, round, biconvex film-coated tablet, 7.5 mm diameter marked with “20” on one side.
Croatian: Bijela, okrugla, bikonveksna filmom obložena tableta, promjera 7,5 mm, s oznakom “20” na jednoj strani.
English: Wakix 18 mg film-coated tablets Pitolisant
Croatian: Wakix 18 mg filmom obložene tablete pitolizant
English: Wakix 4.5 mg film-coated tablets Wakix 18 mg film-coated tablets
Croatian: Wakix 4,5 mg filmom obložene tablete Wakix 18 mg filmom obložene tablete
English: Wakix 4.5 mg film-coated tablet
Croatian: Wakix 4,5 mg filmom obložena tableta
English: Each film-coated tablet of Wakix 4.5 mg contains 5 mg of pitolisant hydrochloride, equivalent to 4.45 mg of pitolisant.
Croatian: Svaka filmom obložena tableta Wakixa od 4,5 mg sadrži 5 mg pitolizantklorida što odgovara 4,45 mg pitolizanta.
English: Wakix 4.5 mg film-coated tablet Each tablet contains 5 mg of pitolisant hydrochloride equivalent to 4.45 mg of pitolisant.
Croatian: Wakix 4,5 mg filmom obložena tableta Svaka tableta sadrži 5 mg pitolizantklorida što odgovara 4,45 mg pitolizanta.
English: Wakix 18 mg film-coated tablet Each tablet contains 20 mg of pitolisant hydrochloride equivalent to 17.8 mg of pitolisant.
Croatian: Wakix 18 mg filmom obložena tableta Svaka tableta sadrži 20 mg pitolizantklorida što odgovara 17,8 mg pitolizanta.
English: Wakix 18 mg tablet Each tablet contains 20 mg of pitolisant hydrochloride, equivalent to 17.8 mg of pitolisant.
Croatian: Wakix 18 mg tableta Svaka tableta sadrži 20 mg pitolizantklorida što odgovara 17,8 mg pitolizanta.
English: Vascular disorders
Croatian: Spori metabolizatori
English: Each film-coated tablet of Wakix 18 mg contains 20 mg of pitolisant hydrochloride equivalent to 17.8 mg of pitolisant.
Croatian: Svaka filmom obložena tableta Wakixa od 18 mg sadrži 20 mg pitolizantklorida što odgovara 17,8 mg pitolizanta.
English: Marketing Autorisation Holder
Croatian: Nositelj odobrenja za stavljanje lijeka u promet
English: Wakix 4.5 mg tablet Each tablet contains 5 mg of pitolisant hydrochloride, equivalent to 4.45 mg of pitolisant
Croatian: Wakix 4,5 mg tableta Svaka tableta sadrži 5 mg pitolizantklorida što odgovara 4,45 mg pitolizanta.
English: Wakix 4.5 mg film-coated tablets Wakix 18 mg film-coated tablets Pitolisant
Croatian: Wakix 4,5 mg filmom obložene tablete Wakix 18 mg filmom obložene tablete pitolizant
English: Wakix 4.5 mg film-coated tablets Pitolisant
Croatian: Wakix 4,5 mg filmom obložene tablete pitolizant
English: The study design was similar to study Harmony I except that the maximum dose for pitolisant reached by 75% of patients was 18 mg once a day instead of 36 mg in Harmony I. As an important unbalance led to comparison of results with or without cluster grouping of sites, the most conservative approach showed non-significant ESS score decrease with pitolisant compared to placebo (pitolisant-placebo=-1.94 with p=0.065).
Croatian: Dizajn ispitivanja je bio sličan onom u ispitivanju Harmony I, osim što je maksimalna doza pitolizanta koju je doseglo 75 % bolesnika iznosila 18 mg jednom dnevno, dok je u ispitivanju Harmony I ta doza iznosila 36 mg.
English: Coating
Croatian: Zijevanje
English: Polska
Croatian: Polakizurija
English: B. PACKAGE LEAFLET
Croatian: Malta Bioprojet
English: Dry mouth Abdominal pain Diarrhoea Abdominal discomfort Abdominal pain upper Constipation
Croatian: Suha usta Bol u abdomenu Proljev Nelagoda u abdomenu Bol u gornjem dijelu abdomena Zatvor Gastroezofagealna refluksna bolest Gastritis Bol u probavnom sustavu Hiperaciditet
English: Microcrystalline cellulose Crospovidone type A Talc
Croatian: Jezgra tablete celuloza, mikrokristalična krospovidon, vrsta A talk magnezijev stearat silicijev dioksid, koloidni, bezvodni
English: Neck pain Musculoskeletal chest pain
Croatian: Placebo Pitolizant Modafinil
English: What Wakix contains
Croatian: Sadržaj pakiranja i druge informacije Što Wakix sadrži
English: Its effect may improve further for up to six months.
Croatian: Njegov učinak može se dodatno poboljšati tijekom sljedećih šest mjeseci.
English: The medicine usually starts to have an effect after four to six weeks.
Croatian: Djelovanje lijeka obično započinje nakon četiri do šest tjedana.
English: This summary was last updated in 04-2015.
Croatian: Ovaj sažetak je posljednji put ažuriran: 04.2015.
English: The applicant presented data on experimental models from the scientific literature.
Croatian: Podnositelj zahtjeva dostavio je podatke o eksperimentalnim modelima iz znanstvene literature.
English: It is available as white round tablets (10 and 20 mg).
Croatian: Dostupan je u obliku tableta (10 i 20 mg).
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Leflunomide ratiopharm.
Croatian: Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet i svoje preporuke za uporabu lijeka Leflunomide ratiopharm.
English: This means that Leflunomide ratiopharm is similar to a ‘reference medicine' already authorised in the European Union (EU) called Arava.
Croatian: To znači da je Leflunomide ratiopharm sličan „referentnom lijeku” koji je već odobren u Europskoj uniji (EU) pod nazivom Arava.
English: Leflunomide ratiopharm treatment starts with a ‘loading dose' of 100 mg once a day for three days, followed by a maintenance dose.
Croatian: Liječenje lijekom Leflunomide ratiopharm obično započinje „udarnom dozom” od 100 mg na dan jednom dnevno tijekom tri dana, nakon čega slijedi doza održavanja.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Leflunomide ratiopharm on 29 November 2010.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Leflunomide ratiopharm na snazi u Europskoj uniji od 29. studenog 2010.
English: Leflunomide ratiopharm is used to treat adults with active rheumatoid arthritis (an immune system disease causing inflammation of the joints) or active psoriatic arthritis (a disease causing red, scaly patches on the skin and inflammation of the joints).
Croatian: Leflunomide ratiopharm koristi se za liječenje odraslih bolesnika s aktivnim reumatoidnim artritisom (bolest imunološkog sustava koja uzrokuje upalu zglobova) ili aktivnim psorijatičnim artritisom (bolest koja uzrokuje crvene, ljuskave mrljaste naslage na koži i upalu zglobova).
English: Leflunomide does this by blocking an enzyme called ‘dihydroorotate dehydrogenase', which is necessary for the lymphocytes to multiply.
Croatian: Leflunomid to čini blokadom enzima zvanog „dihidroorotat dehidrogenaza” koji je potreban za razmnožavanje limfocita.
English: Therefore, the CHMP's view was that, as for Arava, the benefit outweighs the identified risk.
Croatian: Stoga je stav CHMP-a da kao i kod lijeka Arava koristi nadmašuju utvrđene rizike.
English: The doctor should carry out blood tests to check the patient's liver, white blood cell counts and platelet counts before prescribing Leflunomide ratiopharm, and regularly during treatment.
Croatian: Liječnik treba provesti krvne pretrage kako bi provjerio bolesnikova jetra, broj leukocita i trombocita prije propisivanja lijeka Leflunomide ratiopharm te redovito tijekom liječenja.
English: Leflunomide ratiopharm treatment should be started and supervised by a specialist who has experience in the treatment of rheumatoid arthritis and psoriatic arthritis.
Croatian: Liječenje lijekom Leflunomide ratiopharm treba započeti i nadzirati specijalist iskusan u liječenju reumatoidnog artritisa i psorijatičnog artritisa.
English: This is a summary of the European public assessment report (EPAR) for Leflunomide ratiopharm.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Leflunomide ratiopharm.
English: Leflunomide ratiopharm leflunomide
Croatian: Leflunomide ratiopharm leflunomid
English: Leflunomide ratiopharm is a ‘generic medicine'.
Croatian: Leflunomide ratiopharm je "generički lijek".
English: Because Leflunomide ratiopharm is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as the reference medicine's.
Croatian: Budući da je Leflunomide ratiopharm generički lijek te je bioekvivalentan referentnom lijeku, smatra se da su njegove koristi i rizici isti kao i kod referentnog lijeka.
English: The full EPAR for Leflunomide ratiopharm can be searched for on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Cjeloviti EPAR za lijek Leflunomide ratiopharm nalazi se na internetskim stranicama Agencije ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports Više informacija o terapiji lijekom Leflunomide ratiopharm pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: The CHMP concluded that, in accordance with EU requirements, Leflunomide ratiopharm has been shown to have comparable quality and to be bioequivalent to Arava.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji zaključio je da je u skladu sa zahtjevima EU-a, potvrđeno kako Leflunomide ratiopharm posjeduje usporedivu kvalitetu te je bioekvivalentan s lijekom Arava.
English: Because Leflunomide ratiopharm is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Arava.
Croatian: Budući da je Leflunomide ratiopharm generički lijek, ispitivanja na bolesnicima bila su ograničena na ispitivanja za utvrđivanje njegove bioekvivalentnosti referentnom lijeku Arava.
English: The active substance in Leflunomide ratiopharm, leflunomide, is an immunosuppressant.
Croatian: Djelatna tvar u lijeku Leflunomide ratiopharm, leflunomid je imunosupresiv.
English: Leflunomide ratiopharm is a medicine that contains the active substance leflunomide.
Croatian: Leflunomide ratiopharm je lijek koji sadrži djelatnu tvar leflunomid.
English: What are the benefits and risks of Leflunomide ratiopharm?
Croatian: Koje su koristi i rizici od lijeka Leflunomide ratiopharm?
English: Other information about Leflunomide ratiopharm
Croatian: Ostale informacije o lijeku Leflunomide ratiopharm
English: Why has Leflunomide ratiopharm been approved?
Croatian: Zašto je Leflunomide ratiopharm odobren?
English: The Committee recommended that Leflunomide ratiopharm be given marketing authorisation.
Croatian: Odbor preporučuje odobrenje lijeka Leflunomide ratiopharm za korištenje u EU-u.
English: How is Leflunomide ratiopharm used?
Croatian: Kako se Leflunomide ratiopharm koristi?
English: How has Leflunomide ratiopharm been studied?
Croatian: Kako je Leflunomide ratiopharm ispitivan?
English: What is Leflunomide ratiopharm used for?
Croatian: Za što se Leflunomide ratiopharm koristi?
English: What is Leflunomide ratiopharm?
Croatian: Što je Leflunomide ratiopharm?
English: How does Leflunomide ratiopharm work?
Croatian: Kako djeluje Leflunomide ratiopharm?
English: The name of the medicine was changed to Adcirca on 21 October 2009.
Croatian: Naziv lijeka promijenjen je u Adcirca 21. listopada 2009.
English: The full EPAR for Adcirca can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Adcirca nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This authorisation was based on the authorisation granted to Cialis in 2002 (‘informed consent').
Croatian: Odobrenje se temeljilo na odobrenju danom cjepivu Cialis 2002. godine („informirani pristanak”).
English: Adcirca is taken as two tablets (40 mg) once a day, with or without food.
Croatian: Adcirca se uzima kao dvije tablete (40 mg) jednom na dan, sa ili bez hrane.
English: tadalafil
Croatian: Adcirca tadalafil
English: Adcirca was more effective than placebo at improving exercise capacity.
Croatian: Adcirca je bila djelotvornija od placeba u poboljšavanju kapaciteta vježbanja.
English: Before treatment, the patients could walk an average of 343 metres in six minutes.
Croatian: Prije terapije, bolesnici su mogli hodati prosječno 343 metra u šest minuta.
English: What is Adcirca?
Croatian: Što je Adcirca?
English: Previously known as Tadalafil Lilly.
Croatian: Prethodno poznat pod nazivom Tadalafil Lilly.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom necessary depending on the patient's response.
Croatian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom