FrancophonIA/ELRC3.0 huggingface dataset:
English: In the clinical study in men 16 to 26 years, 98.9%, 99.2%, 98.8%, and 97.4% of individuals who received Silgard became anti-HPV 6, anti-HPV 11, anti-HPV 16, and anti-HPV 18 seropositive, respectively, by 1 month Postdose 3.
Croatian: U kliničkom ispitivanju u muškaraca u dobi od 16 do 26 godina, 98,9% postalo je seropozitivno na HPV 6, 99,2% na HPV 11, 98,8% na HPV 16 te 97,4% na HPV 18 mjesec dana nakon 3. doze.
English: The efficacy of Silgard against CIN (any grade) and CIN 2/3 or AIS caused by 10 non-vaccine HPV types (HPV 31, 33, 35, 39, 45, 51, 52, 56, 58, 59) structurally related to HPV 16 or HPV 18 was evaluated in the combined Phase III efficacy database (N = 17,599) after a median follow-up of 3.7 years (at end of study).
Croatian: Nakon medijana trajanja praćenja od 3,7 godine (na kraju ispitivanja), analizirani su objedinjeni podaci ispitivanja faze III (N = 17 599) u kojima je ispitana djelotvornost cjepiva Silgard protiv CIN-a (bez obzira na stupanj) i CIN-a 2/3 ili AIS-a uzrokovanih s 10 HPV tipova koji nisu sadržani u cjepivu (HPV 31, 33, 35, 39, 45, 51, 52, 56, 58, 59) strukturno povezanih s HPV-om 16 odnosno 18.
English: At the injection site: hematoma, pruritus Not known Asthenia*, chills*, fatigue*, malaise*
Croatian: Opći poremećaji i reakcije na vrlo često na mjestu injiciranja: eritem, bol, oticanje na mjestu injiciranja: hematom, pruritus nepoznato astenija*, zimica*, umor*, malaksalost*
English: In the PPE population, no cases of HPV diseases (HPV types 6/11/16/18 related CIN any grade and Genital Warts) were observed through 10.7 years (median
Croatian: U PPE populaciji nije bio opažen nijedan slučaj HPV bolesti (bilo koji stupanj CIN-a povezan s HPV tipovima 6/11/16/18 i genitalne bradavice) tijekom 10,7 godina (medijana praćenja od 10,0 godina).
English: No data
Croatian: N Broj slučajeva
English: 20 single doses, 0.5 ml pre-filled syringes with 2 needles each.
Croatian: 20 jednokratnih doza, napunjene štrcaljke od 0,5 ml svaka s 2 igle.
English: 1 dose, 0.5 ml pre-filled syringe without needle.
Croatian: 1 doza, napunjena štrcaljka od 0,5 ml bez igle.
English: 20 single doses, 0.5 ml pre-filled syringes with 1 needle each.
Croatian: 20 jednokratnih doza, napunjene štrcaljke od 0,5 ml svaka sa po 1 iglom.
English: The efficacy of Silgard against the combined incidence of HPV 16- or 18-related persistent infection, genital warts, vulvar and vaginal lesions, CIN of any grade, AIS, and cervical cancers was 84.7%
Croatian: Djelotvornost cjepiva Silgard s obzirom na kombiniranu incidenciju perzistentne infekcije, genitalnih bradavica, vulvarnih i vaginalnih lezija, CIN-a bilo kojeg stupnja, AIS-a i karcinoma vrata maternice povezanih s tipovima HPV-a 16 ili 18 iznosila je 84,7% (95% CI: 67,5; 93,7).
English: The median duration of follow-up for this study was 4.0 years.
Croatian: Medijan trajanja praćenja u ovom ispitivanju
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE
Croatian: Klasifikacija organskih sustava Učestalost
English: 10 single doses, 0.5 ml pre-filled syringes with 2 needles each.
Croatian: 10 jednokratnih doza, napunjene štrcaljke od 0,5 ml svaka s 2 igle.
English: 10 single doses, 0.5 ml pre-filled syringes with 1 needle each.
Croatian: 10 jednokratnih doza, napunjene štrcaljke od 0,5 ml svaka sa po 1 iglom.
English: EXPIRY DATE
Croatian: Tablični prikaz nuspojava
English: The efficacy of Silgard against the combined incidence of HPV 16- or 18-related persistent infection, genital warts, vulvar and vaginal lesions, CIN of any grade, AIS, and cervical cancers was 41.6%
Croatian: Djelotvornost cjepiva Silgard s obzirom na kombiniranu incidenciju perzistentne infekcije, genitalnih bradavica, vulvarnih i vaginalnih lezija, CIN-a bilo kojeg stupnja, AIS-a i karcinoma vrata maternice povezanih s HPV-om 16 ili 18 iznosila je 41,6% (95% CI: 24,3; 55,2).
English: • the efficacy of Silgard against HPV 6-, 11-, 16-, 18-related VIN2/3 and VaIN 2/3 was 100%
Croatian: • djelotvornost cjepiva Silgard protiv VIN-a 2/3 povezanog s HPV-om tipova 6, 11, 16 i 18 iznosila je 100% (95% CI: 67,2; 100) i za VaIN-a 2/3 povezanog s istim tipovima virusa 100%
English: • the efficacy of Silgard against HPV 6-, 11-, 16-, 18-related genital warts was 99.0% (95% CI:
Croatian: • djelotvornost cjepiva Silgard protiv genitalnih bradavica povezanih s HPV-om tipova 6, 11, 16 i 18 iznosila je 99,0% (95% CI: 96,2; 99,9).
English: On the basis of this immunogenicity bridging, the efficacy of Silgard in 9- to 15-year-old girls is
Croatian: Djelotvornost cjepiva Silgard u djevojčica u dobi od 9 do 15 godina pokazana je na temelju ove ekstenzije podataka imunogenosti.
English: Note: point estimates and confidence intervals are adjusted for person-time of follow-up.
Croatian: Bolesnici su bili praćeni do 4 godine (medijan 3,6 godina) Napomena: Točke procjene i intervali pouzdanosti prilagođeni su osobi-vremenu praćenja.
English: Among women with an abnormal Pap test at Day 1 who were already infected with the relevant vaccine HPV types at Day 1, no vaccine efficacy was
Croatian: Nije zamijećeno zaštitno djelovanje cjepiva među ženama s patološkim nalazima Papa testa prvoga dana ispitivanja koje su pri ulasku u ispitivanje već bile inficirane odgovarajućim tipovima HPV-a sadržanim u cjepivu.
English: N Number of cases HPV 6/11/16/18-related external genital lesions
Croatian: N Broj slučajeva vanjske genitalne lezije povezane s HPV-om tipova 6/11/16/18 Vanjske genitalne lezije 1394 Genitalne bradavice 1394 PIN 1/2/3
English: Respiratory, thoracic and mediastinal disorders: Very rare: bronchospasm.
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja:
English: Tel: +386 1 5204 201 msd.slovenia@merck.com
Croatian: Merck Sharp & Dohme, inovativna zdravila d.o.o. Tel: +386 1 5204 201 msd.slovenia@merck.com
English: The name of the medicine was changed to Trevicta on 26 May 2016.
Croatian: Naziv lijeka promijenjen je u Trevicta 26. svibnja 2016.
English: This gives the medicine a long duration of action.
Croatian: To omogućuje dugo djelovanje lijeka.
English: 1 Previously known as Paliperidone Janssen.
Croatian: 1 Prethodno poznat pod nazivom Paliperidone Janssen.
English: The full EPAR and risk management plan summary for Trevicta can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR kao i sažetak plana upravljanja rizikom za lijek Trevicta nalaze 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 Xeplion in 2011 (‘informed consent').
Croatian: Odobrenje se temeljilo na odobrenju izdanom za lijek Xeplion 2011. godine („informirani pristanak”).
English: Trevicta is available as a prolonged-release suspension for injection in pre-filled syringes (175 mg, 263 mg, 350 mg and 525 mg).
Croatian: Lijek Trevicta dostupan je u obliku suspenzije za injekciju s produljenim otpuštanjem u napunjenim štrcaljkama (od 175 mg, 263 mg, 350 mg i 525 mg).
English: The symptoms of schizophrenia include disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (false beliefs).
Croatian: Simptomi shizofrenije su neorganizirano razmišljanje i govor, halucinacije (bolesnici čuju ili vide nešto čega nema), sumnjičavost i deluzije (pogrešna vjerovanja).
English: Trevicta paliperidone
Croatian: paliperidon
English: It is not intended to provide practical advice on how to use Trevicta.
Croatian: Svrha sažetka nije davati praktične savjete o načinu korištenja lijeka Trevicta.
English: This disrupts signals transmitted between brain cells by ‘neurotransmitters', substances that nerve cells use to communicate with neighbouring cells.
Croatian: To ometa signale koje prenose „neurotransmiteri” između moždanih stanica, tvari kojima se živčane stanice koriste radi komunikacije sa susjednim stanicama.
English: What is Trevicta and what is it used for?
Croatian: Što je Trevicta i za što se koristi?
English: Other information about Trevicta
Croatian: Ostale informacije o lijeku Trevicta
English: What measures are being taken to ensure the safe and effective use of Trevicta?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Trevicta?
English: This is a summary of the European public assessment report (EPAR) for Trevicta.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Trevicta.
English: Trevicta is given by a healthcare professional.
Croatian: Lijek Trevicta daje zdravstveni djelatnik.
English: Paliperidone acts mainly by blocking the receptors for the neurotransmitters dopamine and 5hydroxytryptamine (also called serotonin).
Croatian: Paliperidon djeluje uglavnom tako da onemogućuje djelovanje receptora za neurotransmitere dopamin i 5-hidroksitriptamin (također poznat pod nazivom serotonin).
English: In the brain, paliperidone attaches to several different receptors on the surface of nerve cells.
Croatian: Paliperidon se u mozgu veže na nekoliko različitih receptora na površini živčanih stanica.
English: The Committee therefore decided that Trevicta's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: Odbor je stoga odlučio da koristi od lijeka Trevicta nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
English: By blocking these receptors, paliperidone helps to normalise the activity of the brain and reduce symptoms of the disease.
Croatian: Onemogućivanjem djelovanja tih receptora, paliperidon pomaže u normalizaciji moždane aktivnosti i ublažavanju simptoma bolesti.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Paliperidone Janssen on 5 December 2014.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Paliperidone Janssen na snazi u Europskoj uniji od 5. prosinca 2014.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) noted that paliperidone injections are effective in treating schizophrenia symptoms.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji ocijenio je da su injekcije paliperidona djelotvorne u liječenju simptoma shizofrenije.
English: The most common side effects with Trevicta (seen in at least 5 in 100 patients) are insomnia (difficulty sleeping), headache, anxiety, upper respiratory tract infections (such as colds), reactions at the site of injection and increased weight.
Croatian: Najčešće su nuspojave lijeka Trevicta (zabilježene u najmanje 5 na 100 bolesnika) nesanica (teškoće sa spavanjem), glavobolja, anksioznost, infekcije gornjeg respiratornog trakta (poput prehlade), reakcije na mjestu injekcije i povećanje tjelesne težine.
English: A risk management plan has been developed to ensure that Trevicta is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Trevicta.
English: In the second study (in 305 patients) Trevicta was more effective than placebo (a dummy treatment), with 9% of patients given the medicine suffering a relapse of their condition compared with 29% of those on placebo.
Croatian: U drugom ispitivanju (koje je uključivalo 305 bolesnika), lijek Trevicta pokazao se djelotvornijim od placeba (prividno liječenje), pri čemu je u 9 % bolesnika koji su primili lijek došlo do relapsa bolesti u usporedbi s 29 % u bolesnika koji su primili placebo.
English: Two studies have been conducted with Trevicta given every 3 months.
Croatian: Provedena su dva ispitivanja lijeka Trevicta u kojima se lijek davao svaka tri mjeseca.
English: What are the risks associated with Trevicta?
Croatian: Koji su rizici povezani s lijekom Trevicta?
English: Why is Trevicta approved?
Croatian: Zašto je lijek Trevicta odobren?
English: It is given every 3 months by slow injection into the upper part of the shoulder (deltoid muscle) or the buttocks.
Croatian: Lijek se daje svaka tri mjeseca polaganim ubrizgavanjem u gornji dio ramena (deltoidni mišić) ili u stražnjicu.
English: The dose of Trevicta is 3.5 times the dose of the monthly injections of paliperidone the patient was previously receiving.
Croatian: Doza lijeka Trevicta je 3,5 puta veća od mjesečne doze injekcija paliperidona koju je bolesnik prethodno primao.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Trevicta, 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 o lijeku za lijek Trevicta nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: Paliperidone has been authorised in the European Union (EU) as Invega since 2007 for use by mouth to treat schizophrenia.
Croatian: Paliperidon je odobren u Europskoj uniji (EU) od 2007. pod nazivom Invega za peroralnu primjenu u liječenju shizofrenije.
English: Paliperidone is an active breakdown product (metabolite) of risperidone, another antipsychotic medicine that has been used in the treatment of schizophrenia since the 1990s.
Croatian: Paliperidon je aktivan proizvod razgradnje (metabolit) risperidona, drugog antipsihotika koji se koristio za liječenje shizofrenije od 1990-ih.
English: The active substance in this medicine, paliperidone, is an antipsychotic medicine.
Croatian: Djelatna tvar ovog lijeka, paliperidon, je antipsihotik.
English: Trevicta must not be given to people who are hypersensitive (allergic) to paliperidone or any of the other ingredients, or to risperidone.
Croatian: Lijek Trevicta ne smije se davati osobama koje su preosjetljive (alergične) na paliperidon ili bilo koji drugi sastojak lijeka ili risperidon.
English: Because paliperidone for use by monthly injections has already been authorised in the EU as Xeplion, the company also used data from Xeplion to support the use of Trevicta.
Croatian: Budući da je primjena paliperidona u injekcijama koje se daju na mjesečnoj osnovi već odobrena u EU-u u obliku lijeka Xeplion, tvrtka je, kako bi dokazala korist od primjene lijeka Trevicta, koristila i podatke o lijeku Xeplion.
English: It has also been authorised as Xeplion since 2011 for use by monthly injections for the maintenance treatment of schizophrenia.
Croatian: Odobren je i pod nazivom Xeplion od 2011., i to za primjenu u injekcijama za terapiju održavanja u liječenju shizofrenije koje se daju na mjesečnoj osnovi.
English: Prolonged-release means that the active substance, paliperidone, is released slowly over a few months after being injected.
Croatian: „Produljeno otpuštanje” znači da se djelatna tvar paliperidon otpušta polako tijekom nekoliko mjeseci nakon injiciranja.
English: Trevicta is an antipsychotic medicine used for the maintenance treatment of schizophrenia in adults whose disease has been stable on treatment with once-monthly injections of paliperidone.
Croatian: Trevicta je antipsihotik koji se primjenjuje u terapiji održavanja u liječenju shizofrenije u odraslih osoba čija je bolest stabilizirana putem liječenja injekcijama paliperidona koje se daju jedanput mjesečno.
English: Trevicta, which is given by injection every 3 months, is more effective than placebo and as effective as paliperidone monthly injection in preventing relapses of schizophrenia.
Croatian: Lijek Trevicta, koji se daje injekcijom svaka tri mjeseca, djelotvorniji je od placeba i jednako je djelotvoran kao mjesečne injekcije paliperidona u sprječavanju relapsa shizofrenije.
English: For more information on the use of Trevicta, see the summary of product characteristics (also part of the EPAR).
Croatian: Za dodatne informacije o korištenju lijeka Trevicta pogledajte sažetak opisa svojstava lijeka (također dio EPAR-a).
English: How is Trevicta used?
Croatian: Kako se Trevicta koristi?
English: What benefits of Trevicta have been shown in studies?
Croatian: Koje su koristi lijeka Trevicta utvrđene u ispitivanjima?
English: Trevicta contains the active substance paliperidone.
Croatian: Lijek Trevicta sadrži djelatnu tvar paliperidon.
English: For more information about treatment with Trevicta, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Trevicta pročitajte u uputi o lijeku (također dio EPAR-a), ili se obratite svom liječniku ili ljekarniku.
English: In Trevicta as in Xeplion, paliperidone has been attached to a fatty acid that allows it to be released slowly after being injected.
Croatian: U lijekovima Trevicta i Xeplion paliperidon se vezivao na masnu kiselinu koja omogućuje polagano otpuštanje nakon injiciranja.
English: How does Trevicta work?
Croatian: Kako djeluje Trevicta?
English: In one of them (involving 1,016 patients) Trevicta was as effective as paliperidone monthly injections in preventing relapses of schizophrenia.
Croatian: U jednom od tih ispitivanja (koje je uključivalo 1 016 bolesnika), lijek Trevicta pokazao se jednako djelotvornim kao i mjesečne injekcije paliperidona u sprječavanju relapsa shizofrenije.
English: For practical information about using Trevicta, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju lijeka Trevicta pročitajte u uputi o lijeku, odnosno obratite se svom liječniku ili ljekarniku.
English: For the full list of all side effects reported with Trevicta, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Trevicta potražite u uputi o lijeku.
English: The 3-monthly injection is expected to be more convenient to patients and improve their adherence to treatment, and no new safety concerns were raised with this formulation compared with the known safety profile of paliperidone.
Croatian: Isto tako, nisu se pojavili novi razlozi za zabrinutost u vezi s ovom formulacijom, u usporedbi s već poznatim sigurnosnim profilom paliperidona.
English: Do not take more than this dose.
Croatian: Nemojte uzimati više od ove doze.
English: OTHER Do not open before use.
Croatian: Ne otvarati prije upotrebe.
English: Probability of survival (%)
Croatian: Vjerojatnost preživljenja (%)
English: Results will be provided on a yearly basis.
Croatian: Rezultati će se predavati jednom godišnje.
English: Component of a multipack, cannot be sold separately.
Croatian: Dio višestrukog pakiranja, ne može se odvojeno prodavati.
English: This medicine has not been studied in children or adolescents and is therefore not to be taken by children and adolescents below the age of 18 years.
Croatian: Ovaj lijek nije ispitan u djece i adolescenata te ga stoga djeca i adolescenti mlađi od 18 godina ne smiju uzimati.
English: It is important to take this medicine every day, as long as your doctor prescribes it for you.
Croatian: Važno je da uzimate ovaj lijek svakog dana sve dok ga Vam Vaš liječnik propisuje.
English: Interaction studies have only been performed in adults.
Croatian: Ispitivanja interakcija provedena su samo na odraslim osobama.
English: Primary PFS analysis performed when 713
Croatian: Primarna analiza PFS provedena je kada je uočen 713.
English: Your doctor will discuss the results of these tests with you and decide whether you can be given Vargatef.
Croatian: Vaš liječnik će s Vama raspraviti rezultate ovih pretraga i odlučiti može li Vam se dati Vargatef.
English: The overall recovery was considered complete (above 90 %) within 4 days after dosing.
Croatian: Cjelokupno izlučivanje smatralo se potpunim (iznad 90 %) unutar 4 dana nakon doziranja.
English: The recommended maximum daily dose of 400 mg should not be exceeded.
Croatian: Preporučena maksimalna dnevna doza od 400 mg ne smije se prekoračiti.
English: Do not take this medicine during pregnancy, as it can harm your unborn baby and cause birth defects.
Croatian: Ne uzimajte ovaj lijek tijekom trudnoće, jer može naštetiti Vašem nerođenom djetetu i prouzročiti urođene defekte.
English: Based on this information your doctor may carry out some blood tests, for example to check your liver function and to determine how fast your blood can clot.
Croatian: Na temelju ovih informacija Vaš liječnik može provesti krvne pretrage, primjerice da provjeri funkciju jetre i utvrdi koliko se brzo Vaša krv može zgrušati.
English: This medicine can interact with certain other medicines.
Croatian: Ovaj lijek može imati interakcije s nekim drugim lijekovima.
English: In the overall population, 72.7 % of the patients were male.
Croatian: U ukupnoj populaciji 72,7 % bolesnika bili su muškog spola.
English: Race and body weight
Croatian: Rasa i tjelesna težina
English: Date of latest renewal: 26 August 2019
Croatian: Datum posljednje obnove odobrenja: 26, kolovoza 2019.
English: The age range covered by the analysis was 29 to 85 years; approximately 5 % of the population were older than 75 years.
Croatian: Raspon dobi pokriven ovom analizom iznosio je 29 do 85 godina; približno 5 % populacije bilo je starije od 75 godina.
English: The safety and efficacy of Vargatef in children aged 0-18 years have not been established.
Croatian: Sigurnost i djelotvornost Vargatefa u djece u dobi od 0 do 18 godina nisu još ustanovljene.
English: If you are allergic to peanut or soya, do not use this medicine.
Croatian: Ako ste alergični na kikiriki ili soju, nemojte koristiti ovaj lijek.
English: The disease stage was determined at the time of diagnosis using Union Internationale Contre le Cancer (UICC) / American Joint Committee on Cancer (AJCC) Edition 6 or Edition 7.
Croatian: Stadij bolesti bio je određen u vrijeme dijagnoze pomoću Union Internationale Contre le Cancer (UICC)/American Joint Committee on Cancer (AJCC) izdanja 6 ili izdanja 7.
English: There were no imbalances of respiratory or fatal bleedings and no intracerebral bleeding was reported.
Croatian: Nije bilo pojave neravnoteža respiratornih ili smrtonosnih krvarenja, i nije prijavljeno intracerebralno krvarenje.
English: Take your next dose of Vargatef as planned at the next scheduled time and at the dose recommended by your doctor or pharmacist.
Croatian: Uzmite sljedeću dozu Vargatefa kao što je planirano u sljedeće predviđeno vrijeme i u dozi koju je preporučio Vaš liječnik ili ljekarnik.
English: Your doctor will decide when to resume your treatment with this medicine - if you have cancer that has spread to the brain
Croatian: Vaš liječnik će odlučiti kada nastaviti Vaše liječenje ovim lijekom - ako imate rak koji se proširio na mozak
English: Number of Deaths or Progressions, n (%) Median PFS [months]
Croatian: Broj smrti ili progresija, n (%) Medijan PFS [mjeseci]
English: DCE-MRI effects were seen 24 - 48 h after the first intake of the medicinal product and were preserved or even increased after continuous treatment over several weeks.
Croatian: Učinci DCE-MRI bili su viđeni 24 - 48 h nakon prvog unosa lijeka i bili su očuvani ili čak povećani nakon kontinuiranog liječenja tijekom nekoliko tjedana.
English: It is recommended to take the capsules with food, i.e. during or immediately before or after a meal.
Croatian: Preporučeno je uzeti kapsule s hranom, tj. tijekom ili neposredno prije ili nakon obroka.
English: If you do not take this medicine as prescribed by your doctor, this cancer treatment may not work properly.
Croatian: Ako ne uzmete ovaj lijek kao što Vam je propisao Vaš liječnik, ovo liječenje raka možda neće ispravno djelovati.
English: These two doses should be taken at around the same time each day.
Croatian: Ove dvije doze potrebno je uzimati svakog dana u približno isto vrijeme.
English: No. of patients at risk
Croatian: Broj bolesnika pod rizikom
English: Effect on QT interval
Croatian: Učinak na interval QT
English: However, such patients should be closely monitored for signs and symptoms of cerebral bleeding.
Croatian: Ipak, takve bolesnike se mora pažljivo nadzirati radi znakova i simptoma cerebralnog krvarenja.
English: Swallow the capsules whole with water and do not chew or crush them.
Croatian: Progutajte kapsule cijele s vodom i nemojte ih žvakati ili drobiti.