FrancophonIA/ELRC3.0 huggingface dataset:
English: Sildenafil Teva is available in blister packs of 2, 4, 8 and 12 tablets, and perforated unit dose blisters containing 10 x 1 tablet.
Croatian: Sildenafil Teva dostupan je u blisterima od 2, 4, 8 i 12 tableta, te u perforiranim blisterima djeljivim na jedinične doze koji sadrže 10 x 1 tabletu.
English: Sildenafil Teva is available in blister packs of 2, 4, 8, 12 and 24 tablets, and perforated unit dose blisters containing 10 x 1 tablet.
Croatian: Sildenafil Teva dostupan je u blisterima od 2,4, 8, 12 i 24 tableta, te u perforiranim blisterima djeljivim na jedinične doze koji sadrže 10 x 1 tabletu.
English: Sildenafil Teva 25 mg film-coated tablets Sildenafil Teva 50 mg film-coated tablets Sildenafil Teva 100 mg film-coated tablets
Croatian: Sildenafil Teva 25 mg filmom obložene tablete Sildenafil Teva 50 mg filmom obložene tablete Sildenafil Teva 100 mg filmom obložene tablete
English: The European Medicines Agency has waived the obligation to submit the results of studies with Sildenafil Teva in all subsets of the paediatric population for the treatment of erectile dysfunction.
Croatian: Pedijatrijska populacija Europska Agencija za lijekove se odrekla obaveze da prijavljuje rezultate studija s lijekom Sildenafil
English: In the event of a medical emergency, you should tell your doctor, pharmacist or nurse that you have taken Sildenafil Teva and when you did.
Croatian: ljekarnika ili medicinsku sestru da ste uzeli Sildenafil Teva te kada ste ga uzeli.
English: Sudden cardiac death,*
Croatian: Poremećaj suzenja očiju***,
English: In a specific interaction study, where sildenafil (100 mg) was co-administered with amlodipine in hypertensive patients, there was an additional reduction on supine systolic blood pressure of 8 mmHg.
Croatian: primjenjivao istodobno s amlodipinom u bolesnika s hipertenzijom, došlo je do dodatnog sniženja sistoličkog krvnog tlaka u ležećem položaju od 8 mmHg.
English: Sildenafil Teva 100 mg film-coated tablets PVC/Aluminium blisters in cartons of 2, 4, 8, 12 or 24 tablets.
Croatian: Sildenafil Teva 100 mg filmom obložene tablete Blisteri od PVC/aluminija u kutijama sa 2, 4, 8, 12 ili 24 tablete.
English: Maximum observed plasma concentrations are reached within 30 to 120 minutes (median 60 minutes) of oral dosing in the fasted state.
Croatian: 120 minuta (medijan 60 minuta) od oralnog doziranja natašte.
English: 10 x 1 tablet in PVC/Aluminium perforated unit dose blisters.
Croatian: Perforirani blisteri djeljivi na jedinične doze od PVC/aluminija koji sadrže 10 x 1 tabletu.
English: − If you are using any of the medicines known as nitric oxide donors such as amyl nitrite (“poppers”), as the combination may also lead to a dangerous fall in your blood pressure.
Croatian: • Ako uzimate bilo koje od lijekova poznatih kao donori dušikovog oksida poput amil nitrita, jer kombinacija također može dovesti do opasnog pada krvnog tlaka.
English: Sildenafil Teva 50 mg film-coated tablets PVC/Aluminium blisters in cartons of 2, 4, 8, 12 or 24 tablets.
Croatian: Sildenafil Teva 50 mg filmom obložene tablete Blisteri od PVC/aluminija u kutijama sa 2, 4, 8, 12 ili 24 tablete.
English: Sildenafil Teva 25 mg film-coated tablets PVC/Aluminium blisters in cartons of 2, 4, 8 or 12 tablets.
Croatian: Sildenafil Teva 25 mg filmom obložene tablete Blisteri od PVC/aluminija u kutijama sa 2,4, 8 ili 12 tableta.
English: Lacrimation disorders***, Eye pain, Photophobia, Photopsia, Ocular hyperaemia, Visual brightness, Conjunctivitis
Croatian: bol u oku, fotofobija, fotopsija, kromatopsija, hiperemija oka,
English: With the exception of ritonavir for which co-administration with sildenafil is not advised (see section 4.4) a starting dose of 25 mg should be considered in patients receiving concomitant treatment with CYP3A4 inhibitors (see section 4.5).
Croatian: u bolesnika koji se istodobno liječe CYP3A4 inhibitorima potrebno je razmotriti primjenu početne doze od 25 mg (vidjeti dio 4.5).
English: In a small size placebo-controlled study of patients with documented early age-related macular degeneration (n=9), sildenafil (single dose, 100 mg) demonstrated no significant changes in the visual tests conducted (visual acuity, Amsler grid, colour discrimination simulated traffic light, Humphrey perimeter and photostress).
Croatian: (jednokratna doza, 100 mg) nije prikazao značajne promjene u provedenim testovima vida (oštrina vida, Amslerova mreža, raspoznavanje boja simulacijom semafora, Humphreyev perimetar i fotostres).
English: Sildenafil Teva 25 mg are white, oval-shaped film-coated tablets, engraved with ‘S 25' on one side, and plain on the other side.
Croatian: Sildenafil Teva 25 mg su bijele, ovalne filmom obložene tablete, s oznakom “S 25” na jednoj strani, te bez oznaka na drugoj strani.
English: resulted in a 49.8% increase in bosentan AUC and a 42% increase in bosentan Cmax (125 mg b.i.d.
Croatian: U zdravih muških dobrovoljaca, sildenafil je u stanju dinamičke ravnoteže (80 mg tri puta na dan) rezultirao sa 49,8%-tnim povećanjem AUC bosentana i 42%-tnim povećanjem Cmax bosentana (125
English: Dizziness
Croatian: Gluhoća
English: Cases of non-arteritic anterior ischaemic optic neuropathy, a rare condition, have been reported spontaneously and in an observational study in connection with the intake of sildenafil and other PDE5 inhibitors (see section 4.8).
Croatian: Slučajevi nearteritične anteriorne ishemijske optičke neuropatije, rijetkog stanja, prijavljeni su spontano i u opservacijskom ispitivanju vezano uz uzimanje sildenafila i dugih
English: Sildenafil Teva 100 mg film-coated tablets Each tablet contains sildenafil citrate equivalent to 100 mg of sildenafil.
Croatian: Sildenafil Teva 100 mg filmom obložene tablete Svaka tableta sadrži sildenafilcitrat, što odgovara 100 mg sildenafila.
English: Rare (≥ 1/10,000 and <1/1,000)
Croatian: (≥ 1/10 000 do
English: You may find that Sildenafil Teva takes longer to work if you take it with a heavy meal.
Croatian: Ako uzmete Sildenafil Teva uz obilniji obrok, možda će proći više vremena do početka njegovog djelovanja.
English: Sildenafil Teva 100 mg are white, oval-shaped film-coated tablets, engraved with ‘S 100' on one side, and plain on the other side.
Croatian: Sildenafil Teva 100 mg su bijele, ovalne filmom obložene tablete, s oznakom “S 100” na jednoj strani te bez oznaka na drugoj strani.
English: Sildenafil Teva 25 mg film-coated tablets Each tablet contains sildenafil citrate equivalent to 25 mg of sildenafil.
Croatian: Sildenafil Teva 25 mg filmom obložene tablete Svaka tableta sadrži sildenafilcitrat, što odgovara 25 mg sildenafila.
English: Sildenafil Teva 50 mg are white, oval-shaped film-coated tablets, engraved with ‘S 50' on one side, and plain on the other side.
Croatian: Sildenafil Teva 50 mg su bijele, ovalne filmom obložene tablete, s oznakom s “S 50” na jednoj strani, te bez oznaka na drugoj strani.
English: Each tablet contains 25 mg of sildenafil (as the citrate salt).
Croatian: Svaka tableta sadrži 25 mg sildenafila (u obliku sildenafilcitrata).
English: Sildenafil (100 mg) did not affect the steady state pharmacokinetics of the HIV protease inhibitors, saquinavir and ritonavir, both of which are CYP3A4 substrates.
Croatian: Sildenafil (100 mg) nije utjecao na farmakokinetiku stanja dinamičke ravnoteže inhibitora HIV
English: Each tablet contains 100 mg of sildenafil (as the citrate salt).
Croatian: Svaka tableta sadrži 100 mg sildenafila (u obliku sildenafilcitrata).
English: Irritability
Croatian: Preosjetljivost
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER - Sildenafil Teva 25 mg Film-coated tablets
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTER - Sildenafil Teva 25 mg filmom obložene tablete
English: Read the package leaflet before use For oral use.
Croatian: Prije uporabe pročitajte uputu o lijeku.
English: Package leaflet: Information for the patient Sildenafil Teva 25 mg film-coated tablets
Croatian: Uputa o lijeku: Informacija za bolesnika Sildenafil Teva 25 mg filmom obložene tablete sildenafil
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - Sildenafil Teva 25 mg Film-coated tablets
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA - Sildenafil Teva 25 mg filmom obložene tablete
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER - Sildenafil Teva 100 mg Film-coated tablets
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTER - Sildenafil Teva 100 mg filmom obložene tablete
English: Each tablet contains 50 mg of sildenafil (as the citrate salt).
Croatian: Svaka tableta sadrži 50 mg sildenafila (u obliku sildenafilcitrata).
English: Deafness
Croatian: dispepsija
English: Sildenafil Teva 50 mg film-coated tablets Each tablet contains sildenafil citrate equivalent to 50 mg of sildenafil.
Croatian: Sildenafil Teva 50 mg filmom obložene tablete Svaka tableta sadrži sildenafilcitrat, što odgovara 50 mg sildenafila.
English: White, oval-shaped film-coated tablets, engraved with ‘S 25' on one side, and plain on the other side.
Croatian: Bijele, ovalne filmom obložene tablete, s oznakom “S 25” na jednoj strani, te bez oznaka na drugoj strani.
English: Package leaflet: Information for the patient Sildenafil Teva 100 mg film-coated tablets
Croatian: Uputa o lijeku: Informacija za bolesnika Sildenafil Teva 100 mg filmom obložene tablete sildenafil
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - Sildenafil Teva 100 mg Film-coated tablets
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA - Sildenafil Teva 100 mg filmom obložene tablete
English: White, oval-shaped film-coated tablets, engraved with ‘S 100' on one side, and plain on the other side.
Croatian: Bijele, ovalne filmom obložene tablete, s oznakom “S 100” na jednoj strani, te bez oznaka na drugoj strani.
English: Sildenafil Teva 25 mg film-coated tablets sildenafil
Croatian: Sildenafil Teva 25 mg filmom obložene tablete sildenafil
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER - Sildenafil Teva 50 mg Film-coated tablets
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTER - Sildenafil Teva 50 mg filmom obložene tablete
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - Sildenafil Teva 50 mg Film-coated tablets
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA - Sildenafil Teva 50 mg filmom obložene tablete
English: Sildenafil Teva 100 mg film-coated tablets sildenafil
Croatian: Sildenafil Teva 100 mg filmom obložene tablete sildenafil
English: Package leaflet: Information for the patient Sildenafil Teva 50 mg film-coated tablets
Croatian: Uputa o lijeku: Informacija za bolesnika Sildenafil Teva 50 mg filmom obložene tablete sildenafil
English: Sildenafil Teva 25 mg film-coated tablets
Croatian: Sildenafil Teva 25 mg filmom obložene tablete
English: Sildenafil Teva 50 mg film-coated tablets sildenafil
Croatian: Sildenafil Teva 50 mg filmom obložene tablete sildenafil
English: • Seizures or fits - this occurs rarely
Croatian: • Napadaji - javljaju se rijetko
English: White, oval-shaped film-coated tablets, engraved with ‘S 50' on one side, and plain on the other side.
Croatian: Bijele, ovalne filmom obložene tablete, s oznakom “S 50” na jednoj strani, te bez oznaka na drugoj strani.
English: The most commonly reported adverse reactions in clinical studies among sildenafil treated patients were headache, flushing, dyspepsia, nasal congestion, dizziness, nausea, hot flush, visual disturbance, cyanopsia and.
Croatian: dispepsija, nazalna kongestija, omaglica, mučnina, navale vrućine, poremećaji vida, cijanopsija i zamagljen vid.
English: In volunteers with mild to moderate renal impairment (creatinine clearance = 30-80 mL/min), the pharmacokinetics of sildenafil were not altered after receiving a 50 mg single oral dose.
Croatian: nakon uzimanja jednokratne oralne doze od 50 mg nije bilo promjena u farmakokinetici sildenafila.
English: Throat tightness, Nasal oedema, Nasal dryness
Croatian: neuobičajena osjetljivost oka, edem kapka, diskoloracija bjeloočnice
English: Sildenafil Teva 100 mg film-coated tablets
Croatian: Sildenafil Teva 100 mg filmom obložene tablete
English: Sildenafil Teva 50 mg film-coated tablets
Croatian: Sildenafil Teva 50 mg filmom obložene tablete
English: Asthenopia, Vitreous floaters, Iris disorder, Mydriasis,
Croatian: midrijaza, svjetlosne aureole, edem oka, oticanje oka,
English: Sildenafil
Croatian: Sildenafil Teva.
English: Diplopia, Visual acuity reduced,
Croatian: glaukom, ispadi vidnog polja diplopija,
English: Each tablet contains sildenafil citrate equivalent to 25 mg of sildenafil
Croatian: Svaka tableta sadrži 25 mg sildenafila u obliku sildenafilcitrata.
English: Each tablet contains sildenafil citrate equivalent to 100 mg of sildenafil
Croatian: Svaka tableta sadrži 100 mg sildenafila u obliku sildenafilcitrata.
English: Each tablet contains sildenafil citrate equivalent to 50 mg of sildenafil
Croatian: Svaka tableta sadrži 50 mg sildenafila u obliku sildenafilcitrata.
English: Heart rate increased
Croatian: MATERIJALA KOJI POTJEČU
English: When a single 100 mg dose of sildenafil was administered with erythromycin, a moderate CYP3A4 inhibitor, at steady state (500 mg twice daily for 5 days), there was a 182 % increase in sildenafil systemic exposure (AUC).
Croatian: inhibitorom, u stanju dinamičke ravnoteže (500 mg dva puta dnevno tijekom 5 dana), uočen je 182%
English: STATEMENT OF ACTIVE SUBSTANCE(S)
Croatian: toksična epidermalna nekroliza (TEN) *
English: Chest pain, Fatigue, Feeling hot
Croatian: Razdražljivost mjestu primjene osjećaj vrućine
English: Gastrointestin al disorders
Croatian: Prijavljivanje nuspojava
English: Tabulated list of adverse reactions
Croatian: Opći poremećaji i reakcije na
English: ANNEX
Croatian: DODATAK
English: o Gastrointestinal: diarrhea, bloody stool, abdominal pain, nausea, or vomiting o Liver: yellowing of your skin or whites of your eyes o Skin: rash, blisters and/or peeling, mouth sores o Eye: blurred vision, vision changes, eye pain, o General: fever, headache, feeling tired, dizziness or fainting, dark urine, bleeding, weakness, numbness of legs, arms, or faces, changes in behavior, such as less sex drive, being irritable or forgetful
Croatian: o probavni sustav: proljev, krvava stolica, bol u trbuhu, mučnina ili povraćanje o jetra: žutilo kože ili bjeloočnica o koža: osip, mjehurići na koži i/ili ljuštenje kože, afte u ustima o oči: zamagljen vid, promjene vida, bol u očima o opći simptomi: vrućica, glavobolja, umor, omaglica ili nesvjestica, tamna boja mokraće, krvarenje, slabost, utrnulost nogu, ruku ili lica, promjene ponašanja poput slabljenja spolne želje, razdražljivosti ili zaboravljivosti.
English: The Member States shall ensure that the Marketing Authorisation Holder provides all physicians who are expected to prescribe YERVOY with the following:
Croatian: Zemlje članice će osigurati da Nositelj odobrenja svim liječnicima za koje se očekuje da će propisivati YERVOY dostavi:
English: • Information that ipilimumab can cause serious side effects in many parts of the body that can lead to death and need to be addressed immediately
Croatian: • Informacija o tome da ipilimumab može izazvati ozbiljne nuspojave u brojnim dijelovima tijela koje mogu imati smrtni ishod i moraju se odmah liječiti.
English: It also contains prompts to enter contact details of the physician and to alert other physicians that the patient is treated with ipilimumab.
Croatian: Ona sadrži i naputke da se zabilježe kontaktni podaci nadležnog liječnika te upozorenje drugim liječnicima da se bolesnik liječi ipilimumabom.
English: • Importance of evaluating liver function tests (LFTs), TSH and signs/symptoms of irARs before each treatment.
Croatian: • Važnost procjene rezultata testova jetrene funkcije, TSH-a i znakova/simptoma imunološki uzrokovanih nuspojava prije svake terapije.
English: The Card reminds patients about key symptoms that need to be reported immediately to the physician/nurse.
Croatian: Kartica podsjeća bolesnika na najvažnije simptome koje odmah mora prijaviti liječniku ili medicinskoj sestri.
English: • Request to inform the physician of all medical conditions before treatment.
Croatian: • Zahtjev bolesniku da prije liječenja obavijesti liječnika o svim medicinskim problemima.
English: • Description of the main symptoms of irARs and the importance of notifying their treating physician immediately if symptoms occur, persist or worsen.
Croatian: • Opis glavnih simptoma imunološki uzrokovanih nuspojava i naglašavanje da je važno da bolesnik odmah obavijesti nadležnog liječnika ako se simptomi pojave, ne prolaze ili se pogoršavaju.
English: • Follow-up of patients due to late onset (months after treatment) of irARs
Croatian: • Praćenje bolesnika zbog mogućeg kasnog nastupaimunološki uzrokovanih nuspojava (mjesecima nakon liječenja).
English: • List of important immune-related adverse reactions (irARs) and their symptoms, as outlined in section 4.4 of the Summary of Product Characteristics (SmPC): o Inflammation of the gastrointestinal tract, such as colitis, which can lead to bowel perforation o Inflammation of the liver, such as hepatitis, which can lead to liver failure o Inflammation of the skin that can lead to severe skin reaction (toxic epidermal necrolysis) o Inflammation of the nerves that can lead to neuropathy o Inflammation of the endocrine system.
Croatian: • Popis značajnih imunološki uzrokovanih nuspojava i njihovih simptoma, sukladno navodima u dijelu 4.4 Sažetka opisa svojstava lijeka: o upala gastrointestinalnog trakta, poput kolitisa, koja može dovesti do perforacije crijeva o upala jetre, poput hepatitisa, koja može izazvati zatajenje jetre o upala kože koja može izazvati ozbiljne kožne reakcije (toksična epidermalna nekroliza) o upala živaca koja može izazvati neuropatiju o upala u endokrinom sustavu, uključujući nadbubrežne žlijezde, hipofizu ili štitnjaču o upala očiju o druge imunološki uzrokovane nuspojave povezane s liječenjem (npr. pneumonitis,
English: • Information that ipilimumab can cause serious side effects in many parts of the body that can lead to death and require early intervention, as outlined in the guidelines for the management of immunerelated adverse reactions in section 4.4 of the SmPC.
Croatian: • Upozorenje da ipilimumab može izazvati ozbiljne nuspojave u brojnim dijelovima tijela koje mogu imati smrtni ishod i zahtijevaju brzu intervenciju, kako je opisano u smjernicama za liječenje imunološki uzrokovanih nuspojava u dijelu 4.4 Sažetka opisa svojstava lijeka.
English: The National Competent Authority shall agree the format and content of the above material with the Marketing Authorisation Holder prior to launch of the product in its territory.
Croatian: Nadležno tijelo u pojedinoj državi članici će prije stavljanja lijeka na tržište usuglasiti oblik i sadržaj navedenih materijala s Nositeljem odobrenja.
English: • The importance of not attempting to self-treat any symptoms without consulting their Healthcare professional first.
Croatian: • Naglasiti da je važno da bolesnik ne pokušava sam liječiti niti jedan simptom prije nego se posavjetuje sa zdravstvenim djelatnikom.
English: Key elements for the Patient Information Brochure and Alert Card:
Croatian: Najvažniji elementi brošure s informacijama za bolesnika i Kartice s upozorenjima:
English: • The importance of carrying the detachable wallet-sized Patient Alert Card at all times to show it at all medical visits to healthcare professionals other than the prescriber (e.g. emergency healthcare professionals).
Croatian: • Naglasiti da je važno da bolesnik uvijek sa sobom nosi Bolesničku karticu s upozorenjima, koja se može odvojiti od upute i držati u novčaniku, kako bi je mogao pokazati pri svakom posjetu nekom drugom zdravstvenom djelatniku koji nije propisao lijek (npr. djelatnicima u hitnoj službi).
English: • Reminder to distribute the Patient Information Brochure, and to educate patients/caregivers about symptoms of irARs and of the need to report them immediately to the physician.
Croatian: • Podsjetnik da bolesnicima daju brošuru s informacijama za bolesnike i da bolesnike ili njihove njegovatelje nauče koji su simptomi imunološki uzrokovanih nuspojava te da ih odmah moraju prijaviti liječniku.
English: • Patient Information Brochures including Alert Cards
Croatian: • brošuru s informacijama za bolesnika uključujući Karticu s upozorenjima.
English: including the adrenal, pituitary, or thyroid glands o Inflammation of the eyes o Other related irARs (e.g. pneumonitis, glomerulonephritis, multi-organ failure…) o Severe infusion reaction
Croatian: glomerulonefritis, višeorgansko zatajenje...) o ozbiljna infuzijska reakcija.
English: Key elements of the Healthcare Professional FAQ Brochure (Q&A format):
Croatian: Najvažniji elementi brošure s čestim pitanjima za zdravstvene djelatnike (u obliku pitanja i odgovora):
English: • Healthcare Professional FAQ Brochure
Croatian: • brošuru s čestim pitanjima za zdravstvene djelatnike
English: • Placeholder including the weblink of the Package Leaflet on the EMA website
Croatian: • Internetsku poveznicu na Uputu o lijeku na internetskoj stranici Europske agencije za lijekove (EMA).
English: (See sections 4.2 and 5.2).
Croatian: (Vidjeti dijelove 4.2 i 5.2).
English: It is also normal to see small air bubbles.
Croatian: Isto tako normalno je vidjeti male mjehuriće zraka.
English: Proceed to the next step immediately after shaking.
Croatian: Prijeđite na sljedeći korak odmah nakon protresanja.
English: Check suspension
Croatian: Provjerite suspenziju
English: Place on a clean surface.
Croatian: Odložite na čistu površinu.
English: Administer every 3 months
Croatian: Primijeniti svaka 3 mjeseca
English: The primary efficacy variable was time to first relapse.
Croatian: Primarna varijabla djelotvornosti bilo je vrijeme do prvog relapsa.
English: 90 kg or more yellow hub
Croatian: 90 kg ili više žuti vrh
English: 1 month after day 8
Croatian: 1 mjesec nakon 8. dana
English: It is not known if it is safe and effective in these patients.
Croatian: Nije poznato je li lijek siguran i djelotvoran u tih bolesnika.
English: Significant weight gain may be bad for your health.
Croatian: Značajno povećanje težine može štetno djelovati na Vaše zdravlje.
English: Do not use this medicine in children and adolescents under 18 years of age.
Croatian: Ne primjenjujte ovaj lijek u djece i adolescenata mlađih od 18 godina.
English: The needle is secure when a “click” sound is heard.
Croatian: Igla je učvršćena kada se čuje zvuk „klik”.
English: TREVICTA with alcohol Alcohol should be avoided.
Croatian: TREVICTA i alkohol Alkohol treba izbjegavati.
English: The difference is not likely to be of clinical relevance.
Croatian: Ta razlika vjerojatno nije klinički relevantna.
English: Use the recommended re-initiation regimen shown in the table below.
Croatian: Primijeniti preporučeni režim ponovnog započinjanja kako je prikazano u tablici ispod.
English: The release of the active substance starts as early as day 1 and lasts for as long as 18 months.
Croatian: Oslobađanje djelatne tvari počinje već prvog dana i traje najmanje 18 mjeseci.
English: This is called priapism.
Croatian: To se zove prijapizam.
English: > 3½ months up to 4 months
Croatian: > 3½ mjeseca do 4 mjeseca
English: None of these events were serious or led to discontinuation.
Croatian: Niti jedan od tih događaja nije bio ozbiljan ili doveo do prestanka uzimanja lijeka.
English: The efficacy results were consistent across population subgroups (gender, age, and race) in both studies.
Croatian: Rezultati djelotvornosti bili su dosljedni između populacijskih podskupina (spol, dob i rasa) u oba ispitivanja.
English: What TREVICTA is and what it is used for
Croatian: Što je TREVICTA i za što se koristi
English: This should be considered in cases where full alertness is required, e.g., when driving a car or handling machines.
Croatian: To treba uzeti u obzir pri aktivnostima u kojima je potrebna potpuna budnost, npr. u vožnji ili upravljanju strojevima.
English: Talk to your doctor, pharmacist or nurse before using TREVICTA.
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primijenite lijek TREVICTA.