FrancophonIA/ELRC3.0 huggingface dataset:
English: In the LIR subgroup, the 25 mg dose increased the symptom responder rates in both studies as compared to placebo (Kodiac 4 p=0.001, Kodiac 5 p=0.005).
Croatian: U podskupini bolesnika s NOL-om, doza od 25 mg povećala je stopu bolesnika koji su postigli odgovor uz poboljšanje simptoma u odnosu na placebo u oba ispitivanja (Kodiac 4 p=0,001, Kodiac 5 p=0,005).
English: Method of administration Oral use.
Croatian: Za peroralnu primjenu.
English: The time to first SBM in the LIR subgroup after taking the first dose was shorter for the 25 mg dose as compared to placebo in Kodiac 4 (p<0.001) and Kodiac 5 (p=0.002).
Croatian: Vrijeme do prvog spontanog pražnjenja crijeva nakon primjene doze u podskupini bolesnika s NOL-om bilo je kraće i u bolesnika liječenih dozom od 12,5 mg u odnosu na one koji su primali placebo u ispitivanjima Kodiac 4 (p=0,002) i Kodiac 5 (p<0,001).
English: There is limited clinical experience with the use of naloxegol in OIC patients with cancer-related pain.
Croatian: Bol uzrokovana rakom Kliničko iskustvo s primjenom naloksegola kod bolesnika s konstipacijom uzrokovanom primjenom opioida i boli uzrokovanom rakom je ograničeno.
English: Interaction with strong CYP3A4 inhibitors
Croatian: Interakcija sa snažnim inhibitorima CYP3A4
English: The dose can be increased to 25 mg if 12.5 mg is well tolerated by the patient (see section 5.2).
Croatian: Ako bolesnik dobro podnosi dozu od 12,5 mg, ona se može povećati na 25 mg (vidjeti dio 5.2).
English: Interaction with moderate CYP3A4 inhibitors
Croatian: Interakcija s umjerenim inhibitorima CYP3A4
English: Moventig 12.5 mg film-coated tablets Each film-coated tablet contains naloxegol oxalate equivalent to 12.5 mg naloxegol.
Croatian: Jedna filmom obložena tableta sadrži naloksegoloksalat koji odgovara količini od 12,5 mg naloksegola.
English: Oval, 10.5x5.5 mm, mauve tablet.
Croatian: Ovalna tableta svijetloljubičaste boje, dimenzija 10,5 x 5,5 mm.
English: Talk to your doctor, pharmacist or nurse before taking Moventig:
Croatian: ljekarnikom ili medicinskom sestrom prije nego uzmete Moventig.
English: The dose can be increased to 25 mg if 12.5 mg is well tolerated by the patient (see section 4.5).
Croatian: Ako bolesnik dobro podnosi dozu od 12,5 mg, ona se može povećati na 25 mg (vidjeti dio 4.5).
English: The dose can be increased to 25 mg if 12.5 mg is well tolerated by the patient (see section 4.2).
Croatian: Ako bolesnik dobro podnosi dozu od 12,5 mg, ona se može povećati na 25 mg (vidjeti dio 4.2).
English: • nausea (feeling sick to the stomach)
Croatian: • boli u trbuhu
English: The 12.5 mg dose in the LIR subgroup also resulted in greater improvement in total PAC SYM at week 12 compared with placebo in both studies (p= 0.020 and p=0.001 respectively).
Croatian: Doza od 12,5 mg je u podskupini bolesnika s NOL-om nakon 12 tjedana također dovela do većeg poboljšanja ukupnih PAC-SYM rezultata u usporedbi s placebom u oba ispitivanja (Kodiac 4 p=0,020; Kodiac 5 p=0,001).
English: Each film-coated tablet contains 12.5 mg naloxegol (as naloxegol oxalate).
Croatian: Jedna filmom obložena tableta sadrži 12,5 mg naloksegola (u obliku naloksegoloksalata).
English: Each film-coated tablet contains 25 mg naloxegol (as naloxegol oxalate).
Croatian: Jedna filmom obložena tableta sadrži 25 mg naloksegola (u obliku naloksegoloksalata).
English: Moventig 25 mg film-coated tablets Each film-coated tablet contains naloxegol oxalate equivalent to 25 mg naloxegol.
Croatian: Jedna filmom obložena tableta sadrži naloksegoloksalat koji odgovara količini od 25 mg naloksegola.
English: Strong CYP3A4 inhibitors
Croatian: Snažni inhibitori CYP3A4
English: It is unknown whether naloxegol is excreted in human milk.
Croatian: Nije poznato izlučuje li se naloksegol u majčino mlijeko.
English: Moventig 25 mg film-coated tablets naloxegol
Croatian: Moventig 25 mg filmom obložene tablete naloksegol
English: Interaction with CYP3A4 inhibitors and inducers
Croatian: Interakcija s inhibitorima i induktorima CYP3A4
English: Naloxegol is not recommended in patients who are taking strong CYP3A4 inducers (e.g. carbamazepine, rifampin, St. John's Wort) (see section 4.5).
Croatian: (npr. karbamazepin, rifampicin, gospinu travu) (vidjeti dio 4.5).
English: Moventig 12.5 mg film-coated tablets naloxegol
Croatian: Moventig 12,5 mg filmom obložene tablete naloksegol
English: • headache
Croatian: • vjetrovi
English: In an open-label, nonrandomized, fixed-sequence, 3-period, 3-treatment, crossover study to evaluate the effect of multiple doses of diltiazem on the single dose PK of naloxegol, co-administration of diltiazem and naloxegol resulted in a 3.4-fold (90% CI: 3.2-3.7) increase in naloxegol AUC and a 2.9fold increase in naloxegol Cmax (90% CI: 2.6-3.1), compared to when naloxegol was administered alone.
Croatian: U otvorenom, nerandomiziranom, ukriženom ispitivanju u 3 razdoblja, s primjenom 3 liječenja u fiksnom redoslijedu, u kojem se ocjenjivao učinak višekratnihdoza diltiazema na farmakokinetiku jedne doze naloksegola, istodobna primjena diltiazema i naloksegola povećala je AUC naloksegola
English: Scientific conclusions, grounds for variation to the terms of the marketing authorisations and detailed explanation of the scientific grounds for the differences from the PRAC recommendation
Croatian: Znanstveni zaključci, razlozi za izmjenu uvjeta odobrenja za stavljanje lijeka u promet i detaljno pojašnjenje znanstvenih razloga za razlike u odnosu na preporuku PRAC-a
English: Elderly (65 years of age or above)
Croatian: Stariji (65 godina ili stariji)
English: Half-life, however, was significantly increased by approximately 20%.
Croatian: Poluvijek se, međutim, značajno povećao za otprilike 20%.
English: Patients should be re-evaluated every 3 months.
Croatian: Bolesnike treba ponovno procjenjivati svaka 3 mjeseca.
English: Your doctor will advise you.
Croatian: Liječnik će Vas savjetovati o tome.
English: The expiry date refers to the last day of that month.
Croatian: Rok valjanosti odnosi se na zadnji dan navedeng mjeseca.
English: Ethnic groups/races
Croatian: Etničke grupe/rase
English: No death was considered to be related to treatment.
Croatian: Ni za jednu se smrt nije smatralo da je povezana s liječenjem.
English: Some side effects could be serious:
Croatian: Neke nuspojave mogu biti ozbiljne:
English: These diseases lead to vision loss.
Croatian: Te bolesti dovode do gubitka vida.
English: The potential risk for humans is unknown.
Croatian: Mogući rizik u ljudi nije poznat.
English: Infusion-related problems may also include sudden loss of consciousness.
Croatian: Problemi vezani uz infuziju mogu također uključivati i iznenadni gubitak svijesti.
English: This indicates that clinical benefit may diminish over time.
Croatian: To ukazuje da se postignuta klinička korist s vremenom može smanjiti.
English: Chemical and physical in-use stability has been demonstrated for 4 hours at 25°C.
Croatian: Kemijska i fizikalna stabilnost u primjeni je dokazana tijekom 4 sata pri 25C.
English: Use of rubber gloves and eye protection is recommended.
Croatian: Preporučuje se korištenje gumenih rukavica i zaštita očiju.
English: Therefore it must be washed off extensively with water in the event of direct contact.
Croatian: Stoga se mora temeljito isprati vodom u slučaju izravnog kontakta.
English: For storage conditions, please see section 5 of this leaflet.
Croatian: Za uvjete čuvanja, molimo pogledajte dio 5 u ovoj uputi.
English: - if you have any severe liver problems.
Croatian: - ako imate teško oštećenje jetre.
English: In the event of suspected heart attack, seek medical attention immediately.
Croatian: U slučaju sumnje na srčani udar, odmah potražite liječničku pomoć.
English: During this time, you will have to follow your doctor's instructions and keep your eyes still.
Croatian: Tijekom tog vremena morate se pridržavati liječničkih uputa i paziti da oči miruju.
English: What Visudyne is and what it is used for
Croatian: Što je Visudyne i za što se koristi
English: Injury, poisoning and procedural complications Common
Croatian: Ozljede, trovanja i proceduralne komplikacije Često
English: - if you have porphyria (a rare condition that may increase sensitivity to light).
Croatian: - ako imate porfiriju (rijedak poremećaj koji može pojačati osjetljivost na svjetlost).
English: He/she will decide whether you should be given Visudyne.
Croatian: On/ona će odlučiti biste li trebali primati Visudyne.
English: Eye and skin contact should be avoided.
Croatian: Treba izbjegavati dodir s očima i kožom.
English: Risk of severe decrease of vision
Croatian: Rizik ozbiljnog pogoršanja vida
English: If extravasation occurs, infusion should be stopped immediately.
Croatian: Nastupi li ekstravazacija, infuziju treba odmah prekinuti.
English: Such reactions should be avoided by compliance with the photosensitivity protection instructions given in section 4.4.
Croatian: Te se reakcije moraju izbjegavati pridržavanjem uputa o zaštiti od fotosenzibilnosti, navedenih u poglavlju 4.4.
English: • First your doctor or the pharmacist will prepare the Visudyne infusion solution.
Croatian: • Prvo će Vaš liječnik ili ljekarnik pripremiti infuzijsku otopinu Visudynea.
English: No additional safety concern was identified.
Croatian: Nije bilo nikakvih dodatnih problema vezanih uz sigurnost.
English: Verteporfin was not genotoxic in the absence or presence of light in the usual battery of genotoxic tests.
Croatian: Verteporfin nije bio genotoksičan u odsutnosti ili prisutnosti svjetlosti u standardnoj bateriji testova genotoksičnosti.
English: Partial recovery of vision was observed in some patients.
Croatian: Djelomični oporavak vida zabilježen je u nekih bolesnika.
English: Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: There are two types of choroidal neovascularisation: classic and occult.
Croatian: Postoje dvije vrste neovaskularizacije žilnice: klasična i prikrivena.
English: If not used immediately, the in-use storage time and conditions prior to use are the responsibility of the user and would normally not last longer than 4 hours below 25°C protected from light.
Croatian: Ako se ne primijeni odmah, vrijeme i uvjeti čuvanja prije primjene odgovornost su korisnika i normalno ne smiju biti dulji od 4 sata ispod 25C, zaštićeno od svjetlosti.
English: If this happens to you, do not drive or use any tools or machines until your vision improves.
Croatian: Ako Vam se to dogodi, ne smijete upravljati vozilima ni strojevima, sve dok se vid ne popravi.
English: On rare occasions these reactions may be severe and potentially include convulsions.
Croatian: U rijetkim slučajevima te reakcije mogu biti teške i potencijalno uključivati konvulzije.
English: If you are given more Visudyne than you should be Overdose of Visudyne may prolong the time during which you are sensitive to light and you may need to follow the protection instructions given in section 2 for longer than 48 hours.
Croatian: Ako primijenite više Visudynea nego što ste trebali Predoziranje Visudyneom može produžiti vrijeme tijekom kojeg ćete biti osjetljivi na svjetlost i možda će biti potrebno da se pridržavate uputa o zaštiti koje se nalaze u dijelu 2 i dulje od 48 sati.
English: If necessary, Visudyne therapy can be repeated every 3 months, up to 4 times per year.
Croatian: Ukoliko je potrebno, liječenje Visudyneom može se ponavljati svaka tri mjeseca, a najviše 4 puta godišnje.
English: If you come into direct contact with Visudyne, you must therefore wash it off thoroughly with water.
Croatian: Ako dođete u izravan kontakt s Visudyneom, morate ga odmah temeljito isprati vodom.
English: Your doctor will put a special contact lens onto your eye and treat your eye using a special laser.
Croatian: Liječnik će Vam na oko staviti posebnu kontaktnu leću i osvijetliti oko posebnim laserom.
English: From a microbiological point of view, the medicine should be used immediately.
Croatian: S mikrobiološkog stajališta, lijek treba primijeniti odmah.
English: When energy absorbed by the porphyrin is transferred to oxygen, highly reactive short-lived singlet oxygen is generated.
Croatian: Kada se energija koju apsorbira porfirin prenese na kisik, stvara se vrlo reaktivan, kratkoživući singletni kisik.
English: The adverse reactions are listed by system organ class and frequency using the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Croatian: Nuspojave su razvrstane prema klasifikaciji organskih sustava i učestalosti uz primjenu sljedeće konvencije: vrlo često (≥1/10), često (≥1/100 i <1/10), manje često (≥1/1000 i <1/100), rijetko (≥1/10 000 i <1/1000), vrlo rijetko (<1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: 26 rue de la Chapelle 68330 Huningue France
Croatian: Delpharm Huningue S.A.S. 26 rue de la Chapelle 68330 Huningue Francuska
English: Photosensitivity and exposure to light
Croatian: Fotosenzibilnost i izloženost svjetlosti
English: It is not known how the potential for DNA damage with PDT agents translates into human risk.
Croatian: Nije poznato kako se potencijal za oštećenje DNK-a tijekom uzimanja PDT lijekova pretvara u rizik za ljude.
English: The nasal edge of the treatment spot must be at least 200 m from the temporal edge of the optic disc.
Croatian: Nazalni rub područja primjene mora biti najmanje 200 µm udaljen od temporalnog ruba optičkog diska.
English: For treatment of lesions that are larger than the maximum treatment spot size, apply the light to the greatest possible area of active lesion.
Croatian: Za liječenje lezija većih od maksimalnog područja primjene, svjetlost treba primijeniti na najveću moguću površinu aktivne lezije.
English: There are no clinical data to support concomitant treatment of the second eye.
Croatian: Nema kliničkih podataka koji bi poduprli potrebu istodobnog liječenja drugog oka.
English: Date of first authorisation: 27 July 2000 Date of latest renewal: 05 May 2010
Croatian: Datum prvog odobrenja: 27. srpnja 2000.
English: Visudyne is available in packs containing 1 vial of powder.
Croatian: Visudyne je dostupan u pakiranjima koja sadrže 1 bočicu praška.
English: This medicinal product is intended for intravenous infusion only.
Croatian: Ovaj lijek namijenjen je samo za primjenu u intravenskoj infuziji.
English: If this happens to you, there will be increased sensitivity to light in that part of the skin until the green discolouration disappears.
Croatian: Ako se to Vama dogodi, taj će dio kože biti osjetljiviji na svjetlost sve dok zelena boja kože ne nestane.
English: Ask your doctor or pharmacist for advice before taking any medicine.
Croatian: Obratite se svom liječniku ili ljekarniku za savjet prije nego uzmete ovaj lijek.
English: • The second step is the activation of Visudyne in the eye 15 minutes after the start of the infusion.
Croatian: • Drugi je korak aktivacija Visudynea u oku 15 minuta nakon početka infuzije.
English: No experience is available in these patients.
Croatian: Nema dostupnih podataka u takvih bolesnika.
English: The extent and severity of these effects were consistent among all studies and were dependent on drug dose and dosing duration.
Croatian: Razmjeri i težina tih učinaka bili su dosljedni u svim ispitivanjima i ovisili su o dozi lijeka i trajanju doziranja.
English: Overdose of the medicinal product may result in the prolongation of the period during which the patient remains photosensitive.
Croatian: Zbog predoziranja lijekom može se produžiti razdoblje tijekom kojeg u bolesnika postoji fotosenzibilnost.
English: It is used as a light-activated medicinal product (photosensitiser).
Croatian: Koristi se kao lijek koji se aktivira svjetlošću (fotosenzibilizirajući lijek).
English: You should not be given Visudyne.
Croatian: Ne biste smjeli primati Visudyne.
English: Rash, urticaria, pruritus
Croatian: Osip, urtikarija, pruritus
English: You should not be given Visudyne - if you are allergic to verteporfin or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte primjenjivati Visudyne - ako ste alergični na verteporfin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: When the laser light is shone into the eye, Visudyne is activated.
Croatian: Kada se svjetlost lasera usmjeri na oko, Visudyne se aktivira.
English: However, if treatment of the second eye is deemed necessary, light should be applied to the second eye immediately after light application in the first eye but no later than 20 minutes from the start of the infusion.
Croatian: No, ako se liječenje drugog oka smatra nužno potrebnim, treba ga osvijetliti odmah nakon što se osvijetli prvo oko, a svakako najkasnije u roku od 20 minuta od početka infuzije.
English: Treatment of the second eye with Visudyne
Croatian: Liječenje drugog oka Visudyneom
English: The efficacy parameter was the same as in TAP and VIO (see above).
Croatian: Parametar djelotvornosti bio je isti kao i u ispitivanjima TAP i VIO (vidijeti gore).
English: When you are given an infusion of Visudyne, it is distributed within your body through the blood vessels, including the blood vessels at the back of the eye.
Croatian: Kada primate infuziju Visudynea, ona se distribuira po Vašem tijelu preko krvnih žila, uključujući krvne žile u stražnjem dijelu oka.
English: • Localised death of skin tissue (necrosis).
Croatian: • Lokalizirano odumiranje kožnog tkiva (nekroza).
English: It produces cytotoxic agents only when activated by light in the presence of oxygen.
Croatian: Citotoksične produkte stvara samo nakon aktivacije svjetlošću u prisutnosti kisika.
English: Visudyne should not be used during pregnancy unless clearly necessary (only if the benefit justifies the potential risk to the foetus).
Croatian: Visudyne se ne smije primjenjivati u trudnoći, osim ako to doista nije neophodno (samo ako očekivana korist nadmašuje mogući rizik za plod).
English: It takes 83 seconds to deliver the laser dose required to activate Visudyne.
Croatian: To će trajati 83 sekunde, tijekom kojih će oko primiti dozu laserske svjetlosti potrebnu za aktivaciju Visudynea.
English: Single and repeated dose toxicity
Croatian: Toksičnost pojedinačne i ponovljenih doza
English: Toxicity observed following multiple doses of verteporfin without light was associated mainly with effects on the haematopoietic system.
Croatian: Toksičnost zapažena nakon višestrukih doza verteporfina bez svjetlosti bila je povezana uglavnom s učincima na hematopoetski sustav.
English: - If you have any liver problems or a blockage of your bile duct, please tell your doctor before starting Visudyne therapy.
Croatian: - Ako imate bilo kakvih teškoća s jetrom ili začepljenje žučovoda, molimo Vas da obavijestite svojeg liječnika prije početka terapije Visudyneom.
English: The two regioisomers of verteporfin exhibit similar pharmacokinetic properties of distribution and elimination and thus both isomers are considered verteporfin as a whole from the pharmacokinetic perspective.
Croatian: Dva regioizomera verteporfina pokazuju slična farmakokinetička svojstva distribucije i eliminacije te se tako s farmakokinetičkoga gledišta oba izomera smatraju verteporfinom.
English: The clinical relevance is unknown.
Croatian: Značaj za kliničku primjenu nije poznat.
English: Although mean plasma Cmax and AUC values in elderly patients who received verteporfin are higher than those in young volunteers or patients, these differences are not considered to be clinically significant.
Croatian: Iako su prosječne vrijednosti Cmax i AUC-a u plazmi u starijih bolesnika koji su primali verteporfin više od onih u mladih dobrovoljaca ili bolesnika, takve se razlike ne smatraju klinički značajnima.
English: Verteporfin, also referred to as benzoporphyrin derivative monoacids (BPD-MA) consists of a 1:1 mixture of the equally active regioisomers BPD-MAC and BPD-MAD.
Croatian: Verteporfin, koji se naziva i monokiselinski derivat benzoporfirina (BPD-MA - benzoporphyrin derivative monoacids), sastoji se od smjese 1:1 jednako djelatnih regioizomera BPD-MAC i BPDMAD.
English: Use of a standard infusion line filter with hydrophilic membranes (such as polyethersulfone) of a pore size of not less than 1.2 μm is recommended.
Croatian: Preporučuje se uporaba standardnog filtera infuzijske linije s hidrofilnim membranama (npr. polietersulfon) i promjerom pora većim od 1,2 μm.
English: Patients should not stay in the dark and should be encouraged to expose their skin to ambient indoor light, as it will help eliminate the medicinal product quickly through the skin by a process called photobleaching.
Croatian: Bolesnici ne smiju biti u mraku i treba ih ohrabrivati da kožu izlažu običnom sobnom svjetlu, jer to pomaže da se lijek brže ukloni kroz kožu procesom koji se naziva fotoizbjeljivanje.
English: Adults, including the elderly (≥65 years old) Visudyne photodynamic therapy (PDT) is a two-step process:
Croatian: Odrasli, uključujući i starije (≥65 godina) Fotodinamsko liječenje Visudyneom odvija se u dvije faze:
English: Fundus cameras with a magnification within the range of 2.4 - 2.6X are recommended.
Croatian: Preporučuju se kamere za snimanje fundusa s povećanjem u rasponu 2,4-2,6X.
English: BPD-DA is also a photosensitiser but its systemic exposure is low (5-10% of the verteporfin exposure, suggesting that most of the active substance is eliminated unchanged).
Croatian: BPD-DA se također aktivira djelovanjem svjetlosti, no sustavna izloženost toj tvari je mala (5-10% od izloženosti verteporfinu, što ukazuje da se većina lijeka eliminira u nepromijenjenu obliku).
English: Effects of gender At the intended dose, pharmacokinetic parameters are not significantly affected by gender.
Croatian: Učinci spola Pri planiranoj dozi spol nema značajnog utjecaja na farmakokinetičke parametre.
English: In vitro studies did not show any significant involvement of oxidative metabolism by cytochrome P450 enzymes.
Croatian: In vitro ispitivanja nisu pokazala znatniji udio oksidacijskog metabolizma posredovanog enzimima citokroma P450.
English: However the pharmacological characteristics do not indicate any need to adjust the dose (see “Biotransformation” and “Elimination” under section 5.2).
Croatian: No, farmakološka svojstva ne ukazuju na potrebu za prilagodbom doze (vidjeti „Biotransformacija“ i „Eliminacija“ u dijelu 5.2).
English: Please tell your doctor if you are breastfeeding.
Croatian: Molimo obavijestite svojeg liječnika ako dojite.
English: Pre-dosing with diphenhydramine diminished these effects, suggesting that histamine may play a role in this process.
Croatian: Prethodnim davanjem difenhidramina ti su se učinci ublažili, što upućuje na zaključak da histamin ima ulogu u tom procesu.
English: Free radical scavengers
Croatian: Blokatori slobodnih radikala
English: Photosensitivity reactions (in 2.2 % of patients and <1 % of Visudyne courses) occurred in the form of sunburn following exposure to sunlight, usually within 24 hours from Visudyne treatment.
Croatian: Reakcije fotosenzibilnosti (u 2,2% bolesnika i <1% infuzija Visudyneom) javljale su se u obliku sunčanih opeklina nakon izlaganja sunčevoj svjetlosti, obično unutar 24 sata od liječenja Visudyneom.
English: What you need to know before you are given Visudyne
Croatian: Što morate znati prije nego počnete primjenjivati Visudyne
English: The following adverse reactions were considered potentially related to Visudyne therapy.
Croatian: Za sljedeće nuspojave smatralo se da bi mogle biti povezane s terapijom Visudyneom.
English: It should therefore not be administered to nursing mothers, or breastfeeding should be interrupted for 48 hours after administration.
Croatian: Stoga se ne bi trebao primjenjivati tijekom dojenja ili je dojenje potrebno prekinuti nakon primjene na 48 sati.
English: The primary efficacy parameter was the same as in TAP (see above), with an additional endpoint of month 24 defined.
Croatian: Primarni parametar djelotvornosti bio je isti kao i u ispitivanju TAP (vidjeti gore), ali je definiran dodatni ishod nakon 24 mjeseca.