FrancophonIA/ELRC3.0 huggingface dataset:
English: The analysis of the primary efficacy endpoint Progression-Free Survival (PFS) was conducted after 144 PFS events (central blinded assessment).
Croatian: Analiza preživljenja bez progresije bolesti (PFS), što je bio primarni ishod djelotvornosti, provedena je nakon 144 PFS-događaja (središnja procjena na slijepi način).
English: Keep the desiccant in the bottle.
Croatian: Držite sredstvo za sušenje u bočici.
English: - if you develop a severe and persistent headache, visual disturbances, seizures or altered mental status (such as confusion, memory loss or loss of orientation) please contact your doctor immediately.
Croatian: ako razvijete jaku ili upornu glavobolju, poremećaj vida, napadaje ili promijenjeni mentalni status (poput smetenosti, gubitka pamćenja ili gubitka orijentacije) odmah se obratite liječniku.
English: There are no data on the effect of Stivarga on human fertility.
Croatian: Nema podataka o učinku lijeka Stivarga na plodnost u ljudi.
English: Based on its mechanism of action regorafenib is suspected to cause foetal harm when administered during pregnancy.
Croatian: Na temelju mehanizma djelovanja, pretpostavlja se da regorafenib uzrokuje oštećenja fetusa kad se primjenjuje tijekom trudnoće.
English: There is insufficient data on patients who discontinued sorafenib therapy due to sorafenib-related toxicity or only tolerated a low dose (< 400 mg daily) of sorafenib.
Croatian: Nema dostatnih podataka o bolesnicima koji su prekinuli liječenje sorafenibom zbog toksičnosti povezane sa sorafenibom ili su podnosili samo nisku dozu sorafeniba (<400 mg na dan).
English: Blood pressure should be controlled prior to initiation of treatment with Stivarga.
Croatian: Krvni tlak mora biti pod nadzorom prije početka liječenja lijekom Stivarga.
English: If no improvement occurs despite dose reduction, interrupt therapy for a minimum of 7 days, until toxicity resolves to Grade 0-1.
Croatian: Ako ne nastupi poboljšanje unatoč smanjenju doze, prekinuti terapiju na najmanje 7 dana, dok se toksičnost ne smanji na 0.-1. stupanj.
English: The highest dose of Stivarga studied clinically was 220 mg per day.
Croatian: Najviša klinički ispitana doza lijeka Stivarga bila je 220 mg na dan.
English: Environmental risk assessment studies have shown that regorafenib has the potential to be persistent, bioaccumulative and toxic to the environment and may pose a risk to the surface water and to the sediment compartment (see section 6.6).
Croatian: Ispitivanja procjene rizika za okoliš pokazala su da regorafenib ima potencijal biti postojan, bioakumulativan i toksičan za okoliš i može činiti rizik za površinske vode i sedimentne dijelove (vidjeti dio 6.6).
English: In most cases of severe liver injury, liver dysfunction had an onset within the first 2 months of therapy, and was characterized by a hepatocellular pattern of injury with transaminase elevations >20xULN, followed by bilirubin increase.
Croatian: U većini slučajeva teškog oštećenja jetre, disfunkcija jetre nastupila je unutar prva 2 mjeseca terapije i bila je karakterizirana hepatocelularnim obrascem oštećenja s povišenim transaminazama > 20xGGN nakon čega je slijedio porast koncentracije bilirubina.
English: Swallow the tablet whole with water after a light meal that contains less than 30% fat.
Croatian: Tablete progutajte cijele s vodom nakon laganog obroka koji sadrži manje od 30% masti.
English: Table 7: Efficacy results from the RESORCE study
Croatian: Tablica 7: Rezultati djelotvornosti iz ispitivanja RESORCE
English: The tolerability of Stivarga in these patients has not been established.
Croatian: Podnošljivost lijeka Stivarga u tih bolesnika nije utvrđena.
English: Your doctor may need to reduce your dose or may decide to interrupt or discontinue the treatment permanently if necessary.
Croatian: Liječnik Vam po potrebi može smanjiti dozu ili odlučiti da Vam privremeno ili trajno prekine liječenje.
English: Both women of childbearing potential and men should use effective contraception during treatment and for at least eight weeks after completion of treatment.
Croatian: Žene reproduktivne dobi i muškarci moraju koristiti učinkovitu kontracepciju tijekom liječenja i najmanje osam tjedana nakon završetka liječenja.
English: The recommended daily dose in adults is 4 tablets of Stivarga 40 mg (160 mg regorafenib).
Croatian: Preporučena dnevna doza u odraslih je 4 tablete lijeka Stivarga od 40 mg (160 mg regorafeniba).
English: Before you start taking Stivarga your doctor may decide to do blood tests.
Croatian: Prije nego što počnete uzimati lijek Stivarga, liječnik Vam može odlučiti napraviti krvne pretrage.
English: When re-starting treatment, decrease dose by 40 mg (one tablet).
Croatian: Kod ponovnog početka liječenja, smanjiti dozu za 40 mg (jedna tableta).
English: Clinical data indicate that regorafenib has no effect on digoxin pharmacokinetics, therefore can be given concomitantly with p-glycoprotein substrates, such as digoxin, without a clinically meaningful drug interaction.
Croatian: Klinički podaci ukazuju da regorafenib nema učinka na farmakokinetiku digoksina, stoga se može davati istodobno sa supstratima P-glikoproteina, kao što je digoksin, bez klinički značajnih interakcija između lijekova.
English: The clinical significance of these potential interactions is unknown, but may result in a decreased efficacy of regorafenib.
Croatian: Kliničko značenje ovih mogućih interakcija nije poznato, ali posljedica može biti smanjena djelotvornost regorafeniba.
English: Hepatocellular carcinoma (HCC)
Croatian: Hepatocelularni karcinom (HCC)
English: Institute supportive measures immediately.
Croatian: Odmah uvesti potporne mjere.
English: The safety and efficacy of regorafenib in patients below 18 years of age in the indication gastrointestinal stromal tumours (GIST) have not been established.
Croatian: Sigurnost i djelotvornost regorafeniba u bolesnika mlađih od 18 godina u indikaciji gastrointestinalnih stromalnih tumora (GIST) nisu ustanovljene.
English: The exposure for regorafenib was increased by 48% when administered with a high-fat breakfast, and 36% when administered with a low fat breakfast, compared to fasting.
Croatian: Izloženost regorafenibu bila je viša za 48% kad se primjenjivao s punomasnim doručkom te za 36% kad se primjenjivao s doručkom s niskim udjelom masti, u odnosu na stanje natašte.
English: Grade b
Croatian: Stupanj b
English: They are classified according to System Organ Class and the most appropriate MedDRA term is used to describe a certain reaction and its synonyms and related conditions.
Croatian: Razvrstane su prema klasifikaciji organskih sustava, a za opis određene reakcije i njezinih sinonima i srodnih stanja koristio se najprikladniji MedDRA izraz.
English: Detailed information on this medicine is available on the European Medicines Agency (EMA) website: http://www.ema.europa.eu
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove: http://www.ema.europa.eu.
English: Do not use this medicine after the expiry date which is stated on the carton and the bottle label after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i naljepnici bočice iza oznake „Rok valjanosti“ i „EXP“.
English: Patients with a history of ischaemic heart disease should be monitored for clinical signs and symptoms of myocardial ischaemia.
Croatian: Bolesnike s ishemijskom bolešću srca u anamnezi mora se pratiti zbog mogućih kliničkih znakova i simptoma ishemije miokarda.
English: There is limited data in patients with PS ≥2.
Croatian: Podaci u bolesnika s PS ≥2 su ograničeni.
English: Signs and symptoms of PRES include seizures, headache, altered mental status, visual disturbance or cortical blindness, with or without associated hypertension.
Croatian: Znakovi i simptomi PRES-a uključuju napadaje, glavobolju, promijenjen mentalni status, poremećaj vida ili kortikalnu sljepoću, sa ili bez pridružene hipertenzije.
English: Regorafenib could harm infant growth and development (see section 5.3).
Croatian: Regorafenib može naštetiti rastu i razvoju dojenčeta (vidjeti dio 5.3).
English: Stivarga contains the active substance regorafenib.
Croatian: Stivarga sadrži djelatnu tvar regorafenib.
English: Limited data in patients with moderate hepatic impairment (Child-Pugh B) indicate similar exposure, compared to patients with normal hepatic function after a single 100 mg dose of regorafenib.
Croatian: Ograničeni podaci u bolesnika s umjerenim oštećenjem funkcije jetre (Child-Pugh B) pokazuju sličnu izloženost u usporedbi s bolesnicima s normalnom funkcijom jetre nakon jedne doze od 100 mg regorafeniba.
English: ≤5 times upper limit of normal (ULN) (maximum Grade 2)
Croatian: ≤ 5 puta iznad gornje granice normale (GGN) (najviše 2. stupanj)
English: There was no indication for a genotoxic potential of regorafenib tested in standard assays in vitro and in vivo in mice.
Croatian: Nije bilo znakova genotoksičnosti regorafeniba ispitane standardnim testovima in vitro i in vivo u miševa.
English: This indicates that co-administration of regorafenib may increase the plasma concentrations of other concomitant BCRP substrates (e.g. methotrexate, fluvastatin, atorvastatin).
Croatian: To ukazuje da istodobna primjena regorafeniba može povisiti koncentracije drugih istodobno primijenjenih supstrata BCRP-a u plazmi (npr. metotreksata, fluvastatina, atorvastatina).
English: In the event of severe bleeding necessitating urgent medical intervention, permanent discontinuation of Stivarga should be considered.
Croatian: U slučaju teškog krvarenja koje zahtijeva hitnu liječničku intervenciju, mora se razmotriti trajni prekid primjene lijeka Stivarga.
English: Avoid drinking grapefruit juice while taking Stivarga.
Croatian: Stivarga s hranom i pićem Izbjegavajte piti sok od grejpa dok uzimate lijek Stivarga.
English: Stivarga 40 mg tablets are light pink and oval, marked with “BAYER” on one side and “40” on the other side.
Croatian: Stivarga 40 mg tablete svijetlo su ružičaste boje, ovalne, s oznakom „BAYER“ na jednoj strani i „40“ na drugoj.
English: The primary efficacy endpoint was Overall Survival (OS).
Croatian: Primarni ishod djelotvornosti bio je ukupno preživljenje (OS).
English: Urinary excretion of glucuronides decreased below 10% under steady-state conditions.
Croatian: Izlučivanje glukuronida mokraćom smanjilo se ispod 10% u stanju dinamičke ravnoteže.
English: Plasma concentration-time profiles for regorafenib as well as for the major circulating metabolites showed multiple peaks across the 24-hour dosing interval, which are attributed to enterohepatic circulation.
Croatian: Profil odnosa u plazmi koncentracija-vrijeme za regorafenib i za glavne cirkulirajuće metabolite pokazao je veći broj vršnih vrijednosti u 24-satnom intervalu doziranja, koji se pripisuju enterohepatičkoj cirkulaciji.
English: The desiccant is a moisture absorbing material filled in a small container to protect the tablets from moisture.
Croatian: Sredstvo za sušenje je materijal koji upija vlagu, a pakiran je u mali spremnik kako bi zaštitio tablete od vlage.
English: Therapies included treatment with fluoropyrimidine-based chemotherapy, an anti-VEGF therapy, and, if the patient was KRAS wild type, an anti-EGFR therapy.
Croatian: Terapije su uključivale liječenje kemoterapijom na bazi fluoropirimidina, anti-VEGF terapiju i, ako je bolesnik imao divlji tip KRAS-a, anti-EGFR terapiju.
English: Inhibitors of CYP3A4 and UGT1A9/inducers of CYP3A4
Croatian: Inhibitori CYP3A4 i UGT1A9 / induktori CYP3A4
English: Before you start taking Stivarga and during treatment your doctor will check how well your heart is working.
Croatian: Prije nego što počnete uzimati lijek Stivarga i za vrijeme liječenja, liječnik će provjeravati rad Vašeg srca.
English: Following oral administration, mean elimination half-life for regorafenib and its metabolite M-2 in plasma ranges from 20 to 30 hours in different studies.
Croatian: Nakon peroralne primjene, srednja vrijednost poluvremena eliminacije regorafeniba i njegovog metabolita M-2 u plazmi kreće se u rasponu od 20 do 30 sati u različitim ispitivanjima.
English: - The active substance is regorafenib.
Croatian: Djelatna tvar je regorafenib.
English: Regorafenib, M-2 and M-5 are likely to undergo enterohepatic circulation (see section 5.2).
Croatian: Vjerojatno je da će regorafenib, M-2 i M-5 proći kroz enterohepatičku cirkulaciju (vidjeti dio 5.1).
English: In addition, regorafenib reduced the levels of tumour associated macrophages and has shown anti-metastatic effects in vivo.
Croatian: Osim toga, regorafenib je smanjio broj makrofaga povezanih s tumorima te pokazao antimetastatske učinke in vivo.
English: Within each frequency group, undesirable effects are presented in order of decreasing seriousness.
Croatian: Unutar svake skupine po učestalosti, nuspojave su prikazane slijedom prema sve manjoj ozbiljnosti.
English: In the event of suspected overdose, Stivarga should be discontinued immediately, with best supportive care initiated by a medical professional, and the patient should be observed until clinical stabilisation.
Croatian: U slučaju sumnje na predoziranje, primjenu lijeka Stivarga se mora odmah prekinuti, liječnik treba uvesti najbolju potpornu njegu, a bolesnika se mora nadzirati sve dok se kliničko stanje ne stabilizira.
English: M-5 may be reduced to M-4 in the gastrointestinal tract by microbial flora, allowing reabsorption of M-4 (enterohepatic circulation).
Croatian: M-5 se može smanjiti na M-4 u probavnom sustavu putem mikrobiološke flore, omogućavajući reapsorpciju M-4 (enterohepatička cirkulacija).
English: This medicinal product may pose a risk to the environment (see section 5.3).
Croatian: Ovaj lijek može činiti rizik za okoliš (vidjeti dio 5.3).
English: The safety profile of regorafenib in these studies was consistent with the safety results of a phase III B study conducted in 2872 patients with metastatic colorectal cancer whose disease had progressed after treatment with standard therapies.
Croatian: Sigurnosni profil regorafeniba u ovim ispitivanjima bio je u skladu s rezultatima o sigurnosti primjene iz ispitivanja faze III B, provedenog na 2872 bolesnika s metastatskim kolorektalnim karcinomom čija je bolest dalje napredovala nakon liječenja standardnim terapijama.
English: >3 times ULN (Grade 2 or higher) with concurrent bilirubin >2 times ULN
Croatian: > 3 puta GGN (2. ili viši stupanj) uz bilirubin istodobno > 2 puta iznad
English: The response rate (complete response or partial response) was 1% and 0.4% for Stivarga and placebo treated patients, respectively (p=0.188432, 1-sided).
Croatian: Stopa odgovora (ukupni ili djelomični odgovor) iznosio je 1% i 0,4% za bolesnike liječene lijekom Stivarga odnosno placebom (p=0,188432, jednostrana).
English: Pharmacokinetic data indicate that regorafenib may be given concomitantly with substrates of CYP2C8, CYP2C9, CYP3A4, and CYP2C19 without a clinically meaningful drug interaction (see also section 4.4).
Croatian: Farmakokinetički podaci pokazuju da se regorafenib može primijeniti istodobno sa supstratima CYP2C8, CYP2C9, CYP3A4 i CYP2C19 bez klinički značajnih interakcija između lijekova (vidjeti također dio 4.4).
English: It is recommended to perform liver function tests (ALT, AST and bilirubin) before initiation of treatment with Stivarga and monitor closely (at least every two weeks) during the first 2 months of treatment.
Croatian: Prije početka liječenja lijekom Stivarga preporučuje se napraviti testove jetrene funkcije (ALT, AST i bilirubin) te bolesnika pažljivo pratiti (najmanje svaka dva tjedna) tijekom prva 2 mjeseca liječenja.
English: Women of childbearing potential and men should ensure effective contraception during treatment and up to 8 weeks after completion of therapy.
Croatian: Žene reproduktivne dobi kao i muškarci moraju koristiti učinkovitu kontracepciju tijekom liječenja i do 8 tjedana nakon završetka terapije.
English: In particular, regorafenib inhibits mutated KIT, a major oncogenic driver in gastrointestinal stromal tumours, and thereby blocks tumour cell proliferation.
Croatian: Regorafenib osobito inhibira mutirani KIT, glavni onkogeni pokretač kod gastrointestinalnih stromalnih tumora, te tako blokira proliferaciju tumorskih stanica.
English: The in vitro inhibitory potency towards CYP3A4 (Ki value of 11.1 micromolar) and CYP2C19 (Ki value of 16.4 micromolar) was less pronounced.
Croatian: Snaga inhibicije in vitro prema CYP3A4 (Ki vrijednost od 11,1 µmol) i CYP2C19 (Ki vrijednost od 16,4 µmol) bila je manje izražena.
English: In cases of severe or persistent hypertension despite adequate medical management, treatment should be temporarily interrupted and/or the dose reduced at the discretion of the physician (see section 4.2).
Croatian: U slučajevima teške ili trajne hipertenzije usprkos odgovarajućem medicinskom zbrinjavanju, liječenje se mora privremeno prekinuti i/ili smanjiti dozu ovisno o procjeni liječnika (vidjeti dio 4.2).
English: However, patients could continue Stivarga therapy past progression at the discretion of the investigator.
Croatian: Ipak, bolesnici su mogli nastaviti liječenje lijekom Stivarga nakon progresije prema odluci ispitivača.
English: Pregnancy, breast-feeding and fertility Tell your doctor if you think you are pregnant, may be pregnant or plan on becoming pregnant as Stivarga should not be used during pregnancy unless clearly necessary.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku jer se Stivarga ne smije uzimati tijekom trudnoće, osim kad za time postoji jasna potreba.
English: In preclinical studies regorafenib has demonstrated potent antitumour activity in a broad spectrum of tumour models including colorectal, gastrointestinal stromal and hepatocellular tumour models which is likely mediated by its anti-angiogenic and anti-proliferative effects.
Croatian: U pretkliničkim ispitivanjima regorafenib je pokazao snažno antitumorsko djelovanje na široki spektar tumorskih modela, uključujući i modele kolorektalnih, gastrointestinalnih stromalnih i hepatocelularnih tumora, koje je vjerojatno posredovano njegovim antiangiogenim i antiproliferativnim učincima.
English: This indicates that co-administration of regorafenib may increase systemic exposure to UGT1A1 and UGT1A9 substrates.
Croatian: To pokazuje da istodobna primjena regorafeniba može povećati sistemsku izloženost supstratima UGT1A1 i UGT1A9.
English: Measures for the prevention of HFSR include control of calluses and use of shoe cushions and gloves to prevent pressure stress to soles and palms.
Croatian: Mjere za sprječavanje kožne reakcije na šakama i stopalima uključuju kontrolu kalusa i nošenje jastučića za obuću i rukavica kako bi se spriječio stres zbog pritiska na tabane i dlanove.
English: The maximum daily dose is 160 mg.
Croatian: Najviša dnevna doza je 160 mg.
English: Approximately 90% of the radioactive dose was recovered within 12 days after administration, with about 71% of the dose excreted in faeces (47% as parent compound, 24% as metabolites), and about 19% of the dose excreted in urine as glucuronides.
Croatian: Približno je 90% radioaktivne doze izlučeno u roku od 12 dana nakon primjene, s time da je oko 71% doze bilo izlučeno u stolici (47% u obliku osnovnog spoja, 24% u obliku metabolita), a oko 19% doze u mokraći u obliku glukuronida.
English: Metabolites M-2 and M-5 are weak substrates of P-gp.
Croatian: Metaboliti M-2 i M-5 su slabi supstrati P-gp.
English: Patients receiving regorafenib who experienced disease progression and for whom in the investigator's opinion, treatment with regorafenib was providing clinical benefit, were offered the opportunity to continue open-label regorafenib.
Croatian: Bolesnicima koji su primali regorafenib u kojih je bolest napredovala i kojima je, prema mišljenju ispitivača, liječenje regorafenibom bilo klinički korisno, bila je ponuđena mogućnost da nastave otvoreno liječenje regorafenibom.
English: The overall safety profile of Stivarga is based on data from more than 4,800 treated patients in clinical trials including placebo-controlled phase III data for 636 patients with metastatic colorectal cancer (CRC), 132 patients with gastrointestinal stromal tumours (GIST) and 374 patients with hepatocellular carcinoma (HCC).
Croatian: Ukupni sigurnosni profil lijeka Stivarga temelji se na podacima više od 4800 liječenih bolesnika u kliničkim ispitivanjima, uključujući podatke iz placebom kontroliranih ispitivanja faze III za 636 bolesnika s metastatskim kolorektalnim karcinomom (mCRC), 132 bolesnika s gastrointestinalnim stromalnim tumorima (GIST) i 374 bolesnika s hepatocelularnim karcinomom
English: Dose interruptions and/or dose reductions may be required based on individual safety and tolerability.
Croatian: Prekidi primjene i/ili smanjenja doze mogu biti potrebni ovisno o sigurnosti i podnošljivosti lijeka u pojedinog bolesnika.
English: In clinical studies, no relevant differences in exposure or efficacy were observed between patients of different ethnic groups.
Croatian: U kliničkim ispitivanjima nisu opažene značajne razlike u izloženosti ili djelotvornosti između bolesnika raznih etničkih skupina.
English: However, a potential of regorafenib to adversely affect male and female reproduction has to be considered based on morphological changes in the testes, ovaries, and the uterus observed after repeated dosing in rats and dogs at exposures below the anticipated human exposure (based on AUC comparison).
Croatian: Međutim, potrebno je uzeti u obzir mogućnost štetnih posljedica regorafeniba na reproduktivnu funkciju u muškaraca i žena na temelju morfoloških promjena u testisima, jajnicima i maternici opaženih nakon ponovljene doze u štakora i pasa pri izloženosti manjoj od one koja se očekuje u ljudi (na temelju usporedbe AUC-a).
English: - The other ingredients are: cellulose microcrystalline, croscarmellose sodium, magnesium stearate, povidone (K-25) and silica colloidal anhydrous, iron oxide red (E172), iron oxide yellow (E172), lecithin (derived from soya), macrogol 3350, polyvinyl alcohol (partially hydrolysed), talc and titanium dioxide (E171) (see also section ‘Important information about some of the ingredients of Stivarga').
Croatian: Ostali sastojci su: mikrokristalična celuloza, umrežena karmelozanatrij, magnezijev stearat, povidon (K-25) i koloidni bezvodni silicijev dioksid, crveni željezov oksid (E172), žuti željezov oksid (E 172), lecitin (dobiven iz soje), makrogol 3350, poli(vinilni alkohol) (djelomično hidroliziran), talk i titanijev dioksid (E171) (pogledajte također dio „Važne informacije o nekim sastojcima lijeka Stivarga“).
English: Interrupt therapy until toxicity resolves to Grade 0-1.
Croatian: Prekinuti terapiju dok se toksičnost ne smanji na 0.-1. stupanj.
English: • Caucasian: 36%, Asian: 41%
Croatian: • Muškarci: 88% • bijele rase: 36%, Azijati: 41%
English: Regorafenib is eliminated mainly via the hepatic route.
Croatian: Regorafenib se eliminira uglavnom putem jetre.
English: One case of Grade 4 hypertension was reported in the GIST trial.
Croatian: Jedan slučaj hipertenzije 4. stupnja bio je zabilježen u ispitivanju GIST-a.
English: >5 times ULN ≤20 times ULN (Grade 3)
Croatian: > 5 puta GGN ≤ 20 puta GGN (3. stupanj)
English: Each daily dose of 160 mg contains 2.427 mmol (or 55.8 mg) of sodium (see section 4.4).
Croatian: Jedna dnevna doza od 160 mg sadrži 2,427 mmol (ili 55,8 mg) natrija (vidjeti dio 4.4).
English: UGT1A1 and UGT1A9 substrates
Croatian: Supstrati UGT1A1 i UGT1A9
English: - if you get severe stomach and bowel problems (gastrointestinal perforation or fistula), your doctor should decide to discontinue treatment with Stivarga.
Croatian: ako razvijete teške probleme sa želucem ili crijevima (perforacija probavnog sustava ili fistula) Vaš liječnik mora odlučiti prekinuti liječenje lijekom Stivarga.
English: Treatment-emergent laboratory abnormalities observed in the placebo-controlled phase III trials are shown in Table 4 and Table 4a (see also section 4.4).
Croatian: Poremećaji laboratorijskih nalaza koji su se pojavili za vrijeme liječenja u placebom kontroliranim ispitivanjima faze III prikazani su u tablici 4 i tablici 4a (vidjeti također dio 4.4).