FrancophonIA/ELRC3.0 huggingface dataset:
English: In all treatment groups, including placebo, improvements in PAC-SYM domains observed in Kodiac 4 were maintained for patients continuing in Kodiac 7.
Croatian: U svim skupinama liječenja, uključujući i onu koja je primala placebo, poboljšanja u PAC-SYM domenama primijećena u ispitivanju Kodiac 4 održala su se u bolesnika koji su nastavili liječenje u ispitivanju Kodiac 7.
English: When naloxegol therapy is initiated, it is recommended that all currently used maintenance laxative therapy should be halted, until clinical effect of naloxegol is determined.
Croatian: Kada se započinje terapija naloksegolom, preporučuje se prekinuti sve do tog trenutka korištene terapije održavanja laksativima, sve dok se ne utvrdi klinički učinak naloksegola.
English: Moventig is not expected to affect you being able to drive a car or use any tools or machines.
Croatian: Ne očekuje se da će Moventig utjecati na sposobnost upravljanja vozilom ili rada s alatima ili strojevima.
English: • medicines called ‘opioid antagonists' (such as naltrexone and naloxone) which are used to counteract the effects of opioids
Croatian: • lijekove pod nazivom „antagonisti opioida“ (poput naltreksona i naloksona) koji se primjenjuju za poništavanje učinaka opioida.
English: • allergic reaction • gastrointestinal perforation (a hole developing in the bowel wall)
Croatian: • alergijska reakcija • gastrointestinalna perforacija (stvaranje otvora u stijenci crijeva)
English: 12 hours until your next dose, skip the missed dose.
Croatian: Međutim, ako je do sljedeće doze preostalo manje od 12 sati, preskočite propuštenu dozu.
English: Do not use this medicine after the expiry date which is stated on the carton after “EXP”.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji iza oznake „Rok valjanosti“.
English: Grapefruit juice has been classified as a potent CYP3A4 inhibitor when consumed in large quantities.
Croatian: Sok od grejpa svrstava se u snažne inhibitore CYP3A4 kada se konzumira u velikim količinama.
English: What you need to know before you take Moventig Do not take Moventig:
Croatian: Što morate znati prije nego počnete uzimati Moventig
English: • incomplete emptying of the rectum (after having a bowel movement, the feeling as if a stool is still in the rectum which needs to come out)
Croatian: • nepotpunog pražnjenja rektuma (nakon pražnjenja crijeva i dalje imate osjećaj da se u rektumu nalazi još stolice koja mora izaći)
English: Moventig should be taken on an empty stomach at least 30 minutes prior to the first meal of the day or 2 hours after the first meal of the day.
Croatian: Moventig se mora uzeti na prazan želudac najmanje 30 minuta prije prvog dnevnog obroka ili 2 sata nakon prvog dnevnog obroka.
English: Patients taking methadone for treatment of opioid addiction were not included in the clinical development programme and use of naloxegol in these patients should be approached with caution.
Croatian: Bolesnici koji su uzimali metadon za liječenje ovisnosti o opioidima nisu bili uključeni u program kliničkog razvoja pa se u tih bolesnika naloksegol mora primjenjivati uz oprez.
English: The primary objective was to assess long-term safety and tolerability for naloxegol 25 mg and to compare with usual care treatment using descriptive statistics.
Croatian: Primarni cilj bio je ocijeniti dugoročnu sigurnost i podnošljivost naloksegola u dozi od 25 mg te napraviti usporedbu sa standardnim liječenjem uz pomoć deskriptivne statistike.
English: However, in 2 out of 8 patients (in both the moderate and severe renal impairment groups but not in the end stage renal failure group) up to 10-fold increases in the exposure of naloxegol were observed.
Croatian: 2 od 8 bolesnika (kako u skupinama s umjerenim tako i s teškim oštećenjem bubrežne funkcije, ali ne i u skupini s terminalnim stadijem zatajenja bubrega) primijećena su do deseterostruka povećanja izloženosti naloksegolu.
English: It is important to flush the nasogastric tube through with water after administration of the mixture.
Croatian: Važno je nazogastričnu sondu isprati vodom nakon primjene mješavine lijeka.
English: PEGylation reduces naloxegol's passive permeability and also renders the compound a substrate for the P-glycoprotein transporter.
Croatian: Pegilacija smanjuje pasivnu propusnost naloksegola i također pretvara spoj u supstrat za prijenosnik P-glikoprotein.
English: Naloxegol was found to have no effect on fertility of male and female rats at oral doses up to 1,000 mg/kg per day (greater than 1,000 times the human therapeutic exposure (AUC) at the recommended human dose of 25 mg/day).
Croatian: Utvrđeno je da naloksegol ne utječe na plodnost mužjaka i ženki štakora pri peroralnim dozama do 1000 mg/kg na dan (izloženost više od 1000 puta veća od terapijske izloženosti u ljudi (AUC) nakon primjene preporučene doze u ljudi od 25 mg/dan).
English: Co-administration of naloxegol and quinidine did not antagonize the morphine-induced miosis effect, suggesting that P-gp inhibition does not meaningfully change the capacity of naloxegol to cross the blood-brain barrier at therapeutic doses.
Croatian: Istodobna primjena naloksegola i kinidina nije antagonizirala morfinom izazvan miotički učinak, što ukazuje na to da inhibicija P-gp-a ne mijenja značajno sposobnost naloksegola da u terapijskim dozama prođe kroz krvno-moždanu barijeru.
English: Cases of opioid withdrawal syndrome have been reported in the naloxegol clinical programme (DSM5).
Croatian: U kliničkom programu za naloksegol prijavljeni su slučajevi sindroma ustezanja od opioida (DSM-5).
English: • ketoconazole or itraconazole - to treat fungal infections
Croatian: • ketokonazol ili itrakonazol - koriste se za liječenje gljivičnih infekcija
English: As it is not known whether this medicone is excreted in human milk, do not use Moventig during breast-feeding.
Croatian: Budući da nije poznato izlučuje li se ovaj lijek u majčino mlijeko, nemojte primjenjivati Moventig tijekom dojenja.
English: Moventig is indicated for the treatment of opioid-induced constipation (OIC) in adult patients who have had an inadequate response to laxative(s).
Croatian: Moventig je indiciran za liječenje konstipacije uzrokovane primjenom opioida u odraslih bolesnika koji nemaju odgovarajući odgovor na laksativ(e).
English: Skin and subcutaneous tissue disorders
Croatian: Poremećaji kože i potkožnog tkiva hiperhidroza
English: At therapeutic doses, most opioids (e.g. morphine, meperidine, methadone) are excreted into breast milk in minimal amounts.
Croatian: Većina opioida (npr. morfin, meperidin, metadon) primijenjenih u terapijskim dozama izlučuje se u majčino mlijeko u minimalnim količinama.
English: For information regarding concomitant use with CYP3A4 inhibitors, see sections 4.2, 4.3 and 4.5.
Croatian: Za informacije o istodobnoj primjeni s inhibitorima CYP3A4 vidjeti dijelove 4.2, 4.3 i 4.5.
English: The effect of race on the pharmacokinetics of naloxegol is small (approximately 20% decrease in the AUC of naloxegol when other groups are compared to Caucasian) and, therefore, no dose adjustment is necessary.
Croatian: Učinak rase na farmakokinetiku naloksegola je malen (AUC naloksegola je približno 20% manji u ostalih rasa nego kod bijelaca) i stoga nije potrebna prilagodba doze.
English: • underlying malignancies of gastrointestinal tract or peritoneum
Croatian: • s podležećim zloćudnim bolestima gastrointestinalnog sustava ili peritoneuma
English: If you are not sure, talk to your doctor, pharmacist or nurse before taking Moventig.
Croatian: Ako niste sigurni, razgovarajte sa svojim liječnikom, ljekarnikom ili medicinskom sestrom prije nego uzmete Moventig.
English: They were often reported as having a component of cramping discomfort.
Croatian: Često su prijavljene uz komponentu nelagode zbog grčeva.
English: Effect of severe hepatic impairment (Child-Pugh Class C) on the pharmacokinetics of naloxegol was not evaluated.
Croatian: Učinak teškog oštećenja jetrene funkcije (Child-Pugh stadij C) na farmakokinetiku naloksegola nije procijenjen.
English: This is because large amounts can affect how much of the naloxegol medicine gets into the body.
Croatian: Naime, velike količine soka od grejpa mogu utjecati na to koliko će naloksegola ući u tijelo.
English: Available toxicological data in rats have shown naloxegol excreted in milk (see section 5.3).
Croatian: Dostupni toksikološki podaci prikupljeni u štakora pokazuju da se naloksegol izlučuje u mlijeko (vidjeti dio 5.3).
English: Therefore, caution should be used when prescribing naloxegol to such patients (see section 4.3).
Croatian: Stoga je potreban oprez kada se naloksegol propisuje takvim bolesnicima (vidjeti dio 4.3).
English: In a clinical study of patients with OIC, a daily dose of 50 mg was associated with an increased incidence of intolerable gastrointestinal effects (primarily abdominal pain).
Croatian: U kliničkom ispitivanju bolesnika s konstipacijom uzrokovanom primjenom opioida, dnevna doza od 50 mg bila je povezana s povećanom incidencijom nepodnošljivih gastrointestinalnih učinaka (prvenstveno boli u abdomenu).
English: Tell your doctor, pharmacist or nurse if you are taking any of the following medicines:
Croatian: Obavijestite svog liječnika, ljekarnika ili medicinsku sestru ako uzimate neki od sljedećih lijekova:
English: Following oral administration, naloxegol is absorbed rapidly, with peak concentrations (Cmax) achieved at less than 2 hours.
Croatian: Apsorpcija Naloksegol se nakon peroralne primjene brzo apsorbira, a vršne koncentracije (Cmax) postižu se za manje od 2 sata.
English: If a patient on opioid therapy receives an overdose of naloxegol, the patient should be monitored closely for potential evidence of opioid withdrawal symptoms or reversal of central analgesic effect.
Croatian: Ako bolesnik na opioidnoj terapiji primi prekomjernu dozu naloksegola, mora ga se pomno pratiti zbog moguće pojave simptoma ustezanja od opioida ili reverzije centralnog analgetičkog učinka.
English: A potential CNS effect (reversal of opioid-induced miosis, as measured by pupillometry) was observed in 1 volunteer in the 250 mg group and 1 volunteer in the 1,000 mg group.
Croatian: Mogući učinak na SŽS (reverzija opioidom izazvane mioze, izmjerena pupilometrijom) primijećen je u jednog dobrovoljca iz skupine koja je uzimala dozu od 250 mg te jednog dobrovoljca iz skupine koja je uzimala dozu od 1000 mg.
English: Carcinogenicity studies of naloxegol were conducted in rats and mice.
Croatian: Ispitivanja kancerogenosti naloksegola provedena su na štakorima i miševima.
English: Studies in suckling rats have shown that naloxegol is excreted in the milk.
Croatian: Istraživanja na štakorima koji sišu pokazala su da se naloksegol izlučuje u mlijeko.
English: Across the range of doses evaluated peak plasma concentration and AUC increased in a doseproportional, or approximately dose proportional, manner.
Croatian: Procijenjena vršna koncentracija u plazmi i AUC povećavali su se proporcionalno dozi ili približno proporcionalno dozi u cijelom rasponu doza.
English: Naloxegol functions as a peripherally-acting mu-opioid receptor antagonist in the gastrointestinal tract, thereby decreasing the constipating effects of opioids without impacting opioid-mediated analgesic effects on the central nervous system.
Croatian: Naloksegol djeluje kao periferni antagonist mi-opioidinih receptora u gastrointestinalnom sustavu i tako smanjuje konstipacijske učinke opioida, a da pritom ne utječe na analgetičke učinke opioida na središnji živčani sustav.
English: In cases of known or suspected overdose of naloxegol, symptomatic treatment as well as monitoring of vital functions should be performed.
Croatian: U slučajevima u kojima se zna ili sumnja da se bolesnik predozirao naloksegolom, mora se uvesti simptomatsko liječenje i praćenje vitalnih funkcija.
English: In the pooled data from clinical trials the most commonly reported adverse reactions with naloxegol (≥ 5%) are: abdominal pain, diarrhoea, nausea, headache and flatulence.
Croatian: U objedinjenim podacima iz kliničkih ispitivanja najčešće nuspojave prijavljene pri liječenju naloksegolom (≥ 5%) su: bol u abdomenu, proljev, mučnina, glavobolja i flatulencija.
English: Due to poorer permeability and increased efflux of naloxegol across the blood-brain barrier, related to P-gp substrate properties, the CNS penetration of naloxegol is minimal.
Croatian: Zbog smanjene propusnosti i povećanog otpuštanja naloksegola kroz krvno-moždanu barijeru, što se povezuje sa značajkama supstrata za P-gp, prodiranje naloksegola u SŽS je minimalno.
English: • if you are taking certain other medicines such as ketoconazole or itraconazole (to treat fungal infections), clarithromycin or telithromycin (antibiotics) or ritonavir, indinavir or saquinavir (to treat HIV).
Croatian: • ako uzimate određene lijekove poput ketokonazola ili itrakonazola (za liječenje gljivičnih infekcija), klaritromicina ili telitromicina (antibiotici) ili ritonavira, indinavira ili sakvinavira (za liječenje HIV infekcije)
English: In a separate pre- and post-natal development study in rats, body weights were lower for male pups following maternal administration at the high dose.
Croatian: U zasebnom ispitivanju prenatalnog i postnatalnog razvoja na štakorima, tjelesna težina muške mladunčadi bila je niža nakon primjene visokih doza u majke.
English: Patients with mean Numeric Rating Scale (NRS) pain scores equal to or higher than 7 were not studied due to the risk of confounding the efficacy result as a result of uncontrolled pain.
Croatian: Bolesnici koji su prema brojčanoj ocjenskoj ljestvici za bol imali srednju vrijednost rezultata od 7 ili više nisu ispitivani zbog rizika od mogućeg utjecaja na rezultate djelotvornosti zbog nekontrolirane boli.
English: Most such reports were observed shortly after initial administration with the medicinal product and were mild or moderate in intensity.
Croatian: Većina takvih prijavljenih slučajeva primijećena je ubrzo nakon prve primjene lijeka, i bili su blage do umjerene težine.
English: During the 52-week treatment period there were no important unexpected differences in the safety and tolerability findings between the naloxegol 25 mg treatment group and the usual care treatment group.
Croatian: Tijekom 52-tjednog razdoblja liječenja nisu primijećene važne neočekivane razlike u nalazima sigurnosti i podnošljivosti između skupine koja je liječena naloksegolom u dozi od 25 mg i skupine koja je primala standardno liječenje.
English: Both studies were powered and stratified so that at least 50% of patients randomized to each treatment arm met baseline criteria to be categorized as a laxative inadequate responder (LIR).
Croatian: Oba su ispitivanja bila dizajnirana tako da imaju statističku snagu te su stratificirana na način da je najmanje 50% bolesnika randomiziranih u svaku skupinu liječenja zadovoljavalo početne kriterije za svrstavanje u kategoriju bolesnika s neodgovarajućim odgovorom na laksative (NOL).
English: Interaction with P-gp inhibitors
Croatian: Interakcija s inhibitorima P-gp-a
English: It is used when laxatives have not provided acceptable relief of constipation.
Croatian: Koristi se kada se zatvor ne može dostatno ublažiti laksativima.
English: When treatment with Moventig is started, all currently used laxatives should be stopped, until instructed by your doctor to restart.
Croatian: Kada započinjete liječenje lijekom Moventig, morate prekinuti primjenu svih laksativa koje ste do tada uzimali, sve dok Vam liječnik ne kaže da ih možete ponovno početi uzimati.
English: Efficacy and durability of effect were measured in the primary end-point as response over the 12-week treatment period to naloxegol as defined by > 3 SBMs per week and a change from baseline of > 1 SBM per week for at least 9 out of the 12 study weeks and 3 out of the last 4 weeks.
Croatian: Djelotvornost i trajanje učinka mjereni su u sklopu primarne mjere ishoda kao odgovor na naloksegol tijekom 12-tjednog razdoblja liječenja, koji je definiran kao > 3 spontana pražnjenja crijeva tjedno i promjena od > 1 spontanog pražnjenja crijeva tjedno u odnosu na početnu vrijednost tijekom najmanje 9 od 12 tjedana ispitivanja te tijekom 3 od posljednja 4 tjedna.
English: Keep this medicine out of the sight and reach of children.
Croatian: Kako čuvati Moventig Lijek čuvajte izvan pogleda i dohvata djece.
English: In these patients renal impairment may adversely affect other clearance pathways (hepatic/gut drug metabolism, etc.) resulting in higher exposure.
Croatian: U tih bolesnika oštećenje bubrežne funkcije može negativno utjecati na druge putove klirensa (metabolizam lijeka u jetri/crijevima itd.), što može povećati izloženost.
English: Caution with regards to the use of naloxegol should be exercised in patients with any condition which might result in impaired integrity of the gastrointestinal tract wall (e.g. severe peptic ulcer disease, Crohn's Disease, active or recurrent diverticulitis, infiltrative gastrointestinal tract malignancies or peritoneal metastases).
Croatian: Potreban je oprez kod primjene naloksegola u bolesnika s bilo kojim stanjem koje bi moglo dovesti do oštećenja cjelovitosti stijenke gastrointestinalnog sustava (npr. teškom peptičkom ulkusnom bolešću, Crohnovom bolešću, aktivnim ili rekurentnim divertikulitisom, infiltrativnim zloćudnim bolestima gastrointestinalnog sustava ili peritonealnim metastazama).
English: Patients with clinically important disruptions to the blood-brain barrier (e.g. primary brain malignancies, CNS metastases or other inflammatory conditions, active multiple sclerosis, advanced Alzheimer's disease etc.) were not included in clinical studies and may be at risk for naloxegol entry into the CNS.
Croatian: primarnim zloćudnim bolestima mozga, metastazama u SŽS-u ili drugim upalnim stanjima, aktivnom multiplom sklerozom, uznapredovalom Alzheimerovom bolešću itd.) nisu bili uključeni u klinička ispitivanja, pa u njih može postojati rizik od ulaska naloksegola u SŽS.
English: Response over 12 weeks in patients with an inadequate response to at least two classes of laxative Response to naloxegol over 12 weeks was tested in the sub-group of patients with inadequate response to at least two laxative classes, approximately 20% of the patients randomized.
Croatian: Odgovor na naloksegol tijekom 12 tjedana ispitivan je u podskupini bolesnika s neodgovarajućim odgovorom na najmanje dvije skupine laksativa, koju je činilo približno 20% randomiziranih bolesnika.
English: The starting dose for patients with moderate or severe renal insufficiency is 12.5 mg.
Croatian: Početna doza u bolesnika s umjerenom ili teškom insuficijencijom bubrega iznosi 12,5 mg.
English: It is recommended that Moventig is taken in the morning, for patient convenience to avoid bowel movements in the middle of the night.
Croatian: Bolesnicima se preporučuje uzimanje lijeka Moventig ujutro zbog praktičnosti radi izbjegavanja pražnjenja crijeva usred noći.
English: Conditions in patients with cancer pain
Croatian: Stanja u bolesnika s boli uzrokovanom rakom
English: Naloxegol as a crushed tablet mixed in water, given orally or administered through a nasogastric tube into the stomach, is bioequivalent to the whole tablet, with a median tmax of 0.75 and 1.50 hours (range 0.23 to 5.02 hours) for the crushed tablet given orally and the crushed tablet given via NG tube, respectively.
Croatian: Naloksegol u obliku zdrobljene tablete pomiješane sa vodom, primijenjen peroralno ili kroz nazogastričnu sondu u želudac, bioekvivalentan je cijeloj tableti, s medijanom tmax od 0,75 odnosno 1,50 sati (raspon od 0,23 do 5,02 sati) za zdrobljenu tabletu primijenjenu peroralno odnosno zdrobljenu tabletu primijenjenu putem nazogastrične sonde.
English: The first of three multiplicity protected secondary endpoints was the 12-week responder rate in the LIR subgroup.
Croatian: Prva od triju sekundarnih mjera ishoda zaštićenih od multipliciteta bila je stopa bolesnika koji su odgovorili na liječenje tijekom 12 tjedana u podskupini s NOL-om.
English: Exposure of naloxegol in end-stage renal disease (ESRD) patients on haemodialysis was similar to healthy volunteers with normal renal function.
Croatian: Izloženost naloksegolu u bolesnika s terminalnom fazom bubrežne bolesti na hemodijalizi bila je slična onoj u zdravih dobrovoljaca sa zdravom bubrežnom funkcijom.
English: In a long-term safety study (Kodiac 8), the frequency of AE reports of back pain was 8.9% for naloxegol 25 mg versus 8.8% for usual care.
Croatian: U ispitivanju dugoročne sigurnosti (Kodiac 8), učestalost prijavljenih nuspojava boli u leđima iznosila je 8,9% uz naloksegol u dozi od 25 mg naspram 8,8% uz standardno liječenje.
English: Following oral administration of radiolabelled naloxegol, 68% and 16% of total administered dose were recovered in the faeces and urine, respectively.
Croatian: Nakon peroralne primjene radioaktivno označenog naloksegola, 68% ukupne primijenjene doze pronađeno je u stolici, a 16% u mokraći.
English: • other medicines for constipation (any laxatives)
Croatian: • druge lijekove protiv zatvora (bilo koji laksativ) • metadon
English: Moventig 25 mg: a mauve coloured, oval, dimensions 13 x 7 mm, film-coated tablet, marked “nGL” on one side and “25” on the other side.
Croatian: Moventig 25 mg: ovalna filmom obložena tableta svijetloljubičaste boje, dimenzija 13 x 7 mm, s oznakom „nGL” na jednoj i „25” drugoj strani.
English: • if you have cancer in your gut or ‘peritoneum' (the lining of your stomach area), advanced or recurrent ovarian cancer or if you are taking medicines used to treat cancer such as “VEGF inhibitors” (e.g. bevacizumab).
Croatian: • ako imate rak crijeva ili „peritoneuma“ (ovojnice trbuha), uznapredovao ili ponavljan rak jajnika ili ako uzimate lijekove koji se koriste za liječenje raka, poput „VEGF inhibitora“ (npr.
English: • ritonavir, indinavir or saquinavir - to treat HIV
Croatian: • ritonavir, indinavir ili sakvinavir - koriste se za liječenje HIV infekcije
English: • vascular endothelial growth factor (VEGF) inhibitor treatment.
Croatian: • koji se liječe inhibitorom vaskularnog endotelnog faktora rasta (engl. vascular endothelial growth factor, VEGF)
English: A double-blind, randomized, 2-part, crossover, single centre study was conducted to evaluate the effect of quinidine on the pharmacokinetics of naloxegol and the effect of the co-administration of naloxegol and quinidine on morphine-induced miosis in healthy volunteers.
Croatian: Dvostruko slijepo, randomizirano, 2-dijelno, ukriženo ispitivanje u jednom centru provedeno je kako bi se ocijenio učinak kinidina na farmakokinetiku naloksegola te učinak istodobne primjene naloksegola i kinidina na morfinom izazvanu miozu u zdravih dobrovoljaca.
English: • if you currently have unusually severe, persistent or worsening stomach pain
Croatian: • ako trenutno osjećate neuobičajeno jaku ili dugotrajnu bol u trbuhu ili se bol u trbuhu pogoršava
English: To qualify as LIR, in the two weeks prior to first study visit patients had to have reported concurrent OIC symptoms of at least moderate severity while taking at least one laxative class for a minimum of four days during the pre study period.
Croatian: Da bi se kvalificirali kao bolesnici s NOL-om, morali su unutar dva tjedna prije prvog posjeta u sklopu ispitivanja prijaviti istodobne simptome konstipacije uzrokovane primjenom opioida najmanje umjerene težine uz primjenu laksativa iz najmanje jedne skupine tijekom minimalno četiri dana u razdoblju koje je prethodilo ispitivanju.
English: Efficacy in the patient population targeted in this SmPC Response over 12 weeks in the LIR group
Croatian: Djelotvornost u ciljnoj populaciji bolesnika iz ovoga Sažetka opisa svojstava lijeka Odgovor tijekom 12 tjedana u skupini bolesnika s NOL-om
English: Parent naloxegol excreted in the urine accounted for less than 6% of the total administered dose.
Croatian: Naloksegol izlučen mokraćom u obliku ishodišnog spoja činio je manje od 6% ukupne primijenjene doze.