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.
Slovenian: V vseh terapevtskih skupinah, tudi tisti s placebom, so se bolnikom, ki so nadaljevali v Kodiac 7, ohranila izboljšanja v domenah PAC-SYM, opažena v Kodiac 4.
English: Use in patients with severe hepatic impairment is not recommended.
Slovenian: Uporaba pri bolnikih s hudo okvaro jeter ni priporočljiva.
English: As it is not known whether this medicone is excreted in human milk, do not use Moventig during breast-feeding.
Slovenian: Ker ni znano, ali se to zdravilo izloča v materino mleko, zdravila Moventig ne uporabljajte med obdobjem dojenja.
English: The recommended dose is 1 tablet of 25 mg each day.
Slovenian: Priporočeni odmerek je ena 25 mg tableta vsak dan.
English: SBM was defined as a bowel movement without rescue laxative taken within the past 24 hours.
Slovenian: Spontano iztrebljanje je bilo opredeljeno kot iztrebljanje brez uporabe rešilnega odvajala v zadnjih 24 urah.
English: PEGylation reduces naloxegol's passive permeability and also renders the compound a substrate for the P-glycoprotein transporter.
Slovenian: PEGilacija zmanjša pasivno permeabilnost naloksegola in hkrati doseže, da je spojina substrat za P-glikoproteinski prenašalec.
English: Embryo-foetal development studies were conducted in rats and rabbits.
Slovenian: Študije embrio-fetalnega razvoja so izvedli na podganah in kuncih.
English: Take Moventig in the morning, to avoid bowel movements in the middle of the night.
Slovenian: Zdravilo Moventig vzemite zjutraj, da se ne bo tiščanje na blato pojavilo sredi noči.
English: • vascular endothelial growth factor (VEGF) inhibitor treatment.
Slovenian: • ki se zdravijo z zaviralcem žilnega endotelijskega rastnega dejavnika (vascular endothelial growth factor - VEGF).
English: • medicines called ‘opioid antagonists' (such as naltrexone and naloxone) which are used to counteract the effects of opioids
Slovenian: • zdravila, ki se imenujejo ‘opioidni antagonisti' (na primer naltrekson in nalokson), ki se uporabljajo za nevtraliziranje učinkov opioidov.
English: Moventig should be taken on an empty stomach at least 30 minutes before the first meal of the day or 2 hours after the first meal.
Slovenian: Moventig je treba vzeti na prazen želodec vsaj 30 minut pred prvim dnevnim obrokom ali 2 uri po njem.
English: For patients who are unable to swallow the tablet whole, the tablet can be crushed to a powder and mixed in half a glass of water (120 ml) and drunk immediately.
Slovenian: Bolniki, ki tablete ne morejo pogoltniti cele, lahko tableto zdrobijo v prašek, ki ga zmešajo s pol kozarca vode (120 ml) in takoj popijejo.
English: Tell your doctor immediately, you may need a lower dose or to stop taking Moventig.
Slovenian: O tem morate nemudoma obvestiti zdravnika: morda potrebujete manjši odmerek ali boste morali nehati jemati zdravilo Moventig.
English: In a majority of subjects, a secondary plasma concentration peak of naloxegol was observed approximately 0.4 to 3 hours after the first peak.
Slovenian: Pri večini preiskovancev so drugi vrh koncentracije naloksegola v plazmi opažali približno 0,4 do 3 ure po prvem vrhu.
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.
Slovenian: Odziv v 12 tednih pri bolnikih z nezadostnim odzivom na vsaj dve skupini odvajal Odziv na naloksegol v obdobju 12 tednov so testirali v podskupini bolnikov z nezadostnim odzivom na vsaj dve skupini odvajal, približno 20 % randomiziranih bolnikov.
English: • recurrent or advanced ovarian cancer
Slovenian: • s ponovitvijo ali napredovanjem raka jajčnika,
English: For information regarding concomitant use with CYP3A4 inhibitors, see sections 4.2, 4.3 and 4.5.
Slovenian: Za informacije o sočasni uporabi z zaviralci CYP3A4 glejte poglavja 4.2, 4.3 in 4.5.
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.
Slovenian: Bolniki, ki jemljejo metadon za zdravljenje zasvojenosti z opioidi, niso bili vključeni v program kliničnega razvoja in pri takšnih bolnikih je treba naloksegol uporabljati previdno.
English: The starting dose for patients with moderate or severe renal insufficiency is 12.5 mg.
Slovenian: Začetni odmerek za bolnike z zmerno ali hudo okvaro ledvic je 12,5 mg.
English: Do not use Moventig if any of the above applies to you.
Slovenian: Ne uporabljajte zdravila Moventig, če kaj od naštetega velja za vas.
English: Piramal Pharma Solutions (Dutch) B.V. Bargelaan 200 u 715
Slovenian: Piramal Pharma Solutions (Dutch) B.V.
English: Tell your doctor, pharmacist or nurse if you are taking any of the following medicines:
Slovenian: Zdravniku, farmacevtu ali medicinski sestri povejte, če jemljete katero od naslednjih zdravil:
English: • diltiazem or verapamil (for high blood pressure or angina).
Slovenian: • diltiazem ali verapamil (za visok krvni tlak ali angino pektoris).
English: Use of naloxegol with another opioid antagonist (e.g. naltrexone, naloxone) should be avoided due to the potential for an additive effect of opioid receptor antagonism and an increased risk of opioid withdrawal.
Slovenian: Interakcije z drugimi opioidnimi antagonisti Uporabi naloksegola s kakim drugim opioidnim antagonistom (npr. naltreksonom, naloksonom) se je treba izogibati zaradi možnosti aditivnega učinka antagonizma na opioidnem receptorju in zvečanega tveganja odtegnitve opioidov.
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).
Slovenian: klinični študiji bolnikov z OIC je bil dnevni odmerek 50 mg povezan z večjo incidenco nevzdržnih učinkov na prebavilih (predvsem bolečin v trebuhu).
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).
Slovenian: • če jemljete določena druga zdravila, na primer ketokonazol ali itrakonazol (za zdravljenje glivičnih okužb), klaritromicin ali telitromicin (antibiotika) ali ritonavir, indinavir ali sakvinavir (za zdravljenje HIV).
English: Naloxegol exposure was found to increase with increased weight, however, the differences in exposure were not considered clinically relevant.
Slovenian: Ugotovili so, da se izpostavljenost naloksegolu povečuje s telesno maso, vendar razlik v izpostavljenosti niso ocenili kot klinično pomembnih.
English: The efficacy and safety of naloxegol was established in two replicate double-blind, placebo-controlled studies in patients with OIC and non-cancer related pain (Kodiac 4 and Kodiac 5).
Slovenian: Učinkovitost in varnost naloksegola so ugotovili v dveh repliciranih dvojno slepih, s placebom kontroliranih študijah pri bolnikih z OIC in bolečinami, nepovezanimi z rakom (Kodiac 4 in
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.
Slovenian: Med 52-tedenskim obdobjem zdravljenja niso ugotovili pomembnih nepričakovanih razlik glede varnosti in prenašanja med skupino, ki je prejemala 25 mg naloksegola, in skupino, deležno običajnega zdravljenja.
English: Effect of severe hepatic impairment (Child-Pugh Class C) on the pharmacokinetics of naloxegol was not evaluated.
Slovenian: Vpliva hude okvare jeter (Child-Pugh razred C) na farmakokinetiko naloksegola niso ocenili.
English: Studies in suckling rats have shown that naloxegol is excreted in the milk.
Slovenian: Študije na dojenih podganah so pokazale, da se naloksegol izloča v mleko.
English: This is because large amounts can affect how much of the naloxegol medicine gets into the body.
Slovenian: Velika količina grenivkinega soka namreč lahko vpliva na to, koliko naloksegola pride v telo.
English: • rifampin (an antibiotic), carbmazepine (for epilepsy) or the herbal medicine St. John's wort (for depression).
Slovenian: • rifampin (antibiotik), karbamazepin (za epilepsijo) ali zeliščno zdravilo šentjanževko (za depresijo).
English: Across the range of doses evaluated peak plasma concentration and AUC increased in a doseproportional, or approximately dose proportional, manner.
Slovenian: Največja koncentracija v plazmi in AUC, ocenjeni v razponu odmerkov, sta naraščali sorazmerno ali približno sorazmerno odmerku.
English: Patients with cancer-related pain No dose adjustment is required for patients with cancer-related pain (see sections 4.3 and 4.4).
Slovenian: Bolnikom, ki imajo bolečine zaradi raka, odmerka ni treba prilagoditi (glejte poglavji 4.3 in 4.4).
English: Patients assigned to usual care followed a laxative treatment regimen for OIC determined by the investigator according to best clinical judgment, excluding peripheral mu-opioid receptor antagonists.
Slovenian: Bolniki, razvrščeni na običajno oskrbo, so za OIC dobivali zdravljenje z odvajali, ki ga je izbral raziskovalec po najboljši klinični presoji; izključena je bila uporaba perifernih antagonistov mi-opioidnih receptorjev.
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.
Slovenian: Bolniki s klinično pomembno prizadetostjo krvno-možganske pregrade (npr. s primarnimi malignimi boleznimi možganov, metastazami v osrednjem živčevju ali drugimi vnetnimi stanji, aktivno multiplo sklerozo, napredovalo Alzheimerjevo boleznijo itn.) niso bili vključeni v klinične študije in jih lahko ogroža prehajanje naloksegola v osrednje živčevje.
English: • ketoconazole or itraconazole - to treat fungal infections
Slovenian: • ketokonazol ali itrakonazol - za zdravljenje glivičnih okužb,
English: Cases of opioid withdrawal syndrome have been reported in the naloxegol clinical programme (DSM5).
Slovenian: V kliničnem programu z naloksegolom so bili opisani primeri sindroma odtegnitve opioidov (DSM-5).
English: • rectal straining (having to push very hard to move the stool out of the rectum, which can also cause pain in the anus during pushing)
Slovenian: • naprezanje danke (potreba po zelo močnem pritiskanju, da bi blato šlo iz danke; to lahko povzroča bolečine v zadnjiku med pritiskanjem),
English: • if you are allergic to naloxegol or similar medicines or any of the other ingredients of this medicine (listed in section 6).
Slovenian: • če ste alergični na naloksegol, podobna zdravila ali katero koli sestavino tega zdravila
English: For dose recommendations for patients with moderate or severe renal insufficiency, see section 4.2.
Slovenian: Za priporočila o odmerkih pri bolnikih z zmerno ali hudo okvaro ledvic glejte poglavje 4.2.
English: Patients should be advised to promptly report severe, persistent or worsening symptoms to their physician.
Slovenian: Bolnikom je treba naročiti, da morajo takoj obvestiti zdravnika o hudih, dolgotrajnih simptomih ali poslabšanju simptomov.
English: • allergic reaction • gastrointestinal perforation (a hole developing in the bowel wall)
Slovenian: • alergijska reakcija • perforacija prebavil (predrtje črevesne stene)
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.
Slovenian: V ločeni študiji pre- in postnatalnega razvoja pri podganah je bila telesna masa moških mladičev po uporabi visokega odmerka pri samicah-materah nižja.
English: Exposure of naloxegol in end-stage renal disease (ESRD) patients on haemodialysis was similar to healthy volunteers with normal renal function.
Slovenian: Izpostavljenost naloksegolu je bila pri bolnikih s končno odpovedjo ledvic na hemodializi podobna kot pri zdravih prostovoljcih z normalnim delovanjem ledvic.
English: Concomitant consumption of grapefruit juice while taking naloxegol should generally be avoided and considered only in consultation with a healthcare provider (see section 4.3).
Slovenian: Med jemanjem naloksegola se je treba na splošno izogibati sočasnemu pitju grenivkinega soka; v poštev pride le po posvetu z zdravnikom (glejte poglavje 4.3).
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.
Slovenian: Če bolnik, ki prejema zdravljenje z opioidom, dobi prevelik odmerek naloksegola, ga je treba natančno spremljati glede možnih simptomov odtegnitve opioida ali izginotja centralnega analgetičnega učinka.
English: You should not drink large amounts of grapefruit juice whilst taking Moventig.
Slovenian: Med jemanjem zdravila Moventig ne smete piti večjih količin grenivkinega soka.
English: You may need to take a lower dose of Moventig
Slovenian: Morda boste potrebovali manjši odmerek zdravila Moventig,
English: Available toxicological data in rats have shown naloxegol excreted in milk (see section 5.3).
Slovenian: Razpoložljivi toksikološki podatki pri podganah kažejo na izločanje naloksegola v mleko (glejte poglavje 5.3).
English: Patients were prohibited from using laxatives other than bisacodyl rescue laxative if they had not had a bowel movement for 72 hours.
Slovenian: Bolniki niso smeli uporabljati drugih odvajal razen bisakodila kot rešilnega odvajala v primeru, da na blato niso šli več kot 72 ur.
English: When treatment with Moventig is started, all currently used laxatives should be stopped, until instructed by your doctor to restart.
Slovenian: Ko začnete zdravljenje z zdravilom Moventig, morate prenehati jemati vsa odvajala, ki jih uporabljate trenutno, in jih ne smete znova začeti uporabljati, dokler vam tega ne svetuje zdravnik.
English: This was observed in a higher proportion of patients taking methadone than those not taking methadone.
Slovenian: To so opažali pri večjem deležu bolnikov, ki so jemali metadon, kot pri tistih,
English: Therefore, use in breast-feeding mothers is not recommended.
Slovenian: Zato uporaba pri doječih materah ni priporočljiva.
English: Eligible patients were randomized in a 2:1 ratio to receive either naloxegol 25 mg daily (qd) or usual care treatment for OIC for 52 weeks.
Slovenian: Primerne bolnike so v razmerju 2:1 randomizirali na prejemanje 25 mg naloksegola (enkrat na dan) ali običajnega zdravljenja OIC za 52 tednov.
English: In cases of known or suspected overdose of naloxegol, symptomatic treatment as well as monitoring of vital functions should be performed.
Slovenian: V primeru znanega prevelikega odmerjanja naloksegola ali suma nanj je treba uporabiti simptomatsko zdravljenje in kontrolirati vitalne funkcije.
English: • other medicines for constipation (any laxatives)
Slovenian: • druga zdravila proti zaprtju (katero koli odvajalo),
English: No dose adjustment is recommended based on age (see section 5.2).
Slovenian: Odmerka ni treba prilagoditi glede na starost (glejte poglavje 5.2).
English: In these patients renal impairment may adversely affect other clearance pathways (hepatic/gut drug metabolism, etc.) resulting in higher exposure.
Slovenian: Pri teh bolnikih okvara ledvic morda neugodno vpliva na druge poti očistka (presnova v jetrih/črevesu itn.) in tako poveča izpostavljenost.
English: Carcinogenicity studies of naloxegol were conducted in rats and mice.
Slovenian: Študije kancerogenosti naloksegola so izvedli na podganah in miših.
English: It is recommended that Moventig is taken in the morning, for patient convenience to avoid bowel movements in the middle of the night.
Slovenian: Način uporabe peroralna uporaba Priporočljivo je, da bolniki zdravilo Moventig vzamejo zjutraj, da se izognejo odvajanju blata sredi noči.
English: Interaction with P-gp inhibitors
Slovenian: Medsebojno delovanje z zaviralci P-gp
English: The blood brain barrier integrity is important for minimizing naloxegol uptake into the CNS.
Slovenian: Integriteta krvno-možganske pregrade je pomembna za omejitev prehajanja naloksegola v CNS.
English: Note: Selection of ADRs and their frequencies based on the 25 mg dose a Reflects MedDRA Preferred Terms of: “abdominal pain”, “abdominal pain upper”, “abdominal pain lower” and “gastrointestinal pain”.
Slovenian: Opomba: Izbrani neželeni učinki zdravila in njihove pogostnosti na podlagi odmerka 25 mg. a Zajema prednostne izraze MedDRA: »bolečine v trebuhu«, »bolečine v zgornjem delu trebuha«, »bolečine v spodnjem delu trebuha« in »gastrointestinalne bolečine«.
English: The effect of naloxegol on fertility in humans has not been studied.
Slovenian: Vpliv naloksegola na plodnost pri človeku ni raziskan.
English: Following oral administration of radiolabelled naloxegol, 68% and 16% of total administered dose were recovered in the faeces and urine, respectively.
Slovenian: Po peroralni uporabi radioaktivno označenega naloksegola se je v blatu pojavilo 68 % celotnega uporabljenega odmerka, v urinu pa 16 %.
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.
Slovenian: Rasa malo vpliva na farmakokinetiko naloksegola (približno 20 % nižja AUC naloksegola ob primerjavi drugih rasnih skupin z belci), zato odmerka ni treba prilagoditi.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Slovenian: • Redno posodobljena poročila o varnosti zdravila (PSUR) Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7)
English: It is a medicine used in adults to treat constipation specifically caused by pain medicines, called opioids, (e.g. morphine, oxycodone, fentanyl, tramadol, codeine) taken on a regular basis.
Slovenian: Uporabljamo ga za zdravljenje zaprtja, ki je izrecno posledica rednega jemanja protibolečinskih zdravil, imenovanih opioidi (npr. morfin, oksikodon, fentanil, tramadol, kodein).
English: How to take Moventig
Slovenian: Kako jemati zdravilo Moventig
English: Conditions in patients with cancer pain
Slovenian: Bolniki z bolečinami zaradi raka
English: Kodiac 8 was a Phase III, 52-week, multi-center, open-label, randomized, parallel group, safety and tolerability study of naloxegol versus usual care in the treatment of OIC in patients with non-cancer-related pain.
Slovenian: Kodiac 8 je bila 52-tedenska, multicentrična, odprta, randomizirana študija III. faze z vzporednimi skupinami za preučitev varnosti in prenašanja naloksegola v primerjavi z običajnim zdravljenjem OIC pri bolnikih, ki so imeli OIC in bolečine, nepovezane z rakom.
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.
Slovenian: Ob uvedbi zdravljenja z naloksegolom je priporočljivo popolnoma prekiniti vse trenutno vzdrževalno zdravljenje z odvajali, dokler ni ugotovljen klinični učinek naloksegola.
English: • if you have kidney problems
Slovenian: • če imate težave z ledvicami;
English: • if you develop severe, persistent or worsening stomach pain.
Slovenian: • če se vam pojavijo hude, dolgotrajne bolečine v trebuhu ali se vam takšne bolečine poslabšajo.
English: This medicine contains less than 1 mmol sodium (23 mg) per 12.5 mg / 25 mg tablet, that is to say essentially ‘sodium-free'.
Slovenian: To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na 12,5 mg / 25 mg tableto, kar v bistvu pomeni ‘brez natrija'.
English: The majority of gastrointestinal adverse reactions were graded as mild to moderate, occurred early in treatment and resolved with continued treatment.
Slovenian: Večina neželenih učinkov na prebavilih je bila razvrščenih med blage do zmerne, pojavili so se zgodaj med zdravljenjem in so med nadaljevanjem zdravljenja izginili.
English: • nasopharyngitis (runny or stuffy nose)
Slovenian: • nazofaringitis (izcedek iz nosu ali zamašen nos)
English: Naloxegol should be prescribed with caution in such patients taking into account their individual benefit-risk balance with observation for potential CNS effects, such as symptoms of opioid withdrawal and/or interference with opioid-mediated analgesia.
Slovenian: Takšnim bolnikom je treba naloksegol predpisovati previdno, upoštevaje njihovo individualno razmerje med koristjo in tveganjem, in jih je treba spremljati glede morebitnih učinkov na CNS, npr. glede simptomov odtegnitve opioidov in/ali oviranja analgezije z opioidi.
English: Therefore, naloxegol has not been studied in OIC patients with moderate or severe hepatic impairment.
Slovenian: Zato naloksegol ni raziskan pri bolnikih z OIC in zmerno ali hudo okvaro jeter.
English: What Moventig looks like and contents of the pack
Slovenian: Izgled zdravila Moventig in vsebina pakiranja
English: Moventig is not expected to affect you being able to drive a car or use any tools or machines.
Slovenian: Ni pričakovati, da bi zdravilo Moventig vplivalo na vašo sposobnost za upravljanje vozil ali strojev.
English: Tell your doctor, you may need to stop taking Moventig.
Slovenian: O tem obvestite zdravnika; morda boste morali nehati jemati zdravilo Moventig.
English: There is limited clinical experience with the use of naloxegol in OIC patients with cancer-related pain.
Slovenian: Kliničnih izkušenj z uporabo naloksegola pri bolnikih z OIC in bolečinami zaradi raka je malo.
English: Moventig contains sodium
Slovenian: Moventig vsebuje natrija
English: • ritonavir, indinavir or saquinavir - to treat HIV
Slovenian: • ritonavir, indinavir ali sakvinavir - za zdravljenje HIV.
English: Moventig is indicated for the treatment of opioid-induced constipation (OIC) in adult patients who have had an inadequate response to laxative(s).
Slovenian: Zdravilo Moventig je indicirano za zdravljenje zaprtja, povzročenega z opioidi (OIC - opioid-induced constipation), pri odraslih bolnikih z nezadostnim odzivom na odvajala.
English: The responder rates in this population were placebo 30.0%, 12.5 mg 44.3% and 25 mg 44.4%.
Slovenian: Deleži odziva so bili v tej populaciji 30,0 % s placebom, 44,3 % z 12,5 mg in 44,4 % s 25 mg.
English: Concomitant use with strong CYP3A4 inhibitors (e.g. clarithromycin, ketoconazole, itraconazole or telithromycin; protease inhibitors such as ritonavir, indinavir or saquinavir; grapefruit juice when consumed in large quantities), see section 4.5.
Slovenian: Močni zaviralci CYP3A4 Sočasna uporaba močnih zaviralcev CYP3A4 (npr. klaritromicina, ketokonazola, itrakonazola ali telitromicina; zaviralcev proteaz, npr. ritonavirja, indinavirja ali sakvinavirja; grenivkinega soka v velikih količinah), glejte poglavje 4.5.
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).
Slovenian: Naloksegol je treba uporabljati previdno pri bolnikih z boleznijo, ki bi lahko okrnila integriteto stene prebavil (npr. s hudo peptično ulkusno boleznijo, Crohnovo boleznijo, aktivnim ali ponavljajočim se divertikulitisom, infiltrativnimi malignimi boleznimi prebavil ali peritonealnimi metastazami).