natgillin/translations-raw huggingface dataset:
• if you experience symptoms of opioid withdrawal syndrome (see section 4 below).
• če se vam pojavijo simptomi sindroma odtegnitve opioidov (glejte poglavje 4 spodaj).
At therapeutic doses, most opioids (e.g. morphine, meperidine, methadone) are excreted into breast milk in minimal amounts.
V terapevtskih odmerkih se večina opioidov (npr. morfin, meperidin, metadon) izloča v materino mleko v minimalni količini.
What Moventig is and what it is used for What you need to know before you take Moventig How to take Moventig
Kaj je zdravilo Moventig in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Moventig Kako jemati zdravilo Moventig
Your doctor may tell you to take a lower dose of 12.5 mg
Zdravnik vam bo morda naročil, da jemljite manjši odmerek 12,5 mg:
• Crush the tablet to a powder
• Zdrobite tableto v prašek.
This could be a symptom of damage to the wall of the gut and can be life-threatening.
To je lahko simptom poškodbe stene črevesa, ki je lahko smrtno nevarna.
The mean apparent volume of distribution during the terminal phase (Vz/F) in healthy volunteers ranged from 968 to 2,140 L across dosing groups and studies.
Povprečni navidezni volumen porazdelitve med terminalno fazo (Vz/F) je bil pri zdravih prostovoljcih od 968 do 2.140 l v skupinah z različnim odmerjanjem in v različnih študijah.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or any other opioid antagonist.
Preobčutljivost Preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1, ali na kateri koli drug opioidni antagonist.
Long-term safety and tolerability
Dolgoročna varnost in prenašanje
A QTc study performed with naloxegol in healthy volunteers did not indicate any prolongation of the QT interval.
Študija intervala QTc, ki so jo izvedli z naloksegolom pri zdravih prostovoljcih, ni pokazala podaljšanja intervala QT.
All these effects were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
Vse te učinke so opazili samo pri izpostavljenosti, ki je močno presegala največjo izpostavljenost pri človeku, kar kaže na majhen pomen za klinično uporabo.
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Imetnik dovoljenja za promet bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
Pharmacotherapeutic group: Drugs for constipation, peripheral opioid receptor antagonists ATC code: A06AH03
Farmakoterapevtska skupina: zdravila proti zaprtju, periferno delujoči antagonisti opioidnih receptorjev; oznaka ATC: A06AH03
In clinical pharmacology studies, the half-life of naloxegol at therapeutic dose ranged from 6-11 hours.
V kliničnih farmakoloških študijah je bil razpolovni čas naloksegola v terapevtskih odmerkih od 6 do 11 ur.
If you have trouble swallowing the tablet you can crush it and mix with water as follows:
Če težko pogoltnete tableto Če težko pogoltnete tableto, jo lahko zdrobite in zmešate z vodo na naslednji način:
In a mass balance study in humans, a total of 6 metabolites were identified in plasma, urine and faeces.
V študiji masnega ravnovesja pri človeku so v plazmi, urinu in blatu ugotovili skupaj 6 presnovkov.
• Do not take a double dose to make up for a missed dose.
• Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
• hard stools (stools which are hard “like a rock”)
• trdo blato (blato, ki je trdo »kot kamen«),
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.
Primarni cilj je bila ocena dolgoročne varnosti in prenašanja 25 mg naloksegola in primerjava z običajnim zdravljenjem z uporabo opisnih statistik.
The overall benefit-risk profile for each patient should be taken into account.
Upoštevati je treba celotno razmerje med koristjo in tveganjem pri vsakem bolniku.
Moventig has no or negligible influence on the ability to drive and use machines.
Zdravilo Moventig nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
Frequency categories are defined according to the following conventions: very common (≥ 1/10), common
Kategorije pogostnosti so opredeljene po naslednjem dogovoru: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni
As there are additional data from the use of this medicine in pregnant women, the use of Moventig during pregnancy is not recommended.
Ker so na voljo dodatni podatki o uporabi tega zdravila pri nosečnicah, zdravila Moventig ni priporočljivo uporabljati med nosečnostjo.
The European Medicines Agency has deferred the obligation to submit the results of studies with Moventig in one or more subsets of the paediatric population in opioid induced constipation (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Moventig za eno ali več podskupin pediatrične populacije pri zaprtju, povzročenem z opioidi (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Moventig with drink
Zdravilo Moventig skupaj s pijačo
• if you have kidney problems - your doctor may tell you to take a different dose (see section below “How to take Moventig”)
• če imate težave z ledvicami - vaš zdravnik vam bo morda naročil, da jemljete drugačen odmerek (glejte poglavje spodaj »Kako jemati zdravilo Moventig«),
12 hours until your next dose, skip the missed dose.
Če pa je do naslednjega odmerka manj kot 12 ur, pozabljeni odmerek izpustite.
Other medicines and Moventig
Druga zdravila in zdravilo Moventig
What you need to know before you take Moventig Do not take Moventig:
Kaj morate vedeti, preden boste vzeli zdravilo Moventig Ne jemljite zdravila Moventig:
• clarithromycin or telithromycin - antibiotics
• klaritromicin ali telitromicin - antibiotika,
Following oral administration, naloxegol is absorbed rapidly, with peak concentrations (Cmax) achieved at less than 2 hours.
Po peroralni uporabi se naloksegol hitro absorbira in največjo koncentracijo (Cmax) doseže v manj kot 2 urah.
Overall 393 and 317 patients had at least 6 and 12 months exposure to naloxegol 25 mg, respectively, in this study, which met the specified exposure requirements.
V celoti je bilo v tej študiji 25 mg naloksegola vsaj 6 mesecev izpostavljenih 393 bolnikov in 12 mesecev 317 bolnikov, ki so izpolnili opredeljene zahteve o izpostavljenosti.
• methadone
• metadon,
In some patients, however, a constellation of symptoms has been reported, which resembles the syndrome of central opioid withdrawal.
Vendar je bil pri nekaterih bolnikih opisan skupek simptomov, ki spominja na sindrom centralne odtegnitve opioidov.
They were often reported as having a component of cramping discomfort.
Pogosto je bilo poročano, da jih spremlja občutek nelagodja s krči.
Contents of the pack and other information What Moventig contains
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Moventig
Parent naloxegol excreted in the urine accounted for less than 6% of the total administered dose.
V urinu izločeni matični naloksegol je predstavljal manj kot 6 % celotnega uporabljenega odmerka.
There is a small effect of age on the pharmacokinetics of naloxegol (approximately 0.7% increase in AUC for every year increase in age).
Starost v majhni meri vpliva na farmakokinetiko naloksegola (približno 0,7 % zvišanje AUC za vsako dodatno leto starosti).
Opioid withdrawal syndrome typically develops within minutes to several days following administration of an opioid antagonist.
Sindrom odtegnitve opioidov se značilno pojavi v nekaj minutah do nekaj dneh po dajanju antagonista opioidov.
A “symptom responder” was defined as meeting both the 12-week responder criteria and demonstrating improvement in pre-specified OIC symptoms and no deterioration in symptoms.
Opazovani dogodek odziva simptomov »Odziv simptomov« je bil opredeljen kot izpolnitev 12-tedenskih meril odziva in hkrati dokazano izboljšanje vnaprej opredeljenih simptomov OIC, brez poslabšanja simptomov.
The primary objective was to compare safety and tolerability among the three treatment groups for an additional 12 weeks (beyond that observed in Kodiac 4) using descriptive statistics.
Primarni cilj je bila primerjava varnosti in prenašanja v treh terapevtskih skupinah med obdobjem dodatnih 12 tednov (poleg obdobja v Kodiac 4) z uporabo opisnih statistik.
Safety and efficacy have not been established in patients with severe hepatic impairment (see section 5.2).
Varnost in učinkovitost pri bolnikih s hudo okvaro jeter nista ugotovljeni (glejte poglavje 5.2).
The first of three multiplicity protected secondary endpoints was the 12-week responder rate in the LIR subgroup.
Prvi od treh za večkratnost zavarovanih sekundarnih opazovanih dogodkov je bil 12-tedenski delež odzivnih bolnikov v podskupini LIR.
The safety and efficacy of naloxegol in children <18 years of age has not yet been established.
Pediatrična populacija Varnost in učinkovitost naloksegola pri otrocih, mlajših od 18 let, še nista ugotovljeni.
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.
Toda pri 2 od 8 bolnikov (v skupini z zmerno in v skupini s hudo okvaro ledvic, ne pa v skupini s končno odpovedjo ledvic) so opazili do 10-krat večjo izpostavljenost naloksegolu.
• 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)
• nepopolna izpraznitev danke (po iztrebljanju blata ostaja občutek, kot da je blato še vedno v danki in mora ven).
• Pour the powder into half a glass of water (120 ml)
• Vsujte prašek v pol kozarca vode (120 ml).
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).
Ugotovljeno je, da naloksegol ne vpliva na plodnost podganjih samcev in samic pri peroralnih odmerkih do 1.000 mg/kg na dan (več kot 1.000-kratna terapevtska izpostavljenost pri človeku (AUC) ob priporočenem odmerku za človeka
In all treatment groups, including placebo, improvements in PAC-SYM domains observed in Kodiac 4 were maintained for patients continuing in Kodiac 7.
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.
Use in patients with severe hepatic impairment is not recommended.
Uporaba pri bolnikih s hudo okvaro jeter ni priporočljiva.
As it is not known whether this medicone is excreted in human milk, do not use Moventig during breast-feeding.
Ker ni znano, ali se to zdravilo izloča v materino mleko, zdravila Moventig ne uporabljajte med obdobjem dojenja.
The recommended dose is 1 tablet of 25 mg each day.
Priporočeni odmerek je ena 25 mg tableta vsak dan.
SBM was defined as a bowel movement without rescue laxative taken within the past 24 hours.
Spontano iztrebljanje je bilo opredeljeno kot iztrebljanje brez uporabe rešilnega odvajala v zadnjih 24 urah.
PEGylation reduces naloxegol's passive permeability and also renders the compound a substrate for the P-glycoprotein transporter.
PEGilacija zmanjša pasivno permeabilnost naloksegola in hkrati doseže, da je spojina substrat za P-glikoproteinski prenašalec.
Embryo-foetal development studies were conducted in rats and rabbits.
Študije embrio-fetalnega razvoja so izvedli na podganah in kuncih.
Take Moventig in the morning, to avoid bowel movements in the middle of the night.
Zdravilo Moventig vzemite zjutraj, da se ne bo tiščanje na blato pojavilo sredi noči.
• vascular endothelial growth factor (VEGF) inhibitor treatment.
• ki se zdravijo z zaviralcem žilnega endotelijskega rastnega dejavnika (vascular endothelial growth factor - VEGF).
• medicines called ‘opioid antagonists' (such as naltrexone and naloxone) which are used to counteract the effects of opioids
• zdravila, ki se imenujejo ‘opioidni antagonisti' (na primer naltrekson in nalokson), ki se uporabljajo za nevtraliziranje učinkov opioidov.
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.
Moventig je treba vzeti na prazen želodec vsaj 30 minut pred prvim dnevnim obrokom ali 2 uri po njem.
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.
Bolniki, ki tablete ne morejo pogoltniti cele, lahko tableto zdrobijo v prašek, ki ga zmešajo s pol kozarca vode (120 ml) in takoj popijejo.
Tell your doctor immediately, you may need a lower dose or to stop taking Moventig.
O tem morate nemudoma obvestiti zdravnika: morda potrebujete manjši odmerek ali boste morali nehati jemati zdravilo Moventig.
In a majority of subjects, a secondary plasma concentration peak of naloxegol was observed approximately 0.4 to 3 hours after the first peak.
Pri večini preiskovancev so drugi vrh koncentracije naloksegola v plazmi opažali približno 0,4 do 3 ure po prvem vrhu.
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.
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.
• recurrent or advanced ovarian cancer
• s ponovitvijo ali napredovanjem raka jajčnika,
For information regarding concomitant use with CYP3A4 inhibitors, see sections 4.2, 4.3 and 4.5.
Za informacije o sočasni uporabi z zaviralci CYP3A4 glejte poglavja 4.2, 4.3 in 4.5.
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.
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.
The starting dose for patients with moderate or severe renal insufficiency is 12.5 mg.
Začetni odmerek za bolnike z zmerno ali hudo okvaro ledvic je 12,5 mg.
Do not use Moventig if any of the above applies to you.
Ne uporabljajte zdravila Moventig, če kaj od naštetega velja za vas.
Tell your doctor, pharmacist or nurse if you are taking any of the following medicines:
Zdravniku, farmacevtu ali medicinski sestri povejte, če jemljete katero od naslednjih zdravil:
• diltiazem or verapamil (for high blood pressure or angina).
• diltiazem ali verapamil (za visok krvni tlak ali angino pektoris).
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.
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.
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).
klinični študiji bolnikov z OIC je bil dnevni odmerek 50 mg povezan z večjo incidenco nevzdržnih učinkov na prebavilih (predvsem bolečin v trebuhu).
• 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).
• 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).
Naloxegol exposure was found to increase with increased weight, however, the differences in exposure were not considered clinically relevant.
Ugotovili so, da se izpostavljenost naloksegolu povečuje s telesno maso, vendar razlik v izpostavljenosti niso ocenili kot klinično pomembnih.
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).
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
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.
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.
Effect of severe hepatic impairment (Child-Pugh Class C) on the pharmacokinetics of naloxegol was not evaluated.
Vpliva hude okvare jeter (Child-Pugh razred C) na farmakokinetiko naloksegola niso ocenili.
Studies in suckling rats have shown that naloxegol is excreted in the milk.
Študije na dojenih podganah so pokazale, da se naloksegol izloča v mleko.
This is because large amounts can affect how much of the naloxegol medicine gets into the body.
Velika količina grenivkinega soka namreč lahko vpliva na to, koliko naloksegola pride v telo.
• rifampin (an antibiotic), carbmazepine (for epilepsy) or the herbal medicine St. John's wort (for depression).
• rifampin (antibiotik), karbamazepin (za epilepsijo) ali zeliščno zdravilo šentjanževko (za depresijo).
Across the range of doses evaluated peak plasma concentration and AUC increased in a doseproportional, or approximately dose proportional, manner.
Največja koncentracija v plazmi in AUC, ocenjeni v razponu odmerkov, sta naraščali sorazmerno ali približno sorazmerno odmerku.
Patients with cancer-related pain No dose adjustment is required for patients with cancer-related pain (see sections 4.3 and 4.4).
Bolnikom, ki imajo bolečine zaradi raka, odmerka ni treba prilagoditi (glejte poglavji 4.3 in 4.4).
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.
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.
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.
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.
• ketoconazole or itraconazole - to treat fungal infections
• ketokonazol ali itrakonazol - za zdravljenje glivičnih okužb,
Cases of opioid withdrawal syndrome have been reported in the naloxegol clinical programme (DSM5).
V kliničnem programu z naloksegolom so bili opisani primeri sindroma odtegnitve opioidov (DSM-5).
• 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)
• naprezanje danke (potreba po zelo močnem pritiskanju, da bi blato šlo iz danke; to lahko povzroča bolečine v zadnjiku med pritiskanjem),
• if you are allergic to naloxegol or similar medicines or any of the other ingredients of this medicine (listed in section 6).
• če ste alergični na naloksegol, podobna zdravila ali katero koli sestavino tega zdravila
For dose recommendations for patients with moderate or severe renal insufficiency, see section 4.2.
Za priporočila o odmerkih pri bolnikih z zmerno ali hudo okvaro ledvic glejte poglavje 4.2.
Patients should be advised to promptly report severe, persistent or worsening symptoms to their physician.
Bolnikom je treba naročiti, da morajo takoj obvestiti zdravnika o hudih, dolgotrajnih simptomih ali poslabšanju simptomov.
• allergic reaction • gastrointestinal perforation (a hole developing in the bowel wall)
• alergijska reakcija • perforacija prebavil (predrtje črevesne stene)
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.
V ločeni študiji pre- in postnatalnega razvoja pri podganah je bila telesna masa moških mladičev po uporabi visokega odmerka pri samicah-materah nižja.
Exposure of naloxegol in end-stage renal disease (ESRD) patients on haemodialysis was similar to healthy volunteers with normal renal function.
Izpostavljenost naloksegolu je bila pri bolnikih s končno odpovedjo ledvic na hemodializi podobna kot pri zdravih prostovoljcih z normalnim delovanjem ledvic.
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).
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).
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.
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.
You should not drink large amounts of grapefruit juice whilst taking Moventig.
Med jemanjem zdravila Moventig ne smete piti večjih količin grenivkinega soka.
You may need to take a lower dose of Moventig
Morda boste potrebovali manjši odmerek zdravila Moventig,
Available toxicological data in rats have shown naloxegol excreted in milk (see section 5.3).
Razpoložljivi toksikološki podatki pri podganah kažejo na izločanje naloksegola v mleko (glejte poglavje 5.3).
Patients were prohibited from using laxatives other than bisacodyl rescue laxative if they had not had a bowel movement for 72 hours.
Bolniki niso smeli uporabljati drugih odvajal razen bisakodila kot rešilnega odvajala v primeru, da na blato niso šli več kot 72 ur.
When treatment with Moventig is started, all currently used laxatives should be stopped, until instructed by your doctor to restart.
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.
This was observed in a higher proportion of patients taking methadone than those not taking methadone.
To so opažali pri večjem deležu bolnikov, ki so jemali metadon, kot pri tistih,
Therefore, use in breast-feeding mothers is not recommended.
Zato uporaba pri doječih materah ni priporočljiva.
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.
Primerne bolnike so v razmerju 2:1 randomizirali na prejemanje 25 mg naloksegola (enkrat na dan) ali običajnega zdravljenja OIC za 52 tednov.