natgillin/translations-raw huggingface dataset:
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.
Moventig 25 mg: ovalna filmom obložena tableta svijetloljubičaste boje, dimenzija 13 x 7 mm, s oznakom „nGL” na jednoj i „25” drugoj strani.
• 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).
• 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.
• ritonavir, indinavir or saquinavir - to treat HIV
• ritonavir, indinavir ili sakvinavir - koriste se za liječenje HIV infekcije
• vascular endothelial growth factor (VEGF) inhibitor treatment.
• koji se liječe inhibitorom vaskularnog endotelnog faktora rasta (engl. vascular endothelial growth factor, VEGF)
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.
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.
• if you currently have unusually severe, persistent or worsening stomach pain
• ako trenutno osjećate neuobičajeno jaku ili dugotrajnu bol u trbuhu ili se bol u trbuhu pogoršava
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.
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.
Efficacy in the patient population targeted in this SmPC Response over 12 weeks in the LIR group
Djelotvornost u ciljnoj populaciji bolesnika iz ovoga Sažetka opisa svojstava lijeka Odgovor tijekom 12 tjedana u skupini bolesnika s NOL-om
Parent naloxegol excreted in the urine accounted for less than 6% of the total administered dose.
Naloksegol izlučen mokraćom u obliku ishodišnog spoja činio je manje od 6% ukupne primijenjene doze.
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.
Dugoročna sigurnost i podnošljivost Kodiac 8 bilo je 52-tjedno, multicentrično, otvoreno, randomizirano ispitivanje faze III s paralelnim skupinama, u kojem su se ocjenjivale sigurnost i podnošljivost naloksegola naspram standardnog liječenja za konstipaciju uzrokovanu primjenom opioida u bolesnika s boli koja nije uzrokovana rakom.
Results from a QWBA (Quantitative Whole Body Autoradiography) study in the rat and the lack of antagonism of CNS opiate effects in humans at naloxegol doses less than 250 mg, indicate minimal distribution of naloxegol into the CNS.
QWBA) u štakora te izostanak antagonizma opijatnih učinaka na SŽS u ljudi pri dozama naloksegola manjima od 250 mg ukazuju na minimalnu distribuciju naloksegola u SŽS.
Co-administration of the P-gp inhibitor quinidine resulted in a 1.4 fold increase in the AUC (90% CI: 1.3-1.5) and a 2.4 fold increase in the Cmax (90% CI: 2.2-2.8) of naloxegol.
Istodobna primjena inhibitora P-gp-a kinidina povećala je AUC naloksegola 1,4 puta (90% CI: 1,3-1,5), a Cmax naloksegola 2,4 puta (90% CI: 2,2-2,8).
Definition of laxative inadequate responder
Definicija bolesnika s neodgovarajućim odgovorom na laksative
Gastrointestinal perforation (see section 4.4)
mučnina, povraćanje gastrointestinalna perforacija (vidjeti dio 4.4)
Moventig 12.5 mg: a mauve coloured, oval, dimensions 10.5 x 5.5 mm film-coated tablet, marked “nGL” on one side and “12.5” on the other side.
Moventig 12,5 mg: ovalna filmom obložena tableta svijetloljubičaste boje, dimenzija 10,5 x 5,5 mm, s oznakom „nGL” na jednoj i „12,5” drugoj strani.
Conditions with increased potential for gastrointestinal perforation Cases of gastrointestinal perforation have been reported in the post-marketing setting, including fatal cases when naloxegol was used in patients who were at an increased risk of gastrointestinal (GI) perforation.
Stanja kod kojih postoji povećana mogućnost nastanka gastrointestinalne perforacije Nakon stavljanja lijeka u promet prijavljeni su slučajevi gastrointestinalne perforacije kada se naloksegol primjenjivao u bolesnika u kojih postoji povećan rizik od gastrointestinalne perforacije, uključujući i slučajeve sa smrtnim ishodom.
Plasma protein binding of naloxegol in humans was low and the fraction unbound ranged from 80% to
Naloksegol se u maloj mjeri vezao za proteine u plazmi ljudi, a udio nevezanog naloksegola kretao se u rasponu od 80% do 100%.
In some patients, however, a constellation of symptoms has been reported, which resembles the syndrome of central opioid withdrawal.
Međutim, u nekih je bolesnika prijavljen skup simptoma koji nalikuju sindromu ustezanja od opioida u središnjem živčanom sustavu.
In a few cases, symptoms suggestive of opioid withdrawal when taking naloxegol 25 mg were observed in patients taking methadone for their pain condition.
U nekoliko su slučajeva primijećeni simptomi koji su ukazivali na sindrom ustezanja od opioida kada su naloksegol u dozi od 25 mg uzimali bolesnici koji su za ublažavanje boli uzimali metadon.
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist or nurse for advice before taking this medicine.
Ako ste trudni, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku,
If side effects impacting tolerability occur, naloxegol should be discontinued.
Ako se pojave nuspojave koje utječu na podnošljivost, treba obustaviti primjenu naloksegola.
Naloxegol must not be used in patients with known or suspected gastrointestinal obstruction or in patients at increased risk of recurrent obstruction, or in patients with underlying cancer who are at heightened risk of GI perforation (see section 4.3).
Naloksegol se ne smije primjenjivati u bolesnika s poznatom ili suspektnom gastrointestinalnom opstrukcijom, u bolesnika u kojih postoji povećan rizik od rekurentne opstrukcije ili u bolesnika s podležećim rakom u kojih postoji povećan rizik od gastrointestinalne perforacije (vidjeti dio 4.3).
Stop taking the medicine and tell your doctor straight away if you develop opioid withdrawal symptoms (if you have a combination of three or more of these symptoms: feeling depressed, nausea, vomiting, muscle aches, increased tearing, runny nose, dilation of the pupils, goosebumps, excess sweating, diarrhoea, yawning, fever or insomnia) which would usually occur within the first few days after starting naloxegol.
Prestanite uzimati ovaj lijek i odmah se obratite liječniku ako razvijete simptome ustezanja od opioida (ako imate kombinaciju triju ili više od ovih simptoma: depresivno raspoloženje, mučninu, povraćanje, bol u mišićima, pojačano suzenje, curenje nosa, proširenje zjenica, naježenu kožu,
• 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)
• naprezanja završnog dijela debelog crijeva (rektuma) (kada morate jako tiskati da bi stolica izašla iz rektuma, što može izazvati i bol u završnom otvoru tijekom tiskanja)
The blood brain barrier integrity is important for minimizing naloxegol uptake into the CNS.
Cjelovitost krvno-moždane barijere važna je za minimizaciju unosa naloksegola u SŽS.
• nasopharyngitis (runny or stuffy nose)
• nazofaringitis (curenje iz nosa ili začepljen nos)
Naloxegol acts by binding to mu-opioid receptors in the GI tract targeting the underlying causes of OIC (i.e. reduced GI motility, hypertonicity and increased fluid absorption resulting from long-term opioid treatment).
Naloksegol se veže za mi-opioidne receptore u gastrointestinalnom sustavu i ciljano djeluje na podležeće uzroke konstipacije uzrokovane opioidima (tj. smanjen gastrointestinalni motilitet, hipertoničnost i povećanu apsorpciju tekućine, koji su posljedica dugotrajnog liječenja opioidima).
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.
U tih bolesnika naloksegol se mora propisivati uz oprez, uzimajući u obzir omjer koristi i rizika za pojedinog bolesnika, te nadzirati moguću pojavu učinaka na SŽS, poput simptoma ustezanja od opioida i/ili interferencije s opioidnom analgezijom.
No dosage adjustment is required for patients taking weak CYP3A4 inhibitors.
Nije potrebna prilagodba doziranja u bolesnika koji uzimaju slabe inhibitore CYP3A4.
You may need to stop taking Moventig
možda ćete morati prestati uzimati lijek Moventig
In vitro studies demonstrate that naloxegol is a full neutral antagonist at the mu-opioid receptor.
In vitro ispitivanja pokazala su da je naloksegol potpun i neutralan antagonist mi-opioidnog receptora.
In addition, no safety and tolerability concerns were identified in this study up to the highest dose given (150 mg).
Osim toga, u tom ispitivanju, ni uz najveću primijenjenu dozu (150 mg), nisu identificirani nikakvi sigurnosni problemi niti problemi s podnošljivošću.
The starting dose for patients taking moderate CYP3A4 inhibitors (e.g. diltiazem, verapamil) is 12.5 mg once daily.
Početna doza za bolesnike koji uzimaju umjereno snažne inhibitore CYP3A4 (npr. diltiazem, verapamil) iznosi 12,5 mg jedanput na dan.
This medicinal product does not require any special storage conditions.
6.4 Posebne mjere pri čuvanju lijeka Lijek ne zahtijeva posebne uvjete čuvanja.
Moventig contains sodium
Moventig sadrži natrij
The majority of gastrointestinal adverse reactions were graded as mild to moderate, occurred early in treatment and resolved with continued treatment.
Gastrointestinalne nuspojave većinom su bile ocijenjene kao blage do umjerene, javile su se na početku liječenja, a povukle se s njegovim nastavkom.
Posology The recommended dose of Moventig is 25 mg once daily.
Preporučena doza lijeka Moventig je 25 mg jedanput na dan.
Naloxegol at therapeutic doses has minimal uptake across the blood brain barrier.
U terapijskim dozama, naloksegol minimalno prolazi kroz krvno-moždanu barijeru.
Tablet coat hypromellose (E464) titanium dioxide (E171) macrogol (E1521) iron oxide red (E172) iron oxide black (E172)
Ovojnica tablete hipromeloza (E464) titanijev dioksid (E171) makrogol (E1521) željezov oksid, crveni (E172) željezov oksid, crni (E172)
If opioid withdrawal syndrome is suspected the patient should discontinue Moventig and contact their physician.
Ako se sumnja na sindrom ustezanja od opioida, bolesnik mora prekinuti primjenu lijeka Moventig i obratiti se svome liječniku.
Frequency categories are defined according to the following conventions: very common (≥ 1/10), common
Kategorije učestalosti definirane su kao: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100),
In this study, naloxegol at doses of 12.5 mg and 25 mg was generally safe and well tolerated as compared with placebo in the treatment of OIC patients with non-cancer-related pain.
U ovom se ispitivanju naloksegol u dozama od 12,5 mg i 25 mg pokazao općenito sigurnim i dobro podnošljivim u usporedbi s placebom u liječenju bolesnika s konstipacijom uzrokovanom primjenom opioida i boli koja nije uzrokovana rakom.
If evidence for opioid-mediated interference with analgesia or opioid withdrawal syndrome occurs, patients should be instructed to discontinue Moventig and contact their physician.
Ako se pojave znakovi interferencije s opioidnom analgezijom ili sindrom ustezanja od opioida, bolesnike se mora uputiti da prestanu primjenjivati Moventig i da se obrate svome liječniku.
Patients were prohibited from using laxatives other than bisacodyl rescue laxative if they had not had a bowel movement for 72 hours.
Bolesnicima je zabranjena primjena svih laksativa osim bisakodila kao laksativa za hitno pražnjenje crijeva u bolesnika koji nisu imali pražnjenje crijeva tijekom 72 sata.
• Patients with underlying cancer who are at heightened risk of GI perforation, such as those with:
• Bolesnici s podležećim rakom u kojih postoji povećan rizik od gastrointestinalne perforacije,
Talk to your doctor, pharmacist or nurse whilst taking Moventig:
Obratite se svom liječniku, ljekarniku ili medicinskoj sestri dok uzimate Moventig:
Infections and Infestations
Infekcije i infestacije nazofaringitis
• if you experience symptoms of opioid withdrawal syndrome (see section 4 below).
• ako morate prestati uzimati opioidni lijek na dulje od 24 sata • ako se pojave simptomi sindroma ustezanja od opioida (pogledajte dio 4 u nastavku).
Table 1 Adverse reactions by System Organ Class (SOC) and frequency System Organ Classification
Tablica 1 Nuspojave prema klasifikaciji organskih sustava i učestalosti
Pregnancy There are limited data from the use of naloxegol in pregnant women.
Podaci o primjeni naloksegola u trudnica su ograničeni.
There is a theoretical possibility that naloxegol could provoke opioid withdrawal in a breast-fed neonate whose mother is taking an opioid receptor agonist.
Postoji teoretska mogućnost da bi naloksegol mogao izazvati simptome ustezanja od opioida u dojenog novorođenčeta čija majka uzima antagonist opioidnih receptora.
Therefore, a dose adjustment of naloxegol is recommended when co-administered with diltiazem and other moderate CYP3A4 inhibitors (see section 4.2).
Stoga se preporučuje prilagoditi dozu naloksegola pri istodobnoj primjeni s diltiazemom i drugim umjerenim inhibitorima CYP3A4 (vidjeti dio 4.2).
Moventig contains the active substance naloxegol.
Moventig sadrži djelatnu tvar naloksegol.
Patients who had a QTcF >500 msec at screening, had a recent history of myocardial infarction within 6 months before randomization, had symptomatic congestive heart failure, or had any other overt CV disease were excluded from the clinical studies.
U klinička ispitivanja nisu bili uključeni bolesnici koji su imali QTcF >500 ms pri probiru, u nedavnoj anamnezi infarkt miokarda unutar 6 mjeseci prije randomizacije, simptomatsko kongestivno zatajenje srca ili bilo koju drugu očitu kardiovaskularnu bolest.
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).
Klinička djelotvornost i sigurnost Djelotvornost i sigurnost naloksegola utvrđene su u dvama dvostruko slijepim, placebom kontroliranim ispitivanjima jednakog dizajna u bolesnika s konstipacijom uzrokovanom primjenom opioida i boli koja nije uzrokovana rakom (Kodiac 4 i Kodiac 5).
Naloxegol use is therefore not recommended during pregnancy.
Stoga se ne preporučuje primjena naloksegola u trudnoći.
There is a small effect of age on the pharmacokinetics of naloxegol (approximately 0.7% increase in AUC for every year increase in age).
Dob malo utječe na farmakokinetiku naloksegola (AUC se sa svakom godinom povećava za približno
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.
Istodobna primjena sa snažnim inhibitorima CYP3A4 (npr. klaritromicinom, ketokonazolom, itrakonazolom ili telitromicinom; inhibitorima proteaze poput ritonavira, indinavira ili sakvinavira;
• To make sure there is no medicine left, rinse the empty glass with another half a glass of water (120 ml), and drink it
• kako bi bili sigurni da u čaši nije preostalo lijeka, isperite praznu čašu s dodatnih pola čaše vode
Blister non-perforated
Neperforirani blister
Safety and tolerability over an extended 12-week period Kodiac 7 was a 12-week safety extension that allowed for patients from Kodiac 4 to continue the same blinded treatment from Kodiac 4 for an additional 12 weeks (placebo, naloxegol 12.5 mg or 25 mg daily).
Sigurnost i podnošljivost tijekom produljenog 12-tjednog razdoblja Kodiac 7 bio je 12-tjedni produžetak ispitivanja radi ocjene sigurnosti, koji je bolesnicima iz ispitivanja Kodiac 4 omogućio da tijekom dodatnih 12 tjedana nastave primati isto slijepo liječenje koje su primali u ispitivanju Kodiac 4 (placebo, naloksegol u dozi od 12,5 mg ili naloksegol u dozi od
The responder rates in this population were placebo 30.0%, 12.5 mg 44.3% and 25 mg 44.4%.
U toj su populaciji stope bolesnika s odgovorom na liječenje iznosile 30,0% za placebo, 44,3% za dozu od 12,5 mg te 44,4% za dozu od 25 mg.
In Kodiac 5 the corresponding times to first post dose SBM were 38.2, 12.8, and 18.1 hours, respectively.
U ispitivanju Kodiac 5 su odgovarajuća vremena do prve prvog spontanog pražnjenja crijeva nakon primjene doze iznosila 38,2 sata, 12,8 sati te 18,1 sat.
Opioid withdrawal syndrome is a cluster of three or more of the following signs or symptoms: dysphoric mood, nausea, vomiting, muscle aches, lacrimation, rhinorrhoea, pupillary dilation,
Sindrom ustezanja od opioida je skup triju ili više sljedećih znakova ili simptoma: disforičnog raspoloženja, mučnine ili povraćanja, bolova u mišićima, lakrimacije ili rinoreje, proširenja zjenica ili piloerekcije ili znojenja, proljeva, zijevanja, vrućice ili nesanice.
• if your bowels are, or may be, blocked (obstructed) or you have been warned that your bowels are at risk of becoming blocked.
• ako imate ili biste mogli imati začepljenje (opstrukciju) crijeva ili su Vas upozorili da bi moglo doći do začepljenja crijeva
In an open-label, nonrandomized, fixed-sequence, 3-period, 3-treatment, single-dose, crossover study to evaluate the effect of multiple doses of rifampin on the single dose PK of naloxegol, coadministration of rifampin and naloxegol resulted in a 89% (90% CI: 88%-90%) decrease in naloxegol AUC and a 76% decrease in naloxegol Cmax (90% CI: 69%-80%), compared to when naloxegol was administered alone.
U otvorenom, nerandomiziranom, ukriženom ispitivanju u 3 razdoblja, s primjenom 3 liječenja u fiksnom redoslijedu, u kojem se ocjenjivao učinak višekratnih doza rifampicina na farmakokinetiku jedne doze naloksegola, istodobna primjena rifampicina i naloksegola smanjila je AUC naloksegola za 89% (90% CI: 88%-90%), a Cmax naloksegola za 76% (90% CI: 69%-80%) u usporedbi s primjenom samo naloksegola.
For definition of inadequate response to laxative(s), see section 5.1.
Za definiciju neodgovarajućeg odgovora na laksativ(e) vidjeti dio 5.1. 4.2 Doziranje i način primjene
This medicine contains less than 1 mmol sodium (23 mg) per 12.5 mg / 25 mg tablet, that is to say essentially ‘sodium-free'.
Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po tableti 12,5 mg / 25 mg, tj. zanemarive količine natrija.
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.
U bolesnika u skupini koja je primala standardno liječenje, konstipacija uzrokovana primjenom opioida liječila se laksativom koji je odabrao ispitivač sukladno najboljoj kliničkoj prosudbi, ali to nije mogao biti antagonist perifernih mi-opioidnih receptora.
Reports of severe abdominal pain and diarrhoea have been observed in clinical trials with the 25 mg dose, typically occurring shortly after initiation of treatment.
U kliničkim ispitivanjima doze od 25 mg opaženi su jaka bol u abdomenu i proljev, koji su se obično javljali ubrzo nakon početka liječenja.
Patients taking a minimum of 30 morphine equivalent units (meu) of opioids per day for at least 4 weeks before enrolment and self-reported OIC were eligible.
U ispitivanjima su mogli sudjelovati bolesnici koji su uzimali dnevnu dozu opioida ekvivalentnu dozi od najmanje 30 jedinica morfina tijekom najmanje 4 tjedna prije uključivanja u ispitivanje i koji su samostalno prijavili konstipaciju uzrokovanu primjenom opioida.
No dose adjustment is required for patients taking weak CYP3A4 inhibitors (e.g. alprazolam, atorvastatin (see section 4.5).
Nije potrebna prilagodba doze u bolesnika koji uzimaju slabe inhibitore CYP3A4 (npr. alprazolam, atorvastatin) (vidjeti dio 4.5).
There was no relevant impact on abdominal symptoms in either study (p=0.256 and p=0.916, Kodiac 4 and 5, respectively).
Niti u jednom od ta dva ispitivanja nije zabilježen značajan utjecaj na abdominalne simptome (Kodiac 4 p=0,256; Kodiac 5 p=0,916).
10 film-coated tablets 30 film-coated tablets 90 film-coated tablets 10 x 1 film-coated tablets 30 x 1 film-coated tablets 90 x 1 film-coated tablets 100 x 1 film-coated tablets
10 filmom obloženih tableta 30 filmom obloženih tableta 90 filmom obloženih tableta 10 x 1 filmom obložena tableta 30 x 1 filmom obložena tableta 90 x 1 filmom obložena tableta 100 x 1 filmom obložena tableta
Patients taking methadone as primary therapy for their pain condition were observed in clinical trials to have a higher frequency of gastrointestinal adverse reactions (such as abdominal pain and diarrhoea) than patients not receiving methadone.
U kliničkim je ispitivanjima primijećeno da je u bolesnika koji su uzimali metadon kao primarnu terapiju za ublažavanje boli učestalost gastrointestinalnih nuspojava (poput boli u abdomenu i proljeva) bila veća nego u onih koji nisu primali metadon.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS Blister perforated unit dose
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP Perforirani blister s jediničnim dozama Neperforirani blister
Pack sizes of 10 x 1, 30 x 1, 90 x 1 and 100 x 1 film-coated tablets in perforated unit dose blisters.
Veličina pakiranja: 10 x 1, 30 x 1, 90 x 1 i 100 x 1 filmom obložena tableta u perforiranim blisterima s jediničnim dozama.
Therefore, Moventig is not recommended in patients who are taking strong CYP3A4 inducers (see section 4.4).
Stoga se primjena lijeka Moventig ne preporučuje u bolesnika koji uzimaju snažne induktore CYP3A4 (vidjeti dio 4.4).
SBM was defined as a bowel movement without rescue laxative taken within the past 24 hours.
Spontano pražnjenje crijeva definirano je kao pražnjenje crijeva bez primjene laksativa za hitno pražnjenje crijeva unutar posljednja 24 sata.
Moventig 25 mg tablets are available in aluminium blisters in pack sizes of 10, 30 or 90 film--coated tablets in non-perforated blisters and 10x1, 30x1, 90x1 or 100x1 film-coated tablets in perforated unit dose blisters.
Moventig 25 mg tablete dostupne su u aluminijskim blisterima u pakiranjima s 10, 30 ili 90 filmom obloženih tableta u neperforiranim blisterima te u pakiranjima s 10x1, 30x1, 90x1 ili 100x1 filmom obloženom tabletom u perforiranim blisterima s jediničnim dozama.
Naloxegol was not studied in the clinical trial programme in patients who had a recent history of myocardial infarction within 6 months, symptomatic congestive heart failure, overt cardiovascular (CV) disease or patients with a QT interval of ≥ 500 msec. Moventig should be used with caution in these patients.
U sklopu programa kliničkih ispitivanja, naloksegol nije ispitivan u bolesnika koji su u nedavnoj anamnezi imali infarkt miokarda unutar posljednjih 6 mjeseci, simptomatsko kongestivno zatajenje srca ili očitu kardiovaskularnu bolest, niti u bolesnika s QT intervalom od ≥ 500 ms.
• if you develop severe, persistent or worsening stomach pain.
• ako se pojavi neuobičajeno jaka ili dugotrajna bol u trbuhu ili ako se bol u trbuhu pogorša.
No dose adjustment is required for patients with mild to moderate hepatic impairment.
Nije potrebna prilagodba doze u bolesnika s blagim do umjerenim oštećenjem jetrene funkcije.