natgillin/translations-raw huggingface dataset:
In patients taking opioids with constipation, who have tried at least one laxative and had incomplete relief of constipation, Moventig has been shown in clinical trials to increase the number of bowel movements and improve symptoms of constipation caused by opioids.
Klinička su ispitivanja pokazala da u bolesnika sa zatvorom koji uzimaju opioide i koji su iskušali najmanje jedan laksativ, ali njime nisu uspjeli potpuno riješiti zatvor, Moventig povećava broj pražnjenja crijeva i ublažava simptome zatvora uzrokovane primjenom opioida.
Clinical studies of naloxegol did not include sufficient numbers of patients aged 75 years or over to determine whether they respond differently than younger patients, however, based on the mode of action of the active substance there are no theoretical reasons for any requirement for dose adjustments in this age group.
U kliničkim ispitivanjima naloksegola nije sudjelovao dovoljan broj bolesnika u dobi od 75 ili više godina da bi se moglo utvrditi odgovaraju li ti bolesnici drugačije od mlađih bolesnika.
30 film-coated tablets 90 film-coated tablets 30 x 1 film-coated tablets 90 x 1 film-coated tablets
30 filmom obloženih tableta 90 filmom obloženih tableta 30 x 1 filmom obložena tableta 90 x 1 filmom obložena tableta
The effect of naloxegol on fertility in humans has not been studied.
Nije ispitivan učinak naloksegola na plodnost ljudi.
• diltiazem or verapamil (for high blood pressure or angina).
• ako imate tegoba s bubrezima • ako uzimate diltiazem ili verapamil (za visok krvni tlak ili anginu)
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.
To je lijek koji se koristi u odraslih za liječenje zatvora (konstipacije) koji specifično uzrokuju lijekovi protiv bolova, zvani opioidi (npr. morfin, oksikodon,
Potential for interference with opioid-mediated analgesia There were no clinically relevant differences between naloxegol 12.5 mg, 25 mg, and placebo in average pain intensity, daily opioid dose or in opioid withdrawal scores over the 12-week study.
Mogućnost interferencije s opioidnom analgezijom Tijekom 12-tjednog ispitivanja nisu primijećene klinički značajne razlike između naloksegola u dozi od 12,5 mg, naloksegola u dozi od 25 mg i placeba s obzirom na rezultate za prosječan intenzitet boli,
Therefore, concomitant use with strong CYP3A4 inhibitors is contraindicated (see section 4.3).
Stoga je istodobna primjena sa snažnim inhibitorima CYP3A4 kontraindicirana (vidjeti dio 4.3).
Moventig 12.5 mg tablets are available in aluminium blisters in pack sizes of 30 or 90 film-coated tablets in non-perforated blisters and 30x 1 or 90x1 film-coated tablets in perforated unit dose blisters.
Moventig 12,5 mg tablete dostupne su u aluminijskim blisterima u pakiranjima s 30 ili 90 filmom obloženih tableta u neperforiranim blisterima te u pakiranjima s 30x1 ili 90x1 filmom obloženom tabletom u perforiranim blisterima s jediničnim dozama.
Gastrointestinal obstruction
Gastrointestinalna opstrukcija
Enterohepatic recirculation may be an explanation as extensive biliary excretion was seen in the rat.
Razlog tome mogla bi biti enterohepatička recirkulacija; naime, u štakora je primijećeno opsežno izlučivanje kroz žuč.
Clinically important disruptions of the blood-brain barrier Naloxegol is a peripherally acting mu-opioid receptor antagonist with restricted access to the central nervous system (CNS).
Naloksegol je antagonist mi-opioidnih receptora perifernog djelovanja koji ima ograničen pristup središnjem živčanom sustavu (SŽS).
Package leaflet: Information for the patient Moventig 12.5 mg film-coated tablets Moventig 25 mg film-coated tablets naloxegol
Uputa o lijeku: Informacije za bolesnika Moventig 12,5 mg filmom obložene tablete Moventig 25 mg filmom obložene tablete naloksegol
Paediatric population The pharmacokinetics of naloxegol in the paediatric population has not been studied.
Pedijatrijska populacija Farmakokinetika naloksegola u pedijatrijskoj populaciji nije ispitivana.
Stool consistency in the LIR subgroup as measured by the Bristol stool scale improved in Kodiac 5 versus placebo (p<0.001) but not in Kodiac 4 (p=0.156).
Bristol stool scale) u odnosu na placebo u ispitivanju Kodiac 5 (p<0,001), ali ne i u ispitivanju Kodiac 4 (p=0,156).
Therefore, use in breast-feeding mothers is not recommended.
Stoga se primjena u dojilja ne preporučuje.
Consideration may be given to lowering the dose to 12.5mg in patients experiencing severe gastrointestinal adverse events depending upon the response and tolerability of individual patients.
U bolesnika u kojih se pojave teški gastrointestinalni štetni događaji može se razmotriti smanjenje doze na 12,5 mg, sukladno odgovoru i podnošljivosti pojedinih bolesnika.
In an open-label, non-randomized, fixed-sequence, 3-period, 3-treatment, crossover study to evaluate the effect of multiple doses of ketoconazole on the single dose PK of naloxegol, co-administration of ketoconazole and naloxegol resulted in a 12.9 fold (90% CI: 11.3-14.6) increase in naloxegol AUC and a 9.6-fold increase in naloxegol Cmax (90% CI: 8.1-11.3), 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 ketokonazola na farmakokinetiku jedne doze naloksegola, istodobna primjena ketokonazola i naloksegola povećala je AUC naloksegola 12,9 puta (90% CI: 11,3-14,6), a Cmax naloksegola 9,6 puta (90% CI: 8,1-11,3) u usporedbi s primjenom samo naloksegola.
Naloxegol has not been studied in patients with severe hepatic impairment.
Naloksegol nije ispitivan u bolesnika s teškim oštećenjem jetrene funkcije.
For extremity pain, the rate for naloxegol 25 mg was 3.5% versus 3.3% for usual care.
Stopa boli u ekstremitetima iznosila je 3,5% uz naloksegol u dozi od 25 mg naspram 3,3% uz standardno liječenje.
A possible treatment-related foetal skeletal malformation of fused arches was noted at highest dose tested in the rabbit embryo-foetal development study, in the absence of maternal toxicity.
U ispitivanju embriofetalnog razvoja na kunićima je pri najvećoj ispitivanoj dozi primijećena malformacija na kosturu ploda u vidu spojenih svodova koja bi mogla biti povezana s liječenjem, ali nije primijećena toksičnost za majku.
Under multiplicity testing procedure, statistical significance for the 12.5 mg treatment group versus placebo in the LIR subgroup was observed in Kodiac 4 (p=0.028) but not in Kodiac 5 (p=0.074).
U sklopu postupka testiranja multipliciteta, u podskupini bolesnika s NOL-om primijećena je statistička značajnost za skupinu liječenu dozom od 12,5 mg naspram placebom u ispitivanju Kodiac 4 (p=0,028), ali ne i u ispitivanju Kodiac 5 (p=0,074).
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.
Bolesnici koji su mogli sudjelovati u ispitivanju randomizirani su u omjeru 2:1 za primanje naloksegola u dozi od 25 mg na dan ili standardnog liječenja za konstipaciju uzrokovanu primjenom opioida tijekom 52 tjedna.
Naloxegol 25 mg dose, compared with placebo, also resulted in greater improvement (change from baseline) of week 12 PAC-SYM rectal domain scores in both studies (p=0.004 and p<0.001, Kodiac 4 and 5, respectively) and for the stool domain scores in Kodiac 4 (p=0.031) and Kodiac 5 (p<0.001).
U usporedbi s placebom, doza naloksegola od 25 mg dovela je također do većeg poboljšanja (promjena od početne vrijednosti) PAC-SYM rezultata u 12. tjednu za rektalnu domenu u oba ispitivanja (Kodiac 4 p=0,004; Kodiac 5 p<0,001), kao i rezultata za domenu stolice u ispitivanjima Kodiac 4 (p=0,031) i Kodiac 5 (p<0,001).
The Cmax and area under the plasma concentration-time curve (AUC) were increased by approximately 30% and 45%, respectively.
Cmax se povećao za približno 30%, a područje ispod krivulje „koncentracija u plazmi-vrijeme“ (AUC)
In Kodiac 4, response rates in the placebo, 12.5 mg and 25 mg groups in the LIR subgroup were 28.8%, 42.6% and 48.7%, while in Kodiac 5, the corresponding response rates were 31.4, 42.4% and 46.8%.
U ispitivanju Kodiac 4, stope odgovora u bolesnika koji su primali placebo, dozu od 12,5 mg odnosno dozu od 25 mg u podskupini bolesnika s NOL-om iznosile su 28,8%, 42,6% odnosno 48,7%, dok su u ispitivanju Kodiac 5 odgovarajuće stope iznosile 31,4%, 42,4% odnosno 46,8%.
In the 12-week studies (Kodiac 4 and 5), the frequency of back pain AEs was 4.3% for naloxegol 25 mg versus 2.0% for placebo, and the frequency of extremity pain AEs was 2.2% for naloxegol 25 mg, versus 0.7% for placebo.
U 12-tjednim ispitivanjima (Kodiac 4 i 5) učestalost nuspojave boli u leđima iznosila je 4,3% uz naloksegol u dozi od 25 mg naspram 2,0% uz placebo, dok je učestalost nuspojave boli u ekstremitetima iznosila 2,2% uz naloksegol u dozi od 25 mg naspram 0,7% uz placebo.
Tablet core mannitol (E421) cellulose microcrystalline (E460) croscarmellose sodium (E468) magnesium stearate (E470b) propyl gallate (E310)
karmelozanatrij, umrežena (E468) magnezijev stearat (E470b) propilgalat (E310)
Paediatric population The use of naloxegol in the paediatric population has not been studied.
Pedijatrijska populacija Primjena naloksegola u pedijatrijskoj populaciji nije ispitivana.
In male rats, a dose-related increase in Leydig cell adenomas and interstitial cell hyperplasia was observed at exposures considered sufficiently in excess of the maximum human exposure.
U mužjaka štakora je pri razinama izloženosti koje su se smatrale dovoljno većima od maksimalne kliničke izloženosti u ljudi primijećeno s dozom povezano povećanje incidencije adenoma Leydigovih stanica i hiperplazija intersticijskih stanica.
Concurrent methadone use
Istodobna primjena metadona
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”.
aOdnosi se na preporučene pojmove prema MedDRA-i za: „bol u abdomenu”, „bol u gornjem dijelu abdomena”, „bol u donjem dijelu abdomena” i „gastrointestinalna bol”.
Use in patients with severe hepatic impairment is not recommended.
Ne preporučuje se primjena u bolesnika s teškim oštećenjem jetrene funkcije.
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.
393 bolesnika bilo izloženo naloksegolu u dozi od 25 mg tijekom najmanje 6 mjeseci, a njih
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.
Mjera ishoda: bolesnici s odgovorom i poboljšanjem simptoma „Bolesnik s odgovorom i poboljšanjem simptoma“ definira se kao bolesnik koji je zadovoljio kriterije odgovora na liječenje nakon 12 tjedana i ostvario poboljšanje unaprijed utvrđenih simptoma konstipacije uzrokovane primjenom opioida te nije imao pogoršanja simptoma.
Moventig 25 mg film-coated tablet (tablet).
Moventig 25 mg filmom obložena tableta (tableta).
Moventig 12.5 mg film-coated tablet (tablet).
Moventig 12,5 mg filmom obložena tableta (tableta).
• if you have stomach ulcers, Crohn's Disease (an illness where your gut is inflamed), diverticulitis (another illness where your gut is inflamed), cancer in your gut or ‘peritoneum' (the lining of your stomach area), or any conditon that might damage the wall of your bowel
divertikulitis (još jedna bolest u kojoj je prisutna upala crijeva), rak crijeva ili „peritoneuma“ (ovojnice trbuha) ili bilo koje stanje koje bi moglo oštetiti stijenku crijeva
EU/1/14/962/001 30 film-coated tablets EU/1/14/962/002 90 film-coated tablets EU/1/14/962/008 30 x 1 film-coated tablets (unit dose) EU/1/14/962/003 90 x 1 film-coated tablets (unit dose)
EU/1/14/962/009 10 x 1 filmom obložena tableta (jedinična doza) EU/1/14/962/010 30 x 1 filmom obložena tableta (jedinična doza)
Doses of naloxegol up to 1,000 mg were administered in healthy volunteers in clinical studies.
U kliničkim su ispitivanjima zdravi dobrovoljci primali doze naloksegola do najviše 1000 mg.
Pack sizes of 30 x 1 and 90 x 1 film-coated tablets in perforated unit dose blisters.
Veličina pakiranja: 30 x 1 i 90 x 1 filmom obložena tableta u perforiranim blisterima s jediničnim dozama.
Moventig 12.5 mg film-coated tablets Moventig 25 mg film-coated tablets
Moventig 12,5 mg filmom obložene tablete Moventig 25 mg filmom obložene tablete
The use of naloxegol is not recommended in such patients.
U tih se bolesnika primjena naloksegola ne preporučuje.
In a pooled analysis of Kodiac 4 and Kodiac 5 (90, 88 and 99 patients in the placebo, 12.5 mg and 25 mg groups respectively), higher response rates in this population was observed for the 25 mg dose group compared with placebo (p=0.040).
U objedinjenoj analizi ispitivanja Kodiac 4 i Kodiac 5 (90 bolesnika koji su primali placebo, 88 bolesnika koji su primali dozu od 12,5 mg i 99 bolesnika koji su primali dozu od 25 mg),
Abdominal paina, diarrhoea
Poremećaji probavnog sustava bol u abdomenua, proljev flatulencija,
Mean number of days per week with at least one SBM There was an increase in the mean number of days per week with at least one SBM in the LIR subgroup for the 25 mg dose in Kodiak 4 and Kodiac 5 (p<0.001 in both studies) and also for the 12.5 mg dose (p=0.006 in both studies).
U podskupini bolesnika s NOL-om primijećeno je povećanje srednje vrijednosti broja dana na tjedan s najmanje jednim spontanim pražnjenjem crijeva za dozu od 25 mg u ispitivanjima Kodiac 4 i Kodiac 5 (p<0,001 u oba ispitivanja), ali i za dozu od 12,5 mg (p=0,006 u oba ispitivanja).
No antidote is known for naloxegol and dialysis was noted to be ineffective as a means of elimination in a clinical study in patients with renal failure.
Nema poznatog antidota za naloksegol, a u kliničkom ispitivanju u bolesnika sa zatajenjem bubrega utvrđeno je da dijaliza nije učinkovit način eliminacije naloksegola.
The 25 mg dose in the LIR subgroup increased mean days per week compared with placebo with at least 1 complete spontaneous bowel movement (CSBM) in both studies (Kodiac 4 p=0.002, Kodiac 5 p<0.001).
primjena doze od 25 mg povećala je u usporedbi s placebom srednju vrijednost broja dana na tjedan s najmanje 1 potpunim spontanim pražnjenjem crijeva u oba ispitivanja (Kodiac 4 p=0,002; Kodiac 5 p<0,001).
− tablet core: mannitol (E421), cellulose microcrystalline (E460), croscarmellose sodium (E468) - see section 2 under ‘Moventig contains sodium', magnesium stearate (E470b), propyl gallate (E310)
Jezgra tablete: manitol (E421), mikrokristalična celuloza (E460), umrežena karmelozanatrij (E468) - pogledajte pod naslovom „Moventig sadrži natrij“ u dijelu 2, magnezijev stearat (E470b), propil galat (E310) Film ovojnica: hipromeloza (E464), titanijev dioksid (E171), makrogol (E1521), crveni željezov oksid (E172) i crni željezov oksid (E172)
Patients with known or suspected gastrointestinal (GI) obstruction or in patients at increased risk of recurrent obstruction, due to the potential for gastrointestinal perforation (see section 4.4).
Bolesnici s poznatom ili suspektnom gastrointestinalnom opstrukcijom ili bolesnici u kojih postoji povećan rizik od rekurentne opstrukcije, zbog moguće perforacije u gastrointestinalnom sustavu
Tabulated list of adverse reactions Adverse reactions are classified according to frequency and System Organ Class.
Nuspojave su razvrstane prema učestalosti i klasifikaciji organskih sustava.
Long-term exposure to naloxegol 25 mg, up to 52 weeks, was generally safe and well tolerated in the treatment of OIC patients with non-cancer-related pain.
Dugotrajna izloženost naloksegolu do 52 tjedna u dozi od 25 mg za liječenje konstipacije uzrokovane primjenom opioida u bolesnika s boli koja nije uzrokovana rakom u načelu je bila sigurna i dobro se podnosila.
A potentially treatmentrelated increased incidence of the skeletal variant bipartite vertebral centrum and a single foetus with anorchism was seen at the highest dose tested in the rat embryo-foetal development study.
U ispitivanju embriofetalnog razvoja na štakorima je pri najvećoj ispitivanoj dozi primijećena povećana incidencija kosturne varijacije dvodijelnog središta kralješka koja bi mogla biti povezana s liječenjem te samo jedan plod s anorhizmom.
Oval, 13x7 mm, mauve tablet.
Ovalna tableta svijetloljubičaste boje, dimenzija 13 x 7 mm.
In the pooled data from Kodiac 4 and Kodiac 5, responder rates in the LIR subgroup were 30.1% for placebo, 42.5% for the 12.5 mg dose, and 47.7% for the 25 mg dose, with the relative risk (95% CI) for treatment effect versus placebo of 1.410(1.106, 1.797) and 1.584(1.253, 2.001) for the 12.5 mg and 25 mg groups, respectively.
25 mg, uz relativan rizik (95% CI) za učinak liječenja naspram placeba od 1,410 (1,106; 1,797) za skupinu koja je primala dozu od 12,5 mg te 1,584 (1,253; 2,001) za skupinu koja je primala dozu od 25 mg.
Pack sizes of 10, 30 and 90 film-coated tablets in non-perforated blisters.
Veličine pakiranja: 10, 30 i 90 filmom obloženih tableta u neperforiranim blisterima.
For dose recommendations for patients with moderate or severe renal insufficiency, see section 4.2.
Za preporuke u bolesnika s umjerenom ili teškom insuficijencijom bubrega, vidjeti dio 4.2. Spol ne utječe na farmakokinetiku naloksegola.
Moventig 25 mg tablets naloxegol
Moventig 25 mg tablete naloksegol
Less than 20% decrease in AUC and 10% decrease in Cmax were observed in patients with mild and moderate hepatic impairment (Child-Pugh Class A and B).
U bolesnika s blagim i umjerenim oštećenjem jetrene funkcije (Child-Pugh stadij A i B) primijećeno je smanjenje AUC-a manje od 20% te smanjenje Cmax od 10%.
Patient assessment of constipation symptoms (PAC-SYM) questionnaire Naloxegol 25 mg dose in the LIR subgroup resulted in a greater improvement (change from baseline) of patient assessment of constipation symptoms (PAC-SYM) total scores compared with placebo in both studies at 12 weeks (Kodiac 4 p=0.023, Kodiac 5 p=0.002).
Doza naloksegola od 25 mg je u podskupini bolesnika s NOL-om nakon 12 tjedana dovela do većeg poboljšanja (promjena od početne vrijednosti) ukupnih rezultata za simptome konstipacije prema procjeni bolesnika (PAC-SYM) u usporedbi s placebom u oba ispitivanja (Kodiac 4 p=0,023;
• The active substance is naloxegol.
• Djelatna tvar je naloksegol.
How to store Moventig
Moguće nuspojave Kako čuvati Moventig
The LIR subgroup symptom responder rates in Kodiac 4 for placebo, 12.5 mg and 25 mg arms were 24.6%, 36.5% and 45.3% and the symptom responder rates in Kodiac 5 were 25.6%, 33.6% and 42.7%.
U ispitivanju Kodiac 4 su u podskupini bolesnika s NOL-om stope bolesnika koji su postigli odgovor uz poboljšanje simptoma iznosile 24,6% za placebo, 36,5% za dozu od 12,5 mg i 45,3% za dozu od 25 mg, dok su u ispitivanju Kodiac 5 stope bolesnika koji su postigli odgovor uz poboljšanje simptoma iznosile 25,6% , 33,6% i 42,7%.
Thus renal excretion is a minor clearance pathway for naloxegol.
Dakle, izlučivanje kroz bubrege je sporedan put klirensa naloksegola.
Interaction with strong CYP3A4 inducers
Interakcija sa snažnim induktorima CYP3A4
Mechanism of action and pharmacodynamic effects Naloxegol is a PEGylated derivative of the mu-opioid receptor antagonist naloxone.
Naloksegol je pegilirani derivat antagonista mi-opioidnog receptora naloksona.
As renal clearance is a minor route of elimination for naloxegol, regardless of severity (i.e. moderate, severe and end stage renal failure), the impact of renal impairment on the pharmacokinetics of naloxegol was minimal in most subjects.
Budući da je bubrežni klirens sporedan put eliminacije naloksegola, utjecaj oštećenja bubrežne funkcije na farmakokinetiku naloksegola bio je minimalan u većine ispitanika, neovisno o stupnju oštećenja bubrežne funkcije (tj. umjeren, teški ili terminalni stadij zatajenja bubrega).
Pack sizes of 30 and 90 film-coated tablets in non-perforated blisters.
Veličine pakiranja: 30 i 90 filmom obloženih tableta u neperforiranim blisterima.
If any of the above apply to you, or you are not sure, talk to your doctor, pharmacist or nurse before taking Moventig.
Ako se bilo što od navedenoga odnosi na Vas ili niste sigurni, razgovarajte sa svojim liječnikom,
− Each Moventig 25 mg film-coated tablet (tablet) contains 25 mg naloxegol as naloxegol oxalate.
Jedna Moventig 25 mg filmom obložena tableta (tableta) sadrži 25 mg naloksegola u obliku naloksegoloksalata.
There was a higher incidence of discontinuations in patients taking the 25 mg dose compared to placebo due to diarrhoea (0.7% for placebo versus 3.1% for naloxegol 25 mg) and abdominal pain (0.2% versus 2.9%, respectively).
(0,7% za placebo naspram 3,1% za naloksegol u dozi od 25 mg) i bol u abdomenu (0,2% naspram 2,9%).
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.
Interakcija s drugim antagonistima opioida Potrebno je izbjegavati primjenu naloksegola s drugim antagonistom opioida (npr. naltreksonom,
Moventig 12.5 mg tablets naloxegol
Moventig 12,5 mg tablete naloksegol
• methadone
• mučnina
EU/1/14/962/004 10 film-coated tablets EU/1/14/962/005 30 film-coated tablets EU/1/14/962/006 90 film-coated tablets EU/1/14/962/009 10 x 1 film coated tablets (unit dose) EU/1/14/962/010 30 x 1 film-coated tablets (unit dose) EU/1/14/962/007 90 x 1 film-coated tablets (unit dose) EU/1/14/962/011 100 x 1 film-coated tablets (unit dose)
EU/1/14/962/004 10 filmom obloženih tableta EU/1/14/962/005 30 filmom obloženih tableta EU/1/14/962/006 90 filmom obloženih tableta
12.5 mg film-coated tablets
12,5 mg filmom obložene tablete
The 25 mg dose in the LIR subgroup improved rectal straining (Kodiac 4 p=0.043, Kodiac 5 p<0.001).
Poboljšanje simptoma konstipacije uzrokovane primjenom opioida Primjena doze od 25 mg je u podskupini bolesnika s NOL-om ublažila rektalno napinjanje (Kodiac 4 p=0,043; Kodiac 5 p<0,001).
In Kodiac 4, placebo, 12.5 mg and 25 mg dose had median time to first post dose SBM of 43.4, 20.6, and 5.4 hours, respectively.
U ispitivanju Kodiac 4 je medijan vremena do prvog spontanog pražnjenja crijeva nakon primjene doze iznosio 43,4 sata za placebo, 20,6 sati za dozu od 12,5 mg te 5,4 sata za dozu od
Severe hepatic impairment
Klinički značajna oštećenja krvno-moždane barijere
• rifampin (an antibiotic), carbmazepine (for epilepsy) or the herbal medicine St. John's wort (for depression).
• diltiazem ili verapamil (za visok krvni tlak ili anginu); možda ćete morati uzimati manju dozu lijeka Moventig • rifampicin (antibiotik), karbamazepin (za epilepsiju) ili biljni lijek gospinu travu (za depresiju);
Therefore, naloxegol has not been studied in OIC patients with moderate or severe hepatic impairment.
Stoga naloksegol nije ispitivan u bolesnika s konstipacijom uzrokovanom primjenom opioida koji su imali umjereno ili teško oštećenje jetrene funkcije.
25 mg film-coated tablets
25 mg filmom obložene tablete
Patients with CV conditions
Bolesnici s kardiovaskularnim bolestima
− Each Moventig 12.5 mg film-coated tablet (tablet) contains 12.5 mg naloxegol as naloxegol oxalate.
Jedna Moventig 12,5 mg filmom obložena tableta (tableta) sadrži 12,5 mg naloksegola u obliku naloksegoloksalata.
• excessive sweating
• glavobolja • prekomjerno znojenje
OIC was confirmed through a two week run in period and defined as < 3 spontaneous bowel movements (SBMs) per week on average with constipation symptoms associated with at least 25% of bowel movements.
Konstipacija uzrokovana primjenom opioida potvrđena je tijekom dvotjednog uvodnog razdoblja, a definirana je kao prosječno < 3 spontana pražnjenja crijeva na tjedan,
In the LIR subgroup, the 25 mg dose increased the symptom responder rates in both studies as compared to placebo (Kodiac 4 p=0.001, Kodiac 5 p=0.005).
U podskupini bolesnika s NOL-om, doza od 25 mg povećala je stopu bolesnika koji su postigli odgovor uz poboljšanje simptoma u odnosu na placebo u oba ispitivanja (Kodiac 4 p=0,001, Kodiac 5 p=0,005).
Method of administration Oral use.
Za peroralnu primjenu.