natgillin/translations-raw huggingface dataset:
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).
Bolniki z znano obstrukcijo prebavil ali sumom nanjo, ali bolniki z večjim tveganjem za ponovno obstrukcijo, ker obstaja možnost perforacije prebavil (glejte poglavje 4.4).
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 filmsko obloženih tablet 30 filmsko obloženih tablet 90 filmsko obloženih tablet 10 x 1 filmsko obložena tableta 30 x 1 filmsko obložena tableta 90 x 1 filmsko obložena tableta 100 x 1 filmsko obložena tableta
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.
Pri bolnikih s hudimi neželenimi učinki na prebavilih pride v poštev zmanjšanje odmerka na 12,5 mg, odvisno od odziva in prenašanja pri posameznem bolniku.
Contents of the pack and other information
Shranjevanje zdravila Moventig Vsebina pakiranja in dodatne informacije
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: 10,5 x 5,5 mm velike filmsko obložene tablete ovalne oblike in svetlo vijoličaste barve z oznako »nGL« na eni strani in »12,5« na drugi strani.
Naloxegol at therapeutic doses has minimal uptake across the blood brain barrier.
Naloksegol v terapevtskih odmerkih le minimalno prehaja skozi krvno-možgansko pregrado.
In a few cases, symptoms suggestive of opioid withdrawal when taking naloxegol 25 mg were observed in patients taking methadone for their pain condition.
V posameznih primerih so pri bolnikih, ki so za zdravljenje bolečinskega stanja jemali metadon, med uporabo 25 mg naloksegola opažali simptome, ki nakazujejo na odtegnitev opioidov.
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.
morfinskih ekvivalentnih enot opioidov in so imeli po lastni navedbi OIC. OIC je bila potrjena med dvotedenskim obdobjem uvajanja in je bila opredeljena kot povprečno < 3 spontana iztrebljanja na teden hkrati s simptomi zaprtja pri vsaj 25 % iztrebljanj.
30 film-coated tablets 90 film-coated tablets 30 x 1 film-coated tablets 90 x 1 film-coated tablets
30 filmsko obloženih tablet 90 filmsko obloženih tablet 30 x 1 filmsko obložena tableta 90 x 1 filmsko obložena tableta
Pack sizes of 10 x 1, 30 x 1, 90 x 1 and 100 x 1 film-coated tablets in perforated unit dose blisters.
Pakiranje z 10 x 1, 30 x 1, 90 x 1 in 100 x 1 filmsko obloženo tableto v perforiranih pretisnih omotih za posamezni odmerek.
Patients with moderate or severe hepatic insufficiency (Child's-Pugh Class B or C) were excluded from the Phase III studies (Kodiac 4 and 5).
Študiji III. faze (Kodiac 4 in 5) nista vključili bolnikov z zmerno ali hudo okvaro jeter (Child-Pugh razred B ali C).
The starting dose for patients taking moderate CYP3A4 inhibitors is 12.5 mg once daily and the dose can be increased to 25 mg if 12.5 mg is well tolerated by the patient (see section 4.2).
Začetni odmerek za bolnike, ki jemljejo zmerne zaviralce CYP3A4 (npr. diltiazem, verapamil), je 12,5 mg enkrat na dan. Odmerek je mogoče povečati na 25 mg, če bolnik dobro prenaša odmerek
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.
Zdravilo Moventig 12,5 mg tablete je na voljo v aluminijskih pretisnih omotih v pakiranjih s 30 ali 90 filmsko obloženimi tabletami v neperforiranih pretisnih omotih ter kot 30 x 1 ali 90 x 1 filmsko obložena tableta v perforiranih pretisnih omotih za posamezni odmerek.
Efficacy in the patient population targeted in this SmPC Response over 12 weeks in the LIR group
Odziv v 12 tednih v skupini z LIR
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/1/14/962/001 30 filmsko obloženih tablet EU/1/14/962/002 90 filmsko obloženih tablet EU/1/14/962/008 30 x 1 filmsko obložena tableta EU/1/14/962/003 90 x 1 filmsko obložena tableta
Do not take Moventig if any of the above apply to you.
Ne vzemite zdravila Moventig, če kaj od naštetega velja za vas.
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: 13 x 7 mm velike filmsko obložene tablete ovalne oblike in svetlo vijoličaste barve z oznako »nGL« na eni strani in »25« na drugi strani.
The Cmax and area under the plasma concentration-time curve (AUC) were increased by approximately 30% and 45%, respectively.
Cmax se je zvišala za približno 30 %, površina pod krivuljo plazemske koncentracije po času (AUC) pa za približno
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.
Zdravilo Moventig 25 mg tablete je na voljo v aluminijskih pretisnih omotih v pakiranjih z 10, 30 ali 90 filmsko obloženimi tabletami v neperforiranih pretisnih omotih ter kot 10 x 1, 30 x 1, 90 x 1 ali 100 x 1 filmsko obložena tableta v perforiranih pretisnih omotih za posamezni odmerek.
Naloxegol use is therefore not recommended during pregnancy.
Zato uporaba naloksegola med nosečnostjo ni priporočljiva.
If opioid withdrawal syndrome is suspected the patient should discontinue Moventig and contact their physician.
V primeru suma na sindrom odtegnitve opioidov mora bolnik prenehati jemati zdravilo Moventig in se posvetovati z zdravnikom.
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 periferno delujoč antagonist mi-opioidnih receptorjev z omejenim dostopom v osrednje živčevje (CNS - Central Nervous System).
It is unknown whether naloxegol is excreted in human milk.
Ni znano, ali se naloksegol pri človeku izloča v materino mleko.
Enterohepatic recirculation may be an explanation as extensive biliary excretion was seen in the rat.
Pojasnilo za to je lahko enterohepatično kroženje, kajti pri podganah so ugotovili obsežno izločanje z žolčem.
As the effects of P-gp inhibitors on the PK of naloxegol were small relative to the effects CYP3A4 inhibitors, the dosing recommendations for Moventig when co-administered with medicinal products causing both P-gp and CYP3A4 inhibition should be based on CYP3A4 inhibitor status - strong, moderate or weak (see sections 4.2, 4.3 and 4.5).
CYP3A4, morajo priporočila za sočasno uporabo zdravila Moventig z zdravili, ki zavrejo tako P-gp kot CYP3A4, temeljiti na inhibicijskem stanju CYP3A4 - močno, zmerno ali šibko zavrtje (glejte poglavja 4.2, 4.3 in 4.5).
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).
S postopkom za večkratno testiranje so statistično značilnost z odmerkom 12,5 mg v primerjavi s placebom v podskupini LIR ugotovili v Kodiac 4 (p = 0,028), ne pa v Kodiac 5 (p = 0,074).
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Če imate dodatna vprašanja o uporabi zdravila, se s posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
Paediatric population The pharmacokinetics of naloxegol in the paediatric population has not been studied.
Pediatrična populacija Farmakokinetika naloksegola pri pediatrični populaciji ni raziskana.
If any of the above apply to you, or you are not sure, talk to your doctor, pharmacist or nurse before taking Moventig.
Če kaj od naštetega velja za vas ali če ste negotovi, se pred začetkom jemanja zdravila Moventig posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
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.
Pri podganjih samcih so ob izpostavljenostih, ki so dovolj presegale največjo izpostavljenost pri človeku, opažali z odmerkom povezan porast adenomov Leydigovih celic in hiperplazijo intersticijskih celic.
• underlying malignancies of gastrointestinal tract or peritoneum
osebe • z osnovno maligno boleznijo prebavil ali peritoneja,
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.
Ledvični očistek je ne glede na izrazitost okvare ledvic (tj. zmerna ali huda okvara ali končna odpoved ledvic) manj pomembna pot odstranjevanja naloksegola.
The 25 mg dose in the LIR subgroup improved rectal straining (Kodiac 4 p=0.043, Kodiac 5 p<0.001).
Odmerek 25 mg je v podskupini LIR izboljšal naprezanje danke (Kodiac 4 p = 0,043, Kodiac 5 p < 0,001).
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 filmsko obloženih tablet EU/1/14/962/005 30 filmsko obloženih tablet EU/1/14/962/006 90 filmsko obloženih tablet EU/1/14/962/009 10 x 1 filmsko obložena tableta EU/1/14/962/010 30 x 1 filmsko obložena tableta EU/1/14/962/007 90 x 1 filmsko obložena tableta EU/1/14/962/011 100 x 1 filmsko obložena tableta
Oval, 10.5x5.5 mm, mauve tablet.
Ovalna, 10,5 x 5,5 mm velika tableta svetlo vijoličaste barve.
These metabolites represented more than 32% of the administered dose and were formed via N-dealkylation, O-demethylation, oxidation and partial loss of the PEG chain.
Ti presnovki predstavljajo več kot 32 % uporabljenega odmerka in nastanejo z N-dealkilacijo,
Efficacy and durability of effect were measured in the primary end-point as response over the 12-week treatment period to naloxegol as defined by > 3 SBMs per week and a change from baseline of > 1 SBM per week for at least 9 out of the 12 study weeks and 3 out of the last 4 weeks.
Odziv je bil opredeljen kot > 3 spontana iztrebljanja na teden in sprememba od izhodišča za > 1 spontano iztrebljanje na teden v vsaj 9 od 12
A potential CNS effect (reversal of opioid-induced miosis, as measured by pupillometry) was observed in 1 volunteer in the 250 mg group and 1 volunteer in the 1,000 mg group.
1 prostovoljcu v skupini, ki je dobil 250 mg, in pri 1 prostovoljcu v skupini, ki je dobil 1.000 mg.
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%.
V Kodiac 4 je bil v podskupini LIR delež odziva s placebom 28,8 %, z 12,5 mg 42,6 % in s 25 mg 48,7 %; v Kodiac 5 so bili ustrezni deleži odziva 31,4 %, 42,4 % in 46,8 %.
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.
V študiji embrio-fetalnega razvoja na podganah so ob največjem testiranem odmerku opazili potencialno z zdravilom povezano povečanje incidence skeletne različice bipartitnega vretenčnega centra in en sam zarodek z anorhizmom.
• 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).
napredovalega raka jajčnika ali ponovitev takšnega raka ali dobivate zdravila, ki se uporabljajo za zdravljenje raka, kot so »zaviralci VEGF« (npr. bevacizumab);
Refer to section 6.6 for further information on administration through a nasogastric tube.
Za nadaljnje informacije o uporabi po nazogastrični sondi glejte poglavje 6.6.
For extremity pain, the rate for naloxegol 25 mg was 3.5% versus 3.3% for usual care.
Delež bolečin v udih je bil v skupini s 25 mg naloksegola 3,5 % in v skupini z običajno oskrbo 3,3 %.
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).
Pri bolnikih z blago in zmerno okvaro jeter (Child-Pugh razreda A in B) so ugotovili manj kot 20 % znižanje AUC in 10 % znižanje Cmax.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS Blister perforated unit dose
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU Perforiran pretisni omot za posamezni odmerek Neperforiran pretisni omot
The starting dose for patients taking moderate CYP3A4 inhibitors (e.g. diltiazem, verapamil) is 12.5 mg once daily.
Začetni odmerek za bolnike, ki jemljejo zmerne zaviralce CYP3A4, je 12,5 mg enkrat na dan;
Tablet coat hypromellose (E464) titanium dioxide (E171) macrogol (E1521) iron oxide red (E172) iron oxide black (E172)
Prevleka tablete hipromeloza (E464) titanov dioksid (E171) makrogol (E1521)
Gastrointestinal obstruction
Obstrukcija (zapora) prebavil
• if the natural protective barrier between the blood vessels in the head and in the brain is damaged, for example if you have cancer in the brain or the central nervous system, or if you have a disease of the central nervous system like multiple sclerosis or Alzheimer's diseasecontact your doctor immediately if you experience lack of pain relief from your opioid medicine or symptoms of opioid withdrawal syndrome (see section 4).
• če imate okvarjeno naravno zaščitno pregrado med žilami v glavi in možgani, na primer če imate raka možganov ali osrednjega živčevja, ali če imate kakšno bolezen osrednjega živčevja,
OIC symptom improvement
Izboljšanje simptomov zaprtja zaradi opioidov
There is no gender effect on the PK of naloxegol.
Spol ne vpliva na farmakokinetiko naloksegola.
Pack sizes of 10, 30 and 90 film-coated tablets in non-perforated blisters.
Pakiranje z 10, 30 in 90 filmsko obloženimi tabletami v neperforiranih pretisnih omotih.
If you are not sure, talk to your doctor, pharmacist or nurse before taking Moventig.
Če ste negotovi, se pred začetkom jemanja zdravila Moventig posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
No dose adjustment is required for patients with mild to moderate hepatic impairment.
Bolnikom z blago do zmerno okvaro jeter odmerka ni treba prilagoditi.
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.
Za naloksegol ni znanega antidota; klinična študija pri bolnikih z odpovedjo ledvic je pokazala, da dializa ni učinkovita za njegovo odstranitev.
Pack sizes of 30 and 90 film-coated tablets in non-perforated blisters.
Pakiranje s 30 in 90 filmsko obloženimi tabletami v neperforiranih pretisnih omotih.
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).
Odmerek 25 mg je v podskupini LIR v primerjavi s placebom povečal povprečno število dni z vsaj enim popolnim spontanim iztrebljanjem na teden v obeh študijah (Kodiac 4 p = 0,002, Kodiac 5 p < 0,001).
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).
Odmerek 25 mg naloksegola je v podskupini LIR po 12 tednih v obeh študijah prinesel večje izboljšanje (spremembo od izhodišča) bolnikove celotne ocene simptomov zaprtja (PAC-SYM) kot placebo (Kodiac 4 p = 0,023, Kodiac 5 p = 0,002).
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%.
V Kodiac 4 je bil delež odziva simptomov v podskupini LIR s placebom 24,6 %, z 12,5 mg 36,5 % in s 25 mg 45,3 %, v Kodiac 5 pa so bili ti deleži 25,6 %, 33,6 % in 42,7 %.
If evidence for opioid-mediated interference with analgesia or opioid withdrawal syndrome occurs, patients should be instructed to discontinue Moventig and contact their physician.
Bolniku je treba naročiti, naj v primeru ovirane analgezije z opioidi ali sindroma odtegnitve opioidov neha jemati zdravilo Moventig in naj se posvetujte z zdravnikom.
Infections and Infestations
Infekcijske in parazitske bolezni nazofaringitis
In a long-term safety study (Kodiac 8), the frequency of AE reports of back pain was 8.9% for naloxegol 25 mg versus 8.8% for usual care.
(Kodiac 8) je bila pogostnost neželenega učinka bolečine v hrbtu v skupini s 25 mg naloksegola 8,9 % in v skupini z običajno oskrbo 8,8 %.
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.
89 % (90 % IZ: 88-90 %) znižanje AUC naloksegola in 76 % (90 % IZ: 69-80 %) znižanje Cmax naloksegola v primerjavi z uporabo naloksegola samega.
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.
V dveh 12-tedenskih študijah (Kodiac 4 in 5) je bila pogostnost neželenega učinka bolečine v hrbtu v skupini s 25 mg naloksegola 4,3 % in v skupini s placebom 2,0 %, neželenega učinka bolečine v udih pa v skupini s 25 mg naloksegola 2,2 % in v skupini s placebom 0,7 %.
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).
V podskupini LIR se je povprečno tedensko število dni z vsaj enim spontanim iztrebljanjem povečalo v Kodiac 4 in Kodiac 5 tako z odmerkom 25 mg (p < 0,001 v obeh študijah) kot z odmerkom 12,5 mg (p = 0,006 v obeh študijah).
6.5 Nature and contents of container
6.5 Vrsta ovojnine in vsebina alu/alu pretisni omot
Moventig 12.5 mg film-coated tablets Moventig 25 mg film-coated tablets
Moventig 12,5 mg filmsko obložene tablete Moventig 25 mg filmsko obložene tablete
No dosage adjustment is required for patients taking weak CYP3A4 inhibitors.
Bolnikom, ki jemljejo šibke zaviralce CYP3A4, odmerka ni treba prilagoditi.
• stomach pain • diarrhoea (passing of frequent, watery stools)
• driska (pogosto odvajanje blata, ki je vodeno)
In a thorough QT/QTc study, as defined by the ICH E14 Guideline, there were no clinically important changes in HR, RR, QT, PR or QRS intervals or T wave morphology observed.
ICH E14, ni bilo klinično pomembnih sprememb srčne frekvence, intervalov RR, QT, PR ali QRS ali morfologije vala T. Poleg tega v tej študiji vse do največjega uporabljenega odmerka (150 mg) niso ugotovili nobenih zadržkov glede varnosti in prenašanja.
Pack sizes of 30 x 1 and 90 x 1 film-coated tablets in perforated unit dose blisters.
Pakiranje s 30 x 1 in 90 x 1 filmsko obloženo tableto v perforiranih pretisnih omotih za posamezni odmerek.
Table 1 Adverse reactions by System Organ Class (SOC) and frequency System Organ Classification
Neželeni učinki po organskem sistemu in pogostnosti
• Patients with underlying cancer who are at heightened risk of GI perforation, such as those with:
Stanja pri bolnikih z bolečinami zaradi raka • Bolniki z osnovno onkološko boleznijo, ki imajo večje tveganje za perforacijo prebavil, npr.
Severe hepatic impairment
Klinično pomembna prizadetost krvno-možganske pregrade
− tablet core: mannitol (E421), cellulose microcrystalline (E460), croscarmellose sodium (E468) - see section 2 under ‘Moventig contains sodium', magnesium stearate (E470b), propyl gallate (E310)
• Druge sestavine zdravila so: jedro tablete: manitol (E421), mikrokristalna celuloza (E460), premreženi natrijev karmelozat (E468) - glejte poglavje 2 pod 'Zdravilo Moventig vsebuje natrij', magnezijev stearat (E470b), propilgalat (E310), filmska obloga: hipromeloza (E464), titanov dioksid (E171), makrogol (E1521), rdeči železov oksid (E172) in črni železov oksid (E172).
Patients should be advised to discontinue therapy with naloxegol and promptly notify their physician if they develop unusually severe or persistent abdominal pain.
Bolnikom je treba naročiti, naj v primeru nenavadno hudih ali dolgotrajnih bolečin v trebuhu nehajo jemati naloksegol in nemudoma obvestijo zdravnika.
Therefore, caution should be used when prescribing naloxegol to such patients (see section 4.3).
Zato je pri predpisovanju naloksegola takšnim bolnikom potrebna previdnost (glejte poglavje 4.3) Moventig vsebuje natrija
Moventig 12.5 mg film-coated tablet (tablet).
Moventig 12,5 mg filmsko obložena tableta (tableta)
25 mg film-coated tablets
25 mg filmsko obložene tablete
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.
Naloksegol ni bil raziskan v programu kliničnih preskušanj pri bolnikih z anamnezo nedavnega miokardnega infarkta v zadnjih 6 mesecih, simptomatskega kongestivnega srčnega popuščanja,
Naloxegol has not been studied in patients with severe hepatic impairment.
Huda okvara jeter Naloksegol ni raziskan pri bolnikih s hudo okvaro jeter.
No dose adjustment is required for patients taking weak CYP3A4 inhibitors (e.g. alprazolam, atorvastatin (see section 4.5).
Bolnikom, ki jemljejo šibke zaviralce CYP3A4 (npr. alprazolam, atorvastatin), odmerka ni treba prilagoditi (glejte poglavje 4.5).
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).
Konsistenca blata, merjena z Bristolsko lestvico blata (Bristol stool scale), se je v podskupini LIR v Kodiac 5 v primerjavi s placebom izboljšala (p < 0,001), v Kodiac 4 pa ne
Gastrointestinal perforation (see section 4.4)
rifampin, šentjanževko) (glejte poglavje 4.5).
• if you have cancer-related pain
• če imate hudo bolezen jeter, • če imate bolečine zaradi raka.
Interaction with strong CYP3A4 inducers
Medsebojno delovanje z močnimi induktorji CYP3A4
12.5 mg film-coated tablets
12,5 mg filmsko obložene tablete
The dose can be increased to 25 mg if 12.5 mg is well tolerated by the patient (see section 5.2).
Odmerek je mogoče povečati na 25 mg, če bolnik dobro prenaša odmerek 12,5 mg (glejte poglavje 5.2).
Therefore, a dose adjustment of naloxegol is recommended when co-administered with diltiazem and other moderate CYP3A4 inhibitors (see section 4.2).
Zato je med sočasno uporabo naloksegola in diltiazema ali drugih zmernih zaviralcev CYP3A4 odmerek naloksegola priporočljivo prilagoditi (glejte poglavje
Studies in animals have shown reproductive toxicity where systemic exposures were several times above the therapeutic exposure level (see section 5.3).
Študije na živalih so pokazale vpliv na sposobnost razmnoževanja pri sistemski izpostavljenosti,
The dose can be increased to 25 mg if 12.5 mg is well tolerated by the patient (see section 4.2).
Odmerek je mogoče povečati na 25 mg, če bolnik dobro prenaša odmerek 12,5 mg (glejte poglavje 4.2).