FrancophonIA/ELRC3.0 huggingface dataset:
English: 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).
Slovenian: 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).
English: 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).
Slovenian: 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).
English: If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Slovenian: Če imate dodatna vprašanja o uporabi zdravila, se s posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: Paediatric population The pharmacokinetics of naloxegol in the paediatric population has not been studied.
Slovenian: Pediatrična populacija Farmakokinetika naloksegola pri pediatrični populaciji ni raziskana.
English: If any of the above apply to you, or you are not sure, talk to your doctor, pharmacist or nurse before taking Moventig.
Slovenian: Če kaj od naštetega velja za vas ali če ste negotovi, se pred začetkom jemanja zdravila Moventig posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: 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.
Slovenian: 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.
English: • underlying malignancies of gastrointestinal tract or peritoneum
Slovenian: osebe • z osnovno maligno boleznijo prebavil ali peritoneja,
English: 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.
Slovenian: Ledvični očistek je ne glede na izrazitost okvare ledvic (tj. zmerna ali huda okvara ali končna odpoved ledvic) manj pomembna pot odstranjevanja naloksegola.
English: The 25 mg dose in the LIR subgroup improved rectal straining (Kodiac 4 p=0.043, Kodiac 5 p<0.001).
Slovenian: Odmerek 25 mg je v podskupini LIR izboljšal naprezanje danke (Kodiac 4 p = 0,043, Kodiac 5 p < 0,001).
English: 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)
Slovenian: 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
English: Oval, 10.5x5.5 mm, mauve tablet.
Slovenian: Ovalna, 10,5 x 5,5 mm velika tableta svetlo vijoličaste barve.
English: 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.
Slovenian: Ti presnovki predstavljajo več kot 32 % uporabljenega odmerka in nastanejo z N-dealkilacijo,
English: 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.
Slovenian: 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
English: 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.
Slovenian: 1 prostovoljcu v skupini, ki je dobil 250 mg, in pri 1 prostovoljcu v skupini, ki je dobil 1.000 mg.
English: 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%.
Slovenian: 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 %.
English: 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.
Slovenian: 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.
English: • 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).
Slovenian: napredovalega raka jajčnika ali ponovitev takšnega raka ali dobivate zdravila, ki se uporabljajo za zdravljenje raka, kot so »zaviralci VEGF« (npr. bevacizumab);
English: Refer to section 6.6 for further information on administration through a nasogastric tube.
Slovenian: Za nadaljnje informacije o uporabi po nazogastrični sondi glejte poglavje 6.6.
English: For extremity pain, the rate for naloxegol 25 mg was 3.5% versus 3.3% for usual care.
Slovenian: Delež bolečin v udih je bil v skupini s 25 mg naloksegola 3,5 % in v skupini z običajno oskrbo 3,3 %.
English: 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).
Slovenian: 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.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS Blister perforated unit dose
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU Perforiran pretisni omot za posamezni odmerek Neperforiran pretisni omot
English: The starting dose for patients taking moderate CYP3A4 inhibitors (e.g. diltiazem, verapamil) is 12.5 mg once daily.
Slovenian: Začetni odmerek za bolnike, ki jemljejo zmerne zaviralce CYP3A4, je 12,5 mg enkrat na dan;
English: Tablet coat hypromellose (E464) titanium dioxide (E171) macrogol (E1521) iron oxide red (E172) iron oxide black (E172)
Slovenian: Prevleka tablete hipromeloza (E464) titanov dioksid (E171) makrogol (E1521)
English: Gastrointestinal obstruction
Slovenian: Obstrukcija (zapora) prebavil
English: • 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).
Slovenian: • 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,
English: OIC symptom improvement
Slovenian: Izboljšanje simptomov zaprtja zaradi opioidov
English: There is no gender effect on the PK of naloxegol.
Slovenian: Spol ne vpliva na farmakokinetiko naloksegola.
English: Pack sizes of 10, 30 and 90 film-coated tablets in non-perforated blisters.
Slovenian: Pakiranje z 10, 30 in 90 filmsko obloženimi tabletami v neperforiranih pretisnih omotih.
English: If you are not sure, talk to your doctor, pharmacist or nurse before taking Moventig.
Slovenian: Če ste negotovi, se pred začetkom jemanja zdravila Moventig posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: No dose adjustment is required for patients with mild to moderate hepatic impairment.
Slovenian: Bolnikom z blago do zmerno okvaro jeter odmerka ni treba prilagoditi.
English: 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.
Slovenian: Za naloksegol ni znanega antidota; klinična študija pri bolnikih z odpovedjo ledvic je pokazala, da dializa ni učinkovita za njegovo odstranitev.
English: Pack sizes of 30 and 90 film-coated tablets in non-perforated blisters.
Slovenian: Pakiranje s 30 in 90 filmsko obloženimi tabletami v neperforiranih pretisnih omotih.
English: 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).
Slovenian: 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).
English: 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).
Slovenian: 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).
English: 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%.
Slovenian: 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 %.
English: If evidence for opioid-mediated interference with analgesia or opioid withdrawal syndrome occurs, patients should be instructed to discontinue Moventig and contact their physician.
Slovenian: 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.
English: Infections and Infestations
Slovenian: Infekcijske in parazitske bolezni nazofaringitis
English: 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.
Slovenian: (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 %.
English: 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.
Slovenian: 89 % (90 % IZ: 88-90 %) znižanje AUC naloksegola in 76 % (90 % IZ: 69-80 %) znižanje Cmax naloksegola v primerjavi z uporabo naloksegola samega.
English: 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.
Slovenian: 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 %.
English: 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).
Slovenian: 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).
English: 6.5 Nature and contents of container
Slovenian: 6.5 Vrsta ovojnine in vsebina alu/alu pretisni omot
English: Moventig 12.5 mg film-coated tablets Moventig 25 mg film-coated tablets
Slovenian: Moventig 12,5 mg filmsko obložene tablete Moventig 25 mg filmsko obložene tablete
English: No dosage adjustment is required for patients taking weak CYP3A4 inhibitors.
Slovenian: Bolnikom, ki jemljejo šibke zaviralce CYP3A4, odmerka ni treba prilagoditi.
English: • stomach pain • diarrhoea (passing of frequent, watery stools)
Slovenian: • driska (pogosto odvajanje blata, ki je vodeno)
English: 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.
Slovenian: 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.
English: Pack sizes of 30 x 1 and 90 x 1 film-coated tablets in perforated unit dose blisters.
Slovenian: Pakiranje s 30 x 1 in 90 x 1 filmsko obloženo tableto v perforiranih pretisnih omotih za posamezni odmerek.
English: Table 1 Adverse reactions by System Organ Class (SOC) and frequency System Organ Classification
Slovenian: Neželeni učinki po organskem sistemu in pogostnosti
English: • Patients with underlying cancer who are at heightened risk of GI perforation, such as those with:
Slovenian: Stanja pri bolnikih z bolečinami zaradi raka • Bolniki z osnovno onkološko boleznijo, ki imajo večje tveganje za perforacijo prebavil, npr.
English: Severe hepatic impairment
Slovenian: Klinično pomembna prizadetost krvno-možganske pregrade
English: Moventig 25 mg tablets naloxegol
Slovenian: Moventig 25 mg tablete naloksegol
English: − tablet core: mannitol (E421), cellulose microcrystalline (E460), croscarmellose sodium (E468) - see section 2 under ‘Moventig contains sodium', magnesium stearate (E470b), propyl gallate (E310)
Slovenian: • 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).
English: Patients should be advised to discontinue therapy with naloxegol and promptly notify their physician if they develop unusually severe or persistent abdominal pain.
Slovenian: Bolnikom je treba naročiti, naj v primeru nenavadno hudih ali dolgotrajnih bolečin v trebuhu nehajo jemati naloksegol in nemudoma obvestijo zdravnika.
English: Therefore, caution should be used when prescribing naloxegol to such patients (see section 4.3).
Slovenian: Zato je pri predpisovanju naloksegola takšnim bolnikom potrebna previdnost (glejte poglavje 4.3) Moventig vsebuje natrija
English: Moventig 12.5 mg film-coated tablet (tablet).
Slovenian: Moventig 12,5 mg filmsko obložena tableta (tableta)
English: 25 mg film-coated tablets
Slovenian: 25 mg filmsko obložene tablete
English: 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.
Slovenian: Naloksegol ni bil raziskan v programu kliničnih preskušanj pri bolnikih z anamnezo nedavnega miokardnega infarkta v zadnjih 6 mesecih, simptomatskega kongestivnega srčnega popuščanja,
English: Naloxegol has not been studied in patients with severe hepatic impairment.
Slovenian: Huda okvara jeter Naloksegol ni raziskan pri bolnikih s hudo okvaro jeter.
English: No dose adjustment is required for patients taking weak CYP3A4 inhibitors (e.g. alprazolam, atorvastatin (see section 4.5).
Slovenian: Bolnikom, ki jemljejo šibke zaviralce CYP3A4 (npr. alprazolam, atorvastatin), odmerka ni treba prilagoditi (glejte poglavje 4.5).
English: 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).
Slovenian: 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
English: Gastrointestinal perforation (see section 4.4)
Slovenian: rifampin, šentjanževko) (glejte poglavje 4.5).
English: • if you have cancer-related pain
Slovenian: • če imate hudo bolezen jeter, • če imate bolečine zaradi raka.
English: Interaction with strong CYP3A4 inducers
Slovenian: Medsebojno delovanje z močnimi induktorji CYP3A4
English: 12.5 mg film-coated tablets
Slovenian: 12,5 mg filmsko obložene tablete
English: The dose can be increased to 25 mg if 12.5 mg is well tolerated by the patient (see section 5.2).
Slovenian: Odmerek je mogoče povečati na 25 mg, če bolnik dobro prenaša odmerek 12,5 mg (glejte poglavje 5.2).
English: Therefore, a dose adjustment of naloxegol is recommended when co-administered with diltiazem and other moderate CYP3A4 inhibitors (see section 4.2).
Slovenian: Zato je med sočasno uporabo naloksegola in diltiazema ali drugih zmernih zaviralcev CYP3A4 odmerek naloksegola priporočljivo prilagoditi (glejte poglavje
English: Studies in animals have shown reproductive toxicity where systemic exposures were several times above the therapeutic exposure level (see section 5.3).
Slovenian: Študije na živalih so pokazale vpliv na sposobnost razmnoževanja pri sistemski izpostavljenosti,
English: The dose can be increased to 25 mg if 12.5 mg is well tolerated by the patient (see section 4.2).
Slovenian: Odmerek je mogoče povečati na 25 mg, če bolnik dobro prenaša odmerek 12,5 mg (glejte poglavje 4.2).
English: Mechanism of action and pharmacodynamic effects Naloxegol is a PEGylated derivative of the mu-opioid receptor antagonist naloxone.
Slovenian: Naloksegol je PEGiliran derivat antagonista mi-opioidnih receptorjev naloksona.
English: The 12.5 mg dose in the LIR subgroup also demonstrated shorter time to first post-dose SBM as compared to placebo in Kodiac 4 (p=0.002) and Kodiac 5 (p<0.001).
Slovenian: 12,5 mg je bil čas do prvega spontanega iztrebljanja po odmerku v podskupini LIR krajši kot s placebom tako v Kodiac 4 (p = 0,002) kot v Kodiac 5 (p < 0,001).
English: 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.
Slovenian: Bolezni in motnje, povezane z večjo možnostjo za perforacijo prebavil V obdobju trženja zdravila so poročali o primerih perforacije prebavil, vključno s smrtnimi primeri,
English: Naloxegol functions as a peripherally-acting mu-opioid receptor antagonist in the gastrointestinal tract, thereby decreasing the constipating effects of opioids without impacting opioid-mediated analgesic effects on the central nervous system.
Slovenian: Tako zmanjša konstipacijski učinek opioidov, ne da bi poslabšal njihove analgetične učinke v osrednjem živčevju.
English: • The active substance is naloxegol.
Slovenian: • Učinkovina je naloksegol.
English: Co-administration of naloxegol and quinidine did not antagonize the morphine-induced miosis effect, suggesting that P-gp inhibition does not meaningfully change the capacity of naloxegol to cross the blood-brain barrier at therapeutic doses.
Slovenian: To kaže, da zavrtje P-gp pri terapevtskih odmerkih ne spremeni pomembno zmožnosti naloksegola za prehod skozi krvno-možgansko pregrado.
English: 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).
Slovenian: zmanjšano motiliteto prebavil, hipertoničnost in večjo absorpcijo tekočine kot posledico dolgotrajnega zdravljenja z opioidi).
English: None of the metabolites were present in > 10% of the plasma concentrations of parent or total parent and metabolite related material.
Slovenian: plazemske koncentracije matične snovi ali celotne koncentracije matične spojine in s presnovki povezanih snovi.
English: Moventig 12.5 mg tablets naloxegol
Slovenian: Moventig 12,5 mg tablete naloksegol
English: Name and address of the manufacturers responsible for batch release
Slovenian: A. IZDELOVALCI, ODGOVORNI ZA SPROŠČANJE SERIJ Ime in naslov izdelovalcev, odgovornih za sproščanje serij
English: No dosage adjustment is required for patients with mild renal impairment.
Slovenian: Bolnikom z blago okvaro ledvic odmerka ni treba prilagoditi.
English: It is used when laxatives have not provided acceptable relief of constipation.
Slovenian: Uporabimo ga, če odvajala ne dosežejo ustreznega izboljšanja zaprtja.
English: Moventig 25 mg film-coated tablets Each film-coated tablet contains naloxegol oxalate equivalent to 25 mg naloxegol.
Slovenian: Moventig 25 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 25 mg naloksegola v obliki naloksegolijevega oksalata.
English: The mixture can also be administered via a nasogastric tube (CH8 or greater), in this case the tablet can be crushed to a powder and mixed with water (120 ml).
Slovenian: V tem primeru lahko tableto zdrobite v prašek in zmešate z vodo (120 ml).
English: • if you take diltiazem or verapamil (for high blood pressure or angina) Your doctor may tell you to increase the dose to 25 mg depending on how you respond to the medicine.
Slovenian: • če jemljete diltiazem ali verapamil (za visok krvni tlak ali angino pektoris).
English: − Each Moventig 25 mg film-coated tablet (tablet) contains 25 mg naloxegol as naloxegol oxalate.
Slovenian: Ena filmsko obložena tableta (tableta) zdravila Moventig 25 mg vsebuje 25 mg naloksegola v obliki naloksegolijevega oksalata.
English: Moventig 12.5 mg film-coated tablets Each film-coated tablet contains naloxegol oxalate equivalent to 12.5 mg naloxegol.
Slovenian: Moventig 12,5 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 12,5 mg naloksegola v obliki naloksegolijevega oksalata.
English: 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.
Slovenian: Klinična preskušanja so pokazala, da zdravilo Moventig poveča število iztrebljanj in izboljša simptome zaprtja, ki jih povzročajo opioidi, pri bolnikih, ki jemljejo opioide, so zaprti ter so poskusili vsaj eno odvajalo, vendar z njim niso dosegli popolnega olajšanja zaprtja.
English: GENERAL CLASSIFICATION FOR SUPPLY
Slovenian: Organski sistem Razvrstitev
English: How to store Moventig
Slovenian: Shranjevanje zdravila Moventig
English: Moventig contains the active substance naloxegol.
Slovenian: Zdravilo Moventig vsebuje zdravilno učinkovino naloksegol.