FrancophonIA/ELRC3.0 huggingface dataset:
English: Rizmoic is a round, approximately 6.5 mm diameter, yellow film-coated tablet debossed with '222' and the Shionogi logo on one side and '0.2' on the other side.
Maltese: Rizmoic huwa pillola safra tonda miksija b'rita, b'dijametru ta' madwar 6.5 mm, mnaqqxa b'‘222' u llogo Shionogi fuq naħa waħda u ‘0.2' fuq in-naħa l-oħra.
English: Pharmacotherapeutic group: Drugs for constipation, peripheral opioid receptor antagonists, ATC code: A06AH05.
Maltese: Mediċina għall-istitikezza, antagonisti tar-riċettur tal-opjojdi periferali, kodiċi ATC:
English: Itraconazole, a strong CYP3A inhibitor, increased exposure to naldemedine 2.9 fold that may result in an increased risk of adverse reactions.
Maltese: Itraconazole, inibitur qawwi ta' CYP3A, żied l-esponiment għal naldemedine b'2.9 darbiet, li jista' jirriżulta f'riskju akbar ta' reazzjonijiet avversi.
English: Aluminium/aluminium blister containing 7, 10 or 14 film-coated tablets.
Maltese: Il-mediċina hija disponibbli fil-folji tal-aluminju, li jkun fihom 7, 10 jew 14-il pillola.
English: Patients with cardiovascular disease risk factors were not excluded from the naldemedine clinical trial programme, with BMI ≥ 30 kg/m2, and a medical history of hypertension and/or dyslipidaemia being the most commonly reported risk factors.
Maltese: Pazjenti b'fatturi ta' riskju ta' mard kardjovaskulari ma kinux esklużi millprogramm ta' provi kliniċi b'naldemedine, b'BMI ta' ≥ 30 kg/m2, u storja medika ta' ipertensjoni u/jew dislipidemija bħala l-fatturi ta' riskju l-aktar komuni rrappurtati.
English: Talk to your doctor or pharmacist if you are taking any of the following medicines: - Rifampicin, clarithromycin or telithromycin (antibiotic medicines) - Itraconazole or ketoconazole (medicines to treat fungal infections) - Ritonavir, indinavir or saquinavir (medicines for HIV infection) - Phenytoin, carbamazepine, phenobarbital (medicines to treat epilepsy) - St John's wort (Hypericum perforatum), a herbal medicine used for depression
Maltese: - Rifampicin, clarithromycin jew telithromycin (antibijotiċi) - Itraconazole jew ketoconazole (mediċini li jikkuraw l-infezzjonijiet fungali) - Ritonavir, indinavir jew saquinavir (mediċini għall-infezzjoni tal-HIV) - Phenytoin, carbamazepine, phenobarbital (mediċini biex jikkuraw l-epilessija).
English: Hypersensitivitya
Maltese: Sensittività eċċessivaa
English: The most commonly reported adverse reactions in patients with cancer and OIC were diarrhoea (24.5%) and abdominal pain (3.9%).
Maltese: L-aktar reazzjonijiet avversi komuni rrappurtati fil-pazjenti bil-kanċer u b'OIC kienu dijarea (24.5%) u wġigħ addominali (3.9%).
English: Naldemedine is primarily metabolised by CYP3A with some contribution from UGT1A3 and is a substrate of P-glycoprotein (P-gp) (see section 5.2).
Maltese: Effetti ta' prodotti mediċinali oħrajn fuq naldemedine Naldemedine huwa primarjament metabolizzat permezz ta' CYP3A b'xi kontribuzzjoni minn UGT1A3 u huwa substrat ta' P-glikoproteina (P-gp) (ara sezzjoni 5.2).
English: Pharmacokinetics in subpopulations
Maltese: Farmakokinetika fis-sottopopolazzjonijiet
English: There was a statistically significant difference for naldemedine treatment group versus placebo for the primary endpoint in Studies V9231 and V9232 (see Table 3).
Maltese: Kien hemm differenza statistikament sinifikanti għall-grupp ta' trattament b'naldemedine kontra lplaċebo għall-punt aħħari primarju fi Studji V9231 u V9232 (ara Tabella 3).
English: In the LIR subgroup, a greater proportion of responders was observed with naldemedine (46.4%) compared with placebo (30.2%) and the difference between groups (16.2%) was statistically significant (p<0.0001).
Maltese: 2%) u d-differenza bejn il-gruppi (16.2%) kienet statistikament sinifikanti (p < 0.0001).
English: Placental transfer of [carbonyl-14C]-naldemedine-derived radioactivity was observed in pregnant rats.
Maltese: It-trasferiment mill-plaċenta ta' radjuattività derivata minn [carbonyl-14C]-naldemedine kien osservat f'firien tqal.
English: • an enlarged colon due to a condition known as Ogilvie's syndrome;
Maltese: • kolon imkabbar minħabba kundizzjoni magħrufa bħala s-sindromu ta' Ogilvie;
English: A single dose of naldemedine up to 100 mg and multiple doses of up to 30 mg/day for 10 days were administered to healthy volunteers in clinical studies.
Maltese: Doża waħda ta' naldemedine sa 100 mg u dożi multipli sa 30 mg/jum għal 10 ijiem ngħataw lillvoluntiera b'saħħithom fl-istudji kliniċi.
English: The discontinuation rate due to gastrointestinal treatment emergent adverse events with naldemedine 200 micrograms compared to placebo was 3.2% and 1% respectively in patients with chronic non-cancer pain and OIC and 4.5% and 0% respectively for patients with cancer and OIC.
Maltese: Ir-rata ta' twaqqif minħabba episodji avversi li jirriżultaw mittrattament gastrointestinali b'naldemedine 200 mikrogramma meta mqabbla mal-plaċebo kienet ta' 3.2% u 1% rispettivament f'pazjenti b'uġigħ kroniku mhux ġej mill-kanċer u b'OIC u 4.5% u 0% rispettivament għal pazjenti bil-kanċer u b'OIC.
English: In Studies V9231, V9232 and V9235, the mean age of the subjects in these three studies was 53.2 years; 14.8% were 65 years of age or older; 62.0% were women; 80.2% were white.
Maltese: Fi Studji V9231, V9232 u V9235, l-età medja tal-individwi f'dawn it-tliet studji kienet ta' 53.2 sena; 14.8% kellhom 65 sena jew aktar; 62.0% kienu nisa; 80.
English: Patients with OIC
Maltese: Pazjenti b'OIC
English: Concomitant use of strong CYP3A inducers such as St. John's wort (Hypericum perforatum), rifampicin, carbamazepine, phenobarbital and phenytoin is not recommended.
Maltese: John's wort (Hypericum perforatum), rifampicin, carbamazepine, phenobarbital u phenytoin mhux rakkomandat.
English: Use in patients with severe hepatic impairment is not recommended (see sections 4.4 and 5.2).
Maltese: L-użu f'pazjenti b'indeboliment sever epatiku mhuwiex rakkomandat (ara sezzjonijiet 4.4 u 5.2).
English: A risk to the suckling child cannot be excluded.
Maltese: Ir-riskju gћat-trabi tat-twelid li jkunu qed jerdgħu mhux eskluż.
English: Decreases in the viability index on Day 4 after birth were noted at 30 and 1000 mg/kg/day and low body weights and delayed pinna unfolding were noted at 1000 mg/kg/day in pups.
Maltese: Tnaqqis fl-indiċi ta' vijabbiltà f'Jum 4 wara t-twelid kien osservat f'doża ta' 30 u 1000 mg/kg/jum, u piżijiet baxxi tal-ġisem u dewmien fil-pinna unfolding kienu osservati f'doża ta' 1000 mg/kg/jum fil-frieħ.
English: Following oral administration of [14C]-labelled naldemedine, the primary metabolite in plasma was nor-naldemedine, with a relative exposure compared to naldemedine of approximately 9 to 13%.
Maltese: Wara l-għoti orali ta' naldemedine ittikkettat b'[14C], il-metabolit primarju fil-plażma kien nornaldemedine, b'esponiment relattiv meta mqabbel ma' naldemedine ta' madwar 9 sa 13%.
English: The absolute bioavailability of naldemedine has not been established.
Maltese: Il-bijodisponibilità assoluta ta' naldemedine ma ġietx stabbilita.
English: Name and address of the manufacturers responsible for batch release Manufacturing Packaging Farmaca (MPF) bv Appelhof 13
Maltese: Isem u indirizz tal-manifatturi responsabbli għall-ħruġ tal-lott Manufacturing Packaging Farmaca (MPF) bv Appelhof 13
English: Naldemedine was found to have no clinically relevant adverse effects on fertility or reproductive performance in male and female rats (see section 5.3).
Maltese: Naldemedine nstab li m'għandu l-ebda effetti avversi klinikament rilevanti fuq il-fertilità u l-prestazzjoni riproduttiva fil-firien irġiel u nisa (ara sezzjoni 5.3).
English: • a stomach ulcer;
Maltese: • ulċera fl-istonku;
English: Concomitant use with strong CYP3A inhibitors and inducers Concomitant use of naldemedine with strong CYP3A inhibitors (e.g. grapefruit juice, itraconazole, ketoconazole, ritonavir, indinavir, saquinavir, telithromycin and clarithromycin) leads to an increase in naldemedine exposure and may increase the risk of adverse reactions.
Maltese: Użu fl-istess ħin ma' inibituri u indutturi qawwija ta' CYP3A Użu fl-istess ħin ta' naldemedine ma' inibituri qawwija ta' CYP3A (eż. meraq tal-grejpfrut, itraconazole, ketoconazole, ritonavir, indinavir, saquinavir, telithromycin u clarithromycin) iwassal għal żieda fl-esponiment ta' naldemedine u jista' jżid r-riskju ta' reazzjonijiet avversi.
English: Symptoms included, but were not limited to hyperhidrosis, chills, lacrimation increased, hot flush/flushing, pyrexia, sneezing, feeling cold, abdominal pain, diarrhoea, nausea, vomiting, arthralgia, myalgia, and tachycardia (see section 4.4).
Maltese: Is-sintomi kienu jinkludu, imma ma kinux limitati għal, iperidrożi, tertir, żieda fil-lakrimazzjoni, ħmura tal-wiċċ/ħmura tal-wiċċ bil fwawar, deni, għatis, tħoss il-bard, uġigħ addominali, dijarea, dardir, rimettar, artralġija, mijaġija, utakikardija (ara sezzjoni 4.4).
English: No human data on the effect of naldemedine on fertility are available.
Maltese: M'hemm l-ebda data umana disponibbli dwar l-effett ta' naldemedine fuq il-fertilità.
English: In Study V9235, OIC was confirmed through a 2-week run-in period and was defined as no more than 4 SBMs total over 14 consecutive days and <3 SBMs in a given week.
Maltese: Fi Studju V9235, l-OIC kien ikkonfermat permezz ta' run-in period ta' ġimagħtejn u kien definit bħala mhux aktar minn 4 SBMs globali fuq medda ta' 14-il jum konsekuttiv u <3 SBMs f'ġimgħa partikulari.
English: Proportion of SBM responders in patients with cancer and OIC during the 2-week treatment period (Studies V9222 and V9236)
Maltese: Proporzjon ta' pazjenti b'SBM li kellhom rispons f'pazjenti b'kanċer u b'OIC matul it-trattament ta' perjodu ta' ġimagħtejn (Studji V9222 u V9236)
English: Additionally, naldemedine is a substrate of the P-glycoprotein (P-gp) efflux transporter, which may also be involved in reducing naldemedine penetration into the CNS.
Maltese: Barra minn hekk, naldemedine huwa substrat tat-trasportatur effluss ta'P-glikoproteina (P-gp), li jista' wkoll ikun involut fit-tnaqqis tal-penetrazzjoni ta' naldemedine fisCNS.
English: Molteni Farmaceutici Polska Sp. z o.o.
Maltese: Studji kliniċi f'pazjenti b'kanċer u b'OIC
English: Naldemedine is absorbed with a time to achieve peak plasma concentration of approximately 0.75 hours in the fasted state.
Maltese: Naldemedine jiġi assorbit u jilħaq l-ogħla konċentrazzjoni fil-plażma f'ħin ta' madwar 0.75 siegħa flistat sajjem.
English: Novel histopathology findings were observed at all doses tested in female rats in ovaries (tertiary follicles/luteal cysts) in addition to irregular oestrous cycles, hyperplasia of mammary gland, and vaginal mucification already observed in adult animals (the lowest dose tested corresponded to an exposure margin of 6 or more, depending on the age of the pups).
Maltese: Sejbiet ġodda ta' istopotoloġija ġew osservati fid-dożi kollha ttestjati fil-firien nisa fl-ovarji (follikuli terzjarji/ċesti luteali) flimkien ma' ċikli oestrous irregolari, iperplażija tal-glandola mammarja, u mukifikazzjoni vaġinali diġà osservati f'annimali adulti (l-iktar doża baxxa ttestjata kienet tikkorrispondi għal marġini ta' esponiment ta' 6 jew aktar, skont l-età tal-frieħ).
English: A population pharmacokinetic analysis from clinical studies with naldemedine did not identify a clinically meaningful effect of age, gender, body weight or race on the pharmacokinetics of naldemedine.
Maltese: Analiżi farmakokinetika tal-popolazzjoni mill-istudji kliniċi b'naldemedine ma identifikawx effett klinikament sinifikanti ta' età, sess tal-persuna, piż tal-ġisem jew razza fuq il-farmakokinetika ta' naldemedine.
English: Concomitant use of naldemedine with strong CYP3A inducers (e.g. St. John's wort (Hypericum perforatum), rifampicin, carbamazepine, phenobarbital and phenytoin) leads to a decrease in naldemedine exposure and may reduce the efficacy of naldemedine.
Maltese: L-użu fl-istess ħin ta' naldemedine ma' indutturi qawwija ta' CYP3A (eż. St.John's wort (Hypericum perforatum), rifampin, carbamazepine, phenobarbital u phenytoin) iwassal għal tnaqqis fl-esponiment ta' naldemedine u jista' jnaqqas l-effikaċja ta' naldemedine.
English: Clinical studies in patients with chronic non-cancer pain and OIC The safety and efficacy of naldemedine was evaluated in two identical, 12-week randomised, doubleblind placebo-controlled trials (Studies V9231 and V9232) in which naldemedine was used without laxatives and in a third long-term 52-week randomised, double-blind placebo-controlled trial (Study V9235) in which naldemedine was used with or without stable laxatives in patients with chronic noncancer pain and OIC.
Maltese: Studji kliniċi f'pazjenti b'uġigħ kroniku mhux ġej mill-kanċer u b'OIC Is-sigurtà u l-effikaċja ta' naldemedine kienu evalwati f'żewġ provi identiċi ta' 12-il ġimgħa u kkontrollati bi plaċebo, double-blind u li fihom il-parteċipanti ntgħażlu b'mod każwali, (Studji V9231 u V9232) li fihom naldemedine intuża mingħajr lassattivi, u fit-tielet prova fuq perjodu twil ta' 52 ġimgħa, double-blind u kkontrollata bil-plaċebo, u li fiha l-parteċipanti ntgħażlu b'mod każwali, (Studju V9235) li fiha naldemedine intuża flimkien ma' jew mingħajr lassattivi stabbli f'pazjenti b'uġigħ mhux ġej mill-kanċer u b'OIC.
English: Each tablet contains 200 micrograms naldemedine (as tosylate).
Maltese: Kull pillola fiha 200 mikrogramma ta' naldemedine (bħala tosylate).
English: • diverticulitis (an illness where your gut is inflamed);
Maltese: • divertikulite (marda fejn il-musrana tiegħek tkun infjammata);
English: Round, approximately 6.5 mm diameter, yellow tablet debossed with '222' and Shionogi logo on one side and '0.2' on the other side.
Maltese: Pillola safra tonda, b'dijametru ta' madwar 6.5 mm, imnaqqxa b'‘222' u l-logo ta' Shionogi fuq naħa waħda u ‘0.2' fuq in-naħa l-oħra.
English: Cases of possible opioid withdrawal syndrome have been reported in the naldemedine clinical programme (see section 4.8).
Maltese: Każijiet tas-sindromu ta' meta wieħed jieqaf jieħu l-opjojdi possibbli ġew irrappurtati fil-programm kliniku b'naldemedine (ara sezzjoni 4.8).
English: The safety and efficacy of naldemedine in children and adolescents aged below 18 years have not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' naldemedine fi tfal u adolexxenti li għandhom inqas minn 18-il sena għadhom ma ġewx determinati s'issa.
English: Uncommon Unknown
Maltese: Komuni Ħafna Komuni
English: Rizmoic is indicated for the treatment of opioid-induced constipation (OIC) in adult patients who have previously been treated with a laxative.
Maltese: Rizmoic huwa indikat għat-trattament ta' stitikezza minħabba opjojdi (OIC, opioid-induced constipation) f'pazjenti adulti li fil-passat ġew ttrattati b'lassattiv.
English: The safety and efficacy of naldemedine was also evaluated in 2 randomised, double-blind and placebocontrolled studies (V9222 and V9236) in patients with cancer and OIC.
Maltese: Is-sigurtà u l-effikaċja ta' naldemedine kienu wkoll evalwati f'2 studji li fihom il-pazjenti ntgħażlu b'mod każwali, double-blind u kkontrollati bil-plaċebo (V9222 u V9236) f'pazjenti b'kanċer u b'OIC.
English: Opioid pain medicinal products
Maltese: GĦAMLA FARMAĊEWTIKA
English: In Study V9235, the three most common types of pain were back pain (58.0%); osteoarthritis (9.5%) and neck pain (8.1%).
Maltese: Fi Studju V9235, it-tliet tipi ta' wġigħ l-aktar komuni kienu wġigħ fid-dahar (58.0%); osteoartrite (9.5%) u wġigħ fl-għonq (8.1%).
English: For Study V9235, the efficacy of naldemedine vs. placebo was assessed as secondary endpoints by the frequency of BMs as presented in Table 4.
Maltese: Għal Studju V9235, l-effikaċja ta' naldemedine vs. plaċebo kienet evalwata bħala punti aħħarin sekondarji mill-frekwenza ta' BMs kif ippreżentat f'Tabella 4 hawn taħt.
English: • The recommended dose is one 200 microgram tablet once daily.
Maltese: • Id-doża rakkomandata hi pillola waħda ta' 200 mikrogramma meħuda darba.
English: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Maltese: Studji f'annimali ma jurux effetti ħżiena diretti jew indiretti fuq is-sistema riproduttiva (ara sezzjoni 5.3).
English: There is no risk of interaction with concomitant use of mild CYP3A inhibitors.
Maltese: Interazzjoni ma' indutturi qawwija u moderati ta' CYP3A
English: The effect on oestrous cycle is not considered clinically relevant at the proposed therapeutic dose.
Maltese: L-effett fuq iċċiklu estruż mhuwiex kkunsidrat klinikament rilevanti fid-doża terapewtika proposta.
English: Approximately 20% of the naldemedine dose is excreted unchanged in urine.
Maltese: Madwar 20% ta' naldemedine jiġi eliminat mhux mibdul fl-awrina.
English: Change in frequency of CSBMs per week (LS Mean)
Maltese: Bidla fil-frekwenza ta' CSBMs filġimgħa (Medja tal-LS)
English: Opioid withdrawal syndrome aOne serious report of hypersensitivity reaction was observed in clinical studies with naldemedine.
Maltese: Sindromu ta' meta wieħed jieqaf jieħu lopjojdi aRapport wieħed ta' reazzjoni serja ta' sensittività eċċessiva kienet osservata fi studji kliniċi b'naldemedine.
English: Naldemedine 200 micrograms or placebo was administered for 2 weeks to cancer patients with OIC.
Maltese: Naldemedine 200 mikrogramma jew plaċebo ngħataw għal ġimagħtejn lil pazjenti b'kanċer u b'OIC.
English: INFORMATION IN BRAILLE
Maltese: INFORMAZZJONI BIL-BRAILLE Rizmoic
English: • yawning
Maltese: • tittewweb
English: Proportion of SBM Responders
Maltese: Proporzjon ta' pazjenti SBM li kellhom rispons
English: The primary endpoint for Studies V9231 and V9232 was the proportion of SBM responders, defined as: ≥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.
Maltese: Il-punt primarju aħħari għal Studji V9231 u V9232 kien il-proporzjon ta' pazjenti SBM li kellhom rispons, definit bħala: ≥ 3 SBMs fil-ġimgħa u bidla mil-linja bażi ta' ≥ 1 SBM fil-ġimgħa għal millinqas 9 minn 12-il ġimgħa ta' studju u 3 mill-aħħar 4 ġimgħat.
English: It is unknown whether naldemedine/metabolites are excreted in human milk.
Maltese: Mhux magħruf jekk naldemedine/metaboliti jiġux eliminati mill-ħalib tas-sider tal-bniedem.
English: The apparent terminal elimination half-life of naldemedine is approximately 11 hours, and the apparent total clearance (CL/F) of naldemedine is 8.4 L/h.
Maltese: Il-half-life tal-eliminazzjoni terminali apparenti ta' naldemedine hija ta' madwar 11-il siegħa, u ttneħħija totali apparenti (CL/F) ta' naldemedine hija 8.4
English: Naldemedine is a derivative of naltrexone to which a side chain has been added that increases the molecular weight and the polar surface area, thereby reducing its ability to cross the blood-brain barrier (BBB); the CNS penetration of naldemedine is expected to be negligible at the recommended dose.
Maltese: Naldemedine huwa derivattiv ta' naltrexone li miegħu żdiedet side chain li żżid il-piż molekulari u lerja tas-superfiċje polari, u b'hekk inaqqas l-abbiltà tiegħu li jaqsam il-barriera demm-moħħ (BBB, blood-brain barrier); il-penetrazzjoni ta' naldemedine fis-CNS hija mistennija li tkun negliġibbli fid doża rakkomandata.
English: The adverse reactions with naldemedine 200 microgram tablets in patients with chronic non-cancer pain and OIC and in patients with cancer and OIC reported in clinical studies are presented in the tables according to the MedDRA system organ classification.
Maltese: Ir-reazzjonijiet avversi ma' pilloli naldemedine ta' 200 mikrogramma f'pazjenti b'uġigħ kroniku mhux ġej mill-kanċer u b'OIC u f'pazjenti bil-kanċer u b'OIC irrappurtati fl-istudji kliniċi huma ppreżentati fit-tabelli skont is-sistema tal-klassifikazzjoni tal-organi MedDRA.
English: Severe hepatic impairment
Maltese: Indeboliment sever epatiku
English: Abdominal paina
Maltese: Uġigħ addominalia
English: Rizmoic 200 micrograms film-coated tablets
Maltese: Rizmoic 200 mikrogramma pilloli miksija b'rita
English: In clinical studies, patients with OIC who were administered 0.4 mg/day (twice the recommended dose) over 4 weeks had an increased incidence of GI-related adverse drug reactions including diarrhoea and abdominal pain frequently within 1-2 days after initial dosing.
Maltese: Fl-istudji kliniċi, pazjenti b'OIC li ngħataw 0.4 mg/jum (darbtejn id-doża rakkomandata) fuq medda ta' 4 ġimgħat kellhom inċidenza akbar ta' reazzjonijiet mediċinali avversi relatati mal-GI, inklużi dijarea u wġigħ addominali frekwenti fi żmien minn jum sa jumejn wara d-doża inizjali.
English: The primary efficacy endpoint for Study V9235 was the change in the frequency of BMs per week from baseline to Weeks 12, 24, 36 and 52.
Maltese: Il-punt aħħari tal-effikaċja primarja għal Studju V9235 kien il-bidla fil-frekwenza ta' BMs kull ġimgħa mil-linja bażi sa ġimgħat 12, 24, 36 u 52.
English: The pharmacokinetics of naldemedine between subjects with mild or moderate hepatic impairment and healthy subjects with normal hepatic function were similar.
Maltese: Il-farmakokinetika ta' naldemedine bejn individwi b'indeboliment epatiku ħafif jew moderat u individwi f'saħħithom b'funzjoni epatika normali kienet simili.
English: Rizmoic with drink
Maltese: Rizmoic ma' xorb
English: Read the package leaflet before use.
Maltese: Mhux id-daqsijiet kollha tal-pakkett jistgħu jitqegħdu fis-suq.
English: In Studies V9231 and V9232, OIC was confirmed through a 2-week run-in period and was defined as no more than 4 spontaneous bowel movements (SBMs) total over 14 consecutive days and <3 SBMs in a given week with at least 25% of the SBMs associated with one or more of the following conditions: (1) straining, (2) hard or lumpy stools; (3) having a sensation of incomplete evacuation; and (4) having a sensation of anorectal obstruction/blockage.
Maltese: Fi Studji V9231 u V9232, l-OIC kien ikkonfermat permezz ta' run-in period ta' ġimagħtejn u kien definit bħala total ta' mhux aktar minn 4 episodji ta' ppurgar spontanju (SBMs, spontaneous bowel movements) fuq medda ta' 14-il jum konsekuttiv u <3 SBMs f'ġimgħa partikulari b'minn tal-inqas 25% tal-SBMs assoċjati ma' waħda jew aktar minn dawn il-kundizzjonijiet li ġejjin:
English: In the rat fertility and early embryonic development study, prolongation of the dioestrous phase was observed at 10 mg/kg/day and above, but was not observed at 1 mg/kg/day (12 times the exposure [AUC0-24hr] in humans at an oral dose of 200 micrograms).
Maltese: Ma kien hemm l-ebda effett avvers fl-iżvilupp ta' qabel u wara t-twelid f'doża ta' 1 mg/kg/jum (12-il darba tal-esponiment [AUC0-24hr] fil-bnedmin f'doża orali ta' 200 mikrogramma).
English: In the non-LIR subgroup, consistent with the results in the LIR subgroup, a greater proportion of responders was observed with naldemedine (54.3%) compared with placebo (38.9%) and the difference between groups (15.6%) was statistically significant (p=0.0009).
Maltese: Fis-sottogrupp mhux LIR, b'mod konsistenti mar-riżultati fis-sottogrupp LIR, kien osservat proporzjon akbar ta pazjenti li kellhom rispons b'naldemedine (54.3%) meta mqabbel mal-plaċebo (38.9%) u d-differenza bejn il-gruppi (15.
English: In Study V9231, the three most common types of pain were back pain (62.0%); neck pain (8.3%) and osteoarthritis (5.3%).
Maltese: Fi Studju V9231, it-tliet tipi ta' wġigħ l-aktar komuni kienu wġigħ fid-dahar (62.0%); ugigħ fl-għonq (8.3%) u osteoartrite (5.3%).
English: In juvenile toxicity studies in rats, at the same dose levels, exposure in juvenile animals (PND 10) was increased compared to adult animals (2.3 to 7.4-fold).
Maltese: Fi studji dwar tossiċità ġuvenili fil-firien, fl-istess livelli ta' doża, l-esponiment f'annimali ġuvenili (PND 10) żdiedet meta mqabbla ma' annimali adulti (2.3 sa 7.4 darbiet).