FrancophonIA/ELRC3.0 huggingface dataset:
English: Slovakia Novo Nordisk A/S Novo Allé
Maltese: Is-Slovakkja Novo Nordisk A/S Novo Allé
English: Lithuania Novo Nordisk A/S Novo Allé
Maltese: Il-Litwanja Novo Nordisk A/S Novo Allé
English: List of the names, pharmaceutical forms, strengths of the medicinal products, route of administration, marketing authorisation holders in the Member States
Maltese: Lista tal-ismijiet, għamliet farmaċewtiċi, qawwiet tal-prodotti mediċinali, mod ta' kif jingħata, detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq flistati membri
English: Norditropin SimpleXx 10 mg/1.5 mL cartridge
Maltese: Norditropin SimpleXx 10 mg/1.5 ml skartoċċ
English: Norditropin SimpleXx 5 mg/1.5 mL cartridge
Maltese: Norditropin SimpleXx 5 mg/1.5 ml skartoċċ
English: Norditropin SimpleXx 15 mg/1.5 mL cartridge
Maltese: Norditropin SimpleXx 15 mg/1.5 ml skartoċċ
English: NORDITROPIN SIMPLEXx SOLUTION FOR INJECTION 10MG/1.5ML
Maltese: NORDITROPIN SIMPLEXx SOLUZZJONI GĦALL-INJEZZJONI 10 mg/1.5 ml
English: Belgium
Maltese: Wien
English: Bulgaria
Maltese: L-Irlanda
English: NORDITROPIN SIMPLEXx SOLUTION FOR INJECTION 5MG/1.5ML
Maltese: NORDITROPIN SIMPLEXx SOLUZZJONI GĦALL-INJEZZJONI 5 mg/1.5 ml
English: NORDITROPIN SIMPLEXx SOLUTION FOR INJECTION 15MG/1.5ML
Maltese: NORDITROPIN SIMPLEXx SOLUZZJONI GĦALL-INJEZZJONI 15 mg/1.5 ml
English: NORDITROPIN FLEXPRO SOLUTION FOR INJECTION 15mg/1,5 ml
Maltese: NORDITROPIN FLEXPRO SOLUZZJONI GĦALL-INJEZZJONI 15 mg/1,5 ml
English: NORDITROPIN FLEXPRO SOLUTION FOR INJECTION 10mg/1,5 ml
Maltese: NORDITROPIN FLEXPRO SOLUZZJONI GĦALL-INJEZZJONI 10 mg/1,5 ml
English: The marketing authorisation holder is Daiichi Sankyo Europe GmbH.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq huwa Daiichi Sankyo Europe GmbH.
English: It is available as white, oval tablets (60 mg).
Maltese: Huwa disponibbli bħala pilloli bojod ovali (60 mg).
English: Evista is a medicine containing the active substance raloxifene hydrochloride.
Maltese: Evista huwa mediċina li fiha s-sustanza attiva raloxifene kloridrat (hydrochloride).
English: The active substance in Evista, raloxifene, is a selective oestrogen receptor modulator (SERM).
Maltese: Is-sustanza attiva f'Evista, raloxifene, hija modulatur selettiv tar-riċettur tal-estroġenu (SERM).
English: The marketing authorisation was renewed on 5 August 2003 and on 5 August 2008.
Maltese: L-awtorizzazzjoni għat-tqegħid fis-suq ġiet mġedda fil-5 ta' Awwissu 2003 u fil-5 ta' Awwissu 2008.
English: If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Maltese: Jekk tixtieq aktar informazzjoni relatata mar-rakkomandazzjonijiet tas-CHMP, aqra dDiskussjoni Xjentifika (ukoll parti mill-EPAR).
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) EVISTA EPAR summary for the public
Maltese: RAPPORT PUBBLIKU EWROPEW TA' VALUTAZZJONI (EPAR) EVISTA
English: What is Evista?
Maltese: X'inhu Evista?
English: Over four years, in comparison with placebo, Evista decreased the number of new vertebral fractures by 46% in women who had osteoporosis and by 32% in women who had osteoporosis and an existing fracture.
Maltese: Fuq erba' snin, meta mqabbel mal-plaċebo, Evista naqqas in-numru ta' ksur vertebrali ġodda b'46% f'nisa li jbatu mill-osteoporożi u bi 32% f'nisa li jbatu mill-osteoporożi u ksur eżistenti.
English: • have or have had any blood clot disorders, including deep vein thrombosis and pulmonary embolism (a blood clot in the lungs);
Maltese: • għandhom jew kellhom disturbi fl-għaqid tad-demm, inkluż trombożi tal-vini fil-fond u emboliżmu pulmonari (ċappa demm fil-pulmun);
English: Three studies looked at the prevention of osteoporosis in 1,764 women who took either Evista or placebo (a dummy treatment) for two years.
Maltese: Tliet studji eżaminaw il-prevenzjoni tal-osteoporożi f'1,764 mara ttrattati b'Evista jew bil-plaċebo (trattament finta) għal sentejn.
English: What benefit has Evista shown during the studies?
Maltese: Liema benefiċċju wera Evista waqt l-istudji mwettqa?
English: The fourth study compared the effects of Evista with those of placebo in the treatment of osteoporosis in 7,705 women over four years.
Maltese: Ir-raba' studju qabbel l-effetti ta' Evista ma' dawn ta' plaċebo fit-trattament tal-osteoporożi f'7,705 nisa fuq erba' snin.
English: The most common side effects with Evista (seen in more than 1 patient in 10) are vasodilation (hot flushes) and flu-like symptoms.
Maltese: L-effetti sekondarji l-aktar komuni b'Evista (li jidhru f'aktar minn pazjent 1 minn kull 100) huma ttwessigħ tal-arterji u tal-vini (vasodilation) (fwawar) u sintomi simili għal dawk tal-influwenza.
English: Evista has been studied in the treatment and the prevention of osteoporosis in four main studies.
Maltese: Evista ġie studjat fit-trattament u fil-prevenzjoni tal-osteoporożi f'erba' studji prinċipali.
English: The full EPAR for Evista is available here.
Maltese: Għaliex ġie approvat Evista?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Evista on 5 August 1998.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq fl-Unjoni Ewropea kollha għal Evista fil-5 ta' Awwissu 1998.
English: In the prevention of osteoporosis, women receiving Evista had an increase in bone density in the hip or spine of 1.6% over two years, and those receiving placebo had a decrease of 0.8%.
Maltese: Fil-prevenzjoni tal-osteoporożi, in-nisa ttrattati b'Evista kellhom żieda fid-densità tal-għadam filġenbejn jew fis-sinsla tad-dahar ta' 1.6% fuq sentejn, u dawk ittrattati bil-plaċebo kellhom tnaqqis ta'
English: Raloxifene acts as an ‘agonist' of the oestrogen receptor (a substance that stimulates the receptor for oestrogen) in some tissues in the body.
Maltese: Raloxifene jaġixxi bħala ‘agonista' tar-riċettur tal-estroġenu (sustanza li tistimula r-riċettur għal estroġenu) f'xi tessuti fil-ġisem.
English: Evista was more effective than placebo in preventing and treating osteoporosis.
Maltese: Evista rriżulta aktar effikaċi mill-plaċebo fil-prevenzjoni u fit-trattament tal-osteoporożi.
English: The Committee for Medicinal Products for Human Use (CHMP) concluded that Evista had shown its effectiveness in preventing and treating osteoporosis, and had no effects on the breast or womb.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) ikkonkluda li Evista wera leffikaċja tiegħu fil-prevenzjoni u fit-trattament tal-osteoporożi, u ma kellu ebda effett fuq is-sider jew fuq il-ġuf.
English: • have liver disease, severe kidney disease, unexplained bleeding from the womb or endometrial cancer (cancer of the lining of the womb).
Maltese: • għandhom marda fil-fwied, marda gravi fil-kliewi, fsada mingħajr raġuni mill-ġuf jew kanċer tal-endometriju (kanċer tal-inforra tal-ġuf).
English: How has Evista been studied?
Maltese: Kif ġie studjat Evista?
English: Other information about Evista:
Maltese: Aktar tagħrif dwar Evista:
English: When used to treat osteoporosis, Evista was more effective than placebo in reducing the number of vertebral fractures.
Maltese: Meta użat fit-trattament tal-osteoporożi, Evista rriżulta aktar effikaċi mill-plaċebo fit-tnaqqis tannumru ta' ksur vertebrali.
English: Evista has been shown to significantly reduce vertebral fractures (breaks in the spine), but not hip fractures.
Maltese: Intwera li Evista jnaqqas b'mod sinifikanti l-ksur vertebrali (tas-sinsla tad-dahar), iżda mhux il-ksur fil-ġenbejn.
English: Osteoporosis is more common in women after the menopause, when the levels of the female hormone oestrogen fall: oestrogen slows down bone breakdown and makes the bones less likely to fracture.
Maltese: Losteoporożi hija aktar komuni fin-nisa li għaddew mill-menopawża minħabba t-tnaqqis tal-livelli talormoni tan-nisa, l-estroġeni: l-estroġenu jnaqqas ir-ritmu li bih jitkisser l-għadam u jagħmel l-għadam inqas suxxettibbli għall-ksur.
English: What is the risk associated with Evista?
Maltese: X'inhu r-riskju assoċjat ma' Evista?
English: Treatment Difference [95% Cl]
Maltese: [95% Cl]
English: AT, BE, BG, CY, CZ, DK, EE, IE, EL, FI, FR, HR, HU, IE, IS, LT, LU, LV, MT, , NO, PL, PT, RO, SE, SI, SK
Maltese: AT, BE, BG, CY, CZ, DK, EE, IE, EL, FI, FR, HR, HU, IE, IS, LT, LU, LV, MT, NO, PT, RO, SE, SI, SK Shionogi B.V.
English: Kingsfordweg 151 1043GR Amsterdam The Netherlands
Maltese: Kingsfordweg 151 1043GR Amsterdam L-Olanda
English: Treatment difference
Maltese: Differenza fit-trattament
English: EU/1/18/1291/001 EU/1/18/1291/002 EU/1/18/1291/003 EU/1/18/1291/004 EU/1/18/1291/005 EU/1/18/1291/006
Maltese: EU/1/18/1291/001 EU/1/18/1291/002 EU/1/18/1291/003 EU/1/18/1291/004
English: Shionogi B.V. Tel/Tel./Teл./Tlf/Tél/Puh/Sími/Τηλ:
Maltese: Tel/Tel./Teл./Tlf/Tél/Puh/Sími/Τηλ:
English: Pack sizes of 7, 10, 28, 30, 84 or 100 tablets.
Maltese: Daqs tal-pakkett ta' 7, 10, 28, 30, 84 jew 100 pillola.
English: NL-8448 CN Heerenveen 8448 CN Heerenveen
Maltese: Heerenveen 8448 CN Heerenveen
English: Film coating: hypromellose , talc and yellow iron oxide (E172).
Maltese: Kisi b'rita: hypromellose, talc u yellow iron oxide (E172).
English: (95% CI: 10.8%, 27.0%, p<0.0001*)
Maltese: 8%, 27.0%, p < 0.0001*)
English: System Organ Class
Maltese: Sistema talKlassifika tal
English: The absolute bioavailability of naldemedine is estimated to be in the range of 20% to 56%.
Maltese: Il-bijodisponibilità assoluta ta' naldemedine hija stmata li tkun fil-medda ta' 20% sa 56%.
English: EU/1/18/1291/001 7 film-coated tablets EU/1/18/1291/002 28 film-coated tablets EU/1/18/1291/003 84 film-coated tablets EU/1/18/1291/004 10 film-coated tablets EU/1/18/1291/005 30 film-coated tablets EU/1/18/1291/006 100 film-coated tablets
Maltese: EU/1/18/1291/001 7 pilloli miksija b'rita EU/1/18/1291/002 28 pillola miksija b'rita EU/1/18/1291/003 84 pillola miksija b'rita EU/1/18/1291/004 10 pilloli miksija b'rita EU/1/18/1291/005 30 pilloli miksija b'rita EU/1/18/1291/006 100 pilloli miksija b'rita
English: Rizmoic contains the active substance naldemedine.
Maltese: Rizmoic fih is-sustanza attiva naldemedine.
English: From baseline to week 1**
Maltese: Mil-linja bażi sa ġimgħa 1**
English: Shionogi SLU Tel: +34 911 239 258 contacta@shionogi.eu
Maltese: SLU Tel: +34 911 239258 contacta@shionogi.eu
English: In in vitro studies at clinically relevant concentrations, naldemedine did not inhibit the major CYP enzymes (including CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1, CYP3A, or CYP4A11 isozymes) and is not an inhibitor of OCT1, OCT2, BCRP, P-gp, MATE1, MATE2-K or BSEP transporters.
Maltese: Fi studji in vitro f'konċentrazzjonijiet klinikament rilevanti, naldemedine ma kienx jinibixxi l-enzimi CYP maġġuri (li jinkludu isozimi ta' CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1, CYP3A4/5, jew CYP4A11) u mhuwiex inibitur tat-trasportaturi OCT1, OCT2, BCRP, P-gp, MATE1, MATE2-K jew BSEP).
English: The apparent volume of distribution is approximately 155 litres.
Maltese: Il-volum apparenti tad-distribuzzjoni hu ta' bejn wieħed u ieħor 155 litru.
English: In vitro data also showed that naldemedine is not a direct inhibitor of OATP1B1, OATP1B3, OAT1 and OAT3 transporters.
Maltese: Dejta in vitro wriet ukoll li naldemedine mhuwiex inibitur dirett tat-trasportaturi OATP1B1, OATP1B3, OAT1 u OAT3.
English: See 'Other medicines and Rizmoic'.
Maltese: Ara ‘Mediċini oħra u Rizmoic'.
English: Rizmoic contains sodium
Maltese: Rizmoic fih sodium
English: Tel.: +48 (12) 653 15 71 e-mail: biuro@molteni.com.pl
Maltese: Molteni Farmaceutici Polska Sp. z o.o. Tel.: +48 (12) 653 15 71 e-mail: biuro@molteni.com.pl
English: • cancer of the bowel or peritoneum.
Maltese: • kanċer tal-musrana jew tal-peritonju.
English: The MAH identified nine cases of gastrointestinal perforation in their global database.
Maltese: Il-MAH identifika disa' każijiet ta' perforazzjoni gastrointestinali fid-database globali tagħhom.
English: A SBM was defined as a bowel movement (BM) without rescue laxative taken within the past 24 hours.
Maltese: SBM kien definit bħala ppurgar (BM, bowel movement) mingħajr lassattiv rescue meħud fl-aħħar 24 siegħa.
English: Rare (may affect up to 1 in 1,000 people):
Maltese: Rari (jistgħu jaffettwaw sa 1 minn kull 1,000 persuna):
English: • achy muscles
Maltese: • uġigħ fil-muskoli
English: Naldemedine did not cause significant induction of CYP1A2, CYP2B6 or CYP3A4 isozymes.
Maltese: Naldemedine ma kkawżax induzzjoni sinifikanti ta' isozimi CYP1A2, CYP2B6 jew CYP3A4.
English: Tablet core: Mannitol, croscarmellose sodium (see section 2 under ‘Rizmoic contains sodium') and magnesium stearate.
Maltese: Qalba tal-pillola: Mannitol (E421), croscarmellose sodium (ara sezzjoni 2 taħt ‘Rizmoic fih sodium') u magnesium stearate.
English: A single dose of naldemedine (0.01 mg to 3 mg) and multiple doses of 0.4 mg/day have been administered to patients with OIC in clinical studies.
Maltese: Doża waħda ta' naldemedine (0.01 mg sa 3 mg) u dożi multipli sa 0.4 mg/jum ngħataw lill-pazjenti b'OIC fl-istudji kliniċi.
English: Gastrointestinal perforation
Maltese: Perforazzjoni gastrointestinali
English: There were 4 secondary endpoints in Studies V9231 and V9232 (see Table 3).
Maltese: Kien hemm 4 punti aħħarin sekondarji fi Studji V9231 u V9232 (ara Tabella 3).
English: UNIQUE IDENTIFIER - 2D BARCODE
Maltese: IDENTIFIKATUR UNIKU - BARCODE 2D barcode 2D li jkollu l­identifikatur uniku inkluż.
English: Clinical outcomes for studies V9231 and V9232
Maltese: Tabella 3. Riżultati kliniċi għal Studji V9231 u V9232
English: The mean baseline opioid morphine equivalent daily dosage was 132.42 mg, 120.93 mg, and 122.06 mg per day for Studies V9231, V9232 and V9235 respectively.
Maltese: Il-medja tal-linja bażi tad-dożaġġ ta' opjojdi ekwivalenti għall-morfina kienet 132.42 mg, 120.93 mg, u 122.06 mg kuljum għal Studji V9231, V9232 u V9235 rispettivament.
English: In Study V9232, they were back pain (53.6%); pain (10.2%) and arthralgia (7.8%).
Maltese: Fi Studju V9232, kienu wġigħ fid-dar (53.6%); uġigħ (10.2%) u artralġija (7.8%).
English: Naldemedine is primarily metabolized by CYP3A to nor-naldemedine, with a minor contribution from UGT1A3 to form naldemedine 3-G.
Maltese: Naldemedine huwa primarjament metabolizzat minn CYP3A għal nor-naldemedine, b'kontribuzzjoni minuri minn UGT1A3 biex jifforma naldemedine 3-G.
English: It is a medicine used in adults to treat constipation caused by pain medicines, called opioids (e.g morphine, oxycodone, fentanyl, tramadol, codeine, hydromorphone, methadone).
Maltese: Hija mediċina użata fl-adulti biex tikkura stitikezza kkawżata minn mediċini għall-uġigħ, imsejħa opjojdi (eż. morfina, oxycodone, fentanyl, tramadol, codeine, hydromorphone, methadone).
English: Placebo (N=620)
Maltese: Plaċebo (N = 620)
English: Interactions with CYP3A inhibitors
Maltese: Interazzjonijiet ma' inibituri ta' CYP3A
English: Patients responding, n (%) p value* *Statistically significant: p-values based on the Chi-square test.
Maltese: Pazjenti li kellhom rispons, n valur* p *Statistikament sinifikanti: p-valuri bbażati fuq it-test Chi-square.
English: Naldemedine also undergoes cleavage in the gastrointestinal tract to form benzamidine and naldemedine carboxylic acid.
Maltese: Naldemedine jgħaddi wkoll minn diviżjoni fil-passaġġ gastrointestinali biex jifforma benzamidine u naldemedine carboxylic acid.
English: Rizmoic 200 micrograms tablets naldemedine
Maltese: Rizmoic 200 mikrogramma pilloli naldemedine
English: If use with strong CYP3A inhibitors is unavoidable, monitor for adverse reactions (see section 4.4).
Maltese: Jekk lużu ma' inibituri qawwija ta' CYP3A huwa inevitabbli, immonitorja għal reazzjonijiet avversi (ara sezzjoni 4.4).
English: • Gastrointestinal perforation (a hole developing in the bowel wall)
Maltese: • Perforazzjoni gastrointestinali (l-iżvilupp ta' toqba fil-ħajt tal-musrana)
English: CI=Confidence Interval *Statistically significant: p-values based on the Cochran-Mantel-Haenszel test. ** p<0.0001 *** p=0.0003 for study V9231 and p=0.0011 for study V9232
Maltese: ** p < 0.0001 *** p=0.0003 għal studju V9231 u p=0.0011 għal studju V9232
English: A total of 547 patients in Study V9231, 551 patients in Study V9232 and 1246 patients in Study V9235 were randomised in a 1:1 ratio to receive 200 micrograms of naldemedine or placebo once daily for 12 weeks for Studies V9231 and V9232, for 52 weeks for Study V9235.
Maltese: Total ta' 574 pazjent fi Studju V9231, 551 pazjent fi Studju V9232 u 1246 pazjent fi Studju V9235 intagħżlu b'mod każwali fi proporzjon ta' 1:1 biex jirċievu 200 mikrogramma ta' naldemedine jew plaċebo darba kuljum għal 12-il ġimgħa għal Studji V9231 u V9232, u għal 52 ġimgħa għal Studju V9235.
English: The most commonly reported adverse reactions in patients with chronic non-cancer pain and OIC were abdominal pain (7.8%), diarrhoea (5.9%), nausea (3.6%), and vomiting (1.1%).
Maltese: L-aktar reazzjonijiet avversi komuni rrappurtati fil-pazjenti b'uġigħ kroniku mhux ġej mill-kanċer u b'OIC kienu wġigħ addominali (7.8%), dijarea (5.9%), dardir (3.6%), u rimettar (1.1%).
English: Following oral administration of radiolabelled naldemedine, 57.3% and 34.8% of the dose was excreted in urine and faeces for the [oxadiazole-14C]-naldemedine and 20.4% and 64.3% of the dose was excreted as the [carbonyl-14C]naldemedine in urine and faeces, respectively.
Maltese: Wara l-għoti orali ta' naldemedine radjutikkettat, 57.3% u 34.8% tad-doża ġiet eliminata fl-awrina u fl-ippurgar għal [oxadiazole-14C]naldemedine u 20.
English: In studies V9222 and V9236, the mean age of the subjects was 64.3 years; 51.8% were 65 years of age or older; 39.4% were women and 97.1% were Japanese.
Maltese: Fi Studji V9222 u V9236, l-età medja tal-individwi kienet ta' 64.3 sena; 51.8% kellhom 65 sena jew aktar; 39.4% kienu nisa; 97.1% kienu Ġappuniżi.
English: If used with moderate CYP3A inhibitors, monitor for adverse reactions.
Maltese: Jekk jintuża ma' inibituri moderati ta' CYP3A, immonitorja għal reazzjonijiet avversi.
English: The mean baseline SBMs was 1.31, 1.17, and 1.60, for Studies V9231, V9232 and V9235 respectively.
Maltese: Il-medja tal-SBMs fil-linja bażi kienet 1.31, 1.17, u 1.60, għal Studji V9231, V9232 u V9235 rispettivament.
English: The pharmacokinetics of naldemedine in the paediatric population has not been studied (see section 4.2).
Maltese: Il-farmakokinetika ta' naldemedine fil-popolazzjoni pedjatrika ma ġietx studjata (ara sezzjoni 4.2).
English: Naldemedine is highly bound to serum proteins, predominantly to human serum albumin and to a lesser extent to α1-acid-glycoprotein and γ-globulin, with a mean protein binding ratio in humans of 93.2%.
Maltese: Naldemedine jeħel b'mod qawwi mal-proteini tas-serum, b'mod predominanti għall-albumina fisserum uman u, fi grad inqas, għal α1-acid-glycoprotein u γ-globulin, bi proporzjon ta' twaħħil malproteini medju fil-bnedmin ta' 93.2%.
English: The number of patients in the LIR and non-LIR subgroups were 629 (naldemedine: 317 and placebo: 312) and 451 (naldemedine: 223 and placebo: 228) for pooled Studies V9231 and V9232.
Maltese: 317 u plaċebo: 312) u 451 (naldemedine: 223 u plaċebo: 228) għal Studji miġbura flimkien V9231 u V9232.
English: The effect of hepatic impairment on the pharmacokinetics of a single 200 microgram dose of naldemedine was studied in subjects with hepatic impairment classified as mild (Child-Pugh class A) or moderate (Child-Pugh class B) and compared with healthy subjects with normal hepatic function.
Maltese: L-effett tal-indeboliment epatiku fuq il-farmakokinetika ta' doża waħda 200 mikrogramma ta' naldemedine kien studjat f'individwi b'indeboliment epatiku kklassifikat bħala ħafif (Child-Pugh Klassi A) jew moderat (Child-Pugh Klassi B) u mqabbel ma' individwi f'saħħithom b'funzjoni epatika normali.
English: The frequency categories are defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon
Maltese: Il-kategoriji ta' frekwenza huma definiti bl-użu tal-konvenzjoni li ġejja: komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1,000 sa < 1/100); rari (≥ 1/10,000 sa < 1/1,000); rari ħafna (< 1/10,000); mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Gastrointestinal perforation is added a new adverse reaction with a frequency “Not known”.
Maltese: Perforazzjoni gastrointestinali qed tiġi miżjuda bħala reazzjoni avversa ġdida bi frekwenza “Mhux magħruf”.
English: Age, gender, body weight and race
Maltese: Età, sess tal-persuna, piż tal-ġisem u razza
English: The efficacy and safety were also assessed in the laxative inadequate responders (LIR) and non-LIR subgroups.
Maltese: L-effikaċja u s-sigurtà kienu wkoll evalwati fil-laxative inadequate responders (LIR) u sottogruppi mhux LIR.
English: Cases of gastrointestinal perforation have been reported in the post-marketing setting, including fatal cases, when naldemedine was used in patients who were at an increased risk of gastrointestinal (GI) perforation, (e.g. diverticular disease and underlying malignancies of the gastrointestinal tract or peritoneal metastases).
Maltese: Każijiet ta' perforazzjoni gastrointestinali ġew irrappurtati wara t-tqegħid fis-suq, li kienu jinkludu każijiet fatali, meta naldemedine intuża f'pazjenti b'riskju akbar ta' perforazzjonijiet gastrointestinali (GI), (eż. marda divertikulari u tumuri malinni sottostanti tal-passaġġ gastrointestinali jew metastasi peritoneali).
English: Placebo (N=274)
Maltese: Plaċebo (N = 274)
English: Possible opioid withdrawal, defined as at least three adverse reactions potentially related to opioid withdrawal that occurred on the same day and that were not exclusively related to the gastrointestinal system, occurred in 0.8% (9/1,163) of patients with chronic non-cancer pain and OIC taking naldemedine compared to 0.2% (2/1,165) of patients taking placebo regardless of maintenance opioid treatment, and 0.6% (1/155) of patients with cancer and OIC taking naldemedine 200 micrograms compared to 0% (0/152) of patients taking placebo.
Maltese: Is-sintomi possibbli ta' meta wieħed jieqaf jieħu l-opjojdi definiti bħala mill-inqas tliet reazzjonijiet avversi potenzjalment relatati mas-sintomi kkawżati meta wieħed jieqaf jieħu l-opjojdi li seħħew flistess jum u li ma kinux esklussivament relatati mas-sistema gastrointestinali, seħħew f'0.8% (9/1163) tal-pazjenti b'uġigħ kroniku mhux ġej mill-kanċer u b'OIC li jieħdu naldemedine meta mqabbla ma' 0.2% (2/1165) tal-pazjenti li jieħdu l-plaċebo minkejja trattament ta' manteniment tal-opjojdi, u 0.6% (1/155) ta' pazjenti b'kanċer u b'OIC li kienu qed jieħdu naldemedine 200 mikrogramma meta mqabbel ma' 0% (0/152) tal-pazjenti li kienu qed jieħdu l-plaċebo.
English: Date of first authorisation: 18 February 2019
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 18 ta' Frar, 2019
English: Naldemedine 3-G was a minor metabolite in plasma, with a relative exposure to naldemedine of less than 3%.
Maltese: Naldemedine 3-G kien metabolit minuri fil-plażma, b'esponiment relattiv għal naldemedine ta' inqas minn 3%.
English: Placebo (N=272)
Maltese: Plaċebo (N = 272)
English: This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free'.
Maltese: Din il-mediċina fiha anqas minn 1 mmol sodium (23 mg) f'kull pillola, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: There is limited experience in patients treated with opioid pain medicinal product(s) at daily doses of more than the equivalent of 400 mg of morphine.
Maltese: Hemm esperjenza limitata f'pazjenti ttrattati bi prodott(i) mediċinali opjojdi kontra l-uġigħ f'dożi ta' kuljum ta' aktar mill-ekwivalenti ta' 400 mg ta' morfina.
English: No adverse effects were observed in male or female fertility and reproductive performance at up to 1000 mg/kg/day (in excess of 16,000 times the exposure [AUC0-24hr] in humans at an oral dose of 200 micrograms).
Maltese: L-ebda effetti avversi ma kienu osservati fil-fertilità maskili u femminili u fil-prestazzjoni riproduttiva sa 1000 mg/kg/jum (aktar minn 16,000-il darba tal-esponiment [AUC0-24hr] fil-bnedmin f'doża orali ta' 200 mikrogramma).