FrancophonIA/ELRC3.0 huggingface dataset:
English: In total, 14 clinical trials involving tolvaptan have been completed worldwide in support of the ADPKD indication, including 8 trials in the US, 1 in the Netherlands, 3 in Japan, 1 in Korea, and the multinational phase 3 pivotal trial.
Maltese: B'kollox, madwar id-dinja tlestew 14-il prova klinika li kienu jinvolvu tolvaptan bħala appoġġ għall-indikazzjoni ta' ADPKD, li jinkludu 8 provi fl-Istati Uniti, waħda fl-Olanda, 3 fil-Ġappun, waħda fil-Korea u l-prova pivitali multinazzjonali ta' fażi 3.
English: Jinarc is to be administered twice daily in split dose regimens of 45 mg + 15 mg, 60 mg + 30 mg or 90 mg + 30 mg.
Maltese: Jinarc għandu jingħata darbtejn kuljum f'korsijiet ta' doża maqsuma ta' 45 mg + 15 mg, 60 mg + 30 mg jew 90 mg + 30 mg.
English: CYP3A inhibitors
Maltese: Inibituri ta' CYP3A
English: Wed. Thu.
Maltese: T TL E Ħ Ġ S Ħ
English: Jinarc 30 mg tablets tolvaptan
Maltese: Jinarc 30 mg pilloli tolvaptan
English: This trial evaluated the effects of tolvaptan on safety, TKV and eGFR in subjects receiving active treatment for 5 years (early-treated), compared with subjects treated with placebo for 3 years, then switched to active treatment for 2 years (delayed-treated).
Maltese: Din il-prova evalwat l-effetti ta' tolvaptan fuq is-sigurtà, TKV u eGFR f'pazjenti li ngħataw kura attiva għal 5 snin (kura bikrija), imqabbla ma' pazjenti kkurati bi plaċebo għal 3 snin li mbagħad ġew maqluba għal kura attiva għal sentejn (kura tardiva).
English: Diuretics or non-diuretic anti-hypertensive medicinal product(s) Standing blood pressure was not routinely measured in ADPKD trials, therefore a risk of orthostatic/postural hypotension due to a pharmacodynamic interaction with tolvaptan cannot be excluded.
Maltese: Dijuretiċi jew mediċina(i) kontra l-pressjoni għolja mhux dijuretiċi Il-pressjoni tad-demm meta wieħed ikun wieqaf ma kienetx imkejla b'rutina fi provi b'ADPKD, għalhekk riskju ta' pressjoni ortostatika/tal-pożizzjoni baxxa minħabba interazzjoni farmakodinamika ma' tolvaptan ma jistax jiġi eskluż.
English: Jinarc 30 mg tablets 7 or 28 tablets in PVC/aluminium foil blister
Maltese: Jinarc 30 mg pilloli 7 jew 28 pillola f'folja tal-PVC/fojl tal-aluminju
English: 60 mg tablet: blue, modified rectangular (major axis 9.9 mm, minor axis 5.6 mm), shallow-convex, debossed with “OTSUKA” and “60” on one side
Maltese: Pillola ta' 60 mg: blu, forma ta' rettangolu modifikat (assi maġġuri 9.9 mm, assi minuri 5.6 mm), kemmxejn konvessa, imnaqqxa b'“OTSUKA” u “60” fuq naħa waħda.
English: Jinarc 15 mg tablets Jinarc 30 mg tablets Jinarc 45 mg tablets Jinarc 60 mg tablets Jinarc 90 mg tablets
Maltese: Jinarc 15 mg pilloli Jinarc 30 mg pilloli Jinarc 45 mg pilloli Jinarc 60 mg pilloli Jinarc 90 mg pilloli
English: The incidences of the Adverse Drug Reactions (ADRs) associated with tolvaptan therapy are tabulated below.
Maltese: L-inċidenzi ta' Reazzjonijiet Avversi tal-Mediċina (ADRs) assoċjati ma' terapija b'tolvaptan huma miġbura f'tabella hawn taħt.
English: 15 mg tablet: blue, triangular (major axis: 6.58 mm, minor axis: 6.20 mm), shallow-convex, debossed with “OTSUKA” and “15” on one side.
Maltese: Pillola ta' 15 mg: blu, trijangulari (assi maġġuri: 6.58 mm, assi minuri: 6.20 mm), kemmxejn konvessa, imnaqqxa b'“OTSUKA” u “15” fuq naħa waħda.
English: No mortality was observed in rats or dogs following single oral doses of 2,000 mg/kg (maximum feasible dose).
Maltese: Ma kienet osservata l-ebda mortalità fil-firien jew klieb wara dożi orali singoli ta' 2,000 mg/kg (l-ogħla doża possibbli).
English: However, events of increased uric acid and/or gout were not serious and did not cause discontinuation of therapy in the double-blind, placebo-controlled trial.
Maltese: Madankollu, avvenimenti ta' żieda fl-aċidu uriku u/jew gotta ma kinux serji u ma kkawżawx waqfien tat-terapija fil-prova double blind ikkontrollata bil-plaċebo.
English: Co-administration with medicinal products that increase serum sodium concentration There is no experience from controlled clinical trials with concomitant use of tolvaptan and hypertonic sodium chloride solution, oral sodium formulations, and medicinal products that increase serum sodium concentration.
Maltese: Għoti flimkien ma' prodotti mediċinali li jżidu l-konċentrazzjoni ta' sodium fis-serum M'hemmx esperjenza minn provi kliniċi kkontrollati bl-użu ta' tolvaptan flimkien ma' soluzzjoni ipertonika ta' soluzzjoni ta' sodium chloride, formulazzjonijiet orali ta' sodium, u prodotti mediċinali li jżidu l-konċentrazzjoni tas-sodium fis-serum.
English: Jinarc 15 mg tablets 7 or 28 tablets in PVC/aluminium foil blister
Maltese: Jinarc 15 mg pilloli 7 jew 28 pillola f'folja tal-PVC/fojl tal-aluminju
English: Jinarc 15 mg tablets tolvaptan
Maltese: Jinarc 15 mg pilloli tolvaptan
English: The primary end point for TKV did not distinguish a difference in change (−1.7 %) over the 5 year treatment between early- and delayed-treated subjects at the pre-specified threshold of statistical significance (p = 0.3580).
Maltese: Il-punt finali primarju għal TKV ma jagħrafx differenza fit-tibdil (−1.7 %) fuq il-medda ta' 5 snin ta' kura bejn pazjenti kkurati b'mod bikri u b'mod tardiv fil-limitu statistikament sinifikanti deċiż minn qabel (p = 0.3580).
English: Following single oral doses, Cmax values show less than dose proportional increases from 30 to 240 mg and then a plateau at doses from 240 to 480 mg, AUC increases linearly.
Maltese: Wara dożi orali singoli, il-valuri ta' Cmax juru żidiet inqas minn proporzjonali mad-doża minn 30 sa 240 mg u wara jilħqu quċċata b'dożi minn 240 sa 480 mg, l-AUC tiżdied b'mod lineari.
English: Blue, triangular (major axis: 6.58 mm, minor axis: 6.20 mm), shallow-convex, debossed with “OTSUKA” and “15” on one side.
Maltese: Blu, trijangulari (assi maġġuri: 6.58 mm, assi minuri: 6.20 mm), kemmxejn konvessa, imnaqqxa b'“OTSUKA” u “15” fuq naħa waħda.
English: Jinarc 15 mg tablets + Jinarc 45 mg tablets
Maltese: Jinarc 15 mg pilloli + Jinarc 45 mg pilloli
English: At the onset of symptoms or signs consistent with hepatic injury or if clinically significant abnormal ALT or AST increases are detected during treatment, Jinarc administration must be immediately interrupted and repeat tests including ALT, AST, BT and alkaline phosphatase (AP) must be obtained as soon as possible (ideally within 48-72 hours).
Maltese: Malli jfeġġu sintomi jew sinjali konsistenti ma' ħsara fil-fwied jew jekk jiġu osservati żidiet klinikament sinifikanti mhux normali f'ALT jew AST waqt il-kura, l-għoti ta' Jinarc għandu jiġi interrot minnufih u għandhom jinkisbu testijiet ripetuti inkluż ALT, AST, BT u alkaline phosphatase (AP) kemm jista' jkun malajr (idealment fi żmien 48-72 siegħa).
English: Administration of tolvaptan induces copious aquaresis and may cause dehydration and increases in serum sodium (see section 4.8) and is contraindicated in hypernatraemic patients (see section 4.3).
Maltese: L-għoti ta' tolvaptan jinduċi akwaresi (tneħħija ta' ilma mingħajr telf ta' elettroliti) abbundanti u jista' jikkawża deidratazzjoni u żidiet ta' sodium fis-serum (ara sezzjoni 4.8) u huwa kontraindikat f'pazjenti ipernatrimiċi (ara sezzjoni 4.3).
English: Approximately 5 %, 75 % and 20 % had an eGFR 60 mL/min/1.73 m or greater (CKD stage 2), or less than 60 and greater than 30 mL/min/1.73 m
Maltese: Madwar 5 %, 75 % u 20 % kellhom eGFR ta' 60 mL/min/1.73 m jew aktar (CKD stadju 2), jew inqas minn 60 u aktar minn
English: Jinarc 15 mg tablets: blisters with 7 or 28 tablets
Maltese: Jinarc 15 mg pilloli: folji b'7 jew 28 pillola
English: Less than 1 % of intact active substance is excreted unchanged in the urine.
Maltese: Inqas minn 1 % tas-sustanza attiva intatta titneħħa mhux mibdula fl-awrina.
English: Each 30 mg tablet contains approximately 70 mg lactose (as monohydrate).
Maltese: Kull pillola ta' 30 mg fiha madwar 70 mg lactose (bħala monohydrate).
English: • treatments containing ketoconazole for fungal infections, macrolide antibiotics like clarithromycin, or diltiazem as a treatment for high blood pressure and chest pain.
Maltese: • trattamenti li fihom ketoconazole għal infezzjonijiet ikkawżati mill-moffa, antibijotiċi macrolide bħal clarithromycin, jew diltiazem bħala kura għall-pressjoni għolja u uġigħ fis-sider.
English: 30 mg tablet: blue, round (diameter: 8 mm), shallow-convex, debossed with “OTSUKA” and “30” on one side.
Maltese: Pillola ta' 30 mg: blu, tonda (dijametru: 8 mm), kemmxejn konvessa, imnaqqxa b'“OTSUKA” u “30” fuq naħa waħda.
English: Following single oral doses of ≥ 300 mg, peak plasma concentrations appear to plateau, possibly due to saturation of absorption.
Maltese: Wara dożi orali singoli ta' ≥ 300 mg, il-konċentrazzjonijiet massimi fil-plażma jidhru li jilħqu lquċċata, possibilment minħabba saturazzjoni ta' assorbiment.
English: A total of 1,370 patients (age 18-65) with chronic kidney disease (CKD) with an eGFR between 25 and 65 mL/min/1.73 m if younger than age 56; or eGFR between 25 and 44 mL/min/1.73 m 2, plus eGFR decline >2.0 mL/min/1.73 m2/year if between age 56-65 were randomized to either tolvaptan (n = 683) or placebo (n = 687) and were treated for a period of 12 months.
Maltese: Total ta' 1,370 pazjent (etajiet 18-65) b'mard kroniku tal-kliewi (CKD - chronic kidney disease) b'eGFR ta' bejn 25 u 65 mL/min/1.73 m jekk iżgħar minn 56 sena; jew eGFR bejn 25 u
English: No teratogenic effects were seen in rabbits at 300 mg/kg/day (about 1.25 to 2.65 times the exposure in humans at the 120 mg/day dose, based on AUC).
Maltese: Ma kinux osservati effetti teratoġeniċi fil-fniek bi 300 mg/kg/jum (madwar 1.25 sa 2.65 darba l-espożizzjoni fil-bnedmin biddoża ta' 120 mg/jum, ibbażat fuq l-AUC).
English: 45 mg tablet: blue, square (6.8 mm on a side, major axis 8.2 mm), shallow-convex, debossed with “OTSUKA” and “45” on one side
Maltese: Pillola ta' 45 mg: blu, kwadra (6.8 mm fuq naħa, assi maġġuri 8.2 mm), kemmxejn konvessa, imnaqqxa b'“OTSUKA” u “45” fuq naħa waħda.
English: Aspartate aminotransferase increased,
Maltese: Żieda ta' alanine aminotransferase, Żieda ta' aspartate aminotransferase, Tnaqqis fil-piż
English: Jinarc 15 mg tablets Jinarc 45 mg tablets tolvaptan
Maltese: Jinarc 15 mg pilloli Jinarc 45 mg pilloli tolvaptan
English: While these criteria were useful in enriching the study population with patients who were rapidly progressing, subgroup analyses based on stratification criteria (age, TKV, GFR, Albuminuria, Hypertension) indicated the presence of such risk factors at younger ages predicts more rapid disease progression.
Maltese: Filwaqt li dawn il-kriterji kienu utli biex issaħħu l-popolazzjoni tal-istudju b'pazjenti li kienu qed javvanzaw b'mod rapidu, analiżi tas-sottogrupp ibbażata fuq kriterji ta' stratifikazzjoni (età, TKV, GFR, Albuminurja, Pressjoni għolja) tindika li l-preżenza ta' fatturi ta' riskju bħal dawn f'età iżgħar tbassar progressjoni tal-marda aktar rapida.
English: The key secondary composite endpoint (ADPKD progression) was time to multiple clinical progression events of: 1) worsening kidney function (defined as a persistent [reproduced over at least 2 weeks] 25 %
Maltese: Il-punt finali sekondarju kompost kruċjali (key secondary composite endpoint) (progressjoni ta' ADPKD) kien iż-żmien sakemm seħħew avvenimenti multipli ta' progressjoni klinika ta':
English: Jinarc has not been studied in children and adolescents (under age 18) and its use is therefore not recommended in these age groups.
Maltese: Jinarc ma ġiex studjat fi tfal u adolexxenti (ta' età inqas minn 18-il sena) u għalhekk l-użu tiegħu mhux rakkomandat f'dawn il-gruppi ta' età.
English: Effect of other medicinal products on the pharmacokinetics of tolvaptan
Maltese: Effett ta' prodotti mediċinali oħra fuq il-farmakokinetika ta' tolvaptan
English: • the importance of pregnancy prevention, before and during treatment with Jinarc
Maltese: • l-importanza ta' prevenzjoni tat-tqala, qabel u waqt il-kura b'Jinarc
English: Each 90 mg tablet contains approximately 24 mg lactose (as monohydrate).
Maltese: Kull pillola ta' 90 mg fiha madwar 24 mg lactose (bħala monohydrate).
English: Jinarc contains the active substance tolvaptan which blocks the effect of vasopressin, a hormone involved in the formation of cysts in the kidneys of ADPKD patients.
Maltese: Jinarc fih is-sustanza attiva tolvaptan li timblokka l-effett ta' vasopressin, ormon involut filformazzjoni ta' ċesti fil-kliewi ta' pazjenti li għandhom ADPKD.
English: Data related to smoking or alcohol history in ADPKD trials are too limited to determine possible interactions of smoking or alcohol with efficacy and safety of ADPKD treatment with tolvaptan.
Maltese: Dejta relatata ma' storja ta' tipjip jew ta' teħid ta' alkoħol fi provi dwar ADPKD hija wisq limitata biex jiġu determinati interazzjonijiet possibbli ta' tipjip jew alkoħol mal-effikaċja u mas-sigurtà ta' kura għal ADPKD b'tolvaptan.
English: Jinarc 30 mg tablets + Jinarc 60 mg tablets
Maltese: Jinarc 30 mg pilloli + Jinarc 60 mg pilloli
English: • belly pain
Maltese: • telf ta' piż
English: The primary endpoint of the trial was the change in estimated glomerular filtration rate (eGFR) from pre-treatment baseline levels to post-treatment assessment.
Maltese: Il-punt finali primarju tal-prova kien il-bidla fir-rata ta' filtrazzjoni glomerulari stmata (eGFR) millivelli tal-linja bażi ta' qabel it-trattament sal-valutazzjoni wara t-trattament.
English: The effect of mildly or moderately impaired hepatic function (Child-Pugh classes A and B) on the pharmacokinetics of tolvaptan was investigated in 87 patients with liver disease of various origins.
Maltese: L-effett ta' funzjoni tal-fwied indebolita b'mod ħafif jew moderat (Child-Pugh klassijiet A u B) fuq il-farmakokinetika ta' tolvaptan kien investigat f'87 pazjent b'marda tal-fwied ta' oriġini varji.
English: EU/1/15/1000/005 14 tablets (7 × 15 mg + 7 × 45 mg) EU/1/15/1000/006 28 tablets (14 × 15 mg + 14 × 45 mg) EU/1/15/1000/007 56 tablets (28 × 15 mg + 28 × 45 mg)
Maltese: EU/1/15/1000/005 14-il pillola (7 × 15 mg + 7 × 45 mg) EU/1/15/1000/006 28 pillola (14 × 15 mg + 14 × 45 mg) EU/1/15/1000/007 56 pillola (28 × 15 mg + 28 × 45 mg)
English: • muscle spasms
Maltese: • awrina skura
English: Tolvaptan daily split-dose Reduced dose (once daily) 90+30 mg
Maltese: Doża maqsuma ta' kuljum ta' Tolvaptan Doża mnaqqsa (darba kuljum) 90+30 mg
English: Jinarc 30 mg tablets + Jinarc 90 mg tablets
Maltese: Jinarc 30 mg pilloli + Jinarc 90 mg pilloli
English: 7 × 15 mg tablets and 7 × 45 mg tablets in card packaging 14 × 15 mg tablets and 14 × 45 mg tablets in card packaging 28 × 15 mg tablets and 28 × 45 mg tablets in card packaging
Maltese: 7 × 15 mg pilloli u 7 × 45 mg pilloli fl-ippakkjar tal-kartuna 14 × 15 mg pilloli u 14 × 45 mg pilloli fl-ippakkjar tal-kartuna 28 × 15 mg pilloli u 28 × 45 mg pilloli fl-ippakkjar tal-kartuna
English: 1,692 mL (height adjusted 972 mL/m).
Maltese: (CKD-EPI) b'79% li kellhom pressjoni għolja u TKV medju ta' 1,692 mL (aġġustat għat-tul 972 mL/m).
English: • Elevated liver enzymes and/or signs or symptoms of liver injury prior to initiation of treatment that meet the requirements for permanent discontinuation of tolvaptan (see section 4.4)
Maltese: • Enzimi tal-fwied elevati u/jew sinjali jew sintomi ta' ħsara fil-fwied qabel ma tinbeda l-kura li jissodisfaw ir-rekwiżiti għall-waqfien permanenti ta' tolvaptan (ara sezzjoni 4.4)
English: These data suggest that Jinarc can slow the rate of renal function decline, and that these benefits persist over the duration of therapy.
Maltese: Din id-dejta tissuġerixxi li Jinarc jista' jbaxxi r-rata tat-tnaqqis tal-funzjoni renali, u li dawn il-benefiċċji jippersistu kemm iddum tingħata t-terapija.
English: Diuretics
Maltese: Deidratazzjoni
English: The primary objective of this trial was to evaluate the long-term efficacy of tolvaptan in ADPKD through rate of total kidney volume (TKV) change (%) for tolvaptan-treated compared with placebo-treated subjects.
Maltese: L-għan primarju ta' din il-prova kien li tiġi evalwata l-effikaċja fittul ta' tolvaptan f'ADPKD permezz tar-rata ta' bidla fil-volum totali tal-kliewi (TKV - total kidney volume) (%) għall-individwi kkurati b'tolvaptan meta mqabbel ma' individwi kkurati bil-plaċebo.
English: • ALT or AST > 3-times ULN with persistent symptoms of hepatic injury noted above.
Maltese: • ALT jew AST > 3 darbiet ULN b'sintomi persistenti ta' ħsara fil-fwied innutati fuq.
English: Jinarc 30 mg tablets Jinarc 60 mg tablets tolvaptan
Maltese: Jinarc 30 mg pilloli Jinarc 60 mg pilloli tolvaptan
English: • tiredness
Maltese: • Anurja
English: Jinarc 30 mg tablets + Jinarc 90 mg tablets 14 tablets in 1 PVC/aluminium foil blister with 7 × 30 mg and 7 × 90 mg tablets 28 tablets in 2 PVC/aluminium foil blisters with 7 × 30 mg and 7 × 90 mg tablets 56 tablets in 4 PVC/aluminium foil blisters with 7 × 30 mg and 7 × 90 mg tablets
Maltese: Jinarc 30 mg pilloli + Jinarc 90 mg pilloli 14-il pillola f'folja 1 tal-PVC/aluminju b'7 × 30 mg u 7 × 90 mg pilloli 28 pillola f'2 folji tal-PVC/fojl tal-aluminju b'7 × 30 mg u 7 × 90 mg pilloli 56 pillola f'4 folji tal-PVC/fojl tal-aluminju b'7 × 30 mg u 7 × 90 mg pilloli
English: Jinarc 15 mg tablets + Jinarc 45 mg tablets 14 tablets in 1 PVC/aluminium foil blister with 7 × 15 mg and 7 × 45 mg tablets 28 tablets in 2 PVC/aluminium foil blisters with 7 × 15 mg and 7 × 45 mg tablets 56 tablets in 4 PVC/aluminium foil blisters with 7 × 15 mg and 7 × 45 mg tablets
Maltese: Jinarc 15 mg pilloli + Jinarc 45 mg pilloli 14-il pillola f'folja 1 tal-PVC/aluminju b'7 × 15 mg u 7 × 45 mg pilloli
English: Jinarc 30 mg tablets: blisters with 7 or 28 tablets
Maltese: Jinarc 30 mg pilloli: folji b'7 jew 28 pillola
English: Jinarc 30 mg tablets Jinarc 90 mg tablets tolvaptan
Maltese: Jinarc 30 mg pilloli Jinarc 90 mg pilloli tolvaptan
English: 7 × 30 mg tablets and 7 × 90 mg tablets 14 × 30 mg tablets and 14 × 90 mg tablets 28 × 30 mg tablets and 28 × 90 mg tablets
Maltese: 7 × 30 mg pilloli u 7 × 90 mg pilloli 14 × 30 mg pilloli u 14 × 90 mg pilloli 28 × 30 mg pilloli u 28 × 90 mg pilloli
English: No dose adjustment is needed in patients with mild or moderate hepatic impairment (Child-Pugh classes A and B).
Maltese: Mhux meħtieġ aġġustament fid-doża f'pazjenti b'indeboliment ħafif jew moderat tal-fwied (Child-Pugh klassijiet A u B).
English: Jinarc 45 mg tablets + Jinarc 15 mg tablets: blisters with or without wallet card with 14 (7 tablets of the higher strength + 7 tablets of the lower strength), 28 (14 tablets of the higher strength + 14 tablets of the lower strength) or 56 (28 tablets of the higher strength + 28 tablets of the lower strength) tablets.
Maltese: Jinarc 45 mg pilloli + Jinarc 15 mg pilloli: folji bi jew mingħajr kartuna għall-kartiera b' 14 (7 pilloli tal-qawwa l-għolja + 7 pilloli tal-qawwa l-baxxa), 28 (14-il pillola tal-qawwa l-għolja + 14-il pillola tal-qawwa l-baxxa) jew 56 (28 pillola tal-qawwa l-għolja + 28 pillola tal-qawwa l-baxxa) pillola.
English: Effect of tolvaptan on the pharmacokinetics of other products
Maltese: Effett ta' tolvaptan fuq il-farmakokinetika ta' prodotti oħra
English: Dose adjustment for patients taking strong CYP3A inhibitors In patients taking strong CYP3A inhibitors (see section 4.5), tolvaptan doses have to be reduced as follows:
Maltese: F'pazjenti li qed jieħdu inibituri qawwijin ta' CYP3A (ara sezzjoni 4.5), id-dożi ta' tolvaptan għandhom jiġu mnaqqsa kif ġej:
English: 7 × 30 mg tablets and 7 × 60 mg tablets 14 × 30 mg tablets and 14 × 60 mg tablets 28 × 30 mg tablets and 28 × 60 mg tablets
Maltese: 7 × 30 mg pilloli u 7 × 60 mg pilloli 14 × 30 mg pilloli u 14 × 60 mg pilloli 28 × 30 mg pilloli u 28 × 60 mg pilloli
English: Each 45 mg tablet contains approximately 12 mg lactose (as monohydrate).
Maltese: Kull pillola ta' 45 mg fiha madwar 12 mg lactose (bħala monohydrate).
English: Jinarc 30 mg tablets + Jinarc 60 mg tablets 14 tablets in 1 PVC/aluminium foil blister with 7 × 30 mg and 7 × 60 mg tablets 28 tablets in 2 PVC/aluminium foil blisters with 7 × 30 mg and 7 × 60 mg tablets 56 tablets in 4 PVC/aluminium foil blisters with 7 × 30 mg and 7 × 60 mg tablets
Maltese: Jinarc 30 mg pilloli + Jinarc 60 mg pilloli 14-il pillola f'folja 1 tal-PVC/aluminju b'7 × 30 mg u 7 × 60 mg pilloli 28 pillola f'2 folji tal-PVC/fojl tal-aluminju b'7 × 30 mg u 7 × 60 mg pilloli 56 pillola f'4 folji tal-PVC/fojl tal-aluminju b'7 × 30 mg u 7 × 60 mg pilloli
English: The terminal elimination half-life is about 8 hours and steady-state concentrations of tolvaptan are obtained after the first dose.
Maltese: Il-half-life ta' eliminazzjoni terminali hija ta' madwar 8 sigħat u konċentrazzjonijiet fi stat fiss (steady state concentrations) ta' tolvaptan jinkisbu wara l-ewwel doża.
English: The aim of dose titration is to block activity of vasopressin at the renal V2 receptor as completely and constantly as possible, while maintaining acceptable fluid balance (see section 4.4).
Maltese: titrazzjoni tad-doża huwa li titwaqqaf l-attività ta' vasopressin fuq ir-riċettur V2 tal-kliewi bl-aktar mod komplut u kostanti possibli, filwaqt li jinżamm bilanċ ta' fluwidi aċċettabbli (ara sezzjoni 4.4).
English: Muscle spasms
Maltese: Dijabete mellitus
English: If a patient shows abnormal ALT, AST or BT levels prior to initiation of treatment which fulfil the criteria for permanent discontinuation (see below) the use of tolvaptan is contraindicated (see section 4.3).
Maltese: Jekk pazjent juri livelli mhux normali ta' ALT, AST jew BT qabel tinbeda l-kura li jissodisfaw il-kriterji għal twaqqif permanenti (ara taħt) l-użu ta' tolvaptan huwa kontraindikat (ara sezzjoni 4.3).
English: Each Jinarc 60 mg tablet contains 60 mg tolvaptan.
Maltese: Kull pillola Jinarc 60 mg fiha 60 mg tolvaptan.
English: Jinarc with food and drink Do not drink grapefruit juice when taking Jinarc.
Maltese: Tixrobx meraq tal-grejpfrut meta tkun qed tieħu Jinarc.
English: Jinarc 90 mg tablets + Jinarc 30 mg tablets: blisters with or without wallet card with 14 (7 tablets of the higher strength + 7 tablets of the lower strength), 28 (14 tablets of the higher strength + 14 tablets of the lower strength) or 56 (28 tablets of the higher strength + 28 tablets of the lower strength) tablets.
Maltese: Jinarc 90 mg pilloli + Jinarc 30 mg pilloli: folji bi jew mingħajr kartuna għall-kartiera b' 14 (7 pilloli tal-qawwa l-għolja + 7 pilloli tal-qawwa l-baxxa), 28 (14-il pillola tal-qawwa l-għolja + 14-il pillola tal-qawwa l-baxxa) jew 56 (28 pillola tal-qawwa l-għolja + 28 pillola tal-qawwa l-baxxa) pillola.
English: Jinarc 60 mg tablets + Jinarc 30 mg tablets: blisters with or without wallet card with 14 (7 tablets of the higher strength + 7 tablets of the lower strength), 28 (14 tablets of the higher strength + 14 tablets of the lower strength) or 56 (28 tablets of the higher strength + 28 tablets of the lower strength) tablets.
Maltese: Jinarc 60 mg pilloli + Jinarc 30 mg pilloli: folji bi jew mingħajr kartuna għall-kartiera b' 14 (7 pilloli tal-qawwa l-għolja + 7 pilloli tal-qawwa l-baxxa), 28 (14-il pillola tal-qawwa l-għolja + 14-il pillola tal-qawwa l-baxxa) jew 56 (28 pillola tal-qawwa l-għolja + 28 pillola tal-qawwa l-baxxa) pillola.
English: EU/1/15/1000/014 14 tablets (7 × 15 mg + 7 × 45 mg) EU/1/15/1000/015 28 tablets (14 × 15 mg + 14 × 45 mg) EU/1/15/1000/016 56 tablets (28 × 15 mg + 28 × 45 mg)
Maltese: EU/1/15/1000/014 14-il pillola (7 × 15 mg + 7 × 45 mg) EU/1/15/1000/015 28 pillola (14 × 15 mg + 14 × 45 mg) EU/1/15/1000/017 56 pillola (28 × 15 mg + 28 × 45 mg)
English: • if you are allergic to tolvaptan or any of the other ingredients of this medicine (listed in section 6) or if you are allergic to benzazepine or benzazepine derivatives (e.g. benazepril, conivaptan, fenoldopam mesylate or mirtazapine)
Maltese: • jekk inti allerġiku għal tolvaptan jew għal xi sustanza oħra ta' din il-mediċina (imniżżla fissezzjoni 6) jew jekk inti allerġiku għal benzazepine jew derivati ta' benzazepine (eż. benazepril, conivaptan, fenoldopam mesylate jew mirtazapine).
English: Each 60 mg tablet contains 60 mg of tolvaptan.
Maltese: Kull pillola ta' 60 mg fiha 60 mg tolvaptan.