FrancophonIA/ELRC3.0 huggingface dataset:
English: The renal function events were 61.4 % less likely for tolvaptan compared with placebo (hazard ratio, 0.39; 95 % CI, 0.26 to 0.57; nominal p < 0.0001), while renal pain events were 35.8 % less likely in tolvaptan-treated patients (hazard ratio, 0.64; 95 % CI, 0.47 to 0.89; nominal p = 0.007).
Maltese: L-avvenimenti tal-funzjoni tal-kliewi kienu 61.4 % inqas probabbli għal tolvaptan meta mqabbel ma' plaċebo (proporzjon ta' periklu (hazard ratio), 0.39; CI ta' 95 %, 0.26 sa 0.57; p nominali ta' < 0.0001), filwaqt li avvenimenti ta' uġigħ fil-kliewi kienu 35.8 % inqas probabbli f'pazjenti kkurati b'tolvaptan (proporzjon ta' periklu (hazard ratio), 0.64; CI ta' 95 %, 0.47 sa 0.89; p nominali= 0.007).
English: • digoxin (a medicine for the treatment of irregular heart beat and heart failure), dabigatran (used to thin the blood), rosuvastatin or pitavastatin (used to lower blood cholesterol) methotrexate (used to treat cancer, arthritis), ciprofloxacin (an antibiotic), sulfasalazine (for treatment of inflammatory bowel disease or rheumatoid arthritis) or metformin (for treatment of diabetes).
Maltese: • digoxin (mediċina għall-kura ta' taħbit tal-qalb irregolari u insuffiċjenza tal-qalb), dabigatran (jintuża biex iraqqaq id-demm), rosuvastatin jew pitavastatin (jintużaw biex ibaxxu l-kolesterol fid-demm), methotrexate (jintuża għall-kura tal-kanċer, artrite), ciprofloxacin (antibijotiku), sulfasalazine (għall-kura ta' mard infjammatorja tal-musrana jew artrite rewmatika) jew metformin (għall-kura tad-dijabete).
English: • Pregnancy (see section 4.6)
Maltese: • Tqala (ara sezzjoni 4.6)
English: The CKD stage 3 can be subdivided further to stage 3a 30 %, (eGFR 45 mL/min/1.73 m to less than 60 mL/min/1.73 m 2) and stage 3b 45 %, (eGFR between 30-45 mL/min/1.73 m
Maltese: L-istadju 3 ta' CKD jista' jiġi sottodiviż għal stadju 3a 30 % (eGFR 45 mL/min/1.73 m għal inqas minn 60 mL/min/1.73 m 2) u stadju 3b 45 % (eGFR bejn
English: CYP3A substrates
Maltese: Sottostrati ta' CYP3A
English: The dose combinations are: 45 mg + 15 mg
Maltese: Il-kombinazzjonijiet ta' dożi huma: 45 mg + 15 mg
English: Jinarc 30 mg tablets EU/1/15/1000/003-004 (blister)
Maltese: Jinarc 30 mg pilloli EU/1/15/1000/003-004
English: Fluid and electrolyte balance
Maltese: Bilanċ ta' fluwidi u elettroliti
English: Jinarc is indicated to slow the progression of cyst development and renal insufficiency of autosomal dominant polycystic kidney disease (ADPKD) in adults with CKD stage 1 to 4 at initiation of treatment with evidence of rapidly progressing disease (see section 5.1).
Maltese: Jinarc hu indikat biex inaqqas il-progressjoni tal-iżvilupp ta' ċesti u ta' insuffiċjenza tal-kliewi tal-marda tal-kliewi poliċistiċi li hija awtosomalment dominanti (ADPKD - autosomal dominant polycystic kidney disease) f'adulti b'CKD stadju 1 sa 4 fil-bidu tal-kura b'evidenza ta' progressjoni mgħaġġla tal-marda (ara sezzjoni 5.1).
English: Effect of tolvaptan on glomerular filtration rate (GFR)
Maltese: Effett ta' tolvaptan fuq ir-rata ta' filtrazzjoni glomerulari (GFR - glomerular filtration rate)
English: Tolvaptan is contraindicated in anuric patients (see section 4.3).
Maltese: Tolvaptan huwa kontraindikat f'pazjenti anuriċi (ara sezzjoni 4.3).
English: The phase 3, multi-centre, international, randomized-withdrawal, placebo-controlled, double-blind trial 156-13-210 compared the efficacy and safety of tolvaptan (45 to 120 mg/day) to placebo in patients able to tolerate tolvaptan during a five-week titration and run-in period on tolvaptan.
Maltese: Il-prova multiċentrika, internazzjonali, b'irtirar każwali, bil-plaċebo bħala kontroll, double-blind, 15613-210 ta' fażi 3 qabblet l-effikaċja u s-sigurta ta' tolvaptan (45 sa 120 mg/jum) mal-plaċebo f'pazjenti li kienu kapaċi jittolleraw tolvaptan matul titrazzjoni ta' ħames ġimgħat u f'perijodu ta' tħejjija fuq tolvaptan.
English: Jinarc contains lactose
Maltese: Jinarc fih lactose
English: The potential risk for humans is unknown.
Maltese: Ir-riskju potenzjali għall-bnedmin mhux magħruf.
English: If OATP1B1 and OATP1B3 substrates (e.g., statins such as rosuvastatin and pitavastatin), OAT3 substrates (e.g., methotrexate, ciprofloxacin), BCRP substrates (e.g. sulfasalazine) or OCT1 substrates (e.g. metformin) are co-administered with tolvaptan, patients must be managed cautiously and evaluated for excessive effects of these medicinal products.
Maltese: Jekk sottostrati ta' OATP1B1 u OATP1B3 (eż., statins bħal rosuvastatin u pitavastatin), sottostrati ta' OAT3 (eż., methotrexate, ciprofloxacin), sottostrati ta' BCRP (eż. sulfasalazine) jew sottostrati ta' OCT1 (eż. metformin) jingħataw flimkien ma' tolvaptan, il-pazjenti għandhom jiġu mmaniġġjati b'attenzjoni u evalwati għal effetti eċċessivi ta' dawn il-mediċini.
English: In this trial a total of 1,445 adult patients (age 18-50 years) with evidence of rapidly-progressing, early ADPKD (meeting modified Ravine criteria, total kidney volume (TKV) ≥ 750 mL, estimated creatinine clearance ≥ 60 mL/min) were randomized 2:1 to treatment with tolvaptan or placebo.
Maltese: F'din il-prova total ta' 1,445 pazjent adult (età ta' 18-50 sena) b'evidenza ta' ADPKD bikrija u li qed tavanza malajr (li tissodisfa l-kriterju ta' Ravine modifikat, volum totali tal-kliewi (TKV) ta' ≥ 750 mL, tneħħija stmata tal-krejatinina ≥ 60 mL/min) kienu randomised 2:1 għall-kura b'tolvaptan jew bi plaċebo.
English: Your medicine is supplied in the following pack sizes:
Maltese: Il-mediċina tiegħek hija pprovduta fid-daqsijiet tal-pakketti li ġejjin:
English: In a double-blind, placebo-controlled trial of patients with ADPKD, potentially clinically significant increased uric acid (greater than 10 mg/dL) was reported at a higher rate in tolvaptan-patients (6.2 %) compared to placebo-treated patients (1.7 %).
Maltese: Fi prova double blind, ikkontrollata bi plaċebo b'pazjenti li għandhom ADPKD, żidiet potenzjalment klinikament sinifikanti fl-aċidu uriku (ta' aktar minn 10 mg/dL) kienu rrappurtati b'rata ogħla f'pazjenti fuq tolvaptan (6.2 %) meta mqabbel ma' pazjenti kkurati bil-plaċebo (1.7 %).
English: TEMPO 4:4 is an open-label extension study that included 871 subjects that completed TEMPO 3:4 from 106 centres across 13 countries.
Maltese: TEMPO 4:4 huwa studju ta' estensjoni open-label li jinkludi 871 pazjent li temmew TEMPO 3:4 minn 106 ċentru mifruxa fuq 13-il pajjiż.
English: Serum sodium abnormalities
Maltese: Anormalitajiet ta' sodium fis-serum
English: The initial dose is 60 mg tolvaptan per day as a split-dose regimen of 45 mg + 15 mg (45 mg taken upon waking and prior the morning meal and 15 mg taken 8 hours later).
Maltese: Id-doża tal-bidu hija ta' 60 mg tolvaptan kuljum bħala kors ta' doża maqsuma ta' 45 mg + 15 mg (45 mg meħuda hekk kif wieħed iqum u qabel l-ikla ta' filgħodu u 15 mg meħuda 8 sigħat wara).
English: • gout
Maltese: • gotta
English: For subjects randomized, the baseline, average estimated glomerular filtration rate (eGFR) was 41 mL/min/1.73 m
Maltese: Fil-linja bażi, il-pazjenti kellhom rata medja ta' filtrazzjoni glomerulari stmata (eGFR - estimated glomerular filtration rate) ta' 82 mL/min/1.73 m
English: The rate of TKV increase over 3 years was significantly less for tolvaptan-treated subjects than for subjects receiving placebo: 2.80 % per year vs 5.51 % per year, respectively (ratio of geometric mean 0.974; 95 % CI 0.969 to 0.980; p < 0.0001).
Maltese: Ir-rata ta' żieda f'TKV fuq 3 snin kienet inqas b'mod sinifikanti għall-individwi kkurati b'tolvaptan milli għall-individwi li ngħataw plaċebo: 2.80 % kull sena kontra 5.51 % kull sena, rispettivament (proporzjon ta' medja ġeometrika (ratio of geometric mean) 0.974; CI ta' 95 % 0.969 sa 0.980; p < 0.0001).
English: Steady state digoxin concentrations were increased (1.3-fold in maximum observed plasma concentration [Cmax] and 1.2fold in area under the plasma concentration-time curve over the dosing interval [AUCτ]) when coadministered with multiple once daily 60 mg doses of tolvaptan.
Maltese: Konċentrazzjonijiet fi stat fiss (steady state concentrations) ta' digoxin żdiedu (b'1.3 darbiet fil-konċentrazzjoni massima [Cmax] osservata fil-plażma u b'1.2 darbiet fl-erja taħt il-kurva tal-konċentrazzjoni-ħin tul l-intervall taddożaġġ [AUCτ]) meta jingħata flimkien ma' dożi multipli ta' 60 mg kuljum ta' tolvaptan.
English: In a population pharmacokinetic analysis for patients with ADPKD, tolvaptan concentrations were increased, compared to healthy subjects, as renal function decreased below eGFR of 60 mL/min/1.73 m2. An eGFRCKD-EPI decrease from 72.2 to 9.79 (mL/min/1.73 m2) was associated with a 32 % reduction in total body clearance.
Maltese: F'analiżi farmakokinetika tal-popolazzjoni għall-pazjenti b'ADPKD, il-konċentrazzjonijiet ta' tolvaptan żdiedu, meta mqabbla ma' individwi f'saħħithom, hekk kif il-funzjoni tal-kliewi naqset taħt eGFR ta' 60 mL/min/1.73 m2. Tnaqqis ta' eGFRCKD-EPI minn 72.2 sa 9.79 (mL/min/1.73 m2) kien assoċjat ma' tnaqqis ta' 32 % fit-tneħħija totali mill-ġisem.
English: Teratogenicity was noted in rabbits given 1,000 mg/kg/day (7.5 times the exposure from the 120 mg/day human dose on an AUC basis).
Maltese: Teratoġeniċità kienet osservata fi fniek li ngħataw 1,000 mg/kg/jum (7.5 darbiet lespożizzjoni mid-doża umana ta' 120 mg/jum fuq bażi ta' AUC).
English: Very common Common
Maltese: Komuni ħafna Komuni
English: Polydipsia
Maltese: Polidipsija
English: • Patterns of medicinal product utilisation, especially with regards to off label use and use in patients over 50 years old
Maltese: • Tendenzi ta' utilizzazzjoni tal-mediċina, speċjalment rigward użu off-label u użu f'pazjenti b'età ta' aktar minn 50 sena
English: Jinarc 15 mg tablets + Jinarc 45 mg tablets Jinarc 30 mg tablets + Jinarc 60 mg tablets Jinarc 30 mg tablets + Jinarc 90 mg tablets
Maltese: Jinarc 15 mg pilloli + Jinarc 45 mg pilloli Jinarc 30 mg pilloli + Jinarc 60 mg pilloli Jinarc 30 mg pilloli + Jinarc 90 mg pilloli
English: These may increase the effect of Jinarc.
Maltese: Dawn jistgħu jżidu l-effetti ta' Jinarc.
English: Jinarc 30 mg tablets Blue, round (diameter: 8 mm), shallow-convex, debossed with “OTSUKA” and “30” on one side.
Maltese: Jinarc 30 mg pilloli Blu, tonda (dijametru: 8 mm), kemmxejn konvessa, imnaqqxa b'“OTSUKA” u “30” fuq naħa waħda.
English: Patients have to be carefully monitored during treatment.
Maltese: Pazjenti għandhom jiġu monitorati bir-reqqa waqt it-trattament.
English: Jinarc 15 mg tablets + Jinarc 45 mg tablets EU/1/15/1000/005-007 (blister) EU/1/15/1000/014-016 (blister in wallet card)
Maltese: Jinarc 15 mg pilloli + Jinarc 45 mg pilloli EU/1/15/1000/005-007 (folja) EU/1/15/1000/014-016 (folja fil-kartuna għall-kartiera)
English: Adverse reactions of gout were reported more frequently in tolvaptan-treated patients (28/961, 2.9 %) than in patients receiving placebo (7/483, 1.4 %).
Maltese: Reazzjonijiet avversi ta' gotta kienu rrappurtati b'mod aktar frekwenti f'pazjenti kkurati b'tolvaptan (28/961, 2.9 %) milli f'pazjenti li kienu qed jirċievu l-plaċebo (7/483, 1.4 %).
English: Co-administration of tolvaptan and fluconazole, a moderate CYP3A inhibitor, produced a 200 % and 80 % increase in tolvaptan AUC and Cmax, respectively.
Maltese: L-għoti flimkien ta' tolvaptan u fluconazole, inibituri moderat ta' CYP3A, irriżulta f'żieda ta' 200 % u 800 % fl-AUC u Cmax rispettivament ta' tolvaptan.
English: • flu-like syndrome (joint and muscle pain with fever)
Maltese: • sindrome tixbaħ lill-influwenza (uġigħ fil-ġogi u l-muskoli flimkien ma' deni)
English: Therefore, concomitant administration of tolvaptan with potent CYP3A inducers (e.g., rifampicin, rifabutin, rifapentin, phenytoin, carbamazepine, and St. John's Wort) is to be avoided.
Maltese: Għalhekk, l-għoti ta' tolvaptan flimkien ma' indutturi qawwija ta' CYP3A (eż., rifampicin, rifabutin, rifapentin, phenytoin, carbamazepine, u St.
English: A pre-specified subgroup analysis suggested that tolvaptan had less of an effect in patients older than 55 years of age, a small subgroup with a notably slower rate of eGFR decline.
Maltese: Analiżi speċifikata minn qabel ta' sottogrupp ssuġġeriet li tolvaptan kellu effett inqas f'pazjenti akbar minn 55 sena, sottogrupp żgħir b'rata notevolment inqas ta' tnaqqis f'eGFR.
English: According to these split dose regimens the total daily doses are 60, 90, or 120 mg.
Maltese: Skont dawn il-korsijiet ta' doża maqsuma d-dożi totali ta' kuljum huma ta' 60, 90, jew 120 mg.
English: Jinarc 30 mg tablets + Jinarc 90 mg tablets EU/1/15/1000/011-013 (blister) EU/1/15/1000/020-022 (blister in wallet card)
Maltese: Jinarc 30 mg pilloli + Jinarc 90 mg pilloli EU/1/15/1000/011-013 (folja) EU/1/15/1000/020-022 (folja fil-kartuna għall-kartiera)
English: Data for patients in CKD stage 3 are more limited than for patients in stage 1 or 2 (see section 5.1).
Maltese: Dejta għal pazjenti b'CKD ta' stadju 3 hija aktar limitata milli għal pazjenti fi stadju 1 jew 2 (ara sezzjoni 5.1).
English: Jinarc 30 mg tablets + Jinarc 60 mg tablets EU/1/15/1000/008-010 (blister) EU/1/15/1000/017-019 (blister in wallet card)
Maltese: Jinarc 30 mg pilloli + Jinarc 60 mg pilloli EU/1/15/1000/008-010 (folja) EU/1/15/1000/017-019 (folja fil-kartuna għall-kartiera)
English: For split-dose regimens of 30, 60 and 120 mg/day in ADPKD patients, tolvaptan exposure (AUC) increases linearly.
Maltese: Għal korsijiet ta' doża maqsuma ta' 30, 60 u 120 mg/jum f'pazjenti b'ADPKD, l-espożizzjoni għal tolvaptan (AUC) tiżdied b'mod lineari.
English: It is not recommended to administer Jinarc with vasopressin analogues.
Maltese: Mhux rakkomandat li Jinarc jingħata flimkien ma' analogi ta' vasopressin.
English: • diarrhoea
Maltese: • deidratazzjoni
English: • decreased appetite
Maltese: • tnaqqis ta' aptit
English: Therefore, serum creatinine, electrolytes and symptoms of electrolyte imbalances (e.g. dizziness, fainting, palpitations, confusion, weakness, gait instability, hyper-reflexia, seizures, coma) have to be assessed prior to and after starting tolvaptan to monitor for dehydration.
Maltese: Għalhekk, krejatinina fis-serum, elettroliti u sintomi ta' żbilanċ fl-elettroliti (eż. sturdament, ħass ħażin, palpitazzjonijiet, konfużjoni, dgħjufija, mixja mhux stabbli, iper-riflessja (hyper-reflexia), aċċessjonijiet, koma) għandhom ikunu evalwati qabel u wara l-bidu ta' tolvaptan biex isir monitoraġġ għal deidratazzjoni.
English: The primary focus of the clinical program for development of tolvaptan tablets for the treatment of ADPKD is a single pivotal, multinational, phase 3, randomised, placebo controlled trial in which the long-term safety and efficacy of oral split dose tolvaptan regimens (titrated between 60 mg/day and 120 mg/day) were compared with placebo in 1,445 adult subjects with ADPKD.
Maltese: Il-fokus primarju tal-programm kliniku għall-iżvilupp ta' pilloli tolvaptan għall-kura ta' ADPKD huwa prova pivitali waħda, multinazzjonali, ta' fażi 3, randomised, ikkontrollata bil-plaċebo li fiha is-sigurtà u l-effikaċja fit-tul ta' korsijiet ta' doża orali maqsuma ta' tolvaptan (ittitrata bejn 60 mg/jum u 120 mg/jum) kienu mqabbla mal-plaċebo f'1,445 individwu adult b'ADPKD.
English: • Signs or symptoms of liver toxicity and severe dehydration
Maltese: • Sinjali jew sintomi ta' tossiċità fil-fwied u ta' deidratazzjoni severa
English: A secondary endpoint testing the persistence of positive effects on renal function indicated that the preservation of eGFR observed by the end of the TEMPO 3:4 pivotal trial (3.01 to 3.34 mL/min/1.73 m at follow-up visits 1 and 2) could be preserved during open-label treatment.
Maltese: Testijiet għal punt sekondarju finali għall-persistenza ta' effetti pożittivi fuq il-funzjoni renali kienu jindikaw li l-preservazzjoni ta' eGFR osservata fi tmien il-prova ewlenija ta' TEMPO 3:4 (3.01 sa 3.34 mL/min/1.73 m f'visti 1 u 2 ta' insegwitu) setgħu jiġu preservati fit-trattament bit-tikketta tingħaraf.
English: Even though this increase has no clinical relevance, it indicates tolvaptan can potentially increase exposure to CYP3A4 substrates.
Maltese: Għalkemm din iż-żieda m'għandhiex rilevanza klinika, tindika li tolvaptan potenzjalment jista' jżid l-espożizzjoni għal sottostrati ta' CYP3A4.
English: Statins commonly used in the tolvaptan phase 3 pivotal trial (e.g., rosuvastatin and pitavastatin) are OATP1B1 or OATP1B3 substrates, however no difference in AE profile was observed during the phase 3 pivotal trial for tolvaptan in ADPKD.
Maltese: Statins li ntużaw l-aktar spiss fil-prova pivitali ta' fażi 3 ta' tolvaptan (eż., rosuvastatin u pitavastatin) huma sottostrati ta' OATP1B1 jew OATP1B3, madankollu ma kienet osservata l-ebda differenza fil-profil ta' AE matul il-prova pivitali ta' fażi 3 għal tolvaptan f'ADPKD.
English: Posology
Maltese: spiss
English: Patients with known hypersensitivity reactions to benzazepines or benzazepine derivatives (e.g. benazepril, conivaptan, fenoldopam mesylate or mirtazapine) may be at risk for hypersensitivity reaction to tolvaptan (see section 4.3 Contraindications).
Maltese: Pazjenti b'reazzjonijiet ta' sensittività eċċessiva magħrufa għal benzazepines jew derivati ta' benzazepine (eż. benazepril conivaptan, fenoldopam mesylate jew mirtazapine) jistgħu jkunu ta' riskju għal reazzjoni ta' sensittività eċċessiva għal tolvaptan (ara sezzjoni 4.3 Kontraindikazzjonijiet).
English: 90 mg tablet: blue, pentagonal (major axis 9.7 mm, minor axis 9.5 mm), shallow-convex, debossed with “OTSUKA” and “90” on one side
Maltese: Pillola ta' 90 mg: blu, pentagonali (assi maġġuri 9.7 mm, assi minuri 9.5 mm), kemmxejn konvessa, imnaqqxa b'“OTSUKA” u “90” fuq naħa waħda.
English: Very limited information is available in patients with severe hepatic impairment (Child-Pugh class C).
Maltese: Hemm disponibbli tagħrif limitat ħafna f'pazjenti b'indeboliment sever tal-fwied (Child-Pugh klassi C).
English: Two (2/957, 0.2 %) of these tolvaptan treatedpatients, as well as a third patient from an extension open label trial, exhibited increases in hepatic enzymes (> 3 × ULN) with concomitant elevations in BT (> 2 × ULN).
Maltese: Tnejn (2/957, 0.2 %) minn dawn il-pazjenti kkurati b'tolvaptan, kif ukoll pazjent ieħor minn prova ta' estensjoni open label, urew żidiet fl-enzimi epatiċi (> 3 × ULN) b'żidiet fl-istess waqt f'BT (> 2 × ULN).
English: Other medicines and Jinarc
Maltese: Mediċini oħra u Jinarc
English: Jinarc 30 mg tablets
Maltese: Jinarc 30 mg pilloli
English: In vitro studies indicated that tolvaptan has no inhibitory activity for CYP3A.
Maltese: Studji in vitro indikaw li tolvaptan m'għandu l-ebda attività inibitorja għal CYP3A.
English: • phenytoin or carbamazepine (medicines for the treatment of epilepsy), rifampicin (a medicine for treatment of tuberculosis) or St. John's Wort (a traditional herbal medicinal product for the relief of slightly low mood and mild anxiety).
Maltese: • phenytoin jew carbamazepine (mediċini għall-kura tal-epilessija), rifampicin (mediċina għall-kura tat-tuberkulożi) jew St.
English: Jinarc contains lactose as an excipient.
Maltese: Jinarc fih lactose bħala eċċipjent.
English: • diuretics (used to increase your urine production).
Maltese: • dijuretiċi (użati biex iżidu l-produzzjoni tal-awrina tiegħek).
English: • Patient information pack
Maltese: • Pakkett ta' informazzjoni tal-pazjent
English: Only the oxobutyric acid metabolite is present at greater than 10 % of total plasma radioactivity; all others are present at lower concentrations than tolvaptan.
Maltese: Il-metabolit oxobutyric acid biss huwa preżenti f'aktar minn 10 % tar-radjuattività totali filplażma; l-oħrajn kollha huma preżenti f'konċentrazzjonijiet aktar baxxi minn tolvaptan.
English: Tolvaptan is not recommended in the paediatric age group.
Maltese: Tolvaptan mhux rakkomandat fil-grupp ta' età pedjatrika.
English: Each 15 mg tablet contains approximately 35 mg lactose (as monohydrate).
Maltese: Kull pillola ta' 15 mg fiha madwar 35 mg lactose (bħala monohydrate).
English: Tolvaptan may cause adverse reactions related to water loss such as thirst, polyuria, nocturia, and pollakiuria (see section 4.8).
Maltese: Tolvaptan jista' jikkawża reazzjonijiet avversi relatati ma' telf ta' ilma bħal għatx, poliurja, nokturja, u pollakjurja (ara sezzjoni 4.8).
English: 1 Quarter 2026
Maltese: L-ewwel kwart tal-2026
English: Tolvaptan affinity for the human V2 receptor is 1.8 times that of native AVP.
Maltese: L-affinità ta' tolvaptan għar-riċettur V2 tal-bniedem hija 1.8 darbiet aktar minn dik ta' AVP indiġenu.
English: Radio labelled tolvaptan experiments showed that 40 % of the radioactivity was recovered in the urine and 59 % was recovered in the faeces, where unchanged tolvaptan accounted for 32 % of radioactivity.
Maltese: Esperimenti b'tolvaptan radjutikkettjat urew li 40 % tar-radjuattività kienet irkuprata fl-awrina u 59 % kienet irkuprata fl-ippurgar, fejn tolvaptan mhux mibdul kien jammonta għal 32 % tar-radjuattività.
English: The safety and efficacy of tolvaptan in children and adolescents has not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' tolvaptan fi tfal u adolexxenti ma ġewx determinati s'issa.
English: The initial dose is to be titrated upward to a split-dose regimen of 90 mg tolvaptan (60 mg + 30 mg) per day and then to a target split-dose regimen of 120 mg tolvaptan (90 mg + 30 mg) per day, if tolerated, with at least weekly intervals between titrations.
Maltese: Id-doża tal-bidu għandha tiġi ttitrata 'l fuq għall-kors ta' doża maqsuma ta' 90 mg tolvaptan (60 mg + 30 mg) kuljum u wara għall-kors ta' doża maqsuma mmirata ta' 120 mg tolvaptan (90 mg + 30 mg) kuljum, jekk ikun ittollerat, b'intervalli ta' mill-inqas ġimgħa bejn it-titrazzjonijiet.
English: 7 × 15 mg tablets and 7 × 45 mg tablets 14 × 15 mg tablets and 14 × 45 mg tablets 28 × 15 mg tablets and 28 × 45 mg tablets
Maltese: 7 × 15 mg pilloli u 7 × 45 mg pilloli 14 × 15 mg pilloli u 14 × 45 mg pilloli 28 × 15 mg pilloli u 28 × 45 mg pilloli
English: • high levels of sodium, uric acid and blood sugar
Maltese: • livelli għolja ta' sodium, aċidu uriku u zokkor fid-demm
English: Jinarc 15 mg tablets
Maltese: Jinarc 15 mg pilloli
English: Single oral doses up to 480 mg (4 times the maximum recommended daily dose) and multiple doses up to 300 mg once daily for 5 days have been well tolerated in trials in healthy subjects.
Maltese: Dożi orali singoli sa 480 mg (4 darbiet id-doża massima rakkomandata ta' kuljum) u dożi multipli sa 300 mg darba kuljum għal 5 ijiem ġew ittollerati tajjeb fi provi f'individwi f'saħħithom.
English: Each 60 mg tablet contains approximately 16 mg lactose (as monohydrate).
Maltese: Kull pillola ta' 60 mg fiha madwar 16 mg lactose (bħala monohydrate).
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Maltese: Pazjenti li għandhom problemi ereditarji rari ta' intolleranza għallgalactose, nuqqas ta' Lapp lactase jew malassorbiment tal-glucose-galactose m'għandhomx jieħdu din il-mediċina.
English: The pharmacodynamic effects of tolvaptan have been determined in healthy subjects and subjects with ADPKD across CKD stages 1 to 4.
Maltese: L-effetti farmakodinamiċi ta' tolvaptan kienu determinati f'individwi f'saħħithom u f'individwi b'ADPKD tul stadji 1 sa 4 ta' CKD.
English: Tolvaptan has been associated with idiosyncratic elevations of blood alanine and aspartate aminotransferases (ALT and AST) with infrequent cases of concomitant elevations in bilirubin-total (BT).
Maltese: Tolvaptan kien assoċjat ma' żidiet idjosinkratiċi ta' alanine u aspartate aminotransferases (ALT u AST) fid-demm ma' każijiet mhux frekwenti ta' żidiet fl-istess waqt fil-bilirubina totali (BTbilirubin-total).
English: Tolvaptan is a vasopressin antagonist that specifically blocks the binding of arginine vasopressin (AVP) at the V2 receptors of the distal portions of the nephron.
Maltese: Tolvaptan huwa antagonist ta' vasopressin li jimblokka speċifikament l-irbit ta' arginine vasopressin (AVP) fir-riċetturi V2 tal-porzjonijiet tat-tarf (distal portions) tan-nefron.