FrancophonIA/ELRC3.0 huggingface dataset:
English: Both Guideline 7AE17a and Guideline EMEA/CVMP/EWP/005/2000-Rev.2 state that field studies should be performed in at least two geographical regions and the animal population studied should be representative of the target population.
Maltese: Kemm il-Linja gwida 7AE17a kif ukoll il-Linja gwida EMEA/CVMP/EWP/005/2000-Rev.2 jiddikjaraw li l-istudji fuq il-post għandhom isiru f'tal-inqas żewġ reġjuni ġeografiċi u li l-popolazzjoni tal-annimali li tiġi studjata għandha tkun rappreżentattiva tal-popolazzjoni fil-mira.
English: Iceland
Maltese: L-Iżlanda
English: The collar should be applied just before the beginning of the period of activity of sand fly vectors corresponding to the Leishmania infantum transmission season and worn continuously throughout the risk period.
Maltese: Il-kullar għandu jiġi applikat eżatt qabel il-bidu talperjodu ta' attività tax-xerrieda tas-sand fly li jikkorrispondi mal-istaġun tat-trażmissjoni talLeishmania infantum u jintlibes kontinwament matul il-perjodu ta' riskju.
English: Although a significant reduction in the incidence of L. infantum in dogs has been demonstrated, the product has shown variable repellent (anti-feeding) and insecticidal efficacy against the sand fly P. perniciosus.
Maltese: Għalkemm intwera tnaqqis konsiderevoli fl-inċidenza ta' L. infantum fil-klieb, il-prodott wera effikaċja repellenti (kontra l-għalf) u insettiċidali varjabbli kontra n-nemusa mill-ġenus mutu P. perniciosus.
English: It should be noted that Guideline 7AE17a provides general guidance including a threshold for efficacy against Diptera, but was not established with the aim of providing guidance on studies to support claims relating to vector-borne diseases such as reduction of canine leishmaniosis.
Maltese: Għandu jiġi nnutat li l-Linja gwida 7AE17a tipprovdi gwida ġenerali inkluż limitu għall-effikaċja kontra Diptera, iżda ma ġietx stabbilita bl-għan li tipprovdi gwida dwar studji biex jappoġġjaw dikjarazzjonijiet relatati ma' mard li jinġarr minn vettur bħat-tnaqqis ta' lexmanjożi tal-klieb.
English: The study ran between April/May and December 2013 (approximately eight months), and there was a post-treatment phase which ran until April/May 2014.
Maltese: L-istudju dam bejn April/Mejju u Diċembru 2013 (madwar tmien xhur), u kien hemm fażi ta' wara l-kura li damet sa April/Mejju 2014.
English: Regarding the results of the three field studies presented by the MAH, all three studies were able to demonstrate that use of Seresto led to a significant reduction in the occurrence of infection with L. infantum over a sustained period (between 7 and 8 months), with overall mean efficacies of the collar in preventing leishmaniosis of 93.4% in the first field study, 100% in the second field study, and 88.3% in the third field study as evaluated by the incidence density rate.
Maltese: Fir-rigward tar-riżultati tat-tliet studji fuq il-post ippreżentati mill-MAH, it-tliet studji kollha setgħu juru li l-użu ta' Seresto wassal għal tnaqqis konsiderevoli fl-okkorrenza ta' infezzjoni b'L. infantum fuq perjodu sostnut (bejn 7 u 8 xhur), b'effikaċji medji globali tal-kullar għall-prevenzjoni tallexmanjożi ta' 93.4% fl-ewwel studju fuq il-post, 100% fit-tieni studju fuq il-post, u 88.3% fit-tielet studju fuq il-post kif ivvalutat mir-rata ta' densità ta' inċidenza.
English: Regarding the data requirement for the demonstration of repellent (anti-feeding) efficacy against P. perniciosus, the UK did not accept that the laboratory data submitted by the MAH for the product justify the inclusion of an indication against the sand fly vector.
Maltese: Fir-rigward tar-rekwiżit tad-data għad-dimostrazzjoni tal-effikaċja tar-repellent (kontra l-għalf) kontra P. perniciosus, ir-Renju Unit ma aċċettax li d-data tal-laboratorju ppreżentata mill-MAH għallprodott tiġġustifika l-inklużjoni ta' indikazzjoni kontra l-vettur tan-nemusa mill-ġenus mutu.
English: Conjunctival swabs were collected on study day 0 and samples of bone marrow were collected on study day 0, in April 2012, and October 2012.
Maltese: L-istudju dam bejn Marzu 2011 u April 2012, b'fażi ta' wara l-kura li bdiet f'April 2012 u li tlestiet f'Ottubru 2012.
English: Zuprevo tildipirosin
Maltese: Zuprevo tildipirosina
English: Zuprevo is an antibiotic that belongs to the group ‘macrolides'.
Maltese: Zuprevo huwa antibijotiku li jifforma parti mill-grupp ‘makrolidi'.
English: Other information about Zuprevo:
Maltese: Informazzjoni oħra dwar Zuprevo:
English: Zuprevo is an antibiotic used in pigs to treat swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica and Haemophilus parasuis.
Maltese: Zuprevo huwa antibijotiku użat fil-ħnieżer biex jikkura l-mard respiratorju tal-ħnieżer (SRD) assoċjat ma' Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica u Haemophilus parasuis.
English: Zuprevo is available as a solution for injection containing tildipirosin 40 mg/ml (for pigs) or 180 mg/ml (for cattle).
Maltese: Zuprevo huwa disponibbli bħala soluzzjoni għall-injezzjoni li fiha t-tildipirosina 40 mg/ml (għall-ħnieżer) jew 180 mg/ml (għall-ifrat).
English: Zuprevo is a veterinary medicine that contains tildipirosin.
Maltese: Zuprevo huwa mediċina veterinarja li fiha t-tildipirosina.
English: Zuprevo is used in cattle to treat and prevent bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni.
Maltese: Zuprevo jintuża fl-ifrat biex jikkura u jipprevjeni l-mard respiratorju bovin (BRD) assoċjat ma' Mannheimia haemolytica, Pasteurella multocida u Histophilus somni.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Zuprevo on 6 May 2011.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Zuprevo fis-6 ta' Mejju 2011.
English: The effectiveness of Zuprevo used for treatment and metaphylaxis of SRD in diseased pigs as well as in clinically healthy in-contact pigs was investigated in a field study in which an outbreak of SRD was confirmed with at least 30% of the pens showing clinical signs of SRD, including at least 10% of animals per pen within 1 day or 20% within 2 days or 30% within 3 days.
Maltese: L-effikaċja ta' Zuprevo użat għall-kura u l-metafilassi tal-SRD fi ħnieżer morda kif ukoll fi ħnieżer klinikament b'saħħithom li huma f'kuntatt ġiet investigata fi studju fuq il-post fejn tifqigħa ta' SRD ġiet ikkonfermata b'minn tal-inqas 30% tal-imqajjel li wrew sinjali kliniċi tal-SRD, inkluż minn tal-inqas 10% tal-annimali għal kull maqjel fi żmien ġurnata jew 20% fi żmien jumejn jew 30% fi żmien tlett ijiem. 229 ħanżir ġew ikkurati b'Zuprevo u 227 ħanżir kienu kontrolli mhux ikkurati li rċevew salina.
English: What is Zuprevo?
Maltese: X'inhu Zuprevo?
English: Why has Zuprevo been approved?
Maltese: Għaliex ġie approvat Zuprevo?
English: The treatment studies looked at the improvement of the signs of respiratory disease and the prevention studies looked at the absence of signs of infection (fever, respiratory or behaviour abnormalities) in animals exposed to infection.
Maltese: Listudji dwar il-kura ħarsu lejn it-titjib tas-sinjali ta' mard respiratorju u l-istudji dwar il-prevenzjoni ħarsu lejn in-nuqqas ta' sinjali ta' infezzjoni (deni, anomaliji respiratorji jew ta' mġiba) f'annimali esposti għal infezzjoni.
English: If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR).
Maltese: Jekk trid iktar informazzjoni relatata mar-rakkomandazzjonijiet tas-CVMP, aqra dDiskussjoni Xjentifika (parti wkoll mill-EPAR).
English: What is the risk associated with Zuprevo?
Maltese: X'inhu r-riskju assoċjat ma' Zuprevo?
English: The benefit/risk balance may be found in the scientific discussion module of this EPAR.
Maltese: Ilbilanċ bejn il-benefiċċji/ir-riskji jista' jinstab fil-modulu ta' diskussjoni xjentifika ta' dan l-EPAR.
English: When Zuprevo was used for treatment and metaphylaxis of SRD in diseased and clinically healthy incontact pigs approximately 86% of the healthy pigs remained free of clinical signs of disease compared with approximately 65% of pigs in the untreated control group.
Maltese: Meta Zuprevo ntuża għall-kura u l-metafilassi tal-SRD fi ħnieżer morda u fi ħnieżer klinikament b'saħħithom li huma f'kuntatt, madwar 86% tal-ħnieżer b'saħħithom baqgħu ħielsa minn sinjali kliniċi tal-marda meta mqabbla ma' madwar 65% tal-ħnieżer fil-grupp ta' kontroll mhux ikkurat.
English: The studies in SRD included pigs between three and 21 weeks of age, and those in BRD included cattle between one and 24 months of age.
Maltese: L-istudji fis-SRD inkludew ħnieżer ta' bejn tliet ġimgħat u 21 ġimgħa, u dawk fil-BRD inkludew ifrat ta' bejn xahar u 24 xahar.
English: Animals treated with Zuprevo may develop a swelling at the site of the injection, especially when larger volumes are used, therefore each injection is limited to a maximum volume (5 ml in pigs and 10 ml in cattle).
Maltese: L-annimali kkurati b'Zuprevo jistgħu jiżviluppaw nefħa fil-post tal-injezzjoni, speċjalment meta jintużaw volumi akbar, għaldaqstant kull injezzjoni hija limitata għal volum massimu (5 ml fil-ħnieżer u 10 ml fl-ifrat).
English: Special caution should be taken to avoid accidental self-injection, as laboratory studies in dogs showed cardiovascular effects after intramuscular injection of high doses of tildipirosin.
Maltese: Għandha tingħata attenzjoni speċjali biex jiġi evitat li l-persuna tinjetta lilha nnifisha aċċidentalment, peress li l-istudji fil-laboratorju fil-klieb urew effetti kardjovaskulari wara injezzjoni fil-muskolu ta' dożi għoljin tat-tildipirosina.
English: In the field studies, the medicine was compared with other antibiotics used in these diseases (tulathromycin or florfenicol).
Maltese: Fl-istudji fuq il-post, il-mediċina tqabblet ma' antibijotiċi oħrajn użati f'dan il-mard (tulathromycin jew florfenicol).
English: It works by blocking the bacterias' ribosomes, the parts of the cell where proteins are produced, and blocking the growth of bacteria.
Maltese: Jaħdem billi jimblokka r-ribożomi talbatterji, il-partijiet taċ-ċellola li fihom jiġu prodotti l-proteini, u b'hekk iwaqqaf t-tkabbir tal-batterji.
English: Tildipirosin may cause sensitisation by skin contact.
Maltese: It-tildiprosin tista' tikkawża sensitizzazzjoni jekk tiġi f'kuntatt mal-ġilda.
English: When using the antibiotic Zuprevo, it is essential to closely follow the instructions in the package leaflet to minimise the development of antibiotic resistance.
Maltese: Meta tuża l-antibijotiku Zuprevo, huwa essenzjali li ssegwi mill-qrib l-istruzzjonijiet fil-fuljett ta' tagħrif biex jiġi minimizzat l-iżvilupp ta' reżistenza antibijotika.
English: The effectiveness of Zuprevo was shown to be comparable to that of tulathromycin or florfenicol in the treatment of SRD, and in the treatment and prevention of BRD.
Maltese: L-effikaċja ta' Zuprevo wriet li hija komparabbli għal dik ta' tulathromycin jew florfenicol fil-kura talSRD, u fil-kura u l-prevenzjoni tal-BRD.
English: The withdrawal period for meat is nine days for pigs and 47 days for cattle.
Maltese: Il-perjodu ta' tiżmim huwa disat ijiem għall-ħnieżer u 47 jum għall-ifrat.
English: 1101 CT, Amsterdam Netherlands
Maltese: 1101 CT, Amsterdam L-Olanda
English: (CKD stage 4), respectively.
Maltese: (stadju 4 ta' CKD ), rispettivament.
English: [INR] > 1.5)
Maltese: [INR - International Normalized Ratio] > 1.5)
English: 7 tablets 28 tablets
Maltese: 7 pilloli 28 pillola
English: Almac Pharma Service (Ireland) Limited Finnabair Industrial Estate, Dundalk, Co. Louth - A91 P9KD Ireland
Maltese: Almac Pharma Service (Ireland) Limited Finnabair Industrial Estate, Dundalk, Co. Louth - A91 P9KD L-Irlanda
English: Nocturia, Pollakiuria, Polyuria
Maltese: Nokturja, Pollakjurja, Poliurja
English: Information in braille:
Maltese: Informazzjoni bil-braille:
English: The absolute bioavailability of tolvaptan is about 56 %.
Maltese: Il-bijodisponibilità assoluta (absolute bioavailability) ta' tolvaptan hija madwar 56 %.
English: • ALT or AST > 8-times ULN
Maltese: • ALT jew AST > 8 darbiet ULN
English: Almac House, 20 Seagoe Industrial Estate Craigavon - BT63 5QD United Kingdom
Maltese: Almac House, 20 Seagoe Industrial Estate Craigavon - BT63 5QD Ir-Renju Unit
English: 4) worsening albuminuria
Maltese: 4) aggravar ta' albuminurja
English: The active substance is tolvaptan.
Maltese: Is-sustanza attiva hi tolvaptan.
English: Date of first authorisation: 27 May 2015
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 27 ta 'Mejju 2015
English: Millmount Healthcare Limited Block-7, City North Business Campus, Stamullen, Co. Meath, K32 YD60
Maltese: Millmount Healthcare Limited Block-7, City North Business Campus, Stamullen, Co.
English: • acute liver failure (ALF)
Maltese: • insuffiċjenza tal-fwied akuta (ALF - acute liver failure)
English: Pharmacotherapeutic group: Diuretics, vasopressin antagonists, ATC code: C03XA01.
Maltese: Dijuretiċi, antagonisti ta' vasopressin, Kodiċi ATC: C03XA01.
English: Tolvaptan binds reversibly (98 %) to plasma proteins.
Maltese: Tolvaptan jeħel b'mod riversibbli (98 %) mal-proteini tal-plażma.
English: • Hypernatraemia
Maltese: • Ipernatrimija
English: Transporter substrates
Maltese: Sottostrati ta' trasportaturi
English: Consequently, the frequency of these adverse events is qualified as "not known".
Maltese: Għaldaqstant, il-frekwenza ta' dawn il-każijiet avversi hi kkwalifikata bħala “mhux magħruf”.
English: Tolvaptan is only a minor component in plasma (3 %).
Maltese: Tolvaptan huwa biss komponent minuri fil-plażma (3 %).
English: Tolvaptan increased plasma levels of lovastatin by 1.3- to 1.5-fold.
Maltese: Tolvaptan żied il-livelli fil-plażma ta' lovastatin b'1.3 sa 1.5 darbiet.
English: (CKD-Epidemiology formula) and historical TKV, available in 318 (23 %) of subjects, averaged 2,026 mL.
Maltese: (CKD - Formula Epidemjoloġika) u TKV storiku, disponibbli f'318 (23 %)-il individwu, kellu medja ta' 2,026 mL.
English: Do not take Jinarc:
Maltese: Tiħux Jinarc:
English: Concomitant use of medicinal products that are moderate CYP3A inhibitors (e.g. amprenavir, aprepitant, atazanavir, ciprofloxacin, crizotinib, darunavir/ritonavir, diltiazem, erythromycin, fluconazole, fosamprenavir, imatinib, verapamil) or strong CYP3A inhibitors (e.g., itraconazole, ketoconazole, ritonavir, clarithromycin) increase tolvaptan exposure.
Maltese: L-użu fl-istess waqt ta' prodotti mediċinali li huma inibituri moderati ta' CYP3A (eż. amprenavir, aprepitant, atazanavir, ciprofloxacin, crizotinib, darunavir/ritonavir, diltiazem, erythromycin, fluconazole, fosamprenavir, imatinib, verapamil) jew inibituri qawwija ta' CYP3A (eż. itraconazole, ketoconazole, ritonavir, clarithromycin) iżidu l-espożizzjoni għal tolvaptan.
English: In-vitro studies indicate that tolvaptan or its oxobutyric metabolite may have the potential to inhibit OATP1B1, OATP1B3, OAT3, BCRP and OCT1 transporters.
Maltese: Studji in-vitro jindikaw li tolvaptan jew il-metabolit oxobutyric tiegħu jista' jkollhom il-potenzjal li jinibixxu t-trasportaturi OATP1B1, OATP1B3, OAT3, BCRP u OCT1.
English: 30 but greater than 15 mL/min/1.73 m
Maltese: 30 mL/min/1.73 m
English: The phase 3 pivotal trial (TEMPO 3:4, 156-04-251) included subjects from 129 centres in the Americas, Japan, Europe and other countries.
Maltese: Il-prova pivitali ta' fażi 3 (TEMPO 3:4, 156-04-251) inkludiet individwi minn 129 ċentru fl-Ameriki, il-Ġappun, l-Ewropa u pajjiżi oħra.
English: Otsuka Pharmaceutical Netherlands B.V. Herikerbergweg 292
Maltese: Herikerbergweg 292
English: In-vitro studies indicate that tolvaptan is a substrate and competitive inhibitor of P-glycoprotein (P-gp).
Maltese: Studji in-vitro jindikaw li tolvaptan huwa sottostrat u inibitur kompetittiv ta' P-glycoprotein (P-gp).
English: • ALT or AST > 3-times ULN and (BT > 2-times ULN or International Normalized Ratio
Maltese: • ALT jew AST > 3 darbiet ULN u (BT > darbtejn ULN jew Proporzjon Normalizzat
English: The other ingredients are lactose monohydrate (see section 2), maize starch, microcrystalline cellulose, hydroxypropylcellulose, magnesium stearate, indigo carmine aluminium lake.
Maltese: Is-sustanzi mhux attivi l-oħra huma lactose monohydrate (ara sezzjoni 2), maize starch, microcrystalline cellulose, hydroxypropylcellulose, magnesium stearate, indigo carmine aluminium lake.
English: Co-administration of tolvaptan and ketoconazole resulted in a 440 % increase in area under time-concentration curve (AUC) and 248 % increase in maximum observed plasma concentration (Cmax) for tolvaptan.
Maltese: L-għoti ta' tolvaptan flimkien ma' ketoconazole wassal għal żieda ta' 440 % fl-erja taħt il-kurva (AUC - area under the curve) tal-konċentrazzjoni-ħin u żieda ta' 248 % fil-konċentrazzjoni massima osservata fil-plażma (Cmax - maximum plasma concentration) ta' tolvaptan.
English: These data also showed significant benefit from tolvaptan vs. placebo (p < 0.0001).
Maltese: Dan it-tagħrif wera benefiċċju sinjifikanti minn tolvaptan vs. plaċebo (p < 0.0001).
English: Smoking and alcohol
Maltese: Tipjip u alkoħol
English: ‘Tolvaptan (n = 961) and placebo (n = 484) groups were well matched in terms of gender with an average age of 39 years.
Maltese: Il-gruppi ta' tolvaptan (n = 961) u ta' plaċebo (n = 484) kienu mqabbla tajjeb f'termini ta' sess b'età medja ta' 39 sena.
English: EU/1/15/1000/003 7 tablets EU/1/15/1000/004 28 tablets
Maltese: EU/1/15/1000/003 7 pilloli EU/1/15/1000/004 28 pillola
English: EU/1/15/1000/001 7 tablets EU/1/15/1000/002 28 tablets
Maltese: EU/1/15/1000/001 7 pilloli EU/1/15/1000/002 28 pillola
English: Subgroup analysis of the primary and secondary endpoints by CKD stage found similar, consistent treatment effects relative to placebo for subjects in stages 2, 3a, 3b and 4 at baseline.
Maltese: Ġew osservati effetti ta' trattament simili u konsistenti meta paragunati mal-plaċebo fl-analiżi tassottogrupp tal-punti finali primarji u sekondarji skont l-istadju CKD għal individwi fi Stadji 2, 3a, 3b u 4 fil-linja bażi.
English: Palpitations
Maltese: Palpitazzjonijiet
English: • Breast-feeding (see section 4.6)
Maltese: • Treddigħ (ara sezzjoni 4.6)
English: All ADRs are listed by system organ class and frequency; very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Maltese: L-ADRs kollha huma elenkati skont il-klassi tas-sistemi u tal-organi u l-frekwenza; 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) u mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: 30 mg (further reduction to 15 mg if 30 mg are not well tolerated)
Maltese: 30 mg (aktar tnaqqis għal 15 mg jekk 30 mg ma jkunux ittollerati sew)
English: The relative rate of ADPKD-related events was decreased by 13.5 % in tolvaptan-treated patients, (hazard ratio, 0.87; 95 % CI, 0.78 to 0.97; p = 0.0095).
Maltese: Ir-rata relattiva ta' avvenimenti relatati ma' ADPKD naqset bi 13.5 % f'pazjenti kkurati b'tolvaptan, (proporzjon ta' periklu (hazard ratio), 0.87; CI ta' 95 %, 0.78 sa 0.97; p = 0.0095).
English: The pharmacodynamically predictable and most commonly reported adverse reactions are thirst, polyuria, nocturia, and pollakiuria occurring in approximately 55 %, 38 %, 29 % and 23 % of patients, respectively.
Maltese: Ir-reazzjonijiet avversi rrappurtati bl-aktar mod komuni u li huma farmakodinamikament prevedibbli huma għatx, poliurja, nokturja, u pollakjurja li jseħħu f'madwar 55 %, 38 %, 29 % u 23 % tal-pazjenti, rispettivament.
English: Tolvaptan is extensively metabolised in the liver almost exclusively by CYP3A.
Maltese: Tolvaptan huwa metabolizzat b'mod estensiv fil-fwied kważi esklussivament minn CYP3A.
English: A single oral dose of 2,000 mg/kg was lethal in mice and symptoms of toxicity in affected mice included decreased locomotor activity, staggering gait, tremor and hypothermia.
Maltese: Doża orali waħda ta' 2,000 mg/kg kienet letali fil-ġrieden u sintomi ta' tossiċità fil-ġrieden affettwati inkludew tnaqqis fl-attività lokomotorja, mixja mxengla, rogħda u ipotermja.
English: CYP3A inducers
Maltese: Indutturi ta' CYP3A
English: In a double-blind, placebo-controlled trial in patients with ADPKD, elevation (> 3 × upper limit of normal [ULN]) of ALT was observed in 4.4 % (42/958) of patients on tolvaptan and 1.0 % (5/484) of patients on placebo, while elevation (> 3 × ULN) of AST was observed in 3.1 % (30/958) of patients on tolvaptan and 0.8 % (4/484) patients on placebo.
Maltese: Fi prova double-blind, ikkontrollata bil-plaċebo f'pazjenti b'ADPKD, żidiet (> 3 × il-limitu ta' fuq tan-normal [ULN - upper limit of normal]) ta' ALT kienu osservati f'4.4 % (42/958) tal-pazjenti fuq tolvaptan u f'1.0 % (5/484) tal-pazjenti fuq il-plaċebo, filwaqt li żieda (> 3 × ULN) ta' AST kienet osservata fi 3.1 % (30/958) tal-pazjenti fuq tolvaptan u f'0.8 % (4/484) tal-pazjenti fuq plaċebo.
English: In a population pharmacokinetic analysis in patients with hepatic oedema, AUC of tolvaptan in severely (Child-Pugh class C) and mildly or moderately (Child-Pugh classes A and B) hepatic impaired patients were 3.1 and 2.3 times higher than that in healthy subjects.
Maltese: F'analiżi farmakokinetika tal-popolazzjoni f'pazjenti b'edima tal-fwied, l-AUC ta' tolvaptan f'pazjenti b'indeboliment epatiku sever (Child-Pugh klassi C) u ħafif jew moderat (Child-Pugh klassijiet A u B) kienet 3.1 u 2.3 darbiet ogħla minn dik f'individwi f'saħħithom.
English: • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or to benzazepine or benzazepine derivatives (see section 4.4)
Maltese: • Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe sustanza mhux attiva elenkata fis-sezzjoni 6.1 jew għal benzazepine jew derivati ta' benzazepine (ara sezzjoni 4.4)
English: Jinarc may reduce the effect of desmopressin.
Maltese: Jinarc jista' jnaqqas l-effett ta' desmopressin.
English: Jinarc is a medicine used to treat a disease called “autosomal dominant polycystic kidney disease” (ADPKD).
Maltese: Jinarc huwa mediċina li tintuża biex tikkura marda msejħa “marda poliċistika tal-kliewi awtosomalment dominanti” (ADPKD - autosomal dominant polycystic kidney disease).
English: Acute reductions in mean total kidney volume were also observed following 3 weeks of therapy in all CKD stages, ranging from -4.6 % for CKD stage 1 to -1.9 % for CKD stage 4.
Maltese: Tnaqqis akut fil-medja tal-volum totali tal-kliewi kien osservat ukoll wara 3 ġimgħat ta' terapija fl-istadji kollha ta' CKD, li varja minn −4.6 % għal stadju 1 ta' CKD sa −1.9 % għal stadju 4 ta' CKD.
English: Approximately 35 % of subjects were chronic kidney disease (CKD) stage 1, 48 % CKD stage 2, and 17 % CKD stage 3 (eGFRCKD-EPI).
Maltese: Madwar 35 % tal-individwi kellhom marda kronika tal-kliewi (CKD) ta' stadju 1, 48 % kellhom CKD stadju 2, u 17 % kellhom CKD stadju 3 (eGFRCKD-EPI).
English: Tolvaptan may cause hyperglycaemia (see section 4.8).
Maltese: Tolvaptan jista' jikkawża ipergliċemija (ara sezzjoni 4.8).
English: This difference was maintained in the pre-specified MMRM analysis (3.15 mL/min/1.73 m2, 95 %CI 1.462 to 4.836, p = 0.0003) and with sensitivity analyses where baseline eGFR data were carried forward (2.64 mL/min/1.73 m2, 95 %CI 0.672 to 4.603, p = 0.0086).
Maltese: MMRM speċifikata minn qabel (3.15 mL/min/1.73 m2, 95 % CI 1.462 sa 4.836, p = 0.0003) u b'analiżi ta' sensittività fejn il-linja bażi tad-dejta eGFR kienet imressqa 'il quddiem (2.64 mL/min/1.73 m2, 95 % CI 0.672 sa 4.603, p = 0.0086).