FrancophonIA/ELRC3.0 huggingface dataset:
English: A dual energy X ray absorptiometry (DXA) substudy for both the Phase III studies (C209 and C215) investigated the effect of rilpivirine as compared with control, overall and by background regimen on changes in whole body bone mineral density (BMD) and bone mineral content (BMC) at week 48 and week 96.
Maltese: III (C209 u C215) investiga l-effett ta' rilpivirine kif imqabbel mal-kontroll, globalment u permezz ta' kors fl-isfond dwar tibdil fid-densità minerali tal-għadam (bone mineral density, BMD) tal-ġisem sħiħ u fil-kontenut minerali tal-għadam (BMC) f'ġimgħa 48 u ġimgħa 96.
English: Since emtricitabine and tenofovir are primarily eliminated by the kidneys, co-administration of Eviplera with medicinal products that reduce renal function or compete for active tubular secretion (e.g. cidofovir) may increase serum concentrations of emtricitabine, tenofovir and/or the co-administered medicinal products.
Maltese: Minħabba li emtricitabine u tenofovir huma primarjament eliminati mill-kliewi, l-għoti ta' Eviplera flimkien ma' prodotti mediċinali li jnaqqsu l-funzjoni renali jew jikkompetu għas-sekrezzjoni tubulari attiva (eż. cidofovir) jista' jżid il-konċentrazzjonijiet fis-serum ta' emtricitabine, tenofovir u/jew ilprodotti mediċinali li jingħataw flimkien.
English: Eviplera contains three active substances that are used to treat Human Immunodeficiency Virus (HIV) infection:
Maltese: Eviplera fih tliet sustanzi attivi li jintużaw għal kura ta' infezzjoni bil-Virus tal-Immunodefiċjenza Umana (HIV):
English: ANTICONVULSANTS Carbamazepine Oxcarbazepine Phenobarbital Phenytoin
Maltese: Waqqfu l-mediċina tal-istudju minħabba AE jew mewtd
English: As Eviplera contains emtricitabine, rilpivirine hydrochloride and tenofovir disoproxil, any interactions that have been identified with these active substances individually may occur with Eviplera.
Maltese: Minħabba li Eviplera fiha emtricitabine, rilpivirine hydrochloride u tenofovir disoproxil, kull interazzjoni li ġiet identifikata ma' dawn is-sustanzi attivi individwalment tista' sseħħ b'Eviplera.
English: The bioequivalence of one Eviplera film-coated tablet with one emtricitabine 200 mg hard capsule, one rilpivirine (as hydrochloride) 25 mg film-coated tablet and one tenofovir disoproxil 245 mg film-coated tablet was established following single dose administration to fed, healthy subjects.
Maltese: Il-bijoekwivalenza ta' pillola waħda miksija b'rita ta' Eviplera flimkien ma' kapsula iebsa ta' 200 mg emtricitabine, pillola waħda miksija b'rita ta' 25 mg ta' rilpivirine (bħala hydrochloride) u pillola waħda miksija b'rita ta' 245 mg tenofovir disoproxil kienet stabbilita wara li ngħatat doża waħda lill-individwi f'saħħithom fl-istat mhux sajjem.
English: Eviplera arm n = 317
Maltese: n = 159
English: The K65R, M184V, and K65R+M184V mutants of HIV-1 remain fully susceptible to rilpivirine.
Maltese: Tenofovir disoproxil għandu jkun evitat f'pazjenti bl-HIV-1 bil-mutazzjoni K65R. Il-mutants K65R, M184V, u K65R+M184V ta' HIV-1 jibqgħu suxxettibbli b'mod sħiħ għal rilpivirine.
English: Concomitant use of Eviplera with ritonavir-boosted PIs causes an increase in the plasma concentrations of rilpivirine (inhibition of CYP3A enzymes).
Maltese: L-għoti flimkien x'aktarx li jikkawża tnaqqis sinifikanti talkonċentrazzjonijiet ta' rilpivirine fil-plażma (induzzjoni tal-enzimi ta' CYP3A).
English: In general, emtricitabine pharmacokinetics in HBV infected patients was similar to those in healthy subjects and in HIV infected patients.
Maltese: B'mod ġenerali, il-farmakokinetika ta' emtricitabine f'pazjenti infettati bl-HBV kienet simili għal dik f'individwi f'saħħithom u f'pazjenti infettati bl-HIV.
English: • Talk to your doctor if you are over 65 years of age.
Maltese: • Kellem lit-tabib tiegħek jekk għandek iktar minn 65 sena.
English: 6 This was a rare adverse reaction for tenofovir disoproxil.
Maltese: Din kienet reazzjoni avversa rari għal tenofovir disoproxil.
English: If Eviplera is co-administered with rifabutin, an additional 25 mg tablet of rilpivirine per day is recommended to be taken concomitantly with Eviplera, for the duration of the rifabutin coadministration (see section 4.5).
Maltese: Jekk Eviplera jingħata flimkien ma' rifabutin, pillola addizzjonali ta' 25 mg ta' rilpivirine kuljum hi rakkomandata li tittieħed fl-istess ħin ma' Eviplera, għal kemm idum l-għoti flimkien ta' rifabutin (ara sezzjoni 4.5).
English: *compared to 25 mg once daily rilpivirine alone
Maltese: F'doża ta' 25 mg ta' rilpivirine,
English: AUC: ↔ Cmin: ↑ 26% Cmax: ↔
Maltese: AUC: ↔ Cmax: ↑ 10% Cmin: ↔
English: The single-tablet regimen (STR), Eviplera, has been studied in virologically suppressed patients who switched from a regimen containing a ritonavir-boosted PI (Phase III study GS-US-264-0106) or from efavirenz/emtricitabine/tenofovir disoproxil (Phase IIb study GS-US-264-0111).
Maltese: Pazjenti b'indeboliment moderat jew sever renali jeħtieġu aġġustament fl-intervall taddoża ta' emtricitabine u tenofovir disoproxil li ma jistax jinkiseb bil-pillola kombinata (ara sezzjonijiet 4.4 u 5.2).
English: Concomitant use of Eviplera with azole antifungal agents may cause an increase in the plasma concentrations of rilpivirine (inhibition of CYP3A enzymes).
Maltese: L-użu fl-istess ħin ta' Eviplera ma' mediċini antifungali azole jista' jikkawża żieda talkonċentrazzjonijiet fil-plażma ta' rilpivirine (inibizzjoni tal-enzimi ta' CYP3A).
English: As Eviplera may cause renal damage, monitoring of renal function is recommended (see sections 4.4 and 4.8, Summary of the safety profile).
Maltese: Billi Eviplera jista' jikkawża ħsara renali, il-monitoraġġ tal-funzjoni renali hu rakkomandat (ara sezzjonijiet 4.4 u 4.8 Sommarju tal-profil tas-sigurtà).
English: Contents of the pack and other information What Eviplera contains
Maltese: Aħżen fil-pakkett oriġinali sabiex tilqa' mill-umdità.
English: Co-administration of Eviplera with proton pump inhibitors has been observed to decrease the plasma concentrations of rilpivirine (due to an increase in gastric pH) which could potentially lead to loss of therapeutic effect of Eviplera (see section 4.3).
Maltese: L-għoti flimkien ta' Eviplera ma' inibituri tal-pompa tal-proton ġie osservat li jnaqqas ilkonċentrazzjonijiet fil-plażma ta' rilpivirine (minħabba żieda fil-pH gastriku) li jista' potenzjalment iwassal għat-telf tal-effett terapewtiku ta' Eviplera (ara sezzjoni 4.3).
English: Where discontinuation of therapy with one of the components of Eviplera is indicated or where dose modification is necessary, separate preparations of emtricitabine, rilpivirine hydrochloride and tenofovir disoproxil are available.
Maltese: Meta t-twaqqif tat-terapija b'wieħed mill-komponenti ta' Eviplera jkun indikat, jew meta tibdil fiddoża jkun meħtieġ, preparazzjonijiet separati ta' emtricitabine, rilpivirine hydrochloride u tenofovir disoproxil huma disponibbli.
English: In the week 96 pooled resistance analysis for patients receiving emtricitabine/tenofovir disoproxil + rilpivirine hydrochloride in the Phase III clinical studies C209 and C215, there were 78 virologic failure patients with genotypic resistance information available for 71 of those patients.
Maltese: III C209 u C215, kien hemm 78 pazjent b'insuffiċjenza viroloġika b'informazzjoni dwar ir-reżistenza ġenotipika disponibbli għal 71 minn dawk il-pazjenti.
English: Film-coating
Maltese: Fil-koltura taċ-ċelluli
English: More patients who failed virologically on rilpivirine than who failed virologically on efavirenz developed lamivudine/emtricitabine associated resistance (see section 5.1).
Maltese: Aktar pazjenti b'insuffiċjenza viroloġika fuq rilpivirine minn dawk b'insuffiċjenza viroloġika fuq efavirenz, żviluppaw reżistenza assoċjata ma' lamivudine/ emtricitabine (ara sezzjoni 5.1).
English: The single resistance-associated mutations associated with a loss of susceptibility to rilpivirine were: K101P and Y181V/I.
Maltese: K101P u Y181V/I.
English: If concomitant use of Eviplera and nephrotoxic agents is unavoidable, renal function must be monitored weekly (see sections 4.5 and 4.8).
Maltese: Jekk l-użu fl-istess ħin ta' Eviplera u ta' mediċini nefrotossiċi ma jkunx jista' jiġi evitat, il-funzjoni renali trid tiġi mmonitorjata kull ġimgħa (ara sezzjonijiet 4.5 u 4.8).
English: • Decreases in phosphate levels in the blood
Maltese: • Tnaqqis fil-livelli tal-phosphate fid-demm
English: The terminal elimination half-life of rilpivirine is approximately 45 hours.
Maltese: Il-half-life tal-eliminazzjoni terminali ta' rilpivirine hi ta' madwar 45 siegħa.
English: CCR5 antagonists Maraviroc/Emtricitabine
Maltese: Maraviroc/Emtricitabine
English: Co-administration of Eviplera and didanosine is not recommended (see section 4.4).
Maltese: L-għoti flimkien ta' Eviplera u didanosine mhuwiex rakkomandat (ara sezzjoni 4.4).
English: Famotidine (40 mg single dose taken 12 hours before rilpivirine)/ Rilpivirine1
Maltese: Famotidine (doża waħda ta' 40 mg meħuda 12-il siegħa qabel rilpivirine)/Rilpivirine1
English: Since tenofovir disoproxil can cause renal toxicity, close monitoring of renal function is recommended in any patient with renal impairment treated with Eviplera (see sections 4.2, 4.4 and 5.2).
Maltese: Billi tenofovir disoproxil jista' jikkawża tossiċità renali, monitoraġġ mill-qrib tal-funzjoni renali hu rakkomandat fi kwalunkwe pazjent b'indeboliment renali kkurat b'Eviplera (ara sezzjonijiet 4.2, 4.4 u 5.2).
English: • Softening of the bones (with bone pain and sometimes resulting in fractures)
Maltese: • Dulur u wġigħ (speċjalment tal-ġenbejn, l-irkopptejn u tal-ispallejn)
English: Interactions between Eviplera or its individual component(s) and co-administered medicinal products are listed in Table 1 below (increase is indicated as “↑”, decrease as “↓” and no change as “↔”).
Maltese: Interazzjonijiet bejn Eviplera u l-komponent(i) individwali tiegħu u prodotti mediċinali mogħtija flistess ħin, huma elenkati fit-Tabella 1 hawn taħt (żieda hija indikata b'“↑”, tnaqqis b'“↓” u l-ebda bidla b'“↔”).
English: Therefore, Eviplera is not recommended in patients with severe hepatic impairment (see sections 4.4 and 5.2).
Maltese: Għalhekk, Eviplera mhuwiex rakkomandat f'pazjenti b'indeboliment sever epatiku (ara sezzjonijiet 4.4 u 5.2).
English: A subgroup analysis of the virologic response (< 50 HIV-1 RNA copies/mL) at both 48 weeks and 96 weeks, and virologic failure by baseline viral load (pooled data from the two Phase III clinical studies, C209 and C215, for patients receiving the emtricitabine/tenofovir disoproxil background regimen) is presented in Table 5.
Maltese: Analiżi ta' sottogrupp tar-rispons viroloġiku (<50 HIV-1 RNA kopji/mL) kemm wara 48 ġimgħa kif ukoll wara 96 ġimgħa, u insuffiċjenza viroloġika skont l-ammont virali fil-linja bażi (dejta miġbura miż-żewġ studji kliniċi ta' Fażi
English: • If you are allergic to emtricitabine, rilpivirine, tenofovir disoproxil, or any of the other ingredients of this medicine (listed in section 6 of this leaflet).
Maltese: • Jekk inti allerġiku għal emtricitabine, rilpivirine, tenofovir disoproxil jew għal xi sustanza oħra ta' din il-mediċina (imniżżla fis-sezzjoni 6).
English: The pharmacokinetics of rilpivirine and tenofovir disoproxil in children and adolescents are under investigation.
Maltese: Il-farmakokinetika ta' rilpivirine u tenofovir disoproxil fi tfal u l-adolexxenti qed tiġi investigata.
English: A subgroup of patients with baseline CrCl between 50 and 60 mL/min, receiving once daily dosing, had a 2- to 4-fold increase in tenofovir exposure and worsening renal function.
Maltese: Sottogrupp ta' pazjenti b'CrCl fil-linja bażi bejn 50 u 60 mL/min, li rċivew dożaġġ ta' darba kuljum, kellhom esponiment ogħla ta' 2 sa 4 darbiet aktar għal tenofovir u l-funzjoni renali marret għall-agħar.
English: Resistance to emtricitabine/lamivudine Resistance to rilpivirine Resistance to efavirenz
Maltese: Għalkemm rilpivirine wera attività limitata in vitro kontra
English: It was also identified as an adverse reaction for emtricitabine through post-marketing surveillance but was not observed in randomised controlled clinical studies in adults or paediatric HIV clinical studies of emtricitabine.
Maltese: Ġiet identifikata wkoll bħala reazzjoni avversa għal emtricitabine permezz ta' sorveljanza wara t-tqegħid fis-suq, iżda ma ġietx osservata fi studji kliniċi kkontrollati li fihom il-parteċipanti ntgħażlu b'mod każwali fl-adulti, jew fi studji kliniċi tal-HIV dwar emtricitabine f'pazjenti pedjatriċi.
English: Of the 469 Eviplera-treated patients [317 patients who switched to Eviplera at baseline (Eviplera arm) and 152 patients who switched at week 24 (Delayed Switch arm)], a total of 7 patients were analysed for resistance development and all had genotypic and phenotypic data available.
Maltese: Mill-469 pazjent li rċivew kura b'Eviplera [317-il pazjent li qalbu għal Eviplera fil-linja bażi (parti talistudju ta' Eviplera) u 152 pazjent li qalbu fil-ġimgħa 24 (parti tal-istudju tal-Qlib Ittardjat)], b'kollox ġew analizzati 7 pazjenti għall-iżvilupp ta' reżistenza u kollha kellhom dejta ġenotipika u fenotipika disponibbli.
English: If your doctor decides to stop one of the components of Eviplera or change the dose of Eviplera, you may be given emtricitabine, rilpivirine and/or tenofovir disoproxil separately or with other medicines for the treatment of HIV infection.
Maltese: Jekk it-tabib tiegħek jiddeċiedi li jwaqqaf wieħed mill-komponenti ta' Eviplera jew li jibdel id-doża ta' Eviplera, inti tista' tingħata emtricitabine, rilpivirine u/jew tenofovir disoproxil separatament jew ma' mediċini oħra għat-trattament ta' infezzjoni bl-HIV.
English: The K65R mutation can also be selected by abacavir or didanosine and results in reduced susceptibility to these agents plus to lamivudine, emtricitabine, and tenofovir.
Maltese: Il-mutazzjoni K65R tista' ukoll tintgħażel minn abacavir jew didanosine u tikkawża tnaqqis fis-suxxettibilità għal dawn il-mediċini flimkien għal lamivudine, emtricitabine u tenofovir.
English: Skin and subcutaneous tissue disorders Very common: rash1, 2, 3
Maltese: Komuni ħafna: raxx1, 2, 3 Komuni:
English: The pharmacokinetics of emtricitabine has not been studied in patients with varying degrees of hepatic insufficiency.
Maltese: Il-farmakokinetika ta' emtricitabine ma ġietx studjata f'pazjenti bi gradi diversi ta' insuffiċjenza epatika.
English: Currently available data are described in section 5.2, but no recommendation on a posology can be made.
Maltese: Data disponibbli hija deskritta fis-sezzjoni 5.2 iżda ma tista' ssir l-ebda rakkomandazzjoni dwar pożoloġija.
English: The most common mutations were the same in the week 48 and week 96 analyses.
Maltese: L-iktar mutazzjonijiet komuni kienu l-istess fl-analiżijiet ta' ġimgħa 48 u ġimgħa 96.
English: Paracetamol/Tenofovir disoproxil
Maltese: Tacrolimus/Tenofovir disoproxil/
English: Therefore, Eviplera is not recommended in patients with severe hepatic impairment (see sections 4.2 and 4.4).
Maltese: Għalhekk, Eviplera mhuwiex rakkomandat f'pazjenti b'indeboliment sever epatiku (ara sezzjonijiet 4.2 u 4.4).
English: hypertriglyceridaemia1, 2, hyperglycaemia1, decreased appetite2
Maltese:  Jekk dan japplika għalik, għid lit-tabib tiegħek immedjatament.
English: rhabdomyolysis3, 5, muscular weakness3, 5
Maltese: osteomalaċja (li tidher bħala wġigħ fl-għadam u b'mod mhux frekwenti tikkontribwixxi għal ksur)3, 5, 8, mijopatija3, 5
English: Atazanavir (300 mg once daily)/ Ritonavir (100 mg once daily)/ Tenofovir disoproxil (245 mg once daily)
Maltese: Atazanavir (300 mg darba kuljum)/ Ritonavir (100 mg darba kuljum)/
English: Meningococcal group A oligosaccharide 10 micrograms conjugated to Corynebacterium diphtheriae CRM197 protein 16.7 to 33.3 micrograms/0.5 ml Meningococcal group C oligosaccharide 5 micrograms conjugated to Corynebacterium diphtheriae CRM197 protein 7.1 to 12.5 micrograms/0.5 ml Meningococcal group W135 oligosaccharide 5 micrograms conjugated to Corynebacterium diphtheriae CRM197 protein 3.3 to 8.3 micrograms/0.5 ml Meningococcal group Y oligosaccharide 5 micrograms conjugated to Corynebacterium diphtheriae CRM197 protein 5.6 to 10.0 micrograms/0.5 ml
Maltese: Oligosaccharide ta' grupp meningokokkali A 10 mikrogrammi konjugat għal proteina Corynebacterium diphtheriae CRM197 16.7 sa 33.3 mikrogrammi/0.5 ml Oligosaccharide ta' grupp meningokokkali Ċ 5 mikrogrammi konjugat għal proteina Corynebacterium diphtheriae CRM197 7.1 sa 12.5 mikrogrammi/0.5 ml Oligosaccharide ta' grupp meningokokkali
English: 5 vials + 5 vials
Maltese: 5 kunjetti + 5 kunjetti
English: Calle de la Marina, 206 08013 Barcelona Spain
Maltese: Calle de la Marina, 206 08013 Barcelona Spanja
English: 14 Boulevard Richelieu 92500 Rueil Malmaison France
Maltese: 14 Boulevard Richelieu 92500 Rueil Malmaison Franza
English: 15561 HOLARGOS GREECE
Maltese: 15561 HOLARGOS IL-GREĊJA
English: Discussion of the data available
Maltese: Diskussjoni tad-data disponibbli
English: Novartis Farma-Produtos Farmacêuticos, S.A. Rua do Centro Empresarial, Edifício 8 Quinta da Beloura 2710-444 Sintra Portugal
Maltese: Rua do Centro Empresarial, Edifício 8 Quinta da Beloura 2710-444
English: Biochemiestraße 10 6250 Kundl Austria
Maltese: Biochemiestraße 10 6250
English: ATCvet code: QC09AA07
Maltese: QC09AA07
English: Standard dose Double dose 0.5 tablet
Maltese: Doża standard Doża doppja 0.5 pillola
English: ATCvet code: QC09AA07 5.1 Pharmacodynamic properties
Maltese: QC09AA07 5.1 Kwalitajiet Farmakodinamiċi
English: Claudius Prinsenlaan 142 4818 CP Breda The Netherlands
Maltese: Claudius Prinsenlaan 142 4818 CP Breda Il-Pajjiżi l-Baxxi
English: In line with the principles of referrals under Article 34(1) of Directive 2001/82/EC, on 16 September 2010 Sweden sent a revised referral notification under Article 34(1) of Directive 2001/82/EC, and extended the scope of the referral procedure to all Fortekor and associated names tablet strengths and formulations.
Maltese: F'konformità mal-prinċipji ta' riferiment skont l-Artikolu 34(1) tad-Direttiva 2001/82/KE, fis16 ta' Settembru 2010, l-Isvezja bagħtet notifika riveduta ta' riferiment skont l-Artikolu 34(1) tadDirettiva 2001/82/KE, u estendiet il-kamp ta' applikazzjoni tal-proċedura ta' riferiment għall-pilloli kollha ta' Fortekor u ismijiet assoċjati f'kull qawwa u formulazzjoni.
English: Novartis Veterina d.o.o.
Maltese: Is-Slovenja Novartis Veterina d.o.o.
English: 0.5 tablet
Maltese: 0.5 pillola
English: Benazepril hydrochloride is a prodrug hydrolysed in vivo to its active metabolite, benazeprilat.
Maltese: Benazepril hydrochloride huwa promediċina idrolizzata in vivo sal-metabolit attiv tagħha, benazeprilat.
English: Benazepril and benazeprilat are extensively bound to plasma proteins (85-90%), and in tissues are found mainly in the liver and kidney.
Maltese: Benazepril u benazeprilat huma marbutin b'mod estensiv mal-proteini tal-plasma (85-90%), u f'tessuti jinstabu b'mod prinċipali fil-fwied u l-kliewi.
English: 20 mg Tablets
Maltese: 20 mg Pilloli
English: Novartis Animal Health S.p.A. largo Boccioni 1 21040 Origgio (VA) Italy
Maltese: Novartis Animal Health S.p.A. largo Boccioni 1
English: Benazeprilat is excreted 54% via the biliary and 46% via the urinary route in dogs.
Maltese: Benazeprilat jiġi eliminat 54% permezz tar-rotta biljari u 46% permezz tar-rotta urinarja fil-klieb.
English: Emesis, anorexia, dehydration, lethargy and diarrhoea have been reported in rare occasions in cats.
Maltese: Emeżi, anoressija, deidratazzjoni, letarġija u dijarrea ġew irrapportati f'okkażjonijiet rari fil-qtates.
English: 2,5 mg Tablets
Maltese: 2,5 mg Pilloli
English: Cat: Experimentally to reduce proteinuria in chronic renal failure in which baseline protein/creatinine ratio PCR is >1.
Maltese: B'mod esperimentali biex titnaqqas il-proteinurja f'kollass renali kroniku li fih, il-proporzjon tal-linja bażi proteina/kreatinina PCR huwa >1.
English: By the use of an experimental model with nephrectomised cats, chronic treatment with benazepril lowered glomerular capillary pressure, raised glomerular ultrafiltration coefficient, sustained single nephron Glomerular Filtration Rate (GFR) in remnant nephrons and reduced systemic hypertension.
Maltese: Permezz tal-użu ta' mudell sperimentali bi qtates li kellhom nefrotomija, kura kronika bil-benażepril naqqset il-pressjoni glomerulari kapillari, żiedet il-koeffiċjent ta' ultrafiltrazzjoni glomerulari, sostniet ir-Rata ta' Filtrazzjoni Glomerulari (GFR) single nephron f'nephrons li kien għad fadal u naqqset l-ipertensjoni sistemika.
English: INDICATIONS
Maltese: Indikazzjonijiet
English: Denmark
Maltese: Tanska
English: 2100 København Ø Danmark
Maltese: København Ø
English: PHARMACEUTICAL FORM Tablets.
Maltese: GĦAMLA FARMAĊEWTIKA Pilloli.
English: Belgium Novartis Consumer Health B.V.
Maltese: Novartis Consumer Health B.V.
English: Benazeprilat is excreted 54% via the biliary and 46% via the urinary route in dogs and 85% via the biliary and 15% via the urinary route in cats.
Maltese: Benazeprilat jiġi eliminat 54% permezz tar-rotta biljari u 46% permezz tar-rotta urinarja fil-klieb u 85% permezz tar-rotta biljari u 15% permezz tar-rotta urinarja fil-qtates.
English: 2.5 mg Tablets
Maltese: 2.5 mg Pilloli
English: A significant overall difference in UPC was also recorded.
Maltese: Ġiet irreġistrata wkoll differenza globali sinifikanti fl-UPC.
English: Therefore due to divergent national decisions taken by Member States concerning the authorisations of Fortekor and associated names (5 mg benazepril gydrochloride film-coated tablet), on 16 October 2009, Sweden triggered a referral under Article 34(1) of Directive 2001/82/EC, as amended.
Maltese: Għalhekk minħabba d-deċiżjonijiet nazzjonali diverġenti li ttieħdu mill-Istati Membri fir-rigward talawtorizzazzjonijiet ta' Fortekor u ismijiet assoċjati (idroklorur tal-benażepril, pillola miksija b'rita ta' 5 mg), fis-16 ta' Ottubru 2009, l-Isvezja tat bidu għal riferiment skont l-Artikolu 34(1) tadDirettiva 2001/82/KE, kif emendata.
English: Treatment of heart failure in dogs, also in addition to the diuretic furosemide and/or the antiarrhythmic drug digoxin
Maltese: Klieb Kura ta' indeboliment tal-qalb filklieb, ukoll flimkien maddijuretiku furosemide u/jew ilmediċina antiarritmika digoxin
English: Weight of cat (kg)
Maltese: Piż tal-kelb (kg)
English: The difference in UPC was statistically significant in the group with UPC ≥ 1.0 but not in the group with UPC ≥ 0.2.
Maltese: Id-differenza fl-UPC kienet statistikament sinifikanti fil-grupp b'UPC ≥ 1.0 iżda mhux fil-grupp b'UPC ≥ 0.2.
English: Fortekor and associated names is a veterinary medicinal product containing benazepril hydrochloride presented in 2.5 mg, 5 mg and 20 mg flavoured tablets and 5 mg and 20 mg film-coated tablets intended for use in dogs and cats.
Maltese: Fortekor u ismijiet assoċjati huwa prodott mediċinali veterinarju li fih l-idroklorur tal-benażepril ippreżentat bħala pilloli bit-togħma ta' 2.5 mg, 5 mg u 20 mg u bħala pilloli miksija b'rita ta' 5 mg u 20 mg maħsuba għall-użu fil-klieb u l-qtates.
English: 2100 Kööpenhamina Tanska
Maltese: Köpenhamn Id-Danimarka
English: Interactions with potassium preserving diuretics like spironolactone, triamterene or amiloride cannot be ruled out.
Maltese: Interazzjonijiet ma' dijuretiċi li jippreservaw il-potassju bħal spironolactone, triamterene jew amiloride ma jistgħux jiġu eliminati.
English: In dogs, peak benazeprilat concentrations (Cmax of 37.6 ng/ml after a dose of 0.5 mg/kg benazepril hydrochloride) are achieved with a Tmax of 1.25 hours.
Maltese: Fi klieb, konċentrazzjonijiet massimi ta' benazeprilat (Cmax ta' 37.6 ng/ml wara doża ta' 0.5 mg/kg benazepril hydrochloride) jintlaħqu b'Tmax ta' 1.25 sigħat.