FrancophonIA/ELRC3.0 huggingface dataset:
English: * recombinant murine/human chimeric monoclonal antibody directed against the interleukin-2 receptor -chain (CD25 antigen) produced in a mouse myeloma cell line by recombinant DNA technology.
Maltese: * antikorp rikombinanti monoklonali kimeriku tal-ġurdien/bniedem immirat kontra l-katina- tarriċettur ta' interleukin-2 (antiġen CD25) magħmul minn linja ta'ċelluli tal-majeloma ta' ġurdien permezz tat-teknoloġija ta' DNA rikombinat.
English: For information on preclinical toxicology see section 5.3.
Maltese: Għal tagħrif dwar tossikoloġija ta' qabel l-użu kliniku ara sezzjoni 5.3.
English: One vial contains 10 mg of basiliximab.
Maltese: Kull kunjett fih 10 mg basiliximab.
English: There are limited data available on the use of Simulect in the elderly, but there is no evidence that elderly patients require a different dosage from younger adult patients.
Maltese: Hemm informazzjoni limitata dwar l-użu ta' Simulect fl-anzjani, iżda m'hemmx evidenza li pazjenti anzjani għandhom bżonn doża differenti minn pazjenti adulti iżgħar fl-età.
English: The incidence of CMV infections was similar in both groups (14.6% vs. 17.3%), following either dual or triple therapy regimen (see section 4.4).
Maltese: L-inċidenza ta' infezzjonijiet b'CMV kienet simili fiż-żewġ gruppi (14.6% vs.
English: Each vial contains 20 mg basiliximab*.
Maltese: Kull kunjett fih 20 mg basiliximab*.
English: Paediatric population The efficacy and safety of basiliximab were evaluated in two paediatric studies.
Maltese: L-effikaċja u s-sigurtà ta' basiliximab kienu evalwati f'żewġ studji pedjatriċi.
English: Simulect 10 mg powder for solution for injection/infusion basiliximab
Maltese: Simulect 10 mg trab għal soluzzjoni għall-injezzjoni/infużjoni basiliximab
English: One vial contains 20 mg of basiliximab.
Maltese: Kull kunjett fih 20 mg basiliximab.
English: In paediatric patients weighing less than 35 kg, the recommended total dose is 20 mg, given in two doses of 10 mg each.
Maltese: F'pazjenti pedjatriċi li jiżnu anqas minn 35 kg, id-doża totali rakkomandata hija ta' 20 mg, mogħtija f'żewġ dożi ta' 10 mg kull waħda.
English: There was no significant difference between basiliximab and placebo-treated patients in graft survival after 6 and 12 months (at 12 months 32 graft losses on basiliximab (9%) and 37 graft losses on placebo (10%)).
Maltese: Ma kien hemm l-ebda differenza sinifikanti fuq kemm dam ħaj l-organu tat-trapjant bejn pazjenti kkurati b'basiliximab u dawk ikkurati bil-plaċebo wara 6 u 12-il xahar (fi 12-il xahar kien hemm 32 telf ta' trapjant b'basiliximab (9%) u 37 trapjant kien mitluf bil-plaċebo (10%)).
English: In addition to ciclosporin for microemulsion, steroids, azathioprine and mycophenolate mofetil, other concomitant medications routinely administered in organ transplantation have been administered in clinical trials without any incremental adverse reactions.
Maltese: Minbarra ciclosporin għal mikroemulsjoni, sterojdi, azathioprine u mycophenolate mofetil, medikamenti oħra li s-soltu jingħataw f'każ ta' trapjant ta' organu, ġew mogħtija ma' Simulect waqt provi kliniċi mingħajr ma kien hemm xi reazzjonijiet avversi żejda.
English: The total body clearance of basiliximab was reduced by an average 51% when mycophenolate mofetil was added to a regimen consisting of ciclosporin for microemulsion and corticosteroids.
Maltese: It-tneħħija totali mill-ġisem ta' basiliximab naqset b'medja ta' 51% meta mycophenolate mofetil ingħata mal-kors li kien jikkonsisti f'ciclosporin għal mikroemulsjonijiet u kortikosterojdi.
English: Infusion sets - Luer Lock, H. Noolens - Sterile vented i.v.
Maltese: Sett tal-infużjoni - Luer Lock , H. Noolens - Sterile vented i.v. set, Abbott - Infusion set, Codan - Infusomat , Braun - Infusionsgerät R 87 plus, Ohmeda - Lifecare 5000
English: Simulect is contraindicated in pregnancy and lactation (see section 4.3).
Maltese: Simulect m'għandux jingħata waqt it-tqala jew treddiegħ (ara sezzjoni 4.3).
English: Compatibility with the following infusion sets has been verified:
Maltese: Ġie verifikat li huwa kompatibbli ma' dawn is-settijiet ta' infużjoni:
English: In paediatric patients weighing 35 kg or more, the recommended dose is the adult dose, i.e. a total dose of 40 mg, given in two doses of 20 mg each.
Maltese: F'pazjenti pedjatriċi li jiżnu 35 kg jew aktar, id-doża rakkomandata hija d-doża għall-adulti, jiġifieri doża totali ta' 40 mg, mogħtija f'żewġ dożi ta' 20 mg kull waħda.
English: Do not use this medicine after the expiry date which is stated on the carton and label after EXP.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq it-tikketta wara EXP.
English: Basiliximab does not cause myelosuppression.
Maltese: Basiliximab ma jikkawżax majelosuppressjoni.
English: Acute rejection occurred in 14.6% of patients by 6 months post-transplantation, and in 24.3% by 12 months.
Maltese: Riġett akut seħħ f'14.6% tal-pazjenti fi żmien 6 xhur wara t-trapjant, u f'24.3% fi żmien 12-il xahar.
English: Reconstituted Simulect is administered as an intravenous infusion over 20 to 30 minutes or as a bolus injection.
Maltese: Simulect rikostitwit għandu jingħata bħala infużjoni fil-vina fuq medda ta' 20 u 30 minuta, jew inkella bħala injezzjoni bolus.
English: Colourless glass ampoule, type I glass, containing 5 ml water for injections.
Maltese: Ampulla tal-ħġieġ bla kulur, ħġieġ tip I, li jkun fih 5 ml ilma għall-injezzjonijiet.
English: AMPOULE LABEL
Maltese: GĦAMLA KWALITATTIVA
English: In a pooled analysis of two five-year extension studies the incidence and cause of death remained similar in both treatment groups, (basiliximab 15%, placebo 11%), the primary cause of death being cardiac-related disorders such as cardiac failure and myocardial infarction (basiliximab 5%, placebo 4%).
Maltese: F'analiżi kollettiva minn żewġ studji ta' estensjoni fuq medda ta' ħames snin, l-inċidenza u l-kawża tal-imwiet baqgħu simili fiż-żewġ gruppi ta' kura, (basiliximab 15%, plaċebo 11%), bil-kawża primarja tal-imwiet tkun mard assoċjat mal-qalb bħal insuffiċjenza tal-qalb u infart mijokardijaku (basiliximab 5%, plaċebo 4%).
English: Usual dose for adults The usual dose for adults is 20 mg in each infusion or injection.
Maltese: Id-doża li ssoltu tingħata għall-adulti hija 20 mg f'kull infużjoni jew injezzjoni.
English: In vitro studies using human tissues indicate that basiliximab binds only to activated lymphocytes and macrophages/monocytes.
Maltese: Studji in vitro fejn intuża tessut uman jindikaw li basiliximab jingħaqad biss ma' limfoċiti u makrofaġi/monoċiti attivati.
English: One ml of the reconstituted solution contains 4 mg basiliximab.
Maltese: Millilitru wieħed tas-soluzzjoni rikostitwita fih 4 mg basiliximab.
English: The primary efficacy endpoint, time to first biopsy-proven acute rejection (BPAR) episode or treatment failure defined as graft loss, death or presumptive rejection within the first 6 months post transplantation, occurred in 16.7% of basiliximab-treated patients and 21.7% of placebo-treated patients.
Maltese: L-endpoint primarju dwar l-effikaċja, iżżmien tal-ewwel episodju ta' riġett akut ippruvat b'bijopsija (BPAR) jew tal-falliment tat-trattament mogħti ddefinit bħala telfien tat-trapjant, mewt jew riġett preżunt matul l-ewwel 6 xhur wara ttrapjant, seħħ fost 16.7% tal-pazjenti ttrattati b'basiliximab u f'21.7% tal-pazjenti ttrattati bi plaċebo.
English: Solvent for Simulect Water for injections
Maltese: Solvent għal Simulect Ilma għall-injezzjonijiet
English: The reconstituted solution is isotonic and may be given as a bolus injection or diluted to a volume of 25 ml or greater with normal saline or dextrose 50 mg/ml (5%) for infusion.
Maltese: Is-soluzzjoni rikostitwita hija iżotonika u tista' tingħata bħala injezzjoni bolus jew miżjuda b'salina normali jew b'dextrose 50 mg/ml (5%) għall-infużjoni sa 25 ml jew aktar.
English: The reconstituted solution is isotonic and may be given as a bolus injection or diluted to a volume of 50 ml or greater with normal saline or dextrose 50 mg/ml (5%) for infusion.
Maltese: Is-soluzzjoni rikostitwita hija iżotonika u tista' tingħata bħala injezzjoni bolus jew miżjuda b'salina normali jew b'dextrose 50 mg/ml (5%) għall-infużjoni sa 50 ml jew aktar.
English: The following information is intended for healthcare professionals only:
Maltese: Inċidenza ta' episodji ta' infezzjoni:
English: Incidence of adverse events: In the above four placebo-controlled trials, the pattern of adverse events in 590 patients treated with the recommended dose of basiliximab was comparable to that observed in 595 patients treated with placebo.
Maltese: Fl-erba' provi kontrollati bil-plaċebo t'hawn fuq, it-tipi ta' każijiet avversi li dehru f'590 pazjent li ngħataw id-doża rakkomandata ta' basiliximab kienu komparabbli ma' dawk osservati f' 595 pazjent li ngħataw plaċebo.
English: In adults, the most commonly reported side effects were constipation, nausea, diarrhoea, weight increase, headache, pain, swelling of hands, ankles or feet, high blood pressure, anaemia, changes in blood chemistry (e.g. potassium, cholesterol, phosphate, creatinine), surgical wound complications, and various kinds of infections.
Maltese: Fl-adulti, l-effetti mhux mixtieqa l-aktar kommuni li dehru kienu stitikezza, dardir, dijarea, żieda filpiż, uġigħ ta' ras, uġigħ, nefħa fl-idejn, fl-għekiesi jew fir-riġlejn, pressjoni għolja, anemija, tibdil filkimika tad-demm (eż. potassium, kolesterol, phosphate u krejatenina), kumplikazzjonijiet tal-ġerħa tal-operazzjoni u tipi differenti ta' infezzjonijiet.
English: You will only be given two doses of Simulect.
Maltese: Inti tingħata biss żewġ dożi ta' Simulect.
English: Disposition parameters were not influenced to a clinically relevant extent by age (1-11 years), body weight (9-37 kg) or body surface area (0.44-1.20 m
Maltese: L-età (111 snin), il-piż (9-37 kg) u l-erja tas-superfiċje tal-ġisem (0.44-1.20 m2) m'affettwawx b'mod klinikament rilevanti l-parametri ta' dispożizzjoni fil-grupp ta' dawn l-etajiet.
English: The incidence of acute rejection episode was substantially lower in patients receiving basiliximab and a triple drug immunosuppressive regimen.
Maltese: L-inċidenza ta' episodji ta' riġett akut kienet sostanzjalment anqas f'pazjenti li ġew mogħtija basiliximab u kors bi tliet mediċini immunosuppressivi.
English: It is to be used concomitantly with ciclosporin for microemulsion- and corticosteroid-based immunosuppression, in patients with panel reactive antibodies less than 80%, or in a triple maintenance immunosuppressive regimen containing ciclosporin for microemulsion, corticosteroids and either azathioprine or mycophenolate mofetil.
Maltese: Għandu jintuża flimkien ma' ciclosporin għall-immunosupressjoni bbażata fuq mikroemulsjoni u kortikosterojdi, jew f'pazjenti li għandhom anqas minn 80% tal-antikorpi reattivi għall-pannell, jew inkella f'pazjenti fuq kors bi tlett sustanzi għall-manutenzjoni tal-immosuppressjoni, li jkun fiha ciclosporin għal mikroemulsjoni, kortikosterojdi u azathioprine jew mycophenolate mofetil.
English: After reconstitution, chemical and physical in-use stability has been demonstrated for 24 hours at 2°C - 8C or for 4 hours at room temperature.
Maltese: Wara li jitħallat, l-istabilità kimika u fiżika intweriet għal 24 siegħa f'temperatura ta' bejn 2C - 8C jew għal 4 sigħat f'temperatura ambjentali.
English: Use immediately after reconstitution (chemically and physically stable at 2°C - 8°C for 24 hours or at room temperature for 4 hours).
Maltese: Uża immedjatament wara li tħallat (stabbli b'mod kimiku u fiżiku f'temperatura ta' 2C - 8C għal 24 siegħa jew fit-temperatura ambjentali għal 4 sigħat).
English: Usual dose for children and adolescents (aged 1 to 17 years) - For children and adolescents who weigh less than 35 kg, the dose of Simulect given in each infusion or injection is 10 mg. - For children and adolescents who weigh 35 kg or more, the dose of Simulect given in each infusion or injection is 20 mg.
Maltese: Id-doża li ssoltu tingħata għat-tfal u l-adolexxenti (li għandhom minn sena sa 17-il sena) - Għal tfal u adolexxenti li jiżnu 35 kg jew aktar, id-doża ta' Simulect mogħtija f'kull infużjoni jew injezzjoni hija ta' 20 mg.
English: Total body clearance was 4119 ml/h.
Maltese: It-tneħħija totali mill-ġisem kienet ta' 4119 ml/siegħa.
English: The following adverse reactions have been identified based on post-marketing spontaneous reports and are organised by system organ class.
Maltese: Ir-reazzjonijiet avversi li ġejjin kienu identifikati abbażi ta' rapporti spontanji wara t-tqegħid fis-suq u huma organizzati skont il-klassi tas-sistemi u tal-organi.
English: To prepare the solution for infusion or injection, take 2.5 ml water for injections out of the accompanying 5 ml ampoule aseptically and add this 2.5 ml water for injections to the vial containing the Simulect powder, using aseptic technique.
Maltese: Biex tipprepara s-soluzzjoni għall-infużjoni jew injezzjoni, hu 2.5 ml ilma għall-injezzjonijiet b'mod asettiku mill-ampulla ta' 5 ml li tiġi magħha u żid dawn iż-2.5 ml ilma għall-injezzjonijiet b'mod asettiku ġol-kunjett li fih it-trab ta' Simulect, permezz ta' teknika asettika.
English: It can be used in a ciclosporin for microemulsion- and corticosteroid-based triple immunosuppressive regimen including azathioprine or mycophenolate mofetil.
Maltese: Jista' jintuża f'kors bi tlett sustanzi għall-manutenzjoni tal-immosuppressjoni, li jkun fiha ciclosporin għal mikroemulsjoni, kortikosterojdi u azathioprine jew mycophenolate mofetil.
English: Disposition in adolescents was similar to that in adult renal transplantation patients.
Maltese: Id-dispożizzjoni fl-adolexxenti kienet simili għal dik fil-pazjenti adulti bi trapjant tal-kliewi.
English: The primary objective of the study was to demonstrate superiority of this combination versus treatment with ciclosporin for microemulsion, mycophenolate mofetil and steroids in the prevention of acute rejections.
Maltese: L-objettiv primarju tal-istudju kien li juri s-superjorità ta' din it-taħlita meta mqabbla mat-trattament b'ciclosporin għall-mikroemulsjoni, mycophenolate mofetil u sterojdi fil-prevenzjoni ta' riġetti akuti.
English: Simulect 20 mg powder and solvent for solution for injection or infusion basiliximab
Maltese: Simulect 20 mg trab u solvent għal soluzzjoni għall-injezzjoni jew infużjoni basiliximab
English: Colourless type I glass vial, grey fluor-resin coated butyl rubber stopper, held in place by a flanged aluminium band, blue polypropylene flip-off cap, containing 20 mg basiliximab as powder for solution for injection or infusion.
Maltese: Kunjett tal-ħġieġ tip I bla kulur, tapp tal-lastku butyl miksi b'fluor-resin griż, miżmum f'postu bi strippa ta' aluminium fil-ġenb, tapp ċelesti ta' polypropylene li tiftħu b'subgħajk, li jkun fih 20 mg basiliximab bħala trab għal soluzzjoni għall-injezzjoni jew infużjoni.
English: These events were not influenced by basiliximab.
Maltese: Dawn l-eventi ma kinux influwenzati minn basiliximab.
English: These included anaphylactoid-type reactions such as rash, urticaria, pruritus, sneezing, wheezing, hypotension, tachycardia, dyspnoea, bronchospasm, pulmonary oedema, cardiac failure, respiratory failure and capillary leak syndrome.
Maltese: Dawn jinkludu reazzjonijiet simili għal dawk anafilattiċi bħal raxx, urtikarja, ħakk, għatis, tħarħir, pressjoni baxxa, takikardja, qtugħ ta' nifs, bronkospażmi, ilma fil-pulmun, insuffiċjenza tal-qalb, insuffiċjenza respiratorja u sindrome ta' tnixxija kapillari.
English: Usual dose for children and adolescents (aged 1 to 17 years) - For children and adolescents who weigh 35 kg or more, the dose of Simulect given in each infusion or injection is 20 mg. - For children and adolescents who weigh less than 35 kg, the dose of Simulect given in each infusion or injection is 10 mg.
Maltese: Id-doża li ssoltu tingħata għat-tfal u l-adolexxenti (li għandhom minn sena sa 17-il sena) - Għal tfal u adolexxenti li jiżnu anqas minn 35 kg, id-doża ta' Simulect mogħtija f'kull infużjoni jew injezzjoni hija ta' 10 mg.
English: Graft loss occurred in 6% of basiliximab-treated and 10% of placebo-treated patients by 6 months.
Maltese: It-telf tat-trapjant seħħ f'6% tal-pazjenti ikkurati b'basiliximab u f'10% tal-pazjenti ikkurati bilplaċebo fi żmien 6 xhur.
English: The dose for children who weigh less than 35 kg will be smaller than the dose usually given to adults.
Maltese: Id-doża għat-tfal li jiżnu anqas minn 35 kg tkun inqas mid-doża li s-soltu tingħata lill-adulti.
English: Simulect 10 mg powder and solvent for solution for injection or infusion basiliximab
Maltese: Simulect 10 mg trab u solvent għal soluzzjoni għall-injezzjoni jew infużjoni basiliximab
English: In a pooled analysis of two five-year open-label extension studies (586 patients total) the combined graft and patient survival rates were not statistically different for the basiliximab and placebo groups.
Maltese: F'analiżi kollettiva ta' żewġ studji ta' estensjoni open label fuq medda ta' ħames snin (total ta' 586 pazjent), ir-rati tal-għejxien ta' pazjenti u trapjant flimkien ma kienx statistikament differenti bejn il-gruppi basiliximab u plaċebo.
English: It is supplied in a pack with a colourless glass ampoule containing 5 ml sterile water for injections.
Maltese: Jiġi f'pakkett b'ampulla tal-ħġieġ mingħajr kulur li jkun fiha 5 ml ilma sterili għall-injezzjonijiet.
English: Colourless type I glass vial, grey fluor-resin coated butyl rubber stopper, held in place by a flanged aluminium band, blue polypropylene flip-off cap, containing 10 mg basiliximab as powder for solution for injection or infusion.
Maltese: Kunjett tal-ħġieġ tip I bla kulur tapp tal-lastku butyl miksi b'fluor-resin griż, miżmum f'postu bi strippa ta' aluminium fil-ġenb, tapp ċelesti ta' polypropylene li tiftħu b'subgħajk, li jkun fih 10 mg basiliximab bħala trab għal soluzzjoni għall-injezzjoni jew infużjoni.
English: The total body clearance of basiliximab was reduced by an average 22% when azathioprine was added to a regimen consisting of ciclosporin for microemulsion and corticosteroids.
Maltese: It-tneħħija totali mill-ġisem ta' basiliximab naqset b'medja ta' 22% meta azathioprine ngħata ma' kors li kien jikkonsisti f'ciclosporin għal mikroemulsjonijiet u kortikosterojdi.
English: Paediatric patients
Maltese: Pazjenti pedjatriċi
English: Three clinical trials have investigated basiliximab use in combination with a triple therapy regimen which included either azathioprine or mycophenolate mofetil.
Maltese: Tlett provi kliniċi investigaw l-użu ta' basiliximab flimkien ma' terapija b'kors ta' tlett sustanzi li kienu jinkludu azathioprine jew mycophenolate mofetil.
English: The available clinical data on the use of muromonabCD3 in patients previously treated with basiliximab suggest that subsequent use of muromonab-CD3 or other murine anti-lymphocytic antibody preparations is not precluded.
Maltese: L-informazzjoni klinika li hemm dwar l-użu ta' muromonab-CD3 f'pazjenti li żmien qabel ingħataw basiliximab, jindikaw li l-użu ta' muromonab-CD3 jew preparazzjonijiet oħra ta' antikorp antilimfoċitiku talġurdien mhuwiex prekluż f'dawn il-pazjenti.
English: No maternal toxicity, embryotoxicity, or teratogenicity was observed in cynomolgous monkeys following injections of up to 5 mg/kg basiliximab administered twice weekly during the organogenesis period.
Maltese: Ma ġiet osservata l-ebda tossiċità fl-omm, jew fl-embriju, jew teratoġeniċità, f'xadini cynomolgous, wara injezzjonijiet li laħqu 5 mg/kg ta' basiliximab darbtejn fil-ġimgħa waqt il-perijodu tal-iżvilupp tal-organi fl-embriju.
English: To prepare the solution for infusion or injection, take 2.5 ml water for injections out of the accompanying 5 ml ampoule aseptically and add this 2.5 ml of water for injections aseptically to the vial containing the Simulect powder.
Maltese: Biex tipprepara s-soluzzjoni għall-infużjoni jew għall-injezzjoni, ħu 2.5 ml ilma għall-injezzjonijiet b'mod asettiku mill-ampulla ta' 5 ml li tiġi magħha u żid dawn iż-2.5 ml, ilma għall-injezzjonijiet b'mod asettiku ġol-kunjett li fih it-trab ta' Simulect.
English: Simulect is also available in vials with 20 mg basiliximab.
Maltese: Simulect jiġi wkoll f'kunjetti b'20 mg basiliximab.
English: Simulect 10 mg powder and solvent for solution for injection or infusion
Maltese: Simulect 10 mg trab u solvent għal soluzzjoni għall-injezzjoni jew infużjoni
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Maltese: Prodott mediċinali jingħata b'riċetta ristretta tat-tabib (Ara Anness I: Sommarju tal-Karatteristiċi talProdott, sezzjoni 4.2).
English: Simulect 20 mg powder and solvent for solution for injection or infusion
Maltese: Simulect 20 mg trab u solvent għal soluzzjoni għall-injezzjoni jew infużjoni
English: Single-dose and multiple-dose pharmacokinetic studies have been conducted in adult patients undergoing kidney transplantation.
Maltese: Studji farmakokinetiċi b'doża waħda u b'dożi multipli, saru fuq pazjenti adulti li kien qed ikollhom trapjant tal-kliewi.
English: The efficacy and safety of Simulect for the prophylaxis of acute rejection in recipients of solid organ allografts other than renal have not been demonstrated.
Maltese: Ma ġewx murija l-effikaċja u s-sigurtà ta' Simulect għall-profilassi ta' rifjut akut f'riċevituri ta' allografts ta' organi solidi minbarra dawk tal-kliewi.
English: White powder
Maltese: TAGĦRIF
English: eGFR ≥45 to
Maltese: eGFR ≥45 sa
English: Placebo Empagliflozin 25 mg eGFR ≥60 to <90 ml/min/1.73 m²
Maltese: Empagliflozin 25 mg Plaċebo Empagliflozin 25 mg eGFR ≥60 sa <90 ml/min/1.73 m²
English: Jardiance 10 mg film-coated tablets EU/1/14/930/010
Maltese: Jardiance 10 mg pilloli miksija b'rita EU/1/14/930/010
English: EU/1/14/930/010 7 tablets EU/1/14/930/011 10 tablets EU/1/14/930/012 14 tablets EU/1/14/930/013 28 tablets EU/1/14/930/014 30 tablets EU/1/14/930/015 60 tablets EU/1/14/930/016 70 tablets EU/1/14/930/017 90 tablets EU/1/14/930/018 100 tablets
Maltese: EU/1/14/930/010 7 pilloli EU/1/14/930/011 10 pilloli EU/1/14/930/012 14-il pillola EU/1/14/930/013 28 pillola EU/1/14/930/014 30 pillola EU/1/14/930/015 60 pillola EU/1/14/930/016 70 pillola EU/1/14/930/017 90 pillola EU/1/14/930/018 100 pillola
English: Jardiance contains lactose
Maltese: Jardiance fih lactose.
English: Jardiance 25 mg film-coated tablets EU/1/14/930/001
Maltese: Jardiance 25 mg pilloli miksija b'rita EU/1/14/930/001
English: Lilly S.A.
Maltese: Eli Lilly Italia S.p.A.
English: EU/1/14/930/001 7 tablets EU/1/14/930/002 10 tablets EU/1/14/930/003 14 tablets EU/1/14/930/004 28 tablets EU/1/14/930/005 30 tablets EU/1/14/930/006 60 tablets EU/1/14/930/007 70 tablets EU/1/14/930/008 90 tablets EU/1/14/930/009 100 tablets
Maltese: EU/1/14/930/001 7 pilloli EU/1/14/930/002 10 pilloli EU/1/14/930/003 14 pilloli EU/1/14/930/004 28 pilloli EU/1/14/930/005 30 pilloli EU/1/14/930/006 60 pilloli EU/1/14/930/007 70 pilloli EU/1/14/930/008 90 pilloli EU/1/14/930/009 100 pilloli
English: The apparent steady-state volume of distribution was estimated to be 73.8 l based on the population pharmacokinetic analysis.
Maltese: Distribuzzjoni Il-volum fi stat fiss apparenti ta' distribuzzjoni kien stmat li hu 73.8 l skont l-analiżi farmakokinetika tal-popolazzjoni.
English: Lactose monohydrate Microcrystalline cellulose Hydroxypropylcellulose Croscarmellose sodium Colloidal anhydrous silica Magnesium stearate
Maltese: Qalba tal-pillola Lactose monohydrate Microcrystalline cellulose Hydroxypropylcellulose Croscarmellose sodium
English: Uncommon Rare
Maltese: Mhux komuni Rari
English: achieving HbA1c
Maltese: HbA1c.
English: Difference from glimepiride1 (97.5% CI)
Maltese: Differenza minn glimepiride1 (97.5% CI)
English: INFORMATION IN BRAILLE Jardiance 10 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Jardiance 10 mg