FrancophonIA/ELRC3.0 huggingface dataset:
English: After an initial dose of 20 mg twice daily, valsartan should be titrated to 40 mg, 80 mg, and 160 mg twice daily over the next few weeks.
Maltese: Wara do a tal-bidu ta' 20 mg darbtejn kuljum, valsartan g andu ji i ttitrat g al 40 mg, 80 mg, u 160 mg darbtejn kuljum fuq il-ftit img at ta' wara.
English: The combination with ACE inhibitors is not recommended (see sections 4.4 and 5.1).
Maltese: It-ta lita ma' inibituri ta' ACE mhux irrakkomandata (ara sezzjonijiet 4.4 u 5.1).
English: Renal failure and impairment, Elevation of serum creatinine General disorders and administration site conditions Uncommon
Maltese: Insuffi jenza u indeboliment renali, jieda filkrejatinina fis-serum Disturbi enerali u kondizzjonijiet ta' mnejn jing ata
English: Dose adjustment is therefore not required in patients with renal impairment (creatinine clearance >10 ml/min).
Maltese: G alhekk mhux me tie a ustament tad-do a f'pazjenti b'indeboliment renali (tne ija tal-krejatinina >10 ml/min).
English: Diovan and associated names (see Annex I) 40 mg film-coated tablets Diovan and associated names (see Annex I) 80 mg film-coated tablets Diovan and associated names (see Annex I) 160 mg film-coated tablets Diovan and associated names (see Annex I) 320 mg film-coated tablets [See Annex I -To be completed nationally] Valsartan
Maltese: Diovan u ismijiet asso jati mieg u (Ara Anness I) 40 mg pilloli miksija b'rita Diovan u ismijiet asso jati mieg u (Ara Anness I) 80 mg pilloli miksija b'rita Diovan u ismijiet asso jati mieg u (Ara Anness I) 160 mg pilloli miksija b'rita Diovan u ismijiet asso jati mieg u (Ara Anness I) 320 mg pilloli miksija b'rita [Ara Anness I - Biex timtela mill-pajji partikolari] Valsartan
English: No dose adjustment is required for paediatric patients with a creatinine clearance >30 ml/min (see sections 4.2 and 5.2).
Maltese: Ma huwa me tie l-ebda a ustament tad-do a g al pazjenti pedjatri i bi tne ija tal-krejatinina ta' >30 ml/min (ara sezzjonijiet 4.2 u 5.2).
English: In a subgroup of patients not receiving an ACE inhibitor (n=366), the morbidity benefits were greatest.
Maltese: Il-benefi ji g all-morbidità kienu l-akbar f'sottogrupp ta' pazjenti li ma kienux qed jir ievu inibitur ta' ACE (n=366).
English: Diovan is contraindicated in patients with severe hepatic impairment, biliary cirrhosis and in patients with cholestasis (see sections 4.3, 4.4 and 5.2).
Maltese: Diovan huwa kontraindikat f'pazjenti b'indeboliment epatiku sever, irro i biljari u f'pazjenti bi kolestasi (ara sezzjonijiet 4.3, 4.4 u 5.2).
English: Evaluation of patients with heart failure should always include assessment of renal function (see section 4.2).
Maltese: Valutazzjoni ta' pazjenti wara infart mijokardijaku g andha dejjem tinkludi valutazzjoni tal-funzjoni renali (ara sezzjoni 4.2).
English: • if you are below 18 years of age and you take Diovan in combination with other medicines that inhibit the renin angiotensin aldosterone system (medicines that lower blood pressure), your doctor may check your kidney function and the amount of potassium in your blood at regular intervals.
Maltese: • jekk g andek inqas minn 18 -il sena u qed tie u Diovan flimkien ma' medi ini o ra li jinibixxu s-sistema renin-angiotensin-aldosterone (medi ini li jbaxxu l-pressjoni tad-demm), it-tabib tieg ek jista' ji ekkja l-funzjoni tal-kliewi u l-ammont ta' potassju fid-demm tieg ek f'intervalli regolari.
English: Diovan and associated names (see Annex I) 40 mg film-coated tablets Diovan and associated names (see Annex I) 80 mg film-coated tablets Diovan and associated names (see Annex I) 160 mg film-coated tablets Diovan and associated names (see Annex I) 320 mg film-coated tablets [See Annex I - To be completed nationally]
Maltese: Diovan u ismijiet asso jati mieg u (Ara Anness I) 40 mg pilloli miksija b'rita Diovan u ismijiet asso jati mieg u (Ara Anness I) 80 mg pilloli miksija b'rita Diovan u ismijiet asso jati mieg u (Ara Anness I) 160 mg pilloli miksija b'rita Diovan u ismijiet asso jati mieg u (Ara Anness I) 320 mg pilloli miksija b'rita [Ara Anness I - Biex timtela mill-pajji partikolari]
English: Valsartan was as effective as captopril in reducing all-cause mortality after myocardial infarction.
Maltese: Valsartan kien effettiv daqs captopril biex inaqqas il-mortalità minn kull kaw a wara infart mijokardijaku.
English: These effects above mentioned represent an expected exaggerated pharmacological effect of angiotensin converting enzyme inhibitors and angiotensin II type 1 blockers; such effects are observed if rats are treated during the first 13 days of life.
Maltese: Dawn l-effetti hawn imsemmija jirrapre entaw effett farmakolo iku e a erat u mistenni ta' inibituri ta' angiotensin converting enzyme u mblukkaturi ta'angiotensin II tat-tip I liema effetti huma osservati jekk il- rieden ikunu kkurati matul l-ewwel 13 -il jum tal- ajja.
English: For a full list of excipients, see section 6.1.
Maltese: G al-lista kompleta ta' sustanzi mhux attivi, ara sezzjoni 6.1. [Biex timtela mill-pajji partikolari]
English: The initial dose is 40 mg once daily for children weighing below 35 kg and 80 mg once daily for those weighing 35 kg or more.
Maltese: Id-do a inizzjali hija ta' 40 mg kuljum g at-tfal li jkunu ji nu ta t il-35 kg u 80 mg kuljum g al dawk li ji nu 35 kg jew iktar.
English: Treatment of symptomatic heart failure in adult patients when Angiotensin Converting Enzyme (ACE) inhibitors cannot be used, or as add-on therapy to ACE inhibitors when beta blockers cannot be used (see sections 4.4 and 5.1).
Maltese: Kura ta' insuffi jenza sintomatika tal-qalb f'pazjenti adulti meta inibituri ta' Angiotensin Converting Enzyme (ACE) ma jistg ux ji u w ati, jew b ala terapija mi juda ma' inibituri ta' ACE meta mblokkaturi tar-ri etturi beta ma jistg ux ji u w ati (ara sezzjonijiet 4.4 u 5.1).
English: Following intravenous administration, plasma clearance of valsartan is about 2 l/h and its renal clearance is 0.62 l/h (about 30% of total clearance).
Maltese: Wara goti ol-vini, tneija mill-plama ta' valsartan hija madwar 2 l/h u t-tneija renali tiegu hija 0.62 l/h (madwar 30% tat-tneija totali).
English: MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally]
Maltese: ID-DETENTUR TA' L-AWTORIZZAZZJONI G AT-TQEG ID FIS-SUQ [Ara Anness I - Biex timtela mill-pajji partikolari]
English: Other conditions with stimulation of the renin-angiotensin system In patients whose renal function may depend on the activity of the renin-angiotensin system (e.g patients with severe congestive heart failure), treatment with angiotensin converting enzyme inhibitors has been associated with oliguria and/or progressive azotaemia and in rare cases with acute renal failure and/or death.
Maltese: F'pazjenti li l-funzjoni renali tag hom tista' tiddependi fuq l-attività tas-sistema renin-angiotensin (e . pazjenti b'insuffi jenza kon estiva severa tal-qalb), kura b'inibituri ta' angiotensin converting enzyme kienet asso jata ma' oligurja u/jew a otemja progressiva u f'ka ijiet rari ma' insuffi jenza renali akuta u/jew mewt.
English: This leaflet was last approved in
Maltese: Meta tie u medi ini o ra
English: film coated tablets 40 mg
Maltese: film coated tablets
English: The steady-state volume of distribution of valsartan after intravenous administration is about 17 litres, indicating that valsartan does not distribute into tissues extensively.
Maltese: Il-volum ta' distribuzzjoni fi stat fiss ta' valsartan wara g oti ol-vini huwa ta' madwar 17-il litru, u dan jindika li ma sse x distribuzzjoni estensiva ta' valsartan fit-tessuti.
English: Caution should be observed when initiating therapy in post-myocardial infarction patients.
Maltese: G andu jkun hemm kawtela meta tinbeda terapija f'pazjenti li kellhom infart mijokardijaku.
English: One film-coated tablet contains 160 mg of valsartan.
Maltese: Pillola wa da miksija b'rita fiha 160 mg valsartan.
English: Patients treated with valsartan had a better quality of life as demonstrated by change in the Minnesota Living with Heart Failure Quality of Life score from baseline at endpoint than placebo.
Maltese: Pazjenti kkurati b'valsartan kellhom kwalità ta' ajja a jar kif muri millbidla fil-punte Minnesota Living with Heart Failure Quality of Life mil-linja ba i fir-ri ultat tattmiem meta mqabbel mal-pla ebo.
English: You obtain the 20 mg dose by dividing the 40 mg tablet.
Maltese: Inti tikseb id-do a ta' 20 mg billi taqsam il-pillola ta' 40 mg.
English: However, the triple combination of an ACE inhibitor, a beta blocker and valsartan is not recommended (see sections 4.4 and 5.1).
Maltese: Madankollu, t-ta lita tripla ta' inibitur ta' ACE, imblokkatur tar-ri etturi beta u valsartan mhijiex irrakkomandata (ara sezzjonijiet 4.4 u 5.1).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION
Maltese: G AMLA KWALITATTIVA
English: • to treat high blood pressure in children and adolescents 6 to 18 years of age.
Maltese: • g all-kura ta' pressjoni tad-demm g olja fit-tfal u l-adolexxenti fl-età ta' bejn 6 u 18-il sena.
English: Overall, the dosedependent antihypertensive effect of valsartan was consistent across all the demographic subgroups.
Maltese: B'mod enerali, l-effett g al kontra l-pressjoni g olja ta' valsartan dipendenti mid-do a kien konsistenti matul is-sotto-gruppi demografi i kollha.
English: If symptomatic hypotension or renal dysfunction occur, consideration should be given to a dose reduction.
Maltese: Jekk isse pressjoni baxxa sintomatika jew disfunzjoni renali, g andu ji i kkunsidrat tnaqqis fid-do a.
English: Treatment of essential hypertension in adults, and hypertension in children and adolescents 6 to 18 years of age.
Maltese: Kura ta' pressjoni g olja essenzjali fl-adulti u ta' pressjoni g olja fit-tfal u l-adolexxenti f'età ta' bejn 6 u 18-il sena.
English: Need for dose adaptation when switching between oral solution and tablets.
Maltese: L-u u fi tfal ta t is-sitt snin. tie a ta' adattament tad-do a meta ssir il-bidla bejn soluzzjoni orali u pilloli.
English: • to treat high blood pressure in adult and in children and adolescents 6 to 18 years of age.
Maltese: • g all-kura ta' pressjoni tad-demm g olja fl-adulti u fit-tfal u l-adolexxenti f'età ta' bejn 6 u 18 -il sena.
English: Use of Diovan in patients with heart failure commonly results in some reduction in blood pressure, but discontinuation of therapy because of continuing symptomatic hypotension is not usually necessary provided dosing instructions are followed (see section 4.2).
Maltese: L-u u ta' Diovan f'pazjenti wara infart mijokardijaku b'mod komuni jwassal g al xi tnaqqis filpressjoni tad-demm, ida twaqqif tat-terapija minabba pressjoni baxxa sintomatika li tippersisti eneralment ma jkunx neessarju dejjem jekk jiu segwiti l-istruzzjonijiet dwar id-doa (ara sezzjoni 4.2).
English: These doses in rats (600 mg/kg/day) are approximately 18 times the maximum recommended human dose on a mg/m2 basis (calculations assume an oral dose of 320 mg/day and a 60-kg patient).
Maltese: (600 mg/kg/kuljum) huma madwar 18-il darba og la mid-do a massima rrakkomandata fil-bniedem fuq ba i ta' mg/m2 (kalkulazzjonijet jassumu do a orali ta' 320 mg/kuljum u pazjent ta' 60-kg).
English: Many may feel quite normal.
Maltese: afna jistg u j ossuhom pjuttost normali.
English: Children and adolescents (6 to 18 years of age) with high blood pressure In patients who weigh less than 35 kg the usual dose is 40 mg of valsartan once daily.
Maltese: Tfal u adolexxenti (f'età ta' bejn 6 u 18 -il sena) bi pressjoni tad-demm g olja F'pazjenti li ji nu inqas minn 35 kg id-do a tas-soltu hija ta' 40 mg ta' valsartan darba kuljum.
English: In addition:
Maltese: (Tel:
English: Pharma GmbH
Maltese: Mnejn jingata
English: You may experience symptoms of angioedema (a specific allergic reaction), such as
Maltese: Inti jista' jkollok esperjenza ta' sintomi ta' an joedima (reazzjoni aller ika spe ifika), b al
English: In patients with mild to moderate hepatic impairment without cholestasis, the dose of valsartan should not exceed 80 mg.
Maltese: F'pazjenti b'indeboliment epatiku afif g al moderat ming ajr kolestasi, id-do a ta' valsartan m'g andiex taqbe 80 mg.
English: Cardiac failure
Maltese: Infart mijokardiku ri enti
English: The Risk Management Plan should include the following: o In the safety specification: results of juvenile safety studies regarding the risk of nephrotoxicity and its relevance for the use in the different paediatric groups paediatric exposure in clinical trials and in post marketing use by age group, indication (including off label use), dose, duration of use, gender and ethnicity o As safety concerns:
Maltese: Il-Pjan g all- estjoni tar-Riskji g andu jinkludi s-segwenti: o Fl-ispe ifikazzjoni tas-sigurtà: ri ultati ta' studji ta' sigurtà fuq i - g a ag rigward ir-riskju ta' nefrotossi ità u rrelevanza tag ha g all-u u fi gruppi pedjatri i differenti espo izzjoni pedjatrika fi provi klini i u fl-u u wara t-tqeg id fis-suq skont ilgrupp tal-età, l-indikazzjoni (inklu l-u u off label), id-do a, kemm idum jintu a, is-sess u l-etni ità o B ala t assib dwar is-sigurtà:
English: • medicines that increase the amount of potassium in your blood.
Maltese: • medicini li j idu l-ammont ta' potassium fid-demm tieg ek.
English: One film-coated tablet contains 80 mg of valsartan.
Maltese: Pillola wa da miksija b'rita fiha 80 mg valsartan.
English: Renal function and serum potassium should be closely monitored (see sections 4.2 and 4.4).
Maltese: Il-funzjoni renali u l-potassju fis-serum g andhom ji u ssorveljati mill-qrib (ara sezzjonijiet 4.2 u 4.4).
English: Vasculitis
Maltese: Eskrezzjoni:
English: In another clinical study involving 300 hypertensive paediatric patients 6 to 18 years of age, eligible patients were randomized to receive valsartan or enalapril tablets for 12 weeks.
Maltese: Fi studji klini i o rajn li kienu jinkludu 300 pazjent pedjatriku ta' bejn 6 u 18 -il sena bil-pressjoni g olja, pazjenti eli ibbli ew randomised sabiex jir ievu valsartan jew pilloli enalapril g al 12 -il img a.
English: Intravenous use bag (ethylene vinyl acetate)
Maltese: Użu ġol-vini borża (ethylene vinyl acetate)
English: EU/1/18/1299/001 YESCARTA
Maltese: EU/1/18/1299/001 YESCARTA 0.4 x 1082 x 108 ċelluli
English: Dispersion for infusion
Maltese: Dispersjoni għal infużjoni
English: London, 12 September 2008 EMEA/CHMP/495857/2008
Maltese: Londra, 12 ta' Settembru 2008 EMEA/CHMP/495849/2008
English: The Rapporteur was Dr Tomas Salmonson (SE) and Dr Pierre Demolis (FR) was Co-Rapporteur.
Maltese: Ir-Rapporteur kien Dr Tomas Salmonson (SE) u Dr Pierre Demolis (FR) kien il-Ko-Rapporteur.
English: International Non-Proprietary Name (INN): fentanyl citrate
Maltese: Denominazzjoni Komuni Internazzjonali (DKI): fentanyl citrate
English: The Decentralised Procedure, SE/H/575/07/DC, started on 1 September 2006.
Maltese: Il-Proċedura Deċentralizzata, SE/H/575/07/DC, bdiet fl-1 ta' Settembru 2006.
English: ProStrakan Ltd submitted applications for Rapinyl and associated names, 50µg, 100µg, 200µg, 300µg, 400µg, 600µg, 800µg, sublingual tablets.
Maltese: ProStrakan Ltd issottomettiet applikazzjonijiet għal Rapinyl u ismijiet assoċjati, 50µg, 100µg, 200µg, 300µg, 400µg, 600µg, 800µg, pilloli għal taħt l-ilsien.
English: OPINION FOLLOWING AN ARTICLE 29(4)1 REFERRAL FOR
Maltese: OPINJONI WARA RIFERIMENT SKOND L-ARTIKOLU 29(4)1 GĦAL
English: The Reference Member State was Sweden and the Concerned Member States were Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Norway, Poland, Portugal, Slovak Republic, Slovenia, Spain and United Kingdom.
Maltese: L-Istat Membru tar-Riferiment kien l-Iżvezja u l-Istati Membri Konċernati kienu l-Awstrija, il-Belġju, Ċipru, ir-Repubblika Ċeka, id-Danimarka, l-Estonja, il-Finlandja, Franza, il-Ġermanja, il-Greċja, lUngerija, l-Iżlanda, l-Irlanda, l-Italja, il-Latvja, il-Litwanja, il-Lussemburgu, in-Norveġja, il-Polonja, ilPortugall, ir-Repubblika Slovakka, is-Slovenja, Spanja u r-Renju Unit.
English: Rapinyl and associated names, 50µg, 100µg, 200µg, 300µg, 400µg, 600µg, 800µg, sublingual tablets is indicated for the management of breakthrough pain in adult patients using opioid therapy for chronic cancer pain.
Maltese: Rapinyl u ismijiet assoċjati, 50µg, 100µg, 200µg, 300µg, 400µg, 600µg, 800µg, pilloli għal taħt l-ilsien huwa indikat għall-ġestjoni ta' uġigħ penetranti f'pazjenti adulti li jużaw kura opjode għal uġigħ kroniku ikkawżat minn kanċer.
English: The arbitration procedure started on 18 October 2007 with the adoption of a list of questions.
Maltese: Il-proċedura ta' arbitraġġ bdiet fit-18 ta' Ottubru 2007 bl-adozzjoni ta' lista ta' mistoqsijiet.
English: Significant difference has been identified with regard to the need for further clinical efficacy and safety data for the evaluation of the benefit/risk and the lack of PK data under normal conditions of use of the product.
Maltese: Ġiet identifikata differenza sinifikanti fir-rigward tal-ħtieġa għal aktar effikaċja klinika u dejta dwar issigurtà għall-evalwazzjoni tal-benefiċċju/riskju u n-nuqqas ta' dejta tal-PK f'kundizzjonijiet normali ta' użu tal-prodott.
English: Rapinyl and associated names
Maltese: Rapinyl u ismijiet assoċjati
English: A positive opinion was adopted by consensus on 26 June 2008
Maltese: Fis-26 ta' Ġunju 2008 ġiet adottata opinjoni pożittiva b'konsensus.
English: During their June 2008 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for Rapinyl and associated names, that the objections raised by Germany, France, Norway and United Kingdom should not prevent the granting of a Marketing Authorisation and that the Summary of Product Characteristics, Labelling and Package Leaflet of the Reference Member State should be amended.
Maltese: Matul il-laqgħa tiegħu ta' Ġunju 2008, is-CHMP, fid-dawl tad-dejta ġenerali ippreżentata u tad-diskussjoni xejntifika fi ħdan il-Kumitat, kien tal-opinjoni li l-proporzjon bejn il-benefiċċju/riskju kien wieħed favorevoli għal Rapinyl u ismijiet assoċjati, li l-oġġezzjonijiet imqajma mill-Ġermanja, Franza, inNorveġja u r-Renju Unit ma għandhomx jimpedixxu l-għoti tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u li s-Sommarju tal-Karatteristiċi tal-Prodott, Tikketta u Fuljett ta' Tagħrif tal-Istat Membru ta' Riferiment għandhom jiġu emendati.
English: This refers to the bridging strategy of the Applicant and was considered to be a serious public health concern.
Maltese: Din tirreferi għall-istrateġija ta' bridging tal-Applikant u tqieset bħala ta' tħassib serju għas-saħħa pubblika.
English: These Member States were not able to reach an agreement and Sweden referred the reasons for disagreement to the EMEA on 27 September 2007.
Maltese: Dawn l-Istati Membri ma setgħux jilħqu ftehim u l-Iżvezja rriferiet ir-raġunijiet għan-nuqqas ta' ftehim lillEMEA fis-27 ta' Settembru 2007.
English: Therefore, your heart function will be checked before, during (every three months) and after (up to two to five years) treatment with Herzuma.
Maltese: Dawn jinkludu dgħufija tal-muskolu tal-qalb li tista' twassal għal insuffiċjenza tal-qalb, infjammazzjoni tal-kisja ta' madwar il-qalb u disturbi fir-ritmu tal-qalb.
English: Study BO15935
Maltese: Studju BO15935
English: Biotech Services International Limited Biotec House, Central Park, Western Avenue Bridgend Industrial Estate Bridgend
Maltese: Biotec Services International Limited Biotec House, Central Park, Western Avenue Bridgend Industrial Estate Bridgend
English: Overall response rate, %
Maltese: Rata ta' rispons globali,%
English: Units 2100, 2110, 2120 and 2130 Phase 18, Central Park Bridgend Industrial Estate, Bridgend, CF31 3TY, UNITED KINGDOM
Maltese: Units 2100, 2110, 2120 and 2130 Phase 18, Central Park Bridgend Industrial Estate, Bridgend, CF31 3TY, IR-RENJU UNIT
English: WestEnd Office Building B torony Hungary
Maltese: WestEnd Office Building B torony L-Ungerija
English: Observation N= 1697***
Maltese: Osservazzjoni N = 1697***
English: FP + H: Fluoropyrimidine/cisplatin + trastuzumab FP: Fluoropyrimidine/cisplatin a: Odds ratio
Maltese: FP + H: Fluoropyrimidine/cisplatin + trastuzumab FP: Fluoropyrimidine/cisplatin A: Proporzjon ta' probabbiltà
English: Millmount Healthcare Ltd. Block 7
Maltese: Millmount Healthcare Ltd.
English: Chemo + trastuzumab (n=115)
Maltese: Kimo + trastuzumab (n=115)
English: Observation N=1693
Maltese: Osservazzjoni N = 1693
English: *Cmin,ss = Cmin at steady state **Cmax,ss = Cmax at steady state *** time to 90% of steady state
Maltese: *Cmin,ss - Cmin fi stat fiss **Cmax,ss = Cmax fi stat fiss *** żmien sakemm jintlaħaq 90% ta' stat fiss
English: City North Business Campus Stamullen, Co. Meath K32 YD60 Ireland
Maltese: City North Business Campus Stamullen, Co. Meath K32 YD60 IRLANDA
English: Bridgend Industrial Estate Bridgend, CF31 3RT United Kingdom
Maltese: Bridgend Industrial Estate Bridgend, CF31 3RT Ir-Renju Unit
English: Biotec Services International Ltd. Biotec House
Maltese: Biotec Services International Ltd.
English: Store in a refrigerator (2ºC - 8ºC).
Maltese: Aħżen fi friġġ (2ºC - 8ºC).
English: Table 6 Efficacy results from study BO16348
Maltese: Tabella 6 Riżultati tal-effikaċja minn studju BO16348
English: AC→PH (vs. AC→P) (NSABP B-31 and NCCTG N9831)*
Maltese: AC→PH (kontra AC→P) (NSABP B-31 u NCCTG N9831)
English: Herzuma is a biosimilar medicinal product.
Maltese: Herzuma huwa prodott mediċinali bijoloġiku simili.
English: Table 12 Efficacy results from MO16432
Maltese: Tabella 12 Riżultati tal-effikaċja minn MO16432
English: The non-linear elimination parameter values were 8.81 mg/day for the maximum elimination rate (Vmax) and 8.92 μg/mL for the Michaelis-Menten constant (Km) for the MBC, EBC and AGC patients.
Maltese: Il-valuri tal-parametru ta' eliminazzjoni mhux lineari kienu ta' 8.81 mg/jum għar-rata massima ta' eliminazzjoni (Vmax - maximum elimination rate) u ta' 8.92 µg/mL għall-kostanti ta' Michaelis-Menten (Km- Michaelis-Menten constant) għall-pazjenti b'MBC, EBC, u AGC.
English: 2D barcode carrying the unique identifier included.
Maltese: <barcode 2D li jkollu l-identifikatur uniku inkluż.>
English: Norge Orion Pharma AS
Maltese: Orion Pharma AB
English: t1/2 range from Cmax,ss to Cmin,ss (day)
Maltese: Firxa ta' t1/2 minn Cmax,ss sa Cmin,ss (jum)
English: Trastuzumab plus docetaxel N=110
Maltese: Trastuzumab flimkien ma' docetaxel N = 110
English: Placental transfer of trastuzumab during the early (days 20 - 50 of gestation) and late (days 120 - 150 of gestation) foetal development period was observed.
Maltese: Kien osservat li trastuzumab għadda mill-plaċenta fil-perjodu bikri (20 - 50 jum ta' tqala) u dak tard (120 - 150 jum ta' tqala) tal-iżvilupp tal-fetu.
English: Trastuzumab plus docetaxel N=92
Maltese: Trastuzum ab ma' docetaxel N = 92
English:  Doxorubicin 60mg/m and paclitaxel 150 mg/m 2, administered 3-weekly for 3 cycles,
Maltese: • Doxorubicin 60 mg/m2 u paclitaxel 150 mg/m2, mogħtija darba kull 3 ġimgħat għal 3 ċikli,
English: AUCss, 0-21days (μg.day/mL)
Maltese: AUCss, 0 - 21jum (µg.jum/mL)
English: Cmin,ss* (μg/mL)
Maltese: Cmin,ss* (µg/mL)
English: A minority of patients was tested using fluorescence in-situ hybridisation (FISH).
Maltese: Minnoranza ta' pazjenti ġew ittestjati bl- użu ta' fluorescence in situ hybridisation (FISH).
English: A: doxorubicin; C: cyclophosphamide; P: paclitaxel; D: docetaxel; Carb: carboplatin; H: trastuzumab; CI = confidence interval * At the time of the definitive analysis of DFS.
Maltese: A: doxorubicin; C: cyclophosphamide; P: paclitaxel; D: docetaxel; Carb: carboplatin; H: trastuzumab CI = intervall ta' kunfidenza * Fil-ħin tal-analiżi definittiva ta' DFS.
English: Do not use with glucose-containing solutions (see section 6.2).
Maltese: Tużax ma' soluzzjonijiet li fihom il-glucose (ara sezzjoni 6.2).
English: Trastuzumab plus paclitaxel N=68
Maltese: Trastuzuma b ma' paclitaxel N = 68
English: Trastuzumab plus paclitaxel N=32
Maltese: Trastuzumab flimkien ma' Paclitaxel N = 32
English: 1 Year N = 1702***
Maltese: Trastuzumab Sena Waħda N = 1702***