FrancophonIA/ELRC3.0 huggingface dataset:
English: Rare side effects (these may occur with up to 1 in 1,000 doses of the vaccine) are:
Maltese: Effetti sekondarji rari (dawn jistgħu jseħħu b'sa doża 1 minn kull 1,000 doża tat-tilqima) huma:
English: OUTER CARTON TEXT - 1 vial pack with syringe/needles
Maltese: KLIEM FUQ IL-KAXXA TA' BARRA - Pakkett b'kunjett 1 b'siringa/labar
English: 1 single-dose (0.5 ml) pre-filled syringe with separate needle.
Maltese: Siringa 1 mimlija għal-lest b'doża waħda (0.5 ml) b'labra separata.
English: The effectiveness of Prevenar against IPD (i.e. comprising the protection afforded by vaccination and from herd immunity due to reduced transmission of vaccine serotypes in the population) has been evaluated in national immunisation programmes that employ three-dose or two-dose infant series, each with booster doses.
Maltese: L-effettività ta' Prevenar kontra IPD (i.e. li kienet tinkludi l-protezzjoni mogħtija mit-tilqima u millimmunità tal-'merħla' minħabba t-trasmissjoni mnaqqsa tas-serotipi tat-tilqima fil-popolazzjoni) kienet evalwata fi programmi nazzjonali ta' immunizzazzjoni li jużaw serje tat-trabi bi tliet dożi jew b'żewġ dożi, kull waħda b'dożi booster.
English: Safety and immunogenicity data are not yet available for children in other specific high-risk groups for invasive pneumococcal disease (e.g. children with another congenital or acquired splenic dysfunction, HIV-infected, malignancy, nephrotic syndrome).
Maltese: Dejta dwar is-sigurtà u l-immunoġeniċità għadhom mhumiex disponibbli għal tfal fi gruppi oħrajn speċifiċi li qegħdin f'riskju għoli għal mard pnewmokokkali invażiv (eż. tfal b'disfunzjoni konġenitali oħra jew b'disfunzjoni miksuba tal-milsa, li huma infettati bl-HIV, li għandhom malinn, u li għandhom sindrome nefrotiku).
English: Also contains sodium chloride and water for injections.
Maltese: Fih ukoll sodium chloride u ilma għall-injezzjonijiet.
English: Multipack presentation of 5 packs of 10 pre-filled syringes without needles.
Maltese: Preżentazzjoni ta' pakkett multiplu f'5 pakketti ta' 10 siringi mimlijin għal-lest mingħajr labar.
English: The interval between the pneumococcal conjugate vaccine (Prevenar) and the 23valent pneumococcal polysaccharide vaccine should not be less than 8 weeks.
Maltese: intervall bejn it-tilqima tal-konjugat pnewmokokkali (Prevenar) u t-tilqima tal-polysaccharide pnewmokokkali li fiha 23 valent, m'għandux ikun ta' inqas minn 8 ġimgħat.
English: Infants aged 7 - 11 months: two doses, each of 0.5 ml, with an interval of at least 1 month between doses.
Maltese: Trabi ta' bejn 7 - 11-il xahar: żewġ dożi, kull waħda ta' 0.5 ml, b'intervall ta' mill-anqas xahar bejn id-dożi.
English: Children below 2 years old should receive the appropriate-for-age Prevenar vaccination series (see section 4.2).
Maltese: Tfal ta' taħt is-sentejn għandhom jirċievu s-serje ta' tilqim ta' Prevenar li hi adattata għall-età tagħhom (ara sezzjoni 4.2).
English: These reactions were primarily transient in nature.
Maltese: Kull injezzjoni ser tingħata wara intervall ta' mill-inqas xahar.
English: A higher rate of local reactions has been observed in children older than 24 months of age compared with infants (see section 4.8).
Maltese: Rata ogħla ta' reazzjonijiet lokali kienet osservata fi tfal li kellhom iktar minn 24 xahar, meta mqabbla mat-trabi (ara sezzjoni 4.8).
English: Limited results from open label studies showed an acceptable response to MMR and varicella.
Maltese: Riżultati limitati minn studji open label urew rispons aċċettabbli għall-MMR u l-ġidri r-riħ.
English: Prophylactic antipyretic medication is recommended: - for all children receiving Prevenar simultaneously with vaccines containing whole cell pertussis because of higher rate of febrile reactions - for children with seizure disorders or with a prior history of febrile seizures.
Maltese: Mediċina profilattika kontra d-deni hi rakkomandata: - għat-tfal kollha li jkunu qed jirċievu Prevenar fl-istess ħin ma' tilqim li jkun fih whole cell pertussis minħabba r-rata ogħla rata ta' reazzjonijiet bid-deni - għat-tfal li jkollhom il-puplesiji, jew li jkollhom passat mediku ta' puplesiji kkawżati mid-deni.
English: PRE-FILLED SYRINGE LABEL
Maltese: Il-kopertura tas-serotip tat-tilqima fil-popolazzjoni
English: Prevenar is given to children from 2 months to 5 years to help protect against diseases such as: meningitis, sepsis or bacteraemia (bacteria in blood stream), pneumonia and ear infection caused by seven types of the bacteria Streptococcus pneumoniae.
Maltese: Prevenar jingħata lil tfal ta' minn xahrejn sa 5 snin biex jgħin ħalli jipproteġi kontra mard bħal: meninġite, sepsis jew batteremija (batterji fiċ-ċirkolazzjoni taddemm), pnewmonja u infezzjoni fil-widnejn ikkawżata minn seba' tipi tal-batterju Streptococcus
English: SCIENTIFIC CONCLUSIONS AND GROUNDS FOR VARIATION TO THE TERMS OF THE
Maltese: Konklużjonijiet xjentifiċi u raġunijiet għal varjazzjoni għat-termini tal-awtorizzazzjonijiet għattqegħid fis-suq
English: Prevenar has also been shown to elicit functional antibodies (measured by opsonophagocytosis) to all vaccine serotypes following the primary series.
Maltese: Intwera wkoll li Prevenar jikkaġuna antikorpi funzjonali (kif imkejla permezz ta' opsonofagoċitosi) għas-serotipi kollha tat-tilqima wara sserje primarja.
English: There are no data available to indicate whether the administration of 23-valent pneumococcal polysaccharide vaccine to unprimed children or to children primed with Prevenar might result in hyporesponsiveness to further doses of
Maltese: M'hemm l-ebda informazzjoni disponibbli li tindika jekk l-għoti ta' tilqima tal-polysaccharide pnewmokokkali li fiha 23 valent lil tfal li ma jkunux tlaqqmu, jew lil tfal li jkunu diġà tlaqqmu bi Prevenar, jistax jirriżulta f'rispons eċċessiv għal dożi addizzjonali
English: Significant increases in antibody (measured by ELISA) were seen for all vaccine serotypes following a three-dose primary series of Prevenar in infants and following booster doses although geometric mean concentrations varied between the 7 serotypes.
Maltese: Żidiet sinifikanti fl-antikorp (imkejla permezz ta' ELISA) kienu osservati għas-serotipi tat-tilqim kollu wara serje primarja bi tliet dożi ta' Prevenar fit-trabi u wara dożi booster, għalkemm ilkonċentrazzjonijiet medji ġeometriċi varjaw bejn is-7 serotipi.
English: • Pain, tenderness, redness, swelling, or hardness at the injection site; fever of 38 °C or higher,
Maltese: • Uġigħ, sensittività, ħmura, nefħa, jew ebusija fis-sit tal-injezzjoni; deni ta' 38°C jew ogħla irritabilità, biki, ngħas, irqad bla kwiet
English: A significant increase was seen in the concentrations of antibodies against the seven serotypes after the polysaccharide vaccination, suggesting that immunological memory was well established.
Maltese: Żieda sinifikanti kienet osservata fil-konċentrazzjonijiet ta' antikorpi kontra s-seba' serotipi wara t-tilqima bilpolysaccharide, li tissuġġerixxi li l-memorja immunoloġika kienet stabbilita sew.
English: Upon storage, a white deposit and clear supernatant can be observed.
Maltese: Meta jinħażen, depożitu abjad u supernatant ċar jista' jkun osservat.
English: Repeated dose subcutaneous toxicity studies (13 weeks, 7 injections of the clinical dose, one every other week, followed by a 4-week recovery period) of Prevenar in rats and monkeys revealed no evidence of any significant local or systemic toxic effects.
Maltese: Studju dwar it-tossiċità ta' dożi ripetuti mogħtija taħt il-ġilda (13-il ġimgħa, 7 injezzjonijiet tad-doża klinika, waħda kull ġimagħtejn, segwiti minn perjodu ta' rkupru ta' 4 ġimgħat) ta' Prevenar fil-firien u x-xadini, ma żvela l-ebda evidenza ta' kwalunkwe effetti tossiċi sinifikanti lokali jew sistemiċi.
English: OUTER CARTON TEXT - 10 pre-filled syringes pack with separate needle
Maltese: KLIEM FUQ IL-KAXXA TA' BARRA - Pakkett b'10 siringi mimlijin għal-lest b'labra separata
English: Uncommon side effects (these may occur with up to 1 in 100 doses of the vaccine) are: • Rash/hives (urticaria)
Maltese: Effetti sekondarji komuni (dawn jistgħu jseħħu b'sa doża 1 minn kull 10 dożi tat-tilqima) huma:
English: Skin and subcutaneous tissue disorders:
Maltese: Disturbi fil-ġilda u fit-tessuti ta' taħt il-ġilda:
English: Children with impaired immune responsiveness, whether due to the use of immunosuppressive therapy, a genetic defect, HIV infection, or other causes, may have reduced antibody response to active immunisation.
Maltese: Tfal b'indeboliment fir-rispons immuni, kemm jekk dan iseħħ minħabba l-użu ta' terapija immunosoppressiva, difett ġenetiku, infezzjoni bl-HIV, jew kawżi oħrajn, jista' jkollhom tnaqqis firrispons tal-antikorpi għall-immunizzazzjoni attiva.
English: Children aged 12 - 23 months: two doses, each of 0.5 ml, with an interval of at least 2 months between
Maltese: Tfal li għandhom bejn 12 - 23 xahar: żewġ dożi, kull waħda ta' 0.5 ml, b'intervall ta' mill-anqas
English: - if your child has any present or past medical problems after any dose of Prevenar.
Maltese: - jekk it-tifel/tifla tiegħek għandu/għandha problemi mediċi, jew kellu/kellha problemi fil-passat,
English: Due to the long-standing post marketing experience, the well characterised safety profile and the large exposure of the product the PRAC recommended to amend the PSUR frequency to 10-yearly and to amend Annex II accordingly to reflect the current QRD template sentence referring to the EURD list.
Maltese: Il-persistenza fit-tul tal-antikorpi ma kinitx investigata wara l-għoti ta' serje primarja fit-trabi flimkien ma' booster jew wara l-għoti ta' dożi priming waħidhom lil tfal ikbar.
English: 13 January 2012
Maltese: 13 ta' Jannar 2012
English: International non-proprietary names (inn): ceftiofur and cefquinome
Maltese: Denominazzjoni komuni internazzjonali (inn): ceftiofur u cefquinome
English: Background information
Maltese: Sfond
English: The Committee appointed Dr Karolina Törneke as rapporteur and Dr Claire Chauvin as co-rapporteur.
Maltese: Törneke bħala rapporteur u lil Dr Claire Chauvin bħala korapporteur.
English: Opinion following an Article 35
Maltese: Opinjoni wara riferiment skont l-Artikolu 35
English: oral) 3
Maltese: III.
English: Article 35 of Directive 2001/82/EC Revised reflection paper on use of 3rd and 4th generation cephalosporins in food producing animals in the EU: development of resistance and impact on human and animal health (EMEA/CVMP/SAGAM/81730/2006-Rev.1)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004307.pdf
Maltese: L-Artikolu 35 tad-Direttiva 2001/82/KE Dokument rivedut ta' riflessjoni dwar l-użu ta' kefalosporini tat-tielet u tar-raba' ġenerazzjoni fuq annimali li jipproduċu likel fl-UE: l-iżvilupp ta' reżistenza u l-impatt fuq is-saħħa tal-bniedem u tal-annimal (EMEA/CVMP/SAGAM/81730/2006Rev.1) - http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004307.pdf
English: The Committee adopted a positive opinion on 13 October 2011.
Maltese: Il-Kumitat adotta opinjoni pożittiva fit-13 ta' Ottubru 2011.
English: On 17 March 2011, the European Commission presented to the Agency a referral notification under Article 35 of Directive 2001/82/EC, regarding all veterinary medicinal products containing systemically administered (parenteral and oral) 3
Maltese: Fis-17 ta' Marzu 2011 il-Kummissjoni Ewropea ppreżentati notifika ta' riferiment lill-Aġenzija, skont lArtikolu 35 tad-Direttiva 2001/82/KE, dwar il-prodotti mediċinali veterinarji kollha li fihom kefalosporini tat-tielet u tar-raba' ġenerazzjoni mogħtija b'mod sistemiku (parenterali u orali) maħsuba għall-użu fuq speċi li jipproduċu l-ikel.
English: Written explanations were provided by the applicants/marketing authorisation holders on 22 August 2011.
Maltese: L-applikanti/detenturi tal-awtorizzazzjoni għattqegħid fis-suq ressqu spjegazzjonijiet bil-miktub fit-22 ta' Awwissu 2011.
English: The final opinion was converted into a Decision by the European Commission on 13 January 2012.
Maltese: L-opinjoni finali ġiet ikkonvertita f'Deċiżjoni mill-Kummissjoni Ewropea fi 13 ta' Jannar 2012.
English: Opinion following an Article 35 referral for all veterinary medicinal products containing systemically administered (parenteral and oral) 3rd and 4th generation cephalosporins intended for use in food producing species
Maltese: 1 għallprodotti mediċinali veterinarji kollha li fihom kefalosporini tat-tielet u tar-raba' ġenerazzjoni mogħtija b'mod sistemiku (parenterali u orali) maħsuba għall-użu fuq speċi li jipproduċu l-ikel
English: The referral procedure started on 6 April 2011.
Maltese: Il-proċedura ta' riferiment bdiet fis-6 ta' April 2011.
English: Based on the rapporteurs' assessment of the currently available data, the CVMP considered that the overall benefit-risk balance for these products remains positive subject to the recommended changes of the product information and that variations are necessary to the terms of the marketing authorisation for all veterinary medicinal products containing systemically administered (parenteral and
Maltese: Qies ukoll li hemm il-ħtieġa ta' varjazzjonijiet fit-termini talawtorizzazzjoni għat-tqegħid fis-suq għall-prodotti mediċinali veterinarji kollha li fihom kefalosporini tat-tielet u tar-raba' ġenerazzjoni mogħtija b'mod sistemiku (parenterali u orali) maħsuba għall-użu fuq speċi li jipproduċu l-ikel.
English: 200 tablets
Maltese: 200 pillola
English: Film-coated tablet Oral use bottle (HDPE)
Maltese: Fexeric flixkun (HDPE)
English: EU Number
Maltese: Numru tal-UE
English: 1000 New Horizons Way Vacaville, CA 95688 USA
Maltese: 1000 New Horizons Way Vacaville, CA 95688
English: Malta (See United Kingdom)
Maltese: Malta (See Ireland)
English: Other side effects were similar.
Maltese: Effetti sekondarji oħra kienu simili.
English: D-82377 Penzberg Germany
Maltese: D-82377 Penzberg Il-Ġermanja
English: Observation N= 1697***
Maltese: Osservazzjoni N= 1697***
English: Cycle 1 297 Cycle 7 (steady state)
Maltese: Ċiklu 1 297 Ċiklu 7 (stat fiss)
English: Manufacturer Roche Pharma AG Emil-Barell-Strasse 1
Maltese: Roche Pharma AG Emil-Barell-Strasse 1
English: Recombinant human hyaluronidase (rHuPH20) L-histidine
Maltese: Hyaluronidase rikombinanti uman (rHuPH20) L-histidine
English: • sleepiness (somnolence)
Maltese: • ngħas (somnolenza)
English: United Kingdom Roche Products Ltd.
Maltese: Roche Products Ltd.
English: Pharma Biotech Penzberg Nonnenwald 2
Maltese: Roche Diagnostics GmbH, Pharma Biotech Penzberg Nonnenwald 2
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: Date of first authorisation: 28 August 2000 Date of latest renewal: 28 August 2010
Maltese: Data tal-aħħar tiġdid: 28 ta' Awwissu 2010
English: Portsmouth, NH 03801 USA
Maltese: Portsmouth, NH 03801 L-Istati Uniti tal-Amerika
English: For the comparative safety profile see section 4.8.
Maltese: Għall-profil komparattiv tas-sigurtà ara sezzjoni 4.8.
English: FP + H: Fluoropyrimidine/cisplatin + Herceptin FP: Fluoropyrimidine/cisplatin a Odds ratio
Maltese: FP + H: Fluoropyrimidine/cisplatin + Herceptin
English: 1Palpitation
Maltese: 1 Palpitazzjoni
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: (vs. AC→D) (BCIRG 006)
Maltese: AC→DH (kontra AC→D) (BCIRG 006)
English: Therefore, your heart function will be checked before, during (every three months) and after (up to two to five years) treatment with Herceptin.
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: P-value versus Observation
Maltese: Valur p kontra Osservazzjoni
English: (day)
Maltese: (jum)
English: Table 12: Summary of pathological Complete Response (pCR)
Maltese: Tabella 12: Sommarju ta' Rispons Komplut patoloġiku (pCR - pathological Complete Response)
English: Nervous system disorders 1Tremor
Maltese: Disturbi fis-sistema nervuża 1Rogħda
English: Death (OS event):
Maltese: Mewt (avveniment ta' OS):
English: Two different types (formulations) of Herceptin exist:
Maltese: Jeżistu żewġ tipi differenti (formulazzjonijiet) ta' Herceptin:
English: * Observed with combination therapy following anthracyclines and combined with taxanes
Maltese: * Osservat b'terapija kombinata wara anthracyclines u flimkien ma' taxanes
English: Fertility There is no fertility data available.
Maltese: Fertilità M'hemmx dejta disponibbli dwar il-fertilità.
English: Österreich Roche Austria GmbH Tel: +43 (0) 1 27739
Maltese: Roche Austria GmbH Tel: +43 (0) 1 27739
English: HR (95 % CI) p-value
Maltese: HR (95 % CI) Valur p
English: 101 International Dr.
Maltese: Lonza Portsmouth 101 International Dr.
English: Study H0648g: IHC3+ patient subset
Maltese: Studju H0648g: sotto-sett ta' pazjenti IHC3+
English: Palmar-plantar erythrodysaesthesia syndrome
Maltese: Sindrome ta' eritrodisasteżija palmari plantari
English: Study H0649g: IHC3+ patient subset
Maltese: Studju H0649g: sotto-sett ta' pazjenti IHC3+
English: System organ class
Maltese: Klassi tas-sistemi u tal organi
English: Tlf: +45 - 36 39 99 99
Maltese: Roche a/s Tlf: +45 - 36 39 99 99
English: For monotherapy, the rate was 6 % - 9 %.
Maltese: Għall-monoterapija, ir-rata kienet ta' 6 % - 9 %.
English: AC→P
Maltese: Valur p kontra AC→P
English: t1/2 range from Cmax,ss to
Maltese: Firxa ta' t1/2 minn Cmax,ss sa Cmin,ss
English: For storage conditions of the opened medicinal product, see section 6.3 and 6.6.
Maltese: Għall-kondizzjonijiet ta' ħażna tal-prodott mediċinali miftuħ, ara sezzjoni 6.3 u 6.6.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One vial contains 600 mg/5 mL trastuzumab.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Kunjett wieħed fih 600 mg/5 mL trastuzumab.
English: (L/day)
Maltese: (L/jum)
English: Roche Pharma AG Emil-Barell-Strasse 1 79639 Grenzach-Wyhlen Germany
Maltese: Roche Pharma AG Emil-Barell-Strasse 1 79639 Grenzach-Wyhlen
English: • high potassium levels
Maltese: • livelli għolja ta' potassium
English: Trastuzumab washout
Maltese: Jekk tieqaf tuża Herceptin
English: Table 11: Efficacy results from MO16432
Maltese: Tabella 11: Riżultati tal-effikaċja minn MO16432
English: Overexpression of HER2 is observed in 20 %-30 % of primary breast cancers.
Maltese: Espressjoni żejda ta' HER2 hija osservata f'20 %-30 % ta' kanċers primarji tas-sider.
English: Neoplasm progression
Maltese: Siti ta' progressjoni
English: Overexpression of HER2 is observed in 20% - 30% of primary breast cancers.
Maltese: Espressjoni żejda ta' HER2 hija osservata f'20% - 30% ta' kanċers primarji tas-sider.
English: MBC and EBC patients had similar PK parameters (e.g. clearance (CL), the central compartment volume (Vc)) and population-predicted steady-state exposures (Cmin, Cmax and AUC).
Maltese: Pazjenti b'MBC u EBC kellhom parametri PK (eż. tneħħija (CL - clearance), volum tal-kompartiment ċentrali (Vc - central compartment volume)) u esponimenti fi stat fiss imbassra mill-popolazzjoni (Cmin, Cmax u AUC) simili.
English: +Pulmonary fibrosis
Maltese: Fibrożi pulmonari
English: Glomerulonephropathy
Maltese: Glomerulonefropatija
English: Herceptin 1 Year N = 1702***
Maltese: Sena Waħda N = 1702***
English: Total pathological complete response* (95 % CI)
Maltese: Rispons patoloġiku komplut totali* (CI ta' 95 %)
English: Herceptin plus paclitaxel3
Maltese: Herceptin flimkien ma' Paclitaxel3
English: Herceptin vial:
Maltese: Kunjett ta' Herceptin:
English: Greater than 70 % of patients enrolled exhibited 3+ overexpression.
Maltese: Aktar minn 70 % tal-pazjenti rreġistrati wrew espressjoni żejda ta' 3+.
English: Table 10 Overview of Efficacy Analyses BCIRG 006 AC→D versus DCarbH Parameter
Maltese: Tabella 10 Sommarju tal-Analiżi tal-Effikaċja ta' BCIRG 006 AC→D kontra DCarbH Parametru
English: +Acute pulmonary oedema
Maltese: Edima pulmonari akuta
English: • Hypertension: 4.7 % versus 9.8 % for the intravenous formulation versus subcutaneous formulation respectively.
Maltese: • Pressjoni għolja: 4.7 % kontra 9.8 % għall-formulazzjoni għall-għoti fil-vini kontra lformulazzjoni għall-għoti taħt il-ġilda rispettivament.
English: In the pivotal metastatic trials of intravenous Herceptin, the incidence of cardiac dysfunction varied between 9 % and 12 % when it was combined with paclitaxel compared with 1 % - 4 % for paclitaxel alone.
Maltese: Fil-provi pivitali dwar metastasi b'Herceptin fil-vini, l-inċidenza ta' disfunzjoni kardijaka varjat bejn 9 % u 12 % meta dan kien ikkombinat ma' paclitaxel meta mqabbla ma' 1 % - 4 % għal paclitaxel waħdu.
English: Table 8: Overview of efficacy analyses BCIRG 006 AC→D versus AC→DH Parameter
Maltese: Tabella 8: Sommarju tal-analiżi tal-effikaċja ta' BCIRG 006 AC→D kontra AC→DH Parametru
English: The incidence of symptomatic cardiac dysfunction was 1.7% in the Herceptin arm .
Maltese: L-inċidenza ta' disfunzjoni kardijaka sintomatika kienet ta' 1.7% fil grupp ta' Herceptin.
English: +Acute respiratory distress syndrome
Maltese: Sindrome ta' distress respiratorju akut
English: SISH technology is however, recommended to allow for the parallel evaluation of tumor histology and morphology.
Maltese: Madankollu teknoloġja SISH hija rakkomandata biex tippermetti l-valutazzjoni parallella tal-istoloġija u lmorfoloġija tat-tumur.
English: For overall survival, the HR was 0.75 (95 % CI 0.51-1.11) in the IHC 2+/FISH+ group and the HR was 0.58 (95 % CI 0.41-0.81) in the IHC 3+/FISH+ group.
Maltese: Għas-sopravivenza globali, HR kien ta' 0.75 (CI ta' 95 % 0.51-1.11) fil-grupp ta' IHC 2+/FISH+ u HR kien ta' 0.58 (CI ta' 95 % 0.41-0.81) fil-grupp ta' IHC 3+/FISH+.
English: (95% CI)
Maltese: (CI ta' 95 %)
English: During the adjuvant phase of treatment, at the pre-dose Cycle 13 time point, the mean Ctrough values were 90.4 µg/mL and 62.1 µg/mL, respectively.
Maltese: Matul il-fażi ta' kura awżiljarja, fil-punt ta' ħin ta' qabel iddoża ta' Ċiklu 13, il-valuri medji ta' Ctrough kienu ta' 90.4 µg/mL u 62.1 µg/mL, rispettivament.
English: Tel: +46 (0) 8 726 1200
Maltese: Roche AB Tel: +46 (0) 8 726 1200
English: Linear clearance was 0.111 L/day and the central compartment volume (Vc) was 2.91 L. The Michaelis-Menten parameter values were 11.9 mg/day and 33.9 µg/mL for Vmax and Km, respectively.
Maltese: Il-valuri tal-parametru Michaelis-Menten kienu ta' 11.9 mg/jum u 33.9 µg/mL għal Vmax u Km, rispettivament.
English: Bioavailability of trastuzumab given as the subcutaneous formulation was estimated to be 77.1%, and the first order absorption rate constant was estimated to be 0.4 day-1.
Maltese: Il-bijodisponibilità ta' trastuzumab mogħti bħala formulazzjoni taħt ilġilda kienet stmata bħala 77.1%, u l-kostanti tar-rata ta' assorbiment tal-ewwel ordni kien stmat bħala 0.4 jum-1.
English: No incompatibilities between Herceptin and polyvinylchloride, polyethylene or polypropylene bags have been observed.
Maltese: Ma kinux osservati inkompatibilitajiet bejn Herceptin u boroż tal-polyvinylchloride, polyethylene jew polypropylene.
English: Table 6 Efficacy Results from Study BO16348
Maltese: Tabella 6 Riżultati tal-Effikaċja minn Studju BO16348
English: Treatment with AC→PH resulted in a statistically significant improvement in OS compared with AC→P (stratified HR=0.64; 95% CI [0.55, 0.74]; log-rank p-value < 0.0001).
Maltese: Kura b'AC→PH irriżultat f'titjib statistikament sinifikanti f'OS meta mqabbel ma'AC→P (HR stratifikat=0.64; CI ta' 95% [0.55, 0.74]; valur p log-rank < 0.0001).
English: Table 12 Efficacy Results from MO16432
Maltese: Tabella 12 Riżultati tal-Effikaċja minn MO16432
English: +Respiratory distress
Maltese: Distress respiratorju
English: The frequency of progression in the liver was significantly reduced in patients treated with the combination of Herceptin and paclitaxel, compared to paclitaxel alone (21.8 % versus 45.7 %; p=0.004).
Maltese: Il-frekwenza ta' progressjoni fil-fwied kienet imnaqqsa b'mod sinifikanti fil-pazjenti kkurati bilkombinazzjoni ta' Herceptin u paclitaxel, meta mqabbel ma' paclitaxel waħdu (21.8 % kontra 45.7 %, p = 0.004).
English: FP N = 290
Maltese: N = 290
English: No. patients with event p=0.014**
Maltese: Mewt (avveniment OS): Numru ta' pazjenti blavveniment p=0.014**