FrancophonIA/ELRC3.0 huggingface dataset:
English: Discontinue the use of HES at the first sign of coagulopathy.
Maltese: L-użu tal-HES ma għandux jitkompla mal-ewwel sinjali ta' koagulopatija.
English: You can also report side effects directly via the national reporting system listed in Appendix V*.
Maltese: Tista' wkoll tirrapporta effetti sekondarji direttament permezz tas-sistema ta' rappurtar nazzjonali imniżżla f'Appendiċi V*.
English: The lowest possible effective dose should be applied.
Maltese: Għandha tiġi applikata d-doża effettiva l-aktar baxxa possibbli.
English: Your doctor will use the lowest possible effective dose and will not infuse <Product name> for more than 24 hours.
Maltese: It-tabib tiegħek ser juża l-aktar doża baxxa effettiva possibbli u mhux ser jagħmel infużjoni ta' <Product name> għal aktar minn 24 siegħa.
English: Your doctor will adjust the dose of <Product name> carefully in order to prevent fluid overload.
Maltese: It-tabib tiegħek ser jaġġusta d-doża ta' <Product name> b'attenzjoni sabiex jevita fluwidu żejjed.
English: Because of the risk of allergic (anaphylactoid) reactions, the patient should be monitored closely and the infusion instituted at a low rate (see section 4.8).
Maltese: Minħabba r-riskju ta' reazzjonijiet (anafilattojdi) allerġiċi, il-pazjent għandu jiġi mmonitorjat mill-qrib u l-infużjoni għandha tingħata b'rata baxxa (ara s-sezzjoni 4.8)
English: <Product name> is contraindicated if you have kidney impairment or of kidney injury requiring dialysis.
Maltese: <Product name> huwa kontraindikat jekk għandek indeboliment tal-kliewi jew korriment fil-kliewi li jkunu jeħtieġu dijalisi.
English: • are dehydrated
Maltese: • inti disidratat/a
English: • are critically ill (e.g. you need to stay in an intensive care unit)
Maltese: • inti marid b'mod kritiku (eż. għandek bżonn toqgħod f'taqsima ta' kura intensiva)
English: • have severe liver disease
Maltese: • għandek insuffiċenza tal-qalb severa
English: Because of the risk of allergic (anaphylactic/anaphylactoid) reactions, you will be monitored closely to detect early signs of an allergic reaction when you receive this medicine.
Maltese: Minħabba r-riskju ta' reazzjonijiet allerġiċi (anafilattiċi/anafilattojdi), ser tiġi ssorveljat mill-qrib biex jiġu identifikati sinjali bikrija ta' reazzjoni allerġika meta tirċievi din il-mediċina.
English: What <Product name> is and what it is used for [This section should be amended to include the below wording] <Product name> is a plasma volume substitute that is used to restore the blood volume when you have lost blood when other products called crystalloids are not considered sufficient alone.
Maltese: [Din is-sezzjoni għandha tiġi emendata biex tinkludi l-formulazzjoni li ġejja] <Product name> huwa sostitut tal-volum tal-plażma li jintuża biex ireġġa' lura l-volum tad-demm meta tkun tlift id-demm, meta prodotti oħrajn imsejħin kristallojdi ma jkunux ikkunsidrati bħala suffiċjenti waħedhom.
English: [This section should be amended to reflect the following wording]
Maltese: [Din is-sezzjoni għandha tiġi emendata biex tirrifletti l-formulazzjoni li ġejja]
English: - severe coagulopathy - organ transplant patients
Maltese: - pazjenti bi trapjant tal-organi
English: If you are undergoing open heart surgery and you are on a heart-lung machine to assist in pumping your blood during the surgery, the administration of this solution is not recommended.
Maltese: Hemm nuqqas ta' dejta b'saħħitha fuq perjodu twil ta' żmien dwar is-sigurtà f'pazjenti li għaddew minn proċeduri kirurġiċi u f'pazjenti bi trawma.
English: If you get any side effects, talk to your <doctor> <or> <,> <pharmacist> <or nurse>.
Maltese: Jekk ikollok xi effett sekondarju, kellem <lit-tabib> <jew> <,> <lill-ispiżjar> <jew l-infermier> tiegħek.
English: 1 vial
Maltese: kunjett 1
English: Immediate packaging Pack size
Maltese: Il-pakkett li jmiss malprodott
English: (Invented) name Strength Pharmaceutical form Route of administration
Maltese: Isem (ivvintat) Qawwa Għamla farmaċewtika Mnejn għandu jingħata
English: Intravenous Use vial (glass)
Maltese: Użu għal ġol-vini kunjett (ħġieġ)
English: Powder for solution for infusion
Maltese: Trab għal soluzzjoni għall-infużjoni
English: Section 4.8 - Adverse events
Maltese: Sezzjoni 4.8 - Avvenimenti avversi
English: • The committee considered the referral under Article 30 of Directive 2001/83/EC
Maltese: • Il-Kumitat ikkunsidra r-riferiment skont l-Artikolu 30 tad-Direttiva 2001/83/KE
English: Sensitive human viruses include human cytomegalovirus (HCMV), herpes-simplex virus-1 and -2 (HSV-1 and HSV-2), human herpes virus -6, -7 and -8 (HHV-6, HHV-7, HHV-8), Epstein-Barr virus (EBV), varicella-zoster virus (VZV), and hepatitis B virus.
Maltese: Virusis sensittivi tal-bniedem jinkludu ċ-ċitomegalovirus (HCMV), virus-1 u -2 tal-herpes-simplex (HSV-1 u HSV-2), virus tal-herpes tal-bniedem -6, -7 u -8 (HHV-6, HHV-7, HHV-8), il-virus tal-Epstein-Barr (EBV), il-virus tal-variċella-zoster (VZV) u l-virus tal-epatite B.
English: The only strength of 500 mg is available.
Maltese: L-unika qawwa disponibbli hija ta' 500 mg.
English: Based on the review of data the CHMP adopted a harmonised Module 3.
Maltese: Abbazi tar-reviżjoni tad-data, is-CHMP adotta Modulu 3 armonizzat.
English: Panel on Opportunistic Infections in HIV-exposed and HIV-Infected Children.
Maltese: Panel on Opportunistic Infections in HIV-exposed and HIVInfected Children. 2013 [cited April 2014].
English: Summary of product characteristics (SmPC)
Maltese: Sommarju tal-karatteristiċi tal-prodott (SmPC)
English: b.i.d.
Maltese: Anness II
English: The harmonised information on posology was presented by the MAH per indication, i.e. standard dosage for treatment of CMV disease in adults and adolescents from 12 years of age with normal renal function and standard dosage for prevention of CMV disease in adults and adolescents from 12 years of age with normal renal function using prophylaxis or pre-emptive therapy.
Maltese: L-informazzjoni armonizzata dwar il-pożoloġija kienet ippreżentata mill-MAH għal kull indikazzjoni, jiġifieri dożaġġ standard għall-kura tal-marda tas-CMV fl-adulti u adolexxenti mill-età ta' 12-il sena b'funzjoni tal-kliewi normali u dożaġġ standard għall-prevenzjoni tal-marda tas-CMV fl-adulti u ladolexxenti mill-età ta' 12-il sena b'funzjoni tal-kliewi normali li jużaw il-profilassi jew terapija ta' prevenzjoni.
English: Cymevene is indicated for use in adults and adolescents from 12 years of age.
Maltese: Cymevene huwa indikat fl-adulti u l-adolexxenti mill-età ta' 12-il sena.
English: contains ganciclovir, a synthetic analogue of 2'-deoxyguanosine which inhibits replication of herpes viruses.
Maltese: Cymevene i.v. fih ganciclovir, analogu sintetiku ta' 2'-deoxyguanosine li jinibixxi r-replikazzjoni talvirusis tal-herpes.
English: The referral procedure was initiated at the December 2014 meeting.
Maltese: Il-proċedura ta' riferiment inbdiet fil-laqgħa ta' Diċembru 2014.
English: The MAH submitted a proposal for harmonisation of the Quality module.
Maltese: Il-MAH ippreżenta proposta għall-armonizzazzjoni tal-modulu dwar il-Kwalità.
English: In most of the studies efficacy of ganciclovir 2.5 mg/kg, 5 mg/kg, 6 mg/kg i.v.
Maltese: F'ħafna mill-istudji l-effikaċja tad-dożi ta' ganciclovir 2.5 mg/kg, 5 mg/kg, 6 mg/kg i.v. b.i.d. li ntużaw għal ġimagħtejn (kura inizjali) u aktar tard dożi ta' manteniment ta' 5 mg/kg jew 6 mg/kg kienu evalwati għall-kura ta' retinite CMV f'pazjenti blAIDS.
English: Clinical trials included only patients with haematological malignancy.
Maltese: Il-provi kliniċi inkludew pazjenti b'tumur malinn ematoloġiku biss.
English: The MAH submitted documentation to support both indications of treatment and prevention of the CMV disease.
Maltese: Il-MAH ippreżenta dokumentazzjoni sabiex jappoġġja ż-żewġ indikazzjonijiet ta' kura u prevenzjoni tal-marda tas-CMV.
English: The amended therapeutic indication (and posology) for adolescents from 12 years of age is based on noncompany sponsored ganciclovir studies and treatment guidelines2.
Maltese: L-indikazzjoni terapewtika emendata (u l-pożoloġija) għall-adolexxenti mill-età ta' 12-il sena hija bbażata fuq studji mhux sponsorjati mill-kumpanija ta' ganciclovir u linji gwida tal-kura2.
English: There are no MAH-sponsored studies of CMV treatment in oncology patients.
Maltese: M'hemmx studji sponsorjati mill-MAH ta' kura għas-CMV f'pazjenti tal-onkoloġija.
English: Package Leaflet
Maltese: Tikkettar
English: The medicinal product is available in vials of 10 ml as powder for concentrate for solution for infusion.
Maltese: Ilprodott mediċinali huwa disponibbli f'kunjetti ta' 10 ml bħala trab għal konċentrat għal soluzzjoni għall-infużjoni.
English: In patients with AIDS prevention of CMV disease is no longer recommended because the highly active antiretroviral therapy (HAART) has reduced the risk of CMV disease in patients with AIDS.
Maltese: F'pazjenti bl-AIDS il-prevenzjoni tal-marda tas-CMV mhijiex irrakkomandata aktar minħabba li tterapija antiretrovirali li għandha attività għolja (HAART) naqqset ir-riskju tal-marda tas-CMV f'pazjenti bl-AIDS.
English: The treatment of CMV disease in stem cell transplant (SCT) and solid organ transplant (SOT) recipient is recommended by guidelines, the data supporting the proposed indication are obtained from published literature.
Maltese: Il-kura tal-marda tas-CMV fil-pazjenti li rċevew trapjant taċ-ċelluli staminali (SCT) u trapjant ta' organi solidi (SOT) hija rrakkomandata mil-linji gwida, id-data li tappoġġja l-indikazzjoni proposta nkisbet minn dokumentazzjoni ppubblikata.
English: In animals studies ganciclovir was associated with reproductive toxicity and teratogenicity.
Maltese: Fl-istudji dwar l-annimali ganciclovir kien assoċjat ma' effett tossiku fuq is-sistema riproduttiva u teratoġeniċità.
English: The MAH has not conducted formal studies in the paediatric patient population.
Maltese: L-MAH ma kkonkludiex l-istudji formali fil-popolazzjoni tal-pazjenti pedjatriċi.
English: the CHMP was of the opinion that the benefit/risk ratio of Cymevene i.v.
Maltese: is-CHMP kien tal-opinjoni li l-proporzjon tal-benefiċċju/riskju ta' Cymevene i.v. u ismijiet assoċjati huwa kkunsidrat bħala favorevoli.
English: and associated names for which the MAH is F. HoffmanLa Roche Ltd.
Maltese: Cymevene i.v. huwa approvat fl-Istati Membri kollha ħlief il-Latvja, Malta u s-Slovenja.
English: However, ganciclovir readily diffuses across the human placenta.
Maltese: Madankollu, ganciclovir jinfirex faċilment tul il-plaċenta tal-omm.
English: In allogenic HSCT recipients, the review concluded that CMV disease should be treated with antiviral agents such as ganciclovir or foscarnet with 2-3 weeks of induction therapy followed by 3-4 weeks of maintenance therapy.
Maltese: F'persuni alloġeniċi li rċevew HSTC, ir-reviżjoni kkonkludiet li l-marda tas-CMV għandha tkun ikkurata b'aġenti antivirali bħal ganciclovir jew foscarnet b'2-3 ġimgħat ta' terapija inizjali segwita minn 3-4 ġimgħat ta' terapija ta' manteniment.
English: Safety and efficacy data from valganciclovir studies conducted in children were also presented as relevant to the safety and efficacy of ganciclovir (clinical use of valganciclovir, the pro-drug of ganciclovir, has been approved in EU for paediatric SOT recipients for prevention of CMV disease.)
Maltese: Id-data dwar is-sigurtà u l-effikaċja mill-istudji dwar valganciclovir imwettqa fit-tfal kienu ppreżentati wkoll bħala rilevanti għas-sigurtà u l-effikaċja ta' ganciclovir (l-użu kliniku ta' valganciclovir, il-pro-mediċina ta' ganciclovir, ġie approvat fl-UE għal pazjent pedjatriċi li rċevew SOT għall-prevenzjoni tal-marda tas-CMV.) Dawn iż-żidiet mal-informazzjoni dwar is-sigurtà tqiesu rilevanti u kienu aċċettati mis-CHMP.
English: On 15 September 2014 the European Commission on behalf of all marketing authorisation holders presented to the European Medicines Agency a referral under Article 30 of Directive 2001/83/EC, in order to harmonise the national summary of product characteristics, labelling and package leaflet of the medicinal products, Cymevene i.v.
Maltese: Fil-15 ta' Settembru 2014, il-Kummissjoni Ewropea f'isem id-detenturi tal-awtorizzazzjoni għattqegħid fis-suq ippreżentat riferiment skont l-Artikolu 30 tad-Direttiva 2001/83/KE lill-Aġenzija Ewropea għall-Mediċini, sabiex tarmonizza s-sommarju nazzjonali tal-karatteristiċi tal-prodott, ittikkettar u l-fuljett ta' tagħrif tal-prodotti mediċinali, Cymevene i.v. u ismijiet assoċjati li għalihom il-MAH hija F. Hoffman - La Roche Ltd.
English: Ten clinical studies were conducted during the period from 1986 till 1996 in patients with AIDS.
Maltese: Għaxar studji kliniċi twettqu waqt il-perjodu mill-1986 sal-1996 f'pazjenti bl-AIDS.
English: There were no major discrepancies between the existing wordings in the individual Member States.
Maltese: Ma kien hemm ebda diskrepanza kbira bejn il-formulazzjonijiet eżistenti fl-Istati Membri individwali.
English: Overall summary of the scientific evaluation of Cymevene i.v.
Maltese: Sommarju ġenerali tal-valutazzjoni xjentifika ta' Cymevene i.v. u ismijiet assoċjati (ara Anness I)
English: Before the introduction of HAART, approximately 30% of patients with AIDS experienced CMV retinitis, making CMV prophylaxis necessary.
Maltese: Qabel l-introduzzjoni tal-HAART, bejn wieħed u ieħor 30% tal-pazjenti bl-AIDS esperjenzaw retinite CMV, li jagħmel il-profilassi CMV xi ħaġa meħtieġa.
English: • the scope of the referral was the harmonisation of the summary of products characteristics, labelling and package leaflet;
Maltese: • il-kamp ta' applikazzjoni tar-riferiment kien l-armonizzazzjoni tal-karatteristiċi tassommarju tal-prodotti, it-tikkettar u l-fuljett ta' tagħrif;
English: Treatment guidelines1 recommend using ganciclovir for CMV prophylaxis in allogenic stem cell transplant recipients and in patients receiving alemtuzumab therapy.
Maltese: Għall-prevenzjoni tal-marda tas-CMV, ganciclovir huwa indikat biss f'persuni li rċevew trapjant u pazjenti li qed jirċievu kimoterapija kontra l-kanċer.
English: Clinical studies, pharmacodynamics data, and treatment guidelines are provided to support the use of the same dose in adults and adolescents for treatment and prevention of CMV disease.
Maltese: Huma pprovduti studji kliniċi, data farmakodinamika, u linji gwida tal-kura sabiex jappoġġjaw l-użu tal-istess doża fl-adulti u l-adolexxenti għall-kura u l-prevenzjoni tal-marda tas-CMV.
English: Cymevene i.v.
Maltese: Konklużjonijiet xjentifiċi
English: Various clinical treatment guidelines advise on appropriate treatment and prevention of CMV disease in stem cell transplant recipients.
Maltese: Diversi linji gwida tal-kura klinika jagħtu parir dwar il-kura u l-prevenzjoni xierqa talmarda tas-CMV f'persuni li rċevew trapjant taċ-ċelluli staminali.
English: There are no MAH-sponsored studies of CMV treatment in stem cell transplant recipients but various clinical treatment guidelines advise on appropriate treatment and prevention of CMV disease in these patients.
Maltese: M'hemmx studji sponsorjati mill-MAH tal-kura għas-CMV f'pazjenti li rċevew trapjant taċ-ċelluli staminali madankollu diversi linji gwida tal-kura klinika jagħtu l-parir dwar kura u prevenzjoni xierqa tal-marda tas-CMV f'dawn il-pazjenti.
English: Section 4.2 - Posology and methods of administration
Maltese: Sezzjoni 4.2 - Pożoloġija u metodi ta' kif għandu jingħata
English: MAH state that other oncology patients receiving chemotherapy do not routinely require CMV prophylaxis but certain high-risk patients, such as Asian patients, particularly those receiving rituximab or hyper-CVAD chemotherapy, may benefit.
Maltese: Huma pprovduti struzzjonijiet dwar dożaġġ speċjali għal pazjenti b'indeboliment tal-kliewi, nies akbar fl-età u pazjenti pedjatriċi.
English: In conclusion, based on the assessment of the MAH's proposals and responses and following the discussions of the Committee, the CHMP adopted harmonised sets of product information documents of Cymevene i.v.
Maltese: Raġunijiet għall-varjazzjoni fit-termini tal-awtorizzazzjoni(jiet) għat-tqegħid fis-suq Bħala konklużjoni, abbażi tal-valutazzjoni tal-proposta u r-risponsi tal-MAH u wara d-diskussjonijiet tal-kumitat, is-CHMP adotta settijiet armonizzati ta' dokumenti ta' informazzjoni dwar il-prodott ta' Cymevene i.v. u ismijiet assoċjati.
English: London, June 2008 EMEA/532090/2007- Rev.1
Maltese: Londra, Ġunju 2008 EMEA/532090/2007- Rev.1
English: EMEA/532090/2007-Rev.1
Maltese: EMEA/532090/2007-Rev.1-MT
English: The CVMP Opinion was adopted on 17 April 2007 and the subsequent Commission Decision on 29 June 2007.
Maltese: L-Opinjoni tal-CVMP ġiet adottata fis-17 ta' April 2007 u d-Deċiżjoni tal-Kummissjoni sussegwenti ġiet adottata fid-29 ta' Ġunju 2007.
English: OPINION FOLLOWING AN ARTICLE 33 (4) REFERRAL FOR BOVILIS BVD/BOVILIS BVD-MD
Maltese: OPINJONI WARA REFERENZA SKOND L-ARTIKOLU 33( 4) GĦAL BOVILIS BVD/BOVILIS BVD-MD
English: During its meeting of November 2006, the CVMP started a referral procedure under Article 33(4) of Directive 2001/82/EC as amended for Bovilis BVD/Bovilis BVD-MD.
Maltese: Fil-laqgħa tiegħu ta' Novembru 2006, il-CVMP beda proċedura ta' referenza skond l-Artikolu 33(4) tad-Direttiva 2001/82/KE kif emendata għal Bovilis BVD/Bovilis
English: The production and testing of Bovilis BVD vaccine are in accordance with the relevant requirements of Directive 2001/82/EC, the relevant EU guidelines and the relevant monographs of the Ph.Eur.
Maltese: Il-produzzjoni u l-provi tal-vaċċin ta' Bovilis BVD huma skond ir-rekwiżiti relevanti tad-Direttiva 2001/82/KE, il-linji gwida relevanti ta' l-UE u l-monografi relevanti tal-Ph.Eur.
English: The CVMP concluded that the production of Bovilis BVD vaccine is in compliance with GMP requirements, that extraneous agent testing of raw materials are carried out according to the relevant requirements and that extraneous agent testing of finished batches of Bovilis BVD for FMDV, BLV, BTV and IBRV is not required in the relevant monographs.
Maltese: Is-CVMP ikkonkluda li l-produzzjoni tal-vaċċin tal-Bovilis BVD hija konformi mar-rekwiżiti talGMP, li l-provi għal sustanza barranija fuq materja prima huma mwettqa skond ir-rekwiżiti relevanti u li l-provi għal sustanza barranija ta' lottijiet lesti ta' Bovilis BVD għal FMDV, BLV, BTV u IBRV mhijiex meħtieġa fil-monografi relevanti.
English: Bovilis BVD/Bovilis BVD-MD is an inactivated virus vaccine containing the inactivated antigen of cytopathic BVD virus strain C-86.
Maltese: BVD-MD huwa vaċċin b'vajrus inattivat li fih l-antiġen inattivat tar-razza talvajrus
English: The CVMP concluded that the benefit - risk assessment for Bovilis BVD was favourable.
Maltese: Il-CVMP ikkonkluda li l-valutazzjoni tal-benefiċċju - riskju għal Bovilis BVD kienet waħda favorevoli.
English: Denmark could not agree with the granting of the marketing authorisation and the matter was referred to the Co-ordination Group for Mutual Recognition and Decentralised Procedures, CMD(v) and subsequently the Committee for Medicinal Products for Veterinary Use (CVMP).
Maltese: Id-Danimirka ma setgħetx taqbel ma' l-għoti ta' l-awtorizzazzjoni għat-tqegħid fis-suq u l-kwistjoni ġiet riferuta lill-Grupp ta' Koordinazzjoni għall-Proċeduri ta' Rikonoxximent Reċiproku u ta' Proċeduri Deċentralizzati, CMD(v) u sussegwentament lill-Kumitat għall-Prodotti Mediċinali għal Użu Veterinarju (CVMP).
English: Denmark considered that the proposed testing regime to demonstrate freedom from extraneous agents was insufficient to ensure that Bovilis BVD/Bovilis BVD-MD would not interfere with their national eradication campaigns for certain animal diseases and that, therefore, the benefit/risk assessment for Bovilis BVD/Bovilis BVD-MD was unfavourable, authorisation of the product representing a potential serious risk to animal health.
Maltese: BVD-MD ma jinterferixxix mal-kampanji nazzjonali tagħhom ta' qerda ta' ċertu mard ta' l-annimali u li, għalhekk, il-valutazzjoni talbenefiċċju/riskju għal Bovilis BVD/Bovilis BVD-MD kienet waħda mhux favorevoli, lawtorizzazzjoni tal-prodott tirrappreżenta riskju serju potenzjali għas-saħħa ta' l-annimal.
English: Bovilis BVD was first authorised in Germany as Bovilis BVD-MD.
Maltese: Bovilis BVD/Bovilis
English: In March 2006 an application for a marketing authorisation for this vaccine was submitted, following a repeat use mutual recognition procedure, with Germany acting as Reference Member State.
Maltese: F'Marzu ta' l-2006, ġiet ippreżentata applikazzjoni għall-awtorizzazzjoni għat-tqegħid fis-suq għal dan il-vaċċin, wara proċedura ta' rikonoxximent reċiproku ta' użu ripetut, bil-Ġermanja tkun l-Istat Membru ta' Referenza.
English: The first renewal procedure for the vaccine was finalised in June 2004.
Maltese: L-ewwel proċedura ta' tiġdid għat-tilqima ġiet iffinalizzata f'Ġunju 2004.
English: Median OS (months)
Maltese: OS medjana (xhur) Proporzjon ta' periklu (CI ta'
English: South San Francisco, CA 94080-4990 USA
Maltese: South San Francisco, CA 94080-4990
English: Malta (See Ireland)
Maltese: Malta (Ara Ireland)
English: Overall Survival (final analysis)***
Maltese: Sopravivenza Globali (analiżi finali)***
English: Genentech, Inc. 1 Antibody Way Oceanside, CA 92056 USA
Maltese: 1 Antibody Way Oceanside, CA 92056
English: Overall Survival (OS)
Maltese: Sopravivenza Globali (OS)
English: (See section 5.1).
Maltese: (Ara sezzjoni 5.1).
English: The incidence varied between 10% (4/40) and 20% (3/15).
Maltese: L-inċidenza varjat bejn 10% (4/40) u 20% (3/15).
English: NR 25-75 percentile (months) 5.5 − NR 6.1 − NR 3.8 - 7.8 5.59 - 9.17 5.88 - 13.01
Maltese: 5.5 −NR 6.1 −NR 3.8 - 7.8 5.59 - 9.17 5.88 - 13.01
English: See Section 4.
Maltese: Ara sezzjoni 4.
English: BO17705 Placebo + IFNa
Maltese: BO17705 Plaċebo+ IFNa
English: Date of latest renewal: 14 January 2015
Maltese: Data tal-aħħar tiġdid: 14 ta' Jannar 2015
English: a Interferon alfa-2a 9 MIU 3x/week b
Maltese: Interferon alfa-2a 9 MIU 3x/ġimgħa b
English: • Study E2100 (paclitaxel)
Maltese: • Studju E2100 (paclitaxel)
English: Table 14
Maltese: Tabella 14
English: • The active substance is bevacizumab.
Maltese: • Is-sustanza attiva hi bevacizumab.
English: Reactions (frequency*)
Maltese: Reazzjonijiet (frekwenza*)
English: Secondary endpoints
Maltese: Punti Finali Sekondarji
English: A total of 820 patients were randomised.
Maltese: Total ta' 820 pazjent kienu randomised.
English: (p-value = 0.
Maltese: (valur p = 0.
English: GI-vaginal Fistulae in study GOG-0240
Maltese: Fistuli GI-vaġinali fi studju GOG-0240
English: Ovarian failure/fertility
Maltese: Insuffiċjenza tal-ovarji/fertilità
English: Table 11 Efficacy results for study AVF3694g: - Capecitabinea and Avastin/Placebo (Cap + Avastin/Pl)
Maltese: Tabella 11 Riżultati tal-effikaċja għall-istudju AVF3694g: - Capecitabinea u Avastin/Plaċebo (Cap+ Avastin/Pl)
English: Capecitabine 1000 mg/m2 oral bid Placebo or
Maltese: Capecitabine 1000 mg/m2 orali bid Plaċebo jew
English: Overall Survival 3
Maltese: Sopravivenza globali 6
English: Final overall survival analysis performed when 46.7% of the patients had died with data cut-off date of 31 March 2013.
Maltese: Analiżi finali tas-sopravivenza globali mwettqa meta 46.7% tal-pazjenti kienu mietu b'data meta waqqfet tinġabar id-data ta' 31 ta' Marzu 2013.
English: Metastatic disease progression was inhibited and microvascular permeability was reduced.
Maltese: Progressjoni metastatika tal-marda kienet imwaqqfa u l-permjabilità mikrovaskulari mnaqqsa.
English: 7.5 mg/kg IV 30-90 min
Maltese: 7.5 mg/kg IV 30-90
English: Palmar-plantar erythrodysaesthesia syndrome
Maltese: Sindrome ta' eritrodisasteżija palmari-plantari
English: • CT+BV Arm (chemotherapy plus bevacizumab):
Maltese: • Grupp CT+BV (kimoterapija flimkien ma' bevacizumab):
English: Permanently discontinue Avastin in patients with tracheoesophageal (TE) fistula or any Grade 4 fistula [US National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE v.3)].
Maltese: Waqqaf Avastin b'mod permanenti f'pazjenti b'fistula trakeoesofagali (TE) jew kull fistula ta' Grad 4 [US National Cancer Institute-Common Terminology Criteria għall-Avvenimenti Avversi (NCI-CTCAE v.3)].