FrancophonIA/ELRC3.0 huggingface dataset:
English: However the improvement over formoterol alone was small and not considered clinically significant: FEV1 measured in the morning before the inhalation was 68 ml more with Duaklir Genuair than with formoterol alone.
Maltese: FEV1 imkejjel filgħodu qabel it-teħid man-nifs kien 68 ml aktar bi Duaklir Genuair milli b'formoterol waħdu.
English: The two active substances in Duaklir Genuair, aclinidium bromide and formoterol fumarate dihydrate, work by keeping the airways open and allowing the patient to breathe more easily.
Maltese: Barra minn hekk, peress li l-antagonisti muskariniċi li jaħdmu fit-tul jista' jkollhom effett fuq il-qalb u lvini u l-arterji tad-demm, il-kumpanija li tikkummerċjalizza Duaklir Genuair ser tipprovdi r-riżultati ta' studji biex tevalwa aktar is-sigurtà kardjovaskulari tal-mediċina.
English: Whereas
Maltese: Med.
English: Overall, 9 out of 60 (15%) developed inhibitors.
Maltese: Globalment, 9 minn 60 (15%) żviluppaw inibituri.
English: EUHASS study
Maltese: Studju EUHASS
English: The PRAC reviewed the preliminary 3-year data.
Maltese: Il-PRAC irreveda d-dejta preliminari ta' 3 snin.
English: RODIN/PedNet study
Maltese: Studju RODIN/PedNet
English: In this study, the incidence of inhibitor development ranged from 28.2% to 37.7% for all FVIII products.
Maltese: F'dan l-istudju, l-inċidenza tal-iżvilupp ta' inibituri kienet tvarja minn 28.2% għal 37.7% għall-prodotti kollha b'FVIII.
English: - the EUHASS (European Haemophilia Safety Surveillance System) registry.
Maltese: - ir-reġistru EUHASS (Sistema Ewropea ta' Sorveljanza tas-Sigurtà tal-Emofilja).
English: Five out of 37 (14%) PUP and 4 out of 23 (17%) MTP patients treated with Helixate NexGen developed inhibitors within 20 ED (exposure days).
Maltese: Ħamsa minn 37 (14%) PUP u 4 minn 23 (17%) pazjent MTP li rċevew kura b'Helixate NexGen żviluppaw inibituri fi żmien 20 ED (jiem ta' esponiment).
English: - the RODIN (Research of Determinants of Inhibitor development)/PedNet registry; and
Maltese: - ir-reġistru RODIN (Riċerka ta' Determinanti tal-Iżvilupp ta' inibituri)/PedNet; u
English: Post-hoc analysis of the RODIN study showed that PUPs with severe haemophilia A given Kogenate Bayer were more likely to develop inhibitor than those given another recombinant antihaemophilic factor VIII (adjusted hazard ratio, 1.60; 95%-CI: 1.08 -2.37).
Maltese: Analiżi post-hoc tal-istudju RODIN uriet li PUPs b'emofilja A severa li ngħataw Kogenate Bayer kienu aktar probabbli li jiżviluppaw inibitur minn dawk li ngħataw fattur VIII rikombinanti ieħor kontra lemofilja (proporzjon aġġustat tal-periklu, 1.60; 95%-CI: 1.08 -2.37).
English: In patients given KOGENATE Bayer/Helixate NexGen, 64 out of 183 developed an inhibitor (37.7%), of which 40 had a high-titre inhibitor (25.2%).
Maltese: F'pazjenti li ngħataw KOGENATE Bayer/Helixate NexGen, 64 minn 183 żviluppaw inibitur (37.7%), li minnhom, 40 kellhom inibitur b'titru għoli (25.2%).
English: The results of the RODIN/PedNet study (S. C. Gouw et al., N. Engl.
Maltese: Gouw et al., N.
English: • MAH sponsored and supported clinical trials
Maltese: • Provi kliniċi sponsorjati u appoġġati mill-MAH
English: Overall summary of the scientific evaluation of Kogenate Bayer and Helixate NexGen
Maltese: Kogenate Bayer/Helixate
English: • Observational studies
Maltese: • Studji ta' osservazzjoni
English: Both registries were part of the risk management plan (RMP) of the respective products.
Maltese: Iż-żewġ reġistri kienu parti mill-pjan ta' ġestjoni tar-riskju (RMP) tal-prodotti rispettivi.
English: The Federal Institute for Vaccines and Biomedicines (Germany) informed the Commission on the findings on the 1st of March 2013.
Maltese: L-Istitut Federali għall-Vaċċini u l-Bijomediċini (il-Ġermanja) informa lill-Kummissjoni bis-sejbiet fl1 ta' Marzu 2013.
English: Kogenate Bayer and Helixate NexGen are full-length recombinant human antihaemophilic factor VIII (octocog alfa) produced in baby hamster kidney (BHK) cells.
Maltese: Kogenate Bayer u Helixate NexGen huma fattur VIII full-length rikombinanti uman kontra l-emofilja (octocog alfa) prodott fiċ-ċelloli tal-kliewi (BHK) ta' ħamsters trabi.
English: • The PRAC considered the procedure under Article 20 of Regulation (EC) No 726/2004 for Kogenate Bayer and Helixate NexGen.
Maltese: • Il-PRAC ikkunsidra l-proċedura skont l-Artikolu 20 tar-Regolament (KE) Nru 726/2004 għal Kogenate Bayer u Helixate NexGen.
English: The PRAC noted that the Factor VIII gene mutation profile of these study population (in studies 200021EU and 100074US) reflects the typical distribution seen in patients with severe haemophilia A, indicating that there was no bias in patient recruitment.
Maltese: Il-PRAC innota li l-profil talmutazzjoni tal-ġene tal-Fattur VIII ta' din il-popolazzjoni tal-istudju (fl-istudji 200021EU u 100074US) jirrifletti d-distribuzzjoni tipika li tidher f'pazjenti bl-emofilja A severa, li jindika li ma kienx hemm preġudizzju fir-reklutaġġ tal-pazjenti.
English: Haemophilia centres in Western Europe and major haemophilia centres in North America enrolled a total of 60 PUPs/MTPs without pre-existing inhibitors in two studies (200021EU and 100074US).
Maltese: PUP/MTP mingħajr inibituri pre-eżistenti f'żewġ studji (200021EU u 100074US).
English: The EUHASS study was established in 2008 as an adverse event reporting system for patients with inherited bleeding disorders, including Haemophilia A, in Europe.
Maltese: L-istudju EUHASS ġie stabbilit fl-2008 bħala sistema ta' rappurtar ta' avvenimenti avversi għal pazjenti b'disturbi ta' fsada li ntirtu, inklużi l-Emofilja A, fl-Ewropa.
English: The efficacy of Kogenate Bayer/Helixate NexGen is recognised and the PRAC reviewed the data related to inhibitor development in PUPs and MTPs.
Maltese: NexGen hija rikonoxxuta u l-PRAC irreveda d-dejta relatata mal-iżvilupp ta' inibituri f'PUPs u MTPs.
English: In one observational study, the incidence of inhibitor development in previously untreated patients with severe haemophilia A was 64/183 (37.7%) with Helixate NexGen (followed up to 75 exposure days).
Maltese: Fi studju wieħed ta' osservazzjoni, l-inċidenza tal-iżvilupp ta' inibituri f'pazjenti bl-emofilja A severa li ma kienux irċevew kura preċedenti kienet ta' 64/183 (37.7%) b'Helixate NexGen (segwiti sa 75 jum ta' esponiment).
English: • Quality data
Maltese: • Dejta dwar il-kwalità
English: These two interventional studies were carried out as prospective, uncontrolled trials, for treatment of bleeding episodes in 37 PUPs and 23 MTPs with residual FVIII:C < 2 IU/dl.
Maltese: Dawn iż-żewġ studji ta' intervent saru bħala provi prospettivi u mhux ikkontrollati, għall-kura ta' episodji ta' fsada f'37 PUP u 23 MTP b'FVIII residwu:C < 2 IU/dl.
English: Following the provisions under Article 20 of Regulation (EC) No 726/2004, the CHMP, having considered the PRAC recommendation dated 5 December 2013, is of the opinion that the marketing authorisations for Kogenate Bayer and Helixate NexGen should be varied as recommended by the PRAC.
Maltese: Wara d-dispożizzjonijiet taħt l-Artikolu 20 tar-Regolament (KE) Nru 726/2004, is-CHMP, wara li kkunsidra r-rakkomandazzjoni tal-PRAC datata l-5 ta' Diċembru 2013 huwa tal-fehma li lawtorizzazzjonijiet għat-tqegħid fis-suq għal Kogenate Bayer u Helixate NexGen għandhom jiġu varjati kif rakkomandat mill-PRAC.
English: In view of the above, the PRAC agreed that the current evidence does not confirm an increased risk of developing antibodies against Kogenate Bayer and Helixate NexGen when compared with other factor VIII products in PUPs with the bleeding disorder haemophilia A. However the PRAC considered that the frequency for inhibitor development in PUPs should be amended from “common” to “very common” in the section 4.8 of the SmPC and also recommended that the product information should be updated with results from the RODIN study as part of the routine risk minimisation activities.
Maltese: Madankollu l-PRAC qies li l-frekwenza għalliżvilupp ta' inibituri f'PUPs għandha tiġi emendata minn “komuni” għal “komuni ħafna” fis-sezzjoni 4.8 tal-SmPC u rrakkomanda wkoll li l-informazzjoni dwar il-prodott tiġi aġġornata b'riżultati mill-istudju RODIN bħala parti mill-attivitajiet ta' rutina ta' minimizzazzjoni tar-riskju.
English: • The PRAC considered the publication of the results of the RODIN/PedNet study, the preliminary findings from the European Haemophilia Safety Surveillance System (EUHASS) registry and all available data submitted from clinical trials, observational studies, published literature and quality data for Kogenate Bayer and Helixate NexGen with regards to its potential risk of inhibitor development in previously untreated patients (PUPs).
Maltese: • Il-PRAC ikkunsidra l-pubblikazzjoni tar-riżultati tal-istudju RODIN/PedNet, is-sejbiet preliminari mir-reġistru tas-Sistema Ewropea ta' Sorveljanza tas-Sigurtà tal-Emofilja (EUHASS) u d-dejta kollha disponibbli ppreżentata minn provi kliniċi, studji ta' osservazzjoni, letteratura ppubblikata u dejta dwar il-kwalità għal Kogenate Bayer u Helixate NexGen fir-rigward tarriskju potenzjali tiegħu għall-iżvilupp ta' inibituri f'pazjenti li ma kienux irċevew kura preċedenti (PUPs).
English: In 2006, an EMA expert meeting1 on FVIII products and inhibitor development concluded that there was a need to collect comparable clinical data on the immunogenicity of recombinant and plasmaderived FVIII products as a long-term objective.
Maltese: Fl-2006, laqgħa tal-esperti tal-EMA1 dwar prodotti b'FVIII u l-iżvilupp ta' inibizzjoni kkonkludiet li kien hemm il-ħtieġa li tinġabar dejta klinika komparabbli dwar l-immunoġeniċità ta' prodotti b'FVIII rikombinanti u li ġejjin mill-plasma bħala għan fit-tul.
English: The PRAC considered results from the publication of the RODIN/PedNet study, the preliminary findings from the European Haemophilia Safety Surveillance System (EUHASS) registry and all available data submitted from clinical trials, observational studies, published literature as well as quality data for Kogenate Bayer and Helixate NexGen with regards to its potential risk of inhibitor development in previously untreated patients (PUPs) and minimally treated patients (MTPs).
Maltese: Il-PRAC ikkunsidra r-riżultati mill-pubblikazzjoni tal-istudju RODIN/PedNet, is-sejbiet preliminari mirreġistru tas-Sistema Ewropea ta' Sorveljanza tas-Sigurtà tal-Emofilja (EUHASS) u d-dejta kollha disponibbli ppreżentata mill-provi kliniċi, studji ta' osservazzjoni, letteratura ppubblikata kif ukoll dejta dwar il-kwalità għal Kogenate Bayer u Helixate NexGen fir-rigward tar-riskju potenzjali tiegħu għalliżvilupp ta' inibituri f'pazjenti li ma kienux irċevew kura preċedenti (PUPs) u pazjenti li rċevew kura minima (MTPs).
English: J. Med. 368, 231 (2013)) were made available and seemed to suggest that Kogenate Bayer/Helixate NexGen were associated with an increased risk of inhibitor development in previously untreated patients (PUPs) when compared to another recombinant antihaemophilic factor VIII, after adjustment for confounding factors.
Maltese: 368, 231 (2013)) saru disponibbli u dehru jissuġġerixxu li Kogenate Bayer/Helixate NexGen kienu assoċjati ma' riskju akbar ta' żvilupp ta' inibituri f'pazjenti li ma kinux irċevew kura preċedenti (PUPs) meta mqabbla ma' fattur VIII rikombinanti ieħor kontra l-emofilja, wara l-aġġustament għal fatturi li jfixklu.
English: The CHMP considered the below PRAC recommendation dated 5 December 2013 with regards to the procedure under Article 20 of Regulation (EC) No 726/2004 for Kogenate Bayer and Helixate NexGen.
Maltese: Is-CHMP ikkunsidra r-rakkomandazzjoni tal-PRAC ta' hawn taħt datata l-5 ta' Diċembru 2013 firrigward tal-proċedura skont l-Artikolu 20 tar-Regolament (KE) Nru 726/2004 għal Kogenate Bayer u Helixate NexGen.
English: Kogenate Bayer/Helixate NexGen are indicated for treatment and prophylaxis of bleeding in patients with hemophilia A (congenital factor VIII deficiency).
Maltese: NexGen huma indikati għall-kura u l-profilassi ta' fsada f'pazjenti bl-emofilja A (defiċjenza konġenitali talfattur VIII).
English: The MAH provided data on the above-mentioned observational studies with regards to the risk of inhibitor development in PUPs receiving FVIII products, including KOGENATE Bayer/Helixate NexGen.
Maltese: Il-MAH ipprovda dejta dwar l-istudji ta' osservazzjoni msemmija hawn fuq fir-rigward tar-riskju taliżvilupp ta' inibituri f'PUPs li qed jirċievu prodotti b'FVIII, inklużi KOGENATE Bayer/Helixate
English: According to the MAH, since the Marketing Authorisations, 42 changes in the manufacturing process of KOGENATE Bayer have been introduced.
Maltese: Skont il-MAH, mill-Awtorizzazzjonijiet għat-Tqegħid fis-Suq, ġew introdotti 42 bidla fil-proċess talmanifattura ta' KOGENATE Bayer.
English: The MAH also submitted data from four interventional clinical trials and six observational studies, which investigated the safety and efficacy of Kogenate Bayer/Helixate NexGen in haemophilia A patients, including studies 200021EU and 100074US in PUPs and minimally treated patients (MTPs).
Maltese: Il-MAH ippreżenta wkoll dejta minn erba' provi kliniċi ta' intervent u sitt studji ta' osservazzjoni, li investigaw is-sigurtà u l-effikaċja ta' KOGENATE Bayer/Helixate NexGen f'pazjenti bl-emofilja A, inklużi http://www.ema.europa.eu/docs/en_GB/document_library/Report/2009/11/WC500015512.pdf l-istudji 200021EU u 100074US f'PUPs u f'pazjenti li rċevew kura minima (MTPS).
English: Development of inhibitors against FVIII is the most significant complication of replacement therapy for haemophilia A. These antibodies inactivate the pro-coagulant activity of FVIII and inhibit patients' response to FVIII replacement therapy which may result in life-threatening bleedings and sequelae.
Maltese: L-iżvilupp ta' inibituri kontra FVIII huwa l-aktar komplikazzjoni sinifikanti ta' terapija ta' sostituzzjoni għall-emofilja A.
English: As a consequence, the marketing authorisation holder (MAH) for Kogenate Bayer and Helixate NexGen supported two EU registries:
Maltese: Bħala konsegwenza, id-detentur talawtorizzazzjoni għat-tqegħid fis-suq (MAH) għal Kogenate Bayer u Helixate NexGen appoġġjaw żewġ reġistri tal-UE:
English: • The PRAC noted that the efficacy of Kogenate Bayer/Helixate NexGen is not questioned and, on the basis of the available data, concluded that the current results do not confirm an increased risk of developing antibodies against Kogenate Bayer and Helixate NexGen when compared with other factor VIII products in PUPs with the bleeding disorder haemophilia A.
Maltese: NexGen mhijiex iddubitata u, abbażi tad-dejta disponibbli, ikkonkluda li r-riżultati attwali ma jikkonfermawx riskju akbar tal-iżvilupp ta' antikorpi kontra Kogenate Bayer u Helixate NexGen meta mqabbla ma' prodotti oħra talfattur VIII f'PUPs bid-disturb ta' fsada l-emofilja A.
English: The MAH will continue to support the RODIN/PedNet registry as well as the EUHASS registry, as per current obligations defined in the RMP, to further investigate individual risk factors for inhibitor development and risk mitigation in PUPs.
Maltese: Il-MAH se jkompli jappoġġja r-reġistru RODIN/PedNet kif ukoll ir-reġistru EUHASS, skont l-obbligi attwali definiti fl-RMP, biex ikomplu jiġu investigati l-fatturi ta' riskju individwali għall-iżvilupp ta' inibituri u l-mitigazzjoni tar-riskju f'PUPs.
English: In this context, the PRAC noted that Kogenate Bayer and Helixate Nexgen is potency labelled based on an one-stage clotting assay, in accordance with the approved quality documentation for the product, and not the chromogenic assay as per the European Pharmacopeia.
Maltese: F'dan il-kuntest, il-PRAC innota li Kogenate Bayer u Helixate Nexgen huma tikkettati skont is-saħħa abbażi ta' analiżi ta' tagħqid fuq stadju wieħed, konformi mad-dokumentazzjoni ta' kwalità approvata għall-prodott, u mhux l-analiżi kromoġenika skont il-Farmakopeja Ewropea.
English: In addition, the PRAC noted an update from the on-going EUHASS data, and results showed an inhibitor incidence for Kogenate Bayer and Helixate Nexgen comparable to other products: whereas no adjustment for known risk factors for inhibitor development could be performed due to the study design, the PRAC noted that the 95 % CIs of the point estimates of PUP inhibitor incidence were overlapping substantially between different products.
Maltese: Barra minn hekk, il-PRAC innota aġġornament middejta kontinwa tal-EUHASS, u r-riżultati wrew inċidenza ta' inibituri għal Kogenate Bayer u Helixate Nexgen komparabbli ma' prodotti oħra: għalkemm ma seta' jsir l-ebda aġġustament għall-fatturi ta' riskju magħrufa għall-iżvilupp ta' inibituri minħabba d-disinn tal-istudju, il-PRAC innota li l-95 % CIs tal-istimi tal-punt ta' inċidenza ta' inibituri f'PUPs kienu jikkoinċidu b'mod sostanzjali bejn il-prodotti differenti.
English: • The PRAC considered though that the frequency for inhibitor development in PUPs should be amended from “common” to “very common” in the section 4.8 of the SmPC and also recommended that the product information should be updated to reflect the most recent results from the RODIN study.
Maltese: • Il-PRAC madankollu kkunsidra li fis-sezzjoni 4.8 tal-SmPC, il-frekwenza għall-iżvilupp ta' inibituri f'PUPs għandha tiġi emendata minn “komuni” għal “komuni ħafna” u rrakkomanda wkoll li l-informazzjoni dwar il-prodott għandha tiġi aġġornata biex tirrifletti l-aktar riżultati riċenti mill-istudju RODIN.
English: However, the data presented by the MAH indicate that there are no significant changes in the posttranslational modifications, aggregation profile, specific activity or excipients since MA of Kogenate Bayer that might have increased the risk for inhibitor development over time.
Maltese: Madankollu, id-dejta ppreżentata mill-MAH tindika li m'hemmx tibdil sinifikanti fil-modifiki posttraduzzjonali, fil-profil ta' aggregazzjoni, l-attività speċifika jew fl-eċċipjenti mill-awtorizzazzjoni għat-tqegħid fis-suq ta' Kogenate Bayer li maż-żmien seta' jżid ir-riskju għall-iżvilupp ta' inibituri.
English: The objective of the RODIN/Pednet study was to examine the inhibitor development in PUPs with severe haemophilia A given recombinant or plasma-derived FVIII products.
Maltese: L-għan tal-istudju RODIN/Pednet kien li jeżamina l-iżvilupp ta' inibituri f'PUPs b'emofilja A severa li ngħataw prodotti b'FVIII rikombinanti jew li ġejjin mill-plasma.
English: Further information on Cyramza can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/cyramza.
Maltese: Aktar informazzjoni dwar Cyramza tinstab fis-sit web tal-Aġenzija: ema.europa.eu/medicines/human/EPAR/cyramza.
English: Cyramza received a marketing authorisation valid throughout the EU on 19 December 2014.
Maltese: Cyramza rċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fid-19 ta' Diċembru 2014.
English: Cyramza contains the active substance ramucirumab.
Maltese: Cyramza fih is-sustanza attiva ramuċirumab.
English: Other information about Cyramza
Maltese: Informazzjoni oħra dwar Cyramza
English: Cyramza is given by infusion (drip) into a vein.
Maltese: Cyramza jingħata permezz ta' infużjoni (dripp) ġo vina.
English: What are the risks associated with Cyramza?
Maltese: X'inhuma r-riskji assoċjati ma' Cyramza?
English: The most serious adverse effects reported (either of Cyramza alone or in combination with other cancer medicines) included gastrointestinal perforation (a hole that develops in the wall of the gut), severe gastrointestinal haemorrhage (bleeding from the gut) and arterial thromboembolic events
Maltese: L-effetti avversi l-aktar serji rrappurtati (jew ta' Cyramza waħdu jew f'kombinazzjoni ma' mediċini oħra kontra l-kanċer) inkludew perforazzjoni gastrointestinali (toqba li tiżviluppa fil-ħajt tal-imsaren), emorraġija gastrointestinali severa (emorraġija mill-imsaren) u avvenimenti tromboemboliċi arterjali (problemi kkawżati minn emboli tad-demm u mblokkar talarterji).
English: In one main study involving 665 patients with advanced gastric or gastro-oesophageal junction cancer which worsened despite treatment with medicines containing platinum and a fluoropyrimidine, those treated with Cyramza and paclitaxel lived longer than patients receiving paclitaxel and placebo (a dummy treatment): on average 9.6 months versus 7.4 months respectively.
Maltese: Fi studju ewlieni wieħed li kien jinvolvi 665 pazjent b'kanċer gastriku avvanzat jew tal-ġunzjoni gastroesofagali li aggravaw minkejja kura b'mediċini li fihom il-platinu jew il-fluworopirimidin, dawk li ġew ikkurata b'Cyramza u paclitaxel għexu aktar mill-pazjenti li kienu qed jirċievu paclitaxel u plaċebo (kura finta): bħala medja 9.6 xhur kontra 7.4 xhur rispettivament.
English: The active substance in Cyramza, ramucirumab, is a monoclonal antibody (a type of protein) designed to attach to vascular endothelial growth factor receptor (VEGFR), a protein present at high levels in tumours.
Maltese: Is-sustanza attiva f'Cyramza, ir-ramuċirumab, hija antikorp monoklonali (tip ta' proteina) imfassla biex teħel mar-riċettur tal-fattur tat-tkabbir tal-endotelju vaskulari (VEGFR), proteina preżenti f'livelli għoljin fit-tumuri
English: Cyramza is a cancer medicine used to treat adult patients with:
Maltese: Cyramza huwa mediċina kontra l-kanċer li tintuża fil-kura ta' pazjenti adulti bi:
English: Cyramza is used in combination with another medicine, paclitaxel, or on its own if the combination with paclitaxel is not appropriate, in patients whose disease has worsened despite treatment with medicines containing platinum or fluoropyrimidines (a class of medicines that includes capecitabine, fluorouracil and tegafur);
Maltese: Cyramza jintuża f'kombinazzjoni ma' mediċina oħra, paclitaxel, jew waħdu jekk il-kombinazzjoni ma' paclitaxel ma tkunx xierqa, f'pazjenti li l-marda tagħhom tkun aggravat minkejja l-kura b'mediċini li fihom ilplatinu jew il-fluworopirimidini (klassi ta' mediċini li tinkludi capecitabine, fluorouracil u tegafur);
English: Cyramza is used with ‘FOLFIRI' chemotherapy (a combination of fluorouracil, folinic acid and irinotecan) in patients whose disease has worsened despite treatment with bevacizumab, oxaliplatin and a fluoropyrimidine;
Maltese: Cyramza jintuża mal-kimoterapija ‘FOLFIRI' (kombinazzjoni ta' fluworuraċil, aċidu foliniku u irinotekan) f'pazjenti li l-marda tagħhom aggravat minkejja l-kura b'bevaċiżumab, oksaliplatin u fluworopirimidin;
English: As for all medicines, data on the use of Cyramza is continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Cyramza hija ssorveljata kontinwament.
English: • advanced gastric cancer (cancer of the stomach) or cancer of the area where the gullet (oesophagus) enters the stomach (known as gastro-oesophageal junction adenocarcinoma).
Maltese: • kanċer gastriku avvanzat (kanċer fl-istonku) jew kanċer fiż-żona fejn il-kanal tal-ikel (esofagu) jidħol fl-istonku (magħruf bħala adenokarċinoma tal-ġunzjoni gastroesofagali).
English: Cyramza increased survival of patients with advanced gastric or gastro-oesophageal junction cancer, metastatic colorectal cancer, advanced or metastatic non-small cell lung cancer and hepatocellular carcinoma in 5 main studies.
Maltese: Cyramza żied is-sopravivenza ta' pazjenti b'kanċer gastriku avvanzat jew tal-ġunzjoni gastroesofagali, kanċer kolorettali metastatiku, kanċer tal-pulmun b'ċelloli mhux żgħar avvanzat jew metastatiku u karċinoma epatoċellulari f'5 studji ewlenin.
English: In a main study involving 1,072 patients with metastatic colorectal cancer which worsened despite treatment with bevacizumab, oxaliplatin and a fluoropyrimidine, those treated with Cyramza and FOLFIRI lived longer than patients receiving FOLFIRI and placebo: on average 13.3 months versus 11.7 months respectively.
Maltese: Fi studju ewlieni li kien jinvolvi 1,072 pazjent b'kanċer kolorettali metastatiku li aggrava minkejja kura b'bevaċiżumab, oksaliplatin u fluworopirimidin, dawk li kienu kkurati b'Cyramza u FOLFIRI għexu aktar mill-pazjenti li kienu qed jirċievu FOLFIRI u plaċebo:bħala medja 13.3 xhur kontra 11.7 xhur rispettivament.