FrancophonIA/ELRC3.0 huggingface dataset:
English: The Applicant discussed the efficacy and safety of sequential IV/oral moxifloxacin in the treatment of cSSSI and concluded that non-inferiority was demonstrated, and that the clinical studies and postmarketing safety data show no evidence that moxifloxacin-treated patients are at greater risk for morbidity, including cardiac and hepatic morbidity, than patients receiving comparator antibiotics.
Maltese: L-Applikant iddiskuta l-effikaċja u s-sigurtà ta' moxifloxacin sekwenzjali IV/orali fit-trattament ta' cSSSI u kkonkluda li n-nuqqas ta' inferjorità ntwera, u li l-istudji kliniċi u d-dejta dwar is-sigurtà ta' wara t-tqegħid fis-suq ma juru ebda evidenza li l-pazjenti li jiġu trattati b'moxifloxacin qegħdin f'riskju akbar għall-morbidità, inkluża l-morbidità kardijaka u epatika, milli pazjenti li qegħdin jirċievu antibijotiċi komparaturi.
English: Coxiella burnetii
Maltese: Ir-Repubblika Ċeka
English: - The other ingredients are sodium chloride, hydrochloric acid (for pH-adjustment), sodium hydroxide (for pH-adjustment) and water for injections
Maltese: - Is-sustanzi l-oħra huma sodium chloride, hydrochloric acid (għall-aġġustament tal-pH), sodium hydroxide (għall-aġġustament tal-pH) u ilma għall-injezzjonijiet Id-Dehra ta' Avalox u l-kontenuti tal-pakkett
English: - The efficacy of Avalox in the treatment of severe burns, infections of deep tissue, major purulent ulcers (abscesses) and diabetic foot infections with osteomyelitis (infections of the bone marrow) has not been established.
Maltese: - L-effikaċja ta' Avalox fil-kura ta' ħruq sever, infezzjonijiet fit-tessut fond, ulċeri maġġuri bilmaterja (axxessi) u infezzjonijiet ta' sieq dijabetika b'osteomjelite (infezzjonijiet tal-mudullun tal-għadam) ma ġietx stabbilita.
English: Avalox and associated names (see Annex I) 400mg/250ml solution for infusion
Maltese: Avalox u ismijiet assoċjati (ara Anness I) 400 mg/250 ml soluzzjoni għall-infużjoni [Ara Anness I - Biex timtela mill-pajjiż partikolari]
English: Finland Bayer HealthCare AG Kaiser Wilhelm Allee 51368 Leverkusen Germany
Maltese: Il-Finlandja Bayer HealthCare AG Kaiser Wilhelm Allee 51368 Leverkusen
English: Using Avalox with food and drink The effect of Avalox is not influenced by food including dairy products.
Maltese: Meta tuża Avalox ma' l-ikel u max-xorb L-effett ta' Avalox mhux influwenzat mill-ikel inkluż prodotti tal-ħalib.
English: Slovak Republic
Maltese: Is-Slovakkja:
English: - If you suffer from epilepsy or a condition which makes you likely to have convulsions, tell your doctor before taking Avalox.
Maltese: - Jekk issofri minn epilessija jew minn kundizzjoni li tagħmlek probabbli li jkollok konvulżjonijiet, għid lit-tabib tiegħek qabel tieħu Avalox.
English: Lithuania Bayer HealthCare AG Kaiser Wilhelm Allee 51368 Leverkusen Germany
Maltese: Il-Litwanja Bayer HealthCare AG Kaiser Wilhelm Allee 51368 Leverkusen
English: An early evaluation of the effects of moxifloxacin on QTc showed a correlation between plasma concentration and QTc in healthy subjects and increases in QTc were significantly higher in healthy elderly subjects post-moxifloxacin versus placebo.
Maltese: Pazjenti nisa u pazjenti anzjani jistgħu jkunu aktar sensittivi għall-effetti ta' medikazzjonijiet li jtawwlu QTc bħal moxifloxacin u għalhekk hija meħtieġa kawtela speċjali.
English: Studies in rats (p.o. and i.v.)
Maltese: U PRODOTTI SIMILI TIEGĦU (ARA ANNESS I)
English: Denmark Bayer HealthCare AG Kaiser Wilhelm Allee 51368 Leverkusen Germany
Maltese: Id-Danimarka Bayer HealthCare AG Kaiser Wilhelm Allee 51368 Leverkusen
English: Avalox will always be given to you by a doctor or healthcare professional.
Maltese: Avalox dejjem se jingħata lilek minn tabib jew professjonist fil-qasam tas-saħħa.
English: BEFORE YOU USE AVALOX
Maltese: QABEL MA TUŻA AVALOX
English: Avelox United Kingdom: Avelox
Maltese: Qabel tuża Avalox
English: +Methicillin resistant S. aureus have a high probability of resistance to fluoroquinolones.
Maltese: Pseudomonas aeruginosa *Attività kienet murija b'mod sodisfaċenti fi studji kliniċi. +S. aureus reżistenti għal methicillin għandu probabbiltà għolja ta' reżistenza għal fluoroquinolones.
English: The virus exists in several forms (serotypes) throughout the world; the types used in Zulvac 1+8 Bovis are serotypes 1 and 8.
Maltese: Il-vajrus jeżisti f'diversi forom (serotipi) fid-dinja kollha; it-tipi użati f'Zulvac 1+8 Bovis huma s-serotipi 1 u 8.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Zulvac 1+8 Bovis on 08/03/2012.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea għal Zulvac 1+8 Bovis fit-08/03/2012.
English: Zulvac 1+8 Bovis is a vaccine that contains inactivated (killed) bluetongue serotypes 1 and 8 viruses as the active substance.
Maltese: Zulvac 1+8 Bovis huwa vaċċin li fih il-vajrusis inattivati (maqtula) tas-serotipi 1 u 8 tal-lingwablu bħala s-sustanza attiva.
English: Cattle may show a temporary increase in body temperature (no more than 2.7 °C) in the 48 hours following vaccination.
Maltese: Il-bhejjem tal-ifrat jista' jkollhom żieda temporanja fit-temperatura tal-ġisem, (ta' mhux aktar minn 2.7 C) fi żmien 48 siegħa wara t-tilqima.
English: In 2013 the CVMP considered that the submitted data were adequate for the authorisation of Zulvac 1+8 Bovis to convert to a normal status.
Maltese: Fl-2013 is-CVMP qies li d-dejta mressqa kienet adegwata biex l-awtorizzazzjoni ta' Zulvac 1+8 Bovis tinbidel għal status normali.
English: Local reactions at the injection site are common and normally resolve within 4 weeks.
Maltese: Ir-reazzjonijiet lokali fis-sit tal-injezzjoni huma komuni u normalment jgħibu f'erba' ġimgħat.
English: Another laboratory study in cattle looked at how long the vaccine was able to protect against bluetongue infection.
Maltese: Studju ieħor fil-laboratorju fuq l-ifrat iffoka fuq kemm żmien il-vaċċin kien kapaċi jdum jipproteġi kontra l-infezzjoni tal-lingwablu.
English: The CVMP concluded that the benefits of Zulvac 1+8 Bovis exceed the risks for prevention of viraemia caused by bluetongue virus serotypes 1 and 8 in cattle from three months of age and recommended that Zulvac 1+8 Bovis be given a marketing authorisation.
Maltese: Is-CVMP ikkonkluda li l-benefiċċji ta' Zulvac 1+8 Bovis huma akbar mir-riskji għall-prevenzjoni ta' viremija kkawżata mis-serotipi 1 u 8 tal-vajrus tal-lingwablu fil-bhejjem tal-ifrat minn tliet xhur ‘il fuq u rrakkomanda li Zulvac 1+8 Bovis għandu jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: The vaccine also contains ‘adjuvants' (aluminium hydroxide and saponin) to enhance the immune response.
Maltese: Ilvaċċin fih ukoll ‘aġġuvanti' (l-idrossidu tal-aluminju u s-saponina) li jtejbu r-rispons immunitarju.
English: The benefit-risk balance may be found in the scientific discussion module of this EPAR.
Maltese: Il-bilanċ bejn il-benefiċċju u r-riskju jista' jinstab fil-modulu tad-diskussjoni xjentifika ta' dan l-EPAR.
English: Zulvac 1+8 Bovis is a vaccine.
Maltese: Zulvac 1+8 Bovis huwa vaċċin.
English: Zulvac 1+8 Bovis was studied in calves in four main studies carried out in a laboratory.
Maltese: Zulvac 1+8 Bovis ġie studjat fuq l-għoġġiela f'erba' studji ewlenin li saru ġo laboratorju.
English: What is Zulvac 1+8 Bovis?
Maltese: X'inhu Zulvac 1+8 Bovis?
English: What is the risk associated with Zulvac 1+8 Bovis?
Maltese: X'hinu r-riskju assoċjat ma' Zulvac 1+8 Bovis?
English: Zulvac 1+8 Bovis is used in cattle to protect them against bluetongue disease, an infection caused by the bluetongue virus which is transmitted by midges.
Maltese: Zulvac 1+8 Bovis jintuża fil-bhejjem tal-ifrat biex jipproteġihom kontra l-marda tal-lingwablu, li hija infezzjoni kkawżata mill-vajrus tal-lingwablu li jiġi trażmess mill-insetti dipteri.
English: Why has Zulvac 1+8 Bovis been approved?
Maltese: Għaliex ġie approvat Zulvac 1+8 Bovis?
English: Other information about Zulvac 1+8 Bovis:
Maltese: Tagħrif ieħor dwar Zulvac 1+8 Bovis:
English: How has Zulvac 1+8 Bovis been studied?
Maltese: Kif ġie studjat Zulvac 1+8 Bovis?
English: EMA/49312/2016 EMEA/H/C/002098
Maltese: EMA/49312/2016 EMA/H/C/002098
English: It contains the active substance belatacept.
Maltese: Fih is-sustanza attiva belatacept.
English: The full EPAR for Nulojix can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This summary was last updated in 02-2016.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi 02-2016.
English: The most common serious side effects of Nulojix seen in more than 2% of patients are: urinary tract infection (infection of the structures that carry urine), cytomegalovirus infection, pyrexia (fever), increased blood creatinine (a marker of kidney problems), pyelonephritis (kidney infection), diarrhoea, gastroenteritis (diarrhoea and vomiting), poor functioning of the transplanted kidney, leucopenia (low white blood cell counts), pneumonia (infection of the lungs), basal cell carcinoma (a cancer), anaemia (low red blood cell counts), dehydration.
Maltese: L-effetti sekondarji serji l-aktar komuni bi Nulojix li dehru f'aktar minn 2% tal-pazjenti huma: infezzjoni fl-apparat urinarju (infezzjoni tal-istrutturi li jġorru l-awrina), infezzjoni taċ-ċitomegalovirus, piressija (deni), żieda ta' kreatinina fid-demm (markatur ta' problemi fil-kliewi), pajelonefrite (infezzjoni fil-kliewi), dijarea, gastro-enterite (dijarea u rimettar), funzjonament ħażin tal-kilwa ttrapjantata, lewkopenja (għadd baxx taċ-ċelloli tad-demm bojod), pnewmonja (infezzjoni talpulmuni), karċinoma taċ-ċellola bażali (kanċer), anemija (għadd baxx taċ-ċelloli ħomor tad-demm), deidrazzjoni.
English: The active substance in Nulojix, belatacept, is an immunosuppressive medicine.
Maltese: Is-sustanza attiva fi Nulojix, il-belatacept, hija mediċina immunosuppressiva.
English: This is a summary of the European public assessment report (EPAR) for Nulojix.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Nulojix.
English: In the second study, 89% (155 out of 175) of patients on Nulojix and 85% (157 out 184) of those on cyclosporine A survived with their kidneys intact.
Maltese: Fit-tieni studju, 89% (155 minn 175) tal-pazjenti fuq Nulojix u 85% (157 minn 184) ta' dawk fuq cyclosporine A issopravivew bil-kliewi tagħhom intatti.
English: In the initial phase it is given at a dose of 10 mg per kilogram body weight on day 1 (day of transplantation or the day before) and then again on days 5, 14 and 28.
Maltese: Fil-fażi inizjali jingħata f'doża ta' 10 mg għal kull kilogramma tal-piż tal-ġisem f'jum 1 (ilġurnata tat-trapjant jew il-ġurnata ta' qabel) u mbagħad fil-jiem 5, 14 u 28.
English: In the first study, 97% of patients receiving Nulojix treatment survived with their kidneys intact (218 out of 226) compared with 93% of patients receiving cyclosporine A (206 out 221).
Maltese: Fl-ewwel studju, 97% tal-pazjenti li rċevew kura bi Nulojix issopravivew bil-kliewi tagħhom intatti (218 minn 226) meta mqabbla ma' 93% tal-pazjenti li rċevew cyclosporine A (206 minn 221).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Nulojix on 17 June 2011.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Nulojix fis-17 ta' Ġunju 2011.
English: Other information about Nulojix
Maltese: Informazzjoni oħra dwar Nulojix
English: Nulojix is given as an infusion into a vein over 30 minutes.
Maltese: Nulojix jingħata bħala infużjoni ġo vina fuq perjodu ta' 30 minuta.
English: It is used with corticosteroids and a mycophenolic acid (other medicines used to prevent organ rejection).
Maltese: Jintuża ma' kortikosterojdi u ma' aċidu mikofenoliku (mediċini oħrajn użati biex jipprevjenu r-rifjut talorgani).
English: The proportion of patients who had an episode of organ rejection within one year was 17% for Nulojix and 7% for cyclosporine A.
Maltese: Il-proporzjon ta' pazjenti li kellhom episodju ta' rifjut tal-organu fi żmien sena kien ta' 17% għal Nulojix u 7% għal cyclosporine A.
English: In addition, the company that makes Nulojix will include an alert card in each medicine's pack to increase awareness of the benefits and risks with Nulojix.
Maltese: Barra minn hekk, il-kumpanija li tipproduċi Nulojix se tinkludi karta ta' twissija f'kull pakkett talmediċina sabiex iżżid is-sensibilizzazzjoni tal-benefiċċji u r-riskji bi Nulojix.
English: All patients were also treated with corticosteroids, mycophenolic acid, and basiliximab (an interleukin-2 receptor antagonist) during the first week after transplantation.
Maltese: Il-pazjenti kollha rċevew ukoll kura b'kortikosterojdi, aċidu mikofenoliku, u basiliximab (antagonist tar-riċettur interleukin-2) matul l-ewwel ġimgħa wara t-trapjant.
English: Why has Nulojix been approved?
Maltese: Għaliex ġie approvat Nulojix?
English: After the initial phase, which lasts three months, Nulojix is given at a maintenance dose of 5 mg/kg every four weeks starting from the end of the week 16.
Maltese: Wara l-fażi inizjali, li ddum tliet xhur, Nulojix jingħata f'doża ta' manteniment ta' 5 mg/kg kull erba' ġimgħat li jibdew mill-aħħar tal-ġimgħa 16.
English: It suppresses the activity of ‘T cells', immune system cells that can become involved in organ rejection.
Maltese: Din trażżan l-attività taċ‘ċelloli T', ċelloli tas-sistema immuni li jistgħu jkunu involuti fir-rifjut tal-organu.
English: Belatacept has been designed to attach to two of these molecules called CD80 and CD86.
Maltese: Dan iseħħ meta ċerti molekuli jeħlu ma' riċetturi fuq is-superfiċje taċ-ċelloli T. Il-belatacept ġiet iddiżinjata biex teħel ma' tnejn minn dawn il-molekuli msejħa CD80 u CD86.
English: Overall, the benefits of Nulojix compared well with the comparator medicine.
Maltese: B'mod ġenerali, il-benefiċċji ta' Nulojix kienu komparabbli sew mal-mediċina komparatur.
English: What is the risk associated with Nulojix?
Maltese: X'inhu r-riskju assoċjat ma' Nulojix?
English: The proportion of patients with impaired kidney function was 77% in patients on Nulojix and 85% in patients on cyclosporine A. Around 18% of patients on Nulojix had an episode of organ rejection within one year compared with 14% of patients on cyclosporine A.
Maltese: Il-proporzjon tal-pazjenti b'indeboliment talfunzjoni tal-kliewi kien ta' 77% fil-pazjenti fuq Nulojix u 85% fil-pazjenti fuq cyclosporine A.
English: What is Nulojix?
Maltese: Għal xiex jintuża Nulojix?
English: In two main studies involving 1,209 patients who underwent a kidney transplant, Nulojix was compared with cyclosporine A (another medicine used to prevent organ rejection).
Maltese: F'żewġ studji ewlenin li fihom ħadu sehem 1,209 pazjenti li għaddew minn trapjant tal-kliewi, Nulojix tqabbel ma' cyclosporine A (mediċina oħra użata biex tipprevjeni r-rifjut ta' organu).
English: Around 54% of patients receiving Nulojix and 78% of those receiving cyclosporine A had impaired kidney function.
Maltese: Madwar 54% talpazjenti li rċevew Nulojix u 78% ta' dawk li rċevew cyclosporine A kellhom indeboliment tal-funzjoni tal-kliewi.
English: Nulojix was shown to improve patient and organ survival following kidney transplantation.
Maltese: Nulojix intwera li jtejjeb is-sopravivenza tal-pazjent u tal-organu wara trapjant tal-kliewi.
English: A risk management plan has been developed to ensure that Nulojix is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Nulojix jintuża bl-aktar mod sigur possibbli.
English: This is because patients treated with Nulojix who have had no previous exposure to the virus are at higher risk of getting a type of cancer known as post-transplant lymphoproliferative disorder.
Maltese: Dan huwa għaliex pazjenti li rċevew kura bi Nulojix li ma kellhomx esponiment preċedenti għall-virus qegħdin f'riskju ogħla li jaqbadhom tip ta' kanċer magħruf bħala disturb limfoproliferattiv wara t-trapjant.
English: How has Nulojix been studied?
Maltese: Kif ġie studjat Nulojix?
English: The CHMP noted that Nulojix does not have the toxic effects on the kidneys seen with other immunosuppressive medicines commonly used in transplantation.
Maltese: Is-CHMP innota li Nulojix ma għandux l-effetti tossiċi fuq il-kliewi li kienu dehru bil-mediċini immunosuppressivi oħra użati b'mod komuni fit-trapjanti.
English: For the full list of all side effects reported with Nulojix, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati bi Nulojix, ara l-fuljett ta 'tagħrif.
English: Further information on Zessly can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: Aktar informazzjoni dwar Zessly tista' tinstab fuq is-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: A similar proportion of patients achieved a 20% reduction with the two medicines (around 61.1% with Zessly and 63.5% with Remicade).
Maltese: Proporzjon simili ta' pazjenti kisbu 20% tnaqqis biż-żewġ mediċini (madwar 61.1% b'Zessly u 63.5% b'Remicade).
English: Zessly is a ‘biosimilar medicine'.
Maltese: Zessly huwa ‘mediċina bijosimili'.
English: The reference medicine for Zessly is Remicade.
Maltese: Il-mediċina ta' referenza għal Zessly hija Remicade.
English: The most common side effects with Zessly (seen in more than 1 patient in 10) are viral infections (such as flu and cold sores), headache, upper respiratory tract infection (nose and throat infection), sinusitis (inflammation of the sinuses), nausea (feeling sick), abdominal pain (stomach ache), infusionrelated reactions and pain.
Maltese: L-effetti sekondarji l-aktar komuni b'Zessly (li dehru f'aktar minn pazjent wieħed minn kull 10) huma infezzjonijiet virali (bħall-influwenza u ponot tal-irjiħat), uġigħ ta' ras, infezzjoni fin-naħa ta' fuq talapparat respiratorju (infezzjoni fl-imnieħer u fil-gerżuma), sinusite (infjammazzjoni tas-sinus), nawżja (tħossok ma tiflaħx), uġigħ addominali (uġigħ ta' stonku), reazzjonijiet relatati mal-infużjoni u uġigħ.
English: The active substance in Zessly, infliximab, is a monoclonal antibody (a type of protein) that attaches to a substance in the body called tumour necrosis factor alpha (TNF-α).
Maltese: Is-sustanza attiva f'Zessly, infliximab, hija antikorp monoklonali (tip ta' proteina) li jeħel ma' sustanza fil-ġisem imsejħa fattur alfa ta' nekrożi tumorali (TNF-α).
English: Other information about Zessly
Maltese: Informazzjoni oħra dwar Zessly
English: • psoriatic arthritis (psoriasis with inflammation of the joints).
Maltese: • artrite psorjatika (psorjasi b'infjammazzjoni tal-ġogi).
English: What are the risks associated with Zessly?
Maltese: X'inhuma r-riskji assoċjati ma' Zessly?
English: Laboratory studies comparing Zessly with Remicade have shown that the active substance in Zessly is highly similar to that in Remicade in terms of structure, purity and biological activity.
Maltese: Studji fil-laboratorji li jqabblu Zessly ma' Remicade urew li s-sustanza attiva f'Zessly hija simili ħafna għal dik f'Remicade f'termini ta' struttura, purità u attività bijoloġika.
English: The study looked at the proportion of patients who achieved at least a 20% reduction in ACR scores (a measure of painful, swollen joints and other symptoms) after 14 weeks of treatment.
Maltese: Listudju osserva l-proporzjon ta' pazjenti li kellhom mill-inqas tnaqqis ta' 20% fil-punteġġi ACR (kejl talġogi li jikkawżaw l-uġigħ u li huma minfuħin u sintomi oħrajn) wara 14 ġimgħa ta' kura.
English: How is Zessly used?
Maltese: Kif jaħdem Zessly?
English: • ulcerative colitis (inflammation and ulcers in the lining of the gut)
Maltese: • kolite ulċerattiva (marda li tikkawża infjammazzjoni u ulċeri fir-rita tal-imsaren)
English: • Crohn's disease (disease causing inflammation of the gut)
Maltese: • marda ta' Crohn (marda li tikkawża infjammazzjoni tal-imsaren)
English: • rheumatoid arthritis (disease causing inflammation of the joints)
Maltese: • artrite rewmatojde (marda li tikkawża infjammazzjoni tal-ġogi)
English: Zessly is used mainly in adults, usually when other medicines or treatments have failed or cannot be used.
Maltese: Zessly jintuża l-aktar fl-adulti, normalment meta mediċini jew trattamenti oħrajn ma jkunux ħadmu jew ma jistgħux jintużaw.
English: After the initial doses, it is usually given once every 8 weeks.
Maltese: Wara d-dożi inizjali, normalment tingħata darba kull tmien ġimgħat.
English: Zessly is an anti-inflammatory medicine for treating the following diseases:
Maltese: Zessly huwa mediċina antiinfjammatorja għall-kura tal-mard li ġej:
English: Because Zessly is a biosimilar medicine, the studies on effectiveness and safety carried out with Remicade do not all need to be repeated for Zessly.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Zessly hija ssorveljata kontinwament.
English: The company that markets Zessly will provide an alert card for patients and educational material for prescribers, summarising the safety information about the medicine.
Maltese: Il-kumpanija li tqiegħed Zessly fis-suq sejra tipprovdi kard ta' twissija għall-pazjenti u materjal edukattiv għal min jagħti riċetta, li jiġbor fil-qosor l-informazzjoni rigward is-sigurtà dwar il-mediċina.
English: • ankylosing spondylitis (inflammation of spine causing back pain)
Maltese: • ankylosing spondylitis (infjammazzjoni tax-xewka tad-dahar li tikkawża uġigħ fid-dahar)
English: In particular, information will be provided for doctors who intend to prescribe the medicine to children with Crohn's disease or ulcerative colitis, to explain that these patients may be at an increased risk of developing infections and to remind of the importance of keeping vaccinations up to date.
Maltese: Għaldaqstant, il-fehma tal-Aġenzija kienet li, bħal fil-każ ta' Remicade, il-benefiċċju ta' Zessly huwa akbar mir-riskju identifikat u li jista' jiġi awtorizzat.
English: Zessly must not be used in patients who are hypersensitive (allergic) to infliximab, mouse proteins or any of the other ingredients of Zessly.
Maltese: Zessly m'għandux jintuża minn pazjenti li għandhom sensittività eċċessiva (allerġiċi) għal infliximab, għall-proteini tal-ġrieden jew għal kwalunkwe ingredjent ieħor ta' Zessly.
English: In addition, Zessly was as effective as Remicade in a study of 650 rheumatoid arthritis patients whose previous treatment with methotrexate alone had not worked well enough.
Maltese: Barra minn hekk, Zessly kien effettiv daqs Remicade fi studju b'650 pazjent bl-artrite rewmatojde li lkura preċedenti li kienet ingħatatilhom b'methotrexate waħdu ma kinitx ħadmet tajjeb biżżejjed.
English: By attaching to TNF-α, infliximab blocks its activity and thereby reduces inflammation and other symptoms of the diseases.
Maltese: Meta teħel mat-TNF-α, infliximab timblokka l-attività tiegħu u għaldaqstant tnaqqas l-infjammazzjoni u sintomi oħra tal-mard.
English: Studies have also shown that giving Zessly produces similar levels of the active substance in the body to giving Remicade.
Maltese: L-istudji wrew ukoll li l-għoti ta' Zessly jipproduċi livelli simili tas-sustanza attiva fil-ġisem bħall-għoti ta' Remicade.
English: Bratislava, Slovakia.
Maltese: Bratislava, Slovakkja.
English: DK-3450 Allerød Denmark
Maltese: DK-3450 Allerød Danimarka
English: bl.10, 1408 Sofia, Bulgaria
Maltese: bl.10, 1408 Sofia, Bulgarija
English: Meda AS Solvang 8
Maltese: Danimarka Meda AS Solvang 8
English: 170 09 Sverige (SWE)
Maltese: 170 09 Sverige (SWE) Svezja
English: Bruninieku 5, Riga, LV1001, Latvia
Maltese: Bruninieku 5, Riga, LV1001, Latvja
English: A. Goštauto g. 40A LT-01112 Vilnius, Lithuania
Maltese: Goštauto g. 40A LT-01112 Vilnius, Litwanja
English: 10, A - 6250 Kundl
Maltese: 10, A - 6250
English: 152 32 Halandri, Athens
Maltese: Kifissias 266, 152 32 Halandri, Athens
English: Rua Dr. António Loureiro Borges, 3
Maltese: Rua Dr. António Loureiro
English: Slovak Republic GlaxoSmithKline Slovakia sro., Galvaniho7/A, 82104
Maltese: GlaxoSmithKline Slovakia sro., Galvaniho7/A, 82104