FrancophonIA/ELRC3.0 huggingface dataset:
English: Germany bela-pharm GmbH & Co. KG Lohner Str. 19
Maltese: Il-Ġermanja bela-pharm GmbH & Co.
English: Germany Huvepharma NV Uitbreidingstraat 80
Maltese: L-Irlanda Huvepharma NV Uitbreidingstraat 80
English: Hen turkey pig cattle
Maltese: Ħnieżer Baqar Tjur
English: Tylosin and its phosphate and tartrate salts are used in food producing species for the treatment of conditions caused by sensitive organisms.
Maltese: Tylosin u l-imluħa tal-fosfat u t-tartrate tiegħu jintużaw fi speċijiet li jipproduċu l-ikel għall-kura ta' kondizzjonijiet ikkawżati minn organiżmi sensittivi.
English: The CVMP was asked to conclude on whether the duration of treatment with veterinary medicinal products containing tylosin beyond three weeks is justified and whether these products are still effective against swine dysentery caused by B. hyodysenteriae.
Maltese: Is-CVMP intalab biex jikkonkludi dwar jekk il-perjodu tal-kura bi prodotti mediċinali veterinarji li fihom tylosin għal aktar minn tliet ġimgħat huwiex ġustifikat u jekk dawn il-prodotti għadhomx effikaċi kontra diżenterija tal-majjali kkawżata minn B. hyodysenteriae.
English: Vana GmbH
Maltese: L-Awstrija
English: (EMA/CVMP/SAGAM/741087/2009) mentions with support from data from FINRES-Vet (1999) 2, SVARM
Maltese: Iddokument ta' riflessjoni tas-CVMP dwar l-użu tal-makrolidi, linkosamidi u streptogramini (MLS) flannimali li jipproduċu l-ikel fl-Unjoni Ewropea: l-iżvilupp ta' reżistenza u l-impatt fuq is-saħħa tal bniedem u l-annimali, (EMA/CVMP/SAGAM/741087/2009), isemmi b'appoġġ mid-dejta minn FINRESVet (1999) 2, SVARM (2002-2009) 3, Vyt and Hommez (2006) 4, MARAN (2008)
English: Cattle (calves), pig, chicken (broilers, future layers/breeder s), turkey
Maltese: Annimali talifrat (għoġġiela), ħnieżer, tiġieġ (brojlers, tiġieġ talbajd/tarrazza), dundjani
English: 43206 Reus (Tarragona) Spain
Maltese: REUS-VINYOLS, KM.4,1. RIUDOMS (Tarragona) Spanja
English: In case the indication(s) for a particular product do not specify swine dysentery, but do not exclude such use, the following sentence should be added to section 4.5: A high rate of in vitro resistance has been demonstrated in European strains of Brachyspira hyodysenteriae implying that the product will not be sufficiently efficacious against swine dysentery.
Maltese: F'każ li l-indikazzjoni(jiet) għal prodott partikolari ma jispeċifikaw diżenterija tal-majjali, iżda ma jeskludux tali użu, is-sentenza li ġejja għandha tiżdied mas-sezzjoni 4.5: Ġiet osservata rata għolja ta' reżistenza in vitro fir-razez Ewropej ta' Brachyspira hyodysenteriae, u dan jimplika li l-prodott mhux sejjer ikun effikaċi biżżejjed kontra d-diżenterija tal-majjali.
English: Pigs, poultry
Maltese: Tjur, ħnieżer
English: Belgium Huvepharma NV Uitbreidingstraat 80
Maltese: Il-Bulgarija Huvepharma NV Uitbreidingstraat 80
English: Denmark Huvepharma NV Uitbreidingstraat 80
Maltese: Il-Ġermanja Huvepharma NV Uitbreidingstraat 80
English: In contrast, premix formulations authorised for the treatment and prevention of ileitis (caused by Lawsonia intracellularis) most often recommend treatment for not longer than up to three weeks.
Maltese: B'kuntrast, ilformulazzjonijiet imħallta għal-lest awtorizzati għall-kura u l-prevenzjoni ta' ileite (ikkawżata minn Lawsonia intracellularis) ħafna drabi jirrakkomandaw kura għal mhux aktar minn tliet ġimgħat.
English: Lithuania Huvepharma NV Uitbreidingstraat 80
Maltese: Il-Litwanja Huvepharma NV Uitbreidingstraat 80
English: Ctra.
Maltese: Str.
English: Delete, where applicable, the indication ‘Swine dysentery caused by Brachyspira hyodysenteriae'.
Maltese: Ħassar, fejn applikabbli, l-indikazzjoni għall-kura ta' ‘Diżenterija tal-majjali kkawżata minn Brachyspira hyodysenteriae'.
English: The full EPAR for Prometax 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 12-2012.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'12-2012.
English: It is available as capsules (1.5, 3, 4.5 and 6 mg), as an oral solution (2 mg/ml), and as transdermal patches, which release either 4.6 , 9.5 or 13.3 mg rivastigmine across the skin over 24 hours.
Maltese: Jiġi f'kapsuli (1.5, 3, 4.5 u 6 mg), bħala soluzzjoni orali (2 mg/ml), u fi stikek transdermiċi, li jerħu 4.6, 9.5 jew 13.3 mg rivastigmina mill-ġilda f'24 siegħa.
English: EPAR summary for the public rivastigmine
Maltese: Sommarju tal-EPAR għall-pubbliku rivastigmina
English: The active substance in Prometax, rivastigmine, is an antidementia medicine.
Maltese: Is-sustanza attiva fi Prometax, ir-rivastigmina, hija mediċina kontra d-dimenzja.
English: Prometax is a medicine containing the active substance rivastigmine.
Maltese: Prometax huwa mediċina li fiha s-sustanza attiva rivastigmina.
English: This is a summary of the European public assessment report (EPAR) for Prometax.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Prometax.
English: The capsules have been studied in 2,126 patients in three main studies, and the transdermal patches in one main study involving 1,195 patients.
Maltese: Il-kapsuli ġew studjati fuq 2,126 pazjent fi tliet studji ewlenin, filwaqt li l-istikk transdermiku ġie eżaminat fi studju ewlieni li involva 1,195 pazjent.
English: The starting dose is 1.5 mg twice a day.
Maltese: Id-doża inizjali hija 1.5 mg darbtejn kuljum.
English: An additional study in 27 patients was used to show that Prometax capsules and oral solution produced similar levels of the active substance in the blood.
Maltese: Intuża studju ieħor fuq 27 pazjent biex juri li l-kapsuli u s-soluzzjoni orali Prometax ipproduċew livelli simili tas-sustanza attiva fid-demm.
English: For the global score, patients taking Prometax capsules had in increase in symptoms of 4.1 points, compared with 4.4 in those taking placebo.
Maltese: Kwantu għall punteġġ globali, il-pazjenti ttrattati bil-kapsuli Prometax kellhom żieda fis-sintomi ta' 4.1 punti apparagun ma' 4.4 punti rreġistrati fil-pazjenti ttrattati bil-plaċebo.
English: Prometax is used for the treatment of patients with mild to moderately severe Alzheimer's dementia, a progressive brain disorder that gradually affects memory, intellectual ability and behaviour.
Maltese: Prometax jintuża fit-trattament ta' pazjenti b'dimenzja tat-tip Alzheimer minn ħafifa għal moderatament gravi, li hija tip ta' disturb tal-moħħ progressiv li jolqot gradwalment il-memorja, labilità intellettwali u l-imġiba.
English: Prometax capsules have also been studied in 541 patients with dementia due to Parkinson's disease.
Maltese: Il-kapsuli Prometax ġew studjati fuq 541 pazjent b'dimenza kkaġunata mill-marda ta' Parkinson.
English: This was compared with an increase of 2.6 points from 22.5 in the patients taking placebo.
Maltese: Dan tqabbel ma' żieda ta' 2.6 punti rreġistrati minn 22.5 fil-pazjenti ttrattati bi plaċebo mill-valur inizjali.
English: The CHMP concluded that Prometax has a modest effectiveness in treating the symptoms of Alzheimer's dementia, although this does reflect an important benefit in some patients.
Maltese: Is-CHMP ikkonkluda li Prometax għandu effikaċja modesta fit-trattament tas-sintomi tad-dimenzja ta' Alzheimer, minkejja li dan tabilħaqq iġib benefiċċju importanti lil uħud mill-pazjenti.
English: The capsules and oral solution can also be used to treat mild to moderately severe dementia in patients with Parkinson's disease.
Maltese: Il-kapsuli u s-soluzzjoni orali jistgħu wkoll jintużaw fit-trattament ta' dimenzja minn ħafifa sa moderatament gravi fuq pazjenti bil-marda ta' Parkinson.
English: What is the risk associated with Prometax?
Maltese: X'inhu r-riskju assoċjat ma' Prometax?
English: In the three studies of Prometax capsules in patients with Alzheimer's dementia, patients taking doses of Prometax between 6 and 9 mg per day had an average increase in cognitive symptoms of 0.2 points from a baseline of 22.9 points at the start of the study, where a lower score indicates better performance.
Maltese: Fit-tliet studji li saru fuq ilkapsuli Prometax fil-pazjenti bid-dimenzja ta' Alzheimer, il-pazjenti li ħadu dożi ta' Prometax ta' bejn 6 u 9 mg kuljum kellhom żieda medja ta' 0.2 punti fis-sintomi konjittivi, mill-valur inizjali ta' 22.9 punti tal-bidu tal-istudju; aktar ma jkun baxx ikun il-punteġġ, aħjar ikun tajjeb ir-riżultat.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Prometax on 4 December 1998.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq lil Prometax valida fl-Unjoni Ewropea kollha fl-4 ta' Diċembru 1998.
English: In patients who tolerate this dose, it can be increased in 1.5 mg steps no more frequently than every two weeks, to a regular dose of 3 to 6 mg twice a day.
Maltese: Il-pazjenti li jittolleraw din id-doża, tista' tiżdidilhom 1.5 mg wara 1.5 mg, iżda mhux iżjed spiss minn kull ġimagħtejn, sakemm tintlaħaq doża regolari ta' 3-6 mg darbtejn kuljum.
English: The Committee initially concluded that for the treatment of dementia due to Parkinson's disease, Prometax's benefits did not outweigh its risks.
Maltese: Għall-ewwel, ilKumitat ikkonkluda li, għat-trattament tad-dimenzja dovuta għall-marda ta' Parkinson, il-benefiċċji ta' Prometax ma kinux ogħla mir-riskji tiegħu.
English: What is Prometax?
Maltese: X'inhu Prometax?
English: Rivastigmine works by blocking the enzymes that break down acetylcholine: acetylcholinesterase and butyrylcholinesterase.
Maltese: Ir-rivastigmina taħdem billi timblokka l-enzimi li jkissru l-aċetilkolina: l-aċetilkolinesterażi u l-butirilkolinesterażi.
English: Prometax must also not be used in patients who are suspected to have had in the past a severe allergic reaction called ‘allergic contact dermatitis' to Prometax patch.
Maltese: Prometax ma għandux jintuża minn pazjenti li dwarhom ikun hemm suspett li fl-imgħoddi seta' kellhom reazzjonijiet allerġiċi severi msejħa ‘dermatite allerġika tal-kuntatt' għall-istikk Prometax.
English: Why has Prometax been approved?
Maltese: Għaliex ġie approvat Prometax?
English: In patients with Alzheimer's dementia or dementia due to Parkinson's disease, certain nerve cells die in the brain, resulting in low levels of the neurotransmitter acetylcholine (a substance that allows nerve cells to communicate with each other).
Maltese: Fil-pazjenti b'dimenzja tat-tip Alzheimer jew b'dimenzja kkaġunata mill-marda ta' Parkinson ċerti ċelluli nervużi tal-moħħ imutu, u dan jikkawża livelli baxxi tan-newrotrażmettitur aċetilkolina (sustanza kimika li tippermetti ċ-ċelluli nervużi jikkomunikaw ma' xulxin).
English: Prometax has been studied in mild to moderately severe Alzheimer's disease.
Maltese: Prometax ġie studjat fil-marda ta' Alzheimer minn ħafifa għal moderatament gravi.
English: The patients with dementia due to Parkinson's disease taking Prometax capsules showed an improvement in cognitive symptoms of 2.1 points, compared with a worsening of 0.7 points in those taking placebo, from a baseline of around 24 points.
Maltese: Ilpazjenti li jbatu minn dimenzja dovuta għall-marda ta' Parkinson ittrattati b' kapsuli ta' Prometax urew titjib tas-sintomi konjittivi ta' 2.1 punti meta mqabbla mal-aggravar ta' 0.7 punti osservat fil-pazjenti li ħadu l-plaċebo, minn valur inizjali ta' madwar 24 punt.
English: Prometax was more effective than placebo at controlling symptoms.
Maltese: Irriżulta li Prometax kien aktar effikaċi mill-plaċebo fil-kontroll tas-sintomi.
English: By blocking these enzymes, Prometax allows levels of acetylcholine to be increased in the brain, helping to reduce the symptoms of Alzheimer's dementia and dementia associated with Parkinson's disease.
Maltese: Billi jimblokka dawn l-enzimi, Prometax jippermetti żieda fil-livelli tal-aċetilkolina fil-moħħ, u għaldaqstant jgħin fit-tnaqqis tassintomi tad-dimenzja tat-tip Alzheimer u tad-dimenzja assoċjata mal-marda ta' Parkinson.
English: See the summary of product characteristics (also part of the EPAR) for detailed information.
Maltese: Ara ssommarju tal-karatteristiċi tal-prodott (ukoll parti mill-EPAR) għal informazzjoni dettaljata.
English: Treatment with Prometax should be initiated and supervised by a doctor who has experience in the diagnosis and treatment of Alzheimer's disease or dementia in patients with Parkinson's disease.
Maltese: It-trattament bi Prometax għandu jiġi mibdi u ssorveljat minn tabib li jkollu l-esperjenza fid-dijanjożi u fit-trattament tal-marda ta' Alzheimer jew tad-dimenzja fuq pazjenti bil-marda ta' Parkinson.
English: The capsules should be swallowed whole.
Maltese: Il-kapsuli għandhom jinbelgħu sħaħ.
English: Other information about Prometax
Maltese: Aktar tagħrif dwar Prometax
English: How has Prometax been studied?
Maltese: Kif ġie studjat Prometax?
English: The types of side effects seen with Prometax depend on the type of dementia it is being used to treat and whether the capsules, oral solution or transdermal patches are used.
Maltese: It-tipi ta' effetti sekondarji osservati bl-użu ta' Prometax jiddependu mit-tip ta' dimenzja li tkun qed tiġi ttrattata u minn jekk ikunx qed jintużaw il-kapsuli, is-soluzzjoni orali jew l-istikk transdermiku.
English: The main measures of effectiveness were the change in symptoms in two main areas: cognitive (the ability to think, learn and remember) and global (a combination of several areas including general function, cognitive symptoms, behaviour and the ability to carry out everyday activities).
Maltese: Il-kejl ewlieni tal-effikaċja kien il-bidla fis-sintomi f'żewġ oqsma prinċipali: konjittiv (il-ħila tal-ħsieb, tat-tagħlim u tal-ftakir) u globali (taħlita ta' bosta oqsma fosthom ilfunzjonament ġenerali, is-sintomi konjittivi, l-imġiba u l-kapaċità li jsiru l-attivitajiet ta' kuljum).
English: The company that makes Prometax must ensure that all doctors who intend to prescribe Prometax transdermal patch receive an information pack containing instructions to be given to patients and caregivers on how to use the patch safely as well as a reminder card for patients and caregivers that contains key information on how to use the patch and allows them to record the application and removal of patches.
Maltese: Prometax f'kapsuli jew f'soluzzjoni orali għandhom jingħataw darbtejn kuljum, mal-ikla ta' filgħodu jew ma' dik ta' filgħaxija.
English: The full EPAR for Amgevita can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: L-EPAR sħiħ u s-sommarju għal Amgevita jinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: In the rheumatoid arthritis study, response was measured as a 20% or more improvement in symptom score after 24 weeks of treatment: 75% of those given Amgevita responded, compared with 72% of those given Humira.
Maltese: Fl-istudju tal-artrite rewmatika, ir-rispons tkejjel bħala titjib ta' 20 % jew aktar fil-punteġġ tas-sintomi wara 24 ġimgħa ta' kura: 75 % ta' dawk li ngħataw Amgevita rrispondew, meta mqabbel ma' 72 % ta' dawk li ngħataw Humira.
English: The reference medicine for Amgevita is Humira.
Maltese: Il-mediċina ta' referenza għal Amgevita hija Humira.
English: Why is Amgevita approved?
Maltese: Għaliex ġie approvat Amgevita?
English: Amgevita contains the active substance adalimumab and is a ‘biosimilar medicine'.
Maltese: Amgevita fih is-sustanza attiva adalimumab u huwa ‘mediċina bijosimili'.
English: Other rare serious side effects (seen in between 1 in 10,000 and 1 in 1,000 patients) include failure of bone marrow to produce blood cells, disorder of the nerves, lupus and lupus-like conditions (where the immune system attacks the patient's own tissues, causing inflammation and organ damage), and Stevens-Johnson syndrome (a serious skin condition).
Maltese: Effetti sekondarji serji rari oħrajn (li dehru f'bejn 1 minn kull 10,000 pazjent u 1 minn kull 1,000 pazjent) jinkludu insuffiċjenza tal-mudullun biex jipproduċi ċelluli tad-demm, disturb tannervituri, lupus u kondizzjonijiet simili għal-lupus (meta s-sistema immuni tattakka t-tessuti talpazjent innifsu, u b'hekk tikkawża infjammazzjoni u ħsara fl-organi), u s-sindrome ta' Stevens-Johnson (kondizzjoni serja tal-ġilda).
English: The medicine has been shown to have similar effects to Humira in one main study involving 526 patients with moderate to severe rheumatoid arthritis that had not responded adequately to methotrexate, and in another main study in 350 patients with moderate to severe psoriasis.
Maltese: Il-mediċina wriet li għandha effetti simili għal ta' Humira fi studju ewlieni wieħed li involva 526 pazjent b'artrite rewmatika moderata sa severa li ma kinux irrispondew b'mod adegwat għal methotrexate, u fi studju ewlieni ieħor f'350 pazjent bi psorjasi moderata għal severa.
English: This is a summary of the European public assessment report (EPAR) for Amgevita.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Amgevita.
English: What are the risks associated with Amgevita?
Maltese: X'inhuma r-riskji assoċjati ma' Amgevita?
English: • hidradenitis suppurativa (acne inversa), a chronic skin disease that causes lumps, abscesses
Maltese: • idradenite suppurativa (akne inversa), marda tal-ġilda kronika li tikkawża boċċi, axxessi (ġbir ta'
English: The active substance in Amgevita, adalimumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to a chemical messenger in the body called tumour necrosis factor (TNF).
Maltese: Is-sustanza attiva f'Amgevita, adalimumab, hija antikorp monoklonali (tip ta' proteina) li tfasslet biex tagħraf u teħel ma' messaġġier kimiku fil-ġisem imsejjaħ fattur tan-nekrożi tumorali (TNF, tumour necrosis factor).
English: Extensive laboratory studies comparing Amgevita with Humira have shown that adalimumab in Amgevita is highly similar to adalimumab in Humira in terms of chemical structure, purity and biological activity.
Maltese: Studji estensivi fil-laboratorju li qabblu Amgevita ma' Humira wrew li adalimumab f'Amgevita huwa simili ħafna għal adalimumab f'Humira f'termini ta' struttura kimika, purità u attività bijoloġika.
English: • axial spondyloarthritis (inflammation of the spine causing back pain), including ankylosing spondylitis and when there is no damage on X-ray but clear signs of inflammation
Maltese: • axial spondyloarthritis (infjammazzjoni tas-sinsla li tikkawża uġigħ fid-dahar), inkluż ankylosing spondylitis u fejn ma jkun hemm l-ebda ħsara fuq ir-raġġi X iżda sinjali ċari ta' infjammazzjoni
English: weeks, there was an 81% improvement in symptom score with Amgevita compared with an 83% improvement with Humira.
Maltese: Fl-istudji tal-psorjasi, li ħares lejn il-grad ta' titjib wara 16-il ġimgħa, kien hemm titjib ta' 81 % fil-punteġġ tas-sintomi b'Amgevita meta mqabbel ma' titjib ta' 83 % b'Humira.
English: Other information about Amgevita
Maltese: Kif jintuża Amgevita?
English: • rheumatoid arthritis (a disease causing inflammation of the joints)
Maltese: • artrite rewmatika (marda li tikkawża infjammazzjoni tal-ġogi)
English: • polyarticular juvenile idiopathic arthritis and active enthesitis-related arthritis (both rare diseases causing inflammation in the joints)
Maltese: • artrite idjopatika ġuvenili poliartikulari u artrite relatata ma' entesite attiva (it-tnejn li huma mard rari li jikkawżaw infjammazzjoni tal-ġogi)
English: • ulcerative colitis (a disease causing inflammation and ulcers in the lining of the gut)
Maltese: • kolite ulċerattiva (marda li tikkawża infjammazzjoni u ulċeri fir-rita tal-imsaren)
English: This means that Amgevita is highly similar to a biological medicine (also known as the ‘reference medicine') that is already authorised in the European Union (EU).
Maltese: Dan ifisser li Amgevita huwa simili għal mediċina bijoloġika (magħrufa wkoll bħala l-‘mediċina ta' referenza') li diġà hija awtorizzata fl-Unjoni Ewropea (UE).
English: • Crohn's disease (a disease causing inflammation of the gut)
Maltese: • marda ta' Crohn (marda li tikkawża infjammazzjoni tal-imsaren)
English: The most common side effects with adalimumab (seen in more than 1 patient in 10) are infections in the nose and throat, sinuses and upper respiratory tract, injection site reactions (redness, itching, bleeding, pain or swelling), headache and muscle and bone pain.
Maltese: L-effetti sekondarji l-aktar komuni b'adalimumab (li dehru f'aktar minn 1 minn kull 10) huma infezzjonijiet fl-imnieħer u fil-griżmejn, fis-sinus u fin-naħa ta' fuq tal-passaġġ respiratorju, reazzjonijiet fis-sit tal-injezzjoni (ħmura, ħakk, dmija, uġigħ jew nefħa), uġigħ ta' ras u uġigħ filmuskolu u fl-għadam.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU requirements for biosimilar medicines, Amgevita has a highly similar structure, purity and biological activity to Humira and is distributed in the body in the same way.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija ddeċieda li, b'mod konformi mar-rekwiżiti tal-UE għal mediċini bijosimili, Amgevita għandu struttura, purità u attività bijoloġika simili ħafna għal Humira u jiġi distribwit fil-ġisem bl-istess mod.
English: By attaching to TNF, adalimumab blocks its activity, thereby reducing inflammation and other symptoms of the diseases.
Maltese: Meta teħel mat-TNF, adalimumab timblokka l-attività tiegħu, għaldaqstant tnaqqas l-infjammazzjoni u sintomi oħrajn tal-mard.
English: • non-infectious uveitis (inflammation of the layer beneath the white of the eyeball).
Maltese: • uvejtite mhux infettiva (infjammazzjoni tas-saff ta' wara l-abjad tal-boċċa tal-għajn).
English: For the full list of restrictions with Amgevita, see the package leaflet.
Maltese: Għal-lista sħiħa ta' restrizzjonijiet b'Amgevita, ara l-fuljett ta' tagħrif.
English: The company that markets Amgevita must provide educational packs for doctors who will prescribe the medicine.
Maltese: Il-kumpanija li tqiegħed Amgevita fis-suq għandha tipprovdi pakketti edukattivi lit-tobba li ser jippreskrivu l-mediċina.
English: All these data were considered sufficient to conclude that Amgevita will behave in the same way as Humira in terms of effectiveness and safety in its approved indications.
Maltese: Din id-dejta kollha kienet meqjusa biżżejjed sabiex jiġi konkluż li Amgevita ser jaġixxi bl-istess mod bħal Humira f'termini ta' effettività u sigurtà flindikazzjonijiet approvati tiegħu.
English: • psoriatic arthritis (a disease causing red, scaly patches on the skin with inflammation of the joints)
Maltese: • artrite psorjatika (marda li tikkawża rqajja' ħomor, bil-qxur fuq il-ġilda b'infjammazzjoni tal-ġogi)
English: Amgevita and other medicines of its class may also affect the ability of the immune system to fight off infections and cancer, and there have been some cases of serious infections and blood cancers in patients using adalimumab.
Maltese: Amgevita u mediċini oħrajn tal-klassi tiegħu jistgħu jaffettwaw ukoll l-abbiltà tas-sistema immuni li tiġġieled l-infezzjonijiet u l-kanċer, u kien hemm xi każijiet ta' infezzjonijiet serji u ta' kanċers taddemm f'pazjenti li kienu qed jużaw adalimumab.
English: How is Amgevita used?
Maltese: Kif jaħdem Amgevita?
English: Prof János Borvendég (HU)
Maltese: Profs János Borvendég (HU)
English: Article 30 of Directive 2001/83/EC as amended, referral on the grounds of divergent decisions adopted by member States
Maltese: Artikolu 30 tad-Direttiva 2001/83/KE kif emendata, referenza abbażi ta' deċiżjonijiet diverġenti adottati millIstati Membri
English: Ref. EMEA/CHMP/233264/2009
Maltese: EMEA/202971/2009
English: Dr Ian Hudson (UK)
Maltese: It-tabib Ian Hudson (UK)
English: London, 18 March 2009 Doc.
Maltese: Londra, 18 ta' Marzu 2009 Dok ta' Ref.