FrancophonIA/ELRC3.0 huggingface dataset:
English: Glyxambi must not be used in people who are hypersensitive (allergic) to empagliflozin, linagliptin, any of the other ingredients or who have ever had a serious allergic reaction to any DPP-4 or SGLT2 inhibitor.
Maltese: Glyxambi ma għandux jintuża f'nies li huma ipersensittivi (allerġiċi) għal empagliflozin, linagliptina, kwalunkwe wieħed mill-ingredjenti l-oħra jew li xi darba kellhom reazzjoni allerġika serja għal kwalunkwe inibitur DPP-4 jew SGLT2.
English: Patients switching from empagliflozin and linagliptin to Glyxambi should receive the strength of Glyxambi that corresponds to the doses of empagliflozin and linagliptin in the separate tablets they were taking.
Maltese: Dan jispjega kif l-Aġenzija vvalutat il-mediċina biex tirrakkomanda l-awtorizzazzjoni tagħa fl-UE u l-kondizzjonijiet ta' użu tagħha.
English: Glyxambi is a diabetes medicine used in adults with type 2 diabetes to improve control of their blood glucose (sugar) levels.
Maltese: Glyxambi huwa mediċina kontra d-dijabete li tintuża f'adulti b'dijabete tat-tip 2, sabiex ittejjeb ilkontroll tal-livelli tal-glukożju (zokkor) fid-demm tagħhom.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Glyxambi's benefits are greater than its risks and recommended that it be approved for use in the EU.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija ddeċieda li l-benefiċċji ta' Glyxambi huma akbar mir-riskji tiegħu u rrakkomanda li jkun approvat għall-użu fl-UE.
English: It is not known if the risk of VTE with DNG/EE is better or worse than that of the combined oral contraceptives containing levonorgestrel (5-7 per 10,000 women), etonorgestrel (6-12 per 10,000 women) or drospirenone (9-12 per 10,000 women as compared to 2 out of 10,000 women who do not use a combined hormonal contraceptive).
Maltese: Mhux magħruf jekk ir-riskju ta' VTE b'DNG/EE huwiex aħjar jew agħar minn dak tal-kontraċettivi orali kkombinati li jkun fihom levonorgestrel (5-7 għal kull 10,000 mara), etonorgestrel (6-12 għal kull 10,000 mara) jew drospirenone (912 għal kull 10,000 mara meta mqabbel ma' 2 minn 10,000 mara li ma jużawx kontraċettiv ormonali kkombinat).
English: Ethinylestradiol is a synthetic estrogen while dienogest is a nortestosterone derivative which uniquely contains a cyanomethyl group at position 17α.
Maltese: Etinilestradjol huwa estroġenu sintetiku waqt li dienogest huwa derivattiv tan-nortestosteron li unikament fih grupp ta' cyanomethyl f'pożizzjoni 17α.
English: Dienogest shows antiandrogenic properties, 10-30 fold lower affinity to progesterone receptor in vitro as compared to other synthetic progestogens.
Maltese: Dienogest juri karatteristiċi antiandroġeniċi, affinità ta' 10-30 darba aktar baxxa għar-riċettur ta' proġesteron in vitro meta mqabbel ma' proġestoġeni sintetiċi oħra.
English: • The CHMP considered the procedure under Article 31 of Directive 2001/83/EC for medicines containing dienogest (DNG) 2 mg and ethinylestradiol (EE) 0.03 mg for moderately severe acne in women in whom topical treatment was ineffective.
Maltese: • Is-CHMP ikkunsidra l-proċedura skont l-Artikolu 31 tad-Direttiva 2001/83/KE għal mediċini li fihom 2 mg dienogest (DNG) u 0.03 mg etinilestradijol (EE) għal akne severa b'mod moderat fin-nisa li fihom il-kura topika ma kinitx effettiva.
English: • The CHMP considered the totality of the available clinical studies, published literature and postmarketing experience, including responses from marketing authorisation holders (MAHs) on the efficacy of DNG/EE in the treatment of acne, and on the safety of these medicines, in particular regarding the risk of venous thromboembolic events (VTE) and arterial thromboembolic events (ATE).
Maltese: • Is-CHMP ikkunsidra t-totalità tal-istudji kliniċi disponibbli, il-letteratura ppubblikata u lesperjenza ta' wara t-tqegħid fis-suq, inkluż risponsi mid-detenturi tal-awtorizzazzjoni għattqegħid fis-suq (MAHs) dwar l-effikaċja ta' DNG/EE fil-kura tal-akne, u dwar is-sigurtà ta' dawn il-mediċini, b'mod partikolari dwar ir-riskju ta' avvenimenti tromboemboliċi fil-vini (VTE) u ta' avvenimenti tromboemboliċi fl-arterji (ATE).
English: Dienogest does not have significant androgen, mineralocorticoid or glucocorticoid effects in vivo.
Maltese: Dienogest m'għandux effetti sinifikanti ta' androġenu, mineralokortikojde jew glukokortikojde in vivo.
English: Combined oral contraceptives (COCs) are thought to improve acne by several mechanisms.
Maltese: Il-kontraċettivi orali kkombinati (COCs, combined oral contraceptives) huma maħsuba li jtejbu l-akne b'diversi mekkaniżmi.
English: The risk of venous thromboembolic events (VTE) and arterial thromboembolic events (ATE) is of particular importance as to date there is insufficient data to clearly determine the relative risk for thromboembolic events compared to other combined hormonal contraceptives containing other progestogens.
Maltese: Ir-riskju ta' avvenimenti tromboemboliċi fil-vini (VTE) u ta' avvenimenti tromboemboliċi fl-arterji (ATE, arterial thromboembolic events) huwa ta' importanza partikolari peress li s'issa m'hemmx biżżejjed data biex jiġi ddeterminat b'mod ċar ir-riskju relattiv għal avvenimenti tromboemboliċi meta mqabbla ma' kontraċettivi ormonali kkombinati oħra li fihom proġestoġeni oħra.
English: The phase III clinical studies showed that predominantly moderate acne vulgaris dominated in the studies.
Maltese: III wrew li akne vulgaris moderata b'mod predominanti ddominat fl-istudji.
English: • The CHMP considered that the efficacy of medicines containing dienogest 2 mg and ethinylestradiol 0.03 mg in the treatment of moderately severe acne in women in whom topical treatment or oral antibiotic was ineffective is well supported by phase III clinical trial data and further supported by a Cochrane review of combined oral contraceptive pills for treatment of acne.
Maltese: • Is-CHMP ikkunsidra li l-effikaċja ta' mediċini li fihom 2 mg dienogest u 0.03 mg etinilestradijol fil-kura tal-akne severa b'mod moderat f'nisa li fihom, il-kura topika jew l-antibijotiku orali ma kinux effettivi hi appoġġjata tajjeb mid-data tal-prova klinika tal-fażi
English: The available safety data confirmed that the adverse event (AE) profile of DNG/EE and the comparator products in the phase III trials is very similar, with none of the safety parameters raising any concerns.
Maltese: Id-data tas-sigurtà disponibbli kkonfermat li l-profil tal-avvenimenti avversi (AE, adverse event) ta' DNG/EE u l-prodotti komparaturi fil-provi tal-fażi
English: At the time of triggering the referral, the UK considered that the benefit-risk analysis for the acne indication was not favourable based on insufficient data on the efficacy of the combination in the acne indication, an unacceptable safety profile, in particular regarding to the risk of venous thromboembolic events (VTE) and the fact that the target population covered by the abovementioned indication is broad and would unnecessarily expose women to a treatment with limited efficacy and to a potential higher risk of VTE when alternative and safer options for the treatment of acne are available.
Maltese: Fiż-żmien tal-bidu tar-riferiment, ir-Renju Unit ikkunsidra li l-analiżi benefiċċju/riskju għall-indikazzjoni tal-akne ma kinitx favorevoli abbażi ta' data insuffiċjenti dwar l-effikaċja tat-taħlita fl-indikazzjoni talakne, profil tas-sigurtà inaċċettabbli, b'mod partikolari rigward ir-riskju ta' avvenimenti tromboemboliċi fil-vini (VTE, venous thromboembolic events) u l-fatt li l-popolazzjoni fil-mira koperta mill-indikazzjoni msemmija hawn fuq hija wiesgħa u tkun qed tesponi bla bżonn lin-nisa għal kura b'effikaċja limitata u għal riskju ogħla potenzjali ta' VTE meta hemm disponibbli opzjonijiet alternattivi u aktar siguri għallkura tal-akne.
English: Considering the nature of the disorder, the observed benefits and the relative risks compared to available treatment alternatives and guideline recommendations, local therapies or oral antibiotic treatment should be tried first before resorting to a COC.
Maltese: Meta tiġi kkunsidrata n-natura tad-disturb, il-benefiċċji osservati u r-riskji relattivi meta mqabbla malalternattivi tal-kura disponibbli u r-rakkomandazzjonijiet tal-linji gwida, qabel wieħed jirrikorri għal COC, l-ewwel għandhom jiġu ppruvati terapiji lokali jew kura antibijotika orali.
English: • The CHMP noted that the risk of VTE with dienogest containing combined hormonal contraceptive is not yet fully characterised.
Maltese: • Is-CHMP innota li r-riskju ta' VTE ma' kontraċettiv ormonali kkombinat li jkun fih dienogest għadu mhuwiex ikkaratterizzat b'mod sħiħ.
English: “Treatment of acne with moderate severity in women without contraindications for oral contraceptives and in whom topical treatment was ineffective”.
Maltese: “Kura tal-akne b'severità moderata f'nisa mingħajr kontraindikazzjonijiet għal kontraċettivi orali u li fihom il-kura topika ma kinitx effettiva”.
English: This is in line with the current treatment guidelines which state that combined oral contraceptives (COCs) are not indicated in mild acne, but are considered as treatment alternatives in females with moderate to severe acne.
Maltese: Dan hu f'konformità mal-linji gwida ta' kura attwali li jiddikjaraw li kontraċettivi orali kkombinati (COCs) mhumiex indikati f'akne ħafifa, iżda huma kkunsidrati bħala alternattivi talkura f'nisa b'akne moderata sa severa.
English: In view of the above and the necessity to take an action at EU level, UK considered that it was in the interest of the Union to refer the matter to the CHMP and requested on the 18 February 2016, that it give its opinion under Article 31 of Directive 2001/83/EC as to whether marketing authorisations of these products in the abovementioned indication should be maintained, varied, suspended, or revoked in relation to the below indication:
Maltese: Fid-dawl ta' dan ta' hawn fuq u l-bżonn li tittieħed azzjoni fil-livell tal-UE, ir-Renju Unit ikkunsidra li kien fl-interess tal-Unjoni li l-kwistjoni tiġi rreferuta lis-CHMP, u fit-18 ta' Frar 2016, talab li dan jagħti l-opinjoni tagħha skont l-Artikolu 31 tad-Direttiva 2001/83/KE dwar jekk l-awtorizzazzjonijiet għattqegħid fis-suq ta' dawn il-prodotti fl-indikazzjoni msemmija hawn fuq għandhomx jinżammu, jiġu varjati, jiġu sospiżi jew jiġu rrevokati fir-rigward tal-indikazzjoni ta' hawn taħt:
English: In view of the most prominent effect on acne seen after 6 months of treatment, paired with the still to be quantified risk of VTE, women should be assessed 3-6 months after initiating treatment and periodically thereafter to review the need for continuation of treatment.
Maltese: Fid-dawl tal-effett l-aktar prominenti tal-akne li deher wara 6 xhur ta' kura, flimkien mar-riskju ta' VTE li għad irid jiġi kkwantifikat, in-nisa għandhom jiġu vvalutati 3-6 xhur wara l-bidu tal-kura u perjodikament wara sabiex jiġi rieżaminat il-bżonn biex titkompla l-kura.
English: The contraceptive effect of this combination is based on the interaction of various effects, the most important of which are seen as the inhibition of ovulation and the changes in the cervical secretion.
Maltese: L-effett kontraċettiv ta' din it-taħlita huwa bbażat fuq l-interazzjoni ta' diversi effetti, li dawk l-aktar importanti jidhru bħala l-inibizzjoni tal-ovulazzjoni u l-bidliet fissekrezzjoni ċervikali.
English: In view of the above, the CHMP concluded that the benefit-risk balance of dienogest/ethinylestradiol containing products indicated in acne is favourable subject to changes to the product information as described above.
Maltese: Konsegwentement, is-CHMP ikkunsidra li l-bilanċ bejn il-benefiċċju u r-riskju ta' prodotti mediċinali li fihom dienogest/etinilestradijol indikati għall-akne jibqa' favorevoli soġġett għall-emendi flinformazzjoni dwar il-prodott deskritti hawn fuq.
English: • The CHMP is of the opinion that the benefits of dienogest/ethinylestradiol containing medicinal products continue to outweigh the risks in the second-line treatment of moderate acne in women who elect to use an oral contraceptive, provided that the medicinal products are only used after suitable topical therapies or oral antibiotic treatments have failed.
Maltese: • Is-CHMP huwa tal-fehma li l-benefiċċji ta' prodotti mediċinali li fihom dienogest/etinilestradijol jibqgħu jkunu akbar mir-riskji fil-kura tat-tieni linja ta' akne moderata f'nisa li jagħżlu li jużaw kontraċettiv orali, diment li l-prodotti mediċinali jintużaw biss wara li terapiji topiċi jew kuri antibijotiċi orali adatti ma jkunux ħadmu.
English: 16 December 2016 EMA/817193/2016 EMEA/H/C/004055
Maltese: EMA/817193/2016 EMEA/H/C/004055
English: Graspa was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 26 October 2006 for ALL.
Maltese: Graspa kien ikklassifikat bħala 'mediċina orfni' (mediċina li tintuża f'mard rari) fis-26 ta' Ottubru 2006 għal ALL.
English: Graspa is a cancer medicine that contains the active substance eryaspase (a version of the enzyme asparaginase enclosed in red blood cells compatible with the patient's blood group).
Maltese: Graspa huwa mediċina kontra l-kanċer li fiha s-sustanza attiva eryaspase (verżjoni tal-enzima asparaginażi li tinsab inkapsulata ġewwa ċ-ċelloli ħomor tad-demm li hija kompatibbli mal-grupp taddemm tal-pazjent).
English: Withdrawal of the marketing authorisation application for Graspa (eryaspase) EMA/817193/2016
Maltese: EMA/817193/2016
English: Withdrawal of the marketing authorisation application for Graspa (eryaspase)
Maltese: L-irtirar tal-applikazzjoni għall-awtorizzazzjoni għattqegħid fis-suq għal Graspa (eryaspase)
English: The medicine was intended for use in patients whose cancer was classed ‘Philadelphia chromosome negative' and had not responded to initial treatment, or had come back after treatment.
Maltese: Il-mediċina kienet maħsuba biex tintuża f'pazjenti li l-kanċer tagħhom kien ikklassifikat bħala ‘kromosoma Philadelphia negattiva' u ma kinux wieġbu għal kura inizjali, jew li kienu rkadew wara lkura.
English: Graspa was expected to be used in combination with other cancer medicines to treat adults and children over 1 year of age who have acute lymphoblastic leukaemia (ALL), a cancer of white blood cells.
Maltese: Graspa kien mistenni li jintuża f'kombinazzjoni ma' mediċini oħra ta' kontra l-kanċer għall-kura ta' adulti u tfal ta' aktar minn sena b'lewkimja limfoblastika akuta (ALL), kanċer taċ-ċelluli bojod taddemm.
English: The company provided data on Graspa, including the results of a main study involving 80 patients with ALL whose disease had come back after initial treatment or who had not responded to initial treatment, some of whom had an allergy to other products containing asparaginase.
Maltese: Il-kumpanija pprovdiet dejta dwar Graspa, inklużi r-riżultati ta' studju ewlieni li fih ħadu sehem 80 pazjent b'ALL li l-marda tagħhom kienet irkadiet wara l-kura inizjali jew li ma kinux irrispondew għallkura inizjali, u uħud minnhom kellhom allerġija għal prodotti oħra li fihom asparaginażi.
English: How does Graspa work?
Maltese: Kif jaħdem Graspa?
English: On 14 November 2016, Erytech Pharma SA officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Graspa, for the treatment of acute lymphoblastic leukaemia.
Maltese: Għalhekk, fiż-żmien tal-irtirar, is-CHMP kien tal-opinjoni li l-kumpanija ma kinitx ipprovdiet biżżejjed informazzjoni biex tappoġġja l-applikazzjoni għal Graspa.
English: In its letter notifying the Agency of the withdrawal of the application, the company stated that it was withdrawing the application because the additional data the CHMP considered necessary to support the application could not be obtained in the time available.
Maltese: Fl-ittra li bagħtet lill-Aġenzija biex tgħarrafha bl-irtirar tal-applikazzjoni, il-kumpanija sostniet li kienet qed tirtira l-applikazzjoni għaliex id-dejta addizzjonali li s-CHMP qies bħala meħtieġa biex issostni lapplikazzjoni ma setgħetx tinkiseb fiż-żmien disponibbli.
English: Questions and answers
Maltese: (eryaspase)
English: * efavirenz / emtricitabine / tenofovir disoproxil (as fumarate)
Maltese: * efavirenz / emtricitabine / tenofovir disoproxil (bħala fumarate)
English: Bottle (HDPE/alu) Bottle (HDPE/alu)
Maltese: Flixkun (HDPE/alu) 30 pillola miksija b'rita
English: 30 film-coated tablets
Maltese: Għamla farmaċewtika
English: Atripla Atripla
Maltese: Qawwa
English: 3 x 30 film-coated tablets
Maltese: Flixkun (HDPE/alu) 3 x 30 pillola miksija b'rita
English: Film-coated tablet Film-coated tablet
Maltese: Daqs tal-pakkett
English: The full EPAR for Imraldi 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: Response was measured as a 20% or more improvement in symptom score after 24 weeks of treatment: 68% of those given Imraldi responded (183 of 269 patients), compared with 67% of those given Humira (184 of 273 patients).
Maltese: Ir-rispons tkejjel bħala 20% ta' titjib jew aktar fil-punteġġ tas-sintomu wara 24 ġimgħa ta' kura: 68% ta' dawk li ngħataw Imraldi rrispondew (183 minn 269 pazjent), meta mqabbla ma' 67% ta' dawk li ngħataw Humira (184 minn 273 pazjent).
English: The reference medicine for Imraldi is Humira.
Maltese: Il-mediċina ta' referenza għal Imraldi hija Humira.
English: Imraldi contains the active substance adalimumab and is a ‘biosimilar medicine'.
Maltese: Imraldi fih is-sustanza attiva adalimumab u huwa "mediċina bijosimili".
English: This is a summary of the European public assessment report (EPAR) for Imraldi.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Imraldi.
English: Other information about Imraldi
Maltese: Informazzjoni oħra dwar Imraldi
English: Other rare serious side effects (which may affect up to 1 in 1,000 people) 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 u rari oħra (li jistgħu jaffettwaw persuna 1 minn kull 1,000) jinkludu nuqqas talmudullun milli jipproduċi ċelloli tad-demm, disturb tan-nervituri, lupus u kundizzjonijiet simili għallupus (meta s-sistema immunitarja tattakka t-tessuti tal-pazjent innifsu, b'hekk tikkawża infjammazzjoni u ħsara fl-organi), u s-sindrome ta' Stevens-Johnson (kundizzjoni serja tal-ġilda).
English: Why is Imraldi approved?
Maltese: Għaliex ġie approvat Imraldi?
English: Laboratory studies comparing Imraldi with Humira have shown that the active substance in Imraldi is highly similar to that in Humira in terms of structure, purity and biological activity.
Maltese: Studji fil-laboratorju li jqabblu Imraldi ma' Humira wrew li s-sustanza attiva f'Imraldi hija simili ħafna għal dik f'Humira f'termini ta' struttura, purità u attività bijoloġika.
English: The active substance in Imraldi, 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'Imraldi, l-adalimumab, hija antikorp monoklonali (tip ta' proteina) li tfasslet biex tagħraf u teħel ma' messaġġier kimiku fil-ġisem imsejjaħ fattur ta' nekrożi tumorali (TNF).
English: What are the risks associated with Imraldi?
Maltese: X'inhuma r-riskji assoċjati ma' Imraldi?
English: This means that Imraldi 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 Imraldi huwa simili għal mediċina bijoloġika (magħrufa wkoll bħala l-'mediċina ta' referenza') li diġà hija awtorizzata fl-Unjoni Ewropea (UE).
English: For more information on biosimilar medicines, see the question-and-answer document here.
Maltese: Għal aktar informazzjoni dwar il-mediċini bijosimili, ara d-dokument dwar mistoqsijiet u tweġibiet hawnhekk.
English: In addition, a main study involving 544 patients with moderate or severe rheumatoid arthritis despite treatment with methotrexate showed that Imraldi and Humira had similar effectiveness.
Maltese: Barra minn hekk, studju ewlieni li kien jinvolvi 544 pazjent b'artrite rewmatojde moderata jew gravi minkejja kura b'metotreksat wera li Imraldi u Humira kellhom effikaċja simili.
English: The most common side effects with adalimumab (seen in more than 1 patient in 10) are infections in the nose and throat and sinuses, 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 pazjenti wieħed minn kull 10) huma infezzjonijiet fl-imnieħer u fil-griżmejn u fis-sinus, reazzjonijiet fis-sit tal-injezzjoni (ħmura, ħakk, dmija, uġigħ jew nefħa), uġigħ ta' ras u wġigħ fil-muskoli u fl-għadam.
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: • spondiloartrite aksjali (infjammazzjoni tas-sinsla li tikkawża wġigħ fid-dahar), inkluż spndilite ankilosanti u fejn ma jkun hemm l-ebda ħsara fuq ir-raġġi X iżda sinjali ċari ta' infjammazzjoni
English: Imraldi must not be used in patients with active tuberculosis or other severe infections, or in patients with moderate to severe heart failure (an inability of the heart to pump enough blood around the body).
Maltese: Imraldi ma għandux jintuża f'pazjenti b'tuberkolożi attiva jew infezzjonijiet gravi oħra, jew f'pazjenti b'insuffiċjenza kardijaka moderata sa gravi (il-qalb ma tkunx kapaċi tippompja biżżejjed demm madwar il-ġisem).
English: How is Imraldi used?
Maltese: Kif jaħdem Imraldi?
English: The company that markets Imraldi must provide educational packs for doctors who prescribe the medicine.
Maltese: Dawn il-pakketti ser jinkludu informazzjoni dwar is-sigurtà tal-mediċina.
English: For the full list of side effects and restrictions with Imraldi, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet kollha b'Imraldi, ara l-fuljett ta' tagħrif.
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Imraldi has a highly similar structure, purity and biological activity to Humira and is distributed in the body in the same way.
Maltese: L-Aġenzija Ewropea għall-Mediċini ddeċidiet li, b'mod konformi mar-rekwiżiti tal-UE għal mediċini bijosimili, Imraldi għandu struttura, purità u attività bijoloġika simili ħafna għal Humira u jiġi distribwit bl-istess mod fil-ġisem.
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-qoxra fuq il-ġilda u infjammazzjoni tal-ġogi)
English: By attaching to TNF, adalimumab blocks its activity, thereby reducing inflammation and other symptoms of the diseases.
Maltese: Meta teħel mat-TNF, l-adalimumab timblokka l-attività tiegħu, b'hekk titnaqqas linfjammazzjoni u sintomi oħra tal-mard.
English: The medicine is available as a solution for injection under the skin in a pre-filled syringe.
Maltese: Il-mediċina tiġi bħala soluzzjoni għal injezzjoni taħt il-ġilda f'siringa mimlija lesta.
English: Studies have also shown that giving Imraldi produces similar levels of the active substance in the body to giving Humira.
Maltese: Saru studji sabiex juru li l-għoti ta' Imraldi jipproduċi livelli simili tas-sustanza attiva fil-ġisem bħall-għoti ta' Humira.
English: Imraldi and other medicines of its class may 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: Imraldi u mediċini oħra tal-klassi tiegħu jistgħu wkoll jaffettwaw l-abbiltà tas-sistema immunitarja li tiġġieled l-infezzjonijiet u l-kanċer, u kien hemm xi każijiet ta' infezzjonijiet serji u kanċers tad-demm f'pazjenti li użaw l-adalimumab.