FrancophonIA/ELRC3.0 huggingface dataset:
English: • patients given Velcade with pegylated liposomal doxorubicin whose disease was getting worse after having failed to respond to at least one other treatment, lived for 9.3 months without their disease getting worse compared to 6.5 months for patients receiving Velcade alone.
Maltese: • pazjenti li ngħataw Velcade ma' doksorubiċina liposomal pegilata li l-marda tagħhom kienet qed taqleb għall-agħar wara li ma kinux irrispondew għal tal-inqas trattament wieħed ieħor, għexu 9.3 xhur mingħajr ma l-marda tagħhom marret għall-agħar meta mqabbla ma' 6.5 xhur għal pazjenti li kienu qed jieħdu Velcade waħdu.
English: Velcade is used to treat multiple myeloma, a blood cancer, in the following groups of patients:
Maltese: Velcade jintuża fil-kura ta' majeloma multipla, kanċer tad-demm, fil-gruppi ta' pazjenti li ġejjin:
English: A risk management plan has been developed to ensure that Velcade is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Velcade jintuża bl-aktar mod sigur possibbli.
English: What is Velcade?
Maltese: X'inhu Velcade?
English: How has Velcade been studied?
Maltese: Kif ġie studjat Velcade?
English: • Previously patients receiving Velcade lived for an average of 6.2 months without their disease getting worse, compared with 3.5 months in those receiving dexamethasone.
Maltese: • Pazjenti li kienu ġew kkurati qabel li jieħdu Velcade għexu medja ta' 6.2 xhur mingħajr ma l-marda tagħhom iggravat, meta mqabbla ma' 3.5 xhur f'dawk li ħadu d-deksametażon.
English: • Previously untreated patients lived for an average of 20.7 months without their disease getting worse when they received Velcade together with melphalan and prednisone, compared with 15.0 months in the patients receiving only melphalan and prednisone.
Maltese: • Pazjenti li ma kinux kkurati qabel għexu medja ta' 20.7 xhur mingħajr ma l-marda tagħhom iggravat meta ħadu Velcade flimkien mal-melfalan u l-predniżon, meta mqabbla ma' 15.
English: In this study, Velcade together with rituximab, cyclophosphamide, doxorubicin and prednisone was compared with the same combination containing another medicine, vincristine, in place of Velcade.
Maltese: F'dan listudju, Velcade flimkien ma' rituksimab, ċiklofosfamid, doksorubiċina u predniżon tqabbel mal-istess kombinazzjoni li fiha mediċina oħra, vincristine, minflok Velcade.
English: For the full list of all side effects reported with Velcade, see the package leaflet.
Maltese: Għal-lista sħiħa ta' effetti sekondarji rappurtati b'Velcade, ara l-fuljett ta' tagħrif.
English: In these patients, Velcade is used in combination with melphalan and prednisone;
Maltese: F'dawn il-pazjenti, Velcade jintuża flimkien mal-melfalan u lpredniżon;
English: In mantle cell lymphoma, patients treated with a combination of Velcade plus rituximab, cyclophosphamide, doxorubicin and prednisone lived longer without their disease getting worse (24.7 months) than those given the same combination but with vincristine in place of Velcade (14.4 months).
Maltese: Fil-limfoma taċ-ċelloli tal-“mantle”, il-pazjenti kkurati bil-kombinazzjoni ta' Velcade u rituksimab, ċiklofosfamid, doksorubiċina u predniżon għexu għal żmien itwal mingħajr ma l-marda tagħhom marret għall-agħar (24.7 xhur) minn dawk li ngħataw l-istess kombinazzjoni iżda b'vincristine minflok Velcade (14.4 xhur).
English: What is the risk associated with Velcade?
Maltese: Għal xiex jintuża Velcade?
English: Velcade 1 mg must only be given by injection into a vein, while Velcade 3.5 mg is only given either by injection into a vein or under the skin.
Maltese: Velcade 1 mg għandu jingħata biss b'injezzjoni fil-vina, filwaqt li Velcade 3.5 mg jingħata biss b'injezzjoni fil-vina jew taħt il-ġilda.
English: • adults whose disease is getting worse after at least one other treatment and who have already had, or cannot undergo, a blood stem-cell transplant.
Maltese: • adulti li l-marda tagħhom tkun qed tiggrava wara għallinqas kura waħda u li jkun diġà sarilhom, jew ma jkunx jista' jsirilhom, trapjant taċ-ċelloli staminali tad-demm.
English: • The study that compared Velcade given under the skin with Velcade given into a vein showed that the percentage of patients who responded partially or completely to treatment was the same (42%) when using either route of administration.
Maltese: • L-istudju li qabbel Velcade mogħti taħt il-ġilda ma' Velcade mogħti fil-vina wera li l-perċentwal ta' pazjenti li rrispondew parzjalment jew b'mod sħiħ kien l-istess (42%) ikun kif ikun l-mod li jingħata.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Maltese: Għal iktar informazzjoni dwar l-użu ta' Velcade, ara s-sommarju tal-karatteristiċi tal-prodott (parti wkoll mill-EPAR).
English: Dr. Gonzalo Calvo Rojas (Spain)
Maltese: Dr. Gonzalo Calvo Rojas (Spanja)
English: Ref. EMEA/CHMP/97898/2009 rev 1 EMEA/H/A-30/979
Maltese: EMEA/CHMP/97898/2009 rev1 EMEA/H/A-30/979
English: Contra-indications
Maltese: Kontraindikazzjonijiet
English: Augmentin is an antibiotic.
Maltese: Augmentin huwa antibijotiku.
English: Dr. Broich (Germany)
Maltese: Dr. Broich (Ġermanja)
English: London, 19 October 2009 Doc.
Maltese: Londra, 19 ta' Ottubru 2009 Dok. ta' Ref.
English: Company responses provided on: 2 June 2008, 17 November 2008, 19 January 2009, 23 March 2009 and 25 May 2009
Maltese: Tweġibiet tal-kumpanija pprovduti 2 ta' Ġunju 2008, 17 ta' Novembru 2008, 19 ta' Jannar 2009, 23 ta' Marzu 2009 u 25 ta' Mejju 2009
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 fuq il-bażi ta' deċiżjonijiet diverġenti adottati mill-Istati Membri
English: The ratio of amoxicillin to clavulanic acid can vary from 16:1 (one gram of amoxicillin to 62.5 mg clavulanic acid) to 2:1 (250 mg of amoxicillin to 125mg of clavulanic acid).
Maltese: Il-proporzjon ta' amoxicillin għall-aċidu klavulaniku jista' jvarja minn 16:1 (gramma ta' amoxicillin għal 62.5 mg ta' aċidu klavulaniku) sa 2:1 (250 mg ta' amoxicillin għal 125mg ta' aċidu klavulaniku).
English: The 16:1 ratio is for patients aged at least 16 years.
Maltese: Il-proporzjon ta'16:1 hija għal pazjenti li għandhom millinqas 16-il sena.
English: It is also available under other trade names, such as Augmentan, Augmentine, Clavamel, Clavamox, Clavepen, Clavulin, Clavumox, Clavurion, Neoduplamox, Noprilam, Pangamox, Penilan and Spektramox.
Maltese: Jiġi wkoll taħt ismijiet kummerċjali oħrajn, bħal Augmentan, Augmentine, Clavamel, Clavamox, Clavepen, Clavulin, Clavumox, Clavurion, Neoduplamox, Noprilam, Pangamox, Penilan u Spektramox.
English: Suitability of different types of Augmentin in EU countries
Maltese: L-addattabilità ta' tipi differenti ta' Augmentin fil-pajjiżi tal-UE
English: 21 February 2008
Maltese: 21 ta' Frar 2008
English: What is Augmentin?
Maltese: X'inhu Augmentin?
English: It can be used in the prevention of some infections.
Maltese: Jista' jintuża fil-prevenzjoni ta' xi infezzjonijiet.
English: The European Medicines Agency has completed a review of Augmentin.
Maltese: L-Aġenzija Ewropea għall-Mediċini lestiet reviżjoni ta' Augmentin.
English: Augmentin, also known as ‘coamoxiclav', contains two active substances: amoxicillin, which is an antibiotic belonging to the beta-lactam family (the same family as penicillins), and clavulanic acid, which is a ‘beta-lactamase inhibitor'.
Maltese: Augmentin, magħruf ukoll bħala ‘coamoxiclav', fih żewġ sustanzi attivi: amoxicillin, li hija antibijotiku li jappartjeni għall-familja ta' beta-lactams (l-istess familja bħall-peniċillini), u aċidu klavulaniku, li huwa ‘inibitur tal-beta-lactamase'.
English: The review was carried out under an ‘Article 30' referral
Maltese: Ir-reviżjoni saret skont referenza tal-‘Artikolu 30'1.
English: The indications (the diseases the medicine can be used to treat) for the tablets and oral suspensions depend on the ratio of the active substances and have been harmonised to include: acute bacterial sinusitis (adequately diagnosed), acute otitis media, lower respiratory tract infections (such as acute exacerbations of chronic bronchitis and community acquired pneumonia), cystitis, pyelonephritis, and skin and soft tissue infections in particular cellulites, animal bites, severe dental abscess with spreading cellulitis, and bone and joint infections.
Maltese: L-indikazzjonijiet (il-mard li jista' jiġi kkurat b'din il-mediċina) għall-pilloli u għas-sospensjonijiet orali jiddependu fuq il-proporzjon tas-sustanzi attivi u ġew armonizzati sabiex jinkludu: sinusite batterika akuta (iddijanjostikata b'mod adegwat), otite medja akuta, infezzjonijiet tal-apparat respiratorju t'isfel (bħal aggravament akut ta' bronkite kronika u pulmonite li tittieħed mill-komunità), ċistite, pajelonefrite, u infezzjonijiet tal-ġilda u tat-tessut artab b'mod partikolari ċellulite, gidmiet ta' annimali, axxessi dentali severa b'tixrid ta' ċellulite, u ta' infezzjonijiet tal-għadam u tal-ġogi.
English: • infections of the respiratory tract (airways and lungs) such as tonsillitis, sinusitis, otitis media
Maltese: • infezzjonijiet tal-apparat respiratorju (passaġġi tal-arja u pulmuni) bħal tonsillite, sinusite, otite medja (infezzjoni tal-widna tan-nofs), aggravament (flare up) ta' bronkite u pulmonite;
English: Augmentin is authorised in the EU via national procedures.
Maltese: Augmentin huwa awtorizzat fl-UE permezz ta' proċeduri nazzjonali.
English: Questions and answers on the referral for Augmentin (amoxicillin and clavulanic acid)
Maltese: Mistoqsijiet u tweġibiet dwar ir-referenza għal Augmentin (amoxicillin u aċidu klavulaniku)
English: • infections of the urinary tract (the structures that carry urine in the body);
Maltese: • infezzjonijiet tal-passaġġ urinarju (l-istrutturi li jġorru l-urina fil-ġisem);
English: The CHMP recommended that the indication of tonsillitis for Augmentin be removed.
Maltese: Is-CHMP rrakkomanda li titneħħa l-indikazzjoni tat-tonsillite għal Augmentin.
English: The CHMP harmonised the information in the SPC on the potential interaction of Augmentin with other medicines, and with some laboratory tests.
Maltese: Is-CHMP armonizza t-tagħrif fl-SPC dwar l-effett potenzjali ta' mediċini oħrajn, u ta' xi testijiet tallaboratorju fuq Augmentin.
English: The Committee harmonised the contra-indications for Augmentin to two contra-indications: in case of hypersensitivity to penicillins, or allergic reaction to other beta-lactam antibiotics, and in case of jaundice or liver problems previously caused by amoxicillin/clavulanic acid.
Maltese: Il-Kumitat armonizza l-kontraindikazzjonijiet għal Augmentin għal żewġ kontraindikazzjonijiet: f'każ ta' ipersensittività għall-peniċillini, jew reazzjoni allerġika għal antibijotiċi beta-lactam oħrajn, u f'każ ta' suffejra jew problemi tal-fwied preċedenti kkawżati mill-amoxicillin/aċidu klavulaniku.
English: Tablets containing amoxicillin and clavulanic acid as a 16:1 ratio should only be used for the treatment of community-acquired pneumonia that is likely to have been caused by penicillin-resistant Streptococcus pneumoniae.
Maltese: Pilloli li fihom amoxicillin u aċidu klavulaniku bħala proporzjon ta' 16:1 għandhom jintużaw biss għall-kura ta' pulmonite li tittieħed mill-komunità li x'aktarx tkun ġiet ikkawżata minn Streptococcus pneumoniae reżistenti għall-peniċillina.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that there is a need to harmonise the prescribing information for Augmentin in the European Union (EU).
Maltese: Il-Kumitat tal-Aġenzija għal Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) ikkonkluda li hemm bżonn li tiġi armonizzata linformazzjoni ta' preskrizzjoni għal Augmentin fl-Unjoni Ewropea (UE).
English: Augmentin is available as tablets, oral suspensions and solutions for injections or infusion (drip into vein).
Maltese: Augmentin jiġi f'pilloli, sospensjonijiet orali u soluzzjonijiet għall-injezzjonijiet jew għall-infużjoni (dripp fil-vina).
English: When Augmentin is absorbed in the body, the amoxicillin component kills the bacteria that are causing the infection, while the clavulanic acid component blocks an enzyme, betalactamase that enable the bacteria to destroy amoxicillin.
Maltese: Meta Augmentin jiġi assorbit fil-ġisem, ilkomponent tal-amoxicillin joqtol il-batterji li jkunu qegħdin jikkawżaw l-infezzjoni, filwaqt li lkomponent tal-aċidu klavulaniku jimblokka enzima, betalactamase li jippermetti lill-batterji jeqirdu lamoxicillin.
English: On 28 January 2008, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Augmentin in the EU.
Maltese: Fit-28 ta' Jannar 2008, il-Kummissjoni Ewropea rreferiet il-kwistjoni lis-CHMP sabiex jarmonizza lawtorizzazzjonijiet għat-tqegħid fis-suq għal Augmentin fl-UE.
English: Why was Augmentin reviewed?
Maltese: Għaliex ġie rivedut Augmentin?
English: The CHMP also agreed that the injection can be used to prevent infections in major surgeries involving the gut, pelvic cavity, head and neck and the biliary tract.
Maltese: Is-CHMP qabel ukoll li linjezzjoni tista' tintuża sabiex tipprevjeni infezzjonijiet f'operazzjonijiet kbar li jinvolvu l-imsaren, ilħofra pelvika, ir-ras u l-għonq u l-passaġġ biljari.
English: This applies in particular to medicines with a 2:1 or 4:1 ratio, as these, taken at the recommended dose, may not provide a dose of amoxicillin that is sufficient to kill locally prevalent bacteria in areas where there is a high level of resistance to penicillins.
Maltese: Dan japplika b'mod partikolari għal mediċini bi proporzjon ta' 2:1 jew 4:1, minħabba li dawn, jekk jittieħdu fid-doża rakkomandata, jistgħu ma jipprovdux doża ta' amoxicillin li tkun biżżejjed biex toqtol batterji prevalenti lokalment f'żoni fejn hemm livell għoli ta' reżistenza għall-peniċillini.
English: The CHMP harmonised the posology for children, using the patient's weight as the cut-off point to distinguish the dosage for ‘adults and adolescents' (weighing more than 40 kg) from the dosage for children (below 40 kg).
Maltese: Is-CHMP armonizza l-pożoloġija għat-tfal, billi uża l-piż tal-pazjenti bħala l-punt ta' limitu li permezz tiegħu wieħed jiddistingwi d-dożaġġ għall-‘adulti u l-adolexxenti' (li jiżnu aktar minn 40 kg) mid dożaġġ għat-tfal (taħt l-40 kg).
English: The CHMP harmonised the indications for Augmentin used as an intravenous injection (into a vein) to include certain diseases for which oral treatment is not appropriate: severe infections of the ear, nose and throat, intra-abdominal infections and female genital infections.
Maltese: Is-CHMP armonizza l-indikazzjonijiet għal Augmentin użat bħala injezzjoni ġol-vina sabiex jinkludu ċertu mard li għalih trattament orali mhuwiex adattat: infezzjonijiet severi tal-widna, tal-imnieħer u tal-gerżuma, infezzjonijiet intra-addominali u infezzjonijiet tal-ġenitali femminili.
English: Therapeutic indications
Maltese: Indikazzjonijiet terapewtiċi
English: EMA/242206/2013 EMEA/H/C/002425
Maltese: 25 ta' April 2013 EMA/242206/2013 EMEA/H/C/002425
English: It was to be available as 150 mg tablets.
Maltese: Kienet ser tiġi f'pilloli ta' 150 mg.
English: Raxone is a medicine that contains the active substance idebenone.
Maltese: Raxone huwa mediċina li fiha s-sustanza attiva idebenone.
English: What is Raxone?
Maltese: X'inhu Raxone?
English: The evaluation had finished and the CHMP had given a negative opinion.
Maltese: Il-valutazzjoni kienet intemmet u s-CHMP kien ta opinjoni negattiva.
English: Raxone was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 15 February 2007 for the treatment of LHON.
Maltese: Raxone kien ikklassifikat bħala ‘mediċina orfni' (mediċina li tintuża f'mard rari) fil-15 ta' Frar 2007 għall-kura tal-LHON.
English: Patients affected by LHON have mutations (defects) in the genetic material of mitochondria.
Maltese: Pazjenti affettwati mil-LHON ikollhom mutazzjonijiet (difetti) fil-materjal ġenetiku tal-mitokondrija.
English: On 21 March 2013, Santhera Pharmaceuticals (Deutschland) GmbH officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Raxone, for the treatment of Leber's hereditary optic neuropathy (LHON).
Maltese: Fil-21 ta' Marzu 2013, Santhera Pharmaceuticals (Deutschland) GmbH għarrfet b'mod uffiċjali lillKumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) bil-ħsieb li tirtira l-applikazzjoni tagħha għall-awtorizzazzjoni għat-tqegħid fis-suq għal Raxone, li jintuża għall-kura tan-newropatija ottika ereditarja ta' Leber (LHON).
English: What was Raxone expected to be used for?
Maltese: Għal xiex kien mistenni jintuża Raxone?
English: Withdrawal of the marketing authorisation application for Raxone (idebenone)
Maltese: L-irtirar tal-applikazzjoni għall-awtorizzazzjoni għattqegħid fis-suq għal Raxone (idebenone)
English: How far into the evaluation was the application when it was withdrawn?
Maltese: Sa fejn kienet waslet il-valutazzjoni tal-applikazzjoni qabel ġiet irtirata?
English: At the time of the negative opinion, the CHMP was concerned that in patients with LHON whose symptoms started in the previous five years, taking Raxone for six months did not lead to a significant improvement in vision compared with placebo (patients taking Raxone were able to distinguish three more letters on the letter chart compared with patients taking placebo).
Maltese: Fiż-żmien tal-opinjoni negattiva, is-CHMP kien imħasseb li f'pazjenti bil-LHON li s-sintomi tagħhom bdew fil-ħames snin preċedenti, it-teħid ta' Raxone għal sitt xhur ma wassalx għal titjib sinifikanti filvista apparagun ma' plaċebo (pazjenti li kienu qed jieħdu Raxone kienu kapaċi jiddistingwu tliet ittri aktar fuq it-tabella bl-ittri apparagun ma' pazjenti li kienu qed jieħdu plaċebo).
English: Given the small size of this sub-group, the CHMP considered that a spontaneous improvement could not be ruled out.
Maltese: Minħabba d-daqs żgħir ta' dan is-sottogrupp, is-CHMP qies li ma setax jiġi eskluż titjib spontanju .
English: Raxone was expected to be used for the treatment of LHON, which is an inherited disease characterised by progressive loss of sight.
Maltese: Raxone kien mistenni jintuża għall-kura tal-LHON, li hija marda li tintiret ikkaratterizzata minn telf progressiv fil-vista.
English: The active substance in Raxone, idebenone, acts on structures inside cells known as mitochondria, which produce the energy necessary for cells to function.
Maltese: Is-sustanza attiva f'Raxone,l-idebenone, taġixxi fuq l-istrutturi ġewwa ċ-ċelloli magħrufa bħala mitokondri, li jipproduċu l-enerġija meħtieġa biex iċ-ċelloli jiffunzjonaw.
English: Based on the review of the data, at the time of the withdrawal, the CHMP had given a negative opinion recommending that the marketing authorisation be refused for Raxone for the treatment of Leber's hereditary optic neuropathy (LHON).
Maltese: Abbażi tar-reviżjoni tad-dejta, fiż-żmien tal-irtirar, is-CHMP kien ta opinjoni negattiva li tirrakkomanda li l-awtorizzazzjoni għat-tqegħid fis-suq għal Raxone tiġi rrifjutata għall-kura tan-newropatija ottika ereditarja ta' Leber (LHON).
English: Patients in compassionate use programmes can continue using Raxone.
Maltese: Pazjenti fi programmi ta' użu b'kumpassjoni jistgħu jkomplu jużaw Raxone.
English: The company presented the results from one main study with Raxone involving 85 patients with LHON whose symptoms started in the previous five years.
Maltese: Il-kumpanija ppreżentat ir-riżultati minn studju ewlieni b'Raxone li fih ħadu sehem 85 pazjent bil-LHON li s-sintomi tagħhom bdew fil-ħames snin preċedenti.
English: The effects of Raxone were first tested in experimental models before being studied in humans.
Maltese: L-effetti ta' Raxone ġew l-ewwel ittestjati fuq mudelli sperimentali qabel ma ġew studjati fil-bnedmin.
English: The way idebenone works in LHON is not fully understood but it is thought to reduce the formation of free radicals and to help improve production of energy, thereby preventing the cellular damage and the loss of sight seen in LHON.
Maltese: Il-mod kif l-idebenone taħdem fil-LHON mhuwiex mifhum għalkollox, iżda hemm l-ipoteżi li dan inaqqas il-formazzjoni ta' radikali ħielsa u jgħin itejjeb il-produzzjoni tal-enerġija, u b'hekk jipprevjeni l-ħsara ċellulari u t-telf talvista li tidher fil-LHON.
English: The company informed the CHMP that there are no ongoing clinical trials.
Maltese: Il-kumpanija infurmat lis-CHMP li ma hemm l-ebda prova klinika għaddejja.
English: However, the CHMP concluded that the new subgroup of patients proposed for treatment was not well represented in the study (28 patients) and the reliability of the results is questionable.
Maltese: Madankollu s-CHMP ikkonkluda li s-sottogrupp il-ġdid ta' pazjenti propost għall-kura ma kienx rappreżentat sew fl-istudju (28 pazjent) u l-affidabbiltà tarriżultati hija dubjuża.
English: Consider initial dose of 1 mg/kg/day to 4 mg/kg/day prednisone or equivalent followed by taper
Maltese: Ikkunsidra doża inizjali ta' 1 mg/kg/jum sa 4 mg/kg/jum prednisone jew ekwivalenti segwit bi tnaqqis gradwali
English: Durvalumab - Myasthenia gravis (EPITT no 19451)
Maltese: Durvalumab - Mijastenija gravi (EPITT nru 19451)
English: Withhold dose
Maltese: Issospendi d-doża
English: IMFINZI treatment modification
Maltese: Modifikazzjoni filkura b'IMFINZI
English: treated with IMFINZI monotherapy in clinical trials (n = 1889): myasthenia gravis, myocarditis, myositis, polymyositis.
Maltese: Ir-reazzjonijiet avversi medjati mis-sistema immunitarja li ġejjin ġew irrappurtati f'inqas minn 1 % tal-pazjenti kkurati b'monoterapija b'IMFINZI fil-provi kliniċi (n = 1889): mijastenija gravi, mijokardite, mijożite, polimijożite.
English: Summary of product characteristics 4.2.
Maltese: Sommarju tal-karatteristiċi tal-prodott 4.2.
English: Permanently discontinue d d) For myasthenia gravis, if there are signs of muscular weakness or respiratory insufficiency, IMFINZI should be permanently discontinued.
Maltese: Waqqaf b'mod permanenti d d) Għal mijastenija gravi, jekk ikun hemm sinjali ta' dgħufija muskolari jew insuffiċjenza respiratorja, IMFINZI għandu jitwaqqaf b'mod permanenti.
English: New product information wording - Extracts from PRAC recommendations on signals EMA/PRAC/532016/2019
Maltese: Formulazzjoni ġdida tal-kliem tal-informazzjoni dwar prodott - Siltiet mirrakkomandazzjonijiet tal-PRAC dwar is-sinjali EMA/PRAC/556444/2019
English: Undesirable effects Tabulated list of adverse reactions Skin and subcutaneous tissue disorders Frequency not known: lichenoid drug reaction
Maltese: Lista f'tabella ta' reazzjonijiet avversi Disturbi fil-ġilda u fit-tessuti ta' taħt il-ġilda Frekwenza mhux magħruf: reazzjoni għall-mediċina likenojde
English: Undesirable effects Nervous system disorders Rare: Myasthenia gravis
Maltese: .8. Effetti mhux mixtieqa Disturbi fis-sistema nervuża
English: Rare: a condition in which the muscles become weak and there is a rapid fatigue of the muscles (myasthenia gravis).
Maltese: Rari: kundizzjoni li fiha l-muskoli jsiru dgħajfa u jkun hemm għeja f'daqqa tal-muskoli (mijastenja gravi).
English: • Inflammation or problems of the muscles: symptoms may include muscle pain, or weakness or rapid fatigue of the muscles;
Maltese: • Infjammazzjoni jew problemi tal-muskoli: is-sintomi jistgħu jinkludu uġigħ, jew dgħufija fil muskoli jew għeja f'daqqa tal-muskoli;
English: Posology and method of administration Adverse reactions Severity a
Maltese: Pożoloġija u metodu ta' kif għandu jingħata Reazzjonijiet avversi Severità a
English: Frequency not known: eruption of the skin or mucous membranes (lichenoid drug reaction)
Maltese: Frekwenza mhux magħruf: eruzzjoni tal-ġilda jew tal-membrani mukużi (reazzjoni għall-mediċina likenojde)
English: Patients should be monitored for signs and symptoms and managed as recommended in section 4.2.
Maltese: Il-pazjenti għandhom jiġu mmonitorjati għal sinjali u sintomi u għandhom jiġu mmaniġġjati kif irrakkomandat fis-sezzjoni 4.2.
English: Lithium - Drug-induced lichenoid reaction (EPITT no
Maltese: 2. Litju - Reazzjoni likenojde kkawżata mill-mediċina (EPITT nru 19389)