FrancophonIA/ELRC3.0 huggingface dataset:
English: The most frequent side effects with MabCampath are: infusion reactions (fever, chills, low blood pressure, itching, feeling sick, hives, increased heart rate, breathlessness), low counts of blood cells (white blood cells, platelets and red blood cells), infections (signs of cytomegalovirus in the blood, cytomegalovirus infection or other infections), gastrointestinal symptoms (feeling sick, vomiting, abdominal pain) and neurological symptoms (insomnia, anxiety).
Maltese: L-iktar effetti sekondarji komuni b'MabCampath huma: reazzjoni tal-infużjoni (deni, tertir, pressjoni baxxa tad-demm, ħakk, tħossok ma tiflaħx, ħorriqija, żieda fit-taħbit il-qalb, qtugħ ta' nifs), għadd baxx ta' ċelloli tad-demm (ċelloli tad-demm bojod, plejtlits u ċelloli tad-demm ħomor), infezzjonijiet (sinjali ta' ċitomegalovirus fid-demm, infezzjoni taċ-ċitomegalovirus jew infezzjonijiet oħra), sintomi gastrointestinali (tħossok ma tiflaħx, remettar, uġigħ addominali) u sintomi newroloġiċi (insomnja, anzjetà).
English: This is called ‘dose escalation'.
Maltese: Din hija magħrufa bħala ‘eskalazzjoni tad-doża'.
English: MabCampath has been looked at in four main studies involving a total of 446 patients with CLL.
Maltese: MabCampath ġie eżaminat f'erba' studji ewlenin li involvew total ta' 446 pazjent li kienu jbatu minn CLL.
English: Alemtuzumab has been designed to attach to a glycoprotein (a protein that is coated with sugar molecules) called CD52 that is found on the surface of lymphocytes.
Maltese: Alemtuzumab ġie ddiżinjat biex jeħel mal-glikoproteina (proteina miksija b'rita ta' molekuli taz-zokkor) msejħa CD52 misjuba filwiċċ tal-linfoċiti.
English: In the study of patients who had been treated with fludarabine before, 33% responded partially or completely to treatment with MabCampath.
Maltese: Fl-istudju ta' pazjenti li kienu ttrattati b'fludarabine qabel, 33% rreaġixxew parzjalment jew kompletament għal kura b'MabCampath.
English: One of these studies included 93 patients in whom previous treatment with fludarabine had stopped working.
Maltese: L-istudju ewlieni inkluda 93 pazjent li fuqhom, it-trattament bi fludarabine kienet waqfet taħdem.
English: MabCampath is used to treat patients with B-cell chronic lymphocytic leukaemia (B-CLL), a cancer of a type of white blood cell called B lymphocytes.
Maltese: MabCampath jintuża għal kura ta' pazjeti li jbatu mil-lewċemija linfoċitika kronika (B-cell), tip ta' kanċer taċ-ċelloli bojod tad-demm imsejħa B linfotiċi.
English: In patients who had not received treatment before, MabCampath was more effective than chlorambucil.
Maltese: F'pazjenti li ma kinux irċevew trattament qabel, MabCampath kien aktar effikaċi minn chlorambucil.
English: • who have an active, second cancer; • who are pregnant.
Maltese: • li għandhom kanċers sekondarji attivi;
English: MabCampath is used in patients for whom treatment combinations including fludarabine (another medicine used in leukaemia) are not appropriate.
Maltese: MabCampath jintuża f'pazjenti li għalihom, kombinazzjonijiet ta' trattament inklużi fludarabine (mediċina oħra użata fil-lewċemija) mhumiex adatti.
English: The most frequent serious adverse reactions are low counts of blood cells, infusion reactions, and infections or immunosuppression (reduced activity of the immune system).
Maltese: L-aktar effetti sekondarji serji huma l-pressjoni baxxa tad-demm, reazzjonijiet fis-sit talinfużjoni, u infezzjonijiet jew immunosuppressjoni (tnaqqis fl-attività tas-sistema immunitarja).
English: In CLL, too many lymphocytes are produced.
Maltese: F'CLL, il-produzzjoni ta' linfoċiti hija żżejjed.
English: Why has MabCampath been approved?
Maltese: Għaliex ġie approvat MabCampath?
English: In these studies, MabCampath was not compared with any other treatment.
Maltese: F'dawn l-istudji, MabCampath ma kienx imqabbel ma' kwalunkwe trattament ieħor.
English: It compared a 12-week course of MabCampath with a year-long course of chlorambucil (another anticancer medicine).
Maltese: Huwa qabbel l-effikaċja ta' kors ta' 12-il ġimgħa ta' MabCampath ma' dik ta' kors ta' sena sħiħa ta' chlorambucil (mediċina oħra kontra l-kanċer).
English: MabCampath is a concentrate that is made up into a solution for infusion (drip into a vein).
Maltese: MabCampath huwa konċentrat li jitħallat f'soluzzjoni għall-infużjoni (drip ġol-vina).
English: The European Commission granted a marketing authorisation valid throughout the European Union for MabCampath on 6 July 2001.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal MabCampath fis-6 ta' Lulju 2001.
English: During the first week of treatment, MabCampath should be given in increasing doses: 3 mg on day 1, 10 mg on day 2 and 30 mg on day 3, as long as each dose is well tolerated.
Maltese: Id-doża rakkomandata hija 30 mg kuljum, mogħtija tliet darbiet fil-ġimgħa (jum iva u jum le) għal massimu ta' 12-il ġimgħa.
English: How does MabCampath work?
Maltese: X'inhu MabCampath?
English: What is the risk associated with MabCampath?
Maltese: X'inhu r-riskju assoċjat ma' MabCampath?
English: This is a summary of the European public assessment report (EPAR) for MabCampath.
Maltese: Kif ġie studjat MabCampath?
English: Therefore, the Committee concluded that MabCampath's benefits are greater than its risks for the treatment of patients with B-CLL for whom fludarabine combination chemotherapy is not appropriate.
Maltese: Għaldaqstant, il-Kumitat ikkonkluda li l-benefiċċji ta' MabCampath huma akbar mir-riskji tiegħu għal trattament ta' pazjenti b'B-CLL ċellola-B għal liema, kemjoterapija ta' kombinazzjoni b'fludarabine mhijiex adatta.
English: The CHMP noted that the effectiveness of MabCampath had been demonstrated, but that there is no information from studies directly comparing MabCampath with treatment combinations including fludarabine, which are widely used to treat patients with CLL.
Maltese: Oriġinarjament, MabCampath ġie awtorizzat f'‘ċirkostanzi eċċezzjonali' minħabba li għal raġunijiet xjentifiċi ma kienx possibbli li jinkiseb tagħrif komplut dwaru.
English: MabCampath should not be used in people who may be hypersensitive (allergic) to alemtuzumab, mouse proteins, or any of the other ingredients.
Maltese: MabCampath m'għandux jintuża f'nies li jistgħu jkunu sensittivi żżejjed (allerġiċi) għal alemtuzumab, proteini tal-ġurdien, jew għal kwalunkwe sustanza attiva oħra.
English: A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen) that is found in certain cells in the body.
Maltese: Antikorp monoklonali huwa antikorp (tip ta' proteina) li tfassal biex jagħraf u jeħel ma' struttura speċifika (imsejħa antiġene) li tinstab f'ċerti ċelloli fil-ġisem.
English: In the patients receiving MabCampath, it took an average of 14.6 months for the disease to get worse or for the patient to die, compared with 11.7 months in those taking chlorambucil.
Maltese: F'pazjenti li kienu qegħdin jirċievu MabCampath, ittieħdu madwar 14.6-il xahar biex il-marda marret għall-agħar jew biex il-pazjent imut, meta mqabbel ma' 11.7-il xahar għal dawk li kienu qegħdin jieħdu chlorambucil.
English: 90 (3 x 30) capsules
Maltese: 90 (3 x 30) kapsula
English: Strength Pharmaceutical Form
Maltese: Numru tal-MA Isem (ivvintat) Qawwa Għamla farmaċewtika
English: Further information on Imfinzi 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: Other information about Imfinzi
Maltese: Informazzjoni oħra dwar Imfinzi
English: The active substance in Imfinzi, durvalumab, is a monoclonal antibody, a type of protein designed to recognise and attach to a protein called ‘programmed death-ligand 1' (PD-L1), which is present on the surface of many cancer cells.
Maltese: Is-sustanza attiva f'Imfinzi, id-durvalumab, hija antikorp monoklonali, tip ta' proteina mfassla biex tagħraf u teħel ma' proteina msejħa “programmed death-ligand 1” (PD-L1), li hija preżenti fuq il-wiċċ ta' bosta ċelloli tal-kanċer.
English: What are the risks associated with Imfinzi?
Maltese: X'inhuma r-riskji assoċjati ma' Imfinzi?
English: Imfinzi contains the active substance durvalumab.
Maltese: Imfinzi fih is-sustanza attiva durvalumab.
English: Side effects with Imfinzi were considered manageable, and its safety profile acceptable and in line with that of similar medicines.
Maltese: L-effetti sekondarji b'Imfinzi tqiesu ġestibbli, u lprofil tas-sigurtà tiegħu tqies aċċettabbli u f'konformità ma' dak ta' mediċini simili.
English: Imfinzi is used specifically when the tumour produces a protein known as PD-L1.
Maltese: Imfinzi jintuża speċifikament meta t-tumur jipproduċi proteina magħrufa bħala PDL1.
English: As for all medicines, data on the use of Imfinzi are continuously monitored.
Maltese: Bħal għall-mediċini kollha, id-data dwar l-użu ta' Imfinzi hija ssorveljata kontinwament.
English: In one main study of 713 patients, patients given Imfinzi lived on average for around 17 months without their disease getting worse, compared with 6 months for those given placebo.
Maltese: Fi studju ewlieni wieħed li involva 713-il pazjent, il-pazjenti li ngħataw Imfinzi għexu bħala medja għal madwar 17-il xahar mingħajr ma l-marda tagħhom qalbet għall-agħar, meta mqabbel ma' 6 xhur għal dawk li ngħataw plaċebo.
English: The most common serious side effect (which may affect up to 1 in 10 people) is pneumonia (infection of the lungs).
Maltese: L-effett sekondarju serju l-aktar komuni (li jista' jaffettwa sa persuna 1 minn kull 10) huwa pulmonite (infezzjoni tal-pulmun).
English: PD-L1 acts to switch off immune cells that would otherwise attack the cancer cells.
Maltese: PD-L1 taġixxi biex tmewwet iċ-ċelloli immunitarji li inkella jattakkaw iċ-ċelloli tal-kanċer.
English: Imfinzi is used in adult patients with advanced cancer that cannot be removed by surgery but is not getting worse after treatment with radiation and platinum-based chemotherapy (medicines to treat cancer).
Maltese: Imfinzi jintuża f'pazjenti adulti b'kanċer avvanzat li ma jistax jitneħħa b'kirurġija iżda li ma jkunx qiegħed imur għall-agħar wara kura b'radjazzjoni u kimoterapija bbażata fuq il-platinu (mediċini biex jikkuraw il-kanċer).
English: For the full list of side effects and restrictions of Imfinzi, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet ta' Imfinzi, ara l-fuljett ta' tagħrif.
English: How is Imfinzi used?
Maltese: Kif jaħdem Imfinzi?
English: Imfinzi is a medicine used to treat a type of lung cancer called non-small cell lung cancer (NSCLC).
Maltese: Imfinzi huwa mediċina li tintuża biex tikkura tip ta' kanċer tal-pulmun imsejjaħ kanċer tal-pulmun b'ċelloli mhux żgħar (NSCLC).
English: By attaching to PDL1 and blocking its effects, Imfinzi increases the ability of the immune system to attack the cancer cells and thereby slow down the progression of the disease.
Maltese: Billi jeħel ma' PD-L1 u jimblokka l-effetti tagħha, Imfinzi iżid il-kapaċità tas-sistema immunitarja li tattakka ċ-ċelloli tal-kanċer u b'hekk inaqqas il-progressjoni tal-marda.
English: Imfinzi is given as an infusion (drip) into a vein every 2 weeks.
Maltese: Imfinzi jingħata bħala infużjoni (dripp) ġo vina darba kull ġimagħtejn.
English: An overview of Imfinzi and why it is authorised in the EU
Maltese: Ħarsa ġenerali lejn Imfinzi u għalfejn huwa awtorizzat fl-UE
English: The most common side effects with Imfinzi (which may affect more than 1 in 5 people) are cough, nose and throat infections, and rash.
Maltese: L-effetti sekondarji l-aktar komuni b'Imfinzi (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 5) huma sogħla, infezzjonijiet tal-imnieħer u tal-griżmejn u raxx.
English: The use of Imfinzi is restricted to patients whose tumours produce PD-L1, since a clear benefit was only shown in this group of patients.
Maltese: L-użu ta' Imfinzi huwa ristrett għall-pazjenti li t-tumuri tagħhom jipproduċu PD-L1, peress li benefiċċju ċar intwera biss f'dan il-grupp ta' pazjenti.
English: Preliminary results also indicated that patients given Imfinzi lived longer overall, compared with patients on placebo, though longer monitoring would be needed to confirm the extent of the benefit.
Maltese: Għaldaqstant, l-Aġenzija Ewropea għall-Mediċini ddeċidiet li l-benefiċċji ta' Imfinzi huma akbar mirriskji tiegħu u li jista' jiġi awtorizzat għall-użu fl-UE.
English: Further information on Inbrija can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Inbrija.
Maltese: ema.europa.eu/medicines/human/EPAR/Inbrija.
English: The safety of the medicine is in line with other similar medicines.
Maltese: Is-sigurtà tal-mediċina hija konformi ma' mediċini simili oħra.
English: This overview was last updated in 09-2019.
Maltese: Din il-ħarsa ġenerali ġiet aġġornata l-aħħar f'08-2019.
English: Of patients treated with Inbrija, 71% reported that their symptoms were improved, compared with 46% of patients on placebo.
Maltese: Mill-pazjenti kkurati b'Inbrija, 71 % rrapportaw li ssintomi tagħhom tjiebu, meta mqabbla ma' 46 % tal-pazjenti fuq il-plaċebo.
English: Inbrija contains the active substance levodopa.
Maltese: Inbrija fih is-sustanza attiva levodopa.
English: The recommended dose is 2 capsules in each ‘off' period up to a maximum of 10 capsules per day.
Maltese: Id-doża rakkomandata hija ta' 2 kapsuli f'kull perjodu ‘off' sa massimu ta' 10 kapsuli kuljum.
English: Other information about Inbrija
Maltese: Informazzjoni oħra dwar Inbrija
English: What are the risks associated with Inbrija?
Maltese: X'inhuma r-riskji assoċjati ma' Inbrija?
English: Medicines containing levodopa and a dopa-decarboxylase inhibitor have shown side effects of symptoms like neuroleptic malignant syndrome (a nervous disorder) and rhabdomyolysis (breakdown of muscle fibres).
Maltese: Mediċini li fihom il-levodopa u inibitur dopadekarbossilażi wrew effetti sekondarji ta' sintomi bħal sindrome malinn newroleptiku (disfunzjoni newroloġika) u rabdomijoliżi (tkissir tal-fibri tal-muskoli).
English: Effects were measured using a standard symptom scale known as the unified Parkinson's disease rating scale, UPDRS, part III.
Maltese: Leffetti tkejlu bl-użu ta' skala tas-sintomi standard magħrufa bħala l-iskala ta' klassifikazzjoni unifikata tal-marda ta' Parkinson, UPDRS, il-parti
English: Other common side effects, which may affect up to 1 in 10 people, are falls, upper respiratory tract infection (nose and throat infection), dyskinesia (difficulty controlling movement) and discoloured sputum (phlegm).
Maltese: Effetti sekondarji komuni oħra, li jistgħu jaffettwaw sa persuna waħda minn kull 10, huma waqgħat, infezzjoni fil-parti ta' fuq tal-apparat respiratorju (infezzjoni tal-imnieħer u tal-griżmejn), diskinesja (diffikultà fil-kontroll tal-moviment) u sputum skulurit (bili).
English: In the second study involving 77 patients who had 4 weeks of standard treatment, patients who took Inbrija during ‘off' periods had an average improvement of 10 points on the scale 10 to 60 minutes later, compared with 3 points for patients taking placebo.
Maltese: Fit-tieni studju li kien jinvolvi 77 pazjent li kellhom 4 ġimgħat ta' kura standard, il-pazjenti li ħadu Inbrija matul il-perjodi ‘off' kellhom titjib medju ta' 10 punti fuq l-iskala minn 10 minuti sa 60 minuta aktar tard, meta mqabbla ma' 3 punti għall-pazjenti li kienu qed jieħdu plaċebo.
English: Allergic oedema (swelling) and gastrointestinal haemorrhage (bleeding in the gut) have been reported for other medicines containing levodopa.
Maltese: Edema allerġika (nefħa) u emorraġija gastrointestinali (fsada fil-musrana) ġew irrapportati għal mediċini oħra li fihom il-levodopa.
English: The first study involved 226 patients who had 12 weeks of standard treatment with levodopa and a dopa-decarboxylase inhibitor.
Maltese: L-ewwel studju kien jinvolvi 226 pazjent li kellhom 12-il ġimgħa ta' kura standard bil-levodopa u b'inibitur dopadekarbossilażi.
English: As for all medicines, data on the use of Inbrija are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Inbrija hija ssorveljata kontinwament.
English: Inbrija is a medicine used to treat adults with Parkinson's disease (a progressive brain disease that causes shaking and muscle stiffness and slows movement).
Maltese: Inbrija huwa mediċina li tintuża għall-kura ta' adulti bil-marda ta' Parkinson (marda progressiva filmoħħ li tikkawża rogħda u ebusija tal-muskoli u tnaqqas il-ħeffa tal-moviment).
English: How does Inbrija work?
Maltese: Kif jaħdem Inbrija?
English: Inbrija must not be used in patients with narrow angle glaucoma (an eye disorder) or pheochromocytoma (a tumour of the adrenal glands).
Maltese: Inbrija m'għandux jintuża f'pazjenti bi glawkoma b'angolu dejjaq (disturb fl-għajnejn) jew b'fejokromoċitoma (tumur tal-glandoli adrenali).
English: In this study, patients who took Inbrija during their ‘off' periods had an average improvement of 10 points on the scale 30 minutes later, compared with 6 points for patients taking placebo (a dummy treatment).
Maltese: F'dan l-istudju, il-pazjenti li ħadu Inbrija matul il-perjodu ‘off' tagħhom kellhom titjib medju ta' 10 punti fuq l-iskala 30 minuta aktar tard, meta mqabbla ma' 6 punti għallpazjenti li kienu qed jieħdu plaċebo (kura finta).
English: Studies show that Inbrija is effective at reducing symptoms during ‘off' periods in patients with Parkinson's disease on levodopa/dopa-decarboxylase-inhibitor treatment.
Maltese: L-istudji juru li Inbrija huwa effettiv biex jitnaqqsu s-sintomi matul perjodi ‘off' f'pazjenti bil-marda ta' Parkinson li jkunu fuq kura ta' levodopa/inibitur dopadekarbossilażi.
English: Inbrija should be inhaled using the Inbrija inhaler device when the patient recognises the symptoms of an ‘off' period.
Maltese: Aktar informazzjoni dwar Inbrija tinstab fis-sit web tal-Aġenzija:
English: How is Inbrija used?
Maltese: Kif jintuża Inbrija?
English: Side effects reported with Inbrija are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Inbrija huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: (see section 4.4.)
Maltese: (ara sezzjoni 4.4.)
English: Progressive multifocal leukoencephalopathy (PML)
Maltese: Lewkoenċefalopatija multifokali progressiva (PML)
English: Cases of PML, including fatal cases, have been reported with cladribine.
Maltese: Każijiet ta' PML, inklużi każijiet fatali, ġew irrapportati bi cladribine.
English: Azithromycin; clarithromycin; erythromycin; roxithromycin - Acute generalised exanthematous pustulosis (AGEP) (EPITT no 18891)
Maltese: Azithromycin; clarithromycin; erythromycin; roxithromycin - Pustulożi esantematika ġeneralizzata akuta (AGEP)(EPITT nru 18891)
English: PML was reported 6 months to several years after treatment with cladribine.
Maltese: PML ġiet irrapportata 6 xhur sa diversi snin wara l-kura bi cladribine.
English: Cladribine - Progressive multifocal leukoencephalopathy (PML) (EPITT no 18875)
Maltese: 3. Cladribine - Lewkoenċefalopatija multifokali progressiva (PML) (EPITT nru 18875)
English: Doxycycline - Doxycycline induced Jarisch-Herxheimer reaction (EPITT no 18937)
Maltese: Doxycycline - Reazzjoni ta' Jarisch-Herxheimer ikkawżata minn Doxycycline (EPITT nru 18937)
English: Frequency ‘Not known': Jarisch-Herxheimer reaction (see section 4.4)
Maltese: Reazzjoni ta' Jarisch-Herxheimer (ara sezzjoni 4.4)
English: Adopted at the 25-29 September 2017 PRAC
Maltese: Adottata fil-PRAC ta' bejn il-25 u d-29 ta' Settembru 2017
English: Acetazolamide - Acute generalised exanthematous pustulosis (AGEP) (EPITT no 18892)
Maltese: Acetazolamide - Pustulożi esantematika ġeneralizzata akuta (AGEP)(EPITT nru 18892)
English: Package leaflet 4.
Maltese: Fuljett ta' tagħrif 4.
English: Medicinal products concerned: cladribine-containing products authorised for oncology indications.
Maltese: Prodotti mediċinali kkonċernati: prodotti li fihom cladribine awtorizzati għal indikazzjonijiet ta' onkoloġija.
English: Possible side effects [The following adverse drug reaction should be added with a frequency very rare (may affect up to 1 in 10,000 people)]
Maltese: Effetti sekondarji possibbli [Ir-reazzjoni avversa għall-mediċina li ġejja għandha tiżdied bi frekwenza ta' rari ħafna (tista' taffettwa sa persuna 1 minn kull 10,000)]
English: Undesirable effects Investigations
Maltese: Effetti mhux mixtieqa Investigazzjonijiet
English: As with erythromycin and other macrolides, rare serious allergic reactions, including angioneurotic oedema and anaphylaxis (rarely fatal), dermatologic reactions including acute generalised exanthematous pustulosis (AGEP), Stevens Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) (rarely fatal) and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported.
Maltese: Bħal fil-każ ta' erythromycin u makrolidi oħra, ġew irrapportati reazzjonijiet allerġiċi serji rari, fosthom edema anġjonewrotika u anafilassi (rarament fatali), reazzjonijiet tal-ġilda fosthom pustulożi esantematika ġeneralizzata akuta (AGEP), is-sindrome ta' Stevens Johnson (SJS), nekroliżi epidermali tossika (TEN) (rarament fatali) u reazzjoni għall-mediċina b'eosinofilja u sintomi sistemiċi (DRESS).
English: If flucloxacillin is continued after cessation of paracetamol, it is advisable to ensure that there are no signals of HAGMA, as there is a possibility of flucloxacillin maintaining the clinical picture of HAGMA (see section 4.5).
Maltese: Jekk flucloxacillin jitkompla wara li jitwaqqaf il-paracetamol, huwa rakkomandat li jiġi żgurat li ma jkun hemm ebda sinjal ta' HAGMA, minħabba li hemm possibbiltà li flucloxacillin iżomm l-istampa klinika ta' HAGMA (ara sezzjoni 4.5).
English: Suggested evaluation for PML includes neurology consultation, magnetic resonance imaging of the brain, and cerebrospinal fluid analysis for JC virus (JCV) DNA by polymerase chain reaction (PCR) or a brain biopsy with testing for JCV.
Maltese: Il-valutazzjoni ssuġġerita għal PML tinkludi konsultazzjoni newroloġika, immaġni b'reżonanza manjetika tal-moħħ, u analiżi tal-fluwidu ċerebrospinali għal DNA tal-virus JC (JCV) permezz ta' reazzjoni katina bil-polimerażi (PCR) jew bijopsija tal-moħħ b'testijiet għal JCV. PCR negattiva għal JCV ma teskludix PML.
English: Cases of severe bullous skin reactions such as Stevens Johnson syndrome, toxic epidermal necrolysis and acute generalised exanthematous pustulosis (AGEP), have been reported with roxithromycin.
Maltese: Każijiet ta' reazzjonijiet bullużi serji tal-ġilda bħas-sindrome ta' Stevens Johnson, nekroliżi epidermali tossika u pustulożi esantematika ġeneralizzata akuta (AGEP), ġew irrapportati b'roxithromycin.
English: Skin and subcutaneous tissue disorders Rare: acute generalised exanthematous pustulosis (AGEP)
Maltese: Disturbi fil-ġilda u fit-tessuti ta' taħt il-ġilda Rari: pustulożi esantematika ġeneralizzata akuta (AGEP)
English: Metabolism and nutrition disorders Frequency ‘not known': increased appetite
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni Frekwenza ‘mhux magħrufa': żieda fl-aptit
English: Flucloxacillin - High anion gap metabolic acidosis (HAGMA) (EPITT no 18844)
Maltese: Flucloxacillin - Aċidożi metabolika b'distakk kbir bejn lanjoni (HAGMA) (EPITT nru 18844)
English: Possible side effects Frequency ‘not known': weight increased
Maltese: Effetti sekondarji possibbli Frekwenza ‘mhux magħrufa': żieda fil-piż
English: Patients should be reassured that this is a usually self-limiting consequence of antibiotic treatment of spirochete infections.
Maltese: Il-pazjenti għandhom jiġu assigurati li normalment din hija konsegwenza awtolimitanti tal-kura ta' infezzjonijiet ta' spirochetes bl-antibijotiċi.
English: Not known: acute generalised exanthematous pustulosis (AGEP)
Maltese: Mhux magħruf: pustulożi esantematika ġeneralizzata akuta (AGEP)