FrancophonIA/ELRC3.0 huggingface dataset:
English: 5 ml Type 1 clear glass vials fitted with grey butyl rubber stoppers and snap-off aluminium crimp seals.
Maltese: Kunjetti tal-ħġieġ ta' Tip 1 ċari ta' 5 ml b'tappijiet tal-lastku butyl griżi u b'siġilli ppjegati talaluminju li jinqalgħu bis-saba'.
English: Tygacil 50 mg powder for solution for infusion
Maltese: Tygacil 50 mg trab għal soluzzjoni għall-infużjoni
English: However, polymicrobial intra-abdominal infections have shown to respond to treatment with tigecycline in clinical trials.
Maltese: Madankollu, infezzjonijiet polimikrobjali intra-addominali ġew murija li jirrispondu għat-trattament b'tigecycline fi provi kliniċi.
English: AUC was estimated to be 20 % higher in females than in males.
Maltese: L-AUC kienet stmata li kienet 20% ogħla fin-nisa milli fl-irġiel.
English: A patient developing impaired healing should be monitored for the detection of superinfection (see section 4.8).
Maltese: Pazjent li jiżviluppa fejqan indebolit għandu jiġi mmonitorjat għall-kxif ta' superinfezzjoni (ara sezzjoni 4.8).
English: Very Common
Maltese: Globalment
English: Glucuronidation and renal excretion of unchanged tigecycline are secondary routes.
Maltese: Glukuronidazzjoni u eliminazzjoni renali ta' tigecycline mhux mibdul huma rotot sekondarji.
English: Limited experience is also available in treating patients with concurrent bacteraemia (5.6 %).
Maltese: Hemm ukoll esperjenza ristretta fit-trattament ta' pazjenti b'batterimja konkomitanti (5.6%).
English: Viridans group streptococci
Maltese: Streptococci tat-tip Viridans
English: The recommended dose for adults is an initial dose of 100 mg followed by 50 mg every 12 hours for 5 to 14 days.
Maltese: Id-doża rrakomandata għall-adulti hija doża inizjali ta' 100 mg segwita b'50 mg kull 12-il siegħa għal bejn 5 sa 14-il jum.
English: In clinical studies in complicated skin and soft tissue infections (cSSTI), complicated intra-abdominal infections (cIAI), diabetic foot infections, nosocomial pneumonia and studies in resistant pathogens, a numerically higher mortality rate among tigecycline treated patients has been observed as compared to the comparator treatment.
Maltese: Fi studji kliniċi fejn kien hemm infezzjonijiet tal-ġilda u tessuti rotob ikkumplikati (cSSTI), infezzjonijiet intra-addominali kkumplikati (cIAI), infezzjonijiet dijabetiċi tas-saqajn, pulmonite li tittieħed minn ġo sptar u studji tal-patoġeni reżistenti, kien osservat li ir-rata ta' mortalità fost ilpazjenti kkurati b'tigecycline kienet aktar għloja meta mqabbla mal-pazjenti ikkurati bil-prodott ta' paragun.
English: C-tigecycline, radioactivity was well distributed to most tissues, with the highest overall exposure observed in bone marrow, salivary glands, thyroid gland, spleen, and kidney.
Maltese: C-tigecycline, ir-radjuattivtà kienet iddistribwita sewwa fil-parti l-kbira tat-tessuti, bl-aktar esponiment għoli osservat fil-mudullun, il-glandoli tal-bżieq, il-glandola tat-tirojde, il-milsa, u l-kilwa.
English: Cross-resistance between tigecycline and minocycline-resistant isolates among the Enterobacteriaceae due to multi-drug resistance (MDR) efflux pumps has been shown.
Maltese: Intweriet reżistenza inkroċjata bejn tigecycline u iżolati reżistenti għal minocycline fost lEnterobacteriaceae minħabba l-pompi tal-effluss reżistenti għal ħafna mediċini (MDR).
English: General disorders and administration site conditions impaired healing, injection site reaction, headache injection site inflammation, injection site pain, injection site oedema, injection site phlebitis
Maltese: Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata fejqan indebolit, reazzjoni fis-sit talinjezzjoni, uġigħ ta' ras infjammazzjoni fillok tal-injezzjoni, uġigħ fil-lok talinjezzjoni, edema fil-lok tal-injezzjoni, flebite fil-lok talinjezzjoni
English: • In certain serious infections, your doctor may consider to use Tygacil in combination with other antibiotics.
Maltese: • F'ċerti infezzjonijiet severi, it-tabib tiegħek jista' jikkunsidra li juża Tygacil f'kombinazzjoni ma' antibijotiċi oħrajn.
English: A dosing regimen of 1.2 mg/kg of tigecycline every 12 hours (to a maximum dose of 50 mg every 12 hours) for children aged 8 to <12 years and of 50 mg every 12 hours for adolescents aged 12 to <18 years would likely result in exposures comparable to those observed in adults treated with the approved dosing regimen.
Maltese: Kors ta' dożaġġ ta' 1.2 mg/kg ta' tigecycline kull 12-il siegħa (sa doża massima ta' 50 mg kull 12-il siegħa) għal tfal li jkollhom minn 8 sa <12-il sena u ta' 50 mg kull 12-il siegħa għal adolexxenti li jkollhom minn 12 sa <18-il sena, aktarx li se jirriżulta f'esponimenti komparabbli għal dawk osservati f'adulti kkurati bil-kors ta' dożaġġ approvat.
English: Pregnancy
Maltese: Anerobi
English: Tygacil is an antibiotic of the glycylcycline group that works by stopping the growth of bacteria that cause infections.
Maltese: Tygacil huwa antibijotiku tal-grupp glycylcycline li jaħdem billi jwaqqaf l-iżvilupp ta' batterji li jikkaġunaw infezzjonijiet.
English: Pharmacokinetic parameters are summarised in the table below.
Maltese: Il-parametri farmakokinetiċi qed jintwerew fil-qosor fit-tabella ta' hawn taħt.
English: Co-administration of P-gp inhibitors (e.g., ketoconazole or cyclosporine) or P-gp inducers (e.g., rifampicin) could affect the pharmacokinetics of tigecycline.
Maltese: L-għoti flimkien ta' inibituri ta' P-gp (eż., ketoconazole jew cyclosporine) jew l-indutturi Pgp (eż., rifampicin) jista' jaffettwa l-farmakokinetika ta' tigecycline.
English: Prothrombin time or other suitable anticoagulation test should be used to monitor patients if tigecycline is administered with anticoagulants (see section 4.5).
Maltese: Il-ħin tal-protrombin jew xi test antikoagulanti ieħor li jkun adattat għandu jiġi użat biex jissorvelja pazjenti jekk tigecycline jiġi mogħti ma' antikoagulanti (ara sezzjoni 4.5).
English: Consideration should be given to the use of combination antibacterial therapy whenever tigecycline is to be administered to severely ill patients with cIAI secondary to clinically apparent intestinal perforation or patients with incipient sepsis or septic shock (see section 4.8).
Maltese: Għandha tingħata konsiderazzjoni għal użu ta' terapija antibatterika meta tigelycine jkun se jiġi mogħti 'l-pazjenti li jkunu morda serjament b'cIAI kkawżati minn perforazzjoni tal-musrana klinikament evidenti jew pazjenti bil-bidu ta' sepsis jew xokk settiku (ara sezzjoni 4.8).
English: Overgrowth of non-susceptible organisms, including fungi (see section 4.4).
Maltese: Tkabbir żejjed ta' organiżmi li mhumiex suxxettibli, li jinkludu fungi (ara sezzjoni 4.4)
English: In clinical trials in cIAI patients, impaired healing of the surgical wound has been associated with superinfection.
Maltese: Fi provi kliniċi f'pazjenti b'cIAI, fejqan indebolit tal-ferita kirurġika ġie assoċjat ma' superinfezzjoni.
English: Powder for solution for infusion (powder for infusion).
Maltese: Trab għal soluzzjoni għall-infużjoni (trab għall-infużjoni).
English: Species for which acquired resistance may be a problem Gram-negative Aerobes
Maltese: Speċijiet li għalihom ir-reżistenza miksuba tista' tkun problema Aerobi Gram-negattivi
English: Tigecycline in recommended dosage did not affect the rate or extent of absorption, or clearance of digoxin (0.5 mg followed by 0.25 mg daily) when administered in healthy adults.
Maltese: Fid-dożaġġ irrakkomandat tigecycline ma jaffettwax ir-rata jew l-estensjoni tal-assorbiment, jew t-tneħħija ta' digoxin (0.5 mg segwiti b'0.25 mg kuljum) meta jiġi mogħti lill-adulti f'saħħithom.
English: • Injection site reaction (pain, redness, inflammation)
Maltese: • Reazzjoni fil-lok tal-injezzjoni (uġigħ, ħmura, infjammazzjoni)
English: Pseudomonas aeruginosa *denotes species against which it is considered that activity has been satisfactorily demonstrated in clinical studies.
Maltese: * juri speċi li kontra tagħha huwa kkonsidrat li l-attività ġiet murija sodisfaċenti fl-istudji kliniċi.
English: Tygacil is distributed in a ten vial tray pack.
Maltese: Kif jidher Tygacil u l-kontenut tal-pakkett
English: If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before you are given Riximyo.
Maltese: Qabel ma tingħata Riximyo inti se tingħata mediċini oħra (medikazzjoni ta' qabel) sabiex jiġu evitati jew jitnaqqsu l-effetti sekondarji possibbli.
English: p-value (Wald test,
Maltese: valur p (test ta' Wald,
English: Riximyo contains the active substance “rituximab”.
Maltese: Riximyo fih is-sustanza attiva “rituximab”.
English: Severe (grade 3/4) neutropenia was reported in 4.2%, anaemia in 1.1% and thrombocytopenia in 1.7% of the patients.
Maltese: (grad 3/4) kienet irrapportata f'4.2%, anemija f'1.1% u tromboċitopenija f'1.7% tal-pazjenti.
English: 6336 Langkampfen AUSTRIA
Maltese: 6336 Langkampfen L-Awstrija
English: Riximyo is a biosimilar medicinal product.
Maltese: Riximyo huwa prodott mediċinali bijoloġiku simili.
English: Very Rare Not known aetiology, +acute bronchitis, +sinusitis, hepatitis B1
Maltese: +bronkite akuta, +sinusite, epatite B1
English: Sepsis, +pneumonia, +febrile infection, +herpes zoster, +respiratory tract infection, fungal infections, infections of unknown
Maltese: Sepsi, +pnewmonja, +infezzjoni bid-deni, +herpes zoster, +infezzjoni flapparat respiratorju, infezzjoni mill-moffa, infezzjonijiet b'etjoloġija mhux magħrufa,
English: Age, gender and WHO performance status had no effect on the pharmacokinetics of rituximab.
Maltese: Età, sess, u WHO performance status ma kellhom l-ebda effett fuq il farmakokinetika ta' rituximab.
English: Hazard ratio (95% CI)
Maltese: Proporzjon ta' Periklu (CI ta' 95 %)
English: Riximyo may be used for the treatment of several different conditions in adults.
Maltese: Riximyo jista' jintuża għall-kura ta' diversi kundizzjonijiet differenti fl-adulti.
English: Late neutropenia3
Maltese: Newtropenija ittardjata3
English: • The active ingredient in Riximyo is called rituximab.
Maltese: • Is-sustanza attiva f'Riximyo hija msejħa rituximab.
English: The trial demonstrated non-inferiority of rituximab to cyclophosphamide for complete remission (CR) at 6 months (Table 12).
Maltese: Il-prova wriet nuqqas ta' inferjorità ta' rituximab għal cyclophosphamide għal remissjoni kompluta (CR - complete remission) wara 6 xhur (Tabella 12).
English: visible on a chest X-ray.
Maltese: X-ray tas-sider.
English: Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100) and very rare (< 1/10,000).
Maltese: (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100), rari (≥ 1/10,000
English: Riximyo 500 mg sterile concentrate rituximab
Maltese: Riximyo 500 mg konċentrat sterili rituximab
English: Riximyo 100 mg sterile concentrate rituximab
Maltese: Riximyo 100 mg konċentrat sterili rituximab
English: Riximyo contains sodium
Maltese: Riximyo fih is-sodium
English: A total of 197 patients aged 15 years or older with severely, active granulomatosis with polyangiitis (75%) and microscopic polyangiitis (24%) were enrolled and treated in an active-comparator, randomised, double-blind, multicenter, non-inferiority trial.
Maltese: Total ta' 197 pazjent b'età minn 15-il sena 'l fuq bi granulomatosi b'polianġite attiva severa (75%) u polianġite mikroskopika (24%) kienu rreġistrati u kkurati fi prova b'paragun attiv, randomised, double-blind, b'aktar minn ċentru wieħed, dwar nuqqas ta' inferjorità.
English: Riximyo is indicated in adults for the following indications:
Maltese: Riximyo huwa indikat f'adulti għall-indikazzjonijiet li ġejjin:
English: A total of 6/34 (18%) of rituximab treated patients from the maintenance therapy clinical trial developed ADA.
Maltese: Valutazzjonijiet tal-laboratorju Total ta' 6/34 (18%) tal-pazjenti ttrattati b'rituximab mill-prova klinika dwar terapija ta' manteniment żviluppaw ADA.
English: albumin, B symptoms, bulky disease, extranodal sites, bone marrow involvement), the risk ratios for event-free survival and overall survival (R-CHOP compared with CHOP) were less than 0.83 and 0.95 respectively.
Maltese: bulky disease, siti ekstranodali, involvement tal-mudullun), il-proporzjon tar-riskju għal sopravivenza mingħajr episodji u ta' sopravivenza ġenerali (R-CHOP ikkumparat ma' CHOP) kienu inqas minn 0.83 u 0.95 rispettivament.
English: Kaplan-Meier estimate of median time to event (months)
Maltese: Stima Kaplan-Meier tal-Perijodu Medjan sa Avveniment (xhur)
English: Granulomatosis with polyangiitis and microscopic polyangiitis Riximyo, in combination with glucocorticoids, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (Wegener's) (GPA) and microscopic polyangiitis (MPA).
Maltese: Riximyo, flimkien ma' glukokortikojdi, huwa indikat għat-trattament ta' pazjenti adulti bi granulomatosi b'polianġite (ta' Wegener) (GPA - granulomatosis with polyangiitis) attiva u severa u polianġite mikroskopika (MPA - microscopic polyangiitis).
English: Coagulation disorders, aplastic anaemia, haemolytic anaemia, lymphadeno pathy
Maltese: Disturbi fil-koagulazzj oni, anemija aplastika, anemija emolitika, limfadenopati ja
English: The mean Cmax (N=15) was 408 µg/mL (range, 97 - 764 µg/mL) after the fifth 500 mg/m2 infusion and the mean terminal half-life was 32 days (range, 14 - 62 days).
Maltese: Cmax medja (N = 15) kienet ta' 408 µg/mL (firxa, 97-764 µg/mL) wara l-ħames infużjoni ta' 500 mg/m2 u lhalf-life terminali medja kienet ta' 32 ġurnata (firxa, 14-62 ġurnata).
English: Subsequent doses of Riximyo can be infused at an initial rate of 100 mg/h, and increased by 100 mg/h increments at 30 minute intervals, to a maximum of 400 mg/h.
Maltese: Dożi sussegwenti ta' Riximyo jistgħu jiġu infużi b'rata inizjali ta' 100 mg/siegħa, u miżjuda b'żidiet ta' 100 mg/siegħa f'intervalli ta' 30 minuta, sa massimu ta' 400 mg/siegħa.
English: When should I not have Riximyo?
Maltese: Meta m'għandix nieħu Riximyo?
English: In patients with granulomatosis with polyangiitis (Wegener's) or microscopic polyangiitis in disease remission or pemphigus vulgaris, premedication with 100 mg intravenous methylprednisolone should be completed 30 minutes prior to Riximyo infusions to decrease the incidence and severity of infusion related reactions (IRRs).
Maltese: F'pazjenti bi granulomatosi b'polianġite (ta' Wegener) jew polianġite mikroskopika f'remissjoni tal marda jew pemphigus vulgaris, medikazzjoni minn qabel b'100 mg methylprednisolone fil-vini għandha tiġi kompluta 30 minuta qabel infużjonijiet ta' Riximyo biex titnaqqas l-inċidenza u s-severità ta' reazzjonijiet relatati mal-infuzjoni (IRRs - infusion related reactions).
English: How to store Riximyo
Maltese: X'inhu Riximyo
English: Chemical and physical stability of Riximyo diluted in 0.9% sodium chloride solution has been demonstrated for 30 days at 2°C - 8°C and subsequently 24 hours at room temperature (≤25°C).
Maltese: Stabbiltà kimika u fiżika ta' Riximyo dilwit f'soluzzjoni ta' 0.9% sodium chloride ġiet murija għal 30 ġurnata f'temperatura ta' 2°C - 8°C u sussegwentement għal 24-il siegħa f'temperatura tal-kamra (≤25°C).
English: Angina pectoris,
Maltese: Anġina pectoris, fibrillazzjoni atrijali,
English: Patients received 2 x 1,000 mg of rituximab separated by an interval of two weeks; in addition to methotrexate (10 - 25 mg/week).
Maltese: Il-pazjenti rċevew 2 × 1000 mg ta' rituximab separati b'intervall ta' ġimagħtejn; flimkien ma' methotrexate (10-25 mg/ġimgħa).
English: Asthma, bronchiolitis obliterans, lung disorder, hypoxia
Maltese: bronkolite obliterans, disturb filpulmun, ipoxja
English: Aseptically withdraw the necessary amount of Riximyo, and dilute to a calculated concentration of 1 to 4 mg/mL rituximab into an infusion bag containing sterile, pyrogen-free sodium chloride 9 mg/mL (0.9%) solution for injection or 5% D-Glucose in water.
Maltese: Neħħi b'mod assetiku l-ammont neċessarju ta' Riximyo, u iddilwa għal konċentrazzjoni kkalkulata ta' minn 1 sa 4 mg/mL ta' rituximab f'borża tal-infużjoni li jkun fiha, soluzzjoni għall-injezzjoni sterili u mingħajr piroġeni ta' sodium chloride 9 mg/mL (0.9%) jew 5% D-Glucose fl-ilma.
English: Follicular lymphoma
Maltese: Popolazzjoni pedjatrika
English: Table 10b First-line treatment of chronic lymphocytic leukaemia Hazard ratios of progression-free survival according to Binet stage (ITT) - 48.1 months median observation time
Maltese: Proporzjonijiet ta' periklu ta' sopravivenza mingħajr progressjoni skont l istadju Binet (ITT) - perijodu medjan ta' osservazzjoni ta' 48.1 xahar
English: Riximyo is indicated for the treatment of patients with CD20 positive diffuse large B cell non-Hodgkin's lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy.
Maltese: Riximyo huwa indikat għall-kura ta' pazjenti b'limfoma mhux ta' Hodgkin taċ-ċellula B kbira f'mifruxa pożittiva għal CD20 flimkien ma' kimoterapija CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone).
English: Transient increase in serum IgM levels3
Maltese: Żieda temporanja fil-livelli ta' IgM fis-serum3
English: Anaemia, +pancytopenia, +granulocytopenia
Maltese: +panċitopenija +granuloċitope nija
English: Chemical and physical stability of Riximyo diluted in 5% glucose solution has been demonstrated for 24 hours at 2°C - 8°C and subsequently 12 hours at room temperature (≤25°C).
Maltese: Stabbiltà kimika u fiżika ta' Riximyo dilwit f'soluzzjoni ta' 5% glucose ġiet murija għal 24 siegħa f'temperatura ta' 2°C - 8°C u sussegwentement għal 12-il siegħa f'temperatura tal-kamra (≤25°C).
English: In the maintenance therapy clinical trial, the incidence of all-grade neutropenia was 0% for rituximabtreated patients vs 5% for azathioprine treated patients.
Maltese: 0% għall-pazjenti ttrattati b'rituximab vs 5% għall-pazjenti ttrattati b'azathioprine.
English: The incidence of ADRs of all grades and grade 3 /4 ADR was similar in elderly patients compared to younger patients (< 65 years).
Maltese: L-inċidenza ta' ADRs ta' kull grad u ta' ADRs ta' grad 3/4 kienet simili f'pazjenti anzjani meta mqabbel ma' pazjenti iżgħar (< 65 sena).
English: Figure 2: Number of patients who were off or on minimal corticosteroid (≤10mg/day) therapy over time
Maltese: Figura 2: Numru ta' pazjenti li kienu mingħajr terapija b'kortikosterojdi jew fuq terapija minima ta' kortikosterojdi (≤10mg/jum) maż-żmien
English: Hypertonia, myalgia, arthralgia, back pain, neck pain, pain
Maltese: mijalġja, artralġja, uġigħ fiddahar, uġigħ fl-għonq, uġigħ
English: reactions.
Maltese: Nazzjonali.
English: In placebo-controlled periods of clinical trials, 0.94% (13/1,382) of rituximab treated patients and 0.27% (2/731) of placebo patients developed severe neutropenia.
Maltese: F'perjodi kkontrollati bil-plaċebo tal-provi kliniċi, 0.94% (13/1382) tal-pazjenti kkurati b'rituximab u
English: In the clinical trial evaluating rituximab maintenance treatment in relapsed/refractory follicular lymphoma, median IgG levels were below the lower limit of normal (LLN) (< 7 g/L) after induction treatment in both the observation and the rituximab groups.
Maltese: Livelli ta' IgG Fil-prova klinika li vvalutat kura ta' manteniment b'rituximab f'limfoma follikulari li rkadat jew reġgħet tfaċċat, livelli medjana ta' IgG kienu taħt il-limitu l-baxx tan-normal (LLN) (< 7 g/L) wara l kura ta' induzzjoni kemm fil-grupp ta' osservazzjoni kif ukoll f'dak ta' rituximab.
English: Adverse drug reaction rituximab + low-dose prednisone (n = 38)
Maltese: Reazzjoni avversa tal-mediċina rituximab + doża baxxa ta' prednisone
English: Currently, there are limited data on possible interactions with other medicinal products and rituximab.
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni Attwalment, teżisti informazzjoni limitata dwar l-interazzjonijiet possibbli ma' prodotti mediċinali oħra u rituximab.
English: Riximyo should not be administered to patients with an active, severe infection (e.g. tuberculosis, sepsis and opportunistic infections, see section 4.3) or severely immunocompromised patients (e.g. where levels of CD4 or CD8 are very low).
Maltese: Riximyo m'għandux jingħata lil pazjenti b'infezzjoni attiva, severa (eż. tuberkulożi, sepsis u infezzjonijiet opportunistiċi, ara sezzjoni 4.3) jew pazjenti immunokompromessi severament (eż. fejn il-livelli ta' CD4 jew CD8 ikunu baxxi ħafna).
English: Cases of posterior reversible encephalopathy syndrome (PRES) / reversible posterior leukoencephalopathy syndrome (RPLS) have been reported.
Maltese: Avvenimenti newroloġiċi F'kondizzjonijiet awtoimmuni kienu rrappurtati każijiet ta' sindrome ta' enċefalopatija posterjuri riversibbli (PRES - posterior reversible encephalopathy syndrome)/sindrome ta' lewkoenċefalopatija riversibbli posterjuri (RPLS - reversible posterior leukoencephalopathy).
English: In a non-randomised study, patients with relapsed low-grade NHL who received rituximab monotherapy when compared to healthy untreated controls had a lower rate of response to vaccination with tetanus recall antigen (16% vs. 81%) and Keyhole Limpet Haemocyanin (KLH) neoantigen (4% vs. 76% when assessed for > 2-fold increase in antibody titer).
Maltese: Fi studju mhux randomised, pazjenti b'NHL ta' grad baxx li rkadat li rċevew monoterapija ta' rituximab meta mqabbel ma' kontrolli f'saħħithom mhux ikkurati kellhom rata ta' rispons aktar baxxa għal tilqim b'tetanus recall antigen (16% vs. 81%) u b'Keyhole Limpet Haemocyanin (KLH) neoantigen (4% vs. 76% meta stmat għal żieda ta' > darbtejn fit-titer tal-antikorp).
English: Table 4 Adverse drug reactions occurring in ≥ 5% of patients receiving rituximab for maintenance treatment of GPA and MPA, and at a higher frequency than the comparator group
Maltese: Tabella 4 Reazzjonijiet avversi tal-mediċina li seħħew f'≥ 5% tal-pazjenti li rċevew rituximab għal trattament ta' manteniment ta' GPA u MPA, u bi frekwenza ogħla mill-grupp ta' paragun Sistema tal-Klassifika tal-Organi
English: You will always be given Riximyo as a drip (intra-venous infusion).
Maltese: Inti dejjem se tingħata Riximyo bħala dripp (infużjoni fil-vini).
English: Depending on the severity of the IRR and the required interventions, temporarily or permanently discontinue Riximyo.
Maltese: Skont is-severità tal-IRR u l-interventi meħtieġa, waqqaf Riximyo temporanjament jew b'mod permanenti.
English: Dyspnoea
Maltese: Disġewsja