FrancophonIA/ELRC3.0 huggingface dataset:
English: In the AMBITION study, patients received 5 mg ambrisentan daily for the first 8 weeks before up titrating to 10 mg, dependent on tolerability (see section 5.1).
Maltese: Fl-istudju AMBITION, il-pazjenti rċevew 5 mg ambrisentan kuljum għall-ewwel 8 ġimgħat qabel titrazzjoni għal 10 mg, skont it-tollerabilità (ara sezzjoni 5.1).
English: Therefore, ambrisentan should not be initiated in patients with severe hepatic impairment or clinically significant elevated hepatic aminotransferases (>3xULN) (see sections 4.3 and 4.4).
Maltese: Għalhekk, ambrisentan m'għandux jinbeda f'pazjenti b'indeboliment sever tal-fwied, jew b'aminotransferases klinikament u b'mod sinifikanti għolja fil-fwied (>3× ULN) (ara s-sezzjonijiet 4.3 u 4.4).
English: Nasal bone hyperplasia of the ethmoid turbinates has been observed in the nasal cavity of rats treated with ambrisentan, at exposure levels 3-fold the clinical AUC.
Maltese: Ġiet osservata iperplasja fl-għadam spirali etmojde tal-imnieħer fil-ħofra tal-imnieħer ta' firien ikkurati b'ambrisentan, b'livelli ta' esponiment 3-darbiet aktar mill-AUC kliniku.
English: Adverse reactions identified from 12 week placebo controlled clinical trial data are included below by system organ class and frequency.
Maltese: 12-il ġimgħa kkontrollat bi plaċebo huma inklużi taħt skont is-sistema tal-klassifika tal-organi u l-frekwenza.
English: However no testicular changes were observed in dog studies of up to 39 weeks duration at an exposure 35-fold that seen in humans based on AUC.
Maltese: Madankollu ma kinux osservati bdil fit-testikoli fi studji fi klieb sa tul ta' 39 ġimgħa b'esponiment ta' 35 darba dak osservat fil-bniedem ibbażat fuq AUC.
English: The increase in digoxin exposure observed in the presence of multiple doses of ambrisentan was not considered clinically relevant, and no dose adjustment of digoxin is warranted (see section 4.5).
Maltese: Iż-żieda flesponiment ta' digoxin osservata fil-preżenza ta' dożi ripetuti ta' ambrisentan ma kinitx meqjusa ta' rilevanza klinika, u ma hemm bżonn tal-ebda aġġustament fid-doża (ara sezzjoni 4.5).
English: A decrease in plasma inhibin-B concentration and an increase in plasma FSH concentration were observed.
Maltese: Kienu osservati tnaqqis fil-konċentrazzjoni ta' inhibin-B fil-plażma u żjieda fil-konċentrazzjoni ta' FSH filplażma.
English: This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodiumfree'.
Maltese: Din il-mediċina fiha inqas minn 1 mmol sodium (23 mg) f'kull pillola, li jfisser li essenzjalment hija “mingħajr sodium”.
English: • That Ambrisentan Mylan is teratogenic in animals
Maltese: • Li Ambrisentan Mylan huwa teratoġeniku fl-annimali
English: Mean decreases from baseline (ranging from 0.9 to 1.2 g/dL) in haemoglobin concentrations persisted for up to 4 years of treatment with ambrisentan in the long-term open-label extension of the pivotal Phase 3 clinical studies.
Maltese: Tnaqqis medju mil-linja bażi (li jvarja minn 0.9 sa 1.2 g/dL) fil-konċentrazzjonijiet tal-emoglobina ppersista sa 4 snin ta' kura b'ambrisentan fl-estensjoni open-label fit-tul tal-istudji kliniċi pivitali ta' Fażi 3. Wara t-tqegħid fis-suq, kienu rrappurtati każijiet ta' anemija li jeħtieġu trasfużjoni ta' ċelluli tad-demm (ara sezzjoni 4.8).
English: • inflammation of the liver caused by the body's own defences (autoimmune hepatitis) In combination with tadalafil
Maltese: • infjammazzjoni tal-fwied ikkawżata mid-difiżi tal-ġisem innifsu (epatite awtoimmuni) Flimkien ma' tadalafil
English: When used in combination with tadalafil, Ambrisentan Mylan should be titrated to 10 mg once daily.
Maltese: Meta użat f'kombinazzjoni ma' tadalafil, Ambrisentan Mylan għandu jiġi titrat għal 10 mg darba kuljum.
English: No clinically meaningful effects on the pharmacokinetics of ambrisentan or sildenafil were seen during a drug-drug interaction study in healthy volunteers, and the combination was well tolerated.
Maltese: Ma kien hemm l-ebda effetti ta' valur kliniku fuq il-farmakokinetika ta' ambrisentan jew sildenafil waqt studju fuq interazzjonijiet bejn mediċina u oħra f'voluntiera b'saħħithom u t-taħlita kienet ittollerata tajjeb.
English: Patients on ambrisentan therapy should be closely monitored when starting treatment with rifampicin (see sections 4.4 and 5.2).
Maltese: Pazjenti fuq kura b'ambrisentan għandhom ikunu ssorveljati mill-qrib meta tinbeda kura b'rifampicin (ara sezzjonijiet 4.4 u 5.2).
English: Ambrisentan was clastogenic when tested at high concentrations in mammalian cells in vitro.
Maltese: Ambrisentan kien klastoġeniku meta ttestjat in vitro f'konċentrazzjonijiet għoljin f'ċelluli mammali.
English: Patients on ambrisentan therapy should be closely monitored when starting treatment with rifampicin (see sections 4.4 and 4.5).
Maltese: Pazjenti fuq kura b'ambrisentan għandhom ikunu ssorveljati mill-qrib meta tinbeda kura b'rifampicin (ara sezzjonijiet 4.4 u 4.5).
English: Ambrisentan Mylan 5 mg film-coated tablets
Maltese: Ambrisentan Mylan 5 mg pilloli miksija b'rita
English: The primary endpoint was the time to first occurrence of a clinical failure event, defined as: - death, or - hospitalisation for worsening PAH, - disease progression; - unsatisfactory long-term clinical response.
Maltese: Il-punt ta' tmiem primarju kien iż-żmien sal-ewwel okkorrenza ta' avveniment ta' insuffiċjenza klinika, iddefinit bħala: - mewt, jew - rikoveru l-isptar għall-PAH li tmur għall-agħar, - progressjoni tal-marda, - rispons kliniku fit-tul mhux sodisfaċenti.
English: Ear and labyrinth disorders Tinnitus
Maltese: Disturbi fil-widnejn u fis-sistema labirintika Tinnite
English: • swelling in the hands, ankles or feet caused by fluid (peripheral oedema)
Maltese: • nefħa fl-idejn, fl-għekiesi jew fis-saqajn ikkawżata minn fluwidu (edima periferali)
English: • loss of appetite
Maltese: • nuqqas ta' aptit
English: Cases of pulmonary oedema have been reported with vasodilating medicinal products, such as ERAs, when used in patients with pulmonary veno-occlusive disease.
Maltese: Kienu rrapurtati każi ta' edima pulmonari bi prodotti mediċinali vażodilataturi, bħal ERAs, meta ntużaw f'pazjenti b'mard okklussiv tal-vini tal-pulmun.
English: A total of 17 patients (6.5%) in the ambrisentan treatment groups had decreases in haemoglobin of ≥15% from baseline and which fell below the lower limit of normal.
Maltese: Fil-gruppi ta' trattament ta' ambrisentan total ta' 17-il pazjent (6.5%) kellhom nuqqas fl-emoglobina ta' ≥15% mil-linja bażi u li waqgħat taħt il-limitu l-aktar baxx tannormal
English: The frequency of headache appeared higher with 10 mg ambrisentan.
Maltese: Il-frekwenza ta' uġigħ ta' ras dehret aktar b'10 mg ta' ambrisentan.
English: Patients enrolled had IPAH or PAH associated with connective tissue disease (PAH-CTD).
Maltese: Komponent bħala l-Ewwel Avveniment ta' Insuffiċjenza Klinika (Aġġudikat) Mewt (kull kawża)
English: 10 to 12
Maltese: 10 sa 12
English: 28 days).
Maltese: 28 jum).
English: 101 International Drive Portsmouth, NH 03801-2815 United States
Maltese: 101 International Drive Portsmouth, NH 03801-2815
English: Bradycardia*
Maltese: Bradikardija*
English: Lonza Biologics plc 228 Bath Road Slough, Berks SL1 4DX United Kingdom
Maltese: Lonza Biologics plc 228 Bath Road Slough, Berks SL1 4DX
English: Arzerra and chlorambucil (N=221)
Maltese: Arzerra u chlorambucil (N=221)
English: Diphenhydramine 50 mg or cetirizine 10 mg (or equivalent)
Maltese: Diphenhydramine 50 mg jew cetirizine 10 mg (jew ekwivalenti)
English: Infusion 1
Maltese: Infużoni 1
English: ------Chlorambucil (N=226) Median 13.1 months____Ofatumumab + Chlorambucil (N=221)
Maltese: ------Chlorambucil (N=226) Medjana ta' 13.1 xhur Ofatumumab + Chlorambucil (N=221)
English: Novartis Pharma GmbH, Roonstrasse 25, 90429 Nuremberg, Germany
Maltese: Novartis Pharma GmbH, Roonstrasse 25, 90429 Nuremberg, Il-Ġermanja
English: Glaxo Operations UK Limited (Trading as Glaxo Wellcome Operations), Harmire Road, Barnard Castle, County Durham, DL12 8DT, United Kingdom Novartis Pharmaceuticals UK Limited, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR, United Kingdom
Maltese: Glaxo Operations UK Limited (Trading as Glaxo Wellcome Operations), Harmire Road, Barnard Castle, County Durham, DL12 8DT, Ir-Renju Unit Novartis Pharmaceuticals UK Limited, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR, Ir-Renju Unit
English: st infusion (300 mg)
Maltese: L-1el infużjoni (300 mg)
English: See section 5.1 for further information.
Maltese: Ara sezzjoni 5.1 għal aktar informazzjoni.
English: Refractory CLL (ofatumumab)
Maltese: CLL refrattarja (ofatumumab)
English: Intravenous corticosteroid (prednisolone or equivalent)
Maltese: Kortikosterojde ġolvina (prednisolone jew ekwivalenti)
English: Cycle 1 61.4
Maltese: Ċiklu 1 61.4
English: Age ≥75 years (n=119) Co-morbidity 0 or 1 (n=126) Co-morbidity 2 or more (n=321) ECOG 0, 1 (n=411) ECOG 2 (n=35)
Maltese: Età ≥75 sena (n=119) Komorbidità 0 jew 1 (n=126) Komorbidità 2 jew iktar (n=321) ECOG 0, 1 (n=411) ECOG 2 (n=35)
English: Cycle 1 51.8 2620
Maltese: Ċiklu 1 51.8 2620
English: Elderly (≥65 years of age)
Maltese: Anzjani (≥65 sena)
English: 9/l)
Maltese: NUMRU(I)
English: The ORR was higher for OFA+FC versus FC (84% versus 68%, p=0.0003).
Maltese: L-ORR kien ogħla għal OFA+FC kontra FC (84% kontra 68%, p=0.0003).
English: Arzerra contains sodium
Maltese: Arzerra fih sodium
English: Baseline cytogenetic (FISH) data were available for 209 patients.
Maltese: Dejta ċitoġenika tal-linja bażi (FISH) kienet disponibbli għal 209 pazjenti.
English: See also section 4, ‘Possible side effects'.
Maltese: Ara wkoll sezzjoni 4, ‘Effetti sekondarji li jista' jkollu'.
English: Urticaria*, pruritus*,
Maltese: Urtikarja*, ħakk*,
English: Infusions 3* to 12 Infusion rate (ml/hour)
Maltese: Infużjonijiet 3* sa 12 Ir-rata tal-infużjoni (ml/siegħa)
English: • 2000 mg every 28 days for 4 doses (infusions 9 to 12)
Maltese: • 2000 mg kull 28 jum għal 4 dożi (infużjonijiet 9 sa 12)
English: MedDRA System Organ Class
Maltese: Klassifikazzjoni tas-Sistemi u talOrgani MedDRA
English: Relapsed CLL (ofatumumab + FC)
Maltese: CLL li tirkadi (ofatumumab + FC)
English: One ml contains 20 mg ofatumumab.
Maltese: 1 ml fih 20 mg ofatumumab.
English: ORR (%) 95% CI P value p<0.001
Maltese: ORR (%) CI ta' 95% Valur p p<0.001
English: Oral paracetamol (acetaminophen) Oral or intravenous antihistamine
Maltese: Paracetamol orali (acetaminophen) Antiistamina orali jew ġol-vina
English: Hepatitis B infection and reactivation, progressive multifocal leukoencephalopathy
Maltese: Infezzjoni u riattivazzjoni talepatite B, lewkoenċefalopatija multifokali progressiva
English: What Arzerra contains - The active substance is ofatumumab.
Maltese: X'fih Arzerra - Is-sustanza attiva hi ofatumumab.
English: Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 were enrolled into the study and 91% had an ECOG performance status of 0 or 1.
Maltese: Pazjenti bi status tal-prestazzjoni tal-Eastern Cooperative Oncology Group (ECOG) ta' 0 sa 2 kienu rreġistrati fl-istudju u 91% kellhom status tal-prestazzjoni tal-ECOG ta' 0 jew 1.
English: Refractory CLL:
Maltese: CLL Refrattarja:
English: Median creatinine clearance (CrCl), assessed with the use of the Cockroft-Gault formula, was 70 ml/min and 48% of patients had a CrCl of <70 ml/min.
Maltese: L-ikklirjar medjan tal-kreatinina (CrCl), ivvalutat bl-użu ta' formula Cockroft-Gault, kien ta' 70 ml/min u 48% tal-pazjenti kallhom CrCl ta' <70 ml/min.
English: Also contains: arginine, sodium acetate (E262), sodium chloride, polysorbate 80 (E433), edetate disodium (E386), hydrochloric acid (E507), water for injections.
Maltese: Fih ukoll: arginine, sodium acetate (E262), sodium chloride, polysorbate 80 (E433), edetate disodium (E386), hydrochloric acid (E507), ilma għall-injezzjonijiet.
English: Population (treatment) Dosing regimen
Maltese: Popolazzjoni (trattament)
English: Hazard ratio P value p<0.001
Maltese: Proporzjon tal-periklu Valur p p<0.001
English: Pharmacotherapeutic group: antineoplasic agents, monoclonal antibodies, ATC code: L01XC10
Maltese: Kategorija farmakoterapewtika: aġenti antineoplastiċi, antikorpi monoklonali, Kodiċi ATC:
English: The response rate in patients with prior rituximab therapy was 38% (95% CI: 23, 61).
Maltese: Ir-rata ta' rispons f'pazjenti li kienu ħadu terapija b'rituximab qabel kienet 38% (95% CI: 23, 61).
English: Novartis Europharm Limited Frimley Business Park Camberley GU16 7SR United Kingdom
Maltese: Novartis Europharm Limited Frimley Business Park Camberley GU16 7SR Ir-Renju Unit
English: Patients received a median of 5 prior therapies, including rituximab (57%).
Maltese: Il-pazjenti rċivew medjan ta' 5 terapiji qabel, inkluż rituximab (57%).
English: Approximately 90% of patients received 3-6 cycles of ofatumumab and 66% completed 6 cycles.
Maltese: Madwar 90% tal-pazjenti rċevew 3-6 ċikli ta' ofatumumab u 66% temmew 6 ċikli.
English: Lymphocyte count ≥50% decrease Normalisation (≤4x10
Maltese: Għadd ta' limfoċiti Tnaqqis ta' ≥50% Lura għan-normal (≤4x10
English: There was no statistically significant difference in the primary endpoint of IRC assessed PFS (5.4 vs. 3.6 months, HR=0.79, p=0.27).
Maltese: Ma kien hemm ebda differenza statistikament sinifikanti fil-punt ta' tmiem primarju tal-PFS ivvalutata bl-IRC (5.4 meta mqabbel ma' 3.6 xhur, HR=0.79, p=0:27).
English: MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERS RESPONSIBLE
Maltese: TAS-SUSTANZA BIJOLOĠIKA ATTIVA U MANIFATTURI
English: No clinically relevant pharmacokinetic interactions were observed between ofatumumab and fludarabine, cyclophosphamide,bendamustine, chlorambucil, or its active metabolite, phenylacetic acid mustard.
Maltese: Ma kienet osservata ebda interazzjoni farmakokinetika relevanti klinikament bejn ofatumumab u fludarabine, cyclophosphamide, bendamustine, chlorambucil, jew il-metabolita attiva tagħha, il-mustarda tal-aċidu fenilaċetiku.
English: CIRS-G ≤10 (n=310) CIRS-G >10 (n=137) CrCl <70 ml/min (n=214) CrCl ≥70 ml/min (n=227) 17p or 11q deletion (n=90) IGHV mutated (≤98%) (n=177) IGHV unmutated (>98%) (n=227) β2M ≤3500 μg/l (n=109) β2M >3500 μg/l (n=322) ZAP-70 positive (n=161) ZAP-70 intermediate (n=160) ZAP-70 negative (n=100) IGHV mutated & ZAP-70 negative (n=60)
Maltese: IGHV mutata (≤98%) (n=177) IGHV mhux mutata (>98%) (n=227) β2M ≤3500 μg/l (n=109) β2M >3500 μg/l (n=322) ZAP-70 pożittiva (n=161) ZAP-70 intermedja (n=160)
English: Tumour lysis syndrome
Maltese: Sindrome taddiżintegrazzjoni tattumur
English: Arzerra was administered as monotherapy to 223 patients with refractory CLL (study Hx-CD20-406).
Maltese: Arzerra ingħata bħala monoterapija lil 223 pazjent b'CLL refrattarja (studju Hx-CD20-406).
English: ----OFA + FC (N=183) Median 28.94 months 95% CI (22.80, 35.88) ____FC (N=182) Median 18.83 months 95% CI (14.42,25.82)
Maltese: ----OFA + FC (N=183) Medjana ta' 28.94 xhur CI ta' 95% (22.80, 35.88)
English: Patient median age was 61 years (range: 32 to 90 years, 7% were 75 years of age or older), 60% were male and 16%, 55% and 28% of patients were Binet stage A, B and C, respectively.
Maltese: L-età medjana tal-pazjenti kienet 61 sena (firxa: 32 sa 90 sena, 7% kellhom 75 sena jew aktar), 60% kienu rġiel u 16%, 55% u 28% talpazjenti kellhom stadju Binet A, B u C, rispettivament.
English: The median progression-free survival was 5.5 months (95% CI: 4.6, 6.4) and the median overall survival was 17.4 months (95% CI: 15.0, 24.0).
Maltese: Il-medjan ta' sopravivenza ħielsa minn progressjoni kien 5.5 xhur (95% CI: 4.6, 6.4) u l-medjan ta' sopravivenza globali kien ta' 17.4 xhur (95% CI: 15.0, 24.0).
English: Arzerra in combination with chlorambucil showed a statistically significant (71%) improvement in median PFS compared with chlorambucil alone (HR: 0.57; 95% CI: 0.45, 0.72) (see Table 1 and Figure 1).
Maltese: Arzerra mogħti f'taħlita ma' chlorambucil wera titjib statistikament sinifikanti (71%) fil-PFS medjana meta mqabbel ma' chlorambucil waħdu (HR: 0.57; 95% CI: 0.45, 0.72) (ara t-Tabella 1 u Figura 1).
English: The overall safety profile of ofatumumab is based on data from 1,168 patients in clinical trials in CLL (see section 5.1).
Maltese: Il-profil tas-sikurezza ġenerali ta' ofatumumab huwa bbażat fuq dejta minn 1,168 pazjent fi provi kliniċi dwar CLL (ara sezzjoni 5.1).
English: Thirteen (7%) patients treated with ofatumumab in combination with fludarabine and cyclophosphamide, and 5 (3%) patients treated with fludarabine and cyclophosphamide had late-onset neutropenia.
Maltese: Tlettax-il (7%) pazjent ittrattati b'ofatumumab flimkien ma' fludarabine u cyclophosphamide, u 5 (3%) pazjenti ittrattati b'fludarabine u cyclophosphamide kellhom newtropenija li ħarġet tard.
English: The median number of cycles completed in patients was 6 (total Arzerra dose of 6300 mg).
Maltese: In-numru medjan ta' ċikli mwettqin fil-pazjenti kien ta' 6 (doża totali ta' Arzerra ta' 6300 mg).
English: Pulmonary oedema*, hypoxia*
Maltese: Edema pulmonari*, ipoksja*
English: Approximately 60% of patients received 3-6 cycles of Arzerra and 32% received 7-12 cycles.
Maltese: Madwar 60% tal-pazjenti ngħataw 3-6 ċikli ta' Arzerra u 32% ingħataw 7-12-il ċiklu.
English: Arzerra 100 mg sterile concentrate ofatumumab
Maltese: Arzerra 100 mg konċentrat sterili ofatumumab
English: Median, all patients 95% CI
Maltese: 95% CI
English: Infusion-related reactions may include, but are not limited to, anaphylactoid events, bronchospasm, cardiac events (e.g. myocardial ischaemia/infarction, bradycardia), chills/rigors, cough, cytokine release syndrome, diarrhoea, dyspnoea, fatigue, flushing, hypertension, hypotension, nausea, pain, pulmonary oedema, pruritus, pyrexia, rash, and urticaria.
Maltese: Reazzjonijiet għall-infużjoni jistgħu jinkludu, iżda mhumiex limitati għal każijiet anafilaktojd, bronkospażmi, każijiet tal-qalb (eż. iskemija mijokardijaka/infart, bradikardija), tkexkix ta' bard/tertir, sogħla, sindrome ta' reħi ta' cytokine, dijarea, qtugħ ta' nifs, għeja, fwawar, pressjoni għolja, pressjoni baxxa, tqalligħ, uġigħ, edema pulmonari, prurite, deni, raxx, u urtikarja.
English: Chlorambuci + Chl
Maltese: Ofatumumab flimkien ma' Chlorambuci + Chl
English: Hazard Ratio=0.57 95% CI (0.45, 0.72) p-value<0.001
Maltese: CI ta' 95% (0.45, 0.72) valur p<0.001
English: Median 22.4 months
Maltese: Medjana ta' 22.4 xhur
English: Arzerra 1000 mg sterile concentrate ofatumumab
Maltese: Arzerra 1000 mg konċentrat sterili ofatumumab
English: Nervous system disorders Metabolism and nutrition disorders
Maltese: Disturbi filmetaboliżmu u nnutrizzjoni
English: Possible side effects
Maltese: Effetti sekondarji oħra possibbli
English: The median CIRS score was 7 (range: 4 to 17), 36% of patients had CrCL <70 ml/min, 93% of patients had ECOG 0 or 1.
Maltese: Il-punteġġ CIRS medjan kien 7 (firxa: 4 sa 17), 36% tal-pazjenti kellhom CrCL <70 ml/min, 93% tal-pazjenti kellhom ECOG 0 jew 1.
English: Agranulocytosis, coagulopathy, red cell aplasia, lymphopenia
Maltese: Agranuloċitosi, koagulopatija, aplasja taċ-ċelluli l-ħomor, limfopenija
English: Date of first authorisation: 19 April 2010 Date of latest renewal: 17 February 2015
Maltese: Data tal-aħħar tiġdid: 17 Frar 2015
English: The overall survival results showed a HR=0.78 (56.4 months versus 45.8 months for the OFA+FC arm versus FC arm; 95% CI: 0.56-1.09; p=0.1410).
Maltese: Ir-riżultati tas-sopravivenza globali wrew HR=0.78 (56.4 xhur kontra 45.8 xhur għall-grupp ta' OFA+FC kontra l-grupp ta' FC; CI ta' 95%: 0.56-1.09; p=0.1410).
English: Median Cumulative Illness Rating Score for Geriatrics (CIRS-G) was 9 and 31% of patients had a CIRS-G >10.
Maltese: Il-Punteġġ Medjan tal-Mard Kumulattiv għall-Ġerijatriċi (CIRS-G) kien ta' 9 u 31% tal-pazjenti kellhom CIRS-G >10.
English: The overall response rate in this group was 63% (95.3% CI: 35, 85).
Maltese: 3% CI: 35, 85).
English: Adverse reactions reported in patients treated with ofatumumab as monotherapy and with ofatumumab in combination with chemotherapy, are listed below by MedDRA body system organ class and by frequency, using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (< 1/10,000); not known (cannot be estimated from available data).
Maltese: Reazzjonijiet avversi rrapportati f'pazjenti ttrattati b'ofatumumab bħala monoterapija u b'ofatumumab flimkien ma' kimoterapija, huma elenkati hawn taħt skont il-klassifikazzjoni tas-sistemi u tal-organi tal-ġisem MedDRA u skont il-frekwenza, billi qed tintuża l-konvenzjoni li ġejja: komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10); mhux komuni (≥1/1,000 sa <1/100); rari (≥1/10,000 sa <1/1,000); rari ħafna (<1/10,000); mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Ofatumumab is a human monoclonal antibody produced in a recombinant murine cell line (NS0).
Maltese: Ofatumumab huwa antikorp monoklonali uman magħmul f'linja ta' ċelluli murine rikombinanti (NS0).
English: Bowel obstruction
Maltese: Disturbi vaskulari
English: Ofatumumab has a small volume of distribution, with mean Vss values ranging from 1.7 to 8.1 l across studies, dose levels, and infusion number.
Maltese: Ofatumumab għandu volum żgħir ta' distribuzzjoni, b'valuri medji ta' Vss fuq medda bejn 1.7 u 8.1 l tul studji, livelli ta' doża u numru tal-infużjoni.
English: (E433), edetate disodium (E386), hydrochloric acid (E507) (for pH-adjustment), water for injections (see “Arzerra contains sodium” under section 2).
Maltese: polysorbate 80 (E433), edetate disodium (E386), hydrochloric acid (E507) (għal aġġustament tal-pH), ilma għall-injezzjonijiet (ara “Arzerra fih sodium” taħt sezzjoni 2).
English: Table 5 Ofatumumab pharmacokinetic parameters (geometric mean)
Maltese: Il-parametri farmakokinetiċi ta' ofatumumab (medja ġeometrika)
English: • muscle spasms.
Maltese: • spażmi fil-muskoli.
English: This medicinal product contains 34.8 mg sodium per 300 mg dose, 116 mg sodium per 1000 mg dose and 232 mg sodium per 2000 mg dose.
Maltese: Arzerra fih 34.8 mg ta' sodium f'kull doża ta' 300 mg, 116 mg sodium f'kull doża ta' 1000 mg u 232 mg ta' sodium f'kull doża ta' 2000 mg.
English: 300 mg dose - Use three 100 mg/5 ml vials (15 ml total, 5 ml per vial):
Maltese: Doża ta' 300 mg - Uża tliet kunjetti ta' 100 mg/5 ml (total ta' 15 ml, 5 ml kull kunjett):
English: Glaxo Operations UK Ltd. Harmire Road Barnard Castle Durham, DL12 8DT United Kingdom
Maltese: Harmire Road Barnard Castle Durham, DL12 8DT Ir-Renju Unit
English: • 2000 mg weekly for 7 doses (infusions 2 to 8) followed 4-5 weeks later by
Maltese: • 2000 mg kull ġimgħa għal 7 dożi (infużjonijiet 2 sa 8) segwita 4-5 ġimgħat wara b'
English: Classical biotransformation studies have not been performed.
Maltese: Ma sarux studji klassiċi ta' bijotrasformazzjoni.
English: There was a rapid and sustained depletion of CD20
Maltese: Kien hemm tnaqqis malajr u li nżamm fiċ-ċelluli CD20
English: 36 patients had a normal karyotype and chromosomal aberrations were detected in 174 patients; there were 47 patients with 17p deletion, 73 patients with 11q deletion, 23 patients with trisomy 12q, and 31 patients with 13q deletion as the sole aberration.
Maltese: 36 pazjent kellhom karjotip normali u aberrazzjonijiet tal-kromosomi kienu osservati f'174 pazjent; kien hemm 47 pazjent bi tneħħija ta' 17p, 73 pazjent bi tneħħija ta' 11q, 23 pazjent bi trijostomija 12q, u 31 pazjent bi tneħħija ta' 13q bħala l-unika aberrazzjoni.
English: The ORR in this group was 43% (95.3% CI: 33, 53).
Maltese: 3% CI: 33, 53).
English: Refractory CLL
Maltese: CLL Refrattarja
English: CR (%) CR with MRD negativity (% of CR) Median duration of response, all patients, months 95% CI P value p<0.001
Maltese: CR (%) CR b'negattività tal-MRD (% ta' CR) Tul medjan tar-rispons, pazjenti kollha, xhur CI ta' 95% Valur p p<0.001