FrancophonIA/ELRC3.0 huggingface dataset:
English: The recommended dosage of Ritemvia for induction of remission therapy of granulomatosis with polyangiitis and microscopic polyangiitis is 375 mg/m2 body surface area, administered as an intravenous infusion once weekly for 4 weeks (four infusions in total).
Maltese: Id-dożaġġ rakkomandat ta' Ritemvia għal terapija għall-induzzjoni ta' remissjoni ta' granulomatosi b'polianġite u polianġite mikroskopika hija ta' 375 mg/m2 tal-erja tas-superfiċje tal-ġisem, mogħti bħala infużjoni fil-vini darba fil-ġimgħa għal 4 ġimgħat (total ta' erba' infużjonijiet).
English: Follicular non-Hodgkin's lymphoma
Maltese: Limfoma follikulari mhux ta' Hodgkin
English: Population pharmacokinetic analysis revealed that BSA and gender were the most significant covariates to explain inter-individual variability in pharmacokinetic parameters.
Maltese: Id-differenzi farmakokinetiċi relatati mas-sess tal-persuna mhumiex meqjusa ta' rilevanza klinika u mhuwiex meħtieġ aġġustament fid-doża.
English: Granulomatosis with polyangiitis and microscopic polyangiitis
Maltese: Esperjenza minn granulomatosi b'polianġite u polianġite mikroskopika)
English: Gastrointestinal disorders dyspepsia, diarrhoea, gastro-oesophageal reflux, mouth ulceration, upper abdominal pain
Maltese: Disturbi taddemm u tassistema limfatika newtropenija, lewkopenija, +newtropenija bid-deni,
English: (n=268) or R-FCM (n=44), according to the investigators' choice.
Maltese: n = 231) jew rituximab flimkien ma' CHOP (R-CHOP, n = 234).
English: The proportion of patients with IgG levels below the LLN was about 60% in the rituximab group throughout the 2 year treatment period, while it decreased in the observation group (36% after 2 years).
Maltese: Il-proporzjon ta' pazjenti b'livelli ta' IgG taħt l-LLN kien madwar 60% filgrupp ta' rituximab tul il-perjodu ta' kura ta' sentejn, filwaqt li naqas fil-grupp ta' osservazzjoni (36% wara sentejn).
English: All patients Newly diagnosed Relapsing n=99 n=48 n=51
Maltese: Iddijanjostikati għallewwel darba n = 48
English: Based on the mechanism of action of rituximab and the knowledge that B cells play an important role in maintaining normal immune response, patients have an increased risk of infection following rituximab therapy (see section 5.1).
Maltese: Ibbażat fuq il-mekkaniżmu ta' azzjoni ta' rituximab u l-għarfien li ċ-ċelluli B għandhom rwol importanti fiż-żamma ta' rispons immuni normali, il-pazjenti jkollhom riskju akbar ta' infezzjoni wara terapija bi rituximab (ara sezzjoni 5.1).
English: All patients in the cyclophosphamide arm received azathioprine maintenance therapy during follow-up.
Maltese: Il-pazjenti kollha fil-grupp ta' cyclophosphamide rċevew terapija ta' manteniment ta' azathioprine waqt ilperjodu li fih ġew segwiti.
English: A small number of spontaneous and literature cases of hypogammaglobulinaemia have been observed in paediatric patients treated with rituximab, in some cases severe and requiring long-term immunoglobulin substitution therapy.
Maltese: Numru żgħir ta' każijiet spontanji u fil-letteratura ta' ipogammaglobulinemija kienu osservati f'pazjenti pedjatriċi kkurati b'rituximab, f'xi każijiet severi u li jeħtieġu terapija fit-tul ta' sostituzzjoni tal-immunoglobulina.
English: Median TTF: years Not reached p < 0.001
Maltese: Ma ntlaħaqx p < 0.001
English: Each vial contains 100 mg of rituximab.
Maltese: Kunjett wieħed fih 100 mg ta' rituximab.
English: The recommended dosage of Ritemvia for the treatment of pemphigus vulgaris is 1000 mg administered as an IV infusion followed two weeks later by a second 1000 mg IV infusion in combination with a tapering course of glucocorticoids.
Maltese: Id-dożaġġ rakkomandat ta' rituximab għat-trattament ta' pemphigus vulgaris huwa ta' 1,000 mg mogħti bħala infużjoni IV segwit ġimagħtejn wara mit-tieni infużjoni IV ta' 1,000 mg flimkien ma' kors ta' glukokortikojdi li jitnaqqsu għax-xejn.
English: The overall safety profile was consistent with the well-established safety profile of rituximab in RA and GPA/MPA and no new adverse drug reactions were reported.
Maltese: Il-profil ta' sigurtà globali kien konsistenti mal-profil ta' sigurtà stabbilit sew ta' rituximab f'RA u GPA/MPA u ma kinux irrappurtati reazzjonijiet avversi tal mediċina ġodda.
English: Complete response (CR/CRu) rate* 48% 67% 53% 67% chi-squared test p value odds ratio (95% CI)
Maltese: Evalwazzjoni retrospettiva post hoc tal-laboratorju Total ta' 19/34 (56%) pazjent b'PV, li kienu ttrattati b'rituximab, kellhom test pożittiv għal antikorpi
English: Table 15 Summary of efficacy by baseline autoantibody status Week 24
Maltese: Tabella 15 Sommarju tal-effikaċja skont l-istat tal-awtoantikorpi fil-linja bażi
English: Duration of response * Disease free survival (DFS)**
Maltese: (DFS)**
English: Table 11 Treatment of relapsed/refractory chronic lymphocytic leukaemia - overview of efficacy results for rituximab plus FC vs. FC alone (25.3 months median observation time) Efficacy parameter
Maltese: Tabella 11 Kura ta' lewkimja limfoċitika kronika li reġgħet tfaċċat/refrattarja - sommarju tar-riżultati tal-effikaċja għal rituximab flimkien ma' FC vs.
English: Blood and lymphatic system disorders neutropenia, leucopenia, +febrile neutropenia, +thrombocytope nia anaemia, +pancytopenia, +granulocytope nia coagulation disorders, aplastic anaemia, haemolytic anaemia, lymphadenopa thy transient increase in serum IgM levels3
Maltese: Dawn is-sintomi huma ġeneralment riversibbli blinterruzzjoni tal-infużjoni ta' rituximab u l-amministrazzjoni ta' mediċina kontra d-deni, antistamina, u, xi kultant, ossiġnu, soluzzjoni ta' melħ fil-vini jew bronkodilaturi, u glukokortikojdi jekk meħtieġ.
English: 1 includes reactivation and primary infections; frequency based on R-FC regimen in relapsed/refractory CLL 2 see also section infection below
Maltese: 1 tinkludi riattivazzjoni u infezzjonijiet primarji; frekwenza ibbażata fuq kors ta' R-FC f'CLL li reġgħet tfaċċat/refrattarja 2 ara wkoll is-sezzjoni infezzjoni taħt
English: Duration of response* Disease free survival (DFS)** Time to new treatment
Maltese: Treatment Group: = Grupp ta' Trattament Number of Patients = Numru ta' Pazjenti Day = Jum
English: Musculoskele tal, connective tissue and bone disorders hypertonia, myalgia, arthralgia, back pain, neck pain, pain
Maltese: mijalġja, artralġja, uġigħ fid-dahar, uġigħ fl-għonq, uġigħ
English: The European Medicines Agency has waived the obligation to submit the results of studies with rituximab in all subsets of the paediatric population with follicular lymphoma and chronic lymphocytic leukaemia.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-kartuna u l-kunjett wara EXP.
English: Of 67 patients evaluated for human anti-mouse antibody (HAMA), no responses were noted.
Maltese: Mis-67 pazjent evalwat għall-antikorp uman kontra l-ġrieden (HAMA), ma kien innutat l-ebda rispons.
English: Table 18 Percentage of PV patients who achieved complete remission off corticosteroid therapy for two months or more at month 24 (Intent-to-Treat Population - PV)
Maltese: Tabella 18 Perċentwali ta' pazjenti b'PV li kisbu remissjoni kompluta mingħajr terapija b'kortikosterojdi għal xahrejn jew aktar f'xahar 24 (Popolazzjoni b'Intenzjoni li Tiġi Ttrattata - PV)
English: Tel: +386 1 519 29 22
Maltese: OPH Oktal Pharma d.o.o. Tel: +386 1 519 29 22
English: Based on the population pharmacokinetic analysis of data in 97 patients with granulomatosis with polyangiitis and microscopic polyangiitis who received 375 mg/m2 rituximab once weekly for four doses, the estimated median terminal elimination half-life was 23 days (range, 9 to 49 days).
Maltese: Granulomatosi b'polianġite u polianġite mikroskopika Ibbażat fuq l-analiżi farmakokinetika tal-popolazzjoni ta' dejta minn 97 pazjent bi granulomatosi b'polianġite u polianġite mikroskopika li rċevew 375 mg/m2 rituximab darba fil-ġimgħa għal erba'
English: The acute respiratory failure may be accompanied by events such as pulmonary interstitial infiltration or oedema, visible on a chest X-ray.
Maltese: Kollass respiratorju akut jista' jkun akkompanjat minn episodji bħall-infiltrazzjoni interstizjali pulmonari jew edima, li jkunu jidhru fuq Xray tas-sider.
English: In patients with non-Hodgkin's lymphoma receiving rituximab in combination with cytotoxic chemotherapy, cases of hepatitis B reactivation have been reported (see non-Hodgkin's lymphoma).
Maltese: Avvenimenti ta' newtropenija li l-maġġoranza tagħhom kienu temporanji u ħfief jew moderati fisseverità kienu osservati b'kura b'rituximab.
English: 17 February 2012
Maltese: 17 ta' Frar 2012
English: What is pholcodine?
Maltese: X'inhu pholcodine?
English: Pholcodine-containing medicines are currently approved in the EU in Belgium, France, Ireland, Lithuania, Luxembourg, Malta, Slovenia, Spain and the United Kingdom, either subject to medical prescription or as over-the-counter medicines.
Maltese: Mediċini li fihom pholcodine huma bħalissa approvati fl-UE fil-Belġju, fi Franza, fl-Irlanda, fil-Litwanja, filLussemburgu, f'Malta, fis-Slovenja, fi Spanja u fir-Renju Unit, jew soġġett għal riċetta ta' tabib jew bħala mediċini li ma għandhomx bżonn ta' riċetta ta' tabib.
English: NMBAs are used in emergency hospital procedures to prevent spontaneous muscle movements during surgery.
Maltese: NMBAs jintużaw fi proċeduri ta' emerġenza fi sptarijiet sabiex jipprevjenu movimenti muskolari spontanji matul kirurġija.
English: from spontaneous reports also suggested a 25% increase in anaphylactic reactions to NMBAs coinciding with a 9% increase in pholcodine use.
Maltese: Fi Franza, dejta minn rapporti spontanji ssuġġeriet ukoll żieda ta' 25% fir-reazzjonijiet anafilattiċi għal NMBAs li jikkoinċidu ma' żieda ta' 9% fl-użu ta' pholcodine.
English: In 2009, a study was published indicating that the reduction in pholcodine consumption in these countries was associated with a decrease in reports of anaphylactic reactions to neuromuscular blocking agents (NMBAs).
Maltese: Fl-2009, ġie ppubblikat studju li jindika li t-tnaqqis fil-konsum ta' pholcodine f'dawn il-pajjiżi kien assoċjat ma' tnaqqis fir-rapporti ta' reazzjonijiet anafilattiċi għal sustanzi newromuskulari li jimblokkaw (NMBAs).
English: Pholcodine is an opioid medicine that is used for the treatment of non-productive (dry) cough in children and adults.
Maltese: Pholcodine huwa mediċina opjojde li tintuża għall-kura ta' sogħla mhux produttiva (xotta) fi tfal u adulti.
English: They may be available as syrups, oral solutions, suppositories, tablets and capsules under various trade names and as generics.
Maltese: Jistgħu jkunu disponibbli bħala xiroppi, soluzzjonijiet orali, suppożitorji, pilloli u kapsuli taħt ismijiet kummerċjali varji u bħala ġeneriċi.
English: Consequently, the French medicines regulatory agency changed the prescription status for these medicines in France from over-the-counter to prescription-only, and asked the CHMP to carry out a full assessment of the benefit-risk balance of pholcodine and to issue an opinion on whether the marketing authorisations for pholcodine-containing products should be maintained, varied, suspended or withdrawn across the EU.
Maltese: Konsegwentament, l-aġenzija regolatorja tal-mediċini Franċiża biddlet l-istejtus ta' preskrizzjoni għal dawn il-mediċini fi Franza minn waħda li ma teħtieġx riċetta ta' tabib għal waħda li teħtieġ riċetta ta' tabib, u talbet lis-CHMP sabiex iwettaq valutazzjoni sħiħa tal-bilanċ benefiċċju-riskju ta' pholcodine u li joħroġ opinjoni dwar jekk l-awtorizzazzjonijiet għat-tqegħid fis-suq għal prodotti li fihom pholcodine għandhomx jinżammu, jiġu varjati, jiġu sospiżi jew irtirati madwar l-UE.
English: The hypothesis that pholcodine use could trigger anaphylactic reactions to NMBAs is based on the body producing antibodies against pholcodine, which eventually trigger reactions to NMBAs (‘crosssensitisation').
Maltese: L-ipoteżi li l-użu ta' pholcodine jista' jagħti bidu għal reazzjonijiet anafilattiċi għal NMBAs hija bbażata fuq il-ġisem li jipproduċi antikorpi kontra pholcodine, li eventwalment jagħtu bidu għal reazzjonijiet għal NMBAs ('kross-sensitizzazzjoni').
English: At the time of the review, pholcodine-containing medicines had been withdrawn from the markets in Sweden (in the 1980s) and Norway (in 2007).
Maltese: Fil-ħin tar-reviżjoni, mediċini li fihom pholcodine ġew irtirati mis-swieq fl-Isvezja (fis-snin tmenin) u fin-Norveġja (fl-2007).
English: The CHMP reviewed all the available data on the effects of pholcodine as a cough suppressant.
Maltese: Is-CHMP irreveda d-dejta disponibbli kollha dwar l-effetti ta' pholcodine bħala sustanza li trażżan is-sogħla.
English: The European Medicines Agency has completed a review of the safety and effectiveness of pholcodine, following concerns that its use may put people at risk of developing anaphylactic (severe allergic) reactions to neuromuscular blocking agents used during surgery.
Maltese: L-Aġenzija Ewropea tal-Mediċini temmet reviżjoni tas-sigurtà u l-effikaċja ta' pholcodine, wara tħassib li l-użu tiegħu jista' jpoġġi lin-nies f'riskju li jiżviluppaw reazzjonijiet anafilattiċi (allerġiji severi) għal aġenti newromuskulari li jimblokkaw użati matul kirurġija.
English: A group of experts in immunology and anaesthesia was also convened to provide advice.
Maltese: Tlaqqa' wkoll grupp ta' esperti fl-immunoloġija u l-anesteżija biex jipprovdi parir.
English: Further publications in 2010 and 2011 from the same authors supported the hypothesis that pholcodine use may increase the likelihood of patients having an anaphylactic reaction if they are exposed to an NMBA.
Maltese: Aktar pubblikazzjonijiet fl-2010 u fl-2011 mill-istess awturi appoġġaw l-ipoteżi li l-użu ta' pholcodine jista' jżid il-probabilità li pazjenti jkollhom reazzjoni anafilattika jekk ikunu esposti għal NMBA.
English: • Patients and healthcare professionals are reminded that the benefits of pholcodine continue to outweigh its risks for the treatment of non-productive cough.
Maltese: • Il-pazjenti u l-professjonisti tal-kura tas-saħħa huma mfakkra li l-benefiċċji ta' pholcodine jkomplu jisbqu r-riskji tiegħu għall-kura ta' sogħla mhux produttiva.
English: Regarding pholcodine's safety, the majority of adverse effects reported with pholcodine are those commonly seen with opioid medicines.
Maltese: Firrigward tas-sigurtà ta' pholcodine, il-maġġoranza tal-effetti avversi rrapportati bi pholcodine huma dawk li jidhru b'mod komuni ma' mediċini opjojdi.
English: The Committee noted that the study in Sweden and Norway looked at changes in reporting rates of adverse reactions to NMBAs following the withdrawal of these medicines, without convincingly establishing a causal link with pholcodine use.
Maltese: Is-CHMP qies li, għalkemm dan huwa bijoloġikament plawsibbli, id-dejta disponibbli hija dgħajfa u mhux konsistenti għal kollox.
English: Median a
Maltese: Medjan a
English: Do not take Imnovid:
Maltese: Tiħux Imnovid:
English: Note: CI=Confidence interval.
Maltese: Nota: CI=Intervall ta' kunfidenza.
English: Dyspepsia = Grade 1-2
Maltese: Dispepsja = Grad 1-2
English: • The active substance is pomalidomide.
Maltese: • Is-sustanza attiva hi pomalidomide.
English: See section 4.2 for dosing information.
Maltese: Ara sezzjoni 4.2 għal informazzjoni dwar iddożaġġ.
English: Common Depression
Maltese: Komuni Depressjoni
English: Population Pharmacokinetics (PK)
Maltese: Farmakokinetika tal-Popolazzjoni (PK)
English: System Organ Class/ Preferred Term
Maltese: Sistema tal-Klassifika tal-Organi/Terminu Preferut
English: Rash Rash = Grade 2-3
Maltese: Raxx Raxx = Grad 2-3
English: • some antibiotics (for example ciprofloxacin, enoxacin)
Maltese: • xi antibijotiċi (pereżempju ciprofloxacin, enoxacin)
English: • Swallow the capsules whole, preferably with water.
Maltese: • Ibla' l-kapsuli sħaħ, preferibbilment mal-ilma.
English: Follow CBC*** weekly.
Maltese: Segwi CBC*** kull ġimgħa.
English: Pomalidomide is structurally related to thalidomide.
Maltese: Pomalidomide hu strutturalment relatat ma' thalidomide.
English: Cycle 1 to 8
Maltese: Ċiklu 1 sa 8
English: • certain antidepressants such as fluvoxamine.
Maltese: • ċerti antidipressanti bħal fluvoxamine.
English: Note: CI=Confidence interval; IRAC=Independent Review Adjudication Committee; NE = Not Estimable.
Maltese: Nota: CI=Intervall tal-kunfidenza; IRAC=Kumitat Indipendenti ta' Evalwazzjoni; NE = Ma Jistax Jiġi Stmat.
English: Log-Rank Test Two sided P-Value d
Maltese: Valur P Test Log-Rank Two sidedd
English: 6.1 List of excipients Capsule contents
Maltese: FARMAĊEWTIKU 6.1 Lista ta' eċċipjenti Kontenut tal-kapsula
English: Pomalidomide is also a substrate of P-glycoprotein in vitro.
Maltese: Pomalidomide hu wkoll substrat ta' glikoproteina P in vitro.
English: Interrupt dose until muscle weakness ≤ Grade 1.
Maltese: Interrompi d-doża sakemm dgħufija tal-muskoli tkun ta' ≤ Grad 1.
English: Patients with serum total bilirubin > 1.5 x ULN (upper limit of normal range) were excluded from clinical studies.
Maltese: Pazjenti b'bilirubina totali fis-serum ta' > 1.5 x ULN (upper limit of normal range, medda tal-limitu ta' fuq tan-normal) ġew esklużi mill-istudji kliniċi.
English: Celgene Distribution B.V. Winthontlaan 6 N 3526 KV Utrecht Netherlands
Maltese: Winthontlaan 6 N 3526 KV Utrecht L-Olanda
English: ANC** < 0.5 x 109/l or febrile neutropenia (fever ≥38.5°C and ANC <1 x 109/l)
Maltese: ANC** < 0.5 x 109/l jew newtropenija bid-deni (deni ta' ≥38.5°C u ANC ta' < 1 x 10
English: • Lack of energy.
Maltese: • Nuqqas ta' enerġija.
English: IMN: Imnovid; BOR: Bortezomib; DEX: Dexamethasone
Maltese: Imnovid; BOR: Bortezomib; DEX: Dexamethasone
English: Imnovid contains sodium
Maltese: Imnovid fih sodium
English: Clostridium difficile colitis Bronchitis
Maltese: Kolite tal-Clostridium difficile Bronkite
English: PFS (months) Mediana time (95% CI) b HR c (95% CI), p-valued ORR, n (%) sCR
Maltese: Żmien medjana (95% CI) b HR c (95% CI), valur pd ORR, n (%) sCR
English: Medicine name Day IMN DEX
Maltese: Isem il-mediċina Jum IMN DEX
English: • Need for effective contraception and definition of effective contraception
Maltese: • Il-ħtieġa għal kontraċezzjoni effettiva, u definizzjoni ta' kontraċezzjoni effettiva
English: • Loss of appetite.
Maltese: • Telf ta' aptit.
English: In vitro, CYP1A2 and CYP3A4 were identified as the primary enzymes involved in the CYP-mediated hydroxylation of pomalidomide, with additional minor contributions from CYP2C19 and CYP2D6.
Maltese: In vitro, CYP1A2 u CYP3A4 ġew identifikati bħala lenzimi primarji involuti f'hydroxylation ta' pomalidomide medjata minn CYP, b'kontribuzzjonijiet żgħar addizzjonali minn CYP2C19 u CYP2D6.
English: Imnovid contains the active substance ‘pomalidomide'.
Maltese: Imnovid fih is-sustanza attiva ‘pomalidomide'.
English: Cycle 1-8
Maltese: Ċiklu 1-8
English: Pomalidomide is partly metabolised by CYP1A2 and CYP3A4/5.
Maltese: Pomalidomide hu parzjalment immetabolizzat minn CYP1A2 u CYP3A4/5.
English: Interstitial lung disease (ILD)
Maltese: Mard interstizjali tal-pulmun (ILD)
English: Day IMN BOR DEX
Maltese: Jum IMN BOR DEX
English: Grade 3−4 Adverse Reactions /Frequency
Maltese: Reazzjonijiet Avversi ta' Grad 3−4 /Frekwenza
English: Neutropenic sepsis Bronchopneumonia Bronchitis
Maltese: Sepsis newtropenika Bronkopnewmonja Bronkite
English: • Hives (urticaria).
Maltese: • Ħorriqija (urtikarja).
English: • Infections of the lungs (pneumonia and bronchitis).
Maltese: • Infezzjonijiet tal-pulmun (pnewmonja u bronkite).
English: ITT population is provided in Figure 3.
Maltese: ITT hi pprovduta f'Figura 3.
English: Following multiple doses, pomalidomide has an accumulation ratio of 27 to 31% on AUC.
Maltese: Wara dożi multipli, pomalidomide ikollu proporzjon ta' akkumulazzjoni bejn 27 sa 31% fuq l-AUC.
English: The No Observed Adverse Effect Level (NOAEL) was 0.1 mg/kg/day (0.5-fold exposure ratio relative to a 4 mg clinical dose).
Maltese: In-No Observed Adverse Effect Level (NOAEL) kien ta' 0.1 mg/kg/jum (proporzjon ta' esponiment ta' 0.5 darbiet meta mqabbel ma' doża klinika ta' 4 mg).
English: IMN: Imnovid; DEX: Dexamethasone
Maltese: Imnovid; DEX: Dexamethasone
English: Uncommon Bronchitis Herpes zoster
Maltese: Mhux komuni Bronkite Herpes zoster
English: Significant cardiac dysfunction
Maltese: Disfunzjoni kardijaka sinifikanti
English: (E172), erythrosin (E127) and white ink.
Maltese: (E172), erythrosin (E127) u linka bajda.
English: Approximately 70% of patients were refractory to lenalidomide (71.2% in Pom+Btz+LD-Dex, 68.7 % in Btz+LD-Dex).
Maltese: Madwar 70% tal-pazjenti kienu refrattorji għal lenalidomide (71.2% f'Pom+Btz+LD-Dex, 68.7 % f'Btz+LD-Dex).
English: Strong CYP1A2 inhibitors
Maltese: Inibituri qawwija ta' CYP1A2
English: Each cycle lasts 21 days (3 weeks).
Maltese: Kull ċiklu jdum 21 jum (3 ġimgħat).
English: Each cycle lasts 28 days (4 weeks).
Maltese: Kull ċiklu jdum 28 jum (4 ġimgħat).
English: Pack size of 14 or 21 capsules.
Maltese: Kull pakkett fih 14-il jew 21 kapsula.
English: • Pomalidomide in combination with bortezomib and dexamethasone In randomised study CC-4047-MM-007, 278 patients received pomalidomide, bortezomib and dexamethasone (Pom+Btz+Dex arm).
Maltese: • Pomalidomide flimkien ma' bortezomib u dexamethasone Fl-istudju randomizzat CC-4047-MM-007, 278 pazjent irċivew pomalidomide, bortezomib u dexamethasone (il-parti tal-istudju Pom+Btz+Dex).
English: Dyspepsia ≥ Grade 3
Maltese: Dispepsja ≥ Grad 3
English: Oral pomalidomide dose
Maltese: Doża orali ta' pomalidomide
English: The risk of venous thromboembolism continues for 4-6 weeks after discontinuing combined oral contraception.
Maltese: Irriskju ta' tromboemboliżmu fil-vini jibqa' sejjer għal 4−6 ġimgħat wara t-twaqqif tal-kontraċezzjoni kombinata orali.
English: 2 D bar code carrying the unique identifier
Maltese: barcode 2D li jkollu l­identifikatur uniku inkluż.
English: Drug Reaction with Eosinophilia and Systemic Symptoms Toxic Epidermal Necrolysis Stevens-Johnson Syndrome
Maltese: Reazzjoni tal-Mediċina b'Eosinofilija u Sintomi Sistemiċi Nekrolisi Epidermali Tossika Sindrome ta' Stevens-Johnson
English: • A fast and irregular heartbeat (atrial fibrillation).
Maltese: • Rata mgħaġġla u irregolari ta' taħbit ta' qalb (fibrillazzjoni atrijali).
English: All ADRs/Frequency
Maltese: ADRs kollha/Frekwenza
English: In peripheral tissues, pomalidomide was preferentially taken up by tumors with apparent peripheral distribution clearance (Q/F) and apparent peripheral volume of distribution (V3/F) 3.7-fold and 8-fold higher, respectively, than that of healthy subjects.
Maltese: F'tessut periferali, pomalidomide kien preferenzjalment meħud minn tumuri bi tneħħija ta' distribuzzjoni periferali apparenti (Q/F) u volum ta' distribuzzjoni apparenti (V3/F) 3.7 darbiet u 8 darbiet ogħla, rispettivament, minn dak ta' individwi f'saħħithom.
English: Odds ratio is for Pom+Btz+LD-Dex:Btz+LD-Dex.
Maltese: L-odds ratio għal Pom+Btz+LD-Dex:Btz+LD-Dex.
English: Dexamethasone (20 mg) * • • * For patients > 75 years of age, see Special populations.
Maltese: Dexamethasone (20 mg) * • • * Għal pazjenti li għandhom > 75 sena, ara Popolazzjonijiet speċjali.
English: Summary of overall efficacy data are presented in Table 10 using a cut-off date of 26 Oct 2017.
Maltese: Sommarju tad-data globali dwar l-effikaċja hija ppreżentata f'Tabella 10 bl-użu ta' data limitu tas-26 Ott 2017.
English: Pomalidomide has a mean apparent volume of distribution (Vd/F) between 62 and 138 L at steady state.
Maltese: Pomalidomide għandu medja ta' volum apparenti ta' distribuzzjoni (Vd/F) bejn 62 u 138 L fl-istat fiss.
English: Btz = bortezomib; CI = Confidence interval; CR = Complete response; DoR = Duration of response; HR = Hazard Ratio; LD-Dex = low-dose dexamethasone; OR = Odds ratio; ORR = Overall response rate; PFS = Progression free survival; POM = pomalidomide; PR = Partial Response; sCR = Stringent complete response VGPR = Very good partial response.
Maltese: PFS = Sopravivenza mingħajr progressjoni (Progression free survival); POM = pomalidomide; PR = Rispons Parzjali (Partial Response); sCR = Rispons komplet strett (Stringent complete response) VGPR = Rispons parzjali tajjeb ħafna (Very good partial response).
English: Uncommon Alanine aminotransferase increased
Maltese: Mhux komuni Żieda f'alanine aminotransferase