FrancophonIA/ELRC3.0 huggingface dataset:
English: All Adverse Reactions (ADRs) reported in clinical trial MM-007 in patients treated with pomalidomide in combination with bortezomib and dexamethasone.
Maltese: Ir-Reazzjonijiet Avversi (ADRs) kollha rrappurtati fil-prova klinika MM-007 f'pazjenti kkurati b'pomalidomide flimkien ma' bortezomib u dexamethasone.
English: • Pomalidomide in combination with dexamethasone In randomised study CC-4047-MM-003, 302 patients with relapsed and refractory multiple myeloma were exposed to 4 mg pomalidomide administered once daily for 21 days of each 28-day cycle in combination with a weekly low dose of dexamethasone.
Maltese: Fl-istudju randomizzat CC-4047-MM-003, 302 pazjenti b'majeloma multipla li rkadiet u refrattorja kienu esposti għal 4 mg ta' pomalidomide mogħtija darba kuljum għal 21 jum ta' kull ċiklu ta' 28 jum flimkien ma' doża baxxa ta' dexamethasone fil-ġimgħa.
English: Pomalidomide is the major circulating component (approximately 70% of plasma radioactivity) in vivo in healthy subjects who received a single oral dose of [14C]-pomalidomide (2 mg).
Maltese: Pomalidomide hu l-komponent maġġuri li jkun jiċċirkola (madwar 70% ta' radjuattività fil-plażma) in vivo f' individwi f'saħħithom li rċivew doża orali waħda ta' [14C]-pomalidomide (2 mg).
English: Very Common Neutropenia Thrombocytopenia Leucopenia Anaemia
Maltese: Komuni Ħafna Newtropenija Tromboċitopenija Lewkopenija Anemija
English: PFS is summarised in Table 11 for the ITT population.
Maltese: PFS qed tintwera fil-qosor f'Tabella 11 għall-popolazzjoni ITT.
English: • Flu-like symptoms (influenza).
Maltese: • Sintomi bħal tal-influwenza.
English: • High blood levels of uric acid, which may cause a form of arthritis called gout.
Maltese: • Livelli għoljin ta' uric acid fid-demm, li jistgħu jikkawżaw forma ta' artrite li tissejjaħ gotta.
English: In a second study to evaluate the contribution of a CYP1A2 inhibitor alone to metabolism changes, co-administration of fluvoxamine alone with pomalidomide increased mean exposure to pomalidomide by 125% with a 90% confidence interval [98% to 157%] compared to pomalidomide alone.
Maltese: Fit-tieni studju biex jevalwa l-kontribuzzjoni ta' inibitur ta' CYP1A2 waħdu għal bidliet fil-metaboliżmu, l-għoti flimkien ta' fluvoxamine waħdu ma' pomalidomide żied l-esponiment medju għal pomalidomide b'125%, b'intervall ta' kunfidenza ta' 90% [98% sa 157%] meta mqabbel ma' pomalidomide waħdu.
English: Therefore, the NOAEL for these observed effects was < 25 mg/kg/day (AUC 24h was 39960 ng•h/mL (nanogram•hour/millilitres) at this lowest dose tested, and the exposure ratio was 99-fold relative to a 4 mg clinical dose).
Maltese: Għalhekk, in-NOAEL għal dawn l-effetti osservati kien ta' <25 mg/kg/jum (l-AUC 24h kienet ta' 39960 ng•siegħa/mL (nanogrammi•siegħa/millilitri) f'din l-iktar doża baxxa ttestjata, u lproporzjon ta' esponiment kienet 99 darba meta mqabbel ma' doża klinika ta' 4 mg).
English: Median OS time for the HD-Dex arm was 34 weeks (95% CI: 23.4, 39.9).
Maltese: Il-medjan ta' żmien OS għall-parti tal-istudju dwar HD-Dex kien ta' 34 ġimgħa (95% CI: 23.4, 39.9).
English: Embryo-foetal development
Maltese: Żvilupp embrijofetali
English: Peripheral neuropathy occurred in 55.4 % of patients (10.8% Grade 3; 0.7% Grade 4).
Maltese: 8% ta' Grad 3; 0.7% ta' Grad 4).
English: Dose Level -1
Maltese: Livell tad-doża -1
English: • Low blood level of phosphate (hypophosphataemia), which may cause muscle weakness and irritability or confusion.
Maltese: • Livell baxx ta' phosphate fid-demm (ipofosfatemija), li jista' jikkawża dgħufija fil-muskoli u irritabbiltà jew konfużjoni.
English: Anticoagulation therapy (unless contraindicated) is recommended (see section 4.4).
Maltese: It-terapija kontra l-koagulazzjoni taddemm (ħlief jekk tkun kontraindikata) hi rakkomandata (ara sezzjoni 4.4).
English: Very Common Peripheral sensory neuropathy Dizziness
Maltese: Komuni Ħafna Newropatija sensorjali periferali
English: The most commonly reported Grade 3 or 4 adverse reactions were blood and lymphatic system disorders including neutropenia (41.7%), thrombocytopenia (27.3%) and anaemia (14.0%).
Maltese: L-iktar reazzjonijiet avversi ta' Grad 3 jew 4 irrappurtati b'mod komuni kienu disturbi tad-demm u tas-sistema limfatika li jinkludu newtropenija (41.7%), tromboċitopenija (27.3%) u anemija (14.0%).
English: Each hard capsule contains 4 mg of pomalidomide.
Maltese: Kull kapsula iebsa fiha 4 mg ta' pomalidomide.
English: • Widespread rash, high body temperature, enlarged lymph nodes and other body organs involvement (Drug Reaction with Eosinophilia and Systemic Symptoms which is also known as DRESS or drug hypersensitivity syndrome, Toxic Epidermal Necrolysis or Stevens-Johnson Syndrome).
Maltese: Raxx mifrux, temperatura tal-ġisem għolja, glandoli żgħar tal-limfa (lymph nodes) mkabbra u involviment ta' organi oħrajn tal-ġisem (Reazzjoni tal-Mediċina b'Eosinofilja u Sintomi Sistemiċi magħrufa wkoll bħala DRESS jew sindrome ta' sensittività eċċessiva għallmediċina, Nekrolisi Epidermali Tossika jew Sindrome ta' Stevens-Johnson).
English: • Constipation, diarrhoea or nausea.
Maltese: .6 Fertilità, tqala u treddigħ
English: In a fertility and early embryonic development study in rats, pomalidomide was administered to males and females at dosages of 25, 250, and 1000 mg/kg/day.
Maltese: Fi studju dwar il-fertilità u żvilupp bikri embrijoniku fil-firien, pomalidomide ingħata lil firien irġiel u nisa f'dożaġġi ta' 25, 250, u 1000 mg/kg/jum.
English: Mean exposure to pomalidomide increased by 51% with a 90% confidence interval [9% to 110%] in mildly hepatically impaired patients compared to healthy subjects.
Maltese: Il-medja tal-esponiment għal pomalidomide żdiedet b'51%, b'intervall ta' kunfidenza ta' 90% [9% sa 110%] f'pazjenti b'indeboliment ħafif tal-fwied meta mqabbla ma' individwi f'saħħithom.
English: Platelet count return to ≥ 50 x 109/l
Maltese: Għadd tal-plejtlits jerġa' lura għal ≥ 50 x 109/l
English: In patients receiving combination therapy with pomalidomide in clinical studies, neutropenia occurred in up to 46.8% of patients (41.7% Grade 3 or 4).
Maltese: F'pazjenti li qed jirċievu terapija kombinata b'pomalidomide fi studji kliniċi, in-newtropenija seħħet f'sa 46.8% tal-pazjenti (41.7% ta' Grad 3 jew 4).
English: Imnovid 1 mg hard capsules Gelatin
Maltese: Imnovid 1 mg kapsuli ibsin Gelatin
English: Staphylococcal infection was observed in 4 monkeys; 3 of these animals responded to antibiotic treatment and 1 died without treatment.
Maltese: Infezzjoni stafilokokkali ġiet osservata f'4 xadini; 3 minn dawn l-annimali rrispondew għal kura b'antibijotiċi u 1 miet mingħajr kura.
English: Imnovid 2 mg hard capsules, Imnovid 3 mg hard capsules, Imnovid 4 mg hard capsules White ink
Maltese: Imnovid 2 mg kapsuli ibsin, Imnovid 3 mg kapsuli ibsin, Imnovid 4 mg kapsuli ibsin Linka bajda
English: The maternal NOAEL was 10 mg/kg/day, and the developmental NOAEL was <10 mg/kg/day (AUC24h was 418 ng•h/mL on Gestation Day 19 at this lowest dose tested, which was similar to that obtained from a 4 mg clinical dose).
Maltese: L-NOAEL tal-omm kien ta' 10 mg/kg/jum, u l-NOAEL tal-iżvilupp kien ta' < 10 mg/kg/jum (l-AUC24h kien ta' 418 ng•siegħa/mL f'Jum tat-Tqala 19 f'din l-iktar doża baxxa ttestjata, u dan ir-riżultat kien simili għal dak li nkiseb minn doża klinika ta' 4 mg).
English: Imnovid 2 mg hard capsule:
Maltese: Imnovid 2 mg kapsula iebsa:
English: > 75 years old Days 1, 8, 15 and 22 of each 28-day treatment cycle
Maltese: Età > 75 sena Jiem 1, 8, 15 u 22 ta' kull ċiklu ta' kura ta' 28 jum
English: Imnovid 4 mg hard capsule:
Maltese: Imnovid 4 mg kapsula iebsa:
English: Dexamethasone should be discontinued if the patient is unable to tolerate 8 mg if ≤ 75 years old or 4 mg if > 75 years old.
Maltese: Dexamethasone għandu jitwaqqaf jekk il-pazjent ma jistax jittollera 8 mg jekk għandu ≤ 75 sena jew 4 mg jekk għandu > 75 sena.
English: Maintain dose and treat with histamine (H2) blockers or equivalent.
Maltese: Żomm id-doża fl-istess livell u kkura b'imblokkaturi ta' histamine (H2) jew ekwivalenti.
English: Dexamethasone should be discontinued if the patient is unable to tolerate 10 mg if ≤ 75 years old or 8 mg if > 75 years old.
Maltese: Dexamethasone għandu jitwaqqaf jekk il-pazjent ma jistax jittollera 10 mg jekk għandu ≤ 75 sena jew 8 mg jekk għandu > 75 sena.
English: Patients with a prior history of serious allergic reactions associated with thalidomide or lenalidomide were excluded from clinical studies.
Maltese: Pazjenti li fil-passat kellhom reazzjonijiet allerġiċi serji assoċjati ma' thalidomide jew lenalidomide ġew esklużi millistudji kliniċi.
English: Contraception
Maltese: Tossiċità
English: The adverse reactions observed in patients treated with pomalidomide plus dexamethasone are listed below in Table 8 by system organ class (SOC) and frequency for all adverse reactions (ADRs) and for Grade 3 or 4 adverse reactions.
Maltese: Ir-reazzjonijiet avversi osservati f'pazjenti kkurati b'pomalidomide flimkien ma' dexamethasone huma elenkati hawn taħt f'Tabella 8 skont is-sistema tal-klassifika tal-organi (SOC) u l-frekwenza għar-reazzjonijiet avversi kollha (ADRs) u għal reazzjonijiet avversi ta Grad 3 jew 4.
English: Pomalidomide dose modification instructions Toxicity
Maltese: Istruzzjonijiet għat-tibdil fid-doża ta' pomalidomide Tossiċità
English: Dose Level -2
Maltese: Livell tad-doża -2
English: Therefore, the maternal NOAEL was 1000 mg/kg/day, and the NOAEL for developmental toxicity was < 25 mg/kg/day (AUC24h was 34340 ng•h/mL on Gestation Day 17 at this lowest dose tested, and the exposure ratio was 85-fold relative to a 4 mg clinical dose).
Maltese: Għalhekk, l-NOAEL materna kien ta' 1000 mg/kg/jum, u l-NOAEL għal tossiċità waqt l-iżvilupp kien ta' < 25 mg/kg/jum (l-AUC24h kien ta' 34340 ng•siegħa/mL f'Jum tat-Tqala 17 f'din l-iktar doża baxxa ttestjata, u l-proporzjon ta' esponiment kien ta' 8 darba meta mqabbel ma' doża klinika ta' 4 mg).
English: Dysgeusia
Maltese: • Puplesija
English: Imnovid 3 mg hard capsule:
Maltese: Imnovid 3 mg kapsula iebsa:
English: Approximately 30% of the patients experiencing peripheral neuropathy had a history of neuropathy at baseline.
Maltese: Madwar 30% tal-pazjenti li esperjenzaw newropatija periferali kellhom storja ta' newropatija fil-linja bażi.
English: Clinically relevant drug-drug interactions are not anticipated when pomalidomide is coadministered with substrates of these pathways.
Maltese: Interazzjonijiet klinikament rilevanti bejn mediċina u oħra mhumiex antiċipati meta pomalidomide jingħata fllimkien ma' substrati ta' dawn il-passaġġi.
English: • Each capsule contains 2 mg of pomalidomide.
Maltese: • Kull kapsula fiha 2 mg ta' pomalidomide.
English: The recommended dose of dexamethasone is 40 mg orally once daily on Days 1, 8, 15 and 22 of each 28day treatment cycle.
Maltese: Id-doża tal-bidu rakkomandata ta' dexamethasone hi 40 mg mill-ħalq darba kuljum f'Jiem 1, 8, 15 u 22 ta' kull ċiklu ta' kura ta' 28 jum.
English: In addition, findings consistent with acute myelogenous leukemia led to euthanasia of 1 monkey; clinical observations and clinical pathology and/or bone marrow alterations observed in this animal were consistent with immunosuppression.
Maltese: Barra dan, riżultati konsistenti ma' lewkimja majeloġenika akuta wasslu għal ewtanasja ta' xadina 1; osservazzjonijiet kliniċi u patoloġija klinika u/jew tibdil osservat fil-mudullun f'dawn l-annimali kienu konsistenti ma' immunosoppressjoni.
English: Imnovid 1 mg hard capsules
Maltese: Imnovid 1 mg kapsuli ibsin
English: • To conduct a non-interventional post-authorisation registry of patients treated with pomalidomide for relapsed and refractory multiple myeloma to monitor the incidence of adverse drug reactions in the “real world situation” and to monitor the implementation and compliance of the Celgene PPP and controlled distribution system on a country basis in agreement with the relevant National Competent Authority (ie., monitoring of Patient Card completion).
Maltese: • Biex isir reġistru mingħajr interventi ta' wara l-awtorizzazzjoni ta' pazjenti kkurati b'pomalidomide għal majeloma multipla li rkadiet u refrattorja biex timmonitorja l-inċidenza ta' reazzjonijiet avversi talmediċina f'sitwazzjonijiet li jistgħu jiġru fil-verità, u biex timmonitorja l-implimentazzjoni u l-konformità ta' Celgene PPP, u l-użu off-label u sistema ta' distribuzzjoni kkontrollata fuq bażi ta' pajjiż bi ftehim malAwtorità Nazzjonali Kompetenti rilevanti (ie., monitoraġġ tat-tlestija tal-Karta tal-Pazjent).
English: In the HD-Dex arm, median PFS time was 8.0 weeks (95% CI: 7.0, 9.0); the estimated 26-week event-free survival rate was 12.15% (±3.63%).
Maltese: Fil-parti tal-istudju dwar HD-Dex, il-medjan taż-żmien PFS kien ta' 8.0 ġimgħat (95% CI: 7.0, 9.0); l-istima tar-rata ta' sopravivenza ta' 26 ġimgħa kienet ta' 12.15% (±3.63%).
English: Imnovid 1 mg hard capsules pomalidomide
Maltese: Imnovid 1 mg kapsuli ibsin pomalidomide
English: This medicine is related to thalidomide and belongs to a group of medicines which affect the immune system (the body's natural defences).
Maltese: Din il-mediċina hi relatata ma' thalidomide u tappartjeni għal grupp ta' mediċini li jaffettwaw is-sistema immuni (id-difiża naturali tal-ġisem).
English: • Women of childbearing potential, unless all the conditions of the pregnancy prevention programme are met (see sections 4.4 and 4.6).
Maltese: • Nisa li jista' jkollhom tfal, ħlief meta l-kundizzjonijiet kollha tal-programm tal-prevenzjoni tattqala jkunu ġew issodisfati (ara sezzjonijiet 4.4 u 4.6).
English: Dizziness and confusion
Maltese: Sturdament u konfużjoni
English: Imnovid 2 mg hard capsules Gelatin
Maltese: Imnovid 2 mg kapsuli ibsin Gelatin
English: Pomalidomide is eliminated with a median plasma half-life of approximately 9.5 hours in healthy subjects and approximately 7.5 hours in patients with multiple myeloma.
Maltese: Pomalidomide jiġi eliminat b'medjan ta' half-life fil-plażma ta' madwar 9.5 sigħat f'individwi f'saħħithom u madwar 7.5 sigħat f'pazjenti b'majeloma multipla.
English: Imnovid 2 mg hard capsules pomalidomide
Maltese: Imnovid 2 mg kapsuli ibsin pomalidomide
English: C] -pomalidomide (2 mg) to healthy subjects, approximately 73% and 15% of the radioactive dose was eliminated in urine and faeces, respectively, with approximately 2% and 8% of the dosed radiocarbon eliminated as pomalidomide in urine and faeces.
Maltese: u 15% tad-doża radjuattiva ġiet eliminata fl-awrina u fl-ippurgar, rispettivament, b'madwar 2% u 8% tar-radiocarbon li ngħata bħala doża jitneħħa bħala pomalidomide fl-awrina u fl-ippurgar.
English: Each hard capsule contains 2 mg of pomalidomide.
Maltese: Kull kapsula iebsa fiha 2 mg ta' pomalidomide.
English: Each hard capsule contains 1 mg of pomalidomide.
Maltese: Kull kapsula iebsa fiha 1 mg ta' pomalidomide.
English: Day (of 21-day cycle)
Maltese: Jum (taċ-ċiklu ta' 21 jum)
English: Imnovid 3 mg hard capsules Gelatin
Maltese: Imnovid 3 mg kapsuli ibsin Gelatin
English: All Adverse Reactions /Frequency
Maltese: Kollha /Frekwenza
English: The efficacy of contraceptive steroids may be reduced during cotreatment with dexamethasone (see section 4.5).
Maltese: L-effikaċja ta' sterojdi kontraċettivi tista' titnaqqas matul il-kura li tinkludi dexamethasone ukoll (ara sezzjoni 4.5).
English: Coadministration with a high-fat and high-calorie meal slows the rate of absorption, decreasing mean plasma Cmax by approximately 27%, but has minimal effect on the overall extent of absorption with an 8% decrease in mean AUC.
Maltese: L-għoti flimkien ma' ikla b'ammont għoli ta' xaħam u ammont għoli ta' kaloriji inaqqas il-grad ta' assorbiment, li jirriżulta fi tnaqqis fil-medja tas-Cmax fil-plażma b'madwar 27%, iżda għandu effett minimu fuq il-grad totali ta' assorbiment bi tnaqqis biss ta' 8% fil-medja tal-AUC.
English: Pomalidomide is administered in combination with bortezomib and dexamethasone, as shown in Table 1.
Maltese: Pomalidomide jingħata flimkien ma' bortezomib u dexamethasone, kif jidher f'Tabella 1.
English: • Each capsule contains 4 mg of pomalidomide.
Maltese: • Kull kapsula fiha 4 mg ta' pomalidomide.
English: • Swelling caused by fluid.
Maltese: • Nefħa kkawżata minn fluwidu.
English: In clinical studies, no dose adjustment was required in elderly (> 65 years) patients exposed to pomalidomide (see section 4.2).
Maltese: Fi studji kliniċi, l-ebda aġġustament fid-doża ma kien meħtieġa flanzjani (> 65 sena) esposti għal pomalidomide (ara sezzjoni 4.2).
English: Pomalidomide is not anticipated to cause clinically relevant pharmacokinetic drug-drug interactions due to P450 isoenzyme inhibition or induction or transporter inhibition when co-administered with substrates of these enzymes or transporters.
Maltese: Pomalidomide mhuwiex antiċipat li jikkawża interazzjonijiet farmakokinetiċi klinikament rilevanti bejn mediċina u oħra minħabba inibizzjoni jew induzzjoni tal-isoenzima P450 jew inibizzjoni tattrasportatur meta jingħata ma' substrati ta' dawn l-enzimi jew trasportaturi.
English: • you experience or have experienced in the past a combination of any of the following symptoms: rash on face or extended rash, red skin, high fever, flu-like symptoms, enlarged lymph nodes (signs of severe skin reaction called Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) or drug hypersensitivity syndrome, Toxic Epidermal Necrolysis (TEN) or Stevens-Johnson Syndrome (SJS).
Maltese: • jekk ikollok jew fil-passat kellek kombinazzjoni ta' kwalunkwe mis-sintomi li ġejjin: raxx fuq ilwiċċ jew raxx estiż, ġilda ħamra, deni qawwi, sintomi bħal tal-influwenza, glandoli żgħar tal-limfa (lymph nodes) mkabbra (sinjali ta' reazzjoni severa tal-ġilda msejħa Reazzjoni tal-Mediċina b'Eosinofilja u Sintomi Sistemiċi (DRESS), jew sindrome ta' sensittività eċċessiva għallmediċina, Nekrolisi Epidermali Tossika (TEN) jew Sindrome ta' Stevens-Johnson (SJS), ara wkoll sezzjoni 4 “Effetti sekondarji possibbli”).
English: Each hard capsule contains 3 mg of pomalidomide.
Maltese: Kull kapsula iebsa fiha 3 mg ta' pomalidomide.
English: Common Rash Pruritus
Maltese: Komuni Dijarea Rimettar Stitikezza
English: Common Rash
Maltese: Raxx
English: Imnovid 4 mg hard capsules pomalidomide
Maltese: Imnovid 4 mg kapsuli ibsin pomalidomide
English: Dark blue opaque cap and yellow opaque body, imprinted “POML” in white ink and “1 mg” in black ink, size 4 gelatin hard capsule.
Maltese: Għatu opak blu skur u korp opak isfar, stampat b'“POML” b'linka bajda u “1 mg” b'linka sewda, kapsula iebsa tal-ġelatina daqs 4.
English: Pomalidomide has a mean total body clearance (CL/F) of approximately 7-10 L/hr.
Maltese: Pomalidomide għandu medja ta' tneħħija totali mill-ġisem (CL/F) ta' madwar 7-10
English: Titanium dioxide (E171) Indigotine (E132) Yellow iron oxide (E172) Erythrosin (E127) White ink
Maltese: Iron oxide isfar(E172) Erythrosin (E127) Linka bajda.
English: • Post-authorisation efficacy study (PAES) MM-007: In order to further investigate the efficacy of pomalidomide in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior treatment regimen including lenalidomide, the MAH should submit the final analysis of OS from the phase 3, randomized, open label study MM-007.
Maltese: Sabiex tiġi investigata iżjed l-effikaċja ta' pomalidomide li jingħata flimkien ma' bortezomib u dexamethasone għall-kura ta' pazjenti adulti li għandhom majeloma multipla li ngħataw mill-inqas kors ta' trattament wieħed preċedenti inkluż lenalidomide, lMAH għandu jissottometti l-analiżi finali ta' OS mill-istudju ta' fażi 3, randomizzat u open-label MM-007.
English: Haematological events Neutropenia was the most frequently reported Grade 3 or 4 haematological adverse reaction in patients with relapsed/refractory multiple myeloma, followed by anaemia and thrombocytopenia.
Maltese: In-newtropenija kienet l-iktar reazzjoni avversa ematoloġika ta' Grad 3 jew 4 li kienet irrappurtata b'mod frekwenti f'pazjenti b'majeloma multipla li rkadiet/refrattorja segwita minn anemija u tromboċitopenija.
English: Imnovid 4 mg hard capsules
Maltese: Imnovid 4 mg kapsuli ibsin
English: Dizziness and confusional state have been reported with pomalidomide.
Maltese: Sturdament u stat ta' konfużjoni ġew irrappurtati b'pomalidomide.
English: Imnovid 2 mg hard capsules
Maltese: Imnovid 2 mg kapsuli ibsin
English: Counselling
Maltese: Kontraċezzjoni
English: Non-cardiac chest pain Oedema
Maltese: Uġigħ mhux kardijaku fis-sider Edema
English: Mean exposure to pomalidomide increased by 72% with a 90% confidence interval [24% to 138%] in severely hepatically impaired patients compared to healthy subjects.
Maltese: Il-medja tal-esponiment għal pomalidomide żdiedet bi 72%, b'intervall ta' kunfidenza ta' 90% [24% sa 138%] f'pazjenti b'indeboliment sever tal-fwied meta mqabbla ma' individwi f'saħħithom.
English: Bronchopneumonia Respiratory tract infection Upper respiratory tract infection
Maltese: Bronkopnewmonja Infezzjoni fl-apparat respiratorju Infezzjoni fin-naħa ta' fuq talapparat respiratorju
English: Pomalidomide is contraindicated during pregnancy and in women of childbearing potential, except when all the conditions for pregnancy prevention have been met, see section 4.3 and section 4.4.
Maltese: Pomalidomide hu kontraindikat matul it-tqala u f'nisa li jistgħu joħorġu tqal, ħlief meta l-kundizzjonijiet kollha għall-prevenzjoni tattqala jkunu ġew issodisfati, ara sezzjoni 4.3 u sezzjoni 4.4.
English: In addition to the above adverse reactions identified from the pivotal clinical trials, the following Table 9 is derived from data gathered from post-marketing surveillance.
Maltese: Flimkien mar-reazzjonijiet avversi t'hawn fuq identifikati mill-provi kliniċi pivitali, it-Tabella 9 li ġejja nkisbet minn dejta miġbura minn sorveljanza wara t-tqegħid fis-suq.
English: In patients who received 1 prior antimyeloma line, median PFS time was 20.73 months (95% CI: 15.11, 27.99) in the Pom + Btz + LD-Dex arm and 11.63 months (95% CI: 7.52, 15.74) in the Btz + LD-Dex arm. A 46% risk reduction was observed with Pom + Btz + LD-Dex treatment (HR = 0.54, 95% CI: 0.36,
Maltese: 11, 27.99) fil-grupp ta' Pom + Btz + LD-Dex u 11.63 xhur (95% CI:. 7.52, 15.
English: Administration of pomalidomide in smokers, with smoking tobacco known to induce the CYP1A2 isoform, had no clinically relevant effect on exposure to pomalidomide compared to that exposure to pomalidomide observed in non-smokers.
Maltese: Lgħoti ta' pomalidomide f'persuni li jpejpu, meta hu magħruf li t-tipjip tat-tabakk jinduċi l-isoforma CYP1A2, ma kellu l-ebda effett klinikament rilevanti fuq l-esponiment għal pomalidomide meta mqabbel ma' dak l-esponiment għal pomalidomide osservat f'persuni li ma jpejpux.
English: • Keep this leaflet.
Maltese: Proporzjon ta' Pazjenti
English: Printing ink
Maltese: X'inhu Imnovid
English: Titanium dioxide (E171) Indigotine (E132) Yellow iron oxide (E172) White ink
Maltese: Titanium dioxide (E171) Indigotine (E132)
English: For information on other medicinal products given in combination with Imnovid, refer to the respective current SmPC.
Maltese: Għal informazzjoni dwar prodotti mediċinali oħra li jingħataw flimkien ma' Imnovid, irreferi għallSmPC attwali rispettiv.
English: • Each capsule contains 1 mg of pomalidomide.
Maltese: • Kull kapsula fiha 1 mg ta' pomalidomide.
English: Imnovid 3 mg hard capsules
Maltese: Imnovid 3 mg kapsuli ibsin
English: • Each capsule contains 3 mg of pomalidomide.
Maltese: • Kull kapsula fiha 3 mg ta' pomalidomide.
English: Common Cataract
Maltese: Komuni Katarretti
English: Nausea
Maltese: Irġiel
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Ir-rekwiżiti għas-sottomissjoni ta' rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont lArtikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti huwa ppubblikat fuq il-portal elettroniku Ewropew tal-mediċini.