FrancophonIA/ELRC3.0 huggingface dataset:
English: The most commonly reported Grade 3 or 4 adverse reactions were in the blood and lymphatic system disorders including neutropenia (41.7%), anaemia (27%) and thrombocytopenia (20.7%); in infections and infestations including pneumonia (9%); and in general disorders and administration site conditions including fatigue (4.7%), pyrexia (3%) and oedema peripheral (1.3%).
Maltese: L-iktar reazzjonijiet avversi ta' Grad 3 jew 4 irrappurtati b'mod komuni kienu fid-demm u fis-sistema limfatika li jinkludu newtropenija (41.7%), anemija (27%) u tromboċitopenija (20.7%); infezzjonijiet u infestazzjonijiet li jinkludu pnewmonja (9%); u b'mod ġenerali disturbi li jinkludu għeja kbira (4.7%), deni (3%) u edema periferali (1.3%), u kundizzjonijiet fis-sit tal-għoti.
English: Hazard Ratio (Pom+LD-Dex:HD-Dex) 2-Sided 95% CI c
Maltese: HD-Dex) 2Sided 95% CIċ
English: • The printing ink contains: white ink - shellac, titanium dioxide (E171), simeticone, propylene glycol (E1520) and ammonium hydroxide (E527).
Maltese: • Il-linka tal-istampar fiha: linka bajda - shellac, titanium dioxide (E171), simeticone, propylene glycol (E1520) u ammonium hydroxide (E527).
English: Refer also to the bortezomib SmPC.
Maltese: Irreferi wkoll għall-SmPC ta' bortezomib.
English: Co-administration of pomalidomide with the strong CYP3A4/5 and P-gp inhibitor ketoconazole, or the strong CYP3A4/5 inducer carbamazepine, had no clinically relevant effect on exposure to pomalidomide.
Maltese: L-għoti flimkien ta' pomalidomide mal-inibitur qawwi ta' CYP3A4/5 u P-gp ketoconazole, jew l-induttur qawwi ta' CYP3A4/5 carbamazepine, ma kellu l-ebda effett klinikament rilevanti fuq l-esponiment għal pomalidomide.
English: Progression Free Survival Time by IRAC Review Based on IMWG Criteria (Stratified Log Rank Test) (ITT Population)
Maltese: IMWG (Log Rank Test Stratifikat) (Popolazzjoni ITT)
English: Median OS time from Kaplan-Meier estimates has not been reached for the Pom + LD-Dex, but would be expected to be at least 48 weeks, which is the lower boundary of the 95% CI.
Maltese: Il-medjan ta' żmien OS mill-istimi ta' Kaplan-Meier ma ntlaħaqx għallPom + LD-Dex, iżda se jkun mistenni li jkun ta' mill-inqas 48 ġimgħa, li hu l-lower boundary tal-95% CI.
English: • Severe, persistent or bloody diarrhoea (possibly with stomach pain or fever) caused by bacteria called Clostridium difficile.
Maltese: • Dijarea severa, persistenti jew bid-demm (possibbilment b'uġigħ fl-istonku jew deni) kkawżata minn batterja msejħa Clostridium difficile.
English: The median is based on Kaplan-Meier estimate.
Maltese: Il-medjan hu bbażat fuq stima ta' Kaplan-Meier.
English: Based on Cox proportional hazards model comparing the hazard functions associated with treatment groups, stratified by age (≤75 vs >75),diseases population (refractory to both lenalidomide and bortezomib vs not refractory to both active substances), and prior number of anti myeloma therapy (=2 vs >2).
Maltese: Ibbażat fuq il-mudell ta' perikli proporzjonali ta' Cox li qabbel il-funzjonijiet tal-periklu assoċjati ma' gruppi ta' kura, stratifikati skont letà (≤ 75 vs >75), popolazzjoni bil-marda (refrattorji kemm għal lenalidomide kif ukoll għal bortezomib vs mhux refrattorji għaż-żewġ sustanzi attivi), u n-numru ta' terapiji kontra l-majeloma fil-passat (=2 vs >2).
English: Stop dexamethasone dosing until the adverse event resolves to ≤ Grade 2.
Maltese: Waqqaf l-għoti tad-dożi ta' dexamethasone sakemm l-avveniment avvers ittaffi għal ≤ Grad 2.
English: Specifically, pomalidomide inhibits proliferation and induces apoptosis of haematopoietic tumour cells.
Maltese: Speċifikament, pomalidomide jinibixxi l-proliferazzjoni u jinduċi apoptosi ta' ċelluli ematopojetiċi tattumur.
English: NE = Not Estimable.
Maltese: NE = Ma Jistax Jiġi Stmat.
English: Progression free survival (PFS), N Censored, n (%)
Maltese: Ipprogressaw/mietu, n (%)
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: ILD and related events, including cases of pneumonitis, have been observed with pomalidomide.
Maltese: ILD u avvenimenti relatati li jinkludu każijiet ta' pulmonite, ġew osservati b'pomalidomide.
English: Very Common Neutropenia Thrombocytopenia Anaemia
Maltese: Komuni Ħafna Newtropenija Tromboċitopenija Anemija
English: Mean normalised AUC exposure to pomalidomide increased by 35.8% with a 90% CI [7.5% to 70.0%] in severe renal impairment patients requiring dialysis (CrCl <30mL/minute requiring dialysis) compared to patients with normal renal function.
Maltese: L-esponiment normalizzat medju tal-AUC għal pomalidomide żdied b'35.8%, b'CI ta' 90% [7.5% sa 70.0%] f'pazjenti b'indeboliment sever talkliewi li kienu jeħtieġu d-dijalisi (CrCl < 30 mL/minuta li teħtieġ id-dijalisi) meta mqabbla ma' pazjenti b'funzjoni normali tal-kliewi.
English: Co-administration of the strong CYP1A2 inhibitor fluvoxamine with pomalidomide in the presence of ketoconazole, increased mean exposure to pomalidomide by 107% with a 90% confidence interval [91% to 124%] compared to pomalidomide plus ketoconazole.
Maltese: L-għoti flimkien tal-inibitur qawwi ta' CYP1A2 fluvoxamine ma' pomalidomide fil-preżenza ta' ketoconazole, żied il-medja tal-esponiment għal pomalidomide b'107% b'intervall ta' kunfidenza ta' 90% [91% sa 124%] meta mqabbel ma' pomalidomide flimkien ma' ketoconazole.
English: In the Btz+LD-Dex arm, median PFS time was 7.1 months (95% CI: 5.88, 8.48).
Maltese: Fil-grupp ta' Btz+LD-Dex, iż-żmien PFS medjan kien ta' 7.1 xhur (95% CI: 5.88,
English: • 20 mg once daily on days 1, 8, 15 and 22 of each 28-day treatment cycle.
Maltese: • 20 mg darba kuljum f'jiem 1, 8, 15 u 22 ta' kull ċiklu ta' kura ta' 28 jum.
English: • Pomalidomide in combination with dexamethasone The most commonly reported adverse reactions in clinical studies have been blood and lymphatic system disorders including anaemia (45.7%), neutropenia (45.3%) and thrombocytopenia (27%); in general disorders and administration site conditions including fatigue (28.3%), pyrexia (21%) and oedema peripheral (13%); and in infections and infestations including pneumonia (10.7%).
Maltese: L-iktar reazzjonijiet avversi rrappurtati b'mod komuni fl-istudji kliniċi kienu disturbi fid-demm u fissistema limfatika li jinkludu anemija (45.7%), newtropenija (45.3%) u tromboċitopenija (27%); b'mod ġenerali disturbi u kundizzjonijiet fis-sit tal-għoti li jinkludu għeja kbira (28.3%), deni (21%) u edema periferali (13%); u f'infezzjonijiet u infestazzjonijiet li jinkludu pnewmonja (10.7%).
English: Hypokalaemia Hyperglycaemia Hypomagnaesaemia Hypocalcaemia Hypophosphataemia Hyperkalaemia Hypercalcaemia
Maltese: Komuni Ipomanjesemija Ipokalċemija Ipofosfatemija Iperkalemija Iperkalċemija
English: The primary efficacy endpoint was Progression Free Survival (PFS) assessed by an Independent Response Adjudication Committee (IRAC) according to the IMWG criteria using the intent to treat population (ITT).
Maltese: Il-punt aħħari primarju tal-effikaċja kien is-sopravivenza mingħajr progressjoni (PFS, Progression Free Survival) evalwata minn Independent Response Adjudication Committee (IRAC) skont il-kriterji IMWG bl-użu tal-intenzjoni li l-popolazzjoni tiġi kkurata (ITT, intent to treat).
English: (E133), and white ink.
Maltese: (E133), u linka bajda.
English: For each subsequent drop < 25 x 109/l
Maltese: Għal kull nuqqas sussegwenti ta' < 25 x 109/l
English: Patients with ongoing ≥ Grade 2 peripheral neuropathy were excluded from clinical studies with pomalidomide.
Maltese: Pazjenti b'newropatija periferali kurrenti ta' ≥ Grad 2 ġew esklużi mill-istudji kliniċi dwar pomalidomide.
English: • Dizziness, tremor.
Maltese: • Uġigħ fiż-żaqq, nefħa fiż-żaqq.
English: • Pomalidomide in combination with dexamethasone
Maltese: • Pomalidomide flimkien ma' dexamethasone
English: Cardiac events, including congestive cardiac failure, pulmonary oedema and atrial fibrillation (see section 4.8), have been reported, mainly in patients with pre-existing cardiac disease or cardiac risk factors.
Maltese: Avvenimenti kardijaċi, li jinkludu insuffiċjenza kardijaka konġestiva, edema pulmonari u fibrillazzjoni atrijali (ara sezzjoni 4.8), ġew irrappurtati l-biċċa l-kbira f'pazjenti b'mard kardijaku li kien jeżisti minn qabel jew b'fatturi ta' riskju kardijaku.
English: Slight reduction in maternal body weight gain, significant reduction in triglycerides, and significant dec rease in absolute and relative spleen weights were observed at 100 and 250 mg/kg/day.
Maltese: Tnaqqis żgħir fiż-żieda tal-piż tal-ġisem tal-omm, tnaqqis sinifikanti fit-triglycerides, u tnaqqis sinifikanti fil-piżijiet assoluti u relattivi tal-milsa ġew osservati f'dożi ta' 100 u 250 mg/kg/jum.
English: • The capsule shell contains: gelatin, titanium dioxide (E171), indigotine (E132), yellow iron oxide
Maltese: • Il-qoxra tal-kapsula fiha: gelatin, titanium dioxide (E171), indigotine (E132), yellow iron oxide
English: For the HD-Dex arm, dexamethasone (40 mg) was administered once per day on days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle.
Maltese: Fil-parti tal-istudju dwar HD-Dex, dexamethasone (40 mg) ingħata darba kuljum f'jiem 1 sa 4, 9 sa 12, u 17 sa 20 ta' ċiklu ta' 28 jum.
English: Pneumonia (bacterial, viral and fungal infections, including opportunistic infections)
Maltese: Sepsis newtropenika Pnewmonja (infezzjonijiet batterjali, virali u fungali, li jinkludu infezzjonijiet opportunistiċi)
English: Patients receiving pomalidomide either in combination with bortezomib and dexamethasone or in combination with dexamethasone have developed venous thromboembolic events (predominantly deep vein thrombosis and pulmonary embolism) and arterial thrombotic events (myocardial infarction and cerebrovascular accident).
Maltese: Pazjenti li kienu qed jirċievu pomalidomide jew flimkien ma' bortezomib u dexamethasone jew flimkien ma' dexamethasone żviluppaw avvenimenti tromboemboliċi venużi (il-biċċa l-kbira trombożi tal-vini profondi u emboliżmu pulmonari) u avvenimenti tromboemboliċi arterjali (infart mijokardijaku u inċident ċerebrovaskulari).
English: Pomalidomide was found to impact negatively on fertility and be teratogenic in animals.
Maltese: Instab li pomalidomide kellu impatt negattiv fuq il-fertilità u li kien teratoġeniku fl-annimali.
English: Increased cardiac anomalies were seen at all doses with significant increases at 250 mg/kg/day.
Maltese: Żieda fl-anomaliji kardijaċi ġew osservati fid-dożi kollha, b'żidiet sinifikanti f'doża ta' 250 mg/kg/jum.
English: ADRs reported in clinical study MM-003 in patients treated with pomalidomide in combination with dexamethasone.
Maltese: ADRs irrappurtati fl-istudju kliniku MM-003 f'pazjenti kkurati b'pomalidomide flimkien ma' dexamethasone.
English: CYP dependent metabolites account for approximately 43% of the total excreted radioactivity, while nonCYP dependent hydrolytic metabolites account for 25%, and excretion of unchanged pomalidomide accounted for 10% (2% in urine and 8% in faeces).
Maltese: Metaboliti dipendent fuq CYP jammontaw għal madwar 43% tar-radjuattività totali li tneħħiet, filwaqt li metaboliti idrolitiċi mhux dipendenti fuq CYP jammontaw għal 25%, u t-tneħħija ta' pomalidomide mhux mibdul kienet tammonta għal 10% (2% fl-awrina u 8% fl-ippurgar).
English: Peripheral sensory neuropathy Dizziness
Maltese: Newropatija sensorjali periferali
English: The predominant metabolic pathways of excreted radioactivity are hydroxylation with subsequent glucuronidation, or hydrolysis.
Maltese: Il-passaġġi metaboliċi predominanti ta' radjuattività imneħħija huma hydroxylation bi glukoronidazzjoni sussegwenti, jew idrolisi.
English: • some antifungals such as ketaconazole
Maltese: • xi antifungali bħal ketoconazole
English: This medicinal product contains less than 1 mmol sodium (23 mg) per capsule, i.e. essentially ‘sodium-free'.
Maltese: Dan il-prodott mediċinali fih inqas minn 1 mmol ta' sodium (23 mg) f'kull kapsula, jiġifieri essenzjalment huwa ‘ħieles mis-sodium'.
English: This medicine contains less than 1 mmol sodium (23 mg) per capsule, therefore it is considered essentially ‘sodium-free'.
Maltese: Dan il-prodott mediċinali fih anqas minn 1 mmol ta' sodium (23 mg) f'kull kapsula, jiġifieri huwa essenzjalment ‘ħieles mis-sodium'.
English: Imnovid 1 mg hard capsules Imnovid 2 mg hard capsules Imnovid 3 mg hard capsules Imnovid 4 mg hard capsules pomalidomide
Maltese: Imnovid 1 mg kapsuli ibsin Imnovid 2 mg kapsuli ibsin Imnovid 3 mg kapsuli ibsin Imnovid 4 mg kapsuli ibsin pomalidomide
English: Thrombocytopenia was Grade 3 or 4 in 20.7-27.3% of patients, led to pomalidomide discontinuation in 0.7% of patients and was serious in 0.4-1.7% of patients (see sections 4.2 and 4.4).
Maltese: 7-27.3% tal-pazjenti, wasslet għal twaqqif ta' pomalidomide f'0.7% tal-pazjenti u kienet serja f'0.4-1.7% tal-pazjenti (ara sezzjonijiet 4.2 u 4.4).
English: Very Common Pneumonia (bacterial, viral and fungal infections, including opportunistic infections)
Maltese: Komuni Ħafna Pnewmonja (infezzjonijiet batterjali, virali u fungali, li jinkludu infezzjonijiet opportunistiċi)
English: Other ≥ Grade 3 pomalidomide-related adverse events
Maltese: Avvenimenti avversi oħrajn ta' ≥ Grad 3 relatati ma' pomalidomide.
English: Patients > 75 years of age started treatment with 20 mg dexamethasone.
Maltese: Pazjenti ta' > 75 sena bdew il-kura b'20 mg ta' dexamethasone.
English: • The recommended starting dose of dexamethasone is 20 mg per day.
Maltese: • Id-doża tal-bidu rakkomandata ta' dexamethasone hi ta' 20 mg kuljum.
English: Repeat-dose toxicology studies
Maltese: Studji dwar tossikoloġija ta' dożi ripetuti
English: Progression Free Survival Time (weeks) Median a
Maltese: Sopravivenza Mingħajr Progressjoni (ġimgħa)
English: Mean normalised AUC exposure to pomalidomide was 100.2% with a 90% confidence interval [79.7% to 127.0%] in severe renal impairment patients not requiring dialysis (CrCl <30 or eGFR <30 mL/minute/1.73 m2) compared to patients with normal renal function.
Maltese: 2%, b'intervall ta' kunfidenza ta' 90% [79.7% sa 127.0%] f'pazjenti b'indeboliment sever tal-kliewi li ma kinux jeħtieġu d-dijalisi (CrCl < 30 jew eGFR < 30 mL/minuta/1.73 m2) meta mqabbla ma' pazjenti b'funzjoni normali tal-kliewi.
English: The median duration of treatment was 8.8 months (12 treatment cycles) in the Pom+Btz+LD-Dex arm and 4.9 months (7 treament cycles) in the Btz+LD-Dex arm.
Maltese: It-tul medjan tal-kura kien 8.8 xhur (12-il ċiklu ta' kura) fil-grupp ta' Pom+Btz+LD-Dex u 4.9 xhur (7 ċikli ta' kura) fil-grupp Btz+LD-Dex.
English: In rats, chronic administration of pomalidomide at doses of 50, 250, and 1000 mg/kg/day for 6 months was well tolerated.
Maltese: Fil-firien, l-għoti kroniku ta' pomalidomide f'dożi ta' 50, 250, u 1000 mg/kg/jum għal 6 xhur kien ittollerat tajjeb.
English: Imnovid 4 mg hard capsules: Dark blue opaque cap and blue opaque body, with “POML 4 mg” written on them.
Maltese: Imnovid 4 mg kapsuli ibsin: Għatu opak blu skur u korp opak blu bil-kliem “POML 4 mg” miktubin fuqha.
English: Hepatic impairment has a modest effect on the pharmacokinetics of pomalidomide (see section 5.2).
Maltese: Indeboliment tal-fwied għandu effett modest fuq ilfarmakokinetika ta' pomalidomide (ara sezzjoni 5.2).
English: Based on population pharmacokinetic analyses in healthy subjects and multiple myeloma patients, no significant influence of age (19-83 years) on oral clearance of pomalidomide was observed.
Maltese: Ibbażat fuq analiżijiet farmakokinetiċi tal-popolazzjoni f'individwi f'saħħithom u f'pazjenti b'majeloma multipla, ma ġiet osservata l-ebda influwenza sinifikanti tal-età (19-83 sena) fuq ittneħħija orali ta' pomalidomide.
English: POM+LD-DEX vs HD-DEX Logrank p-value = < 0.001 (2-sided) HR (95% CI) 0.53 (0.37, 0.74) KM median: POM+LD-DEX=NE [48.1, NE] KM median: HD-DEX = 34.0[23.4, 39.9] Events: POM+LD-DEX=75/284 HD-DEX=56/139
Maltese: HR (95% CI) 0.53 (0.37, 0.74) Medjan KM: POM+LD-DEX=NE [48.1, NE]
English: • The recommended starting dose of dexamethasone is 40 mg per day.
Maltese: • Id-doża tal-bidu rakkomandata ta' dexamethasone hi ta' 40 mg kuljum.
English: Or
Maltese: ċ
English: 5.1 Pharmacodynamic properties Pharmacotherapeutic group: Immunosuppressants, Other immunosuppressants, ATC code: L04AX06
Maltese: Immunosoppressanti, Immunosoppressanti oħrajn, Kodiċi ATC:
English: Population pharmacokinetic analyses showed that the pomalidomide pharmacokinetic parameters were not remarkably affected in renally impaired patients (defined by creatinine clearance or estimated glomerular filtration rate [eGFR]) compared to patients with normal renal function (CrCl ≥60 mL/minute).
Maltese: Analiżi farmakokinetika tal-popolazzjoni wriet li l-parametri farmakokinetiċi ta' pomalidomide ma ġewx affettwati b'mod notevoli f'pazjenti b'indeboliment tal-kliewi (definiti mit-tneħħija talkreatinina jew mir-rata stmata tal-filtrazzjoni glomerulari [eGFR]) meta mqabbla ma' pazjenti b'funzjoni normali tal-kliewi (CrCl ≥ 60 mL/minuta).
English: POM+LD-DEX vs HD-DEX Logrank p-value = < 0.001 (2-sided) HR (95% CI) 0.45 (0.35, 0.59) Events: POM+LD-DEX=164/302 HD-DEX=103/153
Maltese: Logrank valur p = < 0.001 (2-sided) HR (95% CI) 0.45 (0.35, 0.59) Avvenimenti:
English: Hyperglycaemia ≥ Grade 3
Maltese: Ipergliċemija ≥ Grad 3
English: Follow-up and end of treatment
Maltese: Organi/Terminu
English: Cardiac failure Atrial fibrillation Myocardial infarction
Maltese: Insuffiċjenza kardijaka Fibrillazzjoni atrijali
English: > 75 years old Dose (Cycle 1-8: Days 1, 2, 4, 5, 8, 9, 11, 12 of a 21-day cycle Cycle ≥ 9: Days 1, 2, 8, 9 of a 21-day cycle)
Maltese: Jiem 1, 2, 4, 5, 8, 9, 11, 12 ta' ċiklu ta' 21 jum Ċiklu ≥ 9: Jiem 1, 2, 8, 9 ta' ċiklu ta' 21 jum)
English: Date of first authorisation: 05 August 2013 Date of latest renewal: 11 July 2018
Maltese: Data tal-aħħar tiġdid: 11/07/2018
English: In rabbits, pomalidomide at dosages ranging from 10 to 250 mg/kg produced embryo-foetal developmental malforma tions.
Maltese: Fil-fniek, pomalidomide f'dożaġġi li jvarjaw minn 10 sa 250 mg/kg ipproduċa malformazzjonijiet embrijofetali waqt l-iżvilupp.
English: Uncommon Pulmonary embolism Cough
Maltese: Mhux komuni Emboliżmu pulmonari Sogħla
English: The efficacy and safety of pomalidomide in combination with dexamethasone were evaluated in a Phase III multi-centre, randomised, open-label study (CC-4047-MM-003), where pomalidomide plus low-dose dexamethasone therapy (Pom+LD-Dex) was compared to high-dose dexamethasone alone (HD-Dex) in previously treated adult patients with relapsed and refractory multiple myeloma, who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy.
Maltese: III, multi-centre, randomizzat, double-blind (CC-4047-MM-003) b'terapija ta' pomalidomide flimkien ma' doża baxxa ta' dexamethasone (POM + LD-Dex) meta mqabbla ma' doża għolja ta' dexamethasone waħdu (HD-Dex) f'pazjenti b'majeloma multipla li rkadiet u refrattorja, li qabel kienu kkurati, li jkunu rċivew mill-inqas żewġ korsijiet ta' kura fil-passat, li jinkludu kemm lenalidomide u bortezomib, u wrew progressjoni tal-marda fl-aħħar terapija.
English: If strong inhibitors of CYP1A2 (e.g. ciprofloxacin, enoxacin and fluvoxamine) are co-administered with pomalidomide, reduce the dose of pomalidomide by 50%.
Maltese: Jekk l-inibituri qawwija ta' CYP1A2 (eż. ciprofloxacin, enoxacin u fluvoxamine) jingħataw flimkien ma' pomalidomide, naqqas id-doża ta' pomalidomide b'50%.
English: Patients with significant cardiac dysfunction (congestive heart failure [NY Heart Association Class III or IV]; myocardial infarction within 12 months of starting study; unstable or poorly controlled angina pectoris) were excluded from clinical studies with pomalidomide.
Maltese: III jew IV]; infart mijokardijaku fi żmien 12-il xahar mill-bidu tal-istudju; anġina pectoris instabbli jew ikkontrollata b'mod batut) ġew esklużi mill-istudji kliniċi dwar pomalidomide.
English: Common Pancytopenia
Maltese: Komuni Panċitopenija
English: Pomalidomide is absorbed with a maximum plasma concentration (Cmax) occurring between 2 and 3 hours and is at least 73% absorbed following administration of single oral dose.
Maltese: Pomalidomide jiġi assorbit b'konċentrazzjoni massima fil-plażma (Cmax) li sseħħ bejn 2 u 3 sigħat u jiġi assorbit b'mill-inqas 73% wara l-għoti ta' doża waħda orali.
English: Based on population PK analysis using a two-compartment model, healthy subjects and MM patients had comparable apparent clearance (CL/F) and apparent central volume of distribution (V2/F).
Maltese: Skont analiżi tal-FK tal-popolazzjoni bl-użu ta' mudell ta' żewġ kompartimenti, individwi f'saħħithom u pazjenti MM kellhom tneħħija apparenti (CL/F) u volum ċentrali ta' distribuzzjoni apparenti (V2/F) komparabbli.
English: Imnovid 2 mg hard capsules: Dark blue opaque cap and orange opaque body, with “POML 2 mg” written on them.
Maltese: Imnovid 2 mg kapsuli ibsin: Għatu opak blu skur u korp opak oranġjo bil-kliem “POML 2 mg” miktubin fuqha.
English: Other serious adverse reactions reported included febrile neutropenia (4.0%), neutropenia (2.0%), thrombocytopenia (1.7%) and VTE adverse reactions (1.7 %).
Maltese: Reazzjonijiet avversi serji oħrajn irrappurtati kienu jinkludu newtropenija bid-deni (4.0%), newtropenija (2.0%), tromboċitopenija (1.7%) u reazzjonijiet avversi
English: The potential for such drug-drug interactions, including the potential impact of pomalidomide on the pharmacokinetics of combined oral contraceptives, has not been evaluated clinically (see section 4.4 Teratogenicity).
Maltese: Il-potenzjal għal interazzjonijiet bejn mediċina u oħra, li jinkludu l-impatt potenzjali ta' pomalidomide fuq ilfarmakokinetika ta' kontraċettivi orali kkombinati, ma ġiex evalwat klinikament (ara sezzjoni 4.4
English: • Age ≥ 50 years and naturally amenorrhoeic for ≥ 1 year (amenorrhoea following cancer therapy or during breast-feeding does not rule out childbearing potential)
Maltese: • Età ≥ 50 sena u amenorreika għal ≥ 1 sena (amenorrea wara terapija tal-kanċer jew waqt ittreddigħ ma teskludix li l-mara jista' jkollha tfal)
English: For patients who test positive for HBV infection, consultation with a physician with expertise in the treatment of hepatitis B is recommended.
Maltese: Għal pazjenti li jkunu pożittivi għal infezzjoni tal-HBV, konsultazzjoni ma 'tabib b'kompetenza fil-kura tal-epatite B hi rakkomandata.
English: No metabolites were present at >10% relative to parent or total radioactivity in plasma.
Maltese: L-ebda metaboliti ma kienu preżenti ta' >10% meta mqabbel mar-radjuattività ġenitur jew totali fil-plażma.
English: • Pomalidomide in combination with bortezomib and dexamethasone The recommended starting dose of Imnovid is 4 mg orally once daily on Days 1 to 14 of repeated 21-day cycles.
Maltese: • Pomalidomide flimkien ma' bortezomib u dexamethasone Id-doża tal-bidu rrakkomandata ta' Imnovid hi 4 mg tittieħed mill-ħalq darba kuljum f'Jiem 1 sa 14 ta' ċikli ripetuti ta' 21 jum.
English: No adverse findings were noted up to 1000 mg/kg/day (175-fold exposure ratio relative to a 4 mg clinical dose).
Maltese: L-ebda riżultati avversi ma ġew osservati f'dożi sa 1000 mg/kg/jum (proporzjon ta' esponiment ta' 175 darba meta mqabbel ma' doża klinika ta' 4 mg).
English: Pomalidomide was not mutagenic in bacterial and mammalian mutation assays, and did not induce chromosomal aberrations in human peripheral blood lymphocytes or micronuclei formation in polychromatic erythrocytes in bone marrow of rats administered doses up to 2000 mg/kg/day.
Maltese: Pomalidomide ma kienx mutaġeniku f'assaġġi ta' mutazzjoni batterjali u tal-mammiferi, u ma induċiex aberrazzjonijiet kromosomali fil-limfoċiti ta' demm periferali uman jew il-formazzjoni ta' mikronuklei f'eritroċiti polikromatiċi fil-mudullun ta' firien li ngħataw dożi sa 2000 mg/kg/jum.
English: Imnovid 1 mg hard capsule:
Maltese: Imnovid 1 mg kapsula iebsa:
English: Uncommon Angioedema Urticaria
Maltese: Komuni Ħafna Dijarea
English: Thrombocytopenia Platelet count < 25 x 10
Maltese: Tromboċitopenija Għadd tal-plejtlits ta' < 25 x 109/l