FrancophonIA/ELRC3.0 huggingface dataset:
English: These symptoms may be signs of the rare and serious skin reactions Stevens-Johnson syndrome, toxic epidermal necrolysis or DRESS syndrome.
Maltese: Dawn is-sintomi jistgħu jkunu sinjali tar-reazzjonijiet tal-ġilda rari u serji, is-sindrome ta' Stevens-Johnson, nekrolisi epidermali tossika jew is-sindrome DRESS.
English: Grade 2 (interfering with function but not with activities of daily living)
Maltese: Grad 2 (li jinterferixxi fil-funzjoni imma mhux f'attivitajiet tal-ħajja ta' kuljum)
English: • Blurred vision.
Maltese: • Vista mċajpra.
English: In 10 healthy women, the pharmacokinetic profiles of norethindrone and ethinyl estradiol following administration of a single dose containing 1.0 mg of norethindrone acetate and 0.75 mg of ethinyl estradiol were studied.
Maltese: F'10 nisa b'saħħithom, il-profili farmakokinetiċi ta' norethindrone u ethinyl estradiol wara l-għoti ta' doża waħda li kien fiha 1.0 mg ta' norethindrone acetate u 0.75 mg ta' ethinyl estradiol ġew studjati.
English: Thromboprophylaxis and dosing/anticoagulation therapy recommendations are provided in section 4.2.
Maltese: Rakkomandazzjonijiet dwar it-tromboprofilassi u t-terapija tad-dożaġġ/antikoagulazzjoni huma pprovduti f'sezzjoni 4.2.
English: Acute myeloid leukaemia*
Maltese: Lewkimja majelodje akuta*,^
English: Acute myeloid leukaemia (AML) and myelodysplastic syndromes (MDS) AML and MDS were reported in one clinical study in patients with previously untreated multiple myeloma receiving the combination of melphalan, prednisone, and thalidomide (see section 4.4).
Maltese: Lewkimja majelojde akuta (AML) u sindromi majelodisplastiċi (MDS) AML u MDS ġew irrappurtati fi studju kliniku wieħed f'pazjenti li fil-passat kellhom majeloma multipla mhux ikkurata li kienu qed jirċievu kombinazzjoni ta' melphalan, prednisone, u thalidomide (ara sezzjoni 4.4).
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini: http://www.ema.europa.eu/.
English: The capsules are supplied in a wallet card containing 28 capsules (2 blisters of 14 capsules each).
Maltese: Il-kapsuli jiġu f'kards tal-kartiera li fihom 28 kapsula (2 folji ta' 14-il kapsula kull waħda).
English: The most clinically important adverse reactions associated with the use of thalidomide in combination with melphalan and prednisone or dexamethasone include: deep vein thrombosis and pulmonary embolism, peripheral neuropathy, severe skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis, syncope, bradycardia, and dizziness (see sections 4.2, 4.4 and 4.5).
Maltese: L-aktar reazzjonijiet avversi klinikament importanti assoċjati ma' l-użu ta' thalidomide f'kombinazzjoni ma' melphalan u prednisone jew dexamethasone jinkludu: trombożi profonda fil-vina u emboliżmu pulmonari, newropatija perferali, reazzjonijiet severi tal-ġilda li jinkludu s-sindromu ta' Stevens-Johnson u nekrolisi epidermali tossika, sinkope, bradikardja u sturdament (ara sezzjonijiet 4.2, 4.4 u 4.5).
English: Thalidomide is a powerful human teratogen, inducing a high frequency (about 30 %) of severe and live-threatening birth defects such as: ectromelia (amelia, phocomelia, hemimelia) of the upper and/or lower extremities, microtia with abnormality of the external acoustic meatus (blind or absent), middle and internal ear lesions (less frequent), ocular lesions (anophthalmia, microphthalmia), congenital heart disease, renal abnormalities.
Maltese: Thalidomide huwa teratoġen uman qawwi li jissensitizza frekwenzi għolja (madwar 30 %) ta' mankamenti severi u ta' periklu għal ħajja mit-twelid bħal: ektromelija (amelija, fokomelija, hemimelija) tal-estremitajiet ta' fuq u/jew ta' taħt, mikrotja b'abnormalità tal-meatus akustiku ta' barra (għami jew assenti), leżjonijiet fil-widna tan-nofs jew interna (inqas ta' spiss), leżjonijiet okulari (anoftalmja, mikroftalmja), mard konġenitali tal-qalb, abnormalitajiet renali.
English: Acute myeloid leukaemia (AML) and myelodysplastic syndromes (MDS) A statistically significant increase of AML and MDS was observed in one clinical study in patients with previously untreated MM receiving the combination of melphalan, prednisone, and thalidomide (MPT).
Maltese: Lewkimja majelojde akuta (AML) u sindromi majelodisplastiċi (MDS) Żieda statistikament sinifikanti ta' AML u MDS ġiet osservata fi studju kliniku wieħed f'pazjenti li fil-passat kellhom MM mhux ikkurata li kienu qed jirċievu kombinazzjoni ta' melphalan, prednisone, u thalidomide (MPT).
English: Patients treated with thalidomide have an increased risk of venous thromboembolism (such as deep vein thrombosis and pulmonary embolism) and arterial thromboembolism (such as myocardial infarction and cerebrovascular event) (see section 4.8).
Maltese: Pazjenti kkurati b'thalidomide għandhom żieda fir-riskju ta' tromboemboliżmu venuż (bħal trombożi tal-vini fil-fond u emboliżmu pulmonari) u tromboemboliżmu arterjali (bħal infart mijokardijaku u avveniment ċerebrovaskulari) (ara sezzjoni 4.8).
English: Toxic skin eruption, Rash, Dry skin
Maltese: Eruzzjoni tossika tal-ġilda, Raxx, Ġilda xotta
English: • Chest infection (pneumonia), lung disease.
Maltese: • Infezzjoni fis-sider (pnewmonja), mard tal-pulmun.
English: Endocrine Disorders
Maltese: Disturbi fis-sistema endokrinarja
English: Deep vein thrombosis*
Maltese: Trombożi tal-vini profondi*
English: Thalidomide Celgene contains an active substance called thalidomide.
Maltese: Thalidomide Celgene fih sustanza attiva msejħa thalidomide.
English: 200 mg daily 0.125 mg/kg daily 2 mg/kg daily
Maltese: 200 mg kuljum 0.125 mg/kg kuljum2 mg/kg kuljum
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 bl-HBV, konsultazzjoni ma' tabib b'kompetenza fil-kura tal-epatite B hi rakkomandata.
English: Additional precautions
Maltese: Prekawzjonijiet addizzjonali
English: • Levonorgestrel-releasing intrauterine system (IUS)
Maltese: • Impjant • Sistema ġo l-utru li tirrilaxxa levonorgestrel (IUS)
English: An increased risk of venous thromboembolism (such as deep vein thrombosis and pulmonary embolism) and arterial thromboembolism (such as myocardial infarction and cerebrovascular event) has been reported in patients treated with thalidomide (see section 4.4).
Maltese: Riskju ogħla ta' tromboemboliżmu venuż (bħal trombożi tal-vini fil-fond u emboliżmu pulmonari) u tromboemboliżmu arterjali (bħal infart mijokardijaku u avveniment ċerebrovaskulari) ġew irrapportati f'pazjenti trattati b'thalidomide (ara sezzjoni 4.4).
English: Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 to < 1/100); rare (≥ 1/10,000 to < 1/1000); very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Maltese: Il-frekwenzi huma mfissra kif ġej: komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1000 sa < 1/100); rari (≥ 1/10.
English: The MAH should agree on the implementation of the patient card system in each Member State.
Maltese: L-MAH għandu jaqbel ma' l-implimentazzjoni tas-sistema tal-kard tal-pazjent f'kull Stat Membru.
English: Grade 1 (paraesthesia, weakness and/or loss of reflexes) with no loss of function
Maltese: Grad 1 (paraestesija, debulezza u/jew telf tar-riflessi) mingħajr telf fil-funzjoni
English: Patients should be monitored for: thromboembolic events, peripheral neuropathy, severe skin reactions, bradycardia, syncope, somnolence, neutropenia and thrombocytopenia (see sections 4.4 and 4.8).
Maltese: Il-pazjenti għandhom jiġu monitorati għal: każijiet tromboembolitiċi, newropatija periferali, reazzjonijiet severi tal-ġilda, bradikardja, sinkope, ngħas, newtropenija u tromboċitopenija (ara sezzjonijiet 4.4 u 4.8).
English: Each capsule contains 50 mg of thalidomide.
Maltese: Kull kapsula fiha 50 mg thalidomide.
English: • you have high blood pressure in the arteries of the lungs (see also section 4 “Possible side effects”).
Maltese: • għandek pressjoni tad-demm għolja fl-arterji tal-pulmun (ara wkoll sezzjoni 4 “Effetti sekondarji possibbli”).
English: Febrile neutropenia
Maltese: Disturbi vaskulari
English: Oxidative metabolism does not contribute significantly to the overall metabolism of thalidomide.
Maltese: Metaboliżmu li jossida ma jikkontribwixxix b'mod sinifikanti għall-metaboliżmu globali ta' thalidomide.
English: * see section 4.8 description of selected adverse reactions identified from post marketing data ^ Acute myeloid leukaemia and Myelodysplastic syndrome were reported in one clinical study in patients with previously untreated MM receiving the combination of melphalan, prednisone and thalidomide (MPT)
Maltese: * ara sezzjoni 4.8 Deskrizzjoni ta' reazzjonijiet avversi magħżula † identifikati minn dejta wara t-tqegħid fis-suq ^ Lewkimja majelojde akuta u Sindrome Majelodisplastiku ġew irrappurtati fi studju kliniku wieħed f'pazjenti b'MM li ma ġewx ikkurati fil-passat li kienu qed jirċievu l-kombinazzjoni ta' melphalan, prednisone u thalidomide (MPT)
English: These can happen during treatment, or after treatment has stopped.
Maltese: Din tista' sseħħ waqt it-trattament, jew wara li t-tratatment ikun waqaf.
English: There is a linear relationship between body weight and estimated thalidomide clearance; in multiple myeloma patients with body weight from 47-133 kg, thalidomide clearance ranged from approximately 6-12 L/h, representing an increase in thalidomide clearance of 0.621 L/h per 10 kg body weight increase.
Maltese: Hemm relazzjoni lineari bejn il-piż tal-ġisem u l-istima tat-tneħħija ta' thalidomide; f'pazjenti b'majeloma multipla li għandhom piż tal-ġisem ta' 47-133 kg, it-tneħħija ta' thalidomide varjat minn madwar 6-12 L/siegħa, li tirrappreżenta żieda fit-tneħħija ta' thalidomide ta' 0.621 L/siegħa għal kull 10 kg ta' żieda ta' piż tal-ġisem.
English: Capsule shell Gelatin
Maltese: Il-qoxra tal-kapsula
English: • Sexual intercourse with a vasectomised male partner only; vasectomy must be confirmed by two negative semen analyses
Maltese: • Att sesswali ma' partner raġel vażektomizzat biss; il-vażektomija trid tiġi b'żewġ testijiet negattivi tas-semen
English: Results from IFM 99-06, a Phase 3, randomised, open label, parallel group, multicentre study have demonstrated a survival advantage when thalidomide is used in combination with melphalan and prednisone for 12 cycles of 6 weeks in the treatment of newly diagnosed multiple myeloma patients.
Maltese: Riżultati minn studju IFM 99-06, ta' Fażi 3, randomizzat, bit-tikketta murija, grupp parallel, multiċentrali wera vantaġġ ta' sopravivenza meta thalidomide jintuża f'kombinazzjoni ma' melphalan u prednisone għal 12-il ċiklu ta' 6 ġimgħat fit-trattament ta' pazjenti li għadhom kif ġew djanjozati b'majeloma multipla.
English: In 18 healthy male volunteers, multiple dose administration of 200 mg thalidomide had no apparent effect on the single dose pharmacokinetics of digoxin.
Maltese: Fi 18-il voluntier raġel b'saħħithom, l-għoti ta' doża multipla ta' 200 mg thalidomide ma deherx li kellu effett fuq il-farmakokinetika ta' doża waħda ta' digoxin.
English: Melphalan dosed once daily on Days 1 to 4 of each 42-day cycle.
Maltese: a Melphalan iddożat darba kuljum f'ħin l-irqad f'Jiem 1 sa 4 ta' kull ċiklu ta' 42 jum.
English: What Thalidomide Celgene looks like and contents of the pack Thalidomide Celgene are white hard capsules marked “Thalidomide Celgene 50 mg”.
Maltese: Kif jidher Thalidomide Celgene u l-kontenut tal-pakkett Thalidomide Celgene huma kapsuli bojod iebsa mmarkati “Thalidomide Celgene 50 mg”.
English: If the patient experiences any thromboembolic events, treatment must be discontinued and standard anticoagulation therapy started.
Maltese: Jekk pazjent ikollu xi każ tromboemboliku, it-trattament għandu jitwaqqaf u għandha tinbeda t-terapija ta' antikoagulazzjoni standard.
English: Prednisone f
Maltese: Prednisonef
English: • Healthcare professional booklet o History of thalidomide, background on Thalidomide Celgene and its licensed indication o Posology
Maltese: • Fuljett għall-professjonisti tal-kura tas-saħħa o L-isfond ta' thalidomide, u l-isfond dwar Thalidomide Celgene u l-indikazzjoni liċenzjata tiegħu o Pożoloġija
English: Pulmonary embolism*, Interstitial lung disease, Bronchopneumopathy, Dyspnea
Maltese: Emboliżmu pulmonari*, Mard tal-interstizju tal-pulmun, Bronkopnewmopatija, Dispnea Mhux Magħrufa Pressjoni għolja pulmonari†
English: • Ovulation inhibitory progesterone-only pills (i.e. desogestrel)
Maltese: • Pilloli tal-progesterone biss li jinpedixxu l-ovulazzjoni (jiġifieri desogestrel)
English: No evidence of carcinogenicity was observed at exposures approximately 15, 13 and 39 times the estimated clinical AUC at the recommended starting dose in mice, male rats and female rats respectively.
Maltese: L-ebda xhieda ta' karċinoġeniċità ma ġiet osservata f'espożizzjonijiet ta' madwar 15, 13 u 39 darba l-AUC kliniku stmat tad-doża rakkomandata mibdija fi ġrieden, firien irġiel u firien nisa rispettivament.
English: Men
Maltese: ISEM
English: • Prior to prescribing all healthcare professionals who intend to prescribe (and in agreement with the National Competent Authority, dispense) Thalidomide Celgene are provided with an Educational Healthcare Professional's Kit containing the following: o Educational healthcare professional booklet o Educational brochures for patient o Patient cards o Summary of product characteristics, package leaflet and labelling
Maltese: • Qabel ma jiktbu r-riċetti l-professjonisti kollha tal-kura tas-saħħa li beħsiebhom jiktbu riċetti (u bi ftehim ma' l-Awtorità Nazzjonali Kompetenti, jagħtu), Thalidomide Celgene qed jiġu provduti b'Kitt Edukattiv tal-Professjonist fil-Qasam tal-Kura tas-Saħħa li fih dan li ġej: o Fuljett edukattiv għall-professjonisti tal-kura tas-saħħa o Fuljetti edukattivi għall-pazjenti o Kards tal-Pazjent o Sommarju tal-karatteristiċi tal-prodott, fuljett ta' tagħrif u tikkettar
English: Discontinue treatment
Maltese: Waqqaf it-trattament
English: Syncope, bradycardia and atrioventricular block
Maltese: Sinkope, bradikardja u imblokk atrijoventikulari
English: Prednisone dosed once daily on Days 1 to 4 of each 42-day cycle.
Maltese: f Prednisone iddożat darba kuljum f'Jiem 1 sa 4 ta' kull ċiklu ta' 42 jum.
English: • Educational brochures for patients: o The educational brochures for patients should be of 3 types:
Maltese: • Fuljetti edukattivi għall-pazjenti: o Il-fuljetti edukattivi għall-pazjenti għandhom jkunu ta' 3 tipi:
English: Thromboembolic events
Maltese: Każijiet tromboemboliċi
English: Uncommon (may affect up to 1 in 100 people)
Maltese: Mhux komuni (jistgħu jaffettwaw sa persuna waħda f'100)
English: Grade 3 (interfering with activities of daily living)
Maltese: Grad 3 (li jinterferixxi fl-attivitajiet ta' kuljum) Waqqaf it-trattament Grad 4 (newropatija li tiddiżabilita)
English: Serious cutaneous reactions including Stevens-Johnson syndrome TEN and DRESS have been reported with the use of thalidomide therapy.
Maltese: Reazzjonijiet severi tal-ġilda li jinkludu s-sindrome ta' Stevens-Johnson, TEN u DRESS ġew irrappurtati bl-użu tat-terapija b'thalidomide.
English: Thalidomide Celgene is used with two other medicines called ‘melphalan' and ‘prednisone' to treat adults with a type of cancer called multiple myeloma.
Maltese: Thalidomide Celgene jintuża ma' żewġ mediċini oħrajn imsejħa ‘melphalan' u ‘prednisone' biex jittratta adulti, b'tip ta' kanċer imsejjaħ majeloma multipla.
English: • Teratogenicity and the need to avoid foetal exposure
Maltese: • Teratogeniċità u l-bżonn li tiġi evitata espożizzjoni tal-fetu
English: Melphalan dosing: reduce by 50 % for moderate (creatinine clearance: ≥ 30 but < 50 mL/min) or severe (CrCl: < 30mL/min) renal insufficiency e
Maltese: d Għoti tad-doża ta' melphalan: naqqas b'50% għal insuffiċjenza tal-kliewi moderata (tneħħija tal-kreatinina: ≥ 30 iżda < 50 mL/min) jew severa (CrCl: < 30 mL/min) e Doża massima ta' kuljum ta' melphalan: 24 mg (individwi li jkollhom ≤ 75 sena) jew 20 mg (individwi li jkollhom > 75 sena).
English: The results were similar with and without co-administration of thalidomide 200 mg/day to steady-state levels.
Maltese: Ir-riżultati kienu simili bi u mingħajr l-amministrazzjoni konġunta ta' thalidomide 200 mg/kuljum f'livelli ta' stat fiss.
English: Table 2: Recommended dose modifications for thalidomide -related neuropathy in first line treatment of multiple myeloma
Maltese: Tabella 2: Modifikazzjonijiet tad-doża rrakkomandati għal newropatija relatata ma' thalidomide fl-ewwel linja ta' trattament ta' myeloma multiplika Severità ta' newropatija
English: • Hypersensitivity to thalidomide or to any of the excipients listed in section 6.1.
Maltese: • Sensittività eċċessiva għal thalidomide jew għal kwalunkwe sustanza mhux attiva elenkata fis-sezzjoni 6.1.
English: Thalidomide Celgene has not formally been studied in patients with impaired renal or hepatic function.
Maltese: Thalidomide Celgene ma ġiex formalment studjat f'pazjenti li għandhom il-funzjoni renali jew epatika indebolita.
English: Measures of renal function (CrCl) and liver function (blood chemistry) indicate minimal effect of kidney and liver function on the pharmacokinetics of thalidomide.
Maltese: Il-kejl tal-funzjoni tal-kliewi (CrCl) u tal-funzjoni tal-fwied (kimika tad-demm) jindika effett minimu tal-funzjoni tal-kliewi u tal-fwied fuq il-farmakokinetika ta' thalidomide.
English: • Worsening of Parkinson's disease symptoms (such as tremor, depression or confusion).
Maltese: • Aggravament tas-sintomi tal-marda ta' Parkinson (bħal rogħda, dipressjoni jew konfużjoni).
English: Table 3: Adverse drug reactions (ADRs) reported in pivotal clinical study with thalidomide in combination with melphalan and prednisone and from post marketing use
Maltese: Tabella 3: Reazzjonijiet avversi tal-mediċina (ADRs) irrappurtati fl-istudju kliniku l-aktar importanti b'thalidomide f'kombinazzjoni ma' melphalan u prednisone u mill-użu ta' wara tqegħid fis-suq
English: If Stevens-Johnson syndrome, TEN or DRESS is suspected, use of thalidomide should not be resumed (see section 4.2 and 4.4).
Maltese: Jekk ikun hemm suspett tas-sindrome ta' Stevens-Johnson, TEN jew DRESS, l-użu ta' thalidomide m'għandux jitkompla (ara sezzjoni 4.2 u 4.4).
English: Educational Healthcare Professional's Kit The Educational Healthcare Professional's Kit shall contain the following elements:
Maltese: Il-Kitt Edukattiv tal-Professjonisti tal-Kura tas-Saħħa għandu jkun fih l-elementi li ġejjin:
English: • Pregnancy prevention requirement, definition and need for adequate contraceptive methods
Maltese: • Rekwiżit ta' prevenzjoni ta' tqala u tifsira u bżonn ta' metodi ta' kontraċezzjoni adegwati
English: Cases of viral reactivation have been reported in patients receiving thalidomide, including serious cases of herpes zoster or hepatitis B virus (HBV) reactivation.
Maltese: Ġew irrappurtati każijiet ta' attivazzjoni mill-ġdid virali f'pazjenti li kienu qed jirċievu thalidomide, li jinkludu każijiet serji ta' attivazzjoni mill-ġdid tal-virus ta' herpes zoster jew tal-epatite B (HBV).
English: WARNING
Maltese: Kontraċezzjoni
English: Neutropenia
Maltese: Irġiel
English: Multiple myeloma generally cannot be cured.
Maltese: Il-majeloma multipla ġeneralment ma tistax tiġi kkurata.
English: No effects were observed in dogs; however in rats, there was an apparent dose-dependent decrease in total and free T4 that was more consistent in the female.
Maltese: Ma ġew osservati ebda effetti fuq il-klieb; madankollu fil-firien kien hemm tnaqqis apparenti fid-dipendenza tad-doża fit-total u it-T4 liberu kien aktar konsistenti fil-mara.
English: Medicinal products known to cause peripheral neuropathy Medicinal products known to be associated with peripheral neuropathy (e.g. vincristine and bortezomib) should be used with caution in patients receiving thalidomide.
Maltese: Prodotti mediċinali magħrufa li huma assoċjati ma' newropatija periferali (eż. vincristine u bortezomib) għandhom jintużaw b'kawtela fuq pazjenti li qed jirċievu thalidomide.
English: • You must not donate semen: o during treatment o for at least 7 days after stopping treatment
Maltese: • Inti m'għandekx tagħti semen: o waqt it-trattament o għal mill-inqas 7 ijiem wara li twaqqaf it-trattament
English: Teratogenicity
Maltese: Newtropenija
English: It is not known whether the effect will be different in multiple myeloma patients.
Maltese: Mhux magħruf jekk l-effett ser ikun differenti f'pazjenti li jbatu minn myeloma mulitiplika.
English: • Underactive thyroid (hypothyroidism).
Maltese: • Rogħda (tkexkiex).
English: Other medicines and Thalidomide Celgene
Maltese: Mediċini oħra u Thalidomide Celgene
English: • Having difficulty in seeing or speaking, which is temporary.
Maltese: • Issibha bi tqila tara jew titkellem, li hi ħaġa temporanja.
English: In thirteen of these cases, patients took thalidomide alone; amounts ranged from 350 mg to 4000 mg.
Maltese: Fi tlettax minn dawn il-każijiet, il-pazjenti ħadu thalidomide waħdu; l-ammonti kienu jvarjaw minn 350 mg sa 4,000 mg.
English: In addition to the adverse reactions outlined above, thalidomide in combination with dexamethasone in other clinical studies led to the very common adverse reaction of fatigue; common adverse reactions of transient ischaemic event, syncope, vertigo, hypotension, mood altered, anxiety, blurred vision, nausea and dyspepsia; and uncommon adverse reactions of cerebrovascular accident, diverticular perforation, peritonitis, orthostatic hypotension and bronchitis.
Maltese: Barra mir-reazzjonijiet avversi mogħtija fil-qosor hawn fuq, thalidomide flimkien ma' dexamethasone ikkaġuna għeja bħala reazzjoni avversa komuni ħafna fi studji kliniċi oħra; reazzjonijiet avversi komuni ta' iskemija mumentanja, sinkope, vertiġini, pressjoni baxxa, tibdil fil-burdata, ansjetà, vista mċajpra, dardir u dispepsja; u reazzjoniiet avversi mhux komuni ta' aċċident ċerebrovaskulari, perforazzjoni divertikulari, peritonite, pressjoni baxxa ortostatika u bronkite.
English: †, Atrial fibrillation Atrioventricular block
Maltese: Infart mijokardijaku†, Fibrillazzjoni tal-atriju†, Imblokk atrijoventrikulari†
English: Bradycardic effect
Maltese: Effett bradikardijaku
English: Thalidomide does not interact with hormonal contraceptives.
Maltese: Thalidomide m'għandux effett ma' kontraċettivi ormonali.
English: Peripheral neuropathy Dose modifications due to peripheral neuropathy are described in Table 2.
Maltese: Newropatija periferali Modifikazzjonijiet għad-doża minħabba newropatija periferali huma deskritti f'Tabella 2.
English: 100 mg daily 0.20 mg/kg daily 2 mg/kg daily
Maltese: 100 mg kuljum 0.20 mg/kg kuljum2 mg/kg kuljum
English: Somnolence
Maltese: Pożoloġija
English: A national controlled distribution system has been implemented in collaboration with each National Competent Authority.
Maltese: Sistema ta' distribuzzjoni nazzjonali kkontrollata tkun ġiet implimentata b'kollaborazzjoni ma' kull Awtorità Kompetenti Nazzjonali.
English: There is no relevant use of Thalidomide Celgene in the paediatric population in the indication of multiple myeloma.
Maltese: M'hemm l-ebda użu rilevanti ta' Thalidomide Celgene fil-popolazzjoni pedjatrika għal indikazzjoni ta' majeloma multipla.
English: 100 mg daily 0.10 mg/kg daily 2 mg/kg daily
Maltese: 100 mg kuljum 0.10 mg/kg kuljum2 mg/kg kuljum
English: Thalidomide does not interact with digoxin.
Maltese: Thalidomide m'għandux effett fuq digoxin.