FrancophonIA/ELRC3.0 huggingface dataset:
English: In the clinical development program of ropeginterferon alfa-2b, two cases of serious depression (1.1%; incidence rate: 0.4 events/100 patients per year) occurred.
Maltese: Fil-programm ta' żvilupp kliniku ta' ropeginterferon alfa-2b, żewġ każijiet ta' depressjoni serja (1.1%; rata ta' frekwenza: 0.4 każijiet/100 pazjent kull sena) seħħew.
English: • Take a new needle and remove the protective foil.
Maltese: • Ħu labra ġdida u neħħi l-fojl protettiv.
English: Nervous system disorders common headache, dizziness, hypoesthesia, somnolence, paraesthesia uncommon polyneuropathy, peripheral motor neuropathy, radiculopathy, migraine, mental impairment, tremor, aura
Maltese: Disturbi fis-sistema nervuża komuni uġigħ ta' ras, stordament, ipoestesija, ngħas, paraestesija mhux komuni polinewropatija, newropatija motorja periferali, radikulopatija, emigranja, indeboliment mentali, rogħda, awra
English: Uncommon side effects (may affect up to 1 in 100 people): - infection and re-infection with herpes, bacterial infections - increase in the number of platelets - autoimmune disorder of the thyroid gland, sarcoidosis (areas of inflamed tissue in different parts of the body) - diabetes - panic attack, hallucination (seeing, hearing or feeling things that are not there), feeling stressed, feeling nervous, lack of interest in activities, nightmare, irritability, confusion - damage to the nervous system, migraine, mental disorder (health condition involving changes in thinking, emotion or behaviour), visual or sensory disturbances, shaky hands - eye discomfort, eyelid eczema - hearing loss, ringing in ears (tinnitus), spinning feeling (vertigo) - heart disorders such as heart block (a disorder in the heart´s electrical activity), blood clots in the blood vessels of the heart, leakage of the aortic valve - high blood pressure, reduced blood supply to certain parts of the body, haematoma (collection of blood under the skin), flushing - inflammation of lung tissue, coughing, nosebleed, sore throat - inflammation of the stomach, abdominal wall disorder, intestinal gas, indigestion, painful swallowing, bleeding gums - inflammation of the liver, damage to the liver, enlarged liver - sensitivity to sunlight, peeling of the skin, nail disorder - muscle weakness, neck pain, groin pain - inflammation of the bladder, painful urination, increased need to urinate, inability to urinate - sexual problems - pain or itching at the site of injection, sensitivity to weather change - loss of weight - in blood tests: increase of uric acid, antibodies produced by the body´s immune system against red blood cells
Maltese: Effetti sekondarji mhux komuni (jistgħu jaffettwaw sa persuna 1 f'100): - infezzjoni u infezzjoni mill-ġdid b'herpes, infezzjonijiet batteriċi - żieda fl-għadd ta' pjastrini - disturb awtoimmuni tal-glandola tat-tirojde, sarkojdożi (żoni ta' tessut infjammat f'partijiet differenti tal-ġisem) - dijabete - attakk ta' paniku, alluċinazzjoni (tara, tisma' jew tħoss affarijiet li mhumiex hemm), tħossok stressjat, tħossok nervuż, nuqqas ta' interess fl-attivitajiet, ħmar il-lejl, irritabilità, konfużjoni - ħsara lis-sistema nervuża, emigranja, disturb mentali (kundizzjoni ta' saħħa li tinvolvi bidliet fil-mod ta' ħsieb, emozzjoni jew imġieba), disturbi viżivi jew sensorjali, idejn jirtgħodu - skumdità tal-għajn, ekżema tal-kappa tal-għajn - telf tas-smigħ, ċenċil fil-widnejn (tinnite), tħossok iddur (vertiġni) - disturbi tal-qalb, bħal imblokk tal-qalb (disturb fl-attività elettrika tal-qalb), emboli tad-demm fil-vażi tad-demm tal-qalb, tnixxija tal-valv aortiku - pressjoni għolja, forniment imnaqqas ta' demm f'ċertu partijiet tal-ġisem, ematoma (ġbir tad demm taħt il-ġilda), fwawar - infjammazzjoni tat-tessut tal-pulmun, sogħla, jinfaraġ l-imnieħer, griżmejn bl-uġigħ - infjammazzjoni tal-istonku, disturb tal-ħajt tal-addome, gass fl-imsaren, indiġestjoni, bligħ bl uġigħ, emorraġija fil-ħanek
English: The disease response (defined as haematocrit <45% without phlebotomy [at least 3 months since last phlebotomy], platelets <400 x 109/L and leukocytes <10 x 109/L after 12 months of treatment) was 43.1% [53/123 of patients] in the ropeginterferon alfa-2b arm after 12 months of treatment.
Maltese: Ir-rispons għall-marda (imfisser bħala ematokrit <45% mingħajr flebotomija [tal-inqas 3 xhur mill-aħħar flebotomija], plejtlits <400 x 109/L u lewkoċiti <10 x 109/L wara 12-il xahar ta' trattament) kien 43.1% [53/123 pazjent] fil-grupp ta' ropeginterferon alfa-2b wara 12-il xahar ta' trattament.
English: Further, it was demonstrated that interferon alfa is able to decrease the mutated JAK2V617F allele burden in patients with polycythaemia vera (a V617F point mutation in the JAK2 kinase is a hallmark of polycythaemia vera and is present in approximately 95% of patients).
Maltese: Barra minn hekk, ġie muri li interferon alfa hu kapaċi jnaqqas it-tagħbija tal-allel mutat JAK2V617F f'pazjenti b'poliċitemija vera (mutazzjoni puntata ta' V617F fil-JAK2 kinase hija karatteristika ta' poliċitemija vera u hi preżenti f'95% tal-pazjenti).
English: Complete haematological responsea Complete haematological responsea and improvement in disease burdenb a defined as haematocrit <45% without phlebotomy (at least 3 months since last phlebotomy), platelets <400 x 109/L and leukocytes <10 x 109/L.
Maltese: Rispons ematoloġiku kompluta Rispons ematoloġiku kompluta u titjib fit-tagħbija tal-mardab a imfisser bħala ematokrit <45% mingħajr flebotomija (tal-anqas 3 xhur sa mill-aħħar flebotomija), plejtlits <400 x 109/L u lewkoċiti <10 x 109/L.
English: Cardiac events including cardiomyopathy, myocardial infarction, atrial fibrillation and ischaemic coronary artery disorders have been associated with interferon alfa treatment (see section 4.8).
Maltese: Każijiet kardijaċi li jinkludu kardjomijopatija, infart mijokardijaku, fibrillazzjoni atrijali u disturbi iskemiċi tal-arterja koronarja ġew assoċjati ma' trattament b'interferon alfa (ara sezzjoni 4.8).
English: JAK2V617F allele burden JAK2V617F changes from baseline
Maltese: tagħbija tal-allel ta' JAK2 V617F
English: The maximum recommended single dose is 500 micrograms injected every two weeks.
Maltese: Id-doża massima unika rakkomandata hi ta' 500 mikrogramma injettata kull ġimgħatejn.
English: Patients with renal impairment receiving a single dose of 1.0 micrograms/kg pegylated interferon alfa-2b showed an increased relation of Cmax, AUC, and half-life to the degree of renal impairment.
Maltese: Pazjenti b'indeboliment tal-kliewi li kienu qed jirċievu doża unika ta' 1.0 mikrogramma/kg pegylated interferon alfa-2b urew relazzjoni akbar ta' Cmax, AUC, u half-life għall-grad ta' indeboliment tal-kliewi.
English: Very rare side effects (may affect up to 1 in 10,000 people): - idiopathic or thrombotic thrombocytopenic purpura (increased bruising, bleeding, decreased platelets, anaemia and extreme weakness) - myocardial ischemia (reduced blood flow to your heart muscle)
Maltese: Effetti sekondarji rari ħafna (jistgħu jaffettwaw sa persuna 1 f'10,000): - purpura tromboċitopenika idjopatika jew trombotika (żieda fit-tbenġil, emorraġija, tnaqqis fil-plejtlits, anemija u dgħufija estrema) - iskemija mijokardjali (fluss imnaqqas tad-demm għall-muskolu tal-qalb)
English: The strength indicates the quantity of the interferon alpha-2b moiety of ropeginterferon alfa-2b without consideration of the pegylation.
Maltese: Il-qawwa tindika l-kwantità tal-porzjon ta' interferon alpha-2b ta' ropeginterferon alfa-2b mingħajr konsiderazzjoni ta' pegilazzjoni.
English: - The other ingredients are sodium chloride, polysorbate 80, benzyl alcohol, anhydrous sodium acetate, glacial acetic acid, and water for injections.
Maltese: - Is-sustanzi l-oħra huma sodium chloride, polysorbate 80, benzyl alcohol, sodium acetate anidru, acetic acid glaċjali, u ilma għall-injezzjonijiet.
English: For benzyl alcohol and sodium, see section 2 “Besremi contains benzyl alcohol” and “Besremi contains sodium”.
Maltese: Għal benzyl alcohol u sodju ara sezzjoni 2 “Besremi fih benzyl alcohol” u “Besremi fih is-sodju”.
English: Following treatment-related adverse reactions were reported with ropeginterferon alfa-2b in clinical studies in 178 polycythaemia vera adult patients.
Maltese: Ir-reazzjonijiet avversi marbuta mat-trattament li ġejjin ġew rapportati b'ropeginterferon alfa-2b fi studji kliniċi f'178 pazjent adult b'poliċitemija vera.
English: An open label, randomised phase III study (PROUD-PV) evaluated the efficacy and safety of ropeginterferon alfa-2b in comparison to hydroxycarbamide in 254 adult polycythaemia vera patients (randomisation 1:1).
Maltese: III bit-tikketta tingħaraf (PROUD-PV) ivvaluta l-effikaċja u s-sigurtà ta' ropeginterferon alfa-2b meta mqabbel ma' hydroxycarbamide f'254 pazjent adult b'poliċitemija vera (każwalità 1.1).
English: Following multiple dosing of pegylated interferon alfa-2b (1.0 micrograms/kg subcutaneously administered every week for four weeks), the clearance of pegylated interferon alfa-2b was reduced by a mean of 17% and 44% in patients with moderate or severe renal impairment, respectively, compared to subjects with normal renal function.
Maltese: Wara dożaġġ multiplu ta' pegylated interferon alfa-2b (1.0 mikrogramma/kg mogħti taħt il-ġilda kull ġimgħa għal erba' ġimgħat), it-tneħħija ta' pegylated interferon alfa-2b tnaqqset minn medja ta' 17% u 44% f'pazjenti b'indeboliment moderat jew sever tal-kliewi, rispettivament, meta mqabbel ma' individwi b'funzjoni normali tal-kliewi.
English: Over a dose range of 24 to 270 micrograms, ropeginterferon alfa-2b Cmax increased proportionally with dose in a pharmacokinetic study with healthy subjects.
Maltese: Fuq firxa dożali ta' 24 sa 270 mikrogramma, ropeginterferon alfa-2b Cmax żdied b'mod proporzjonali mad-doża fi studju farmakokinetiku b'individwi b'saħħithom.
English: Interaction studies of other pegylated interferon alfa medicinal products Co-administration of pegylated interferon alfa-2a with telbivudine in patients with hepatitis B increased the risk of developing peripheral neuropathy.
Maltese: Studji ta' interazzjoni ta' prodotti mediċinali oħra ta' pegylated interferon alfa L-għoti flimkien ta' pegylated interferon alfa-2a ma' telbivudine f'pazjenti b'epatite B żied ir-riskju li tiżviluppa newropatija periferika.
English: Pharmacokinetic interaction studies in humans with pegylated interferon alfa-2a indicated a moderate inhibitory effect on substrates metabolised by CYP1A2 and CYP2D6 (see section 4.5).
Maltese: Studji ta' interazzjoni farmakokinetika fil-bniedem b'pegylated interferon alfa-2a indikaw effett impeditorju moderat fuq sottostrati metabolizzati b'CYP1A2 u CYP2D6 (ara sezzjoni 4.5).
English: Hepatobiliary very common gamma-glutamyltransferase increased disorders common liver disorder, alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased uncommon hepatotoxicity, hepatitis toxic, hepatomegaly rare hepatic failure#
Maltese: komuni ħafna żieda fil-gamma glutamyltransferase komuni disturb fil-fwied, żieda fl-alanine aminotransferase, żieda fl-aspartate aminotransferase, żieda tal-alkaline phosphatase fid-demm mhux komuni epatossiċità, epatite tossika, epatomegalija rari falliment epatiku#
English: Arthralgia 23 (12.9) 8.5 1 (4.3)* 4 (17.4) 4 (17.4) Fatigue
Maltese: Tromboċitopenija 33 (18.5) 15.0
English: In 13 patients with ESRD requiring chronic haemodialysis, administration of 135 micrograms pegylated interferon alfa-2a once weekly resulted in a 34% lower drug exposure than in patients with normal renal function.
Maltese: Fi 13-il pazjent b'ESRD li kienu jeħtieġu emodijalisi kronika, l-għoti ta' 135 mikrogramma pegylated interferon alfa-2a darba fil-ġimgħa rriżulta f'esponiment ta' 34% inqas tal-mediċina milli f'pazjenti bil-funzjoni tal-kliewi normali.
English: Enzymes of the protein catabolism are considered to be involved in the metabolism of ropeginterferon alfa-2b.
Maltese: Enzimi tal-kataboliżmu ta' proteini huma maħsubin li huma involuti fil-metaboliżmu ta' ropeginterferon alfa-2b.
English: b defined as the improvement of disease-related signs (clinically significant splenomegaly) and disease-related symptoms (microvascular disturbances, pruritus, headache).
Maltese: b imfisser bħala titjib tas-sinjali marbuta mal-marda (splenomegalija klinikament rilevanti) u sintomi marbuta mal-marda (disturbi mikrovaskulari, ħakk, uġigħ ta' ras).
English: No n (%)
Maltese: Le n (%)
English: In patients with compensated cirrhosis (i.e. Child-Pugh A), another pegylated interferon alfa medicinal product (pegylated interferon alfa-2a) has been shown to be safe.
Maltese: F'pazjenti b'ċirrosi kompensata (i.e. Child-Pugh A), prodott mediċinali pegylated interferon alfa ieħor (pegylated interferon alfa-2a) ġie muri li hu sikur.
English: Visual system
Maltese: Sistema viżwali
English: A reduced starting dose for ropeginterferon alfa-2b of 50 micrograms is recommended for patients with severe (GFR 1529 mL/min) renal impairment.
Maltese: Doża talbidu ridotta għal ropeginterferon alfa-2b ta' 50 mikrogramma hi rakkomandata għal pazjenti b'indeboliment tal-kliewi sever (GFR 15-29 mL/min).
English: Ropeginterferon alfa-2b is contraindicated in patients with end stage renal disease (GFR <15 mL/min) (see section 4.3).
Maltese: Ropeginterferon alfa-2b huwa kontraindikat f'pazjenti b'mard tal-kliewi tal-aħħar stadju (GFR <15 mL/min) (ara sezzjoni 4.3).
English: Ropeginterferon alfa-2b treatment arm
Maltese: Ropeginterferon alfa-2b
English: The Besremi 250 micrograms pre-filled pen can be used to inject doses of 50, 100, 150, 200 and 250 micrograms.
Maltese: Il-pinna mimlija għal-lest ta' Besremi 250 mikrogramma tista' tintuża biex tinjetta dożi ta' 50, 100, 150, 200 u 250 mikrogramma.
English: Increased liver enzyme levels have been observed in patients treated with ropeginterferon alfa-2b.
Maltese: Ġew osservati livelli ogħla ta' enzimi tal-fwied f'pazjenti trattati b'ropeginterferon alfa-2b.
English: Vogt-Koyanagi-Harada disease#, acute hypersensitivity reactions#**
Maltese: mhux magħruf marda ta' Vogt-Koyanagi-Harada#, reazzjonijiet akuti ta' sensittività eċċessiva#**
English: The pen can be adjusted to administer doses in 50 microgram intervals in the range of 50 to 250 micrograms or 50 to 500 micrograms.
Maltese: Il-pinna tista' tiġi aġġustata sabiex jingħataw dożi ta' 50 mikrogramma f'intervalli fil-firxa ta' 50 sa 250 mikrogramma jew 50 sa 500 mikrogramma.
English: This medicine contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially ‘sodiumfree'.
Maltese: Din il-mediċina fiha inqas minn 1 mmol ta' sodju (23 mg) f'kull ml, jiġifieri hija essenzjalment ‘ħielsa mis-sodju'.
English: Interferon alfa belongs to the class of type I interferons which exhibit their cellular effects by binding to a transmembrane receptor termed interferon alfa receptor (IFNAR).
Maltese: Interferon alfa jappartjeni għall-klassi ta' interferoni ta' tip I li jesebixxu l-effetti ċellulari tagħhom billi jittrakkaw mar-riċettatur transmembrani li jissejjaħ riċettatur ta' interferon alfa (IFNAR, interferon alfa receptor).
English: Also contains sodium chloride, polysorbate 80, anhydrous sodium acetate, glacial acetic acid, water for injections, and benzyl alcohol.
Maltese: Fih ukoll sodium chloride, polysorbate 80, sodium acetate anidru, acetic acid glaċjali, ilma għallinjezzjonijiet, u benzyl alcohol.
English: Diabetes mellitus have been observed with other interferon alfa medicinal products (see section 4.8).
Maltese: Id-dijabete mellitus ġiet osservata ma' prodotti mediċinali oħrajn li fihom interferon alfa (ara sezzjoni 4.8).
English: The response to ropeginterferon alfa-2b treatment is presented in Table 3 and Table 4.
Maltese: Ir-rispons għat-trattament ta' ropeginterferon alfa-2b hu preżentat f'Tabella 3 u Tabella 4.
English: 1 Patients with 36 months of ropeginterferon alfa-2b treatment (12-month treatment duration in the PROUD-PV Study and 24-month treatment duration in the extension study).
Maltese: 1 Pazjenti b'36 xahar fuq trattament b'ropeginterferon alfa-2b (tul ta' trattament ta' 12-il xahar fl-Istudju PROUD-PV u tul ta' trattament ta' 24 xahar fl-istudju ta' estensjoni).
English: No dose adjustment for ropeginterferon alfa-2b is required for adult patients with mild (GFR 6089 mL/min) or moderate (GFR 30-59 mL/min) renal impairment.
Maltese: L-ebda aġġustament fid-doża għal ropeginterferon alfa-2b mhu meħtieġ għal pazjenti adulti b'indeboliment tal-kliewi ħafif (GFR 60-89 mL/min) jew moderat (GFR 30-59 mL/min).
English: No dose adaptions for ropeginterferon alfa-2b should be necessary when concomitantly administered with medicinal products metabolised via CYP2C9/19, CYP3A4 or by N-acetyltransferase.
Maltese: L-ebda adattament tad-doża għal ropeginterferon alfa-2b mhu meħtieġ meta jingħata flimkien ma' prodotti mediċinali metabolizzati permezz ta' CYP2C9/19, CYP3A4 jew b'N-acetyltransferase.
English: The patient recovered completely after paracetamol administration and temporary discontinuation of ropeginterferon alfa-2b therapy.
Maltese: Il-pazjent irkupra kompletament wara li ngħata paracetamol u l-waqfien temporanju tat-terapija b'ropeginterferon alfa-2b.
English: Blood and lymphatic system disorders very common leukopenia, thrombocytopenia common pancytopenia, neutropenia, anaemia
Maltese: Disturbi tad-demm u tas-sistema limfatika komuni ħafna lewkopenija, tromboċitopenija komuni panċitopenija, newtropenija, anemija
English: Name and address of the manufacturer(s) responsible for batch release AOP Orphan Pharmaceuticals AG
Maltese: Isem u indirizz tal-manifattur(i) responsabbli għall-ħruġ tal-lott AOP Orphan Pharmaceuticals AG Wilhelminenstrasse 91/IIf
English: • Press the push button with your thumb until the “0” mark is aligned with the dot in the display window.
Maltese: • Agħfas il-buttuna 'l isfel kollha sakemm il-marka ta' “0” tiġi allinejata mal-punt fit-tieqa.
English: Eye disorders common dry eye uncommon retinal haemorrhage#, retinal exudates#, visual impairment, visual acuity reduced, vision blurred, ocular discomfort, eczema eyelids rare retinopathy#, optic neuropathy#, retinal artery occlusion#, retinal vein occlusion#,
Maltese: Disturbi fl-għajnejn komuni għajn xotta mhux komuni emorraġija retinali#, tisfija retinali#, indeboliment viżwali, tnaqqis fir-reqqa viżiva, vista mċajpra, skumdità okulari, kpiepel tal-għajnejn bl-ekżema rari retinopatija#, newropatija ottika#, sadd fl-arterja retinali#, sadd fil-vina retinali#
English: Studies in rats with a similar interferon alfa medicinal product (pegylated interferon alfa-2a) showed a primarily elimination via hepatic metabolism.
Maltese: L-istudji fil-firien bi prodott mediċinali simili ta' interferon alfa (pegylated interferon alfa-2a) urew li leliminazzjoni prinċipali hi permezz tal-metaboliżmu epatiku.
English: Patients were stratified by previous exposure to hydroxycarbamide, age at screening (≤60 or >60 years) and presence of thromboembolic events in the past.
Maltese: Il-pazjenti ġew imqassma skont l-esponiment minn qabel għal hydroxycarbamide, età ta' skrinjar (≤60 jew >60 sena) u l-preżenza ta' każijiet tromboembolitiċi fil-passat.
English: Respiratory disorders such as lung infiltration, pneumonitis, pneumonia or pulmonary arterial hypertension have been observed rarely in patients treated with interferon alfa (see section 4.8).
Maltese: Disturbi respiratorji bħal infiltrazzjoni tal-pulmun, pulmonite, pnewmonja jew pressjoni għolja flarterja tal-pulmun ġew osservati b'mod rari f'pazjenti trattati b'interferon alfa (ara sezzjoni 4.8).
English: Studies with a similar interferon alfa medicinal product (pegylated interferon alfa-2a) indicated that the kidney is a major organ for excretion of radiolabelled metabolic products (study in rats) and that the systemic clearance of pegylated interferon alfa-2a in humans is about 100-fold lower compared to the native, unpegylated interferon alfa-2a.
Maltese: Studji bi prodott mediċinali simili ta' interferon alfa (pegylated interferon alfa-2a) indika li l-kliewi huwa organu ewlieni ta' eliminazzjoni ta' prodotti metaboliċi radjutikkettati (studju fil-firien) u li t-tneħħija sistemika ta' pegylated interferon alfa-2a fil-bniedem hi madwar 100 darba inqas meta mqabbel ma' unpegylated interferon alfa-2a nattiv.
English: Endocrine disorders common hypothyroidism, hyperthyroidism, thyroiditis uncommon diabetes mellitus#
Maltese: Disturbi fis-sistema endokrinarja komuni ipotirojdiżmu, ipertirojdiżmu, tirojdite mhux komuni dijabete mellitus#
English: GGT (≥3 times the upper limit of normal) and bilirubin (>2 times the upper limit of normal) levels have been observed in patients treated with ropeginterferon alfa-2b.
Maltese: Żidiet fil-livelli ta' ALT (≥3 darbiet il-limitu ta' fuq tan-normal), AST (≥3 darbiet il-limitu ta' fuq tannormal), GGT (≥3 darbiet il-limitu ta' fuq tan-normal) u bilirubin (>darbtejn il-limitu ta' fuq tan normal) ġew osservati f'pazjenti kkurati b'ropeginterferon alfa-2b.
English: This medicine contains 5 mg benzyl alcohol in each 0.5 mL.
Maltese: Din il-mediċina fiha 5 mg benzyl alcohol f'kull 0.5 mL. Benzyl alcohol jista' jikkaġuna reazzjonijiet allerġiċi.
English: Interferon alfa was shown to be abortifacient in primates and ropeginterferon alfa-2b is expected to have a similar effect.
Maltese: Interferon alfa intwera li hu abortifiċenti fil-primati u ropeginterferon alfa-2b hu mistenni li jkollu effett simili.
English: CNS effects, in particular depression, have been observed in some patients treated with ropeginterferon alfa-2b during the clinical development program (see section 4.8).
Maltese: Effetti fuq is-SNĊ, b'mod partikolari d-depressjoni, ġew osservati f'xi pazjenti trattati b'ropeginterferon alfa-2b waqt il-programm tal-iżvilupp kliniku (ara sezzjoni 4.8).
English: Treatment with ropeginterferon alfa-2b should be discontinued when, despite dose reduction, the increase in liver enzyme levels is progressive and clinically significant.
Maltese: It-trattament b'ropeginterferon alfa-2b għandu jitwaqqaf meta, minkejja ttnaqqis fid-doża, iż-żieda fil-livelli ta' enzimi tal-fwied tkun progressiva u klinikament sinifikanti.
English: Yes n (%) *values are mean ±SD.
Maltese: n (%) *valuri huma medji ±SD.
English: Reproductive system and breast disorders uncommon erectile dysfunction, haematospermia
Maltese: Disturbi fis-sistema riproduttiva u fissider mhux komuni impotenza, ematospermja
English: Patients with moderate or severe renal impairment receiving 180 micrograms of pegylated interferon alfa-2a once weekly showed a comparable or 60% higher drug plasma exposure, respectively, compared to subjects with normal renal function.
Maltese: Pazjenti b'indeboliment tal-kliewi moderat jew sever li kienu qed jirċievu 180 mikrogramma ta' pegylated interferon alfa-2a darba fil-ġimgħa wrew esponiment paragunabbli jew esponiment 60% ogħla tal-mediċina fil-plażma rispettivament, meta mqabbel ma' individwi b'funzjoni tal-kliewi normali.
English: CNS effects including suicide attempt, suicidal ideation, aggression, bipolar disorder, mania and confusion have been reported with interferon alfa (see section 4.4).
Maltese: L-effetti ta' SNĊ li jinkludu attentat ta' suwiċidju, ħsibijiet ta' suwiċidju, aggressjoni, disturb bipolari, manija u konfużjoni ġew rapportati b'interferon alfa (ara sezzjoni 4.4).
English: Disease response after 24 and 36 months of ropeginterferon alfa-2b.
Maltese: Tabella 3. Rispons għal marda wara 24 u 36 xahar b'ropeginterferon alfa-2b.
English: Serious eye disorders have been reported with interferon alfa such as retinopathy, retinal haemorrhage, retinal exudates, retinal detachment and retinal artery or vein occlusion (see section 4.4).
Maltese: Disturbi serji tal-għajnejn ġew rapportati b'interferon alfa bħal retinopatija, emorraġija retinali, tisfija retinali, distakkament retinali u sadd fl-arterja jew fil-vina retinali (ara sezzjoni 4.4).
English: Vascular disorders common microangiopathy uncommon
Maltese: Ilma għall-injezzjonijiet