FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients who develop symptoms indicative of a thyroid dysfunction during ropeginterferon alfa-2b therapy, should evaluate their thyroid stimulating hormone (TSH) levels.
Maltese: Pazjenti li jiżviluppaw sintomi indikattivi ta' disfunzjoni tat-tirojde waqt it-terapija ta' ropeginterferon alfa 2b għandhom jivvalutaw il-livelli tal-ormon li jistimula t-tirojde (TSH, thyroid stimulating hormone) tagħhom.
English: The mean dose after 36 months of treatment (12-month treatment duration in the PROUD-PV Study and 24month treatment duration in the extension study) was 363 (±149) micrograms for ropeginterferon alfa2b.
Maltese: Id-doża medja wara 36 xahar ta' trattament (tul ta' trattament għal 12-il xahar fl-istudju PROUD-PV u tul ta' 24 xahar bit-trattament fl-istudju ta' estensjoni) kienet ta' 363 (±149) mikrogramma għal ropeginterferon alfa-2b.
English: The use of interferon alfa has not been evaluated in patients with decompensated cirrhosis (i.e. ChildPugh B or C) and is contraindicated in these patients (see section 4.3).
Maltese: L-użu ta' interferon alfa ma ġiex evalwat f'pazjenti b'ċirrożi dekompensata (i.e. Child-Pugh B jew Ċ) u huwa kontraindikat f'dawn il-pazjenti (ara sezzjoni 4.3).
English: JAK2V617F allele burden and changes from baseline in the CONTINUATION-PV extension study.
Maltese: Tagħbija tal-allel JAK2 V617F u bidliet mil-linja bażi fl-istudju ta' estenzjoni CONTINUATION-PV.
English: The dose should be gradually increased by 50 micrograms every two weeks (in parallel, other cytoreductive therapy should be decreased gradually, as appropriate) until stabilisation of the haematological parameters is achieved (haematocrit <45%, platelets <400 x 109/L and leukocytes <10 x 109/L).
Maltese: Id-doża għandha togħla gradwalment b'50 mikrogramma kull ġimagħtejn (b'mod parallel, terapija ċitoriduttiva oħra għandha titnaqqas gradwalment, kif jixraq) sakemm tintlaħaq stabilità fil-parametri ematoloġiċi (ematokrit <45%, plejtlits <400 x 109/L u and lewkoċiti <10 x 109/L).
English: Effects on fertility was not assessed.
Maltese: L-effetti fuq ilfertilità ma ġewx analizzati.
English: Besremi is indicated as monotherapy in adults for the treatment of polycythaemia vera without symptomatic splenomegaly.
Maltese: Besremi hu indikat bħala monoterapija għal adulti għat-trattament ta' poliċitemija vera mingħajr sintomi ta' splenomegalija.
English: Besremi 250 micrograms/0.5 mL solution for injection in pre-filled pen Besremi 500 micrograms/0.5 mL solution for injection in pre-filled pen
Maltese: Besremi 250 mikrogramma/0.5 mL soluzzjoni għall-injezzjoni f'pinna mimlija għal-lest Besremi 500 mikrogramma/0.5 mL soluzzjoni għall-injezzjoni f'pinna mimlija għal-lest
English: The absorption of ropeginterferon alfa-2b is sustained in patients with peak serum concentrations reached after 3 to 6 days.
Maltese: L-assorbiment ta' ropeginterferon alfa 2b hu sostnut f'pazjenti bl-ogħla konċentrazzjonijiet milħuqa fis-serum wara 3 sa 6 ijiem.
English: Hepatic failure in hepatitis C virus infected patients was reported with other interferon alfa medicinal products (see section 4.8).
Maltese: Insuffiċjenza epatika f'pazjenti infettati bil-vajrus ta' epatite Ċ ġiet rapportata bi prodotti mediċinali oħrajn ta' interferon alfa (ara sezzjoni 4.8).
English: Infections and infestations common respiratory tract infection, rhinitis, fungal skin infection uncommon oral herpes, herpes zoster, oral candidiasis, sinusitis, oesophageal candidiasis, vulvovaginal mycotic infection, hordeolum, onychomycosis
Maltese: Infezzjonijiet u Infestazzjonijiet komuni infezzjoni fil-passaġġ respiratorju, rinite, infezzjoni fungali tal-ġilda mhux komuni herpes orali, herpes zoster, kandidjasi orali, sinusite, kandidjasi esofageali, infezzjoni mikotika vulvovaġinali,
English: Cases of pulmonary arterial hypertension (PAH) have been reported with interferon alfa, notably in patients with risk factors for PAH (such as portal hypertension, HIV infection, cirrhosis).
Maltese: Każijiet ta' pressjoni għolja fl-arterja pulmonari (PAH, pulmonary arterial hypertension) ġew rapportati b'interferon alfa, notevolment f'pazjent b'fatturi ta' riskju għal PAH (bħal pressjoni għolja fis-sistema portali, infezzjoni b'HIV, ċirrożi).
English: Most common adverse reactions
Maltese: L-aktar reazzjonijiet avversi komuni
English: During the clinical study program, one accidental case of overdose has been reported with ropeginterferon alfa-2b.
Maltese: Waqt il-programm tal-istudju kliniku, ġie rapportat każ inċidentali wieħed ta' doża eċċessiva b'ropeginterferon alfa-2b.
English: One patient who experienced serious acute stress disorder (0.6%; incidence rate: 0.2 events/100 patients per year) with moderate intensity recovered completely after the dose of ropeginterferon alfa-2b was reduced.
Maltese: Pazjent wieħed li esperjenza disturb akut serju talistress (0.6%; rata ta' inċidenza: 0.2 każijiet/100 pazjent kull sena) b'intensità moderata rkupra kompletament wara li d-doża ta' ropeginterferon alfa-2b ġiet imnaqqsa.
English: Ear and labyrinth disorders uncommon deafness, tinnitus, vertigo
Maltese: Disturbi fil-widnejn u fis-sistema labirintika mhux komuni truxija, tinnite, vertiġini
English: Thrombocytopenia
Maltese: L-Awstrija
English: Dose reduced
Maltese: U KWANTITATTIVA
English: No data are available (see section 4.4).
Maltese: M'hemm l-ebda data disponibbli (ara sezzjoni 4.4).
English: 112-month treatment duration in the PROUD-PV Study and 12-month treatment duration in the extension study 212-month treatment duration in the PROUD-PV Study and 24-month treatment duration in the extension study
Maltese: 2 tul ta' trattament ta' 12 xahar fl-Istudju PROUD-PV u tul ta' trattament ta' 24-il xahar fl-istudju ta' estensjoni.
English: Respiratory, thoracic and mediastinal disorders common dyspnoea uncommon pneumonitis, cough, epistaxis, throat irritation very rare lung infiltration#
Maltese: toraċiċi u medjastinali komuni dispnea mhux komuni pnewmonite, sogħla, epistassi, irritazzjoni tal-griżmejn rari ħafna infiltrazzjoni tal-pulmun#
English: Hepatic impairment
Maltese: Mediċina mwaqqfa
English: Comparable exposure and pharmacokinetic profile was reported for another interferon alfa medicinal product (pegylated interferon alfa-2a) in cirrhotic (Child-Pugh A) and non-cirrhotic patients.
Maltese: L-esponiment komparabbli u l-profil farmakokinetiku ġew rapportati għal prodott mediċinali ieħor ta' interferon alfa (pegylated interferon alfa-2a) f'pazjenti b'ċirrożi (Child-Pugh A) u mingħajr ċirrożi.
English: Ropeginterferon alfa-2b treatment was continued and the patients received appropriate medicinal products to treat these events.
Maltese: Peress li ropeginterferon alfa-2b jista' jkollu l-istess effett, dan il-prodott mediċinali mhux rakkomandat waqt it-tqala.
English: Cardiovascular system
Maltese: Sistema kardjovaskulari
English: White n (%)
Maltese: Bojod n (%)
English: CNS
Maltese: SNĊ
English: The pre-filled pen label must always be checked before each injection to avoid medication errors between Besremi 250 micrograms/0.5 mL solution for injection and Besremi 500 micrograms/0.5 mL solution for injection.
Maltese: It-tikketta tal-pinna mimlija għal-lest għandha dejjem tiġi ċċekkjata qabel kull injezzjoni biex tevita żbalji mediċinali bejn Besremi 250 mikrogrammi/0.5 mL soluzzjoni għall-injezzjoni u Besremi 500 mikrogrammi/0.5 mL soluzzjoni għall-injezzjoni.
English: Liver disorders have been reported in patients after long-term ropeginterferon alfa-2b therapy (see section 4.8).
Maltese: Disturbi fil-fwied u parametri epatiċi abnormali tal-laboratorju ġew rapportati f'pazjenti fuq terapija b'ropeginterferon alfa-2b fuq terminu ta' żmien twil (ara sezzjoni 4.8).
English: Gastrointestinal disorders common diarrhoea, nausea, abdominal pain, constipation, abdominal distension, dry mouth uncommon gastritis, abdominal wall disorder, flatulence, frequent bowel movements, odynophagia, gingival bleeding not known tooth disorder#, periodontal disease#
Maltese: Disturbi gastrointestinali komuni dijarea, dardir, uġigħ addominali, stitikezza, distensjoni addominali, ħalq xott mhux komuni gastrite, disturb fis-superfiċji addominali, gass, ċaqlieq tal-imsaren frekwenti, odinofaġja, emorraġija ġenġivali mhux magħruf disturb tas-snien#, mard perjodontali#
English: Ropeginterferon alfa-2b is contraindicated in patients with end stage renal disease (see section 4.3).
Maltese: Ropeginterferon alfa-2b huwa kontraindikat f'pazjenti b'mard tal-kliewi tal-aħħar stadju (ara sezzjoni 4.3).
English: Psychiatric disorders common depression, aggression#, insomnia, anxiety, mood altered, mood swings, listless uncommon suicide attempt#, suicidal ideation#, confusional state#, acute stress disorder, hallucination, emotional distress, nervousness, apathy, nightmare, irritability rare bipolar disorder#, mania#
Maltese: Disturbi psikjatriċi komuni depressjoni, aggressjoni#, insomnija, ansjetà, burdata mibdula, bidliet fil-burdata, bla ħeġġa mhux komuni tentattiv ta' suwiċidju#, ħsieb suwiċidali#, stat konfużjonali#, disturb akut tal-istress, alluċinazzjoni,
English: Description Besremi 500 micrograms pre-filled pen
Maltese: Deskrizzjoni Besremi 500 mikrogramma pinna mimlija għal-lest
English: The average molecular mass is approximately 60 kDa, of which the PEG moiety constitutes approximately 40 kDa .
Maltese: Il-massa molekulari medja hi ta' madwar 60 kDa, li minnhom il-porzjon PEG jikkostitwixxi 40 kDa.
English: Likewise, caution is recommended with CYP2D6 substrates (e.g. vortioxetine, risperidone) combined with ropeginterferon alfa-2b.
Maltese: Hekk ukoll, kawtela hija rakkomandata b'sottostrati ta' CYP2D6 (eż. vortioxetine, risperidone) flimkien ma' ropeginterferon alfa-2b.
English: The dose is titrated individually with a recommended starting dose of 100 micrograms (or 50 micrograms in patients under another cytoreductive therapy).
Maltese: Id-doża għandha tiġi ttitrata individwalment b'doża rakkomandata tal-bidu ta' 100 mikrogramma (jew 50 mikrogramma f'pazjenti taħt terapija ċitoriduttiva oħra).
English: Besremi 250 micrograms/0.5 mL solution for injection in pre-filled pen Each pre-filled pen of 0.5 mL solution contains 250 micrograms of ropeginterferon alfa-2b as measured on a protein basis, corresponding to 500 micrograms/mL.
Maltese: Kull pinna mimlija għal-lest ta' 0.5 mL soluzzjoni fiha 250 mikrogramma ta' ropeginterferon alfa-2b kif imkejjel fuq bażi ta' proteina, li tikkorispondi għal 500 mikrogramma/mL.
English: Besremi 250 mcg/0.5 mL injection ropeginterferon alfa-2b SC
Maltese: Besremi 250 mikrogramma/0.5 mL soluzzjoni għall-injezzjoni f'pinna mimlija għal-lest ropeginterferon alfa-2b
English: Besremi contains the active substance ropeginterferon alfa-2b, which belongs to the class of medicinal products called interferons.
Maltese: Besremi fih is-sustanza attiva ropeginterferon alfa-2b, li jappartjeni għall-klassi ta' prodotti mediċinali li jissejħu interferoni.
English: Most common adverse reactions during ropeginterferon alfa-2b treatment.
Maltese: L-aktar reazzjonijiet avversi komuni waqt it-trattament b'ropeginterferon alfa-2b.
English: Each cartridge contains 0.5 mL of solution.
Maltese: Kull skartoċċ fih 0.5 mL ta' soluzzjoni.
English: Description Besremi 250 micrograms pre-filled pen
Maltese: Deskrizzjoni Besremi 250 mikrogramma pinna mimlija għal-lest
English: An open-label, phase IIIb extension study (CONTINUATION-PV) enrolled 171 adult polycythaemia vera patients who previously completed the PROUD-PV Study to evaluate the long-term efficacy and safety of ropeginterferon alfa-2b.
Maltese: Ġew arwolati 171 pazjent adult b'poliċitemija vera għall-istudju ta' estensjoni, bit-tikketta tingħaraf ta' fażi IIIb (CINTINUATION-PV) li qabel kienu temmew l-istudju PROUD-PV biex jiġu evalwati l-effikaċja u s-sigurtà fuq terminu ta' żmien twil ta' ropeginterferon alfa-2b.
English: Besremi 500 mcg/0.5 mL injection ropeginterferon alfa-2b SC
Maltese: Besremi 500 mikrogramma/0.5 mL soluzzjoni għall-injezzjoni f'pinna mimlija għal-lest ropeginterferon alfa-2b
English: Besremi 500 micrograms/0.5 mL solution for injection in pre-filled pen Each pre-filled pen of 0.5 mL solution contains 500 micrograms of ropeginterferon alfa-2b as measured on a protein basis, corresponding to 1,000 micrograms/mL.
Maltese: Kull pinna mimlija għal-lest ta' 0.5 mL soluzzjoni fiha 500 mikrogramma ta' ropeginterferon alfa-2b kif imkejjel fuq bażi ta' proteina, li tikkorispondi għal 1,000 mikrogramma/mL.
English: Common side effects (may affect up to 1 in 10 people): - infection of the respiratory tract, runny or stuffy nose, fungal infections - decrease in the number or size of red blood cells - increase or decrease in the thyroid gland activity, increase of thyroid stimulating hormone, inflammation of the thyroid gland - increase of triglycerides (a type of lipid) in the blood, decreased appetite - aggressive behaviour, feeling depressed, feeling anxious, problems with falling asleep or staying asleep, mood changes, lacking bodily energy or motivation - headache, feeling dizzy, reduced sense of touch or sensation, feeling sleepy, sensation of tingling and ‘pins and needles' - dry eyes - damage of the capillaries (very small blood vessels) in the body - breathing problems
Maltese: Effetti sekondarji komuni (jistgħu jaffettwaw sa persuna 1 f'10): - infezzjoni fil-passaġġ respiratorju, imnieħer iqattar jew miżdud, infezzjonijiet fungali - tnaqqis fl-għadd jew fid-daqs ta' ċelloli ħomor tad-demm - żieda jew tnaqqis fl-attività tal-glandola tat-tirojde, żieda fl-ormon li jistimula t-tirojde, infjammazzjoni tal-glandola tat-tirojde
English: Rare side effects (may affect up to 1 in 1,000 people): - bipolar disorders (mood disorders with episodes of sadness and excitement), mania (extreme excitement or unreasonable enthusiasm) - cardiomyopathy (diseases that affect the heart muscle), angina pectoris (a severe chest pain as a result of blockage of the heart vessels) - liver failure
Maltese: Effetti sekondarji rari (jistgħu jaffettwaw sa persuna 1 f'1,000): - disturbi bipolari (disturbi tal-burdata b'episodji ta' dwejjaq u eċitament), manija (eċitament estrem jew entużjażmu mhux raġonevoli)
English: Solution for injection in pre-filled pen 1 pre-filled pen + 2 injection needles 0.5 mL solution
Maltese: Soluzzjoni għall-injezzjoni f'pinna mimlija għal-lest Pinna 1 mimlija għal-lest + 2 labar tal-injezzjoni soluzzjoni ta' 0.5 mL
English: - diarrhoea, nausea, abdominal pain or stomach discomfort, constipation, dry mouth - liver disorder, increase in certain liver enzymes (shown in blood tests) - itching, hair loss, rash, redness of skin, psoriasis, dry and scaly skin, acne, thickening of the outer layer of the skin, increased sweating - a disorder called Sjogren's syndrome where the body's immune system attacks glands that produce fluid (such as the tear and saliva glands), arthritis, pain in arms and legs, bone pain, painful sudden tightening of a muscle - fever, weakness, chills, general health problems, irritation or redness at the site of injection - in blood tests: antibodies which are produced by the body´s immune system, increase of an enzyme called lactate dehydrogenase
Maltese: - ħsara lil kapillari (vażi tad-demm żgħar ħafna) fil-ġisem - problemi bin-nifs - dijarea, dardir, uġigħ ta' żaqq jew dwejjaq fl-istonku, stitikezza, ħalq xott - disturb tal-fwied, żieda f'ċertu enzimi tal-fwied (murija fit-testijiet tad-demm) - ħakk, telf ta' xagħar, raxx, ħmura tal-ġilda, psorjasi, ġilda xotta jew imqaxxra, akne, tħaxxin tas saff ta' barra tal-ġilda, żieda fl-għaraq - disturb li jissejjaħ is-sindrome ta' Sjogren fejn is-sistema immuni tal-ġisem tattakka glandoli li jipproduċu fluwidu (bħal demgħat u tal-glandoli tar-riq), artrite, uġigħ fid-dirgħajn u r-riġlejn,
English: Interferon alfa therapy has been associated with hepatotoxicity characterized by potentially significant increases in liver enzymes.
Maltese: It-terapija b'interferon alfa ġiet assoċjata ma' tossiċità tal-fwied kkaratterizzata b'żidiet potenzjalment sinifikanti fl-enzimi tal-fwied.
English: Other medicines and Besremi
Maltese: Mediċini oħra u Besremi
English: Raynaud's phenomenon, hypertension, haematoma, flushing
Maltese: Disturbi vaskulari komuni mikroanġjopatija mhux komuni fenomenu ta' Raynaud, pressjoni għolja, ematoma , fwawar
English: Basedow's disease, sarcoidosis very rare idiopathic or thrombotic thrombocytopenic purpura#
Maltese: rari ħafna purpura tromboċitopenika idjopatika jew trombotika#
English: Patients with 24 months of ropeginterferon alfa-2b treatment1
Maltese: Pazjenti b'24 xahar ta' trattament b'ropeginterferon alfa-2b1
English: If renal function decreases during treatment, ropeginterferon alfa-2b therapy should be discontinued.
Maltese: Jekk il-funzjoni tal-kliewi tonqos waqt it-trattament, it-terapija b'ropeginterferon alfa-2b għandha titwaqqaf.
English: • Existence of, or history of severe psychiatric disorders, particularly severe depression, suicidal ideation or suicide attempt
Maltese: • L-eżistenza ta', jew storja ta' disturbi psikjatriċi severi, partikolarment depressjoni severa,
English: Patients with 36 months of ropeginterferon alfa-2b treatment2
Maltese: Pazjenti b'36 xahar ta' trattament b'ropeginterferon alfa-2b2
English: The attachment of interferon alfa-2b to a high molecular weight (40 kDa) branched polyethylene glycol moiety is considered as the main reason for the differences in the elimination compared to unpegylated interferons.
Maltese: L-ittrakkar ta' interferon alfa-2b ma' porzjon ta' fergħa ta' polyethylene glycol b'piż molekulari għoli (40 kDa) hu kkonsidrat r-raġuni ewlenija għad-differenzi fl-eliminazzjoni meta mqabbel ma' unpegylated inteferon.
English: Do not use this medicine after the expiry date which is stated on the label and the outer carton after “EXP”.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq it-tikketta u l-kartuna ta' barra wara “EXP”.
English: including suicidal ideation, attempted suicide, aggression, bipolar disorder, mania and confusion have been observed with other interferon alfa medicinal products.
Maltese: Effetti oħra fuq is-SNĊ, li jinkludu ħsibijiet ta' suwiċidju, attentati ta' suwiċidju, aggressjoni, disturb bipolari, manija u konfużjoni ġew osservati ma' prodotti mediċinali oħrajn b'interferon alfa.
English: Very rare side effects (may affect up to 1 in 10,000 people): - blindness - breathing problems including shortness of breath, cough and chest pain which may be caused by lung infiltration, pneumonia (lung infection), pulmonary arterial hypertension (high blood pressure in the blood vessels bringing blood from the heart to the lungs) and pulmonary fibrosis (a lung disease where scars are formed in the lung tissue)
Maltese: - problemi bit-teħid ta' nifs li jinkludu nuqqas ta' nifs, sogħla u uġigħ fis-sider li jistgħu jkunu ikkaġunati minn infiltrazzjoni tal-pulmun, pnewmonja (infezzjoni tal-pulmun), pressjoni għolja fl-arterja pulmonari (pressjoni għolja fil-vażi tad-demm li jġibu d-demm mill-qalb għall-pulmun) u fibrożi pulmonari (mard tal-pulmun fejn ċikatriċi jiġu fformati fit-tessut talpulmun)
English: No interaction studies have been performed with ropeginterferon alfa-2b.
Maltese: Ma sarux studji ta' interazzjoni b'ropeginterferon alfa-2b.
English: A risk to the suckling child cannot be excluded.
Maltese: Ir-riskju għal trabi mreddgħa ma jistax jiġi eskluż.
English: This medicinal product is contraindicated in patients with severe preexisting cardiovascular disease or patients who had recently suffered from a stroke or myocardial infarction (see section 4.3).
Maltese: Dan il-prodott mediċinali huwa kontraindikat f'pazjenti b'mard kardjovaskulari li kien jeżisti qabel jew pazjenti li riċentement esperjenzaw attakk pupletiku jew infart mijokardijaku (ara sezzjoni 4.3).
English: Besremi is used as monotherapy for the treatment of polycythaemia vera in adults.
Maltese: Besremi jintuża bħala monoterapija għat-trattament ta' poliċitemija vera fl-adulti.
English: Investigations common antithyroid antibody positive, blood thyroid stimulating hormone increased, body temperature increased, antinuclear antibody positive, blood lactate dehydrogenase increased uncommon platelet count increased, blood uric acid increased,
Maltese: Investigazzjonijiet komuni pożittiv għall-antikorp antitirojde, żieda fl-ormon li jistimula t-tirojde fid-demm, żieda fit-temperatura tal-ġisem, pożittiv għall-antikorp antinukleari, żieda fil-lactate dehydrogenase fid-demm mhux komuni żieda fl-għadd ta' pjastrini, żieda fl-aċidu uriku fid-demm,
English: Severe eye disorders such as retinopathy, retinal haemorrhage, retinal exudates, retinal detachment and retinal artery or vein occlusion which may result in blindness have been observed rarely in patients treated with interferon alfa (see section 4.8).
Maltese: Disturbi severi tal-għajnejn bħal retinopatija, emorraġija retinali, tisfija retinali, distakkament retinali u sadd fl-arterja jew vina retinali li jistgħu jwasslu f'għama ġew osservati b'mod rari f'pazjenti trattati b'interferon alfa (ara sezzjoni 4.8).
English: Excipient with known effect Each pre-filled pen contains 10 mg benzyl alcohol per mL.
Maltese: Kull pinna mimlija għal-lest fiha 10 mg benzyl alcohol kull mL.
English: Renal function
Maltese: Funzjoni tal-kliewi
English: In a clinical study in polycythaemia vera, the end of the mean individual titration phase for ropeginterferon alfa-2b was reached after approximately 3.7 months, for hydroxycarbamide after approximately 2.6 months of treatment.
Maltese: Fi studju kliniku f'poliċitemija vera, it-tmiem tal-fażi tat-titrazzjoni tad-doża medja għal ropeginterferon alfa-2b intlaħaq wara madwar 3.7 xhur, għal hydroxycarbamide wara madwar 2.6 xhur ta' trattament.
English: • Pre-existing thyroid disease unless it can be controlled with conventional treatment
Maltese: • Mard tat-tirojde eżistenti minn qabel għajr meta jkun ikkontrollat bi trattament konvenzjonali.
English: very rare myocardial ischemia#
Maltese: hordeolum, onikomikożi
English: • Severe pre-existing cardiovascular disease, (i.e. uncontrolled hypertension, congestive heart failure (≥ NYHA class 2), serious cardiac arrhythmia, significant coronary artery stenosis,
Maltese: insuffiċjenza konġestiva tal-qalb (≥ NYHA ta' klassi 2), arritmija serja tal-qalb, stenożi sinjifikanti tal-arterja kardijaka, anġina instabbli) jew puplesija riċenti jew infart mijokardijaku.
English: From mass balance, tissue distribution and whole body autoradioluminography studies performed in rats, it was shown that a similar interferon alfa medicinal product (pegylated interferon alfa-2a) was distributed to the liver, kidney and bone marrow in addition to being highly concentrated in the blood.
Maltese: Minn studji fuq il-bilanċ tal-massa, id-distribuzzjoni fit-tessuti u t'awtoradjuluminografija tal-ġisem kollu li saru fuq il-firien, intwera li prodott mediċinali simili ta' interferon alfa (pegylated interferon alfa-2a) kien mifrux fil-fwied, kliewi u l-mudullun minbarra li kien f'konċentrazzjoni għolja fiddemm.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Maltese: Informazzjoni ddettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini http://www.ema.europa.eu.
English: Each pre-filled pen contains a cartridge (type 1 colourless glass) with a grey plunger (bromobutyl rubber) and a flanged cap (aluminium) with a stopper (bromobutyl rubber).
Maltese: Kull pinna mimlija għal-lest fiha skartoċċ (ħġieġ bla kulur, tip 1) bi planġer griż (lastku ta' bromobutyl) u kappa bi flanġ (aluminju) b'tapp (lastku ta' bromobutyl).
English: You should brush your teeth thoroughly twice daily and have regular dental checks.
Maltese: Għandek tnaddaf snienek sew darbtejn kuljum u jkollok visti dentali regolari.
English: The recommended posology for the titration phase of ropeginterferon alfa-2b (see section 4.2) results in a prolonged time to reach the individual optimal dose compared to hydroxycarbamide.
Maltese: Il-pożoloġija rakkomandata għall-fażi tat-titrazzjoni ta' ropeginterferon alfa-2b (ara sezzjoni 4.2) tirriżulta f'ħin itwal sabiex tintlaħaq id-doża ottimali individwali meta mqabbla ma' hydroxycarbamide.