FrancophonIA/ELRC3.0 huggingface dataset:
English: ViraferonPeg 50 micrograms powder and solvent for solution for injection ViraferonPeg 80 micrograms powder and solvent for solution for injection ViraferonPeg 100 micrograms powder and solvent for solution for injection ViraferonPeg 120 micrograms powder and solvent for solution for injection ViraferonPeg 150 micrograms powder and solvent for solution for injection peginterferon alfa-2b
Maltese: ViraferonPeg 80 mikrogramma trab u solvent għal soluzzjoni għall-injezzjoni ViraferonPeg 100 mikrogramma trab u solvent għal soluzzjoni għall-injezzjoni ViraferonPeg 120 mikrogramma trab u solvent għal soluzzjoni għall-injezzjoni ViraferonPeg 150 mikrogramma trab u solvent għal soluzzjoni għall-injezzjoni peginterferon alfa-2b
English: Renal impairment
Maltese: Nisa: Dismenorrea
English: ViraferonPeg in combination with ribavirin (bitherapy) is indicated for the treatment of CHC infection in adult patients who are previously untreated including patients with clinically stable HIV co-infection and in adult patients who have failed previous treatment with interferon alpha (pegylated or nonpegylated) and ribavirin combination therapy or interferon alpha monotherapy (see section 5.1).
Maltese: ViraferonPeg flimkien ma' ribavirin (terapija b'żewġ mediċini) huwa indikat għall-kura ta' infezzjoni b'CHC f'pazjenti adulti li ma kinux ikkurati qabel inkluż pazjenti b'koinfezzjoni ta' HIV klinikament stabbli u f'pazjenti adulti li ma ħadmitx fuqhom kura li tkun ingħatat qabel ta' interferon alpha (pegilat jew mhux pegilat) u terapija kombinata b'ribavirin jew monoterapija b'interferon alpha (ara sezzjoni
English: - Hypersensitivity to the active substance or to any interferon or to any of the excipients listed in section 6.1; - A history of severe pre-existing cardiac disease, including unstable or uncontrolled cardiac disease in the previous six months (see section 4.4); - Severe, debilitating medical conditions; - Autoimmune hepatitis or a history of autoimmune disease; - Severe hepatic dysfunction or decompensated cirrhosis of the liver; - Pre-existing thyroid disease unless it can be controlled with conventional treatment; - Epilepsy and/or compromised central nervous system (CNS) function; - HCV/HIV patients with cirrhosis and a Child-Pugh score ≥ 6.
Maltese: - Sensittività eċċessiva għas-sustanza attiva jew għal xi interferon jew għal kwalunkwe wieћed mill eċċipjenti elenkati fis-sezzjoni 6.1; - Storja medika ta' mard sever tal-qalb li kien jeżisti minn qabel, inkluż mard tal-qalb mhux stabbli jew mhux ikkontrollat fis-sitt xhur ta' qabel (ara sezzjoni 4.4); - Kundizzjonijiet mediċi severi li jinkapaċitaw; - Epatite awtoimmuni jew storja medika ta' mard awtoimmuni; - Disfunzjoni severa tal-fwied jew ċirrożi mhux kumpensata tal-fwied; - Mard tat-tirojde li kien jeżisti minn qabel ħlief jekk ikun jista' jiġi kkontrollat b'kura konvenzjonali;
English: HVL (>600,000 IU/ml)
Maltese: Ġenotip 1 > 600.000 IU/ml
English: Non-responders to prior therapy with pegylated interferon alpha/ribavirin were less likely to achieve a week 12 response to retreatment than non-responders to nonpegylated interferon alpha/ribavirin (12.4 % vs. 28.6 %).
Maltese: Dawk li ma kellhomx rispons għat-terapija li ngħatat qabel b'interferon alpha pegilat/ribavirin kellhom anqas ċans li jiksbu rispons f'ġimgħa 12 għall-kura mill-ġdid minn dawk li ma kellhomx rispons għal interferon alpha mhux pegilat/ribavirin (12,4 % vs 28,6 %).
English: Loss of visual acuity or visual fields, retinal haemorrhage, retinopathy, retinal artery occlusion, retinal vein occlusion, optic neuritis, papilloedema, macular oedema
Maltese: Telf taċ-ċarezza viżiva jew firxa tal-viżjoni, emorraġija tar-retina, retinopatija, okklużjoni ta' arterja tar-retina, okklużjoni ta' vina tarretina, nevrite ottika, papilloedima, edima fil-makula
English: Cough, epistaxis, pharyngolaryngeal pain
Maltese: Sogħla, epistassi, uġigħ fil-farinġi u fil-larinġi
English: Table 7 Adverse reactions very commonly, commonly and uncommonly reported in the clinical trial in children and adolescent patients treated with ViraferonPeg in combination with ribavirin
Maltese: Tabella 7 Reazzjonijiet avversi rrappurtati b'mod komuni ħafna, komuni u mhux komuni fil prova klinika f'pazjenti tfal u adolexxenti kkurati b'ViraferonPeg flimkien ma'
English: The reconstituted solution has a concentration of 100 micrograms/0.5 ml.
Maltese: Is-soluzzjoni rikostitwita għandha konċentrazzjoni ta' 100 mikrogramma/0,5 ml.
English: ViraferonPeg 80 micrograms powder for injection peginterferon alfa-2b
Maltese: ViraferonPeg 80 mikrogramma trab għall-injezzjoni. peginterferon alfa-2b
English: Tritherapy
Maltese: Treddigħ
English: The reconstituted solution has a concentration of 120 micrograms in 0.5 ml.
Maltese: Issoluzzjoni rikostitwita għandha konċentrazzjoni ta' 120 mikrogramma f'0,5 ml.
English: 3 was observed in 4 % (8/194) of patients receiving ViraferonPeg in combination with ribavirin.
Maltese: 3 ġie osservat f'4% (8/194) tal-pazjenti li kienu qed jirċievu ViraferonPeg flimkien ma' ribavirin.
English: Hepatobiliary disorders Uncommon:
Maltese: Infezzjonijiet u infestazzjonijiet Komuni ħafna:
English: One vial of powder contains 50 micrograms of peginterferon alfa-2b and provides 50 micrograms/0.5 ml of peginterferon alfa-2b when reconstituted as recommended.
Maltese: Kunjett wieħed bit-trab fih 50 mikrogramma ta' peginterferon alfa-2b u jipprovdi 50 mikrogramma/0,5 ml ta' peginterferon alfa-2b meta jiġi rikostitwit kif irrakkomandat.
English: ViraferonPeg has a potential to depegylate to free interferon alfa-2b.
Maltese: ViraferonPeg jista' jitlef il-pegylate biex isir interferon alfa-2b liberu.
English: Retinal exudates
Maltese: Ipotirojdiżmu
English: The reconstituted solution has a concentration of 50 micrograms/0.5 ml.
Maltese: Is-soluzzjoni rikostitwita għandha konċentrazzjoni ta' 50 mikrogramma/0,5 ml.
English: Predictability of response and non-response in HCV/HIV co-infection - Early virological response by week 12, defined as a 2 log viral load decrease or undetectable levels of HCV-RNA, has been shown to be predictive for sustained response.
Maltese: Tbassir tar-rispons u tan-nuqqas ta' rispons f'infezzjoni fl-istess ħin b'HCV/HIV - Intwera li rispons viroloġiku bikri sa ġimgħa 12, definit bħala tnaqqis ta' 2 log tal-ammont virali jew livelli li ma jitkejlux ta' HCV-RNA, jista' jbassar rispons sostnut.
English: One vial of powder contains 100 micrograms of peginterferon alfa-2b and provides 100 micrograms/0.5 ml of peginterferon alfa-2b when reconstituted as recommended.
Maltese: Kunjett wieħed bit-trab fih 100 mikrogramma ta' peginterferon alfa-2b u jipprovdi 100 mikrogramma/0,5 ml ta' peginterferon alfa-2b meta jiġi rikostitwit kif irrakkomandat.
English: ViraferonPeg 120 micrograms powder for injection peginterferon alfa-2b
Maltese: ViraferonPeg 120 mikrogramma trab għall-injezzjoni. peginterferon alfa-2b
English: Very rare side effects (may affect up to 1 in 10,000 people): - aplastic anaemia, stroke (cerebrovascular events), toxic epidermal necrolysis/Stevens Johnson Syndrome/erythema multiforme (a spectrum of rashes with varying degree of severity including death which may be associated with blisters in the mouth, nose, eyes and other mucosal membranes and sloughing of the affected area of the skin).
Maltese: Effetti sekondarji rari ħafna (jistgħu jaffettwaw sa persuna waħda minn kull 10.000): - anemija aplastika, puplesija (każijiet ċerebrovaskulari), nekrolisi tossika tal-ġilda/Sindrome ta' Stevens Johnson/eritema multiforme (varjetà ta' tipi ta' raxx bi gradi differenti ta' severità inkluż mewt li tista' tkun assoċjata ma' nfafet fil-ħalq, imnieħer, għajnejn u membrani mukużi oħrajn u tqaxxir tal-parti tal-ġilda li tkun affettwata). - telf mis-sensi seħħ b'mod rari ħafna b'alpha interferoni, l-aktar f'pazjenti anzjani kkurati b'dożi għoljin.
English: Treatment with ViraferonPeg in combination with ribavirin was associated with decreases in absolute CD4+ cell counts within the first 4 weeks without a reduction in CD4+ cell percentage.
Maltese: Kura b'ViraferonPeg flimkien ma' ribavirin kienet assoċjata ma' tnaqqis fl-għadd assolut ta' ċelluli CD4+ fl-ewwel 4 ġimgħat mingħajr tnaqqis fil-perċentwali taċ-ċelluli CD4+.
English: The reconstituted solution has a concentration of 150 micrograms in 0.5 ml.
Maltese: Issoluzzjoni rikostitwita għandha konċentrazzjoni ta' 150 mikrogramma f'0,5 ml.
English: Mix
Maltese: Rimettar
English: Administer once weekly (ml)
Maltese: Agħti darba filġimgħa (ml)
English: Muscle contracture, muscle twitching Renal and urinary disorders Uncommon:
Maltese: Disturbi muskolu-skeletriċi u tat-tessuti konnettivi Komuni ħafna:
English: ViraferonPeg 80 micrograms powder and solvent for injection peginterferon alfa-2b
Maltese: ViraferonPeg 80 mikrogramma trab u solvent għall-injezzjoni. peginterferon alfa-2b
English: HCV/HIV Co-infection
Maltese: Infezzjoni fl-istess ħin b'HCV/HIV
English: ViraferonPeg 50 micrograms powder and solvent for solution for injection in pre-filled pen ViraferonPeg 80 micrograms powder and solvent for solution for injection in pre-filled pen ViraferonPeg 100 micrograms powder and solvent for solution for injection in pre-filled pen ViraferonPeg 120 micrograms powder and solvent for solution for injection in pre-filled pen ViraferonPeg 150 micrograms powder and solvent for solution for injection in pre-filled pen
Maltese: ViraferonPeg 50 mikrogramma ta' trab u solvent għal soluzzjoni għall-injezzjoni ViraferonPeg 80 mikrogramma ta' trab u solvent għal soluzzjoni għall-injezzjoni ViraferonPeg 100 mikrogramma ta' trab u solvent għal soluzzjoni għall-injezzjoni ViraferonPeg 120 mikrogramma ta' trab u solvent għal soluzzjoni għall-injezzjoni ViraferonPeg 150 mikrogramma ta' trab u solvent għal soluzzjoni għall-injezzjoni
English: Caution should be used when adding ViraferonPeg and ribavirin to HAART therapy (see ribavirin SmPC).
Maltese: Wieħed għandu joqgħod attent meta jżid ViraferonPeg u ribavirin ma' terapija HAART (ara lSmPC ta' ribavirin).
English: The reconstituted solution has a concentration of 80 micrograms in 0.5 ml.
Maltese: Issoluzzjoni rikostitwita għandha konċentrazzjoni ta' 80 mikrogramma f'0,5 ml.
English: Events were reported at various time points typically several months after starting treatment with interferon alfa.
Maltese: Ġew irrapportati avvenimenti f'diversi punti ta' żmien, ġeneralment diversi xhur wara l-bidu tal-kura b'interferon alfa.
English: Negative predictive value
Maltese: Valur imbassar negattiv
English: METAVIR Fibrosis score F2
Maltese: Punteġġ METAVIR talFibrożi
English: ViraferonPeg 120 micrograms powder and solvent for solution for injection in pre-filled pen Each pre-filled pen contains 120 micrograms of peginterferon alfa-2b measured on a protein basis.
Maltese: ViraferonPeg 120 mikrogramma trab u solvent għal soluzzjoni għall-injezzjoni Kull kunjett fih 120 mikrogramma ta' peginterferon alfa-2b imkejjel fuq bażi ta' proteina.
English: Although data are limited, no evidence of long-term effects on sexual maturation was noted in the 5-year observational follow-up study.
Maltese: Għalkemm id-dejta hija limitata, ma kienet innotata l-ebda evidenza ta' effetti fit-tul fuq il-maturazzjoni sesswali fi studju ta' osservazzjoni b'segwitu ta' 5 snin.
English: ViraferonPeg 50 micrograms powder and solvent for solution for injection in pre-filled pen ViraferonPeg 80 micrograms powder and solvent for solution for injection in pre-filled pen ViraferonPeg 100 micrograms powder and solvent for solution for injection in pre-filled pen ViraferonPeg 120 micrograms powder and solvent for solution for injection in pre-filled pen ViraferonPeg 150 micrograms powder and solvent for solution for injection in pre-filled pen peginterferon alfa-2b
Maltese: ViraferonPeg 50 mikrogramma trab u solvent għal soluzzjoni għall-injezzjoni f'pinna mimlija għal-lest ViraferonPeg 80 mikrogramma trab u solvent għal soluzzjoni għall-injezzjoni f'pinna mimlija għal-lest ViraferonPeg 100 mikrogramma trab u solvent għal soluzzjoni għall-injezzjoni f'pinna mimlija għal-lest ViraferonPeg 120 mikrogramma trab u solvent għal soluzzjoni għall-injezzjoni f'pinna mimlija għal-lest ViraferonPeg 150 mikrogramma trab u solvent għal soluzzjoni għall-injezzjoni f'pinna mimlija għal-lest peginterferon alfa-2b
English: ViraferonPeg 50 micrograms powder for injection peginterferon alfa-2b
Maltese: ViraferonPeg 50 mikrogramma trab għall-injezzjoni. peginterferon alfa-2b
English: Adults - Duration of treatment - Retreatment Tritherapy: Refer to the SmPC for boceprevir.
Maltese: Terapija bi tliet mediċini Irreferi għall-SmPC ta' boceprevir.
English: Sarcoidosis
Maltese: Sarkojdożi
English: Uncommon side effects (may affect up to 1 in 100 people): - painful or difficult urination, urinary frequency, the presence of excess protein in the urine, painful menstruation, - itchy anal area (pinworms or ascarids), inflammation of the lining membrane of the stomach and the intestines, inflamed gums, enlarged liver, - abnormal behaviour, emotional disorder, fear, nightmare, tremor, decreased sensitivity to touch, numbness or tingling feeling, pain radiating along the course of one or more nerves, drowsiness, - bleeding of the mucous membrane that lines the inner surface of the eyelids, itchy eyes, eye pain, blurred vision, intolerance to light, - low blood pressure, paleness, nasal discomfort, runny nose, wheezing, difficult breathing, chest pain or discomfort, - redness, swelling, pain of skin, shingles, skin sensitive to sunlight, rash with raised spotted lesions, skin discolouration, peeling of skin, shortening of muscle tissue, muscle twitching, facial pain, bruising.
Maltese: Effetti sekondarji mhux komuni (jistgħu jaffettwaw sa persuna waħda minn kull 100): - tweġġa' jew tbati biex tagħmel l-awrina, tagħmel l-awrina ta' sikwit, il-preżenza ta' proteina eċċessiva fl-awrina, uġigħ mestrwali, - ħakk fil-parti tal-anus (ħniex jew askaridi), infjammazzjoni tal-membrana li tiksi l-istonku u limsaren, ħanek infjammat, fwied imkabbar, - imġiba anormali, disturb emozzjonali, biża', ħmar il-lejl, tregħid, tnaqqis fis-sensittività għallmess, sensazzjoni ta' tnemnim jew tingiż, uġigħ li jinfirex tul nerv wieħed jew aktar, ngħas, - ħruġ ta' demm mill-membrana mukuża li tiksi tebqet il-għajn min-naħa ta' ġewwa, ħakk flgħajnejn, uġigħ fl-għajnejn, vista mċajpra, intolleranza għad-dawl, - pressjoni baxxa, sfurija, skumdità fl-imnieħer, imnieħer inixxi, tħarħir, tbati biex tieħu n-nifs, uġigħ jew skumdità fis-sider, - ħmura, nefħa, uġigħ fil-ġilda, ħruq ta' Sant Antnin, il-ġilda tkun sensittiva għad-dawl tax-xemx, raxx b'ponot imqabbżin, il-ġilda titlef il-kulur, il-ġilda titqaxxar, it-tessut tal-muskoli jiqsar, muskoli jinġibdu b'mod spontanju, uġigħ fil-wiċċ, tbenġil.
English: • Turn the dial to number 1 (see Figure 1).
Maltese: • Dawwar ir-rota tad-dożaġg san-numru 1 (ara Figura 1).
English: Colitis ischaemic
Maltese: - Is-sustanzi l-oħra huma:
English: Standard methods to increase elimination of the medicinal product, e.g., dialysis, have not been shown to be useful.
Maltese: Metodi standard biex tiżdied l-eliminazzjoni talprodott mediċinali, eż. dijalisi, ma ntwerewx li kienu utli.
English: • Genotype 1: - Patients who have undetectable HCV-RNA at treatment week 12, treatment should be continued for another nine month period (i.e., a total of 48 weeks).
Maltese: • Ġenotip 1: - Għal pazjenti li jkollhom HCV-RNA li ma jistax jitkejjel f'ġimgħa 12, il-kura għandha titkompla għal perijodu ieħor ta' disa' xhur (i.e., total ta' 48 ġimgħa).
English: ViraferonPeg 150 micrograms powder for injection peginterferon alfa-2b
Maltese: ViraferonPeg 150 mikrogramma trab għall-injezzjoni. peginterferon alfa-2b
English: Twenty-four percent of subjects (11/46) treated for 24 weeks and 40 % of subjects (19/48) treated for 48 weeks had a > 15 percentile height-for-age decrease from pre-treatment to the end of the 5 year long-term follow-up compared to pre-treatment baseline percentile.
Maltese: Erbgħa u għoxrin fil-mija tal-individwi (11/46) ikkurati għal 24 ġimgħa u 40% tal-individwi (19/48) ikkurati għal 48 ġimgħa kellhom tnaqqis ta' > 15-il percentile fit-tul għall-età minn qabel il-kura sal-aħħar tas-segwitu fit-tul ta' 5 snin meta mqabbel mal-percentile fil-linja bażi ta' qabel il-kura.
English: Vasculitis
Maltese: Plejtlits
English: ViraferonPeg 100 micrograms powder for injection peginterferon alfa-2b
Maltese: ViraferonPeg 100 mikrogramma trab għall-injezzjoni. peginterferon alfa-2b
English: Because of marked inter-subject variability in interferon pharmacokinetics, it is recommended that patients with severe renal impairment be closely monitored during treatment with ViraferonPeg (see section 4.2)
Maltese: Minħabba differenzi kbar bejn individwu u ieħor fil-farmakokinetika ta' interferon, huwa rrakkomandat li pazjenti b'indeboliment renali sever ikunu mmonitorjati mill-qrib waqt kura b'ViraferonPeg (ara sezzjoni 4.2).
English: ViraferonPeg 50 micrograms powder and solvent for injection peginterferon alfa-2b
Maltese: ViraferonPeg 50 mikrogramma trab u solvent għall-injezzjoni. peginterferon alfa-2b
English: ViraferonPeg 150 micrograms powder and solvent for injection peginterferon alfa-2b
Maltese: ViraferonPeg 150 mikrogramma trab u solvent għall-injezzjoni. peginterferon alfa-2b
English: Prompt discontinuation of interferon alpha administration and treatment with corticosteroids appear to be associated with resolution of pulmonary adverse events.
Maltese: It-twaqqif fil-pront tal-għoti ta' interferon alpha u kura b'kortikosterojdi jidhru illi huma assoċjati malfejqan tal-avvenimenti avversi fil-pulmun.
English: Histological response: Liver biopsies were obtained before and after treatment in Study 1 and were available for 210 of the 412 subjects (51 %).
Maltese: Bijopsiji tal-fwied ittieħdu qabel u wara l-kura fi Studju 1 u kienu disponibbli għal 210 mill-412-il individwu (51%).
English: ViraferonPeg 120 micrograms powder and solvent for injection peginterferon alfa-2b
Maltese: ViraferonPeg 120 mikrogramma trab u solvent għall-injezzjoni. peginterferon alfa-2b
English: Once bound to the cell membrane, interferon initiates a complex sequence of intracellular events that include the induction of certain enzymes.
Maltese: Ladarba jeħel mal-membrana taċ-ċellula, interferon jibda sekwenza kumplessa ta' avvenimenti intraċellulari li jinkludu l-induzzjoni ta' ċerti enzimi.
English: Powder and solvent for solution for injection in pre-filled pen 1 pen (CLEARCLICK), 1 injection needle and 2 cleansing swabs 4 pens (CLEARCLICK), 4 injection needles and 8 cleansing swabs 12 pens (CLEARCLICK), 12 injection needles and 24 cleansing swabs 150 micrograms/0.5 ml
Maltese: Trab u solvent għal soluzzjoni għall-injezzjoni f'pinna mimlija għal-lest Pinna (CLEARCLICK) waħda, labra tal-injezzjoni u 2 imsielaħ biex tnaddaf 4 pinen (CLEARCLICK), 4 labriet tal-injezzjoni u 8 imsielaħ biex tnaddaf 12-il pinna (CLEARCLICK), 12-il labra tal-injezzjoni u 24 imselħa biex tnaddaf 150 mikrogramma/0,5 ml
English: Retreatment duration greater than 48 weeks in non-responder patients with genotype 1 has not been studied with pegylated interferon alfa-2b and ribavirin combination therapy.
Maltese: Tul ta' kura mill-ġdid ta' aktar minn 48 ġimgħa f'pazjenti b'ġenotip 1 li ma wrewx rispons ma ġiex studjat b'terapija kombinata ta' interferon alfa-2b pegilat u ribavirin.
English: Cutaneous sarcoidosis
Maltese: Il-Ġenotipi kollha
English: ViraferonPeg 100 micrograms powder and solvent for injection peginterferon alfa-2b
Maltese: ViraferonPeg 100 mikrogramma trab u solvent għall-injezzjoni. peginterferon alfa-2b
English: ViraferonPeg 50 micrograms powder and solvent for solution for injection in pre-filled pen Each pre-filled pen contains 50 micrograms of peginterferon alfa-2b measured on a protein basis.
Maltese: ViraferonPeg 50 mikrogramma trab u solvent għal soluzzjoni għall-injezzjoni Kull kunjett fih 50 mikrogramma ta' peginterferon alfa-2b imkejjel fuq bażi ta' proteina.
English: Interferon neutralising factor assays were performed on serum samples of patients who received ViraferonPeg in the clinical trial.
Maltese: Assaġġi tal-fatturi li jinnewtralizzaw l-interferon saru fuq kampjuni ta' serum ta' pazjenti li rċivew ViraferonPeg fil-prova klinika.
English: Dysphonia, epistaxis, respiratory disorder, respiratory tract congestion, sinus congestion, nasal congestion, rhinorrhea, increased upper airway secretion, pharyngolaryngeal pain
Maltese: Disfonja, epistassi, disturbi respiratorji, konġestjoni tal-passaġġ tan-nifs, konġestjoni tas-sinus, konġestjoni tal-imnieħer, rinoreja, żieda fit-tnixxija mill-parti ta' fuq tal-passaġġ tan-nifs, uġigħ filfarinġi u fil-larinġi
English: The clinical incidence of neutralising factors in patients who received ViraferonPeg 0.5 micrograms/kg is 1.1 %.
Maltese: L-inċidenza klinika tal-fatturi li jinnewtralizzaw f'pazjenti li rċivew ViraferonPeg 0,5 mikrogramma/kg hija ta' 1,1 %.
English: Severe CNS effects, particularly depression, suicidal ideation and attempted suicide have been observed in some patients during ViraferonPeg therapy, and even after treatment discontinuation mainly during the 6-month follow-up period.
Maltese: Sistema Psikjatrika u Sistema Nervuża Ċentrali (CNS - Central Nervous System) Effetti severi fis-CNS, l-aktar depressjoni, ħsibijiet ta' suwiċidju u attentat ta' suwiċidju ġew osservati f'xi pazjenti waqt terapija b'ViraferonPeg, u anki wara t-twaqqif tal-kura l-aktar fil-perijodu tas-sitt xhur ta' wara li fih ġew segwiti.
English: ViraferonPeg 150 micrograms powder and solvent for solution for injection in pre-filled pen Each pre-filled pen contains 150 micrograms of peginterferon alfa-2b measured on a protein basis.
Maltese: ViraferonPeg 150 mikrogramma trab u solvent għal soluzzjoni għall-injezzjoni Kull kunjett fih 150 mikrogramma ta' peginterferon alfa-2b imkejjel fuq bażi ta' proteina.
English: The powder and solvent are both contained in a two-chamber cartridge (Type I flint glass) separated by a bromobutyl rubber plunger.
Maltese: Kemm it-trab kif ukoll is-solvent jinsabu fi skartoċċ b'żewġ kompartimenti (ħġieġ taż-żnied ta' Tip I), separat bi planġer tal-lastku tal-bromobutyl.
English: - have a current or previous infection with the hepatitis B virus, since your doctor may want to monitor you more closely.
Maltese: - għandkom infezzjoni attwali jew preċedenti bil-virus tal-epatite B, peress li t-tabib tagħkom jista' jkun jixtieq jimmonitorjakom aktar mil-qrib.
English: Effects on fertility have not been determined.
Maltese: Effetti fuq il-fertilità ma ġewx determinati.
English: Injection site infection, lower respiratory tract infection
Maltese: Infezzjonijiet u infestazzjonijiet Korriment u avvelenament
English: Powder
Maltese: Tieqa
English: Ninety-four of 107 subjects enrolled in the 5 year long-term follow-up trial.
Maltese: Erbgħa u disgħin minn 107 itfal kienu rreġistrati fil-prova ta' segwitu fit-tul ta' 5 snin.
English: ViraferonPeg 80 micrograms powder and solvent for solution for injection Each vial contains 80 micrograms of peginterferon alfa-2b measured on a protein basis.
Maltese: ViraferonPeg 80 mikrogramma trab u solvent għal soluzzjoni għall-injezzjoni Kull kunjett fih 80 mikrogramma ta' peginterferon alfa-2b imkejjel fuq bażi ta' proteina.
English: ViraferonPeg 100 micrograms powder and solvent for solution for injection Each vial contains 100 micrograms of peginterferon alfa-2b measured on a protein basis.
Maltese: ViraferonPeg 100 mikrogramma trab u solvent għal soluzzjoni għall-injezzjoni Kull kunjett fih 100 mikrogramma ta' peginterferon alfa-2b imkejjel fuq bażi ta' proteina.
English: Discontinue combination therapy if:
Maltese: Tkomplix it-terapija kkombinata jekk:
English: In Study 1 (see section 5.1), decrease in absolute neutrophil count levels below 500 cells/mm
Maltese: Fi Studju 1 (ara sezzjoni 5.1), tnaqqis fil-livelli tal-għadd assolut tan-newtrofili taħt il-500 ċellula/mm
English: Serous retinal detachment Ear and labyrinth disorders Common:
Maltese: Tromboċitopenija, limfadenopatija Disturbi fis-sistema endokrinarja Komuni: