FrancophonIA/ELRC3.0 huggingface dataset:
English: - are being treated with telbivudine (see section “Other medicines and ViraferonPeg”).
Maltese: - jekk qed tingħataw kura b'telbivudine (ara sezzjoni “Mediċini oħra u ViraferonPeg”).
English: There were some cases of more severe neutropenia in patients treated with the recommended doses of ViraferonPeg in combination with ribavirin (WHO grade 3: 39 of 186 [21 %]; and WHO grade 4: 13 of 186 [7 %]).
Maltese: Kien hemm xi każijiet ta' newtropenija aktar severa f'pazjenti li ġew ikkurati bid-dożi rrakkomandati ta' ViraferonPeg flimkien ma' ribavirin (Gradi ta' WHO 3 : 39 minn 186 [21 %]; u gradi ta' WHO 4: 13 minn 186 [7 %]).
English: • Platelets
Maltese: • Plejtlits
English: In those patients the SVR was 12 %.
Maltese: F'dawk il-pazjenti, l-SVR kien ta' 12 %.
English: Total daily ribavirin dose (mg)
Maltese: Doża totali ta' ribavirin kuljum (mg)
English: The solvent is presented in a 2 ml ampoule (Type I flint glass).
Maltese: Is-solvent huwa ppreżentat f'ampulla ta' 2 ml, (ħġieġ taż-żnied ta' Tip I).
English: Viral infection *, pharyngitis
Maltese: Infezzjoni virali*, farinġite*
English: Important treatment-emergent adverse reactions that occurred in this patient population were nervousness (8 %), aggression (3 %), anger (2 %), depression/depressed mood (4 %) and hypothyroidism (3 %) and 5 subjects received levothyroxine treatment for hypothyroidism/elevated TSH.
Maltese: Reazzjonijiet avversi importanti li seħħew f'din ilpopolazzjoni ta' pazjenti minħabba l-kura kienu nervi (8%), aggressjoni (3%), rabja (2%), depressjoni/burdata depressa (4%) u ipotirojdiżmu (3%) u 5 individwi rċivew kura b'levothyroxine għal ipotirodjiżmu/TSH għoli.
English: Table 3a Dose modification guidelines for ViraferonPeg monotherapy in adults based on laboratory parameters
Maltese: Tabella 3a Linji gwida għall-modifikazzjoni tad-doża għal monoterapija b'ViraferonPeg fl adulti ibbażati fuq parametri tal-laboratorju
English: 15 SEC
Maltese: 15 SEK
English: The mechanism behind these events is not known (see sections 4.3, 4.4 and 4.5 of the telbivudine SmPC).
Maltese: Il-mekkaniżmu wara dawn l-avvenimenti mhux magħruf (ara sezzjonijiet 4.3, 4.4 u 4.5 tal-SmPC ta' telbivudine).
English: Getting ready
Maltese: Preparazzjoni
English: Recombinant interferon alfa-2b is covalently conjugated with monomethoxy polyethylene glycol at an average degree of substitution of 1 mole of polymer/mole of protein.
Maltese: Interferon alfa-2b rikombinanti huwa konjugat b'mod kovalenti ma' monomethoxy polyethylene glycol bi grad medju ta' sostituzzjoni ta' mole wieħed ta' polimer/mole ta' proteina.
English: ViraferonPeg is a well characterized polyethylene glycol-modified (“pegylated”) derivative of interferon alfa-2b and is predominantly composed of monopegylated species.
Maltese: ViraferonPeg huwa derivattiv modifikat ta' polyethylene glycol (“pegilat”) ikkaratterizzat tajjeb ta' interferon alfa-2b u huwa magħmul prinċipalment minn speċi monopegylated.
English: Thirty two percent (30/94) of subjects demonstrated > 15 percentile decrease in height-for-age percentile 5 years after completion of therapy (see sections 4.8 and 5.1).
Maltese: Tnejn u tletin fil-mija (30/94) talindividwi wrew tnaqqis ta' > 15-il percentile fil-percentile tat-tul għall-età 5 snin wara li ntemmet itterapija (ara sezzjonijiet 4.8 u 5.1).
English: ViraferonPeg 0.5 microgram/kg
Maltese: ViraferonPeg 0,5 mikrogramma/kg
English: Date of first authorisation: 29 May 2000 Date of latest renewal: 29 May 2010
Maltese: Data tal-aħħar tiġdid: 25 ta' Mejju 2010
English: Tritherapy (ViraferonPeg with ribavirin and boceprevir): applies to adult patients with genotype 1 CHC.
Maltese: Terapija bi tliet mediċini (ViraferonPeg ma' ribavirin u boceprevir): tapplika għall-pazjenti adulti b'CHC ta' ġenotip 1.
English: * (HCV-RNA PCR assay, with a lower limit of quantitation of 27 IU/ml) Lack of early virologic response by Treatment week 12 (detectable HCV-RNA with a < 2 log10 reduction from baseline) was a criterion for discontinuation of treatment.
Maltese: * (Assaġġ PCR ta' HCV-RNA, bil-limitu l-baxx li jista' jiġi kkwantifikat ta' 27 IU/ml) Nuqqas ta' rispons viroloġiku bikri sa Ġimgħa ta' kura 12 (HCV-RNA li jista' jitkejjel bi tnaqqis ta' < 2 log10 mil-linja bażi) kien kriterju għat-twaqqif tal-kura.
English: Note: The needle shield will automatically SNAP UP as you dial (see Figure 9).
Maltese: Nota: L-għatu ta' protezzjoni tal-labra awtomatikament JITLA' 'L FUQ inti u ddawwar (ara Figura 9).
English: Carton 150 micrograms
Maltese: Kartuna 150 mikrogramma
English: Overall, approximately 36 % (821/2,286) of patients had undetectable plasma HCV-RNA levels at week 12 of therapy measured using a research-based test (limit of detection 125 IU/ml).
Maltese: B'mod globali, madwar 36 % (821/2.286) tal-pazjenti kellhom livelli ta' HCV-RNA fil-plażma li ma setgħux jitkejlu fit-12-il ġimgħa ta' terapija mkejla permezz ta' test ibbażat fuq riċerka (limitu li seta' jitkejjel ta' 125 IU/ml).
English: SN: NN
Maltese: NN:
English: > 4 mg/dl (for > 4 weeks)
Maltese: > 4 mg/dl (għal > 4 ġimgħat)
English: Interferon alfa-2b (3 MIU) + ribavirin (1,000/1,200 mg) p < 0.001 P 1.5 vs.
Maltese: Interferon alfa-2b (3 MIU) + ribavirin (1.000/1.200 mg) p < 0,001 P 1,5 vs. I p = 0,0143 P 1,5/R vs.
English: Table 9 Sustained response rates with ViraferonPeg + ribavirin (by ribavirin dose, genotype and viral load)
Maltese: Tabella 9 Rati ta' rispons sostnut b'ViraferonPeg + ribavirin (skont id-doża ta' ribavirin, ilġenotip u l-ammont virali)
English: Carton 80 micrograms
Maltese: Kartuna 80 mikrogramma
English: A wide variety of autoimmune and immune-mediated disorders have been reported with alpha interferons including thyroid disorders, systemic lupus erythematosus, rheumatoid arthritis (new or aggravated), idiopathic and thrombotic thrombocytopenic purpura, vasculitis, neuropathies including mononeuropathies and Vogt-Koyanagi-Harada syndrome (see also section 4.4).
Maltese: Varjetà wiesa' ta' disturbi awtoimmuni jew li jseħħu permezz tas-sistema immuni ġew irrappurtati b'alfa interferons, inkluż disturbi tat-tirojde, lupus eritematuż sistemiku, artrite rewmatojde (ġdida jew aggravata), pupura tromboċitopenika idjopatika u trombotika, vaskulite, u newropatiji li jinkludu mononewropatiji u sindrome Vogt-Koyanagi-Harada (ara wkoll sezzjoni 4.4).
English: Be sure the solution is at room temperature up to 25°C.
Maltese: Aċċerta ruħek li s-soluzzjoni tkun ħadet it-temperatura tal-kamra sa 25ºC.
English: Suicidal ideation §, suicide attempt
Maltese: §, attentat ta' suwiċidju
English: Chronic Hepatitis C Subjects (N=22)
Maltese: Individwi b'Epatite Ċ Kronika (N=22)
English: Renal failure, renal insufficiency Reproductive system and breast disorders Common:
Maltese: Indeboliment renali, insuffiċjenza renali Disturbi fis-sistema riproduttiva u fis-sider Komuni:
English: d: ribavirin dosing was 800 mg for patients < 60 kg, 1,000 mg for patients 60-75 kg, and 1,200 mg for patients > 75 kg.
Maltese: d: id-dożaġġ għal ribavirin kien ta' 800 mg għall-pazjenti li jiżnu < 60 kg, 1,000 mg għall-pazjenti li jiżnu 60-75 kg, u
English: In children and adolescent patients receiving body surface area-adjusted dosing of ViraferonPeg at 60 g/m2/week, the log transformed ratio estimate of exposure during the dosing interval is predicted to be 58 % (90 % CI: 141-177 %) higher than observed in adults receiving 1.5 g/kg/week.
Maltese: F'pazjenti tfal u adolexxenti li kienu qed jirċievu dożaġġi ta' ViraferonPeg ta' 60 μg/m2/ġimgħa aġġustati skont lerja tas-superfiċje tal-ġisem, l-istima tal-proporzjon tal-esponiment mibdul b'log waqt l-intervall bejn id-dożaġġi huwa mbassar li jkun 58 % (90 % CI: 141-177 %) ogħla minn dak osservat f'adulti li jirċievu 1,5 μg/kg/ġimgħa.
English: LVL (≤600,000 IU/ml)
Maltese: LVL (≤600.000
English: ViraferonPeg 1.0 microgram/kg
Maltese: ViraferonPeg 1,0 mikrogramma/kg
English: Carton 100 micrograms
Maltese: Kartuna 100 mikrogramma
English: - Remove the protective cap from the ViraferonPeg vial.
Maltese: - Neħħi l-għatu protettiv mill-kunjett ta' ViraferonPeg.
English: Table 1 Dosing for combination therapy* Body weight (kg)
Maltese: Tabella 1 - Dożaġġ għal terapija kkombinata* Piż tal-ġisem (kg)
English: For storage conditions of the reconstituted medicinal product, see section 6.3.
Maltese: Għall-kondizzjonijiet ta' ħażna tal-prodott mediċinali rikostitwit, ara sezzjoni 6.3.
English: 9/l, and < 50 x 10
Maltese: 9/l, u < 50 x 10
English: The population enrolled mainly consisted of children with mild to moderate hepatitis C. Due to the lack of data in children with severe progression of the disease, and the potential for undesirable effects, the benefit/risk of the combination of ViraferonPeg with ribavirin needs to be carefully considered in this population (see sections 4.1, 4.4 and 4.8).
Maltese: Minħabba n-nuqqas ta' dejta fi tfal bi progressjoni severa tal-marda, u lpotenzjal ta' effetti mhux mixtieqa, il-benefiċċju/riskju tal-kombinazzjoni ta' ViraferonPeg ma' ribavirin għandu jiġi kkunsidrat b'attenzjoni f'din il-popolazzjoni (ara sezzjonijiet 4.1, 4.4 u 4.8).
English: The high sustained response rate in this subgroup of patients was identified in an interim analysis (n=49) and prospectively confirmed (n=48).
Maltese: Ir-rata għolja ta' rispons sostnut f'dan is-sottogrupp ta' pazjenti ġiet identifikata f'analiżi interim (n=49) u kienet ikkonfermata b'mod prospettiv (n=48).
English: Some bubbles may be present, but this is normal.
Maltese: Jista' jkun hemm xi bżieżaq, iżda dan huwa normali.
English: This medicine contains less than 1 mmol sodium (23 mg) per 0.7 ml, i.e., essentially "sodium-free".
Maltese: Dan il-prodott mediċinali fih anqas minn 1 mmol (23 mg) sodium f'kull 0,7 ml, i.e. huwa essenzjalment “mingħajr sodium”.
English: Metabolism of theophylline is suppressed by inhibitory action of the product (ViraferonPeg) on CYP1A2.
Maltese: Il-metaboliżmu ta' theophylline jitrażżan permezz tal-azzjoni inibitorja tal-prodott (ViraferonPeg) fuq CYP1A2.
English: Diabetes mellitus, hypertriglyceridaemia
Maltese: Dijabete mellitus, ipertrigliċeridemija
English: Caucasian patients had a higher sustained virologic response rate compared to the African Americans.
Maltese: Pazjenti Kawkasi kellhom rati ta' rispons viroloġiku sostnut ogħla meta mqabbla malAfrikani Amerikani.
English: 9/l, and
Maltese: 9/l, u
English: When patients are administered ViraferonPeg with medications metabolized by CYP1A2 or CYP2D6, the extent of the decrease in cytochrome P 450 activity is unlikely to have a clinical impact, except with medicines which have a narrow therapeutic margin (Table 5).
Maltese: Meta l-pazjenti jingħataw ViraferonPeg ma' mediċini li jiġu metabolizzati permezz ta' CYP1A2 jew ta' CYP2D6, l-estent tat-tnaqqis fl-attività taċ-ċitokromju P 450 mhuwiex probabbli li jkollu impatt kliniku, ħlief ma' mediċini li għandhom marġni terapewtiku dejjaq (Tabella 5).
English: 1.5 mcg/kg/week (4 weeks)
Maltese: 1.5 mcg/kg/ġimgħa (4 ġimgħat)
English: Only 5 children and adolescents with Genotype 4 were treated in the ViraferonPeg/ribavirin clinical trial.
Maltese: 5 itfal u adolexxenti biss b'Ġenotip 4 kienu kkurati fil-prova klinika b'ViraferonPeg/ribavirin.
English: Another approximately 2 % had a transient decrease below the lower limit of normal.
Maltese: Madwar 2% oħra kellhom tnaqqis temporanju taħt il-limitu ta' taħt tan-normali.
English: Two pivotal trials have been conducted, one (C/I97-010) with ViraferonPeg monotherapy; the other (C/I98-580) with ViraferonPeg in combination with ribavirin.
Maltese: Saru żewġ provi pivitali, wieħed (C/I97-010) b'monoterapija b'ViraferonPeg; l-ieħor (C/I98-580) b'ViraferonPeg flimkien ma' ribavirin.
English: If available, prescribers are advised to consult with a poison control centre (PCC).
Maltese: Jekk ikun hemm, it-tobba li jordnawh huma rrakkomandati li jikkonsultaw ċentru tal-kontroll tal-veleni (PCC - poison control centre).
English: Genotype 1 > 600,000 IU/ml
Maltese: Ġenotip 1 > 600,000 IU/ml
English: Among children and adolescents treated with interferon alfa-2b in combination with ribavirin, suicidal ideation or attempts were reported more frequently compared to adult patients (2.4 % vs 1 %) during treatment and during the 6-month follow-up after treatment.
Maltese: Fost tfal u adolexxenti kkurati b'interferon alfa-2b flimkien ma' ribavirin, ħsibijiet dwar suwiċidju jew attentati ta' suwiċidju kienu rrappurtati b'mod aktar frekwenti meta mqabbel ma' pazjenti adulti (2,4 % vs 1 %) waqt il-kura u fis-6 xhur ta' wara l-kura li fih ġew segwiti.
English: 4 vials of powder, 4 ampoules of solvent, 4 injection syringes, 8 injection needles and 4 cleansing swabs
Maltese: 4 kunjetti ta' trab, 4 ampulli ta' solvent, 4 siringi għall-injezzjoni, 8 labriet tal-injezzjoni u 4 imsielaħ biex tnaddaf
English: Table 12 Predictive value of in-treatment Virologic Response while on ViraferonPeg 1.5 µg/kg/ribavirin 800-1,400 mg combination therapy Negative
Maltese: Tabella 12 Valur imbassar għar-Rispons Viroloġiku waqt il-kura waqt terapija kkombinata b'ViraferonPeg 1,5 µg/kg/ribavirin 800-1.400 mg Negattiv
English: Chronic Hepatitis C Subjects (N=24)
Maltese: Individwi b'Epatite Ċ Kronika (N=24)
English: Facial palsy, mononeuropathies
Maltese: Paralisi fil-wiċċ, mononewropatiji
English: • Genotype 2 or 3:
Maltese: • Ġenotipi 2 jew 3:
English: The 6 month treatment duration in this trial was better tolerated than one year of treatment in the pivotal combination trial; for discontinuation 5 % vs. 14 %, for dose modification 18 % vs. 49 %.
Maltese: Il-kura ta' 6 xhur f'din il-prova kienet ittollerata aħjar mill-kura ta' sena fil-prova pivitali bilkombinazzjoni; għat-twaqqif 5 % vs 14 %, għal modifikazzjoni fid-doża 18 % vs 49 %.
English: Genotype 1  600,000 IU/ml
Maltese: Ġenotip 1  600,000 IU/ml
English: In patients with chronic hepatitis C that were on stable methadone maintenance therapy and naïve to peginterferon alfa-2b, addition of 1.5 microgram/kg/week of ViraferonPeg subcutaneously for 4 weeks increased R-methadone AUC by approximately 15 % (95 % Cl for AUC ratio estimate 103 - 128 %).
Maltese: F'pazjenti b'epatite Ċ kronika li kienu fuq terapija stabbli ta' manteniment b'methadone u li qatt ma kienu ħadu peginterferon alfa-2b qabel, iż-żieda ta' 1.5 mikrogrammi/kg/ġimgħa ta' ViraferonPeg minn taħt ilġilda għal 4 ġimgħat żiedet l-AUC ta' R-methadone b'madwar 15% (95% Cl għall-istima tal-proporzjon tal-AUC 103 - 128%).
English: Carton 50 micrograms
Maltese: Kartuna 50 mikrogramma
English: Tongue pigmentation
Maltese: Piż talġise
English: Acute hypersensitivity reactions including angioedema, anaphylaxis and anaphylactic reactions including anaphylactic shock, idiopathic thrombocytopenic purpura, thrombotic thrombocytopenic purpura, systemic lupus erythematosus
Maltese: Reazzjonijiet akuti ta' sensittività eċċessiva inkluża anġjoedima, anafilassi u reazzjonijiet anafilattiċi inklużi xokk anafilattiku, purpura tromboċitopenika idjopatika, purpura tromboċitopenika trombotika, lupus eritematuż sistemiku Disturbi fis-sistema endokrinarja Komuni:
English: 8 injection needles and 4 cleansing swabs; - 6 vials of powder for solution for injection and 6 ampoules of solvent for injection; - 12 vials of powder for solution for injection, 12 ampoules of solvent for injection, 12 injection syringes, 24 injection needles and 12 cleansing swabs.
Maltese: siringi għall-injezzjoni, 8 labriet tal-injezzjoni u 4 imsielaħ għat-tindif; - 6 kunjetti ta' trab għal soluzzjoni għall-injezzjoni u 6 ampulli ta' solvent għall-użu parenterali. - 12-il kunjett ta' trab għal soluzzjoni għall-injezzjoni, 12-il ampulla ta' solvent għall-użu parenterali, 12-il siringa għall-injezzjoni, 24 labra tal-injezzjoni u 12-il imselħa għat-tindif;
English: Concomitant administration of peginterferon alfa-2b (ViraferonPeg) with caffeine or desipramine modestly increased the exposure of caffeine and desipramine.
Maltese: L-għoti flimkien ta' peginterferon alfa-2b (ViraferonPeg) mal-kaffeina jew ma' desipramine żied moderatament l-espożizzjoni talkaffeina u ta' desipramine.
English: Dial dose
Maltese: Issettja d-Doża
English: Neuralgia, lethargy, paraesthesia, hypoaesthesia, psychomotor hyperactivity, tremor
Maltese: Nevralġija, letarġija, parestesija, ipoestesija, attività psikomotorja eċċessiva, rogħda
English: Clinical efficacy and safety - paediatric population Children and adolescents 3 to 17 years of age with compensated chronic hepatitis C and detectable HCV-RNA were enrolled in a multicentre trial and treated with ribavirin 15 mg/kg per day plus ViraferonPeg 60 g/m2 once weekly for 24 or 48 weeks, based on HCV genotype and baseline viral load.
Maltese: Effikaċja klinika u sigurtà - popolazzjoni pedjatrika Tfal u adolexxenti b'età minn 3 snin sa 17-il sena b'epatite Ċ kronika kkompensata u HCV-RNA li jista' jitkejjel kienu rreġistrati fi prova multiċentrika u kkurati b'ribavirin 15 mg/kg kuljum flimkien ma' ViraferonPeg 60 μg/m2 darba fil-ġimgħa għal 24 jew 48 ġimgħa, skont il-ġenotip tal-HCV u lammont virali fil-linja bażi.
English: ViraferonPeg (1.5 µg/kg/ week) + ribavirin (800 mg)
Maltese: ViraferonPeg (1.5 µg/kg/ ġimgħa) + ribavirin (800 mg)
English: Patients with undetectable HCV-RNA at treatment week 12 and SVR upon retreatment interferon alpha/ribavirin peginterferon alpha/ribavirin
Maltese: Pazjenti b'HCV-RNA li ma setax jitkejjel f'ġimgħa tal-kura 12 u SVR wara kura mill-ġdid interferon alpha/ribavirin peginterferon alpha/ribavirin
English: *, cough
Maltese: *, sogħla
English: Co-administered Medicine
Maltese: TAL-PRODOTT MEDIĊINALI
English: Table 3b Reduced ViraferonPeg dose (0.25 g/kg) for the 0.5 g/kg monotherapy regimen in adults Body weight (kg)
Maltese: Tabella 3b Doża mnaqqsa ta' ViraferonPeg (0,25 g/kg) għall-iskeda ta' monoterapija ta' 0,5 g/kg fl-adulti Piż tal-ġisem (kg)
English: Rhabdomyolysis, myositis, rheumatoid arthritis Renal and urinary disorders Common:
Maltese: Rabdomijolisi, mijosite, artrite rewmatika Disturbi fil-kliewi u fis-sistema urinarja Komuni:
English: ViraferonPeg 1.5 micrograms/kg/week in combination with ribavirin capsules.
Maltese: ViraferonPeg 1,5 mikrogrammi/kg/ġimgħa flimkien ma' kapsuli ta' ribavirin.
English: Table 6 Adverse reactions reported in adults in clinical trials or through post-marketing surveillance in patients treated with peginterferon alfa-2b, including ViraferonPeg monotherapy or ViraferonPeg + ribavirin
Maltese: Tabella 6 Reazzjonijiet avversi rrappurtati fl-adulti fil-provi kliniċi jew minn sorveljenza ta' wara t-tqegħid fis-suq f'pazjenti kkurati b'peginterferon alfa-2b, inkluż monoterapija b'ViraferonPeg jew ViraferonPeg + ribavirin Infezzjonijiet u infestazzjonijiet
English: Table 11 Virologic response at treatment week 12, end of treatment response, relapse rate *and Sustained Virologic Response (SVR) Treatment group
Maltese: Tabella 11 Rispons viroloġiku f'ġimgħa ta' kura 12, rispons fit-tmiem tal-kura, rata ta' rikaduta* u Rispons Viroloġiku Sostnut (SVR) Grupp ta' Kura
English: In these studies, the effects of multiple-dose regimens of peginterferon alfa-2b (ViraferonPeg) were investigated in Hepatitis C subjects (1.5 mcg/week) or healthy subjects (1 mcg/week or 3 mcg/week) (Table 4).
Maltese: F'dawn l-istudji, l-effetti ta' skemi ta' dożi multipli ta' peginterferon alfa-2b (ViraferonPeg) ġew investigati f'individwi b'Epatite C (1.5 mcg/ġimgħa) jew fuq individwi b'saħħithom (1 mcg/ġimgħa jew 3 mcg/ġimgħa) (Tabella 4).
English: Hepatitis B reactivation in HCV/HBV co-infected patients Blood and lymphatic system disorders Very common:
Maltese: Riattivazzjoni tal-epatite B f'pazjenti infettati fl-istess ħin b'HCV/HBV Disturbi tad-demm u tas-sistema limfatika Komuni ħafna:
English: In patients with moderate renal dysfunction (creatinine clearance 30-50 ml/minute), the starting dose of ViraferonPeg should be reduced by 25 %.
Maltese: F'pazjenti li jkollhom disfunzjoni renali moderata (tneħħija tal-krejatinina 30-50 ml/minuta), id-doża tal-bidu ta' ViraferonPeg għandha titnaqqas b'25%.
English: Dyspepsia, gastroesophageal reflux disease, stomatitis, mouth ulceration, glossodynia, gingival bleeding, constipation, flatulence, haemorrhoids, cheilitis, abdominal distension, gingivitis, glossitis, tooth disorder
Maltese: Dispepsja, marda ta' rifluss gastroesofagali, stomatite, ulċera filħalq, glossodinja, fsada mill-ħanek, stitikezza, gass, murliti, kelite, nefħa fl-addome, ġinġivite, glossite, disturb fis-snien
English: Severe adverse reactions were reported in 7 % (8/107) of all subjects and included injection site pain (1 %), pain in extremity (1 %), headache (1 %), neutropenia (1 %), and pyrexia (4 %).
Maltese: Reazzjonijiet avversi severi kienu rrappurtati f'7 % (8/107) talindividwi kollha u kienu jinkludu wġigħ fis-sit tal-injezzjoni (1 %), uġigħ fl-estermitajiet (1 %), uġigħ ta' ras (1 %), newtropenija (1 %) u deni (4 %).
English: Description of selected adverse reactions in adults
Maltese: Deskrizzjoni ta' reazzjonijiet avversi magħżula fl-adulti
English: In a clinical trial, approximately 1.2 % of patients treated with ViraferonPeg or interferon alfa-2b in combination with ribavirin reported life-threatening psychiatric events during treatment.
Maltese: Fi prova klinika, madwar 1,2% tal-pazjenti li kienu kkurati b'ViraferonPeg jew interferon alfa-2b flimkien ma' ribavirin irrappurtaw avvenimenti psikjatriċi li kienu ta' periklu għall-ħajja waqt il-kura.
English: The relative non-toxicity of monomethoxy-polyethylene glycol (mPEG), which is liberated from ViraferonPeg by metabolism in vivo has been demonstrated in preclinical acute and subchronic toxicity studies in rodents and monkeys, standard embryo-foetal development studies and in in vitro mutagenicity assays.
Maltese: In-nuqqas ta' tossiċità relattiva ta' monomethoxy-polyethylene glycol (mPEG), illi jinħeles minn ViraferonPeg permezz ta' metaboliżmu in vivo, intwera fi studji li saru qabel l-użu kliniku dwar tossiċità akuta u sottokronika li saru fuq annimali gerriema u xadini, studji standard dwar l-iżvilupp tal-embriju-fetu u assaġġi in vitro dwar il-mutaġeniċità.
English: Reports of mitochondrial toxicity, in particular lactic acidosis and pancreatitis, of which some fatal, have been reported (see ribavirin SmPC).
Maltese: Rapporti ta' tossiċità mitokondrijali, l-aktar aċidożi lattika u pankreatite, ftit minnhom fatali, kienu rrappurtati (ara lSmPC ta' ribavirin).
English: In a single dose study (1.0 microgram/kg) in patients with impaired renal function, Cmax, AUC, and half-life increased in relation to the degree of renal impairment.
Maltese: Fi studju fejn ingħatat doża waħda (1,0 mikrogramma/kg) f'pazjenti b'funzjoni tal-kliewi indebolita, is-Cmax, lAUC, u l-half-life żdiedu b'mod proporzjonali mal-grad ta' indeboliment tal-kliewi.
English: A clinical trial investigating the combination of telbivudine, 600 mg daily, with pegylated interferon alfa-2a, 180 micrograms once weekly by subcutaneous administration, indicates that this combination is associated with an increased risk of developing peripheral neuropathy.
Maltese: Prova klinika li kienet qed tinvestiga l-kombinazzjoni ta' telbivudine, 600 mg kuljum, ma' interferon alfa-2a pegilat, 180 mikrogramma darba fil-ġimgħa permezz ta' għoti taħt il-ġilda, tindika li din ilkombinazzjoni hija assoċjata ma' riskju akbar li tiżviluppa newropatija periferali.
English: ViraferonPeg in combination with ribavirin and boceprevir (tritherapy) is indicated for the treatment of chronic hepatitis C (CHC) genotype 1 infection in adult patients (18 years of age and older) with compensated liver disease who are previously untreated or who have failed previous therapy (see section 5.1).
Maltese: ViraferonPeg flimkien ma' ribavirin u boceprevir (terapija bi tliet mediċini) huwa indikat għall-kura ta' infezzjoni kronika tal-epatite Ċ (CHC - chronic hepatitis C) ta' ġenotip 1 f'pazjenti adulti (età ta' 18-il sena u akbar) b'mard kumpensat tal-fwied li qatt ma ġew ikkurati qabel jew li l-kura li ħadu qabel ma ħadmitx fuqhom (ara sezzjoni 5.1).