FrancophonIA/ELRC3.0 huggingface dataset:
English: EU/1/00/132/047 (1 pen, 1 injection needle and 2 cleansing swabs) EU/1/00/132/048 (4 pens, 4 injection needles and 8 cleansing swabs) EU/1/00/132/050 (12 pens, 12 injection needles and 24 cleansing swabs)
Maltese: EU/1/00/132/048 (4 pinen, 4 labriet tal-injezzjoni u 8 imsielaħ biex tnaddaf) EU/1/00/132/050 (12-il pinna, 12-il labra tal-injezzjoni u 24 imselħa biex tnaddaf)
English: EU/1/00/132/001 (1 vial of powder, 1 ampoule of solvent) EU/1/00/132/002 (1 vial of powder, 1 ampoule of solvent, 1 injection syringe, 2 injection needles and 1 cleansing swab)
Maltese: EU/1/00/132/002 (kunjett wieħed ta' trab, ampulla waħda ta' solvent, siringa waħda għall-injezzjoni, 2 labriet tal-injezzjoni u mselħa waħda biex tnaddaf) EU/1/00/132/003 (4 kunjetti ta' trab, 4 ampulli ta' solvent)
English: ViraferonPeg is supplied as: - 1 vial of powder for solution for injection and 1 ampoule of solvent for parenteral use; - 1 vial of powder for solution for injection, 1 ampoule of solvent for parenteral use, 1 injection syringe, 2 injection needles and 1 cleansing swab; - 4 vials of powder for solution for injection and 4 ampoules of solvent for parenteral use;
Maltese: ViraferonPeg huwa fornut bħala: - kunjett wieħed ta' trab għal soluzzjoni għall-injezzjoni u ampulla waħda ta' solvent għall-użu parenterali; - kunjett wieħed ta' trab għal soluzzjoni għall-injezzjoni, ampulla waħda ta' solvent għall-użu parenterali, siringa għall-injezzjoni waħda, 2 labriet tal-injezzjoni u mselħa waħda għat-tindif; - 4 kunjetti ta' trab għal soluzzjoni għall-injezzjoni u 4 ampulli ta' solvent għall-użu parenterali; - 4 kunjetti ta' trab għal soluzzjoni għall-injezzjoni, 4 ampulli ta' solvent għall-użu parenterali, 4
English: 11 months) + ribavirin (1,000/1,200 mg/day), (n = 514).
Maltese: 0.5 mikrogrammi/kg/ġimgħa għal 11-il xahar) + ribavirin (1.000/1.200 mg kuljum), (n = 514).
English: Data are not available for the use of ViraferonPeg in patients with creatinine clearance < 15 ml/minute (see section 5.2).
Maltese: M'hemmx dejta dwar l-użu ta' ViraferonPeg f'pazjenti bi tneħħija tal-krejatinina < 15 ml/min (ara sezzjoni 5.2).
English: Psychiatric disorders Very common:
Maltese: Infezzjonijiet u infestazzjonijiet Mhux komuni:
English: This decline was significant among responders (-0.3 for Metavir and -1.2 for Ishak) and stable (-0.1 for Metavir and -0.2 for Ishak) among non-responders.
Maltese: Dan it-tnaqqis kien sinifikanti fost dawk li wrew rispons (-0,3 għal Metavir u -1,2 għal Ishak) u stabbli (-0,1 għal Metavir u -0,2 għal Ishak) fost dawk li ma kellhomx rispons.
English: Dyspnoea
Maltese: Kollha
English: ViraferonPeg showed no genotoxic potential.
Maltese: ViraferonPeg ma wera l-ebda potenzjal ġenotossiku.
English: The combination of this medicine, ribavirin and boceprevir is recommended for use for some types of chronic hepatitis C virus infection (also called HCV infection) in adults 18 years of age and older.
Maltese: Il-kombinazzjoni ta' din il-mediċina, ribavirin and boceprevir hija rrakkomandata biex tintuża għal xi tipi ta' infezzjonijiet kroniċi bil-virus tal-epatite Ċ (imsejħa wkoll infezzjoni tal-HCV) f'adulti b'età minn 18-il sena 'l fuq.
English: ViraferonPeg 150 micrograms powder and solvent for solution for injection in pre-filled pen Each pre-filled pen (CLEARCLICK) is reconstituted with the solvent provided in the two-chamber cartridge (water for injections) for administration of up to 0.5 ml of solution.
Maltese: Kull pinna mimlija għal-lest (CLEARCLICK) għandha tiġi rikostitwita bis-solvent ipprovdut fl-iskartoċċ b'żewġ kompartimenti (ilma għall-injezzjonijiet) biex tingħata sa 0,5 ml ta' soluzzjoni.
English: EU/1/00/132/031 (1 pen, 1 injection needle and 2 cleansing swabs) EU/1/00/132/032 (4 pens, 4 injection needles and 8 cleansing swabs) EU/1/00/132/034 (12 pens, 12 injection needles and 24 cleansing swabs)
Maltese: EU/1/00/132/032 (4 pinen, 4 labriet tal-injezzjoni u 8 imsielaħ biex tnaddaf) EU/1/00/132/034 (12-il pinna, 12-labra tal-injezzjoni u 24 imselħa biex tnaddaf)
English: EU/1/00/132/043 (1 pen, 1 injection needle and 2 cleansing swabs) EU/1/00/132/044 (4 pens, 4 injection needles and 8 cleansing swabs) EU/1/00/132/046 (12 pens, 12 injection needles and 24 cleansing swabs)
Maltese: EU/1/00/132/044 (4 pinen, 4 labriet tal-injezzjoni u 8 imsielaħ biex tnaddaf) EU/1/00/132/046 (12-il pinna, 12-labra tal-injezzjoni u 24 imselħa biex tnaddaf)
English: Paediatric population (bitherapy)
Maltese: Tkabbir u żvilupp (tfal u adolexxenti)
English: ViraferonPeg 80 micrograms powder and solvent for solution for injection peginterferon alfa-2b
Maltese: ViraferonPeg 80 mikrogramma trab u solvent għal soluzzjoni għall-injezzjoni peginterferon alfa-2b
English: Depression, anxiety *, emotional lability *, concentration impaired, insomnia
Maltese: Depressjoni, ansjetà*, burdati emozzjonali
English: Following single doses of ViraferonPeg between 0.25 and 2.0 micrograms/kg/week, serum neopterin concentration was increased in a dose-related manner.
Maltese: Wara dożi singoli ta' ViraferonPeg ta' bejn 0,25 u 2,0 mikrogrammi/kg/ġimgħa, il-konċentrazzjoni ta' neopterin fis-serum żdiedet b'mod li kien relatat mad-doża.
English: ViraferonPeg 150 micrograms powder and solvent for solution for injection Each vial is to be reconstituted with 0.7 ml of water for injections for administration of up to 0.5 ml of solution.
Maltese: Kull kunjett għandu jiġi rikostitwit b'0,7 ml ta' ilma għall-injezzjonijiet biex tingħata sa 0,5 ml ta' soluzzjoni.
English: ViraferonPeg 80 micrograms powder and solvent for solution for injection Each vial is to be reconstituted with 0.7 ml of water for injections for administration of up to 0.5 ml of solution.
Maltese: Kull pinna mimlija għal-lest tipprovdi 80 mikrogramma/0,5 ml ta' soluzzjoni meta tkun rikostitwita kif rakkomandat.
English: EU/1/00/132/008 (4 vials of powder, 4 ampoules of solvent) EU/1/00/132/009 (4 vials of powder, 4 ampoules of solvent, 4 injection syringes, 8 injection needles and 4 cleansing swabs)
Maltese: EU/1/00/132/009 (4 kunjetti ta' trab, 4 ampulli ta' solvent, 4 siringi għall-injezzjoni, 8 labriet talinjezzjoni u 4 imsielaħ biex tnaddaf)
English: Predictability of sustained virological response - Naïve patients: Virological response by week 12 is defined as at least 2-log viral load decrease or undetectable levels of HCV-RNA.Virological response by week 4 is defined as at least 1-log viral load decrease or undetectable levels of HCV-RNA.
Maltese: Tbassir ta' rispons viroloġiku sostnut - Pazjenti li qatt ma kienu ħadu din il-kura qabel: Rispons viroloġiku sa ġimgħa 12 huwa definit bħala mill-anqas tnaqqis ta' 2-log fl-ammont virali jew livelli ta' HCV-RNA li ma jistgħux jitkejlu.
English: Interferon neutralising factors are antibodies which neutralise the antiviral activity of interferon.
Maltese: Il-fatturi li jinnewtralizzaw interferon huma antikorpi li jinnewtralizzaw l-attività antivirali ta' interferon.
English: EU/1/00/132/023 (4 vials of powder, 4 ampoules of solvent) EU/1/00/132/024 (4 vials of powder, 4 ampoules of solvent, 4 injection syringes, 8 injection needles and 4 cleansing swabs)
Maltese: EU/1/00/132/024 (4 kunjetti ta' trab, 4 ampulli ta' solvent, 4 siringi għall-injezzjoni, 8 labriet talinjezzjoni u 4 imsielaħ biex tnaddaf)
English: Plasma HCV-RNA is measured with a research-based quantitative polymerase chain reaction assay by a central laboratory *Intent to treat population includes 7 patients for whom at least 12 weeks of prior therapy could not be confirmed.
Maltese: HCV-RNA fil-plażma jitkejjel b'assaġġ kwantitattiv ta' polymerase chain reaction ibbażat fuq riċerka minn laboratorju ċentrali.
English: Body weight (kg)
Maltese: Piż talġisem (kg)
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 120 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 120 mikrogramma/0,5 ml
English: EU/1/00/132/021 (1 vial of powder, 1 ampoule of solvent) EU/1/00/132/022 (1 vial of powder, 1 ampoule of solvent, 1 injection syringe, 2 injection needles and 1 cleansing swab)
Maltese: EU/1/00/132/022 (kunjett wieħed ta' trab, ampulla waħda ta' solvent, siringa waħda għall-injezzjoni, 2 labriet tal-injezzjoni u mselħa waħda biex tnaddaf) EU/1/00/132/023 (4 kunjetti ta' trab, 4 ampulli ta' solvent)
English: EU/1/00/132/006 (1 vial of powder, 1 ampoule of solvent) EU/1/00/132/007 (1 vial of powder, 1 ampoule of solvent, 1 injection syringe, 2 injection needles and 1 cleansing swab)
Maltese: EU/1/00/132/007 (kunjett wieħed ta' trab, ampulla waħda ta' solvent, siringa waħda għall-injezzjoni, 2 labriet tal-injezzjoni u mselħa waħda biex tnaddaf) EU/1/00/132/008 (4 kunjetti ta' trab, 4 ampulli ta' solvent)
English: EU/1/00/132/013 (4 vials of powder, 4 ampoules of solvent) EU/1/00/132/014 (4 vials of powder, 4 ampoules of solvent, 4 injection syringes, 8 injection needles and 4 cleansing swabs)
Maltese: EU/1/00/132/014 (4 kunjetti ta' trab, 4 ampulli ta' solvent, 4 siringi għall-injezzjoni, 8 labriet talinjezzjoni u 4 imsielaħ biex tnaddaf)
English: The reconstituted solution has a concentration of 50 micrograms in 0.5 ml.
Maltese: Issoluzzjoni rikostitwita għandha konċentrazzjoni ta' 50 mikrogramma f'0,5 ml.
English: EU/1/00/132/003 (4 vials of powder, 4 ampoules of solvent) EU/1/00/132/004 (4 vials of powder, 4 ampoules of solvent, 4 injection syringes, 8 injection needles and 4 cleansing swabs)
Maltese: EU/1/00/132/004 (4 kunjetti ta' trab, 4 ampulli ta' solvent, 4 siringi għall-injezzjoni, 8 labriet talinjezzjoni u 4 imsielaħ biex tnaddaf)
English: For weight, pre-treatment to end of long-term follow-up, weightfor-age percentiles decreased 1.3 and 5.5 percentiles among subjects treated for 24 weeks or 48 weeks, respectively.
Maltese: Għall-piż, minn qabel il-kura sal-aħħar tas-segwitu fit-tul ta' 5 snin, il-percentiles tal-piż għall-età naqsu b'1,3 u 5,5 percentiles fost individwi kkurati għal 24 ġimgħa jew 48 ġimgħa, rispettivament.
English: - Interferon alfa-2b (3 MIU three times a week) + ribavirin (1,000/1,200 mg/day) (n = 505).
Maltese: - Interferon alfa-2b (3 MIU tliet darbiet fil-ġimgħa) + ribavirin (1.000/1.200 mg kuljum)
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 80 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 80 mikrogramma/0,5 ml
English: NR: Non-responder defined as serum/plasma HCV-RNA positive at the end of a minimum of 12 weeks of treatment.
Maltese: NR: Individwu li ma rrispondiex definit bħala pożittiv għal HCV-RNA fis-serum/plażma fi tmiem mill-anqas 12-il ġimgħa ta' kura.
English: EU/1/00/132/015 (6 vials of powder, 6 ampoules of solvent) EU/1/00/132/028 (12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs)
Maltese: EU/1/00/132/028 (12-il kunjett ta' trab, 12-il ampulla ta' solvent, 12-il siringa għall-injezzjoni, 24 labra tal-injezzjoni u 12-il imselħa biex tnaddaf)
English: EU/1/00/132/039 (1 pen, 1 injection needle and 2 cleansing swabs) EU/1/00/132/040 (4 pens, 4 injection needles and 8 cleansing swabs) EU/1/00/132/042 (12 pens, 12 injection needles and 24 cleansing swabs)
Maltese: EU/1/00/132/040 (4 pinen, 4 labriet tal-injezzjoni u 8 imsielaħ biex tnaddaf) EU/1/00/132/042 (12-il pinna, 12-labra tal-injezzjoni u 24 imselħa biex tnaddaf)
English: EU/1/00/132/035 (1 pen, 1 injection needle and 2 cleansing swabs) EU/1/00/132/036 (4 pens, 4 injection needles and 8 cleansing swabs) EU/1/00/132/038 (12 pens, 12 injection needles and 24 cleansing swabs)
Maltese: EU/1/00/132/036 (4 pinen, 4 labriet tal-injezzjoni u 8 imsielaħ biex tnaddaf) EU/1/00/132/038 (12-il pinna, 12-labra tal-injezzjoni u 24 imselħa biex tnaddaf)
English: In general, the adverse events seen in overdose cases involving ViraferonPeg are consistent with the known safety profile for ViraferonPeg; however, the severity of the events may be increased.
Maltese: B'mod ġenerali, l-avvenimenti avversi li dehru f'każijiet ta' doża eċċessiva li kienu jinvolvu ViraferonPeg huma konsistenti mal-profil ta' sigurtà magħruf għal ViraferonPeg; madankollu, is-severità tal-avvenimenti tista' tiżdied.
English: Monotherapy with ViraferonPeg and bitherapy with ViraferonPeg and ribavirin Naïve patients
Maltese: Monoterapija b'ViraferonPeg u terapija b'żewġ mediċini b'ViraferonPeg u ribavirin Pazjenti li qatt ma kienu ħadu din il-kura qabel
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 50 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 50 mikrogramma/0,5 ml
English: In a clinical trial with 107 children and adolescent patients (3 to 17 years of age) treated with combination therapy of ViraferonPeg and ribavirin, dose modifications were required in 25 % of patients, most commonly for anaemia, neutropenia and weight loss.
Maltese: Fi prova klinika b'107 pazjent tifel u tifla u adolexxenti (3 sa 17-il sena) ikkurati b'terapija kombinata ta' ViraferonPeg u ribavirin, bidliet fid-doża kienu meħtieġa f'25% tal-pazjenti, l-aktar komuni minħabba anemija, newtropenija jew telf tal-piż.
English: The reconstituted solution has a concentration of 100 micrograms in 0.5 ml.
Maltese: Issoluzzjoni rikostitwita għandha konċentrazzjoni ta' 100 mikrogramma f'0,5 ml.
English: Failure to prior therapy was defined as relapse or non-response (HCV-RNA positive at the end of a minimum of 12 weeks of treatment).
Maltese: Terapija fil-passat li ma rnexxietx kienet definita bħala rikaduta jew nuqqas ta' rispons (pożittivi għal HCV-RNA fi tmiem mill-anqas 12-il ġimgħa ta' kura).
English: EU/1/00/132/025 (6 vials of powder, 6 ampoules of solvent) EU/1/00/132/030 (12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs)
Maltese: EU/1/00/132/030 (12-il kunjett ta' trab, 12-il ampulla ta' solvent, 12-il siringa għall-injezzjoni, 24 labra tal-injezzjoni u 12-il imselħa biex tnaddaf)
English: ViraferonPeg 120 micrograms powder and solvent for solution for injection peginterferon alfa-2b
Maltese: ViraferonPeg 120 mikrogramma trab u solvent għal soluzzjoni għall-injezzjoni peginterferon alfa-2b
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 100 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 100 mikrogramma/0,5 ml
English: Adults - Duration of treatment - HCV/HIV co-infection Bitherapy: The recommended duration of treatment for HCV/HIV co-infected patients is 48 weeks with bitherapy, regardless of genotype.
Maltese: Adulti - Tul tal-kura - Infezzjoni fl-istess ħin b'HCV/HIV Terapija b'żewġ mediċini:
English: 3 mcg/kg/week (2 weeks)
Maltese: 3 mcg/kg/ġimgħa (ġimgħatejn)
English: ViraferonPe g strength (g/0.5 ml)
Maltese: Qawwa ta' ViraferonP eg (g/0,5 ml)
English: Study 2 (P02080) was a randomized, single centre study that enrolled 95 previously untreated adult patients with chronic hepatitis C who were co-infected with HIV.
Maltese: Studju 2 (P02080) kien studju li fih il-parteċipanti ntgħażlu b'mod każwali, b'ċentru wieħed li fih ħadu sehem 95 pazjent adult li ma kinux ikkurati fil-passat, li kellhom epatite Ċ kronika u li kellhom ukoll infezzjoni b'HIV.
English: ViraferonPeg 150 micrograms powder and solvent for solution for injection peginterferon alfa-2b
Maltese: ViraferonPeg 150 mikrogramma trab u solvent għal soluzzjoni għall-injezzjoni peginterferon alfa-2b
English: EU/1/00/132/018 (4 vials of powder, 4 ampoules of solvent) EU/1/00/132/019 (4 vials of powder, 4 ampoules of solvent, 4 injection syringes, 8 injection needles and 4 cleansing swabs)
Maltese: EU/1/00/132/019 (4 kunjetti ta' trab, 4 ampulli ta' solvent, 4 siringi għall-injezzjoni, 8 labriet talinjezzjoni u 4 imsielaħ biex tnaddaf)
English: These measures will help protect the environment.
Maltese: Neħħi lgħatu ta' protezzjoni tal-labra.
English: This medicine, when given alone, is usually given at a dose of 0.5 or 1.0 microgram per kilogram of body weight once a week, for 6 months to 1 year.
Maltese: Din il-mediċina, meta tingħata waħedha, normalment tingħata f'doża ta' 0,5 jew 1,0 mikrogramma għal kull kilogramma ta' piż tal-ġisem darba fil-ġimgħa, għal 6 xhur sa sena.
English: However, an overall 24 weeks treatment duration may be associated with a higher risk of relapse than a 48 weeks treatment duration (see section 5.1).
Maltese: Madankollu, tul ta' kura li jdum 24 ġimgħa b'kollox jista' jkun assoċjat ma' riskju ogħla ta' rikaduta minn kura li ddum 48 ġimgħa (ara sezzjoni 5.1).
English: Interstitial lung disease
Maltese: Mard tal-interstizzju tal-pulmun
English: (8/194) of patients and decrease in platelets below 50,000/mm
Maltese: 3 ġie osservat f'4% (8/194) tal-pazjenti u tnaqqis fl-għadd tal-plejtlits taħt 50,000/mm
English: In general, patients infected with genotype 4 are considered harder to treat and limited study data (n=66) indicate they are compatible with a duration of treatment with bitherapy as for genotype 1.
Maltese: B'mod ġenerali, pazjenti infettati b'ġenotip 4 huma kkunsidrati li hu aktar diffiċli biex tikkurahom u dejta minn studju limitat (n=66) tindika li huma kompatibbli ma' tul ta' żmien ta' kura b'terapija ta' żewġ mediċini bħal dak ta' ġenotip 1.
English: The negative predictive value for sustained response in patients treated with ViraferonPeg in monotherapy was 98 %.
Maltese: Il-valur negattiv li jbassar rispons sostnut f'pazjenti li ġew ikkurati b'ViraferonPeg bħala monoterapija kien ta' 98%.
English: Each vial provides 120 micrograms/0.5 ml of peginterferon alfa-2b when reconstituted as recommended.
Maltese: Kull kunjett jipprovdi 120 mikrogramma/0,5 ml ta' peginterferon alfa-2b meta rikostitwit kif irrakkomandat.
English: Bone pain, muscle weakness
Maltese: Pressjoni baxxa, sfurija
English: Subjects treated with ViraferonPeg showed mild dose-related elevations in body temperature.
Maltese: Individwi kkurati b'ViraferonPeg urew żidiet żgħar relatati mad-doża fit-temperatura tal-ġisem.
English: Discontinue ViraferonPeg if:
Maltese: Disturbi fil-fwied u fil-marrara Komuni:
English: However, certain monkey species, e.g., Rhesus monkeys are susceptible to pharmacodynamic stimulation upon exposure to human type 1 interferons.
Maltese: Madankollu, ċerti speċi ta' xadini, eż., xadini tal-ispeċi Rhesus, huma suxxettibbli għal stimulazzjoni farmakodinamika meta dawn ikunu esposti għal interferons tat-tip-1 tal-bniedem.
English: Ophthalmologic disorders, including retinal haemorrhages, retinal exudates, serous retinal detachment, and retinal artery or vein occlusion have been reported in rare instances after treatment with alpha interferons (see section 4.8).
Maltese: Disturbi oftalmoloġiċi, li jinkludu emorraġiji fir-retina, tnixxijiet mir-retina, distakk tar-retina bi tnixxija, kif ukoll okklużjoni ta' arterja jew vina tar-retina ġew irrappurtati f'każijiet rari wara kura b'alfa interferons (ara sezzjoni 4.8).
English: ViraferonPeg 50 micrograms powder and solvent for solution for injection peginterferon alfa-2b
Maltese: ViraferonPeg 50 mikrogramma trab u solvent għal soluzzjoni għall-injezzjoni peginterferon alfa-2b
English: delusions, hallucination, - hypersensitivity reaction to the medication, heart attack, inflammation of the pancreas, pain in bone and diabetes mellitus, - cotton wool spots (white deposits on the retina).
Maltese: delużjonijiet, alluċinazzjoni, - reazzjoni ta' sensittività eċċessiva għall-medikazzjoni, attakk tal-qalb, infjammazzjoni tal-frixa,
English: Pancreatitis, oral pain
Maltese: Bidliet fil-pulmun
English: Bitherapy: Predictability of sustained virological response - Patients infected with virus genotype 1 who fail to achieve undetectable HCV-RNA or demonstrate adequate virological response at week 4 or 12 are highly unlikely to become sustained virological responders and should be evaluated for discontinuation (see also section 5.1).
Maltese: Tbassir tar-rispons viroloġiku sostnut - Pazjenti infettati b'virus talġenotip 1 li jonqsu milli jiksbu HCV-RNA li ma jistax jitkejjel jew juru rispons viroloġiku adegwat wara 4 jew 12-il ġimgħa għandhom possibbiltà kbira li ma jirrispondux b'mod viroloġiku sostnut u għandhom jiġu evalwati għat-twaqqif (ara ukoll sezzjoni 5.1).
English: EU/1/00/132/020 (6 vials of powder, 6 ampoules of solvent) EU/1/00/132/029 (12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs)
Maltese: EU/1/00/132/029 (12-il kunjett ta' trab, 12-il ampulla ta' solvent, 12-il siringa għall-injezzjoni, 24 labra tal-injezzjoni u 12-il imselħa biex tnaddaf)
English: Each vial provides 150 micrograms/0.5 ml of peginterferon alfa-2b when reconstituted as recommended.
Maltese: Kull kunjett jipprovdi 150 mikrogramma/0,5 ml ta' peginterferon alfa-2b meta rikostitwit kif irrakkomandat.
English: Therefore, the combination of ViraferonPeg with telbivudine is contraindicated (see section 4.3).
Maltese: Għalhekk, il-kombinazzjoni ta' ViraferonPeg ma' telbivudine hija kontraindikata (ara sezzjoni 4.3).
English: Co-administration of theophylline with the product (ViraferonPeg) may increase the blood concentrations of theophylline.
Maltese: Dawn jinkludu adulti li huma infettati wkoll bl-HIV (Virus tal-Immunodeffiċjenza tal-Bniedem) klinikament stabbli.
English: It is thought that this process, at least in part, is responsible for the various cellular responses to interferon, including inhibition of virus replication in virusinfected cells, suppression of cell proliferation and such immunomodulating activities as enhancement of the phagocytic activity of macrophages and augmentation of the specific cytotoxicity of lymphocytes for target cells.
Maltese: Huwa maħsub illi dan il-proċess, għall-inqas parzjalment, huwa responsabbli għar-risponsi varji fiċ-ċellula għal interferon, inkluż l-impediment tarreplikazzjoni tal-virusis f'ċelluli infettati bil-virus, trażżin tal-proliferazzjoni ta' ċelluli u attivitajiet immunomodulaturi bħalma huma t-titjib tal-attività fagoċitika ta' makrofaġi u żjieda fit-ċitotossiċità speċifika ta' limfoċiti għal ċelluli fil-mira.
English: EU/1/00/132/005 (6 vials of powder, 6 ampoules of solvent) EU/1/00/132/026 (12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs)
Maltese: EU/1/00/132/027 (12-il kunjett ta' trab, 12-il ampulla ta' solvent, 12-il siringa għall-injezzjoni, 24 labra tal-injezzjoni u 12-il imselħa biex tnaddaf)
English: Long-term efficacy data - paediatric population
Maltese: Effikaċja klinika u sigurtà - Adulti