FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 8 Sustained virological response (% patients HCV negative) PegIntron monotherapy
Maltese: Tabella 8 Rispons viroloġiku sostnut (% ta' pazjenti negattivi għal HCV) Monoterapija b'PegIntron
English: All subjects HCV 2  600,000 IU/ml > 600,000 IU/ml HCV 3  600,000 IU/ml > 600,000 IU/ml
Maltese: L-individwi kollha HCV 2  600.000 IU/ml > 600.000 IU/ml HCV 3  600.000 IU/ml > 600.000 IU/ml
English: - Combination of PegIntron with telbivudine.
Maltese: - Kombinazzjoni ta' PegIntron ma' telbivudine.
English: Reduce only PegIntron dose (see note 2) if:
Maltese: Naqqas biss id-doża ta' PegIntron (ara nota 2) jekk:
English: Date of first authorisation: 25 May 2000 Date of latest renewal: 25 May 2010
Maltese: Data tal-aħħar tiġdid: 25 ta' Mejju 2010
English: The potential interaction of peginterferon alfa-2b (PegIntron) on substrates of metabolic enzymes was evaluated in 3 multiple-dose clinical pharmacology studies.
Maltese: L-interazzjoni potenzjali ta' peginterferon alfa-2b (PegIntron) fuq substrati ta' enzimi metaboliċi ġiet ivvalutata fi studji farmakoloġiċi kliniċi bi 3 dożi multipli.
English: PegIntron monotherapy - Adults
Maltese: Monoterapija b'PegIntron - Adulti
English: a: p value based on Cochran-Mantel Haenszel Chi square test. b: p value based on chi-square test. c: subjects < 75 kg received 100 µg/week PegIntron and subjects ≥ 75 kg received 150 µg/week PegIntron.
Maltese: a: valur p ibbażat fuq it-test Cochran-Mantel Haenszel Chi square. b: valur p ibbażat fuq it-test chi-square. ċ: individwi < 75 kg irċevew 100 µg/ġimgħa PegIntron u individwi ≥ 75 kg irċevew 150 µg/ġimgħa PegIntron.
English: PegIntron contains sucrose
Maltese: PegIntron fih sucrose
English: PegIntron - ampoule of solvent
Maltese: PegIntron - ampulla tas-solvent
English: P 1.5/R PegIntron (1.5 micrograms/kg) + ribavirin (800 mg) P 0.5/R PegIntron (1.5 to 0.5 microgram/kg) + ribavirin (1,000/1,200 mg) I/R
Maltese: P 1,5/R PegIntron (1,5 mikrogrammi/kg) + ribavirin (800 mg) P 0,5/R PegIntron (1,5 to 0,5 mikrogramma/kg) + ribavirin (1.000/1.200 mg) I/R
English: Genotype 1  600,000 IU/ml
Maltese: Ġenotip 1  600.000 IU/ml
English: The negative predictive value for sustained response in HCV/HIV co-infected patients treated with PegIntron in combination with ribavirin was 99 % (67/68; Study 1) (see section 5.1).
Maltese: Il-valur ta' tbassir negattiv għal rispons sostnut f'pazjenti infettati fl-istess ħin b'HCV/HIV ikkurati b'PegIntron flimkien ma' ribavirin kien 99% (67/68; Studju 1) (ara sezzjoni 5.1).
English: (8/194) of patients and decrease in platelets below 50,000/mm
Maltese: (8/194) tal-pazjenti u tnaqqis fl-għadd tal-plejtlits taħt 50,000/mm
English: A clinically significant pharmacokinetic interaction was not observed between peginterferon alfa-2b (PegIntron) and tolbutamide, midazolam or dapsone; therefore, no dosing adjustment is necessary when peginterferon alfa-2b (PegIntron) is administered with medicines metabolized by CYP2C9, CYP3A4 and N-acetyltransferase.
Maltese: Ma kinitx osservata interazzjoni farmakokinetika klinikament sinifikanti bejn peginterferon alfa-2b (PegIntron) u tolbutamide, midazolam jew dapsone; għalhekk, ma huwa meħtieġ ebda aġġustament fid-doża meta peginterferon alfa-2b (PegIntron) jingħata ma' mediċini li jiġu metabolizzati permezz ta' CYP2C9, CYP3A4 u N-acetyltransferase.
English: - Remove the protective cap from the PegIntron vial.
Maltese: - Neħħi l-għatu protettiv mill-kunjett ta' PegIntron.
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: Table 3a Dose modification guidelines for PegIntron monotherapy in adults based on laboratory parameters
Maltese: Tabella 3a Linji gwida għall-modifikazzjoni tad-doża għal monoterapija b'PegIntron fl-adulti ibbażati fuq parametri tal-laboratorju
English: Genotype 1 > 600,000 IU/ml
Maltese: Ġenotip 1 > 600.000 IU/ml
English: For HCV/HIV co-infected patients receiving PegIntron in combination with ribavirin, other undesirable effects (that were not reported in mono-infected patients) which have been reported in the larger studies with a frequency > 5 % were: oral candidiasis (14 %), lipodystrophy acquired (13 %), CD4 lymphocytes decreased (8 %), appetite decreased (8 %), gamma-glutamyltransferase increased (9 %), back pain (5 %), blood amylase increased (6 %), blood lactic acid increased (5 %), cytolytic hepatitis (6 %), lipase increased (6 %) and pain in limb (6 %).
Maltese: Għal pazjenti infettati fl-istess ħin b'HCV/HIV li qed jirċievu PegIntron flimkien ma' ribavirin, effetti mhux mixtieqa oħra (li ma kinux irrappurtati f'pazjenti b'infezzjoni waħda) li kienu rrappurtati fl-istudji akbar bi frekwenza ta' > 5% kienu: kandidajasi orali (14%), lipodistrofija akkwistata (13%), tnaqqis fillimfoċiti CD4 (8%), tnaqqis fl-aptit (8%), żieda tal-gamma-glutamyltransferase (9%), uġigħ fid-dahar (5%), żieda tal-amylase fid-demm (6%), żieda tal-lactic acid fid-demm (5%), epatite ċitolitika (6%), żieda tal-lipase (6%) u wġigħ fir-riġel/driegħ (6%).
English: Contusion class effect of interferon-alfa containing products - reported with standard interferon therapy in adult and paediatric patients; with PegIntron reported in adult patients.
Maltese: Tbenġila effett tal-klassi tal-prodotti li fihom interferon-alfa - irrappurtat b'terapija ta' interferon standard f'pazjenti adulti u pedjatriċi; b'PegIntron irrappurtat f'pazjenti adulti.
English: PegIntron is a well characterized polyethylene glycol-modified (“pegylated”) derivative of interferon alfa-2b and is predominantly composed of monopegylated species.
Maltese: PegIntron huwa derivattiv modifikat ta' polyethylene glycol (“pegilat”) ikkaratterizzat tajjeb ta' interferon alfa-2b u huwa magħmul prinċipalment minn speċi monopegylated.
English: There were some cases of more severe neutropenia in patients treated with the recommended doses of PegIntron 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' PegIntron flimkien ma' ribavirin (Gradi ta' WHO 3 : 39 minn 186 [21 %]; u gradi ta' WHO 4: 13 minn 186 [7 %]).
English: Table 9 Sustained response rates with PegIntron + ribavirin (by ribavirin dose, genotype and viral load)
Maltese: Tabella 9 Rati ta' rispons sostnut b'PegIntron + ribavirin (skont id-doża ta' ribavirin, ilġenotip u l-ammont virali)
English: PegIntron (1.5 µg/kg/ week) + ribavirin (800 mg)
Maltese: PegIntron (1,5 µg/kg/ ġimgħa) + ribavirin (800 mg)
English: PegIntron 0.5 microgram/kg
Maltese: PegIntron 0,5 mikrogramma/kg
English: PegIntron 1.0 microgram/kg
Maltese: PegIntron 1,0 mikrogramma/kg
English: Only 5 children and adolescents with Genotype 4 were treated in the PegIntron/ribavirin clinical trial.
Maltese: 5 itfal u adolexxenti biss b'Ġenotip 4 kienu kkurati fil-prova klinika b'PegIntron/ribavirin.
English: PegIntron strength (g/0.5 ml)
Maltese: Qawwa ta' PegIntron (g/0,5 ml)
English: Discontinue PegIntron if:
Maltese: Waqqaf PegIntron jekk:
English: Tritherapy (PegIntron with ribavirin and boceprevir): applies to adult patients with genotype 1 CHC.
Maltese: Terapija bi tliet mediċini (PegIntron ma' ribavirin u boceprevir): tapplika għall-pazjenti adulti b'CHC ta' ġenotip 1.
English: Two pivotal trials have been conducted, one (C/I97-010) with PegIntron monotherapy; the other (C/I98-580) with PegIntron in combination with ribavirin.
Maltese: Saru żewġ provi pivitali, wieħed (C/I97-010) b'monoterapija b'Pegintron; l-ieħor (C/I98-580) b'PegIntron flimkien ma' ribavirin.
English: At the PegIntron 1.5 µg/kg plus ribavirin dose, sustained virologic response rates were lower in patients with cirrhosis, in patients with normal ALT levels, in patients with a baseline viral load > 600,000 IU/ml, and in patients > 40 years old.
Maltese: Bid-doża ta' PegIntron 1,5 µg/kg flimkien ma' ribavirin, irrati ta' rispons viroloġiku sostnut kienu aktar baxxi f'pazjenti b'ċirrożi, f'pazjenti b'livelli normali ta' ALT, f'pazjenti b'ammont virali ta' > 600.000 IU/ml fil-linja bażi, u f'pazjenti b'età > 40 sena.
English: In children and adolescent patients receiving body surface area-adjusted dosing of PegIntron 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' PegIntron 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: Additional 5 seconds ensures complete dose delivery.
Maltese: 5 darbiet id-doża intenzjonata.
English: Table 12 Predictive value of in-treatment Virologic Response while on PegIntron 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'PegIntron 1,5 µg/kg/ribavirin 800-1.400 mg Negattiv
English: This activity could potentiate the risk of lactic acidosis induced by purine nucleoside analogs (e.g. didanosine or abacavir).
Maltese: Din l-attività tista' żżid ir-riskju ta' aċidożi lattika kkaġunata minn analogi ta' purine nucleosides (eż. didanosine jew abacavir).
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 mal-Afrikani Amerikani.
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: Metabolism of theophylline is suppressed by inhibitory action of the product (PegIntron) on CYP1A2.
Maltese: Il-metaboliżmu ta' theophylline jitrażżan permezz tal-azzjoni inibitorja tal-prodott (PegIntron) fuq CYP1A2.
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, l-AUC, u l-half-life żdiedu b'mod proporzjonali mal-grad ta' indeboliment tal-kliewi.
English: PegIntron 1.5 micrograms/kg/week in combination with ribavirin capsules.
Maltese: PegIntron 1,5 mikrogrammi/kg/ġimgħa flimkien ma' kapsuli ta' ribavirin.
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: Anaemia (hemoglobin < 9.4 g/dl) was reported in 12 % (23/194) of patients treated with PegIntron in combination with ribavirin.
Maltese: 4g/dl) kienet irrappurtata fi 12% (23/194) tal-pazjenti kkurati b'PegIntron flimkien ma' ribavirin.
English: In these studies, the effects of multiple-dose regimens of peginterferon alfa-2b (PegIntron) 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 (PegIntron) 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: 2 injection needles and 1 cleansing swab; - 4 vials of powder for solution for injection and 4 ampoules of solvent for injection; - 4 vials of powder for solution for injection, 4 ampoules of solvent for injection, 4 injection syringes, 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: 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-injezzjoni; - 4 kunjetti ta' trab għal soluzzjoni għall-injezzjoni, 4 ampulli ta' solvent għall-injezzjoni, 4 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-injezzjoni; - 12-il kunjett ta' trab għal soluzzjoni għall-injezzjoni, 12-il ampulla ta' solvent għall-injezzjoni,
English: When patients are administered PegIntron 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 lpazjenti jingħataw PegIntron 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: 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 PegIntron 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' PegIntron ma' ribavirin għandu jiġi kkunsidrat b'attenzjoni f'din il-popolazzjoni (ara sezzjonijiet 4.1, 4.4 u 4.8).
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 PegIntron 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' PegIntron 60 μg/m2 darba fil-ġimgħa għal 24 jew 48 ġimgħa, skont il-ġenotip tal-HCV u lammont virali fil-linja bażi.
English: No pharmacokinetic interactions were noted between PegIntron and ribavirin in a multiple-dose pharmacokinetic study.
Maltese: Ma ġewx osservati interazzjonijiet farmakokinetiċi bejn PegIntron u ribavirin fi studju farmakokinetiku fejn ingħataw ħafna dożi.
English: The relative non-toxicity of monomethoxy-polyethylene glycol (mPEG), which is liberated from PegIntron 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 PegIntron 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-embrijufetu u assaġġi in vitro dwar il-mutaġeniċità.
English: Concomitant administration of peginterferon alfa-2b (PegIntron) with caffeine or desipramine modestly increased the exposure of caffeine and desipramine.
Maltese: L-għoti flimkien ta' peginterferon alfa-2b (PegIntron) mal-kaffeina jew ma' desipramine żied bi ftit l-espożizzjoni tal-kaffeina u ta' desipramine.
English: PegIntron pharmacodynamics were assessed in a rising single-dose trial in healthy subjects by examining changes in oral temperature, concentrations of effector proteins such as serum neopterin and 2'5'oligoadenylate synthetase (2'5'-OAS), as well as white cell and neutrophil counts.
Maltese: Il-farmakodinamika ta' PegIntron kienet evalwata fi prova ta' doża waħda li tiżdied f'individwi b'saħħithom billi ġew eżaminati bidliet fit-temperatura orali, konċentrazzjonijiet ta' proteini effector bħalma huma neopterin tas-serum u 2'5'-oligoadenylate synthetase (2'5'-OAS), kif ukoll l-għadd ta' ċelluli bojod u tan-newtrofili.
English: The dose of PegIntron for monotherapy should be reduced in patients with moderate or severe renal impairment (see sections 4.2 and 4.4).
Maltese: Id-doża ta' PegIntron għal monoterapija għandha titnaqqas f'pazjenti b'indeboliment renali moderat jew sever (ara sezzjonijiet 4.2 u 4.4).
English: In patients with moderate renal dysfunction (creatinine clearance 30-50 ml/minute), the starting dose of PegIntron 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' PegIntron għandha titnaqqas b'25%.
English: Table 3b Reduced PegIntron dose (0.25 g/kg) for the 0.5 g/kg monotherapy regimen in adults Body weight (kg)
Maltese: Tabella 3b Doża mnaqqsa ta' PegIntron (0,25 g/kg) għall-iskeda ta' monoterapija ta' 0,5 g/kg fl-adulti Piż tal-ġisem (kg)
English: Table 6 Adverse reactions reported in adults in clinical trials or through post-marketing surveillance in patients treated with peginterferon alfa-2b, including PegIntron monotherapy or PegIntron + 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'PegIntron jew PegIntron + ribavirin Infezzjonijiet u infestazzjonijiet
English: Tongue pigmentation
Maltese: Popolazzjoni pedjatrika
English: - hepatitis B reactivation in HCV/HBV co-infected patients (recurrence of hepatitis B disease).
Maltese: - riattivazzjoni tal-epatite B f'pazjenti infettati fl-istess ħin b'HCV/HBV (rikorrenza tal-marda epatite B).
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 PegIntron 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' PegIntron minn taħt il-ġilda għal 4 ġimgħat żiedet l-AUC ta' R-methadone b'madwar 15% (95% Cl għall-istima talproporzjon tal-AUC 103 - 128%).
English: - are being treated with telbivudine (see section “Other medicines and PegIntron”).
Maltese: - jekk qed tingħataw kura b'telbivudine (ara sezzjoni “Mediċini oħra u PegIntron”).
English: PegIntron Cmax and AUC measurements increase in a dose-related manner.
Maltese: Cmax u l-AUC ta' PegIntron jiżdiedu b'mod relatat mad-doża.
English: Use in adults - PegIntron alone
Maltese: Użu fl-adulti - PegIntron waħdu
English: The following treatment-related adverse reactions were reported in adults in clinical trials or through post-marketing surveillance in patients treated with peginterferon alfa-2b, including PegIntron monotherapy or PegIntron/ribavirin.
Maltese: Ir-reazzjonijiet avversi li ġejjin relatati mal-kura kienu rrappurtati fl-adulti fi provi kliniċi jew waqt issorveljanza ta' wara t-tqegħid fis-suq f'pazjenti kkurati b'peginterferon alfa-2b, inkluża monoterapija b'PegIntron jew PegIntron/ribavirin.
English: 3 was observed in 4 % (8/194) of patients receiving PegIntron in combination with ribavirin.
Maltese: 3 ġie osservat f'4% (8/194) talpazjenti li kienu qed jirċievu PegIntron flimkien ma' ribavirin.
English: During combination therapy for up to 48 weeks with PegIntron and ribavirin, growth inhibition was observed that resulted in reduced height in some patients (see section 4.4).
Maltese: Waqt terapija kombinata għal sa 48 ġimgħa b'PegIntron u ribavirin, ġiet osservata inibizzjoni tat-tkabbir li f'xi pazjenti wasslet għal tnaqqis fit-tul (ara sezzjoni 4.4).
English: Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme
Maltese: Sindrome ta' Stevens Johnson, nekrolisi tossika tal-epidermide, eritema multiforme Disturbi muskolu-skeletriċi u tat-tessuti konnettivi Komuni ħafna:
English: Approximately 21 % of children treated with PegIntron/ribavirin combination therapy developed increase in thyroid stimulating hormone (TSH).
Maltese: Madwar 21% tat-tfal ikkurati b'terapija kombinata b'PegIntron/ribavirin żviluppaw żieda fl-ormon li jistimula t-tirojde (TSH - thyroid stimulating hormone).
English: Following multiple dosing of PegIntron (1.0 microgram/kg subcutaneously administered every week for four weeks) the clearance of PegIntron is reduced by a mean of 17 % in patients with moderate renal impairment (creatinine clearance 30-49 ml/minute) and by a mean of 44 % in patients with severe renal impairment (creatinine clearance 15-29 ml/minute) compared to subjects with normal renal function.
Maltese: Wara li jingħataw ħafna dożi ta' PegIntron (1,0 mikrogramma/kg minn taħt il-ġilda kull ġimgħa għal erba' ġimgħat) it-tneħħija ta' PegIntron titnaqqas b'medja ta' 17% f'pazjenti b'indeboliment renali moderat (tneħħija tal-krejatinina ta' 30-49 ml/minuta) u b'medja ta' 44% f'pazjenti b'indeboliment renali sever (tneħħija tal-krejatinina ta' 15-29 ml/minuta) mqabbla ma' individwi b'funzjoni renali normali.
English: These adverse reactions were common (≥1/100 to < 1/10) in clinical trials in patients treated with PegIntron monotherapy.
Maltese: Dawn ir-reazzjonijiet avversi kienu komuni (≥1/100 sa < 1/10) fi provi kliniċi f'pazjenti kkurati b'monoterapija b'PegIntron.
English: In a clinical trial, approximately 1.2 % of patients treated with PegIntron 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'PegIntron jew interferon alfa-2b flimkien ma' ribavirin irrappurtaw avvenimenti psikjatriċi li kienu ta' periklu għall-ħajja waqt il-kura.
English: Multiple-dose pharmacokinetic properties for PegIntron and ribavirin (capsules and oral solution) in children and adolescent patients with chronic hepatitis C have been evaluated during a clinical study.
Maltese: Il-karatteristiċi tal-farmakokinetika ta' dożi multipli ta' PegIntron u ribavirin (kapsuli u soluzzjoni orali) f'pazjenti tfal u adolexxenti b'epatite Ċ kronika kienu evalwati waqt studju kliniku.
English: How to store PegIntron
Maltese: Tużax PegIntron
English: Metabolism of thioridazine is suppressed by inhibitory action of the product (PegIntron) on CYP2D6.
Maltese: Il-metaboliżmu ta' thioridazine jitrażżan permezz tal-azzjoni inibitorja tal-prodott (PegIntron) fuq CYP2D6.
English: Table 13 Sustained virological response based on genotype after PegIntron in combination with Ribavirin in HCV/HIV Co-infected patients Study 1
Maltese: Tabella 13 Rispons viroloġiku sostnut ibbażat fuq il-ġenotip wara PegIntron f'kombinazzjoni ma' Ribavirin f'pazjenti infettati fl-istess ħin b'HCV/HIV Studju 1