FrancophonIA/ELRC3.0 huggingface dataset:
English: EU/1/07/382/001 14 film-coated tablets EU/1/07/382/002 28 film-coated tablets EU/1/07/382/019 30 film-coated tablets EU/1/07/382/003 56 film-coated tablets EU/1/07/382/004 84 film-coated tablets EU/1/07/382/020 90 film-coated tablets EU/1/07/382/005 98 film-coated tablets EU/1/07/382/006 50 x 1 film-coated tablets
Maltese: EU/1/07/382/001 14-il pillola miksija b'rita EU/1/07/382/002 28 pillola miksija b'rita EU/1/07/382/019 30 pillola miksija b'rita EU/1/07/382/003 56 pillola miksija b'rita EU/1/07/382/004 84 pillola miksija b'rita EU/1/07/382/020 90 pillola miksija b'rita EU/1/07/382/005 98 pillola miksija b'rita EU/1/07/382/006 50 x 1 pillola miksija b'rita
English: The incidence of hypoglycaemia was 25.2 % in patients treated with sitagliptin and insulin (with or without metformin) and 36.8 % in patients treated with placebo and insulin (with or without metformin).
Maltese: 2 % f'pazjenti kkurati b' sitagliptin u l insulina (b'metformin jew mingħajru) u 36.8 % f'pazjenti kkurati bi plaċebo u l-insulina (b'metformin jew mingħajru).
English: EU/1/07/382/007 14 film-coated tablets EU/1/07/382/008 28 film-coated tablets EU/1/07/382/021 30 film-coated tablets EU/1/07/382/009 56 film-coated tablets EU/1/07/382/010 84 film-coated tablets EU/1/07/382/022 90 film-coated tablets EU/1/07/382/011 98 film-coated tablets EU/1/07/382/012 50 x 1 film-coated tablets
Maltese: EU/1/07/382/007 14-il pillola miksija b'rita EU/1/07/382/008 28 pillola miksija b'rita EU/1/07/382/021 30 pillola miksija b'rita EU/1/07/382/009 56 pillola miksija b'rita EU/1/07/382/010 84 pillola miksija b'rita EU/1/07/382/022 90 pillola miksija b'rita EU/1/07/382/011 98 pillola miksija b'rita EU/1/07/382/012 50 x 1 pillola miksija b'rita
English: When blood glucose concentrations are normal or elevated, GLP-1 and GIP increase insulin synthesis and release from pancreatic beta cells by intracellular signaling pathways involving cyclic AMP.
Maltese: Meta l-konċentrazzjonijiet ta' glucose fid-demm ikunu normali jew elevati, GLP-1 and GIP ikattru s-sintesi u r-reħa tal-insulina miċ-ċelluli beta tal-frixa permezz ta'
English: Additional adverse experiences reported regardless of causal relationship to medication that occurred more frequently in patients treated with sitagliptin (not reaching the 5 % level, but occurring with an incidence of > 0.5 % higher with sitagliptin than that in the control group) included osteoarthritis and pain in extremity.
Maltese: Esperjenzi avversi addizjonali rrappurtati mingħajr ma tqies jekk ilkawża tagħhom kinitx il-mediċina, li seħħew b'mod aktar frekwenti f'pazjenti kkurati b'sitagliptin (li ma laħqux il-livell ta' 5 %, iżda li seħħew b'inċidenza ta' > 0.5 % ogħla b'sitagliptin minn dik fil grupp ta' kontroll) kienu jinkludu osteoartrite u uġigħ fid-dirgħajn u fir-riġlejn.
English: Xelevia 100 mg tablets Sitagliptin
Maltese: Pilloli Xelevia 100 mg
English: Compared to normal healthy control subjects, plasma AUC of sitagliptin was increased by approximately 1.2-fold and 1.6-fold in patients with mild renal impairment (GFR ≥ 60 to
Maltese: Meta mqabbla ma' individwi normali f'saħħithom bħala kontroll, l-AUC ta' sitagliptin fil-plażma żdiedet b'madwar 1.2 drabi u 1.6 drabi f'pazjenti b'indeboliment ħafif tal-kliewi (GFR ≥ 60 sa < 90 mL/min) u pazjenti b'indeboliment moderat tal-kliewi (GFR ≥ 45 sa < 60 mL/min), rispettivament.
English: Reproductive toxicity studies showed a slight treatment-related increased incidence of foetal rib malformations (absent, hypoplastic and wavy ribs) in the offspring of rats at systemic exposure levels more than 29 times the human exposure levels.
Maltese: Studji ta' tossiċità fir-riproduzzjoni wrew li kien hemm inċidenza kemxejn ikbar marbuta mal-kura ta' malformazzjonijiet fil-kustilji fil-ġuf (kustilji neqsin, ipoplastiċi jew immewġin) fil-friegħ tal-firien li kienu esposti għal dożi sistemiċi iktar minn 29 darba l-livell uman.
English: When Xelevia is used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin may be considered to reduce the risk of hypoglycaemia (see section 4.4).
Maltese: Għalhekk, biex jitnaqqas ir-riskju ta' ipogliċemija, għandha tiġi kkunsidrata doża aktar baxxa ta' sulphonylurea jew insulina (ara sezzjoni 4.2).
English: Cases of inflammation of the pancreas (pancreatitis) have been reported in patients receiving Xelevia (see section 4).
Maltese: Każijiet ta' infjammazzjoni tal-frixa (pankreatite) ġew irrapportati f'pazjenti li kienu qegħdin jirċievu Xelevia (ara sezzjoni 4).
English: For patients with moderate renal impairment (GFR  30 to < 45 mL/min), the dose of Xelevia is 50 mg once daily.
Maltese: Għal pazjenti b'indeboliment moderat tal-kliewi (GFR ≥ 30 sa < 45 mL/min), id-doża ta' Xelevia hija
English: In addition to the drug-related adverse experiences described above, adverse experiences reported regardless of causal relationship to medication and occurring in at least 5 % and more commonly in patients treated with sitagliptin included upper respiratory tract infection and nasopharyngitis.
Maltese: Barra mill-esperjenzi avversi marbuta mal-mediċina deskritti fuq, esperjenzi avversi li ġew irrappurtati mingħajr ma tqies jekk il-kawża tagħhom kinitx il-mediċina u li seħħew f'mill-inqas 5 % u b'mod aktar komuni f'pazjenti kkurati b'sitagliptin kienu jinkludu infezzjoni fil-parti ta' fuq talapparat tan-nifs u nażofarinġite.
English: If a hypersensitivity reaction is suspected, Xelevia should be discontinued.
Maltese: reazzjoni ta' sensittività eċċessiva, Xelevia għandu jitwaqqaf.
English: Do not take Xelevia - if you are allergic to sitagliptin or any of the other ingredients of this medicine (listed in section 6).
Maltese: Tiħux Xelevia: - jekk inti allerġiku għal sitagliptin jew għal xi sustanza oħra ta' din il-mediċina (imniżżla fis sezzjoni 6).
English: However, when driving or using machines, it should be taken into account that dizziness and somnolence have been reported.
Maltese: Jekk ikun hemm suspett ta' reazzjoni ta' sensittività eċċessiva, Xelevia għandu jitwaqqaf.
English: Treatment with GLP-1 or with DPP-4 inhibitors in animal models of type 2 diabetes has been demonstrated to improve beta cell responsiveness to glucose and stimulate insulin biosynthesis and release.
Maltese: il-kura b'GLP-1 jew b'inibituri DPP-4 uriet titjib fil-livell ta' rispons taċ-ċelluli beta għall-glucose, u stimulat kemm tintreħa u l-bijosintesi tal-insulina.
English: Chimeric yellow fever dengue virus serotype 1* (live, attenuated).............................................4.5 - 6.0 log10 CCID50/dose** Chimeric yellow fever dengue virus serotype 2* (live, attenuated).............................................4.5 - 6.0 log10 CCID50/dose** Chimeric yellow fever dengue virus serotype 3* (live, attenuated).............................................4.5 - 6.0 log10 CCID50/dose** Chimeric yellow fever dengue virus serotype 4* (live, attenuated).............................................4.5 - 6.0 log10 CCID50/dose** * Produced in Vero cells by recombinant DNA technology.
Maltese: Virus tad-deni dengue kimeriku isfar serotip 1 (attenwat ħaj)*……………….4.5-6.0 log10 CCID50/doża** Virus tad-deni dengue kimeriku isfar serotip 2 (attenwat ħaj)*……………….4.5-6.0 log10 CCID50/doża** Virus tad-deni dengue kimeriku isfar serotip 3 (attenwat ħaj)*……………….4.5-6.0 log10 CCID50/doża** Virus tad-deni dengue kimeriku isfar serotip 4 (attenwat ħaj)*……………….4.5-6.0 log10 CCID50/doża** * Prodott f'ċelluli Vero permezz ta' teknoloġija rikombinanti tad-DNA.
English: ** CCID50: 50% Cell Culture Infectious Dose.
Maltese: Dan il-prodott fih organiżmi ġenetikament modifikati (genetically modified organisms, GMOs) ** CCID50: 50 % Doża Infettiva tal-Koltura taċ-Ċelluli.
English: 5 sets of 2 vials (1 with powder + 1 with solvent, 5 doses each)
Maltese: 5 settijiet ta '2 kunjetti (1 bi trab + 1 b'solvent, 5 dożi kull wieħed)
English: --¹ After reconstitution, one dose (0.5 mL) contains:
Maltese: Wara r-rikostituzzjoni, doża waħda (0.5 ml) fiha:
English: 10 vials + 10 pre-filled syringes + 20 needles
Maltese: 10 kunjetti + 10 mimlija għal-lest + 20 labriet separati
English: 1 vial + 1 pre-filled syringe + 2 needles
Maltese: 1 kunjett + 1 siringa mimlija għal-lest + 2 labriet separati
English: 1 vial + 1 pre-filled syringe
Maltese: 1 kunjetti + 1 siringi mimlija għal-lest
English: Pen (CLEARCLICK)
Maltese: Pinna (CLEARCLICK)
English: Overall population*
Maltese: Popolazzjoni globali*
English: Bilirubin - indirect
Maltese: Bilirubin - indirett
English: Bilirubin - direct
Maltese: Bilirubin - dirett
English: This may take up to 20 minutes.
Maltese: Dan jista' jieħu sa 20 minuta.
English: Response at end of treatment 49 % 41 % 33 % 24 % 65 % 56 % 54 % Sustained response
Maltese: Rispons fit-tmiem tal-kura 49% 41% 33% 24% 65% 56% 54%
English: Number of capsules (200 mg)
Maltese: Numru ta' kapsuli (200 mg)
English: Genotype 2, 3**
Maltese: Ġenotip 2, 3**
English: Nucleoside analogues
Maltese: Analogi ta' nucleoside
English: Theophylline, Antipyrine, Warfarin
Maltese: Theophylline, Antipyrine, Warfarina
English: Pharmacotherapeutic group: Immunostimulants, Interferons, ATC code: L03AB10.
Maltese: Immunostimulanti, Interferoni, Kodiċi ATC: L03AB10.
English: Table 15 Sustained virological response rates (n a,b
Maltese: Tabella 15 Rati ta' rispons viroloġiku sostnut (n a,b
English: 9/l (adults) ≥ 50 x 10
Maltese: 9/l (adulti) ≥ 50 x 10
English: Immuno-suppressive therapy
Maltese: Terapija immunosoppressiva
English: By week 12*** (n=915)
Maltese: Sa ġimgħa 12*** (n=915)
English: 2 x baseline and > 10 x ULN
Maltese: 2 x linja bażi u > 10 x ULN
English: Genotype 1/4 59.7 (129/216) 51.2 (66/129)
Maltese: Ġenotip 1/4 59,7 (129/216) 51,2 (66/129)
English: Pharmacologically, ribavirin increases phosphorylated metabolites of purine nucleosides in vitro.
Maltese: Farmakoloġikament, ribavirin iżid il-metaboliti fosforilati ta' purine nucleosides in vitro.
English: HCV-RNA negative
Maltese: HCV-RNA negattiv 508
English: Elderly ( 65 years of age)
Maltese: Anzjani (età  65 sena)
English: Genotype 1* By week 4*** (n=950) HCV-RNA negative 834
Maltese: Ġenotip 1* Sa ġimgħa 4*** (n=950) HCV-RNA negattiv 834
English: ≥ 8.5 g/dl, and < 10 g/dl
Maltese: ≥ 8,5 g/dl, u < 10 g/dl
English: Colitis ulcerative
Maltese: Kolite ulċerattiva
English: Dapsone (N-acetyltransferase substrate)
Maltese: Dapsone (substrat ta' Nacetyltransferase)
English: Ribavirin capsules
Maltese: Kapsuli ta' ribavirin
English: There are no apparent age-related effects on the pharmacokinetics of ViraferonPeg.
Maltese: M'hemm l-ebda effetti evidenti relatati mal-età fuq il-farmakokinetika ta' ViraferonPeg.
English: Combination therapy with ribavirin
Maltese: Terapija kombinata ma' ribavirin
English: Genotype 2/3 88.9 (72/81)
Maltese: Ġenotip 2/3 88,9 (72/81)
English: Genotype 1/4 23.0 (182/790) 51.6 (94/182)
Maltese: Ġenotip 1/4 23,0 (182/790) 51,6 (94/182)
English: Tolbutamide (CYP2C9 substrate)
Maltese: Tolbutamide (substrat ta' CYP2C9)
English: Midazolam (CYP3A4 substrate)
Maltese: Midazolam (substrat ta' CYP3A4)
English: In this subgroup, there was a 92 % (89/97) sustained virological response rate.
Maltese: F'dan is-sottogrupp, kien hemm rata ta' rispons viroloġiku sostnut ta' 92 % (89/97).
English: Discontinue ribavirin if CrCL < 50ml/min
Maltese: Waqqaf ribavirin jekk is-CrCL < 50ml/min
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: Genotype 2/3 67.9 (74/109) 70.3 (52/74)
Maltese: Ġenotip 2/3 67,9 (74/109) 70,3 (52/74)
English: Caffeine (CYP1A2 substrate)
Maltese: Kaffeina (substrat ta' CYP1A2)
English: Sustained Virologic Response
Maltese: Rispons Viroloġiku Sostnut
English: Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme
Maltese: Sindrome ta' Stevens Johnson, nekrolisi tossika tal-epidermide, eritema multiforme
English: • Genotype 4:
Maltese: • Ġenotip 4:
English: Table 8 Sustained virological response (% patients HCV negative) ViraferonPeg monotherapy ViraferonPeg + ribavirin
Maltese: Tabella 8 Rispons viroloġiku sostnut (% ta' pazjenti negattivi għal HCV) Monoterapija b'ViraferonPeg ViraferonPeg + ribavirin
English: Response week 12 % (n/N)
Maltese: Ġimgħa ta' rispons 12 % (n/N)
English: Refer to the SmPC for boceprevir.
Maltese: Irreferi għall-SmPC ta' boceprevir.
English: Reduce only ViraferonPeg dose (see note 2) if:
Maltese: Naqqas biss id-doża ta' ViraferonPeg (ara nota 2) jekk:
English: ViraferonPeg contains sucrose
Maltese: ViraferonPeg fih sucrose
English: • Genotype 1:
Maltese: • Ġenotip 1:
English: This medicine contains sucrose.
Maltese: Din il-mediċina fiha sucrose.
English: Psychiatric and central nervous system:
Maltese: Sistema psikjatrika u sistema nervuża ċentrali:
English: - Combination of ViraferonPeg with telbivudine.
Maltese: - Kombinazzjoni ta' ViraferonPeg ma' telbivudine.
English: Dextromethorphan hydrobromide (CYP2D6 and CYP3A substrate)
Maltese: Dextromethorphan hydrobromide (substrat ta' CYP2D6
English: The potential interaction of peginterferon alfa-2b (ViraferonPeg) on substrates of metabolic enzymes was evaluated in 3 multiple-dose clinical pharmacology studies.
Maltese: L-interazzjoni potenzjali ta' peginterferon alfa-2b (ViraferonPeg) fuq substrati ta' enzimi metaboliċi ġiet ivvalutata fi studji farmakoloġiċi kliniċi bi 3 dożi multipli.
English: Doses up to 10.5 times the intended dose have been reported.
Maltese: Kienu rrappurtati dożi sa 10,5 darbiet id-doża intenzjonata.
English: Ribavirin dose (mg/kg)
Maltese: Doża ta' Rebetol (mg/kg)
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 ViraferonPeg and subjects ≥ 75 kg received 150 µg/week ViraferonPeg.
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 ViraferonPeg u individwi ≥ 75 kg irċevew 150 µg/ġimgħa ViraferonPeg.
English: Upon multiple dosing, there is an accumulation of immunoreactive interferons.
Maltese: Meta jingħataw ħafna dożi, ikun hemm akkumulazzjoni ta' interferons immunoreattivi.
English: Recombinant interferon alfa-2b also inhibits viral replication in vitro and in vivo.
Maltese: Interferon alfa-2b rikombinanti jimpedixxi wkoll replikazzjoni tal-virus in vitro u in vivo.
English: 9/l (children and adolescents)
Maltese: 9/l (tfal u adolexxenti)
English: Cardiac ischaemia
Maltese: Iskemija kardijaka
English: The active substance is a covalent conjugate of recombinant interferon alfa-2b* with monomethoxy polyethylene glycol.
Maltese: Is-sustanza attiva hija konjugat kovalenti ta' interferon alfa-2b* rikombinanti ma' monomethoxy polyethylene glycol.
English: Dose of peginterferon alfa-2b
Maltese: Doża ta' peginterferon alfa-2b
English: All Genotype 1,
Maltese: Kollha Ġenotip 1,
English: The negative predictive value for sustained response in HCV/HIV co-infected patients treated with ViraferonPeg 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'ViraferonPeg flimkien ma' ribavirin kien 99% (67/68; Studju 1) (ara sezzjoni 5.1).
English: - The active substance is peginterferon alfa-2b.
Maltese: - Is-sustanza attiva hija peginterferon alfa-2b.
English: Alopecia, pruritus
Maltese: Alopeċja, ġilda xotta
English: Limited safety data (N= 25) are available in co-infected patients with CD4+ cell counts < 200/µl (see section 4.4).
Maltese: Hemm dejta limitata disponibbli dwar is-sigurtà (N=25) f'pazjenti li jkollhom infezzjoni fl-istess ħin b'għadd ta' ċelluli CD4+ < 200/µl (ara sezzjoni 4.4).
English: • TSH level must be within normal limits
Maltese: għandu jkun fil-limiti normali
English: - a pre-filled pen (CLEARCLICK) - a needle ("Push-On Needle") - 2 alcohol swabs
Maltese: - pinna mimlija għal-lest (CLEARCLICK) - labra ("Labra Push-On") - 2 imsielaħ tal-alkoħol
English: 9/l, and < 0.75 x 10
Maltese: 9/l, u < 0,75 x 10
English: Serum Creatinine
Maltese: Krejatinina fis-Serum
English: A clinically significant pharmacokinetic interaction was not observed between peginterferon alfa-2b (ViraferonPeg) and tolbutamide, midazolam or dapsone; therefore, no dosing adjustment is necessary when peginterferon alfa-2b (ViraferonPeg) is administered with medicines metabolized by CYP2C9, CYP3A4 and N-acetyltransferase.
Maltese: Ma kinitx osservata interazzjoni farmakokinetika klinikament sinifikanti bejn peginterferon alfa-2b (ViraferonPeg) u tolbutamide, midazolam jew dapsone; u għalhekk, ma huwa meħtieġ ebda aġġustament fid-doża meta peginterferon alfa-2b (ViraferonPeg) jingħata ma' mediċini li jiġu metabolizzati permezz ta' CYP2C9, CYP3A4 u N-acetyltransferase.
English: Myalgia, arthralgia, musculoskeletal pain
Maltese: Mijalġja, artralġja, uġigħ muskoluskeletriku
English: - are infected with both Human Immunodeficiency Virus (HIV-positive) and Hepatitis C Virus (HCV) and are being treated with an anti-HIV medicine(s) - [nucleoside reverse transcriptase inhibitor (NRTI), and/or highly active anti-retroviral therapy (HAART)].
Maltese: Virus) u qed tingħataw kura b'mediċina(i) kontra l-HIV - [inibitur ta' nucleoside reverse transcriptase (NRTI - nucleoside reverse transcriptase inhibitor), u/jew terapija attiva ħafna kontra r-retrovirus (HAART - highly active anti-retroviral therapy)].
English: Acute hypersensitivity reactions (e.g., urticaria, angioedema, bronchoconstriction, anaphylaxis) have been observed rarely during interferon alfa-2b therapy.
Maltese: Reazzjonijiet ta' sensittività eċċessiva akuta (eż. urtikarja, anġjoedima, bronkokostrizzjoni, anafilassi) ġew osservati b'mod rari waqt it-terapija b'interferon alfa-2b.
English: Sustained response
Maltese: Rispons sostnut
English: ViraferonPeg - ampoule of solvent
Maltese: ViraferonPeg - ampulla tas-solvent
English: The average molecular mass is approximately 31,300 daltons of which the protein moiety constitutes approximately 19,300.
Maltese: Il-massa molekulari medja hija madwar 31.300 daltons li madwar 19.300 minnhom huma magħmula minn proteina.
English: A total of 107 patients received treatment of whom 52 % were female, 89 % Caucasian, 67 % with HCV Genotype 1 and 63 % < 12 years of age.
Maltese: Total ta' 107 pazjent irċivew kura li minnhom 52 % kienu nisa, 89 % Kawkasi, 67 % b'HCV Ġenotip 1 u 63 % kellhom < 12-il sena.
English: The Kaplan-Meier estimate for continued sustained response over 5 years for all patients is 99 % (95 % CI: 98-100 %).
Maltese: L-istima Kaplan-Meier għal rispons viroloġiku sostnut fuq medda ta' 5 snin għall-pazjenti kollha hija ta' 99 % (95 % CI: 98-100 %).
English: Excipients: disodium phosphate, anhydrous; sodium dihydrogen phosphate dihydrate, sucrose and polysorbate 80.
Maltese: Eċċipjenti: disodium phosphate, anhydrous; sodium dihydrogen phosphate dihydrate, sucrose u polysorbate 80.
English: 9/l, and < 1.5 x 10
Maltese: 9/l, u < 1,5 x 10
English: Anaemia (hemoglobin < 9.4 g/dl) was reported in 12 % (23/194) of patients treated with ViraferonPeg in combination with ribavirin.
Maltese: Anemija (emoglobina < 9,4g/dl) kienet irrappurtata fi 12% (23/194) tal-pazjenti kkurati b'ViraferonPeg flimkien ma' ribavirin.
English: Mitochondrial toxicity and lactic acidosis
Maltese: Tossiċità mitokondrijali u aċidożi lattika
English: Powder: disodium phosphate, anhydrous; sodium dihydrogen phosphate dihydrate; sucrose and polysorbate 80.
Maltese: Trab: disodium phosphate, anhydrous; sodium dihydrogen phosphate dihydrate; sucrose u polysorbate 80.
English: Cerebrovascular haemorrhage, cerebrovascular ischaemia, encephalopathy
Maltese: Emorraġija ċerebrovaskulari, iskemija ċerebrovaskulari, enċefalopatija
English: if:
Maltese: a:
English: ViraferonPeg monotherapy - Adults
Maltese: Monoterapija b'ViraferonPeg - Adulti
English: Upper limit of normal
Maltese: Limitu ta' fuq tan-normal
English: HCV Genotype
Maltese: Ġenotip ta' HCV
English: P 1.5/R ViraferonPeg (1.5 micrograms/kg) + ribavirin (800 mg) P 0.5/R ViraferonPeg (1.5 to 0.5 microgram/kg) + ribavirin (1,000/1,200 mg) I/R
Maltese: P 1.5/R ViraferonPeg (1,5 mikrogrammi/kg) + ribavirin (800 mg) P 0.5/R ViraferonPeg (1,5 sa 0.5 mikrogramma/kg) + ribavirin (1.000/1.200 mg) I/R
English: The potential risk in humans is unknown.
Maltese: Mhux magħruf ir-riskju potenzjali fuq in-nies.
English: Myalgia, arthralgia
Maltese: Mijalġja, artralġja
English: In the treatment phase of this study, the most prevalent adverse reactions in all subjects were pyrexia (80 %), headache (62 %), neutropenia (33 %), fatigue (30 %), anorexia (29 %) and injection-site erythema (29 %).
Maltese: Fil-fażi ta' kura ta' dan l-istudju, l-aktar reazzjonijiet avversi komuni fl-individwi kollha kienu deni (80%), uġigħ ta' ras (62%), newtropenija (33%), għeja (30%), anoressija (29%) u eritema fis-sit talinjezzjoni (29%).
English: HCV-RNA should be measured periodically during treatment (see section 4.2).
Maltese: HCV-RNA għandu jitkejjel perjodikament waqt ilkura (ara sezzjoni 4.2).
English: Metabolic disturbances
Maltese: Disturbi bipolari
English: Congestive heart failure, cardiomyopathy, arrhythmia, pericarditis
Maltese: Insuffiċjenza konġestiva tal-qalb, kardjomijopatija, arritmija, perikardite
English: This activity could potentiate the risk of lactic acidosis induced by purine nucleoside analogs (e.g. didanosine or abacavir).
Maltese: Din lattività tista' żżid ir-riskju ta' aċidożi lattika kkaġunata minn analogi ta' purine nucleosides (eż. didanosine jew abacavir).
English: Contusion class effect of interferon-alfa containing products - reported with standard interferon therapy in adult and paediatric patients; with ViraferonPeg 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'ViraferonPeg irrappurtat f'pazjenti adulti.
English: For HCV/HIV co-infected patients receiving ViraferonPeg 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 ViraferonPeg 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: The overall sustained response rate after a 24-week treatment duration was 50 %.
Maltese: Ir-rata globali ta' rispons sostnut wara 24 ġimgħa ta' kura kienet 50 %.
English: 6 vials of powder, 6 ampoules of solvent
Maltese: 6 kunjetti ta' trab, 6 ampulli ta' solvent
English: A positive predictive value of 50 % (52/104; Study 1) was observed for HCV/HIV co-infected patients receiving bitherapy.
Maltese: Valur ta' tbassir pożittiv ta' 50% (52/104; Studju 1) ġie osservat għal pazjenti infettati fl-istess ħin b'HCV/HIV li kienu qed jirċievu terapija b'żewġ mediċini.
English: Mean apparent volume of distribution is 0.99 l/kg.
Maltese: Il-volum tad-distribuzzjoni apparenti medju huwa ta' 0,99 l/kg.
English: Haemolytic anaemia, leukopenia, thrombocytopenia, lymphadenopathy
Maltese: Anemija emolitika, lewkopenija, tromboċitopenija, limfadenopatija
English: Anorexia, decreased appetite
Maltese: Anoressija, nuqqas ta' aptit
English: MIU = million international units; TIW = three times a week.
Maltese: MIU =miljun unità internazzjonali;
English: Carton 120 micrograms
Maltese: Kartuna 120 mikrogramma