FrancophonIA/ELRC3.0 huggingface dataset:
English: High tumour burden is defined as having at least one of the following: bulky tumour mass (> 7 cm), involvement of three or more nodal sites (each > 3 cm), systemic symptoms (weight loss > 10 %, pyrexia > 38°C for more than 8 days, or nocturnal sweats), splenomegaly beyond the umbilicus, major organ obstruction or compression syndrome, orbital or epidural involvement, serous effusion, or leukaemia.
Maltese: Kura ta' limfoma follikulari b'ammont għoli ta' tumur bħala kura aġġuntiva ma' kimoterapija ta' induzzjoni kombinata xierqa bħal kors li jixbah lil CHOP. Ammont għoli ta' tumur huwa definit bħala li jkollu mill-inqas wieħed minn dawn li ġejjin: massa kbira ta' tumur (> 7 ċm), l-involviment ta' tliet siti nodali jew aktar (kull wieħed ta' > 3 ċm), sintomi sistematiċi (telf ta' piż > 10 %, deni ta' > 38°C għal aktar minn 8 ijiem, jew għaraq matul il-lejl), splenomegalija lil hemm miż-żokra, imblukkar ta' organu maġġuri jew sindrome ta' kompressjoni, involviment orbitali jew epidurali, effużjoni seruża, jew lewkimja.
English: Severe CNS effects, particularly depression, suicidal ideation and attempted suicide have been observed in some patients during IntronA therapy, and even after treatment discontinuation mainly during the 6-month follow-up period.
Maltese: Sistema psikjatrika u sistema nervuża ċentrali (CNS) Effetti severi tas-CNS, l-aktar dipressjoni, ħsibijiet ta' suwiċidju u attentat ta' suwiċidju ġew osservati f'xi pazjenti waqt terapija b'IntronA, u anki wara li twaqqfet il-kura, l-iktar waqt il-perjodu ta' followup ta' 6 xhur.
English: HAART therapy (see ribavirin SPC).
Maltese: Tkabbir u żvilupp (epatite Ċ kronika)
English: Thyroid supplemental monitoring specific for children and adolescents Approximately 12 % of children treated with interferon alfa-2b and ribavirin combination therapy developed increase in thyroid stimulating hormone (TSH).
Maltese: Monitoraġġ supplimentari tat-tirojde speċifiku għal tfal u adolexxenti Madwar 12 % tat-tfal ikkurati b'terapija kombinata b'interferon alfa-2b u ribavirin żviluppaw żieda fitormon li jistimula t-tirojde (TSH). 4 % oħra kellhom tnaqqis temporanju taħt il-limitu ta' taħt tannormal.
English: EU/1/99/127/042 12 multiple dose vials, 72 injection syringes of 1 mL, 72 injection needles and 144 cleansing swabs
Maltese: EU/1/99/127/042 12-il kunjett b'ħafna dożi, 72 siringa għall-injezzjoni ta' 1 mL, 72 labra għallinjezzjoni u 144 tajjara għall-injezzjoni
English: A total of 345 interferon alpha relapse patients were treated in two clinical trials with IntronA monotherapy or in combination with ribavirin.
Maltese: Total ta' 345 pazjent ta' interferon alpha li rkadew kienu kkurati f'żewġ provi kliniċi b'monoterapija ta' IntronA jew flimkien ma' ribavirin.
English: - The active substance is recombinant interferon alfa-2b Each vial contains 18 million IU in 3 mL of solution.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Kunjett wieħed fih 18-il miljun IU ta' interferon alfa-2b f'soluzzjoni ta' 3 mL.
English: Ear and labyrinth Common:
Maltese: Tfal u adolexxenti:
English: Children 3 years of age and older and adolescents - 3 million IU/m2 3 times a week (every other day) injected subcutaneously (under the skin) in combination with ribavirin (Please also see ribavirin package leaflet).
Maltese: Tfal li għandhom 3 snin jew akbar u adolexxenti - 3 miljun IU/m2 3 darbiet fil-ġimgħa (darba kull jumejn) injettati taħt il-ġilda flimkien ma' ribavirin (Jekk jogħġbok ara wkoll il-fuljett ta' tagħrif ta' ribavirin).
English: During treatment for hepatitis B or C the recommended testing schedule is at weeks 1, 2, 4, 8, 12, 16, and every other month, thereafter, throughout treatment.
Maltese: Matul il-kura għal epatite B jew Ċ, l-iskeda rakkomandata għat-testijiet hija f'ġimgħat numru 1, 2, 4, 8, 12, 16, u wara dan il-perjodu kull xahrejn, tul iż-żmien kollu tal-kura.
English: Kidney and liver graft rejection
Maltese: Rappurtar ta' reazzjonijiet avversi suspettati
English: Carcinoid tumour
Maltese: Tumur karċinojde
English: 1 single dose vial, 1 injection syringe of 1 mL, 1 injection needle and 1 cleansing swab 6 single dose vials, 6 injection syringes of 1 mL, 6 injection needles and 6 cleansing swabs 12 single dose vials, 12 injection syringes of 1 mL, 12 injection needles and 12 cleansing swabs
Maltese: Pakkett ta' 1 kunjett Pakkett ta' 1 kunjett, 1 siringa għall-injezzjoni ta' 1 mL, 1 labra għall-injezzjoni u 1 tajjara għattindif Pakkett ta' 6 kunjetti, 6 siringi għall-injezzjonijiet ta' 1 mL, 6 labar għall-injezzjoni u 6 tajjar għat-tindif Pakkett ta' 12-il kunjett, 12-il siringa għall-injezzjoni ta' 1 mL, 12-il labra għall-injezzjoni u 12il tajjara għat-tindif
English: IntronA contains less than 1 mmol sodium (23 mg) per 0.5 mL, i.e., essentially "sodium-free".
Maltese: Dan il-prodott mediċinali fih anqas minn 1 mmol sodium (23 mg) kull 0.5 mL, i.e., jista' jitqies “mingħajr sodium”.
English: - if you are being treated with telbivudine (see section "Other medicines and IntronA").
Maltese: - jekk għandek mard tat-tirojde li mhux ikkontrollat sew. - jekk qed tingħata kura b'telbivudine (ara sezzjoni “Mediċini oħra u IntronA”).
English: It is obtained from a clone of E. coli, which harbours a genetically engineered plasmid hybrid encompassing an interferon alfa-2b gene from human leukocytes.
Maltese: Huwa jinkiseb minn klonu ta' E. coli, li għandu ġo fih ibridu plażmidu magħmul ġenetikament li hu mdawwar ma' ġene ta' interferon alfa-2b minn lewkoċiti umani.
English: Ocular adverse events (see section 4.8) including retinal haemorrhages, cotton wool spots, serous retinal detachment, and retinal artery or vein obstruction have been reported in rare instances after treatment with alpha interferons.
Maltese: Avvenimenti avversi okulari (ara sezzjoni 4.8) li jinkludu emorraġiji tar-retina, tara tikek qishom tajjar, distakk seruż tar-retina, u ostruzzjoni f'arterja jew vina tar-retina, kienu irrappurtati f'każijiet rari wara l-kura b'interferon alpha.
English: IntronA 10 million IU/mL solution for injection or infusion Interferon alfa-2b
Maltese: IntronA 10 miljun IU/mL soluzzjoni għall-injezzjoni jew infużjoni interferon alfa-2b
English: Interferon alfa-2b treatment is to be restarted at 50 % of the previous dose.
Maltese: Il-kura b'interferon alfa-2b għandha terġa' tinbeda b'50 % tad doża ta' qabel.
English: EU/1/99/127/044 12 multiple dose vials, 72 injection syringes of 1 mL, 72 injection needles and 144 cleansing swabs
Maltese: EU/1/99/127/044 12-il kunjett b'ħafna dożi, 72 siringa għall-injezzjoni, 72 labra għall-injezzjoni u 144 tajjara għall-injezzjoni
English: Multiple myeloma: 3 million IU/m 2, 3 times a week (every other day) injected subcutaneously (under the skin).
Maltese: Majeloma multipla: 3 miljun IU/m², 3 darbiet fil-ġimgħa (darba kull jumejn) injettati taħt il-ġilda.
English: Collect necessary items before you begin: - a vial of IntronA solution for injection; - a 1 mL syringe with an attached needle and a needle protection device (BD SafetyGlide syringe); - a cleansing swab.
Maltese: Iġbor l-affarijiet kollha li għandek bżonn qabel tibda: - kunjett ta' IntronA soluzzjoni għall-injezzjoni; - siringa ta' 1 mL b'labra mqabbda u strument ta' protezzjoni tal-labra (siringa BD SafetyGlide); - tajjara għat-tindif.
English: Determine TSH levels if, during the course of IntronA therapy, a patient develops symptoms consistent with possible thyroid dysfunction.
Maltese: Stabbilixxi l-livelli ta' TSH jekk, matul ilkors tat-terapija b'IntronA, pazjent jiżviluppa sintomi konsistenti ma' disfunzjoni possibbli tat-tirojde.
English: IntronA 5 million IU/0.5 mL solution for injection or infusion Interferon alfa-2b
Maltese: IntronA 5 miljun IU/0.5 mL soluzzjoni għall-injezzjoni jew infużjoni Interferon alfa-2b
English: The treatment is to be temporarily discontinued during and after surgery.
Maltese: Il-kura għandha tkun imwaqqfa b'mod temporanju waqt u wara l-kirurġija.
English: One vial contains 10 million IU of interferon alfa-2b in 1 mL of solution.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Kunjett wieħed fih 10 miljun IU ta' interferon alfa-2b f'soluzzjoni ta' 1 mL.
English: Eligible patients for these trials had chronic hepatitis C confirmed by a positive HCV-RNA polymerase chain reaction assay (PCR) (> 100 copies/mL), a liver biopsy consistent with a histologic diagnosis of chronic hepatitis with no other cause for the chronic hepatitis, and abnormal serum ALT.
Maltese: Il-pazjenti eliġibbli għal dawn il-provi kellhom epatite Ċ kronika kkonfermata minn assaġġ pożittiv (>100 kopji/mL) tar-reazzjoni katina ta' polymerase (PCR) HCV-RNA, bijopsija tal-fwied konsistenti ma' dijanjosi istoloġika ta' epatite kronika bla ebda kawża oħra għall-epatite kronika, u ALT anormali fis serum.
English: Periodontal (affecting gums) and dental disorders, change in colour of the tongue, altered mental status, loss of consciousness, acute hypersensitivity reactions including urticaria (hives), angioedema (swelling of the hands, feet, ankles, face, lips, mouth, or throat which may cause difficulty in swallowing or breathing), bronchoconstriction and anaphylaxis (a severe, whole-body allergic reaction) have been reported, but their frequency is unknown.
Maltese: Disturbi perjodontali (li jaffettwaw il-ħanek) u disturbi tas-snien, tibdil fil-kulur tal-ilsien, tibdil fl-istat mentali, tintilef minn sensik, reazzjonijiet akuti ta' sensittività eċċessiva inkluża urtikarja (ħorriqija), anġjoedema (nefħa tal-idejn, riġlejn, għekiesi, wiċċ, xufftejn, ħalq, jew gerżuma li tista' tikkawża tbatija biex tibla' jew tieħu n-nifs), bronkokostrizzjoni u anafilassi (reazzjoni allerġika severa, li taffettwa l-ġisem kollu) kienu rrappurtati, iżda l-frekwenza tagħhom mhijiex magħrufa.
English: Regardless of genotype, patients who received IntronA in combination with ribavirin and received  80 % of their treatment had a higher sustained response 6 months after 1 year of treatment than those who took < 80 % of their treatment (56 % vs. 32 % in trial C/I98-580).
Maltese: Irrispettivament mill-ġenotip, il-pazjenti li rċivew IntronA f'kombinazzjoni ma' ribavirin u rċivew ≥ 80 % tal-kura tagħhom kellhom rispons sostnut ogħla 6 xhur wara sena ta' kura minn dawk li ħadu < 80 % tal-kura tagħhom (56 % vs.
English: One vial of solution for injection or infusion contains 3 million IU of recombinant interferon alfa-2b produced in E. coli by recombinant DNA technology, in 0.5 mL of solution.
Maltese: U KWANTITATTIVA Kunjett wieħed ta' soluzzjoni għall-injezzjoni jew infużjoni fih 3 miljun IU ta' interferon alfa-2b rikombinanti magħmul fl-E. coli bit-teknoloġija ta' DNA rikombinanti, ġo 0.5 mL ta' soluzzjoni.
English: Carcinoid tumour Treatment of carcinoid tumours with lymph node or liver metastases and with "carcinoid syndrome".
Maltese: Tumur karċinojde Kura ta' tumuri karċinojdi b'metastasi fin-nodi limfatiċi jew tal-fwied u bis-“sindrome karċinojde”.
English: IntronA 3 million IU/0.5 mL solution for injection or infusion Interferon alfa-2b
Maltese: IntronA 3 miljun IU/0.5 mL soluzzjoni għall-injezzjoni jew infużjoni Interferon alfa-2b
English: Additionally, 98 % (51/52) with normal ALT levels at follow-up week 24 maintained normal ALT levels at their last visit.
Maltese: ALT normali fil-ġimgħa ta' follow-up 24 żammew livelli normali ta' ALT sa l-aħħar viżta tagħhom.
English: One vial of solution for injection or infusion contains 5 million IU of recombinant interferon alfa-2b produced in E. coli by recombinant DNA technology, in 0.5 mL of solution.
Maltese: U KWANTITATTIVA Kunjett wieħed ta' soluzzjoni għall-injezzjoni jew infużjoni fih 5 miljun IU ta' interferon alfa-2b rikombinanti magħmul fl-E. coli bit-teknoloġija ta' DNA rikombinanti, ġo 0.5 mL ta' soluzzjoni.
English: EU/1/99/127/019 EU/1/99/127/020 EU/1/99/127/021 EU/1/99/127/022
Maltese: EU/1/99/127/023 EU/1/99/127/024
English: 25 million IU/2.5 mL solution for injection or infusion 1 multiple dose vial
Maltese: 25 miljun IU/2.5 mL soluzzjoni għall-injezzjoni jew infużjoni 1 kunjett 1 b'ħafna dożi
English: IntronA is supplied as:
Maltese: IntronA jiġi bħala:
English: EU/1/99/127/011 EU/1/99/127/012 EU/1/99/127/013 EU/1/99/127/014
Maltese: EU/1/99/127/051 EU/1/99/127/052 EU/1/99/127/053
English: The longer term data available in children treated with the combination therapy with standard interferon/ribavirin are also indicative of substantial growth retardation (> 15 percentile decrease in height percentile as compared to baseline) in 21 % of children (n=20) despite being off treatment for more than 5 years.
Maltese: Id-dejta fuq żmien itwal disponibbli dwar tfal ikkurati bit-terapija kombinata b'interferon/ribavirin standard jindikaw ukoll li jkun hemm ittardjar sostanzjali fir-rata ta' tkabbir (tnaqqis ta' > 15 percentile fit-tul meta mqabbel mal-linja bażi) f'21% tat-tfal (n=20) minkejja li kienu ilhom aktar minn 5 snin li twaqqfitilhom il-kura.
English: IntronA alone or in combination with ribavirin has been studied in 4 randomised Phase III clinical trials in 2,552 interferon-naïve patients with chronic hepatitis C. The trials compared the efficacy of IntronA used alone or in combination with ribavirin.
Maltese: III li fihom ilpazjenti ntgħażlu b'mod każwali f'2,552 pazjent b'epatite Ċ kronika li qatt ma ħadu interferon filpassat.
English: IntronA is indicated for the treatment of adult patients with chronic hepatitis C who have elevated transaminases without liver decompensation and who are positive for hepatitis C virus RNA (HCV-RNA) (see section 4.4).
Maltese: IntronA huwa indikat għall-kura ta' pazjenti adulti li għandhom l-epatite Ċ kronika u għandhom transaminases għoljin mingħajr dikumpensazzjoni tal-fwied u li huma pożittivi għall-RNA tal-virus tal-epatite Ċ (HCV-RNA) (ara sezzjoni 4.4).
English: Carcinoid tumour: 5 million IU, 3 times a week (every other day) injected subcutaneously (under the skin).
Maltese: Tumur karċinojde: 5 miljun IU, 3 darbiet fil-ġimgħa (darba kull jumejn) injettati taħt il-ġilda.
English: Patients with signs or symptoms compatible with autoimmune disorders should be evaluated carefully, and the benefit-risk of continued interferon therapy should be reassessed (see also section 4.4 Chronic hepatitis C, Monotherapy (thyroid abnormalities) and section 4.8).
Maltese: Pazjenti b'sinjali jew b'sintomi kompatibbli ma' disturbi awtoimmuni għandhom ikunu evalwati b'attenzjoni, u l-benefiċċju-riskju tat-tkomplija tat-terapija b'interferon għandu jiġi evalwat mill-ġdid (ara wkoll sezzjoni 4.4 Epatite Ċ kronika, Monoterpaija (anormalitajiet tat-tirojde) u sezzjoni 4.8).
English: IntronA contains less than 1 mmol sodium (23 mg) per 3 mL, i.e., essentially "sodium-free".
Maltese: Dan il-prodott mediċinali fih anqas minn 1 mmol sodium (23 mg) kull 3 mL, i.e., jista' jitqies “mingħajr sodium”.
English: In studies of interferon use in non-human primates, abnormalities of the menstrual cycle have been observed (see section 4.4).
Maltese: Fi studji dwar l-użu ta' interferon fi primati mhux umani, anormalitajiet taċ-ċiklu mestrwali kienu osservati (ara sezzjoni 4.4).
English: Preliminary data indicates that interferon alpha therapy may be associated with an increased rate of kidney graft rejection.
Maltese: Dejta preliminari tindika li t-terapija b'interferon alpha tista' tkun assoċjata ma' rata miżjuda ta' rifjut ta' trapjant tal-kliewi.
English: EU/1/99/127/021 6 single dose vials, 6 injection syringes of 2 mL, 6 injection needles and 6 cleansing swabs
Maltese: EU/1/99/127/021 6 kunjetti b'doża waħda, 6 siringi għall-injezzjoni ta' 2 mL, 6 labar għall-injezzjoni u 6 tajjariet għat-tindif
English: Important information about some of the ingredients of IntronA This medicinal product contains less than 1 mmol sodium (23 mg) per 0.5 mL, i.e., essentially "sodium-free".
Maltese: Tagħrif importanti dwar xi wħud mill-ingredjenti ta' IntronA Dan il-prodotti mediċinali fih anqas minn 1 mmol sodium (23 mg), għal kull 0.5 mL, i.e. jista' jitqies “mingħajr sodium”.
English: 12 multiple dose vials, 72 injection syringes of 1 mL, 72 injection needles and 144 cleansing swabs 12 multiple dose vial, 72 injection syringes with attached needle and needle protection device of 1 mL and 144 cleansing swabs
Maltese: 12-il kunjett b'ħafna dożi, 72 siringa għall-injezzjoni ta' 1 mL, 72 labra għall-injezzjoni u 144 tajjara għat-tindif
English: - The active substance is recombinant interferon alfa-2b Each vial contains 25 million IU in 2.5 mL of solution.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Kunjett wieħed fih 25 miljun IU ta' interferon alfa-2b f'soluzzjoni ta' 2.5 mL.
English: 0.5 mL of solution (corresponding to 3 MIU) is contained in a single dose vial (type I glass) with a stopper (halobutyl rubber) in a flip-off seal (aluminium) with a bonnet (polypropylene).
Maltese: Soluzzjoni ta' 0.5 mL (li tikkorrispondi għal 3 MIU) miżmuma f'kunjett b'doża waħda (ħġieġ ta' tip I) b'tapp (lasktu tal-halobutyl) f'siġill flip-off (aluminju) b'bonnet (polypropylene).
English: Important information about some of the ingredients of IntronA This medicinal product contains less than 1 mmol sodium (23 mg) per 2.5 mL, i.e., essentially "sodium-free".
Maltese: Tagħrif importanti dwar xi wħud mill-ingredjenti ta' IntronA Dan il-prodotti mediċinali fih anqas minn 1 mmol sodium (23 mg), għal kull 2.5 mL, i.e. jista' jitqies “mingħajr sodium”.
English: The relative benefit of combination therapy with IntronA + ribavirin is particularly significant in the most difficult to treat subgroup of patients (genotype 1 and high virus load) (Table 3).
Maltese: Il-benefiċċju relattiv tat-terapija kombinata b'IntronA + ribavirin hi b'mod partikulari sinifikattiva fis-sottogrupp ta' pazjenti li huma l-aktar diffiċli biex ikunu kkurati (ġenotip 1 u ammont għoli ta' virus) (Tabella 3).
English: The increased response rate to the combination of IntronA + ribavirin, compared with IntronA alone, is maintained across all subgroups.
Maltese: Iż-żieda firrata ta' rispons għall-kombinazzjoni ta' IntronA + ribavirin, imqabbla ma' IntronA waħdu, tinżamm fis-sottogruppi kollha.
English: Stomatitis ulcerative, right upper quadrant pain, glossitis, gingivitis, constipation, loose stools Pancreatitis, ischaemic colitis, ulcerative colitis, gingival bleeding
Maltese: Stomatite ulċerattiva, uġigħ fil-parti tal-lemin ta' fuq, glossite, ġinġivite, stitikezza, ippurgar maħlul Pankreatite, kolite iskemika, kolite ulċerattiva, fsada talħanek
English: 18 million IU/3 mL solution for injection or infusion 1 multiple dose vial
Maltese: 18-il miljun IU/3 mL soluzzjoni għall-injezzjoni jew infużjoni 1 kunjett 1 b'ħafna dożi
English: In patients who are in the plateau phase (more than 50 % reduction of myeloma protein) following initial induction chemotherapy, interferon alfa-2b may be administered as monotherapy, subcutaneously, at a dose of 3 million IU/m2 three times a week (every other day).
Maltese: Fil-pazjenti li jinsabu fil-fażi għolja stabbli (aktar minn 50 % tnaqqis tal-proteina tal-majeloma) wara kimoterapija tal-induzzjoni inizjali, interferon alfa-2b jista' jingħata bħala monoterapija, taħt il-ġilda, f'doża ta' 3 miljun IU/m2 tliet darbiet fil-ġimgħa (darba kull jumejn).
English: SVR after treatment of chronic HCV with non-pegylated interferon alfa-2b with ribavirin results in long-term clearance of the virus providing resolution of the hepatic infection and clinical 'cure' from chronic HCV.
Maltese: Għalkemm ilmod eżatt ta' azzjoni antivirali ta' interferon alfa-2b rikombinanti mhuwiex magħruf, jidher li dan jibdel il-metaboliżmu taċ-ċellula ospitu.
English: IntronA contains less than 1 mmol sodium (23 mg) per 1 mL, i.e., essentially "sodium-free".
Maltese: Dan il-prodott mediċinali fih anqas minn 1 mmol sodium (23 mg) kull 1 mL, i.e., jista' jitqies “mingħajr sodium”.
English: EU/1/99/127/047 12 multiple dose vial, 72 injection syringes with attached needle and needle protection device of 1 mL and 144 cleansing swabs
Maltese: EU/1/99/127/046 12-il kunjett b'ħafna dożi, 72 siringa għall-injezzjoni b'labra mqabbda u apparat ta' protezzjoni tal-labra ta' 1 mL u 144 tajjara għat-tindif
English: Dilute prior to intravenous use.
Maltese: L-interferoni jistgħu jaffettwaw il-proċess metaboliku ossidattiv.
English: c: Patients with genotype 3 low viral load (< 600,000 IU/mL) were to receive 24 weeks of treatment while those with genotype 3 and high viral load (≥ 600,000 IU/mL) were to receive 48 weeks of treatment.
Maltese: IU/mL) kellhom jirċievu 24 ġimgħa ta' kura filwaqt li dawk b'ġenotip 3 u ammont virali għoli(≥ 600,000
English: EU/1/99/127/017 6 single dose vials, 6 injection syringes of 1 mL, 6 injection needles and 6 cleansing swabs
Maltese: EU/1/99/127/017 6 kunjetti b'doża waħda, 6 siringi għall-injezzjoni ta' 1 mL, 6 labar għall-injezzjoni u 6 tajjariet għat-tindif
English: Table 2 Adverse reactions very commonly and commonly reported during clinical trials in children and adolescent patients treated with IntronA in combination with ribavirin
Maltese: Tabella 2 Reazzjonijiet avversi rrappurtati b'mod komuni ħafna u komuni fi provi kliniċi fuq pazjenti tfal u adolexxenti kkurati b'IntronA f'kombinazzjoni ma' ribavirin
English: th percentile).
Maltese: Ġenotip ta'
English: Chronic hepatitis C
Maltese: Epatite Ċ kronika:
English: 0.5 mL of solution (corresponding to 5 MIU) is contained in a single dose vial (type I glass) with a stopper (halobutyl rubber) in a flip-off seal (aluminium) with a bonnet (polypropylene).
Maltese: Soluzzjoni ta' 0.5 mL (li tikkorrispondi għal 10 MIU) miżmuma f'kunjett b'doża waħda (ħġieġ ta' tip I) b'tapp (lasktu tal-halobutyl) f'siġill flip-off (aluminju) b'bonnet (polypropylene).
English: EU/1/99/127/041 2 multiple dose vials, 12 injection syringes of 1 mL, 12 injection needles and 24 cleansing swabs
Maltese: EU/1/99/127/041 2 kunjetti b'ħafna dożi, 12-il siringa għall-injezzjoni ta' 1 mL, 12-il labra għallinjezzjoni u 24 tajjara għall-injezzjoni
English: EU/1/99/127/016 1 single dose vial, 1 injection syringe of 1 mL, 1 injection needle and 1 cleansing swab
Maltese: EU/1/99/127/016 1 kunjett b'doża waħda, 1 siringa għall-injezzjoni ta' 1 mL, 1 labra għall-injezzjoni u 1 tajjara għall-injezzjoni
English: One vial contains 3 million IU of interferon alfa-2b in 0.5 mL of solution.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Kunjett wieħed fih 3 miljun IU ta' interferon alfa-2b f'soluzzjoni ta' 0.5 mL.
English: Very rarely reported side effects: low blood pressure, puffy face, diabetes, leg cramps, back pain, kidney problems, nerve damage, bleeding gums, aplastic anaemia.
Maltese: Effetti sekondarji rrappurtati rari ħafna: pressjoni baxxa, wiċċ impaħpaħ, dijabete, bugħawwieġ fir-riġlejn, uġigħ fid-dahar, problemi talkliewi, ħsara fin-nervaturi, ħruġ ta' demm mill-ħanek, anemija aplastika.
English: EU/1/99/127/020 1 single dose vial, 1 injection syringe of 2 mL, 1 injection needle and 1 cleansing swab
Maltese: EU/1/99/127/020 1 kunjett b'doża waħda, 1 siringa għall-injezzjoni ta' 2 mL, 1 labra għall-injezzjoni u 1tajjara għall-injezzjoni
English: Ribavirin concentration in seminal fluid is approximately two-fold higher compared to serum.
Maltese: Dawn huma kollha effetti sekondarji serji ħafna.
English: Pack of 1 vial, 1 injection syringe of 1 mL, 1 injection needle and 1 cleansing swab Pack of 6 vials, 6 injection syringes of 1 mL, 6 injection needles and 6 cleansing swabs Pack of 12 vials, 12 injection syringes of 1 mL, 12 injection needles and 12 cleansing swabs Not all pack sizes may be marketed.
Maltese: Pakkett ta' 1 kunjett Pakkett ta' 1 kunjett, 1 siringa għall-injezzjoni ta' 1 mL, 1 labra għall-injezzjoni u 1 tajjara għattindif Pakkett ta' 6 kunjetti, 6 siringi għall-injezzjonijiet ta' 1 mL, 6 labar għall-injezzjoni u 6 tajjar għat-tindif Pakkett ta' 12-il kunjett, 12-il siringa għall-injezzjoni ta' 1 mL, 12-il labra għall-injezzjoni u 12il tajjara għat-tindif Jista' jkun li mhux il-pakketti tad-daqsijiet kollha jkunu fis-suq.
English: EU/1/99/127/013 6 single dose vials, 6 injection syringes of 1 mL, 6 injection needles and 6 cleansing swabs
Maltese: EU/1/99/127/013 6 kunjetti b'doża waħda, 6 siringi għall-injezzjoni ta' 1 mL, 6 labar għall-injezzjoni u 6 tajjariet għat-tindif