FrancophonIA/ELRC3.0 huggingface dataset:
English: Superior efficacy has been demonstrated with the combination of pegylated interferon with ribavirin (sustained response rate of 61 % achieved in a study performed in naïve patients with a ribavirin dose > 10.6 mg/kg, p < 0.01).
Maltese: Effikaċja superjuri ntweriet bil-kombinazzjoni ta' interferon pegilat ma' ribavirin (rata ta' rispons sostnut ta' 61 % inkisbet fi studju li sar fuq pazjenti li qatt ma rċivew kura fil-passat b'doża ta' ribavirin ta' > 10.6 mg/kg, p < 0.01).
English: Study 1 (RIBAVIC; P01017) was a randomized, multicentre study which enrolled 412 previously untreated adult patients with chronic hepatitis C who were co-infected with HIV.
Maltese: Studju 1 (RIBAVIC; P01017) kien studju li fih il-pazjenti ntgħażlu b'mod każwali, multiċentriku li ingaġġa 412-il pazjent adult li ma kinux ingħataw kura fil-passat b'epatite Ċ kronika li kienu koinfettati b'HIV.
English: Interferon alfa-2b has been shown to have abortifacient effects in Macaca mulatta (rhesus monkeys) at 90 and 180 times the recommended intramuscular or subcutaneous dose of 2 million IU/m2.
Maltese: Interferon alfa-2b intwera li għandu effetti li jwasslu għal abort fil-Macaca mulatta (xadini tar-razza rhesus) b'doża ta' 90 u 180 darba iktar minn dik rakkomandata ta' 2 miljun IU/m² ġol-muskoli jew taħt il-ġilda.
English: Dyspnoea, tachypnea, epistaxis, coughing, nasal congestion, nasal irritation, rhinorrhea, sneezing
Maltese: Dispneja, takipnea, epistassi, sogħla, konġestjoni fl-imnieħer, irritazzjoni fl-imnieħer, rinorrea, għatis
English: Arthralgia, myalgia, musculoskeletal pain
Maltese: Artralġja, mijalġja, uġigħ muskolskeletriku
English: a: Response to treatment was defined as undetectable HCV-RNA at 24 weeks post-treatment, lower limit of detection=125 IU/mL.
Maltese: a: Rispons għall-kura kien definit bħala HCV-RNA li ma jistax jitkejjel wara 24 ġimgħa wara l-kura, bil limitu t'isfel li jista' jitkejjel = 125 IU/mL.
English: However, as for any pharmacologically active compound, symptomatic treatment with frequent monitoring of vital signs and close observation of the patient is indicated.
Maltese: Madankollu, bħal kwalunkwe kompost farmakoloġikament attiv, huwa indikat li tingħata kura sintomatika b'monitoraġġi frekwenti tas-sinjali vitali u osservazzjoni mill-qrib tal-pazjent.
English: As induction therapy, interferon alfa-2b is administered intravenously at a dose of 20 million IU/m daily for five days a week for a four-week period; the calculated interferon alfa-2b dose is added to sodium chloride 9 mg/mL (0.9 %) solution for injection and administered as a 20-minute infusion (see section 6.6).
Maltese: Bħala terapija tal-induzzjoni, interferon alfa-2b jingħata ġol-vina b'doża ta' 20 miljun IU/m² kuljum għal ħamest ijiem fil-ġimgħa għal perjodu ta' erba' ġimgħat; id-doża kkalkulata ta' interferon alfa-2b tiżdied ma' sodium chloride 9 mg/mL (0.9 %) soluzzjoni għall-injezzjoni u tingħata bħala infużjoni ta' 20 minuta (ara sezzjoni 6.6).
English: IntronA 3 MIU/m 2 3 times a week (n = 54)
Maltese: 3 MIU/m2 3 darbiet fil-ġimgħa (n = 54)
English: IntronA 25 MIU
Maltese: IntronA 25 miljun
English: A clinical trial investigating the combination of telbivudine, 600 mg daily, with pegylated interferon alfa-2a, 180 micrograms once weekly by subcutaneous administration, indicates that this combination is associated with an increased risk of developing peripheral neuropathy.
Maltese: Prova klinika li kienet qed tinvestiga l-kombinazzjoni ta' telbivudine, 600 mg kuljum, ma' interferon alfa-2a pegilat, 180 mikrogramma darba fil-ġimgħa permezz ta' għoti taħt il-ġilda, tindika li din ilkombinazzjoni hija assoċjata ma' żieda fir-riskju li tiżviluppa newropatija periferali.
English: Female: amenorrhea, menorrhagia, menstrual disorder, vaginal disorder
Maltese: Nisa: amenorrea, menorraġja, disturbi mestrwali, disturbi filvaġina
English: A wide variety of autoimmune and immune-mediated disorders have been reported with alpha interferons including thyroid disorders, systemic lupus erythematosus, rheumatoid arthritis (new or aggravated), idiopathic and thrombotic thrombocytopenic purpura, vasculitis, neuropathies including mononeuropathies (see also section 4.4).
Maltese: Varjetà kbira ta' problemi awtoimmunitarji u ta' problemi medjati mill-immunità kienu rrappurtati b'interferoni alpha, u jinkludu disturbi tat-tirojde, lupus erythematosus sistemiku, artrite rewmatika (ġdida jew taggrava), purpura idjopatika u tromboċitopenika trombotika, vaskulite, u newropatiji li jinkludu mononewropatiji (ara wkoll sezzjoni 4.4).
English: Thyroid dysfunction during treatment with interferon alfa-2b and ribavirin has been observed.
Maltese: Disfunzjoni tat-tirojde waqt il-kura b'interferon alfa-2b u ribavirin kienet osservata.
English: Pack of 1 vial
Maltese: Daqsijiet ta' pakketti ta' 1.
English: Myalgia, arthralgia, musculoskeletal pain Arthritis
Maltese: Mijalġja, artralġja, uġigħ muskoluskeletriku
English: Clinically significant laboratory abnormalities, most frequently occurring at doses greater than 10 million IU daily, include reduction in granulocyte and white blood cell counts; decreases in haemoglobin level and platelet count; increases in alkaline phosphatase, LDH, serum creatinine and serum urea nitrogen levels.
Maltese: Anormalitajiet tal-laboratorju klinikament sinifikanti, li l-aktar li jseħħu f'dożi ta' aktar minn 10 miljun IU kuljum, jinkludu t-tnaqqis fl-għadd tal-granuloċiti u taċ-ċelluli bojod tad-demm; tnaqqis fil-livell tal-emoglobina u tal-għadd tal-plejtlits; żidiet fil-livelli ta' alkaline phosphatase, LDH, krejatinina fis-serum u tan-nitroġenu tal-urea fis-serum.
English: Human interferon receptors, as isolated from human lymphoblastoid (Daudi) cells, appear to be highly asymmetric proteins.
Maltese: Ir-riċetturi ta' interferon uman, kif iżolati minn ċelluli limfoblastojdi (Daudi) talbniedem, jidhru li huma proteini asimmetriċi ħafna.
English: 10 million IU/mL
Maltese: 10 miljun IU/1 mL
English: IntronA plus ribavirin
Maltese: IntronA ma' ribavirin
English: Caution should be used when adding IntronA and ribavirin to HAART therapy (see ribavirin SPC).
Maltese: Għandha tintuża attenzjoni meta jiżdiedu IntronA u ribavirin mat-terapija HAART (ara l-SPC ta' ribavirin).
English: For paediatric patients who weigh < 47 kg or cannot swallow capsules, see ribavirin oral solution SPC.)
Maltese: Għal pazjenti pedjatriċi li jiżnu < 47 kg jew li ma jistgħux jibilgħu kapsuli, ara lSPC tas-soluzzjoni orali ribavirin.)
English: Sarcoidosis, exacerbation of sarcoidosis Systemic lupus erythematosus, vasculitis, rheumatoid arthritis (new or aggravated), Vogt-Koyanagi-Harada syndrome, acute hypersensitivity reactions including urticaria, angioedema, bronchoconstriction, anaphylaxis
Maltese: Sarkojdożi, aggravament tas-sarkojdożi Lupus erythematosus sistemiku, vaskulite, artrite rewmatika (ġdida jew taggrava), sindrome ta' Vogt-Koyanagi-Harada, reazzjonijiet ta' sensittività eċċessiva akuti li jinkludu urtikarja, anġjoedema, bronkokostrizzjoni, anafilassi§
English: §, virilism
Maltese: Ipertijrojdiżmu§, viriliżmu
English: Suicide, suicide attempts, aggressive behaviour (sometimes directed against others), psychosis including hallucinations
Maltese: Suwiċidju, attentati ta' suwiċidju, imġiba aggressiva (kultant indirizzata lejn l-oħrajn), psikożi inklużi alluċinazzjonijiet
English: Amenorrhea, breast pain, dysmenorrhea, menorrhagia, menstrual disorder, vaginal disorder
Maltese: Amenorrea, uġigħ fis-sider, dismenorrea, menorraġija, disturbi mestrwali, disturbi fil-vaġina
English: Standard haematological tests and blood chemistries (complete blood count and differential, platelet count, electrolytes, liver enzymes, serum protein, serum bilirubin and serum creatinine) are to be conducted in all patients prior to and periodically during systemic treatment with IntronA.
Maltese: Testijiet ematoloġiċi standard u tal-komponenti kimiċi tad-demm (għadd totali u differenzjali taddemm, għadd tal-plejlits, elettroliti, enzimi tal-fwied, proteina fis-serum, bilirubina fis-serum u krejatinina fis-serum) għandhom isiru lill-pazjenti kollha qabel u b'mod perjodiku matul il-kura sistemika b'IntronA.
English: Mutagenicity studies with interferon alfa-2b revealed no adverse events.
Maltese: Studji dwar il-mutaġeniċità b'interferon alfa-2b ma wrew ebda avvenimenti avversi.
English: Interferon alfa-2b (6 MIU/m2 3 times a week for 6 months) has been given to children with chronic active hepatitis B. Because of a methodological flaw, efficacy could not be demonstrated.
Maltese: Interferon alfa-2b (6 MIU/m² tliet darbiet fil-ġimgħa għal 6 xhur) ingħata lil tfal b'epatite B attiva kronika.
English: Uncommon: Very rarely:
Maltese: Mhux komuni: Rari:
English: Neoplasm (unspecified)
Maltese: Neoplażmu (mhux speċifikat)
English: Nausea/vomiting, abdominal pain, diarrhoea, stomatitis, dyspepsia
Maltese: Tqalligħ/rimettar, uġigħ fl-addome, dijarea, stomatite, dispepsija
English: Pack of 12 vials
Maltese: Pakkett ta' 12-il kunjett
English: HCV/HBV Coinfection
Maltese: Koinfezzjoni b'HCV/HBV
English: Anaemia, neutropaenia Thrombocytopaenia, lymphadenopathy
Maltese: Anemija, newtropenija Tromboċitopenija, limfadenopatija
English: Within the organ system classes, adverse reactions are listed under headings of frequency using the following categories: very common (≥1/10); common (≥1/100, <1/10).
Maltese: Fil-klassijiet tas-sistemi tal-organi, ir-reazzjonijiet avversi huma elenkati taħt it-titli tal-frekwenza bl-użu tal-kategoriji li ġejjin: komuni ħafna (≥1/10); komuni (≥1/100, <1/10).
English: Twenty (21 %) of 97 children had a > 15 percentile decrease in height percentile, of whom 10 of the 20 children had a > 30 percentile decrease in their height percentile from the start of treatment to the end of long-term follow-up (up to 5 years).
Maltese: Għoxrin (21 %) mis-97 tifel u tifla kellhom tnaqqis ta' > 15 percentile fit-tul tagħhom, li minnhom 10 mill-20 tifel u tifla kellhom tnaqqis ta' > 30 percentile fil-mija tnaqqis fil-percentile tattul tagħhom minn meta nbdiet il-kura sat-tmiem tal-follow-up fit-tul (sa 5 snin).
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 rreġistra 95 pazjent adult li ma kinux ingħataw kura fil-passat, b'epatite Ċ kronika li kienu koinfettati b'HIV.
English: EU/1/99/127/050 12 multiple dose vial, 72 injection syringes with attached needle and needle protection device of 1 mL and 144 cleansing swabs EU/1/99/127/053 12 multiple dose vial, 72 injection syringes with attached needle of 1 mL and 144 cleansing swabs
Maltese: EU/1/99/127/050 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 EU/1/99/127/053 12-il kunjett b'ħafna dożi, 72 siringa għall-injezzjoni b'labra mqabbda ta' 1 mL u 144 tajjara għat-tindif
English: In combination therapy with ribavirin, take notice of the respective informing texts of ribavirin containing medicinal products.
Maltese: F'terapija kombinata ma' ribavirin, agħti każ tat-tagħrif rispettiv tal-prodotti mediċinali li fihom ribavirin.
English: Enuresis, micturition disorder, urinary incontinence
Maltese: Enureżi, disturbi tal-awrina, inkontinenza tal-awrina
English: HCV/HIV Coinfection
Maltese: Koinfezzjoni b'HCV/HIV
English: In adult patients with loss of HBeAg and HBV-DNA, a significant reduction in morbidity and mortality has been observed.
Maltese: F'pazjenti adulti bi tnaqqis ta' HBeAg u ta' HBV-DNA, kien osservat tnaqqis sinifikattiv filmorbidità u fil-mortalità.
English: Table 4 Sustained virological response based on genotype after IntronA in combination with ribavirin versus pegylated interferon alfa-2b in combination with ribavirin in HCV/HIV co-infected patients Study 1
Maltese: IntronA f'kombinazzjoni ma' ribavirin kontra interferon alfa-2b pegilat flimkien ma' ribavirin f'pazjenti koinfettati b'HCV/HIV
English: The elimination half-life was approximately two hours.
Maltese: Ilhalf life tal-eliminazzjoni kienet ta' madwar sagħtejn.
English: Patients were randomized to receive either pegylated interferon alfa-2b (100 or 150 µg /week based on weight) plus ribavirin (800-1,200 mg/day based on weight) or IntronA (3 MIU TIW) plus ribavirin (800-1,200 mg/day based on weight).
Maltese: Il-pazjenti ntgħażlu b'mod każwali sabiex jirċievu interferon alfa-2b pegilat (100 jew 150 µg/ġimgħa skont il-piż) flimkien ma' ribavirin (800-1,200 mg/jum skont il-piż) jew IntronA (3 MIU TIW) flimkien ma' ribavirin (800 mg-1,200 mg/jum skont il-piż).
English: Children and adolescents 3 to 16 years of age with compensated chronic hepatitis C and detectable HCV-RNA (assessed by a central laboratory using a research-based RT-PCR assay) were enrolled in two multicentre trials and received IntronA 3 MIU/m2 3 times a week plus ribavirin 15 mg/kg per day for 1 year followed by 6 months follow-up after-treatment.
Maltese: Tfal u adolexxenti minn 3 sa 16-il sena b'epatite Ċ kronika kumpensata u HCV-RNA li jista' jitkejjel (evalwat minn laboratorju ċentrali b'assaġġ ta' RT-PCR ibbażat fuq riċerka) ġew irreġistrati f'żewġ provi multiċentriċi u rċivew IntronA 3 MIU/m2 3 darbiet fil-ġimgħa ma' ribavirin 15 mg/kg kuljum għal sena, segwiti minn 6 xhur ta' follow-up wara l-kura.
English: (See ribavirin capsules SPC for dose of ribavirin capsules and dose modification guidelines for combination therapy.
Maltese: (Ara l-SPC tal-kapsuli ribavirin għad-doża tal-kapsuli ribavirin u l-linji gwida għal tibdil fid-doża għal terapija kombinata.
English: - IntronA alone
Maltese: IntronA.
English: Some patients have been shown to benefit from IntronA 5 million IU/m administered daily subcutaneously in association with cytarabine (Ara-C) 20 mg/m2 administered daily subcutaneously for 10 days per month (up to a maximum daily dose of 40 mg).
Maltese: Intwera li xi pazjenti bbenefikaw minn 5 miljun IU/m2 ta' IntronA mogħtija kuljum taħt il-ġilda flimkien ma' 20 mg/m2 ta' cytarabine (Ara-C) mogħtija kuljum taħt il-ġilda għal 10 ijiem kull xahar (sa doża massima ta' 40 mg kuljum).
English: Cerebrovascular haemorrhage, cerebrovascular ischaemia, seizure, impaired consciousness, encephalopathy Mononeuropathies, coma
Maltese: Emorraġija ċerebrovaskulari, iskemija ċerebrovaskulari, aċċessjoni, koxjenza indebolita, enċefalopatija Mononewropatiji, koma§
English: IntronA is usually intended for subcutaneous use.
Maltese: IntronA huwa normalment maħsub għall-użu taħt il-ġilda.
English: In general, the adverse reaction profile in the limited children and adolescent population studied was similar to that observed in adults, although there is a paediatric- specific concern regarding growth inhibition as decrease in height percentile (mean percentile decrease of 9 percentile) and weight percentile (mean percentile decrease of 13 percentile) were observed during treatment.
Maltese: B'mod ġenerali, il-profil ta' reazzjonijiet avversi fil-popolazzjoni limitata tat-tfal u adolexxenti kien jixbah lil dak tal-adulti, għalkemm hemm tħassib speċifiku għat-tfal dwar linibizzjoni tat-tkabbir, għax tnaqqis fil-percentile tat-tul (medja ta' tnaqqis tal-percentile ta' 9 fil-mija) u fil-percentile tal-piż (medja ta' tnaqqis tal-percentile ta' 13 fil-mija) ġew osservati waqt il-kura.
English: Commonly reported side effects: thirst, dehydration, high blood pressure, migraines, swollen glands, flushing, menstrual problems, decreased sexual drive, vaginal problem, breast pain, pain in testicle, problems with thyroid gland, red gums, dry mouth, red or sore mouth or tongue, tooth ache or tooth disorder, herpes simplex (fever blisters), taste change, upset stomach, dyspepsia (heartburn), constipation, enlargement of liver (liver problems, sometimes severe), loose stools, bedwetting in children, inflammation of the sinuses, bronchitis, eye pain, problem with your tear ducts, conjunctivitis (“pink eye”), agitation, sleepiness, sleepwalking, problem with behaviour, nervousness, stuffy or runny nose, sneezing, rapid breathing, pale or reddened skin, bruising, problem with skin or nails, psoriasis (new or worsened), increased sweating, increased need to pass urine, fine shaking movements, decreased sensitivity to touch, arthritis.
Maltese: għatx, deidratazzjoni, pressjoni għolja, attakki tal-migranja, glandoli minfuħin, fwawar, problemi mestrwali, tnaqqis fl-aptit sesswali, problemi fil-vaġina, uġigħ tas-sider, uġigħ fit-testikoli, problemi fil-glandola tat-tirojde, ħmura fil-ħanek, ħalq xott, il-ħalq jew l-ilsien jiħmaru jew jinselħu, uġigħ fissnien jew disturbi fis-snien, herpes simplex (infafet tad-deni), tibdil fit-togħma, taqlib tal-istonku, dispepsija (ħruq ta' stonku), stitikezza, tkabbir tal-fwied (problemi fil-fwied, kultant severi), ippurgar maħlul, tfal jagħmlu l-pipi taħthom, infjammazzjoni tas-sinuses, bronkite, uġigħ fl-għajnejn, problema fil-kanali tad-dmugħ, konġuntivite (“għajn roża”), aġitazzjoni, ngħas, ħmar il-lejl, problema fl-imġiba, nervożità, imnieħer imblukkat jew inixxi, għatis, nifs mgħaġġel, ġilda pallida jew ħamra, tbenġil, problema fil-ġilda jew fid-dwiefer, psorjasi (ġdida jew li tmur għall-agħar), żieda fl-għaraq, żieda filbżonn li tagħmel l-awrina, movimenti fini ta' tregħid, nuqqas ta' sensittività biex tħoss, artrite.
English: Current clinical experience in patients who remain on interferon alfa-2b for 4 to 6 months indicates that therapy can produce clearance of serum HBV-DNA.
Maltese: L-esperjenza klinika attwali f'pazjenti li jibqgħu fuq interferon alfa-2b għal 4 sa 6 xhur tindika li tterapija tista' tipproduċi l-eliminazzjoni tal-HBV-DNA fis-serum.
English: Myocardial infarction, cardiac ischaemia Congestive heart failure, pericardial effusion, arrhythmia
Maltese: Infart majokardijaku, iskemija kardijaka Insuffiċjenza konġestiva tal-qalb, effużjoni perikardijaka, arritmija
English: Pneumonia
Maltese: pulmonite.
English: Genotype 1
Maltese: Ġenotip 1 Ġenotip 1
English: Prior to initiation of IntronA therapy for the treatment of chronic hepatitis C, evaluate serum thyroid-stimulating hormone (TSH) levels.
Maltese: Qabel tibda t-terapija b'IntronA għall-kura ta' epatite Ċ kronika, evalwa l-livelli tal-ormon li jistimula t-tirojde (TSH) fis-serum.
English: Among children and adolescents treated with IntronA 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 it-tfal u adolexxenti kkurati b'IntronA f'kombinazzjoni ma' ribavirin, ħsibijiet dwar suwiċidju jew attentati ta' suwiċidju kienu rrappurtati aktar ta' spiss meta mqabbla ma' pazjenti adulti (2.4 % vs 1 %) waqt il-kura u waqt il-perjodu ta' follow-up ta' 6 xhur wara l-kura.
English: Recombinant interferon alfa-2b has exhibited antiproliferative effects in studies employing both animal and human cell culture systems as well as human tumour xenografts in animals.
Maltese: Interferon alfa-2b rikombinanti wera effetti antiproliferattivi fi studji fejn intużaw kemm sistemi ta' koltura ta' ċelluli umani kif ukoll tal-annimali kif ukoll xenografts ta' tumur uman fl-annimali.
English: Severity also increased with high dose therapy (WHO Grade 3 and 4, in 66 % and 14 % of patients, respectively), in comparison with the mild to moderate severity usually associated with lower doses.
Maltese: Is-severità żdiedet ukoll b'terapija b'doża għolja (Grad 3 u 4 tal-WHO, f'66 % u 14 % tal-pazjenti, rispettivament), imqabbla mas-severità minn ħafifa sa moderata normalment assoċjata ma' dożi baxxi.
English: EU/1/99/127/015 EU/1/99/127/016 EU/1/99/127/017 EU/1/99/127/018
Maltese: EU/1/99/127/016 EU/1/99/127/017 EU/1/99/127/018
English: §, asthenia,
Maltese: Ipotijrojdiżmu§
English: §, sepsis Hepatitis B reactivation in HCV/HBV co-infected patients
Maltese: Riattivazzjoni tal-epatite B f'pazjenti koinfettati b'HCV/HBV
English: Your doctor may prescribe a different dose of IntronA alone or in combination with other medicines (e.g., cytarabine, ribavirin).
Maltese: It-tabib tiegħek jista' jippreskrivi doża differenti ta' IntronA, waħdu jew flimkien ma' mediċini oħra (eż., cytarabine, ribavirin).
English: The Kaplan-Meier estimate for continued sustained response over 5 years is 98 % [95 % CI: 95 %, 100 %] for paediatric patients treated with interferon alfa-2b and ribavirin.
Maltese: L-individwi pedjatriċi kollha ħlief għal wieħed baqgħu b'rispons viroloġiku sostnut waqt ilperjodu ta' follow-up fit-tul wara li temmew il-kura b'interferon alfa-2b flimkien ma' ribavirin. Listima Kaplan-Meier għar-rispons sostnut kontinwu fuq 5 snin huwa 98 % [95 % CI: 95 %, 100 %] għal pazjenti pedjatriċi kkurati b'interferon alfa-2b u ribavirin.
English: Hairy cell leukaemia Treatment of patients with hairy cell leukaemia.
Maltese: Lewkimja tal-hairy cell Il-kura ta' pazjenti bil-lewkimja tal-Hairy cell.
English: Therefore, the combination of IntronA with telbivudine is contraindicated (see section 4.3).
Maltese: Għalhekk, il-kombinazzjoni ta' IntronA ma' telbivudine hija kontraindikata (ara sezzjoni 4.3).
English: The abnormalities were controlled by conventional therapy for thyroid dysfunction.
Maltese: L-anormalitajiet kienu kkontrollati b'terapija konvenzjonali għal disfunzjoni tat-tirojde.
English: Combination of IntronA with telbivudine.
Maltese: Għalhekk, il-kombinazzjoni ta' IntronA ma' telbivudine hija kontraindikata.
English: The pharmacokinetics of IntronA were studied in healthy volunteers following single 5 million IU/m and 10 million IU doses administered subcutaneously, at 5 million IU/m2 administered intramuscularly and as a 30-minute intravenous infusion.
Maltese: Il-farmakokinetika ta' IntronA kienet studjata f'voluntiera b'saħħithom wara dożi waħidhom ta' 5 miljun IU/m² mogħtija taħt il-ġilda, 10 miljun IU mogħtija taħt il-ġilda, 5 miljun IU/m² mogħtija ġolmuskoli u bħala infużjoni ta' 30 minuta ġol-vina.
English: Table 5 Sustained virological response in previously untreated children and adolescents IntronA 3 MIU/m2 3 times a week ribavirin 15 mg/kg/day
Maltese: IntronA 3 MIU/m2 3 darbiet fil-ġimgħa ribavirin 15 mg/kg/jum
English: Suomi/Finland MSD Finland Oy Puh/Tel: +358 (0)9 804650 info@msd.fi
Maltese: +358 (0)9 804650 info@msd.fi
English: Results from the clinical trial conducted with pegylated interferon alfa-2b and ribavirin In a multicentre trial children and adolescents 3 to 17 years of age with compensated chronic hepatitis C and detectable HCV-RNA were treated with peginterferon alfa-2b 60 g/m2 plus ribavirin
Maltese: Riżultati mill-prova klinika li saret b'interferon alfa-2b pegilat u ribavirin Fi prova multiċentrika, tfal u adolexxenti 3 sa 17-il sena b'epatite Ċ kronika kumpensata u HCV-RNA li jista' jitkejjel kienu kkurati b'peginterferon alfa-2b pegilat 60 μg/m2 flimkien ma' ribavirin 15 mg/kg kuljum darba fil-ġimgħa għal 24 jew 48 ġimgħa, skont il-ġenotip tal-HCV u l-ammont virali fil-linja bażi.
English: IntronA 5 MIU
Maltese: IntronA 5 miljun
English: I/R N=505 C/I98-580
Maltese: C/I98-580
English: Table 3 Sustained virologic response rates with IntronA + ribavirin (one year of treatment) by genotype and viral load
Maltese: Tabella 3 Rati ta' rispons viroloġiku sostnut b'IntronA + ribavirin (sena waħda ta' kura) skont il-ġenotip u l-ammont virali
English: Children and adolescent population: Growth and development (chronic hepatitis C) During the course of interferon (standard and pegylated)/ribavirin combination therapy lasting up to 48 weeks in patients ages 3 through 17 years, weight loss and growth inhibition were common (see sections 4.8 and 5.1).
Maltese: Waqt il-kors ta' terapija kombinata b'interferon (standard u pegilat)/ribavirin li dam sa 48 ġimgħa f'pazjenti ta' etajiet minn 3 sa 17-il sena, telf tal-piż u inibizzjoni tat-tkabbir kienu komuni (ara sezzjonijiet 4.8 u 5.1).
English: During ALT flare, the following liver function tests must be monitored at two-week intervals: ALT, prothrombin time, alkaline phosphatase, albumin and bilirubin.
Maltese: ALT, ħin tal-protrombin, alkaline phosphatase, albumina u bilirubina.