FrancophonIA/ELRC3.0 huggingface dataset:
English: The MAH shall agree the details of an education programme for surgeons with the National Competent Authorities and must implement such programme nationally to ensure that:
Maltese: L-MAH ser taqbel id-dettalji ta' programm edukattiv għall-kirurgi mal-Awtoritajiet Nazzjonali Kompitenti u trid timplimenta tali programm b'mod nazzjonali biex tiżgura li:
English: • have an active infection at the site of spinal fusion or history of recurring infections;
Maltese: • għandhom infezzjoni attiva fis-sit tal-fużjoni spinali jew passat ta' infezzjonijiet rikorrenti;
English: • Use of this medicine does not guarantee fusion.
Maltese: • L-użu ta' din il-mediċina ma jiggarantixxix l-fużjoni.
English: Opgenra has no known pharmacological effect on neuro-motor coordination or performance consequently it is unlikely to alter any pre-existing skills used for driving vehicles or operating machines.
Maltese: Opgenra ma għandu l-ebda effett magħruf farmakoloġiku fuq il-koordinazzjoni newro-motorja jew loperat u għalhekk probabbilment mhux ser jibdel kwalunkwe ħilijiet li kienu jeżistu qabel biex isuqu vetturi jew iħaddmu magni.
English: • product migration (this has been observed when the product was mixed with a synthetic product used to fill the bone void)
Maltese: • migrazzjoni tal-prodott (dan kien osservat meta l-prodott kien imħallat ma' prodott sintetiku wżat biex jimla l-vojt tal-għadam).
English: Opgenra 3.3 mg powder for implantation suspension.
Maltese: Opgenra 3.3 mg, trab għal suspensjoni tal-impjantazzjoni
English: Marketing Authorisation Holder Olympus Biotech International Limited Block 2, International Science Centre National Technology Park Castletroy
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq Olympus Biotech International Limited Block 2, International Science Centre National Technology Park Castletroy
English: Implant field preparation (haemostasis)
Maltese: TWISSIJA(IET) SPEĊJALI
English: Bovine collagen Carmellose
Maltese: mg trab ta' carmellose
English: Store in a refrigerator (2 °C - 8 °C).
Maltese: Aħżen fil-friġġ (2ºC - 8ºC).
English: However, results from implantation studies in animals demonstrate that the active substance eptotermin alfa is released from the implant site over several weeks and never reaches a level higher than 3% of the total amount implanted in the peripheral blood.
Maltese: Imma, r-riżultati minn studji ta' impjantazzjoni f'bhejjem urew li s-sustanza attiva eptotermin alfa tinħareġ mis-sit ta' limpjant fuq medda ta' ġimgħat, u qatt ma tilħaq livell ogħla minn 3% ta' l-ammont totali impjantat fid-demm periferali.
English: The clinical implications of these observations for human use of the finished medicinal product remain uncertain (see section 4.6).
Maltese: L-implikazzjonijiet kliniċi ta' dawn l-osservazzjonijet għall-użu uman talprodott mediċinali lest għadhom mhumiex ċerti (ara sezzjoni 4.6).
English: Potential interaction with Calstrux, a bone void filler has been reported (see section 4.5).
Maltese: Kienet irrapportata interazzjoni potenzjali ma' Calstrux, li hu filler tal-vojt tal-għadam (ara sezzjoni
English: • localised swelling, swelling over the implant site,
Maltese: • nefħa lokalizzata, nefħa fuq il-post tal-impjantazzjoni
English: Repeat use of this bone morphogenetic protein (BMP) is not recommended.”
Maltese: L-użu ripetut ta' dan il-proteina morfoġenetika tal-għadam (BMP) mhux irrakkomandat.
English: Not known: hypersensitivity, urticaria
Maltese: Ipersensittività, urtikarja
English: This is normally done under a full general anaesthetic so you will not be awake during the surgery.
Maltese: Dan normalment isir permezz ta' anestesija ġenerali totali biex hekk int ma tkunx imqajjem matul l-operazzjoni.
English: - if you are an adolescent (12-18 years old) or your skeleton is not yet be fully formed (you are still growing).
Maltese: - jekk int adolexxent (12-18-il sena) jew * l-iskeletru tiegħek ikun għadu ma ġiex iffurmat kompletament (int għadek qed tikber).
English: Sjögren's syndrome and dermatomyositis/ polymyositis.
Maltese: - Żomm dan il-fuljett.
English: The CHMP recommend an additional five-year renewal based on the following pharmacovigilance grounds: the clinical experience with the product in the designated indication has been very limited in the EU during the first 5-year period of marketing authorisation.
Maltese: Is-CHMP irrakkomanda tiġdid għal ħames snin addizzjonali abbażi tar-raġunijiet ta' farmakoviġilanza li ġejjin: l-esperjenza klinika bil-prodott fl-indikazzjoni indikata kienet limitata ħafna fl-UE matul lewwel perjodu ta' 5 snin tal-awtorizzazzjoni għat-tqegħid fis-suq.
English: Antibodies to eptotermin alfa were also found in sera from pooled foetal and umbilical cord blood, at levels that correlated to that of the maternal blood.
Maltese: Antikorpi għal eptotermin alfa nstabu wkoll fis-sera mid-demm fetali u tal-kurdun ta' umbelikali miġbura flimkien, f'livelli li kienu korrelati mad-demm matern.
English: The powders come in glass vials.
Maltese: Jekk tista' poġġih taħt il-ġilda.
English: This effect, termed solid state carcinogenicity, has been frequently observed in rats in which solid materials (plastics or metals) were implanted subcutaneously.
Maltese: Dan l-effett magħruf bħala karċinoġeniċità fi stat solidu, dehret ta' spiss fil-firien meta kienu impjantati taħt il-ġilda materjali solidi (plastik u metalli).
English: • redness of the skin (erythema) ,
Maltese: • ħmura tal-ġilda (eritema),
English: If you are nursing, you should receive this medicine only if your treating physician or surgeon considers the benefits to you outweigh the risks to your child.
Maltese: Jekk int qed tredda', int għandek tingħata din il-mediċina biss jekk it-tabib jew il-kirurgu kuranti jemmen li l-benefiċċji huma akbar mir-riskji għat-tifel/tifla tiegħek.
English: Post-marketing surveillance data includes reports that the use of the medicinal product in combination with a synthetic bone void filler, may lead to an increase in local inflammation, infection and occasionally migration of the implanted materials.
Maltese: Id-dejta tas-sorveljanza ta' wara t-tqegħid fis-suq tinkludi rapporti li l-użu tal-prodott mediċinali flimkien ma' filler għall-mili tal-vojt tal-għadam, jista' jwassal għal żieda f'infjammazzjoni lokali, infezzjoni u migrazzjoni okkażjonali tal-materjali impjantati.
English: As human IgG is secreted into human milk, and the potential for harm to the infant is unknown, women should not breast-feed during Opgenra therapy (see section 5.3).
Maltese: Peress li l-IgG joħroġ fil-ħalib uman, u l-potenzjal tal-ħsara għat-tarbija mhux magħruf, in-nisa ma għandhomx ireddgħu matul it-terapija b'Opgenra (ara sezzjoni 5.3).
English: Common: bone formation increased (heterotopic bone formation)
Maltese: Komuni: Żieda fil-formazzjoni tal-għadam (formazzjoni tal-għadam eterotopiċi)
English: Gently stir the contents of the bowl with a sterile spatula to aid mixing.
Maltese: Neħħi l-prodott rikostitwit mill-iskutella sterili b'istrument sterili bħal ngħidu aħna spatula jew kurette.
English: Treatment requires a single surgery.
Maltese: Jista' jkun hemm bżonn ta' aktar operazzjonijiet.
English: The peak antibody response was seen 3 months following treatment.
Maltese: L-ogħla rispons ta' antikorp deher 3 xhur wara t-trattament.
English: The effect of anti-OP-1 antibodies on the bone healing process was studied in dogs with two long bone defects treated with repeat implantations.
Maltese: L-effett ta' antikorpi anti-OP-1 fuq il-proċess ta' fejqan tal-għadam kien studjat fil-klieb fil-każ ta' difetti ta' żewġ għadmiet twal li kienu kkurati b'impjantazzjonijiet ripetuti.
English: *Grading according to Trey, Burns and Saunders (1966)
Maltese: *Klassifikazzjoni skont Trey, Burns u Saunders (1966)
English: Increased alanine aminotransferase (ALT)
Maltese: Żieda f'alanine aminotransferase (ALT)
English: Odds Ratio (95% CI)
Maltese: Odds Ratio (CI ta' 95%)
English: Malta (See Ireland)
Maltese: (See Ireland)
English: Endocarditis, otitis externa
Maltese: Endokardite, otite esterna
English: Study ML17131
Maltese: Studju ML17131
English: Study NV15496 + NV15497 + NV15801
Maltese: Studju NV15496 + NV15497 + NV15801
English: # p-value (vs. lamivudine) < 0.01 (stratified Cochran-Mantel-Haenszel test)
Maltese: # valur p (vs. lamivudine) < 0.01 (test Cochran-Mantel-Haenszel stratifikat)
English: < 10 g/dl, and ≥ 8.5 g/dl
Maltese: < 10 g/dl, u ≥ 8.5 g/dl
English: 180 micrograms <75 kg = 1000 mg ≥75 kg = 1200 mg
Maltese: 180 mikrogramma <75 kg = 1000 mg ≥75 kg = 1200 mg
English: Luxembourg/Luxemburg (Voir/siehe Belgique/Belgien)
Maltese: (Voir/siehe Belgique/Belgien)
English: Roche România S.R.L.
Maltese: România Roche România S.R.L.
English: Endocrine system
Maltese: Sistema endokrinarja
English: Haematological (see also Table 3)
Maltese: Ematoloġiċi (ara wkoll Tabella 3)
English: Benzyl alcohol Sodium acetate Acetic acid Water for injections
Maltese: Benzyl alcohol Sodium acetate Acetic acid
English: Grade 3-4*
Maltese: Grad 1-2 Grad 3-4*
English: Study WV16240
Maltese: Studju WV16240
English: Date of latest renewal: 20 June 2007
Maltese: Data tal-aħħar tiġdid: 20 ta' Ġunju 2007
English: Depression*, anxiety, insomnia*
Maltese: Depressjo ni*, ansjetà, insomnja*
English: S-Bilirubin (mg/dl)
Maltese: Bilirubina-S (mg/dl)
English: SI unit = µmol/l)
Maltese: Kejl SI = µmol/l
English: COBAS AMPLICOR HBV MONITOR: HBV-DNA (IU/mL) = HBV-DNA
Maltese: kopji/mL. COBAS AMPLICOR HBV MONITOR: DNA ta' HBV (IU/mL) = DNA ta' HBV
English: The Child-Pugh classification divides patients into groups A, B, and C, or "Mild", "Moderate" and "Severe" corresponding to scores of 5-6, 7-9 and 10-15, respectively.
Maltese: Il-klassifikazzjoni Child-Pugh taqsam il-pazjenti fi gruppi A, B, u Ċ, jew “Ħafif”, “Moderat” u “Sever” li jikkorrispondu għall-punteġġ ta' 5-6, 7-9 u 10-15, rispettivament.
English: P=0.0006 P=0.11 P=0.002
Maltese: 0006 P=0.11 P=0.002
English: Pegasys contains benzyl alcohol.
Maltese: Pegasys fih benzyl alcohol.
English: Study NV17317
Maltese: Studju NV17317
English: * Similar to end point of HBV DNA < 10
Maltese: * Simili għal punt finali ta' DNA ta' HBV < 10
English: Genotype 1 (N= 569)
Maltese: Ġenotip 1 (N=569)
English: Pharmacotherapeutic group: Immunostimulants, interferons, ATC code: L03AB11
Maltese: Immunostimulanti, interferoni, Kodiċi ATC: L03AB11
English: Genotype 2 and 3 (N=96)
Maltese: Ġenotip 2 u 3 (N=96)
English: Anti-interferon antibodies
Maltese: Anti-korpi kontra interferon
English: A total of 283/1351 (21%) of patients had advanced fibrosis or cirrhosis, 85/1351 (6%) had cirrhosis.
Maltese: Total ta' 283/1351 (21%) tal-pazjenti kellhom fibrożi avanzata jew ċirrożi, 85/1351 (6%) kellhom ċirrożi.
English: Genotype 2-3
Maltese: Ġenotip 2-3
English: Roche AB
Maltese: Sverige Roche AB
English: copies/ml.
Maltese: kopja/ml.
English: cells/mm3
Maltese: /mm3
English: Study NV15801
Maltese: Studju NV15801
English: HCV genotype 2 and 3
Maltese: HCV ta' ġenotip 2 u 3
English: 1 - <2 log10 decline
Maltese: Tnaqqis ta' 1<2 log10
English: D-82377 Penzberg Germany
Maltese: Nonnenwald 2 D-82377 Penzbergi
English: • Combination with telbivudine (see section 4.5)
Maltese: • Taħlita ma' telbivudine (ara sezzjoni 4.5)
English: The absolute bioavailability of Pegasys is 84% and is similar to that seen with interferon alfa-2a.
Maltese: Il-bijodisponibiltà assoluta ta' Pegasys hija ta' 84% u hija simili għal dik osservata b'interferon alfa-2a.
English: p value
Maltese: Valur p
English: 500 to < 750 cells/mm3
Maltese: 500 sa < 750 ċellula/mm3
English: Gastrointestinal disorder
Maltese: Disturbi gastrointestinali
English: The conjugation of PEG reagent (bis-monomethoxypolyethylene glycol) to interferon alfa-2a forms a pegylated interferon alfa-2a (Pegasys).
Maltese: Il-konjugazzjoni tar-reaġent PEG (bis-monomethoxypolyethylene glycol) ma' interferon alfa-2a jifforma interferon alfa-2a pegilat (Pegasys).
English: INFORMATION IN BRAILLE pegasys 135 mcg
Maltese: INFORMAZZJONI BIL-BRAILLE pegasys 135 mcg
English: Both studies compared Pegasys plus placebo vs Pegasys plus lamivudine vs lamivudine alone.
Maltese: Iż-żewġ studji qabblu Pegasys u plaċebo vs Pegasys u lamivudine vs lamivudine waħdu.
English: Body weight kg (lbs)
Maltese: Piż tal-ġisem kg (lbs)
English: Pegylated interferon Interferon plus ribavirin Pegylated interferon plus ribavirin
Maltese: Interferon pegilat Interferon flimkien ma' ribavirin Interferon pegilat flimkien ma' ribavirin
English: Response Parameter
Maltese: Parametru ta' Rispons
English: 135 micrograms/0.5 ml
Maltese: 135 mikrogramma/0.5 ml
English: Chronic hepatitis B - adult patients
Maltese: Epatite B kronika - pazjenti adulti
English: Pegasys pharmacokinetics have been characterized in paediatric patients with CHB (YV25718), as well as in paediatric patients with CHC (NR16141), using population pharmacokinetics.
Maltese: Il-farmakokinetika ta' Pegasys kienet ikkaratterizzata f'pazjenti pedjatriċi b'CHB (YV25718), kif ukoll f'pazjenti pedjatriċi b'CHC (NR16141), bl-użu tal-farmakokinetika tal-popolazzjoni.
English: Pegasys contains benzyl alcohol
Maltese: Pegasys fih benzyl alcohol
English: Roche Diagnostics GmbH Nonnenwald 2
Maltese: Roche Diagnostics GmbH
English: Reduce Pegasys to 135/90/45 micrograms
Maltese: Pegasys għal 135/90/45 mik rogramma
English: Odds Ratio (95% CI) = 0.53 (0.33 to 0.85), P-value (stratified Cochran-Mantel-Haenszel test) = < 0.0084
Maltese: Odds Ratio (CI ta' 95%) = 0.53 (0.33 sa 0.85), Valur p (test Cochran-Mantel-Haenszel stratifikat) = < 0.0084
English: A similar negative predictive value has been observed in HIV-HCV co-infected patients treated with Pegasys monotherapy or in combination with ribavirin (100% (130/130) or 98% (83/85), respectively).
Maltese: Valur negattiv imbassar simili kien osservat f'pazjenti b'infezzjoni fl-istess waqt ta' HIV-HCV ikkurati b'monoterapija ta' Pegasys jew f'taħlita ma' ribavirin (100% (130/130) jew 98% (83/85), rispettivament).
English: - Adequately controlled thyroid function (TSH and T4)
Maltese: - Funzjoni tat-tirojde kkontrollata kif jixraq (TSH u T4)
English: HBsAg Seroconversion
Maltese: Serokonverżjoni ta' HBsAg
English: The dose reduction levels are provided in Table 8.
Maltese: Il-livelli ta' tnaqqis fid-doża huma pprovduti f'Tabella 8.
English: ● The active substance is peginterferon alfa-2a.
Maltese: • Is-sustanza attiva hija peginterferon alfa-2a.
English: Group B** Untreated (N=50)
Maltese: Grupp B** Mhux ittrattati (N=50)
English: INFORMATION IN BRAILLE pegasys 90 mcg
Maltese: INFORMAZZJONI BIL-BRAILLE pegasys 90 mcg
English: A total of 151 patients without advanced fibrosis were 2:1 randomized to Pegasys (group A, n=101) or untreated control (group B, n=50), respectively.
Maltese: Total ta' 151 pazjent mingħajr fibrożi avanzata kienu randomised 2:1 għal Pegasys (grupp A, n=101) jew kontroll mingħajr trattament (grupp B, n=50), rispettivament.
English: Anaphylaxis, systemic lupus erythematosu s rheumatoid arthritis
Maltese: Anafilassi, lupus erythematosus sistemika, artrite rewmatojda
English: Excipient with known effect: Benzyl alcohol (10 mg/ 1 ml) For the full list of excipients, see section 6.1.
Maltese: Eċċipjent b'effett magħruf: Benzyl alcohol (10 mg/ 1 ml) Għal-lista sħiħa ta' eċċipjenti, ara sezzjoni 6.1.
English: Pegasys plus ribavirin
Maltese: Pegasys ma' ribavirin
English: Aggression, mood alteration, emotional disorders, nervousness, libido decreased
Maltese: Aggressjoni, tibdil filburdata, disturbi emozzjonali, nervi, tnaqqis fil-libido
English: Pancytopenia Aplastic anaemia
Maltese: Panċitopenija Anemija aplastika
English: Study NV15495
Maltese: Studju NV15495
English: Limited safety data are available in co-infected patients with CD4+ cell counts <200/µl.
Maltese: Dejta limitata dwar is-sigurtà hija disponibbli f'pazjenti ko-infettati b'għadd ta' ċelluli CD4+ ta' < 200/µl.
English: Only HIV-HCV co-infected patients were included in the study NR15961 (see Table 21).
Maltese: Pazjenti ko-infettat b'HIV-HCV biss kienu inklużi fl-istudju NR15961 (ara Tabella 21).
English: Study NV15942
Maltese: Studju NV15942
English: 25,000 to cells/mm3
Maltese: 25,000 sa ċellula/mm3
English: ALT <1xULN >=1xULN<1.5xULN >=1.5xULN<2xULN >=2xULN<5xULN >=5xULN<10xULN >=10xULN
Maltese: <1.5xULN >=1.5xULN
English: Peptic ulcer, pancreatitis
Maltese: Ulċera peptika,
English: For more information, see section 5.1.
Maltese: Għal informazzjoni dwar valuri mbassra għal rispons waqt it-trattament, ara sezzjoni 5.1.
English: Hypoglycaemia, hyperglycaemia and diabetes mellitus have been observed with Pegasys (see section 4.8).
Maltese: Ipogliċemija, ipergliċemija u dijabete mellitus kienu osservati b'Pegasys (ara sezzjoni 4.8).
English: Treatment difference [95%CI]
Maltese: Differenza fil-kura [CI ta' 95%]
English: No single biomarker with a cut-off can be identified to optimize all the operating characteristics (negative predictive value [NPV], sensitivity, specificity) and practical characteristics (simplicity, convenience).
Maltese: (valur ta' tbassir negattiv [NPV - negative predictive value], sensittività, speċifiċità) u karatteristiċi prattiċi (sempliċità, konvenjenza).
English: S-Albumin (g/dl) >3.5
Maltese: Albumina-S (g/dl)
English: 1-5% of patients treated with Pegasys developed neutralising anti-interferon antibodies.
Maltese: 1-5% tal-pazjenti kkurati b'Pegasys żviluppaw anti-korpi newtralizzanti kontra interferon.
English: The possibility to consider shortening treatment duration to 24 weeks in genotype 1 and 4 patients was examined based on a sustained rapid virological response observed in patients with rapid virological response at week 4 in studies NV15942 and ML17131 (see Table 15).
Maltese: Il-possibbiltà li jiġi kkunsidrat tnaqqis fit-tul tal-kura għal 24 ġimgħa f'pazjenti b'ġenotip 1 u 4 kienet studjata bbażata fuq rispons viroloġiku rapidu sostenut osservat f'pazjenti b'rispons viroloġiku rapidu f'ġimgħa 4 fl-istudji NV15942 u ML17131 (ara Tabella 15).
English: Dyspnoea, epistaxis
Maltese: Qtugħ ta' nifs, epistassi
English: Positive predictive values of 45% (50/110) and 70% (59/84) were observed for genotype 1 and genotype 2/3 HIV-HCV co-infected patients receiving combination therapy.
Maltese: Valuri pożittivi mbassra ta' 45% (50/110) u 70% (59/84) kienu osservati f'pazjenti b'infezzjoni fl-istess waqt ta' HIV-HCV ta' ġenotip 1 u ġenotip 2/3 li kienu qed jirċievu terapija kombinata.
English: 180 micrograms/0.5 ml
Maltese: 180 mikrogramma/0.5 ml
English: Dental and periodontal disorders
Maltese: Disturbi dentali u paradentali
English: 180 micrograms/1 ml
Maltese: 180 mcg/1 ml
English: Patients with advanced fibrosis were assigned to Pegasys treatment (group C, n=10).
Maltese: Pazjenti b'fibrożi avanzata kienu assenjati għal trattament b'Pegasys (grupp Ċ, n=10).
English: HBsAg > 20,000 HBV DNA > 8 log10
Maltese: HBsAg > 20,000 DNA ta' HBV > 8 log10
English: Odds Ratio (95% CI) = 2.89 (1.93 to 4.32), P-value (stratified Cochran-Mantel-Haenszel test) = < 0.0001 * Interferon alfa-2a 3 MIU & ribavirin 800 mg vs. Pegasys 180 mcg:
Maltese: Odds Ratio (-CI ta' 95%) = 2.89 (1.93 sa 4.32), Valur p (test Cochran-Mantel-Haenszel stratifikat) = < 0.0001 * Interferon alfa-2a 3 MIU & ribavirin 800 mg vs.
English: copies/mL.
Maltese: kopji/ml
English: Group A (Pegasys treatment) (N=101)
Maltese: Grupp A (Trattament b'Pegasys)
English: Pegasys 360/180 or 180 mcg
Maltese: Pegasys 360/180 jew 180 mcg
English: • Autoimmune hepatitis
Maltese: • Epatite awtoimmuni
English: Idiopathic or thrombotic thrombocytop enic purpura
Maltese: Purpura tromboċitop enika idjopatika jew trombotika
English: If VKH syndrome is suspected, antiviral treatment should be withdrawn and corticosteroid therapy discussed (see section 4.8).
Maltese: Jekk hemm suspett tas-sindrome VKH, kura antivirali għandha titwaqqaf u għandha tiġi diskussa terapija b'kortikosterojdi (ara sezzjoni 4.8).
English: * 95% CI for difference: 11% to 33% p-value (stratified Cochran-Mantel-Haenszel test) = 0.001 ** 95% CI for difference: 3% to 16% p-value (stratified Cochran-Mantel-Haenszel test) = 0.003
Maltese: * CI ta' 95% għad-differenza: 11% sa 33% valur p (test Cochran-Mantel-Haenszel stratifikat) = 0.001 ** CI ta' 95% għad-differenza: 3% sa 16% valur p (test Cochran-Mantel-Haenszel stratifikat) = 0.003
English: Pegasys is indicated for the treatment of hepatitis B envelope antigen (HBeAg)-positive or HBeAgnegative chronic hepatitis B (CHB) in adult patients with compensated liver disease and evidence of viral replication, increased alanine aminotransferase (ALT) and histologically verified liver inflammation and/or fibrosis (see sections 4.4 and 5.1).
Maltese: Pegasys huwa indikat għall-kura ta' epatite B kronika (CHB - chronic hepatitis B) pożittiva għallenvelope antigen tal-epatite B (HBeAg - hepatitis B envelope antigen) jew negattiva għal HBeAg f'pazjenti adulti b'mard kumpensat tal-fwied u b'evidenza ta' replikazzjoni virali, żieda fl-alanine aminotransferase (ALT) u infjammazzjoni tal-fwied verifikata b'mod istoloġiku u/jew fibrożi (ara sezzjonijiet 4.4 u 5.1).
English: HBV DNA response *
Maltese: DNA ta' HBV*
English: 1 Cochran-Mantel-Haenszel test, stratified by genotype (A vs. non-A) and baseline ALT (< 5 × ULN and >= 5 × ULN) 2 Fisher's Exact Test
Maltese: 1 Test ta' Cochran-Mantel-Haenszel, stratifikat skont il-ġenotip (A vs. mhux A) u ALT fil-linja bażi (< 5 × ULN u >= 5 × ULN)
English: Pegasys treatment was associated with abnormal laboratory values: ALT increase, bilirubin increase, electrolyte disturbance (hypokalaemia, hypocalcaemia, hypophosphataemia), hyperglycaemia, hypoglycaemia and elevated triglycerides (see section 4.4.).
Maltese: Kura b'Pegasys kienet assoċċjata ma' riżultati tal-laboratorju mhux normali: żieda fl-ALT, żieda filbilirubina, disturbi fl-elettroliti (ipokalimja, ipokalċimija, ipofosfatimija), ipergliċemija, ipogliċemija u żieda fit-trigliċeridi (ara sezzjoni 4.4).
English: Special populations
Maltese: eritema multiforme
English: Infectious mononucleosis, pharyngitis streptococcal, influenza, gastroenteritis viral, candidiasis, gastroenteritis, tooth abscess, hordeolum, urinary tract infection, nasopharyngitis
Maltese: Mononukleosi infettiva, farinġite kkawżata minn streptokokki, influwenza, gastroenterite virali, kandidjasi, gastroenterite, axxess f'sinna, hordeolum, infezzjoni fl apparat tal-awrina, nażofarinġite
English: Anaemia (haemoglobin < 10 g/dl) was reported in 7% and 14% of patients treated with Pegasys monotherapy or in combination therapy, respectively.
Maltese: Anemija (emoglobina < 10g/dl) kienet irrappurtata f'7% u f'14% tal-pazjenti kkurati b'Pegasys waħdu jew f'terapija kombinata, rispettivament.
English: Lamivudine 100 mg (N=271)
Maltese: 100 mg (N=271)
English: Table 12: Serological, virological and biochemical responses in chronic hepatitis B HBeAg positive Study WV16240
Maltese: Tabella 12: Risponsi seroloġiċi, viroloġiċi u bijokimiċi f'epatite B kronika Pożittivi għal HBeAg Studju WV16240
English: ● Remove the protective cap from the Pegasys vial (1).
Maltese: ● Neħħi l-għatu protettiv mill-kunjett ta' Pegasys (1).
English: Thrombocytopenia Platelet 25,000 to <50,000 cells/mm3: 2 level adjustment.
Maltese: Plejtlits 25,000 sa <50,000 ċellula/mm3: aġġustament ta' 2 livelli.
English: Pegasys possesses the in vitro antiviral and antiproliferative activities that are characteristic of interferon alfa-2a.
Maltese: Pegasys in vitro għandu l-attivitajiet antivirali u antiproliferattivi li huma karatteristiċi ta' interferon alfa-2a.
English: Tachycardia, oedema peripheral, palpitations
Maltese: Takikardija, edima periferali, palpitazzjonijie t
English: *The active substance, peginterferon alfa-2a, is a covalent conjugate of the protein interferon alfa-2a produced by recombinant DNA technology in Escherichia coli with bis-[monomethoxy polyethylene glycol].
Maltese: *Is-sustanza attiva, peginterferon alfa-2a, hija konjugat kovalenti tal-proteina interferon alfa-2a magħmula permezz ta' teknoloġija tat-tfassil tad-DNA f'Escherichia coli flimkien ma' bis[monomethoxy polyethylene glycol].
English: Genotype 2 or 3 RVR
Maltese: Ġenotip 2 jew 3 RVR