FrancophonIA/ELRC3.0 huggingface dataset:
English: In the meantime, the applicant withdrew the application in the Netherlands.
Maltese: Fil-frattemp, l-applikant irtira l-applikazzjoni fin-Netherlands.
English: The CMDh 60 day procedure was initiated on 29 January 2018.
Maltese: Il-proċedura ta' 60 jum tas-CMDh inbdiet fid-29 ta' Jannar 2018.
English: The reference medicinal product (Taxol) has a complex formulation for which it is known that the micellar formulation affects the pharmacokinetic profile of paclitaxel after intravenous administration.
Maltese: Il-prodott mediċinali ta' referenza (Taxol) għandu formulazzjoni kumplessa li għaliha huwa magħruf li l-formulazzjoni ta' miċelli taffettwa l-profil farmakokinetiku ta' paclitaxel wara amministrazzjoni intravenuża.
English: The CHMP considered that it is essential in order to waive the bioequivalence study requirement to establish that the generic medicinal product and the reference medicinal product have the same behaviour in plasma and ultimately in vivo, i.e. a direct comparison of the free fraction between the two medicinal products should be considered in line with the “Reflection paper on the pharmaceutical development of intravenous medicinal products containing active substances solubilised in micellar systems” (EMA/CHMP/QWP/799402/2011
Maltese: Is-CHMP ikkunsidra li sabiex jitneħħa r-rekwiżit tal-istudju ta' bijoekwivalenza, huwa essenzjali li jiġi stabbilit li l-prodott mediċinali ġeneriku u l-prodott mediċinali ta' referenza għandhom l-istess imġiba fil-plażma u finalment in vivo, jiġifieri tqabbil dirett tal-frazzjoni ħielsa bejn iż-żewġ prodotti mediċinali għandu jiġi kkunsidrat f'konformità mar-”Reflection paper on the pharmaceutical development of intravenous medicinal products containing active substances solubilised in micellar systems” (Dokument ta' riflessjoni dwar l-iżvilupp farmaċewtiku tal-prodotti mediċinali intravenużi li fihom sustanzi attivi solubilizzati f'sistemi ta' miċelli) (EMA/CHMP/QWP/799402/2011
English: • The Committee considered the referral under Article 29(4) of Directive 2001/83/EC.
Maltese: • Il-Kumitat ikkunsidra r-riferiment skont l-Artikolu 29(4) tad-Direttiva 2001/83/KE.
English: On 29 March 2018 Portugal therefore triggered a referral under Article 29(4) of Directive 2001/83/EC.
Maltese: Fid-29 ta' Marzu 2018, il-Portugall għaldaqstant skatta riferiment skont l-Artikolu 29(4) tad-Direttiva 2011/83/KE.
English: On day 210, major issues on bioequivalence, raised by the Netherlands, remained unresolved; hence the procedure was referred to the Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), under Article 29, paragraph 1 of Directive 2001/83/EC, by Portugal on 02 November 2017.
Maltese: Fil-210 jum, kwistjonijiet ewlenin dwar il-bijoekwivalenza, imqajma min-Netherlands, baqgħu mhux solvuti; għaldaqstant il-proċedura ġiet riferuta lill-Grupp ta' Koordinazzjoni għal Proċedura tarRikonoxximent Reċiproku u l-Proċedura Deċentralizzata - Bniedem (CMDh), skont l-Artikolu 29, paragrafu 1 tad-Direttiva 2001/83/KE, mill-Portugall fit-02 ta' Novembru 2017.
English: The applicant submitted a study report with results of the direct comparison of micelles' characteristics of Paclitaxel Hetero and Taxol and another publication containing data on the free drug fraction of Taxol in human plasma.
Maltese: L-applikant issottometta rapport ta' studju bir-riżultati tat-tqabbil dirett tal-karatteristiċi tal-miċelli ta' Paclitaxel Hetero u Taxol u pubblikazzjoni oħra li fiha data dwar il-frazzjoni ħielsa mid-droga ta' Taxol fil-plażma umana.
English: However, the additional data provided were not robust enough to establish equivalence between Paclitaxel Hetero and the EU reference medicinal product.
Maltese: Madankollu, id-data addizzjonali pprovduta ma kinitx robusta biżżejjed biex tistabbilixxi ekwivalenza bejn Paclitaxel Hetero u l-prodott mediċinali ta' referenza tal-UE.
English: Day 60 of the CMDh procedure was on 29 March 2018 and as no agreement could be reached the procedure was referred to the CHMP.
Maltese: Is-60 jum tal-proċedura CMDh kien id-29 ta' Marzu 2018 u peress li ma seta' jintlaħaq l-ebda ftehim, il-proċedura ġiet riferuta lis-CHMP.
English: The CHMP considered, as a consequence, that the benefit-risk balance of Paclitaxel Hetero is not favourable.
Maltese: Konsegwentament, il-Kumitat ikkunsidra li l-bilanċ bejn il-benefiċċju u r-riskju ta' Paclitaxel Hetero mhuwiex favorevoli.
English: The Netherlands raised objections on the fact that the indirect comparison data on which the applicant based its claim for equivalence was not considered robust nor was convincing enough to support a biowaiver, and this was regarded to be a potential serious risk to public health.
Maltese: In-Netherlands oġġezzjona dwar il-fatt li d-data ta' tqabbil indirett li fuqha l-applikant ibbaża t-talba tiegħu għal ekwivalenza ma kinitx ikkunsidrata robusta u lanqas ma kienet konvinċenti biżżejjed biex tappoġġa bijoderoga, u din kienet ikkunsidrata bħala riskju potenzjali serju għas-saħħa pubblika.
English: • The Committee considered the totality of the data submitted by the applicant in relation to the objections raised as potential serious risk to public health.
Maltese: • Il-Kumitat ikkunsidra t-totalità tad-data sottomessa mill-applikant fir-rigward tal-oġġezzjonijiet li tqajmu bħala riskju serju potenzjali għas-saħħa pubblika.
English: In such case, in principle a biowaiver of in vivo bioequivalence study is only possible when there are adequate in vitro data to demonstrate similarity between generic and reference medicinal product.
Maltese: F'tali każ, fil-prinċipju, bijoderoga ta' studju ta' bijoekwivalenza in vivo tkun possibbli biss meta jkun hemm data in vitro adegwata biex turi similarità bejn prodott mediċinali ġeneriku u prodott ta' referenza.
English: • The Committee considered that the data available was insufficient to establish equivalence between Paclitaxel Hetero and the EU reference medicinal product.
Maltese: Paclitaxel Hetero u l-prodott mediċinali ta' referenza tal-UE.
English: While there may be occasions where an indirect comparison may be acceptable to support a biowaiver, having assessed the literature provided, the CHMP concluded that the data was not sufficiently robust nor convincing enough to replace the need for a head-to-head comparison using identical methods and performed at the same time for test and reference product, and therefore should be understood as supportive only.
Maltese: Filwaqt li jista' jkun hemm okkażjonijiet fejn tqabbil indirett jista' jkun aċċettabbli biex tiġi appoġġata bijoderoga, wara li vvaluta l-litteratura pprovduta, is-CHMP ikkonkluda li d-data ma kinitx robusta biżżejjed u lanqas konvinċenti biżżejjed biex tissostitwixxi l-bżonn għal tqabbil ras imb ras li juża metodi identiċi u li jitwettaq fl-istess ħin għal prodott ta' test u ta' referenza, u għaldaqstant id-data għandha tinftiehem biss bħala ta' appoġġ.
English: It may harm them,
Maltese: L-effett ta' Besremi fit-tqala mhuwiex magħruf.
English: Control treatment arm (n=127)
Maltese: Grupp ta' trattament Kontroll (n=127)
English: Endocrine system
Maltese: Sistema endokrinali
English: System organ class Frequency
Maltese: Sistema talKlassifika talOrgani
English: Haematocrit (%)* Platelets (109/L)* Leukocytes (109/L)*
Maltese: Ematokrit (%)* Plejtlits (109/L)*
English: • Optional: adhesive plaster
Maltese: • Fakultattiv: stikka
English: Pharmacotherapeutic group: Immunostimulants, interferons, ATC code: L03AB15
Maltese: Immunostimulanti, interferoni, Kodiċi ATC: L03AB15
English: Nuclear translocation of STAT proteins controls distinct gene-expression programs and exhibit various cellular effects.
Maltese: It-traslokazzjoni nukleari ta' proteini STAT tikkontrolla programmi distinti ta' espressjoni ta' ġeni u tesebixxi effetti ċellulari diversi.
English: Central nervous system (CNS)
Maltese: Sistema nervuża ċentrali (SNĊ)
English: Mean % (± SD)
Maltese: Medja % (± SD)
English: • Combination with telbivudine (see section 4.5)
Maltese: • Kombinazzjoni ma' telbivudine (ara sezzjoni 4.5)
English: Do not apply further force.
Maltese: Tapplikax aktar forza.
English: Sodium chloride Sodium acetate, anhydrous Acetic acid, glacial Benzyl alcohol Polysorbate 80
Maltese: Sodium chloride Sodium acetate, anidru Acetic acid, glaċjali Benzyl alcohol Polysorbate 80
English: Responder % (n/N)
Maltese: Irrispondew % (n/N)
English: Besremi contains benzyl alcohol.
Maltese: Besremi fih benzyl alcohol.
English: Presence of splenomegaly
Maltese: Preżenza ta' splenomegalija
English: very rare blindness#
Maltese: rari ħafna għama#
English: The most common adverse reactions are leukopenia (19.1%), thrombocytopenia (18.5%), arthralgia (12.9%), fatigue (12.4%), increased gamma-glutamyltransferase (11.2%), influenza like illness (10.7%), myalgia (10.7%), pyrexia (8.4%), pruritus (8.4%), increased alanine aminotransferase (8.4%), anaemia (7.9%), pain in extremity (6.7%), alopecia (6.7%), neutropenia (6.7%), increased aspartate aminotransferase (6.2%), headache (6.2%), diarrhoea (5.6%), chills (5.1%), dizziness (5.1%) and injection site reaction (5.1%).
Maltese: 7%), deni (8.4%), ħakk (8.4%), żieda fl-alanine aminotransferase (8.4%), anemija (7.9%), uġigħ fl-estremitajiet (6.7%), alopeċja (6.7%), newropenija (6.7%), żieda flaspartate aminotransferase (6.2%), uġigħ ta' ras (6.2%), dijarea (5.6%), sirdat (5.1%), sturdament (5.1%) u reazzjoni fis-sit tal-injezzjoni (5.1%).
English: • End stage renal disease (GFR <15 mL/min)
Maltese: • Mard tal-aħħar stadju tal-kliewi (GFR <15 mL/min)
English: Duration of PV (months)*
Maltese: Tul ta' PV (xhur)*
English: Abbreviations: CTCAE, common terminology criteria for adverse events; n.r., not reported; ADR, adverse drug reaction; PT, preferred term; IR, incidence rate of mean adverse events per 100 patients per year; N: number of patients.
Maltese: ADR, adverse drug reaction (reazzjoni avversa għall-mediċina); PT, preferred term (terminu ppreferut); IR, incidence rate of mean adverse events per 100 patients per year (rata ta' inċidenzi tal-medja tal-każijiet avversi għal kull 100 pazjent fis-sena); N: number of patients (l-għadd ta' pazjenti).
English: • Decompensated cirrhosis of the liver (Child-Pugh B or C)
Maltese: • Ċirrożi dekompensata tal-fwied (Child-Pugh B jew Ċ)
English: not known pulmonary fibrosis#, pneumonia#, pulmonary arterial hypertension#*
Maltese: mhux magħruf fibrożi pulmonari#, pnewmonja#, pressjoni għolja fl-arterja pulmonari#*
English: • Immunosuppressed transplant recipients
Maltese: • Reċipjenti immunosoppressivi ta' trapjant
English: Besremi contains benzyl alcohol
Maltese: Besremi fih benzyl alcohol
English: Binding to IFNAR initiates a downstream signalling cascade through the activation of kinases, in particular Janus kinase 1 (JAK1) and tyrosine kinase 2 (TYK2) and activator of transcription (STAT) proteins.
Maltese: Janus kinase 1 (JAK1) u tyrosine kinase 2 (TYK2) u attivatur ta' proteini ta' traskrizzjoni (STAT).
English: After 36 months of treatment, the complete haematological response was 70.5%.
Maltese: Wara 36 xahar ta' trattament, ir-rispons ematoloġiku komplut kien 70.5%.
English: - The active substance is ropeginterferon alfa-2b.
Maltese: - Is-sustanza attiva hi ropeginterferon alfa-2b.
English: Besremi 250 micrograms/0.5 mL
Maltese: Besremi 250 mikrogramma/0.5 mL
English: Besremi 500 micrograms/0.5 mL
Maltese: Besremi 500 mikrogramma/0.5 mL
English: Dental and periodontal disorders
Maltese: Disturbi dentali u perjodontali
English: Serious adverse reactions are depression (1.1%), atrial fibrillation (1.1%) and acute stress disorder
Maltese: Reazzjonijiet avversi serji huma depressjoni (1.1%) fibrillazzjoni atrijali (1.1%) u disturb akut tal-istress (0.6%).
English: Inter-subject variability was observed with 25% and 35% for AUC and Cmax, respectively, in healthy volunteers.
Maltese: u 35% għal AUC u Cmax, rispettivament, f'voluntiera b'saħħithom.
English: This droplet is normal and does not mean that you underdosed.
Maltese: Din il-qatra hija normali u ma tfissirx li ġejt sottodożat.
English: Inter-subject variability for ropeginterferon alfa-2b was 35% (Cmax) and 25% (AUC).
Maltese: Varjabilità bejn individwu u ieħor għal ropeginterferon alfa-2b kienet ta' 35% (Cmax) u 25% (AUC).
English: Ropeginterferon alfa-2b is a recombinant interferon alfa-2b conjugated with a two-arm methoxypolyethylene glycol (mPEG) at a degree of substitution of 1 mole of polymer/mole of protein.
Maltese: Ropeginterferon alfa-2b huwa interferon alfa-2b rikombinanti kkonjugat b'żewġ gruppi ta' methoxypolyethylene glycol (mPEG) fi grad ta' sostituzzjoni ta' mole 1 ta' polymer/mole ta' proteina.
English: TAIWAN
Maltese: IT-TAJWAN
English: The Besremi 500 micrograms pre-filled pen can be used to inject doses of 50, 100, 150, 200, 250, 300, 350, 400, 450 and 500 micrograms.
Maltese: Il-pinna mimlija għal-lest ta' Besremi 500 mikrogramma tista' tintuża biex tinjetta dożi ta' 50, 100, 150, 200, 250, 300, 350, 400, 450 u 500 mikrogramma.
English: An abortifacient effect was reported in primates receiving other interferon alfa medicinal products.
Maltese: Effett abortifiċenti ġie rapportat fi primati li rċevew prodotti mediċinali oħra ta' interferon.
English: Years*
Maltese: Snin*
English: How to store Besremi 6.
Maltese: Kif taħżen Besremi 6.
English: Mean Cmax was 2.4 ng/mL (with a dose of 5080 micrograms) to 49 ng/mL (with a dose of 450 micrograms) and AUC0-t ranged from 28.5 ng.h/mL (with a dose of 50 - 80 micrograms) to 552.6 ng.h/mL (with a dose of 450 micrograms) in patients after subcutaneous multiple dose administration.
Maltese: Is-Cmax medja kienet ta' 2.4 ng/mL (b'doża ta' 50-80 mikrogramma) għal 49 ng/mL (b'doża ta' 450 mikrogramma) u l-AUC0-t kienet fuq firxa ta' 28.5 ng.h/mL (b'doża ta' 50-80 mikrogramma) għal 552.6 ng.h/mL (b'doża ta' 450 mikrogramma)
English: Co-administration of pegylated interferon alfa-2b showed no significant interaction with tolbutamide (CYP2C9 substrate), midazolam (CYP3A4 substrate), dapsone (N-acetyltransferase substrate) and modestly increased the exposure of caffeine (CYP1A2 substrate) and desipramine (CYP2D6 substrate).
Maltese: L-għoti fl-istess waqt ta' pegylated interferon alfa-2b ma wera l-ebda interazzjoni sinjifikanti ma' tolbutamide (sottostrat ta' CYP2C9), midazolam (sottostrat ta' CYP3A4), dapsone (sottostrat ta' N-acetyltransferase) u żied b'mod modest l-esponiment ta' kaffeina (sottostrat ta' CYP1A2) u desipramine (sottostrat ta' CYP2D6).
English: Name and address of the manufacturer(s) of the biological active substance(s) PharmaEssentia Corp.
Maltese: Isem u indirizz tal-manifattur(i) tas-sustanza(i) bijoloġika(ċi attiva/i PharmaEssentia Corp.
English: Hydroxycarbamide treatment-naïve (n=160) or hydroxycarbamide treated (n=94) patients were randomised to receive ropeginterferon alfa-2b or hydroxycarbamide.
Maltese: Pazjenti li qatt ma kienu ħadu hydroxycarbamide (n=160) jew trattati b'hydroxycarbamide (n=94) ġew magħżula b'mod każwali biex jirċievu ropeginterferon alfa-2b jew hydrxycarbamide.
English: During ropeginterferon alfa-2b therapy, three cases of atrial fibrillation (1.1%; incidence rate: 0.5 events/100 patients per year) with intensity grade 1 to 3 occurred in two patients.
Maltese: Waqt terapija b'ropeginterferon alfa-2b, tliet każijiet ta' fibrillazzjoni atrijali (1.1%; rata ta' inċidenza: 0.5 każijiet/100 pazjent kull sena) b'intensità ta' grad 1 sa 3 seħħew f'żewġ pazjenti.
English: Ropeginterferon alfa-2b clinical studies ADR >10%
Maltese: Studji kliniċi b'ropeginterferon alfa-2b ADR >10%
English: After subcutaneous multiple dose administration (dose range 50 - 450 micrograms), the terminal halflife of ropeginterferon alfa-2b in patients is approximately 6 to 10 days and the clearance of ropeginterferon alfa-2b is 0.023 to 0.061 L/h.
Maltese: Wara l-għoti ta' doża multipla taħt il-ġilda (firxa dożali 50 - 450 mikrogramma), il-half-life terminali ta' ropeginterferon alfa-2b f'pazjenti hu madwar 6 sa 10 ijiem u t-tneħħija ta' ropeginterferon alfa-2b hi ta' 0.023 sa 0.061 L/h.
English: 250 μg, 300 μg, 350 μg, 400 μg, 450 μg and 500 μg.
Maltese: Hi tagħti dożi ta' 50 μg, 100 μg, 150 μg,200 μg, 250 μg, 300 μg, 350 μg, 400 μg, 450 μg u 500 μg.
English: Gastrointestinal disorders have been reported with other interferon alfa medicinal products and have been reported in 15.2% of patients with ropeginterferon alfa-2b treatment.
Maltese: Disturbi gastrointestinali ġew rapportati ma' prodotti mediċinali oħrajn ta' interferon alfa u ġew rapportati f'15.2% tal-pazjenti trattati b'ropeginterferon alfa-2b.
English: Patients showed a statistically significant difference in the JAK2V617F allele burden (19.7%) and JAK2V617F allele change from baseline (-22.9%).
Maltese: Il-pazjenti urew differenza statistikament sinifikanti fit-tagħbija tal-allel JAK2V617F (19.7%) u l-bidla fl-allel JAK2V617F mil-linja bażi (-22.9%).
English: • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
Maltese: • Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis-sezzjoni 6.1
English: Interferon alfa has shown to influence the activity of cytochrome P450 (CYP) isozymes CYP1A2 and CYP2D6.
Maltese: Interferon alfa intwera li jinfluwenza l-attività ta' isoenzimi CYP1A2 u CYP2D6 taċ-ċitokroma P450 (CYP).
English: Cardiac disorders common atrial fibrillation uncommon myocardial infarction#, atrioventricular block, intracardiac thrombus, aortic valve incompetence, cardiovascular disorder rare cardiomyopathy#, angina pectoris#
Maltese: Disturbi fil-qalb komuni fibrillazzjoni atrijali mhux komuni infart mijokardijaku#, imblokk atrijoventrikulari, trombus intrakardijaku, inkompetenza tal-valv aortiku, disturb kardjovaskulari rari kardjomijopatija#, anġina pektoris#
English: Adverse reactions are listed by system organ class and frequency (very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) or not known (cannot be estimated from available data).
Maltese: Ir-reazzjonijiet avversi huma elenkati skont is-sistema tal-klassifikazzjoni tal-organi u l-frekwenza (komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100), rari (≥ 1/10,000 sa < 1/1,000), rari ħafna (< 1/10,000) jew mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Administration of 180 micrograms of pegylated interferon alfa-2a once weekly for 4 weeks in healthy male subjects did not show any effect on mephenytoin, dapsone, debrisoquine and tolbutamide pharmacokinetics profiles, suggesting that pegylated interferon alfa-2a has no effect on in vivo metabolic activity of cytochrome P450 (CYP) 3A4, 2C9, 2C19 and 2D6 isozymes.
Maltese: L-għoti ta' 180 mikrogramma ta' pegylated interferon alfa-2a darba fil-ġimgħa għal 4 ġimgħat f'individwi maskili b'saħħithom ma wriex xi effett fuq il-profili farmakokinetiċi ta' mephenytoin, dapsone, debrisoquine u tolbutamide, li jissuġerixxi li pegylated interferon alfa-2a m'għandux effett in vivo fuq l-attività metabolika ta' isoenzimi ta' ċitokroma P450 (CYP) 3A9, 2C9, 2C19 u 2D6.
English: There is no antidote for the medicinal product available.
Maltese: M'hemmx antidot għall-prodott mediċinali disponibbli.
English: The use of ropeginterferon alfa-2b is associated with skin disorders (pruritus, alopecia, rash, erythema, psoriasis, xeroderma, dermatitis acneiform, hyperkeratosis, hyperhydrosis).
Maltese: L-użu ta' ropeginterferon alfa-2b hu marbut ma' disturbi tal-ġilda (ħakk, alopeċja, raxx, eritema, psorjasi, kseroderma, dermatite akneiforma, iperkeratożi, iperidrożi).
English: not known retinal detachment#
Maltese: mhux magħruf distakkament retinali#
English: Serious, acute hypersensitivity reactions (e.g., urticaria, angioedema, bronchoconstriction, anaphylaxis) have been rarely observed with other interferon alfa medicinal products.
Maltese: Reazzjonijiet serji ta' sensittività eċċessiva akuta (eż. urtikarja, anġjoedema, tidjiq tal-bronki, anafilassi) ġew osservati b'mod rari ma' prodotti mediċinali oħrajn ta' interferon alfa.
English: The pharmacokinetic profile of other interferon alfa medicinal products (pegylated interferon alfa-2a and pegylated interferon alfa-2b) was evaluated in renal impaired patients (see section 5.2).
Maltese: Il-profil farmakokinetiku ta' prodotti mediċinali oħra ta' interferon alfa (pegylated interferon alfa-2a u pegylated interferon alfa-2b) kien evalwat f'pazjenti b'indeboliment tal-kliewi (ara sezzjoni 5.2).
English: Ropeginterferon alfa-2b is a covalent conjugate of the protein interferon alpha-2b, produced in Escherichia coli cells by recombinant DNA technology, with a methoxypolyethylene glycol (mPEG) moiety.
Maltese: Ropeginterferon alfa-2b huwa konjugat kovalenti tal-proteina interferon alpha-2b, prodott minn ċelloli ta' Escherichia coli b'teknoloġija rikombinanti tad-DNA, b'porzjon ta' methoxypolyethylene glycol (mPEG).
English: The mean dose after 12 months of treatment was 382 (±141) micrograms for ropeginterferon alfa-2b.
Maltese: Id-doża medja wara 12-il xahar ta' trattament kienet ta' 382 (±141) mikrogramma għal ropeginterferon alfa-2b.
English: Coombs test positive, weight decreased #Reported as adverse reactions during treatment with other interferon alfa medicinal products.
Maltese: test ta' Coombs pożittiv, tnaqqis fil-piż #Rapportati bħala reazzjonijiet avversi waqt it-trattament bi prodotti mediċinali oħra ta' interferon alfa.
English: - if you take telbivudine (a medicine used to treat hepatitis B infection).
Maltese: - jekk tieħu telbivudine (mediċina użata għal trattament ta' infezzjoni tal-epatite B).
English: • If you do not see a droplet at the needle tip, repeat steps 5 and 6 up to six times until a droplet emerges.
Maltese: • Jekk ma tarax taqtira f'ras il-labra, irrepeti l-istadji 5 u 6 sa sitt darbiet sakemm it-taqtira titfaċċa.
English: The most common gastrointestinal disorders reported in these studies were diarrhoea (5.1%; incidence rate: 2.8 [events/100 patients per year]) and nausea (4.5%; incidence rate: 1.6 events/100 patients per year]).
Maltese: L-aktar disturbi gastrointestinali komuni rapportati f'dawn l-istudji kienu dijarea (5.1%; rata ta' frekwenza : 2.8 [każijiet/100 pazjent kull sena]) u dardir (4.5%; rata ta' frekwenza ta': 1.6 każijiet/100 pazjent kull sena]).
English: A combination therapy with telbivudine and ropeginterferon alfa-2b is contraindicated (see section 4.3).
Maltese: Terapija ta' kombinazzjoni b'telbivudine u ropeginterferon alfa-2b hi kontraindikata (ara sezzjoni 4.3).
English: It delivers doses of 50 μg, 100 μg, 150 μg, 200 μg and 250 μg.
Maltese: Hi tagħti dożi ta' 50 μg, 100 μg, 150 μg, 200 μg u 250 μg.
English: Then press the push button until the display window shows “0”.
Maltese: Imbagħad agħfas il-buttuna li timbotta sakemm id-displej juri “0”.
English: Ropeginterferon alfa-2b treatment arm1 (n=94)
Maltese: Grupp ta' trattament ta' ropeginterferon alfa-2b1 (n=94)
English: In the same study, a 25% increase in the AUC of theophylline (CYP1A2 substrate) was observed, demonstrating that pegylated interferon alfa-2a is an inhibitor of CYP1A2 activity.
Maltese: Fl-istess studju, żieda ta' 25% fl-AUC ta' theophylline (sottostrat ta' CYP1A2) ġiet osservata, li juri li pegylated interferon alfa-2a huwa impeditur tal-attività ta' CYP1A2.
English: • Alcohol wipe
Maltese: • Msiħ tal-alkoħol
English: Ropeginterferon alfa-2b is found mainly in the bloodstream and extracellular fluid as seen by the volume of distribution at steady-state (Vd) of 6.6 to 17 litres in patients after subcutaneous administration (dose range 50 - 450 micrograms).
Maltese: Ropeginterferon alfa-2b jinsab prinċipalment fiċ-ċirkolazzjoni tad-demm u fil-fluwidu ekstraċellulari kif osservat bil-volum ta' distribuzzjoni fl-istadju fiss (Vd) ta' 6.6 għal 17-il litru f'pazjenti wara l-għoti taħt il-ġilda (firxa dożali ta' 50-450 mikrogramma).
English: Based on data in monkeys, it is approx. 80%, similar to that seen for pegylated interferon alfa-2a.
Maltese: Abbażi ta' tagħrif minn fuq ix-xadini, huwa madwar 80% simili ta' dak osservat f'pegylated interferon alfa-2a.