FrancophonIA/ELRC3.0 huggingface dataset:
English: Portugal iapsa portuguesa pecuária, lda Av. Do Atlântico, nª 16 - 11ª piso- Escritório 12 PT-1990-019 Lisboa
Maltese: Do Atlântico, nª 16 - 11ª piso- Escritório 12 PT-1990-019 Lisboa
English: Av. Párroco Pablo Diez, 49-57 24010 LEÓN
Maltese: Párroco Pablo Diez, 49-57 24010
English: Potassium dihydrogen phosphate Disodium hydrogen phosphate anhydrous Sodium chloride
Maltese: Fosfat tad-di-idroġenu tal-potassju Disodium hydrogen phosphate anhydrous Klorur tas-sodju
English: * Relative potency compared to a reference vaccine.
Maltese: * Qawwa relattiva mqabbla ma' vaċċin ta' referenza.
English: Date of first authorisation:09/01/2019
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 09/01/2019
English: Inactivated bluetongue virus (BTV)
Maltese: Virus tal-ilsien blu (BTV) inattivat
English: *Below the level of detection by the validated RT-PCR method at 1.32 log10 TCID50/ml
Maltese: *Aktar baxx mil-livell ta' identifikazzjoni mill-metodu RT-PCR validat f'1.32 log10
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Maltese: Il-frekwenza ta' effetti mhux mixtieqa hija definita skont din il-konvenzjoni: - komuni ħafna (aktar minn wieħed f'10 annimali li juru effett(i) mhux mixtieqa matul il-perjodu ta' kura waħda) - komuni (aktar minn wieħed iżda inqas minn 10 annimali f'100 annimal) - mhux komuni (aktar minn wieħed iżda inqas minn 10 annimali f'1,000 annimal ikkurati) - rari (aktar minn wieħed iżda inqas minn 10 annimali f'10,000 annimal ikkurati) - rari ħafna (inqas minn annimal wieħed f'10,000 annimal ikkurati, inklużi rapporti iżolati).
English: Parque Tecnológico de León Av. Portugal s/n
Maltese: Parque Tecnológico de León Av.
English: For the full list of excipients, see section 6.1.
Maltese: Għal-lista sħiħa ta' ingredjenti (mhux attivi), ara Sezzjoni 6.1.
English: Semi-purified saponin from Quillaja saponaria Thiomersal
Maltese: Saponina semipurifikata mill-Quillaja saponaria Tjomersal
English: Store and transport refrigerated (2 C - 8 C).
Maltese: Aħżen u ttrasporta fil-friġġ (2 C - 8 C).
English: Active substance(s):
Maltese: Sustanza/i attiva/i:
English: A painless nodule that may reach up to 3.8 cm diameter in sheep and 7 cm diameter in cattle develops very commonly after 2 to 6 days and diminishes progressively over time.
Maltese: Nodulu li ma jikkawżax uġigħ u li jista' jikber sa 3.8 cm bħala dijametru fin-ngħaġ u 7 cm bħala dijametru fil-frat jiżviluppa ta' spiss ħafna wara jumejn u 6 ijiem u maż-żmien jiċkien progressivament.
English: Adjuvants: Aluminium hydroxide (Al
Maltese: Idrossidu tal-aluminju (Al 3+)
English: * Maximum of two different inactivated bluetongue virus serotypes:
Maltese: * Massimu ta' żewġ serotipi tal-virus tal-ilsien blu inattivat differenti:
English: - Reduction in milk production - Neurological disorders: paralysis, ataxia, blindness or incoordination - Respiratory tract disorders: pulmonary congestion, dyspnoea - Digestive tract disorders: rumen atony or bloating - Hypersensitivity reactions: with hypersalivation - Death.
Maltese: - Tnaqqis fil-produzzjoni tal-ħalib - Disturbi newroloġiċi: paraliżi, atassija, telf tal-vista jew inkoordinazzjoni - Disturbi tas-sistema respiratorja: konġestjoni pulmonarja, dispnea - Disturbi tas-sistema diġestiva: atonija jew nefħa tal-kirxa - Reazzjonijiet ta' sensittività eċċessiva: bl-ipersalivazzjoni - Mewt.
English: - Primary vaccination: administer a single 2 ml dose
Maltese: - Tilqim primarju: amministra doża unika ta' 2 ml.
English: Each ml contains:
Maltese: U KWANTITATTIVA Kull ml fih:
English: Active substances*:
Maltese: Sustanzi attivi*:
English: Onset of immunity: 39 days after completion of the primary vaccination scheme.
Maltese: Bidu tal-immunità: 39 jum wara t-tlestija tal-iskema ta' tilqim primarju.
English: Pack sizes:
Maltese: Aġġuvanti:
English: Inactivated bluetongue virus, serotype 1 (BTV-1), strain ALG2006/01 E1
Maltese: Virus tal-ilsien blu inattivat, serotip 1 (BTV-1), razza ALG2006/01 E1
English: The number and type(s) of strains included in the final product will be adapted to the current epidemiological situation at the time of formulation of the final product and will be shown on the label.
Maltese: In-numru u t-tip(i) ta' razez inklużi fil-prodott finali se jiġu adattati għas-sitwazzjoni epidemjoloġika attwali fil-mument tal-formulazzjoni tal-prodott finali u se jintwerew fuq it-tikketta.
English: Cardboard box with 1 vial containing 80 ml.
Maltese: Kaxxa tal-kartun b'kunjett 1 li fih 80 ml.
English: Semi-purified saponin from Quillaja saponaria
Maltese: Saponina semipurifikata mill-Quillaja saponaria
English: The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
Maltese: Is-sustanza attiva li hija prinċipju ta'oriġini bijoloġiku maħsuba sabiex tipproduċi immunità passiva ma taqax fi ħdan il-kamp ta' applikazzjoni tar-Regolament (KE) Nru 470/2009.
English: Polypropylene colourless vial containing 80 ml or 200 ml, with a type I bromobutyl rubber stopper, sealed with an aluminium closure.
Maltese: Kunjett mingħajr kulur tal-polipropilen li fih 80 ml jew 200 ml, b'tapp tal-lastiku tal-bromobutil tattip I, issiġillat b'għeluq tal-aluminju.
English: The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Maltese: L-addittivi (inklużi l-aġġuvanti) elenkati f'Sezzjoni 6.1 tal-Karatteristiċi tal-Prodott fil-Qosor huma jew sustanzi ammissibbli li għalihom ma hemmx bżonn ta' limiti massimi ta' residwi kif indikat fittabella numru 1 tal-anness tar-Regolament tal-Kummissjoni (UE) Nru 37/2010 jew huma kkunsidrati li ma jaqgħux fi ħdan il-kamp ta' applikazzjoni tar-Regolament (KE) Nru 470/2009 meta użati bħal f'dan il-prodott mediċinali veterinarju.
English: Cardboard box with 1 vial containing 200 ml.
Maltese: Kaxxa tal-kartun b'kunjett 1 li fih 200 ml.
English: Erythema associated with mild to moderate oedema is very common from 1 to 6 days after the administration.
Maltese: Eritema assoċjata ma' edema ħafifa sa moderata hija komuni ħafna bejn jum u 6 ijiem wara lamministrazzjoni.
English: People with known hypersensitivity to aluminium hydroxide, thiomersal or saponins should avoid contact with the veterinary medicinal product.
Maltese: Nies li jbatu minn sensittività eċċessiva għall-idrossidu tal-aluminju, it-tijomersal jew is-saponini għandhom jevitaw li jmissu mal-prodott mediċinali veterinarju.
English: ** Relative potency measured by ELISA in relation to a reference vaccine whose efficacy has been demonstrated by challenge in the target species.
Maltese: ** Qawwa relattiva mkejla mill-ELISA fir-rigward ta' vaċċin ta' referenza li l-effikaċja tiegħu ntweriet bi sfida fl-ispeċi fil-mira.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali tinsab fuq il-websajt tal-Aġenzija Ewropea dwar il-Mediċini http://www.ema.europa.eu/.
English: According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, a Member State may, in accordance with its national legislation, prohibit the manufacture, import, possession, sale, supply and/or use of immunological veterinary medicinal products on the whole or part of its territory if it is established that:
Maltese: Skont l-Artikolu 71 tad-Direttiva 2001/82/KEE tal-Parlament Ewropew u tal-Kunsill, kif emendata, Stat Membru jista', skont il-liġijiet nazzjonali tiegħu, jipprojbixxi l-manifattura, l-importazzjoni, ilpussess, il-bejgħ, il-forniment u/jew l-użu ta' prodotti mediċinali veterinarji immunoloġiċi fit-territorju sħiħ tiegħu jew parti minnu jekk jiġi stabbilit illi:
English: 6.1 List of excipients
Maltese: Lista ta' ingredjenti
English: Sheep:
Maltese: Frat:
English: Inactivated bluetongue virus, serotype 4 (BTV-4), strain BTV-4/SPA-1/2004 Inactivated bluetongue virus, serotype 8 (BTV-8), strain BEL2006/01
Maltese: Virus tal-ilsien blu inattivat, serotip 4 (BTV-4), razza BTV-4/SPA-1/2004
English: Administer subcutaneously to sheep from 3 months of age, according to the following scheme: - Primary vaccination: administer a single 2 ml dose.
Maltese: - Tilqim primarju: amministra doża unika ta' 2 ml - Tilqim mill-ġdid: amministra doża waħda ta' 2 ml wara 12-il xahar.
English: IMMUNOLOGICAL PROPERTIES
Maltese: Inkompatibilitajiet maġġuri
English: For active immunisation of cattle to prevent viraemia* caused by bluetongue virus serotypes 1 and/or 8 and/or to reduce viraemia* caused by bluetongue virus serotype 4 (combination of maximum 2 serotypes).
Maltese: Għall-immunizzazzjoni attiva tal-frat biex tiġi evitata l-viremija* kkawżata mill-virus tal-ilsien blu serotipi 1 u/jew 8 u/jew biex titnaqqas il-viremija* kkawżata mill-virus tal-ilsien blu serotip 4 (kombinazzjoni ta' massimu ta' 2 serotipi).
English: Pinkish-white suspension for injection easily homogenised by shaking.
Maltese: Vaċċini tal-virus tal-ilsien blu inattivat għan-nagħaġ.
English: No information is available on the use of the vaccine containing BTV4 serotype in cattle with maternally-derived antibodies.
Maltese: M'hemm l-ebda informazzjoni disponibbli dwar l-użu tal-vaċċin fin-nagħaġ b'antikorpi derivati b'mod maternali.
English: Duration of immunity: one year after completion of the primary vaccination scheme.
Maltese: Perjodu tal-immunità: sena wara t-tlestija tal-iskema ta' tilqim primarju.
English: The import, possession, sale, supply and/or use of this veterinary medicinal product may be prohibited in a Member State on the whole or part of its territory, see package leaflet for further information.
Maltese: Il-manifattura, l-importazzjoni, il-pussess, il-bejgħ, il-provvista u/jew l-użu ta' dan il-prodott mediċinali veterinarju jista' jkun ipprojbit fit-territorju kollu ta' Stat Membru jew f'parti minnu, ara lfuljett ta' tagħrif għal aktar informazzjoni.
English: Administer intramuscularly to cattle from 2 months of age in naïve animals or from 3 months of age in calves born to immune cattle, according to the following scheme:
Maltese: Amministra ġol-muskoli lil frat ta' xahrejn u akbar fl-età f'annimali naïve jew ta' 3 xhur u akbar fl-età f'għoġġiela mwielda lil frat immuni, skont l-iskema li ġejja:
English: Silicon antifoaming agent Water for injections
Maltese: Aġent kontra r-ragħwa tas-siliċju Ilma għall-injezzjonijiet
English: Disposal: read package leaflet.
Maltese: Jista' jkun li mhux tad-daqsijiet kollha tal-pakkett ikunu fis-suq.
English: Inactivated bluetongue virus, serotype 4 (BTV-4), strain BTV-4/SPA-1/2004 RP* ≥ 1 Inactivated bluetongue virus, serotype 8 (BTV-8), strain BEL2006/01
Maltese: RP* ≥ 1 Virus tal-ilsien blu inattivat, serotip 8 (BTV-8), razza BEL2006/01 RP* ≥ 1
English: In this category of animals the vaccine should be used only according to the benefit/risk assessment by the responsible veterinarian and/or National Competent Authorities on the current vaccination policies against Bluetongue Virus (BTV).
Maltese: F'din il-kategorija ta' annimali, il-vaċċin għandu jintuża biss skont il-valutazzjoni tal-benefiċċji/tar-riskji mill-veterinarju responsabbli u/jew mill-Awtoritajiet Kompetenti Nazzjonali dwar il-politiki ta' tlaqqim attwali kontra l-Virus tal-Ilsien Blu (BTV).
English: For active immunisation of sheep to prevent viraemia* and reduce clinical signs and lesions caused by bluetongue virus serotypes 1 and/or 8 and/or to reduce viraemia* and clinical signs and lesions caused by bluetongue virus serotype 4 (combination of maximum 2 serotypes).
Maltese: Għall-immunizzazzjoni attiva tan-nagħaġ biex tiġi evitata l-viremija* u biex jitnaqqsu s-sinjali kliniċi u l-leżjonijiet ikkawżati mis-serotipi 1 u/jew 8 tal-virus tal-ilsien blu u/jew biex titnaqqas il-viremija* u s-sinjali kliniċi u l-leżjonijiet ikkawżati mis-serotip 4 tal-virus tal-ilsien blu (kombinazzjoni ta' massimu ta' 2 serotipi).
English: LABORATORIOS SYVA, S.A.U.
Maltese: LABORATORIOS SYVA, S.
English: Loc. Fontana del Ceraso
Maltese: Fontana del Ceraso
English: * Includes patients co-infected with human immunodeficiency virus (HIV).
Maltese: * Tinkludi pazjenti ko-infettati b'virus tal-immunodefiċjenza umana (HIV).
English: Daclatasvir in vitro did not inhibit (IC50 >40 µM) CYP enzymes 1A2, 2B6, 2C8, 2C9, 2C19, or 2D6.
Maltese: Daclatasvir in vitro ma impedixxix (IC50 >40 µM) l-enzimi ta' CYP 1A2, 2B6, 2C8, 2C9, 2C19, jew 2D6.
English: Study AI444010
Maltese: AI444043:
English: Polyvinyl Chloride/poly-chloro-tri-fluoro-ethylene (PVC/PCTFE) clear blister/aluminum foil lidding.
Maltese: Polyvinyl Chloride/poly-chloro-tri-fluoro-ethylene (PVC/PCTFE) folja ċara/inforra bil-fojl tal
English: Nucleotide analogue polymerase inhibitor
Maltese: Impeditur ta' polymerase analogu nukleotide
English: - Tablet core: anhydrous lactose (see section 2), microcrystalline cellulose, croscarmellose sodium, silicon dioxide (E551) and magnesium stearate - Film-coating: hypromellose, titanium dioxide (E171), macrogol 400, indigo carmine aluminum lake (E132), yellow iron oxide (E172)
Maltese: Is-sustanzi l-oħra huma - Il-qalba tal-pillola: lactose anidru, (ara sezzjoni 2) microcrysalline cellulose, croscarmellose sodium, silicon dioxide (E551) u magnesium stearate - Il-kisi tar-rita: hypromellose, titanium dioxide (E171), macrogol 400, indigo carmine aluminum lake, (E132) yellow iron oxide (E172)
English: All Genotype 3 N=18
Maltese: Ġenotip 3 Kollha N=18
English: ** One patient considered a protocol failure (non-SVR) achieved SVR *** NS5A RAVs monitored at amino acid positions are 28, 29, 30, 31, 32, 58, 62, 92, and 93
Maltese: ** Pazjent wieħed ikkunsidrat bħala falliment tal-protokoll (mhux SVR) kiseb SVR *** NS5A RAVs issorveljati f'pożizzjonijiet tal-aċidu amminiku huma 28, 29, 30, 31, 32, 58, 62, 92, u 93
English: No antagonism of antiviral activity was observed.
Maltese: L-ebda antagoniżmu ta' attività antivirali
English: In genotype 4, amino acid substitutions at 30 and 93 (EC50 < 16 nM) were frequently selected.
Maltese: F'ġenotip 4, sostituzzjonijiet ta' aċidu amminiku f'30 u 93 (EC50 <16 nM) kienu magħżula ta' spiss.
English: Non-nucleoside reverse transcriptase inhibitors (NNRTIs)
Maltese: Impedituri mhux nukleosidi ta' reverse transcriptase (non-nucleoside reverse transcriptase inhibitors,
English: Daclatasvir showed additive to synergistic interactions with interferon alfa, HCV nonstructural protein 3 (NS3) PIs, HCV nonstructural protein 5B (NS5B) non-nucleoside inhibitors, and HCV NS5B nucleoside analogues in combination studies using the cell-based HCV replicon system.
Maltese: Daclatasvir wera interazzjonijiet addittivi għal sinerġistiċi b'interferon alfa, PIs mhux strutturali ta' HCV (nonstructural protein 3, NS3), impedituri mhux nukleosidi mhux strutturali 5B ta' HCV (ninstructural protein 5B, NS5B), u analogi ta' nukleosidi HCV NS5B fi studji ta' kombinazzjoni permezz tas-sistema replikon ta' HCV bbażata fuq ċelluli.
English: Tabulated list of adverse reactions
Maltese: Elenku tabulat ta' reazzjonijiet avversi
English: Adverse reactions are listed in Table 5 by regimen, 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)
Maltese: Reazzjonijiet avversi huma elenkati f'Tabella 5 skont il-kors, tas-sistema 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
English: Potential for interaction with other medicinal products Daclatasvir is a substrate of CYP3A4, P-gp and organic cation transporter (OCT) 1.
Maltese: Potenzjal għal interazzjoni ma' prodotti mediċinali oħra Daclatasvir huwa sottostrat ta' CYP3A4, P-gpu t-trasportatur katajoniku organiku (OCT) 1.
English: Daclatasvir unbound AUC was estimated to be 18%, 39% and 51% higher for subjects with creatinine clearance (CLcr) values of 60, 30 and 15 ml/min, respectively, relative to subjects with normal renal function.
Maltese: L-AUC ta' daclatasvir mhix marbuta kienet stmata li hi ta' 18%, 39% u 51% ogħla għal individwi b'valuri ta' eliminazzjoni tal-kreatinina (CLcr) ta' 60, 30 u 15 mL/min, rispettivament, meta mqabbel ma' individwi b'funzjoni normali tal-kliewi.
English: Cirrhotic cohort N=60
Maltese: Koorti ċirrotika N=60
English: The majority of genotype 1a failures had emergent NS5A variants detected at Q30 (127/139 [91%]), and the majority of genotype 1b failures had emergent NS5A variants detected at L31 (37/49 [76%]) and/or Y93H (34/49 [69%]).
Maltese: Ilmaġġoranza ta' fallimenti ta' ġenotip 1a kellhom varjanti NS5A emerġenti osservati fi Q30 (127/139 [91%]) u l-maġġoranza ta' fallimenti ta' ġenotip 1b kellhom varjanti ta' NS5A emerġenti osservati f'L31 (37/49 [76%]) u jew Y93H (34/49 [69%]).
English: Category/ Substitution, n (%) Genotype 1a Genotype 1b Genotype 2 Genotype 3 N=79
Maltese: Ġenotip 1a Ġenotip 1b Ġenotip 2 Ġenotip 3 N=79
English: All Genotype 2 N=26
Maltese: Ġenotip 2 Kollha N=26
English: Age (years): median (range) Race: White
Maltese: Età (snin): medjan (medda)
English: Table 8: Demographics and main disease characteristics in Study ALLY-1 Cirrhotic cohort N = 60
Maltese: Tabella 8: Demografija u karatteristiċi ewlenin tal-marda fl-Istudju ALLY-1 Koorti ċirrotika N=60
English: SVR was the primary endpoint to determine the HCV cure rate, which was defined as HCV RNA less than LLOQ at 12 weeks after the end of treatment (SVR12) for studies AI444040, ALLY-1 (AI444215), ALLY-2 (AI444216), ALLY-3 (AI444218), ALLY-3C (AI444379), AI444042 and AI444043 and as HCV RNA undetectable at 24 weeks after the end of treatment (SVR24) for study
Maltese: Is-SVR kien l-end-point primarju sabiex tiġi ddeterminata r-rata ta' kura tal-HCV, li ġiet definita bħala HCV RNA inqas minn LLOQ wara 12-il ġimgħa fl-aħħar tal-kura (SVR12) għall-istudji AI444040, ALLY-1 (AI444215), ALLY-2 (AI444216), ALLY-3 (AI444218), ALLY-3C (AI444379), AI444042 u AI444043 u bħala HCV RNA li ma jinstabx wara 24 ġimgħa fl-aħħar tal-kura (SVR24)
English: Treatment outcomes in study AI444042 are presented in Table 14.
Maltese: Riżultati ta' trattament fl-istudju AI444042 huma ppreżentati f'Tabella 14.
English: *results are dose-normalised to 60 mg
Maltese: *ir-riżultati huma normalizzati għaddoża sa doża ta' 60 mg.
English: No metabolites circulated at levels more than 5% of the parent concentration.
Maltese: L-ebda metabolit ma ċċirkula f'livelli ta' aktar minn 5% tal-konċentrazzjoni tal-ġenitur.
English: In limited numbers of genotype 4-infected patients with non-response, substitutions L28M and L30H/S were detected at failure.
Maltese: F'numri limitati ta' pazjenti infettati b'ġenotip 4 b'nuqqas ta' rispons, ġew osservati is-sostituzzjonijiet L28M u L30H/S fil-falliment.
English: The daclatasvir EC50 values in the replicon system were 0.003-1.25 nM for genotypes 3a, 4a, 5a and 6a, and 0.034-19 nM for genotype 2a as well as 0.020 nM for infectious genotype 2a (JFH-1) virus.
Maltese: 003-1.25 nM għal ġenotipi 3a, 4a, 5a u 6a, u 0.034-19 nM għal ġenotipi 2a kif ukoll bħala 0.020 nM għal virus b'ġenotip 2a infettiv (JFH-1).
English: The efficacy and safety of daclatasvir 60 mg once daily in combination with sofosbuvir 400 mg once daily in the treatment of patients with chronic HCV infection were evaluated in five open-label studies (AI444040, ALLY-1, ALLY-2, ALLY-3, and ALLY-3C).
Maltese: L-effikaċja u s-sigurtà ta' daclatasvir 60 mg darba kuljum flimkien ma' sofosbuvir 400 mg darba kuljum fil-kura ta' pazjenti b'infezzjoni kronika tal-HCV ġew evalwati f'ħames studji b'tikketta mikxufa (AI444040, ALLY-1, ALLY-2, ALLY-3, u ALLY-3C).
English: s r.o.
Maltese: IU/mL.
English: Relapse was defined as HCV RNA ≥LLOQ during follow-up after HCV RNA <LLOQ at end of treatment.
Maltese: Ir-rikaduta kienet definita HCV RNA ≥ LLOQ waqt follow-up wara HCV RNA < LLOQ fi tmiem ta' trattament.
English: Seventy-seven (77 [98.7%]) of treated patients in this study were infected with HCV GT-3a, and 1 patient (1.3%) was infected with HCV GT-3b.
Maltese: Sebgħa u sebgħin (77 [98.7 %]) tal-pazjenti kkurati f'dan l-istudju kienu infettati b'HCV GT-3a, u pazjent 1 (1.3 %) kien infettat b'HCV GT-3b.
English: The most resistant variants with single amino acid substitution in genotype 2a and genotype 3a were F28S (EC50 >300 nM) and Y93H (EC50 >1,000 nM), respectively.
Maltese: L-aktar varjanti reżistenti b'sostituzzjoni ta' aċidu amminiku wieħed f'ġenotip 2a u ġenotip 3a kienu F28S (EC50 >300 nM) u Y93H (EC50 >1,000 nM), rispettivament.
English: No dose adjustment of Daklinza 60 mg once daily, darunavir/ritonavir (800/100 mg once daily or 600/100 mg twice daily) or darunavir/cobicistat is required.
Maltese: L-ebda aġġustament fid-doża ta' Daklinza 60 mg darba kuljum, darunavir/ritonavir (800/100 mg darba kuljum jew 600/100 mg darbtejn kuljum) jew darunavir/cobicistat mhu rakkomandat.
English: In vitro and in vivo studies demonstrate that daclatasvir is a substrate of CYP3A, with CYP3A4 being the major CYP isoform responsible for the metabolism.
Maltese: Studjiin vitro u in vivo wrew li daclatasvir huwa sottostrat ta' CYP3A, b'CYP3A4 ikun l-isoforma ta' CYP ewlieni responsabbli għall-metaboliżmu.
English: EU/1/14/939/003 28 tablets (calendar pack)
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/14/939/003 28 pillola (pakkett kalendarju)
English: HCV Genotype 3 with compensated cirrhosis (ALLY-3C) In study ALLY-3C, the combination of daclatasvir, sofosbuvir and ribavirin administered for 24 weeks was evaluated in 78 adults infected with HCV genotype 3 with compensated cirrhosis; the majority of patients were male (57 [73.1%]); median age was 55 years (range 33 to 70); 88.5% were white; 9.0% were Asian; and 2.6% were American Indian or Alaska native; 54 (69.2%) patients were treatment-naïve and 24 (30.8%) patients were treatment-experienced.
Maltese: Fl-istudju ALLY-3C, il-kombinazzjoni ta' daclatasvir, sofosbuvir u ribavirin mogħtija għal 24 ġimgħa ġiet evalwata fi 78 adult infettati bil-ġenotip 3 tal-HCV b'ċirrożi kkumpensata; il-maġġoranza tal-pazjenti kienu rġiel (57 [73.1 %]); l-età medjana kienet 55 sena (medda 33 sa 70); 88.5 % kienu bojod, 9.0 % kienu Asjatiċi; u 2.6 % kienu Amerikani Indjani jew nattivi tal-Alaska; 54 (69.2 %) pazjent qatt ma rċevew kura fil-passat u 24 (30.8 %) pazjent irċevew kura fil-passat.
English: Nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs)
Maltese: Impedituri nukleosidi/nukleotidi ta' reverse transcriptase (nucleoside/nucleotide reverse transcriptase L-ebda aġġustament fid-doża ta'
English: Daclatasvir in combination with peginterferon alfa and ribavirin Baseline NS5A RAVs (at M28T, Q30, L31, and Y93 for genotype 1a; at L31 and Y93 for genotype 1b) increase the risk for non-response in treatment-naive patients infected with genotype 1a and genotype 1b infection.
Maltese: Daclatasvir flimkien ma' peginterferon alfa u ribavirin NS5A RAVs fil-linja bażi (f'M28T, Q30, L31, u Y93 għall-ġenotip 1a; f'L31 u Y93 għall-ġenotip 1b) iżidu r-riskju ta' nuqqas ta' rispons f'pazjenti li qatt ma ġew ikkurati qabel infettati b'infezzjoni ta' ġenotip 1a u ġenotip 1b.