FrancophonIA/ELRC3.0 huggingface dataset:
English: This corresponds to a strength of 100 IU/mL.
Maltese: Dan jikkorrispondi ma' qawwa ta' 100 IU/mL.
English: Clinical signs and symptoms of mild and moderate OHSS are abdominal pain, nausea, diarrhoea, mild to moderate enlargement of ovaries and ovarian cysts.
Maltese: Sinjali u sintomi kliniċi ta' OHSS ħafif u moderat huma wġigħ addominali, nawsja, dijarea, tkabbir minn ħafif sa moderat tal-ovarji u ċesti tal-ovarji. OHSS sever jista' jkun ta' periklu għall-ħajja.
English: Median total dose (IU)
Maltese: Medjan tad-doża totali (IU)a Medjan tat-tul ta' żmien tal-kura (jiem)a
English: Paediatric population There is no relevant use of Fertavid in the paediatric population for the approved indication.
Maltese: Fertavid fil-popolazzjoni pedjatrika m'għandux użu rilevanti fl-indikazzjoni approvata.
English: In males
Maltese: follikuli
English: Fertavid may affect milk production.
Maltese: Fertavid jista' jaffettwa l-produzzjoni tal-ħalib.
English: • stroke
Maltese: Tfal
English: Transient liver function test abnormalities suggestive of hepatic dysfunction with or without morphologic changes on liver biopsy have also been reported in association with OHSS.
Maltese: Dawn l-antibijotiċi jistgħu jikkawżaw reazzjonijiet ta' sensittività eċċessiva f'persuni suxxettibbli.
English: The solution for injection contains the active substance follitropin beta, produced by genetic engineering of a Chinese hamster ovary (CHO) cell line.
Maltese: Is-soluzzjoni għall-injezzjoni fiha s-sustanza attiva follitropin beta magħmula b'inġinerija ġenetika minn ċelluli żviluppati minn ċellula waħda mill-ovarji tal-ħemster Ċiniż (CHO).
English: The Rapporteur was Dr Karl Broich and Co-Rapporteur was Dr Eric Abadie.
Maltese: Ir-rapporteur kien Dr Karl Broich u l-Ko-Rapporteur kien Dr Eric Abadie.
English: London, 23 October 2007 EMEA/331678/2007
Maltese: Londra, it-23 ta' Ottubru 2007 EMEA/331678/2007
English: International Non-Proprietary Name (INN): fentanyl
Maltese: L-Isem Internazzjonali mhux Patentat (INN): fentanyl
English: 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 86 13 E-mail: mail@emea.europa.eu http://www.emea.europa.eu©EMEA 2007 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged
Maltese: Fax (44-20) 74 18 86 13 E-mail: mail@emea.europa.eu http://www.emea.europa.eu©EMEA 2007 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged
English: OPINION FOLLOWING AN ARTICLE 29(4)1 REFERRAL FOR Fentanyl-ratiopharm 25/50/75/100 µg/h TTS and associated names
Maltese: OPINJONI LI SSEGWI L-ARTIKOLU 29(4)1 RERERENZA GĦAL Fentanyl-ratiopharm 25/50/75/100 µg/h TTS u assoċjati
English: The Reference Member State was Germany and the Concerned Member States were Austria, France, the Netherlands, Spain and the United Kingdom.
Maltese: L-Istat Membru ta' Referenza kien il-Ġermanja u l-Istati Membri Konċernati kienu l-Awstrija, Franza, l-Olanda, Spanja u r-Renju Unit.
English: Fentanyl-ratiopharm 25/50/75/100 µg/h TTS and associated names, is an opioid analgesic which is indicated in severe chronic pain which can be adequately managed only with opioid analgesics.
Maltese: Fentanyl-ratiopharm 25/50/75/100 µg/h TTS u ismijiet assoċjati, hu analġesiku opioid li hu indikat għal uġigħ kroniku sever li jkun jista' jiġi ġestit adegwatament biss b'analġesiċi opioid.
English: The Marketing Authorisation Holder provided written explanations on 13 April 2007.
Maltese: Id-Detentur ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq ipprovda spjegazzjonijiet bil-miktub fit-13 ta' April ta' l-2007.
English: Ratiopharm GmbH submitted applications for mutual recognition of Fentanyl-ratiopharm 25/50/75/100 µg/h TTS and associated names, transdermal patch on the basis of the marketing authorisation granted by Germany 04 April 2006.
Maltese: Ratiopharm GmbH ippreżentat applikazzjonijiet għal għarfien reċiproku għal Fentanyl-ratiopharm 25/50/75/100 µg/h TTS u ismijiet assoċjati, stikka transdermali skond l-awtorizzazzjoni għat-tqegħid fis-suq mogħtija mill-Ġermanja fl-4 ta' April ta' l-2006.
English: During their July 2007 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for Fentanylratiopharm 25/50/75/100 µg/h TTS and associated names, that the objections raised by France should not prevent the granting of a Marketing Authorisation and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended.
Maltese: Waqt il-laqgħa tagħhom ta' Lulju ta' l-2007, is-CHMP, fid-dawl tad-dejta globali ppreżentata u d-diskussjoni xjentifika fi ħdan il-Kumitat, kien tal-fehma li l-bilanċ bejn il-benefiċċju u r-riskju kien favorevoli għal Fentanyl-ratiopharm 25/50/75/100 µg/h TTS u ismijiet assoċjati, li l-objezzjonijiet imqajma minn Franza m'għandhomx jipprevjenu l-għoti ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq u li s-Sommarju talKaratteristiċi tal-Prodott, it-tikketta u l-fuljett ta' tagħrif ta' l-Istat Membru ta' Referenza għandhom jiġu emendati.
English: Germany referred the reasons for disagreement to the EMEA on 20 December 2006.
Maltese: IlĠermanja rreferiet ir-raġunijiet għan-nuqqas ta' qbil lill-EMEA fl-20 ta' Diċembru ta' l-2006.
English: The arbitration procedure started on 24 January 2007 with the adoption of a list of questions.
Maltese: Il-proċedura ta' arbitraġġ inbdiet fl-24 ta' Jannar ta' l-2007 bl-adozzjoni ta' lista ta' mistoqsijiet.
English: Significant difference has been identified with regard to the proposed indication, posology and contraindications in the product information and the demonstration of bioequivalence and this was considered to be of serious public health concern.
Maltese: Ġiet identifikata differenza sinjifikanti fir-rigward ta' l-indikazzjoni proposta, il-pożoloġija u lkontraindikazzjonijiet fit-tagħrif dwar il-prodott u t-turija tal-bijoekwivalenza u dan ġie kkunsidrat ta' tħassib għas-saħħa pubblika.
English: This refers to the extension of the indication to non-cancer patients, the choice of conversion tables, whether contraindication for breastfeeding and for interactions with partial agonist opioids should be given inn the product information and the studies needed to demonstrate bioequivalence with the reference medicinal product.
Maltese: Dan jirreferi għall-estensjoni ta' l-indikazzjoni għal pazjenti li ma jkollhomx kankru, lgħażla ta' tabelli ta' konverżjoni, jekk għandux jingħata tagħrif dwar il-kontraindikazzjonijiet għat-treddigħ u dwar l-interazzjonijiet ma' opioids agonisti parzjali fit-tagħrif dwar il-prodott u fl-istudji meħtieġa biex tintwera l-bijoekwivalenza bil-prodott mediċinali ta' referenza.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP)
Maltese: IL-KUMITAT GĦALL-PRODOTTI MEDIĊINALI GĦALL-UŻU MILL-BNIEDEM (CHMP)
English: Study 1468 (LEPTON)
Maltese: Studju 1468 (LEPTON)
English: EU/1/14/958/002
Maltese: EU/1/14/958/001 EU/1/14/958/002
English: Study 0122 (ELECTRON-2) 6 25 0% (0/25)
Maltese: Studju 0122 (ELECTRON-2) 6 25 0% (0/25)
English: Harvoni contains lactose monohydrate.
Maltese: Harvoni fih lactose monohydrate.
English: c, d
Maltese: ċ, d
English: HCV RNA < 6 million IU/mL HCV RNA ≥ 6 million IU/mL
Maltese: HCV RNA < 6 miljun IU/mL HCV RNA ≥ 6 miljun IU/mL
English: IMMUNOSUPPRESSANTS Ciclosporing
Maltese: IMMUNOSUPPRESSANTI Ciclosporin g
English: GT n TE
Maltese: GT n TEa
English: h. Bioequivalence/Equivalence boundary 80-125%.
Maltese: Bijoekwivalenza/Limitu tal-ekwivalenza 80-125%
English: ANTICONVULSANTS Carbamazepine Phenobarbital Phenytoin
Maltese: Carbamazepine Phenytoin Phenobarbital
English: (Inhibition of drug transporters OATP and BCRP)
Maltese: (Inibizzjoni ta' trasportaturi tal-mediċina OATP u BCRP)
English: Ribavirin was discontinued in 19% of the patients.
Maltese: Ribavirin twaqqaf f'19% tal-pazjenti.
English: PEG-IFN+RBV 39% (43)
Maltese: Kura kontra HCV fil-passat PEG-IFN+RBV 39% (43)
English: Genotype 2b 16-530b
Maltese: 16-530b
English: In vitro ledipasvir inhibits intestinal CYP3A4 and UGT1A1.
Maltese: In vitro ledipasvir jinibixxi CYP3A4 u UGT1A1 fl-imsaren.
English: (≥ 1/10,000 to < 1/1,000) or very rare (< 1/10,000).
Maltese: (≥ 1/1,000 sa < 1/100), rari (≥ 1/10,000 sa < 1/1,000) jew rari ħafna (< 1/10,000).
English: Distribution Ledipasvir is > 99.8% bound to human plasma proteins.
Maltese: Ledipasvir huwa > 99.8% marbut ma' proteini tal-plażma tal-bniedem.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/958/001 28 film-coated tablets EU/1/14/958/002 84 (3 bottles of 28) film-coated tablets
Maltese: EU/1/14/958/001 28 pillola miksija b'rita EU/1/14/958/002 84 (3 fliexken ta' 28) pillola miksija b'rita
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 17 November 2014
Maltese: Data tal-ewwel awtorizzazzjoni: 17 ta' Novembru 2014
English: In clinical studies - Genotype 1
Maltese: Fi studji kliniċi - Ġenotip 1
English: Table 4: Adverse drug reactions identified with Harvoni Frequency
Maltese: Tabella 4: Reazzjonijiet avversi tal-mediċina identifikati b'Harvoni Frekwenza
English: Other c
Maltese: Le c c
English: INFORMATION IN BRAILLE Harvoni [Outer packaging only]
Maltese: INFORMAZZJONI BIL-BRAILLE Harvoni [Ippakkjar ta' barra biss]
English: HCV PRODUCTS Simeprevir (150 mg once daily)/ ledipasvir (30 mg once daily)
Maltese: PRODOTTI HCV Simeprevir (150 mg darba kuljum)/ ledipasvir (30 mg darba kuljum)
English: Harvoni is indicated for the treatment of chronic hepatitis C (CHC) in adults (see sections 4.2, 4.4 and
Maltese: Harvoni hu indikat għall-kura ta' epatite C kronika (CHC - chronic hepatitis C) fl-adulti (ara sezzjonijiet 4.2, 4.4 u 5.1).
English: Mean ratio (90% confidence interval) for AUC, Cmax, Cmin a, b
Maltese: għal AUC, Cmax, Cmin a,b
English: ↔ Sofosbuvir ↔ GS-331007
Maltese: sofosbuvir jew GS-331007.
English: Cirrhosis d
Maltese: Ċirrożid d
English: • tipranavir (used to treat HIV infection).
Maltese: • tipranavir (użat biex jikkura infezzjoni tal-HIV).
English: Harvoni + ribavirin for 12 weeks (see section 5.1).
Maltese: Harvoni + ribavirin għal 12-il ġimgħa (ara sezzjoni 5.1).
English: • rifampicin and rifabutin (antibiotics used to treat infections, including tuberculosis);
Maltese: • Rifampicin u rifabutin (antibijotiċi li jintużaw għall-kura ta' infezzjonijiet, li jinkludu t tuberkulożi);
English: ↔ GS-331007 (Induction of P-gp)
Maltese: ↔ GS-331007 (Induzzjoni ta' P-gp)
English: Do not take Harvoni
Maltese: Tiħux Harvoni
English: b. Non-missing FibroTest results are mapped to Metavir scores according to: 0-0.31 = F0-F1; 0.32-0.58 = F2; 0.59-1.00 = F3-F4.
Maltese: Ir-riżultati tat-Test Fibro mhux neqsin ġew immappjati għal punteġġi ta' Metavir skont: 0-0.31 = F0-F1; 0.32-0.58 = F2;
English: The pharmacokinetics of ledipasvir, sofosbuvir and GS-331007 in paediatric patients have not been established (see section 4.2).
Maltese: Il-farmakokinetika ta' ledipasvir, sofosbuvir u GS-331007 f'pazjenti pedjatriċi ma ġietx stabbilita (ara sezzjoni 4.2).
English: The efficacy of Harvoni (ledipasvir [LDV]/sofosbuvir [SOF]) was evaluated in three open-label Phase 3 studies with data available for a total of 1,950 patients with genotype 1 CHC.
Maltese: L-effikaċja ta' Harvoni (ledipasvir [LDV]/sofosbuvir [SOF]) ġiet evalwata fi tliet studji open-label ta' Fażi 3 b'dejta disponibbli għal total ta' 1,950 pazjent b'CHC ta' ġenotip 1.
English: The majority of the sofosbuvir dose recovered in urine was GS-331007 (78%) while 3.5% was recovered as sofosbuvir.
Maltese: Il-maġġoranza tad-doża ta' sofosbuvir irkuprata fl awrina kienet GS-331007 (78%) filwaqt li 3.5% ġiet irkuprata bħala sofosbuvir.
English: Among patients with a baseline HCV RNA < 6 million IU/mL, the SVR was 97% (119/123) with 8-week treatment of ledipasvir/sofosbuvir and 96% (126/131) with 12-week treatment of ledipasvir/sofosbuvir.
Maltese: SVR kien 97% (119/123) b'kura ta' 8 ġimgħat ta' ledipasvir/sofosbuvir u 96% (126/131) b'kura ta' 12-il ġimgħa ta' ledipasvir/sofosbuvir.
English: ↔ GS-331007 (Increase in gastric pH)
Maltese: ↔ GS-331007 (Żieda fil-pH gastriku)
English: (n = 163)
Maltese: (n = 163)a
English: Further data include a double-blind comparison of the safety of ledipasvir/sofosbuvir (12 weeks) and placebo in 155 cirrhotic patients (see section 5.1).
Maltese: Dejta addizzjonali tinkludi paragun double-blind tas-sigurtà ta' ledipasvir/sofosbuvir (12-il ġimgħa) u plaċebo f'155 pazjent ċirrotiku (ara sezzjoni 5.1).
English: d. Metavir score = 4 or Ishak score ≥ 5 by liver biopsy, or FibroTest score of > 0.75 and (APRI) of > 2.
Maltese: Punteġġ Metavir = 4 jew punteġġ Ishak > 5 skont il-bijopsija tal-fwied, jew punteġġ ta' FibroTest > 0.75 u (APRI) ta' > 2.
English: Genotype 2, 3, 4, 5 and 6
Maltese: ġenotip 2, 4, 5 u 6 Studju
English: Harvoni is contraindicated with carbamazepine, phenobarbital and phenytoin, potent intestinal P-gp inducers (see section 4.3).
Maltese: Harvoni hu kontraindikat ma' carbamazepine, phenobarbital u phenytoin, indutturi potenti ta' P-gp fl-imsaren (ara sezzjoni 4.3).
English: Prior HCV therapy PEG-IFN+RBV HCV protease inhibitor + PEG-IFN+RBV
Maltese: Kura kontra HCV fil-passat PEG-IFN+RBV Inibitur tal-protease talHCV + PEG-IFN+RBV
English: Table 3: Interactions between Harvoni and other medicinal products Medicinal product by therapeutic areas
Maltese: Tabella 3: Interazzjonijiet bejn Harvoni u prodotti mediċinali oħrajn
English: No
Maltese: ċ
English: ORAL CONTRACEPTIVES Norgestimate/ ethinyl estradiol (norgestimate 0.180 mg/ 0.215 mg/ 0.25 mg/ ethinyl estradiol 0.025 mg)/ ledipasvir (90 mg once daily)
Maltese: Norgestimate/ ethinyl estradiol (norgestimate 0.180 mg/ 0.215 mg/ 0.25 mg/ ethinyl estradiol 0.025 mg)/ ledipasvir (90 mg darba kuljum)
English: American
Maltese: Afrikana
English: Relative to patients with normal renal function (eGFR > 80 mL/min/1.73 m2), the sofosbuvir AUC0-inf was 61%, 107% and 171% higher in mild, moderate and severe renal impairment, while the GS-331007 AUC0-inf was 55%, 88% and 451% higher, respectively.
Maltese: Fir-rigward ta' pazjenti b'funzjoni normali tal-kliewi (eGFR > 80 mL/min/1.73 m2), l-AUC0-inf ta' sofosbuvir kienet ta' 61%, 107% u 171% ogħla f'pazjenti b'indeboliment ħafif, moderat u sever tal-kliewi, filwaqt li l-AUC0-inf ta' GS-331007 kienet ta' 55%,
English: Simeprevir h
Maltese: Simeprevirh
English: Genotype 1a a
Maltese: Ġenotip 1a a
English: The pharmacokinetics of sofosbuvir were studied in HCV negative patients with mild (eGFR ≥ 50 and < 80 mL/min/1.73 m2), moderate (eGFR ≥ 30 and < 50 mL/min/1.73 m2), severe renal impairment (eGFR < 30 mL/min/1.73 m2) and patients with ESRD requiring haemodialysis following a single 400 mg dose of sofosbuvir.
Maltese: Il-farmakokinetika ta' sofosbuvir ġiet studjata f'pazjenti li kienu negattivi għal HCV, b'indeboliment tal-kliewi ħafif (eGFR ≥ 50 u < 80 mL/min/1.73m2), moderat (eGFR ≥ 30 u < 50 mL/min/1.73m2), u sever (eGFR < 30 mL/min/1.73 m2) u pazjenti b'ESRD li kienu jeħtieġu l-emodijaliżi wara doża waħda ta' 400 mg ta' sofosbuvir.
English: In clinical studies - Genotype 2, 3, 4, 5 and 6
Maltese: Fi studji kliniċi - Ġenotip 2, 3, 4, 5 u 6 NS5A RAVs:
English: Cardiac arrhythmias
Maltese: MEDIĊINI ANTIKONVULŻIVI
English: Table 5: Activity of ledipasvir and sofosbuvir against chimeric replicons Genotype replicons
Maltese: Attività ta' ledipasvir u sofosbuvir kontra replikons kimeriċi Ġenotip tar replikons
English: Genotype 4d 0.60 Genotype 5a
Maltese: Ġenotip 3a Ġenotip 4a Ġenotip 4d Ġenotip 5a
English: Relapse b
Maltese: Rikaduta b
English: NS5B transient replicons Median (range)
Maltese: Replikons NS5B temporanji Medjan (medda)a
English: Cirrhosis was defined by biopsy, Fibroscan (> 12.5 kPa) or FibroTest > 0.75 and an AST:platelet ratio index (APRI) of > 2.
Maltese: Fibroscan (> 12.5 kPa) jew FibroTest ta' > 0.75 u indiċi ta' proporzjon ta' AST:plejtlits (APRI) ta'
English: Harvoni contains sunset yellow FCF aluminium lake (E110)
Maltese: Harvoni fih sunset yellow FCF aluminium lake (E110)
English: The safety assessment of ledipasvir/sofosbuvir is based on pooled data from three Phase 3 clinical studies (ION-3, ION-1 and ION-2) including 215, 539 and 326 patients who received ledipasvir/sofosbuvir for 8, 12 and 24 weeks, respectively; and 216, 328 and 328 patients who received ledipasvir/sofosbuvir + ribavirin combination therapy for 8, 12 and 24 weeks, respectively.
Maltese: Il-valutazzjoni tas-sigurtà ta' ledipasvir/sofosbuvir hija bbażata fuq dejta miġbura minn tliet studji kliniċi ta' Fażi 3 (ION-3, ION-1 u ION-2) li jinkludu 215, 539 u 326 pazjent li rċivew ledipasvir/sofosbuvir għal 8, 12 u 24 ġimgħa, rispettivament; u 216, 328 u 328 pazjent li rċivew kura ta' kombinazzjoni ta' ledipasvir/sofosbuvir + ribavirin għal 8, 12 u 24 ġimgħa, rispettivament.
English: NS5A RAVs were seen at relapse in 5/5 patients (for genotype 1a: Q30R/H + L31M/V [n = 1] and Q30R [n = 1]; for genotype 1b: Y93H [n = 3]).
Maltese: NS5A RAVs ġew osservati fir rikaduta f'5/5 tal-pazjenti (għal ġenotip 1a: Q30R/H + L31M/V [n = 1] u Q30R [n = 1]; għal ġenotip 1b: Y93H [n = 3]).
English: f. Staggered administration (12 hours apart) of atazanavir/ritonavir + emtricitabine/tenofovir disoproxil fumarate or darunavir/ritonavir + emtricitabine/tenofovir disoproxil fumarate and Harvoni provided similar results.
Maltese: Għoti mifrux (12-il siegħa l-bogħod minn xulxin) ta' atazanavir/ritonavir + emtricitabine/tenofovir disoproxil fumarate jew darunavir/ritonavir + emtricitabine/tenofovir disoproxil fumarate u Harvoni ta riżultati simili. g.
English: • simeprevir (a medicine used to treat hepatitis C infection);
Maltese: • simeprevir (mediċina li tintuża għall-kura ta' infezzjoni ta' epatite Ċ);
English: • oxcarbazepine (a medicine used to treat epilepsy and prevent seizures);
Maltese: • oxcarbazepine (mediċina li tintuża għal kura ta' epilessija u għal prevenzjoni ta' aċċessjonijiet);
English: The median age was 52 years (range: 26 to 72); 82% of the patients were male; 61% were white; 34% were black; 75% had genotype 1a HCV infection; 2% had genotype 4 infection; 76% had non-CC IL28B alleles (CT or TT); and 20% had compensated cirrhosis.
Maltese: L-età medjana kienet ta' 52 sena (medda: 26 sa 72); 82% tal-pazjenti kienu rġiel; 61% kienu bojod; 34% kienu suwed; 75% kellhom infezzjoni bl-HCV ta' ġenotip 1a; 2% kellhom infezzjoni ta'
English: Medicinal products that are potent P-glycoprotein (P-gp) inducers in the intestine (rifampicin, rifabutin, St. John's wort [Hypericum perforatum], carbamazepine, phenobarbital and phenytoin).
Maltese: Prodotti mediċinali li huma indutturi potenti ta' P-gp (rifampicin, rifabutin, St.
English: ANTIMYCOBACTERIALS Rifampicin (600 mg once daily)/ ledipasvir (90 mg single dose)
Maltese: ANTIMIKOBATTERJALI Rifampicin (600 mg darba kuljum)/ ledipasvir (90 mg doża waħda) d
English: The 8-week treatment of ledipasvir/sofosbuvir without ribavirin was non-inferior to the 8-week treatment of ledipasvir/sofosbuvir with ribavirin (treatment difference 0.9%; 95% confidence interval: -3.9% to 5.7%) and the 12-week treatment of ledipasvir/sofosbuvir (treatment difference -2.3%; 97.5% confidence interval: -7.2% to 3.6%).
Maltese: -3.9% sa 5.7%) u l-kura ta' 12-il ġimgħa ta' ledipasvir/sofosbuvir (differenza fil-kura -2.3%; 97.5% intervall ta' fiduċja: -7.2% sa 3.6%).
English: • rosuvastatin (a medicine used to treat high cholesterol).
Maltese: • rosuvastatin (mediċina li tintuża għall-kura ta' kolesterol għoli).
English: In vitro potential for ledipasvir/sofosbuvir to affect other medicinal products At concentrations achieved in the clinic, ledipasvir is not an inhibitor of hepatic transporters including the OATP 1B1 or 1B3, BSEP, OCT1, OCT2, OAT1, OAT3, multidrug and toxic compound extrusion (MATE) 1 transporter, multidrug resistance protein (MRP) 2 or MRP4.
Maltese: F'konċentrazzjonijiet miksubin fil-klinika, ledipasvir mhuwiex inibitur ta' trasportaturi tal-fwied li jinkludu OATP 1B1 jew 1B3, BSEP, OCT1, OCT2, OAT1, OAT3, trasportatur ta' estrużjoni ta' mediċini differenti u ta' komposti tossiċi (MATE - multidrug and toxic compound extrusion) 1, ilproteina ta' reżistenza ta' mediċini differenti (MRP) 2 jew MRP4.
English: Harvoni + ribavirin for 12 weeks or
Maltese: Harvoni + ribavirin għal 12-il ġimgħa jew
English: Protein binding of GS-331007 was minimal in human plasma.
Maltese: GS-331007 mal-proteina kien minimu fil-plażma tal-bniedem.
English: Safety and efficacy of ledipasvir/sofosbuvir have been established in patients with decompensated cirrhosis (see section 5.1).
Maltese: Is-sigurtà u l effikaċja ta' ledipasvir/sofosbuvir ġew determinati f'pazjenti b'ċirrożi dikumpensata (ara sezzjoni 5.1).
English: Table 6: Demographics and baseline characteristics in study ION-3 Patient disposition
Maltese: Tabella 6: Demografiċi u karatteristiċi tal-linja bażi fi studju ION-3 Dispożizzjoni tal-pazjent
English: NARCOTIC ANALGESICS Methadone
Maltese: ANALĠESIĊI NARKOTIĊI
English: NS5A transient replicons
Maltese: NS5B RAVs:
English: Raltegravir (400 mg twice daily)/ sofosbuvir (400 mg once daily)
Maltese: Raltegravir (400 mg darbtejn kuljum)/ sofosbuvir (400 mg darba kuljum)
English: Nervous system disorders: Very common headache
Maltese: Disturbi fis-sistema nervuża:
English: Table 9: Demographics and baseline characteristics in study ION-1 Patient disposition
Maltese: Tabella 9: Demografiċi u karatteristiċi tal-linja bażi fl-istudju ION-1 Dispożizzjoni tal-pazjent
English: Post-baseline NS5A and NS5B deep sequencing data (assay cut off of 1%) were available for 37/37 and 36/37 patients, respectively.
Maltese: 1%) kienet disponibbli għal 37/37 u 36/37 pazjent, rispettivament.
English: Genotype 1b 0.004 Genotype 2a
Maltese: Ġenotip 1a Ġenotip 1b Ġenotip 2a Ġenotip 2b
English: These data suggest that biliary excretion of unchanged ledipasvir is a major route of elimination with renal excretion being a minor pathway (approximately 1%).
Maltese: Din id-dejta tissuġġerixxi li l-eliminazzjoni biljari ta' ledipasvir mhux mibdul hija r-rotta maġġuri ta' eliminazzjoni bl-eliminazzjoni renali tkun biss mogħdija minuri (madwar 1%).
English: Elimination Following a single 90 mg oral dose of [14C]-ledipasvir, mean total recovery of the [14C]-radioactivity in faeces and urine was 87%, with most of the radioactive dose recovered from faeces (86%).
Maltese: Wara doża orali waħda ta' 90 mg ta' [14C]-ledipasvir, il-medja tal-irkupru totali tas-[14C]-radjuattività fl-ippurgar u fl-awrina kienet ta' 87%, b'ħafna mid-doża radjuattiva rkuprata mill-ippurgar (ta' 86%).
English: All patients were treatment-naïve to HCV therapy without cirrhosis, 26% (13/50) of patients were HIV antiretroviral naïve and 74% (37/50) of patients were receiving concomitant HIV antiretroviral therapy.
Maltese: HCV fil-passat u kienu mhux ċirrotiċi, 26% (13/50) tal-pazjenti qatt ma kienu ħadu antiretrovirali għall-HIV u 74% (37/50) tal-pazjenti kienu qed jirċievu terapija antiretrovirali tal-HIV konkomittanti.
English: The following adverse drug reactions have been identified with Harvoni (Table 4).
Maltese: Ir-reazzjonijiet avversi tal-mediċina li ġejjin ġew identifikati b'Harvoni (Tabella 4).
English: Atazanavir concentrations are also increased, with a risk for an increase in bilirubin levels/icterus.
Maltese: b'riskju ta' żieda fil-livelli tal-bilirubina/icterus.
English: LDV/SOF 12 weeks
Maltese: LDV/SOF
English: Co-administration of Harvoni with rosuvastatin is contraindicated (see section 4.3).
Maltese: rosuvastatin hu kontraindikat (ara sezzjoni 4.3).
English: IL28CC genotype FibroTest-Determined Metavir score b
Maltese: Punteġġ Metavir Stabbilit b'Test Fibro b