FrancophonIA/ELRC3.0 huggingface dataset:
English: Eyelid oedema, lacrimation increased, conjunctival haemorrhage, conjunctivitis, dry eye, blurred vision Eye irritation, eye pain, orbital oedema, scleral haemorrhage, retinal haemorrhage, blepharitis, macular oedema
Maltese: Edema mad-dawra ta' l-għajnejn, dermatite/ekżema/raxx Ħakk, edema fil-wiċċ, ġilda xotta, ħmura, alopeċja, tgħereq ħafna matul il lejl, reazzjoni ta' fotosensittività
English: The experience with imatinib in patients with MDS/MPD associated with PDGFR gene re-arrangements is very limited (see section 5.1).
Maltese: L-esperjenza bl-użu ta' imatinib f'pazjenti b'MDS/MPD assoċjat mal-arranġamenti mill-ġdid talġene PDGFR hija ferm limitata (ara sezzjoni 5.1).
English: • Sudden swelling and redness of the skin (signs of a skin infection called cellulitis).
Maltese: Infjammazzjoni f'daqqa tal-ġilda u ħmura (sinjali ta' infezzjoni fil-ġilda msejħa ċellulite).
English: imatinib teva b.v. 400 mg hard capsules
Maltese: Imatinib Teva B.V. 400 mg kapsuli iebsin
English: There are no controlled trials in paediatric patients with c-Kit positive GIST.
Maltese: M'hemmx provi kkontrollati fost pazjenti pedjatriċi b'c-Kit b'GIST pożittiv.
English: Very common:
Maltese: Insuffiċjenza epatika:
English: Unchanged imatinib accounted for 25% of the dose (5% urine, 20% faeces), the remainder being metabolites.
Maltese: tad-doża). 25% tad-doża ta' imatinib kienet eliminata fil-forma mhux mibdula (5% fl-awrina, 20% fl ippurgar) u l-bqija kienu tneħħew bħala sustanzi li jirriżultaw mill-metaboliżmu.
English: G-CSF (5 μg/kg, SC): days 6-15 or until ANC > 1500 post nadir IT Methotrexate (age-adjusted): day 1 ONLY Triple IT therapy (age-adjusted): day 8, 15
Maltese: IT Methotrexate (aġġustata skont l-età): jum 1 BISS Terapija IT tripla (aġġustata skont l-età): jum 8, 15
English: Imatinib Teva B.V. is a medicine containing an active substance called imatinib.
Maltese: Imatinib Teva B.V. huwa mediċina li fih is-sustanza attiva imatinib.
English: The age of these patients ranged from 8 to 18 years and imatinib was given in both adjuvant and metastatic settings at doses ranging from 300 to 800 mg daily.
Maltese: L-età ta' dawn il-pazjenti kienet minn 8 snin sa 18-il sena u imatinib ingħata kemm f'kundizzjonijiet adjuvanti kif ukoll metastatiċi f'dożi li jvarjaw minn 300 sa 800 mg kuljum.
English: Uncommon:
Maltese: Mhux Komuni
English: Name and address of the manufacturers responsible for batch release Teva Czech Industries s.r.o.
Maltese: Teva Czech Industries s.r.o.
English: One 3-year-old male exposed to a single dose of 400 mg experienced vomiting, diarrhoea and anorexia and another 3-year-old male exposed to a single dose of 980 mg experienced decreased white blood cell count
Maltese: Popolazzjoni pedjatrika Tifel wieħed ta' 3 snin li kien espost għal doża waħda ta' 400 mg sofra minn rimettar, dijarea u anoreksja u tifel ieħor ta' 3 snin li kien espost għal doża ta' 980 mg sofra minn tnaqqis fl-għadd taċ-ċelluli l-bojod u dijarea.
English: Each hard capsule contains 400 mg of imatinib (as mesilate).
Maltese: Kull kapsula iebsa fiha 400 mg imatinib (bhal mesilate).
English: Renal function should, therefore, be evaluated prior to the start of imatinib therapy and closely monitored during therapy, with particular attention to those patients exhibiting risk factors for renal dysfunction.
Maltese: terapija b'imatinib u mmonitorjata mill-qrib waqt it-terapija, b'attenzjoni partikolari għal dawk il-pazjenti li juru fatturi ta' riskju għal disfunzjoni renali.
English: The analysis confirmed that exposure of imatinib in paediatric patients receiving 260 mg/m2 once daily (not exceeding 400 mg once daily) or 340 mg/m2 once daily (not exceeding 600 mg once daily) were similar to those in adult patients who received imatinib 400 mg or 600 mg once daily.
Maltese: (mhux aktar minn 400 mg darba kuljum) jew 340 mg/m2 darba kuljum (mhux aktar minn 600 mg darba kuljum) kienu l-istess bħal dawk f'pazjenti adulti li ngħataw 400 mg jew 600 mg imatinib darba kuljum.
English: Dizziness, paraesthesia, taste disturbance, hypoaesthesia Migraine, somnolence, syncope, peripheral neuropathy, memory impairment, sciatica, restless leg syndrome, tremor, cerebral haemorrhage Increased intracranial pressure, convulsions, optic neuritis
Maltese: Emigranja, ngħas, sinkope, newropatija periferali, tixkil fil-memorja, xjatika, sindrome tas-sieq irrekwieta, tregħid, emorraġija ċerebrali
English: Dose adjustment for adverse reactions
Maltese: Rappurtar tal-effetti sekondarji
English: The dose of 340 mg/m2 daily is recommended for children with Ph+ ALL (not to exceed the total dose of 600 mg).
Maltese: Hija rrakkomandata doża ta' 340 mg/m2 għal tfal b'Ph+ ALL (m'għandhiex taqbeż id-doża sħiħa ta' 600 mg).
English: Imatinib Teva B.V. 100 mg hard capsules are non-transparent orange capsules with black marking 7629 on capsule body and black marking TEVA on capsule cap.
Maltese: Id-doża tal-bidu hija ta' 100 mg, li għandha tittieħed bħala kapsuli darba kuljum.
English: All patients received imatinib and consolidation chemotherapy (see Table 3) after induction and the levels of bcr-abl transcripts were identical in the two arms at 8 weeks.
Maltese: Il-pazjenti kollha rċevew imatinib u terapija konsolidata (ara Tabella 3) wara induzzjoni u l-livelli ta' bcr-abl transcripts kienu identiċi fiż-żewġt ifriegħi mat-8 ġimgħa.
English: In newly diagnosed chronic phase CML grade 4 neutropenia (ANC < 0.5 x 109/l) and thrombocytopenia (platelet count < 10 x 109/l) were observed in 3.6% and < 1% of patients, respectively.
Maltese: (għadd tal-plejtlets < 10 x 109/L) f' 3.6% u f' < 1% tal-pazjenti, rispettivament.
English: Imatinib Teva B.V. 400 mg film-coated tablets are available in pack sizes of 30 or 90 film-coated tablets in blisters.
Maltese: Imatinib Teva B.V. 400 mg pilloli miksija b'rita huma disponibbli f'pakketti ta '30 jew 90 pillola miksija b'rita f'folji.
English: Isolated cases of imatinib overdose have been reported spontaneously and in the literature.
Maltese: imatinib kienu rrappurtati b'mod spontanju u fil-letteratura.
English: The safety and efficacy of imatinib in children with MDS/MPD, DFSP, GIST and HES/CEL aged less than 18 years of age have not been established in clinical trials.
Maltese: Is-sigurta u l-effikaċija ta' imatinib fit-tfal u adoloxxenti b'MDS/MPD, DFSP u HES/CEL li huma anqas minn 18-il sena ma ġewx stabbiliti waqt provi kliniċi.
English: From the safety data available, escalating the dose to 800 mg daily in patients progressing at lower doses of 400 mg or 600 mg daily does not seem to affect the safety profile of imatinib.
Maltese: 400 mg u 600 mg kuljum ma jishirx li taffettwa l-profil ta' sigurtà ta' imatinib.
English: The dose of 340 mg/m2 daily is recommended for children with chronic phase CML and advanced phase CML (not to exceed the total dose of 800 mg).
Maltese: Doża ta' 340 mg/m2 kuljum hija rakkomandata fi tfal u adolexxenti li jkollhom CML f'fażi kronika u CML fil-fażi lavvanzata (sabiex ma tinqabiżx id-doża totali ta' 800 mg).
English: Posology for CML in children
Maltese: MOD TA' KIF U MNEJN JINGĦATA
English: Imatinib and its metabolites are not excreted via the kidney to a significant extent.
Maltese: Din il-medicina m'ghandiex hazna specjali.
English: - Each film-coated tablet of Imatinib Teva B.V. contains 400 mg imatinib (as mesilate).
Maltese: Kull pillola miksija b'rita fiha 400 mg ta' imatinib (bħala mesilate).
English: Study 0102 38-month data Myeloid blast crisis (n=260) % of patients (CI95%)
Maltese: Proporzjon ta' periklu 0.46 (95% Cl, 0.32-0.65)
English: HIV ANTIVIRALS: NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS Rilpivirine
Maltese: INIBITURI NON-NUCLEOTIDE REVERSE TRANSCRIPTASE Rilpivirine
English: See sections 4.8 and 5.1 for additional information.
Maltese: Ara sezzjonijiet 4.8 u 5.1 għal informazzjoni addizzjonali.
English: Dose normalised parameters reported for methadone, buprenorphine and naloxone.
Maltese: Dożi normalizzati parametric rapportati għal methadone, buprenorphine u naloxone .
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/983/001
Maltese: EU/1/14/983/001
English: ANTICONVULSANTS carbamazepine
Maltese: ANTITKONVULSANTI carbamazepine
English: Expected: ↓ esomeprazole, lansoprazole
Maltese: ↓ esomeprazole, lansoprazole
English: Do not take Exviera:
Maltese: Tiħux Exviera :
English: 60%) of drug related radioactivity in plasma.
Maltese: 60%) tar-radjuattività relatata mal-mediċina fil-plażma.
English: − Tablet film-coating: polyvinyl alcohol (E1203), titanium dioxide (E171), polyethylene glycol 3350, talc (E553b), iron oxide yellow (E172), iron oxide red (E172) and iron oxide black (E172).
Maltese: − Kisja b'rita tal-pillola: polyvinyl alcohol (E1203), titanium dioxide (E171), polyethylene glycol 3350, talc (E553b), iron oxide yellow (E172) , iron oxide red (E172) u iron oxide black (E172).
English: INFORMATION IN BRAILLE exviera
Maltese: INFORMAZZJONI BIL-BRAILLE exviera
English: It contains the active substance dasabuvir.
Maltese: Fih is-sustanza attiva dasabuvir.
English: ANTIBIOTICS (SYSTEMIC ADMINISTRATION) Sulfamethoxazole, trimethoprim
Maltese: Sulfamethoxazole, trimethoprim
English: Pharmacotherapeutic group: Antivirals for systemic use; direct-acting antivirals, ATC code: J05AX16 Mechanism of action
Maltese: Antivirali b'azzjoni diretta, Kodiċi ATC: J05AX16 Mekkaniżmu ta' azzjoni
English: Exviera 250 mg film-coated tablets dasabuvir
Maltese: Exviera 250 mg pilloli dasabuvir
English: Mechanism: CYP3A4/CY P2C8 induction by rifampicin.
Maltese: Induzzjoni ta' CYP3A4/CYP2C8 minn rifampicin
English: Pharmacokinetics of the combination of ombitasvir 25 mg, paritaprevir 150 mg, and ritonavir 100 mg, with dasabuvir 400 mg were evaluated in subjects with mild (CrCl: 60 to 89 ml/min), moderate (CrCl: 30 to 59 ml/min) and severe (CrCl: 15 to 29 ml/min) renal impairment, relative to subjects with normal renal function.
Maltese: Il-farmokokinetika tal-kombinazzjoni ta' ombitasvir 25 mg, paritaprevir150 mg, u ritonavir 100 mg, ma' dasubuvir 400 mg jew mingħajru kienet evalwata f'individwi b'indeboliment renali ħafif (CrCl: 60 sa 89 ml/min), moderat (CrCl: 30 sa 59 ml/min), u sever (CrCl: 15 sa 29 ml/min), meta mqabbla ma' individwi b'funzjoni renali normali.
English: ↑ dabigatran etexilate
Maltese: Mistenni: ↑ dabigatran etexilate
English: ANTIMYCOBACTERIALS
Maltese: ANTIKOAGULANTI
English: Main demographics in TURQUOISE-III
Maltese: Demografiji ewlenin f' TURQUOISE-III
English: SAPPHIRE-I - genotype 1, treatment-naïve
Maltese: SAPPHIRE-I - naïve għall-kura, ġenotip 1
English: Dasabuvir M1 AUC values were 6% lower, 10% lower, and 13% lower, respectively.
Maltese: Valuri medja ta' AUC ta' dasabuvir M1 kienu 6% inqas, 10% inqas, u 13% inqas, rispettivament.
English: PEARL-III - genotype 1b, treatment-naïve
Maltese: PEARL-III - ġenotip 1b, naïve għall-kura
English: Arm A 12 Weeks N = 31
Maltese: 12 Ġimgħa N = 31
English: 5 mg single dose and other vitamin K antagonists
Maltese: 5 mg u antagonisti oħra tal-vitamina K
English: 600/300 mg once daily
Maltese: 600/300 mg
English: 800/160 mg twice daily
Maltese: 800/160 mg Darbtejn kuljum
English: Arm B 24 Weeks N = 32
Maltese: 24 Ġimgħa N = 32
English: In subjects with mild, moderate and severe hepatic impairment, dasabuvir AUC values were 17% higher, 16% lower and 325% higher, respectively.
Maltese: F'suġġetti b'indeboliment epatiku ħafif, moderat u sever, valuri AUC ta' dasabuvir kienu 17% ogħla, 16% inqas u 325% ogħla, rispettivament.
English: Exviera and ombitasvir/paritaprevir/ritonavir + ribavirin* N = 2,044
Maltese: Exviera u ombitasvir/paritaprevir/ritonavir + ribavirin* N = 2,044
English: In subjects receiving Exviera and ombitasvir/paritaprevir/ritonavir without ribavirin, adverse events typically associated to ribavirin (e.g. nausea, insomnia, anaemia) were less frequent and no subjects (0/588) permanently discontinued treatment due to adverse reactions.
Maltese: F'individwi li qed jirċievu Exviera u ombitasvir/paritaprevir/ritonavir mingħajr ribavirin, reazzjonijiet avversi tipikament assoċjati ma' ribavirin (e.ż. dardir, għejja, anemija) kienu anqas frekwenti u l-ebda individwi (0/588) ma waqqfu l-kura b'mod permanenti minħabba avvenimenti avversi.
English: HIV-1 Co-infection
Maltese: Ko-infezzjoni ta' HIV-1
English: Exviera ombitas vir/parit aprevir/r itonavir atazanavir dasabuvir ombitasvir paritaprevir
Maltese: Exviera + ombitasvir/ paritaprevi r/ritonavir atazanavir dasabuvir ombitasvir paritaprevir
English: Polyvinyl alcohol (E1203) Titanium dioxide (E171) Polyethylene glycol 3350 Talc (E553b) Iron oxide yellow (E172) Iron oxide red (E172) Iron oxide black (E172)
Maltese: Polyvinyl alcohol (E1203) Titanium dioxide (E171) Polyethylene glycol 3350 Talc (E553b)
English: With RBV
Maltese: RBV
English: Mechanism: decrease possibly due to CYP1A2 induction by ritonavir
Maltese: tnaqqis possibilment minħabba induzzjoni ta' CYP1A2 minn ritonavir
English: SVR12, n/N (%) [95% CI] Outcome for subjects not achieving SVR12 On-treatment virologic failurea Post-treatment relapse a
Maltese: SVR12, n/N (%) [95% CI] Riżultati għall-individwi li ma kisbux SVR12
English: Follow the dosing recommendations in Table 1.
Maltese: Segwi r-rakkomandazzjonijiet tad-dożaġġ f'Tabella 1.
English: Exviera is not recommended in patients with moderate hepatic impairment (Child-Pugh B).
Maltese: Exviera mhux rrakkomandat f'pazjenti b'indeboliment epatiku moderat (Child-Pugh B).
English: Coadministration with ethinylestradiol may lead to increased risk of ALT elevations (see sections 4.3 and 4.4).
Maltese: Koamministrazzjoni ma' ethinylestradiol jista' jwassal għal riskju akbar ta' żiediet fl-ALT (ara sezzjonijiet 4.3 u 4.4).
English: Exviera + ombitasvir/paritaprevir/ritonavir was administered as multiple doses in all the drug interaction studies except the drug interaction studies with carbamazepine, gemfibrozil, ketoconazole, and sulfamethoxazole/trimethoprim.
Maltese: ombitasvir/paritaprevir/ritonavir ingħataw bħala dożi multipli fl-istudji kollha ta' interazzjoni tal-mediċina ħlief l istudji ta' interazzjoni tal-mediċina ma' carbamazepine, gemfibrozil, ketoconazole, u sulfamethoxazole/trimethoprim..
English: TURQUOISE-III: Clinical Trial of GT1b-Infected Subjects with Cirrhosis without RBV
Maltese: TURQUOISE-III: Prova klinika ta' individwi infettati bi GT1b b' ċirrożi mingħajr RBV.
English: PEARL-II - genotype 1b, peginterferon+ribavirin-experienced
Maltese: PEARL-II - ġenotip 1b, li esperjenzaw peginterferon+ribavirin
English: SAPPHIRE-II - genotype 1, peginterferon+ribavirin-experienced
Maltese: SAPPHIRE-II - ġenotip 1, li esperjenzaw peginterferon+ribavirin
English: ANTIARRYTHMICS
Maltese: ANTIARRITMIĊI
English: No increase in incidence of ALT elevations was observed with other types of systemic estrogens commonly used for hormone replacement therapy (e.g., estradiol and conjugated estrogens).
Maltese: Ebda żieda fl-inċidenza ta' elevazzjoni fl-ALT ma kienet osservata ma' tipi oħra ta' estroġeni sistemiċi komunament użati għal terapija ta' sostituzzjoni bl-ormoni (e.ż, estradiol u estroġeni konjugat).
English: Table 16 shows the SVR12 rates for subjects with HCV genotype 1 infection and HIV-1 co-infection in TURQUOISE-I.
Maltese: Tabella 16 turi r-rati ta' SVR12 għas-Suġġetti b'infezzjoni ta' HCV ta'ġenotip 1 u b'ko-infezzjoni b' HIV-1 fit-Turquoise-I.
English: Alprazolam Exviera
Maltese: X'fih Exviera
English: Clinical trials in treatment-naïve adults
Maltese: Provi kliniċi f'adulti naïve għall-kura
English: Purpose of the medicine alprazolam, diazepam for anxiety, panic attacks and trouble sleeping ciclosporin, tacrolimus to suppress the immune system cyclobenzaprine, carisoprodol for muscle spasms dabigatran to thin the blood deferasirox to help reduce iron levels in the blood digoxin, amlodipine for heart problems or high blood pressure furosemide for the build-up of too much fluid in the body hydrocodone for pain imatinib for the treatment of some cancers of the blood levothyroxine for thyroid problems darunavir/ritonavir, atazanavir/ritonavir, rilpivirine for HIV infection omeprazole, lansoprazole, esomeprazole for stomach ulcers and other stomach problems rosuvastatin, pravastatin, fluvastatin, pitavastatin to lower blood cholesterol s-mephenytoin for epilepsy teriflunomide for multiple sclerosis sulfasalazine to treat and manage inflammatory bowel disease or to treat rheumatoid arthritis warfarin and other similar medicines called vitamin K antagonists*
Maltese: Levothyroxine għall-problemi tat-tirojde darunavir/ritonavir, atazanavir/ritonavir, rilpivirine għal infezzjoni tal-HIV omeprazole, lansoprazole, esomeprazole għal ulċeri fl-istonku u problemi fl istonku oħra rosuvastatin, pravastatin, fluvastatin,pitavastatin biex jitnaqqas il-kolesterol fid-demm s-mephenytoin għall-epilessija
English: Hepatitis B Virus Reactivation)
Maltese: Riattivazzjoni tal-Virus tal-Epatite B
English: Mechanism: increase in dasabuvir possibly due to CYP2C8 inhibition by trimethoprim
Maltese: Mekkaniżmu: żieda f'dasabuvir possibilment minħabba l inibizzjoni ta' CYP2C8 mnn trimethoprim
English: Characteristics
Maltese: Karatteristiċi
English: Extreme caution must be taken to avoid pregnancy in female patients and female partners of male patients when Exviera is used with ribavirin.
Maltese: Għandha tingħata kawtela estrema biex tiġi evitata tqala f'pazjenti nisa u fil-partners femminili ta' pazjenti rġiel meta Exviera jintuża ma' ribavirin.
English: Note: Doses used for Exviera + ombitasvir/paritaprevir/ritonavir were: ombitasvir 25 mg paritaprevir 150 mg, ritonavir 100 mg, once daily and dasabuvir 400 mg twice daily or 250 mg twice daily.
Maltese: Nota: Id-dożi użati għal Exviera + ombitasvir/paritaprevir/ritonavir kienu: ombitasvir 25 mg, paritaprevir 150 mg,
English: Ελλάδα AbbVie ΦΑΡΜΑΚΕΥΤΙΚΗ Α.Ε.
Maltese: tkun minħabba l inibizzjoni ta' OATPs minn atazanavir.
English: Tacrolimus 2 mg was dosed alone and 2 mg was administered with Exviera + ombitasvir/paritaprevir/ritonavir.
Maltese: Tacrolimus 2 mg ingħata waħdu u 2 mg ingħataw ma' Exviera + ombitasvir/paritaprevir/ritonavir.
English: S-warfarin dasabuvir ombitasvir
Maltese: S-warfarin dasabuvir ombitasvir paritaprevir
English: Emtricitabine/ tenofovir 200 mg once daily/300 mg once daily
Maltese: 200 mg darba kuljum /300 mg darba kuljum
English: CONTRACEPTIVES ethinylestradi ol/ norgestimate 0.035/0.25 m g once daily
Maltese: 0.035/0.25 mg darba kuljum
English: The efficacy and safety of Exviera in combination with ombitasvir/paritaprevir/ritonavir with and without ribavirin was evaluated in seven Phase 3 clinical trials, including two trials exclusively in subjects with compensated cirrhosis (Child-Pugh A), in over 2,360 subjects with genotype 1 chronic hepatitis C infection as summarised in Table 6.
Maltese: L-effikaċja u sigurtà ta' Exviera f'kombinazzjoni ma' ombitasvir/paritaprevir/ritonavir bi jew mingħajr ribavirin ġew evalwati f'seba' provi kliniċi ta' Fażi 3, inklużi żewġ provi esklussivament f'individwi b'ċirrożi ikkumpensata (Child-Pugh A), f'iktar minn 2,360 individwu b'infezzjoni tal epatite Ċ kronika ta' ġenotip 1 kif imqassra f'Tabella 6.
English: Dose normalized cyclosporine ratios are shown for interaction with Exviera + ombitasvir/paritaprevir/ritonavir.
Maltese: Dożi normalizzati tal-proporzjonijiet ta' cyclosporine huma murija għal interazzjoni mal Exviera + ombitasvir/paritaprevir/ritonavir.
English: PEARL-IV was a randomised, global multicentre, double-blind, controlled trial conducted in 305 treatment-naïve adults with genotype 1a chronic hepatitis C virus infection without cirrhosis.
Maltese: PEARL-IV kienet prova kkontrollata, double-blind, multiċentrika globali, randomizzata f'305 adult naïve għall-kura b'infezzjoni tal-virus tal-epatite Ċ kronika tal-ġenotip 1a mingħajr ċirrożi.
English: Dasabuvir does not inhibit organic anion transporter (OAT1) in vivo and is not expected to inhibit organic cation transporters (OCT2), organic anion transporters (OAT3), or multidrug and toxin extrusion proteins (MATE1 and MATE2K) at clinically relevant concentrations; therefore, Exviera does not affect medicinal product transport by these proteins.
Maltese: Dasabuvir ma jimpedixxix trasportatur anion organiku (OAT1) in vivo u mhuwiex mistenni li jinibixxi t-trasportaturi organiċi katjoni (OCT2), it-trasportaturi anjoni organiċi (OAT3), jew proteini talestrużjoni ta' ħafna mediċini u tossini MATE1 u MATE2K) f'konċentrazzjonijiet klinikament rilevanti; għalhekk , Exviera ma taffettwax it-trasport tal-prodott mediċinali minn dawn il-proteini .
English: TURQUOISE-II: relapse rates by baseline laboratory values after 12 and 24 weeks of treatment in subjects with genotype 1a infection and compensated cirrhosis
Maltese: TURQUOISE-II: rati ta' rikaduta minn valuri bażiċi tal-laboratorju wara 12 u 24 ġimgħa ta' kuraf'individwi b'infezzjoni ta' ġenotip 1a u ċirrożi kkumpensata
English: Mechanism: CYP2C19 induction by ritonavir
Maltese: induzzjoni ta' CYP2C19 minn ritonavir
English: The pharmacokinetics of Exviera with ombitasvir/paritaprevir/ritonavir in paediatric patients has not been investigated (see section 4.2).
Maltese: Il-farmakokinetiċi ta' Exviera ma' ombitasvir/paritaprevir/ritonavir f'pazjenti pedjatriċi ma ġewx investigati(ara sezzjoni 4.2).
English: The mean EC50 of dasabuvir against replicons containingNS5B from a panel of treatment-naïve genotype 1a and 1b isolates in the HCV replicon cell culture assay was 0.77 nM (range 0.4 to 2.1 nM; n=11) and 0.46 nM (range 0.2 to 2 nM; n=10), respectively.
Maltese: L-EC50 medju ta' dasabuvir kontra replikons li fihom NS5B minn penil ta' iżolati ta' ġenotip 1a u 1b li qatt ma ħadu l-kura qabel fittestijiet fuq kulturi ta' ċelloli HCV replikon kienu 0.77 nM (firxa ta' 0.4 sa 2.1 nM; n=11) u 0.46 nM
English: Mechanism: CYP3A4/Pgp inhibition by ketoconazole and paritaprevir/ ritonavir/ ombitasvir
Maltese: Inibizzjoni ta' CYP3A4/P-gp minn ketoconazole u paritaprevir /ritonavir/ ombitasvir
English: Atazanavir/ ritonavir 300/100 mg once daily
Maltese: Lopinavir/ritonavir 400/100mg darbtejn kuljum
English: SAPPHIRE-I was a randomised, global multicentre, double-blind, placebo-controlled trial conducted in 631 treatment-naïve adults with genotype 1 chronic hepatitis C virus infection without cirrhosis.
Maltese: SAPPHIRE-I kienet prova kkontrollata bi plaċebo, double-blind, multiċentrika globali, randomizzata f'631 adult naïve għall-kura b'infezzjoni tal-virus tal-epatite Ċ kronika tal-ġenotip 1 mingħajr ċirrożi.
English: 20-120 mg once daily5
Maltese: 4-24 mg/ 1-6 mg darba kuljum 5
English: Exviera and ombitasvir/paritaprevir/ritonavir with RBV for 12 weeks n/N % 95% CI
Maltese: Exviera u ombitasvir/paritaprevir/ritonavir ma' RBV għal 12-il ġimgħa n/N % 95% CI
English: In this study, Exviera and ombitasvir/paritaprevir/ritonavir without ribavirin had similar SVR12 rates (100%) compared to Exviera and ombitasvir/paritaprevir/ritonavir with ribavirin (99.5%).
Maltese: F'dan l-istudju, Exviera u ombitasvir/paritaprevir/ritonavir mingħajr ribavirin kellhom rati ta' SVR12 (100%) simili meta mqabbel ma' Exviera u ombitasvir/paritaprevir/ritonavir mingħajr ribavirin (99.5%).
English: Exviera is recommended in combination with paritaprevir/ombitasvir/ritonavir, and ritonavir may select for PI resistance in HIV co-infected patients without ongoing antiretroviral therapy.
Maltese: Exviera huwa rrakkomandat flimkien ma' paritaprevir/ombitasvir/ritonavir,u ritonavir jista' jagħżel reżistenza għall-PI f'pazjenti ko-infettati b'HIV mingħajr terapija antiretrovirali kontinwa.
English: Transient elevations in serum bilirubin (predominantly indirect) were observed in subjects receiving Exviera and ombitasvir/paritaprevir/ritonavir with ribavirin, related to the inhibition of the bilirubin transporters OATP1B1/1B3 by paritaprevir and ribavirin-induced haemolysis.
Maltese: Elevazzjonijiet temporanji tal-bilirubin fis-serum (il-biċċa l-kbira indiretti) ġew osservati f'individwi li kienu qed jirċievu Exviera u ombitasvir/paritaprevir/ritonavir b'ribavirin, relatati mal-inibizzjoni ta' trasportaturi ta' bilirubin OATP1B1/1B3 minn paritapreviru u emoliżi indotta minn ribavirin.