FrancophonIA/ELRC3.0 huggingface dataset:
English: During the Randomised Treatment Withdrawal Phase (weeks 32-52), patients originally randomised to apremilast who achieved at least a 75% reduction in their PASI score (PASI-75) (ESTEEM 1) or a 50% reduction in their PASI score (PASI-50) (ESTEEM 2) were re-randomised at week 32 to either placebo or apremilast 30 mg twice daily.
Maltese: Matul il-Fażi ta' Rtirar mill-Kura b'Mod Każwali (ġimgħat 32-52), il-pazjenti li oriġinarjament kienu ntgħażlu b'mod każwali għal apremilast li kisbu mill-inqas tnaqqis ta' 75% fil-punteġġ PASI tagħhom (PASI-75) (ESTEEM 1) jew tnaqqis ta' 50% fil-punteġġ PASI tagħhom (PASI-50) (ESTEEM 2), intgħażlu b'mod każwali mill-ġdid f'ġimgħa 32 jew għal plaċebo jew għal apremilast 30 mg darbtejn kuljum.
English: Hence, clinically relevant drug-drug interactions are unlikely when apremilast is co-administered with drugs that are substrates or inhibitors of these transporters.
Maltese: Għalhekk, interazzjonijiet klinikament rilevanti bejn mediċina mhumiex probabbli meta apremilast jingħata flimkien ma' mediċini li huma sottostrati jew inibituri ta' dawn it-trasportaturi.
English: Among 497 patients initially randomised to apremilast 30 mg twice daily, 375 (75%) patients were still on this treatment on week 52.
Maltese: Fost l-497 pazjent li inizjalment intgħażlu b'mod każwali għal apremilast 30 mg darbtejn kuljum, 375 (75%) pazjent daħlu fl-istudji ta'
English: The Otezla 30 mg film-coated tablet is a beige, diamond shaped film-coated tablet with “APR” engraved on one side and “30” on the opposite side.
Maltese: Il-pillola Otezla miksija b'rita ta' 30 mg hi ta' lewn beige, b'forma ta' djamant, b'“APR” imnaqqxa fuq naħa waħda u “30” fuq in-naħa l-oħra.
English: Pink, diamond shaped 10 mg film-coated tablet of 8 mm length with “APR” engraved on one side and “10” on the opposite side.
Maltese: Pillola miksija b'rita 10 mg, ta' lewn roża, b'forma ta' djamant, twila 8 mm, b'“APR” imnaqqxa fuq naħa waħda u “10” fuq in-naħa l-oħra.
English: The frequencies of adverse drug reactions are those reported in the apremilast arms of the four Phase III studies in PsA (n = 1,945) or the two Phase III studies in PSOR (n=1184) (highest frequency from either data pool is represented in Table 2).
Maltese: III f'PSOR (n=1,184) (l-ogħla frekwenza minn kull waħda miżżewġ ġabriet ta' dejta hi rrappreżentata f'Tabella 2).
English: Day
Maltese: PASI
English: Otezla 10 mg film-coated tablets
Maltese: Otezla 10 mg pilloli
English: The other most commonly reported adverse reactions include upper respiratory tract infections (8.4%), headache (7.9%), and tension headache (7.2%) and are mostly mild to moderate in severity.
Maltese: Ir-reazzjonijiet avversi l-oħrajn irrappurtati bl-aktar mod komuni jinkludu infezzjonijiet fil-parti ta' fuq tal-apparat respiratorju (8.4%), uġigħ ta' ras (7.9%), u wġigħ ta' ras minħabba t-tensjoni (7.2%) u l-biċċa l-kbira huma ħfief jew moderati fis-severità tagħhom.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Ir-rekwiżiti biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont lArtikolu 107c(7) tad-Di rettiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq ilportal elettroniku Ewropew tal-mediċini.
English: • Otezla 20 mg film-coated tablets: each film-coated tablet contains 20 mg of apremilast.
Maltese: • Otezla 20 mg pilloli miksija b'rita: kull pillola miksija b'rita fiha 20 mg ta' apremilast.
English: • The treatment initiation pack is a folding wallet containing 27 film-coated tablets: 4 x 10 mg tablets, 4
Maltese: • Il-pakkett tal-bidu tal-kura hu kartiera li tintewa li jkun fih 27 pillola miksija b'rita: 4 x 10 mg pilloli, 4 x 20 mg pilloli u 19 x 30 mg pillola.
English: Treatment with apremilast resulted in significant improvements in the signs and symptoms of PsA, as assessed by the ACR 20 response criteria compared to placebo at weeks 16.
Maltese: Il-kura b'apremilast irriżultat f'titjib sinifikanti fis-sinjali u s-sintomi ta' PsA, kif evalwat mill-kriterji ta' rispons ACR 20 meta mqabbla ma' plaċebo f'ġimgħa 16.
English: Rash Urticaria
Maltese: Studji oħrajn
English: The Otezla 10 mg film-coated tablet is a pink, diamond shaped film-coated tablet with “APR” engraved on one side and “10” on the opposite side.
Maltese: Il-pillola Otezla miksija b'rita ta' 10 mg hi ta' lewn roża, b'forma ta' djamant, b'“APR” imnaqqxa fuq naħa waħda u “10” fuq in-naħa l-oħra.
English: Change in DLQI from baseline, mean± SDa
Maltese: Studji dwar il-ġenotossiċità
English: Accumulation is minimal when apremilast is administered once daily and approximately 53% in healthy subjects and 68% in patients with psoriasis when administered twice daily.
Maltese: L-akkumulazzjoni hi minima meta apremilast jingħata darba kuljum, u madwar 53% f'individwi b'saħħithom, u 68% f'pazjenti bi psorjasi meta jingħata darbtejn kuljum.
English: Brown, diamond shaped 20 mg film-coated tablet of 10 mm length with “APR” engraved on one side and “20” on the opposite side.
Maltese: Pillola miksija b'rita 20 mg, ta' lewn kannella, b'forma ta' djamant, twila 10 mm, b'“APR” imnaqqxa fuq naħa waħda u “20” fuq in-naħa l-oħra.
English: Consistent with apremilast being a substrate of CYP3A4, apremilast exposure is decreased when administered concomitantly with rifampicin, a strong inducer of CYP3A4.
Maltese: B'mod konsistenti mal-fatt li apremilast hu sottostrat ta' CYP3A4, l-esponiment għal apremilast jonqos meta jingħata fl-istess ħin ma' rifampicin, induttur qawwi ta' CYP3A4.
English: • stomach pain
Maltese: • uġigħ fid-dahar
English: • Otezla 30 mg film-coated tablets: each film-coated tablet contains 30 mg of apremilast.
Maltese: • Otezla 30 mg pilloli miksija b'rita: kull pillola miksija b'rita fiha 30 mg ta' apremilast.
English: Apremilast-treated patients demonstrated statistically significant improvement in physical function, as assessed by the disability index of the health assessment questionnaire (HAQ-DI) change from baseline, compared to placebo at weeks 16 in PALACE 1, PALACE 2 and PALACE 3 and in the pooled studies Improvement in HAQ-DI scores was maintained at week 24.
Maltese: Il-pazjenti kkurati b'apremilast urew titjib statistikament sinifikanti fil-funzjoni fiżika, kif evalwat mill-bidla fid-Disability Index of the Health Assessment Questionnaire (HAQ-DI - Indiċi ta' Diżabilità tal-Kwestjonarju dwar l-Evalwazzjoni tas-Saħħa) mil-linja bażi, meta mqabbel ma' plaċebo f'ġimgħat 16 f'PALACE 1, PALACE
English: Each film-coated tablet contains 20 mg of apremilast.
Maltese: Kull pillola miksija b'rita fiha 20 mg ta' apremilast.
English: Among patients who were initially randomised to apremilast 30 mg twice daily treatment, ACR 20/50/70 response rates were maintained through week 52 in the pooled studies PALACE 1, PALACE 2 and PALACE 3 (Figure 1).
Maltese: Fost pazjenti li inizjalment intgħażlu b'mod każwali għall-kura b'apremilast 30 mg darbtejn kuljum, ir-rati ta' rispons ACR 20/50/70 inżammu sa ġimgħa 52 fl-Istudji miġbura PALACE 1, PALACE
English: Proportion of patients with ACR responses in studies PALACE 1, PALACE 2 and PALACE 3 and pooled studies at week 16
Maltese: Tabella 3. Proporzjon ta' pazjenti b'risponsi ACR fi studji PALACE 1, PALACE
English: • Otezla 10 mg film-coated tablets: each film-coated tablet contains 10 mg of apremilast.
Maltese: • Otezla 10 mg pilloli miksija b'rita: kull pillola miksija b'rita fiha 10 mg ta' apremilast.
English: In addition, apremilast demonstrated a treatment benefit across multiple manifestations of psoriasis including pruritus, nail disease, scalp involvement and quality of life measures.
Maltese: Ma' dan, apremilast wera benefiċċju tal-kura f'manifestazzjonijiet multipli ta' psorjasi li jinkludu ħakk, mard tad-dwiefer, involviment tal-qorriegħa u kejl tal-kwalità tal-ħajja.
English: In a combined female mouse fertility and embryo-foetal developmental toxicity study with oral dosages of 10, 20, 40, and 80 mg/kg/day, a prolongation of oestrous cycles and increased time to mating were observed at 20 mg/kg/day and above; despite this, all mice mated and pregnancy rates were unaffected.
Maltese: Fi studju kombinat dwar il-fertilità ta' ġrieden nisa u t-tossiċità fl-iżvilupp embrijufetali b'dożaġġi orali ta' 10, 20, 40, u 80 mg/kg/jum, ġie osservat titwil fiċ-ċikli estrużi u żieda fiż-żmien għattgħammir f'doża ta' 20 mg/kg/jum u aktar; minkejja dan, il-ġrieden kollha għammru u r-rati tat-tqala ma kinux affettwati.
English: Week 16 Week 32
Maltese: Ġimgħa 16 Ġimgħa 32
English: • The 20 mg film-coated tablet also contains iron oxide yellow (E172).
Maltese: • Il-pillola miksija b'rita ta' 20 mg fiha wkoll iron oxide yellow (E172).
English: The proportion of patients with ACR 20/50/70 (responses in studies PALACE 1, PALACE 2 and PALACE 3, and the pooled data for studies PALACE 1, PALACE 2 and PALACE 3) for apremilast 30 mg twice daily at week 16 are shown in Table 3.
Maltese: Wara 52 ġimgħa ta' kura, il-pazjenti setgħu jkomplu fuq apremilast 20 mg jew 30 mg openlabel fi ħdan l-estensjoni fit-tul tal-istudji PALACE 1, PALACE 2, u PALACE 3 għal tul ta' żmien totali tal-kura sa 5 snin (260 ġimgħa).
English: At week 24, all remaining placebo-treated patients were switched to either apremilast 20 or 30 mg twice daily.
Maltese: F'ġimgħa 24, ilpazjenti kollha li kien fadal ikkurati bi plaċebo, inqalbu jew għal apremilast 20 jew 30 mg darbtejn kuljum.
English: The safety of apremilast was not evaluated in PsA or PSOR patients with moderate or severe renal impairment in the clinical studies.
Maltese: Is-sigurtà ta' apremilast ma ġietx evalwata f'pazjenti b'PsA jew PSOR li kellhom indeboliment moderat jew sever tal-kliewi fl-istudji kliniċi.
English: Apremilast is extensively metabolised by both CYP and non-CYP mediated pathways including oxidation, hydrolysis, and conjugation, suggesting inhibition of a single clearance pathway is not likely to cause a marked drug-drug interaction.
Maltese: Apremilast jiġi metabolizzat b'mod estensiv kemm minn CYP kif ukoll minn passaġġi li mhumiex medjati minn CYP, li jinkludu ossidazzjoni, idrolisi, u konjugazzjoni, u dan jissuġġerixxi li linibizzjoni ta' passaġġ wieħed tat-tneħħija mhux probabbli li se tikkawża interazzjoni notevoli bejn mediċina u oħra.
English: Each film-coated tablet contains 10 mg of apremilast.
Maltese: Kull pillola miksija b'rita fiha 10 mg ta' apremilast.
English: Based on the study design, patients whose tender and swollen joint counts had not improved by at least 20% were considered non-responders at week 16.
Maltese: Ibbażat fuq id-disinn tal-istudju, pazjenti li l-ġogi sensittivi jew minfuħin tagħhom ma wrewx titjib ta' mill-inqas 20%, ġew ikkunsidrati bħala li ma rrispondewx f'ġimgħa 16.
English: Back pain*
Maltese: Rimettar*
English: LIST OF EXCIPIENTS Contains lactose.
Maltese: TA' EĊĊIPJENTI Fih il-lactose.
English: If you are 65 years of age or older, you might have a higher risk of complications of severe diarrhoea, nausea and vomiting.
Maltese: Jekk għandek 65 sena jew aktar, jista' jkollok riskju ogħla ta' kumplikazzjonijiet ta' dijarea, dardir u rimettar severi.
English: In addition, at week 32, subjects who did not achieve a PASI-75 response in ESTEEM 1, or a PASI-50 response in ESTEEM 2, were permitted to use topical psoriasis therapies and/or phototherapy in addition to apremilast 30 mg twice daily treatment.
Maltese: Ukoll, f'ġimgħa 32, individwi li ma kisbux rispons PASI-75 f'ESTEEM 1, jew rispons PASI-50 f'ESTEEM 2, kienu permessi li jużaw terapiji topiċi u/jew fototerapija flimkien mal-kura b'apremilast 30 mg darbtejn kuljum.
English: People with severe kidney problems
Maltese: Nies bi problemi tal-kliewi severi
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Otezla 10 mg film-coated tablets
Maltese: U KWANTITATTIVA Otezla 10 mg pilloli miksija b'rita
English: Of the patients with at least a PASI-50 response who were re-randomised to placebo at week 32, 24.2% were PASI-50 responders at week 52.
Maltese: Mill-pazjenti b'mill-inqas rispons PASI-50 li ntgħażlu b'mod każwali mill-ġdid għal plaċebo f'ġimgħa 32, 24.2% kellhom rispons PASI-50 f'ġimgħa 52.
English: In both studies, patients were randomised 2:1 to apremilast 30 mg twice daily or placebo for 16 weeks (placebo-controlled phase) and from weeks 16-32, all patients received apremilast 30 mg twice daily (maintenance phase).
Maltese: Dawn l-istudji kellhom disinn simili sa ġimgħa 32. Fiż-żewġ studji, il-pazjenti ntgħażlu b'mod każwali fi proporzjon ta' 2:1 għal apremilast 30 mg darbtejn kuljum jew plaċebo għal 16-il ġimgħa (fażi kkontrollata bi plaċebo) u minn ġimgħat 16-32, il-pazjenti kollha rċivew apremilast 30 mg darbtejn kuljum (fażi ta' manteniment).
English: It may harm them, even if their signs of illness are the same as yours.
Maltese: Nisa li jistgħu joħorġu tqal għandu jsirilhom test tat-tqala qabel jinbeda Dovato.
English: ViiV Healthcare BV Huis ter Heideweg 62 3705 LZ Zeist Netherlands
Maltese: ViiV Healthcare BV Huis ter Heideweg 62 3705 LZ Zeist In-Netherlands
English: Sorbitol solution (3.2 g, 10.2 g, 13.4 g)/Lamivudine
Maltese: Soluzzjoni ta' sorbitol (3.2 g, 10.2 g, 13.4 g)/Lamivudine
English: Transmission of HIV
Maltese: Trasmissjoni ta' HIV
English: Hypromellose (E464)
Maltese: Hypromellose (E464) Macrogol
English: Nucleoside reverse transcriptase inhibitors (NRTIs) Tenofovir disoproxil
Maltese: Inibituri ta' nucleoside reverse transcriptase (NRTIs) Tenofovir disoproxil
English: • wind (flatulence)
Maltese: • gass (flatulenza)
English: Dovato contains dolutegravir.
Maltese: Dovato fih dolutegravir.
English: • hyperactivity (excessive restlessness and movement)
Maltese: • iperattività (irrekwjetezza u moviment eċċessivi)
English: ATC code: J05AR25
Maltese: J05AR25
English: creatine phosphokinase (CPK) elevations alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) elevations
Maltese: żidiet fil-creatine phosphokinase (CPK) żidiet fl-alanine aminotransferase (ALT) u/jew fl-aspartate aminotransferase (AST)
English: arthralgia, muscle disorders (including myalgia)
Maltese: artralġja, disturbi fil-muskoli (inkluża majalġja)
English: The absolute bioavailability of oral lamivudine in adults is approximately 80-85%.
Maltese: Il-bijodisponibbiltà assoluta ta' lamivudine orali fl-adulti hija madwar 80-85%.
English: Oral contraceptives Ethinyl estradiol (EE) and Norgestromin (NGMN)/Dolutegravir
Maltese: Ethinyl estradiol (EE) u Norgestromin (NGMN)/Dolutegravir
English: Ledipasvir/Sofosbuvir/ Lamvudine (with abacavir)
Maltese: Ledipasvir/Sofosbuvir/ Lamvudine (ma' abacavir)
English: United Kingdom ViiV Healthcare UK Limited Tel: + 44 (0)800 221441 customercontactuk@gsk.com
Maltese: ViiV Healthcare UK Limited Tel: + 44 (0)800 221441 customercontactuk@gsk.com
English: Adults and adolescents (above 12 years of age weighing at least 40 kg).
Maltese: Adulti u adolexxenti (li għandhom 12‑il sena u aktar, li jiżnu mill‑inqas 40 kg).
English: Assessed using a non-inferiority margin of 10%.
Maltese: Evalwata permezz ta' marġni ta' non-inferjorità ta' 10%.
English: • The other ingredients are microcrystalline cellulose, sodium starch glycolate, magnesium stearate, mannitol (E421), povidone (K29/32), sodium stearyl fumarate, hypromellose (E464), macrogol, titanium dioxide (E171).
Maltese: • L-ingredjenti l-oħrajn huma microcrystalline cellulose, sodium starch glycolate, magnesium stearate, mannitol (E421), povidone (K29/32), sodium stearyl fumarate, hypromellose (E464), macrogol, titanium dioxide (E171).
English: (organic cation transporter inhibition)
Maltese: (inibizzjoni tattrasportatur tal-katjon organiku)
English: See section 4 for more information.
Maltese: Ara ssezzjoni 4 għal aktar informazzjoni.
English: Repeated dose toxicity
Maltese: Tossiċità b'doża ripetuta
English: Anti-infective products Trimethoprim/sulfamethoxazole (Co-trimoxazole)/Lamivudine (160 mg/800 mg once daily for 5 days/300 mg single dose)
Maltese: Trimethoprim/sulfamethoxazole (Co-trimoxazole)/Lamivudine (160 mg/800 mg darba kuljum għal 5 ijiem/300 mg doża waħda)
English: Individual components have been investigated in adolescents (12 to 17 years).
Maltese: Il-komponenti individwali ġew investigati fl-adoloxxenti (12 sa 17-il sena).
English: The adjusted difference was -2.6 (95% CI: -6.7; 1.5) for GEMINI-1 and0.7 (95% CI: -4.3; 2.9) for GEMINI-2 with a prespecified non-inferiority margin of 10%.
Maltese: Id-differenza aġġustata kienet -2.6 (95% CI: -6.7; 1.5) għal GEMINI-1 u -0.7 (95% CI: -4.3; 2.9) għal GEMINI-2 b'marġni ta' non-inferjorità speċifikat minn qabel ta' 10%. †
English: • emtricitabine, etravirine, efavirenz, nevirapine or tipranavir/ritonavir, to treat HIV infection
Maltese: • emtricitabine, etravirine, efavirenz, nevirapine jew tipranavir/ritonavir, għat-trattament tal-infezzjoni tal-HIV
English: Baseline CD4+ (cells/ mm3)
Maltese: Linja Bażi CD4+ (ċelloli/ mm3) Ġeneru
English: Magyarország GlaxoSmithKline Kft. Tel.: + 36 1 225 5300
Maltese: GlaxoSmithKline Kft. Tel.: + 36 1 225 5300
English: Metabolism of lamivudine is a minor route of elimination.
Maltese: Il-metaboliżmu ta' lamivudine huwa rotta minuri ta' eliminazzjoni.
English: Mitochondrial dysfunction
Maltese: Disfunzjoni mitokondrijali
English: rash, pruritus, alopecia
Maltese: raxx, ħakk, alopeċja
English: Interaction table
Maltese: Tabella ta' interazzjonijiet
English: PHARMACEUTICAL FORM AND CONTENTS 30 tablets.
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 30 pillola.
English: • phenytoin and phenobarbital, to treat epilepsy
Maltese: • phenytoin u phenobarbital, għat-trattament tal-epilessija
English: In HIV-1-infected adult subjects following dolutegravir 50 mg once daily, the steady-state pharmacokinetic parameters (geometric mean [%CV]) based on population pharmacokinetic analyses were AUC(0-24) = 53.6 (27) µg.h/mL, Cmax = 3.67 (20) µg/mL, and Cmin = 1.11 (46) µg/mL.
Maltese: F'individwi adulti infettati bl-HIV-1 wara dolutegravir 50 mg darba kuljum, il-parametri farmakokinetiċi fi stat fiss (medja ġeometrika [%CV]) abbażi tal-analiżijiet farmakokinetiċi tal-popolazzjoni kienu AUC(0-24) = 53.6 (27) µg.h/mL, Cmax = 3.67 (20) µg/mL, u Cmin = 1.11 (46) µg/mL.
English: HIV-1 isolates (CRF01_AE, n=12; CRF02_AG, n=12; and Subtype C or CRF_AC, n=13) from 37 untreated patients in Africa and Asia were susceptible to lamivudine (IC50 fold changes < 3.0.
Maltese: Iżolati tal-HIV-1 (CRF01_AE, n=12; CRF02_AG, n=12; u Sottotip C jew CRF_AC, n=13) minn 37 pazjent mhux ittrattat fl-Afrika u fl-Asja kienu suxxettibbli għal lamivudine (bidliet drabi IC50 < 3.0.
English: PHARMACEUTICAL FORM AND CONTENTS Multipack: 90 (3 packs of 30) tablets
Maltese: Pakkett multiplu: 90 (3 pakketti ta' 30) pillola
English: Dolutegravir is eliminated mainly through metabolism by uridine diphosphate glucuronosyl transferase (UGT) 1A1.
Maltese: Dolutegravir huwa eliminat l-aktar permezz tal-metaboliżmu permezz ta' uridine diphosphate glucuronosyl transferase (UGT) 1A1.
English: Data in window and ≥50 copies/mL
Maltese: Data fil-parametru u ≥50 kopja/mL
English: • oxcarbazepine and carbamazepine, to treat epilepsy or bipolar disorder
Maltese: • oxcarbazepine u carbamazepine, għat-trattamenttal-epilessija jew ta' disturb bipolari
English: • increase in the level of enzymes produced in the muscles (creatine phosphokinase).
Maltese: • żieda fil-livell ta' enzimi prodotti fil-muskoli (creatinine phosphokinase).
English: Luxembourg/Luxemburg ViiV Healthcare sprl/bvba Belgique/Belgien Tél/Tel: + 32 (0) 10 85 65 00
Maltese: ViiV Healthcare sprl/bvba Belgique/Belgien Tél/Tel: + 32 (0) 10 85 65 00
English: A total of 1433 HIV-1 infected antiretroviral treatment-naïve adult subjects received treatment in the trials.
Maltese: Total ta' 1433 individwu adult infettati bl-HIV-1 u naïve għat-trattament antivirali rċevew trattament fil-provi.
English: In vitro, dolutegravir demonstrated no direct, or weak inhibition (IC50>50 μM) of the enzymes cytochrome P450 (CYP)1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 CYP3A, UGT1A1 or UGT2B7, or the transporters Pgp, BCRP, BSEP, organic anion transporting polypeptide (OATP) 1B1, OATP1B3, OCT1, MATE2-K, multidrug resistance-associated protein (MRP) 2 or MRP4.
Maltese: In vitro, dolutegravir ma wera l-ebda inibizzjoni diretta jew wera inibizzjoni baxxa (IC50>50 μM) tal-enzimi taċ-ċitokromu P450 (CYP)1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 CYP3A, UGT1A1 jew UGT2B7, jew tat-trasportaturi Pgp, BCRP, BSEP, tal-polieptide li jittrasporta l-anjoni organiċi (OATP) 1B1, OATP1B3, OCT1, MATE2-K, tal-proteina assoċjata mar-reżistenza għal diversi mediċini (MRP) 2 jew MRP4.
English: Cytotoxics Cladribine/Lamivudine
Maltese: Cladribine/Lamivudine
English: In vitro, dolutegravir inhibited the renal transporters OCT2 and MATE1.
Maltese: In vitro, dolutegravir inibixxa t-trasportaturi renali OCT2 u MATE1.
English: In vitro, dolutegravir did not induce CYP1A2, CYP2B6 or CYP3A4.
Maltese: In vitro, dolutegravir ma induċiex CYP1A2, CYP2B6 jew CYP3A4.
English: • inflammation of the pancreas (pancreatitis)
Maltese: • infjammazzjoni tal-frixa (pankreatite)
English: The likelihood of metabolic drug interactions with lamivudine is low due to the small extent of hepatic metabolism (5-10%).
Maltese: Il-probabbiltà ta' interazzjonijiet mediċinali metaboliċi ma' lamivudine hija baxxa minħabba l-firxa żgħira ta' metaboliżmu epatiku (5-10%).
English: Corticosteroids Prednisone/Dolutegravir
Maltese: Kortikosterojdi Prednisone/Dolutegravir
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER ViiV Healthcare BV
Maltese: ViiV Healthcare BV
English: There are limited pharmacokinetic data on subjects with hepatitis B co-infection (see section 4.4).
Maltese: Hemm data farmakokinetika limitata dwar individwi b' infezzjoni tal-epatite B (ara sezzjoni 4.4).
English: Thirty-two percent of the total oral dose is excreted in the urine, represented by ether glucuronide of dolutegravir (18.9% of total dose), N-dealkylation metabolite (3.6% of total dose), and a metabolite formed by oxidation at the benzylic carbon (3.0% of total dose).
Maltese: Tnejn u tletin fil-mija tad-doża orali totali titneħħa fl-awrina, irrappreżentata minn glucuronide ether ta' dolutegravir (18.9% tad-doża totali), metabolit N-dealkylation (3.6% tad-doża totali), u metabolit iffurmat bl-ossidazzjoni fil-karbonju benzylic (3.0% tad-doża totali).
English: neutropenia, anaemia, thrombocytopenia
Maltese: newtropenija, anemija, tromboċitopenija
English: Proton pump inhibitors Omeprazole
Maltese: Inibituri tal-pompa tal-proton Omeprazole
English: Protease inhibitors Atazanavir/Dolutegravir
Maltese: Inibituri tal-protease Atazanavir/Dolutegravir
English: The efficacy of Dovato is supported by data from 2 identical 148-week, Phase III, randomised, double-blind, multicentre, parallel-group, non-inferiority controlled trials GEMINI-1 (204861) and GEMINI-2 (205543).
Maltese: III, randomised, double-blind, b'ħafna ċentri, bi gruppi paralleli, ta' non-inferjorità GEMINI-1 (204861)
English: Because gastrointestinal (GI) intolerance is considered to be due to local active substance administration, mg/kg or mg/m2 metrics are appropriate determinates of safety cover for this toxicity.
Maltese: Peress li l-intolleranza gastrointestinali (GI) hija kkunsidrata dovuta għall-għoti lokali tas-sustanza attiva, il-metrika mg/kg jew mg/m2 hija determinanti xierqa għal kopertura tas-sigurtà għal din it-tossiċità.
English: Dolutegravir has a terminal half-life of ~14 hours.
Maltese: Dolutegravir għandu half-life terminali ta' ~14-il siegħa.
English: † Based on CMH-stratified analysis adjusting for the following baseline stratification factors: Plasma HIV-1 RNA (≤100,000 c/mL vs. >100,000 c/mL) and CD4+ cell count (≤200 cells/mm3 vs. >200 cells/mm3).
Maltese: Ibbażata fuq analiżi stratifikata skont CMH li taġġusta għall-fatturi ta' stratifikazzjoni tal-linja bażi li ġejjin: HIV-1 RNA fil-plażma (≤100,000 c/mL vs >100,000 c/mL) u CD4+ għadd ta' ċelloli (≤200 ċellola/mm3 vs >200 ċellola/mm3).