FrancophonIA/ELRC3.0 huggingface dataset:
English: Although the aetiology is considered to be multifactorial (including corticosteroid use, biphosphonates, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported in patients with advanced HIV-disease and/or long-term exposure to CART.
Maltese: Għalkemm l-etjoloġija hija kkunsidrata bħala multifattorjali (li tinkludi l-użu ta' kortikosterojdi, bifosfonati, konsum tal-alkoħol, immunosoppressjoni severa, indiċi tal-massa tal-ġisem iżjed għoli), kienu rrappurtati każijiet ta' osteonekrożi f'pazjenti b'mard tal-HIV avvanzat u/jew esponiment fit-tul għas-CART.
English: Interactions between dolutegravir and co-administered medicinal products are listed in Table 2 (increase is indicated as “↑”, decrease as “↓”, no change as “↔”, area under the concentration versus time curve as “AUC”, maximum observed concentration as “Cmax”, concentration at end of dosing interval as “Cτ”).
Maltese: L-interazzjonijiet bejn dolutegravir u prodotti mediċinali mogħtija fl-istess ħin miegħu huma elenkati f'Tabella 2 (żieda hija indikata bħala “↑”, tnaqqis bħala “↓”, l-ebda bidla bħala “↔”, lerja taħt il-kurva tal-konċentrazzjoni mal-ħin bħala “AUC”, il-konċentrazzjoni massima osservata bħala “Cmax”).
English: Tivicay is used to treat HIV (human immunodeficiency virus) infection in adults, adolescents and children over 6 years old, who weigh at least 15 kg.
Maltese: Tivicay jintuża għall-kura ta' infezzjoni bl-HIV (virus tal-immunodefiċjenza tal-bniedem) f'persuni adulti, adolexxenti u tfal ta'aktar minn 6 snin, li jiżnu mill-anqas 15-il kg.
English: At baseline, median patient age was 43 years, 32% were female, 50% non-white, 16% had hepatitis B and/or C co-infection, and 46% were CDC Class C. All patients had at least two class ART resistance, and 49% of subjects had at least 3-class ART resistance at baseline.
Maltese: Fil-linja bażi, l-età medjana tal-pazjenti kienet ta' 43 sena, 32% kienu nisa, 50% ma kinux bojod, 16% kellhom ko-infezzjoni tal-epatite B u/jew Ċ, u 46% kienu CDC ta' Klassi C.
English: At baseline, median patient age was 48 years, 23% were female, 29% non-white, and 20% had hepatitis B and/or C co-infection.
Maltese: Fil linja bażi, l-età medjana tal-pazjenti kienet ta' 48 sena, 23% kienu nisa, 29% ma kinux bojod, u 20% kellhom ko-infezzjoni tal-epatite B u/jew Ċ.
English: Antidiabetics Metformin
Maltese: EFFIKAĊI TAL-PRODOTT MEDIĊINALI
English: HIV-1 RNA <50 copies/mL by baseline covariates
Maltese: LE HIV-1 RNA <50 kopja/mL skont is-Sess talpersuna
English: EU/1/13/892/002
Maltese: EU/1/13/892/001 EU/1/13/892/002
English: Please refer to section 4.5.
Maltese: (sezzjoni 4.4).
English: The systemic exposure at this dose (based on AUC) to dolutegravir was ~17-20-fold higher than humans at the recommended pediatric exposure.
Maltese: L-esponiment sistemiku b'din id-doża (ibbażata fuq AUC) għal dolutegravir kien ta' 17-20-darba ogħla milli fil-bnedmin bl-esponiment pedjatriku rakkomandat.
English: In SPRING-2, 822 adults were randomized and received at least one dose of either dolutegravir 50 mg once daily or raltegravir (RAL) 400 mg twice daily, both administered with either ABC/3TC or TDF/FTC.
Maltese: Fi SPRING-2, 822 persuna adulta ġew magħżula b'mod aleatorju u ngħataw mill-anqas doża waħda ta' Tivicay 50 mg darba kuljum jew raltegravir (RAL) 400 mg darbtejn kuljum, it-tnejn mogħtija ma' terapija ta' doża fissa b'żewġ NRTI ( ABC/3TC jew TDF/FTC).
English: • St. John's wort (Hypericum perforatum), a herbal remedy to treat depression
Maltese: John's wort (Hypericum perforatum), rimedju mill-ħxejjex għall-kura taddipressjoni
English: Signs include:
Maltese: Sími:
English: Dolutegravir is the predominant circulating compound in plasma; renal elimination of unchanged active substance is low (< 1% of the dose).
Maltese: l-eliminazzjoni mill-kliewi tas-sustanza attiva mhux mibdula hija baxxa (< 1% tad-doża).
English: Oral administration of dolutegravir to pregnant rabbits at doses up to 1000 mg/kg daily from days 6 to 18 of gestation did not elicit developmental toxicity or teratogenicity (0.40 times the 50 mg twice daily human clinical exposure based on AUC).
Maltese: L-għoti ta' dolutegravir b'mod orali lil fniek tqal b'dożi sa 1000 mg/kg kuljum mill-jiem 6 sa 18 tat-tqala, ma kkawżax effett tossiku fuq l-iżvilupp jew teratoġeniċità (0.40 darbiet l-esponiment kliniku tal-bniedem b'doża ta' 50 mg darbtejn kuljum, fuq il-bażi tal-AUC).
English: Treatment emergent resistance in previously untreated patients failing therapy Through 96 weeks in SPRING-2 and FLAMINGO and 144 weeks in SINGLE, no cases of treatment emergent primary resistance to the integrase- or NRTI-class were seen in the dolutegravir-containing arms.
Maltese: Tul 96 ġimgħa fi SPRING-2 u FLAMINGO u 144 ġimgħa f'SINGLE, ebda każ ta' reżistenza primarja emerġenti għall-kura għall-klassi ta' integrase jew NRTI ma deher fil-fergħat li kien fihom dolutegravir.
English: Dolutegravir was not mutagenic or clastogenic using in vitro tests in bacteria and cultured mammalian cells, and an in vivo rodent micronucleus assay.
Maltese: 5.3 Tagħrif ta' qabel l-użu kliniku dwar is-sigurtà Dolutegravir ma kienx mutaġeniku jew klastoġeniku meta ntużaw testijiet in vitro f'batterji u kulturi ta' ċelloli mammiferi, u assaġġ tal-mikronukleu tal-ġurdien in vivo.
English: White, round, biconvex tablets approximately 6 mm in diameter debossed with ‘SV 572' on one side and ‘10' on the other side.
Maltese: Pilloli bojod, tondi, bikonvessi, b'dijametru ta' madwar 6 mm u mnaqqxa b'‘SV 572' fuq naħa u ‘10' fuq in-naħa l-oħra.
English: Dolutegravir should not be used with etravirine without coadministration of atazanavir/ritonavir, darunavir/ritonavir or lopinavir/ritonavir in INIresistant patients (see further below in table).
Maltese: Dolutegravir m'għandux jintuża ma' etravirine mingħajr l-għoti fl-istess ħin ta' atazanavir/ritonavir, darunavir/ritonavir jew lopinavir/ritonavir f'pazjenti reżistenti għal INI
English: EU/1/13/892/004
Maltese: EU/1/13/892/003 EU/1/13/892/004
English: In Phase III studies patients with hepatitis B and/or C co-infection were permitted to enrol provided that baseline liver chemistry tests did not exceed 5 times the upper limit of normal (ULN).
Maltese: III, pazjenti b'ko-infezzjoni tal-epatite B u/jew Ċ kienu permessi li jirreġistraw bil-kundizzjoni li t-testijiet fil-linja bażi tal-kimika tal-fwied ma kinux jaqbżu 5 darbiet il-limitu ta' fuq tan-normal (ULN).
English: In HIV-infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic infections may arise.
Maltese: Sindrome riattivazzjoni immunitarju F'pazjenti infettati bl-HIV u b'defiċjenza immunitarja severa fil-bidu tat-terapija antiretrovirali kombinata (CART), tista' tiżviluppa reazzjoni infjammatorja għal infezzjonijiet asintomatiċi jew opportunistiċi residwi.
English: Tivicay 10 mg film-coated tablets are white, round, biconvex tablets marked with the code ‘SV 572' on one side and ‘10' on the other side.
Maltese: Tivicay 10 mg pilloli miksijin b'rita huma pilloli bojod, tondi, bikonvessi u mmarkati bil-kodiċi ‘SV 572' fuq naħa u ‘10' fuq in-naħa l-oħra.
English: Of these four, two subjects had a unique R263K integrase substitution, with a maximum FC of 1.93, one subject had a polymorphic V151V/I integrase substitution, with maximum FC of 0.92, and one subject had pre-existing integrase mutations and is assumed to have been integrase experienced or infected with integrase resistant virus by transmission.
Maltese: integrase V151V/I polimorfika, b'FC massimu ta' 0.92, u individwu wieħed kellu mutazzjonijiet ta' integrase diġà eżistenti u huwa preżunt li kellu integrase jew infettat b'virus reżistenti għall integrase permezz ta' trasmissjoni.
English: Table 6 Response in SAILING at 48 Weeks (Snapshot algorithm, <50 copies/mL) Dolutegravir 50 mg Once Daily + BR N=354§
Maltese: Rispons f'SAILING wara 48 Ġimgħa (Algoritmu ritratt, <50 kopja/mL)
English: Etravirine ↔
Maltese: SPRING-2
English: In serial passage with strain NL432, starting with site directed mutants harbouring N155H or E92Q, no further selection of resistance was seen (FC unchanged around 1).
Maltese: F'passaġġ serjali bir-razza NL432, li beda bil-mutanti diretti mis-sit li kellhom N155H jew E92Q, ma dehret l-ebda għażla ulterjuri ta' reżistenza (FC mhux mibdul madwar 1).
English: Total blood and plasma drug-related radioactivity concentration ratios averaged between 0.441 to 0.535, indicating minimal association of radioactivity with blood cellular components.
Maltese: Il-proporzjonijiet relatati mal-mediċina, tar radjuattività fid-demm totali u fil-plażma kienu bħala medja bejn 0.441 sa 0.535, li jindika rabta minima tar-radjuattività mal-komponenti ċellulari tad-demm.
English: The effect by the Q148-mutations (H/R/K) was also verified in passage experiments with site directed mutants.
Maltese: L-effett mill-mutazzjonijiet Q148 (H/R/K) ġie vverifikat ukoll f'esperimenti tal-passaġġ b'mutanti diretti mis-sit.
English: HIV-1 RNA <50 copies/mL Adjusted treatment difference‡
Maltese: HIV-1 RNA < 50 kopja/mL skont it-Terapija ta' Sfond
English: Median Change from Baseline, cells/mm3
Maltese: CD4+ fil-linja bażi (ċelloli/ mm3)
English: Each film-coated tablet contains dolutegravir sodium equivalent to 25 mg dolutegravir.
Maltese: Kull pillola miksija b'rita fiha dolutegravir sodium ekwivalenti għal 25 mg dolutegravir.
English: The PK variability of dolutegravir is low to moderate.
Maltese: Il-varjabilità farmakokinetika ta' dolutegravir hija baxxa sa moderata.
English: Based on this data, dolutegravir is not expected to affect the pharmacokinetics of medicinal products that are substrates of major enzymes or transporters (see section 4.5).
Maltese: Fuq il-bażi ta' din id-dejta, dolutegravir mhuwiex mistenni li jaffettwa l-farmakokinetika tal-prodotti mediċinali li huma substrati ta' enzimi jew trasportaturi maġġuri (ara sezzjoni 4.5).
English: More than 1000 outcomes from second and third trimester exposure in pregnant women indicate no evidence of increased risk of malformative and foeto/neonatal negative effects.
Maltese: Aktar minn 1000 riżultat minn esponiment fit-tieni u fit-tielet trimestru għal dolutegravir f'nisa tqal ma jindikaw l-ebda evidenza ta' żieda fir-riskju ta' effetti negattivi malformattivi u fuq il fetu/it-tarbija tat-twelid.
English: Dolutegravir should only be used during the second and third trimester of pregnancy when the expected benefit justifies the potential risk to the foetus.
Maltese: Dolutegravir għandu jingħata biss waqt it-tieni u t-tielet trimestru tat-tqala meta l-benefiċċju mistenni jiġġustifika r-riskju potenzjali għall-fetu.
English: There is no evidence that common polymorphisms in drug metabolising enzymes alter dolutegravir pharmacokinetics to a clinically meaningful extent.
Maltese: Polimorfiżmi fl-enzimi li jimmetabolizzaw il-mediċini Ma hemm ebda evidenza li l-polimorfiżmi komuni fl-enzimi li jimmetabolizzaw il-mediċini jbiddlu l-farmakokinetika ta' dolutegravir b'mod klinikament sinifikanti.
English: The most commonly seen treatment emergent adverse reactions were nausea (13%), diarrhoea (18%) and headache (13%).
Maltese: L-aktar reazzjonijiet avversi komuni li kienu osservati b'riżultat tal-kura kienu dardir (13%), dijarea (18%) u wġigħ ta' ras (13%).
English: These increases may be clinically relevant in the presence of certain integrase class resistance.
Maltese: ma' rifampicin fin-nuqqas ta' reżistenza għallklassi integrase.
English: Virologic non-response HIV-1 RNA <50 copies/mL by baseline covariates Baseline Viral Load (copies/mL) ≤50,000 copies/mL >50,000 copies/mL Baseline CD4+ (cells/ mm3)
Maltese: L-intolleranza gastrointestinali fix-xadini seħħet b'doża 15-il darba d-doża ekwivalenti tal-bniedem f'mg/kg (ibbażata fuq bniedem ta' 50 kg), u 5 darbiet id-doża ekwivalenti tal bniedem f'mg/m2 għal doża klinika ta' 50 mg darbtejn kuljum.
English: Daclatasvir did not change dolutegravir plasma concentration to a clinically relevant extent.
Maltese: Dawn il-bidliet mhumiex ikkunsidrati bħala klinikament rilevanti billi ma jirriflettux bidla fir-rata ta'
English: EU/1/13/892/006
Maltese: EU/1/13/892/005 EU/1/13/892/006
English: In the SAILING study, virologic suppression (HIV-1 RNA <50 copies/mL) in the Tivicay arm (71%) was statistically superior to the raltegravir arm (64%), at Week 48 (p=0.03).
Maltese: Tivicay (71%) kienet statistikament superjuri għall-grupp li ħadu raltegravir (64%), f'Ġimgħa 48
English: People with advanced HIV infection (AIDS) have weak immune systems, and are more likely to develop serious infections (opportunistic infections).
Maltese: Persuni b'infezzjoni avanzata tal-HIV (AIDS) għandhom sistemi immuni dgħajfa, u huma aktar probabbli li jiżviluppaw infezzjonijiet serji (infezzjonijiet opportunistiċi).
English: Clade B
Maltese: ANNESS II
English: Binding of dolutegravir to plasma proteins is independent of dolutegravir concentration.
Maltese: It-twaħħil ta' dolutegravir mal-proteini tal-plażma huwa indipendenti mill-konċentrazzjoni ta' dolutegravir.
English: Table 8 Response by baseline Resistance, VIKING-3.
Maltese: għal VIKING-3 fuq il-bażi tad-dejta osservata.
English: In HIV-infected patients with severe immune deficiency at the time of institution of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
Maltese: F'pazjenti infettati bl-HIV u b'defiċjenza immunitarja severa fiż-żmien tal-bidu tat-terapija antiretrovirali kombinata (CART), tista' tiżviluppa reazzjoni infjammatorja għal patoġeni asintomatiċi jew opportunistiċi residwi u tikkawża kondizzjonijiet kliniċi serji, jew taħrix tassintomi.
English: At baseline, median patient age was 34 years, 15% were female, 28% non-white, 10% had hepatitis B and/or C co-infection, and 3% were CDC Class C; these characteristics were similar between treatment groups.
Maltese: Fil-linja bażi, l-età medjana talpazjent kienet ta' 34 sena, 15% kienu nisa, 28% kienu mhux bojod, 10% kellhom ko-infezzjoni tal-epatite B u/jew Ċ, u 3% kienu CDC
English: In rabbits, maternal toxicity (decreased food consumption, scant/no faeces/urine, suppressed body weight gain) was observed at 1000 mg/kg (0.40 times the 50 mg twice daily human clinical exposure based on AUC).
Maltese: soppressjoni taż-żieda fil-piż tal-ġisem) b'dożi sa 1000 mg/kg (0.40 darbiet l-esponiment kliniku tal-bniedem b'doża ta' 50 mg darbtejn kuljum, fuq il-bażi tal-AUC).
English: Common side effects
Maltese: Effetti sekondarji komuni ħafna
English: As dolutegravir is highly bound to plasma proteins, it is unlikely that it will be significantly removed by dialysis.
Maltese: Billi dolutegravir jeħel ħafna mal-proteini tal-plażma, mhuwiex probabbli li se jitneħħa b'mod sinifikanti permezz ta' dijalisi.
English: In vivo, dolutegravir may increase plasma concentrations of medicinal products in which excretion is dependent upon OCT2 or MATE-1 (e.g. dofetilide, metformin) (see Table 2 and section 4.3).
Maltese: In vivo, dolutegravir jista' jżid il-konċentrazzjonijiet fil-plażma ta' prodotti mediċinali li t-tneħħija tagħhom tiddependi fuq OCT2 jew MATE-1 (eż. dofetilide,
English: Cmax ↑ 6% Cτ ↑ 17%
Maltese: Dolutegravir ↔ AUC ↑ 11% Cmax ↑ 6% Cτ ↑ 17%
English: Uncommon Arthralgia Uncommon Myalgia
Maltese: Mhux komuni Artralġja
English: Tivicay 25 mg and 50 mg film-coated tablets
Maltese: Tivicay 25 mg u 50 mg pilloli miksijin b'rita
English: Each film-coated tablet contains dolutegravir sodium equivalent to 10 mg dolutegravir.
Maltese: Kull pillola miksija b'rita fiha dolutegravir sodium ekwivalenti għal 10 mg dolutegravir.
English: This includes co-administration with medicinal products that reduce dolutegravir exposure (e.g. magnesium/ aluminium-containing antacid, iron and calcium supplements, multivitamins and inducing agents, etravirine (without boosted protease inhibitors), tipranavir/ritonavir, rifampicin, St. John's wort and certain antiepileptic medicinal products) (see section 4.5).
Maltese: Dan jinkludi l-għoti fl-istess ħin ma' prodotti mediċinali li jnaqqsu l-esponiment għal dolutegravir (eż. antaċidu li fih il-manjeżju/aluminju, supplimenti tal-ħadid u tal-kalċju, multivitamini u sustanzi indutturi, etravirine (mingħajr inibituri tal-protease msaħħa),
English: Dose recommendations according to weight are presented in table 1.
Maltese: Lista ta' reazzjonijiet avversi miġburin f'tabella
English: How to take Tivicay
Maltese: Tivicay.
English: Dolutegravir did not affect male or female fertility in rats at doses up to 1000 mg/kg/day, the highest dose tested (24 times the 50 mg twice daily human clinical exposure based on AUC).
Maltese: Dolutegravir ma affettwax il-fertilità tar-raġel jew tal-mara fil-firien b'dożi sa 1000 mg/kg/jum, l ogħla doża ttestjata (24 darba l-esponiment kliniku tal-bniedem b'doża ta' 50 mg darbtejn kuljum,
English: Population PK analyses using pooled pharmacokinetic data from Phase IIb and Phase III adult trials revealed no clinically relevant effect of race on the exposure of dolutegravir.
Maltese: III fl-adulti ma wrew l-ebda effett klinikament rilevanti tar-razza fuq l-esponiment għal dolutegravir.
English: In the presence of documented resistance that includes Q148 + ≥2 secondary mutations from G140A/C/S, E138A/K/T, L74I, modelling suggests that an increased dose may be considered for patients with limited treatment options (less than 2 active agents) due to advanced multi class resistance (see section 5.2).
Maltese: Fil-preżenza ta' reżistenza dokumentata li tinkludi mutazzjonijiet sekondarji Q148 + ≥2 minn G140A/C/S, E138A/K/T, L74I, l-immudellar jissuġġerixxi li tista' tiġi kkunsidrata doża aktar għolja għal pazjenti b'għażliet limitati ta' kura (inqas minn 2 aġenti attivi) minħabba reżistenza avvanzata għal ħafna klassijiet (ara sezzjoni 5.2).
English: Subjects were enrolled with a screening plasma HIV-1 RNA of 1000
Maltese: Pazjenti infettati bl-HIV-1 mingħajr reżistenza dokumentata jew klinikament suspettata għall klassi integrase
English: Do not swallow the desiccant.
Maltese: Fl-istudji ta' Fażi
English: Antimycobacterials Rifampicin
Maltese: Disturbi psikjatriċi
English: 8%b a 22 subjects contributed Week 48 CD4+ cell count data b 21 subjects contributed Week 24 CD4+ cell count data
Maltese: 8%b a 22 individwu kkontribwixxew f'Ġimgħa 48 CD4+ data ta' għadd ta' ċelloli b 21 individwu kkontribwixxew f'Ġimgħa 24 CD4+ data ta' għadd ta' ċelloli L-Awtorità Ewropea għall-Mediċini iddifferiet l-obbligu li jiġu ppreżentati riżultati tal-istudji b'Tivicay f'pazjenti pedjatriċi mill-età ta' 4 ġimgħat sa taħt is-6 snin li għandhom infezzjoni talHIV (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: No dosage adjustment is required in patients with mild, moderate or severe (CrCl <30 mL/min, not on dialysis) renal impairment.
Maltese: M'hemmx bżonn ta' aġġustament fid-doża f'pazjenti b'indeboliment ħafif, moderat jew sever talkliewi (CrCl <30 mL/min, mhux fuq dijalisi).
English: Patients infected with HIV-1 with resistance to the integrase class (documented or clinically suspected) The recommended dose of dolutegravir is 50 mg (one tablet) twice daily.
Maltese: HIV-1 mingħajr reżistenza għall-klassi integrase, id-doża rakkomandata ta' dolutegravir hija 50 mg darba kuljum.
English: Dolutegravir inhibits HIV integrase by binding to the integrase active site and blocking the strand transfer step of retroviral Deoxyribonucleic acid (DNA) integration which is essential for the HIV replication cycle.
Maltese: J05AX12 Mekkaniżmu ta' azzjoni Dolutegravir jinibixxi l-integrase tal-HIV billi jeħel mas-sit attiv tal-integrase u jimblokka l-pass tat-trasferiment tal-linja (strand) tal-integrazzjoni tad-Deoxyribonucleic acid (DNA) retrovirali li huwa essenzjali għaċ-ċiklu ta' replikazzjoni tal-HIV.
English: Other†
Maltese: Ħakk
English: A mean change from baseline of 9.96 µmol/L was observed after 48 weeks of treatment.
Maltese: Kienet osservata bidla medja ta' 9.96 µmol/L mil-linja bażi wara 48
English: Animal studies indicate no effects of dolutegravir on male or female fertility (see section 5.3).
Maltese: John's wort u ċerti prodotti mediċinali antiepilettiċi) (ara sezzjoni 4.5).
English: In further selection experiments using clinical isolates of subtype B, mutation R263K was seen in all five isolates (after 20 weeks and onwards).
Maltese: F'esperimenti oħra ta' għażla fejn intużaw iżolati kliniċi tas-sottotip B, il-mutazzjoni R263K dehret fil-ħames iżolati kollha (wara 20 ġimgħa u suċċessivament).
English: In previously untreated patients receiving dolutegravir + 2 NRTIs in Phase IIb and Phase III, no development of resistance to the integrase class, or to the NRTI class was seen (n=1118 follow-up of 48-96 weeks).
Maltese: F'pazjenti li kienu qegħdin jirċievu dolutegravir + 2 NRTIs f'Fażi IIb u Phase III u li ma kinux irċevew kura qabel, ma deher l-ebda żvilupp ta' reżistenza għall-klassi ta' integrase, jew għall klassi tal-NRTI (n=876, segwitu ta' 48-96 ġimgħa).
English: Children and adolescents weighing at least 40 kg can take the adult dose of one tablet (50 mg), once a day.
Maltese: Tfal u adolexxenti li jiżnu mill-anqas 40 kg jistgħu jieħdu d-doża adulta ta' pillola waħda (50 mg), darba kuljum.
English: Median baseline CD4+ was 140 cells/mm3, median duration of prior ART was 14 years, and 56% were CDC Class C. Subjects showed multiple class ART resistance at baseline: 79% had ≥2
Maltese: Is-CD4+ medjan fil-linja bażi kien ta' 140 ċellola/mm3, id-dewmien medjan tal-ART preċedenti kien ta' 13-il sena, u 56% kienu CDC
English: Each film-coated tablet contains dolutegravir sodium equivalent to 50 mg dolutegravir.
Maltese: Kull pillola miksija b'rita fiha dolutegravir sodium ekwivalenti għal 50 mg dolutegravir.
English: The overall response rate through 24 weeks of therapy, 69% (126/183), was generally sustained through 48 weeks with 116/183 (63%) of patients with HIV-1 RNA <50c/mL (ITT-E, Snapshot algorithm).
Maltese: Fuq il-bażi ta' dejta ta' 24 ġimgħa għall-183 pazjent kollha, 126 (69%) kellhom <50 kopja/mL RNA f'Ġimgħa 24 (Algoritmu ritratt).
English: Signs of osteonecrosis include:
Maltese: Inibitur Protease:
English: • stomach pain (abdominal pain)
Maltese: • skumdità fl-istonku (addominali)
English: Dolutegravir and dofetilide co-administration is contraindicated due to potential life-threatening toxicity caused by high dofetilide concentration (see section 4.3).
Maltese: L-għoti flimkien ta' Tivicay u dofetilide huwa kontraindikat minħabba l-effett tossiku potenzjali ta' periklu għall-ħajja kkawżat minn konċentrazzjoni għolja ta' dofetilide (ara sezzjoni 4.3).
English: Hepatic impairment
Maltese: Skumdità addominali
English: Table 2: Drug Interactions Medicinal products by therapeutic areas
Maltese: Tabella 2: Interazzjonijiet bejn il-Mediċini
English: Creatinine increases were comparable by various background regimens.
Maltese: Iż-żidiet fil-krejatinina kienu komparabbli minn diversi terapiji ta' sfond.
English: In 100% human serum, the mean protein fold shift was 75 fold, resulting in protein adjusted IC90 of 0.064 µg/mL.
Maltese: aġġustat għall-proteini ta' 0.064 ug/mL.
English: Table 3 Adverse Reactions Immune system disorders
Maltese: Disturbi fis-sistema immuni
English: blister (PVC/PVDC/alu) 50 x 1 tablets (unit dose)
Maltese: 4 x 1 pilloli (doża waħda)
English: The decentralised procedure PT/H/1256/001/DC started on 04 June 2014.
Maltese: Il-proċedura deċentralizzata PT/H/1256/001/DC bdiet fl-04 ta' Ġunju 2014.
English: The application was submitted to the reference Member State (RMS): Portugal and the concerned Member States (CMS): Germany, Netherlands and United Kingdom.
Maltese: L-applikazzjoni ġiet sottomessa lill-Istat Membru ta' referenza (RMS): il-Portugall u l-Istati Membri kkonċernati (CMS): il-Ġermanja, in-Netherlands u r-Renju Unit.
English: An application was submitted under the decentralised procedure for Paclitaxel Hetero, 6 mg/mL, concentrate for solution for infusion on 15 May 2014.
Maltese: Ġiet sottomessa applikazzjoni skont il-proċedura deċentralizzata għal Paclitaxel Hetero, 6 mg/mL, konċentrat għal soluzzjoni għall-infużjoni fil-15 ta' Mejju 2014.