FrancophonIA/ELRC3.0 huggingface dataset:
English: At 96 weeks, virologic suppression in the dolutegravir group (80%) was superior to the DRV/r group (68%), (adjusted treatment difference [DTG-(DRV+RTV)]: 12.4%; 95% CI: [4.7, 20.2]).
Maltese: DRV/r (68%), (differenza fil-kura aġġustata [DTG-(DRV+RTV)]: 12.4%; 95% CI: [4.7, 20.2]).
English: Neutropenia1, anaemia1, thrombocytopenia1
Maltese: Newtropenja1, anemija1, tromboċitopenja1
English: * Adjusted for baseline stratification factors, p=0.025.
Maltese: * Aġġustat għall-fatturi tal-istratifikazzjoni tal-linja bażi, p=0.025.
English: Dolutegravir is eliminated mainly through metabolism by uridine diphosphate glucuronosyl transferase (UGT) 1A1.
Maltese: Dolutegravir huwa eliminat prinċipalment mill-metaboliżmu permezz ta' uridine diphosphate glucuronosyl transferase (UGT) 1A1.
English: • inflammation of the pancreas (pancreatitis)
Maltese: • infjammazjoni tal-frixa (pankreatite)
English: DTG/ABC/3TC FDC - abacavir/dolutegravir/lamivudine fixed-dose combination ATV+RTV+TDF/FTC FDC -atazanavir plus ritonavir plus tenofovir disproxil/emtricitabine fixeddose combination
Maltese: DTG/ABC/3TC FDC - kombinazzjoni ta' doża fissa ta' abacavir/dolutegravir/lamivudine ATV+RTV+TDF/FTC FDC -kombinazzjoni ta' doża fissa ta' atazanavir flimkien ma' ritonavir flimkien ma' tenofovir disproxil/emtricitabine
English: • emtricitabine, etravirine, efavirenz, nevirapine or tipranavir/ritonavir, to treat HIV infection
Maltese: • emtricitabine, etravirine, efavirenz, nevirapine jew tipranavir/ritonavir, għat-trattament ta'
English: Abacavir: AUC ↑ 41% Ethanol: AUC ↔
Maltese: AUC ↑ 41% Ethanol:
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: Mitochondrial dysfunction following exposure in utero
Maltese: Disfunzjoni mitokondrijali wara espożizzjoni in utero
English: Marketing Authorisation Holder ViiV Healthcare BV, Huis ter Heideweg 62, 3705 LZ Zeist, Netherlands.
Maltese: ViiV Healthcare BV, Huis ter Heideweg 62, 3705 LZ Zeist, L-Olanda
English: immune reconstitution syndrome (see section 4.4) Metabolism and nutrition disorders: Common:
Maltese: sindromu tar-rikostituzzjoni immunitarja (ara sezzjoni 4.4) Disturbi fil-metaboliżmu u n-nutrizzjoni:
English: Eesti GlaxoSmithKline Eesti OÜ Tel: + 372 6676 900 estonia@gsk.com
Maltese: GlaxoSmithKline Eesti OÜ Tel: + 372 6676 900 estonia@gsk.com
English: In vitro, dolutegravir did not induce CYP1A2, CYP2B6 or CYP3A4.
Maltese: In vitro, dolutegravir ma induċix CYP1A2, CYP2B6 jew CYP3A4.
English: In subtype C (n=2) and A/G (n=2) isolates the integrase substitution R263K was selected in one isolate, and G118R in two isolates.
Maltese: Fl-iżolati tas-sottotip C (n=2) u A/G (n=2) intgħażlet is-sostituzzjoni tal-integrase R263K f'iżolat wieħed, u G118R f'żewġ iżolati.
English: Sorbitol Sorbitol solution (3.2 g, 10.2 g, Single dose lamivudine When possible, avoid chronic
Maltese: Soluzzjoni ta' sorbitol (3.2 g, 10.2 g, 13.4 g)/Lamivudine
English: • fever (high temperature)
Maltese: • deni (temperature għolja)
English: R263K was reported from two individual patients with subtype B and subtype C in the clinical program for ART experienced, INI naive subjects, but without effects on dolutegravir susceptibility in vitro.
Maltese: R263K kien irrapportat minn żewġ pazjenti individwali bis-sottotip B u s-sottotip C fil-programm kliniku għal individwi naive għal INI, esperjenzati b'ART, iżda mingħajr effetti fuq is-suxxettibbiltà ta' dolutegravir in vitro.
English: Elevated creatinine, renal failure
Maltese: Kreatina għolja, insuffiċjenza renali
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 1B1 (OATP1B1), OATP1B3, OCT1, MATE2-K, multidrug resistance-associated protein 2 (MRP2) or MRP4.
Maltese: In vitro, dolutegravir ma wera ebda, inibizzjoni diretta jew dgħajfa (IC50>50 μM) tal-enzimi ta' ċitokromju P450 (CYP)1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP3A, UGT 1A1 jew UGT2B7, jew it-trasportaturi Pgp, BCRP, BSEP, polypeptide 1B1 ta' trasportazzjoni anijonika organika (OATP1B1), OATP1B3, OCT1, MATE2-K, proteina 2 assoċjata mar-reżistenza għal ħafna mediċini (MRP2) jew MRP4.
English: Notes: ABC/3TC = abacavir 600 mg, lamivudine 300 mg in the form of Kivexa/Epzicom fixed dose combination (FDC)
Maltese: Noti: ABC/3TC = abacavir 600 mg, lamivudine 300 mg fl-għamla ta' kombinazzjoni ta' doża fissa (FDC) ta' Kivexa/Epzicom
English: The antiviral activity of abacavir in cell culture was not antagonized when combined with the nucleoside reverse transcriptase inhibitors (NRTIs) didanosine, emtricitabine, lamivudine, stavudine, tenofovir, zalcitabine or zidovudine, the non-nucleoside reverse transcriptase inhibitor (NNRTI) nevirapine, or the protease inhibitor (PI) amprenavir.
Maltese: L-attività antivirali ta' abacavir fil-kultura taċ-ċelloli ma kinitx antagonizzata meta kkombinata mal inibituri nucleoside reverse transcriptase (NRTIs) didanosine, emtricitabine, lamivudine, stavudine, tenofovir, zalcitabine jew zidovudine, l-inibitur non-nucleoside reverse transcriptase (NNRTI) nevirapine, jew l-inibitur protease (PI) amprenavir.
English: Baseline CD4+ (cells/ mm3)
Maltese: Linja Bażi CD4+ (ċelloli/
English: There are limited pharmacokinetic data on subjects with hepatitis B co-infection (see section 4.4).
Maltese: Hemm dejta farmakokinetika limitata dwar is-suġġetti b' infezzjoni tal-epatite B (ara sezzjoni 4.4).
English: Dolutegravir has a terminal half-life of ~14 hours.
Maltese: Dolutegravir għandu half-life terminali ta' 14-il siegħa.
English: • St. John's wort (Hypericum perforatum), a herbal remedy to treat depression
Maltese: John's wort (Hypericum perforatum), rimedju erbali għat-trattament ta' dipressjoni
English: Deutschland ViiV Healthcare GmbH Tel.: + 49 (0)89 203 0038-10 viiv.med.info@viivhealthcare.com
Maltese: ViiV Healthcare GmbH Tel.: + 49 (0)89 203 0038-10 viiv.med.info@viivhealthcare.com
English: Virologic suppression (HIV-1 RNA <50 copies/mL) in the ABC/DTG/3TC FDC group (85%) was statistically non-inferior to the current ART groups (88%) at 24 weeks.
Maltese: Trażżin viroloġiku (HIV-1 RNA <50 kopja/mL) fil-grupp ABC/DTG/3TC FDC (85%) kien statistikament mhux inferjuri għall-gruppi ART attwali (88%) wara 24 ġimgħa.
English: Dolutegravir is also a substrate of UGT1A3, UGT1A9, CYP3A4, Pglycoprotein (P-gp), and breast cancer resistance protein (BCRP).
Maltese: Dolutegravir huwa wkoll sottostrat ta' UGT1A3, UGT1A9, CYP3A4, glikoproteina-P (P-gp), u proteina ta' reżistenza għall-kanċer tas-sider (BCRP).
English: The proportion with a positive HCV serology was 7%.
Maltese: Il-proporzjon b'seroloġija HCV pożittiva kien ta' 7%.
English: Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1000 to < 1/100), rare (≥ 1/10,000 to < 1/1000), very rare
Maltese: Il-frekwenzi huma ddefiniti bħala komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1000 sa < 1/100); rari (≥ 1/10,000 sa < 1/1000); rari ħafna
English: Response rates at 96 weeks were 82% for DTG+ABC/3TC and 75% for DRV/r+ABC/3TC.
Maltese: Ir-rati ta' rispons wara 96 ġimgħa kienu 82% għal DTG+ABC/3TC u 75% għal DRV/r+ABC/3TC.
English: erythema multiform1, Stevens-Johnson syndrome1, toxic epidermal necrolysis1
Maltese: eritema multiformi1, sindromu ta' Stevens-Johnson 1,
English: Antiviral activity in vitro
Maltese: Reżistenza in vitro:
English: Following multiple-dose oral administration of lamivudine 300 mg once daily for seven days, the mean (CV) steady-state Cmax is 2.04 µg/ml (26%) and the mean (CV) AUC24 is 8.87 µg.h/ml (21%).
Maltese: Wara għoti orali ta' diversi dożi ta' lamivudine 300 mg darba kuljum għal sebat ijiem, is-Cmax fi stat fiss (CV) medju huwa 2.04 µg/ml (26%) u l-AUC (CV) medju24 huwa 8.87 µg.h/ml (21%).
English: The median time to viral suppression was shorter with ABC/3TC + DTG (28 vs 84 days, p<0.0001).
Maltese: Il-ħin medju għal suppressjoni virali kien iqsar b'ABC/3TC + DTG (28 vs 84 jum, p<0.0001).
English: At 24 weeks, 16 of 23 (69%) adolescents (12 to 17 years of age) treated with dolutegravir once daily (35 mg n=4; 50 mg n=19) plus OBR achieved viral load less than 50 copies/mL.
Maltese: F'24 ġimgħa, 16 minn 23 (69%) adolexxent (12 sa 17-il sena ta' età) ikkurati b'dolutegravir darba kuljum (35 mg n=4; 50 mg n=19) flimkien ma' OBR kisbu tagħbija virali anqas minn 50 kopja/mL.
English: Teл.
Maltese: Pol.
English: In ARIA (ING117172), a randomized, open-label, active-controlled, multicenter, parallel group, noninferiority study; 499 HIV-1 infected ART naïve adult women were randomized 1:1 to receive either; DTG/ABC/3TC FDC 50 mg/600 mg/300 mg; or atazanavir 300 mg plus ritonavir 100 mg plus tenofovir disproxil / emtricitabine 245 mg/200 mg (ATV+RTV+TDF/FTC FDC), all administered once daily.
Maltese: multiċentriku, bi grupp parallel, mhux ta' inferjorità, 499 mara adulta li qatt ma ġew ikkurati qabel b'ART u infettati bl-HIV-1 ġew randomizzati 1:1 biex jingħataw jew; DTG/ABC/3TC FDC 50 mg/600 mg/300 mg; jew atazanavir 300 mg flimkien ma' ritonavir 100 mg flimkien ma' tenofovir disproxil / emtricitabine 245 mg/200 mg (ATV+RTV+TDF/FTC FDC), li lkoll ingħataw darba kuljum.
English: Lamivudine: AUC ↑43% Cmax ↑7%
Maltese: AUC ↑43% Cmax ↑7%
English: Established and theoretical interactions with selected antiretrovirals and non-antiretroviral medicinal products are listed in Table 1.
Maltese: L-interazzjonijiet stabbiliti u teoretiċi bi prodotti mediċinali antiretrovirali u li mhumiex antiretrovirali huma elenkati fit-Tabella 1.
English: The analyses included two randomized, international, double-blind, activecontrolled trials, SINGLE (ING114467) and SPRING-2 (ING113086), the international, open-label, active-controlled trial FLAMINGO (ING114915), and the randomized, open-label, active-controlled, multicentre, non-inferiority study ARIA (ING117172).
Maltese: L-analiżijiet inkludew żewġ provi kkontrollati b'mod attiv, doubleblind, internazzjonali, randomizzati SINGLE (ING114467) u SPRING-2 (ING113086), il-prova internazzjoni, bit-tikketta mikxufa, ikkontrollata b'mod attiv FLAMINGO (ING114915) u l-istudju mhux ta' inferjorità, randomizzat, bit-tikketta mikxufa, ikkontrollat b'mod attiv, multiċentriku, ARIA (ING117172).
English: Following a single dose of 600 mg of abacavir, the mean (CV) Cmax is 4.26 µg/ml (28%) and the mean (CV)
Maltese: Wara doża unika ta' 600 mg ta' abacavir, is-Cmax medja (CV) huwa 4.26 µg/ml (28%) u l
English: → Read the information ‘Other possible side effects of combination therapy for HIV' in Section 4 of this leaflet.
Maltese: → Aqra l-informazzjoni ‘Effetti sekondarji possibbli oħrajn ta' terapija ta' kombinazzjoni għal HIV' f'Sezzjoni 4 ta' dan il-fuljett.
English: There is no evidence that elderly patients require a different dose than younger adult patients (see section 5.2).
Maltese: M'hemm ebda evidenza li pazjenti anzjani jeħtieġu doża differenti minn pazjenti adulti iżgħar (ara sezzjoni 5.2).
English: In a Phase I/II 48 week multicentre, open-label study (P1093/ING112578), the pharmacokinetic parameters, safety, tolerability and efficacy of dolutegravir was evaluated in combination regimens in HIV-1 infected infants, children and adolescents.
Maltese: I/II (P1093/ING112578), il parametri tal-farmakokinetika, is-sigurtà, it-tollerabbiltà u l-effikaċja ta' dolutegravir kienet evalwata f'kombinazzjoni ta' reġimi fi trabi, tfal u adoloxxenti infettati bl-HIV.
English: RAL 400mg twice daily + 2 NRTI N=411
Maltese: RAL 400mg darbtejn kuljum + 2 NRTI N=411
English: Retinoid compounds (e.g. Isotretinoin)
Maltese: Komposti ta' retinojdi (eż. Isotretinoin)
English: See sections 4.4 and 4.8.
Maltese: varja minn 1.4 sa 5.8 µM.
English: At baseline, median patient age was 35 years, 16% were female, 32% non-white, 7% had hepatitis C coinfection and 4% were CDC Class C, these characteristics were similar between treatment groups.
Maltese: Fil-linja bażi, l-età medja tal-pazjenti kienet 35 sena, 16% kienu nisa, 32 mhux bojod, 7% kellhom ko-infezzjoni tal-epatite C u 4% kienu tal-Klassi C ta' CDC, dawn il-karatteristiċi kienu simili fil-gruppi ta' kura kollha.
English: Elevated liver function tests, hepatitis, hepatic failure
Maltese: Testijiet ta' funzjoni tal-fwied, epatite, insuffiċjenza epatika
English: The most frequently reported adverse reactions considered possibly or probably related to dolutegravir and abacavir/lamivudine were nausea (12%), insomnia (7%), dizziness (6%) and headache (6%).
Maltese: Ir-reazzjonijiet avversi rrapportati l-aktar frekwenti li huma kkunsidrati possibbli jew probabbli b'rabta ma' dolutegravir u abacavir/lamivudine kienu dardir (12%), insomnja (7%) sturdament (6%) u uġigħ ta' ras (6%).
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 ta' sustanza attiva lokali, il-metrika mg/kg jew mg/m2 hija xierqa għal determinati xierqa ta' kopertura tas-sigurtà għal din it-tossiċità.
English: There have been reports of mitochondrial dysfunction in HIVnegative infants exposed in utero and/or post-natally to nucleoside analogues (see section 4.4).
Maltese: Kien hemm rapporti ta' disfunzjoni mitokondrijali fi trabi negattivi għall-HIV esposti in utero u/jew wara t-twelid għal analogi tan-nukleosidi (ara sezzjoni 4.4).
English: AUC ↓ 14%; 32%; 36% Cmax ↓ 28%; 52%, 55%.
Maltese: Cmax ↓ 28%; 52%, 55%.
English: PARTICULARS TO APPEAR ON THE INTERMEDIATE PACKAGING INTERMEDIATE CARTON (WITHOUT BLUE BOX - COMPONENT OF MULTIPACK)
Maltese: KARTUNA INTERMEDJA (MINGĦAJR KAXXA BLU - KOMPONENT TA' PAKKETT MULTIPLU)
English: 13.4 g)/Lamivudine oral solution 300 mg Lamivudine:
Maltese: lamivudine soluzzjoni orali 300 mg
English: Dolutegravir had no Pharmacodynamic effect on Luteinizing Hormone (LH), Follicle Stimulating Hormone (FSH) and progesterone.
Maltese: Dolutegravir ma kellu ebda effett farmakodinamiku fuq l-Ormon Lewtanizzanti (LH), l-Ormon Stimulanti tal-Follikuli (FSH) u l-proġesteron.
English: Interaction not studied (Inhibition of alcohol dehydrogenase)
Maltese: alkoħol dehydrogenase)
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 abacavir (IC50 fold changes < 2.5), and lamivudine (IC50 fold changes < 3.0), except for two CRF02_AG isolates with fold changes of 2.9 and 3.4 for abacavir.
Maltese: Iżolati tal-HIV-1 (CRF01_AE, n=12; CRF02_AG, n=12; u s-Sottotip C jew CRF_AC, n=13) minn 37 pazjent mhux ikkurati fl-Afrika u l-Asja kienu suxxettibbli għal abacavir (bidliet fil-valur ta' IC50 ta' < 2.5 darbiet), u lamivudine (bidla fil-valur ta' IC50 ta'< 3.0 darbiet), ħlief għall-iżolati ta' CRF02_AG b'bidla fil-valur ta' 2.9 u 3.4 darbiet għal abacavir.
English: Median Age (years) Female
Maltese: Età Medja (snin) Mara
English: In vivo, dolutegravir may increase plasma concentrations of medicinal products in which excretion is dependent upon OCT2 or MATE-1 (e.g. metformin) (see Table 1).
Maltese: In vivo, dolutegravir jista' jżid il-konċentrazzjonijiet fil-plażma tal-prodotti mediċinali fejn l-eskrezzjoni hija dipendenti fuq OCT2 jew MATE-1 (eż.metformin) (ara Tabella 1).
English: De novo resistance in patients failing therapy in SINGLE, SPRING-2 and FLAMINGO
Maltese: Reżistenza De novo f'pazjenti li ma tirnexxilhomx it-terapija f'SINGLE, SPRING-2 u FLAMINGO
English: Dolutegravir, abacavir and lamivudine have been shown to inhibit replication of lab-strains and clinical isolates of HIV in a number of cell types, including transformed T cell lines, monocyte/macrophage derived lines and primary cultures of activated peripheral blood mononuclear cells (PMBCs) and monocyte/macrophages.
Maltese: Attività antivirali in vitro Dolutegravir, abacavir u lamivudine ntwerew li jinibixxu r-replikazzjoni ta' razez fil-laboratorju u iżolati kliniċi ta' HIV f'numru ta' tipi ta' ċelluli, inklużi linji taċ-ċelloli T trasformati, linji derivati mill-monoċiti/makrofaġi u kulturi primarji ta' ċelluli mononukleari tad-demm periferali (PMBCs) attivati u monoċiti/makrofaġi.
English: Dolutegravir, abacavir and lamivudine are present in cerebrospinal fluid (CSF).
Maltese: Dolutegravir, abacavir u lamivudine huma preżenti fil-fluwidu ċerobrospinali (CSF).
English: DTG 50 mg once daily + 2 NRTI N=411
Maltese: DTG 50 mg darba kuljum + 2 NRTI N=411
English: The adverse reactions considered at least possibly related to treatment with the components of Triumeq from clinical study and post-marketing experience are listed in Table 2 by body system, organ class and absolute frequency.
Maltese: Ir-reazzjonijiet avversi kkunsidrati tal-anqas possibbilment relatati mal-komponenti ta' Triumeq millistudju kliniku u l-esperjenza wara t-tqegħid fis-suq fit-Tabella 2 mis-sistema tal-ġisem, il-klassi talorgani u l-frekwenza assoluta.
English: Important information about the contents of Triumeq tablets.
Maltese: Informazzjoni importanti dwar il-kontenut ta' Triumeq pilloli.
English: In vitro, dolutegravir inhibited the renal uptake organic anion transporters (OAT)1 and OAT3.
Maltese: In vitro, dolutegravir inibixxa t-trasportaturi anion organiċi ta' teħid renali (OAT1) u OAT3.
English: The combination of abacavir/lamivudine has demonstrated decreased susceptibility to viruses with the substitutions K65R with or without the M184V/I substitution, and to viruses with L74V plus the M184V/I substitution.
Maltese: Il kombinazzjoni ta' abacavir/lamivudine wriet tnaqqis fis-suxxettibbiltà għal viruses bissostituzzjonijiet K65R bis-sostituzzjoni M184V/I jew mingħajrha, u għall-viruses bi L74V flimkien mas-sostituzzjoni M184V/I.
English: Twenty out of 23 children and adolescents (87%) had >1 log10 c/mL decrease from Baseline in HIV-1 RNA or HIV-1 RNA <400 c/mL at Week 24.
Maltese: Għoxrin minn 23 tifel u tifla u adoloxxenti (87%) kellhom tnaqqis ta' >1 log10 c/mL mil-Linja Bażi f'HIV-1 RNA jew HIV-1 RNA <400 c/mL fl-24 Ġimgħa.
English: The apparent oral clearance (CL/F) is approximately 1 L/hr in HIV-infected patients based on a population pharmacokinetic analysis.
Maltese: It-tneħħija orali evedenti (CL/F) hija madwar 1 L/hr f'pazjenti infettati b'HIV abbażi ta' analiżi tal-farmokinetika tal-popolazzjoni.
English: DTG 50 mg once daily + 2 NRTI
Maltese: DTG 50 mg darba kuljum + 2 NRTI
English: Triumeq is indicated for the treatment of Human Immunodeficiency Virus (HIV) infected adults and adolescents above 12 years of age weighing at least 40 kg (see sections 4.4 and 5.1).
Maltese: Triumeq huwa indikat għall-kura ta' adulti infettati b'Virus tal-Immunodefiċjenza Umana (HIV) u adoloxxenti li għandhom aktar minn 12-il sena li jiżnu għallinqas 40 kg (ara sezzjonijiet 4.4 u 5.1).
English: At 96 weeks, the response was 80% vs 72%, respectively.
Maltese: Fis-96 ġimgħa, ir-rispons kien 80 % vs 72%, rispettivament.
English: Table 4: Demographics and virologic outcomes of randomized treatment of SPRING-2 (snapshot algorithm)
Maltese: Tabella 4: Demografija u eżiti viroloġiċi ta' kura randomizzata ta' SPRING-2 (algorittmu snapshot)
English: • oxcarbazepine and carbamazepine, to treat epilepsy and bipolar disorder
Maltese: • okskarbażepin u karbameżibin, għat-trattament ta' epilessija u disturb bipolari
English: - Triumeq should never be initiated in patients with a positive HLA-B*5701 status, nor in patients with a negative HLA-B*5701 status who had a suspected abacavir HSR on a previous abacavircontaining regimen.
Maltese: - Triumeq qatt ma għandu jinbeda f'pazjenti bi status HLA-B*5701 pożittiv, lanqas f'pazjenti bi status HLA-B*5701 negattiv li kellhom HSR ta' abacavir suspettat fuq reġiment preċedenti li kien fih abacavir.
English: Immune Reactivation Syndrome
Maltese: Sindromu ta' Riattivazzjoni Immunitarja
English: Headache, paraesthesia
Maltese: Uġigħ ta' ras, parasteżija
English: Table 7: Outcomes of randomized treatment of STRIIVING (snapshot algorithm) Study Outcomes (Plasma HIV-1 RNA <50 c/mL) at Week 24 and Week 48 - Snapshot Analysis (ITT-E Population)
Maltese: Eżiti ta' Studju (Plasma HIV-1 RNA <50 c/mL) wara Ġimgħa 24 u Ġimgħa 48 - Analiżi Snapshot
English: A single dose of 50 mg of dolutegravir was administered to 8 subjects with moderate hepatic impairment (Child-Pugh class B) and to 8 matched healthy adult controls.
Maltese: dolutegavir ingħatat lil 8 individwi b'indeboliment epatiku moderat (klassi B ta' Child-Pugh) u lil 8 kontrolli ta' adulti b'saħħithom imqabbla.
English: The geometric mean terminal half-life of intracellular active moiety carbovirtriphosphate (TP) at steady-state is 20.6 hours.
Maltese: Il-half-life terminali medja ġeometrika ta' carbovirtriphosphate moiety (TP) attiv ġoċ-ċelloli fi stat fiss hija ta' 20.6 siegħa.
English: Abacavir and lamivudine belong to a group of anti-retroviral medicines (medicines used to treat HIV infection) called nucleoside analogue reverse transcriptase inhibitors (NRTIs), and dolutegravir belongs to a group of anti-retroviral medicines called integrase inhibitors (INIs).
Maltese: Abacavir u lamivudine jappartjenu għal grupp ta' mediċini anti retrovirali msejħin nucleoside analogue reverse transcriptase inhibitors (NRTIs), u dolutegravir jappartjeni għal grupp ta' mediċini anti-retrovirali msejħin integrase inhibitors (INIs).
English: In SINGLE, 833 patients were treated with dolutegravir 50 mg once daily plus fixed-dose abacavirlamivudine (DTG + ABC/3TC) or fixed-dose efavirenz-tenofovir-emtricitabine (EFV/TDF/FTC).
Maltese: F'SINGLE, 833 pazjent ġew ikkurati b'dolutegravir 50 mg darba kuljum flimkien ma' doża fissa ta' abacavir-lamivudine (DTG + ABC/3TC) jew efavirenz-tenofovir-emtricitabine (EFV/TDF/FTC) b'doża fissa.
English: Hypersensitivity reactions (see section 4.8)
Maltese: Reazzjonijiet ta' sensittività eċċessiva (ara wkoll sezzjoni 4.8)
English: Dolutegravir is highly bound (> 99%) to human plasma proteins based on in vitro data.
Maltese: Dolutegravir jeħel ħafna (> 99%) ma' proteini fil-plażma tal-bniedem abbażi tad-dejta in vitro.
English: Diagnosis of Abacavir Hypersensitivity Reaction Major symptoms associated with ABC HSR are fever (~80%), rash (~70%), gastrointestinal symptoms (>50%) such as nausea, abdominal pain, vomiting, and diarrhoea, generalise malaise, fatigue, and headache (~50%) and other symptoms (~30%) such as respiratory, mucosal, and musculoskeletal symptoms.
Maltese: HSR huma deni (~80%), raxx (~70%), sintomi gastrointestinali (>50%) bħal dardir, uġigħ addominali, rimettar u dijarrea, tħossok ma tiflaħx b'mod ġenerali, għejja u uġigħ ta' ras (~50%) u sintomi oħrajn (~30%) bħal sintomi respiratorji, mukosali u muskuloskeletali.
English: PHARMACEUTICAL FORM AND CONTENTS Multipack: 90 (3 packs of 30) film-coated tablets
Maltese: Pakkett multiplu: 90 (3 pakketti ta' 30) pillola miksija b'rita
English: Resistance in vitro and in vivo: (abacavir and lamivudine) Abacavir-resistant isolates of HIV-1 have been selected in vitro and in vivo and are associated with specific genotypic changes in the RT codon region (codons M184V, K65R, L74V and Y115F).
Maltese: (abacavir u lamivudine) Iżolati ta' HIV-1 reżistenti għal abacavir intgħażlu in vitro u in vivo u huma assoċjanti ma' bidliet ġenotipiċi speċifiċi fir-reġjun tal-codon RT (codons M184V, K65R, L74V u Y115F).
English: Rash (usually maculopapular or urticarial)
Maltese: Raxx (ġeneralment makulopapulari jew urtikarja)