FrancophonIA/ELRC3.0 huggingface dataset:
English: The most important side effect of treatment is bleeding but it is considered manageable.
Maltese: L-effett sekondarju l-aktar importanti tal-kura huwa fsada iżda hija meqjusa ġestibbli.
English: ISG-DSG, Difference (95 % CI)*
Maltese: ISG-DSG, Differenza (CI ta' 95 %)*
English: Parameter GM ( %CV)
Maltese: GM ( %CV)
English: Psychostimulants modafinil
Maltese: Psikostimulanti modafinil
English: ABC=abacavir; FTC=emtricitabine; DRV=darunavir; r=ritonavir
Maltese: FTC= emtricitabine; DRV=darunavir; r=ritonavir
English: Delstrigo contains lactose monohydrate.
Maltese: Delstrigo fih lactose monohydrate.
English: Miscellaneous sorbitol solution (3.2 g, 10.2 g, 13.4 g)/lamivudine
Maltese: Mixxellanja soluzzjoni ta' sorbitol (3.2 g, 10.2 g, 13.4 g)/lamivudine
English: EU/1/18/1333/001 EU/1/18/1333/002
Maltese: EU/1/18/1333/002
English: Week 96*
Maltese: Ġimgħa 96*
English: Immunosuppressants tacrolimus sirolimus
Maltese: Immunosoppressanti tacrolimus sirolimus
English: Antiandrogens enzalutamide
Maltese: Antiandroġeni enzalutamide
English: Lamivudine is a nucleoside analogue.
Maltese: Lamivudine huwa analogu ta' nucleoside.
English: ombitasvir/paritaprevir/ ritonavir and dasabuvir +/ritonavir
Maltese: ombitasvir/paritaprevir/ ritonavir u dasabuvir +/ritonavir
English: Date of first authorisation: 22 November 2018
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 22 ta' Novembru 2018
English: Antineoplastics mitotane
Maltese: Antineoplastiċi mitotane
English: AUC0-24 μM hr
Maltese: AUC0-24
English: CD4 count, cells/µL
Maltese: Għadd ta' CD4, ċelluli/µL
English: *NRTI in DOR arm: FTC/TDF (333) or ABC/3TC (50); NRTI in DRV+r arm: FTC/TDF (335) or ABC/3TC (48) **Subjects received FTC/TDF
Maltese: *NRTIs fil-fergħa ta' DOR: FTC/TDF (333) jew ABC/3TC (50); NRTIs fil-fergħa ta' DRV+r: FTC/TDF (335) jew ABC/3TC (48) **Individwi rċevew FTC/TDF
English: Expected:  lisinopril
Maltese: Mistenni: ↔ lisinopril
English: EU/1/18/1333/001 EU/1/18/1333/002 90 (3 x 30) tablets
Maltese: EU/1/18/1333/002 90 (3 x 30) pilloli
English: C24 nM
Maltese: C24
English: Repeat dose toxicity
Maltese: Tossiċità minn dożi ripetuti
English: Kinase Inhibitors dabrafenib
Maltese: Inibituri ta' Kinase dabrafenib
English: Table 1: Interactions between the individual components of Delstrigo and other medicinal products
Maltese: Tabella 1: Interazzjonijiet bejn il-komponenti individwali ta' Delstrigo u prodotti mediċinali oħra
English: NRTI backbone M184I/V only K65R only K65R + M184I/V
Maltese: Il-qafas tal-NRTI M184I/V biss K65R biss K65R + M184I/V
English: Week 24 N=223
Maltese: N=223
English: Other substitutions yielded a fold change of 5-10 (G190S (5.7); K103N/P225H (7.9), V108I/Y181C (6.9), Y181V (5.1)).
Maltese: Sostituzzjonijiet oħra taw bidla ta' 5-10 darbiet (G190S (5.7); K103N/P225H (7.9), V108I/Y181C (6.9), Y181V (5.1)).
English: Anticonvulsants carbamazepine oxcarbazepine phenobarbital phenytoin
Maltese: Antikonvulżivi carbamazepine oxcarbazepine phenobarbital phenytoin
English: < 200 cells/mm
Maltese: < 200 ċellula/mm3
English: Calcium Channel Blockers diltiazem verapamil
Maltese: Imblokkaturi tal-Kanali tal-Kalċju diltiazem verapamil
English: Azole Antifungal Agents ketoconazole
Maltese: Sustanzi Azole Kontra l-Fungi ketoconazole
English: Antidiarrhoeals telotristat ethyl
Maltese: Mediċini kontra d-dijarea telotristat ethyl
English: Rare rectal tenesmus
Maltese: Rari tenesmus tar-rektum
English: Delstrigo is used to treat HIV (‘human immunodeficiency virus') infection.
Maltese: Delstrigo jintuża għat-trattament ta' infezzjoni tal-HIV (‘human immunodeficiency virus', virus talimmunodefiċjenza umana).
English: Endothelin Receptor Antagonists bosentan
Maltese: Antagonisti tar-Riċettur ta' Endothelin bosentan
English: Interaction table
Maltese: Tabella ta' interazzjoni
English: Rare dermatitis allergic, rosacea, angioedema* Musculoskeletal and connective tissue disorders Common muscle disorders*
Maltese: Rari dermatite allerġika, rożaċea, anġioedima* Disturbi muskoluskeletriċi u tat-tessuti konnettivi Komuni disturbi fil-muskoli*
English: The median EC50 values of lamivudine were 60 nM (range: 20 to 70 nM), 35 nM (range: 30 to 40 nM), 30 nM (range: 20 to 90 nM), 20 nM (range: 3 to 40 nM), 30 nM (range: 1 to 60 nM), 30 nM (range: 20 to 70 nM), 30 nM (range: 3 to 70 nM), and 30 nM (range: 20 to 90 nM) against HIV-1 clades A-G and group O viruses (n = 3 except n = 2 for clade B) respectively.
Maltese: 20 sa 70 nM), 35 nM (firxa: 30 sa 40 nM), 30 nM (firxa: 20 sa 90 nM), 20 nM (firxa: 3 sa 40 nM), 30 nM (firxa: 1 sa 60 nM), 30 nM (firxa: 20 sa 70 nM), 30 nM (firxa: 3 sa 70 nM), u 30 nM (firxa: 20 sa 90 nM) kontra l-kladi A-G u l-virusus tal-grupp O ta' HIV-1 (n = 3 ħlief n = 2 għal klad B)
English: The Phase 3 studies, DRIVE-FORWARD and DRIVE-AHEAD, included previously untreated patients (n = 747) where the following NNRTI substitutions were part of exclusion criteria: L100I, K101E, K101P, K103N, K103S, V106A, V106I, V106M, V108I, E138A, E138G, E138K, E138Q, E138R, V179L, Y181C, Y181I, Y181V, Y188C, Y188H, Y188L, G190A, G190S, H221Y, L234I, M230I, M230L, P225H, F227C, F227L, F227V.
Maltese: L-istudji ta' Fażi 3, DRIVE-FORWARD u DRIVE-AHEAD, inkludew pazjenti li ma kinux ġew ittrattati qabel (n = 747) fejn is-sostituzzjonijiet NNRTI li ġejjin kienu jagħmlu parti mill-kriterji ta' esklużjoni: L100I, K101E, K101P, K103N, K103S, V106A, V106I, V106M, V108I, E138A, E138G, E138K, E138Q, E138R, V179L, Y181C,Y181I, Y181V, Y188C, Y188H, Y188L, G190A, G190S, H221Y, L234I, M230I, M230L, P225H, F227C, F227L, F227V.
English: Intracellularly, lamivudine is phosphorylated to its active 5´- triphosphate metabolite, lamivudine triphosphate (3TC-TP).
Maltese: Ġoċ-ċelluli, lamivudine jiġi fosforilat għall-metabolit 5´- triphosphate attiv tiegħu, lamivudine triphosphate (3TC-TP).
English: ≥ 200 cells/mm
Maltese: ≥ 200 ċellula/mm3
English: Tenofovir disoproxil was mutagenic in the in vitro mouse lymphoma assay and negative in an in vitro bacterial mutagenicity test (Ames test).
Maltese: Tenofovir disoproxil kien mutaġeniku f'assaġġ ta' limfoma tal-ġurdien in vitro u kien negattiv f'test ta' mutaġeniċità tal-batterji in vitro (test Ames).
English: Expected:  doravirine ↓ tacrolimus, sirolimus (Induction of CYP3A)
Maltese: ↔ doravirine ↓ tacrolimus, sirolimus (Induzzjoni ta' CYP3A)
English: HIV is the virus that causes AIDS (‘acquired immune deficiency syndrome').
Maltese: HIV huwa l-virus li jikkawża l-AIDS (‘acquired immune deficiency syndrome', sindrome akkwiżit ta' defiċjenza immuni).
English: Antimycobacterials
Maltese: Antimikobatteriċi
English: • decreased levels of magnesium
Maltese: • tnaqqis fil-livelli tal-magnesium
English: *The 95 % CI for the treatment difference was calculated using stratum-adjusted Mantel-Haenszel method.
Maltese: *Is-CI ta' 95 % għad-differenza fit-trattament ġiet ikkalkulata bl-użu tal-metodu Mantel-Haenszel aġġustat għallistratum.
English: Viral subtype non-B
Maltese: Sottotip tal-virus B
English:  = increase, ↓ = decrease, ↔ = no change CI = Confidence Interval; SD = Single Dose; QD = Once Daily; BID = Twice Daily *AUC0- for single dose, AUC0-24 for once daily.
Maltese: CI, Confidence Interval = Intervall ta' Kunfidenza; SD, Single Dose = Doża Waħda; QD = Darba Kuljum; BID = Darbtejn Kuljum *AUC0-∞ għal doża waħda, AUC0-24 għal darba kuljum.
English: Tenofovir disoproxil is an acyclic nucleoside phosphonate diester analog of adenosine monophosphate.
Maltese: Tenofovir disoproxil huwa analogu aċikliku tan-nucleoside phosphonate diester ta' adenosine monophosphate.
English: Immune reactivation syndrome has been reported in patients treated with combination antiretroviral therapy.
Maltese: Sindrome ta' riattivazzjoni immuni kien irrappurtat f'pazjenti ttrattati b'terapija antiretrovirali kombinata.
English: Cmax and AUC values were 0.30 ± 0.09 micrograms per mL and 2.29 ± 0.69 µg•hr per mL, respectively.
Maltese: Il-valuri tas-Cmax u tal-AUC kienu 0.30 ± 0.09 mikrogrammi f'kull mL u 2.29 ± 0.69 µg•siegħa kull mL, rispettivament.
English: Rare blood creatine phosphokinase increased
Maltese: Rari żieda ta' creatine phosphokinase fid-demm
English: The antiviral activity of lamivudine against HIV-1 was assessed in a number of cell lines including monocytes and peripheral blood mononuclear cells (PBMCs) using standard susceptibility assays.
Maltese: L-attività antivirali ta' lamivudine kontra HIV-1 ġiet stmata f'numru ta' linji ta' ċelluli inklużi monoċiti u ċelluli mononukleari tad-demm periferali (PBMCs, peripheral blood mononuclear cells) bl-użu ta' assaġġi standard ta' suxxettibbiltà.
English: Investigations Common alanine aminotransferase increased
Maltese: Investigazzjonijiet Komuni żieda fl-alanine aminotransferase9
English: Common NNRTI resistant mutations (K103N, Y181C) were not selected in the in vitro study.
Maltese: Mutazzjonijiet komuni reżistenti għal NNRTI (K103N, Y181C) ma ntagħżlux fl-istudju in vitro.
English: Less than 0.7 % of tenofovir binds to human plasma proteins in vitro over the range of 0.01 to 25 micrograms per mL.
Maltese: Inqas minn 0.7 % ta' tenofovir jintrabat mal-proteini tal-plażma tal-bniedem in vitro fuq firxa minn 0.01 sa 25 mikrogramma f'kull mL.
English: The EC50 values for tenofovir were in the range of 0.04-8.5 microM.
Maltese: Il-valuri EC50 għal tenofovir kienu jvarjaw minn 0.04-8.5 mikroM.
English: Pharmacokinetic parameters of tenofovir were determined following administration of a single dose of tenofovir disoproxil 245 mg to 40 non-HIV infected adult subjects with varying degrees of renal impairment defined according to baseline CrCl (normal renal function when CrCl > 80 mL/min; mild with CrCl = 50-79 mL/min; moderate with CrCl = 30-49 mL/min and severe with CrCl = 10-29 mL/min).
Maltese: Parametri farmakokinetiċi ta' tenofovir ġew determinati wara l-għoti ta' doża waħda ta' tenofovir disoproxil 245 mg lill-40 individwu adult mhux infettati bl-HIV bi gradi varji ta' indeboliment talkliewi definit skont il-CrCl fil-linja bażi (funzjoni normali tal-kliewi meta CrCl hija > 80 mL/min; ħafifa bi CrCl = 50-79 mL/min; moderata bi CrCl = 30-49 mL/min u severa bi CrCl = 10-29 mL/min).
English: For potential medicine product interactions with tenofovir disoproxil or lamivudine, (see sections 4.4 and 5.2).
Maltese: Għal interazzjonijiet possibbli ta' prodotti mediċinali ma' tenofovir disoproxil jew lamivudine, (ara sezzjonijiet 4.4 u 5.2).
English: Metabolism of lamivudine is a minor route of elimination.
Maltese: Ilmetaboliżmu ta' lamivudine huwa rotta minuri ta' eliminazzjoni.
English: Impairment of fertility
Maltese: Indeboliment fil-fertilità
English: The most frequently reported adverse reactions considered possibly or probably related to doravirine were nausea (4 %) and headache (3 %).
Maltese: L-aktar reazzjonijiet avversi rrappurtati b'mod frekwenti meqjusa li possibilment jew probabbilment kienu marbuta ma' doravirine kienu nawsja (4 %) u uġigħ ta' ras (3 %).
English: Effects of other medicinal products on doravirine, lamivudine, and tenofovir disoproxil Doravirine
Maltese: Effetti ta' prodotti mediċinali oħra fuq doravirine, lamivudine, u tenofovir disoproxil Doravirine
English: The M184I/V lamivudine resistance substitution confers resistance to emtricitabine.
Maltese: Is-sostituzzjoni M184I/V ta' reżistenza għal lamivudine tagħti reżistenza għal emtricitabine.
English: Steady state was generally achieved by Day 2 of once daily dosing, with accumulation ratios of 1.2 to 1.4 for AUC0-24, Cmax, and C24.
Maltese: L-istat fiss ġeneralment inkiseb ma' Jum 2 ta' għoti darba kuljum, bi proporzjonijiet ta' akkumulazzjoni ta' 1.2 sa 1.4 għal AUC0-24, Cmax, u C24.
English: • The other ingredients are croscarmellose sodium E468; hypromellose acetate succinate; magnesium stearate E470b; microcrystalline cellulose E460; silica, colloidal anhydrous E551; sodium stearyl fumarate.
Maltese: • Is-sustanzi l-oħra huma croscarmellose sodium E468; hypromellose acetate succinate; magnesium stearate E470b; microcrystalline cellulose E460; silica, colloidal anhydrous E551; sodium stearyl fumarate.
English: Very rare peripheral neuropathy (or paraesthesia)*
Maltese: Rari ħafna newropatija periferali (jew parestesija)*
English: Sedatives/Hypnotics midazolam (2 mg SD, doravirine 120 mg QD)
Maltese: Sedattivi/Ipnotiċi midazolam (2 mg SD, doravirine 120 mg QD)
English: Compared with subjects with normal renal function, the mean (% CV) tenofovir exposure increased from 2,185 (12 %) ng·h/mL in subjects with CrCl > 80 mL/min to respectively 3,064 (30 %) ng·h/mL, 6,009 (42 %) ng·h/mL and 15,985 (45 %) ng·h/mL in subjects with mild, moderate, and severe renal impairment.
Maltese: Meta mqabbla ma' individwi b'funzjoni normali tal-kliewi, il-medja (% CV) tal-esponiment għal tenofovir żdiedet minn 2,185 (12 %) ng·siegħa/mL f'individwi bi CrCl > 80 mL/min sa 3,064 (30 %) ng·siegħa/mL, 6,009 (42 %) ng·siegħa/mL u 15,985 (45 %) ng·siegħa/mL rispettivament f'individwi b'indeboliment ħafif, moderat, u sever tal-kliewi.
English: Doravirine is a pyridinone non-nucleoside reverse transcriptase inhibitor of HIV-1 and inhibits HIV-1 replication by non-competitive inhibition of HIV-1 reverse transcriptase (RT).
Maltese: Doravirine huwa inibitur pyridinone mhux nucleoside ta' reverse transcriptase ta' HIV-1 u jinibixxi rreplikazzjoni ta' HIV-1 permezz ta' inibizzjoni mhux kompetittiva ta' reverse transcriptase (RT) ta' HIV-1.
English: Discuss your hepatitis B therapy with your doctor.
Maltese: Iddiskuti t-terapija tal-epatite B tiegħek mat-tabib tiegħek.
English: Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), or very rare (< 1/10,000).
Maltese: Il-frekwenzi huma definiti bħala komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100), rari (≥ 1/10,000 sa < 1/1,000), jew rari ħafna (< 1/10,000).
English: The DRIVE-SHIFT study included virologically suppressed patients (N=670) with no history of treatment failure (see section, Clinical experience).
Maltese: L-istudju DRIVE-SHIFT inkluda pazjenti (N=670) soppressi b'mod viroloġiku mingħajr storja ta' falliment tat-trattament (ara s-sezzjoni, Esperjenza klinika).
English: EC50 values were in the range of 0.003 to 15 microM (1 microM = 0.23 micrograms per mL).
Maltese: Il-valuri EC50 kienu jvarjaw minn 0.003 sa 15 mikroM (1 mikroM = 0.23 mikrogramma kull mL).
English: Doravirine demonstrated antiviral activity against a broad panel of primary HIV-1 isolates (A, A1, AE, AG, B, BF, C, D, G, H) with EC50 values ranging from 1.2 nM to 10.0 nM.
Maltese: Doravirine wera attività antivirali kontra firxa wiesa ta' iżolati primarji ta' HIV-1 (A, A1, AE, AG, B, BF, C, D, G, H) b'valuri EC50 li varjaw minn 1.2 nM sa 10.
English: • Tenofovir disoproxil - a nucleoside analogue reverse transcriptase inhibitor (NRTI)
Maltese: • Tenofovir disoproxil - inibitur ta' reverse transcriptase analogu ta' nucleoside (NRTI, nucleoside analogue reverse transcriptase inhibitor)
English: HIV-1 RNA < 40 copies/mL
Maltese: RNA ta' HIV-1 < 40 kopja/mL
English: Angiotensin Converting Enzyme Inhibitors lisinopril
Maltese: Inibituri tal-Enzima li Tikkonverti Angiotensin lisinopril
English: Cystic Fibrosis Treatment lumacaftor
Maltese: Trattament għall-Fibrożi Ċistika lumacaftor
English:  doravirine AUC 0.12 (0.10, 0.15) Cmax 0.43 (0.35, 0.52) C24 0.03 (0.02, 0.04) (Induction of CYP3A)
Maltese: ↓ doravirine AUC 0.12 (0.10, 0.15) Cmax 0.43 (0.35, 0.52) C24 0.03 (0.02, 0.04) (Induzzjoni ta' CYP3A)
English: Tenofovir displayed antiviral activity in cell culture against HIV-1 clades A, B, C, D, E, F, G, and O (EC50 values ranged from 0.5-2.2 microM).
Maltese: Tenofovir wera attività antivirali f'koltura ta'ċelluli kontra kladi A, B, C, D, E, F, G, u O ta' HIV-1 (il-valuri ta' EC50 kienu jvarjaw minn 0.5-2.2 mikroM).
English: Cross-resistance has been observed among NRTIs.
Maltese: Reżistenza inkroċjata ġiet osservata fost l-NRTIs.
English: Doravirine exhibited an EC50 value of 12.0±4.4 nM against wild-type laboratory strains of HIV-1 when tested in the presence of 100 % normal human serum using MT4-GFP reporter cells.
Maltese: Doravirine wera valur EC50 ta' 12.0±4.4 nM kontra rażeż tal-laboratorju ta' HIV-1 li jinsabu fin-natura meta ġie ttestjat fil-preżenza ta' serum 100 % normali tal-bniedem bl-użu ta' ċelluli rapportaturi MT4GFP.
English: Very rare: may affect up to 1 in 10,000 people
Maltese: Rari ħafna: jista' jaffettwa sa persuna 1 minn kull 10,000
English: • lumacaftor
Maltese: • enzalutamide • lumacaftor
English: • decreased levels of haemoglobin
Maltese: • tnaqqis fil-livelli tal-emoglobina
English: Renal and urinary disorders Uncommon increased creatinine*, proximal renal tubulopathy (including Fanconi syndrome)*
Maltese: Mhux komuni żieda fil-kreatinina*, tubulopatija prossimali talkliewi (inkluż is-sindrome ta' Fanconi)*,
English: Yellow, oval-shaped, tablet of dimensions 21.59 mm x 11.30 mm, debossed with the corporate logo and 776 on one side and plain on the other side.
Maltese: Pillola safra, ta' għamla ovali, b'daqs ta' 21.59 mm x 11.30 mm, imnaqqxa bil-logo tal-kumpanija u 776 fuq naħa waħda u bla marki fuq in-naħa l-oħra.
English: In HIV-1-infected subjects, total clearance was 398.5 ± 69.1 mL per min (mean ± SD).
Maltese: F'individwi infettati b'HIV-1, it-total tat-tneħħija kien 398.5 ± 69.1 mL kull min (medja ± SD).
English: Doravirine is primarily metabolised and eliminated by the liver.
Maltese: Doravirine huwa metabolizzat u eliminat primarjament mill-fwied.
English: V106A (yielding a fold change of around 19) appeared as an initial substitution in subtype B virus, and V106A or M in subtype A and C virus.
Maltese: V106A (li jagħti drabi ta' bidla ta' madwar 19) deher bħala sostituzzjoni inizjali fis-sottotip B tal-virus, u V106A jew M fis-sottotipi A u C talvirus.
English: Doravirine has an estimated absolute bioavailability of approximately 64 % for the 100 mg tablet.
Maltese: Doravirine għandu bijodisponibbiltà assoluta stmata ta' madwar 64 % għall-pillola ta' 100 mg.
English: Laboratory strains of HIV-1 harbouring the common NNRTI-associated mutations K103N, Y181C, or K103N/Y181C substitutions in RT exhibit less than a 3-fold decrease in susceptibility to doravirine compared to wild-type virus when evaluated in the presence of 100 % normal human serum.
Maltese: Razez ta' HIV-1 tal-laboratorju li kellhom fihom sostituzzjonijiet f'RT assoċjati ma' NNRTI talmutazzjonijiet komuni K103N, Y181C, jew K103N/Y181C juru tnaqqis ta' anqas minn 3 drabi aktar fis-suxxettibbiltà għal doravirine meta mqabbla mal-virus li jinsab fin-natura meta ġew evalwati filpreżenza ta' 100 % serum normali tal-bniedem.
English: Uncommon nightmare, depression 2, anxiety 3, irritability, confusional state, suicidal ideation
Maltese: Mhux komuni ħmar il-lejl, depressjoni2, ansjetà3, irritabilità, stat ta' konfużjoni, ħsibijiet ta' suwiċidju
English: Ribavirin (50 microM) used in the treatment of chronic HCV infection decreased the anti-HIV-1 activity of lamivudine by 3.5-fold in MT-4 cells.
Maltese: Ribavirin (50 mikroM) użat fit-trattament ta' infezzjoni kronika tal-HCV naqqas lattività ta' lamivudine kontra HIV-1 bi 3.5 drabi aktar f'ċelluli MT-4.
English: • Doravirine - a non-nucleoside reverse transcriptase inhibitor (NNRTI)
Maltese: • Doravirine -inibitur mhux nucleoside ta' reverse transcriptase (NNRTI, non-nucleoside reverse transcriptase inhibitor)
English: Some examples include, but are not limited to, acyclovir, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides (e.g., gentamicin), and high-dose or multiple NSAIDs (see section 4.4).
Maltese: Xi eżempji jinkludu, iżda mhumiex limitati għal, acyclovir, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides (eż., gentamicin), u doża għolja jew numru ta' NSAIDs (ara sezzjoni 4.4).
English: • muscle symptoms (pain, stiffness)
Maltese: • sintomi fil-muskoli (uġigħ, ebusija)
English: Week 48 N=447
Maltese: N=447
English: A breakpoint for a reduction in susceptibility, yielded by various NNRTI substitutions, that is associated with a reduction in clinical efficacy has not been established (see section 5.1).
Maltese: Ma ġiex stabbilit punt li ogħla minnu jkunx hemm tnaqqis fissuxxettibbiltà, li rriżulta minn diversi sostituzzjonijiet ta' NNRTI, li huwa assoċjat ma' tnaqqis fleffikaċja klinika (ara sezzjoni 5.1).
English: Doravirine is primarily eliminated via oxidative metabolism mediated by CYP3A4.
Maltese: Doravirine jitneħħa primarjament permezz ta' metaboliżmu ossidattiv medjat minn CYP3A4.
English: • cough, nasal symptoms
Maltese: • sogħla, sintomi tal-imnieħer
English: Excipient with known effect Each film-coated tablet contains 8.6 mg lactose (as monohydrate).
Maltese: Eċċipjent b'effett magħruf Kull pillola miksija b'rita fiha 8.6 mg lactose (bħala monohydrate).
English: Rare hypomagnesaemia, lactic acidosis*
Maltese: Rari ipomagnesimja, aċidożi lattika*
English: Delstrigo contains the active substances:
Maltese: Delstrigo fih is-sustanzi attivi:
English: Delstrigo 100 mg/300 mg/245 mg film-coated tablets.
Maltese: Delstrigo 100 mg/300 mg/245 mg pilloli miksija b'rita.
English:  doravirine AUC 3.06 (2.85, 3.29) Cmax 1.25 (1.05, 1.49) C24 2.75 (2.54, 2.98) (Inhibition of CYP3A)
Maltese: ↑ doravirine AUC 3.06 (2.85, 3.29) Cmax 1.25 (1.05, 1.49) C24 2.75 (2.54, 2.98) (Inibizzjoni ta' CYP3A)
English: In a population pharmacokinetic analysis, which included subjects with CrCl between 17 and 317 mL/min, renal function did not have a clinically relevant effect on doravirine pharmacokinetics.
Maltese: F'analiżi farmakokinetika ta' popolazzjoni, li kienet tinkludi individwi bi CrCl bejn 17 u 317-il mL/min, il-funzjoni tal-kliewi ma kelliex effett rilevanti b'mod kliniku fuq il-farmakokinetika ta' doravirine.
English:  doravirine AUC 1.56 (1.45, 1.68) Cmax 1.41 (1.25, 1.58) C24 1.61 (1.45, 1.79) (Inhibition of CYP3A)
Maltese: ↑ doravirine AUC 1.56 (1.45, 1.68) Cmax 1.41 (1.25, 1.58) C24 1.61 (1.45, 1.79) (Inibizzjoni ta' CYP3A)
English: • 90 film-coated tablets (3 bottles of 30 film-coated tablets) Not all pack sizes may be marketed.
Maltese: • 90 pillola miksija b'rita (3 fliexken ta' 30 pillola miksija b'rita) Jista' jkun li mhux il-pakketti tad-daqsijiet kollha jkunu fis-suq.
English: • increased levels of amylase
Maltese: • żieda fil-livelli tal-amylase
English: Table 4: Efficacy response (< 40 copies/mL, Snapshot approach) in the pivotal studies
Maltese: Tabella 4: Rispons ta' effikaċja (<40 kopja/mL, approċċ Snapshot) fl-istudji pivitali
English: Doravirine has a terminal half-life (t1/2) of approximately 15 hours.
Maltese: Doravirine għandu half-life (t1/2) terminali ta' madwar 15-il siegħa.
English: In clinical trials
Maltese: Fi provi kliniċi
English: Do not take Delstrigo:
Maltese: Tiħux Delstrigo jekk:
English: Delstrigo 100 mg / 300 mg / 245 mg film-coated tablets doravirine/lamivudine/tenofovir disoproxil
Maltese: Delstrigo 100 mg / 300 mg / 245 mg pilloli miksija b'rita doravirine/lamivudine/tenofovir disoproxil
English: Doravirine has been evaluated in a limited number of patients with NNRTI resistance (K103N n = 7, G190A n = 1); all patients were suppressed to < 40 copies/mL at Week 48.
Maltese: Doravirine ġie evalwat f'numru limitat ta' pazjenti b'reżistenza għal NNRTI (K103N n = 7, G190A n = 1); il-pazjenti kollha ġew soppressi għal < 40 kopja/mL f'Ġimgħa 48.
English: Blood and lymphatic systems disorders Uncommon neutropenia*, anaemia*, thrombocytopenia*
Maltese: Mhux komuni newtropenija*, anemija*, tromboċitopenija*
English: HIV-1 RNA ≥ 40 copies/mL
Maltese: RNA ta' HIV-1 ≥ 40 kopja/mL†
English: When possible, avoid chronic co-administration of doravirine/lamivudine/tenofovir disoproxil with medicinal products containing sorbitol or other osmotic acting polyalcohols (e.g., xylitol, mannitol, lactitol, maltitol).
Maltese: Fejn possibbli, evita l-għoti kroniku ta' doravirine/lamivudine/tenofovir disoproxil flimkien ma' prodotti mediċinali li jkun fihom sorbitol jew poly-alchohols oħra li jaħdmu b'mod osmotiku (eż., xylitol, mannitol, lactitol, maltitol).
English: GM: Geometric mean, %CV: Geometric coefficient of variation
Maltese: 100 mg darba kuljum GM: Medja geometrika, %CV: koeffiċjent ġeometriku ta' varjazzjoni