FrancophonIA/ELRC3.0 huggingface dataset:
English: The mean IC50 for 3 HIV-2 isolates was 0.18 nM (range 0.09-0.61).
Maltese: L-IC50 medja għal 3 iżolati ta' HIV-2 kienet 0.18 nM (medda 0.09-0.61).
English: Lamivudine is also substrate of the hepatic uptake transporter OCT1.
Maltese: Lamivudine huwa substrat ukoll tat-trasportatur ta' teħid epatiku OCT1.
English: Dolutegravir ↓ AUC ↓ 54% Cmax ↓ 43% Cτ ↓ 72% (induction of UGT1A1 and CYP3A enzymes)
Maltese: Dolutegravir ↓ AUC ↓ 54% Cmax ↓ 43% Cτ ↓ 72% (induzzjoni tal-enzimi UGT1A1 u CYP3A)
English: Antihistamines (histamine H2 receptor antagonists) Ranitidine
Maltese: Antistamini (antagonisti tar-riċettur tal-istamina H2)
English: Dovato is indicated in the absence of documented or suspected resistance to the integrase inhibitor class and to lamivudine (see section 4.1).
Maltese: Dovato huwa indikat fl-assenza ta' reżistenza dokumentata jew suspettata għall-klassi ta' inibituri integrase u għal lamivudine (ara sezzjoni 4.1).
English: → Read the information ‘Other possible side effects' in section 4 of this leaflet.
Maltese: → Aqra l-informazzjoni “Effetti sekondarji oħrajn possibbli” fis-sezzjoni 4 ta' dan il-fuljett.
English: Musculoskeletal and connective tissue disorders: Common:
Maltese: Disturbi muskoluskeletali u tat-tessuti konnettivi:
English: België/Belgique/Belgien ViiV Healthcare sprl/bvba Tél/Tel: + 32 (0) 10 85 65 00
Maltese: ViiV Healthcare sprl/bvba Tél/Tel: + 32 (0) 10 85 65 00
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 apparenti (CL/F) hija madwar 1 L/hr f'pazjenti infettati b'HIV abbażi ta' analiżi tal-farmokinetika tal-popolazzjoni.
English: In vivo, dolutegravir did not have an effect on midazolam, a CYP3A4 probe.
Maltese: In vivo, dolutegravir ma kellux effett fuq midazolam, sonda ta' CYP3A4.
English: Lamivudine exhibits linear pharmacokinetics over the therapeutic dose range and displays limited plasma protein binding in vitro (< 16%- 36% to serum albumin).
Maltese: Lamivudine jeżebixxi farmakokinetika lineari fuq il-medda tad-doża terapewtika u juri twaħħil mal-proteina tal-plażma baxx in vitro (< 16%- 36% mal-albumin fis-seru).
English: There have been reports of mitochondrial dysfunction in HIV-negative 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: 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 and section 4.3).
Maltese: In vivo, dolutegravir jista' jżid il-konċentrazzjonijiet fil-plażma tal-prodotti mediċinali fejn leskrezzjoni hija dipendenti fuq OCT2 jew MATE-1 (eż. metformin) (ara Tabella 1 u sezzjoni 4.3).
English: Effects on electrocardiogram
Maltese: Effetti fuq l-elettrokardjogramma
English: In vitro, lamivudine was an inhibitor of OCT1 and OCT2; the clinical consequences are not known.
Maltese: In vitro, lamivudine kien inibitur ta' OCT1 u OCT2; il-konsegwenzi kliniċi mhumiex magħrufa.
English: Pharmacokinetic data for dolutegravir and lamivudine in subjects >65 years of age are limited.
Maltese: Id-data dwar il-farmakokinetika għal dolutegravir u lamivudine f'individwi >65 sena ta' età hija limitata.
English: hypersensitivity (see section 4.4), immune reconstitution syndrome (see section 4.4)
Maltese: sensittività eċċessiva (ara sezzjoni 4.4), sindrome ta'
English: Lamivudine: AUC ↑ 43% Cmax ↑ 7%
Maltese: AUC ↑ 43% Cmax ↑ 7%
English: HIV-1 RNA <50 copies/mL Treatment Difference† (95% confidence intervals) Virologic non response
Maltese: HIV-1 RNA <50 kopja/mL Differenza fit-Trattament†
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: Dovato 50 mg/300 mg film-coated tablets dolutegravir/lamivudine
Maltese: Dovato 50 mg/300 mg pilloli dolutegravir/lamivudine
English: Subjects were randomised to a two-drug regimen of dolutegravir 50 mg plus lamivudine 300 mg once daily or dolutegravir 50 mg plus tenofovir disoproxil/emtricitabine 245/200 mg once daily.
Maltese: 50 mg flimkien ma' lamivudine 300 mg darba kuljum jew ta' dolutegravir 50 mg flimkien ma' tenofovir disoproxil/emtricitabine 245/200 mg darba kuljum.
English: Single dose lamivudine oral solution 300 mg. Lamivudine:
Maltese: soluzzjoni orali ta' lamivudine 300 mg.
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: Doża waħda ta' 50 mg ta' dolutegavir ingħatat lil 8 individwi b'indeboliment epatiku moderat (klassi B ta' Child-Pugh) u lil 8 kontrolli ta' adulti b'saħħithom korrispondenti.
English: Subjects were enrolled with a screening plasma HIV-1 RNA of 1000 c/mL to ≤500,000 c/mL.
Maltese: L-individwi ġew irreġistrati b' HIV-1 RNA tal-plażma skrinjat ta' 1000 c/mL sa ≤500,000 c/mL.
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-data in vitro.
English: Dolutegravir is also a substrate of UGT1A3, UGT1A9, CYP3A4, P-glycoprotein (P-gp), and breast cancer resistance protein (BCRP).
Maltese: Dolutegravir huwa wkoll substrat ta' UGT1A3, UGT1A9, CYP3A4, P-glycoprotein
English: The pharmacokinetics of dolutegravir in 10 antiretroviral treatment-experienced HIV-1 infected adolescents (12 to 17 years) showed that dolutegravir 50 mg once daily dosage resulted in dolutegravir exposure comparable to that observed in adults who received dolutegravir 50 mg once daily.
Maltese: Tfal Il-farmakokinetika ta' dolutegravir f'10 adoloxxenti infettati b'HIV-1 li esperjenzaw trattament antiretrovirali (12 sa 17-il sena) uriet li dożaġġ ta' kuljum ta' darba ta' 50 mg ta' dolutegravir rriżulta f'esponiment ta' dolutegravir komparabbli ma' dak osservat f'adulti li rċevew dolutegravir 50 mg darba kuljum.
English: The most frequently reported adverse reactions are headache (3%), diarrhoea (2%), nausea (2%) and insomnia (2%).
Maltese: L-aktar reazzjonijiet avversi rrappurtati b'mod frekwenti huma uġigħ ta' ras (3%), dijarea (2%), dardir (2%)
English: Metformin ↑ Dolutegravir ↔ When co-administered with dolutegravir 50 mg QD:
Maltese: Meta jingħata flimkien ma' dolutegravir 50 mg QD:
English: Nucleoside and nucleotide analogues have been demonstrated in vitro and in vivo to cause a variable degree of mitochondrial damage.
Maltese: Intwera li analogi nukleosidi u nukleotidi in vitro u in vivo jikkaġunaw gradi varjabbli ta' ħsara mitokondrijali.
English: Herbal products St. John's wort/Dolutegravir
Maltese: John's wort/Dolutegravir
English: A study of the pharmacokinetics of dolutegravir was performed in subjects with severe renal impairment (CLcr <30 mL/min).
Maltese: Sar studju tal-farmakokinetika ta' dolutegravir f'individwi b'indeboliment renali sever (CLcr <30 mL/min).
English: Dolutegravir 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: 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: Nervous system disorders: Very common:
Maltese: Disturbi fis-sistema nervuża:
English: Dolutegravir and lamivudine are present in cerebrospinal fluid (CSF).
Maltese: Dolutegravir u lamivudine huma preżenti fil-fluwidu ċerobrospinali (CSF).
English: Dolutegravir belongs to a group of anti-retroviral medicines called integrase inhibitors (INIs), and lamivudine belongs to a group of anti-retroviral medicines called nucleoside analogue reverse transcriptase inhibitors (NRTIs).
Maltese: Dolutegravir jappartjeni għal grupp ta' mediċini antiretrovirali msejħa inibituri ta' integrase (INIs), u lamivudine jappartjeni għal grupp ta' mediċini antiretrovirali msejħa inibituri ta' nucleoside analogue reverse transcriptase (NRTIs).
English: Pharmacotherapeutic group: Antivirals for systemic use, antivirals for treatment of HIV infections, combinations.
Maltese: Antivirali għal użu sistemiku, antivirali għall-kura ta' infezzjonijiet tal-HIV, kombinazzjonijiet.
English: Dovato includes lamivudine, which is active against hepatitis B. Dolutegravir lacks such activity.
Maltese: Dovato jinkludi lamivudine, li huwa attiv kontra l-epatite B. Dolutegravir huwa nieqes minn tali attività.
English: : + 33 (0)1 39 17 69 69 Infomed@viivhealthcare.com
Maltese: ViiV Healthcare SAS Tél.: + 33 (0)1 39 17 69 69 Infomed@viivhealthcare.com
English: Immune system disorders: Uncommon:
Maltese: Disturbi fis-sistema immuni: Mhux komuni:
English: Oval, biconvex, white, film coated tablet, approximately 18.5 x 9.5 mm, debossed with “SV 137” on one face.
Maltese: Pillola bajda ta' għamla ovali, konvessa miż-żewġ naħat, miksija b'rita, b'daqs ta' madwar 18.5 x 9.5 mm, imnaqqxa b'“SV 137” fuq naħa waħda.
English: Lamivudine, via its active metabolite 5'-triphosphates (TP) (an analogue for cytidine), inhibits reverse transcriptase of HIV-1 and HIV-2 through incorporation of the monophosphate form into the viral DNA chain, resulting in chain termination.
Maltese: Lamivudine, permezz tal-metabolit attiv tiegħu 5'-triphosphates (TP) (analogu għaċ-ċitidina), jinibixxi r reverse transcriptase tal-HIV-1 u tal-HIV-2 permezz tal-inkorporazzjoni tal-forma monophosphate fil-katina tad-DNA virali, li tirriżulta f'terminazzjoni tal-katina.
English: • symptoms of infections and inflammation
Maltese: • sintomi ta' infezzjonijiet u infjammazzjoni
English: Dovato is not recommended for use in patients with a creatinine clearance < 50 mL/min (see section 5.2).
Maltese: Dovato mhuwiex irrakkomandat għall-użu f'pazjenti b'eliminazzjoni tal-kreatinina ta' < 50 mL/min (ara sezzjoni 5.2).
English: peripheral neuropathy, paraesthesia Gastrointestinal disorders:
Maltese: Disturbi gastrointestinali:
English: • medicines (usually liquids) containing sorbitol and other sugar alcohols (such as xylitol, mannitol, lactitol or maltitol), if taken regularly
Maltese: • mediċini (normalment likwidi) li fihom sorbitol u alkoħols taz-zokkor oħrajn (bħal xylitol, mannitol, lactitol jew maltitol), jekk jittieħdu regolarment
English: hepatitis
Maltese: epatite
English: • This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodiumfree'.
Maltese: • Din il-mediċina fiha anqas minn 1 mmol sodium (23 mg) f'kull pillola, jiġifieri essenzjalment ma fihiex melħ.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (MULTIPACKS ONLY - WITH BLUE BOX)
Maltese: KARTUNA TA' BARRA (PAKKETTI MULTIPLI BISS - BIL-KAXXA BLU)
English: Established and theoretical interactions with selected antiretrovirals and non-antiretroviral medicinal products are listed in Table 1.
Maltese: L-interazzjonijiet stabbiliti u teoretiċi ma' prodotti mediċinali antiretrovirali u mhux antiretrovirali magħżula huma elenkati fit-Tabella 1.
English: GI intolerance in monkeys occurred at 30 times the human mg/kg equivalent dose (based on 50 kg human), and 11 times the human mg/m2 equivalent dose for a total daily clinical dose of 50 mg.
Maltese: Intolleranza GI fix-xadini seħħet fi 30 darba d-doża ekwivalenti mg/kg tal-bniedem (skont bniedem ta' 50 kg), u fi 11-il darba d-doża ekwivalenti mg/m2 tal-bniedem għal doża klinika ta' kuljum totali ta' 50 mg.
English: Based on in vivo and/or in vitro data, dolutegravir is not expected to affect the pharmacokinetics of medicinal products that are substrates of any major enzyme or transporter such as CYP3A4, CYP2C9 and P-gp (for more information see section 5.2).
Maltese: dolutegravir mhuwiex mistenni li jaffettwa l-farmakokinetika ta' prodotti mediċinali li huma substrati ta' kwalunkwe enzima jew trasportatur ewlieni bħal CYP3A4, CYP2C9 u P-gp (għal aktar informazzjoni ara sezzjoni 5.2).
English: In vitro lamivudine inhibits the intracellular phosphorylation of cladribine leading to a potential risk of cladribine loss of efficacy in case of combination in the clinical setting.
Maltese: In vitro lamivudine jinibixxi l-fosforilazzjoni intraċellulari ta' cladribine u jwassal għal riskju potenzjali ta' telf tal-effikaċja ta' cladribine fil-każ ta' kombinazzjoni fl-ambjent kliniku.
English: • St. John's wort (Hypericum perforatum), a herbal remedy to treat depression.
Maltese: John's wort (Hypericum perforatum), mediċina li ġejja mill-ħxejjex għalt-trattament tad dipressjoni.
English: Sulfamethoxazole: AUC ↔
Maltese: Sulfamethoxazole:
English: In vitro, dolutegravir was not a substrate of human OATP 1B1, OATP 1B3 or OCT 1.
Maltese: In vitro, dolutegravir ma kienx substrat tal-OATP 1B1, OATP 1B3 jew OCT 1 tal-bniedem.
English: • breakdown of muscle tissue.
Maltese: • kollass tat-tessut muskolari.
English: Each tablet contains dolutegravir sodium equivalent to 50 mg dolutegravir and 300 mg lamivudine.
Maltese: Kull pillola fiha dolutegravir sodium ekwivalenti għal 50 mg dolutegravir u 300 mg ta' lamivudine.
English: The IC50 values of lamivudine against HIV-1 subtypes (A-G) ranged from 0.001 to 0.170 µM, against Group O from 0.030 to 0.160 µM and against HIV-2 isolates from 0.002 to 0.120 µM in peripheral blood mononuclear cells.
Maltese: Il-valuri tal-IC50 ta' lamivudine kontra s-sottotipi ta' HIV-1 (A-G) kienu jvarjaw minn 0.001 sa 0.170 µM, kontra Grupp O minn 0.030 sa 0.160 µM u kontra iżolati tal-HIV-2
English: None of the six subjects in the dolutegravir plus lamivudine group or the four subjects in the dolutegravir plus tenofovir disoproxil/emtricitabine FDC group that met virological withdrawal criteria through Week 48 across the GEMINI-1 (204861) and GEMINI-2 (205543) studies had treatment emergent integrase inhibitor or NRTI class resistance.
Maltese: rtirar viroloġiku sat-48 Ġimgħa fl-istudji GEMINI-1 (204861) u GEMINI-2 (205543) ma kellu reżistenza għall-inibitur tal-integrase ikkawżata mit-trattament jew għall-klassi tal-NRTI.
English: Pharmacokinetic/pharmacodynamic relationship(s)
Maltese: Relazzjoni(jiet) farmakokinetika/farmakokinetiċi/farmakodinamika/farmakodinamiċi
English: No clinically important pharmacokinetic differences between subjects with severe renal impairment (CLcr <30 mL/min) and matching healthy subjects were observed.
Maltese: Ma ġew osservati ebda differenzi farmakokinetiċi klinikament importanti bejn l-individwi b'indeboliment renali sever (CLcr <30 mL/min) u l-individwi b'saħħithom korrispondenti.
English: The frequency category of rare was estimated based on post-marketing reports.
Maltese: Il-kategorija ta' frekwenza “rari” ġiet stmata abbażi ta'rapporti ta' wara t-tqegħid fis-suq.
English: Inhibition of OAT3 has not been studied in vivo.
Maltese: L-inibizzjoni ta' OAT3 ma ġietx studjata in vivo.
English: The main adverse reactions reported are haematological disorders (anaemia, neutropenia), and metabolic disorders (hyperlactatemia, hyperlipasemia).
Maltese: L-effetti avversi ewlenin li kienu rrappurtati huma disturbi ematoloġiċi (anemija, newrotropenja), u disturbi fil-metaboliżmu (iperlaktatimja, iperlipażemija).
English: Dovato film-coated tablets are oval, biconvex, white tablets debossed with 'SV 137' on one face.
Maltese: Dovato pilloli miksija b'rita huma pilloli ovali, bikonvessi, bojod b'“SV 137” imnaqqxa fuq naħa waħda.
English: Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment (see section 4.4).
Maltese: Disturbi awtoimmuni (bħall‑marda ta' Graves u epatite awtoimmuni) ġew irrappurtati wkoll; madankollu, iż‑żmien irrappurtat sal‑bidu tagħhom hu iktar varjabbli, u dawn l‑avvenimenti jistgħu jseħħu ħafna xhur wara l‑bidu tat‑trattament (ara sezzjoni 4.4).
English: Dose reduction is required for patients with creatinine clearance < 50 mL/min (see section 4.2).
Maltese: Huwa meħtieġ tnaqqis fid-doża għal pazjenti bi tneħħija ta' kreatinina ta' < 50 mL/min (ara sezzjoni 4.2).
English: Clinically significant interaction unlikely.
Maltese: Interazzjoni klinikament sinifikanti mhijiex probabbli.
English: AUC ↑ 145 %
Maltese: AUC ↑ 145 % Cmax ↑ 111%
English: Renal impairment Pharmacokinetic data have been obtained for dolutegravir and lamivudine separately.
Maltese: Inkisbet data dwar il-farmakokinetika għal dolutegravir u lamivudine b'mod separat.
English: Limited data are available in adolescents receiving a daily dose of 300 mg of lamivudine.
Maltese: Data limitata hija disponibbli fl-adoloxxenti li jirċievu doża ta' kuljum ta' 300 mg ta' lamivudine.
English: • metformin, to treat diabetes
Maltese: • metformin, għat-trattament tad-dijabete
English: • skin rash
Maltese: PK. Razza
English: Co-administration of Dovato and other medicinal products that inhibit UGT1A1, UGT1A3, UGT1A9, CYP3A4, and/or P-gp may, therefore, increase dolutegravir plasma concentration.
Maltese: L-għoti flimkien ta' Dovato u prodotti mediċinali oħra li jinibixxu UGT1A1, UGT1A3, UGT1A9, CYP3A4, u/jew P-gp jista', għalhekk, iżid ilkonċetrazzjoni fil-plażma ta' dolutegravir.
English: At week 48, dolutegravir plus lamivudine was non-inferior to dolutegravir plus tenofovir disoproxil/emtricitabine FDC in GEMINI-1 and GEMINI-2 studies.
Maltese: tenofovir disoproxil/emtricitabine FDC fl-istudji GEMINI-1 u GEMINI-2.
English: Tel: + 34 902 051 260 es-ci@viivhealthcare.com
Maltese: Laboratorios ViiV Healthcare, S.L. Tel: + 34 902 051 260 es-ci@viivhealthcare.com
English: The incidence of neural tube defects in the general population ranges from 0.5-1 case per 1,000 live births (0.05-0.1%).
Maltese: L‑inċidenza ta' difetti fit-tubu newrali fil-popolazzjoni ġenerali tvarja minn 0.5 - każ f'kull 1,000 twelid ħaj (0.05-0.1%).
English: The combination of Dovato with cladribine is not recommended (see section 4.5).
Maltese: Il-kombinazzjoni ta' Dovato ma' cladribine mhijiex rakkomandata (ara sezzjoni 4.5).
English: • increase in the level of liver enzymes (aminotransferases)
Maltese: • żieda fil-livell ta' enzimi tal-fwied (aminotransferases)
English: The mean IC50 against lab-strains of HIV-2 (LAV2 and EHO) ranged from 0.16 to 0.51 µM for lamivudine.
Maltese: L-IC50 medja għar-razez tal-laboratorju ta' HIV-2 (LAV2 u EHO) kienu jvarjaw minn 0.16 sa 0.51 µM għal lamivudine.
English: In vitro, dolutegravir inhibited the renal uptake organic anion transporters (OAT)1 and OAT3.
Maltese: In vitro, dolutegravir inibixxa t-trasportaturi tal-anjoni organiċi ta' teħid renali (OAT)1 u OAT3.
English: Based on the lack of effect on the in vivo pharmacokinetics of the OAT substrate tenofovir, in vivo inhibition of OAT1 is unlikely.
Maltese: Abbażi tan nuqqas ta' effett fuq il-farmakokinetika in vivo ta' tenofovir, substrat tal-OAT, l-inibizzjoni in vivo ta' OAT1
English: How to take Dovato
Maltese: X'fih Dovato
English: While effective viral suppression with antiretroviral therapy has been proven to substantially reduce the risk of sexual transmission, a residual risk cannot be excluded.
Maltese: Filwaqt li soppressjoni virali effettiva b'terapija antiretrovirali ġiet ippruvata li tnaqqas b'mod sostanzjali rriskju ta' trasmissjoni sesswali, ma jistax jiġi eskluż riskju residwu.
English: Relevant examples are Cytomegalovirus retinitis, generalised and/or focal mycobacterial infections, and Pneumocystis jirovecii pneumonia (often referred to as PCP).
Maltese: Eżempji rilevanti huma Retinite ċitomegalovirus, infezzjonijiet mikobatterjali ġeneralizzati u/jew fokali, u pulmonite tat-tip Pneumocystis jirovecii (spiss magħrufa bħala PCP).
English: Darunavir ↔
Maltese: AUC ↔
English: Trimethoprim: AUC ↔
Maltese: Trimethoprim:
English: Lamivudine was not mutagenic in bacterial tests, but consistent with other nucleoside analogues, inhibits cellular DNA replication in in vitro mammalian tests such as the mouse lymphoma assay.
Maltese: Lamivudine ma kienx mutaġeniku fit-testijiet tal-batterji, iżda kien konsistenti ma' analogi ta' nukleosidi oħra, jinibixxi r replikazzjoni tad-DNA ċellulari f'testijiet tal-mamiferi in vitro bħal assaġġ tal-limfoma fil-ġrieden.
English: Multipacks containing 90 (3 packs of 30) film-coated tablets.
Maltese: Pakketti multipli li fihom 90 (3 pakketti ta' 30) pillola miksija b'rita.
English: In vivo, a 10-14% decrease of creatinine clearance (secretory fraction is dependent on OCT2 and MATE-1 transport) was observed in patients.
Maltese: In vivo, kien osservat tnaqqis ta' 1014% ta' tneħħija tal-kreatinina (il-frazzjoni sekretarja hija dipendenti fuq it-trasport ta' OCT2 u MATE-1)
English: A separate preparation of dolutegravir is available where a dose adjustment is indicated due to drug-drug interactions (e.g. rifampicin, carbamazepine, oxcarbazepine, phenytoin, phenobarbital, St. John's wort, etravirine (without boosted protease inhibitors), efavirenz, nevirapine, or tipranavir/ritonavir, see sections 4.4 and 4.5).
Maltese: Preparazzjoni separata ta' dolutegravir hija disponibbli fejn huwa indikat aġġustament tad-doża minħabba interazzjonijiet mediċinali (eż. rifampicin, carbamazepine, oxcarbazepine, phenytoin, phenobarbital, St.
English: • difficulty sleeping (insomnia)
Maltese: • diffikultà biex torqod (insomnja)
English: Consider more frequent monitoring of HIV-1 viral load when chronic coadministration cannot be avoided.
Maltese: Ikkunsidra monitoraġġ aktar frekwenti tal-kontenut virali tal-HIV-1 meta l għoti kroniku tagħhom flimkien ma jkunx jista' jiġi evitat.
English: In 13 treatment-naïve subjects on a stable dolutegravir plus abacavir/lamivudine regimen, dolutegravir concentration in CSF averaged 18 ng/mL (comparable to unbound plasma concentration, and above the IC50).
Maltese: Fi 13-il individwu naïve għall kura fuq kors stabbli ta' dolutegravir flimkien ma' abacavir/lamivudine, il-konċentrazzjoni ta' dolutegravir fis-CSF kellha medja ta' 18 ng/mL (komparabbli mal-konċentrazzjoni mhux marbuta mal-plażma, u 'l fuq mill-IC50).
English: Effect of dolutegravir: EE ↔ AUC ↑ 3% Cmax ↓ 1%
Maltese: Effett ta' dolutegravir: EE ↔ AUC ↑ 3% Cmax ↓ 1%
English: When co-administered with dolutegravir 50 mg BID:
Maltese: Meta jingħata flimkien ma' dolutegravir 50 mg BID:
English: Interaction geometric mean change (%)
Maltese: Bidla fil-medja ġeometrika tal interazzjoni (%)
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 (inkluż użu ta' kortikosterojdi, bisfosfonati, ilkonsum ta' alkoħol, immunosoppressjoni severa, indiċi tal-massa tal-ġisem ogħla), ġew irrapportati każijiet ta' osteonekrożi f'pazjenti b'mard HIV avvanzat u/jew esponiment fit-tul għal CART.
English: Lamivudine has not shown any genotoxic activity in the in vivo studies.
Maltese: Lamivudine ma wera ebda attività ġenotossika fl-istudji in vivo.
English: Effect of other medicinal products on the pharmacokinetics of dolutegravir and lamivudine
Maltese: Effett ta' prodotti mediċinali oħra fuq il-farmakokinetika ta' dolutegravir u lamivudine
English: MARKETING AUTHORISATION NUMBER(S) EU/1/19/1370/002
Maltese: EU/1/19/1370/001 EU/1/19/1370/002
English: Drug interactions
Maltese: Interazzjonijiet Mediċinali