FrancophonIA/ELRC3.0 huggingface dataset:
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: Dolutegravir jinibixxi l-integrase tal-HIV billi jeħel mas-sit attiv tal-integrase u jimblokka l-pass tattrasferiment tal-istrand tal-integrazzjoni ta' Deoxyribonucleic acid (DNA) retrovirali li huwa essenzjali għaċ-ċiklu ta' replikazzjoni tal-HIV.
English: It is very important that you read and understand the information about this serious reaction.
Maltese: Huwa importanti li taqra u tifhem l-informazzjoni dwar din ir-reazzjoni serja.
English: Consider more frequent monitoring of HIV-1 viral load when chronic coadministration cannot be avoided.
Maltese: Ikkunsidra monitoraġġ aktar frekwenti tat-tagħbija virali tal-HIV-1 meta l-għoti flimkien kroniku ma jkunx jista' jiġi evitat.
English: Hypersensitivity reactions have been reported in <1% of patients treated with dolutegravir in clinical studies, and were characterized by rash, constitutional findings, and sometimes, organ dysfunction, including severe liver reactions.
Maltese: Ġew irrapportati reazzjonijiet ta' sensittività eċċessiva f' <1% tal-pazjenti kkurati b'dolutegravir fi studji kliniċi, u kienu kkaratterizzati minn raxx, sejbiet kostituzzjonali, u xi drabi, disfunzjoni tal organi, inkluż reazzjonijiet severi tal-fwied.
English: If Triumeq is discontinued in patients co-infected with hepatitis B virus, periodic monitoring of both liver function tests and markers of HBV replication is recommended, as withdrawal of lamivudine may result in an acute exacerbation of hepatitis.
Maltese: Jekk Triumeq jitwaqqaf f'pazjenti ko-infettati bil-virus tal-epatite B, huwa rrakkomandat monitoraġġ perjodiku kemm tat-testijiet tal-funzjoni tal-fwied kif ukoll il-markaturi tar-replikazzjoni HBV, peress li t-twaqqif ta' lamivudine jista' jwassal f'aggravar akut tal-epatite.
English: Female
Maltese: Wara
English: NAME OF THE MEDICINAL PRODUCT Triumeq 50 mg/600 mg/300 mg film-coated tablets
Maltese: Triumeq 50 mg/600 mg/300 mg pilloli miksijin b'rita
English: At 144 weeks in the open-label phase of SINGLE, virologic suppression was maintained, the DTG +ABC/3TC arm (71%) was superior to the EFV/TDF/FTC arm (63%), treatment difference was 8.3% (2.0, 14.6).
Maltese: EFV/TDF/FTC (63%), id-differenza fil-kura kienet 8.3% (2.0, 14.6).
English: No clinically significant drug interactions are expected between dolutegravir, abacavir and lamivudine.
Maltese: Mhuma mistennija ebda interazzjonijiet klinikament sinifikanti tal-mediċina bejn dolutegravir, abacavir u lamivudine.
English: The individual preparations of abacavir and lamivudine have been investigated separately, and as a dual nucleoside backbone, in combination antiretroviral therapy to treat ART- naive and ARTexperienced HIV- infected paediatric patients (data available on the use of abacavir and lamivudine in infants less than three months are limited).
Maltese: Il-preparazzjonijiet individwali ta' abacavir u lamivudine ġew investigati b'mod separat, u bħala lbażi doppja tan-nukleosidi, fit-terapija antiretrovirali ta' kombinazzjoni biex jiġu kkurati pazjenti pedjatriċi infettati naive għall-ART u esperjenzati bl-ART (dejta disponibbli dwar l-użu ta' abacavir u lamivudine fi trabi li għandhom anqas minn tliet xhur hija limitata).
English: Both abacavir and dolutegravir are associated with a risk for hypersensitivity reactions (HSR), which were observed more commonly with abacavir.
Maltese: Kemm abacavir kif ukoll dolutegravir huma assoċjati ma' riskju ta' reazzjonijiet ta' sensittività eċċessiva (HSR), li kienu osservati aktar komunement b'abacavir.
English: Osteonecrosis
Maltese: Kortikosterojdi
English: During in vitro abacavir selection the M184V mutation occurred first and resulted in about a 2-fold increase in IC50, below the abacavir clinical cut-off of 4.5-fold change.
Maltese: Matul selezzjoni ta' abacavir in vitro, l-ewwel seħħet il-mutazzjoni M184V u rriżultat f'madwar żieda ta' darbtejn f'IC50, taħt il-cut-off kliniku ta' abacavir ta' bidla fil-valur ta' 4.5 darbiet.
English: Hepatobiliary disorders: Uncommon:
Maltese: Kategorija fatmakoterapewtika:
English: This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially ‘sodium-free'.
Maltese: Din il-mediċina fiha inqas minn 1 mmol sodju (23 mg) f'kull unità tad-dożaġġ, jiġifieri hija essenzjalment “mingħajr sodju”.
English: (see reverse of card)
Maltese: (Ma ġiex studjat)
English: Concomitant use of Triumeq with cladribine is not recommended (see section 4.4).
Maltese: cladribine mhuwiex irrakkomandat (ara sezzjoni 4.4).
English: If you could get pregnant while receiving Triumeq, you need to use a reliable method of barrier contraception (for example, a condom) with other methods of contraception including oral (pill) or other hormonal contraceptives (for example, implants, injection), to prevent pregnancy.
Maltese: Jekk tista' toħroġ tqila waqt li tkun qed tirċievi Triumeq, jeħtieġ li tuża metodu ta' kontraċettiv barriera affidabbli (pereżempju, kondom) flimkien ma' metodi oħra ta' kontraċezzjoni inkluż orali (pillola) jew kontraċettivi ormonali oħrajn (pereżempju, impjanti, injezzjoni), biex tipprevjeni t-tqala.
English: Exposure to dolutegravir was generally similar between healthy subjects and HIV-1-infected subjects.
Maltese: L-espożizzjoni għal dolutegravir kienet ġeneralment simili bejn l-individwi b'saħħithom u l-individwi infettati bl-HIV-1.
English: Rarely, patients who have stopped abacavir for reasons other than symptoms of HSR have also experienced life-threatening reactions within hours of re- initiating abacavir therapy (see Section 4.8 Description of selected adverse reactions).
Maltese: B'mod rari, pazjenti li waqfu abacavir għal raġunijiet differenti minn sintomi ta' HSR, esperjenzaw ukoll reazzjonijiet ta' theddid għall-ħajja fi żmien sigħat minn mindu reġgħu bdew il-kura b'abacavir (ara Sezzjoni 4.8 Deskrizzjoni ta' reazzjonijiet avversi magħżula)
English: • rifampicin, to treat tuberculosis (TB) and other bacterial infections
Maltese: • cladribine, użat għat-trattament ta' lewkimja ta' ċelloli ċiljati • rifampicin, użat għat-trattament ta' tuberkolożi (TB) u infezzjonijiet batterjali oħrajn
English: Clinically it is not possible to determine whether a HSR with Triumeq would be caused by abacavir or dolutegravir.
Maltese: Klinikament mhuwiex possibbli li tiddetermina jekk HSR b'Triumeq tkunx ikkawżata minn abacavir jew dolutegravir.
English: Dolutegravir↓ (Not studied, decrease expected due to induction of UGT1A1 and CYP3A enzymes, a similar reduction in exposure as observed with carbamazepine is expected)
Maltese: (Ma ġiex studjat, tnaqqis mistenni minħabba l induzzjoni ta' enzimi UGT1A1 u CYP3A, huwa mistenni li jkun hemm tnaqqis simili fl espożizzjoni kif ġie osservat b'carbamazepine)
English: Isolates resistant to abacavir may also show reduced sensitivity to lamivudine.
Maltese: Il-potenzjal karċinoġeniku ta' kombinazzjoni ta' dolutegravir, abacavir u lamivudine ma ġiex ittestjat.
English: The pharmacokinetics of abacavir in patients with end-stage renal disease is similar to patients with normal renal function.
Maltese: Il-farmokokinetika ta' abacavir f'pazjenti b'marda renali fl-istadju finali hija simili għal pazjenti b'funzjoni renali normali.
English: The metabolites and unchanged abacavir account for about 83% of the administered abacavir dose in the urine.
Maltese: Il-metaboliti u abacavir mhux mibdul jammontaw għal madwar 83% tad doża mogħtija ta' abacavir fl-awrina.
English: Other antiviral agents Boceprevir
Maltese: Boceprevir
English: (See ‘Patients with chronic hepatitis B or C' earlier in this section and also see section 4.8).
Maltese: (Ara ‘Pazjenti b'epatite kronika B jew C' qabel f'din is-sezzjoni u ara wkoll is-sezzjoni 4.8).
English: Dolutegravir hypersensitivity
Maltese: Studji tal-każijiet ta' sensittività eċċessiva
English: Dolutegravir was non-inferior to raltegravir, including within the subset of patients with the abacavir/lamivudine background regimen.
Maltese: Dolutegravir ma kienx inferjuri għal raltegravir, inkluż fi ħdan is-subsett ta' pazjenti bir-reġimen ta' sfond ta' abacavir/lamivudine.
English: Multipacks containing 90 film-coated tablets (3 packs of 30 film-coated tablets) are also available.
Maltese: Pakketi multipli li fihom 90 pilloli miksijin b'rita (3 pakketti ta' 30 pilloli miksijin b'rita) huma wkoll disponibbli.
English: Fever, lethargy, malaise, oedema, lymphadenopathy, hypotension, conjunctivitis, anaphylaxis
Maltese: Deni, letarġija, tħossok ma tiflaħx, edema, limfadenopatija, pressjoni baxxa, konġuntivite, anafilassi
English: If possible, show them the Triumeq pack.
Maltese: Jekk hu possibbli, urihom il-pakkett ta' Triumeq.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Detach enclosed Alert Card, it contains important safety information.
Maltese: OĦRA, JEKK MEĦTIEĠA Aqla' l-Kard ta' Twissija mehmuża, fiha informazzjoni importanti dwar is-sigurtà.
English: Patients with chronic hepatitis B or C and treated with combination antiretroviral therapy are at an increased risk of severe and potentially fatal hepatic adverse reactions.
Maltese: Il-pazjenti b'epatite kronika B jew C u kkurati b'terapija antiretrovirali ta' kombinazzjoni huma f'riskju miżjud ta' reazzjonijiet epatiċi avversi severi u potenzjalment fatali.
English: White
Maltese: Mara
English: Triumeq is used to treat HIV (human immunodeficiency virus) infection in adults and children over 12 years old who weigh at least 40 kg.
Maltese: Triumeq jintuża biex jikkura infezzjoni tal-HIV (virus tal-immunodefiċjenza umana) f'adulti u tfal li għandhom 'il fuq minn 12-il sena li jiżnu għallinqas 40 kg.
English: TRIUMEQ TABLETS PATIENT ALERT CARD SIDE 1
Maltese: nekroliżi epidermali tossika1
English: Calcium supplements/Dolutegravir
Maltese: kalċju/Dolutegravir
English: The likelihood of metabolic drug interactions with lamivudine is low due to the small extent of hepatic metabolism (5-10%).
Maltese: Il-probabbiltà ta' interazzjonijiet metaboliċi tal-mediċina ma' lamivudine hija baxxa minħabba l-firxa żgħira ta' metaboliżmu epatiku
English: Dolutegravir, abacavir and lamivudine are rapidly absorbed following oral administration.
Maltese: Dolutegravir, abacavir u lamivudine huma assorbiti rapidament wara għoti fil-ħalq.
English: Patients with chronic hepatitis B or C
Maltese: Pazjenti b'epatite kronika B jew C
English: In patients with mild hepatic impairment (Child-Pugh score 5-6) close monitoring is required, including monitoring of abacavir plasma levels if feasible (see sections 4.4 and 5.2).
Maltese: F'pazjenti b'indeboliment epatiku ħafif (punteġġ 5-6 ta' Child-Pugh) huwa meħtieġ monitoraġġ mill-qrib, inkluż monitoraġġ tal-livelli tal-plażma ta'
English: The results of an in vivo rat micronucleus test with abacavir and lamivudine in combination were negative.
Maltese: Ir-riżultati ta' test tal-mikronukleu tal-firien in vivo b'abacavir u lamivudine f'daqqa kienu negattivi.
English: STRIIVING (201147) is a 48-week, randomized, open-label, active controlled, multicenter, noninferiority study in patients without any prior treatment failure, and without any documented resistance to any class.
Maltese: STRIIVING (201147) huwa studju randomizzat, bit-tikketta mikxufa, ikkontrollat b'mod attiv, multiċentriku, mhux ta' inferjorità ta' 48 ġimgħa fuq pazjenti mingħajr ebda falliment tal-kura preċedenti, u mingħajr ebda reżistenza dokumentata għal xi klassi.
English: Similar IC50s were seen for clinical isolates without any major difference between subtypes; in a panel of 24 HIV-1 isolates of clades A, B, C, D, E, F and G and group O the mean IC50 value was 0.2 nM (range 0.02-2.14).
Maltese: L-IC50 għal dolutegravir f'diversi razez tal-laboratorju permezz ta' PBMC kien 0.5 nM, u meta ntużaw ċelloli MT-4, varja minn 0.7-2 nM. IC50s simili ntwerew għal iżolati kliniċi mingħajr ebda differenza ewlenija bejn is-sottotipi; f'pannell ta' 24 iżolati ta' HIV-1 ta' clades A, B, C, D, E, F u G u grupp O, il-valur IC50 kien 0.2 nM (medda ta' 0.
English: Other key symptoms include gastrointestinal, respiratory or constitutional symptoms such as lethargy and malaise.
Maltese: Sintomi ewlenin oħrajn jinkludu sintomi gastrointestinali, respiratorji jew kostituzzjonali bħal letarġija u telqa.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 50 mg dolutegravir (as sodium), 600 mg abacavir (as sulfate), 300 mg lamivudine.
Maltese: Kull pillola miksija b'rita fiha 50 mg dolutegravir (bħala sodium), 600 mg abacavir (bħala sulfat), 300 mg lamivudine.
English: HLA-B*5701 screening for risk of ABC hypersensitivity should never be substituted for appropriate clinical vigilance and patient management in individuals receiving ABC.
Maltese: L-iskrinjar ta' HLA-B*5701 għal riskju ta' sensittività eċċessiva għal ABC qatt ma għandu jiġi sostitwit b'viġilanza klinika u ġestjoni xierqa tal-pazjenti f'indivdwi li jirċievu ABC.
English: controls) (inhibition of UGT1A1 and CYP3A enzymes)
Maltese: (induzzjoni tal-enzimi UGT1A1 u CYP3A)
English: • feeling weak
Maltese: Indeboliment renali
English: lactic acidosis1
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA
English: Malignant tumours occurred in the preputial gland of males and the clitoral gland of females of both species, and in rats in the thyroid gland of males and in the liver, urinary bladder, lymph nodes and the subcutis of females.
Maltese: Seħħew tumuri malinni fil-glandola tal-prepuzju tal-irġiel u l glandola klitorali tan-nisa taż-żewġ speċi, u fil-firien fil-glandola tat-tirojde tal-irġiel u fil-fwied, ilbużżieqa tal-awrina, in-noduli tal-limfi u s-subkute tan-nisa.
English: dizziness, somnolence, lethargy1
Maltese: sturdament, ngħas, letarġija1
English: There is no evidence that a dose adjustment of dolutegravir, abacavir or lamivudine would be required based on the effects of race on PK parameters.
Maltese: M'hemm ebda evidenza li jkun meħtieġ aġġustament fid-doża ta' dolutegravir, abacavir jew lamivudine abbażi tal effetti tar-razza fuq il-parametri PK.
English: Iron supplements/Dolutegravir Dolutegravir ↓ AUC ↓ 54% Cmax ↓ 57% C24 ↓ 56% (Complex binding to polyvalent ions)
Maltese: Dolutegravir ↓ AUC ↓ 54% Cmax ↓ 57% C24 ↓ 56%
English: Children and adolescents aged between 12 and 17 years and weighing at least 40 kg can take the adult dose of one tablet once a day.
Maltese: Tfal u adoloxxenti bejn l-etajiet ta' 12 u 17-il sena u li jiżnu ta' lanqas 40kg jistgħu jieħdu d-doża adulta ta' pillola waħda darba kuljum.
English: For patients receiving lamivudine 300 mg once daily, the terminal intracellular half-life of lamivudine-TP was 16 to 19 hours.
Maltese: Għal pazjenti li jirċievu lamivudine 300 mg darba kuljum, il-half-life intraċellulari terminali ta' lamivudine-TP kienet 16 sa
English: Tabulated summary of adverse reactions associated with the combination of dolutegravir + abacavir/lamivudine in an analysis of pooled data from: Phase IIb to Phase IIIb clinical trials or post-marketing experience; and adverse reactions to treatment with dolutegravir, abacavir and lamivudine from clinical studies and post-marketing experience when used with other antiretrovirals
Maltese: IIb sal-Fażi IIIb jew esperjenza ta' wara t-tqegħid fis-suq; u reazzjonijiet avversi għall-kura b'dolutegravir, abacavir u lamivudine minn provi kliniċi u l-esperjenza wara t-tqegħid fis-suq, meta jintuża ma' antiretrovirali oħra
English: More than 1000 outcomes from second and third trimester exposure to dolutegravir 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: The risk for abacavir HSR to occur is high for patients who test positive for the HLA-B*5701 allele.
Maltese: Il-pazjenti li jiġu dijanjostikati b'reazzjoni ta' sensittività eċċessiva għandhom iwaqqfu abacavir immedjatament irrispettivament mill-istatus ta' HLA-B*5701.
English: Management of ABC HSR reaction
Maltese: Sensittività eċċessiva għal Abacavir
English: Virologically suppressed (HIV-1 RNA <50 c/mL) subjects were randomly assigned (1:1) to continue their current ART regimen (2 NRTIs plus either a PI, NNRTI, or INI), or switch to ABC/DTG/3TC FDC once daily (Early Switch).
Maltese: ART attwali tagħhom (2 NRTIs flimkien ma' PI, NNRTI, jew INI), jew jaqilbu għal ABC/DTG/3TC FDC darba kuljum (Qlib Bikri).
English: For abacavir there was a decrease in Cmax with 23% and AUC was unchanged.
Maltese: Għal abacavir kien hemm tnaqqis f'Cmax b'23% u AUC baqa' l-istess.
English: Abacavir and lamivudine triphosphates show significantly less affinity for host cell DNA polymerases.
Maltese: It trifosfati ta' abacavir u lamivudine juru ferm anqas affinità għall-polymerases tad-DNA taċ-ċelloli ospitanti.
English: Daclatasvir did not change dolutegravir plasma concentration to a clinically relevant extent.
Maltese: Daclatasvir ma biddilx il konċentrazzjoni ta' dolutegravir filplażma b'mod klinikament rilevanti.
English: Of these four, two subjects had a unique R263K integrase substitution, with a maximum fold change of 1.93, one subject had a polymorphic V151V/I integrase substitution, with maximum fold change 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: Minn dawn l-erbgħa, żewġ individwi kellhom sostituzzjoni unika ta' integrase R263K, b'bidla fil-valur massima ta' 1.93 darba, individwu kellu sostituzzjoni ta' integrase V151V/I
English: Blood and lymphatic systems disorders: Uncommon:
Maltese: Disturbi fis-sistema immunitarja:
English: In dolutegravir 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: sakemm it-testijiet tal-kimika fil-fwied ta' linja bażi ma kinux jaqbżu b'5 darbiet il-limitu superjuri tan-normal (ULN).
English: The terminal intracellular half-life of lamivudine-TP was prolonged to 16-19 hours, compared to the plasma lamivudine half-life of 5-7 hours, supporting once daily dosing of ABC and 3TC.
Maltese: Il-half-life intraċellulari terminali ta' lamuvidine-TP kienet imtawla għal 16-19-il siegħa, meta mqabbel mal-half-life ta' lamivudine fil-plażma ta' 5-7 sigħat, li tappoġġja dożaġġ ta' kuljum wieħed ta' ABC u 3TC.
English: Medicinal products that induce those enzymes or transporters may decrease dolutegravir plasma concentration and reduce the therapeutic effect of dolutegravir (see Table 1).
Maltese: Il-prodotti mediċinali li jinduċu dawn l-enzimi jew trasportaturi jistgħu jnaqqsu l-konċentrazzjoni fil-plażma ta' dolutegravir u jnaqqsu l-effett terapewtiku ta' dolutegravir (ara Tabella 1).
English: Renal impairment Triumeq is not recommended for use in patients with a creatinine clearance < 50 ml/min (see section
Maltese: Huwa meħtieġ tnaqqis fid-doża għal pazjenti bi tneħħija ta' kreatinina ta' < 50 ml/min (ara sezzjoni
English: Triumeq contains dolutegravir, abacavir and lamivudine, therefore any interactions identified for these individually are relevant to Triumeq.
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni Triumeq fih dolutegravir, abacavir u lamivudine, għalhekk kwalunkwe interazzjoni identifikata għal dawn individwalment hija rilevanti għal Triumeq.
English: There are limited data available on the use of dolutegravir, abacavir and lamivudine in patients aged 65 years and over.
Maltese: Hemm dejta limitata disponibbli dwar l-użu ta' dolutegravir, abacavir u lamivudine f'pazjenti li għandhom 65 sena u aktar.
English: Similar studies were not conducted with either abacavir or lamivudine.
Maltese: Ma twettqux studji simili la b'abacavir u lanqas b'lamivudine.
English: HIV-1 RNA <50 copies/mL for those on ABC/3TC * Adjusted for baseline stratification factors.
Maltese: HIV-1 RNA <50 kopja/mL għal dawk fuq ABC/3TC
English: Fosamprenavir/ritonavir decreases dolutegravir concentrations, but based on limited data, did not result in decreased efficacy in Phase III studies.
Maltese: Fosamprenavir/ritonavir inaqqas il konċentrazzjonijiet ta' dolutegravir, iżda abbażi ta' dejta limitata, ma rriżultax fi tnaqqis tal-effikaċja fl-istudji ta' Fażi
English: In FLAMINGO, 485 patients were treated with dolutegravir 50 mg once daily or darunavir/ritonavir (DRV/r) 800 mg/100 mg once daily, both with ABC/3TC (around 33%) or TDF/FTC (around 67%).
Maltese: Fi FLAMINGO, 485 pazjent ġew ikkurati b'dolutegravir 50 mg darba kuljum jew darunavir/ritonavir
English: Lamivudine exhibits linear pharmacokinetics over the therapeutic dose range and displays low plasma protein binding (less than 36%).
Maltese: Lamivudine jesibixxi farmakokinetika lineari fuq il medda tad-doża terapewtika u juri twaħħil mal-proteina tal-plażma baxx (anqas minn 36%).
English: M184V is associated with about a 2-fold increase in abacavir resistance but does not confer clinical resistance for abacavir.
Maltese: M184V huwa assoċjat ma' żieda ta' madwar darbtejn fir-reżistenza għal abacavir iżda ma jikkonferixxix reżistenza klinika għal abacavir.
English: Dolutegravir is the predominant circulating compound in plasma; renal elimination of unchanged active substance is low (< 1% of the dose).
Maltese: Dolutegravir huwa lkomponenti li jiċċirkola prinċipalment fil-plażma; it-tneħħija mill-kliewi ta' sustanza attiva mhux mibdula hija baxxa (< 1% tad-doża).
English: To date, there is no established biological mechanism to explain a potential increase in risk.
Maltese: S'issa, m'hemm ebda mekkaniżmu bijoloġiku stabbilit biex jispjega żieda potenzjali fir-riskju.
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: • jekk inti allerġiku (sensittività eċċessiva) għal dolutegravir, abacavir (jew għal xi mediċina oħra li fiha abacavir, jew lamivudine, jew xi ingredjenti oħra ta' din il-mediċina (elenkati fis sezzjoni 6).
English: Metformin ↑ Dolutegravir ↔ When co-administered with dolutegravir 50mg QD:
Maltese: Meta jingħata flimkien ma' dolutegravir 50mg darbtejn kuljum:
English: This antiviral response was maintained for 3 to 4 days after the last dose in the 50 mg group.
Maltese: 4 ijiem wara l-aħħar doża fil-grupp ta' 50 mg.
English: Plasma protein binding studies in vitro indicate that abacavir binds only low to moderately (~49%) to human plasma proteins at therapeutic concentrations.
Maltese: L-istudji in vitro ta' twaħħil tal-proteina mal-plażma jindikaw li abacavir jeħel biss f'livell baxx sa moderat (~49%) ma' proteini fil-plażma tal-bniedem f'konċetrazzjonijiet terapewtiċi.
English: This combination may increase the risk for lactic acidosis in patients with moderate renal impairment (stage 3a creatinine clearance [CrCl] 45- 59 mL/min) and a cautious approach is recommended.
Maltese: (tneħħija tal-kreatinina fl-istadju 3a [CrCl] 45- 59 mL/min) u huwa rakkomandat approċċ kawt.
English: No additional types of adverse reactions have been observed beyond those characterised for the adult population.
Maltese: Ma ġew osservati ebda tipi addizzjonali ta' reazzjonijiet avversi lil hinn dawk ikkaratterizzati għall-popolazzjoni tal-adulti.
English: Table 1:
Maltese: NAĦA 1
English: Discontinued study/study drug due to adverse event or death‡
Maltese: Studju/mediċina ta' studju mwaqqfa għal raġunijiet oħra§
English: The systemic exposure at the no effect level in mice and rats was equivalent to 3 and 7 times the human systemic exposure during therapy.
Maltese: L-espożizzjoni sistemika fil-livell ta' ebda effett fil-ġrieden u l-firien kienet ekwivalenti għal 3 u 7 darbiet l-espożizzjoni sistemika tal-bniedem matul it-terapija.