FrancophonIA/ELRC3.0 huggingface dataset:
English: Group O isolates from antiviral naïve patients tested for lamivudine activity were highly sensitive.
Maltese: L-iżolati tal-Grupp O minn pazjenti naïve għall-antivirali ttestjati għall-attività ta' lamivudine kienu sensittivi ħafna.
English: No antagonistic effects in vitro were seen with lamivudine and other antiretrovirals (tested agents: abacavir, didanosine, nevirapine, zalcitabine, and zidovudine).
Maltese: abacavir, didanosine, nevirapine, zalcitabine, u zidovudine).
English: The pharmacokinetics of abacavir have been studied in patients with mild hepatic impairment (Child-Pugh score 5-6) receiving a single 600 mg dose.
Maltese: Il-farmakokinetika ta' abacavir ġiet studjata f'pazjenti b'indeboliment epatiku ħafif (punteġġ 5-6 ta' Child-Pugh) li jingħataw doża waħda ta' 600 mg.
English: The effect of the Q148-based mutations (H/R/K) was also consistent with in vitro passage experiments with site directed mutants.
Maltese: L-effett tal-mutazzjonijiet ibbażati fuq Q148 (H/R/K) kienu wkoll konsistenti mal-esperimenti fil-passaġġ in vitro bil-mutanti diretti lejn is-sit.
English: Although the aetiology is considered to be multifactorial (including corticosteroid use, bisphosphonates, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly 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, il-konsum ta' alkoħol, immunosoppressjoni severa, indiċi tal-massa tal-ġisem ogħla), ġew irrapportati każijiet ta' osteonekrożi partikolarment f'pazjenti b'mard HIV avvanzat u/jew esponiment fit-tul għal CART.
English: Effect of dolutegravir, abacavir and lamivudine on the pharmacokinetics of other medicinal products
Maltese: Effett ta' prodotti mediċinali oħra ta' dolutegravir, abacavir u lamivudine fuq il-farmakokinetika
English: The apparent volume of distribution of dolutegravir (following oral administration of suspension formulation, Vd/F) is estimated at 12.5 L. Intravenous studies with abacavir and lamivudine showed that the mean apparent volume of distribution is 0.8 and 1.3 l/kg respectively.
Maltese: Vd/F) huwa stmat f'12.5 L. Studji ġol-vina b'abacavir u lamivudine urew li l-volum medju evidenti ta' distribuzzjoni hu 0.8 u 1.3 l/kg rispettivament.
English: In vitro, abacavir did not inhibit or induce CYP enzymes (such as CYP3A4, CYP2C9 or CYP2D6) and demonstrates no or weak inhibition of OATP1B1, OAT1B3, OCT1, OCT2, BCRP and P-gp or
Maltese: In vitro, abacavir ma inibixxiex jew ma induċiex enzimi CYP (bħal CYP3A4, CYP2C9 jew CYP2D6) u ma wera l-ebda inibizzjoni jew wera inibizzjoni dgħajfa ta' OATP1B1, OAT1B3, OCT1, OCT2,
English: In rabbits, maternal toxicity (decreased food consumption, scant/no faeces/urine, suppressed body weight gain) was observed at 1000 mg/kg (0.74 times the 50 mg human clinical exposure when administered in combination with abacavir and lamivudine based on AUC).
Maltese: Fil-fniek, kienet osservata tossiċità materna (tnaqqis fil-konsum tal-ikel, insuffiċjenti, ebda ppurgar/awrina jew skarsa, żieda fil-piż tal-ġisem imrażżna) f'1000 mg/kg (0.74 darba l-50 mg espożizzjoni klinika talbniedem meta jingħata flimkien ma' abacavir u lamivudine abbażi ta' AUC).
English: Population pharmacokinetic analysis of dolutegravir using data in HIV-1 infected adults showed that there was no clinically relevant effect of age on dolutegravir exposure.
Maltese: L-analiżi tal-farmokokinetika tal-popolazzjoni ta' dolutegravir permezz ta' dejta fl-adulti infettati b'HIV-1 uriet li ma kien ebda effett klinikament rilevanti tal-età fuq l-espożizzjoni ta' dolutegravir.
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 taċ-ċitomegalovirus, infezzjonijiet mikobatterjali ġeneralizzati u/jew fokali, u pulmonite Pneumocystis jirovecii (ħafna drabi ssir referenza għaliha bħala PCP).
English: Oral administration of dolutegravir to pregnant rats at doses up to 1000 mg/kg daily from days 6 to 17 of gestation did not elicit maternal toxicity, developmental toxicity or teratogenicity (50 times the 50 mg human clinical exposure when administered in combination with abacavir and lamivudine based on AUC).
Maltese: L-għoti orali ta' dolutegravir lill-firien tqal f'dożi sa 1000 mg/kg kuljum mis-6 sa 17-jiem 6 sa 17 talġestjoni ma wassalx għal tossiċità materna, tossiċita tal-iżvilupp jew teratoġeniċità (50 darba l-50 mg espożizzjoni klinika tal-bniedem meta jingħata flimkien ma' abacavir lamivudine abbażi ta' AUC).
English: Psychiatric disorders:
Maltese: Disfunzjoni mitokondrijali
English: In the primary 48 weeks analysis, the proportion of patients with virologic suppression in the dolutegravir + ABC/3TC arm, was superior to the EFV/TDF/FTC arm, p=0.003, the same treatment difference was observed in subjects defined by baseline HIV RNA level (< or > 100,000 copies/mL).
Maltese: Fl-analiżi primarja ta' 48 ġimgħa, il-proporzjon ta' pazjenti b'suppressjoni viroloġika fil-fergħa dolutegravir + ABC/3TC, kien superjuri għall-fergħa ta' EFV/TDF/FTC, p=0.003, l-istess differenza fil-kura kienet osservata fl-individwi ddefiniti mil-livell HIV RNA tal-linja bażi (< jew > 100,000
English: The mean ratio of CSF/serum lamivudine concentrations 2-4 hours after oral administration was approximately 12%.
Maltese: Il-proporzjon medju ta' konċetrazzjonijiet ta' lamivudine fis-CSF/serum ta' lamivudine 2-4 sigħat wara l-għoti orali kien madwar 12%.
English: Population pharmacokinetic analysis indicated that hepatitis C virus co-infection had no clinically relevant effect on the exposure to dolutegravir.
Maltese: Analiżi tal-farmakokinetika tal-popolazzjoni indikat li l-ko-infezzjoni tal-virus tal-epatite C ma kellha ebda effett rilevanti fuq l-espożizzjoni għal dolutegravir.
English: In further selection experiments using clinical isolates of subtype B, mutation R263K was seen in all five isolates (after 20 weeks and onwards).
Maltese: F'esperimenti ta' għażla oħrajn permezz ta' iżolati kliniċi tas-sottotip B, ġiet osservata mutazzjoni R263K fil-ħames iżolati kollha (minn 20 ġimgħa 'l quddiem).
English: What Triumeq looks like and contents of the pack Triumeq film-coated tablets are purple, biconvex, oval tablets, debossed with “572 Trı” on one side.
Maltese: Triumeq pilloli miksijin b'rita huma pilloli vjola, bikonvessi, ovali, imnaqqxa bi “572 Tri” fuq naħa waħda.
English: In the case of the Q148-mutation viruses, increasing dolutegravir fold change is seen as the number of secondary mutations increase.
Maltese: Fil-każ tal-viruses tal-mutazzjoni Q148, iż-żieda tal-bidla fil-valur ta' dolutegravir hija kkunsidrata bħala n numru ta' żidiet fil-mutazzjonijiet sekondarji.
English: Neither abacavir nor lamivudine were mutagenic in bacterial tests, but consistent with other nucleoside analogues, inhibit cellular DNA replication in in vitro mammalian tests such as the mouse lymphoma assay.
Maltese: La abacavir u lanqas lamivudine ma kienu mutaġeniċi fit-testijiet tal-batterja, iżda kienu konsistenti ma' analogi ta' nukleosidi oħra, jinibixxu r-replikazzjoni tad-DNA ċellulari f'testijiet tal-mamiferi in vitro bħal analiżi tal-limfoma fil-ġrieden.
English: Key elements included in the educational material to increase understanding and awareness of ABC HSR and expand on the information already included in the SmPC:
Maltese: HSR u jespandu l-informazzjoni diġà inkluża fl-SmPC:
English: The results showed that there was a mean increase of 1.89-fold [1.32; 2.70] in the abacavir AUC, and 1.58 [1.22; 2.04] fold in the elimination half-life.
Maltese: Ir-riżultati urew li kien hemm żieda medja ta' 1.89 darba [1.32; 2.70] fl-AUC ta' abacavir, u
English: Abacavir can cause a hypersensitivity reaction (a serious allergic reaction), especially in people who carry a particular type of gene called HLA-B*5701.
Maltese: Abacavir jista' jikkawża reazzjoni ta' sensittività eċċessiva (reazzjoni allerġika serja), speċjalment f'persuni li għandhom tip partikolari ta' ġene msejjaħ HLA-B*5701.
English: Renal impairment Pharmacokinetic data have been obtained for dolutegravir, lamivudine and abacavir separately.
Maltese: Inkisbet dejta farmakokinetika għal olutegravir, abacavir u lamivudine, b'mod separat.
English: The frequency of this is unknown (see section 4.4).
Maltese: efavirenz ma' Triumeq mhuwiex irrakkomandat (ara sezzjoni 4.4).
English: You must carefully read all the information under ‘Hypersensitivity reactions' in the panel in Section 4.
Maltese: Għandek taqra sew l-informazzjoni kollha taħt ‘Reazzjonijiet ta' sensittività eċċessiva' fil-panil f'Sezzjoni 4.
English: Dolutegravir was not mutagenic or clastogenic using in vitro tests in bacteria and cultured mammalian cells, and an in vivo rodent micronucleus assay.
Maltese: Dolutegravir ma kienx mutaġeniku jew klastoġeniku permezz ta' testijiet in vitro fil-batterja u ċċelloli tal-mammiferi kulturati, u f'analiżi tal-mikronukleu tar-rodituri in vivo.
English: Dolutegravir may increase plasma concentrations of medicinal products in which excretion is dependent upon OAT3.
Maltese: Dolutegravir jista' jżid il konċentrazzjonijiet fil-plażma tal-prodotti mediċinali fejn l-eskrezzjoni hija dipendenti fuq OAT3.
English: In contrast, starting passage with mutants with mutation Q148H (fold change 1), a variety of raltegravir associated secondary mutations accumulated with a consequent increase of fold change to values >10.
Maltese: B'kuntrast, il-bidu b'passaġġ b'mutanti li għandhom mutazzjoni Q148H (bidla fil-valur ta' darba), varjetà ta' mutazzjonijiet sekondarji assoċjati ma' raltegravir akkumulati b'żieda konsegwenti ta' bidla fil-valur ta' >10 darbiet.
English: There have been reports of mitochondrial dysfunction in HIV-negative infants exposed in utero and/or post-natally to nucleoside analogues, these have predominantly concerned treatment with regimens containing zidovudine.
Maltese: Kien hemm rapporti ta' disfunzjoni mitokondrijali fi trabi negattivi għall-HIV esposti in utero u/jew wara t-twelid għal analogi tannukleosidi, dawn kienu jikkonċernaw b'mod predominanti kura b'korsijiet li fihom zidovudine .
English: It is important to read the information in this section under the heading ‘Other possible side effects of combination therapy for HIV'.
Maltese: Huwa importanti li taqra l-informazzjoni taħt l-intestatura ‘Effetti sekondarji oħra possibbli ta'
English: Interactions between dolutegravir, abacavir, lamivudine and co-administered medical products are listed in Table 1 (increase is indicated as “↑”, decrease as “↓”, no change as “↔”, area under the concentration versus time curve as “AUC”, maximum observed concentration as “Cmax”).
Maltese: L-interazzjonijiet bejn dolutegravir, abacavir, lamivudine u prodotti mediċi li jingħataw flimkien huma elenkati fit-Tabella 1 (żieda hija indikata bħala “↑”, tnaqqis bħala “↓”, ebda bidla bħala “↔”, erja taħt il-konċentrazzjoni meta mqabbel mal-kurva tal-ħin bħala “AUC”, konċentrazzjoni massima osservata bħala “Cmax”).
English: Male
Maltese: Manjesju/
English: rhabdomyolysis1
Maltese: aċidożi lattika1
English: asthenia, fever1, malaise1
Maltese: sogħla1, sintomi nażali1
English: Trimethoprim: AUC ↔
Maltese: Cmax u AUC
English: A clinically relevant phenotypic cut-off value (fold change vs wild type virus) has not been determined; genotypic resistance was a better predictor for outcome.
Maltese: Ma ġiex iddeterminat valur cut-off fenotipiku klinikament rilevanti (bidla fil-valur vs virus tat-tip wild); reżistenza ġenotipika kienet previżjoni aħjar għall-eżitu.
English: Darunavir ↔ Ritonavir ↔ (induction of UGT1A1 and CYP3A enzymes)
Maltese: Darunavir ↔ Ritonavir ↔ (induzzjoni tal-enzimi UGT1A1 u CYP3A)
English: Since the recommended dose of dolutegravir is 50 mg twice daily when co-administered with etravirine (without boosted protease inhibitors), efavirenz, nevirapine, rifampicin, tipranavir/ritonavir, carbamazepine, phenytoin, phenobarbital and St. John's wort, the use of Triumeq is not recommended for patients taking these medicines (see section 4.5).
Maltese: Interazzjonijiet ma' prodotti mediċinali Peress li d-doża rakkomandata ta' dolutegravir hija ta' 50 mg darbtejn kuljum meta jingħata flimkien ma' etravirine (mingħajr inibituri tal-protease msaħħa), efavirenz, nevirapine, rifampicin, tipranavir/ritonavir, carbamazepine, phenytoin, phenobarbital u St.
English: AUC ↓ 25% Cmax ↓ 12% Cτ ↓ 36%
Maltese: Dolutegravir ↓ AUC ↓ 25% Cmax ↓ 12% Cτ ↓ 36%
English: Table 6: Demographics and Week 48 virologic outcomes of randomized treatment of ARIA (snapshot algorithm)
Maltese: Tabella 6: Demografika u eżiti viroloġiċi wara Ġimgħa 48 ta' kura randomizzata ta' ARIA (algorittmu snapshot)
English: Patients with pre-existing liver dysfunction, including chronic active hepatitis have an increased frequency of liver function abnormalities during combination antiretroviral therapy, and should be monitored according to standard practice.
Maltese: Il-pazjenti b'disfunzjoni tal-fwied pre-eżistenti, inkluż epatite attiva kronika għandhom frekwenza miżjuda ta' anormalitajiet fil-funzjoni tal-fwied matul terapija antiretrovirali ta' kombinazzjoni, u għandhom jiġu sorveljati skont il-prattika standard.
English: However, some patients with a suspected ABC hypersensitivity reaction may not have the HLA-B*5701 allele.
Maltese: Madankollu, xi pazjenti b'reazzjoni ta' sensittività eċċessiva ta' ABC suspettata jista' jkun li ma jkollhomx l-allele HLA-B*5701.
English: Ethanol/Abacavir (0.7 g/kg single dose/600mg single dose)
Maltese: (doża waħda ta' 0.7 g/kg/ doża waħda ta' 600 mg)
English: In HIV-infected patients with severe immune deficiency at the time of institution of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
Maltese: F'pazjenti infettati bl-HIV b'defiċjenza immunitarja severa meta tinbeda t-terapija antiretrovirali b'kombinazzjoni (CART), tista' tirriżulta reazzjoni infjammatorja għal patoġeni opportunistiċi asintomatiċi jew residwi u tikkawża kundizzjonijiet klinikament serji, jew aggravar tas-sintomi.
English: Lymphopenia
Maltese: Osteonekrożi
English: Methadone/Abacavir (40 to 90mg once daily for 14 days/600mg single dose, then 600mg twice daily for 14 days)
Maltese: (40 sa 90 mg darba kuljum għal doża waħda ta' 14il jum/600 mg, imbagħad 600 mg darbtejn kuljum għal
English: Polymorphisms in drug metabolising enzymes
Maltese: Piż u parametri metaboliċi
English: The absorption of dolutegravir is reduced by certain anti-acid medicinal products (see Table 1).
Maltese: L-assorbiment ta' dolutegravir jitnaqqas minn ċerti prodotti mediċinali kontra l-aċidi (ara Tabella 1).
English: Day 1 to W 24 Day 1 to W 24 Day 1 to W48 W24 to W48
Maltese: Jum 1 sa Ġ 48 Ġ 24 sa Ġ 48
English: Triumeq includes lamivudine, which is active against hepatitis B. Abacavir and dolutegravir lack such activity.
Maltese: Triumeq jinkludi lamivudine, li huwa attiv kontra l-epatite B.
English: The mean IC50 for abacavir against lab-strains of HIV-1IIIB and HIV-1HXB2 ranged from 1.4 to 5.8 µM.
Maltese: L-IC50 medju għal abacavir meta mqabbel mar-razez tal-laboratorju ta' HIV-1IIIB u HIV-1HXB2
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: (12 sa 17-il sena) uriet li dożaġġ ta' kuljum ta' darba ta' 50 mg ta' dolutegravir rriżulta f'espożizzjoni ta' dolutegravir komparabbli ma' dik osservata f'adulti li rċevew dolutegravir 50 mg darba kuljum.
English: Plasma Cmax and AUC of dolutegravir following administration of Triumeq with a high fat meal were 37% and 48% higher, respectively, than those following administration of Triumeq in the fasted state).
Maltese: Cmax u AUC tal-plażma ta' dolutegravir wara l-għoti ta' Triumeq b'ikla b'ħafna xaħam kienu 37% u 48% ogħla, rispettivament, minn dawk mogħtija wara l-għoti ta' Triumeq fl-istat sajjem).
English: Before initiating treatment with abacavir-containing products, screening for carriage of the HLAB*5701 allele should be performed in any HIV-infected patient, irrespective of racial origin (see section 4.4).
Maltese: HLA-B*5701 fi kwalunkwe pazjent infettat bl-HIV, irrispettivament mill-oriġini etnika (ara sezzjoni 4.4).
English: The primary effect of dolutegravir was gastrointestinal intolerance or irritation in rats and monkeys at doses that produce systemic exposures approximately 38 and 1.5 times the 50 mg human clinical exposure based on AUC, respectively.
Maltese: dolutegravir kien intolleranza gastrointestinali jew irritazzjoni fil-firien u x-xadini b'dożi li jipproduċu espożizzjonijiet sistemiċi ta' madwar 38 u darba u nofs l-50 mg espożizzjoni klinika tal-bniedem abbażi tal-AUC, rispettivament.
English: Herbal products
Maltese: Prodotti erbali St.
English: peripheral neuropathy1, paraesthesia1 Respiratory, thoracic and mediastinal disorders: Common:
Maltese: Disturbi respiratorji, toraċiċi u medjastinali:
English: Lamivudine is cleared renally.
Maltese: lamivudine jew emtricitabine.
English: Signs of osteonecrosis include:
Maltese: Disturbi gastrointestinali:
English: • other medicines containing lamivudine, used to treat HIV infection or hepatitis B infection
Maltese: • mediċini oħrajn li fihom other lamivudine, użat għat-trattament ta' infezzjoniji HIV jew infezzjoni epatite B
English: The IC50 values of abacavir against HIV-1 Group M subtypes (A-G) ranged from 0.002 to 1.179 µM, against Group O from 0.022 to 1.21 µM, and against HIV-2 isolates, from 0.024 to 0.49 µM.
Maltese: 022 sa 1.21 µM, u meta mqabbel mal-iżolati ta' HIV-2, minn 0.024 sa 0.49 µM.
English: Warnings and precautions
Maltese: Antaċidi u supplimenti
English: Asymptomatic creatine phosphokinase (CPK) elevations mainly in association with exercise have also been reported with dolutegravir therapy.
Maltese: Ġew irrapportati elevazzjonijiet fil-fosfokinażi tal-kreatina (CPK) asintomatika prinċipalment flimkien mal-eżerċizzju bit-terapija b'dolutegravir.
English: Following multiple oral doses of abacavir 300 mg twice a day there is no significant accumulation of abacavir.
Maltese: Wara dożi orali multipli ta' abacavir 300 mg darbtejn kuljum, m'hemm ebda akkumulazzjoni sinifikanti ta' abacavir.
English: If Triumeq is used in patients co-infected with hepatitis B an additional antiviral is, therefore, generally needed.
Maltese: Jekk Triumeq jintuża f'pazjenti ko-infettati b'epatite B, huwa ġeneralment meħtieġ antivirali addizzjonali.
English: In vitro, lamivudine did not inhibit or induce CYP enzymes (such as CYP3A4, CYP2C9 or CYP2D6) and demonstrated no or weak inhibition of OATP1B1, OAT1B3, OCT3, BCRP, P-gp, MATE1 or MATE2-K. Lamivudine is therefore not expected to affect the plasma concentrations of drugs that are substrates of these enzymes or transporters.
Maltese: In vitro, lamivudine ma inibixxiex jew ma induċiex enzimi CYP (bħal CYP3A4, CYP2C9 jew CYP2D6) u ma wera ebda inibizzjoni jew wera inibizzjoni dgħajfa ta' OATP1B1, OAT1B3, OCT3, BCRP, P-gp, MATE1 jew MATE2-K.
English: • skin rash, which may form blisters and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme)
Maltese: • raxx tal-ġilda, li jista' jifforma infafet u jidher qisu miri zgħar (tikek skuri ċentrali imdawrin b'żona iktar ċara, b'ċirku skur madwar it-tarf) (eritema multiformi)
English: vomiting, flatulence, abdominal pain, abdominal pain upper, abdominal distension, abdominal discomfort, gastrooesophageal reflux disease, dyspepsia
Maltese: nefħa addominali, skonfort addominali, marda ta' rifluss gastro-esofagali, dispepsja
English: Since the recommended dose of dolutegravir is 50 mg twice daily when co-administered with carbamazepine, DTG/ABC/3TC FDC is not recommended for patients taking carbamazepine.
Maltese: dolutegravir hija ta' 50 mg darbtejn kuljum meta jingħata flimkien ma' dawn l-indutturi metaboliċi, DTG/ABC/3TC FDC mhuwiex rakkomandat għal pazjenti li jkunu qed jieħdu dawn lindutturi metaboliċi.
English: The mean systemic clearance of lamivudine is approximately 0.32 l/h/kg, predominantly by renal clearance (> 70%) via the organic cationic transport system.
Maltese: 32 l/h/kg, fil-biċċa kbira bi tneħħija mill-kliewi (> 70%) permezz tas-sistema ta' trasport katjonika organika.
English: Patients with this gene are at a high risk of developing a serious hypersensitivity (allergic) reaction if they use Triumeq (see ‘hypersensitivity reactions' in section 4).
Maltese: sensittività eċċessiva (allerġika) jekk jużaw Triumeq (ara ‘reazzjonijiet ta' sensittività eċċessiva'
English: Clinical diagnosis of suspected hypersensitivity to ABC remains the basis for clinical decision making.
Maltese: Dijanjożi klinika ta' sensittività eċċessiva suspettata għal ABC tibqa' l-bażi għat-teħid ta' deċiżjonijiet kliniċi.
English: The median or mean IC50 values for lamivudine against lab-strains of HIV-1 ranged from 0.007 to 2.3 µM.
Maltese: Il-valuri IC50 medjani jew medji għal lamivudine meta mqabbel mar-razez tal-laboratorju ta' HIV-1 varjaw minn 0.007 sa 2.3 µM.
English: Based on limited available data with the dolutegravir single entity used in combination with other antiretroviral agents to treat adolescents (12 to 17 years), there were no additional types of adverse reactions beyond those observed in the adult population.
Maltese: Abbażi tad-dejta limitata disponibbli b'doża waħda ta' dolutegravir użata flimkien ma' aġenti antiretrovirali oħra biex jiġu kkurati l-adoloxxenti (12 sa 17-il sena), ma kien hemm ebda tipi addizzjonali ta' reazzjonijiet avversi lil hinn dawk osservati fil-popolazzjoni tal-adulti.
English: Possible interaction given common pathway of elimination via alcohol dehydrogenase (abacavircomponent).
Maltese: L-interazzjoni ma ġietx studjata Interazzjoni possibbli fid dawl tal-passaġġ possibbli permezz tal-alkoħol dehydrogenase (komponent ta' abacavir).
English: Virologic non response† No virologic data at Weeks 48 window
Maltese: Ebda dejta viroloġika fit tieqa ta' 48 Ġimgħa
English: In SPRING-2, 822 patients were treated with either dolutegravir 50 mg once daily or raltegravir 400 mg twice daily (blinded), both with fixed-dose ABC/3TC (around 40%) or TDF/FTC (around 60%), given open label.
Maltese: Fi SPRING-2, 822 pazjent ġew ikkurati jew b'dolutegravir 50 mg darba kuljum jew b'raltegravir 400 mg darbtejn kuljum (blinded), kemm b'ABC/3TC (madwar 40%) jew TDF/FTC (madwar 60%) ta'
English: Oral administration of dolutegravir to pregnant rabbits at doses up to 1000 mg/kg daily from days 6 to 18 of gestation did not elicit developmental toxicity or teratogenicity (0.74 times the 50mg human clinical exposure when administered in combination with abacavir and lamivudine based on AUC).
Maltese: L-għoti orali ta' dolutegravir lil fniek tqal f'dożi sa 1000 mg/kg kuljum mis-6 sat-18-il jum talġestjoni ma wassalx għal tossiċita fl-iżvilupp jew teratoġeniċità (0.74 darba l-50 mg espożizzjoni klinika tal-bniedem meta jingħata flimkien ma' abacavir u lamivudine abbażi ta' AUC).
English: Abacavir is metabolised primarily by the liver.
Maltese: Abacavir huwa metabolizzat prinċipalment mill-fwied.
English: • breakdown of muscle tissue
Maltese: • tkissir tat-tessut tal-muskoli.
English: The most severe adverse event possibly related to the treatment with dolutegravir and abacavir/lamivudine, seen in individual patients, was a hypersensitivity reaction that included rash and severe liver effects (see section 4.4 and Description of selected adverse reactions in this section).
Maltese: L-avveniment avvers l-aktar serju possibbilment relatat mal-kura b'dolutegravir u abacavir/lamivudine, li ntwera f'pazjenti individwali, kien reazzjoni ta' sensittività eċċessiva li inkludiet raxx u effetti serji fuq il-fwied (ara sezzjoni 4.4 u Deskrizzjoni ta' reazzjonijiet avversi magħżula f'din is-sezzjoni).