FrancophonIA/ELRC3.0 huggingface dataset:
English: If DUTREBIS is discontinued in patients co-infected with hepatitis B virus, periodic monitoring of liver function tests and markers of HBV replication is recommended, as withdrawal of lamivudine may result in an acute exacerbation of hepatitis.
Maltese: Jekk DUTREBIS jitwaqqaf f'pazjenti ko-infettati bil-virus tal-epatite B, huwa rrakkomandat monitoraġġ perjodiku tat-testijiet talfunzjoni tal-fwied kif ukoll tal-markaturi tar-replikazzjoni HBV, peress li t-twaqqif ta' lamivudine jista' jwassal f'aggravar akut tal-epatite.
English: Co-administration of zidovudine with lamivudine results in a 13 % increase in zidovudine exposure and a 28 % increase in peak plasma levels.
Maltese: L-għoti flimkien ta' zidovudine ma' lamivudine jwassal għal żieda ta' 13 % fl-espożizzjoni ta' zidovudine u f'żieda ta' 28% fl-ogħla livelli fil-plażma.
English: Advice on missed doses
Maltese: Twissijiet u prekawzjonijiet
English: DUTREBIS should be used in combination with other active anti-retroviral therapy (ART) (see
Maltese: DUTREBIS għandu jintuża flimkien ma' terapija antiretrovirali attiva oħra (ART) (ara sezzjonijiet 4.4
English: DUTREBIS is indicated in combination with other anti-retroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in adults, adolescents, and children from the age of 6 years and weighing at least 30 kg without present or past evidence of viral resistance to antiviral agents of the InSTI (Integrase Strand Transfer Inhibitor) and NRTI (Nucleoside Reverse Transcriptase Inhibitor) classes (see sections 4.2, 4.4 and 5.1).
Maltese: DUTREBIS huwa indikat flimkien ma' prodotti mediċinali antiretrovirali oħra għall-kura ta' infezzjoni ta' virus tal-immunodefiċjenza tal-bniedem (HIV-1) fl-adulti, l-adolexxenti, u t-tfal li għandhom minn 6 snin 'il fuq u li jiżnu tal-inqas 30 kg mingħajr evidenza fil-preżent jew fil-passat ta' reżistenza virali għall-aġenti antivirali tal-klassijiet ta' Inibitur tat-Trasferiment tal-Istrand Integrase (InSTI - Integrase Strand Transfer Inhibitor) u NRTI (Inibitur Nucleoside Reverse Transcriptase) (ara
English: Frequency Lamivudine and/or Raltegravir (alone or in combination with other ART)* tissue disorders uncommon acne, dermatitis acneiforme, dry skin, erythema, facial wasting, hyperhidrosis, lipoatrophy, lipodystrophy acquired, lipohypertrophy, night sweats, prurigo, pruritus, pruritus generalised, rash macular, rash maculo-papular, rash pruritic, skin lesion, urticaria, xeroderma, Stevens Johnson syndrome, drug rash with eosinophilia and systemic symptoms (DRESS)
Maltese: Disturbi filwidnejn u ssistema labirintika komuni vertigo mhux komuni tinnite palpitazzjonijiet, bradikardija tas-sinus, ekstrasistoli ventrikulari nefħa fl-addome, dijarea, gass, dardir, rimettar, dispepsja, uġigħ gastrite, skumdità addominali, uġigħ addominali fin-naħa ta' fuq, tenerezza fl-addome, skumdità anorettali, stitikezza, ħalq xott, skumdità epigastriku, duwodenite erożiva, tifwiq, mard ta' rifluss gastroosofogali, ġinġivite, glossite, odinofaġja, pankreatite, ulċera epatite, stejatożi epatika, epatite alkoħolika, insuffiċjenza epatika akne, acneiforme ta' dermatite, ġilda xotta, eritema, ħela tal-wiċċ, iperidrożi, lipoatrofija, lipodistrofija miksuba, lipoipertrofija, għaraq bil-lejl, prurigo, ħakk, ħakk ġeneralizzat, raxx makulari, raxx makulo-papulari, raxx pruritiku, ferita fil-ġilda, urtikarja, xeroderma, sindromu ta' Stevens Johnson, raxx mill-mediċina b'eosinofilja u sintomi sistemiċi (DRESS)
English: common dizziness, headache, psychomotor hyperactivity uncommon amnesia, carpal tunnel syndrome, cognitive disorder, disturbance in attention, dizziness postural, dysgeusia, hypersomnia, hypoaesthesia, lethargy, memory impairment, migraine, neuropathy peripheral, paraesthesia, somnolence, tension headache, tremor, poor quality uncommon palpitations, sinus bradycardia, ventricular extrasystoles common abdominal distention, diarrhoea, flatulence, nausea, vomiting,
Maltese: Disturbi fissistema nervuża komuni sturdament, uġigħ ta' ras, iperattività psikomotorili mhux komuni amnesija, sindromu ta' carpal mina, disturb konjittiv, disturbi flattenzjoni, sturdament kif tiċċaqlaq, disgewżja, ipersomnja, ipoestesija, letarġija, indeboliment tal-memorja, emigranja, newropatija periferali, parestesija, ħedla, uġigħ ta' ras b'tensjoni, rogħda, irqad ta' kwalità ħażina
English: If creatinine clearance decreases to <50 ml/min, DUTREBIS should be switched to a regimen of the individual components (lamivudine and raltegravir) (see section 4.2).
Maltese: Jekk l-eliminazzjoni tal-kreatinina tonqos għal <50 ml/min, DUTREBIS għandu jinqaleb għal reġim tal-komponenti individwali (lamivudine u raltegravir) (ara sezzjoni 4.2).
English: CZ
Maltese: C.
English: Myopathy and rhabdomyolysis
Maltese: Mijopatija u rabdomijoliżi
English: Raltegravir is an integrase strand transfer inhibitor active against the Human Immunodeficiency Virus
Maltese: Raltegravir huwa inibitur tat-trasferiment tal-istrand integrase attiv kontra l-Virus talImmunodefiċjenza tal-Bniedem (HIV-1).
English: Overall, considerable variability was observed in the pharmacokinetics of raltegravir.
Maltese: B'mod ġenerali, kienet osservata varjabbiltà konsiderevoli fil-farmakokinetika ta' raltegravir.
English: • you have a history of depression or psychiatric illness.
Maltese: • għandek storja ta' depressjoni jew mard psikjatriku.
English: Interaction not studied calcium carbonate antacid /raltegravir (raltegravir 400 mg Twice Daily)
Maltese: atazanavir /ritonavir /raltegravir (raltegravir 400 mg Darbtejn Kuljum)
English: DUTREBIS film-coated tablets contain lactose.
Maltese: Il-proporzjonalità tad-doża ma ġietx stabbilita fil-pazjenti.
English: IMPAACT P1066 is a Phase I/II open label multicentre study to evaluate the pharmacokinetic profile, safety, tolerability, and efficacy of raltegravir in HIV infected children.
Maltese: I/II biex jevalwa l-profil farmakokinetiku, is-sigurtà, it-tollerabbiltà, u l-effikaċja ta' raltegravir fi tfal infettati bl-HIV.
English: • feeling anxious; feeling of confusion; depressed mood; mood changes; panic attack
Maltese: • tħossok ansjuż/a; sensazzjoni ta' konfużjoni; burdata depressa; bidliet fil-burdata; attakk
English: See leaflet for further information.
Maltese: Lista tabulata ta' reazzjonijiet avversi
English: M184V mutants display greatly reduced susceptibility to lamivudine and show diminished viral replicative capacity in vitro.
Maltese: Il-mutanti M184V juru suxxettibbiltà mnaqqsa ħafna għal lamivudine u juru kapaċità replikattiva virali mnaqqsa in vitro.
English: Patients co-infected with hepatitis C and treated with alpha interferon and ribavirin may constitute a special risk.
Maltese: Il-pazjenti ko-infettati b'epatite Ċ u kkurati b'interferon alfa u ribavirin jistgħu jikkostitwixxu riskju speċjali.
English: trimethoprim /sulfamethoxazole /lamivudine lamivudine AUC 40 %
Maltese: zidovudine /lamivudine lamivudine PK ↔
English: • kidney stones; urination at night; kidney cyst
Maltese: • ġebel fil-kliewi; awrina bil-lejl; ċisti tal-kliewi
English: • chest discomfort; chills; swelling of face; feeling jittery; lump in the neck; swelling of
Maltese: • ħolm stramb; inkubi; imġiba stramba; sentimenti ta' dwejjaq kbar u nuqqas ta' stima
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 suppressjoni virali effikaċji b'terapija antiretrovirali ntweriet li tnaqqas b'mod sostanzjali rriskju ta' trażmissjoni sesswali, riskju residwali ma jistax jiġi eskluż.
English: This variant arises both in vitro and in HIV-1 infected patients treated with lamivudine-containing antiretroviral therapy.
Maltese: Dan il-varjant jitfaċċa kemm in vitro kif ukoll f'pazjenti infettati bl-HIV-1 ikkurati b'terapija antiretrovirali li fiha lamivudine.
English: Please refer to the SmPC for the individual components of DUTREBIS for dosing instructions (see section 4.4).
Maltese: Jekk jogħġbok ara l-SmPC għall-komponenti individwali ta' DUTREBIS għallistruzzjonijiet dwar id-dożaġġ (ara sezzjoni 4.4).
English: Multiple drug antiretroviral therapy containing lamivudine has been shown to be effective in antiretrovirally-naive patients as well as in patients presenting with viruses containing the M184V
Maltese: It-terapija antiretrovirali b'aktar minn mediċina waħda li tinkludi lamivudine rriżultat li kienet effikaċi f'pazjenti naïve antiretroviralment kif ukoll f'pazjenti bil-virusijiet bil-mutazzjonijiet M184V.
English: Non-nucleoside reverse transcriptase inhibitors (NNRTIs) efavirenz /raltegravir (raltegravir 400 mg Single Dose)
Maltese: tipranavir /ritonavir /raltegravir (raltegravir 400 mg Darbtejn Kuljum)
English: This is slightly faster than the raltegravir poloxamer formulation, which has a Tmax of approximately 3 hours.
Maltese: Dan huwa ftit aktar rapidu mill-formulazzjoni ta' raltegravir poloxamer, li għandha Tmax ta' madwar 3 sigħat.
English: Metabolism and nutrition disorders common decreased appetite uncommon cachexia, diabetes mellitus, dyslipidaemia, hypercholesterolaemia, hyperglycaemia, hyperlipidaemia, hyperphagia, increased appetite, polydipsia, body fat disorder
Maltese: rari ħafna aplasija pura taċ-ċelloli ħomor sindromu tar-rikostituzzjoni immunitarja, sensittività eċċessiva għall-mediċina, sensittività eċċessiva cachexia, dijabete mellitus, dislipidemija, iperkolesterolimja, ipergliċemija, iperlipidimja, iperfaġja, żieda fl-aptit, polidipsja,
English: A connection between visceral lipomatosis and protease inhibitors (PIs) and lipoatrophy and NRTIs has been hypothesised.
Maltese: Ġiet ipotizzata rabta bejn il-lipomatożi vixxerali u l-inibituri talprotease (PIs) u l-lipoatrofija u l-NRTIs.
English: Psychiatric disorders common abnormal dreams, insomnia, nightmare, abnormal behaviour, depression uncommon mental disorder, suicide attempt, anxiety, confusional state, depressed mood, major depression, middle insomnia, mood altered, panic attack, sleep disorder, suicidal ideation, suicidal behaviour (particularly in patients with a pre-existing history of psychiatric illness)
Maltese: ħolm stramb, nuqqas ta' rqad, inkubi, imġiba anormali, depressjoni disturb mentali, tentattiv ta' suwiċidju, ansjetà, stat konfużjonali, burdata depressa, depressjoni maġġuri, insomnja medjana, tibdil fil-burdata, attakk ta' paniku, disturbi fl-irqad, ħsibijiet suwiċidali, imġiba suwiċidali (b'mod partikolari f'pazjenti bi storja preċedenti
English: MSD Pharma Hungary Kft. Tel.: +361 888 53 00 hungary_msd@merck.com
Maltese: +361 888 53 00 hungary_msd@merck.com
English: Frequency Lamivudine and/or Raltegravir (alone or in combination with other ART)*
Maltese: Frekwenza Lamivudine u/jew Raltegravir (waħdu jew flimkien ma' ART ieħor)*
English: • Raltegravir belongs to a group of medicines called HIV integrase strand transfer inhibitors
Maltese: • Raltegravir jagħmel parti minn grupp ta' mediċini msejħa inibituri tat-trasferiment tal-istrand ta'
English: For each of the following clinical adverse reactions reported for raltegravir there was at least one serious occurrence: genital herpes, anaemia, immune reconstitution syndrome, depression, mental disorder, suicide attempt, gastritis, hepatitis, renal failure, accidental overdose.
Maltese: Għal kull waħda mir-reazzjonijiet avversi kliniċi li ġejjin għal raltegravir, kien hemm tal-inqas okkorrenza serja waħda: ħerpes ġenitali, anemija, sindromu tar-rikostituzzjoni immunitarja, depressjoni, disturb mentali, tentattiv ta' suwiċidju, gastrite, epatite, insuffiċjenza renali, doża
English: The pharmacokinetic properties of lamivudine have been determined in adults with impaired hepatic function.
Maltese: Il-proprjetajiet farmakokinetiċi ta' lamivudine ġew stabbiliti f'adulti b'indeboliment tal-funzjoni epatika.
English: Patient demographics (gender, age and race) and baseline characteristics were comparable between the group receiving raltegravir 400 mg twice daily and the group receiving efavirenz 600 mg at bedtime.
Maltese: Id-demografija tal-pazjenti (sess, età u razza) u l-karatteristiċi fil-linja bażi kienu paragunabbli bejn ilgruppi li jirċievu raltegravir 400 mg darbtejn kuljum u l-grupp li jirċievi efavirenz 600 mg fil-ħin tal
English: 96 Weeks
Maltese: Ġimgħa 96
English: Percent of patients with response and associated 95 % confidence interval (CI) are reported.
Maltese: Perċentawl ta' pazjenti b'reazzjoni u intervall ta' kunfidenza (CI) assoċjata ta' 95 % huma rrapportati.
English: These neoplasia could result from local deposition and/or aspiration of drug on the mucosa of the nose/nasopharynx during oral gavage dosing and subsequent chronic irritation and inflammation; it is likely that they are of limited relevance for the intended clinical use.
Maltese: Dawn in-neoplażiji jistgħu jirriżultaw minn depożizzjoni lokali u/jew laspirazzjoni ta' mediċina fuq il-mukoża tal-imnieħer/nasofarinġi matul dożaġġ gavage orali u irritazzjoni kronika u infjammazzjoni sussegwenti; huwa probabbli li huma ta' rilevanza limitata għallużu kliniku maħsub.
English: A study of the pharmacokinetics of raltegravir was performed in adult patients with severe renal insufficiency.
Maltese: Twettaq studju tal-farmakokinetika ta' raltegravir f'pazjenti adulti b'insuffiċjenza renali severa.
English: Some clinical findings also support a possible interaction between lamivudine and cladribine.
Maltese: Xi sejbiet kliniċi jappoġġjaw ukoll interazzjoni possibbli bejn lamivudine u cladribine.
English: A carcinogenicity study of raltegravir in mice did not show any carcinogenic potential.
Maltese: Studju karċinoġeniku ta' raltegravir fi ġrieden ma wera ebda potenzjal karċinoġeniku potenzjali.
English: Frequency Lamivudine and/or Raltegravir (alone or in combination with other ART)* uncommon genital herpes, folliculitis, gastroenteritis, herpes simplex, herpes virus infection, herpes zoster, influenza, lymph node abscess, molluscum contagiosum, nasopharyngitis, upper respiratory tract uncommon iron deficiency anaemia, lymph node pain, lymphadenopathy, neutropenia and anaemia (both occasionally severe),
Maltese: ħerpes ġenitali, follikulite, gastroenterite, herpes simplex, infezzjoni bil-virus tal-ħerpes, herpes zoster, influwenza, axxessi tal-glandoli limfatiċi, molluscum contagiosum, nażofarinġite, infezzjoni fil-parti ta' fuq tal-apparat respiratorju anemija ta' defiċjenza tal-ħadid, uġigħ fil-glandoli limfatiċi, limfadenopatija, newtropenja u anemija (it-tnejn kultant qawwija),
English: The adverse reactions seen in clinical studies and in post-marketing experience are listed below by body system, organ class and absolute frequency.
Maltese: Ir-reazzjonijiet avversi osservati fl-istudji kliniċi u fl-esperjenza wara t-tqegħid fis-suq huma elenkati hawn taħt, skont is-sistema tal-ġisem, il-klassi tal-organi u l-frekwenza assoluta.
English: Tablet core
Maltese: Studju STARTMRK
English: There were no clinically important pharmacokinetic differences due to gender, race or body mass index (BMI) for
Maltese: Ma kien hemm ebda differenza farmakokinetika klinikament importanti minħabba s-sess, razza jew indiċi talmassa tal-ġisem (BMI) għal raltegravir fl-adulti.
English: In general the safety profile of raltegravir in patients with hepatitis B and/or hepatitis C virus co-infection was similar to that in patients without hepatitis B and/or hepatitis C virus co-infection, although the rates of AST and ALT abnormalities were somewhat higher in the subgroup with hepatitis B and/or hepatitis C virus co-infection for both treatment groups.
Maltese: B'mod ġenerali, il-profil tas-sigurtà ta' raltegravir f'pazjenti bil-ko-infezzjoni tal-virus tal-epatite B u/jew l-epatite Ċ kien simili għal dak f'pazjenti mingħajr il-ko-infezzjoni tal-epatite B u/jew l-epatite Ċ, għalkemm ir-rati ta' anormalitajiet AST u ALT kienu kemxejn ogħla fis-sottogrupp bil-ko-infezzjoni tal-epatite B u/jew l-epatite C għaż-żewġ gruppi ta' kura.
English: • loss of memory; pain in the hand due to nerve compression; disturbance in attention; dizziness with rapid changes in posture; abnormal taste; increased sleepiness; lack of energy; forgetfulness; migraine headache; reduced sense of touch, numbness or weakness of the arms and/or legs; tingling; sleepiness; tension headache; tremors; poor quality sleep
Maltese: • telf tal-memorja; uġigħ fl-idejn minħabba kompressjoni tan-nervituri; disturbi flattenzjoni; sturdament b'bidliet mgħaġġla fil-qagħda; togħma anormali; żieda fin-ngħas; nuqqas ta' enerġija; nisi; uġigħ ta' ras b'emigranja; tnaqqis fis-sens tal-mess, tnemnim jew dgħjufija tad-dirgħajn u/jew ir-riġlejn; tnemnim; ngħas; uġigħ ta' ras b'tensjoni;
English: Discontinue DUTREBIS and other suspect agents immediately if signs or symptoms of severe skin reactions or hypersensitivity reactions develop (including, but not limited to, severe rash or rash accompanied by fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, facial oedema, hepatitis, eosinophilia, angioedema).
Maltese: Waqqaf DUTREBIS u aġenti ssuspettati oħrajn minnufih, jekk jiżviluppaw sinjali jew sintomi ta' reazzjonijiet severi tal-ġilda jew sensittività eċċessiva (inkluż, iżda mhux limitat għal, raxx sever jew raxx akkumpanjat minn deni, telqa ġenerali, għeja, uġigħ fil-muskoli jew il-ġogi, infafet, leżjonijiet orali, konġuntivite, edema tal-wiċċ, epatite, eosinofilja, anġjoedema).
English: Investigations common atypical lymphocytes, elevations in liver enzymes (AST, ALT), blood triglycerides increased, lipase increased, blood pancreatic amylase uncommon absolute neutrophil count decreased, alkaline phosphatase increased, blood albumin decreased, blood amylase increased, blood bilirubin increased, blood cholesterol increased, blood creatinine increased, blood glucose increased, blood urea nitrogen increased, creatine phosphokinase increased, fasting blood glucose increased, glucose urine present, high density lipoprotein increased, international normalised ratio increased, low density lipoprotein increased, platelet count decreased, red blood cells urine positive, waist circumference increased, weight increased, white blood cell count decreased
Maltese: Investigazzjonijiet komuni limfoċiti atipiċi, elevazzjonijiet fl-enzimi tal-fwied (AST, ALT), żieda fit-trigliċeridi fid-demm, żieda fil-lipase, żieda fl-amilażi pankreatika tad-demm mhux komuni tnaqqis fl-għadd ta' newtrofili assoluti, żieda fil-fosfati alkalini, tnaqqis tal-albumina tad-demm, żieda tal-amylase fid-demm, żieda tal-bilirubina fid-demm, żieda tal-kolesterol fid-demm, żieda talkreatinina fid-demm, żieda tal-glokożju fid-demm, żieda tannitroġenu fl-urea fid-demm, żieda tal-phosphokinase fil-kreatina, żieda tal-glukożju fid-demm waqt is-sawm, glukożju fl-awrina preżenti, żieda fil-lipoproteina ta' densità għolja, żieda fir-ratio internazzjonali normalizzat, żieda fil-lipoproteina ta' densità baxxa, tnaqqis fl-għadd ta' plejtlits, pożittiv għal ċelloli ħomor taddemm fl-awrina, żieda fiċ-ċirkonferenza tal-qadd, żieda fil-piż, tnaqqis fl-għadd ta' ċelloli bojod tad-demm
English: Patients with HIV and hepatitis B or C virus co-infection Patients with chronic hepatitis B or C treated with ART are at an increased risk for severe and potentially fatal hepatic adverse reactions.
Maltese: Pazjenti infettati kemm bl-HIV kif ukoll bil-virus tal-epatite B jew Ċ Pazjenti b'epatite B jew Ċ kronika u li huma kkurati b'ART huma f'riskju akbar li jiżviluppaw reazzjonijiet avversi epatiċi severi u potenzjalment fatali.
English: Patient demographics (gender, age and race) and baseline characteristics were comparable between the groups receiving raltegravir 400 mg twice daily and placebo.
Maltese: Id-demografija tal-pazjenti (sess, età u razza) u l-karatteristiċi tal-linja bażi kienu paragunabbli bejn ilgruppi li jirċievu raltegravir 400 mg darbtejn kuljum u plaċebo.
English: trimethoprim PK ↔ sulfamethoxazole PK ↔
Maltese: Flixkun tal-polyethylene ta' densità għolja (HDPE) b'tapp li ma jinfetaħx mit-tfal (HDPE) b'inforra ta'
English: There are no adequate data from the use of raltegravir in pregnant women; however, a large amount of data on pregnant women who were administered lamivudine (more than 1,000 exposed outcomes) indicate no malformative toxicity.
Maltese: M'hemm ebda dejta mill-użu ta' raltegravir f'nisa tqal; madankollu, ammont kbir ta' dejta dwar nisa tqal li ngħataw lamivudine (aktar minn 1,000 eżitu espost) ma jindika ebda tossiċità malformattiva.
English: Given that raltegravir is metabolised primarily via UGT1A1, caution should also be used when co-administering DUTREBIS with other strong inducers of UGT1A1.
Maltese: Peress li raltegravir huwa metabolizzat prinċipalment permezz ta' UGT1A1, għandha tiġi eżerċitata kawtela fl-għoti flimkien ta' DUTREBIS ma' indutturi qawwija oħra ta' UGT1A1.
English: Two components, namely raltegravir and raltegravir-glucuronide, were detected in urine and accounted for approximately 9 and 23 % of the dose, respectively.
Maltese: Żewġ komponenti, jiġifieri raltegravir u raltegravir-glucuronide, ġew skoperti fl-awrina u ammontaw għal madwar 9 % u 23 % tad-doża, rispettivament.
English: Myopathy and rhabdomyolysis have been reported with raltegravir.
Maltese: Mijopatija u rabdomijoliżi ġew irrapportati b'raltegravir.
English: Date of first authorisation:
Maltese: Tiqafx tieħdu peress li:
English: Very rare (may affect up to 1 in 10,000 people)
Maltese: Rari (jistgħu jaffettwaw sa persuna 1 minn kull 1,000)
English: The study demonstrated that foetuses exposed in utero to the combination sustained a higher level of nucleoside analogue-DNA incorporation into multiple foetal organs, and showed evidence of more telomere shortening than in those exposed to zidovudine alone.
Maltese: L-istudju wera li feti esposti in utero għat-taħlita spiċċaw b'livell ogħla ta' analogi nukleosidi-inkorporazzjoni ta' DNA f'organi multipli tal-feti, u wera sinjali ta' aktar tqassir ta' telomere minn dawk esposti għal zidovudine waħdu.
English: The bioavailablity of the raltegravir component of DUTREBIS in the fasted state is approximately 60 %, which is higher than the bioavailability of raltegravir in the raltegravir poloxamer formulation, and accounts for the difference in raltegravir dose.
Maltese: Il-bijodisponibbiltà tal-komponent ta' raltegravir ta' DUTREBIS fl-istat sajjem huwa madwar 60 %, li hija ogħla mill-bijodisponibbiltà fil-formulazzjoni ta' raltegravir poloxamer, u tammonta għad-differenza fid-doża ta' raltegravir.
English: Physicians are encouraged to register patients in this registry.
Maltese: Tiħux aktar pilloli milli jirrakkomandalek it-tabib.
English: Lamivudine demonstrates low cytotoxicity to peripheral blood lymphocytes, to established lymphocyte and monocyte-macrophage cell lines, and to a variety of bone marrow progenitor cells in vitro.
Maltese: Lamivudine juri ċitotossiċità baxxa għal-limfoċiti periferali tad-demm, għal-linji ta' ċelloli stabbiliti ta' limfoċiti u monoċiti-makrofagi, u għal varjetà ta' ċelloli proġenituri tal-mudullun in vitro.
English: Merck Sharp & Dohme, s. r. o. Tel.: +421 2 58282010 dpoc_czechslovak@merck.com
Maltese: Merck Sharp & Dohme, inovativna zdravila d.o.o. Tel: + 386 1 5204201 msd_slovenia@merck.com
English: Co-administration of DUTREBIS with other agents that increase gastric pH (e.g., omeprazole and famotidine) may increase the rate of raltegravir absorption and result in increased plasma levels of raltegravir (see Table 1).
Maltese: L-għoti flimkien ta' DUTREBIS ma' aġenti oħrajn li jżidu l-pH gastriku (eż. omeprazole u famotidine) jista' jżid ir-rata tal-assorbiment ta' raltegravir u jirriżulta f'żieda fil-livelli fil-plażma ta' raltegravir (ara Tabella 1).
English: See section 4.4 regarding the need to administer raltegravir with another active agent.
Maltese: 4.4 Twissijiet speċjali u prekawzjonijiet għall-użu