FrancophonIA/ELRC3.0 huggingface dataset:
English: The Genotypic Sensitivity Score (GSS) was defined as the total oral ARTs in the optimised background therapy (OBT) to which a patient's viral isolate showed genotypic sensitivity based upon genotypic resistance test. Enfuvirtide use in OBT in enfuvirtide-naïve patients was counted as one active drug in OBT.
Maltese: Il-Punteġġ tas-Sensittività Ġenotipika (GSS) ġie definit bħala l-ARTs orali totali fit-terapija ta' sfond ottimizzata (OBT) li għalihom iżolat virali ta' pazjent wera sensittività ġenotipika bbażata fuq test tar-reżistenza ġenotipika.
English: Common abnormal dreams, insomnia, nightmare, abnormal behaviour, depression
Maltese: Komuni ħolm abnormali, insomnja, ħmar il-lejl, imġiba mhux normali, depressjoni
English: BENCHMRK 1 and 2 Pooled
Maltese: BENCHMRK 1 u 2 Miġburin Flimkien
English: Baseline Characteristic HIV-RNA > 100,000 copies/mL
Maltese: HIV-RNA > 100,000 kopja/mL
English: In addition, relative to the raltegravir 400 mg formulation the raltegravir 600 mg formulation used in the 1,200 mg (2 x 600 mg) once daily dosing regimen has higher relative bioavailability (by 21 to 66%).
Maltese: B'żieda ma' dan, b'mod relattiv malformulazzjoni ta' raltegravir 400 mg il-formulazzjoni ta' raltegravir 600 mg użata fir-reġimen taddożaġġ-1,200 mg (2x600 mg) għandha biodisponibbiltà relattivament ogħla (b'21 sa 66%).
English: In the first study (n=18), the median cerebrospinal fluid concentration was 5.8 % (range 1 to 53.5 %) of the corresponding plasma concentration.
Maltese: Fl-ewwel studju (n=18), il-konċentrazzjoni medjana fil-fluwidu tal-moħħ u s-sinsla kienet ta' 5.8% (medda minn 1 sa 53.5%) tal-konċentrazzjoni korrispondenti fil-plażma.
English: Respiratory, thoracic and mediastinal disorders
Maltese: Distrbi respiratorji, toraċiċi u medjastinali
English: In addition, raltegravir inhibited viral replication in cultures of mitogen-activated human peripheral blood mononuclear cells infected with diverse, primary clinical isolates of HIV-1, including isolates from 5 non-B subtypes, and isolates resistant to reverse transcriptase inhibitors and protease inhibitors.
Maltese: Barra minn hekk, raltegravir impedixxa r-replikazzjoni virali f'kulturi ta' ċelloli mononukleari tad-demm periferali uman attivati b'mitoġen, infettati b'iżolati kliniċi primarji differenti tal-HIV-1, inklużi iżolati minn 5 sottotipi mhux B, u iżolati reżistenti għal inibituri ta' reverse transcriptase u inibituri protease.
English: • allergic reaction;
Maltese: • reazzjoni allerġika;
English: Percent HIV-RNA < 50 copies/mL (95 % CI)
Maltese: Perċentwali HIV-RNA < 50 kopja/ml (95% CI)
English: a clean glass
Maltese: tazza nadifa
English: No evidence of mutagenicity or genotoxicity was observed in in vitro microbial mutagenesis (Ames) tests, in vitro alkaline elution assays for DNA breakage and in vitro and in vivo chromosomal aberration studies.
Maltese: L-ebda evidenza ta' mutaġeniċità jew ġenotossiċità ma ġiet osservata f'testijiet (Ames) ta' mutaġenesi mikrobjali in vitro, assaġġi alkaline elution in vitro għat-tkissir tad-DNA u studji ta' aberrazzjoni tal-kromożoni in vitro u in vivo.
English: • Isentress 1,200 mg (two 600 mg tablets once daily) is not recommended in pregnancy because it has not been studied in pregnant women.
Maltese: • Isentress 1,200 mg (żewġ pilloli ta' 600 mg darba kuljum) m'huwiex rakkomandat waqt it-tqala minħabba li ma ġiex studjat f'nisa tqal.
English: At Week 240, the treatment difference (raltegravir - efavirenz) was 9.5 % with an associated 95 % CI of (1.7, 17.3).
Maltese: F'ġimgħa 240, id-differenza fil-kura (raltegravir - efavirenz) kienet ta' 9.5% b'95% CI assoċjat ta' (1.7, 17.3).
English: 1.5 x 100 mg † twice daily
Maltese: 1.5 x 100 mg† darbtejn kuljum28 sa inqas minn 40
English: Standard genotoxicity studies to evaluate mutagenicity and clastogenicity were negative.
Maltese: Studji tal-ġenotossiċità standard sabiex jiġu evalwati l-mutaġeniċità u lklastoġeniċità kienu negattivi.
English: Merck Sharp & Dohme s.r.o.
Maltese: CZ Merck Sharp & Dohme s.r.o.
English: tipranavir /ritonavir (raltegravir 400 mg Twice Daily)
Maltese: tipranavir /ritonavir (raltegravir 400 mg Darbtejn Kuljum)
English: In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, titanium dioxide, polyethylene glycol 3350, talc, red iron oxide and black iron oxide.
Maltese: Barra minn hekk, il-kisja b'rita fiha s-sustanza inattivi li ġejjin: polyvinyl alcohol, titanium dioxide, polyethylene glycol 3350, talc, red iron oxide u black iron oxide.
English: 25 mg chewable tablets:
Maltese: 25 mg pilloli li tomgħodhom:
English: The virus produces an enzyme called HIV integrase.
Maltese: Il-virus tal-HIV jipproduċi enzima msejħa integrase tal-HIV.
English: At Week 96, the proportion of patients achieving HIV RNA < 40 copies/mL was 433/531(81.5 %) in the group receiving raltegravir 1,200 mg once daily and 213/266 (80.1 %) in the group receiving raltegravir 400 mg twice daily.
Maltese: F'Ġimgħa 96, il-proporzjon ta' pazjenti li kisbu HIV RNA < 40 kopja/mL kien 433/531(81.5 %) filgrupp li kien qed jirċievu raltegravir 1,200 mg darba kuljum u 213/266 (80.1 %) fil-grupp li kien qed jirċievi raltegravir 400 mg darbtejn kuljum.
English: The effect of severe hepatic insufficiency on the pharmacokinetics of raltegravir has not been studied (see sections 4.2 and 4.4 of the 400 mg twice daily SmPC).
Maltese: L-effett ta' indeboliment epatiku serju fuq il-farmakokinetiċi ta' raltegravir ma ġiex studjat (ara sezzjoni 4.2 u 4.4 tal-SmPC tal-400 mg darbtejn kuljum).
English: Myopathy and rhabdomyolysis
Maltese: Mijopatija u rabdomijolisi
English: Switch to raltegravir
Maltese: raltegravir.
English: 14 to less than 20 † 10 mL (100 mg) twice daily 1 x 100 mg twice daily 20 to less than 25
Maltese: 8 mL (80 mg) darbtejn kuljum 3 x 25 mg darbtejn kuljum 14 sa inqas minn 20† 10 mL (100 mg) darbtejn kuljum 1 x 100 mg darbtejn kuljum 20 sa inqas minn 25
English: Patients with a prior history of virological failure were not excluded and the number of previous antiretroviral therapies was not limited.
Maltese: Ma kinux esklużi pazjenti bi storja preċedenti ta' falliment viroloġiku u n-numru tat-terapiji antiretrovirali preċedenti ma kienx limitat.
English: Co-administration of raltegravir 1,200 mg once daily with aluminium/magnesium and calcium carbonate containing antacids are likely to result in clinically meaningful reductions in the plasma trough levels of raltegravir.
Maltese: L-għoti flimkien ta' raltegravir 1,200 mg darba kuljum ma' antaċidi li fihom aluminium/magnesium u calcium carbonate huwa probabbli li jirriżulta fi tnaqqis klinikament sinifikanti fil-livelli l-iktar baxxi fil-plażma ta' raltegravir.
English: Of the 126 patients, 96 received the recommended dose of raltegravir (see section 4.2).
Maltese: Mill-126 pazjent, 96 irċevew id-doża rakkomandata ta' raltegravir (ara sezzjoni 4.2).
English: Uncommon acne, alopecia, dermatitis acneiforme, dry skin, erythema, facial wasting, hyperhidrosis, lipoatrophy, lipodystrophy acquired, lipohypertrophy, night sweats, prurigo, pruritus, pruritus generalised, rash macular, rash maculopapular, rash pruritic, skin lesion, urticaria, xeroderma, Stevens Johnson syndrome, drug rash with eosinophilia and systemic symptoms (DRESS)
Maltese: Mhux komuni akne, alopeċja, dermatite akneiforme, ġilda xotta, eritema, facial wasting, iperidrosi, lipoatrofija, lipodistrofija akkwiżita, lipoipertrofija, għaraq billejl, prurigo, ħakk, ħakk ġeneralizzat, raxx makulari, raxx makulo-papulari, raxx tal-ħakk, leżjoni fil-ġilda, urtikarja, xeroderma, sindrome ta' Stevens Johnson, raxx ikkawżat mill-mediċina b'eosinofilja u sintomi sistemiċi (DRESS - drug rash with eosinophilia u systemic symptoms)
English: One pack size is available: 1 bottle with 60 tablets.
Maltese: Huwa disponibbli daqs wieħed tal-pakkett: flixkun b'60 pillola.
English: HCV ANTIVIRALS NS3/4A protease inhibitors (PI) boceprevir (raltegravir 400 mg Single Dose)
Maltese: Inibituri ta' protease (PI - protease inhibitors) NS3/4A Boceprevir (raltegravir 400 mg Doża Waħda)
English: SEDATIVE midazolam (raltegravir 400 mg Twice Daily)
Maltese: SEDATTIV midazolam (raltegravir 400 mg Darbtejn kuljum)
English: Grade 2-4 creatine kinase laboratory abnormalities were observed in patients treated with raltegravir.
Maltese: Anormalitajiet tal-laboratorju ta' grad 2-4 fil-creatine kinase ġew osservati f'pazjenti ttrattati b' raltegravir.
English: Patients co-infected with hepatitis B and/or hepatitis C virus In clinical trials, there were 79 patients co-infected with hepatitis B, 84 co-infected with hepatitis C, and 8 patients co-infected with hepatitis B and C who were treated with raltegravir in combination with other agents for HIV-1.
Maltese: Fil-provi kliniċi, kien hemm 79 pazjent ko-infettati bl-epatite B, 84 ko-infettati bl-epatite Ċ, u 8 pazjenti ko-infettati bl-epatite B u Ċ li ġew ittrattati b'raltegravir flimkien ma' aġenti oħra għallHIV-1.
English: Administration of a low fat meal with raltegravir 1,200 mg once daily resulted in a 42% decrease in AUC0-last, 52% decrease in Cmax, and 16% decrease in C24hr.
Maltese: L-għoti ta' ikla b'xaħam baxx ma' raltegravir 1,200 mg darba kuljum irriżultat f'nuqqas ta' 42% f' AUC0-last, 52% nuqqas f' Cmax, u nuqqas ta' 16% f' C24hr.
English: 100 mg chewable tablets:
Maltese: 100 mg pilloli li tomgħodhom:
English: In vitro studies indicate that raltegravir is not a substrate of cytochrome P450 (CYP) enzymes, does not inhibit CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 or CYP3A, does not inhibit UDP glucuronosyltransferases (UGTs) 1A1 and 2B7, does not induce CYP3A4 and does not inhibit P-glycoprotein-mediated transport.
Maltese: Studji in vitro jindikaw li raltegravir m'huwiex sottostrat ta' enzimi ċitokromi P450 (CYP), ma jimpedixxix CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 jew CYP3A, ma jimpedixxix il-UDP glucuronosyltransferases (UGTs) 1A1 u 2B7, ma jinduċix CYP3A4 u ma jimpedixxix it-trasport imwettaq minn P-glycoprotein.
English: 1.5 mL (15 mg) twice daily *No data are available in pre-term neonates.
Maltese: 1.5 mL (15 mg) darbtejn kuljum *M'hemm l-ebda dejta disponibbli fi trabi tat-twelid ta' qabel it-terminu.
English: The apparent terminal half-life of raltegravir is approximately 9 hours, with a shorter α-phase half-life (~1 hour) accounting for much of the AUC.
Maltese: Il-half-life terminali apparenti huwa ta' madwar 9 sigħat, b'half-life ta' α-phase iqsar (~1 siegħa) li tammonta għal ħafna mill-AUC.
English: - Crospovidone, Type A - Sodium stearyl fumarate - Magnesium stearate - Hypromellose 2910/6cP - Macrogol/PEG 400 - Ethylcellulose 20 cP - Ammonium hydroxide - Medium chain triglycerides - Oleic acid - Yellow iron oxide
Maltese: - Crospovidone, Type A - Magnesium stearate - Hypromellose 2910/6cP - Macrogol/PEG 400 - Ethylcellulose 20 cP - Ammonium hydroxide - Medium chain triglycerides - Oleic acid - Microcrystalline cellulose - Carmellose sodium
English: Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterial infections and pneumonia caused by Pneumocystis jiroveci (formerly known as Pneumocystis carinii).
Maltese: Eżempji relevanti huma retinite b'cytomegalovirus, infezzjonijiet ġeneralizzati u/jew fokali b'majkobatterji u pnewmonja ikkaġunata minn Pneumocystis jiroveci (qabel magħruf bħala Pneumocystis carinii).
English: The other ingredients are: lactose monohydrate, microcrystalline cellulose, calcium phosphate dibasic anhydrous, hypromellose 2208, poloxamer 407, sodium stearyl fumarate, and magnesium stearate.
Maltese: Is-sustanzi mhux attivi l-oħra huma: lactose monohydrate, microcrystalline cellulose, calcium phosphate dibasic anhydrous, hypromellose 2208, poloxamer 407, sodium stearyl fumarate, u magnesium stearate.
English: Measure Isentress
Maltese: Tiħux ISENTRESS
English: Table 5 Efficacy Outcome at Weeks 48 and 240
Maltese: Analiżi tar-riżultati ta' ġimgħa 48 u ġimgħa 240
English: In drug interaction studies performed using raltegravir 400 mg twice daily, raltegravir did not have a clinically meaningful effect on the pharmacokinetics of etravirine, maraviroc, tenofovir disoproxil fumarate, hormonal contraceptives, methadone, midazolam or boceprevir.
Maltese: Fi studji ta' interazzjoni mediċinali mwettqa bl-użu ta' raltegravir 400 mg darbejn kuljum, raltegravir ma kellux effett klinikament sinifikanti fuq il-farmakokinetiċi ta' etravirine, maraviroc, tenofovir disoproxil fumarate, kontraċettivi ormonali, methadone, midazolam jew boceprevir.
English: Table 3 Pharmacokinetic Interaction Data in Adults
Maltese: Tabella 3 Tagħrif dwar l-Interazzjonijiet Farmakokinetiċi fl-Adulti
English: • This medicine has been prescribed for you or your child only.
Maltese: • Tibdiex tieħu mediċina ġdida mingħajr ma tgħid lit-tabib tiegħek.
English: 1 mL (10 mg) twice daily
Maltese: 1 mL (10 mg) darbtejn kuljum
English: • certain kinds of kidney problems
Maltese: • ċerti tipi ta' problemi fil-kliewi
English: Mean CD4 Cell Change (95 % CI), cells/mm
Maltese: Bidla Medja fiċ-Ċelloli CD4 (95% CI), ċelloli/mm3
English: Available pharmacodynamics/toxicological data in animals have shown excretion of raltegravir/metabolites in milk (for details see section 5.3).
Maltese: Dejta farmakodinamika / tossikoloġika fl-annimali uriet li kien hemm eliminazzjoni ta' raltegravir/metaboliti fil-ħalib tas-sider (gћad-dettalji ara sezzjoni 5.3).
English: 60 film-coated tablets Multipack: 180 (3 bottles of 60) film-coated tablets
Maltese: 60 pillola miksija b'rita Pakkett multiplu: 180 (3 fliexken ta' 60) pillola miksija b'rita
English: One patient experienced drug related laboratory abnormalities, Grade 4 AST and Grade 3 ALT, which were considered serious.
Maltese: Pazjent wieħed esperjenza abnormalitajiet tal-laboratorju relatati mal-mediċina, AST ta' Grad 4 u ALT ta' Grad 3, li kienu kkunsidrati bħala serji.
English: Patients with chronic hepatitis B or C and treated with combination anti-retroviral therapy are at an increased risk for severe and potentially fatal hepatic adverse reactions.
Maltese: Pazjenti b'epatite B jew Ċ kronika u ttrattati b'terapija antiretrovirali ta' kombinazzjoni huma f'riskju akbar għal reazzjoniijiet epatiċi avversi gravi u potenzjalment fatali.
English: > 200 cells/mm
Maltese: <400 kopja/mL
English: Administration of a high fat meal resulted in a 1.9% increase in AUC0-last, 28% decrease in Cmax, and 12% decrease in C24 hr.
Maltese: L-għoti ta ikla b'xaħam għoli rriżultat f'żieda ta' 1.9% f' AUC0-last,2.8% nuqqas f' Cmax, u nuqqas ta' 12% f' C24 hr.
English: The treatment difference (raltegravir - efavirenz) was 4.2 % with an associated 95 % CI of (-1.9, 10.3) establishing that raltegravir is non-inferior to efavirenz (pvalue for non-inferiority < 0.001).
Maltese: Id-differenza fil-kura (raltegravir - efavirenz) kienet ta' 4.2 % b'95 % CI assoċjat ta' (-1.9, 10.3) li jistabbilixxi li raltegravir huwa ‘mhux inferjuri' għal efavirenz (valur p għal fatt li ‘mhux inferjuri'< 0.001).
English: Previous studies of raltegravir 400 mg twice daily showed that co-administration of tenofovir disoproxil fumarate (a component of emtricitabine/tenofovir disaproxil fumarate) increased raltegravir exposure.
Maltese: Studji preċedenti ta' raltegravir 400 mg darbtejn kuljum urew li l-għoti flimkien ta' tenofovor disoproxil fumarate (komponent ta' emtricitabine/tenofovir disaproxil fumarate) żied l-esponiment ta' raltegravir.
English: Treatment-naïve adult patients (1,200 mg [2 x 600 mg] once daily) ONCEMRK (multi-centre, randomised, double-blind, active-control trial; Protocol 292) evaluated the safety and anti-retroviral activity of raltegravir 1,200 mg once daily + emtricitabine (+) tenofovir disoproxil fumarate vs. raltegravir 400 mg twice daily, in combination with emtricitabine (+) tenofovir disoproxil fumarate, in treatment-naïve HIV-infected patients with HIV RNA > 1,000 copies/mL.
Maltese: Pazjenti adulti li ma rċevewx it-trattament qabel (1,200 mg [2 x 600 mg]darba kuljum) ONCEMRK (prova b'aktar minn ċentru wieħed, randomizzata, double-blind, ikkontrollata bissustanza attiva; Protokoll 292) evalwat is-sigurtà u l-attività antiretrovirali ta' raltegravir 1,200 mg darba kuljum + emtricitabine (+) tenofovir disoproxil fumarate vs. raltegravir 400 mg darbtejn kuljun, f'kombinazzjoni ma' emtricitabine (+) tenofovir disoproxil fumarate, f'pazjenti infettati bl-HIV li ma rċevewx trattament qabel, li kellhom HIV RNA > 1,000 kopja/mL.
English: The tablet may also contain trace amount of carnauba wax.
Maltese: Ilpillola jista' jkun fiha wkoll ammont traċċa ta' carnauba wax.
English: The safety profile observed in patients who used atazanavir and / or tenofovir disoproxil fumarate was generally similar to the safety profile of patients who did not use these agents.
Maltese: Il-profil tas-sigurtà osservat f'pazjenti li użaw atazanavir u / jew tenofovir disoproxil fumarate kien ġeneralment simili għall-profil tas-sigurtà tal-pazjenti li ma użawx dawn issustanzi.
English: Geometric Mean (% CV Ctrough (ng/mL)
Maltese: Ctrough (ng/mL)
English: IMPAACT P1110 is a Phase I trial to evaluate the safety and pharmacokinetics of raltegravir granules for suspension (GFS) with standard care PMTCT in full term HIV-1-exposed neonates.
Maltese: IMPAACT P1110 huwa prova ta' Fażi 1 biex tevalwa l-sigurtà u l-farmakokinetiċi ta' raltegravir granuli għal sospensjoni (GFS) b'kura standard PMTCT fi trabi tat-twelid esposti għall-HIV-1 ta' terminu sħiħ.
English: 2 x 100 mg twice daily
Maltese: 200 mg darbtejn kuljum2 x 100 mg darbtejn kuljum
English: For mean CD4 changes, baseline-carryforward was used for virologic failures.
Maltese: CD4, intuża l-carry-forward tal-linja bażi għall-fallimenti viroloġiċi.
English: 3 syringes
Maltese: 2 u ogħla
English: In addition, the film coating contains the following inactive ingredients: lactose monohydrate, hypromellose 2910, titanium dioxide, triacetin, iron oxide yellow and black iron oxide.
Maltese: Barra minn hekk il-kisi b'rita fih l-ingredjenti inattivi li ġejjin: lactose monohydrate, hypromellose 2910, titanium dioxide, triacetin, iron oxide yellow u black iron oxide.
English: In adults, there were no clinically important pharmacokinetic differences between patients with moderate hepatic insufficiency and healthy subjects.
Maltese: Fl-adulti, ma kien hemm l-ebda differenza farmakokinetika klinikament importanti bejn pazjenti b'indeboliment epatiku moderat u suġġetti f'saħħithom.
English: For observed C12 hr in BENCHMRK 1 and 2 the coefficient of variation (CV) for inter-subject variability = 212 % and the CV for intra-subject variability = 122 %.
Maltese: GħallC12 hr osservat f'BENCHMRK 1 u 2, il-koeffiċjent tal-varjazzjoni (CV) għall-varjabilità bejn persuna u oħra = 212% u CV għall-varjabilità fl-istess persuna = 122%.
English: Effect of other medicinal products on the pharmacokinetics of raltegravir
Maltese: Effett ta' prodotti mediċinali oħra fuq il-farmakokinetiċi ta' raltegravir
English: Isentress is also available in a 400 mg tablet, a 600 mg tablet and in granules for oral suspension.
Maltese: Isentress huwa disponibbli wkoll f'pillola ta' 400 mg, f'pillola ta' 600 mg u fi granuli għal sospensjoni orali.
English: In adults, there were no clinically important pharmacokinetic differences between patients with severe renal insufficiency and healthy subjects (see section 4.2 of the 400 mg twice daily SmPC).
Maltese: Fl-adulti, ma kien hemm l-ebda differenza farmakokinetika klinikament importanti bejn pazjenti b'indeboliment tal-kliewi serju u suġġetti f'saħħithom (ara sezzjoni 4.2 tal-SmPC tal-400 mg darbtejn kuljum).
English: The impact of other strong inducers of drug metabolizing enzymes, such as phenytoin and phenobarbital, on UGT1A1 is unknown.
Maltese: L-impatt ta' provokaturi qawwija oħra ta' enzimi li jimmetabolizzaw il-mediċina, bħal phenytoin u phenobarbital, fuq UGT1A1, mhuwiex magħruf.
English: Infections and infestations Uncommon genital herpes, folliculitis, gastroenteritis, herpes simplex, herpes virus infection, herpes zoster, influenza, lymph node abscess, molluscum contagiosum, nasopharyngitis, upper respiratory tract infection
Maltese: Infezzjonijiet u infestazzjonijiet Mhux komuni herpes ġenitali, follikulite, gastroenterite, herpes simplex, infezzjoni virali b'herpes, herpes zoster, influwenza, axxess fil-glandoli tal-limfa, molluscum contagiosum, nasofarinġite, infezzjoni fil-parti ta' fuq tal-passaġġ tal-arja
English: There were no clinically important pharmacokinetic differences due to gender, race or body mass index (BMI) in adults.
Maltese: Ma kien hemm ebda differenzi farmakokinetiċi klinikament importanti minħabba s-sess, razza jew indiċi tal-massa tal-ġisem (BMI) fl-adulti.
English: In vitro studies indicate that raltegravir is not a substrate of cytochrome P450 (CYP) enzymes, does not inhibit CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 or CYP3A, does not inhibit UDP glucuronosyltransferases (UGTs) 1A1 and 2B7, does not induce CYP3A4 and is not an inhibitor of P-glycoprotein (P-gp), breast cancer resistance protein (BCRP), organic anion-transporting polypeptides (OATP) 1B1, OATP1B3, organic cation transporters (OCT)1 and OCT2, or multidrug and toxin extrusion proteins (MATE)1 and MATE2-K. Based on these data, raltegravir is not expected to affect the pharmacokinetics of medicinal products that are substrates of these enzymes or transporters.
Maltese: Studji in vitro jindikaw li raltegravir m'huwiex sottostrat ta' enzimi ċitokromi P450 (CYP), ma jimpedixxix CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 jew CYP3A, ma jimpedixxix il-UDP glucuronosyltransferases (UGTs) 1A1 u 2B7, ma jinduċix CYP3A4 u mhuwiex inibitur ta' P-glycoprotein (P-gp), proteina ta' reżistenza għall-kanċer tas-sider (BCRP), polipeptidi li jittrasportaw l-anjon organiku (OATP) 1B1, OATP1B3, trasportaturi tal-katjon organiku (OCT)1 u OCT2, jew proteini ta' estrużjoni ta' bosta mediċini u tossini (MATE)1 u MATE2-K.
English: 2 green (3 mL) syringes
Maltese: 2 siringi ħodor (ta' 3 mL)
English: Vascular disorders
Maltese: Disturbi vaskolari
English: Population pharmacokinetic analysis from ONCEMRK (Protocol 292) showed that co-administration of raltegravir 1,200 mg once daily with PPIs or H2 blockers did not result in statistically significant changes in the pharmacokinetics of raltegravir.
Maltese: Analiżi tal-popolazzjoni farmakokinetika minn ONCEMRK (Protokoll 292) uriet li l-għoti flimkien ta' raltegravir 1,200 mg darba kuljum ma'impedituri tal-PPIs jew H2 ma rriżultatx f'tibdil statistikament sinifikanti fil-farmakokinetiċi ta' raltegravir.
English: 60 chewable tablets
Maltese: kull wieħed fih 60 pillola.
English: Therefore, co administration of emtricitabine/tenofovir disaproxil fumarate and raltegravir 1,200 mg once daily ispermitted.
Maltese: B'hekk, l-għoti flimkien ta emtricitabine/tenofovir disaproxil fumarate u raltegravir 1,200 mg darba kuljum huwa permess.
English: Refer to the 600 mg tablet SmPCs for additional dosing information.
Maltese: Irreferi għall-SmPC tal-pillola ta' 600 mg għal informazzjoni addizzjonali dwar id-dożaġġ.
English: UGT1A1 catalytic activity is negligible at birth and matures after birth.
Maltese: L-attività katalitika ta' UGT1A1 hija negliġibbli fittwelid u timmatura wara t-twelid.
English: In adults, there were no clinically important pharmacokinetic differences between patients with severe renal insufficiency and healthy subjects (see section 4.2).
Maltese: Fl-adulti, ma kien hemm l-ebda differenza farmakokinetika klinikament importanti bejn pazjenti b'indeboliment tal-kliewi serju u suġġetti f'saħħithom (ara sezzjoni 4.2).
English: Patients with pre-existing liver dysfunction including chronic hepatitis have an increased frequency of liver function abnormalities during combination anti-retroviral therapy and should be monitored according to standard practice.
Maltese: Pazjenti li diġà jkollhom disfunzjoni tal-fwied fosthom epatite kronika għandhom frekwenza akbar ta' anormalitajiet fil-funzjoni tal-fwied waqt terapija antiretrovirali ta' kombinazzjoni u għandhom jiġu mmonitorjati skont metodi standard.
English: • allergic reaction
Maltese: • attività eċċessiva