FrancophonIA/ELRC3.0 huggingface dataset:
English: During the darunavir/ritonavir clinical development program (N = 3,063), severe skin reactions, which may be accompanied with fever and/or elevations of transaminases, have been reported in 0.4% of patients.
Maltese: Matul l-iżvilupp tal-programm kliniku ta' darunavir/ritonavir (N = 3,063), kienu rrappurtati reazzjonijiet severi fil-ġilda, li jistgħu jseħħu flimkien ma' deni u/jew żidiet fil-livelli tattransaminases, f'0.4% tal-pazjenti.
English: The bioavailability of all components of Symtuza was comparable to that when darunavir 800 mg, cobicistat 150 mg, and emtricitabine/tenofovir alafenamide 200/10 mg were co-administered as separate formulations; bioequivalence was established following single-dose administration under fed conditions in healthy subjects (N = 96).
Maltese: Il-bijodisponibbiltà tal-komponenti kollha ta' Symtuza kienet kumparabbli ma' dik meta darunavir 800 mg, cobicistat 150 mg, u emtricitabine/tenofovir alafenamide 200/10 mg ingħataw flimkien bħala formulazzjonijiet separati; il-bijoekwivalenza ġiet stabbilita wara għoti ta' doża waħda f'kundizzjonijiet fejn l-individwi f'saħħithom kienu mitmugħa (N = 96).
English: Virologic response was defined as < 50 copies/mL using the snapshot approach (see Table 5).
Maltese: Rispons viroloġiku kien iddefinit bħala < 50 kopja/mL bl-użu talapproċ snapshot (ara Tabella 5)
English: 111-1921 x 10
Maltese: 6 ċellula/mm 3 (firxa 111-1921 x 10
English: Janssen-Cilag AB Tel: +46 8 626 50 00 jacse@its.jnj.com
Maltese: +46 8 626 50 00 jacse@its.jnj.com
English: Concomitant administration of Symtuza with dabigatran or ticagrelor is contraindicated (see section 4.3).
Maltese: L-għoti ta' Symtuza flimkien ma' dabigatran jew ticagrelor huwa kontraindikat (ara sezzjoni 4.3).
English: ANTIEMETICS Domperidone
Maltese: KONTRAĊETTIVI ABBAŻI
English: One film-coated tablet of Symtuza once daily taken with food may be used in patients with prior exposure to antiretroviral medicinal products but without darunavir resistance associated mutations (DRV-RAMs)* and who have plasma HIV-1 RNA < 100,000 copies/mL and CD4+ cell count ≥ 100 cells x 10
Maltese: Pillola waħda miksija b'rita ta' Symtuza li tittieħed darba kuljum mal-ikel tista' tintuża f'pazjenti li kellhom esponiment preċedenti għal prodotti mediċinali antiretrovirali iżda mingħajr mutazzjonijiet ta' reżistenza assoċjati ma' darunavir (DRV-RAMs)* u li għandhom < 100,000 kopja/mL ta' RNA ta' HIV-1 fil-plażma u għadd ta' ≥ 100 ċellula x 10
English: Based on theoretical considerations DRV/COBI is expected to increase these immunosuppressant plasma concentrations.
Maltese: Abbażi ta' konsiderazzjonijiet teoretiċi DRV/COBI huwa mistenni li jżid dawn ilkonċentrazzjonijiet ta' immunosoppressanti fil-plażma.
English: Emtricitabine displayed antiviral activity in cell culture against HIV-1 clades A, B, C, D, E, F, and G (EC50 values ranged from 0.007 to 0.075 μM) and showed strain specific activity against HIV-2 (EC50 values ranged from 0.007 to 1.5 μM).
Maltese: Il-valuri EC50 għal emtricitabine kienu jvarjaw minn 0.0013 sa 0.64 μM. Emtricitabine wera attività antivirali f'koltura ta' ċelluli kontra l-clades A, B, C, D, E, F, u G ta' HIV-1 (il-valuri EC50 kienu jvarjaw minn 0.007 sa 0.075 μM) u wera attività speċifika għar-razza kontra
English: Week 48 and 96 Virologic Outcomes in EMERALD Trial Week 48
Maltese: Tabella 6: Riżultati Viroloġiċi mill-Prova EMERALD f'Ġimgħa 48 u 96 Ġimgħa 48
English: In vitro and clinical pharmacokinetic drug-drug interaction studies have shown that the potential for CYP-mediated interactions involving emtricitabine with other medicinal products is low.
Maltese: Studji in vitro u studji farmakokinetiċi kliniċi dwar interazzjoni bejn mediċina u oħra wrew li lpossibbiltà ta' interazzjonijiet medjati minn CYP li jinvolvu emtricitabine ma' prodotti mediċinali oħrajn hija baxxa.
English: Unlike ritonavir, cobicistat is not an inducer of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 or UGT1A1.
Maltese: F'kuntrast ma' ritonavir, cobicistat mhuwiex induttur ta' CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 jew UGT1A1.
English: Based on theoretical considerations DRV/COBI may increase buprenorphine and/or norbuprenorphine plasma concentrations.
Maltese: Abbażi ta' konsiderazzjonijiet teoretiċi DRV/COBI jista' jżid ilkonċentrazzjonijiet ta' buprenorphine u/jew norbuprenorphine fil-plażma.
English: Caution should be exercised when clarithromycin is combined with Symtuza.
Maltese: Għandu jkun hemm kawtela meta clarithromycin jiġi kombinat ma' Symtuza.
English: C]-darunavir with ritonavir showed that approximately 7.7% of the administered dose of darunavir is excreted in the urine unchanged.
Maltese: C] b'ritonavir wera li madwar 7.7% tad-doża ta' darunavir mogħtija titneħħa mhux mibdula fl-awrina.
English: 2 consecutive HIV-1 RNA ≥ 50 copies/mL, or in case of discontinuation or at Week 48/96 for any reason, (single) HIV-1 RNA ≥ 50 copies/mL as of baseline (included)
Maltese: ≥ 50 kopja/mL RNA ta' HIV-1 darbtejn konsekuttivi, jew f'każ ta' waqfien jew f'Ġimgħa 48/96 għal kwalunkwe raġuni, ≥ 50 kopja/mL RNA ta' HIV-1 (darba) mil-linja bażi (inkluża) Exact Two-sided CI 95% ta' Clopper-Pearson
English: Naloxegol to treat opioid induced constipation
Maltese: Naloxegol biex tittratta stitikezza kkawżata mill-opiojdi
English: Based on theoretical considerations clarithromycin is expected to increase darunavir and/or cobicistat plasma concentrations.
Maltese: Abbażi ta' konsiderazzjonijiet teoretiċi clarithromycin huwa mistenni li jżid ilkonċentrazzjonijiet ta' darunavir u/jew cobicistat fil-plażma.
English: Darunavir Results from a mass balance study with [
Maltese: Darunavir Riżultati minn studju ta' bilanċ tal-massa b'darunavir [
English: In vitro experiments with human liver microsomes (HLMs) indicate that darunavir primarily undergoes oxidative metabolism.
Maltese: Esperimenti in vitro b'mikrosomi tal-fwied tal-bniedem (HLMs, human liver microsomes) jindikaw li darunavir jgħaddi l-aktar minn metaboliżmu ossidattiv.
English: Based on theoretical considerations DRV/COBI is expected to increase these sedative/hypnotic plasma concentrations.
Maltese: Abbażi ta' konsiderazzjonijiet teoretiċi DRV/COBI huwa mistenni li jżid dawn ilkonċentrazzjonijiet sedattivi/ipnotiċi fil-plażma.
English: The safety and efficacy of Symtuza in patients co-infected with HIV-1 and hepatitis C virus (HCV) have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Symtuza f'pazjenti koinfettati bil-virus tal-HIV-1 u tal-epatite Ċ (HCV, hepatitis C virus) ma ġewx iddeterminati s'issa.
English: HIV-1 RNA < 50 copies/mL CD4+ percent median change from baseline CD4+ cell count mean change from baseline ≥ 1.0 log10 decrease from baseline in plasma viral load
Maltese: RNA ta' HIV-1 < 50 kopja/mL Medjan ta' bidla tal-perċentwal tal- taċ-ċelluli CD4+ mil-linja bażi
English: At Week 48 changes from baseline were smaller with D/C/F/TAF than D/C+F/TDF.
Maltese: Il-bidliet f'Ġimgħa 48 mil-linja bażi kienu inqas b'D/C/F/TAF milli b'D/C+F/TDF.
English: It is recommended that the international normalised ratio (INR) be monitored when warfarin is co-administered with Symtuza.
Maltese: Huwa rrakkomandat li jiġi mmonitorjat il-proporzjon normalizzat internazzjonli (INR, international normalised ratio) meta warfarin jingħata flimkien ma' Symtuza.
English: Co-administration of tenofovir alafenamide with other medicinal products that inhibit P-gp (e.g., cobicistat, ritonavir, ciclosporin) are expected to increase the absorption and plasma concentration of tenofovir alafenamide.
Maltese: L-għoti ta' tenofovir alafenamide flimkien ma' prodotti mediċinali oħra li jinibixxu P-gp (eż., cobicistat, ritonavir, ciclosporin) huma mistennija li jżidu l-assorbiment u l-konċentrazzjoni ta' tenofovir alafenamide fil plażma.
English: 6/L.
Maltese: 6 ġimgħat
English: Based on theoretical considerations DRV/COBI is expected to increase these anti-depressant plasma concentrations.
Maltese: Abbażi ta' konsiderazzjonijiet teoretiċi DRV/COBI huwa mistenni li jżid dawn ilkonċentrazzjonijiet ta' antidepressanti fil-plażma.
English: (drug) hypersensitivity uncommon immune reconstitution inflammatory syndrome
Maltese: Disturbi fis-sistema immuni komuni sensittività eċċessiva (għall-mediċina)
English: Please see section ‘Other medicines and Symtuza'.
Maltese: Jekk jogħġbok ara ssezzjoni ‘Mediċini oħra u Symtuza'.
English: In vitro binding of emtricitabine to human plasma proteins was < 4% and independent of concentration over the range of 0.02-200 mcg/mL.
Maltese: L-irbit ta' emtricitabine ma' proteini tal-plażma tal-bniedem in vitro kien < 4% u indipendenti millkonċentrazzjoni fuq firxa minn 0.
English: Film coating:
Maltese: Jekk taqbeż doża:
English: (CYP3A inhibition) Co-administration of ciclosporin is expected to increase plasma concentrations of tenofovir alafenamide.
Maltese: (inibizzjoni ta' CYP3A) L-għoti flimkien ma' ciclosporin huwa mistenni li jżid ilkonċentrazzjonijiet ta' tenofovir alafenamide fil-plażma.
English: Based on theoretical considerations DRV/COBI may alter norethindrone plasma concentrations.
Maltese: Abbażi ta' konsiderazzjonijiet teoretiċi DRV/COBI jista' jibdel il-konċentrazzjonijiet ta' norethindrone fil-plażma.
English: Your doctor will advise you how to deal with your symptoms or whether Symtuza must be stopped.
Maltese: Ma twettqu l-ebda provi ta' interazzjoni bejn mediċina u oħra fejn intuża Symtuza.
English: A potential risk of nephrotoxicity resulting from chronic exposure to low levels of tenofovir due to dosing with tenofovir alafenamide cannot be excluded (see section 5.3).
Maltese: Ma tistax tiġi eskluża l-possibbiltà ta' riskju ta' tossiċità fil-kliewi li tiġi minn esponiment kroniku għal livelli baxxi ta' tenofovir mill-għoti ta' dożi ta' tenofovir alafenamide (ara sezzjoni 5.3).
English: Based on theoretical considerations boceprevir may decrease darunavir and/or cobicistat plasma concentrations and adversely affect the intracellular activation and clinical antiviral efficacy of tenofovir alafenamide.
Maltese: Abbażi ta' konsiderazzjonijiet teoretiċi boceprevir jista' jnaqqas il-konċentrazzjonijiet ta' darunavir u/jew cobicistat fil-plażma u jaffettwa b'mod avvers lattivazzjoni intraċellulari u leffikaċja antivirali klinika ta' tenofovir alafenamide.
English: Symtuza should not be used in treatment-experienced patients with one or more DRV-RAMs (see section 5.1) or with HIV-1 RNA ≥ 100,000 copies/mL or CD4+ cell count < 100 cells x 10
Maltese: (ara sezzjoni 5.1) jew li għandhom ≥ 100,000 kopja/mL ta' RNA ta' HIV-1 jew għadd ta' < 100 ċellula x 10
English: Week 48 and 96 virologic outcomes in the EMERALD trial are provided in Table 6.
Maltese: f'Ġimgħa 48 u 96 huma pprovduti f'Tabella 6.
English: For more details, refer to the prescribing information of darunavir and emtricitabine/ tenofovir alafenamide.
Maltese: Għal aktar dettalji, irreferi għall-informazzjoni dwar kif jiġu ordnati darunavir u emtricitabine/tenofovir alafenamide.
English: Female
Maltese: Nisa
English: Based on theoretical considerations DRV/COBI may alter warfarin plasma concentrations.
Maltese: Abbażi ta' konsiderazzjonijiet teoretiċi DRV/COBI jista' jibdel il-konċentrazzjonijiet ta' warfarin fil-plażma.
English: Postpartum (6-12 weeks) N = 6
Maltese: Wara t-twelid (6 ġimgħat-12-il ġimgħa) N=6
English: Blood and lymphatic system disorders common anaemia
Maltese: Disturbi tad-demm u tas-sistema limfatika komuni anemija
English: Ex vivo rabbit studies and in vivo dog studies suggest that cobicistat has a low potential for QT prolongation, and may slightly prolong the PR interval and decrease left ventricular function at mean concentrations at least 10-fold higher than the human exposure at the recommended 150 mg daily dose.
Maltese: Studji ex vivo fil-fniek u studji in vivo fil-klieb jissuġġerixxu li cobicistat għandu possibbiltà baxxa li jtawwal l-intervall QT, u jista' jtawwal kemxejn l-intervall PR u jnaqqas il-funzjoni tal-ventrikulu taxxellug f'konċentrazzjonijiet medji li kienu mill-inqas 10 darbiet ogħla mill-esponiment fil-bniedem bid-doża rrakkomandata ta' 150 mg kuljum.
English: Based on theoretical considerations, no mechanistic interaction is expected.
Maltese: Abbażi ta' konsiderazzjonijiet teoretiċi, ma hija mistennija l-ebda interazzjoni mekkanistika.
English: Based on theoretical considerations DRV/COBI is expected to increase lumefantrine plasma concentrations.
Maltese: Abbażi ta' konsiderazzjonijiet teoretiċi DRV/COBI huwa mistenni li jżid dawn ilkonċentrazzjonijiet talantiarritmiċi fil-plażma.
English: ENDOTHELIN RECEPTOR ANTAGONISTS Bosentan
Maltese: TAR-RIĊETTUR TAL-ENDOTELIN Bosentan
English: Human experience of acute overdose with Symtuza is limited.
Maltese: L-espserjenza ta' doża eċċessiva akuta b'Symtuza hija limitata.
English: A minimal infiltration of histiocytes was present in the eye in dogs at tenofovir alafenamide and tenofovir exposures of approximately 15 and 40 times greater, respectively, than those expected after administration of Symtuza.
Maltese: Infiltrazzjoni minima ta' istjoċiti kienet preżenti fl-għajnejn tal-klieb b'esponimenti ta' tenofovir alafenamide u tenofovir ta' madwar 15 u 40 darba ikbar, rispettivament, minn dawk mistennija wara l-għoti ta' Symtuza.
English: Symtuza should not be used in paediatric patients below 3 years of age (see sections 4.2 and 5.3).
Maltese: Symtuza m'għandux jintuża f'pazjenti pedjatriċi li għandhom età inqas minn 3 snin (ara sezzjonijiet 4.2 u 5.3).
English: Reproductive system and breast disorders uncommon gynaecomastia
Maltese: Disturbi fis-sistema riproduttiva u fis-sider mhux komuni ġinekomastja
English: Co-administration of oral midazolam or triazolam and Symtuza is contraindicated (see section 4.3).
Maltese: L-għoti ta' midazolam mill-ħalq jew triazolam flimkien ma' Symtuza huwa kontraindikat (ara sezzjoni 4.3).
English: Gastrointestinal disorders very common diarrhoea common vomiting, nausea, abdominal pain, abdominal distension, dyspepsia, flatulence uncommon pancreatitis acute, pancreatic enzymes increased
Maltese: Disturbi gastrointestinali komuni ħafna dijarea komuni rimettar, nawsja, uġigħ fl-addome, nefħa fladdome, dispepsja, gass fl-istonku mhux komuni pankreatite akuta, żieda fl-enzimi tal-frixa
English: The below list of examples of drug drug interactions is not comprehensive and therefore the label of each drug that is co-administered with Symtuza should be consulted for information related to the route of metabolism, interaction pathways, potential risks, and specific actions to be taken with regards to co-administration.
Maltese: Il-lista t'hawn taħt ta' eżempji ta' interazzjonijiet bejn mediċina u oħra mhijiex komprensiva u għalhekk it-tikketta ta' kull mediċina li tittieħed flimkien ma' Symtuza għandha tiġi kkonsultata għal informazzjoni marbuta mar-rotta ta' metaboliżmu, is-sensiela ta' reazzjonijiet ta' interazzjoni, riskji possibbli, u azzjonijiet speċifiċi li għandhom jittieħdu dwar l-għoti tagħhom flimkien.
English: • if you notice any symptoms of infection (e.g. swollen lymph nodes and fever).
Maltese: • jekk tinnota kwalunkwe sintomi ta' infezzjoni (eż. għoqiedi tal-limfa minfuħa u deni).
English: Upon co-administration with the moderate CYP3A inducer probe efavirenz, tenofovir alafenamide exposure was not significantly affected.
Maltese: Meta ngħata flimkien mal-induttur investigattiv moderat ta' CYP3A efavirenz, l-esponiment għal tenofovir alafenamide ma ġiex affettwat b'mod sinifikanti.
English: Musculoskeletal and connective tissue disorders common arthralgia, myalgia uncommon osteonecrosis
Maltese: Disturbi muskoluskeletriċi u tat-tessuti konnettivi komuni artralġja, majalġja mhux komuni osteonekrożi
English: Interactions that have been identified in studies with individual components of Symtuza, i.e. with darunavir (in combination with low dose ritonavir), cobicistat, emtricitabine or tenofovir alafenamide, determine the interactions that may occur with Symtuza.
Maltese: Interazzjonijiet li ġew identifikati fi studji bil-komponenti individwali ta' Symtuza i.e. b'darunavir (flimkien ma' doża baxxa ta' ritonavir), cobicistat, emtricitabine jew tenofovir alafenamide, jiddeterminaw linterazzjonijiet li jistgħu jseħħu b'Symtuza.
English: Weight and levels of blood lipids and glucose may increase during antiretroviral therapy (see section 4.4).
Maltese: Il-piż u l-livelli tax-xaħmijiet u tal-glukożju fid-demm jista' jiżdied waqt terapija antiretrovirali (ara sezzjoni 4.4).
English: Tell your doctor if you take: - Amlodipine, diltiazem, disopyramide, felodipine, flecainide, mexiletine, nicardipine, nifedipine, propafenone, lidocaine, verapamil (for heart disease) as the therapeutic effect or side effects of these medicines may be increased.
Maltese: Għid lit-tbib tiegħek jekk inti tieħu: - Amlodipine, diltiazem, disopyramide, felodipine, flecainide, mexiletine, nicardipine, nifedipine,
English: Based on theoretical considerations DRV/COBI is expected to increase salmeterol plasma concentrations.
Maltese: Abbażi ta' konsiderazzjonijiet teoretiċi DRV/COBI huwa mistenni li jżid ilkonċentrazzjonijiet ta' salmeterol fil-plażma.
English: No clinically relevant pharmacokinetic differences due to gender have been identified for cobicistat, emtricitabine or tenofovir alafenamide.
Maltese: Ma ġew identifikati l-ebda differenzi farmakokinetiċi minħabba s-sess tal- persuna rilevanti b'mod kliniku għal cobicistat, emtricitabine jew tenofovir alafenamide.
English: HIV-1 RNA ≥ 50 copies/mL Virologic Failure Leading to Discontinuation Discontinued study drug due to other reasons and last available HIV-1 RNA ≥ 50 copies/mL
Maltese: RNA ta' HIV-1 ≥ 50 kopja/mL Falliment Viroloġiku li Wassal għall-Waqfien d
English: Cobicistat is 97% to 98% bound to human plasma proteins and the mean plasma to blood-drug concentration ratio was approximately 2.
Maltese: Minn 97% sa 98% ta' cobicistat jintrabat mal-proteini tal-plażma tal-bniedem u l-medja tal-proporzjon tal-konċentrazzjoni tal-mediċina fil-plażma mqabbla ma' dik fid-demm kienet ta' madwar 2.
English: Some late-onset neurological disorders have been reported (hypertonia, convulsion, abnormal behaviour).
Maltese: Ġew irrappurtati xi disturbi newroloġiċi li dehru iktar tard (ipertonja, konvulżjoni, imġiba mhux normali).
English: Based on theoretical considerations DRV/COBI is expected to increase these corticosteroid plasma concentrations.
Maltese: Abbażi ta' konsiderazzjonijiet teoretiċi DRV/COBI huwa mistenni li jżid dawn ilkonċentrazzjonijiet ta' kortikosterojd fil-plażma .
English: An increase in weight and in levels of blood lipids and glucose may occur during antiretroviral therapy.
Maltese: Żieda fil-piż u fil-livelli tal-lipidi u l-glukożju fid-demm jistgħu jseħħu waqt terapija antiretrovirali.
English: Low levels of metabolites are observed in urine and feces and do not contribute to the CYP3A inhibitory activity of cobicistat.
Maltese: Livelli baxxi tal-metaboliti jiġu osservati fl-awina u fl-ippurgar u ma jikkontribwixxux għall-attività inibitorja ta' cobicistat fuq CYP3A.
English: Table 7: Virologic Outcome in ART- naïve Adolescents at Week 48 (TLOVR algorithm) TMC114-C230
Maltese: .7 Effetti fuq il-ħila biex issuq u tħaddem magni
English: Cobicistat increases serum creatinine due to inhibition of tubular secretion of creatinine without affecting renal glomerular function as assessed, for instance, by using Cystatin C (Cyst C) as filtration marker.
Maltese: Cobicistat iżid il-kreatinina fis-serum minħabba inibizzjoni tas-sekrezzjoni tal-kreatinina mit-tubuli mingħajr ma jaffettwa l-funzjoni tal-glomeruli tal-kliewi kif stmat, per eżempju, bl-użu ta' Cystatin C (Cyst C) bħala markatur ta' filtrazzjoni.
English: • Push the plastic screw cap down while turning it counter clockwise.
Maltese: • Agħfas l-għatu tal-plastik 'l isfel filwaqt li ddawru lejn ix-xellug.
English: Your doctor might want to do some additional tests.
Maltese: Jistgħu jkunu meħtieġa xi testijiet addizzjonali.
English: Based on theoretical considerations co-administration of DRV/COBI with dabigatran or ticagrelor may increase concentrations of the anticoagulant.
Maltese: Abbażi ta' konsiderazzjonijiet teoretiċi DRV/COBI huwa mistenni li jżid dawn ilkonċentrazzjonijiet newrolettiċi filplażma.
English: Although darunavir has not been studied in patients with renal impairment, population pharmacokinetic analysis showed that the pharmacokinetics of darunavir were not significantly affected in HIV infected patients with moderate renal impairment (eGFRCG between 30-60 mL/min, N = 20) (see sections 4.2 and 4.4).
Maltese: Għalkemm darunavir ma ġiex studjat f'pazjenti b'indeboliment tal-kliewi, analiżi farmakokinetika talpopolazzjoni uriet li l-farmakokinetika ta' darunavir ma kinitx affettwata b'mod sinifikanti f'pazjenti infettati bl-HIV b'indeboliment moderat tal-kliewi (eGFRCG bejn 30-60 mL/min, N = 20)
English: Co-administration of Symtuza and medicinal products primarily metabolised by CYP3A may result in increased systemic exposure to such medicinal products, which could increase or prolong their therapeutic effect and adverse reactions.
Maltese: L-għoti ta' Symtuza flimkien ma' prodotti mediċinali metabolizzati primarjament minn CYP3A jista' jwassal għal żieda fl-esponiment sistemiku ta' dawn il-prodotti mediċinali, li jista' jżid jew idewwem l-effett terapewtiku u r-reazzjonijiet avversi tagħhom.
English: How to store Symtuza
Maltese: X'fih Symtuza
English: ART-experienced patients
Maltese: TAL-PRODOTT MEDIĊINALI
English: Based on theoretical considerations DRV/COBI may increase methadone plasma concentrations.
Maltese: Abbażi ta' konsiderazzjonijiet teoretiċi DRV/COBI jista' jżid ilkonċentrazzjonijiet ta' methadone fil-plażma.
English: Cobicistat has no detectable antiviral activity against HIV-1 and does not antagonise the antiviral effect of darunavir, emtricitabine, or tenofovir.
Maltese: Cobicistat m'għandu l-ebda attività antivirali li tista' titkejjel kontra HIV-1 u ma jantagonizzax l-effett antivirali ta' darunavir, ta' emtricitabine, jew ta' tenofovir.
English: Immune reconstitution inflammatory syndrome
Maltese: Sindrom infjammatorju ta' rikostituzzjoni immuni
English: Concomitant use of Symtuza with lovastatin and simvastatin is contraindicated (see section 4.3).
Maltese: L-użu ta' Symtuza flimkien ma' lovastatin u simvastatin huwa kontraindikat (aras sezzjoni 4.3).
English: Tenofovir alafenamide was not mutagenic or clastogenic in conventional genotoxicity assays.
Maltese: Tenofovir alafenamide ma kienx mutaġeniku jew klastoġeniku f'analiżi konvnezjonali ta' effett tossiku fuq il-ġeni.
English: Patients should be informed that dizziness may occur when treated with Symtuza (see section 4.8).
Maltese: Il-pazjenti għandhom jiġu infurmati li jista' jseħħ sturdament meta jiġu ttrattati b'Symtuza (ara sezzjoni 4.8).
English: There have been reports of mitochondrial dysfunction in HIV negative infants exposed in utero and/or postnatally to nucleoside analogues.
Maltese: Kien hemm rapporti ta' disfunzjoni tal-mitokondrija fi trabi li huma negattivi għallHIV u li kienu esposti għall-analogi tan-nukleosidi in utero u/jew wara t-twelid.
English: Clinical monitoring is recommended, as maintenance therapy may need to be adjusted in some patients.
Maltese: Huwa rrakkomandat monitoraġġ kliniku, minħabba li jista' jkun li t-terapija ta' manteniment tkun teħtieġ li tiġi aġġustata f'xi pazjenti.
English: The data from these studies showed that the overall safety profile of components of Symtuza in paediatric patients aged 12 to < 18 years and weighing at least 40 kg was similar to that observed in the adult population (see section 5.1).
Maltese: Id-dejta minn dawn l-istudji uriet li l-profil globali ta' sigurtà talkomponenti ta' Symtuza f'pazjenti pedjatriċi li għandhom minn 12 sa < 18-il sena u jiżnu mill-inqas 40 kg kienet tixbah dik osservata fil-popolazzjoni adulta (ara sezzjoni 5.1).
English: The concomitant use of Symtuza with alfusozin is contraindicated (see section 4.3).
Maltese: L-użu ta' Symtuza flimkien ma' alfusozin huwa kontraindikat (ara sezzjoni 4.3).