FrancophonIA/ELRC3.0 huggingface dataset:
English: Plasma concentrations of tipranavir can be reduced by concomitant use of the herbal preparation St John's wort (Hypericum perforatum).
Maltese: Il-konċentrazzjonijiet fil-plażma ta' tipranavir jistgħu jitnaqqsu blużu fl-istess ħin tal-preparazzjoni li ġejja mill-ħxejjex St John's wort (Hypericum perforatum).
English: Tipranavir showed no evidence of genetic toxicity in a battery of in vitro and in vivo tests.
Maltese: Tipranavir ma wera l-ebda prova ta' tossiċità għal materjal ġenetiku wara li saru sensiela ta' testijiet in vitro u in vivo.
English: These belong to a class of HIV medicines called nucleoside reverse transcriptase inhibitors (NRTIs).
Maltese: Dawn jappartjenu għal klassi ta' mediċini tal-HIV li jissejħu impedituri ta' nucleoside reverse transcriptase (NRTIs).
English: Midazolam Cmax ↔ Midazolam AUC ↑ 5.1 fold
Maltese: L-ewwel doża ta' tipranavir/r: Cmax ta' Midazolam ↔ AUC ta' Midazolam ↑ 5.1 darbiet
English: NAME OF THE MEDICINAL PRODUCT Aptivus 250 mg soft capsules
Maltese: Aptivus 250 mg kapsuli rotob
English: - Sleepiness - Dizziness - Numbness and/or tingling and/or pain in the feet or hands - Breathing difficulties - Heartburn - Inflammation of the pancreas - Skin inflammation - Itching - Muscle cramp - Muscle pain - Kidney disease - Flu like symptoms (feeling unwell) - Fever - Weight loss - Increased blood levels of the pancreas enzyme amylase - Increases in liver enzyme activity - Hepatitis with liver cell damage due to influence of a toxin
Maltese: - Sintomi bħal tal-influwenza (ma tħossokx f'sikktek) - Deni - Telf ta' piż - Żieda fil-livelli tal-enzima tal-frixa amylase fid-demm - Żieda fl-attività enzimatika tal-fwied - Epatite bi ħsara fiċ-ċelluli tal-fwied minħabba influwenza ta' tossina
English: Concentrations of cyclosporin, tacrolimus, or sirolimus cannot be predicted when co-administered with tipranavir co-administered with low dose ritonavir, due to conflicting effect of tipranavir, coadministered with low dose ritonavir, on CYP 3A and P-gp.
Maltese: Konċentrazzjonijiet ta' cyclosporin, tacrolimus, jew sirolimus ma jistgħux jiġu mbassra meta jingħataw flimkien ma' tipranavir mogħti flimkien ma' doża baxxa ta' ritonavir, minħabba effett konfliġġenti ta' tipranavir, mogħti flimkien ma' doża baxxa ta' ritonavir, fuq CYP 3A u P-gp.
English: The most abundant faecal metabolite, at 4.9% of faecal radioactivity (3.2% of dose), was a hydroxyl metabolite of tipranavir.
Maltese: L-aktar metabolit ta' tipranavir li nstab fl-ippurgar kien il-hydroxyl u ta riżultat ta' 4.9% tar-radjuattivita ta' l-ippurgar (3.2% tad-doża).
English: The clinical relevance of the reduced loperamide plasma concentration is unknown.
Maltese: Irrilevanza klinika tal-konċentrazzjoni mnaqqsa ta' loperamide fil-plażma mhijiex magħrufa.
English: At steady state, there was a significant induction of CYP 1A2 and a slight induction on CYP 2C9.
Maltese: Fl-istat fiss kien hemm sensibilazzjoni sinifikanti ta' CYP 1A2 u induzzjoni żgħira ta' CYP 2C9.
English: The metabolism of tipranavir in the presence of low dose ritonavir is minimal.
Maltese: Il-metaboliżmu ta' tipranavir fil-preżenza ta' doża baxxa ta' ritonavir hu minimu.
English: Analyses were conducted to assess virological outcome by the number of primary PI mutations (any change at protease codons 30, 32, 36, 46, 47, 48, 50, 53, 54, 82, 84, 88 and 90) present at baseline.
Maltese: Analiżi sar ukoll sabiex jassessja ukoll l-eżitu viroloġiku skond l-għadd ta' mutazzjonijiet primarji ta' PIs (kull bidla fil-protease codons 30, 32, 36, 46, 47, 48, 50, 53, 54, 82, 84, 88 u 90) preżenti fil-livell ta' riferiment bażi.
English: Baseline phenotypic susceptibility was evaluated in 454 baseline patient samples.
Maltese: Suxxetibilità fenotipika ta' riferiment bażi ġiet evalwata f'454 kampjun ta' pazjent ta' riferiment bażi.
English: In an open-label, dose-finding study of tipranavir plus ritonavir (Trial 1182.14), 28 children who were 12 years of age or above received Aptivus capsules.
Maltese: Fi studju sabiex tinstab id-doża adattata bit-tikketta tidher ta' tipranavir li ngħata flimkien ma' ritonavir (Prova 1182.14), 28 tifel u tifla li kien għad ma għalqux 12-il sena rċevew kapsuli ta' Aptivus.
English: All patients * Includes patients who did not receive ENF and those who were previously treated with and continued ENF ** Mutations in HIV protease at positions L10V, I13V, K20M/R/V, L33F, E35G, M36I, K43T, M46L, I47V, I54A/M/V, 58E, H69K, T74P, V82L/T, N83D or I84V ENF Enfuvirtide; TPV/r Tipranavir with ritonavir
Maltese: Pazjenti kollha -2.0 * Jinkludi pazjenti li ma rċevewx ENF u dawk li qabel kienu ttrattati bi u kontinwament b'ENF ** Mutazzjonijiet f'HIV protease fil-pożizzjonijiet L10V, I13V, K20M/R/V, L33F, E35G, M36I, K43T, M46L, I47V, I54A/M/V, 58E, H69K, T74P, V82L/T, N83D jew I84V ENF Enfuvirtide;
English: For patients with renal impairment dose reduction of clarithromycin should be considered (see clarithromycin and ritonavir product information).
Maltese: Għal pazjenti b'indeboliment tal-kliewi, għandu jiġi kkunsidrat tnaqqis fid-doża ta' clarithromycin (ara l-informazzjoni dwar il-prodott ta' clarithromycin u ritonavir).
English: Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterial infections and pneumocystis pneumonia.
Maltese: Eżempji rilevanti huma infezzjonijiet b'cytomegalovirus retinitis, infezzjonijiet majkobatteriċi ġenerali u/jew iffokati u pneumocystis pneumonia.
English: Aptivus, co-administered with low dose ritonavir, is indicated for combination antiretroviral treatment of HIV-1 infection in highly pre-treated adults and adolescents 12 years of age or older with virus resistant to multiple protease inhibitors.
Maltese: Aptivus, li jingħata ma' doża baxxa ta' ritonavir, huwa indikat f'terapija antiretrovirali kombinata kontra l-infezzjoni bl-HIV-1 f'pazjenti adulti u adolexxenti ta' 12-il sena jew aktar li jkunu ġew ittrattati diversi drabi qabel u li għandhom il-virus reżistenti għall-enżimi multipli li jaġixxu fuq ilproteini.
English: In vitro, there is an inverse correlation between the degree of resistance to tipranavir and the capacity of viruses to replicate.
Maltese: In vitro, hemm korrelazzjoni inversa bejn il-qawwa tar-reżistenza kontra tipranavir u l-kapaċità tal-virus biex jirreplika.
English: Additional side effects in children and adolescents The most common side effects were generally similar to those described in adults.
Maltese: L-aktar effetti sekondarji komuni kienu ġeneralment simili bħal dawk deskritti f'adulti.
English: Due to reduction in the levels of the active metabolite norbuprenorphine, co-administration of Aptivus, coadministered with low dose ritonavir, and buprenorphine/naloxone may result in decreased clinical efficacy of buprenorphine.
Maltese: Minħabba t-tnaqqis fil-livelli talmetabolit attiv norbuprenorphine, lgħoti flimkien ta' Aptivus, mogħti flimkien ma' doża baxxa ta' ritonavir, u buprenorphine/ naloxone jista' jirriżulta fi tnaqqis tal-effikaċja klinika ta' buprenorphine.
English: If you have:
Maltese: NN:
English: Package leaflet: Information for the user Aptivus 250 mg soft capsules tipranavir
Maltese: Informazzjoni għall-utent Aptivus 250 mg kapsuli rotob tipranavir
English: The concurrent administration of tipranavir and low dose ritonavir may result in increased risk of cardiovascular adverse events associated with salmeterol, including QT prolongation, palpitations and sinus tachycardia.
Maltese: L-għoti fl-istess ħin ta' tipranavir u doża baxxa ta' ritonavir jista' jirriżulta f'żieda fir-riskju ta' avvenimenti avversi kardjovaskulari assoċjati ma' salmeterol, li jinkludu titwil tal-QT, palpitazzjonijiet u takikardija tassinus.
English: The superiority of tipranavir co-administered with low dose ritonavir over the comparator protease inhibitor/ritonavir arm was observed for all efficacy parameters at week 48.
Maltese: Is-superjorità ta' tipranavir, mogħti flimkien ma' doża baxxa ta' ritonavir fuq il-komparatur, impeditur tal-protease/ritonavir kien osservat fuq il-parametri ta' effikaċja kollha f'ġimgħa 48.
English: As demonstrated in a doseranging evaluation in 113 HIV-negative healthy male and female volunteers, ritonavir increases AUC012h, Cmax and Cmin and decreases the clearance of tipranavir.
Maltese: Prova b'diversi dożi fuq 113-il voluntiera rġiel u nisa f'saħħithom, li rriżultaw negattivi għal HIV, uriet li ritonavir iżid l-AUC 0-12h, Cmax and Cmin u jnaqqas ir-rata ta' l-eliminazzjoni totali mill-ġisem ta' tipranavir.
English: Tipranavir is a non-peptidic inhibitor of the HIV-1 protease that inhibits viral replication by preventing the maturation of viral particles.
Maltese: Tipranavir huwa impeditur ta' l-enżima HIV-1 protease, mhux peptidiku, li jimpedixxi r-replikazzjoni tal-virus billi ma' jħallix il-partiċelli virali jimmaturaw.
English: Co-administration of valaciclovir, tipranavir and low dose ritonavir was not associated with clinically relevant pharmacokinetic effects.
Maltese: L-għoti flimkien ta' valaciclovir, tipranavir u doża baxxa ta' ritonavir ma kienx assoċjat ma' effetti farmakokinetiċi klinikament rilevanti.
English: - bosentan (used to treat pulmonary artery hypertension) - halofantrine or lumefantrine (used to treat malaria) - tolterodine (used to treat overactive bladder (with symptoms of urinary frequency, urgency, or urge incontinence)) - boceprevir and telaprevir (used to treat hepatitis C) - cobicistat and products containing cobicistat (used to increase effectiveness of HIV medicines).
Maltese: frekwenza urinarja, urġenza, jew inkontinenza urġenti)) - boceprevir u telaprevir (jintużaw għall-kura epatite Ċ) - cobicistat u prodotti li fihom cobicistat (jintużaw biex iżidu l-effettività ta' mediċini kontra l
English: What Aptivus looks like and contents of the pack Aptivus soft capsules are pink coloured, oblong soft gelatin capsules with a black print imprint of ‘TPV 250'.
Maltese: Il-kapsuli rotob ta' Aptivus huma ta' lewn roża, tawwalin, kapsuli rotob tal-ġelatina, u fuqhom hemm stampat bl-iswed “TPV 250”.
English: NRTIs
Maltese: Remettar
English: The length of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this disease.
Maltese: It-tul tat-terapija antiretrovirali kombinata, l-użu ta' corticosteroids, il-konsum ta' alkoħol, immunosoppressjoni qawwija u indiċi korporali ogħla, fost oħrajn, jistgħu jkunu ftit mill-ħafna fatturi ta' riskju għall-iżvilupp tal-marda.
English: Nucleoside and nucleotide reverse transcriptase inhibitors (NRTIs) Since there is no significant impact of nucleoside and nucleotide analogues on the P450 enzyme system no dosage adjustment of Aptivus is required when co-administered with these agents.
Maltese: Impedituri nucleoside u nucleotide reverse transcriptase (NRTIs) Billi m'hemm l-ebda impatt sinifikanti ta' analogi ta' nucleoside u nucleotide fuq is-sistema tal-enzimi P450, l-ebda aġġustament fid-dożaġġ ta' Aptivus mhu meħtieġ meta jingħata flimkien ma' dawn ilmediċini.
English: Mutations at position 82 occur via two pathways: one from preexisting mutation 82A selecting to 82T, the other from wild type 82V selecting to 82L.
Maltese: Mutazzjonijiet f'pożizzjoni 82 jiżvillupaw permezz ta' żewġ modi: waħda minn mutazzjoni eżistenti 82A għal 82T, u l-oħra mit-tip selvaġġ 82V għal 82L.
English: Animal toxicology studies have been conducted with tipranavir alone, in mice, rats and dogs, and coadministered with ritonavir (3.75:1 w/w ratio) in rats and dogs.
Maltese: Saru studji tossikoloġiċi fuq l-annimali b'tipranavir biss, fuq ġriedien, firien u klieb, u b'tipranavir flimkien ma' ritonavir (bi proporzjon ta' 3.75:1 w/w) fuq firien u klieb.
English: A significant decrease in plasma concentrations of atazanavir and a marked increase of tipranavir and ritonavir concentrations was observed when Aptivus, associated with low dose ritonavir, was coadministered with atazanavir (see section 4.5).
Maltese: Tnaqqis sinifikanti fil-konċentrazzjonijiet tal-plażma ta' atazanavir u żjieda notevoli fil-konċentrazzjonijiet ta' tipranavir u ritonavir ġiet osservata meta Aptivus, assoċjat ma' doża baxxa ta' ritonavir, ġew mogħtija flimkien ma' atazanavir (ara sezzjoni 4.5).
English: Hepatotoxicity
Maltese: Antibijotiċi
English: Aptivus must always be given with low dose ritonavir as a pharmacokinetic enhancer, and in combination with other antiretroviral medicinal products.
Maltese: Aptivus għandu dejjem jingħata ma' doża baxxa ta' ritonavir bħala promotur farmakokinetiku, u flimkien ma' prodotti mediċinali antiretrovirali oħrajn.
English: In addition, most radioactivity (56%) was excreted between 24 and 96 hours after dosing.
Maltese: Barra minn hekk, l-ogħla radjuattività (56%) kienet eliminata bejn 24 u 96 siegħa wara t-teħid tad-doża.
English: Concomitant use of Aptivus, coadministered with low dose ritonavir, and oral midazolam is contra-indicated (see section 4.3).
Maltese: L-użu fl-istess ħin ta' Aptivus, mogħti flimkien ma' doża baxxa ta' ritonavir, u midazolam orali, hu kontraindikat (ara sezzjoni 4.3).
English: Ritonavir is a potent inhibitor of CYP3A4 and therefore affect drugs metabolised by this enzyme.
Maltese: Ritonavir hu impeditur qawwi ta' CYP3A4 u għalhekk jaffettwa mediċini metabolizzati minn din l-enzima.
English: Metabolism and nutrition disorders common hypertriglyceridaemia, hyperlipidaemia uncommon anorexia, decreased appetite, weight decreased, hyperamylasaemia, hypercholesterolaemia, diabetes mellitus, hyperglycaemia rare dehydration
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni komuni ipertrigliċeridemija, iperlipidimja mhux komuni anoreksja, nuqqas ta' aptit, tnaqqis fil-piż, iperamijalasemija, iperkolesterolemija, dijabete mellitus, ipergliċemija rari deidrazzjoni
English: Whilst the changes in clarithromycin parameters are not considered clinically relevant, the reduction in the 14-OH metabolite AUC should be considered for the treatment of infections caused by Haemophilus influenzae in which the 14-OH metabolite is most
Maltese: Filwaqt li tibdil fil-parametri ta' clarithromycin mhumiex kkunsidrati li huma klinikament rilevanti, it-tnaqqis fl-AUC tal-metabolit 14-OH, għandu jiġi kkunsidrat għall-kura ta' infezzjonijiet ikkawżati minn Haemophilus influenzae li fihom ilmetabolit 14-OH hu l-aktar attiv.
English: If another cause is identified (eg acute hepatitis A, B or C virus, gallbladder disease, other medicinal products), then rechallenge with Aptivus may be considered when ASAT/ALAT have returned to the patient's baseline levels.
Maltese: Jekk kawża oħra tiġi identifikata (eż. virus ta' l-epatite A, B jew Ċ akuta, mard tal-marrara, prodotti mediċinali oħra), allura l-għoti mill-ġdid ta' Aptivus għandu mnejn jiġi kkonsidrat la darba l-ASAT/ALAT ikunu rritornaw fil-livelli ta' riferiment bażi tal-pazjent.
English: C-tipranavir with 200 mg ritonavir, twice daily), unchanged tipranavir was predominant and accounted for 98.4% or greater of the total plasma radioactivity circulating at 3, 8, or 12 hours after dosing.
Maltese: C-tipranavir ma' ritonavir 200 mg, darbtejn kuljum), irriżulta li tipranavir mhux mibdul kien aktar predominanti u kien jammonta għal 98.4% jew iżjed tar-radjuattività totali tal-plażma li kienet qed tiċċirkula 3, 8, jew 12-il siegħa wara li ttieħdet id-doża.
English: Paediatric population The oral solution has been shown to have greater bioavailability than the soft capsule formulation.
Maltese: Is-soluzzjoni orali intweriet li għandha bijodisponibilità ogħla mill-formulazzjoni tal-kapsula ratba.
English: A 5 ml oral syringe and adapter is supplied for dosing.
Maltese: Siringa orali ta' 5 ml u adapter huma fornuti għad-dożaġġ.
English: In addition, co-administration of Aptivus with low dose ritonavir, and medicinal products that are highly dependent on CYP2D6 for clearance, such as the antiarrhythmics flecainide, propafenone and metoprolol given in heart failure (see section 4.5).
Maltese: Barra minn hekk, l-għoti konġunt ta' Aptivus flimkien ma' ritonavir b'doża baxxa u prodotti mediċinali oħra li l-eliminazzjoni tagħhom tiddependi prinċipalment fuq CYP2D6, bħall-anti-arritmiċi flecainide, propafenone u metoprotol mogħti f'falliment kardijaku (ara sezzjoni 4.5).
English: Baseline characteristics for patients 2 - <12 years treated with Aptivus oral solution
Maltese: Karatteristiċi ta' linja bażi għal pazjenti ta' bejn 2 - <12-il sena trattati b'soluzzjoni orali ta' Aptivus
English: An increased risk of ICH has previously been observed in patients with advanced HIV disease/AIDS such as those treated in the Aptivus clinical trials.
Maltese: Riskju ogħla ta' ICH kien osservat qabel f'pazjenti li għandhom HIV/AIDS bħal dawk trattati fil-provi kliniċi ta' Aptivus.
English: Tipranavir pharmacokinetics have not been studied in patients with renal impairment.
Maltese: Il-farmakokinetika ta' tipranavir ma ġietx mistħarrġa f'pazjenti li għandhom indeboliment renali.
English: RESIST-1 and RESIST-2 are ongoing, randomised, open-label, multicentre studies in HIV-positive, triple-class experienced patients, evaluating treatment with tipranavir 500 mg co-administered with low dose ritonavir 200 mg (twice daily) plus an optimised background regimen (OBR) individually defined for each patient based on genotypic resistance testing and patient history.
Maltese: Il-provi RESIST-1 u RESIST-2 li għadhom għadejjin, huma mingħajr ordni partikolari, bittikketta-miftuħa, multi-ċentrali u qed isiru fuq pazjenti li rriżultaw pożittivi għal HIV u b'esperjenza ta' klassi-tripla, u dawn qed jivvalutaw it-trattament b'500 mg ta' tipranavir mogħti flimkien ma' ritonavir b'doża baxxa, (500 mg/200 mg darbtejn kuljum), kif ukoll trattament sekondarju ottimizzat (OBR) li huwa speċifiku għall-pazjent u bbażat skond ir-riżultati tat-testijiet dwar ir-reżistenza ġenotipika kif ukoll skond l-istorja medika tal-pazjent.
English: Based on theoretical considerations, tipranavir, co-administered with low dose ritonavir, is expected to increase pimozide, sertindole, quetiapine and lurasidone concentrations.
Maltese: Ibbażat fuq konsiderazzjonijiet teoretiċi, tipranavir mogħti flimkien ma' doża baxxa ta' ritonavir, hu mistenni li jżid ilkonċentrazzjonijiet ta' pimozide, sertindole, quetiapine u lurasidone.
English: Patients with mild hepatic impairment (Child-Pugh Class A) should be closely monitored.
Maltese: Pazjenti li għandhom ideboliment epatiku ħafif (Child-Pugh Klassi A) għandhom jiġu monitorati mill-qrib.
English: Rash consists of one or more of the preferred terms of rash, drug eruption, rash macular, rash papular, erythema, rash maculo-papular, rash pruritic, and urticaria.
Maltese: Raxx li jikkonsisti f'wieħed jew aktar tat-termini ppreferuti ta' raxx, eruzzjoni ta' mediċina, raxx makulari, raxx papulari, eritema, raxx makulo-papulari, raxx minħabba l-ħakk u urtikarja.
English: Nevertheless, the clinical data available from the RESIST trials did not suggest any significant alteration of the tipranavir with ritonavir safety profile when combined with enfuvirtide as compared to patients treated with tipranavir with ritonavir without enfuvirtide.
Maltese: Madankollu, id-dejta klinika disponibbli millprovi RESIST ma tissuġġerixxi lebda bidla sinifikanti tal-profil tassigurtà ta' tipranavir ma' ritonavir meta jiġi kkombinat ma' enfuvirtide meta mqabbel ma' pazjenti kkurati b'tipranavir ma' ritonavir mingħajr enfuvirtide.
English: Relationships between baseline phenotypic susceptibility to tipranavir, primary PI mutations, protease mutations at codons 33, 82, 84 and 90, tipranavir resistance-associated mutations, and response to tipranavir with ritonavir therapy were assessed.
Maltese: Ir-relazzjonijiet bejn is-suxxetibilità fenotipika ta' riferiment għal tipranavir, il-mutazzjonijiet primarji ta' PI, mutazzjonijiet tal-protease f'kodons 33, 82, 84 u 90, il-mutazzjonijiet assoċjati mar-reżistenza ta' tipranavir, u r-rispons għat-terapija ta' tipranavir ma' ritonavir ġew assessjati.
English: Breastfeeding
Maltese: Rilpivirine
English: Patients with moderate or severe (Child-Pugh B or C) hepatic impairment.
Maltese: F'pazjenti li għandhom indeboliment epatiku minn moderat sa serju (Child-Pugh B jew Ċ).
English: Amber glass bottle, with two-piece plastic child-resistant closure (outer shell high density polyethylene (HDPE), inner shell polypropylene resin with a foamed laminated polyethylene liner.. Each pack contains 1 bottle of 95 ml oral solution and is supplied with a clear polypropylene 5 ml oral syringe, HDPE syringe tip cap and clear LDPE bottle-syringe adapter.
Maltese: Kull pakkett fih flixkun wieħed ta' 95 ml ta' soluzzjoni orali u huwa fornut b'siringa orali ċara ta' 5 ml tal-polypropylene, għatu tat-tarf tas-siringa tal-HDPE u adapter ċar tal-LDPE tal-flixkun-siringa.
English: Protease inhibitors
Maltese: Impedituri ta' enżimi protease
English: 150 mg/m 2 ritonavir, twice daily.
Maltese: Aptivus li għandu jingħata ma' 150 mg/m 2 ritonavir, darbtejn kuljum.
English: In rats, co-administration with vitamin E increased the bleeding effects of tipranavir (see section 5.3).
Maltese: Fil-firien, meta ngħata flimkien ma' vitamina E kien hemm żieda fl-effetti ta' emorraġija ta' tipranavir (ara sezzjoni 5.3).
English: Each bottle contains 120 soft capsules.
Maltese: Kull flixkun fih 120 kapsula ratba.
English: Most frequently reported moderate or severe adverse reactions in paediatric patients aged 12 to 18 years who took Aptivus capsules (reported in 2 or more children, Trial 1182.14, week 48 analyses, Full Analysis Set).
Maltese: L-aktar reazzjonijiet avversi moderati jew severi f'pazjenti pedjatriċi minn età ta' 12 sa 18-il sena li ħadu l-kapsuli Aptivus (rapportati f'żewġt itfal jew aktar, fil-Prova 1182.
English: This adverse reaction was identified through post-marketing surveillance but not observed in randomised controlled clinical trials (n=6300).
Maltese: Din ir-reazzjoni avversa ġiet identifikata minn sorveljanza ta' wara t-tqegħid fis-suq iżda ma ġietx osservata fi provi kliniċi kkontrollati li fihom il-parteċipanti ntgħażlu b'mod każwali (n=6300).
English: Since Aptivus capsules and oral solution are not bioequivalent, results obtained with the oral solution cannot be extrapolated to the capsules (see also section 5.2).
Maltese: Peress li l-kapsuli u s-soluzzjoni orali ta' Aptivus mhumiex bijoekwivalenti, ir-riżultati miksuba bis-soluzzjoni orali ma jistgħux jiġu estrapolati għal fuq il-kapsuli (ara wkoll sezzjoni 5.2).
English: The following medicines are not recommended: - fluticasone (used to treat asthma) - atorvastatin (used to lower blood cholesterol) - salmeterol (used to achieve long-term asthma control, bronchospasm prevention with COPD) - bosentan (used to treat pulmonary artery hypertension) - halofantrine or lumefantrine (used to treat malaria) - tolterodine (used to treat overactive bladder (with symptoms of urinary frequency, urgency, or urge incontinence)) - boceprevir and telaprevir (used to treat hepatitis C) - cobicistat and products containing cobicistat (used to increase effectiveness of HIV medicines).
Maltese: Il-mediċini li ġejjin mhumiex rakkomandati - fluticasone (użat għat-trattament tal-ażma) - atorvastatin (użat biex ibaxxi l-livell ta' kolesterol fid-demm) - salmeterol (jintuża biex jinkiseb kontroll fit-tul tal-ażżma, prevenzjoni ta' bronkospażmu b'COPD) - bosentan (jintuża għall-kura ta' pressjoni għolja arterjali pulmonari). - halofantrine jew lumefantrine (jintużaw għal kura tal-malarja) - tolterodine (jintuża għal kura ta' bużżieqa tal-awrina li tkun attiva żżejjed (b'sintomi ta'
English: The ritonavir-boosted PI was chosen from among saquinavir, amprenavir, indinavir or lopinavir/ritonavir.
Maltese: Ir-ritonavir mqawwi b'PI kien magħżul minn fost saquinavir, amprenavir, indinavir jew lopinavir/ritonavir.
English: Concomitant use of Aptivus, coadministered with low dose ritonavir, and rifampicin is contraindicated (see section 4.3).
Maltese: L-użu fl-istess ħin ta' Aptivus, mogħti flimkien ma' doża baxxa ta' ritonavir, u rifampicin, hu kontraindikat (ara sezzjoni 4.3).