FrancophonIA/ELRC3.0 huggingface dataset:
English: Each of the clinical pharmacokinetic studies (single dose (SD) as well as multiple dose (MD)), confirmed that for the Fentrix patch, the percentage of skin irritation scores of 0 (no irritation) and score 1 (minimal erythema, barely perceptible, scoring according to the FDA Guidance for industry, Skin Irritation and Sensitization Testing of Generic Transdermal Products) reached more than 90 %.
Maltese: Kull wieħed mill-istudji kliniċi farmakokinetiċi (b'doża unika (SD) kif ukoll b'doża multipla (MD)), ikkonferma li għall-istikk ta' Fentrix, il-perċentwal ta' punteġġ 0 ta' irritazzjoni tal-ġilda (ebda irritazzjoni) u punteġġ 1 (eritema minima, li kważi ma tistax tiġi pperċepita, bl-għoti ta' punti skont il-Gwida tal-FDA għall-industrija, Irritazzjoni tal-Ġilda u l-Ittestjar tasSensitizzazzjoni tal-Prodotti Transdermiċi Ġeneriċi) laħaq aktar minn 90%.
English: - the Fentrix transdermal patch was shown to be well tolerated and comparable to the reference medicinal product Dorogesic the CHMP has recommended the granting of the Marketing Authorisation for which the Summary of Product Characteristics, labelling and package leaflet remain as per the final versions achieved during the Coordination group procedure as mentioned in Annex III for Fentrix and associated names (see Annex I).
Maltese: - l-istikk transdermiku ta' Fentrix wera li huwa tollerata sew u li huwa komparabbli mal-prodott mediċinali ta' referenza Dorogesic is-CHMP rrakkomanda li tingħata l-Awtorizzazzjoni għat-Tqegħid fis-Suq, li s-Sommarju talKaratteristiċi tal-Prodott, it-tikketta u l-fuljett ta' tagħrif tagħha jibqgħu bħall-verżjonijiet finali miksuba matul il-proċedura tal-grupp ta' Koordinament kif imsemmi fl-Anness
English: Single dose study: the mean score for test was 0.39 and 0.25 for the reference.
Maltese: Studju b'doża waħda: il-punteġġ medju għat-test kien ta' 0.39 u 0.25 għar-referenza.
English: Multiple dose study: the number of observations with skin irritation above score 1 was 77 for the test and 56 for the reference, in the same number (26) of subjects with skin irritation.
Maltese: Studju b'doża multipla: l-għadd ta' osservazzjonijiet b'irritazzjoni tal-ġilda b'punteġġ ta' aktar minn 1 kien ta' 77 għat-test u 56 għar-referenza, fl-istess numru (26) ta' suġġetti b'irritazzjoni tal-ġilda.
English: More importantly, the Applicant reproduced the statistically significant product effect for the single dose study (p= 0.0371), whereas for the multiple dose study the differences were not statistically significant (p=0.0716).
Maltese: 0371), filwaqt li għall-istudju b'doża multipla, id-differenzi ma kinux statistikament sinifikanti (p=0.0716).
English: The Applicant acknowledged that only non-clinical single dose studies have been performed in spite of the fact that section 4.2 “Dermal tolerance testing” of the Note for Guidance on Non-clinical Tolerance Testing of Medicinal Products (CPMP/SWP/2145/00), indicates that dermal tolerance is tested by a single and repeat dose administration and an evaluation of the sensitising potential.
Maltese: L-Applikant irrikonoxxa li saru biss studji ta' dożaġġ uniku mhux kliniċi minkejja l-fatt li s-sezzjoni 4.2 “Prova dwar it-tolleranza dermika” tan-Nota ta' Gwida dwar il-Provi Mhux Kliniċi ta' Tolleranza ta' Prodotti Mediċinali (CPMP/SWP/2145/00), tindika li t-tolleranza dermikahija ttestjata b'amministrazzjoni ta' doża waħda u ripetuta u b'evalwazzjoni tal-potenzjal ta' sensitizzazzjoni.
English: Fentanyl is a synthetic opioid analgesic, belonging to the piperidine derivatives, and is chemically related to pethidine.
Maltese: Fentanyl huwa analġeżiku oppjojde sintetiku, li jappartjeni għad-derivati tal-piperidine, u huwa relatat kimikament ma' pethidine.
English: In Study A/PK 02-P013, skin reactions were assessed in compliance with existing guidance on single dermal tolerance tests (CPMP/SWP/2145/00) and were rated negligible to slightly irritant for both test item and reference patch.
Maltese: Fl-Istudju A/PK 02-P013, ir-reazzjonijiet tal-ġilda ġew ivvalutati f'konformità mal-gwida eżistenti dwar it-testijiet singoli ta' tolleranza dermika (CPMP/SWP/2145/00) u ġew stmati bħala negliġibbli għal ftit irritanti kemm għall-oġġett li kien qiegħed jiġi ttestjat kif ukoll għall-istikk ta' referenza.
English: Performing this model, statistically significant differences were found between treatments in both studies (the single dose study and the multiple dose study), and the point estimate of the odds ratio was 8.35 in the single dose study and 1.45 in the multiple dose study.
Maltese: Fl-eżekuzzjoni ta' dan il-mudell, instabu differenzi statistikament sinifikanti bejn it-trattamenti fiż-żewġ studji (l-istudju b'doża waħda u listudju b'doża multipla), u l-istima tal-punti tal-proporzjon ta' probbabiltà kienet ta' 8.35 fl-istudju b'doża waħda u 1.45 fl-istudju b'doża multipla.
English: Both clinical pharmacokinetic studies, single dose (SD) as well as multiple dose (MD), confirmed that the Fentrix patch is in general well tolerated when applied to the human skin.
Maltese: Iż-żewġ studji farmakokinetiċi kliniċi, ta' doża waħda (single dose - SD) kif ukoll ta' doża multipla (multiple doseMD), ikkonfermaw li l-istikk ta' Fentrix huwa ġeneralment tollerat sew meta jiġi applikat fuq il-ġilda tal-bniedem.
English: If it can be agreed that irritation scores at or below 1 are without clinical relevance and that more than 90 % of the reported incidences are well within this accepted range, it would consequently be erroneous to base the decision about a potential serious risk solely on a small portion (less than 4 % (SD) respectively 9 % (MD)) of the entity.
Maltese: Jekk jista' jintlaħaq qbil li punti ta' irritazzjoni ta' 1 jew taħtu m'għandhom ebda rilevanza klinika u li aktar minn 90% tal-inċidenzi rrappurtati jaqgħu sew fi ħdan din il-medda aċċettata, konsegwentament ikun żbaljat li wieħed jibbaża d-deċiżjoni dwar riskju potenzjali gravi biss fuq proporzjon żgħir (inqas minn 4 % (SD) rispettivament 9 % (MD)) tal-entità.
English: The transdermal fentanyl patch technology has been used clinically to provide analgesia since 1991.
Maltese: It-teknoloġija tal-istikk transdermiku fentanyl ilha tintuża klinikament biex tipprovdi l-analġeżija mill1991.
English: However, the objecting Concerned Member State (CMS) considered that the authorisation of this medicinal product Fentrix, transdermal patch, may present a potential serious risk to public health on the grounds of non-clinical and clinical safety.
Maltese: Madankollu, l-Istat Membru kkonċernat li oġġezzjona kkunsidra li l-awtorizzazzjoni ta' dan il-prodott mediċinali Fentrix, stikk transdermiku, tista' tippreżenta riskju potenzjali gravi għas-saħħa pubblika minħabba raġunijiet ta' sigurtà mhux klinika u klinika.
English: This can be possibly attributed to different algorithms/specifications of the model or similar reasons.
Maltese: Dan jista' jiġi attribwit għal algoritmi/speċifikazzjonijiet differenti tal-mudell jew raġunijiet simili.
English: Taking all these aspects into consideration, the CHMP accepted the argument that the available nonclinical data sufficiently demonstrate the comparable local tolerability of Fentrix and Dorogesic.
Maltese: Wara li kkunsidra dawn l-aspetti kollha, is-CHMP aċċetta l-argument li d-dejta mhux klinika disponibbli turi b'mod suffiċjenti t-tollerabbiltà lokali komparabbli ta' Fentrix u Dorogesic.
English: Transdermal patches are applied to intact skin in order to deliver at a constant rate the active substance to the systemic circulation.
Maltese: L-istikks transdermiċi jiġu applikati fuq ġilda intatta sabiex jagħtu s-sustanza attiva liċċirkolazzjoni sistemika b'rata kostanti.
English: Today fentanyl is extensively used as an anaesthetic and analgesic.
Maltese: Illum fentanyl jintuża b'mod estensiv bħala anestetiku u analġeżiku.
English: The dermal tolerability of the current bilayer patch formulation was non-clinically analysed in comparison to the reference product “Dorogesic 25” in rabbits as part of the pharmacokinetic studies A/PK 02-P012 and A/PK 02-P013.
Maltese: It-tollerabbiltà dermika tal-formulazzjoni attwali tal-istikk b'saff doppju ġiet analizzata b'mod mhux kliniku mqabbla mal-prodott ta' referenza “Dorogesic 25” fil-fniek bħala parti mill-istudji farmakokinetiċi
English: Hence, efficacy and systemic tolerability of the active substance remains unaffected.
Maltese: Għalhekk, l-effikaċja u t-tollerabiltà sistemika tas-sustanza attiva jibqgħu mhux affettwati.
English: Therefore, the elimination half-life is longer compared to other administration routes, with about 17 h for fentanyl after transdermal administration, compared to parenteral and transmucosal administered drug of 7 h. The release of the drug from the patch is controlled without membrane.
Maltese: Għalhekk, il-half life tal-eliminazzjoni huwa itwal meta mqabbel ma' rotot ta' amministrazzjoni oħrajn, b'madwar 17-il siegħa għal fentanyl wara amministrazzjoni transdermika, meta mqabbel mal-amministrazzjoni parenterali u transmukożali ta' 7 sigħat.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANT IN THE MEMBER STATES
Maltese: ANNESS I LISTA TA'L-ISMIJIET, GĦAMLIET FARMAĊEWTIKA, QAWWIET TAL-PRODOTTI MEDIĊINALI, MNEJN JINGĦATA, L-APPLIKANTI, ID-DETENTURI TA` LAWTORIZZAZZJONI GĦAT-TQEGĦID
English: Therefore, the objecting MS were of the view that the difference was not only statistically significant but that the difference was also considered to be clinically relevant.
Maltese: Għalhekk, l-Istati Membri li oġġezzjonaw kienu talopinjoni li d-differenza ma kinitx biss statistikament sinifikanti iżda li d-differenza kienet ikkunsidrata wkoll bħala klinikament rilevanti.
English: The Applicant's justification was that the evaluation of the local tolerance after repeat dose administration has been carried out during the multiple dose bioequivalence study in humans.
Maltese: Ilġustifikazzjoni tal-Applikant kienet li l-evalwazzjoni tat-tolleranza lokali wara amministrazzjoni b'doża ripetuta saret matul l-istudju ta' bijoekwivalenza b'doża multipla fil-bnedmin.
English: The issue was referred to the CMD(h) and an assessment was carried out by the Reference Member State (RMS).
Maltese: Il-kwistjoni ġiet riferuta lis-CMD(h) u l-Istat Membru ta' Referenza għamel valutazzjoni.
English: Germany transdermique/transdermales Pflaster
Maltese: Mikrogramm/h Transdermales Pflaster
English: The McNemar test was then used investigating whether significant differences between the test and the reference in the number of patients who suffered adverse events were observed or not.
Maltese: Imbagħad intuża t-test McNemar biex jinvestiga jekk ġewx osservati differenzi sinifikanti bejn it-test u r-referenza fl-għadd ta' pazjenti li ġarrbu episodji avversi.
English: In principle, the non-clinical data on local tolerance of the bilayer patch should have been complemented by an analysis of its sensitisation potential.
Maltese: Fil-prinċipju, id-dejta mhux klinika dwar it-tolleranza lokali tal-istikk b'saff doppju kellha tiġi appoġġata minn analiżi tal-potenzjal ta' sensitizzazzjoni tagħha.
English: As absence of any sensitising potential is also well-known for the active substance and all other excipients of the patch and could be clinically confirmed (see below), no new information can be reasonably expected from additional studies in animals.
Maltese: Minħabba li n-nuqqas ta' kwalunkwe potenzjal ta' sensitizzazzjoni huwa wkoll magħruf għas-sustanza attiva u s-sustanzi mhux attivi l-oħrajn kollha tal-istikks u dan jista' jiġi kkonfermat klinikament (ara hawn taħt), ebda informazzjoni ġdida ma tista' tkun mistennija b'mod raġonevoli minn studji addizzjonali fuq l-annimali.
English: Fentanyl Helm Pharmaceuticals 100µg/h Pleister voor transdermaal gebruik/Dispositif
Maltese: Fentanyl Helm Pharmaceuticals 100µg/h Pleister voor transdermaal gebruik/Dispositif transdermique/transdermales Pflaster
English: To clarify the clinical relevance of these concerns and to assess the significance of the statistical analysis performed by the CMS, the following points were considered by the CHMP:
Maltese: Biex tiġi ċċarata r-rilevanza klinika ta' dan it-tħassib u biex jiġi vvalutat is-sinifikat tal-anliżi statistika mwettqa mill-Istat Membru kkonċernat, is-CHMP kkunsidra l-punti li ġejjin:
English: The guideline on non-clinical investigations of local tolerance was developed before the introduction of transdermal systems.
Maltese: Il-linja gwida dwar investigazzjonijiet mhux kliniċi ta' tolleranza lokali ġiet żviluppata qabel lintroduzzjoni ta' sistemi transdermiċi.
English: Once the patch is applied to the skin the drug diffuses in the subcutaneous tissues and forms a reservoir.
Maltese: Ladarba l-istikk jiġi applikat mal-ġilda, il-mediċina tinxtered fit-tessuti subkutanji u tifforma depożitu.
English: They shall ensure that Glybera is only supplied if the healthcare professionals involved in the treatment of a patient have received the educational pack and if the prescriber confirms that the patient agrees to participate in the registry.
Maltese: Għandhom jiżguraw li Glybera jingħata biss jekk il-professjonisti tal-kura tas-saħħa involuti fil-kura tal-pazjenti jkunu ngħataw il-pakkett edukattiv u jekk min jagħti l-prodott b'riċetta jikkonferma li l-pazjent jaqbel li jipparteċipa fir-reġistru.
English: Observed difference (95% CI)
Maltese: Differenza osservata (95% CI)
English: Tenofovir/emtricitabine
Maltese: Tenofovir/emtricitabin
English: Week 240 N=32
Maltese: Ġimgħa 240 N=32
English: HMG CO-A REDUCTASE INHIBITORS Atorvastatin*
Maltese: IMPEDITURI TA' HMG CO-A REDUCTASE Atorvastatin*
English: MACROLIDE ANTIBIOTICS Clarithromycin
Maltese: ANTIBIJOTIĊI MACROLIDE Clarithromycin
English: ANTIMYCOBACTERIALS Rifabutin*
Maltese: ANTIMIKOBATTERIĊI Rifabutin*
English: PHOSPHODIESTERASE TYPE 5 (PDE-5) INHIBITORS Sildenafil*
Maltese: TA' PHOSPHODIESTERASE TAT-TIP 5 (PDE-5) Sildenafil*
English: NARCOTIC ANALGESICS Methadone*
Maltese: ANALĠEŻIĊI NARKOTIĊI Methadone*
English: Rilpivirine inhibits P-glycoprotein in vitro (IC50 is 9.2 μM).
Maltese: Rilpivirine jimpedixxi P-glycoprotein in vitro (IC50 is 9.2 μM).
English: Other boosted PIs (atazanavir/ritonavir, fosamprenavir/ritonavir, saquinavir/ritonavir, tipranavir/ritonavir)
Maltese: PIs rinforzati oħra (atazanavir/ritonavir, fosamprenavir/ritonavir, saquinavir/ritonavir, tipranavir/ritonavir)
English: OTHER AGENTS ANTICONVULSANTS Carbamazepine Oxcarbazepine Phenobarbital Phenytoin
Maltese: SUSTANZI OĦRA ANTIKONVULŻIVI Carbamazepine Oxcarbazepine Phenobarbital Phenytoin
English: 60-100 mg once daily, individualised dose
Maltese: 60-100 mg darba kuljum, doża individwalizzata
English: 6 cells/l (range: 25 to 983 × 10
Maltese: 6 ċellula/l (firxa: 25 sa 983 x 10
English: ANTACIDS Antacids (e.g., aluminium or magnesium hydroxide, calcium carbonate)
Maltese: ANTAĊIDI Antaċidi (eż., aluminium jew magnesium hydroxide, calcium carbonate)
English: R(-) methadone AUC ↓ 16% R(-) methadone Cmin ↓ 22% R(-) methadone Cmax ↓ 14% rilpivirine AUC ↔* rilpivirine Cmin ↔* rilpivirine Cmax ↔* * based on historic controls
Maltese: R(-) methadone AUC ↓ 16% R(-) methadone Cmin ↓ 22% R(-) methadone Cmax ↓ 14% rilpivirine AUC ↔* rilpivirine Cmin ↔* rilpivirine Cmax ↔* * ibbażat fuq kontrolli storiċi
English: ANTIARRHYTHMICS Digoxin*
Maltese: ANTIARRITMIĊI Digoxin*
English: Pharmacotherapeutic group: Antiviral for systemic use, non-nucleoside reverse transcriptase inhibitors, ATC code: J05AG05.
Maltese: Antivirali għal użu sistemiku, impeditur ta' reverse transcriptase mhux nucleoside, Kodiċi ATC: J05AG05.
English: Other NRTIs (abacavir, emtricitabine, lamivudine, stavudine and zidovudine)
Maltese: NRTIs oħra (abacavir, emtricitabine, lamivudine, stavudine u zidovudine)
English: Pharmacokinetics of total rilpivirine (mean ± SD, tmax: median [range])
Maltese: Farmakokinetika ta' rilpivirine totali (medja ± SD, tmax: medjan [firxa])
English: # to emtricitabine/lamivudine % (n/N)
Maltese: # għal emtricitabine/lamivudine % (n/N)
English: 6 cells/l in the efavirenz arm in the pooled analysis of the ECHO and THRIVE trials [estimated treatment difference (95% CI): 11.3 (-6.8; 29.4)].
Maltese: 6 ċellula/l fil-fergħa ta' efavirenz fil-ġabra ta' analiżi mill-provi ECHO u THRIVE [stima ta' differenza fil-kura (95% CI): 11.3 (-6.8; 29.4)].
English: Alternatively, switching to another ART regimen could be considered (see sections 4.4, 4.6, 5.1 and 5.2).
Maltese: ART ieħor (ara sezzjonijiet 4.4, 4.6, 5.1 u 5.2).
English: No grade 3-4 laboratory abnormalities for AST/ALT or grade 3-4 ADRs of transaminase increased were reported.
Maltese: Ma ġew irrappurtati l-ebda anormalitajiet tal-laboratorju ta' grad 3-4 għal AST/ALT jew ADRs ta' grad 3-4 ta' żieda fit-transaminase.
English: 6 cells/l
Maltese: 6 ċelluli/l
English: 300 mg once daily (+ 50 mg once daily rilpivirine)
Maltese: 300 mg darba kuljum (+ 50 mg rilpivirine darba kuljum)
English: 400 mg once daily ketoconazole AUC ↓ 24% ketoconazole Cmin ↓ 66% ketoconazole Cmax ↔
Maltese: 400 mg darba kuljum ketoconazole AUC ↓ 24% ketoconazole Cmin ↓ 66% ketoconazole Cmax ↔
English: PROTON PUMP INHIBITORS Omeprazole*
Maltese: TAL-POMPA TAL-PROTON Omeprazole*
English: HIV PIs - with co-administration of low dose ritonavir Darunavir/ritonavir*
Maltese: HIV PIs - mogħtija flimkien ma' doża baxxa ta' ritonavir Darunavir/ritonavir*
English: Paediatric population (12 to less than 18 years of age)
Maltese: Popolazzjoni pedjatrika (b'età ta' 12 sa inqas minn 18-il sena)
English: HIV Integrase Strand Transfer Inhibitors Raltegravir*
Maltese: HIV Impedituri tat-trasferiment tad-DNA tal-virus permezz ta' Integrase Raltegravir*
English: Rilpivirine is an in vitro inhibitor of the transporter MATE-2K with an IC50 of < 2.7 nM.
Maltese: In vitro rilpivirine huwa impeditur tat-trasportatur MATE-2K b'IC50 ta' < 2.7 nM.
English: 6 cells/l)
Maltese: 6 ċelluli/l)
English: What EDURANT contains - The active substance is rilpivirine in the form of rilpivirine hydrochloride.
Maltese: X'fih EDURANT - Is-sustanza attiva hi rilpivirine, fil-forma ta' rilpivirine hydrochloride.
English: Rilpivirine is a diarylpyrimidine NNRTI of HIV-1.
Maltese: Rilpivirine huwa diarylpyrimidine NNRTI ta' HIV-1.
English: AZOLE ANTIFUNGAL AGENTS Ketoconazole*
Maltese: SUSTANZI AZOLE KONTRA L-MOFFA Ketoconazole*
English: 300 mg once daily (+ 25 mg once daily rilpivirine)
Maltese: 300 mg darba kuljum (+ 25 mg rilpivirine darba kuljum)
English: Rilpivirine also demonstrated antiviral activity against a broad panel of HIV-1 group M (subtype A, B, C, D, F, G, H) primary isolates with EC50 values ranging from 0.07 to 1.01 nM (0.03 to 0.37 ng/ml) and group O primary isolates with EC50 values ranging from 2.88 to 8.45 nM (1.06 to 3.10 ng/ml).
Maltese: Rilpivirine wera wkoll attività antivirali kontra grupp sostanzjali ta' iżolati primarji tal-grupp M (sottotip A, B, C, D, F, G, H) ta' HIV-1 b'valuri EC50 fuq medda bejn 0.07 u 1.01 nM (0.03 sa 0.37 ng/ml) u iżolati primarji tal-grupp O b'valuri EC50 fuq medda bejn 2.88 u 8.45 nM (1.06 sa 3.10 ng/ml).
English: - The other ingredients of the film-coated tablet core are lactose monohydrate, croscarmellose sodium, povidone K30, polysorbate 20, silicified microcrystalline cellulose and magnesium stearate.
Maltese: - Is-sustanzi mhux attivi l-oħra tal-qalba tal-pillola miksija b'rita huma lactose monohydrate, croscarmellose sodium, povidone K30, polysorbate 20, silicified microcrystalline cellulose u magnesium stearate.
English: Rilpivirine retained sensitivity (FC ≤ BCO) against 62% of 4,786 HIV-1 recombinant clinical isolates resistant to efavirenz and/or nevirapine.
Maltese: Rilpivirine żamm is-sensittività (FC ≤ BCO) kontra 62% mill-4,786 iżolat kliniku rikombinanti ta' HIV-1 reżistenti għal efavirenz u/jew nevirapine.
English: ANTIDIABETICS Metformin* 850 mg single dose metformin AUC ↔ metformin Cmin NA metformin Cmax ↔
Maltese: ANTIDIJABETIĊI Metformin* 850 mg doża waħda metformin AUC ↔ metformin Cmin NA metformin Cmax ↔
English: 6 cells/l).
Maltese: 6 ċellula/l).
English: Non-response Virologic failure
Maltese: Nuqqas ta' respons Falliment viroloġiku
English: Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10) and uncommon (≥ 1/1,000 to < 1/100).
Maltese: Il-frekwenzi huma ddefiniti bħala komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10) u mhux komuni (≥ 1/1,000 sa < 1/100).
English: N=number of subjects per treatment group.
Maltese: N=numru ta' individwi f'kull grupp ta' trattament.
English: 25-O-desacetyl-rifabutin AUC ↔ 25-O-desacetyl-rifabutin Cmin ↔ 25-O-desacetyl-rifabutin Cmax ↔
Maltese: rifabutin AUC ↔ rifabutin Cmin ↔ rifabutin Cmax ↔ 25-O-desacetyl-rifabutin AUC ↔ 25-O-desacetyl-rifabutin Cmin ↔ 25-O-desacetyl-rifabutin Cmax ↔
English: The film-coating contains lactose monohydrate, hypromellose 2910 6 mPa.s, titanium dioxide E171, macrogol 3000 and triacetin.
Maltese: Il-kisja tar-rita fiha lactose monohydrate, hypromellose 2910 6 mPa.s, titanium dioxide E171, macrogol 3000 u triacetin.
English: Predicted difference of response rates (95% CI) for the week 48 analysis: 1.6% (-2.2%; 5.3%) and for the week 96 analysis: -0.4% (-4.6%; 3.8%); both p-value < 0.0001 (non-inferiority at 12% margin) from logistic regression model, including stratification factors and study.
Maltese: Differenza mbassra fir-rati ta' rispons (95% CI): għall-analiżi tal-ġimgħa 48: 1.6% (-2.2%; 5.3%) u għall-analiżi talġimgħa 96: -0.4% (-4.6%; 3.8%); għat-tnejn valur p < 0.0001 (mhux inferjuri b'marġini ta' 12%) mill-mudell ta' rigressjoni loġistika, inkluż fatturi ta' klassifikazzjoni u studju.
English: Important information about some of the ingredients of EDURANT EDURANT contains lactose.
Maltese: Informazzjoni importanti dwar uħud mill-ingredjenti ta' EDURANT EDURANT fih lactose.
English: Resistance outcome by background NRTI regimen used (pooled data from the ECHO and THRIVE trials in the week 96 resistance analysis) tenofovir/ emtricitabine zidovudine/ lamivudine abacavir/ lamivudine
Maltese: Riżultat ta' reżistenza permezz ta' reġim ta' sfond NRTI (ġabra ta' analiżi ta' reżistenza tal-ġimgħa 96 mill-provi tal-ECHO u THRIVE) tenofovir/ emtricitabine zidovudine/ lamivudine abacavir/ lamivudine
English: Rilpivirine activity is mediated by non-competitive inhibition of HIV-1 reverse transcriptase (RT).
Maltese: L-attività ta' rilpivirine hija medjata minn inibizzjoni mhux kompetittiva ta' reverse transcriptase (RT) ta' HIV-1.
English: 20 mg once daily omeprazole AUC ↓ 14% omeprazole Cmin NA omeprazole Cmax ↓ 14% rilpivirine AUC ↓ 40% rilpivirine Cmin ↓ 33% rilpivirine Cmax ↓ 40%
Maltese: 20 mg darba kuljum omeprazole AUC ↓ 14% omeprazole Cmin NA omeprazole Cmax ↓ 14% rilpivirine AUC ↓ 40% rilpivirine Cmin ↓ 33% rilpivirine Cmax ↓ 40%
English: Immune system disorders uncommon immune reactivation syndrome
Maltese: Disturbi fis-sistema immuni mhux komuni sindrome ta' riattivazzjoni immunitarja
English: Interaction table Interaction studies have only been performed in adults.
Maltese: Tabella ta' interazzjoni Studji ta' interazzjoni twettqu biss f'adulti.
English: In these patients, phenotypic cross-resistance to other NNRTIs was noted as follows: etravirine 32/42, efavirenz 30/42, and nevirapine 16/42.
Maltese: F'dawn il-pazjenti, reżistenza inkroċjata fenotipika għal NNRTIs oħra ġiet innutata kif imiss: etravirine 32/42, efavirenz 30/42, u nevirapine 16/42.
English: rd
Maltese: D.
English: Other medicines and EDURANT
Maltese: Mediċini oħra u EDURANT
English: ND 18.2%
Maltese: 201.2 x 10
English: EDURANT contains lactose
Maltese: EDURANT fih lactose
English: From the week 48 to the week 96 analysis, 24 (3.5%) and 14 (2.1%) additional virologic failures occurred in the rilpivirine and efavirenz arm, respectively.
Maltese: Mill-analiżi ta' bejn ġimgħa 48 u 96, 24 (3.5%) u 14 (2.1%) ta' fallimenti viroloġiċi addizzjonali seħħew fil-fergħat ta' kura b'rilpivirine u efavirenz, rispettivament.
English: Interaction Geometric mean change (%)
Maltese: Interazzjoni Bidla ġeometrika medja (%)
English: The ADRs are listed by system organ class (SOC) and frequency.
Maltese: L-ADRs huma elenkati skont il-klassi tas-sistemi u tal-organi (SOC) u l-frekwenza.