FrancophonIA/ELRC3.0 huggingface dataset:
English: Carbamazepine total* Cmax ↑ 13% Carbamazepine total* AUC ↑ 16% Carbamazepine total* Cmin ↑ 23%
Maltese: Cmax totali* ta' Carbamazepine AUC totali* ta' Carbamazepine Cmin totali* ta' Carbamazepine
English: Inhibition of CYP 3A4 and CYP 2D6 by tipranavir/r
Maltese: Inibizzjoni ta' CYP 3A4 u CYP 2D6 minn tipranavir/r
English: In vitro metabolism studies with human liver microsomes indicated that CYP3A4 is the predominant CYP isoform involved in tipranavir metabolism.
Maltese: Studji fuq il-metaboliżmu in vitro fuq mikrosomi tal-fwied uman, indikaw li CYP3A4 hija l-isoform prinċipali ta' CYP li tieħu sehem fil-metaboliżmu ta' tipranavir.
English: Inhibition of CYP 2D6 by tipranavir/r
Maltese: Inibizzjoni ta' CYP 2D6 minn tipranavir/r
English: The trial evaluated pharmacokinetics, safety and tolerability, as well as virologic and immunologic responses through 48 weeks.
Maltese: Il-prova vvalutat ilfarmakokinetiċi, is-sigurtà u t-tollerabilità kif ukoll risponsi viroloġeniċi u immunoloġiċi sa 48 ġimgħa.
English: Value
Maltese: Valur
English: It blocks an enzyme called protease that is involved in the reproduction of HIV.
Maltese: Jimblokka enzima msejħa protease li hi involuta fir-riproduzzjoni tal-HIV jeħtieġ.
English: 14-OH-clarithromycin Cmax ↓ 97% 14-OH-clarithromycin AUC ↓ 97% 14-OH-clarithromycin Cmin ↓ 95%
Maltese: Cmax ta' Clarithromycin ↔ AUC ta' Clarithromycin ↑ 19% Cmin ta' Clarithromycin ↑ 68% Cmax ta' 14-OH-clarithromycin ↓ AUC ta' 14-OH-clarithromycin ↓ Cmin ta' 14-OH-clarithromycin ↓
English: The HMG-CoA reductase inhibitors simvastatin and lovastatin are highly dependent on CYP3A for metabolism.
Maltese: L-impedituri ta' HMG-CoA reductase simvastatin u lovastatin jiddependu ħafna fuq CYP3A għal metaboliżmu.
English: The effective mean elimination half-life of tipranavir with ritonavir in healthy volunteers (n = 67) and HIV-infected adult patients (n = 120) was approximately 4.8 and 6.0 hours, respectively, at steady state following a dose of 500 mg/200 mg twice daily with a light meal.
Maltese: Il-valur medju effettiv tal-half life ta' l-eliminazzjoni ta' tipranavir ma' ritonavir f'volontiera b'saħħithom (n = 67) u f'pazjenti adulti infettati bl-HIV (n = 120) kien ta' madwar 4.8 u 6.0 sigħat, rispettivament, waqt l-istat fiss u wara li ntużat doża ta' 500 mg/200 mg, darbtejn kuljum ma' ikla ħafifa.
English: After four weeks of Aptivus 500 mg with 200 mg ritonavir (twice daily) the median plasma trough concentration of tipranavir was 43.9 µM for females and 31.1 µM for males.
Maltese: Wara erba' ġimgħat ta' 500 mg ta' Aptivus ma' 200 mg ta' ritonavir (darbtejn kuljum), il-konċentrazzjoni minima medja ta' tipranavir fil-plażma kienet ta' 43.9 µM għan-nisa u 31.1 µM għall-irġiel.
English: At tipranavir exposures in rats at 0.8-fold human exposure at the clinical dose, foetal toxicity (decreased sternebrae ossification and body weights) was observed.
Maltese: Flespożizzjonijiet ta' tipranavir fil-firien 0.8 darbiet aktar mill-espożizzjoni tal-bniedem tad-doża klinika, kienet osservata tossiċità fetali (tnaqqis ta' ossifikazzjoni sternebrae u piżijiet tal-ġisem).
English: Aptivus is supplied in bottles containing 120 capsules.
Maltese: APTAVUS jiġi fi fliexken li fihom 120 kapsula.
English: Based on data from the cocktail study where caffeine (CYP1A2 substrate) AUC was reduced by 43%, tipranavir with ritonavir is expected to decrease theophylline concentrations.
Maltese: Ibbażat fuq dejta minn cocktail study fejn l-AUC tal-kaffeina (substrat ta' CYP1A2) tnaqqset bi 43%, tipranavir ma' ritonavir hu mistenni li jnaqqas ilkonċentrazzjonijiet ta' theophylline.
English: Propafenone Metoprolol (given in heart failure)
Maltese: Propafenone Metoprolol (mogħti waqt insuffiċjenza tal-qalb) Ma sarux studji dwar linterazzjonijiet
English: The mean half-life was 5.5 (females) or 6.0 hours (males).
Maltese: Il-half-life medja kienet ta' 5.5 (nisa) jew 6.0 sigħat (irġiel).
English: Dosing with Aptivus capsules 500 mg twice daily concomitant with 200 mg ritonavir twice daily for 2 to 4 weeks and without meal restriction produced a mean tipranavir peak plasma concentration (Cmax) of 94.8 ± 22.8 µM for female patients (n=14) and 77.6 ± 16.6 µM for male patients (n=106), occurring approximately 3 hours after administration.
Maltese: Dożaġġ b'kapsuli ta' Aptivus 500 mg darbtejn kuljum flimkien ma' 200 mg ritonavir darbtejn kuljum għal bejn ġimagħtejn sa 4 ġimgħat u mingħajr restrizzjoni ta' ikel irriżulta f'konċentrazzjoni medja laktar għolja ta' tipranavir fil-plażma (Cmax) ta' 94.8 ± 22.8 µM għal pazjenti femminili (n=14) u 77.6 ± 16.6 µM għal pazjenti maskili (n=106), li seħħet f'madwar 3 sigħat wara t-teħid.
English: The potential net effect of tipranavir with ritonavir on CYP 2D6 is inhibition, because ritonavir is also a CYP 2D6 inhibitor.
Maltese: L-effett potenzjali nett ta' tipranavir ma' ritonavir fuq CYP 2D6 hu ta' impediment, peress li ritonavir huwa impeditur CYP 2D6.
English: Patients had prior exposure to a median of 6 NRTIs, 1 NNRTI, and 4 PIs.
Maltese: Il-pazjenti kellhom espożizzjoni minn qabel għal medjan ta' 6 NRTIs, 1 NNRTI, u 4 PIs.
English: Other HMG-CoA reductase inhibitors should be considered such as pravastatin, fluvastatin or rosuvastatin (see section 4.5).
Maltese: Impedituri HMG-CoA reductase oħrajn għandhom jiġu konsidrati bħal pravastatin, fluvastatin jew rosuvastatin (ara sezzjoni 4.5).
English: 25-O-desacetylrifabutin AUC ↑ 21 fold
Maltese: AUC ta' 25-O-desacetylrifabutin ↑ 21 darba
English: What Aptivus contains - The active substance is tipranavir.
Maltese: X'fih Aptivus - Is-sustanza attiva hi tipranavir.
English: ECG evaluation
Maltese: KG organizačná zložka
English: RESIST participants receiving tipranavir with ritonavir tended to have an increased risk of bleeding; at 24 weeks the relative risk was 1.98 (95% CI=1.03, 3.80).
Maltese: Parteċipanti fl-istudju RESIST li kienu qed jirċievu tipranavir ma' ritonavir intwerew li jinsabu f'riskju akbar ta' fsada; wara 24 ġimgħa r-riskju relattiv kien ta' 1.98 (95% CI=1.03, 3.80).
English: A reduced virological response was observed in patients with viral strains harbouring two or more mutations at HIV protease codons 33, 82, 84 or 90, and not receiving new enfuvirtide.
Maltese: Tnaqqis fir-rispons viroloġiku ġie osservat f'pazjenti b'razez virali li għandhom żewġ mutazzjonijiet jew aktar fil-codons tal-protease ta' HIV 33, 82, 84 jew 90, u li mhux qed jirċievu enfuvirtide ġdid.
English: Steady-state tipranavir/r: S-warfarin Cmax ↓ 17% S-warfarin AUC ↓ 12%
Maltese: Cmax ta' S-warfarin ↓ 17% AUC ta' S-warfarin ↓ 12%
English: MARKETING AUTHORISATION NUMBER(S) EU/1/05/315/002
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/05/315/002
English: Herbal preparations containing St John's wort (Hypericum perforatum) due to the risk of decreased plasma concentrations and reduced clinical effects of tipranavir (see section 4.5).
Maltese: Preparazzjonijiet bi ħxejjex li fihom St John's wort (Hypericum perforatum) minħabba r-riskju li titbaxxa l-konċentrazzjoni fil-plażma ta' tipranavir u jitnaqqsu l-effetti kliniċi (ara sezzjoni 4.5).
English: The study was prematurely stopped after 60 weeks.
Maltese: L-istudju ġie mwaqqaf b'mod prematur wara 60 ġimgħa.
English: - Protease Inhibitors (PIs): Taking Aptivus may cause large decreases in the blood levels of other HIV protease inhibitors.
Maltese: - Impedituri tal-Protease (PIs): Meta tieħu Aptivus jista' jkun hemm tnaqqs sostanzjali fil-livelli ta' demm ta' impedituri tal-protease oħra tal-HIV.
English: Fluconazole ↔ Tipranavir Cmax ↑ 32% Tipranavir AUC ↑ 50% Tipranavir Cmin ↑ 69% Mechanism unknown
Maltese: Fluconazole ↔ Cmax ta' Tipranavir ↑ 32% AUC ta' Tipranavir ↑ 50% Cmin ta' Tipranavir ↑ 69% Mekkaniżmu mhux magħruf
English: Telaprevir is metabolized in the liver by CYP3A and is a Pglycoprotein (P-gp) substrate, but other enzymes may be involved in the metabolism.
Maltese: Telaprevir jiġi metabolizzat filfwied minn CYP3A u hu substrat ta' glikoproteina P (P-gp), iżda enzimi oħrajn jistgħu jkunu involuti fil-metaboliżmu.
English: Boehringer Ingelheim RCV GmbH & Co KG Magyarországi Fióktelepe Tel.: +36 1 299 89 00
Maltese: KG Magyarországi Fióktelepe Tel: +36 1 299 8900
English: Serious side effects associated with Aptivus:
Maltese: Effetti sekondarji serji assoċjati ma' Aptivus:
English: In the tipranavir and comparator arms median baseline CD4 cell counts were 158 and 166 cells/mm
Maltese: Fil-grupp ta' tipranavir u dak komparattiv, il-linja bażi ta' referenza medja ta' l-għadd ta' ċelluli ta' CD4 kienet ta' 158 u 166 ċelluli/mm
English: Frequencies of marked clinical laboratory abnormalities (Grade 3 or 4) reported in at least 2% of patients in the tipranavir with ritonavir arms in the phase III clinical studies (RESIST-1 and RESIST2) after 48-weeks were increased ASAT (6.1%), increased ALAT (9.7%), increased amylase (6.0%), increased cholesterol (4.2%), increased triglycerides (24.9%), and decreased white blood cell count
Maltese: Il-frekwenżi ta' riżultati abnormali tal-laboratorju li spikkaw (Grad 3 jew 4) ġew rapportati f' mill-anqas 2% tal-pazjenti fuq tipranavir ma' ritonavir li ħadu sehem fl-istudji kliniċi (RESIST-1 u RESIST-2) tal-Fażi III wara 48 ġimgħa wrew żjieda fl-ASAT (6.1%), żjieda fl-ALAT (9.7%), żjieda fl-amylase (6.0%), żjieda fil-kolesterol (4.2%), żjieda fit-trigliċeridi (24.9%) u tnaqqis fl-għadd totali ta' ċelluli bojod tad-demm, (5.7%).
English: Close clinical and biological (INR measurement) monitoring is recommended when warfarin and tipranavir are combined.
Maltese: Monitoraġġ kliniku u bijoloġiku mill-qrib (kejl ta' INR) hu rakkomandat meta warfarin u tipranavir jiġu kombinati.
English: Through a series of multiple stepwise regression analyses of baseline and on-treatment genotypes from all clinical studies, 16 amino acids have been associated with reduced tipranavir susceptibility and/or reduced 48-week viral load response: 10V, 13V, 20M/R/V, 33F, 35G, 36I, 43T, 46L, 47V, 54A/M/V, 58E, 69K, 74P, 82L/T, 83D and 84V.
Maltese: Permezz ta' serje ta' analiżi rigressivi fi stadji multipli tal-linja ta' referenza bażi u tal-ġenotipi li kienu ttrattati waqt l-istudji kliniċi, 16-il aċidu amminiku nstabu li kienu assoċjati ma' tnaqqis fis-suxxettibblità għal tipranavir u/jew tnaqqis ta' 48 ġimgħa fl-għadd ta' viruses: 10V, 13V, 20M/R/V, 33F, 35G, 36I, 43T, 46L, 47V, 54A/M/V, 58E, 69K, 74P, 82L/T, 83D u 84V.
English: The net effect will vary depending on the relative affinity of the co-administered substance for CYP3A and P-gp, and the extent of intestinal first-pass metabolism/efflux.
Maltese: L-effett nett se jvarja skond l-affinità relattiva ta' sustanzi amministrati konġuntivament għal CYP3A u P-gp, u l-firxa ta' metaboliżmu intestinali fl-ewwel stadji/efluss.
English: Induction of CYP 2C19 by tipranavir/r
Maltese: Induzzjoni ta' CYP 2C19 minn tipranavir/r
English: Greater than 10-fold resistance to tipranavir is uncommon (< 2.5% of tested isolates) in viruses obtained from highly treatment experienced patients who have received multiple peptidic protease inhibitors.
Maltese: Mhux komuni li jkun hemm aktar minn 10 darbiet reżistenza għal tipranavir (< 2.5% tal-kampjuni ttestjati) ġo viruses meħuda minn pazjenti b'esperjenza ta' ħafna terapiji li ngħataw aktar minn tip wieħed ta' impeditur tal- peptide protease.
English: Steady-state tipranavir/r: Midazolam Cmax ↓ 13% Midazolam AUC ↑ 181%
Maltese: Cmax ta' Midazolam ↓ 13% AUC ta' Midazolam ↑ 181%
English: Patients using clarithromycin at doses higher than 500 mg twice daily should be carefully monitored for signs of toxicity of clarithromycin and tipranavir.
Maltese: Pazjenti li jużaw clarithromycin f'dożi ogħla minn 500 mg darbtejn kuljum, għandhom jiġu mmonitorjati bl-attenzjoni għal sinjali ta' tossiċità ta' clarithromycin u tipranavir.
English: Pink, oblong soft gelatin capsules imprinted with “TPV 250” in black.
Maltese: Kapsuli rotob tal-ġelatina, tawwalin ta' lewn roża u fuqhom hemm stampat “TPV 250” bl-iswed.
English: Inhibition of CYP 2C9 with firstdose tipranavir/r, then induction of CYP 2C9 with steady-state tipranavir/r
Maltese: Inibizzjoni ta' CYP 2C9 malewwel doża ta' tipranavir/r, imbagħad induzzjoni ta' CYP 2C9 b'tipranavir/r fl-istat fiss
English: Keep the container in the outer carton.
Maltese: Żomm il-kontenitur fil-kartuna ta' barra.
English: After 48 weeks of follow-up, the frequency of Grade 3 or 4 ALAT and/or ASAT abnormalities was higher in tipranavir with ritonavir patients compared with comparator arm patients (10% and 3.4%, respectively).
Maltese: Wara 48 ġimgħa ta' segwitu, il-frekwenza ta' abnormalitajiet ALAT u/jew ASAT ta' Grad 3 jew 4 kienet ogħla f'pazjenti fuq tipranavir ma' ritonavir meta mqabbla ma' pazjenti bil-komparatur (10% u 3.4%, rispettivament).
English: Steady-state tipranavir/r Digoxin Cmax ↓ 20% Digoxin AUC ↔
Maltese: Tipranavir/r fl-istat fiss Cmax ta' Digoxin ↓ 20% AUC ta' Digoxin ↔
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 active.
Maltese: Filwaqt li tibdil fil-parametri ta' clarithromycin mhumiex kkunsidrati li huma klinikament rilevanti, ittnaqqis fl-AUC tal-metabolit 14OH, għandu jiġi kkunsidrat għallkura ta' infezzjonijiet ikkawżati minn Haemophilus influenzae li fihom il-metabolit 14-OH hu l-aktar attiv.
English: In in vitro experiments, tipranavir was observed to inhibit human platelet aggregation at levels consistent with exposures observed in patients receiving Aptivus with ritonavir.
Maltese: F'esperimenti in vitro, tipranavir kien osservat li jimpedixxi l-aggregazzjoni ta' pjastrini umani f'livelli konsistenti ma' espożizzjonijiet osservati f'pazjenti li qed jirċievu Aptivus ma' ritonavir.
English: Protein binding studies have shown that the antiviral activity of tipranavir decreases on average 3.75fold in conditions where human serum is present.
Maltese: Studji fuq kif jeħel mal-proteini wera li l-attività antiretrovirali ta' tipranavir, tonqos b'medja ta' 3.75 darbiet meta jkun hemm serum uman.
English: At least one primary protease gene mutation from among 30N, 46I, 46L, 48V, 50V, 82A, 82F, 82L, 82T, 84V or 90M had to be present at baseline, with not more than two mutations on codons 33, 82, 84 or 90.
Maltese: Mill-anqas mutazzjoni ewlenija waħda fil-gene tal-protease minn fost 30N, 46I, 46L, 48V, 50V, 82A, 82F, 82L, 82T, 84V jew 90M kellha tkun preżenti fil-linja ta' referenza bażi, b'mhux aktar minn żewġ mutazzjonijiet fuq codons 33, 82, 84 jew 90.
English: Hepatobiliary disorders uncommon hepatic enzyme increased (ALAT, ASAT), cytolytic hepatitis, liver function test abnormal (ALAT, ASAT), hepatitis toxic rare hepatic failure (including fatal outcome), hepatitis, hepatic steatosis, hyperbilirubinaemia
Maltese: Disturbi fil-fwied u fil-marrara mhux komuni żieda fl-enzimi tal-fwied (ALAT, ASAT), epatite ċitolitika, test tal-funzjoni tal-fwied b'riżultat anormali (ALAT, ASAT), epatite tossika rari insuffiċjenza tal-fwied (li tinkludi riżultat fatali), epatite, steatożi tal-fwied, iperbilirubinemija
English: Clarithromycin Cmax ↔ Clarithromycin AUC ↑ 19% Clarithromycin Cmin ↑ 68%
Maltese: Cmax ta' Clarithromycin ↔ AUC ta' Clarithromycin ↑ 19% Cmin ta' Clarithromycin ↑ 68% Cmax ta' 14-OH-clarithromycin AUC ta' 14-OH-clarithromycin Cmin ta' 14-OH-clarithromycin
English: This score (counting the 16 amino acids that have been associated with reduced tipranavir susceptibility and/or reduced viral load response: 10V, 13V, 20M/R/V, 33F, 35G, 36I, 43T, 46L, 47V, 54A/M/V, 58E, 69K, 74P, 82L/T, 83D and 84V) was applied to baseline viral protease sequences.
Maltese: Dan il-punteġġ (li jgħodd 16-il aċidu amminiku huwa assoċjat ma' tnaqqis fis-suxxettibblità għal tipranavir u/jew tnaqqis ta' 24 ġimgħa fl-għadd tal-viruses: 10V, 13V, 20M/R/V, 33F, 35G, 36I, 43T, 46L, 47V, 54A/M/V, 58E, 69K, 74P, 82L/T, 83D u 84V) kien applikat għal sekwenzi ta' livelli ta' riferiment bażi għal protease virali.
English: Patients using oestrogens as hormone replacement therapy should be clinically monitored for signs of oestrogen deficiency.
Maltese: Pazjenti li jużaw oestrogens bħala terapija ta' sostituzzjoni ormonali għandhom jiġu monitorati b'mod kliniku għal sinjali ta' defiċjenza fl-oestrogen.
English: Lansoprazole Pantoprazole Rabeprazole No interaction study performed
Maltese: Lansoprazole Pantoprazole Rabeprazole Ma sarux studji dwar linterazzjonijiet
English: Systemic corticosteroid effects including Cushing's syndrome and adrenal suppression have been reported in patients receiving ritonavir and inhaled or intranasally administered fluticasone propionate; this could also occur with other corticosteroids metabolised via the P450 3A pathway e.g. budesonide.
Maltese: Effetti kortikosterojdi sistemiċi li jinkludu is-sindrome ta' Cushing u trażżin adrenali, kienu rrappurtati f'pazjenti li kienu qed jirċievu ritonavir u fluticasone propionate li jinġibed man-nifs jew minn ġol-imnieħer; dan jista' jseħħ ukoll ma' kortikosterojdi oħrajn metabolizzati permezz tal-passaġġ P450 3A, eż. budesonide.
English: Aptivus is contraindicated in patients with moderate or severe (Child-Pugh Class B or C) hepatic insufficiency.
Maltese: Aptivus huwa konta-indikat f'pazjenti li għandhom insuffiċjenza epatika moderata jew gravi (ChildPugh Klassi B jew Ċ).
English: Generally, it is not recommended to take Aptivus, with ritonavir, together with oral contraceptives or hormone replacement therapy (HRT).
Maltese: Ġeneralment mhux rakkomandat li Aptivus jittieħed flimkien ma' ritonavir, flimkien ma' kontraċettivi orali jew terapija ta' sostituzzjni ormonali (HRT).
English: The influence of moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment on the multiple dose pharmacokinetics of either tipranavir or ritonavir has so far not been investigated.
Maltese: L-influwenza ta' indeboliment moderat (Child-Pugh B) jew qawwi (Child-Pugh C) tal-fwied fuq il-farmakokinetika ta' dożi multipli ta' tipranavir jew ritonavir għadha ma ġietx mistħarrġa.
English: After baseline and placebo adjustment, the maximum mean QTcF change was 3.2 ms (1-sided 95% Upper CI: 5.6 ms) for the 500/200 mg dose and 8.3 ms (1-sided 95% Upper CI: 10.8 ms) for the supra-therapeutic 750/200 mg dose.
Maltese: Wara aġġustament fil-linja bażi u plaċebo, il-medja massima tat-tibdil tal-QTcF kienet ta' 3.2 ms (1-sided 95% Upper CI: 5.6 ms) għad-doża ta' 500/200 mg u 8.3 ms (1-sided 95% Upper CI: 10.
English: Musculoskeletal and connective tissue disorders uncommon myalgia, muscle spasms
Maltese: Disturbi muskolu-skeletriċi u tat-tessuti konnettivi mhux komuni majalġja, spażmi fil-muskoli
English: Aptivus contains very small amounts of alcohol (see Aptivus capsules contain ethanol).
Maltese: Aptivus fih ammonti żgħar ħafna ta' alkoħol (ara Il-kapsuli Aptivus fihom l-ethanol).
English: Each ml contains 100 mg tipranavir.
Maltese: Kull ml fih 100 mg tipranavir
English: In general, adverse reactions were similar to those seen in adults, with the exception of vomiting, rash and pyrexia which were reported more frequently in children than in adults.
Maltese: B'mod ġenerali, ir-reazzjonijiet avversi kienu simili bħal fl-adulti, ħlief li remettar, raxx u deni kienu rapportati aktar frekwenti fi tfal milli f'adulti.
English: Group O and HIV-2 isolates have reduced susceptibility in vitro to tipranavir with EC50 values ranging from 0.164-1 µM and 0.233-0.522 µM, respectively.
Maltese: Grupp O u kampjuni iżolati ta' HIV-2 għandhom suxxettibilità mnaqqsa in vitro għal tipranavir b'valuri ta' EC50 li jvarjaw minn 0.164-1 µM u 0.
English: Tabulated summary of adverse reactions associated with Aptivus based on clinical studies and postmarketing experience:
Maltese: Sommarju tabulat ta' reazzjonijiet avversi assoċjati ma' Aptivus ibbażat fuq studji kliniċi u esperjenza ta' wara t-tqegħid fis-suq:
English: Nausea
Maltese: Riżultat
English: RESIST participants receiving Aptivus with ritonavir tended to have an increased risk of bleeding; at 24 weeks the relative risk was 1.98 (95% CI=1.03, 3.80).
Maltese: Il-parteċipanti fl-istudju RESIST li kienu qed jirċievu Aptivus ma' ritonavir kellhom riskju akbar ta' fsada; wara 24 ġimgħa r-riskju relattiv kien ta' 1.98 (95% CI=1.03, 3.80).
English: Also the use of the alpha-1 adrenoceptor antagonist alfuzosin, and sildenafil when used for the treatment of pulmonary arterial hypertension.
Maltese: L-użu tal-alpha-1 adrenoceptor antagonist alfuzosin u sildenafil meta jintuża għall-kura ta' pressjoni għolja arterjali pulmonari wkoll.
English: Inhibition of CYP 3A4 by atazanavir/ritonavir and induction by tipranavir/r.
Maltese: Inibizzjoni ta' CYP 3A4 minn atazanavir/ritonavir u induzzjoni minn tipranavir/r.
English: NAME OF THE MEDICINAL PRODUCT Aptivus 250 mg soft capsules tipranavir
Maltese: Aptivus 250 mg kapsuli rotob tipranavir
English: Rash gamma GT increased ALAT increased
Maltese: Raxx gamma GT ogħla ALAT ogħla
English: Median # previous
Maltese: Medjan # NRTI preċedenti
English: Rabeprazole plasma concentrations might decrease as a result of induction of CYP2C19 by tipranavir/r.
Maltese: Il-konċentrazzjonijiet ta' rabeprazole fil-plażma jistgħu jonqsu bħala riżultat ta' induzzjoni ta' CYP2C19 minn tipranavir/r.
English: Of note, patients in the RESIST studies had a specific mutational pattern at baseline of at least one primary protease gene mutation among codons 30N, 46I, 46L, 48V, 50V, 82A, 82F, 82L, 82T, 84V or 90M, and no more than two mutations on codons 33, 82, 84 or 90.
Maltese: Ta' min jinnota, il-pazjenti fl-istudji RESIST kellhom skema ta' mutazzjoni speċifika fil-linja ta' riferiment ta' mil-lanqas mutazzjoni primarja waħda ta' ġene fost kodons 30N, 46I, 46L, 48V, 50V, 82A, 82F, 82L, 82T, 84V jew 90M, u mhux aktar minn żewġ mutazzjonijiet fuq kodons 33, 82, 84 jew
English: * see section Description of selected adverse reactions “Bleeding” for source of information
Maltese: * ara sezzjoni Deskrizzjoni ta' reazzjonijiet avversi magħżula “Fsada” għal aktar informazzjoni
English: As a result of CYP3A4 inhibition and CYP2C19 induction by tipranavir/r, lansoprazole and pantoprazole plasma concentrations are difficult to predict.
Maltese: Bħala riżultat ta' inibizzjoni ta' CYP3A4 u induzzjoni ta' CYP2C19 minn tipranavir/r, ilkonċentrazzjonijiet ta' lansoprazole u pantoprazole filplażma huma diffiċli biex jitbassru.
English: Clinical isolates that exhibited a  10-fold decrease in tipranavir susceptibility harboured 8 or more tipranavir-associated mutations.
Maltese: Il-kampjuni iżolati kliniċi li wrew tnaqqis ta' 10 darbiet fis-suxxetabilità ta' tipranavir kellhom 8 mutazzjonijiet jew aktar assoċjati ma' tipranavir.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/05/315/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/05/315/001
English: propylene glycol, mono/diglycerides of caprylic/capric acid, sucralose, ascorbic acid, Butter
Maltese: - Is-sustanzi mhux attivi l-oħra huma macrogol vitamina E - polyethylene glycol succinate, ilma purifikat, propylene glycol, mono/diglycerides of caprylic/capric acid, sucralose, ascorbic acid,
English: Anti-HCV agents Boceprevir No interaction study performed
Maltese: Mediċini kontra l-HCV Boceprevir
English: HIV-positive, paediatric patients, aged 2 through 18 years, were studied in a randomized, open-label, multicenter study (trial 1182.14).
Maltese: Pazjenti pedjatriċi pożittivi għal HIV, bejn l-etajiet ta' sentejn u 18-il sena kienu studjati fi studju każwali, multiċentrali, bit-tikketta tidher (prova 1182.14).
English: The clinical relevance of this reduction has not been established, but may decrease the efficacy of abacavir.
Maltese: Ir-rilevanza klinika ta' dan ittnaqqis ma ġietx stabbilita, iżda tista' tnaqqas l-effikaċja ta' abacavir.
English: A pharmacokinetic interaction is mechanistically unexpected and the interaction has not been confirmed in a controlled interaction study.
Maltese: Interazzjoni farmakokinetika hi mekkanistalment mhux mistennija u l-interazzjoni ma kinitx ikkonfermata fi studju kkontrollat dwar l-interazzjonijiet.