FrancophonIA/ELRC3.0 huggingface dataset:
English: In both studies, a total of 67% patient viruses were resistant and 22% were possibly resistant to the pre-selected comparator PIs.
Maltese: Fiż-żewġ studji, total ta' 67% viruses ta' pazjenti kienu reżistenti u 22% kienu possibilment reżistenti għal PIs komparaturi magħżula minn qabel.
English: Excipients with known effect: Each soft capsule contains 100.0 mg ethanol, 455.0 mg macrogolglycerol ricinoleate and 12.6 mg sorbitol For the full list of excipients, see section 6.1.
Maltese: mg ethanol, 455.0 mg macrogolglycerol ricinoleate u 12.6 mg sorbitol Għal-lista sħiħa ta' eċċipjenti, ara sezzjoni 6.1.
English: Tipranavir Cmin ↓ 61% (compared to historical data)
Maltese: Cmin ta' Tipranavir ↓ 61% (meta mqabbel ma' dejta storika)
English: PHARMACEUTICAL FORM AND CONTENTS 95 ml oral solution (1 bottle) Oral syringe
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 95 ml soluzzjoni orali (flixkun wieħed) Siringa orali
English: Tipranavir AUC over a 12 hour dosing interval averaged 851 ± 309 µM•h (CL=1.15 l/h) for female patients and 710 ± 207 µM•h (CL=1.27 l/h) for male patients.
Maltese: L-AUC ta' tipranavir fuq intervall medju ta' dożaġġ ta' 12-il siegħa kienet ta' 851 ± 309 µM•h (CL=1.15 l/h) għal pazjenti nisa u 710 ± 207 µM•h (CL=1.27 l/h) għal pazjenti rġiel.
English: Store in a refrigerator (2°C to 8°C).
Maltese: Aħżen fi friġġ (f'temperatura ta' bejn 2°C sa 8°C).
English: Other medicines and Aptivus
Maltese: Mediċini oħra u Aptivus
English: Total plasma tipranavir concentrations for these samples ranged from 9 to 82 M.
Maltese: Il-livelli totali ta' tipranavir fil-plażma f'dawn il-kampjuni, kien bejn 9 u 82 M.
English: First-dose tipranavir/r Digoxin Cmax ↔ Digoxin AUC ↔
Maltese: L-ewwel doża ta' tipranavir/r Cmax ta' Digoxin ↔ AUC ta' Digoxin ↔
English: First-dose tipranavir/r Midazolam Cmax ↑ 5.0 fold Midazolam AUC ↑ 27 fold
Maltese: L-ewwel doża ta' tipranavir/r Cmax ta' Midazolam ↑ 5.0 darbiet AUC ta' Midazolam ↑ 27 darba
English: Pharmacotherapeutic group: antivirals for systemic use, protease inhibitors, ATC code: J05AE09
Maltese: Kategorija farmakoterapewtika: mediċini antivirali għal użu sistemiku, impedituri tal-enżima protease, Kodiċi ATC:
English: In Phase II and III clinical trials, 276 patients with on-treatment genotypes have demonstrated that the predominant emerging mutations with tipranavir treatment are L33F/I/V, V82T/L and I84V.
Maltese: II u III, 276 pazjent b'ġenotipi ta' trattament urew li l-mutazzjonijiet emerġenti predominanti bit-trattament ta' tipranavir kienu L33F/I/V, V82T/L and I84V.
English: Number of patients Primary efficacy endpoint: % with VL < 400
Maltese: Punt ta' riferiment aħħari għal effikaċja primarja: % b'VL < 400
English: Tipranavir inhibits the replication of laboratory strains of HIV-1 and clinical isolates in acute models of T-cell infection, with 50% and 90% effective concentrations (EC50 and EC90) ranging from 0.03 to 0.07 µM (18-42 ng/ml) and 0.07 to 0.18 µM (42-108 ng/ml), respectively.
Maltese: Tipranavir jimpedixxi r-replikazzjoni ta' razez tal-laboratorju ta' HIV-1 u ta' kampjuni kliniċi elevati, waqt studji fuq mudelli ta' infezzjoni akuta taċ-ċelluli-T, b'valuri ta 50% u 90% ta' konċentrazzjonijiet effettivi (EC50 u EC90) fuq firxa bejn 0.03 sa 0.07 µM (18-42 ng/ml) u 0.07 sa 0.18 µM (42108 ng/ml), rispettivment.
English: Lopinavir Cmax ↓ 47% Lopinavir AUC ↓ 55% Lopinavir Cmin ↓ 70%
Maltese: Cmax ta' Lopinavir ↓ 47% AUC ta' Lopinavir ↓ 55% Cmin ta' Lopinavir ↓ 70%
English: Antithrombotics Warfarin 10 mg QD First-dose tipranavir/r: S-warfarin Cmax ↔ S-warfarin AUC ↑ 18%
Maltese: Mediċini antitrombotiċi Warfarin 10 mg QD L-ewwel doża ta' tipranavir/r: Cmax ta' S-warfarin ↔ AUC ta' S-warfarin ↑ 18%
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 25 October 2005
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 25 t'Ottubru 2005
English: Inhaled beta agonists Salmeterol
Maltese: Beta agonisti li jinġibdu man-nifs Salmeterol
English: Through 48 weeks of treatment, the proportion of patients in the tipranavir with ritonavir arm compared to the comparator PI/ritonavir arm with HIV-1 RNA < 400 copies/ml was 30% and 14% respectively, and with HIV-1 RNA < 50 copies/ml was 23% and 10% respectively.
Maltese: Fi 48 ġimgħa ta' trattament, il-proporzjon ta' pazjenti li użaw tipranavir ma' ritonavir meta mqabbel mal-komparatur ta' PI/ritonavir b'HIV-1 RNA < 400 kopji/ml kien ta' 30% u 14% rispettivament, u b'HIV-1 RNA < 50 kopji/ml kien 23% u 10% rispettivament.
English: - The other ingredients are macrogolglycerol ricinoleate, ethanol (alcohol), mono/diglycerides of caprylic/capric acid, propylene glycol, purified water, trometamol and propyl gallate.
Maltese: - Is-sustanzi mhux attivi l-oħra huma macrogolglycerol ricinoleate, ethanol (alkoħol), mono/diglycerides ta' caprylic/capric acid, propylene glycol, ilma purifikat, trometamol u propyl gallate.
English: Antacids aluminium- and magnesiumbased antacid QD
Maltese: Antaċidi antaċidu bbażat fuq aluminju u magnesium QD
English: This is very important.
Maltese: Dan importanti ħafna.
English: 25-O-desacetylrifabutin Cmax ↑ 3.2 fold
Maltese: Cmax ta' 25-O-desacetylrifabutin ↑ 3.2 darbiet
English: Tipranavir phenotypic resistance
Maltese: Phenobarbital Phenytoin
English: PP * Composite endpoint defined as patients with a confirmed 1 log RNA drop from baseline and without evidence of treatment failure ** Comparator PI/RTV: LPV/r 400 mg/100 mg twice daily (n=358), IDV/r 800 mg/100 mg twice daily (n=23), SQV/r 1000 mg/100 mg twice daily or 800 mg/200 mg twice daily (n=162), APV/r 600 mg/100 mg twice daily (n=194)
Maltese: PP * Endpoint komposta hija mfissra hekk kif il-pazjenti jkunu kkonfermati b'1 log RNA li taqa' milllinja ta' referenza bażi u mingħajr ħjiel li t-trattament ifalli ** PI/RTV komparatur : LPV/r 400 mg/100 mg darbtejn kuljum (n=358), IDV/r 800 mg/100 mg darbtejn kuljum (n=23), SQV/r 1000 mg/100 mg darbtejn kuljum jew 800 mg/200 mg darbtejn kuljum (n=162), APV/r 600 mg/100 mg darbtejn kuljum (n=194) ENF Enfurvirtide; FAS Full Analysis Set; PP Per Protocol; APV/rtv Amprenavir/ritonavir;
English: Tipranavir is metabolised by the hepatic system.
Maltese: Tipranavir hu metabolizzat mis-sistema epatika.
English: % White % Black % Asian
Maltese: % Bojod % Suwed % Ażjatiċi
English: S-methadone Cmax ↓ 62% S-methadone AUC ↓ 63%
Maltese: Cmax ta' S-methadone ↓ 62% AUC ta' S-methadone ↓ 63%
English: Tipranavir adversely interacts with oral contraceptives.
Maltese: Tipranavir jinteraġixxi b'mod avvers ma' kontraċettivi orali.
English: This medicinal product contains 7 vol % ethanol (alcohol), i.e. up to 400 mg per daily dose, equivalent to 8 ml of beer, or less than 4 ml of wine.
Maltese: Dan il-prodott mediċinali fih 7 vol% ta' ethanol (alkoħol), i.e. sa 400 mg f'kull doża ta' kuljum, ekwivalenti 8 ml ta' birra, jew inqas minn 4 ml ta' nbid.
English: Tipranavir has been used in limited number of patients 65 years or older.
Maltese: Tipanavir ġie użat f'numru limitat ta' pazjenti ta' 65 sena jew aktar.
English: Aptivus contains the active substance tipranavir.
Maltese: Aptivus fih is-sustanza attiva tipanavir.
English: Bleeding observed in rats was associated with prolonged prothrombin time (PT), activated partial thromboplastin time (APTT) and a decrease in some vitamin K dependent factors.
Maltese: Il-fsada osservata fil-firien kienet assoċjata ma' prothrombin time (PT) mdewwem, activated partial thromboplastin time (APTT) u tnaqqis f'fatturi li huma dipendenti fuq il-vitamina K.
English: Aptivus is contraindicated in patients with moderate or severe (Child-Pugh Class B or C) hepatic impairment (see sections 4.3, 4.4 and 5.2).
Maltese: Aptivus huwa kontraindikat f'pazjenti li għandhom indeboliment moderat jew sever (Child-Pugh Klassi B jew Ċ) (ara sezzjonijiet 4.3, 4.4 u 5.2).
English: - Abnormal liver function - Hepatitis and fatty liver - Liver failure.
Maltese: - Funzjoni abnormali tal-fwied - Epatite u fwied bix-xaħam - Falliment epatiku.
English: Volume Aptivus (ml)
Maltese: Volum ta' Aptivus (ml)
English: Volume ritonavir (ml)
Maltese: Volum ta' ritonavir (ml)
English: ENF Enfuvirtide; FAS Full Analysis Set; PP Per Protocol; APV/rtv Amprenavir/ritonavir; IDV/rtv Indinavir/ritonavir; LPV/rtv Lopinavir/ritonavir; SQV/rtv Saquinavir/ritonavir
Maltese: IDV/rtv Indinavir/ritonavir; LPV/rtv Lopinavir/ritonavir;
English: These active substances include antiarrhythmics (such as amiodarone, bepridil, quinidine), antihistamines (such as astemizole, terfenadine), ergot derivatives (such as dihydroergotamine, ergonovine, ergotamine, methylergonovine), gastrointestinal motility agents (such as cisapride), antipsychotics (such as pimozide, sertindole, quetiapine, lurasidone), sedatives/hypnotics (such as orally administered midazolam and triazolam) and HMG-CoA reductase inhibitors (such as simvastatin and lovastatin) (see section 4.5).
Maltese: Dawn is-sustanzi attivi jinkludu anti-arritmiċi (bħal amiodarone, bepridil, quinidine), antiħistamini (bħal astemizole, terfenadine), derivati ta' ergot (bħal dihydroergotamine, ergonovine, ergotamine, methylergonovine), dawk li jagħmlu effett fuq il-movimenti ta' l-istonku u l-imsaren (bħal cisapride), antipsikotiċi (bħal pimozide, sertindole, quetiapine, lurasidone), sedattivi/ipnotiċi (bħal midazolam u triazolam mogħtijin b'mod orali) u impedituri ta' l-enzima HMG-CoA reductase (bħal simvastatin u lovastatin) (ara sezzjoni 4.5).
English: Antispasmodic Tolterodine No interaction study performed
Maltese: Mediċini antispasmodiċi Tolterodine
English: Aptivussoft capsules are indicated for: adolescents12 years of age or older adults
Maltese: Il-kapsuli rotob Aptivus huma indikati għal: - adolexxenti li mhumiex iżgħar minn 12-il sena - adulti
English: Nervous system disorders common headache uncommon dizziness, neuropathy peripheral, somnolence rare intracranial haemorrhage*
Maltese: Disturbi fis-sistema nervuża komuni uġigħ ta' ras mhux komuni sturdament, newropatija periferali, ngħas rari emorraġija intrakranjali*
English: Anticonvulsants
Maltese: Antikonvulsanti
English: Genotypically Resistant LPV/rtv
Maltese: Ġenotipikament reżistenti LPV/rtv
English: Fluconazole doses 200 mg/day are not recommended.
Maltese: Dożi ta' fluconazole 200 mg/kuljum mhumiex rakkomandati.
English: Aptivus soft capsules contain alcohol (7% ethanol, ie 100 mg per capsule or up to 200 mg per dose) which can produce disulfiram-like reactions when co-administered with disulfiram or other medicinal products which produce this reaction (e.g. metronidazole).
Maltese: Il-kapsuli rotob ta' Aptivus fihom l-alkoħol (7% ethanol, ie 100 mg kull kapsula jew sa 200 mg kull doża) li jistgħu jikkaġunaw reazzjonijiet simili għal ta' disulfiram meta jiġu mogħtija flimkien ma' disulfiram jew prodotti mediċinali oħra li jipproduċu din ir-reazzjoni (eż metronidazole).
English: CYP 3A4 inhibition by tipranavir/r and P-gp (an intestinal efflux transporter) inhibition by clarithromycin.
Maltese: L-inibizzjoni ta' CYP 3A4 minn tipranavir/r u P-gp (trasportatur tal-effluss intestinali) inibizzjoni minn clarithromycin.
English: No clinically significant interaction is observed.
Maltese: L-ebda interazzjoni klinikament sinifikanti ma ġiet osservata.
English: The increase of tipranavir Cmin may be clinically relevant.
Maltese: Iżżieda tas-Cmin ta' tipranavir jista' jkun klinikament rilevanti.
English: A cocktail study was conducted in 16 healthy volunteers with twice-daily tipranavir 500 mg with ritonavir 200 mg capsule administration for 10 days to assess the net effect on the activity of hepatic CYP 1A2 (caffeine), 2C9 (warfarin), 2D6 (dextromethorphan), both intestinal/hepatic CYP 3A4 (midazolam) and P-glycoprotein (P-gp) (digoxin).
Maltese: Sar studju koktejl fuq 16-il volutier b'saħħithom b'għoti darbtejn kuljum ta' kapsula ta' tipranavir 500 mg ma' ritonavir 200 mg għal 10 ijiem sabiex jiġi assessjat l-effett nett fuq l-attività ta' CYP 1A2 epatiku (kaffeina), 2C9 (warfarina), 2DG (dextromethorphan), CYP 3A4 (midazolam) kemm ta' limsaren/fwied u P-glycoprotein (P-gp) (digoxin).
English: The effect of tipranavir with low dose of ritonavir on the QTcF interval was measured in a study in which 81 healthy subjects received the following treatments twice daily for 2.5 days: tipranavir/ritonavir (500/200 mg), tipranavir/ritonavir at a supra-therapeutic dose (750/200 mg), and placebo/ritonavir (-/200 mg).
Maltese: L-effett ta' tipranavir ma' doża baxxa ta' ritonavir fuq l-intervall tal-QTcF tkejjel fi studju li fih 81 persuna b'saħħithom irċivew il-kuri li ġejjin darbtejn kuljum għal 2.5 jiem: tipranavir/ritonavir (500/200 mg), tipranavir/ritonavir f'doża supraterapewtika (750/200 mg), u plaċebo/ritonavir (-/200 mg).
English: III trials, rash of various types was observed in 15.5% males and 20.5% females receiving Aptivus coadministered with low dose ritonavir.
Maltese: III raxx ta' diversi tipi kien osservat f'15.5% ta' l-irġiel u 20.
English: Total patients treated (N) 62 Events [N(%)]
Maltese: Total ta' pazjenti trattati (N)
English: The human immunodeficiency virus (HIV-1) encodes an aspartyl protease that is essential for the cleavage and maturation of viral protein precursors.
Maltese: Il-virus ta' l-immunodefiċjenza umana (HIV-1) jikkodifika enżima aspartyl protease li hi essenzjali biex il-prekursuri tal-proteina virali jinqasmu u jimmaturaw.
English: For example the protease inhibitors amprenavir, atazanavir, lopinavir and saquinavir will be decreased.
Maltese: Pereżempju l-impedituri tal-protease amprenavir, atazanavir, lopinavir u saquinavir ser jonqsu.
English: When coadministered with ritonavir at the recommended dosage (see section 4.2) there is a net inhibition of P450 CYP3A.
Maltese: Meta jingħata ma' ritonavir bid-doża rakkomandata (ara sezzjoni 4.2), ikun hemm impediment nett ta' P450 CYP3A.
English: In a clinical study where ritonavir 100 mg capsules bid were coadministered with 50 µg intranasal fluticasone propionate (4 times daily) for 7 days in healthy subjects, the fluticasone propionate plasma levels increased significantly, whereas the intrinsic cortisol levels decreased by approximately 86% (90% confidence interval 82-89%).
Maltese: Fi studju kliniku fejn kapsuli ta' ritonavir 100 mg kapsuli bid ingħataw flimkien ma' 50 µg ta' fluticasone propionate minn ġolimnieħer (4 darbiet kuljum) għal 7 ijiem f'pazjenti b'saħħithom, il-livelli ta' fluticasone propionate fil-plażma żdiedu b'mod sinifikanti, filwaqt li llivelli intrinsiċi ta' cortisol naqsu b'madwar 86% (90% intervall ta' kunfidenza 82-89%).
English: Reverse genetic experiments showed that the presence of 6 mutations in the protease (I13V, V32I, L33F, K45I, V82L, I84V) was required to confer > 10-fold resistance to tipranavir while the full 10-mutation genotype conferred 69-fold resistance to tipranavir.
Maltese: Esperimenti ġenetiċi riversi wrew li lpreżenza ta' 6 mutazzjonijiet fil-protease (I13V, V32I, L33F, K45I, V82L, I84V) kienet meħtieġa biex tkun aktar minn 10 darbiet reżistenti għal tipranavir, filwaqt li meta jkun hemm ġenotip mimli bl-10 mutazzjonijiet, ikun hemm reżistenza ta' 69 darba.
English: Interaction Geometric mean change (%)
Maltese: Interazzjoni Bidla medja ġeometrika (%)
English: - omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole (proton pump inhibitors used to reduce the gastric acid production) - metronidazole (used to treat infections) - disulfiram (used to treat alcohol dependence) - buprenorphine/naloxone (medicines used to treat severe pain) - cyclosporin, tacrolimus, sirolimus (used to prevent organ rejection (to suppress the immune system)) - warfarin (used to treat and prevent thrombosis)
Maltese: - omerprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole (impedituri tal-pompa protonika użata biex tnaqqas il-produzzjoni ta' aċidu gastriku) - metronidazole (użat biex jikkura infezzjonijiet) - disulfiram (użat biex jittratta id-dipendenza fuq l-alkoħol) - buprenorphine/naloxone (mediċini li jintużaw għal kura ta' wġigħ sever) - cyclosporin, tacrolimus, sirolimus (jintużaw għal prevenzjoni ta' rifjut ta' organu (biex irażżnu lis-sistema immuni)) - warfarin (jintuża għal kura u l-prevenzjoni ta' trombożi) - digoxin (jintuża għal kura ta' arritmiji tal-qalb u insuffiċjenza tal-qalb)
English: From clinical samples of healthy volunteers and HIV-1 positive subjects who received tipranavir without ritonavir the mean fraction of tipranavir unbound in plasma was similar in both populations (healthy volunteers 0.015%  0.006%; HIV-positive subjects 0.019%  0.076%).
Maltese: Minn kampjuni kliniċi meta tipranavir ingħata mingħajr ritonavir, instab li kampjuni kliniċi meħuda minn voluntiera f'saħħithom u pazjenti pożittivi għal HIV-1, kellhom valur medju kważi l-istess, tal-proporzjon ta' tipranavir liberu fil-plażma (voluntiera f'saħħithom 0.015%  0.006%; suġġetti pożittivi għal HIV 0.019%  0.076%).
English: Further information on possible side effects related to combination antiretroviral treatment: - Bleeding - Increased bleeding.
Maltese: Aktar tagħrif dwar effetti sekondarji possibbli relatati ma' trattament antiretrovirali kkombinat: Emorraġija - Żieda fl-emorraġija.
English: No information is available for the parameters AUC and Cmax.
Maltese: Lebda informazzjoni mhi disponibbli għall-parametri talAUC u tas-Cmax.
English: In the RESIST trials, the risk of rash was similar between tipranavir with ritonavir and comparator arms (16.3% vs. 12.5%, respectively; see section 4.4).
Maltese: Fil-provi ta' RESIST, irriskju ta' raxx kien simili bejn tipranavir ma' ritonavir u l-komparaturi (16.3% vs.
English: At maternal doses producing systemic exposure levels similar to or below those at the recommended clinical dose, tipranavir did not produce teratogenic effects.
Maltese: Fid-dożi maternali li jipproduċu livelli ta' espożizzjoni sistematiċi simili għal jew taħt id-doża klinika rakkomandata, tipranavir ma pproduċiex effetti teratoġeniċi.
English: The in vivo net effect of tipranavir with ritonavir on CYP 1A2, CYP 2C9 and CYP 2C19, indicates, through a preliminary study, an inducing potential of tipranavir with ritonavir on CYP1A2 and, to a lesser extent, on CYP2C9 and P-gp after several days of treatment.
Maltese: L-effett nett in vivo ta' tipranavir ma' ritonavir fuq CYP 1A2, CYP 2C9 u CYP 2C19, jindika, minn studju preliminari, potenzjal li tipranavir ma' ritonavir jissensitizza CYP1A2 u, f'każ aktar ristrett, lil CYP2C9 u P-gp wara diversi jiem ta' trattament.
English: Baseline % CD4+ cells Median (Min - Max)
Maltese: Riferiment bażi % CD4+ celluli
English: First-dose tipranavir/r:
Maltese: Tipranavir/r fl-istat fiss:
English: In in vitro studies, tipranavir was found to inhibit platelet aggregation when using human platelets (see section 4.4) and thromboxane A2 binding in an in vitro cell model at levels consistent with exposure observed in patients receiving Aptivus with ritonavir.
Maltese: Fi studji in vitro, tipranavir instab li jimpedixxi l-aggregazzjoni ta' plejtlets meta intużaw plejtlets talbniedem (ara sezzjoni 4.4) u thromboxane A2 binding f'mudell ta' ċelluli in vitro f'livelli konsistenti ma' l-espożizzjoni osservata f'pazjenti li qed jirċievu Aptivus ma' ritonavir.
English: % Male
Maltese: % Rġiel
English: New ENF No New ENF*
Maltese: ENF ġdid L-ebda ENF* ġdid
English: Each Aptivus capsule contains 250 mg of the active substance tipranavir.
Maltese: Kull kapsula Aptivus fiha 250 mg tas-sustanza attiva tipranavir.
English: Sustained HIV-1 RNA decreases up to week 48 were mainly observed in patients who received tipranavir with ritonavir and new enfuvirtide.
Maltese: Tnaqqis sostnut ta' HIV-1 RNA sa Ġimgħa 48 kien osservat f'pazjenti li ħadu tipranavir ma' ritonavir u enfuvirtide ġdid.
English: Food improves the tolerability of tipranavir with ritonavir.
Maltese: L-ikel itejjeb it-tollerabilità ta' tipranavir ma' ritonavir.
English: The reduction of bupropion plasma levels is likely due to induction of CYP2B6 and UGT activity by RTV
Maltese: It-tnaqqis tal-livelli ta' bupropion fil-plażma x'aktarx li jseħħ minħabba induzzjoni ta' attività ta' CYP2B6 u UGT minn RTV
English: Patients were required to have a baseline HIV-1 RNA concentration of at least 1500 copies/ml, were stratified by age (2 to < 6 years, 6 to < 12 years and 12 to 18 years) and randomized to receive one of two tipranavir with ritonavir dose regimens: 375 mg/m2/150 mg/m dose, compared to the 290 mg/m2/115 mg/m2 dose, plus background therapy of at least two nonprotease inhibitor antiretroviral medicinal products, optimized using baseline genotypic resistance testing.
Maltese: Il-pazjenti kienu meħtieġa li jkollhom linja ta' riferiment bażi ta' konċentrazzjoni ta' RNA ta' HIV tal-anqas ta' 1500 kopja/ml, kienu mqassma skont l-età (2 sa <6 snin, 6 sa < 12-il sena u minn 12-il sena sa 18-il sena) u magħżula każwalment sabiex jirċievu doża ta' reġimen wieħed minn tnejn ta' tipranavir ma' ritonavir: doża ta' 375 mg/m2/150 mg/m2 mqabbla ma doża 290 mg/m2/115 mg/m2, flimkien ma' terapija fl-isfond ta' wieħed minn żewġ prodotti mediċinali antiretrovirali impedituri mhux ta' protease, li ġew ottimizzati b'testijiet ta' riferenza bażika għal reżistenza ġenotipika.
English: The 1483 patients included in the primary analysis had a median age of 43 years (range 17-80), were 86% male, 75% white, 13% black and 1% Asian.
Maltese: L-1483 pazjent inklużi fl-analiżi temporanja primarja, kienu ta' età medja ta' 43 sena (firxa ta' bejn 17-80), fejn minnhom 86% kienu irġiel, 75% bojod, 13% suwed u 1% Asjatiċi.
English: Based on theoretical considerations, tipranavir, co-administered with low dose ritonavir, is expected to increase dihydroergotamine, ergonovine, ergotamine and methylergonovine concentrations.
Maltese: Ibbażat fuq konsiderazzjonijiet teoretiċi, tipranavir mogħti flimkien ma' doża baxxa ta' ritonavir, hu mistenni li jżid ilkonċentrazzjonijiet ta' dihydroergotamine, ergonovine, ergotamine u methylergonovine.
English: Aptivus may lead to a loss of effectiveness of some medicines including: - methadone, meperidine (pethidine), used as morphine substitutes
Maltese: Aptivus jista' jwassal għal telf fl-effettività ta' xi mediċini li jinkludu: - methadone, meperidine (pethidine), użati bħala sostituti għal morfina
English: tipranavir is contraindicated in moderate or severe hepatic impairment (see sections 4.2 and 4.3).
Maltese: Tipranavir huwa kontra-indikat f'indeboliment epatiku moderat jew serju (ara sezzjonijiet 4.2 u 4.3).
English: Blood and lymphatic system disorders uncommon neutropenia, anaemia, thrombocytopenia
Maltese: Disturbi tad-demm u tas-sistema limfatika mhux komuni newtropenija, anemija, tromboċitopenija
English: Steady-state tipranavir/r Digoxin Cmax ↓ 38% Digoxin AUC ↔
Maltese: Tipranavir/r fl-istat fiss Cmax ta' Digoxin ↓ 38% AUC ta' Digoxin ↔
English: Itraconazole or ketoconazole should be used with caution (doses 200 mg/day are not recommended).
Maltese: Itraconazole jew ketoconazole għandhom jintużaw bl-attenzjoni (dożi 200 mg/kuljum mhumiex rakkomandati).
English: Reactivation of herpes simplex and herpes zoster virus infections were observed in the RESIST trials.
Maltese: Ġie osservat li kien hemm riattivazzjoni tal-virus ta' herpes simplex u herpes zoster fil-provi RESIST.
English: In some patients with advanced HIV infection (AIDS) and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started.
Maltese: F'xi pazjenti li għandhom infezzjoni ta' HIV avvanzata (AIDS) u bi storja ta' infezzjonijiet opportunistiċi, sinjali u sintomi ta' infjammazzjoni minn infezzjonijiet preċedenti jistgħu jseħħu wara li jkun beda t-trattament ta' kontra l-HIV.
English: Tipranavir resistant viruses which emerge in vitro from wild-type HIV-1 show decreased susceptibility to the protease inhibitors amprenavir, atazanavir, indinavir, lopinavir, nelfinavir and ritonavir but remain sensitive to saquinavir.
Maltese: Viruses reżistenti għal tipranavir li joħorġu in vitro minn HIV-1 ta' tip selvaġġ juru tnaqqis fis-suxxetibilità għall-impedituri ta' l-enżima protease amprenavir, atazanavir, indinavir, lopinavir, nelfinavir u ritonavir imma jibqgħu sensittivi għal saquinavir.