FrancophonIA/ELRC3.0 huggingface dataset:
English: Co-administration of Aptivus with low dose ritonavir, with active substances that are highly dependent on CYP3A for clearance, and for which elevated plasma concentrations are associated with serious and/or life-threatening events.
Slovenian: Sočasno dajanje zdravila Aptivus ob majhnih odmerkih ritonavirja z zdravilnimi učinkovinami, katerih očistek je močno odvisen od CYP3A in ki lahko ob povečani koncentraciji v plazmi povzročijo resne ali življenjsko nevarne dogodke.
English: Aptivus is available as soft capsules for adults and adolescents from 12 years of age (please refer to the respective SmPC for further details).
Slovenian: Zdravilo Aptivus mehke kapsule se uporablja pri odraslih in mladostnikih starejših od 12. leta (za natančnejše podatke glejte ustrezni Povzetek glavnih značilnosti zdravila).
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.
Slovenian: Pri dajanju kapsul Aptivus v odmerkih po 500 mg dvakrat na dan hkrati z 200 mg ritonavirja dvakrat na dan 2 do 4 tedne brez omejitev v prehrani je bila približno 3 ure po dajanju srednja največja koncentracija tipranavirja (Cmax) 94,8  22,8 µM pri ženskah (n = 14) in 77,6  16,6 µM pri moških (n = 106).
English: Unless otherwise stated, studies detailed below have been performed with the recommended dosage of Aptivus/r (i.e. 500/200 mg BID).
Slovenian: Če ni navedeno drugače, so v raziskavah uporabili priporočeno odmerjanje zdravila Aptivus/r (to je 500/200 mg 2-krat na dan).
English: The baseline characteristics and the key efficacy results at 48 weeks for the paediatric patients receiving Aptivus oral solution are displayed in the tables below.
Slovenian: Izhodiščne značilnosti in ključni izsledki o učinkovitosti po 48 tednih pri otrocih, ki so prejemali peroralno raztopino Aptivus, so navedeni v spodnjih preglednicah.
English: - Abnormal liver function - Hepatitis and fatty liver - Liver failure.
Slovenian: Nenormalno jetrno delovanje hepatitis in zamaščena jetra, jetrna odpoved.
English: Analyses of tipranavir resistance in treatment experienced patients Tipranavir with ritonavir response rates in the RESIST studies were assessed by baseline tipranavir genotype and phenotype.
Slovenian: Analize odpornosti proti tipranavirju pri bolnikih, ki so že prejeli več režimov zdravljenja V raziskavah RESIST so stopnjo odzivanja na tipranavir ob ritonavirju ocenjevali glede na izhodiščni genotip in fenotip pri tipranavirju.
English: Key efficacy results at 48 weeks for patients 2 - <12 years treated with Aptivus oral solution Endpoint
Slovenian: Ključni izsledki o učinkovitosti po 48 tednih za bolnike od 2 do < 12 let, zdravljene s peroralno raztopino Aptivus
English: C-tipranavir to subjects (n = 8) that received 500 mg tipranavir with 200 mg ritonavir twice daily dosed to steady-state demonstrated that most radioactivity (median 82.3%) was excreted in faeces, while only a median of 4.4% of the radioactive dose administered was recovered in urine.
Slovenian: C-tipranavirja osebam (n = 8), ki so prejemale 500 mg tipranavirja ob 200 mg ritonavirja, dvakrat na dan do ravnovesnega stanja, je odkrilo, da se večina radioaktivnosti (srednja vrednost 82,3%) izloči z blatom, s sečem pa se izloči samo do srednje vrednosti 4,4% radioaktivnega odmerka.
English: It has to be noted that the switch from the oral solution to the capsule formulation of Aptivus could be associated with decreased exposure.
Slovenian: Vedeti je treba, da se lahko po prehodu z zdravila Aptivus peroralna raztopina na kapsule Aptivus zmanjša izpostavljenost zdravilu.
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).
Slovenian: Pri 16 zdravih prostovoljcih, ki so 10 dni dvakrat na dan jemali kombinacijo 500 mg tipranavirja ob 200 mg ritonavirja v obliki kapsul, so izvedli koktajl študijo, da bi ocenili neto učinek na aktivnost CYP 1A2 v jetrih (kofein), 2C9 (varfarin), 2D6 (deksametorfan), CYP 3A4 v črevesu in jetrih (midazolam) in P-glikoprotein (P-gp) (digoksin).
English: Atazanavir Cmax ↓ 57% Atazanavir AUC ↓ 68% Atazanavir Cmin ↓ 81%
Slovenian: Cmax atazanavirja ↓ 57% AUC atazanavirja ↓ 68% Cmin atazanavirja ↓ 81%
English: Concomitant use of rilpivirine with some ritonavir-boosted protease inhibitors has demonstrated an increase in the plasma concentrations of rilpivirine.
Slovenian: Pri sočasni uporabi rilpivirina in nekaterih z ritonavirjem okrepljenih zaviralcev proteaze se je zvečala koncentracija rilpivirina v plazmi.
English: Aptivus, co-administered with low dose ritonavir, is indicated for combination antiretroviral treatment of HIV-1 infection in highly pre-treated children from 2 to 12 years of age with virus resistant to multiple protease inhibitors.
Slovenian: Zdravilo Aptivus je ob sočasnem zdravljenju z majhnimi odmerki ritonavirja indicirano za kombinirano protiretrovirusno zdravljenje okužbe s HIV-1 pri 2 do 12 let starih otrocih, ki so se že zdravili s številnimi zdravili in pri katerih je virus odporen proti več zaviralcem proteaze.
English: Carbamazepine induces CYP3A4.
Slovenian: Karbamazepin inducira CYP3A4.
English: Before starting treatment, your doctor will have taken blood samples to test the resistance of your HIV.
Slovenian: Zdravnik bo pred začetkom zdravljenja naročil vzorce krvi za preizkus odpornosti virusa HIV, s katerim ste okuženi.
English: Renal impairment No dosage adjustment is required in patients with renal impairment (see sections 4.4 and 5.2).
Slovenian: Ledvična okvara Bolnikom z ledvično okvaro ni treba prilagajati odmerkov (glejte poglavji 4.4 in 5.2).
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).
Slovenian: Pri udeležencih v raziskavi RESIST, ki so prejemali tipranavir ob ritonavirju, so zasledili nagibanje k večjemu tveganju krvavitve: po 24 tednih je bilo relativno tveganje 1,98 (95-odstotni interval zaupanja = 1,03; 3,80).
English: Patients with mild hepatic impairment (Child-Pugh Class A) should be closely monitored.
Slovenian: Bolnike z blago ledvično okvaro (stopnje A po Child-Pughovi klasifikaciji) je treba natančno spremljati.
English: Amprenavir Cmax ↓ 39% Amprenavir AUC ↓ 44% Amprenavir Cmin ↓ 55%
Slovenian: Cmax amprenavirja ↓ 39% AUC amprenavirja ↓ 44% Cmin amprenavirja ↓ 55%
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).
Slovenian: Sočasna uporaba zdravila Aptivus ob hkratnem jemanju z majhnimi odmerki ritonavirja in zdravil, katerih očistek je zelo odvisen od CYP2D6, na primer antiaritmikov flekainida, propafenona in metoprolola za zdravljenje srčnega popuščanja (glejte poglavje 4.5).
English: Liver monitoring
Slovenian: Spremljanje jetrnega delovanja
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
Slovenian: Bolezni jeter, žolčnika in žolčevodov občasni zvišanje vrednosti jetrnih encimov (ALAT, ASAT), citolitični hepatitis, nenormalen izvid preiskave jetrnega delovanja (ALAT, ASAT), toksični hepatitis redki jetrna odpoved (tudi z usodnim izidom), hepatitis, jetrna steatoza, hiperbilirubinemija
English: These may decrease the effectiveness of Aptivus.
Slovenian: Ta lahko moti pravilno delovanje zdravila Aptivus.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each soft capsule contains 250 mg tipranavir.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena mehka kapsula vsebuje 250 mg tipranavirja.
English: Co-administration of Aptivus and low dose ritonavir with agents primarily metabolised by CYP3A may result in changed plasma concentrations of tipranavir or the other agents, which could alter their therapeutic and undesirable effects (see list and details of considered agents, below).
Slovenian: Sočasno dajanje zdravila Aptivus ob hkratnih majhnih odmerkih ritonavirja in zdravil, ki se pretežno presnavljajo s CYP3A, lahko spremeni plazemske koncentracije tipranavirja ali drugih zdravil, kar bi lahko spremenilo njihove terapevtske in neželene učinke (glejte seznam in spodnje podrobnosti o teh zdravilih).
English: Tipranavir, co-administered with low dose ritonavir, increases the plasma concentrations of atorvastatin (see section 4.5).
Slovenian: Tipranavir ob hkratnih majhnih odmerkih ritonavirja poveča koncentracijo atorvastatina v plazmi (glejte poglavje 4.5).
English: If you have any further questions about ritonavir or the other medicines your child is prescribed, please ask your child's doctor or pharmacist.
Slovenian: Če imate dodatna vprašanja o ritonavirju ali otrokovih drugih predpisanih zdravilih, vprašajte otrokovega zdravnika ali farmacevta.
English: In the case of tipranavir co-administered with low dose ritonavir, concomitant use with rifampicin is expected to result in sub-optimal levels of tipranavir which may lead to loss of virologic response and possible resistance to tipranavir.
Slovenian: Pri dajanju tipranavirja ob hkratnih majhnim odmerkih ritonavirja sočasno z rifampicinom je pričakovati učinek suboptimalne ravni tipranavirja, kar lahko izniči virološki odgovor in odpornost proti tipranavirju.
English: Phenobarbital and phenytoin induce CYP3A4.
Slovenian: Fenobarbital in fenitoin inducirata CYP3A4.
English: Aptivus 100 mg/ml oral solution tipranavir
Slovenian: Aptivus 100 mg/ml peroralna raztopina tipranavir
English: Aptivus is not a cure for HIV-1 infection or AIDS.
Slovenian: Zdravilo Aptivus okužbe s HIV-1 niti aidsa ne ozdravi.
English: Some of the side effects of Aptivus may affect your child's ability to drive or operate machinery (e.g. dizziness and sleepiness).
Slovenian: Vpliv na sposobnost upravljanjavozil in strojev Nekateri neželeni učinki zdravila Aptivus lahko zmanjšajo otrokovo sposobnost za vožnjo ali upravljanje strojev(npr. omotica in zaspanost).
English: Aptivus oral solution is supplied in amber glass bottles containing 95 ml of oral solution.
Slovenian: Zdravilo Aptivus peroralna raztopina je na voljo v steklenicah jantarne barve s 95 ml peroralne raztopine.
English: If a rash occurs, it is usually mild to moderate.
Slovenian: Izpuščaj je običajno blag do zmeren.
English: Zidovudine Cmax ↓ 49% Zidovudine AUC ↓ 36%
Slovenian: Cmax zidovudina ↓ 49% AUC zidovudina ↓ 36%
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).
Slovenian: Te zdravilne učinkovine so antiaritmiki (kot so amiodaron, bepridil, kinidin), antihistaminiki (kot sta astemizol, terfenadin), derivati rženih rožičkov (kot so dihidroergotamin, ergonovin, ergotamin, metilergonovin), zdravila, ki vplivajo na motiliteto prebavil (kot je cisaprid), antipsihotiki (kot so pimozid, sertindol, kvetiapin, lurasidon), sedativi ali hipnotiki (kot sta peroralna oblika midazoloma in triazolama) in zaviralci reduktaze HMG-CoA (kot sta simvastatin in lovastatin) (glejte poglavje 4.5).
English: Data suggest that, although ritonavir is a P-gp inhibitor, the net effect of Aptivus, coadministered with low dose ritonavir, at the proposed dose regimen at steady-state, is P-gp induction.
Slovenian: Podatki kažejo, da je neto učinek zdravila Aptivus, ob hkratnih majhnih odmerkih ritonavirja, ob priporočenem režimu odmerjanja v ravnovesnem stanju indukcija P-gp, čeprav je ritonavir zaviralec P-gp.
English: Baseline characteristics for patients 12 - 18 years of age who took capsule
Slovenian: Izhodiščne značilnosti bolnikov, starih 12 do 18 let, zdravljenih s kapsulami Spremenljivka
English: What Aptivus is and what it is used for What you need to know before you take Aptivus How to take Aptivus
Slovenian: Kaj je zdravilo Aptivus in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Aptivus Kako jemati zdravilo Aptivus Možni neželeni učinki
English: - abacavir and zidovudine.
Slovenian: Abakavir in zidovudin.
English: The predominant effects of repeated administration of tipranavir across all species toxicologically tested were on the gastrointestinal tract (emesis, soft stool, diarrhoea) and the liver (hypertrophy).
Slovenian: Pri vseh živalskih vrstah, pri katerih so proučevali toksičnost, so učinke večkratnih odmerkov tipranavirja odkrili pretežno v prebavilih (emeza, mehko blato, driska) in jetrih (hipertrofija).
English: Amongst the most common adverse reactions reported for Aptivus were gastrointestinal complaints such as diarrhoea and nausea as well as hyperlipidaemia.
Slovenian: Poročila o zdravilu Aptivus med najpogostnejšimi neželenimi reakcijami navajajo prebavne motnje, na primer drisko in siljenje na bruhanje, ter hiperlipidemijo.
English: Valaciclovir and Aptivus with low dose of ritonavir may be coadministered without dose adjustment.
Slovenian: Valaciklovir in zdravilo Aptivus ob hkratnih majhnih odmerkih ritonavirja lahko bolniki jemljejo sočasno brez prilagajanja odmerkov.
English: Additionally, in one interaction trial, in healthy female volunteers administered a single dose of ethinyl oestradiol followed by Aptivus co-administered with low dose ritonavir, 33% of subjects developed a rash.
Slovenian: Poleg tega se je izpuščaj razvil pri 33% žensk v preskušanju o medsebojnem delovanju pri zdravih prostovoljkah, ki so prejele enkratni odmerek etinilestradiola in nato zdravilo Aptivus ob hkratnem majhnem odmerku ritonavirja.
English: Flecainide
Slovenian: Flekainid
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).
Slovenian: Pri udeležencih v raziskavi RESIST, ki so prejemali zdravilo Aptivus ob ritonavirju, so zasledili nagibanje k večjemu tveganju krvavitve: po 24 tednih je bilo relativno tveganje 1,98 (95-odstotni interval zaupanja = 1,03; 3,80).
English: Do not take Aptivus - if you are allergic to tipranavir or any of the other ingredients of this medicine (listed in section
Slovenian: Ne jemljite zdravila Aptivus: - če ste alergični na tipranavir ali katero koli sestavino tega zdravila (navedeno v poglavju 6); - če imate zmerne do hude jetrne težave.
English: If your child uses oral contraceptives or HRT they have an increased chance of developing a skin rash while taking Aptivus.
Slovenian: Če bo vaš otrok uporabljal peroralne kontraceptive ali zdravila za hormonsko nadomestno zdravljenje, se bo med jemanjem zdravila Aptivus povečala verjetnost razvoja kožnega izpuščaja.
English: Your doctor will monitor your liver function by blood tests before and during Aptivus treatment.
Slovenian: Vaš zdravnik bo spremljal delovanja jeter s krvnimi preiskavami pred zdravljenjem z zdravilom Aptivus in med njim.
English: Increased CPK, myalgia, myositis and, rarely, rhabdomyolysis, have been reported with protease inhibitors, particularly in combination with nucleoside reverse transcriptase inhibitors.
Slovenian: V povezavi z zdravljenjem z zaviralci proteaze so poročali o porastu CPK, mialgiji, miozitisu in, redko, rabdomiolizi, zlasti kadar so jih uporabili v kombinaciji z nukleozidnimi zaviralci reverzne transkriptaze.
English: Interactions between Aptivus and co-administered medicinal products are listed in the table below (increase is indicated as “↑”, decrease as “↓”, no change as “↔”,once daily as “QD”, twice daily as “BID”).
Slovenian: V preglednici so navedene interakcije med zdravilom Aptivus in hkrati danimi zdravili (povečanje je označeno s “↑”, zmanjšanje s “↓” in nespremenjeno s “↔”).
English: If you miss a dose of Aptivus and/or ritonavir by less than 5 hours, take your missed dose immediately.
Slovenian: Če ste pozabili vzeti zdravilo Aptivus ali ritonavir in je minilo manj kot 5 ur, pozabljeni odmerek vzemite takoj.
English: Your child's doctor will monitor their liver function by blood tests before and during Aptivus treatment.
Slovenian: Otrokov zdravnik bo spremljal delovanja otrokovih jeter s krvnimi preiskavami pred zdravljenjem z zdravilom Aptivus in med njim.
English: Due to multiple CYP isoenzyme systems involved in voriconazole metabolism, it is difficult to predict the interaction with tipranavir, coadministered with low-dose ritonavir.
Slovenian: Ker vorikonazol presnavlja več encimskih sistemov, je medsebojno delovanje s tipranavirjem ob hkratnih majhnih odmerkih ritonavirja težko predvideti.
English: However a decrease of colchicine concentrations cannot be excluded since both tipranavir and ritonavir exhibit inducing potential towards CYP3A and P-gp.
Slovenian: Zmanjšanja koncentracije kolhicina pa zaradi možnega indukcijskega učinka tipranavirja in ritonavirja na CYP3A in P-gp ni mogoče izključiti.
English: Before starting treatment, your child's doctor will have taken blood samples to test the resistance of your child's HIV.
Slovenian: Otrokov zdravnik bo pred začetkom zdravljenja naročil vzorce krvi za preizkus odpornosti virusa HIV, s katerim je vaš otrok okužen.
English: Patients treated with Aptivus and reaching the age of 12 years should be switched to the capsule formulation (see sections 4.4 and 5.1).
Slovenian: Bolnikom, ki se zdravijo z zdravilom Aptivus peroralna raztopina, je treba pri starosti 12 let zamenjati to obliko zdravila s kapsulami (glejte poglavji 4.4 in 5.1).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of oral solution contains 100 mg tipranavir.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA En ml peroralne raztopine vsebuje 100 mg tipranavirja.
English: Aptivus is contraindicated in patients with moderate or severe (Child-Pugh Class B or C) hepatic insufficiency.
Slovenian: Zdravilo Aptivus je kontraindicirano pri bolnikih z zmerno ali hudo jetrno insuficienco (stopnje B ali C po Child-Pughovi razvrstitvi).
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.
Slovenian: Zdravilo Aptivus je ob sočasnem zdravljenju z majhnimi odmerki ritonavirja indiciran za kombinirano protiretrovirusno zdravljenje okužbe s HIV-1 pri odraslih in mladostnikih, starih 12 let ali starejših, ki so prejeli že več režimov zdravljenja in pri katerih je virus odporen proti več zaviralcem proteaz.
English: If you have any further questions about ritonavir or the other medicines you are prescribed, please ask your doctor or pharmacist.
Slovenian: Če imate dodatna vprašanja o ritonavirju ali drugih predpisanih zdravilih, vprašajte izbranega zdravnika ali farmacevta.
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.
Slovenian: Sočasno dajanje tipranavirja in majhnih odmerkov ritonavirja lahko poveča tveganje neželenih učinkov salmeterola na srce in žilje, med drugim se lahko podaljša QT interval ter se pojavijo palpitacije in sinusna tahikardija.
English: The comparator regimen included a ritonavir-boosted PI (also individually defined) plus an OBR.
Slovenian: Primerjani režim sestavlja z ritonavirjem ojačeni zaviralec proteaze (ki je prav tako individualno prilagojen) in optimizirani osnovni režim zdravljenja (OBR).
English: You must take Aptivus together with ritonavir.
Slovenian: Zdravilo Aptivus morate jemati skupaj z ritonavirjem.
English: This indication is based on the results of two phase III studies, performed in highly pre-treated adult patients (median number of 12 prior antiretroviral agents) with virus resistant to protease inhibitors and of one phase II study investigating pharmacokinetics, safety and efficacy of Aptivus in mostly treatment-experienced adolescent patients aged 12 to 18 years.
Slovenian: Podlaga za to indikacijo so bili izsledki dveh študij III. faze, ki sta zajeli odrasle, predhodno že intenzivno zdravljene bolnike (srednje število protiretrovirusnih zdravil, s katerimi so se predhodno že zdravili, je bilo 12), pri katerih je bil virus odporen proti zaviralcem proteaze, in študije II.
English: If the co-administration is nevertheless considered necessary, a close monitoring of the safety of tipranavir and a monitoring of plasma concentrations of atazanavir are strongly encouraged (see section
Slovenian: Če je sočasno dajanje kljub temu potrebno, moramo natančno spremljati varnost tipranavirja in koncentracijo atazanavirja v plazmi (glejte poglavje 4.4).
English: No particular dose adjustment is recommended.
Slovenian: Ni priporočila o specifičnem prilagajanju odmerka.
English: Co-administration of protease inhibitors with rifampicin substantially decreases protease inhibitor concentrations.
Slovenian: Pri sočasnem dajanju zaviralcev proteaze in rifampicina se precej zmanjša koncentracija zaviralca proteaze.
English: Inhibition of CYP 2C9 with firstdose tipranavir /r, then induction of CYP 2C9 with steady-state tipranavir/r
Slovenian: Zaviranje CYP 2C9 pri prvem odmerku tipranavirja/r, nato indukcija CYP 2C9 pri ravnovesnem stanju tipranavirja/r.
English: NAME OF THE MEDICINAL PRODUCT Aptivus 250 mg soft capsules
Slovenian: IME ZDRAVILA Aptivus 250 mg mehke kapsule
English: S-methadone Cmax ↓ 62% S-methadone AUC ↓ 63%
Slovenian: Cmax S-metadona ↓ 62% AUC S-metadona ↓ 63%
English: Do not give a double dose to make up for a forgotten dose.
Slovenian: Ne dajte mu dvojnega odmerka, če stemu pozabili dati prejšnjega.
English: Aptivus co-administered with low dose ritonavir, has been associated with reports of significant liver toxicity.
Slovenian: Zdravilo Aptivus ob hkratnih majhnih odmerkih ritonavirja povezujejo s poročili o pomembnih toksičnih učinkih na jetra.
English: Theophylline plasma concentrations should be monitored during the first two weeks of co-administration with Aptivus, co-administered with low dose ritonavir, and the theophylline dose should be increased as needed.
Slovenian: Prva dva tedna sočasnega dajanja z zdravilom Aptivus ob ritonavirju je treba spremljati koncentracijo teofilina v plazmi in njegov odmerek po potrebi povečati.
English: When co-administered, tipranavir and cobicistat exposures are markedly lower compared to that of tipranavir when boosted with low dose ritonavir.
Slovenian: Pri sočasni uporabi je izpostavljenost tipranavirju in kobicistatu znatno manjša kot pri tipranavirju, okrepljenim z majhnim odmerkom ritonavirja.
English: What Aptivus contains - The active substance is tipranavir.
Slovenian: Kaj vsebuje zdravilo Aptivus - Učinkovina je tipranavir.
English: Based on the metabolic profiles of tipranavir/r and the proton pump inhibitors, an interaction can be expected.
Slovenian: Zaradi presnovnih lastnosti tipranavirja/r in zaviralcev protonske črpalke so medsebojni učinki možni.
English: High density polyethylene (HDPE) bottle with two-piece child-resistant closure (outer and inner shell polypropylene, with a pulpboard/aluminium liner).
Slovenian: Steklenica iz polietilena visoke gostote (HDPE) z dvodelno za otroke varno zaporko (zunanji in notranji del iz polipropilena, z vložkom iz stisnjene lepenke/aluminija).Ena steklenica vsebuje 120 mehkih kapsul.