FrancophonIA/ELRC3.0 huggingface dataset:
English: Tipranavir demonstrates antiviral activity in vitro against a broad panel of HIV-1 group M non-clade B isolates (A, C, D, F, G, H, CRF01 AE, CRF02 AG, CRF12 BF).
Croatian: Tipranavir pokazuje antivirusnu aktivnost in vitro protiv niza izolata HIV-1 skupine M, koji ne pripadaju podskupini B (A, C, D, F, G, H, CRF01 AE, CRF02 AG, CRF12 BF).
English: Gently empty Aptivus oral solution from the syringe into your child's mouth.
Croatian: Nježno ispraznite Aptivus oralnu otopinu iz štrcaljke u usta svog djeteta.
English: If you have liver disease or hepatitis, your doctor will decide if you need additional testing.
Croatian: Ako imate bolest jetre ili hepatitis, liječnik će odlučiti trebate li dodatno testiranje.
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.
Croatian: U 1483 bolesnika uključenih u primarnu analizu, medijan dobi je bio 43 godine (raspon 17-80), od toga je bilo 86% muškaraca, 75% bijelaca, 13% crnaca i 1% Azijata.
English: If your HIV is resistant to some HIV medicines, this means that the medicine will not work so well, or will not work at all.
Croatian: Ako je Vaš HIV otporan na neke HIV lijekove, to znači da taj lijek neće tako dobro djelovati, ili neće uopće djelovati.
English: PHARMACEUTICAL FORM AND CONTENTS 95 ml oral solution (1 bottle) Oral syringe
Croatian: OBLIK I SADRŽAJ 95 ml oralne otopine (1 boca) Oralna štrcaljka
English: rilpivirine: If you are taking rilpivirine, your doctor will monitor you closely.
Croatian: - rilpivirin: ako uzimate rilpivirin, liječnik će vas pažljivo pratiti.
English: If there is more than a thin layer of crystals at the bottom of the bottle or uncertainty about the amount of crystals observed, the bottle should be returned for a replacement as soon as possible.
Croatian: Ako je na dnu boce prisutno malo više od tankog sloja kristala ili niste sigurni u vezi uočene količine kristala, boca se mora vratiti i zamijeniti što je prije moguće.
English: PHARMACEUTICAL FORM AND CONTENTS 120 soft capsules
Croatian: OBLIK I SADRŽAJ 120 mekih kapsula
English: Genotypically Resistant LPV/rtv
Croatian: Genotipski rezistentni LPV/rtv
English: Alternate antimycobacterial agents such as rifabutin should be considered.
Croatian: Potrebno je razmotriti primjenu alternativnih antimikobakterijskih lijekova, kao što je rifabutin.
English: Absorption of tipranavir in humans is limited, though no absolute quantification of absorption is available.
Croatian: Apsorpcija tipranavira u ljudi je ograničena, iako proces nije apsolutno kvantificiran.
English: In urine, unchanged tipranavir was found in trace amounts (0.5% of urine radioactivity).
Croatian: U urinu, nepromijenjeni tipranavir otkriven je u tragovima (0,5% radioaktivnosti urina).
English: Mutations at position 82 occur via two pathways: one from preexisting mutation 82A selecting to 82T, the other from wild type 82V selecting to 82L.
Croatian: Mutacije na poziciji 82 se javljaju na dva načina: jedna od prethodno postojeće mutacije 82A na 82T, druga od divljeg tipa 82V na 82L.
English: However, children previously treated with Aptivus oral solution and becoming 12 years of age should be switched to capsules, particularly because of the more favourable safety profile of the capsules.
Croatian: Međutim, djeca koja su prethodno liječena Aptivus oralnom otopinom i koja navršavaju 12 godina starosti prelaze na kapsule, naročito zbog povoljnijeg sigurnosnog profila kapsula.
English: Tipranavir adversely interacts with oral contraceptives.
Croatian: Tipranavir ulazi u različite interakcije s oralnim kontraceptivima.
English: Food improves the tolerability of tipranavir with ritonavir.
Croatian: Hrana poboljšava podnošljivost tipranavira s ritonavirom.
English: Some patients who developed rash also had: - joint pain or stiffness - throat tightness - generalized itching
Croatian: Neki bolesnici koji su razvili osip također su imali: - bol ili ukočenost zglobova - zatezanje u grlu - generalizirani svrbež
English: The available clinical data do not support the use of Aptivus oral solution in adolescents or adults.
Croatian: Dostupni klinički podaci ne podupiru primjenu Aptivus oralne otopine u adolescenata i odraslih.
English: Your child must take Aptivus together with:
Croatian: Vaše dijete mora uzimati Aptivus zajedno s:
English: Bone problems: Some patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone).
Croatian: Problemi s kostima: Neki bolesnici koji uzimaju kombiniranu antiretrovirusnu terapiju mogu razviti bolest kostiju koja se naziva osteonekroza (odumiranje koštanog tkiva izazvano gubitkom dotoka krvi u kost).
English: What Aptivus looks like and contents of the pack Aptivus oral solution is a clear yellow liquid.
Croatian: Kako Aptivus izgleda i sadržaj pakiranja Aptivus oralna otopina je bistra žuta tekućina.
English: - with ENF (FAS) - without ENF (FAS)
Croatian: - s ENF (svi ispitanici) - bez ENF (svi ispitanici)
English: Haemophiliac patients should therefore be made aware of the possibility of increased bleeding.
Croatian: Stoga oboljele od hemofilije treba obavijestiti o mogućnosti pojačanog krvarenja.
English: Vomiting, rash and fever were observed more frequently in children than in adults.
Croatian: Povraćanje, osip i vrućica primijećeni su češće u djece nego u odraslih.
English: Your child's doctor will test for these changes.
Croatian: Djetetov liječnik će uputiti dijete na testiranja za ove promjene.
English: Patients should be instructed to observe closely for crystals.
Croatian: Bolesnike se mora uputiti da pažljivo prate prisustvo kristala.
English: For this reason it is very important that you tell your child's doctor about any changes in their health.
Croatian: Iz tog razloga je važno obavijestiti djetetovog liječnika o svakoj promjeni zdravlja Vašeg djeteta.
English: You should know that you may continue to develop infections and other illnesses associated with HIV disease.
Croatian: Potrebno je znati da možete nastaviti razvijati infekcije i druge bolesti povezane s HIV bolešću.
English: You should know that your child may continue to develop infections and other illnesses associated with HIV disease.
Croatian: Potrebno je znati da Vaše dijete može nastaviti razvijati infekcije i druge bolesti povezane s HIV bolešću.
English: Similar effects were observed for the S-enantiomer, esomeprazole.
Croatian: Slični učinci primijećeni su za Senantiomer, esomeprazol.
English: See also Section 2, under “Oral contraceptives/hormone replacement therapy (HRT)”.
Croatian: Također pogledajte dio 2, pod “Oralni kontraceptivi/hormonska nadomjesna terapija (HNT)”.
English: The significance of this finding is being further monitored.
Croatian: Značaj ovog opažanja se i dalje prati.
English: There is increased potential for PDE5 inhibitorassociated adverse events (which include visual disturbances, hypotension, prolonged erection, and syncope).
Croatian: Postoji povećani potencijal za nuspojave povezane s PDE5 inhibitorima (što uključuje poremećaje vida, hipotenziju, produljenu erekciju i sinkopu).
English: The decrease in tipranavir concentrations may result in decreased effectiveness.
Croatian: Smanjenje koncentracija tipranavira može rezultirati smanjenom djelotvornošću.
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu/
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove http://www.ema.europa.eu/.
English: Any inflammatory symptoms should be evaluated and treatment instituted when necessary.
Croatian: Svi upalni simptomi se moraju istražiti, a liječenje započeti prema potrebi.
English: Only a few metabolites were found in plasma, and all were at trace levels (0.2% or less of the plasma radioactivity).
Croatian: Samo je nekoliko metabolita otkriveno u plazmi, te su sve vrijednosti bile u tragovima (0,2% ili manje od radioaktivnosti u plazmi).
English: Patients with pre-existing liver dysfunction including chronic active hepatitis have an increased frequency of liver function abnormalities during combination therapy and should be monitored according to standard practice.
Croatian: Bolesnici s prethodnom disfunkcijom jetre, uključujući kronični aktivni hepatitis, imaju povećanu učestalost abnormalnosti jetrene funkcije tijekom kombinirane terapije te se moraju pratiti prema standardnoj praksi.
English: Tipranavir showed no evidence of genetic toxicity in a battery of in vitro and in vivo tests.
Croatian: Tipranavir nije pokazao gensku toksičnost u nizu in vitro i in vivo testova.
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.
Croatian: Dok se promjene u parametrima klaritromicina ne smatraju klinički relevantnima, smanjenje AUC 14OH metabolita se mora razmotriti u liječenju H. influenzae infekcija u kojima je 14-OH metabolit najaktivniji.
English: The combination is not recommended.
Croatian: Kombinacija se ne preporučuje.
English: These factors lead to the conclusion that the benefits outweigh the risks of Aptivus oral solution only in children between 2 and 12 years of age without any other therapeutic option (see section 4.1).
Croatian: Ova opažanja podupiru zaključak da pozitivni učinci primjene Aptivus oralne otopine nadilaze rizike samo u djece starosti od 2 do 12 godina bez druge terapijske opcije (vidjeti dio 4.1).
English: However, some PK interaction studies were not performed with this recommended dosage.
Croatian: Međutim, neka ispitivanja farmakokinetičkih interakcija nisu izvedena uz ovakvo preporučeno doziranje.
English: A small amount of crystals may be observed in the bottle, which does not affect the potency or safety of the product.
Croatian: Dopuštena je malena količina kristala u boci, koja ne utječe na jačinu djelovanja ili sigurnost lijeka.
English: Children and adolescents
Croatian: Dodatne nuspojave u djece i adolescenata
English: *Carbamazepine total = total of carbamazepine and epoxycarbamazepine (both are pharmacologically active moieties).
Croatian: *Karbamazepin ukupni = karbamazepin i epoksikarbamazepin (oba farmakološki aktivni).
English: Aptivus may be less effective due to decreased tipranavir plasma concentrations in patients taking these agents concomitantly.
Croatian: Aptivus može biti manje učinkovit zbog smanjenih koncentracija tipranavira u plazmi u bolesnika koji istodobno uzimaju ove lijekove.
English: Potent inhibition of CYP 2D6 and both hepatic and intestinal CYP 3A4 activities were observed.
Croatian: Primijećena je snažna inhibicija CYP 2D6, kao i hepatičke i intestinalne CYP 3A4 aktivnosti.
English: As demonstrated in a doseranging evaluation in 113 HIV-negative healthy male and female volunteers, ritonavir increases AUC012h, Cmax and Cmin and decreases the clearance of tipranavir.
Croatian: Kako je pokazano u ispitivanju određivanja doze u 113 HIV-negativnih zdravih muških i ženskih dobrovoljaca, ritonavir povećava AUC0-12h, Cmax i Cmin te smanjuje klirens tipranavira.
English: If affected, you should not drive or operate machinery.
Croatian: Ako utječu, ne smijete upravljati vozilima ili strojevima.
English: Based on the metabolic profiles of tipranavir/r and the proton pump inhibitors, an interaction can be expected.
Croatian: Temeljem metaboličkih profila tipranavira/r i inhibitora protonske pumpe mogu se očekivati interakcije.
English: RESIST study
Croatian: Ispitivanje RESIST
English: Liver impairment could therefore result in an increase of tipranavir exposure and a worsening of its safety profile.
Croatian: Oštećenje jetre može rezultirati povećanim izlaganjem tipranaviru te pogoršanjem njegova profila sigurnosti.
English: These effects are called interactions, and can lead to serious side effects, or prevent proper control of other conditions your child may have.
Croatian: Ovi učinci se nazivaju interakcije, te mogu dovesti do teških nuspojava, ili spriječiti ispravnu kontrolu drugih stanja od kojih Vaše dijete možda boluje.
English: Ritonavir is a potent inhibitor of CYP3A4 and therefore affect drugs metabolised by this enzyme.
Croatian: Ritonavir je snažan inhibitor CYP3A4 te stoga utječe na lijekove koji se metaboliziraju putem ovog enzima.
English: Unless otherwise stated, studies detailed below have been performed with the recommended dosage of Aptivus/r (i.e. 500/200 mg BID).
Croatian: Osim ako se drugačije ne navodi, ispitivanja su provedena s preporučenim dozama Aptivusa/r (tj. 500/200 mg BID).
English: However, without new enfuvirtide some patients began to lose antiviral activity between weeks 4 and 8.
Croatian: Međutim, neki bolesnici koji nisu dobivali enfuvirtid počeli su gubiti virološki odgovor između 4. i 8. tjedna liječenja.
English: Warnings and precautions Talk to your child's doctor or pharmacist before giving Aptivus to your child.
Croatian: Upozorenja i mjere opreza Obratite se djetetovom liječniku ili ljekarniku prije nego počnete davati Aptivus svom djetetu.
English: With repeated dosing, tipranavir plasma concentrations are lower than predicted from single dose data, presumably due to hepatic enzyme induction.
Croatian: Uz ponavljano doziranje, koncentracije tipranavira u plazmi su niže od predviđenih iz podataka za jednokratnu dozu, pretpostavlja se zbog indukcije jetrenih enzima.
English: In faeces, unchanged tipranavir represented the majority of faecal radioactivity (79.9% of faecal radioactivity).
Croatian: U stolici, nepromijenjeni tipranavir je predstavljao većinu radioaktivnosti (79,9% radioaktivnosti).
English: What Aptivus is and what it is used for What you need to know before you take Aptivus How to take Aptivus
Croatian: Što je Aptivus i za što se koristi Što morate znati prije nego počnete uzimati Aptivus Kako uzimati Aptivus
English: Total patients treated (N) Events [N(%)] Vomiting/ retching Nausea
Croatian: Ukupni broj liječenih bolesnika (N) Događaji [N(%)] Povraćanje/podizanje želuca Mučnina
English: The following clinical data is derived from analyses of 48-week data from ongoing studies (RESIST-1 and RESIST-2) measuring effects on plasma HIV RNA levels and CD4 cell counts.
Croatian: Klinički podaci izvedeni su iz analiza 48-tjednih podataka iz tekućih kliničkih ispitivanja (RESIST-1 i RESIST-2) koji mjere učinke na vrijednosti HIV RNA u plazmi i broj CD4 stanica.
English: Endothelin receptor antagonists Bosentan
Croatian: Antagonisti endotelinskih receptora Bosentan
English: It belongs to a group of medicines called protease inhibitors and is used in the treatment of Human Immunodeficiency Virus (HIV) infection.
Croatian: Pripada skupini lijekova koji se nazivaju inhibitori proteaze te se primjenjuje u liječenju infekcije humanim virusom imunodeficijencije (HIV).
English: If you notice any of these symptoms please inform your doctor.
Croatian: Ako primijetite neki od ovih simptoma, molimo, obavijestite svog liječnika.
English: Median (Min - Max) % with VL > 100,000 copies/ml
Croatian: medijan (min.-maks.) % s > 100 000 kopija/ml
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).
Croatian: Aptivus meke kapsule sadrže alkohol (7% etanola, tj. 100 mg po kapsuli ili do 200 mg po dozi), što može dovesti do reakcije slične disulfiramskoj reakciji kad se primjenjuje istodobno s disulfiramom ili drugim lijekovima koji potiču ovakvu reakciju (npr. metronidazol).
English: Dosage reductions of rifabutin by at least 75% of the usual 300 mg/day are recommended (ie 150 mg on alternate days, or three times per week).
Croatian: Preporučuje se sniženje doze rifabutina za najmanje 75% od uobičajenih 300 mg/dan (tj. 150 mg svaki drugi dan, ili tri puta tjedno).
English: The combination should be used with caution and a lower dose of trazodone should be considered.
Croatian: Kombinacija se primjenjuje s oprezom te je potrebno razmotriti nižu dozu trazodona.
English: If patients experience fatigue, dizziness, or somnolence they should avoid potentially hazardous tasks such as driving or operating machinery.
Croatian: U slučaju da bolesnik osjeti umor, omaglicu ili somnolenciju treba izbjegavati potencijalno opasne radnje kao što su upravljanje vozilom ili rukovanje sa strojevima.
English: Mutations at protease codons 33, 82, 84 and 90
Croatian: Mutacije u proteaznim kodonima 33, 82, 84 i 90
English: For lipids, there is in some cases evidence for a treatment effect, while for weight gain there is no strong evidence relating this to any particular treatment.
Croatian: U nekim slučajevima postoji dokaz o učinku liječenja na lipide, dok o povezanosti debljanja s bilo kojim posebnim liječenjem nema čvrstog dokaza.
English: You should write the date of opening the bottle on the label and/or outer carton.
Croatian: Potrebno je napisati datum otvaranja boce na naljepnici i/ili vanjskoj kutiji.
English: Moreover a study with TPV/r and another NNRTI (efavirenz) did not show any clinically relevant interaction (see above).
Croatian: Štoviše, ispitivanje s TPV/r i drugim NNRTI (efavirenz) nije pokazalo nikakvu klinički značajnu interakciju (vidjeti prethodni tekst).
English: Clinical studies of Aptivus did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects (see section 5.2).
Croatian: Klinička ispitivanja Aptivusa nisu uključila dostatan broj bolesnika u dobi od 65 godina i starijih, pa nije moguće utvrditi da li je njihov odgovor na liječenje različit nego u mlađih bolesnika (vidjeti dio
English: The clinical relevance of this reduction has not been established, but may decrease the efficacy of zidovudine.
Croatian: Klinički značaj ovog smanjenja nije utvrđen, ali može smanjiti učinkovitost zidovudina.
English: Although the aetiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV-disease and/or long-term exposure to combination antiretroviral therapy (CART).
Croatian: Iako se etiologija smatra multifaktorijalnom (uključujući primjenu kortikosteroida, konzumaciju alkohola, tešku imunosupresiju, veći indeks tjelesne mase), prijavljeni su slučajevi osteonekroze, osobito u bolesnika s uznapredovalom HIV-bolešću i/ili pri dugotrajnom izlaganju kombiniranoj antiretrovirusnoj terapiji.
English: In the paediatric clinical trial, the frequency of rash (all grades, all causality) through 48 weeks of treatment was higher than in adult patients.
Croatian: U pedijatrijskom kliničkom ispitivanju, učestalost osipa (svi stupnjevi, svi uzroci), tijekom 48 tjedana liječenja, bila je veća nego u odraslih bolesnika.
English: Due to this and to the high vitamin E content of the oral solution, the risk of adverse reactions (type, frequency and/or severity) may be higher than with the capsule formulation.
Croatian: Zbog toga, kao i zbog visokog sadržaja vitamina E u oralnoj otopini, rizik nuspojava (vrsta, učestalost, i/ili težina) može biti veći nego za kapsule.
English: If you take more Aptivus than you should Inform your doctor as soon as possible if you take more than the prescribed dose of Aptivus.
Croatian: Ako uzmete više Aptivusa nego što ste trebali Obavijestite liječnika što je prije moguće ako uzmete više od propisane doze Aptivusa.
English: Clinical isolates that exhibited a  10-fold decrease in tipranavir susceptibility harboured 8 or more tipranavir-associated mutations.
Croatian: Klinički izolati koji su pokazali  10-struko smanjenje osjetljivosti na tipranavir imali su 8 ili više mutacija povezanih s tipranavirom.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 25 October 2005
Croatian: Datum prvog odobrenja: 25. listopada 2005.
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.
Croatian: U nekih bolesnika s uznapredovalom infekcijom HIV-om (AIDS) i anamnezom oportunističke infekcije može doći do pojave znakova i simptoma upale od prethodnih infekcija ubrzo nakon početka anti-HIV liječenja.
English: Therefore, an alternative, effective, safe method of contraception should be used during treatment (see section 4.5).
Croatian: Stoga je potrebno primjenjivati alternativnu djelotvornu, sigurnu metodu kontracepcije tijekom liječenja (vidjeti dio 4.5).
English: rilpivirine: If your child is taking rilpivirine, your child's doctor will monitor your child closely.
Croatian: - rilpivirin: Ako Vaše dijete uzima rilpivirin, djetetov liječnik će ga pažljivo pratiti.
English: Aptivussoft capsules are indicated for: adolescents12 years of age or older adults
Croatian: Aptivus meke kapsule su indicirane za: adolescente u dobi od 12 i više godina odrasle osobe
English: Aptivusoral solution is indicated for: children from 2 to 12 years of age
Croatian: Aptivus oralna otopina je indicirana za: djecu u dobi od 2 do 12 godina
English: Includes abdominal pain (N=1), dysphagia (N=1) and epigastric discomfort (N=1).
Croatian: Uključuje abdominalnu bol (N=1), disfagiju (N=1) i epigastrične tegobe (N=1).
English: Antacids aluminium- and magnesiumbased antacid QD
Croatian: Aluminijev i magnezijev antacid QD
English: Tabulated summary of adverse reactions associated with Aptivus based on clinical studies and postmarketing experience:
Croatian: Tablični pregled nuspojava povezanih s Aptivusom na temelju kliničkih ispitivanja i postmarketinškog iskustva:
English: Result
Croatian: Rezultat
English: Cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term exposure to combination antiretroviral therapy (CART).
Croatian: Prijavljeni su slučajevi osteonekroze, osobito u bolesnika s općenito poznatim rizičnim faktorima, uznapredovalom HIV bolešću ili dugotrajnim izlaganjem kombiniranoj antiretrovirusnoj terapiji.
English: Aptivustreatment is therefore appropriate for you.
Croatian: Stoga je liječenje Aptivusom odgovarajuće za Vas.
English: You should continue to take Aptivus for as long as your doctor tells you.
Croatian: Trebate nastaviti uzimati Aptivus toliko dugo koliko Vam liječnik propiše.
English: Your doctor may have to increase or decrease the dose of other medicines which you take together with Aptivus.
Croatian: Liječnik će možda morati povisiti ili sniziti dozu drugih lijekova koje uzimate zajedno s Aptivusom.
English: Interactions with other HIV medicines: - etravirine belongs to a class of HIV medicines called non-nucleoside reverse transcriptase inhibitors (NNRTIs).
Croatian: Interakcije s drugim HIV lijekovima: - etravirin pripada skupini lijekova protiv HIV-a koji se nazivaju nenukleozidni inhibitori reverzne transpkriptaze (NNRTI).
English: Due to limitations in the study design (e.g. nonrandomized switch allowed according to patient/clinician decision), any comparisons between patients taking capsules and oral solution are not meaningful.
Croatian: Zbog ograničenja u dizajnu ispitivanja (npr. nerandomizirani prijelaz dozvoljen prema odluci bolesnika/liječnika), usporedbe između kapsula i oralne otopine nisu valjane.
English: By contrast, evaluation of the steady-state plasma tipranavir trough concentrations at 10-14 h after dosing from the RESIST-1 and RESIST-2 studies demonstrate that females generally had higher tipranavir concentrations than males.
Croatian: Za razliku od toga, ocjena minimalnih koncentracija tipranavira u plazmi pri stanju ravnoteže, 10-14 sati nakon doziranja, iz RESIST-1 i RESIST-2 ispitivanja pokazuje da su žene općenito imale više koncentracije tipranavira nego muškarci.