FrancophonIA/ELRC3.0 huggingface dataset:
English: An increase in gastric pH that may result from H2-receptor antagonist therapy is not expected to have an impact on tipranavir plasma concentrations.
Croatian: Ne očekuje se da povećanje želučanog pH, koje može biti rezultat terapije antagonistom H2receptora, utječe na koncentracije tipranavira u plazmi.
English: If unavoidable, upward dose adjustments for either omeprazole or esomeprazole may be considered based on clinical response to therapy.
Croatian: Ako je nužno, može se razmotriti povišenje doze omeprazola ili esomeprazola, temeljem kliničkog odgovora na terapiju.
English: It may be difficult to tell the difference between: - side effects caused by Aptivus - side effects caused by the other medicines you are also taking - complications of HIV infection.
Croatian: Može biti teško naći razliku između: - nuspojava koje izaziva Aptivus - nuspojava izazvanih drugim lijekovima koje istodobno uzimate - komplikacija infekcije HIV-om.
English: Preclinical studies performed with tipranavir showed no adverse effect on fertility (see section 5.3).
Croatian: Pretklinička ispitivanja tipranavira nisu pokazala štetne učinke na plodnost (vidjeti dio 5.3).
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.
Croatian: Općenito, nuspojave su bile slične onima u odraslih bolesnika, s iznimkom povraćanja, osipa i pireksije, koji su bili češći u djece nego u odraslih.
English: Aptivus with ritonavir should be discontinued once signs of worsening liver function occur in patients with pre-existing liver disease.
Croatian: Primjena Aptivusa s ritonavirom se mora prekinuti kada se pojave znakovi pogoršanja jetrene funkcije u bolesnika s prethodno prisutnom bolešću jetre.
English: Total patients treated (N) 62 Events [N(%)]
Croatian: Ukupni broj liječenih bolesnika (N) Događaji [N(%)] Proljev
English: Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported to occur in the setting of immune reactivation; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment.
Croatian: Također su prijavljeni autoimuni poremećaji (kao što su Gravesova bolest i autoimuni hepatitis) u uvjetima imunološke reaktivacije; međutim, prijavljeno vrijeme do nastupa je varijabilnije te se ovi događaji mogu pojaviti više mjeseci nakon početka liječenja.
English: Clinical pharmacodynamic data
Croatian: Klinički farmakodinamički podaci
English: Aptivus capsules contain ethanol, macrogolglycerol ricinoleate and sorbitol (E420) Aptivus contains 7 % ethanol (alcohol), i.e. up to 400 mg per daily dose, equivalent to 8 ml of beer, or less than 4 ml of wine.
Croatian: Aptivus kapsule sadrže etanol, makrogolglicerolricinoleat i sorbitol (E420) Aptivus sadrži 7 % etanola (alkohola), tj. do 400 mg po dnevnoj dozi, što odgovara 8 ml piva ili manje od 4 ml vina.
English: Your doctor will take a blood sample to test how well your liver is working (your liver function).
Croatian: Liječnik će uputiti uzorke Vaše krvi na testiranje koliko dobro funkcionira Vaša jetra (jetrena funkcija).
English: Tell your child's doctor if your child experiences fainting or a sensation of abnormal heart beats.
Croatian: Obavijestite djetetovog liječnika ako Vaše dijete ima nesvjesticu ili osjeti abnormalne otkucaje srca.
English: Nervous system disorders common headache uncommon dizziness, neuropathy peripheral, somnolence rare intracranial haemorrhage*
Croatian: Poremećaji živčanog sustava često glavobolja manje često omaglica, periferna neuropatija, somnolencija rijetko intrakranijalno krvarenje*
English: Steady-state is attained in most subjects after 7 days of dosing.
Croatian: U većine, stanje ravnoteže postiže se nakon 7 dana ponovljenog doziranja.
English: Volume Aptivus (ml)
Croatian: Volumen Aptivusa (ml)
English: For example the protease inhibitors amprenavir, atazanavir, lopinavir and saquinavir will be decreased.
Croatian: Na primjer, inhibitori proteaze, amprenavir, atazanavir, lopinavir i sakvinavir bit će smanjeni.
English: Nevertheless, the clinical data available from the RESIST trials did not suggest any significant alteration of the tipranavir with ritonavir safety profile when combined with enfuvirtide as compared to patients treated with tipranavir with ritonavir without enfuvirtide.
Croatian: Ipak, klinički podaci iz RESIST studije nisu ukazali na značajne promjene profila sigurnosti tipranavira s ritonavirovom u kombinaciji s enfuvirtidom, u usporedbi s bolesnicima liječenima tipranavirom s ritonavirom bez enfuvirtida.
English: Remove the syringe cap covering the tip of the oral syringe (the cap will not be attached if this is the first time you are using the syringe).
Croatian: Uklonite kapicu sa štrcaljke koja pokriva vrh oralne štrcaljke (kapica neće prianjati ako prvi puta koristite štrcaljku).
English: Doses of ritonavir lower than 150 mg/m 2 twice daily, should not be used as they might alter the efficacy profile of the combination.
Croatian: Doze ritonavira niže od 150 mg/m 2 dvaput dnevno ne smiju se primjenjivati jer mogu promijeniti profil učinkovitosti kombinacije.
English: These drug-drug interactions may reduce the effectiveness of HIV protease inhibitors and/or boceprevir when co-administered.
Croatian: Ovakve interakcije među lijekovima mogu smanjiti učinkovitost ihibitora proteaze HIV-a i/ili boceprevira kod istodobne primjene.
English: The interaction profile of Aptivus, co-administered with low dose ritonavir, is complex and requires special attention in particular in combination with other antiretroviral agents.
Croatian: Profil interakcija Aptivusa s niskom dozom ritonavira je složen te zahtijeva posebnu pažnju, osobito u kombinaciji s drugim antiretrovirusnim lijekovima.
English: Do not take Aptivus - if you are allergic to tipranavir or any of the other ingredients of this medicine (listed in section
Croatian: Nemojte primjenjivati Aptivus - ako je Vaše dijete alergično na tipranavir ili neki drugi sastojak ovog lijeka (naveden u dijelu
English: Since Aptivus capsules and oral solution are not bioequivalent, results obtained with the oral solution cannot be extrapolated to the capsules (see also section 5.2).
Croatian: S obzirom da Aptivus kapsule i oralna otopina nisu bioekvivalentni, rezultati dobiveni za oralnu otopinu ne mogu se ekstrapolirati na kapsule (vidjeti dio 5.2).
English: Aptivus therapy should not be initiated in patients with pre-treatment ASAT or ALAT greater than 5 times the Upper Limit Normal (ULN) until baseline ASAT/ALAT is stabilised at less than 5X ULN, unless the potential benefit justifies the potential risk.
Croatian: Terapija Aptivusom se ne smije počinjati u bolesnika s vrijednostima AST ili ALT 5 puta višima od gornje granice normalnih vrijednosti (GGN) prije liječenja, sve dok se AST/ALT ne stabiliziraju na vrijednostima nižim od 5 X GGN, osim ako potencijalni pozitivni učinak ne opravdava potencijalni rizik.
English: - Protease Inhibitors (PIs): Taking Aptivus may cause large decreases in the blood levels of other HIV protease inhibitors.
Croatian: - Inhibitori proteaze (IP): Uzimanje Aptivusa može izazvati velika smanjenja razine drugih inhibitora proteaze HIV-a u krvi.
English: If your child is pregnant or breast-feeding, you think your child may be pregnant or is planning to have a baby, ask your child's doctor or pharmacist for advice before giving this medicine.
Croatian: Ako je Vaša kćer trudna ili doji, mislite da bi mogla biti trudna ili planira imati dijete, obratite se njezinom liječniku ili ljekarniku za savjet prije nego uzme ovaj lijek.
English: It has been shown that taking all doses at the appropriate times: - greatly increases the effectiveness of your combination antiretroviral medicines - reduces the chances of your HIV becoming resistant to your antiretroviral medicines
Croatian: Pokazalo se da uzimanje svih doza u odgovarajuće vrijeme: - uvelike povećava učinkovitost kombiniranih antiretrovirusnih lijekova - smanjuje mogućnost razvoja otpornosti HIV-a na antiretrovirusne lijekove
English: You should check with your doctor if you do wish to continue taking oral contraceptives or HRT.
Croatian: Potrebno je provjeriti s liječnikom ako želite nastaviti uzimati oralne kontraceptive ili HNT.
English: Aptivus co-administered with low dose ritonavir, has been associated with reports of clinical hepatitis and hepatic decompensation, including some fatalities.
Croatian: Aptivus primijenjen s niskom dozom ritonavira, povezan je s prijavama kliničkog hepatitisa i dekompenzacije jetre, uključujući i nekoliko smrtnih ishoda.
English: Aptivus should be used in this patient population only if the potential benefit outweighs the potential risk, and with increased clinical and laboratory monitoring.
Croatian: U tih se bolesnika Aptivus primjenjuje samo ako potencijalni pozitivni učinci nadilaze potencijalni rizik, te uz povećano kliničko i laboratorijsko praćenje.
English: Tipranavir is a substrate, an inducer and an inhibitor of cytochrome P450 CYP3A.
Croatian: Tipranavir je supstrat, induktor i inhibitor citokroma P450 CYP3A.
English: Antiarrhythmics Amiodarone Bepridil
Croatian: Antiaritmici Amiodaron
English: Tell your doctor if you experience fainting or a sensation of abnormal heart beats.
Croatian: Obavijestite liječnika ako imate nesvjesticu ili osjetite abnormalne otkucaje srca.
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.
Croatian: Zbog višestrukih CYP izoenzimskih sustava uključenih u metabolizam vorikonazola, teško je predvidjeti interakcije s tipranavirom s niskom dozom ritonavira.
English: If your child stops taking Aptivus It has been shown that taking all doses at the appropriate times: - greatly increases the effectiveness of your child's combination antiretroviral medicines - reduces the chances of your child's HIV becoming resistant to his/her antiretroviral medicines.
Croatian: Ako Vaše dijete prestane uzimati Aptivus Pokazalo se da uzimanje svih doza u odgovarajuće vrijeme: - uvelike povećava učinkovitost kombiniranih antiretrovirusnih lijekova - smanjuje mogućnost razvoja otpornosti HIV-a na antiretrovirusne lijekove
English: Nucleoside and nucleotide reverse transcriptase inhibitors (NRTIs) Since there is no significant impact of nucleoside and nucleotide analogues on the P450 enzyme system no dosage adjustment of Aptivus is required when co-administered with these agents.
Croatian: Nukleozidni i nukleotidni inhibitori reverzne transkriptaze (NRTI) S obzirom da nukleozidni i nukleotidni analozi nemaju značajan utjecaj na P450 enzimski sustav, nije potrebno podešavanje doza APTIVUSA kada se primjenjuje istodobno s ovim lijekovima.
English: Caution should be used when prescribing carbamazepine, phenobarbital, and phenytoin.
Croatian: Potreban je oprez u propisivanju karbamazepina, fenobarbitala i fenitoina.
English: Generally, it is not recommended to take Aptivus, with ritonavir, together with oral contraceptives or hormone replacement therapy (HRT).
Croatian: Općenito se ne preporučuje uzimati Aptivus s ritonavirom zajedno s oralnim kontraceptivima ili hormonskom nadomjesnom terapijom (HNT).
English: Aptivus should be prescribed by physicians who are experienced in the treatment of HIV-1 infection.
Croatian: Aptivus bi morali propisivati liječnici s iskustvom u liječenju infekcije virusom HIV-1.
English: Moreover, in case of withdrawal of glucocorticoids progressive dose reduction may have to be performed over a longer period.
Croatian: Štoviše, u slučaju prekida primjene glukokortikoida možda će biti potrebno progresivno snižavanje doze tijekom duljeg razdoblja.
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.
Croatian: Potrebno je naglasiti da prijelaz s oralne otopine na formulaciju kapsula Aptivusa može rezultirati smanjenim izlaganjem tipranaviru.
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.
Croatian: Nadalje, u jednom ispitivanju interakcija u zdravih žena koje su dobile jednu dozu etinilestradiola, nakon čega je slijedio Aptivus s niskom dozom ritonavira, 33% ih je razvilo osip.
English: Lipid disorders should be managed as clinically appropriate.
Croatian: Poremećaje lipida potrebno je odgovarajuće klinički liječiti.
English: Coadministration of Aptivus and medicinal products that inhibit P-gp may increase tipranavir plasma concentrations.
Croatian: Istodobna primjena Aptivusa i lijekova koji inhibiraju P-gp može povećati koncentracije tipranavira u plazmi.
English: Rabeprazole plasma concentrations might decrease as a result of induction of CYP2C19 by tipranavir/r.
Croatian: Koncentracije rabeprazola u plazmi se mogu smanjiti kao rezultat indukcije CYP2C19 putem tipranavira/r.
English: Baseline characteristics for patients 2 - <12 years treated with Aptivus oral solution
Croatian: Početna svojstva za bolesnike 2 - < 12 godina liječene Aptivus oralnom otopinom
English: Your doctor will carefully consider whether to treat you with combinations of Aptivus and protease inhibitors.
Croatian: Liječnik će pažljivo razmotriti da li Vam je potrebno liječenje kombinacijama Aptivusa i inhibitora proteaze.
English: Interaction study performed only with ritonavir
Croatian: Ispitivanje interakcija provedeno samo s ritonavirom
English: Aptivus in combination with low dose ritonavir may cause changes in your heart rhythm and the electrical activity of your heart.
Croatian: Aptivus u kombinaciji s niskom dozom ritonavira može izazvati promjene u ritmu srca i električnoj aktivnosti srca.
English: If Aptivus with ritonavir is administered with parenteral midazolam, close clinical monitoring for respiratory depression and/or prolonged sedation should be instituted and dosage adjustment should be considered.
Croatian: Ako se Aptivus s ritonavirom primjenjuje uz parenteralni midazolam, potrebno je pomno kliničko praćenje radi respiratorne depresije i/ili produljene sedacije te je potrebno razmotriti prilagodbu doza.
English: Children Aptivus soft capsules should not be used by children under 12 years of age.
Croatian: Djeca Aptivus meke kapsule se ne primjenjuju u djece mlađe od 12 godina.
English: Adults and adolescents (from 12 - 18 years of age) The recommended dose of Aptivus is 500 mg, co-administered with 200 mg ritonavir (low dose ritonavir), twice daily (see section 4.4 for precautionary measures in adolescents).
Croatian: Odrasli i adolescenti (u dobi od 12 - 18 godina) Preporučena doza Aptivusa je 500 mg, uz istodobnu primjenu 200 mg ritonavira (niska doza ritonavira), dvaput dnevno (vidjeti dio 4.4 za mjere opreza u adolescenata).
English: It may be difficult to tell the difference between: - side effects caused by Aptivus - side effects caused by the other medicines your child is also taking - complications of HIV infection.
Croatian: Može biti teško naći razliku između: - nuspojava koje izaziva Aptivus - nuspojava izazvanih drugim lijekovima koje Vaše dijete istodobno uzima - komplikacija infekcije HIV-om.
English: No pattern of abnormal haematological or coagulation parameters has been observed in patients in general, or preceding the development of ICH.
Croatian: Nije primijećen obrazac abnormalnih hematoloških ili koagulacijskih parametara u bolesnika liječenih tipranavirom općenito, ili prije razvoja ICH.
English: No data are available on the efficacy and safety of Aptivus capsules in children less than 12 years of age.
Croatian: Nema dostupnih podataka o djelotvornosti i sigurnosti Aptivus kapsula za djecu ispod 12 godina starosti.
English: Paediatric patients who were 12 years or older and received the maximum dose of 500 mg/200 mg twice daily could change to Aptivus capsules from study day 28.
Croatian: Pedijatrijski bolesnici u dobi 12 ili više godina koji su primali maksimalnu dozu od 500 mg/200 mg dvaput dnevno mogli su prijeći na Aptivus kapsule od 28. dana ispitivanja.
English: C-tipranavir with 200 mg ritonavir, twice daily), unchanged tipranavir was predominant and accounted for 98.4% or greater of the total plasma radioactivity circulating at 3, 8, or 12 hours after dosing.
Croatian: C-tipranavira s 200 mg ritonavira, dvaput dnevno), nepromijenjeni tipranavir bio je dominantan i na njega je otpadalo 98,4% ili više ukupne radioaktivnosti u plazmi 3, 8 ili 12 sati nakon doziranja.
English: No cases of Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis have been reported in the clinical development programme of tipranavir.
Croatian: Nisu prijavljeni slučajevi StevensJohnsonovog sindroma ili toksične epidermalne nekrolize u premarketinškim kliničkim ispitivanjima s tipranavirom.
English: Baseline characteristics for patients 12 - 18 years of age who took capsule
Croatian: Početna svojstva za bolesnike 12 - 18 godina starosti koji su uzimali kapsule
English: Generally, an increased frequency and higher severity of adverse reactions may result from overdose.
Croatian: Općenito, povećana učestalost i veća ozbiljnost nuspojava može biti rezultat predoziranja.
English: Also, the composition of the oral solution is different from that of the capsules, with the high vitamin E content being especially noteworthy.
Croatian: Također, sastav oralne otopine različit je od sastava kapsula, pri čemu valja uočiti veliku količinu vitamina E.
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.
Croatian: Telaprevir se metabolizira u jetri putem CYP3A te je supstrat Pglikoproteina (P-gp), ali i drugi enzimi mogu biti uključeni u njegov metabolizam.
English: If your child takes other medicines at the same time as Aptivus and ritonavir, this can strengthen or weaken the effect of the medicines.
Croatian: Ako Vaše dijete istodobno uz Aptivus i ritonavir uzima druge lijekove, to može ojačati ili oslabiti učinak lijekova.
English: This indication is based on the results of one phase II study investigating pharmacokinetics, safety and efficacy of Aptivus oral solution in mostly treatment-experienced children aged 2 to 12 years.
Croatian: Ova indikacija se zasniva na rezultatima jednog ispitivanja faze II koje je ispitivalo farmakokinetiku, sigurnost i djelotvornost Aptivusa na adolescentima u dobi 12 do 18 godina starosti koji su većinom već imali iskustvo liječenja.
English: The effects of high fluticasone systemic exposure on ritonavir plasma levels are as yet unknown.
Croatian: Učinci sistemskog izlaganja flutikazonu na koncentracije ritonavira u plazmi još uvijek nisu poznati.
English: Initiation of treatment should take into account the combinations of mutations which may negatively impact the virological response to Aptivus, coadministered with low dose ritonavir (see section 5.1).
Croatian: Na početku liječenja potrebno je uzeti u obzir kombinacije mutacija koje mogu negativno utjecati na virusnu reakciju na Aptivus, uz istodobnu primjenu niske doze ritonavira (vidjeti dio 5.1).
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%).
Croatian: U kliničkom ispitivanju na zdravim dobrovoljcima u kojem su ritonavir 100 mg kapsule bile primjenjivane s 50 µg intranazalnog flutikazonpropionata (4 puta dnevno) u trajanju 7 dana, vrijednosti flutikazonpropionata u plazmi su se značajno povisile, dok su se vrijednosti endogenog kortizola smanjile za oko 86% (90% interval pouzdanosti 82-89%).
English: This leaflet was last approved in {MM/YYYY} Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Croatian: Ova uputa je zadnji puta revidirana u {MM/GGGG} Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove: http://www.ema.europa.eu.
English: In a study performed in antiretroviral naïve adult patients, tipranavir 500 mg with ritonavir 200 mg twice daily, as compared to lopinavir/ritonavir, was associated with an excess in the occurrence of significant (grade 3 and 4) transaminase elevations without any advantage in terms of efficacy (trend towards a lower efficacy).
Croatian: U kliničkom ispitivanju s prethodno neliječenim odraslim bolesnicima tipranavir 500 mg s ritonavirom 200 mg dvaput dnevno, u usporedbi s lopinavir/ritonavirom, bio je povezan s prekomjernim značajnim (stupanj 3 i 4) povišenjem transaminaza, bez ikakvih prednosti u smislu djelotvornosti (tendencija k manjoj djelotvornosti).
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.
Croatian: Reverzni genetski eksperimenti pokazuju da je potrebno prisustvo 6 mutacija u proteazi (I13V, V32I, L33F, K45I, V82L, I84V) za postizanje > 10-struke rezistencije na tipranavir, dok je potpuni 10mutacijski genotip imao 69-struku rezistenciju na tipranavir.
English: Taking Aptivus, with atazanavir, may cause the blood levels of Aptivus and ritonavir to increase a lot.
Croatian: Uzimanje Aptivusa s atazanavirom može izazvati veliko povišenje razine Aptivusa i ritonavira u krvi.
English: At maternal doses producing systemic exposure levels similar to or below those at the recommended clinical dose, tipranavir did not produce teratogenic effects.
Croatian: Pri dozama koje u majke rezultiraju sistemskom izloženošću koja je slična ili niža od one koja se postiže u ljudi preporučenom kliničkom dozom, tipranavir nije imao teratogene učinke.
English: Based on similarities in the elimination between pravastatin and rosuvastatin, TPV/r could increase the plasma levels of pravastatin.
Croatian: Temeljem sličnosti eliminacije pravastatina i rosuvastatina, TPV/r može povisiti vrijednosti pravastatina u plazmi.
English: Before giving Aptivus you should check that the oral solution is clear.
Croatian: Prije davanja Aptivusa potrebno je provjeriti da li je oralna otopina bistra.
English: Aptivus oral solution is available for children between 2 and 12 years of age (please refer to the respective SmPC for further details).
Croatian: Za djecu između 2 i 12 godina starosti dostupna je Aptivus oralna otopina (molimo, referirati na relevantni Sažetak opisa svojstava lijeka za dodatne detalje).
English: Close clinical and biological (INR measurement) monitoring is recommended when warfarin and tipranavir are combined.
Croatian: Preporučuje se pomno kliničko i biološko (INR mjerenje) praćenje kada se kombiniraju varfarin i tipranavir.
English: 14-OH-clarithromycin Cmax ↓ 97% 14-OH-clarithromycin AUC ↓ 97% 14-OH-clarithromycin Cmin ↓ 95%
Croatian: 14-OH-klaritromicin Cmax ↓ 97% 14-OH-klaritromicin AUC ↓ 97% 14-OH-klaritromicin Cmin ↓ 95%
English: - jaundice (yellowing of the skin or the eyeballs)
Croatian: - žutica (žutilo kože ili bjeloočnica)
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.
Croatian: Desetorostruka ili veća otpornost na tipranavir je manje česta (< 2,5% testiranih izolata) u izolatima bolesnika s opsežnim prethodnim liječenjem koji su primali višestruke peptidne inhibitore proteaze.
English: 25-O-desacetylrifabutin AUC ↑ 21 fold
Croatian: 25-O-dezacetilrifabutin AUC ↑ 21 puta
English: Patients should be advised of the need to take Aptivus and ritonavir every day as prescribed.
Croatian: Bolesnike je potrebno savjetovati da se Aptivus i ritonavir moraju svakodnevno primjenjivati prema propisanoj liječničkoj uputi.