FrancophonIA/ELRC3.0 huggingface dataset:
English: Glaxo Operations UK Ltd (trading as GlaxoWellcome Operations)
Croatian: Glaxo Operations UK Ltd (posluje kao GlaxoWellcome Operations)
English: Severe and life-threatening skin reactions, including Stevens-Johnson syndrome, were reported in less than 1% of patients included in the clinical development programme.
Croatian: Teške kožne reakcije opasne po život, uključujući Stevens-Johnsonov sindrom prijavljene su u manje od 1% bolesnika uključenih u klinički razvojni program.
English: Conclusions regarding the relevance of particular mutations or mutational patterns are subject to change with additional data, and it is recommended to always consult current interpretation systems for analysing resistance test results.
Croatian: Zaključci o značaju određenih mutacija ili mutacijskih obrazaca podložni su promjenama u skladu s dodatnim podacima te se za analizu rezultata ispitivanja rezistencije preporučuje konzultirati trenutno važeći interpretacijski sistem.
English: ITT-E observed analysis
Croatian: Opažena ITT-E analiza
English: Significant ↓ APV expected
Croatian: Očekuje se značajno ↓ APV
English: • Increases in enzymes produced by the liver called transaminases, increases of an enzyme produced by the pancreas called lipase.
Croatian: • povećanje enzima koje stvara jetra, a koji se nazivaju transaminaze, povećanje enzima koje stvara gušterača a koji se nazivaju lipaze.
English: With this condition, parts of the bone tissue die because of reduced blood supply to the bone.
Croatian: U tom stanju, dijelovi koštanog tkiva odumiru zbog smanjene opskrbe krvi u kostima.
English: Aspen Bad Oldesloe GmbH, Industriestrasse 32-36, D-23843, Bad Oldesloe, Germany or
Croatian: Aspen Bad Oldesloe GmbH, Industriestrasse 32-36, D-23843, Bad Oldesloe, Njemačka ili
English: This dose adjustment cannot be made with Telzir tablets.
Croatian: Tu prilagodbu doze nije moguće učiniti s Telzir tabletama.
English: When Telzir is co-administered with ritonavir, the half-life of amprenavir is increased to 15 - 23 hours.
Croatian: Kada se Telzir istodobno primjenjuje s ritonavirom poluvrijeme amprenavira povećava se na 15-23 sata.
English: Study performed with amprenavir.
Croatian: Ispitivanje je provedeno s amprenavirom.
English: Etravirine Cmin↔a Etravirine Cmax↔a a Comparison based on historic control.
Croatian: Etravirin AUC ↔a Etravirin Cmin↔a Etravirin Cmax↔a a Usporedba temeljena na povijesnoj kontroli.
English: You may experience muscle problems
Croatian: Možete imati tegobe s mišićima
English: Hormonal contraception
Croatian: Hormonska kontracepcija
English: The mean AAUCMBs (log10 c/ml) in the ITT (E) population (Observed analysis) at 48 weeks (primary end-point) and other efficacy outcomes by subgroup are described in the tables below:
Croatian: Srednja vrijednost AAUCMB (log10 c/ml) u ITT (E) populaciji (opažena analiza) u 48. tjednu (primarni ishod) i drugi ishodi djelotvornosti prema podskupinama opisuju se u tablicama koje slijede:
English: Greater effects may be expected when fluticasone propionate is inhaled.
Croatian: Mogu se očekivati snažniji učinci pri inhalaciji flutikazon propionata.
English: If you notice any muscle problems: →Tell your doctor.
Croatian: Ako primijetite bilo kakav problem s mišićima: →Obavijestite svog liječnika.
English: You may get a skin rash.
Croatian: Možda će se kod Vas razviti kožni osip.
English: Telzir does not require any special storage conditions.
Croatian: Telzir ne zahtijeva posebne uvjete čuvanja.
English: • clarithromycin, erythromycin (an antibiotic)
Croatian: • klaritromicin, eritromicin (antibiotik)
English: Some people taking combination therapy for HIV develop a condition called osteonecrosis.
Croatian: Kod nekih ljudi koji uzimaju kombinirani terapiju za HIV može se razviti stanje koje nazivamo osteonekroza.
English: Adults with liver disease
Croatian: Odrasli s bolešću jetre
English: Therapy should be initiated by a physician experienced in the management of HIV infection.
Croatian: Terapiju treba započeti liječnik koji je iskusan u liječenju HIV infekcija.
English: In view of the low exposure in reproductive toxicity studies, the potential developmental toxicity of Telzir has not been fully determined.
Croatian: U pogledu niske izloženosti tijekom ispitivanja reproduktivne toksičnosti, potencijalna razvojna toksičnost lijeka Telzir nije u cijelosti utvrđena.
English: Aspartate aminotransferase increased
Croatian: Povećana razina aspartat aminotransferaze
English: It is not known whether amprenavir can be removed by peritoneal dialysis or haemodialysis.
Croatian: Nije poznato može li se amprenavir ukloniti peritonealnom dijalizom ili hemodijalizom.
English: A reduction in the rifabutin dosage by at least 75 % is recommended when administered with Telzir with ritonavir.
Croatian: Preporučuje se smanjenje doze rifabutina za barem 75% kada ga se primjenjuje s lijekom Telzir i s ritonavirom.
English: Telzir is a type of medicine known as an anti-retroviral.
Croatian: Telzir je vrsta lijeka poznata kao antiretrovirusni lijek.
English: 150 mg every other day
Croatian: 150 mg svaki drugi dan
English: The dose recommendations for this population therefore take into account the observed food effect (see section 4.2).
Croatian: Preporuke doziranja za ovu populaciju uzimaju u obzir zamijećene utjecaje hrane (vidjeti dio 4.2).
English: (Ritonavir 100 mg capsules twice daily for 7 days)
Croatian: (Ritonavir 100 mg kapsule 2 puta dnevno tijekom 7 dana)
English: Increased bleeding may occur while taking protease inhibitors (such as Telzir).
Croatian: Može doći do povećanih krvarenja tijekom uzimanja inhibitora proteaze (poput lijeka Telzir).
English: Doses of atorvastatin no greater than 20 mg/day should be administered, with careful monitoring for atorvastatin toxicity.
Croatian: Treba primijeniti doze atorvastatina koje nisu veće od 20 mg/dan uz pažljivo praćenje toksičnosti atorvastatina.
English: Potential for increased alfuzosin concentrations which can result in hypotension.
Croatian: Postoji potencijal za povećanje koncentracije alfuzosina što može dovesti do hipotenzije.
English: The pharmacokinetics of fosamprenavir in combination with ritonavir has not been studied in patients over 65 years of age.
Croatian: Farmakokinetika fosamprenavira u kombinaciji s ritonavirom nije ispitana kod bolesnika starijih od 65 godina.
English: • The active substance is fosamprenavir.
Croatian: • Djelatna tvar je fosamprenavir.
English: < 4 mutations from score
Croatian: < 4 mutacije od ocjene
English: Taking Telzir and ritonavir while taking the contraceptive pill may harm your liver and may stop the contraceptive from working properly.
Croatian: Uzimanje lijeka Telzir i ritonavira dok uzimate kontracepcijske pilule može oštetiti Vašu jetru i spriječiti odgovarajuće djelovanje kontraceptiva.
English: Week 96 Week 144
Croatian: 96. tjedan 144. tjedan
English: In females, at the high dose, there was a reduction in the weight of gravid uterus (0 to 16%) probably due to a reduction of the number of ovarian corporea lutea and implantations.
Croatian: Kod ženki je pri visokim dozama došlo do smanjenja težine gravidnih uterusa (0-16%), najvjerojatnije zbog smanjenja broja žutih tijela u ovarijima i broja implantacija.
English: Telzir belongs to a group of anti-retroviral medicines called protease inhibitors.
Croatian: Telzir pripada skupini antiretrovirusnih lijekova koje nazivamo inhibitori proteaze.
English: Capsule or Solution 100 mg
Croatian: Kapsule ili otopina 100 mg
English: Co-administration of amprenavir with grapefruit juice was not associated with clinically significant changes in plasma amprenavir pharmacokinetics.
Croatian: Istodobna primjena amprenavira sa sokom od grejpa nije bila povezana s klinički značajnim promjenama farmakokinetike amprenavira u plazmi.
English: If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment must be considered.
Croatian: Ako postoje dokazi da se kod tih bolesnika bolest jetre pogoršava, mora se razmotriti mogućnost privremenog ili trajnog prekida liječenja.
English: In case of withdrawal of glucocorticoids, progressive dose reduction may have to be performed over a longer period (see section 4.4).
Croatian: U slučaju da se prestaje s korištenjem glukokortikoida, progresivno postupno smanjenje doze možda treba provesti kroz duže vremensko razdoblje (vidjeti dio 4.4).
English: AAUCMB Observed Analysis
Croatian: AAUCMB analiza opaženog
English: The decrease of (R-) methadone (active enantiomer) is not expected to be clinically significant.
Croatian: Ne očekuje se klinički značajno smanjenje (R-) metadona (aktivnog enantiomera).
English: The relationship between in vitro anti-HIV-1 activity of amprenavir and the inhibition of HIV-1 replication in humans has not been defined.
Croatian: Nije definiran odnos između in vitro anti-HIV-1 aktivnosti amprenavira i inhibicije HIV-1 replikacije kod ljudi.
English: If you forget to take Telzir
Croatian: Ako ste zaboravili uzeti Telzir
English: Ritonavir induces CYP3A4, CYP1A2, CYP2C9 and glucuronosyl transferase.
Croatian: Ritonavir inducira CYP3A4, CYP1A2, CYP2C9 i glukuronozil transferazu.
English: When treating HIV, it can be hard to tell whether side effects are caused by Telzir, by other medicines taken at the same time or by the HIV disease itself.
Croatian: Kod liječenja HIV-a, ponekad može biti teško utvrditi da li su nuspojave uzrokovane lijekom Telzir, drugim lijekovima koje istodobno uzimate ili samom HIV bolesti.
English: Midazolam: ↑ expected (3-4 fold for parenteral midazolam)
Croatian: Midazolam: očekuje se ↑ (3-4 puta pri parenteralnoj primjeni midazolama)
English: Any inflammatory symptoms should be evaluated and treatment instituted when necessary.
Croatian: Sve simptome upale mora se procijeniti i prema potrebi započeti liječiti.
English: Other medicines and Telzir
Croatian: Drugi lijekovi i Telzir
English: Potential for serious and/or life-threatening reactions such as acute ergot toxicity characterized by peripheral vasospasm and ischemia of the extremities and other tissues.
Croatian: Postoji potencijal za ozbiljne i/ili po život opasne reakcije kao što je akutna ergot toksičnosti koju karakterizira periferni vazospazam i ishemija ekstremiteta i drugih tkiva.
English: There have been reports of muscle pain, tenderness or weakness, particularly with antiretroviral therapy including protease inhibitors and nucleoside analogues.
Croatian: Bilo je prijava boli u mišićima, osjetljivosti ili slabosti, pogotovo s antiretrovirusnom terapijom koja uključuje inhibitore proteaze i analoge nukleozida.
English: Fosamprenavir AUC values are, in general, less than 1 % of those observed for amprenavir.
Croatian: Vrijednosti AUC za fosamprenavir općenito su manje od 1% zabilježenih za amprenavir.
English: Pharmacotherapeutic group: Antivirals for systemic use, protease inhibitor, ATC Code: J05AE07 Mechanism of action
Croatian: Farmakoterapijska skupina: Antivirusni lijekovi za sistemsku primjenu, inhibitori proteaze, ATK oznaka: J05AE07
English: FPV/RTV BID - Fosamprenavir with ritonavir twice daily, LPV/RTV BID - Lopinavir / ritonavir twice daily
Croatian: FPV/RTV BID - Fosamprenavir s ritonavirom 2 puta dnevno, LPV/RTV BID - Lopinavir/ritonavir 2 puta dnevno
English: • Problems with your bones.
Croatian: • Tegobe s kostima.
English: No dosing recommendations can be made for the very young (children < 2 years of age) and Telzir with ritonavir is not recommended for this patient population (see section 4.2).
Croatian: Ne mogu se donijeti preporuke o doziranju za jako mladu djecu (djeca u dobi < 2 godine starosti) te se Telzir s ritonavirom ne preporučuje za tu populaciju bolesnika (vidjeti dio 4.2).
English: Single 30 ml dose of antacid suspension (equivalent to 3.6 grams aluminium hydroxide and 1.8 grams magnesium hydroxide
Croatian: Jedna doza od 30 ml suspenzije antacida (ekvivalent 3,6 g aluminijhidroksida i 1,8 g magnezijhidroksida
English: ANTIHISTAMINES (HISTAMINE H1 RECEPTOR ANTAGONISTS) Astemizole Terfenadine
Croatian: ANTIHISTAMINICI (ANTAGONISTI HISTAMINSKIH H1 RECEPTORA) Astemizol
English: Resistance testing diagnostic companies have developed clinical phenotypic cut-offs for FPV/RTV that can be used to interpret resistance test results.
Croatian: Dijagnostičke tvrtke za ispitivanje rezistencije razvile su fenotipske skale isključenja za FPV/RTV koje se mogu koristiti za interpretaciju rezultata testiranja rezistencije.
English: Stevens Johnson syndrome
Croatian: Stevens-Johnsonov sindrom Angioedem
English: Therefore, any medicinal products that either share this metabolic pathway or modify CYP3A4 activity may modify the pharmacokinetics of amprenavir and ritonavir.
Croatian: Stoga, bilo koji lijek koji također ima taj metabolički put ili modificira aktivnost CYP3A4, može modificirati farmakokinetiku amprenavira i ritonavira.
English: Osteonecrosis: cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term exposure to CART.
Croatian: Osteonekroza: prijavljeni su slučajevi osteonekroze, osobito kod bolesnika s opće poznatim faktorima rizika, uznapredovalom HIV bolešću ili dugotrajnom izloženošću CART-u.
English: Both of these studies compared fosamprenavir/ritonavir with lopinavir / ritonavir.
Croatian: Oba ova ispitivanja uspoređivala su kombinacije fosamprenavira/ritonavira s lopinavirom/ritonavirom.
English: Telzir is supplied in plastic bottles containing 225 ml oral suspension.
Croatian: Telzir dolazi u plastičnim bocama koje sadrže 225 ml oralne suspenzije.
English: PDE5 INHIBITORS Sildenafil
Croatian: INHIBITORI PDE5 Sildenafil
English: Fosamprenavir is converted in man to amprenavir.
Croatian: Fosamprenavir se kod ljudi pretvara u amprenavir.
English: It is taken with low doses of another medicine, ritonavir, which boosts the level of Telzir in the blood.
Croatian: Uzima se s malom dozom drugog lijeka, ritonavira, koji podiže razine lijeka Telzir u krvi.
English: It can be treated with antihistamines.
Croatian: Osip se može liječiti antihistaminicima.
English: Due to CYP3A inhibition by Telzir, concentrations of quetiapine are expected to increase.
Croatian: Budući da Telzir inhibira CYP3A, očekuje se povećanje koncentracija kvetiapina.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Croatian: Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP), koji se nalazi u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet te svim sljedećim dogovorenim ažuriranim verzijama RMP-a.
English: Fosamprenavir is a pro-drug of amprenavir and must not be administered concomitantly with other medicinal products containing amprenavir.
Croatian: Fosamprenavir je predlijek amprenavira i ne smije se primjenjivati istodobno s drugim lijekovima koji sadrže amprenavir.
English: If your liver disease gets worse, you may need to stop taking Telzir for a while, or permanently.
Croatian: Ako dođe do pogoršanja bolseti jetre, možda ćete privremeno ili trajno morati prestati uzimati Telzir.
English: Shake the bottle vigorously for 20 seconds before first dose is removed and 5 seconds before each subsequent dose.
Croatian: Prije uzimanja prve doze bocu snažno tresite 20 sekundi, a prije uzimanja svake sljedeće doze 5 sekundi.
English: The pharmacokinetics of fosamprenavir have not been studied in this patient population (see section 5.2).
Croatian: Farmakokinetika fosamprenavira nije ispitivana u ovoj populaciji bolesnika (vidjeti dio 5.2).
English: ERGOT DERIVATIVES
Croatian: ERGOT DERIVATI
English: Concomitant use is not recommended unless the potential benefit of treatment outweighs the risk of systemic corticosteroid effects (see section 4.4).
Croatian: Istodobna primjena se ne preporučuje ukoliko potencijalna korist liječenja nije veća od rizika sistemskih učinaka kortikosteroida (vidjeti dio 4.4).
English: Take special care with Telzir Talk to your doctor or pharmacist before taking Telzir:
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete Telzir:
English: The population enrolled mainly consisted of moderately antiretroviral experienced patients.
Croatian: Populacija je uglavnom uključivala bolesnike s umjerenim iskustvom s antiretrovirusnim lijekovima.
English: These include:
Croatian: Ta stanja uključuju:
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove (EMA) http://www.ema.europa.eu.
English: There are some medicines that must not be taken with Telzir.
Croatian: Neki se lijekovi ne smiju uzimat s lijekom Telzir.
English: Toxicity was similar to that of amprenavir and occurred at amprenavir plasma exposure levels below human exposure after treatment with fosamprenavir in combination with ritonavir at the recommended dose.
Croatian: Toksičnost je bila slična onoj kod amprenavira i do nje je dolazilo pri razinama izloženosti amprenaviru u plazmi ispod razine izloženosti kod ljudi nakon liječenja fosamprenavirom u kombinaciji s ritonavirom u preporučenoj dozi.
English: In case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant Summary of Product Characteristics for these medicinal products.
Croatian: U slučaju istodobne antivirusne terapije za hepatitis B ili C, za te lijekove molimo proučite relevantne Sažetke opisa svojstava lijeka.
English: Turn the bottle the right way up and remove the syringe from the adapter.
Croatian: Okrenite bocu na pravu stranu i skinite štrcaljku s nastavka.
English: If you have taken more than the prescribed dose of Telzir: →Contact your doctor or pharmacist immediately for advice.
Croatian: Ako ste uzeli veću dozu lijeka Telzir od one koja Vam je propisana: →Odmah se obratite svom liječniku ili ljekarniku za savjet.
English: Anti-hepatitis C virus medicinal products
Croatian: Antivirotici za terapiju hepatitisa C
English: Lipase increased
Croatian: Povećana razina lipaze
English: Genotypic resistance testing
Croatian: Testiranje genotipske rezistencije
English: Fosamprenavir was not mutagenic or genotoxic in a standard battery of in vitro and in vivo assays.
Croatian: Fosamprenavir nije pokazao mutagenost ili genotoksičnost u standardnom setu in vitro i in vivo testova.
English: • If you have liver disease.
Croatian: • Imate li bolest jetre.
English: 3 mg/kg
Croatian: Otopina 3 mg/kg
English: • aches and pains (especially in the hip, knee or shoulder)
Croatian: • stalni tupi bolovi i povremeno jači bolovi (osobito u kukovima, koljenima ili ramenima)
English: Potential for serious and/or life-threatening reactions such as cardiac arrhythmias.
Croatian: Postoji potencijal za ozbiljne i/ili po život opasne reakcije kao što su srčane aritmije.
English: Amprenavir-related material was found in rat milk, but it is not known whether amprenavir is excreted in human milk.
Croatian: U mlijeku štakora pronađene su tvari povezane s amprenavirom, ali nije poznato izlučuje li se on u majčino mlijeko u ljudi.
English: Amprenavir appears to penetrate into semen, though semen concentrations are lower than plasma concentrations.
Croatian: Čini se da amprenavir prodire u sjemenu tekućinu, iako su koncentracije u sjemenoj tekućini niže od onih u plazmi.
English: As shown in the above table, there were only 16 patients harbouring baseline virus with resistance to FPV/RTV according to the ANRS score.
Croatian: Kao što je prikazano u gornjoj tablici, samo 16 bolesnika imalo je početnu vrijednost virusa s rezistencijom na FPV/RTV prema ANRS ocjeni.
English: In pregnant rats and rabbits there were no major effects on embryo-foetal development.
Croatian: skotnih štakora i kunića nisu zamijećeni značajniji učinci na embrio-fetalni razvoj.
English: No dose recommendation can be made for children and adolescents with hepatic impairment as no studies have been conducted in these age groups.
Croatian: Ne postoje preporučene doze za djecu i adolescente s oštećenjem jetre jer se nisu provodila ispitivanja na bolesnicima u tim dobnim skupinama.
English: Appropriate antihistamines (e.g. cetirizine dihydrochloride) may reduce pruritus and hasten the resolution of rash.
Croatian: Odgovarajući antihistaminici (npr. cetirizin dihidroklorid) mogu smanjiti pruritus i ubrzati nestanak osipa.
English: I62V, V82A/C/F/G, I84V and L90M and is associated with increased phenotypic resistance to fosamprenavir with ritonavir as well as reduced likelihood of virological response (resistance).
Croatian: V82A/C/F/G, I84V i L90M, i povezan je s povećanom fenotipskom rezistencijom na fosamprenavir s ritonavirom kao i sa smanjenjem vjerojatnošću virološkog odgovora (rezistencija).
English: ViiV Healthcare Trading Services UK Limited, 12 Riverwalk, Citywest Business Campus Dublin 24, Ireland
Croatian: ViiV Healthcare Trading Services UK Limited, 12 Riverwalk, Citywest Business Campus Dublin 24, Irska
English: You may need additional factor VIII to control any bleeding.
Croatian: Možda će Vam za kontrolu krvarenja trebati dodatna količina faktora VIII.
English: As it is not possible to achieve this fosamprenavir dose using the tablet formulation, these patients should be treated with fosamprenavir oral suspension.
Croatian: Budući da se ta doza fosamprenavira ne može postići primjenom tableta, bolesnici kojima je ona potrebna trebaju se liječiti oralnom suspenzijom fosamprenavira.
English: If Telzir/ritonavir is coadministered with parenteral midazolam, it should be done in an intensive care unit (ICU) or similar setting which ensures close clinical monitoring and appropriate medical management in case of respiratory depression and/or prolonged sedation.
Croatian: Ako se Telzir/ritonavir primjenjuju istodobno s parenteralnom primjenom midazolama, trebalo bi to provesti u jedinici intenzivne skrbi ili u sličnom okružju koji omogućuje pažljivi klinički nadzor i prikladnu medicinsku skrb u slučaju respiratorne depresije i/ili produljene sedacije.
English: • doses of ketoconazole and itraconazole greater than 200 mg per day (used to treat fungal infections)
Croatian: • doze ketokonazola i itrakonazola veće od 200 mg na dan (koristi se za liječenje gljivičnih infekcija)
English: If you get any side effects
Croatian: Ako primijetite bilo koju nuspojavu
English: In some patients taking antiretroviral medicines including protease inhibitors, there have been reports of increased sugar in the blood and diabetes getting worse.
Croatian: Prijavljeno je da je kod nekih bolesnika koji su uzimali antiretrovirusne lijekove, uključujući inhibitore proteaze, došlo do povećanja razine šećera u krvi i pogoršanja dijabetesa.
English: In reproductive toxicity studies with fosamprenavir in rats, male fertility was not affected.
Croatian: U ispitivanjima reproduktivne toksičnosti fosamprenavira provedenim na štakorima nije bilo utjecaja na mušku plodnost.
English: The potential for cross-sensitivity between medicinal products in the sulphonamide class and fosamprenavir is unknown.
Croatian: Nije poznat potencijal ukrižene osjetljivosti između lijekova sulfonamidne skupine i fosamprenavira.
English: Key: 1GSS to OBT: Genotypic Sensitivity Score to Optimised Background.
Croatian: Legenda: 1GSS do OBT: Ocjena genotipske osjetljivosti (Genotypic Sensitivity Score, GSS) do optimizirane osnovne terapije (Optimised Background, OBT).
English: You will need extra check-ups, including blood tests, while you're taking your medication.
Croatian: Tijekom liječenja bit će potrebni dodatni pregledi, uključujući i krvne pretrage.