FrancophonIA/ELRC3.0 huggingface dataset:
English: APV geometric mean (95% CI) and Ctau values were 1.31 (0.97, 1.77), 1.34 (0.95, 1.89), and 2.03 (1.46, 2.83) µg/mL for the second trimester, third trimester, and postpartum, respectively and within the range of values in non-pregnant patients on the same FPV/RTV containing regimens.
Croatian: (95% CI) i vrijednost Ctau APV-a iznosile su 1,31 (0,97; 1,77) µg/ml za drugo tromjesečje, 1,34 (0,95; 1,89) µg/ml za treće tromjesečje te 2,03 (1,46; 2,83) µg/ml nakon poroda i kretale su se unutar raspona vrijednosti opaženog u bolesnica koje nisu bile trudne, a koje su liječene istim režimima koji su sadržavali FPV/RTV.
English: (Induction and/or inhibition of CYP2C9 by RTV)
Croatian: (Indukcija i/ili inhibicija CYP2C9 lijekom RTV)
English: By stopping protease from working, Telzir stops HIV multiplying and infecting more CD4 cells.
Croatian: Sprječavajući djelovanje proteaze, Telzir zaustavlja umnožavanje HIV-a i infekciju dodatnih CD4 stanica.
English: It is bound to the alpha-1acid glycoprotein (AAG) and albumin,but has a higher affinity for AAG.
Croatian: kiselina (AAG) i albumin, ali ima veći afinitet za AAG.
English: Ritonavir: Cmax ↑ 63%* Ritonavir: AUC ↑ 45%* * compared to historical data
Croatian: Ritonavir: Cmax ↑63%* Ritonavir: AUC ↑45%* * u usporedbi s povijesnim podacima
English: ANTACIDS, HISTAMINE H2 RECEPTOR ANTAGONIST AND PROTON-PUMP INHIBITORS
Croatian: ANTACIDI, ANTAGONISTI HISTAMINSKOG H2 RECEPTORA I INHIBITORI
English: Contraindicated (see section 4.3).
Croatian: Kontraindicirani (vidjeti dio 4.3).
English: Hypromellose Titanium dioxide (E171) Glycerol triacetate Iron oxide red (E172)
Croatian: Film-ovojnica tablete: hipromeloza titanijev dioksid (E171) gliceroltriacetat željezov oksid, crveni (E172)
English: Table 2 Efficacy Outcome at Weeks 96 and 144 in ESS100732 Extension (ART-Naïve Patients)
Croatian: Tablica 2 Ishod djelotvornosti u 96. i 144. tjednu u ESS100732 produžetku (bolesnici koji nisu ranije primali antiretrovirusnu terapiju)
English: Resistant to FPV/RTV
Croatian: Prijemčivi za FPV/RTV
English: This product also contains preservatives: methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216), see leaflet for further information
Croatian: Ovaj lijek također sadrži konzervanse: metilparahidroksibenzoat (E218) i propilparahidroksibenzoat (E216), za dodatne informacije vidjeti uputu o lijeku
English: B CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Croatian: UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I
English: Repeat dose studies with fosamprenavir in rats produced effects consistent with hepatic enzyme induction, which predisposes rats to thyroid neoplasms.
Croatian: Ispitivanja ponovljenih doza s fosamprenavirom provedena na štakorima pokazala su učinke konzistentne s indukcijom jetrenih enzima što kod štakora predstavlja predispoziciju za razvoj neoplazmi štitnjače.
English: Table 3 Efficacy at Week 48 Outcomes in APV30003 ITT(E) Population (ART-experienced Patients)
Croatian: Tablica 3 Ishodi djelotvornosti u 48. tjednu u APV30003 na ITT(E) populaciji (bolesnici koji su ranije primali antiretrovirusnu terapiju)
English: Telzir is also available as 700 mg film-coated tablets.
Croatian: Telzir je također dostupan u obliku 700 mg filmom obloženih tableta.
English: Amprenavir binds to the active site of HIV-1 protease and thereby prevents the processing of viral gag and gag-pol polyprotein precursors, resulting in the formation of immature non-infectious viral particles.
Croatian: Amprenavir se vezuje za aktivno mjesto HIV-1 proteaze i time sprječava obradu virusnih gag i gag-pol poliproteinskih prekursora, što rezultira stvaranjem nezrelih neinfektivnih virusnih čestica.
English: Indinavir Saquinavir
Croatian: Indinavir Sakvinavir
English: In protease inhibitor (PI) experienced patients, the choice of Telzir should be based on individual viral resistance testing and treatment history (see section 5.1).
Croatian: Kod bolesnika koji su primali inhibitore proteaze (IP) odabir lijeka Telzir treba temeljiti na individualnim testovima virusne rezistencije i podacima o ranijem liječenju (vidjeti dio 5.1).
English: • doses of atorvastatin greater than 20 mg per day (used to lower cholesterol)
Croatian: • doze atorvastatina veće od 20 mg na dan (koristi se za snižavanje kolesterola)
English: Unless otherwise stated, studies detailed below have been performed with the recommended dosage of fosamprenavir/ritonavir (i.e. 700/100 mg twice daily), and the interaction was assessed under steadystate conditions where drugs were administered for 10 to 21 days.
Croatian: Osim kada je navedeno drugačije, ispitivanja koja se detaljno navode u nastavku provodila su se preporučenim dozama fosamprenavira/ritonavira (tj. 700/100 mg 2 puta dnevno), a interakcije su procijenjene u uvjetima stanja dinamičke ravnoteže kada su lijekovi primjenjivani tijekom razdoblja od 10 do 21 dan.
English: Rarely, the skin rash can be severe and serious (Stevens Johnson syndrome).
Croatian: U rijetkim slučajevima, kožni osip može biti težak i ozbiljan (Stevens
English: Telzir will not stop you passing on HIV.
Croatian: Telzir ne zaustavlja mogućnost da HIV-om zarazite druge.
English: In a clinical study on pharmacokinetics of fosamprenavir in paediatric patients, eight subjects 12 to 18 years of age received the standard fosamprenavir adult tablet dose of 700 mg twice daily (with ritonavir 100 mg twice daily).
Croatian: U kliničkom ispitivanju farmakokinetike fosamprenavira kod pedijatrijskih bolesnika 8 ispitanika u dobi od 12 do 18 godina primilo je standardnu dozu tableta fosamprenavira za odrasle od 700 mg 2 puta dnevno (s ritonavirom 100 mg 2 puta dnevno).
English: Co-administration of the antipsychotic medicinal product lurasidone and fosamprenavir/ritonavir (FPV/RTV) is contraindicated (see section 4.5).
Croatian: Istodobna primjena antipsihotika lurasidona i fosamprenavira/ritonavira (FPV/RTV) je kontraindicirana (vidjeti dio 4.5).
English: After multiple dose oral administration of equivalent fosamprenavir and amprenavir doses, comparable amprenavir AUC values were observed; however, Cmax values were approximately 30 % lower and Cmin values were approximately 28 % higher with fosamprenavir.
Croatian: Nakon peroralne primjene višestrukih ekvivalentnih doza fosamprenavira i amprenavira, zamijećene su usporedive vrijednosti AUC za amprenavir, međutim, vrijednosti Cmax bile su oko 30% niže, a vrijednosti Cmin oko 28% više kod fosamprenavira.
English: Telzir dose (TWICE DAILY)
Croatian: Doza lijeka Telzir (DVA PUTA DNEVNO)
English: Telzir must not be administered concurrently with medicinal products with narrow therapeutic windows that are substrates of cytochrome P450 3A4 (CYP3A4), e.g. alfuzosin, amiodarone, astemizole, bepridil, cisapride, dihydroergotamine, ergotamine, pimozide, quetiapine, quinidine, terfenadine, oral midazolam (for caution on parenterally administered midazolam, see section 4.5), oral triazolam, sildenafil used for the treatment of pulmonary arterial hypertension (for use of sildenafil in patients with erectile dysfunction, see sections 4.4 and 4.5).
Croatian: Telzir se ne smije primjenjivati istodobno s lijekovima koji imaju usku terapijsku širinu, a koji su supstrati citokroma P450 3A4 (CYP3A4) npr. alfuzosin, amiodaron, astemizol, bepridil, cisaprid, dihidroergotamin, ergotamin, pimozid, kvetiapin, kinidin, terfenadin, oralni midazolam (za mjere opreza pri parenteralnoj primjeni midazolama, vidjeti dio 4.5), oralni triazolam, sildenafil koji se koristi za liječenje plućne arterijske hipertenzije (za primjenu sildenafila kod bolesnika s erektilnom disfunkcijom vidjeti dijelove 4.4 i 4.5).
English: • cyclosporin, rapamycin, tacrolimus (used to suppress the immune system)
Croatian: • ciklosporin, rapamicin, takrolimus (koriste se za supresiju imunološkog sustava)
English: APV29005 enrolled 30 patients aged 6 to 11 (the majority of whom were treated with fosamprenavir / ritonavir 18/3 mg/kg twice daily or the adult tablet regimen) and 40 patients aged 12 to 18 (the majority of whom were treated with the adult tablet regimen).
Croatian: U APV29005 uključeno je 30 bolesnika u dobi od 6 do 11 godina (od kojih je većina liječena fosamprenavirom/ritonavirom u dozi od 18/3 mg/kg 2 puta dnevno ili prema režimu primjene tableta za odrasle) i 40 bolesnika u dobi od 12 do 18 godina (od kojih je većina liječena režimom primjene tableta za odrasle).
English: Amprenavir exposure unchanged when compared to historical data.
Croatian: U usporedbi s povijesnim podacima, izloženost amprenaviru nije se mijenjala.
English: No clinically significant interaction observed.
Croatian: Nije uočena klinički značajna interakcija.
English: One resistance mutation was observed in each of 3 isolates: K20K/R, I54I/L and I93I/L respectively
Croatian: svakom od 3 izolata zamijećena je jedna mutacija za otpornost: K20K/R, I54I/L odnosno I93I/L.
English: Co-administration of Telzir with low dose ritonavir and these medicinal products is expected to substantially increase their concentrations and may result in PDE5 inhibitor-associated adverse events such as hypotension, visual changes and priapism (see section 4.5).
Croatian: Očekuje se da bi istodobna primjena tih lijekova s lijekom Telzir i niskom dozom ritonavira značajno povećala njihovu koncentraciju što bi moglo dovesti do nuspojava povezanih s inhibitorima PDE5, poput hipotenzije, promjena vida i prijapizma (vidjeti dio 4.5).
English: A MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturers responsible for batch release Film-coated tablets
Croatian: Naziv(i) i adresa(e) proizvođača odgovornog(ih) za puštanje serije lijeka u promet Filmom obložene tablete
English: mechanism of interaction is CYP3A4 inhibition by fosamprenavir/ritonavir.
Croatian: Mehanizam interakcija je inhibicija CYP3A4 fosamprenavirom/ritonavirom.
English: How to store Telzir
Croatian: Kako čuvati Telzir
English: You must take Telzir oral suspension.
Croatian: Koristite Telzir oralnu suspenziju.
English: ANTINEOPLASTIC AGENTS METABOLISED BY CYP3A
Croatian: METABOLIZIRAJU PUTEM CYP3A
English: Drug-related adverse reactions were more common in APV20003 (57%) where subjects received once daily fosamprenavir / ritonavir when compared to APV29005 (33%) where subjects received twice daily fosamprenavir / ritonavir.
Croatian: Nuspojave povezane s lijekom bile su učestalije u ispitivanju APV20003 (57%) tijekom kojeg su ispitanici primali fosamprenavir/ritonavir jednom dnevno nego li u ispitivanju APV29005 (33%) tijekom kojeg su ispitanici primali fosamprenavir/ritonavir 2 puta dnevno.
English: In the paediatric studies APV20003 and APV29005, 77 PI-experienced patients were treated with fosamprenavir / ritonavir-based regimens and 43 patients met study-defined virologic failure criteria through 48 weeks in APV29005 and up to 108 weeks in APV20003.
Croatian: U pedijatrijskim ispitivanjima APV20003 i APV29005, 77 bolesnika koji su ranije primali IP terapiju liječeno je režimima koji su sadržavali fosamprenavir/ritonavir; a 43 bolesnika zadovoljila su utvrđene kriterije za virološki neuspjeh tijekom 48 tjedana u ispitivanju APV29005 te do 108 tjedana u ispitivanju APV20003.
English: Any unused medicinal product should be disposed of in accordance with local requirements.
Croatian: Neiskorišteni lijek ili otpadni materijal potrebno je zbrinuti sukladno nacionalnim propisima.
English: Sixteen of 434 ART-naïve patients who received fosamprenavir 700 mg/ritonavir 100 mg twice daily in ESS100732 experienced virological failure by Week 48 with 14 isolates genotyped.
Croatian: 16 od 434 bolesnika koji ranije nisu primali antiretrovirusnu terapiju, a koji su primili fosamprenavir 700 mg/ritonavir 100 mg 2 puta dnevno u ESS100732 do 48. tjedna imalo je virološki neuspjeh s 14 genotipiziranih izolata.
English: Signs to look out for include:
Croatian: Znakovi na koje treba paziti uključuju: • ukočenost zglobova
English: High doses (> 200 mg/day) of ketoconazole or itraconazole are not recommended.
Croatian: (> 200 mg/dan) ketokonazola ili itrakonazola.
English: In the pivotal studies of Telzir, in patients receiving fosamprenavir with ritonavir there was no evidence of an increased risk of rashes in patients with a history of sulphonamide allergy versus those who did not have a sulphonamide allergy.
Croatian: U ključnim ispitivanjima lijeka Telzir nije dokazan povećani rizik za razvijanje osipa kod bolesnika koji primaju fosamprenavir s ritonavirom, neovisno o tome jesu li u anamnezi imali alergiju na sulfonamide naspram onih koji je nisu imali.
English: Rat pups exposed pre and post-natally to amprenavir and fosamprenavir showed developmental toxicity (see section 5.3).
Croatian: Mladunčad štakora koja je pre- i postnatalno bila izložena amprenaviru i fosamprenaviru pokazala je razvojnu toksičnost (vidjeti dio 5.3).
English: No drug interaction studies.
Croatian: Nije bilo ispitivanja interakcija lijeka.
English: Herbal preparations containing St John's wort must not be combined with Telzir (see section 4.3).
Croatian: Biljni pripravci koji sadrže Gospinu travu ne smiju se kombinirati s lijekom Telzir (vidjeti dio 4.3).
English: Didanosine gastro-resistant capsule
Croatian: Didanozin želučanootporna kapsula
English: For children weighing less than 39 kg, Telzir oral suspension is the recommended option for the most accurate dosing in children based on body weight (please refer to the Summary of Product Characteristics for Telzir oral suspension).
Croatian: Za djecu čija je tjelesna težina manja od 39 kg, u svrhu što ispravnijeg doziranja temeljem tjelesne težine, preporučuje se primjena Telzir oralne suspenzije (potrebno vidjeti sažetak opisa svojstava lijeka za Telzir oralnu suspenziju).
English: You must check the list of medicines under 'Don't take Telzir' at the beginning of section 2 of this leaflet.
Croatian: "Nemojte uzimati Telzir" na početku dijela 2 ove Upute o lijeku.
English: Additional mutations observed which may contribute to resistance were: L10V/F/R, I13V, K20R/T, L33F/V, M36I, M46I/L, I47V/L Q58E, I62V, L63P, V77I, I85V, and I93L.
Croatian: Dodatne zamijećene mutacije koje mogu doprinijeti rezistenciji bile su: L10V/F/R, I13V, K20R/T, L33F/V, M36I, M46I/L, I47V/L Q58E, I62V, L63P, V77I, I85V i I93L.
English: Among the 81 PI-naïve paediatric patients treated with fosamprenavir / ritonavir, 15 patients met protocol-defined virological failure through 48 weeks in APV29005 and up to 108 weeks in APV20003.
Croatian: Od 81 pedijatrijskog bolesnika liječenog fosamprenavirom/ritonavirom koji ranije nije primao IP terapiju, u njih 15 zabilježen je protokolom definiran virološki neuspjeh tijekom 48 tjedana u ispitivanju APV29005 te do 108 tjedana u ispitivanju APV20003.
English: Hepatitis C virus (HCV) Direct-Acting Antivirals: When hepatitis C virus direct-acting antiviral (DAA) drugs, which are metabolised by CYP3A4 or are inducers/inhibitors of CYP3A4, are coadministered with fosamprenavir/ritonavir, altered plasma concentrations of medications are expected due to inhibition or induction of CYP3A4 enzyme activity (see sections 4.3 and 4.5).
Croatian: Antivirotici koji djeluju izravno na virus hepatitisa C (HCV): Kada se istodobno s fosamprenavirom/ritonavirom primjenjuju antivirotici koji djeluju izravno na virus hepatitisa C, a koji se metaboliziraju putem CYP3A4 ili inhibiraju/induciraju CYP3A4, očekuje se da će se promijeniti koncentracije lijekova u plazmi zbog inhibicije ili indukcije aktivnosti enzima CYP3A4 (vidjeti dijelove 4.3 i 4.5).
English: The relevance of the hepatocellular findings in the rodents for humans is uncertain; however, there is no evidence from clinical trials or marketed use to suggest that these findings are of clinical significance.
Croatian: Značaj hepatocelularnih nalaza kod glodavaca za ljude nije poznat, međutim, iz kliničkih ispitivanja ili podataka nakon stavljanja lijeka u promet ne postoje dokazi koji bi upućivali da ti nalazi imaju klinički značaj.
English: Because there may be an increased risk of hepatic transaminase elevations and hormonal levels may be altered with co-administration of fosamprenavir, ritonavir and oral contraceptives, alternative nonhormonal methods of contraception are recommended for women of childbearing potential (see section 4.5).
Croatian: Budući da pri istodobnoj primjeni fosamprenavira, ritonavira i oralnih kontraceptiva može postojati povećan rizik za povišenje razina jetrenih transaminaza i razina hormona, ženama reproduktivne dobi preporučuje se primjena drugih, nehormonalnih kontracepcijskih metoda (vidjeti dio 4.5).
English: 25-O-desacetylrifabutin: AUC(0-48) ↑ 11-fold* *compared to rifabutin 300 mg once daily
Croatian: 25-O-desacetilrifabutin: AUC(048) ↑ 11 puta* *u usporedbi s rifabutinom 300 mg jednom dnevno
English: No dosage adjustment necessary with antacids, proton-pump inhibitors or histamine H2 receptor antagonists.
Croatian: S antacidima, inhibitorima protonske pumpe ili antagonistima histaminskih H2 receptora nije potrebno prilagođavanje doze.
English: In animal studies at systemic plasma exposures (AUC) to amprenavir lower than therapeutic exposure in patients treated with Telzir, some developmental toxicity was observed (see section 5.3).
Croatian: Ispitivanja na životinjama pokazala su da se pri sistemskoj izloženosti plazme (AUC) amprenaviru, u vrijednostima nižim od terapijske izloženosti u bolesnika liječenih lijekom Telzir, kod određenoj mjeri javlja razvojna toksičnost (vidjeti dio 5.3).
English: Shake the bottle for 20 seconds before the first use.
Croatian: Prije prve primjene, protresite bočicu tijekom 20 sekundi.
English: The adverse reaction profile was similar across all the respective adult studies: antiretroviral naïve patients (APV30002, ESS100732), protease inhibitor experienced (twice daily dosing, APV30003) patients.
Croatian: Profil nuspojava bio je sličan u svim ispitivanjima provedenim kod odraslih, i kod bolesnika koji ranije nisu primali antiretrovirotike (APV30002, ESS100732) i kod bolesnika koji su ranije primali inhibitore proteaze (doziranje 2 puta dnevno, APV30003).
English: No studies have been done on the use of Telzir/ritonavir with other hormonal therapies, such as hormone replacement therapy (HRT).
Croatian: Nisu se provodila ispitivanja lijeka Telzir/ritonavira u kombinaciji s drugim hormonskim terapijama, poput hormonske nadomjesne terapije.
English: Autoimmune disorders (such as Graves' disease) have also been reported to occur in the setting of immune reactivation; however, the reported time to onset is more variable and can occur many months after initiation of treatment.
Croatian: U uvjetima imunološke reaktivacije prijavljeni su i autoimuni poremećaji (poput Gravesove bolesti i autoimunog hepatitisa); međutim, prijavljeno vrijeme do nastupa bolesti je varijabilno pa se ona može javiti i mjesecima nakon uvođenja liječenja.
English: Subjects (%) with plasma HIV-1 RNA <50 copies/ml Subjects (%) with plasma HIV-1 RNA <400 copies/ml Subjects with >1 log10 change from baseline in plasma HIV1 RNA Change from baseline in CD4 cells (cells/µl)
Croatian: Ispitanici (%) s HIV-1 RNK u plazmi <50 kopija/ml Ispitanici (%) s HIV-1 RNK u plazmi <400 kopija/ml Ispitanici s promjenom HIV-1 RNK u plazmi >1 log10 od početnih vrijednosti
English: Compared to the historical adult population receiving fosamprenavir / ritonavir 700 / 100 mg twice daily, 12 to 18 year old subjects had 20 % lower plasma APV AUC(024), 23 % lower Cmax, and 20 % lower Cmin values.
Croatian: U usporedbi s ranijim podacima o odrasloj populaciji koja je primala fosamprenavir/ritonavir 700/100 mg 2 puta dnevno, ispitanici od 12 do 18 godina imali su 20% niže vrijednosti APV AUC(0-24) u plazmi, 23% nižu vrijednost Cmax, i 20% nižu vrijednost Cmin.
English: Amprenavir: ↓ expected (Modest CYP3A4 induction)
Croatian: Amprenavir: očekuje se ↓ (Blaga indukcija CYP3A4)
English: Telzir helps to control your condition, but it is not a cure for HIV infection.
Croatian: Održavajte redovite kontakte sa svojim liječnikom Telzir pomaže u držanju Vašeg stanja pod kontrolom, ali neće izliječiti HIV infekciju.
English: After oral administration, fosamprenavir is rapidly and almost completely hydrolysed to amprenavir and inorganic phosphate prior to reaching the systemic circulation.
Croatian: Nakon peroralne primjene fosamprenavir se, prije dolaska u sistemski krvotok, brzo i gotovo u cijelosti hidrolizira na amprenavir i anorganske fosfate.
English: Various regimens have been assessed in the amprenavir/fosamprenavir development programs with and without co-administration of ritonavir.
Croatian: U razvojnim programima amprenavira/fosamprenavira ispitivali su se različiti režimi terapije, s ili bez istodobne primjene ritonavira.
English: Telzir/ritonavir should not be co-administered with orally administered midazolam (see section 4.3), whereas caution should be used with co-administration of Telzir/ritonavir and parenteral midazolam.
Croatian: Telzir/ritonavir ne smiju se primijeniti istodobno s midazolamom primijenjenim oralno (vidjeti dio 4.3), dok se u slučaju primjene parenteralnim putem, midazolam može, uz mjere opreza, primijeniti istodobno s lijekom Telzir/ritonavirom.
English: Ketoconazole: Cmax ↑ 25% Ketoconazole: AUC ↑ 2.69fold.
Croatian: Ketokonazol: Cmax ↑ 25% Ketokonazol: AUC ↑ 2,69 puta.
English: All Subjects
Croatian: Svi ispitanici
English: These products may cause an allergic reaction in some individuals.
Croatian: U nekih osoba te tvari mogu uzrokovati alergijsku reakciju koja može biti odgođena.
English: Drugs by Therapeutic Area Interaction
Croatian: Lijekovi prema terapijskom području
English: Telzir 700 mg film-coated tablets Fosamprenavir
Croatian: Telzir 700 mg filmom obložene tablete fosamprenavir
English: 6-17 years >39 kg Tablet or Oral suspension 700 mg (1 tablet or 14 ml suspension)
Croatian: >39 kg Tablete ili oralna suspenzija 700 mg (1 tableta ili 14 ml suspenzije)
English: ≤ 200 mg once daily
Croatian: ≤ 200 mg jednom dnevno
English: The recommended dose is 0.36 ml/kg of Telzir oral suspension (18 mg per kg fosamprenavir) twice daily with 3 mg/kg ritonavir oral solution twice daily.
Croatian: Preporučena doza je 0,36 ml/kg Telzir oralne suspenzije dva puta dnevno (18 mg/kg fosamprenavira) dva puta dnevno s 3 mg/kg oralne otopine ritonavira dva puta dnevno.
English: The mutational profiles were similar to those described for PIexperienced adults treated with fosamprenavir / ritonavir.
Croatian: Profili mutacija bili su slični onima opisanim kod odraslih bolesnika liječenih fosamprenavirom/ritonavirom, a koji su ranije primali IP terapiju.
English: The use of Telzir concomitantly with halofantrine or lidocaine (systemic) is not recommended (see section 4.5).
Croatian: Ne preporučuje se istodobna primjena lijeka Telzir s halofantrinom ili lidokainom (sistemskim) (vidjeti dio 4.5).
English: methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216).
Croatian: metilparahidroksibenzoat (E218), propilparahidroksibenzoat (E216).
English: No new safety concerns were identified from analyses of 48 week data from studies APV29005 or APV20002, in which 54 subjects 4 weeks to <2 years of age received twice daily fosamprenavir / ritonavir with background nucleoside reverse transcriptase inhibitor therapy and 5 subjects received only single doses of fosamprenavir with or without ritonavir.
Croatian: Nisu identificirana nova sigurnosna pitanja u analizama podataka nakon 48 tjedana iz ispitivanja APV29005 ili APV20002, u kojima su 54 ispitanika u dobi od 4 tjedna do < 2 godine primala fosamprenavir/ritonavir dvaput na dan uz osnovnu terapiju nukleozidnim inhibitorima reverzne transkriptaze, dok je 5 ispitanika primilo samo jednokratnu dozu fosamprenavira s ritonavirom ili bez njega.
English: 400 mg/100 mg twice daily
Croatian: 400 mg/100 mg 2 puta dnevno
English: Please refer to the table below for the dosing recommendations in adults.
Croatian: Za preporuke doziranja u odraslih molimo pogledajte niže navedenu tablicu.
English: Very common side effects These may affect more than 1 in 10 people:
Croatian: Vrlo česte nuspojave mogu se javiti u više od 1 na 10 osoba:
English: ViiV Healthcare Trading Services UK Limited 12 Riverwalk,
Croatian: ViiV Healthcare Trading Services UK Limited 12 Riverwalk, Citywest Business Campus Dublin 24,