natgillin/translations-raw huggingface dataset:
Results from studies with other HIV protease inhibitors and simeprevir or daclatasvir, suggest that coadministration with fosamprenavir/ritonavir is likely to lead to increased plasma exposures of simeprevir or daclatasvir due to CYP3A4 enzyme inhibition. 
Rezultati iz ispitivanja s drugim inhibitorima HIV proteaze i simeprevirom ili daklatazvirom ukazuju na to da će istodobna primjena s fosamprenavirom/ ritonavirom vjerojatno dovesti do povećanja plazmatske izloženosti simepreviru ili daklatazviru zbog inhibicije enzima CYP3A4.
Tel: + 39 (0)45 9212611 
ViiV Healthcare S.r.l. Tel: + 39 (0)45 9212611
The use of Telzir concomitantly with halofantrine or lidocaine (systemic) is not recommended. 
Lijekovi - interakcije Ne preporučuje se istodobna primjena lijeka Telzir s halofantrinom ili (sistemskim) lidokainom.
When ART naïve adult patients were treated with the currently approved doses of fosamprenavir/ritonavir, as for other ritonavir boosted PI regimens, the mutations described were infrequently observed. 
U režimima u kojima su odrasli bolesnici, koji ranije nisu primali antiretrovirusnu terapiju, bili liječeni odobrenim dozama fosamprenavira/ritonavira, kao i u drugim IP režimima , opisane mutacije nisu bile često opažene.
Close the bottle tightly with the cap. 
11. Zatvaračem čvrsto zatvorite bocu.
Desipramine Nortriptyline 
Dezipramin Nortriptilin
Phenotypic resistance testing 
Testiranje fenotipske rezistencije
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL FOR TABLETS 
PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU NALJEPNICA NA BOCI ZA TABLETE
The median durations of prior exposure to protease inhibitors were 149 weeks for patients receiving fosamprenavir with ritonavir twice daily (49 % received ≥ 2 prior PIs) and 130 weeks for patients receiving lopinavir/ritonavir (40 % received ≥ 2 prior PIs). 
Medijan trajanja prethodne izloženosti inhibitorima proteaze bio je 149 tjedana za bolesnike koji su primali fosamprenavir s ritonavirom 2 puta dnevno (49 % primilo je ≥2 prethodna IP) i 130 tjedana za bolesnike koji su primali lopinavir/ritonavir (40 % primilo je ≥2 prethodna IP).
This value is decreased by approximately 40 % when Telzir is co-administered with ritonavir, most likely due to an increase in amprenavir bioavailability. 
Pri istodobnoj primjeni lijeka Telzir i ritonavira ta se vrijednost smanjuje za oko 40%, najvjerojatnije zbog povećanja bioraspoloživosti amprenavira.
Concomitant use of Telzir with simvastatin or lovastatin is contraindicated because of increased plasma concentrations of lovastatin and simvastatin which can increase the risk of myopathy, including rhabdomyolysis (see section 4.5). 
Istodobna primjena lijeka Telzir sa simvastatinom ili lovastatinom kontraindicirana je zbog njihove povećane koncentracije u plazmi što može povećati rizik od miopatije, uključujući rabdomiolizu
Anticonvulsants (carbamazepine, phenobarbital) should be used with caution. 
Potreban je oprez pri primjeni antikonvulziva (karbamazepina, fenobarbitala).
Hypersensitivity to fosamprenavir, amprenavir, or ritonavir, or to any of the excipients listed in section 
Preosjetljivost na fosamprenavir, amprenavir, ritonavir ili neku od pomoćnih tvari navedenih u dijelu 6.1.
Don't take other medicines for the infection without your doctor's advice. 
Bez savjeta svog liječnika nemojte uzimati druge lijekove za liječenje infekcije.
Cyclosporin Rapamycin Tacrolimus 
Ciklosporin Rapamicin Takrolimus
Median Change from baseline in CD4 cells (cells/µl) 
Medijan promjene od početnih vrijednosti CD4 stanica (stanica/µl)
Atazanavir: Cmax ↓ 24%* Atazanavir: AUC↓ 22%* Atazanavir: Cmin↔* *compared to atazanavir/ ritonavir 300 mg/ 100 mg once daily 
Atazanavir: Cmax ↓ 24%* Atazanavir: AUC↓ 22%* Atazanavir: Cmin↔* * u usporedbi s atazanavir/ ritonavir 300 mg / 100 mg jednom dnevno
Compared to the historical adult population receiving fosamprenavir with ritonavir 700 mg / 100 mg twice daily, a subset of five pediatric subjects ages 6 to < 24-months receiving fosamprenavir / ritonavir 45/7 mg/kg twice daily demonstrated that despite an approximate 5-fold increase in fosamprenavir and ritonavir doses on a mg/kg basis, plasma amprenavir AUC(0-τ) was approximately 48 % lower, Cmax 26 % lower, and Cτ 29 % lower in the paediatric subjects. 
U usporedbi s ranije ispitivanom odraslom populacijom koja je primala fosamprenavir s ritonavirom u dozama 700 mg/100 mg 2 puta dnevno, podskupina od 5 pedijatrijskih ispitanika u dobi od 6 do 24 mjeseca koji su primali fosamprenavir/ritonavir u dozi od 45/7 mg/kg 2 puta dnevno pokazala je, unatoč oko 5 puta povećanju doza fosamprenavira i ritonavira prema mg/kg, da je u pedijatrijskih ispitanika AUC(0-τ) amprenavira u plazmi oko 48 % niži, Cmax 26 % niži, i Cτ 29 % niži.
Norethisterone: Cmax ↓ 38% Norethisterone: AUC ↓ 34% Norethisterone: Cmin ↓ 26 
Noretisteron: Cmax ↓38% Noretisteron: AUC ↓34% Noretisteron: Cmin ↓ 26
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL FOR ORAL SUSPENSION 
PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU NALJEPNICA NA BOCI ZA ORALNU SUSPENZIJU
As a precaution, patients should be monitored for withdrawal syndrome. 
Kao mjeru opreza, kod bolesnika treba pratiti je li se pojavio sindrom prekida uzimanja droga.
Children and adolescents: The adverse reaction profile in children and adolescents is based on integrated safety data from two studies (APV29005 Week 24 data and APV20003 Week 168 data [final data]) in which 158 HIV-1 infected subjects 2 to 18 years of age received fosamprenavir with ritonavir with background nucleoside reverse transcriptase inhibitor therapy (see section 5.1 for information on dosing regimens applied for each age group). 
Djeca i adolescenti: profil nuspojava kod djece i adolescenata temelji se na integriranim podacima o sigurnosti iz 2 ispitivanja (podaci nakon 24 tjedna iz ispitivanja APV29005 i podaci nakon 168 tjedana iz ispitivanja APV20003 [završni podaci]) u kojima je 158 ispitanika s HIV-1 infekcijom u dobi od 2 do 18 godina primalo fosamprenavir s ritonavirom uz osnovnu terapiju nukleozidnim inhibitorima reverzne transkriptaze (za informacije o primijenjenim doznim režimima za svaku dobnu skupinu vidjeti dio 5.1).
Rash / cutaneous reactions: erythematous or maculopapular cutaneous eruptions, with or without pruritus, may occur during therapy. 
Osip/kožne reakcije: tijekom terapije može doći do eritematoznih ili makulopapularnih izbijanja kožnih promjena, sa ili bez pruritusa.
Atorvastatin 10 mg once daily for 4 days 
10 mg jednom dnevno tijekom 4 dana
magnesium stearate, colloidal anhydrous silica, hypromellose, titanium dioxide (E171), glycerol triacetate, iron oxide red (E172). 
• Drugi sastojci su: mikrokristalična celuloza, umrežena karmelozanatrij, povidon K30, magnezijev stearat, koloidni bezvodni silicijev dioksid, hipromeloza, titanijev dioksid (E171), gliceroltriacetat, željezov oksid crveni (E172).
In children and adolescents the fosamprenavir oral suspension should be taken with food. 
Djeca i adolescenti trebaju oralnu suspenziju fosamprenavira uzeti s obrokom.
In this patient population, the oral suspension should be taken without food and on an empty stomach. 
U ovoj skupini bolesnika, oralnu suspenziju treba uzimati bez hrane, na prazan želudac.
Haemophiliac patients: there have been reports of increased spontaneous bleeding in haemophiliac patients receiving antiretroviral protease inhibitors (see section 4.4). 
Bolesnici s hemofilijom: kod bolesnika s hemofilijom koji su primali antiretrovirusne inhibitore proteaze prijavljeni su slučajevi povećanja spontanih krvarenja (vidjeti dio 4.4).
Tricyclic antidepressant: ↑ expected 
Triciklički antidepresiv: očekuje se ↑
Maraviroc: C12 ↑ 4.74 
Maravirok: Cmax↑ 1,52 Maravirok: C12 ↑ 4,74
• If you have haemophilia. 
• Bolujete li od hemofilije.
Children can take the adult dose of one 700 mg Telzir tablet twice daily (with ritonavir 100 mg twice daily) if they weigh at least 39 kg and can swallow the tablets whole. 
Djeca mogu primati dozu za odrasle od jedne tablete od 700 mg dva puta dnevno (s ritonavirom od 100 mg dva puta dnevno) ako im je tjelesna težina barem 39 kg te ako mogu progutati cijele tablete.
Insert the syringe firmly into the adapter. 
4. Čvrsto umetnite štrcaljku u nastavak.
300 mg once daily 
300 mg jednom dnevno
>100,000 copies/ml, n (%) 
100.000 kopija/ml
Alfuzosin, 
RECEPTORA Alfuzosin
• if you are allergic to fosamprenavir, amprenavir or any of the other ingredients of this medicine 
• ako ste alergični na fosamprenavir, amprenavir ili neki drugi sastojak ovog lijeka (naveden u dijelu 6) ili na ritonavir.
If this happens to you: →Talk to your doctor immediately. 
→Odmah se obratite svom liječniku.
Don't stop unless your doctor advises you to. 
Nemojte prestati uzimati Telzir osim ako to nije zatražio Vaš liječnik.
Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterium infections, and Pneumocystis carinii pneumonia. 
generalizirana i/ili žarišna infekcija mikobakterijama i upala pluća uzrokovana s Pneumocystis carinii.
• Feeling sick or being sick (nausea or vomiting), pain in the stomach, loose stools 
• povećanje razine triglicerida (vrsta masnoća u krvi). mučnina ili povraćanje, bol u trbuhu, meke stolice
fosamprenavir/ritonavir, plasma concentrations of these antineoplastic medications may be increased and could increase the risk of adverse events usually associated with these antineoplastic agents. 
može se povećati koncentracija antineoplastika u plazmi, što može povećati rizik od štetnih događaja koje se obično povezuje s tim antineoplasticima.
Industriestrasse 32-36 D-23843 Bad Oldesloe Germany or 
D-23843 Bad Oldesloe
Metabolic parameters: Weight and levels of blood lipids and glucose may increase during antiretroviral therapy (see section 4.4). 
Metabolički parametri: tijekom antivirusne terapije mogu se povećati tjelesna težina i povisiti razine lipida i glukoze u krvi (vidjeti dio 4.4).
Co-administration of TELZIR/ritonavir with alfuzosin is contraindicated (see section 4.3). 
Istodobna primjena lijeka Telzir/ritonavira s alfuzosinom je kontraindicirana (vidjeti dio 4.3).
Pravastatin or fluvastatin are recommended because their metabolism is not dependent on CYP 3A4 and interactions are not expected with protease inhibitors. 
Preporučuju se pravastatin ili fluvastatin s obzirom da njihov metabolizam ne ovisi o CYP
ALPHA 1 
ANTAGONISTI ALFA-1
The recommended dose is 700 mg fosamprenavir twice daily with 100 mg ritonavir twice daily. 
Preporučena doza je 700 mg fosamprenavira 2 puta dnevno sa 100 mg ritonavira 2 puta dnevno.
The 
U
amprenavir and raltegravir (especially in fed conditions) may result in virological 
Uočeno značajno smanjenje izloženosti i Cmin za oba lijeka, amprenavir i raltegravir (posebice nakon obroka) kod bolesnika može dovesti do neuspješnog virološkog djelovanja.
(Mixed CYP3A4 induction/inhibition, Pgp induction) 
(Miješano indukcija/inhibicija CYP3A4, indukcija Pgp)
• injectable midazolam (used to treat anxiety) 
• midazolam u injekcijama (koriste se za liječenje tjeskobe)
No FPV/RTV drug interaction studies. 
Nije bilo FPV/RTV ispitivanja interakcija lijeka.
Possible ↓ or ↑ of antithrombotic effect. 
antitrombotičkog učinka.
Please refer to the relevant product information for these medications (see section 4.5). 
Za više informacija potrebno je vidjeti sažetke opisa svojstava lijeka za navedene lijekove (vidjeti dio 4.5).
Children 6 to 11 years of age (n=9) receiving fosamprenavir / ritonavir 18 / 3 mg/kg twice daily had 26 % higher AUC(0-24) and similar Cmax and Cmin values when compared to the historical adult population receiving fosamprenavir / ritonavir 700 / 100 mg twice daily. 
Djeca u dobi od 6 do 11 godina (n=9) koja su primala fosamprenavir / ritonavir u dozi 18/3 mg/kg 2 puta dnevno imala su 26% veću AUC(0-24) te slične vrijednosti Cmax i Cmin onima kod starije populacije koja je primala fosamprenavir / ritonavir u dozama od 700/100 mg 2 puta dnevno.
ANTIARRHYTHMICS 
ANTIARITMICI
Lopinavir: Cmax ↔* Lopinavir: AUC ↔* Lopinavir: Cmin ↔* * compared to lopinavir / ritonavir 400 mg/100 mg twice daily 
Lopinavir: Cmax ↔* Lopinavir: AUC ↔* Lopinavir: Cmin ↔* * u usporedbi s lopinavirom / ritonavirom 400 mg/100 mg 2 puta dnevno
Administration of the fosamprenavir oral suspension formulation with a high fat meal (967 kcal, 67 grams fat, 33 grams protein, 58 grams carbohydrate) reduced plasma amprenavir AUC(0-∞) by 28% and Cmax by 46% and delayed Tmax by 0.72 hours. 
kcal, 67 grama masti, 33 grama proteina, 58 grama ugljikohidrata) smanjila je vrijednost AUC(0-∞) za amprenavir u plazmi za 28% i Cmax za 46% te je produljila Tmax za 0,72 sata.
Blood cholesterol increased Blood triglycerides increased Alanine aminotransferase increased 
Povećanje kolesterola u krvi Povećanje triglicerida u krvi
Predicted exposures are based on extrapolation from data observed following administration of fosamprenavir 300 mg twice daily with ritonavir 100 mg once daily in subjects with moderate hepatic impairment. 
Predviđene razine izloženosti temelje se na ekstrapolaciji iz podataka prikupljenih u ispitanika s umjerenim oštećenjem jetre nakon primjene fosamprenavira u dozi od 300 mg dvaput na dan u kombinaciji s ritonavirom u dozi od 100 mg jedanput na dan.
AUC ↓ 16% (-36%; +8%) Cmin ↓ 19% (-42%; +13%) 
Cmax ↓ 14% (-36%; +15%) AUC ↓ 16% (-36%; +8%) Cmin ↓ 19% (-42%; +13%)
Clinical experience with fosamprenavir boosted with ritonavir is mainly based on two open label studies, one in antiretroviral naïve patients (study ESS100732), and one study in antiretroviral experienced patients (study APV30003). 
Kliničko iskustvo Kliničko iskustvo s fosamprenavirom pojačanim ritonavirom uglavnom se temelji na 2 otvorena ispitivanja: prvom, na bolesnicima koji nisu primali raniju terapiju antiretrovirusnim lijekovima (ispitivanje ESS100732) i drugom, na bolesnicima koji su primali raniju terapiju antiretrovirusnim lijekovima (ispitivanje APV30003).
Non-nucleoside reverse transcriptase inhibitors: 
Nenukleozidni inhibitori reverzne transkriptaze:
In patients with haemophilia type A and B, there have been reports of increased bleeding while taking protease inhibitors. 
A i B bilo je prijava o pojačanim krvarenju tijekom uzimanja inhibitora proteaze.
Telzir tablets may be taken without regard to food intake. 
Tablete lijeka Telzir mogu se uzimati neovisno o unosu hrane.
Cisapride 
Učestalost
No dosage adjustment of fosamprenavir or dolutegravir is recommended based on observed exposureresponse relationships of clinical data. 
Na temelju opaženih odnosa izloženosti-terapijskog odgovora iz kliničkih podataka prilagođavanje doze fosamprenavira ili dolutegravira se ne preporučuje.
Maraviroc: AUC12 ↑ 2.49 Maraviroc: Cmax ↑ 1.52 
Maravirok: AUC12 ↑ 2,49
Median CD4 cells/μl CD4 count < 350 cells/μl, n (%) 
>100,000 kopija/ml, n (%) Medijan CD4 stanica/μl broj CD4 stanica < 350 stanica/μl, n (%)
Despite reducing the dosing frequency of ritonavir, subjects with severe hepatic impairment had 64% higher ritonavir Cmax, 40% higher ritonavir AUC(0-24), and 38% higher ritonavir C12 than achieved in subjects with normal hepatic function receiving the standard fosamprenavir with ritonavir 700 mg / 100 mg twice daily regimen. 
Unatoč smanjenju učestalosti doziranja ritonavirom, ispitanici s teškim oštećenjem jetre imali su 64% višu vrijednost Cmax za ritonavir, 40% višu vrijednost AUC(0-24) za ritonavir i 38% višu vrijednost C12 za ritonavir od onih koje se postižu kod ispitanika s normalnom funkcijom jetre, a koji primaju standardni režim doziranja fosamprenavirom i ritonavirom 700 mg/100 mg 2 puta dnevno.
In moderately antiretroviral experienced adults, Telzir in combination with low dose ritonavir has not been shown to be as effective as lopinavir / ritonavir. 
Telzir u kombinaciji s niskom dozom ritonavira nije se pokazao jednako učinkovitim kao lopinavir/ritonavir kod odraslih osoba koje su umjereno liječene antiretrovirusnim lijekovima.
Note that co-administration of Telzir with low dose ritonavir with sildenafil used for the treatment of pulmonary arterial hypertension is contraindicated (see section 4.3). 
Kontraindicirana je istodobna primjena lijeka Telzir i niskih doza ritonavira sa sildenafilom koji se primjenjuje za liječenje plućne arterijske hipertenzije (vidjeti dio 4.3).
The current (July 2006) ANRS AC-11 algorithm for fosamprenavir / ritonavir defines resistance as the presence of the mutations V32I+I47A/V, or I50V, or at least four mutations among: L10F/I/V, L33F, M36I, I54A/L/M/S/T/V, 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). 
V32I+I47A/V ili I50V, ili barem četiri mutacije od: L10F/I/V, L33F, M36I, I54A/L/M/S/T/V, I62V, 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).
(CYP3A4 induction by rifampicin) 
(indukcija CYP3A4 rifampicinom)
Telzir 50 mg/ml oral suspension 
Telzir 50 mg/ml oralna suspenzija
• The other ingredients are: hypromellose, sucralose, polysorbate 80, calcium chloride dihydrate, 
• Drugi sastojci su: hipromeloza, sukraloza, polisorbat 80, kalcijev klorid dihidrat, umjetna aroma gume za žvakanje s okusom grožđa, prirodna aroma peperminta, pročišćena voda, propilenglikol,
Alternative non-hormonal methods of contraception are recommended for women of childbearing potential (see section 4.4). 
nehormonske kontracepcijske metode (vidjeti dio 4.4).
Co-administration of ritonavir with fosamprenavir increase plasma amprenavir AUC by approximately 2-fold and plasma Cτ,ss by 4- to 6-fold, compared to values obtained when fosamprenavir is administered alone. 
Uspoređujući s vrijednostima dobivenim kada se fosamprenavir primjenjuje samostalno, istodobna primjena ritonavira s fosamprenavirom povećava AUC amprenavira u plazmi za oko 2 puta, a vrijednost Cτ,ss u plazmi za 4 do 6 puta.
In a randomised open-label study (ESS100732 - KLEAN) in antiretroviral naïve patients, fosamprenavir (700 mg) co-administered with low dose ritonavir (100 mg) in a twice daily regimen including abacavir / lamivudine (600 mg / 300 mg) fixed dose combination tablet once daily showed comparable efficacy over 48 weeks to lopinavir / ritonavir (400 mg / 100 mg) given twice daily in combination with abacavir / lamivudine (600 mg / 300 mg once daily). 
U randomiziranom otvorenom ispitivanju (ESS100732 - KLEAN) na bolesnicima koji nisu primali raniju antiretrovirusnu terapiju, fosamprenavir (700 mg) istodobno primijenjen s niskom dozom ritonavira (100 mg) u režimu 2 puta na dan uz tabletu s fiksnom kombinacijom abakavira/lamivudina (600 mg / 300 mg) 1 put na dan i tijekom 48 tjedana, pokazana je usporediva djelotvornost prema lopinavir/ritonavir (400 mg / 100 mg) primijenjenom 2 puta dnevno u kombinaciji s abakavirom/lamivudinom (600 mg / 300 mg jednom dnevno).
Adults The recommended dose is one 700 mg Telzir tablet twice daily with 100 mg ritonavir twice daily. 
Odrasli Preporučena doza je jedna tableta lijeka Telzir od 700 mg dva puta dnevno s 100 mg ritonavira dva puta dnevno.
Lopinavir / ritonavir 533 mg/133 mg twice daily 
533 mg/133 mg 2 puta dnevno
Fluticasone propionate 50 µg intranasal 4 times daily) for 7 days 
50 µg u nos, 4 puta dnevno) tijekom 7 dana
It may cause serious adverse reactions (see section 4.4). 
Može uzrokovati ozbiljne nuspojave (vidjeti dio
• If you have diabetes. 
• Bolujete li od dijabetesa.
(CYP2D6 inhibition by RTV) 
(inhibicija CYP2D6 lijekom RTV)
Caution is advised if the recommended dose of fosamprenavir with ritonavir detailed below are exceeded (see section 4.4). 
Preporučuju se mjere opreza u slučajevima kada su premašene preporučene doze fosamprenavira s ritonavirom navedene u nastavku (vidjeti dio 4.4).
Clinical chemistry abnormalities: clinical chemistry abnormalities (Grade 3 or 4) potentially related to treatment with fosamprenavir with ritonavir and reported in greater than or equal to 1 % of adult patients, included: increased ALT (common), AST (common), serum lipase (common) and triglycerides (common). 
(3. i 4. stupnja) potencijalno povezanih s terapijom fosamprenavirom s ritonavirom, a koje su prijavljene u 1% ili više odraslih bolesnika, uključivale su: povećane razine ALT-a (često), AST-a
For adults with severe hepatic impairment (Child-Pugh score: 10-15): fosamprenavir should be used with caution and at a reduced dose of 300 mg fosamprenavir twice daily with 100 mg ritonavir once daily. 
Za odrasle s teškim oštećenjem jetre (Child-Pugh indeks: 10-15): fosamprenavir treba primijeniti oprezno, u smanjenoj dozi od 300 mg fosamprenavira 2 puta dnevno sa 100 mg ritonavira jedanput dnevno.
In the studies of PI-experienced adult patients, APV30003 and its extension, APV30005 (fosamprenavir 700 mg / ritonavir 100 mg twice daily: n=107), the following mutations emerged in patients experiencing virological failure through 96 weeks: L10F/I, L24I, V32I, L33F, M36I, M46I/L, I47V, I50V, I54L/M/S, A71I/T/V, G73S, V82A, I84V, and L90M. 
U ispitivanjima na odraslim bolesnicima koji su ranije primali terapiju s IP, ispitivanju APV30003 i njegovoj ekstenziji, APV30005 (fosamprenavir 700 mg/ritonavir 100 mg 2 puta dnevno: n=107), kod bolesnika s virološkim neuspjehom kroz 96 tjedana pojavile su se sljedeće mutacije: L10F/I, L24I, V32I, L33F, M36I, M46I/L, I47V, I50V, I54L/M/S, A71I/T/V, G73S, V82A, I84V i L90M.
Recommendation concerning coadministration 
Preporuke za istodobnu primjenu
Shake the bottle for 5 seconds before subsequent uses. 
Prije svake sljedeće primjene, protresite bočicu tijekom 5 sekundi.
All Subjects Baseline HIV-1 RNA < 100,000 copies/ml 
Svi ispitanici Početna HIV-1 RNK < 100.000 kopija/ml
Therefore medicinal products that are inducers, inhibitors or substrates of CYP3A4 must be used with caution when administered concurrently with Telzir with ritonavir (see sections 4.3 and 4.5). 
Stoga je potreban oprez pri istodobnoj primjeni lijeka Telzir i ritonavira s lijekovima koji induciraju, inhibiraju ili su supstrati CYP3A4 (vidjeti dijelove 4.3 i 4.5).
These may affect up to 1 in 1000 people: 
Rijetke nuspojave mogu se javiti u manje od 1 na 1000 osoba:
stable dose of paroxetine who start treatment with Telzir and ritonavir should be monitored for antidepressant response. 
Telzir i ritonavirom treba pratiti antidepresivni odgovor.
Caution is advised if the recommended doses of Telzir with ritonavir detailed below are exceeded (see section 4.4). 
Preporučuju se mjere opreza u slučajevima kada su premašene preporučene doze lijeka Telzir s ritonavirom navedene u nastavku (vidjeti dio 4.4).
Telzir suspension is administered orally. 
Suspenzija lijeka Telzir uzima se peroralno.
Anti-fungals: Ketoconazole 
Ketokonazol
(CYP3A4 inhibition) 
(inhibicija CYP3A4)
ombitasvir +/- dasabuvir suggest that coadministration of fosamprenavir/ritonavir with paritaprevir/ritonavir/ ombitasvir+/-dasabuvir is likely to lead to increased plasma exposures of paritaprevir due to CYP3A4 enzyme inhibition and higher ritonavir dose. 
Rezultati iz ispitivanja s drugim inhibitorima HIV proteaze i paritaprevirom/ritonavirom/ ombitasvirom +/- dasabuvirom ukazuju na to da će istodobna primjena fosamprenavira/ ritonavira s paritaprevirom/ ritonavirom/ombitasvirom +/dasabuvirom vjerojatno dovesti do povećanja plazmatske izloženosti paritapreviru zbog inhibicije enzima CYP3A4 i veće doze ritonavira.
Lovastatin: ↑ expected Simvastatin: ↑ expected (CYP3A4 inhibition by FPV/RTV) 
Lovastatin: očekuje se ↑ Simvastatin: očekuje se ↑ (inhibicija CYP3A4 lijekovima FPV/RTV)
Please refer to the table below for the dosing recommendations in paediatric patients. 
Za preporuke doziranja u pedijatrijskih bolesnika molimo pogledajte niže navedenu tablicu.
Paroxetine 
Paroksetin
Clinically significant hepatic transaminase elevations occurred in some subjects. 
Kod nekih ispitanika došlo je do klinički značajnog povećanja jetrenih transaminaza.
and 6 patients from APV20003. 
Ti podaci dodatno su potkrijepljeni suportivnim ispitivanjem APV20003.
Nervous system disorders 
Poremećaji probavnog sustava Proljev