natgillin/translations-raw huggingface dataset:
Interaction studies have only been performed in adults. 
Ispitivanja interakcija lijekova provodila su se samo kod odraslih osoba.
Clinical experience 
KLINIČKI PODACI
Additionally, both amprenavir, the active metabolite of fosamprenavir, and ritonavir are primarily metabolised in the liver by CYP3A4. 
Uz to, amprenavir, aktivni metabolit fosamprenavira, i ritonavir primarno se metaboliziraju u jetri putem CYP3A4.
The plasma amprenavir pharmacokinetics were evaluated in a 14 day repeat-dose study in HIV-1 infected adult subjects with mild, moderate, or severe hepatic impairment receiving fosamprenavir with ritonavir compared to matched control subjects with normal hepatic function. 
Farmakokinetika amprenavira u plazmi procjenjivala se tijekom 14 dana u ispitivanju ponovljenih doza na odraslim ispitanicima inficiranim HIV-1 koji su bolovali od blagog, umjerenog ili teškog oštećenja jetre, a koji su primali fosamprenavir s ritonavirom u usporedni s uparenim kontrolnim ispitanicima s normalnom funkcijom jetre.
The Telzir oral suspension contains propyl and methyl parahydroxybenzoate. 
Telzir oralna suspenzija sadrži propil i metil parahidroksibenzoat.
→Talk to your doctor or pharmacist. 
→Obavijestite svog liječnika ili ljekarnika.
No dose separation or dosage adjustment necessary (see Antacids). 
Nije potrebno odvajati doze ili ih prilagođavati (vidjeti dio
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 12 July 2004 
Datum prvog odobrenja: 12. srpnja 2004.
Children can take the adult dose of ritonavir capsules (100 mg twice daily) if they weigh at least 33 kg and can swallow the capsules whole. 
Djeca mogu uzimati dozu ritonavir kapsula za odrasle (100 mg dva puta na dan) ako imaju težinu od barem 33 kg i ako mogu progutati cijelu kapsulu.
It is recommended that phenytoin plasma concentrations be monitored and phenytoin dose increased as appropriate. 
Preporučuje se praćenje koncentracije fenitoina u plazmi i sukladno tome povećanje doze fenitoina.
• doses of rifabutin greater than 150 mg every other day (an antibiotic) 
• doze rifabutina veće od 150 mg svaki drugi dan (antibiotik) • lidokain primijenjen injekcijom
You will be monitored while you are taking Telzir. 
Pratit će se Vaše stanje tijekom uzimanja lijeka Telzir.
Treatment-emergent major or APV-associated protease mutations were observed in virus isolated from 2 patients. 
Značajne mutacije proteaze uzrokovane liječenjem ili povezane s amprenavirom (APV) primijećene su u virusu izoliranom u 2 bolesnika.
The increase of 25-Odesacetylrifabutin (active metabolite) could potentially lead to an increase of rifabutin related adverse events, notably uveitis. 
desacetilrifabutina (aktivnog metabolita) potencijalno može dovesti do povećanja nuspojava vezanih za rifabutin, posebice uveitis.
INFECTION Antibacterials: 
Antibakterijski lijekovi:
As a general rule, when deciding to use antiretroviral agents for the treatment of HIV infection in pregnant women and consequently for reducing the risk of HIV vertical transmission to the newborn, the animal data (see section 5.3) as well as the clinical experience in pregnant women should be taken into account. 
HIV infekcije u trudnica, a time i za smanjenje rizika od vertikalnog prijenosa HIV-a na novorođenče, treba uzeti u obzir podatke iz ispitivanja na životinjama (vidjeti dio 5.3) kao i kliničko iskustvo s primjenom kod trudnica.
When these people start treatment, they may find that old, hidden infections flare up, causing signs and symptoms of inflammation. 
može se dogoditi da je došlo do ponovne aktivacije starijih, do tada skrivenih infekcija koje se mogu razbuktati i uzrokovati znakove i simptome upale.
The frequency of this is unknown (see section 4.4). 
Učestalost te pojave nije poznata (vidjeti dio 4.4).
You need to keep taking it every day to stop your illness getting worse. 
Kako bi spriječili pogoršanje svoje bolesti, morate ga uzimati svakoga dana.
Administration of the fosamprenavir tablet formulation in the fed state (standardised high fat meal: 967 kcal, 67 grams fat, 33 grams protein, 58 grams carbohydrate) did not alter plasma amprenavir pharmacokinetics (Cmax, tmax or AUC0-∞) compared to the administration of this formulation in the fasted state. 
Postprandijalna primjena fosamprenavira u obliku tableta (standardizirani obrok s visokim udjelom masnoća: 967 kcal, 67 g masti, 33 g proteina, 58 g ugljikohidrata) nije promijenila farmakokinetiku amprenavira u plazmi (Cmax, tmax ili AUC0-∞) u usporedbi s onom kod primjene ovog oblika lijeka natašte.
The primary route of elimination of amprenavir is via hepatic metabolism with less than 1 % excreted unchanged in the urine and no detectable amprenavir in faeces. 
Primarni put eliminacije amprenavira je kroz metabolizam jetre s izlučivanjem manje od 1 % nepromijenjene tvari u urin, bez detektabilnih količina amprenavira u fecesu.
A dose reduction of the glucocorticoid with close monitoring of local and systemic effects or a switch to a glucocorticoid, which is not a substrate for CYP3A4 (e.g. beclomethasone) should be considered. 
Treba razmotriti smanjenje doze glukokortikoida s pažljivim praćenjem lokalnih i sistemskih učinaka ili prebaciti bolesnika na terapiju glukokortikoidom koji nije supstrat za CYP3A4 (npr.
Liver disease 
Bolesti jetre
In rats, there was no major effect on fertillty or reproductive performance with fosamprenavir (see section 5.3). 
Fosamprenavir nije imao značajnog učinka na plodnost ni reproduktivnu sposobnost štakora (vidjeti dio 5.3).
Amprenavir is primarily metabolised by the liver with less than 1 % excreted unchanged in the urine. 
Amprenavir se primarno metabolizira u jetri s izlučivanjem manje od 1% nepromijenjene tvari putem urina.
In rabbits, systemic exposure at the high dose level was only 0.3 times human exposure at the maximum clinical dose and thus the developmental toxicity of fosamprenavir has not been fully determined. 
Sistemska izloženost kod kunića pri visokim dozama bila je samo 0,3 puta od one koju nalazimo kod izloženosti ljudi pri maksimalnoj kliničkoj dozi te stoga razvojna toksičnost fosamprenavira nije u cijelosti utvrđena.
Telzir must only be given with low dose ritonavir as a pharmacokinetic enhancer of amprenavir and in combination with other antiretroviral medicinal products. 
Telzir se mora primjenjivati samo s niskom dozom ritonavira koja služi kao farmakokinetički pojačivač amprenavira i u kombinaciji s drugim antiretrovirusnim lijekovima.
Glaxo Operations UK Ltd (trading as GlaxoWellcome Operations), Harmire Road, Barnard Castle, Co. Durham DL12 8DT, United Kingdom or 
Glaxo Operations UK Ltd (posluje kao GlaxoWellcome Operations), Harmire Road, Barnard Castle, Co.
Co-administration of fosamprenavir/ritonavir with other antineoplastics metabolised by CYP3A (for example dasatinib, nilotinib, ibrutinib, vinblastine and everolimus) may increase concentrations of these medicinal products, potentially increasing the risk of adverse events usually associated with these agents. 
Istodobna primjena fosamprenavira/ritonavira s drugim antineoplasticima koji se metaboliziraju putem CYP3A (na primjer dasatinib, nilotinib, ibrutinib, vinblastin i everolimus) može povećati koncentraciju tih lijekova, što potencijalno povećava rizik od štetnih događaja koji se obično povezuju s tim lijekovima.
Loose stools, nausea, vomiting, abdominal pain 
Meka stolica, mučnina, povraćanje, bolovi u abdomenu
Push the plastic adapter into the neck of the bottle, while holding the bottle firmly. 
Držeći čvrsto bocu, u grlo boce gurnite plastični nastavak.
Ritonavir also inhibits CYP2D6 but to a lesser extent than CYP3A4. 
Ritonavir također inhibira i CYP2D6, ali u manjoj mjeri od CYP3A4.
Amprenavir in addition is also an inhibitor of the CYP3A4 enzyme, although to a lesser extent than ritonavir. 
Amprenavir je k tome također inhibitor enzima CYP3A4, iako u manjoj mjeri od ritonavira.
Concomitant use of Telzir with ritonavir and fluticasone or other glucocorticoids that are metabolised by CYP3A4 is not recommended unless the potential benefit of treatment outweighs the risk of systemic corticosteroid effects, including Cushing's syndrome and adrenal suppression (see section 
Ne preporučuje se istodobna primjena lijeka Telzir s ritonavirom i flutikazonom ili drugim glukokortikoidima koji se metaboliziraju putem CYP3A4, osim u slučaju kada potencijalna korist od takvog liječenja nadmašuje rizik od sistemskih učinaka kortikosteroida, uključujući Cushingov sindrom i supresiju nadbubrežnih žlijezda (vidjeti dio 4.5).
(see section 4.3) 
(vidjeti dio 4.5).
Patients with chronic hepatitis B or C and treated with combination antiretroviral therapy are at an increased risk of severe and potentially fatal hepatic adverse reactions. 
Bolesnici s kroničnim hepatitisom B ili C, a koji su liječeni kombiniranom antiretrovirusnom terapijom, su pod povećanim rizikom za teške i potencijalno smrtonosne nuspojave.
Treatment-emergent major protease or APV-associated mutations were observed in virus isolated from 1 patient in APV29005 and 6 patients from APV20003. 
Značajne mutacije proteaze uzrokovane liječenjem ili povezane s amprenavirom primijećene su u virusu izoliranom u 1 bolesnika iz ispitivanja APV29005 i 6 bolesnika iz ispitivanja APV20003.
Children and adolescents should take the Telzir oral suspension with food. 
Djeca i adolescenti bi trebali oralnu suspenziju lijeka Telzir uzimati s hranom.
No dose adjustment is considered necessary in patients with renal impairment (see section 5.2). 
Nije potrebna prilagodba doze kod bolesnika s oštećenjem bubrega (vidjeti dio 5.2).
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 these events can occur many months after initiation of treatment (see section 4.4). 
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 ti događaji mogu javiti i mjesecima nakon uvođenja liječenja (vidjeti dio 4.4).
Use with caution (see section 4.4). 
Primijeniti uz mjere opreza (vidjeti dio 4.4).
These medicines are not recommended with Telzir/ritonavir: 
Ne preporučuje se korištenje sljedećih lijekova s lijekom Telzir/ritonavirom:
In rats only there was an increase in interstitial cell hyperplasia in males at exposure levels equivalent to 0.5-fold those in humans, and an increase in uterine endometrial adenocarcinoma in females at an exposure level equivalent to 1.1-fold those in humans. 
Samo kod štakora zamijećeno je povećanje hiperplazije intersticijskih stanica kod muških jedinki pri razinama izloženosti koje su bile ekvivalentne 0,5-puta onih koje nalazimo kod ljudi, kao i povećanje adenokarcinoma endometrija uterusa kod ženki pri razinama izloženosti koje su bile ekvivalentne 1,1-puta onih koje nalazimo kod ljudi.
Step by step instructions Do not mix Telzir with any other medicines in the bottle or the syringe. 
Telzir nemojte miješati s drugim lijekovima koristeći bocu ili štrcaljku.
In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection. 
Osim oportunističkih infekcija, nakon što počnete uzimati lijekove za liječenje HIV infekcije mogu se javiti i autoimuni poremećaji (stanja kod kojih imunološki sustav napada zdravo tkivo u tijelu).
What Telzir looks like and contents of the pack Telzir is supplied in plastic bottles containing 60 film-coated tablets. 
Telzir je pakiran u plastične boce koje sadrže 60 filmom obloženih tableta.
Significant reductions in amprenavir Cmin observed may result in virological failure in patients. 
Uočena značajna smanjenja Cmin amprenavira kod bolesnika mogu dovesti do njegovog neuspješnog virološkog djelovanja.
The relevance of the uterine endometrial adenocarcinomas for humans is uncertain; however there is no evidence from clinical trials or marketed use to suggest that these findings are of clinical significance. 
Nije poznat značaj adenokarcinoma endometrija uterusa za ljude, međutim, iz kliničkih ispitivanja ili podataka nakon stavljanja lijeka u promet ne postoje dokazi koji bi upućivali da ti nalazi imaju klinički značaj.
Yet, Telzir should be used with caution in patients with a known sulphonamide allergy. 
Potreban je daljnji oprez pri primjeni lijeka Telzir kod bolesnika s poznatom alergijom na sulfonamide.
Examples of antineoplastic agents: dasatinib nilotinib ibrutinib vinblastine everolimus 
dasatinib nilotinib ibrutinib vinblastin everolimus
Immune Reactivation Syndrome: in HIV-infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic infections may arise. 
Sindrom imunološke reaktivacije: kod HIV-om inficiranih bolesnika koji u početku kombinirane antiretrovirusne terapije (CART) imaju tešku deficijenciju imunološkog sustava može doći do pojave upalne reakcije na asimptomatske ili rezidualne oportunističke infekcije.
Concentrations of AAG have been shown to decrease during the course of antiretroviral therapy. 
Pokazano je da se tijekom terapije antiretrovirusnim lijekovima koncentracije AAG-a smanjuju.
In HIV-infected patients with severe immune deficiency at the time of institution of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms. 
Kod HIV-om inficiranih bolesnika, koji u vrijeme uvođenja kombinirane antiretrovirusne terapije (CART) imaju tešku deficijenciju imunološkog sustava, može doći do pojave upalne reakcije na asimptomatske ili rezidualne oportunističke patogene što može dovesti do ozbiljnih kliničkih stanja ili pogoršanja simptoma.
Overall, even with these dose adjustments for adults with hepatic impairment, some patients may have higher or lower than anticipated amprenavir and/or ritonavir plasma concentrations as compared to patients with normal hepatic function, due to increased inter-patient variability (see section 5.2), therefore close monitoring of safety and virologic response is warranted. 
Općenito, čak i uz navedene prilagodbe doza kod odraslih s oštećenjem jetre, zbog povećane varijabilnosti između bolesnika (vidjeti dio 5.2) kod nekih bolesnika očekivane koncentracije amprenavira i/ili ritonavira u plazmi mogu biti više ili niže od onih kod bolesnika s normalnom funkcijom jetre te je stoga potrebno pomno praćenje virološkog odgovora i sigurnosnog profila.
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. 
(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.
(Induction and/or inhibition of CYP2C9 by RTV) 
(Indukcija i/ili inhibicija CYP2C9 lijekom RTV)
By stopping protease from working, Telzir stops HIV multiplying and infecting more CD4 cells. 
Sprječavajući djelovanje proteaze, Telzir zaustavlja umnožavanje HIV-a i infekciju dodatnih CD4 stanica.
It is bound to the alpha-1acid glycoprotein (AAG) and albumin,but has a higher affinity for AAG. 
kiselina (AAG) i albumin, ali ima veći afinitet za AAG.
Ritonavir: Cmax ↑ 63%* Ritonavir: AUC ↑ 45%* * compared to historical data 
Ritonavir: Cmax ↑63%* Ritonavir: AUC ↑45%* * u usporedbi s povijesnim podacima
ANTACIDS, HISTAMINE H2 RECEPTOR ANTAGONIST AND PROTON-PUMP INHIBITORS 
ANTACIDI, ANTAGONISTI HISTAMINSKOG H2 RECEPTORA I INHIBITORI
Contraindicated (see section 4.3). 
Kontraindicirani (vidjeti dio 4.3).
Hypromellose Titanium dioxide (E171) Glycerol triacetate Iron oxide red (E172) 
Film-ovojnica tablete: hipromeloza titanijev dioksid (E171) gliceroltriacetat željezov oksid, crveni (E172)
Table 2 Efficacy Outcome at Weeks 96 and 144 in ESS100732 Extension (ART-Naïve Patients) 
Tablica 2 Ishod djelotvornosti u 96. i 144. tjednu u ESS100732 produžetku (bolesnici koji nisu ranije primali antiretrovirusnu terapiju)
Resistant to FPV/RTV 
Prijemčivi za FPV/RTV
This product also contains preservatives: methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216), see leaflet for further information 
Ovaj lijek također sadrži konzervanse: metilparahidroksibenzoat (E218) i propilparahidroksibenzoat (E216), za dodatne informacije vidjeti uputu o lijeku
B CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I
Repeat dose studies with fosamprenavir in rats produced effects consistent with hepatic enzyme induction, which predisposes rats to thyroid neoplasms. 
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.
Table 3 Efficacy at Week 48 Outcomes in APV30003 ITT(E) Population (ART-experienced Patients) 
Tablica 3 Ishodi djelotvornosti u 48. tjednu u APV30003 na ITT(E) populaciji (bolesnici koji su ranije primali antiretrovirusnu terapiju)
Telzir is also available as 700 mg film-coated tablets. 
Telzir je također dostupan u obliku 700 mg filmom obloženih tableta.
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. 
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.
Indinavir Saquinavir 
Indinavir Sakvinavir
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). 
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).
• doses of atorvastatin greater than 20 mg per day (used to lower cholesterol) 
• doze atorvastatina veće od 20 mg na dan (koristi se za snižavanje kolesterola)
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. 
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.
Rarely, the skin rash can be severe and serious (Stevens Johnson syndrome). 
U rijetkim slučajevima, kožni osip može biti težak i ozbiljan (Stevens
Telzir will not stop you passing on HIV. 
Telzir ne zaustavlja mogućnost da HIV-om zarazite druge.
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). 
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).
Co-administration of the antipsychotic medicinal product lurasidone and fosamprenavir/ritonavir (FPV/RTV) is contraindicated (see section 4.5). 
Istodobna primjena antipsihotika lurasidona i fosamprenavira/ritonavira (FPV/RTV) je kontraindicirana (vidjeti dio 4.5).
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. 
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.
Telzir dose (TWICE DAILY) 
Doza lijeka Telzir (DVA PUTA DNEVNO)
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). 
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).
• cyclosporin, rapamycin, tacrolimus (used to suppress the immune system) 
• ciklosporin, rapamicin, takrolimus (koriste se za supresiju imunološkog sustava)
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). 
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).
Amprenavir exposure unchanged when compared to historical data. 
U usporedbi s povijesnim podacima, izloženost amprenaviru nije se mijenjala.
No clinically significant interaction observed. 
Nije uočena klinički značajna interakcija.
One resistance mutation was observed in each of 3 isolates: K20K/R, I54I/L and I93I/L respectively 
svakom od 3 izolata zamijećena je jedna mutacija za otpornost: K20K/R, I54I/L odnosno I93I/L.
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). 
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).
A MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturers responsible for batch release Film-coated tablets 
Naziv(i) i adresa(e) proizvođača odgovornog(ih) za puštanje serije lijeka u promet Filmom obložene tablete
mechanism of interaction is CYP3A4 inhibition by fosamprenavir/ritonavir. 
Mehanizam interakcija je inhibicija CYP3A4 fosamprenavirom/ritonavirom.
How to store Telzir 
Kako čuvati Telzir
You must take Telzir oral suspension. 
Koristite Telzir oralnu suspenziju.
ANTINEOPLASTIC AGENTS METABOLISED BY CYP3A 
METABOLIZIRAJU PUTEM CYP3A