FrancophonIA/ELRC3.0 huggingface dataset:
English: Most of the adverse reactions below were reported from three large clinical studies in adults, where the adverse events were of at least moderate intensity (Grade 2 or more) occurring in at least 1% of patients and reported by investigators as being attributable to the medicinal products used in the studies.
Croatian: Većina niže navedenih nuspojava prijavljena je u sklopu 3 velika klinička ispitivanja koja su provedena na odraslima, pri čemu su nuspojave prema intenzitetu bile barem umjerene (2. ili višeg stupnja) te zamijećene kod barem 1% bolesnika i prijavljene od strane ispitivača kao vjerojatno uzrokovane lijekovima korištenim u ispitivanjima.
English: You may also be allergic to Telzir.
Croatian: Ako imate, mogli biste također biti alergični i na Telzir.
English: → Keep in touch with your doctor, and don't stop taking Telzir without your doctor's advice.
Croatian: → Ostanite u kontaktu sa svojim liječnikom, i nemojte prestati uzimati Telzir bez prethodnog savjetovanja s liječnikom.
English: There is no known antidote for Telzir.
Croatian: Antidot za Telzir nije poznat.
English: All Patients
Croatian: Svi bolesnici
English: Less than 1 % of the therapeutic dose of amprenavir is excreted unchanged in the urine.
Croatian: Manje od 1% terapijske doze amprenavira izlučuje se nepromijenjeno u urin.
English: People with advanced HIV infection (AIDS) have weak immune systems and are more likely to develop serious infections (opportunistic infections).
Croatian: Bolesnici s uznapredovalom HIV infekcijom (SIDA) imaju oslabljen imunološki sustav te su skloniji razvoju ozbiljnih infekcija (tzv. oportunističke infekcije).
English: • dasatinib, nilotinib, ibrutinib, vinblastine and everolimus (used to treat several types of cancer)
Croatian: • dasatinib, nilotinib, ibrutinib, vinblastin i everolimus (koriste se za liječenje nekoliko vrsta raka).
English: Amiodarone Bepridil Quinidine Flecainide Propafenone
Croatian: Amiodaron Bepridil Kinidin Flekainid Propafenon
English: Protease Inhibitors:
Croatian: Inhibitori proteaze:
English: The tablets are capsule shaped, biconvex, pink coloured and marked with ‘GXLL7' on one side.
Croatian: Tablete su u obliku kapsule, bikonveksne, ružičaste s oznakom ‘GXLL7' na jednoj strani.
English: Telzir oral suspension is the recommended option for the most accurate dosing in children based on body weight.
Croatian: Telzir oralna suspenzija je preporučena terapijska opcija za djecu zbog preciznog načina doziranja ovisno o tjelesnoj težini.
English: There is limited clinical experience (less than 300 pregnancy outcomes) from the use of fosamprenavir in pregnant women.
Croatian: Kliničko iskustvo s primjenom fosamprenavira kod trudnica je ograničeno (manje od 300 ishoda trudnoća).
English: Frequencies are defined as: Very common (≥ 1/10), Common (≥ 1/100 to < 1/10), Uncommon (≥ 1/1,000 to < 1/100), Rare (≥ 1/10,000 to < 1/1,000) or Very rare (< 1/10,000), or Not known.
Croatian: manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000) ili vrlo rijetko (< 1/10 000), ili nepoznato.
English: HIV infection is spread by sexual contact with someone who has the infection, or by transfer of infected blood (for example, by sharing injection needles).
Croatian: HIV infekcija prenosi se putem spolnog kontakta s inficiranom osobom ili putem inficirane krvi (na primjer zajedničkom uporabom igala).
English: Paediatric patients from 6 years of age
Croatian: Pedijatrijski bolesnici od 6. godine života
English: Only 22% of the original population of the KLEAN study was enrolled in the study extension
Croatian: U nastavak ispitivanja bilo je uključeno samo 22% originalne populacije KLEAN
English: People with hepatitis B or C taking combination therapy are at increased risk of getting severe liver problems.
Croatian: Osobe s hepatitisom B ili C koje uzimaju kombiniranu terapiju imaju povećan rizik za razvijanje teških tegoba s jetrom.
English: The absolute bioavailability of fosamprenavir in humans has not been established.
Croatian: Nije ustanovljena apsolutna bioraspoloživost fosamprenavira kod ljudi.
English: A dosing syringe with a 10 ml graduation is supplied with the pack so you can measure your dose accurately.
Croatian: U pakiranju se nalazi štrcaljka za doziranje sa 10 ml graduacijama kako biste točno mogli izmjeriti dozu.
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Croatian: Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenom člankom 107.c stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuiranim verzijama objavljenima na europskom internetskom portalu za lijekove.
English: It is therefore important that you carefully read the package leaflet provided with these medicines.
Croatian: Važno je stoga da pozorno pročitate uputu o lijeku za sve lijekove koje uzimate.
English: The conversion of fosamprenavir to amprenavir appears to primarily occur in the gut epithelium.
Croatian: Čini se da se konverzija fosamprenavira u amprenavir primarno događa u crijevnom epitelu.
English: HDPE bottles with a child resistant polypropylene closure containing 60 tablets.
Croatian: HDPE bočice s polipropilenskim sigurnosnim zatvaračem za djecu koje sadrže 60 tableta.
English: The pharmacokinetic properties of amprenavir following co-administration of Telzir with ritonavir have been evaluated in healthy adult subjects and HIV-infected patients and no substantial differences were observed between these two groups.
Croatian: Farmakokinetička svojstva amprenavira nakon istodobne primjene lijeka Telzir s ritonavirom procjenjivala su se na zdravim odraslim ispitanicima i bolesnicima inficiranim HIV-om te nije primijećena značajna razlika između te dvije skupine.
English: Children and adolescent patients above the age of six
Croatian: Bolesnici dječje i adolescentske dobi iznad 6 godina
English: During attempts to overcome the decreased exposure by increasing the dose of other protease inhibitors with ritonavir, a high frequency of liver reactions was seen.
Croatian: Tijekom pokušaja da se smanjena izloženost prevlada povećanjem doze drugih inhibitora proteaze s ritonavirom, primijećena je velika učestalost reakcija jetre.
English: This adjusted dose has not been evaluated in a clinical study and has been derived from extrapolation (see section 5.2).
Croatian: Ova prilagođena doza nije ocijenjena u kliničkom ispitivanju nego je dobivena ekstrapolacijom (vidjeti dio 5.2).
English: The in vitro antiviral activity of amprenavir was evaluated against HIV-1 IIIB in both acutely and chronically infected lymphoblastic cell lines (MT-4, CEM-CCRF, H9) and in peripheral blood lymphocytes.
Croatian: Antivirusna aktivnost amprenavira in vitro procjenjivana je protiv HIV-1 IIIB na akutno i na kronično inficiranim staničnim linijama limfoblasta (MT-4, CEM-CCRF, H9) kao i na limfocitima u perifernoj krvi.
English: No human data on the effect of fosamprenavir on fertility are available.
Croatian: Nisu dostupni podaci o učinku fosamprenavira na plodnost u ljudi.
English: Tablet or Oral suspension 700 mg (1 tablet or 14 ml suspension)
Croatian: Tablete ili oralna suspenzija 700 mg (1 tableta ili 14 ml suspenzije)
English: The 50% inhibitory concentration (IC50) of amprenavir ranged from 0.012 to 0.08 µM in acutely infected cells and was 0.41 µM in chronically infected cells (1 µM = 0.50 µg/ml).
Croatian: Inhibitorna koncentracija amprenavira od 50% (IC50) kretala se u rasponu od 0,012 do 0,08 µM kod akutno inficiranih stanica, a 0,41 µM kod kronično inficiranih stanica (1 µM = 0,50 µg/ml).
English: If overdose occurs, the patient should be monitored for evidence of toxicity (see section 4.8) and standard supportive treatment applied as necessary.
Croatian: U slučaju predoziranja bolesnika treba nadzirati zbog pojave znakova toksičnosti (vidjeti dio 4.8) te prema potrebi primijeniti standardne mjere suportivnog liječenja.
English: Haemophiliac patients should therefore be informed of the possibility of increased bleeding.
Croatian: Osobe koje boluju od hemofilije stoga treba informirati o mogućnosti pojačanog krvarenja.
English: Genotypic Sensitivity Score in OBT
Croatian: Ocjena genotipske osjetljivosti u OBT
English: Some people taking medicines for HIV infection develop other conditions, which can be serious.
Croatian: Kod nekih osoba koje su primale lijekove za HIV infekciju pojavila su se stanja koja mogu biti ozbiljna.
English: The mean steady state plasma amprenavir trough concentration (Cmin) was 2.12 (1.77-2.54) µg/ml and AUC0-tau was 39.6 (34.5-45.3) h*µg/ml.
Croatian: Srednja vrijednost koncentracije amprenavira u plazmi pri stanju dinamičke ravnoteže (Cmin) bila je 2,12 (1,77-2,54) µg/ml i AUC0-tau bilo je 39,6 (34,5-45,3) h*µg/ml.
English: Toxicity was not aggravated when juvenile animals were treated as compared with adult animals, but the data did indicate a steeper dose response.
Croatian: Pri liječenju mladih životinja, a u usporedbi s odraslim životinjama, nije došlo do akumuliranja toksičnosti, ali podaci su upućivali na strmiji odgovor na dozu.
English: Oral suspension should be taken without food
Croatian: Oralnu suspenziju treba uzimati bez hrane
English: HERBAL PRODUCTS St. John's wort (Hypericum perforatum)
Croatian: BILJNI PRIPRAVCI Gospina trava (Hypericum perforatum)
English: Body System
Croatian: Organski sustav
English: Oral suspension should be taken with food
Croatian: Oralnu suspenziju treba uzimati s hranom
English: 1000 - 10,000 copies/ml >10,000 - 100,000 copies/ml >100,000 copies/ml AAUCMB Observed Analysis
Croatian: 1 000 - 10 000 kopija/ml >10 000 - 100 000 kopija/ml >100 000 kopija/ml AAUCMB analiza opaženog
English: Dose titration of paroxetine based on a clinical assessment of antidepressant response is recommended.
Croatian: Preporučuje se titracija doze paroksetina ovisno o kliničkoj procjeni odgovora na antidepresive.
English: No dosing recommendations can be made for children weighing less than 25 kg.
Croatian: Nije moguće preporučiti dozu za djecu čija je tjelesna težina manja od 25kg.
English: Analysis of the virological failure samples across these regimens defined four main resistance pathways: V32I+I47V, I50V, I54L/M and I84V.
Croatian: Analiza uzorka viroloških neuspjeha u tim režimima definirala je 4 glavna puta rezistencije: V32I+I47V, I50V, I54L/M i I84V.
English: Although the aetiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV-disease and/or long-term exposure to CART.
Croatian: Iako se smatra da u etiologiji osteonekroze sudjeluje više faktora (koji uključuju primjenu kortikosteroida, konzumiranje alkohola, tešku imunosupresiju, viši indeks tjelesne mase), prijavljeni su slučajevi osteonekroze, osobito kod bolesnika s uznapredovalom HIV bolešću i/ili dugotrajnom izloženošću CART-u.
English: HMG-COA REDUCTASE INHIBITORS
Croatian: INHIBITORI HMG-COA REDUKTAZE
English: The inducing effect may persist for at least 2 weeks after cessation of treatment with St John's wort.
Croatian: Inducirajući učinak može potrajati barem 2 tjedna nakon prestanka liječenja
English: Ritonavir dose (TWICE DAILY)
Croatian: Doza Ritonavira (DVA PUTA DNEVNO)
English: The primary route of metabolism is via the cytochrome P450 3A4 enzyme.
Croatian: Primarni metabolički put je preko enzima citokroma P450 3A4.
English: The effects of high fluticasone systemic exposure on ritonavir plasma levels are unknown.
Croatian: Nisu poznati učinci sistemske izloženosti visokim dozama flutikazona na koncentracije ritonavira u plazmi.
English: Patients with renal impairment have not been specifically studied.
Croatian: Bolesnici s oštećenjem bubrega nisu se posebno ispitivali.
English: Fosamprenavir contains a sulphonamide moiety.
Croatian: Fosamprenavir sadrži sulfonamidnu grupu.
English: Concomitant administration of Telzir and quetiapine is contra-indicated as it may increase quetiapine-related toxicity.
Croatian: Istodobna primjena lijeka Telzir i kvetiapina je kontraindicirana jer može povećati toksičnost povezanu s primjenom kvetiapina.
English: Sildenafil Vardenafil Tadalafil
Croatian: Vardenafil Tadalafil
English: APV20002 is a 48 week, Phase II, open label study designed to evaluate the pharmacokinetics, safety, tolerability and antiviral activity of fosamprenavir with and without ritonavir in paediatric subjects 4 weeks to < 2 years of age.
Croatian: APV20002 je faza II otvorenog ispitivanja u trajanju od 48 tjedana, osmišljena za procjenu farmakokinetike, sigurnosti, podnošljivosti i antivirusne aktivnosti fosamprenavira sa i bez ritonavira kod pedijatrijskih ispitanika u dobi od 4 tjedna < 2 godine starosti.
English: SELECTIVE SEROTONIN REUPTAKE INHIBITORS (SSRIS)
Croatian: SELEKTIVNI INHIBITORI PONOVNE POHRANE SEROTONINA (SSRI)
English: Pink film coated, capsule shaped, biconvex tablets, marked with GXLL7 on one side.
Croatian: Ružičaste, filmom obložene, bikonveksne tablete u obliku kapsule s oznakom "GXLL7" na jednoj strani.
English: The pack also includes a polyethylene syringe-adapter and a 10 ml oral dosing syringe comprised of a polypropylene barrel (with ml graduations) and a polyethylene plunger.
Croatian: Pakiranje također sadrži i polietilenski nastavak za štrcaljku i odmjernu štrcaljku za usta od 10 ml koja se sastoji od polipropilenskog tijela (s oznakama ml) i polietilenskog klipa.
English: • halofantrine (used to treat malaria)
Croatian: • halofantrin (koristi se za liječenje malarije)
English: How to store Telzir Keep this medicine out of the sight and reach of children.
Croatian: Kako čuvati Telzir Lijek čuvajte izvan pogleda i dohvata djece.
English: Telzir with ritonavir is not recommended in children below 6 years due to insufficient data on pharmacokinetics, safety and antiviral response (see section 5.2).
Croatian: Telzir s ritonavirom ne preporučuje se kod djece mlađe od 6 godina zbog nedostatnih podataka o farmakokinetici, sigurnosti i antivirusnom odgovoru (vidjeti dio 5.2).
English: Only applicable to outer carton
Croatian: Primjenjivo samo za vanjsku kartonsku kutiju.
English: Nucleoside / Nucleotide reverse transcriptase inhibitors:
Croatian: Nukleozidni/nukleotidni inhibitori reverzne transkriptaze:
English: In rats exposed pre- and post-natally to fosamprenavir, pups showed impaired physical and functional development and reduced growth.
Croatian: Kod štakora koji su pre- i postnatalno bili izloženi fosamprenaviru, kod mladunčadi je došlo do poremećenog fizičkog i funkcionalnog razvoja te smanjenja rasta.
English: Please read the information on ‘Other side effects of combination therapy for HIV' in section 4 of this leaflet.
Croatian: Molimo pročitajte informacije "Ostale moguće nuspojave u kombiniranoj terapiji za HIV",
English: If you have any questions about this information or the advice given: →Talk to your doctor.
Croatian: Ako imate pitanja o tim informacijama ili savjetima koje ste primili:
English: Your doctor will decide if these medicines are suitable for you to take with Telzir and ritonavir.
Croatian: Liječnik će odlučiti o tome jesu li ti lijekovi podobni za istodobno uzimanje s lijekom Telzir i ritonavirom.
English: Therefore for adult patients the Telzir oral suspension should be taken without food and on an empty stomach (see section 4.2).
Croatian: Stoga, odrasli bolesnici Telzir oralnu suspenziju trebaju uzimati bez hrane i na prazan želudac (vidjeti dio 4.2).
English: If you get any symptoms of infection or signs of inflammation while you're taking Telzir: →Tell your doctor immediately.
Croatian: Ako dobijete bilo koje simptome infekcije ili znakove upale dok uzimate Telzir:
English: Telzir in combination with low dose ritonavir is indicated for the treatment of Human Immunodeficiency Virus Type 1 (HIV-1) infected adults, adolescents and children of 6 years and above in combination with other antiretroviral medicinal products.
Croatian: Telzir je indiciran u kombinaciji s niskom dozom ritonavira u liječenju infekcije virusom humane imunodeficijencije tipa 1 (HIV-1) kod odraslih, adolescenata i djece u dobi od 6 godina i starije u kombinaciji s drugim antiretrovirusnim lijekovima.
English: Severe or life-threatening cases of rash, including Stevens-Johnson syndrome are rare.
Croatian: Teški ili opasni po život osipi, uključujući i Stevens-Johnsonov sindrom su rijetki.
English: 25-O-desacetylrifabutin: Cmax ↑ 6-fold*
Croatian: 25-O-desacetilrifabutin: Cmax↑ 6 puta*
English: Telzir tablets can be taken with or without food.
Croatian: Telzir tablete možete uzimati sa ili bez hrane.
English: Efficacy outcomes by subgroups are described in the table below.
Croatian: Ishodi djelotvornosti prema podskupinama pokazani su u niže navedenoj tablici.
English: In repeated dose toxicity studies in adult rats and dogs, fosamprenavir produced evidence of gastrointestinal disturbances (salivation, vomiting and soft to liquid faeces), and hepatic changes (increased liver weights, raised serum liver enzyme activities and microscopic changes, including hepatocyte necrosis).
Croatian: U ispitivanjima toksičnosti ponovljenih doza provedenim na odraslim štakorima i psima za fosamprenavir su se pojavili dokazi o uzrokovanju gastrointestinalnih poremećaja (salivacija, povraćanje, meki do tekući feces) i o promjenama na jetri (povećane težine jetre, povišenoj aktivnosti jetrenih enzima u serumu i mikroskopskih promjena, uključujući nekrozu hepatocita).
English: Adverse reactions are listed by MedDRA system organ class and absolute frequency.
Croatian: Nuspojave su navedene prema MedDRA klasifikaciji organskih sustava i apsolutnoj učestalosti.
English: Efficacy outcomes are described in the table below.
Croatian: Ishodi djelotvornosti pokazani su u dolje navedenoj tablici.
English: Further dose reduction may be necessary (see section 4.5).
Croatian: Možda će biti potrebno daljnje smanjenje doze (vidjeti dio 4.5).
English: • sildenafil, vardenafil or tadalafil (used to treat erectile dysfunction)
Croatian: • sildenafil, vardenafil ili tadalafil (koriste se za liječenje erektilne disfunkcije)
English: • atorvastatin up to 20 mg per day (used to lower cholesterol)
Croatian: • atorvastatin do 20 mg dnevno (koristi se za snižavanje kolesterola)
English: After single dose administration of fosamprenavir, amprenavir peak plasma concentrations are observed approximately 2 hours after administration.
Croatian: Nakon primjene jedne doze fosamprenavira vršne koncentracije amprenavira u plazmi zamijećene su oko 2 sata nakon primjene.
English: In paediatric patients, the oral suspension should be taken with food in order to aid palatability and assist compliance (see section 5.2).
Croatian: Pedijatrijski bolesnici bi trebali uzimati oralnu suspenziju sa hranom kako bi olakšali gutanje i povećali suradljivost (vidjeti dio 5.2).
English: Pup survival was decreased.
Croatian: Došlo je do smanjenog preživljenja mladunčadi.
English: ORAL ANTICOAGULANTS Warfarin
Croatian: ORALNI ANTIKOAGULANSI Varfarin
English: Telzir is also available as an oral suspension for those patients unable to swallow the tablets.
Croatian: Telzir je također dostupan u obliku oralne suspenzije za one bolesnike koji ne mogu progurati tablete.
English: Most adverse reactions associated with fosamprenavir/ritonavir combination therapies were mild to moderate in severity, early in onset and rarely treatment limiting.
Croatian: Najveći broj nuspojava povezanih s terapijom kombinacije fosamprenavira/ritonavira bile su blage do umjerene po težini, rano su se javljale i rijetko su ograničavale daljnje liječenje.
English: No clinically significant interaction is expected.
Croatian: Ne očekuje se klinički značajna interakcija.
English: The rash generally will resolve spontaneously without the necessity of discontinuing treatment with the fosamprenavir with ritonavir.
Croatian: Općenito, osip spontano prolazi bez potrebe za prekidanjem terapije fosamprenavirom s ritonavirom.
English: • A severe or life-threatening skin reaction (Stevens Johnson syndrome).
Croatian: • teška, po život opasna, kožna reakcija (Stevens Johnson sindrom).
English: Do not use this medicine after the expiry date which is stated on the carton and the bottle.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i boci iza oznake „EXP“.
English: Table 4 AAUCMB at Week 48 by genotypic sensitivity score in OBT and baseline resistance to FPV/RTV
Croatian: Tablica 4 AAUCMB u 48. tjednu prema ocjeni genotipske osjetljivosti OBT početnih vrijednosti rezistencije na FPV/RTV
English: More serious adverse reactions such as serious skin rashes and hepatic transaminase elevations have also been reported (cf paragraph Description of selected adverse reactions).
Croatian: Prijavljene su i ozbiljnije nuspojave poput ozbiljnih kožnih osipa i povećanja razine jetrenih transaminaza (iz dijela Opis odabranih nuspojava).
English: No dose recommendations can be given.
Croatian: Nije moguće dati preporuke o dozi.
English: Fluticasone propionate: ↑ Intrinsic cortisol levels: ↓
Croatian: Flutikazon propionat: ↑ Unutarnje razine kortizola: ↓
English: The incidence of endometrial findings was slightly increased over concurrent controls, but within background range for female rats.
Croatian: Incidencija nalaza na endometriju bila je blago povećana u usporedbi s istodobnom kontrolnom skupinom, ali unutar poznatog raspona za ženke štakora.
English: Telzir tablet can be taken with or without food.
Croatian: Telzir tableta može se uzimati sa ili bez hrane.
English: Renal clearance of ritonavir is also negligible, therefore the impact of renal impairment on amprenavir and ritonavir elimination should be minimal
Croatian: Bubrežni klirens ritonavira također je zanemariv, te bi utjecaj oštećenja bubrega na eliminaciju amprenavira i ritonavira trebao biti minimalan.
English: GASTROINTESTINAL MOTILITY AGENTS Cisapride
Croatian: LIJEKOVI ZA GASTROINTESTINALNI MOTILITET Cisaprid
English: Telzir tablet and oral suspension formulations, both given fasted, delivered equivalent plasma amprenavir AUC∞ values and the Telzir oral suspension formulation delivered a 14 % higher plasma amprenavir Cmax as compared to the oral tablet formulation.
Croatian: Telzir u obliku tableta i oralne suspenzije, kada se oba oblika daju natašte, daje vrijednosti AUC ekvivalentne amprenaviru u plazmi, a Telzir u obliku oralne suspenzije davao je 14% viši Cmax amprenavira u plazmi od oralnih tableta.
English: An increase in weight and in levels of blood lipids and glucose may occur during antiretroviral therapy.
Croatian: Povećanje tjelesne težine i povišene razine lipida i glukoze u krvi mogu se pojaviti tijekom antiretrovirusne terapije.
English: Results were in favour of the lopinavir / ritonavir arm as detailed below.
Croatian: Rezultati su bili u korist grane lopinavira/ritonavira, kao što se detaljnije navodi u nastavku.
English: Shake the bottle vigorously before use.
Croatian: Snažno protresite bocu prije primjene.
English: Telzir is also available as an oral suspension for use in patients unable to swallow tablets, and in paediatric patients less than 39 kg (please refer to the Summary of Product Characteristics for Telzir oral suspension).
Croatian: Telzir je također dostupan i kao oralna suspenzija za primjenu kod bolesnika koji ne mogu progutati tablete i za djecu čija je tjelesna težina manja od 39 kg (potrebno vidjeti sažetak opisa svojstava lijeka za Telzir oralnu suspenziju).
English: PDE5 inhibitors used for the treatment of erectile dysfunction: The use of Telzir concomitantly with PDE5 inhibitors (e.g. sildenafil, tadalafil, vardenafil) is not recommended (see section 4.5).
Croatian: PDE5 inhibitori koji se primjenjuju za liječenje erektilne disfunkcije: ne preporučuje se istodobna primjena lijeka Telzir s PDE5 inhibitorima (npr. sildenafil, tadalafil, vardenafil) (vidjeti dio 4.5).