FrancophonIA/ELRC3.0 huggingface dataset:
English: United Kingdom ViiV Healthcare UK Ltd Tel: + 44 (0)800 221441 customercontactuk@gsk.com
Croatian: ViiV Healthcare UK Ltd Tel: + 44 (0)800 221441 customercontactuk@gsk.com
English: The in vitro antiviral activity observed with fosamprenavir is due to the presence of trace amounts of amprenavir.
Croatian: Antivirusna aktivnost fosamprenavira zamijećena je in vitro zbog prisutnosti amprenavira u tragovima.
English: Similarily, administration of fosamprenavir with ritonavir may modify the pharmacokinetics of other active substances that share this metabolic pathway.
Croatian: Slično tomu, primjena fosamprenavira s ritonavirom može modificirati farmakokinetiku drugih djelatnih tvari koje dijele taj metabolički put.
English: Antiviral activity according to genotypic/phenotypic resistance
Croatian: Antivirusna aktivnost prema genotipskoj/fenotipskoj rezistenciji
English: Not recommended.
Croatian: Ne preporučuje se.
English: Phenobarbital Carbamazepine
Croatian: Fenobarbital Karbamazepin
English: Slowly push the plunger in, allowing time to swallow.
Croatian: Polako pritisnite klip, dajte si dovoljno vremena da progutate lijek.
English: In the Time to loss of virological response (TLOVR) analysis for the ITT(E) population, the proportion of patients achieving <400 copies/ml was 73 % (315 / 434) in the fosamprenavir with ritonavir group compared to 71 % (317 / 444) of patients receiving lopinavir / ritonavir, with a 95 % confidence interval of the difference of [-4,84%; 7;05%].
Croatian: Time to loss of virological response (TLOVR)) za ITT(E) populaciju, udio bolesnika koji su dostigli <400 kopija/ml bio je 73 % (315 / 434) u skupini koja je primala fosamprenavir ritonavir, a 71 % (317 / 444) u skupini koja je primala lopinavir/ritonavir, s 95% intervalom pouzdanosti razlike [-4,84%; 7;05%].
English: No studies on the effects of Telzir in combination with ritonavir on the ability to drive and use machines have been performed.
Croatian: Nisu se provodila ispitivanja o učincima kombinacije lijeka Telzir s ritonavirom na sposobnost upravljanja vozilima i rada sa strojevima.
English: Most patients with mild or moderate rash can continue Telzir.
Croatian: Većina bolesnika s blagim do umjerenim osipom može nastaviti primjenjivati Telzir.
English: The principal route of amprenavir and ritonavir elimination is hepatic metabolism.
Croatian: Glavni put eliminacije amprenavira i ritonavira je putem metabolizma jetre.
English: Telzir is also available as a liquid (oral suspension) for people who are unable to swallow tablets.
Croatian: Telzir je također dostupan i u obliku tekućine (oralna suspenzija) za osobe koje ne mogu progutati tablete.
English: Patients should be advised that treatment with Telzir, or any other current antiretroviral therapy, does not cure HIV and that they may still develop opportunistic infections and other complications of HIV infection.
Croatian: Bolesnici trebaju biti obaviješteni da liječenje lijekom Telzir, ili bilo koja druga antiretrovirusna terapija, ne liječi HIV te se kod njih i dalje mogu razviti oportunističke infekcije i druge komplikacije
English: Telzir can make you feel dizzy and have other side effects that make you less alert.
Croatian: Od lijeka Telzir možete osjećati omaglicu ili neku drugu nuspojavu zbog koje možete postati manje oprezni.
English: Concomitant administration of fosamprenavir /ritonavir with lurasidone is contraindicated due to the potential for serious and/or life-threatening reactions related to lurasidone (see section 4.3)
Croatian: Istodobna primjena fosamprenavira/ritonavira s lurasidonom je kontraindicirana jer postoji potencijal za ozbiljne i/ili po život opasne reakcije povezane s lurasidonom (vidjeti dio 4.3).
English: Rash (see text below “rash/cutaneous reactions”)
Croatian: Osip (vidjeti u nastavku “osip/kožne reakcije”)
English: (Telzir 1400 mg twice daily)
Croatian: (Telzir 1400 mg 2 puta dnevno)
English: Patients with pre-existing liver dysfunction, including chronic active hepatitis, have an increased frequency of liver function abnormalities during combination antiretroviral therapy and should be monitored according to standard practice.
Croatian: Bolesnici s postojećom disfunkcijom jetre, uključujući kronični aktivni hepatitis, tijekom kombinirane antiretrovirusne terapije imaju učestalije abnormalnosti jetrene funkcije te ih se mora pratiti sukladno uobičajenoj praksi.
English: The most frequently (> 5% of adult subjects treated) reported adverse reactions with fosamprenavir/ritonavir combination were gastrointestinal reactions (nausea, diarrhoea, abdominal pain and vomiting) and headache.
Croatian: Najučestalije (>5% liječenih odraslih ispitanika) prijavljene nuspojave s kombinacijom fosamprenavira/ritonavira bile su gastrointestinalne reakcije (mučnina, proljev, bol u abdomenu i povraćanje) i glavobolja.
English: Fosamprenavir with ritonavir was generally well-tolerated in subjects with mild, moderate, or severe hepatic impairment, and these regimens had similar adverse event and clinical laboratory profiles as previous studies of HIV-1 infected subjects with normal hepatic function.
Croatian: Kombinacija fosamprenavira s ritonavirom općenito je bila dobro podnošljiva kod ispitanika s blagim, umjerenom ili teškim oštećenjem jetre, a navedeni režimi doziranja imali su slične profile nuspojava kao i kliničke laboratorijske profile, poput onih u ranijim ispitivanjima na ispitanicima s normalnom funkcijom jetre inficiranih s HIV-1.
English: Co-administration of paritaprevir and fosamprenavir/ritonavir (FPV/RTV) is contraindicated due to the expected increase of paritaprevir exposure and the lack of clinical data assessing the magnitude of this increase (see section 4.5).
Croatian: Istodobna primjena paritaprevira i fosamprenavira/ritonavira (FPV/RTV) kontraindicirana je zbog očekivanog povećanja izloženosti paritapreviru i nedostatka kliničkih podataka na temelju kojih bi se ocijenila veličina tog povećanja (vidjeti dio 4.5).
English: Methyl parahydroxybenzoate (E218) 1.5 mg/ml Propyl parahydroxybenzoate (E216) 0.2 mg/ml
Croatian: Metilparahidroksibenzoat (E218) 1,5 mg/ml Propilparahidroksibenzoat (E216) 0,2 mg/ml
English: Ritonavir AUC12 ↓ 0.66 Ritonavir Cmax ↓ 0.61 Ritonavir C12 ↔ 0.86
Croatian: Ritonavir AUC12 ↓ 0,66 Ritonavir Cmax ↓ 0,61
English: HDPE bottle with a child resistant polypropylene closure containing 225 millilitres oral suspension.
Croatian: HDPE boca s polipropilenskim sigurnosnim zatvaračem za djecu koja sadrži 225 mililitara oralne suspenzije.
English: No data are available on the co-administration of fosamprenavir and ritonavir with oestrogens and/or progestogens when used as hormonal replacement therapies.
Croatian: Nema dostupnih podataka o istodobnoj primjeni fosamprenavira i ritonavira s estrogenima i/ili progestogenima koji se primjenjuju kao hormonalna nadomjesna terapija.
English: Dosing recommendations for Telzir with ritonavir Age
Croatian: Preporuke za doziranje lijeka Telzir s ritonavirom
English: (Increase in gastric pH)
Croatian: (Povećanje pH u želudcu)
English: The apparent volume of distribution of amprenavir following administration of Telzir is approximately 430 l (6 l/kg assuming a 70 kg body weight), suggesting a large volume of distribution, with penetration of amprenavir freely into tissues beyond the systemic circulation.
Croatian: Očiti volumen distribucije amprenavira nakon primjene lijeka Telzir je oko 430 l (6 l/kg uz pretpostavku tjelesne težine od 70 kg) što upućuje na velik volumen distribucije, sa slobodnim prodiranjem amprenavira u tkiva izvan sistemske cirkulacije.
English: How to take Telzir
Croatian: Kako uzimati Telzir
English: Telzir is to be taken in combination with low doses of ritonavir and other antiretroviral medicines.
Croatian: Telzir se treba uzimati u kombinaciji s niskim dozama ritonavira i drugim antiretrovirusnim lijekovima.
English: • lopinavir/ritonavir combination (used to treat HIV infection)
Croatian: • kombinacija lopinavira/ritonavira (koristi se za liječenje HIV infekcije)
English: • carbamazepine, phenobarbital, phenytoin (used to treat epilepsy)
Croatian: • karbamazepin, fenobarbital, fenitoin (koriste se za liječenje epilepsije)
English: (Telzir 1400 mg single dose)
Croatian: (Telzir 1400 mg u jednoj dozi)
English: Interaction studies have only been performed in adults.
Croatian: Ispitivanja interakcija lijekova provodila su se samo kod odraslih osoba.
English: Clinical experience
Croatian: KLINIČKI PODACI
English: Additionally, both amprenavir, the active metabolite of fosamprenavir, and ritonavir are primarily metabolised in the liver by CYP3A4.
Croatian: Uz to, amprenavir, aktivni metabolit fosamprenavira, i ritonavir primarno se metaboliziraju u jetri putem CYP3A4.
English: 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.
Croatian: 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.
English: The Telzir oral suspension contains propyl and methyl parahydroxybenzoate.
Croatian: Telzir oralna suspenzija sadrži propil i metil parahidroksibenzoat.
English: →Talk to your doctor or pharmacist.
Croatian: →Obavijestite svog liječnika ili ljekarnika.
English: No dose separation or dosage adjustment necessary (see Antacids).
Croatian: Nije potrebno odvajati doze ili ih prilagođavati (vidjeti dio
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 12 July 2004
Croatian: Datum prvog odobrenja: 12. srpnja 2004.
English: 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.
Croatian: 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.
English: It is recommended that phenytoin plasma concentrations be monitored and phenytoin dose increased as appropriate.
Croatian: Preporučuje se praćenje koncentracije fenitoina u plazmi i sukladno tome povećanje doze fenitoina.
English: • doses of rifabutin greater than 150 mg every other day (an antibiotic)
Croatian: • doze rifabutina veće od 150 mg svaki drugi dan (antibiotik) • lidokain primijenjen injekcijom
English: You will be monitored while you are taking Telzir.
Croatian: Pratit će se Vaše stanje tijekom uzimanja lijeka Telzir.
English: Treatment-emergent major or APV-associated protease mutations were observed in virus isolated from 2 patients.
Croatian: Značajne mutacije proteaze uzrokovane liječenjem ili povezane s amprenavirom (APV) primijećene su u virusu izoliranom u 2 bolesnika.
English: The increase of 25-Odesacetylrifabutin (active metabolite) could potentially lead to an increase of rifabutin related adverse events, notably uveitis.
Croatian: desacetilrifabutina (aktivnog metabolita) potencijalno može dovesti do povećanja nuspojava vezanih za rifabutin, posebice uveitis.
English: INFECTION Antibacterials:
Croatian: Antibakterijski lijekovi:
English: 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.
Croatian: 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.
English: When these people start treatment, they may find that old, hidden infections flare up, causing signs and symptoms of inflammation.
Croatian: može se dogoditi da je došlo do ponovne aktivacije starijih, do tada skrivenih infekcija koje se mogu razbuktati i uzrokovati znakove i simptome upale.
English: The frequency of this is unknown (see section 4.4).
Croatian: Učestalost te pojave nije poznata (vidjeti dio 4.4).
English: You need to keep taking it every day to stop your illness getting worse.
Croatian: Kako bi spriječili pogoršanje svoje bolesti, morate ga uzimati svakoga dana.
English: 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.
Croatian: 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.
English: 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.
Croatian: Primarni put eliminacije amprenavira je kroz metabolizam jetre s izlučivanjem manje od 1 % nepromijenjene tvari u urin, bez detektabilnih količina amprenavira u fecesu.
English: 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.
Croatian: Treba razmotriti smanjenje doze glukokortikoida s pažljivim praćenjem lokalnih i sistemskih učinaka ili prebaciti bolesnika na terapiju glukokortikoidom koji nije supstrat za CYP3A4 (npr.
English: Liver disease
Croatian: Bolesti jetre
English: In rats, there was no major effect on fertillty or reproductive performance with fosamprenavir (see section 5.3).
Croatian: Fosamprenavir nije imao značajnog učinka na plodnost ni reproduktivnu sposobnost štakora (vidjeti dio 5.3).
English: Amprenavir is primarily metabolised by the liver with less than 1 % excreted unchanged in the urine.
Croatian: Amprenavir se primarno metabolizira u jetri s izlučivanjem manje od 1% nepromijenjene tvari putem urina.
English: 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.
Croatian: 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.
English: Telzir must only be given with low dose ritonavir as a pharmacokinetic enhancer of amprenavir and in combination with other antiretroviral medicinal products.
Croatian: Telzir se mora primjenjivati samo s niskom dozom ritonavira koja služi kao farmakokinetički pojačivač amprenavira i u kombinaciji s drugim antiretrovirusnim lijekovima.
English: Glaxo Operations UK Ltd (trading as GlaxoWellcome Operations), Harmire Road, Barnard Castle, Co. Durham DL12 8DT, United Kingdom or
Croatian: Glaxo Operations UK Ltd (posluje kao GlaxoWellcome Operations), Harmire Road, Barnard Castle, Co.
English: 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.
Croatian: 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.
English: Loose stools, nausea, vomiting, abdominal pain
Croatian: Meka stolica, mučnina, povraćanje, bolovi u abdomenu
English: Push the plastic adapter into the neck of the bottle, while holding the bottle firmly.
Croatian: Držeći čvrsto bocu, u grlo boce gurnite plastični nastavak.
English: Ritonavir also inhibits CYP2D6 but to a lesser extent than CYP3A4.
Croatian: Ritonavir također inhibira i CYP2D6, ali u manjoj mjeri od CYP3A4.
English: Amprenavir in addition is also an inhibitor of the CYP3A4 enzyme, although to a lesser extent than ritonavir.
Croatian: Amprenavir je k tome također inhibitor enzima CYP3A4, iako u manjoj mjeri od ritonavira.
English: 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
Croatian: 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).
English: (see section 4.3)
Croatian: (vidjeti dio 4.5).
English: 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.
Croatian: Bolesnici s kroničnim hepatitisom B ili C, a koji su liječeni kombiniranom antiretrovirusnom terapijom, su pod povećanim rizikom za teške i potencijalno smrtonosne nuspojave.
English: Treatment-emergent major protease or APV-associated mutations were observed in virus isolated from 1 patient in APV29005 and 6 patients from APV20003.
Croatian: 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.
English: Children and adolescents should take the Telzir oral suspension with food.
Croatian: Djeca i adolescenti bi trebali oralnu suspenziju lijeka Telzir uzimati s hranom.
English: No dose adjustment is considered necessary in patients with renal impairment (see section 5.2).
Croatian: Nije potrebna prilagodba doze kod bolesnika s oštećenjem bubrega (vidjeti dio 5.2).
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 these events can occur many months after initiation of treatment (see section 4.4).
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 ti događaji mogu javiti i mjesecima nakon uvođenja liječenja (vidjeti dio 4.4).
English: Use with caution (see section 4.4).
Croatian: Primijeniti uz mjere opreza (vidjeti dio 4.4).
English: These medicines are not recommended with Telzir/ritonavir:
Croatian: Ne preporučuje se korištenje sljedećih lijekova s lijekom Telzir/ritonavirom:
English: 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.
Croatian: 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.
English: Step by step instructions Do not mix Telzir with any other medicines in the bottle or the syringe.
Croatian: Telzir nemojte miješati s drugim lijekovima koristeći bocu ili štrcaljku.
English: 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.
Croatian: 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).
English: What Telzir looks like and contents of the pack Telzir is supplied in plastic bottles containing 60 film-coated tablets.
Croatian: Telzir je pakiran u plastične boce koje sadrže 60 filmom obloženih tableta.
English: Significant reductions in amprenavir Cmin observed may result in virological failure in patients.
Croatian: Uočena značajna smanjenja Cmin amprenavira kod bolesnika mogu dovesti do njegovog neuspješnog virološkog djelovanja.
English: 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.
Croatian: 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.
English: Yet, Telzir should be used with caution in patients with a known sulphonamide allergy.
Croatian: Potreban je daljnji oprez pri primjeni lijeka Telzir kod bolesnika s poznatom alergijom na sulfonamide.
English: Examples of antineoplastic agents: dasatinib nilotinib ibrutinib vinblastine everolimus
Croatian: dasatinib nilotinib ibrutinib vinblastin everolimus
English: 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.
Croatian: 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.
English: Concentrations of AAG have been shown to decrease during the course of antiretroviral therapy.
Croatian: Pokazano je da se tijekom terapije antiretrovirusnim lijekovima koncentracije AAG-a smanjuju.
English: 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.
Croatian: 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.
English: 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.
Croatian: 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.