FrancophonIA/ELRC3.0 huggingface dataset:
English: Carcinogenesis: There was no evidence of carcinogenic activity after the administration of saquinavir mesilate for 96 to 104 weeks to rats and mice.
Croatian: Kancerogenost: Davanje sakvinavirmesilata štakorima i miševima u razdoblju od 96 do 104 tjedna nije pružilo dokaze o kancerogenom djelovanju.
English: Invirase/ritonavir may increase ergot alkaloids exposure, and consequently, increase the potential for acute ergot toxicity.
Croatian: Invirase/ritonavir mogu povećati izloženost ergot alkaloidima te tako povećati mogućnost akutne toksičnosti ergota.
English: The clinical relevance of these preclinical results are unknown, however cardiac conduction and repolarisation abnormalities in humans have been observed with saquinavir and ritonavir combination therapy (see section 4.4 and 5.1).
Croatian: Klinički značaj tih pretkliničkih rezultata nije poznat, no pri kombiniranom liječenju sakvinavirom i ritonavirom u ljudi opaženi su poremećaji srčane provodljivosti i repolarizacije (vidjeti dio 4.4 i 5.1).
English: Terfenadine AUC ↑, associated with a prolongation of QTc intervals.
Croatian: Terfenadin AUC ↑, povezano s produljenjima QTc-intervala.
English: Table 7: Outcomes at Week 48 MaxCmin1 and MaxCmin2†
Croatian: Tablica 7: Ishodi ispitivanja MaxCmin1 i MaxCmin2 u 48. tjednu† Ishodi
English: In a small, preliminary study, hepatocellular enzyme elevations occurred in 13 % of subjects during the first several weeks of the delavirdine and saquinavir combination (6 % Grade 3 or 4).
Croatian: U malom preliminarnom ispitivanju, u prvih nekoliko tjedana primjene kombinacije delavirdina i sakvinavira povišenje vrijednosti hepatocelularnih enzima nastupilo je u 13% ispitanika (6% stupnja 3 ili 4).
English: Antiviral activity according to baseline genotype and phenotype:
Croatian: Antivirusna aktivnost prema početnom genotipu i fenotipu:
English: • herbal preparations containing St. John's wort or garlic capsules
Croatian: • biljne pripravke koji sadrže gospinu travu ili kapsule češnjaka
English: The geometric mean ratio (ratio of pharmacokinetic parameters in hepatically impaired patients to patients with normal liver function) (90% confidence interval) was 0.7 (0.3 to 1.6) for both AUC0-12 and Cmax, which suggests approximately 30% reduction in the pharmacokinetic exposure in patients with moderate hepatic impairment.
Croatian: Omjer geometrijske sredine (omjer farmakokinetičkih parametara između bolesnika s oštećenjem jetrene funkcije i bolesnika s normalnom jetrenom funkcijom) (interval pouzdanosti 90%) bio je 0,7 (0,3 do 1,6) i za AUC0-12 i za Cmax, što ukazuje na približno 30% manju farmakokinetičku izloženost u bolesnika s umjerenim oštećenjem jetrene funkcije.
English: Combination not recommended as may result in increased risk of cardiovascular adverse events associated with salmeterol, including QT prolongation, palpitations, and sinus tachycardia (see section 4,4).
Croatian: Ova se kombinacija ne preporučuje jer može povećati rizik od kardiovaskularnih nuspojava povezanih sa salmeterolom, uključujući produljenje QT-intervala, palpitacije i sinusnu tahikardiju (vidjeti dio 4.4).
English: No dose adjustment required when saquinavir/ritonavir combined with ≤ 200 mg/day ketoconazole.
Croatian: Nije potrebna prilagodba doze kad se sakvinavir/ritonavir kombiniraju s ketokonazolom u dozi ≤ 200 mg/dan.
English: Because of a potential increase of colchicine-related toxicity (neuromuscular events including rhabdomyolysis), its concomitant use with saquinavir/ritonavir is not recommended, especially in the case of renal or hepatic impairment (see section 4.4).
Croatian: Zbog moguće povećane toksičnosti povezane s kolhicinom (neuromišićni događaji, uključujući rabdomiolizu), ne preporučuje se istodobna primjena kolhicina sa sakvinavirom/ritonavirom, osobito u bolesnika s oštećenom bubrežnom ili jetrenom funkcijom (vidjeti dio 4.4)
English: Nucleoside reverse transcriptase inhibitors (NRTIs) - Zalcitabine and/or
Croatian: Nukleozidni inhibitori reverzne transkriptaze (NRTI) - Zalcitabin i/ili zidovudin
English: In combination with ritonavir, bioequivalence of Invirase hard capsules and film-coated tablets was demonstrated under fed conditions.
Croatian: U kombinaciji s ritonavirom bioekvivalencija Invirase tvrdih kapsula i filmom obloženih tableta dokazana je u uvjetima kada se lijek uzimao uz obrok.
English: Invirase 500 mg film-coated tablets are light orange to greyish or brownish orange tablets of oval shape with the marking "SQV 500" on one side and "ROCHE" on the other side.
Croatian: Invirase 500 mg filmom obložene tablete su svjetlonarančaste do sivkaste ili smećkasto-narančaste tablete ovalnog oblika, s oznakom “SQV 500” na jednoj i “ROCHE” na drugoj strani.
English: Digoxin AUC0-72 ↑ 49% Digoxin Cmax ↑ 27%
Croatian: Digoksin AUC0-72 ↑ 49% Digoksin Cmax ↑ 27% Koncentracije digoksina se vremenom mogu mijenjati.
English: If treatment with a HMG-CoA reductase inhibitor is indicated, pravastatin or fluvastatin is recommended with careful monitoring (see section
Croatian: Ako je indicirano liječenje inhibitorom HMG-KoA reduktaze, preporučuju se pravastatin ili fluvastatin uz pomno praćenje (vidjeti dio 4.5).
English: Interaction with HMG-CoA reductase inhibitors: Caution must be exercised if Invirase/ritonavir is used concurrently with atorvastatin, which is metabolised to a lesser extent by CYP3A4.
Croatian: Interakcija s inhibitorima HMG-KoA reduktaze: Nužan je oprez pri istodobnoj primjeni lijekova Invirase/ritonavir i atorvastatina, koji se u manjoj mjeri metabolizira putem CYP3A4.
English: Other less frequently reported side effects (in more than one in one thousand persons but less than one in a hundred persons) include: decreased appetite, visual disturbance, inflammation of the liver, fits, allergic reactions, blisters, sleepiness, abnormal renal function, inflammation of the pancreas, yellowing of the skin or whites of the eyes caused by liver problems and Steven's Johnson syndrome (a serious illness with blistering of the skin, eyes, mouth and genitals).
Croatian: Ostale, manje često prijavljene nuspojave (u više od jedne na tisuću, ali manje od jedne na sto osoba) uključuju: smanjen tek, vidne smetnje, upalu jetre, napadaje, alergijske reakcije, mjehuriće na koži, pospanost, poremećaj bubrežne funkcije, upalu gušterače, žutu boju kože ili bjeloočnica uzrokovanu jetrenim tegobama i Stevens-Johnsonov sindrom (ozbiljnu bolest kod koje dolazi da nastanka mjehurića na koži, očima, ustima i genitalijama).
English: For patients demonstrating a subsequent increase in QT-interval to > 480 msec or increase by > 20 msec after commencing concomitant therapy, the physician should use best clinical judgment to discontinue either ritonavir-boosted Invirase or the concomitant therapy or both.
Croatian: Bolesnicima u kojih se utvrdi naknadno produljenje QT-intervala na > 480 ms ili produljenje nakon započinjanja istodobnog liječenja za > 20 ms, liječnik mora na temelju najbolje kliničke prosudbe prekinuti ili primjenu lijeka Invirase pojačanog ritonavirom, ili istodobne terapije ili oboje.
English: • The active substance is saquinavir.
Croatian: • Djelatna tvar je sakvinavir.
English: Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterial infections, and Pneumocystis carinii pneumonia.
Croatian: Relevantni primjeri su upala rožnice izazvana citomegalovirusom, opće i/ili lokalizirane infekcije mikobakterijama i upala pluća izazvana uzročnikom Pneumocystis carinii.
English: Saquinavir AUC ↑ 177 % Saquinavir Cmax ↑ 187 % Clarithromycin AUC ↑ 40 % Clarithromycin Cmax ↑ 40 %
Croatian: - Sakvinavir AUC ↑ 177% Sakvinavir Cmax ↑ 187% Klaritromicin AUC ↑ 40% Klaritromicin Cmax ↑ 40%
English: The following adverse events were reported with the highest severity (grades 3 and 4): anaemia, diabetes mellitus, diarrhoea, nausea, vomiting and fatigue.
Croatian: Sljedeće nuspojave prijavljene su kao najteže (stupnja 3 i 4): anemija, šećerna bolest, proljev, mučnina, povraćanje i umor.
English: The safety and activity of saquinavir boosted with ritonavir in HIV-infected patients less than 2 years have not been established.
Croatian: Sigurnost i djelotvornost sakvinavira pojačanoga ritonavirom u bolesnika mlađih od 2 godine zaraženih HIV-om nisu ustanovljene.
English: Table 1: Interactions and dose recommendations with other medicinal products Medicinal product by therapeutic area (dose of
Croatian: Tablica 1: Interakcije i preporuke za doziranje s drugim lijekovima
English: Contraindicated in combination with Invirase/ritonavir due to potential increase in alfuzosin concentration which can result in hypotension and potentially life-threatening cardiac arrhythmia.
Croatian: Primjena alfuzozina u kombinaciji s lijekovima Invirase/ritonavir je kontraindicirana zbog mogućega povišenja koncentracije alfuzozina koje može uzrokovati hipotenziju i srčanu aritmiju koja može biti opasna po život..
English: Immune Reactivation Syndrome: 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: Sindrom imunološke reaktivacije: U bolesnika zaraženih HIV-om s izraženim imunološkim deficitom u trenutku uvođenja kombiniranog antiretrovirusnog liječenja (CART), može se razviti upalna reakcija na asimptomatske ili rezidualne oportunističke patogene te uzrokovati ozbiljna klinička stanja ili pogoršanje simptoma.
English: Patients with chronic hepatitis B or C and treated with antiretroviral agents are at increased risk of severe and potentially fatal liver adverse events and may require blood tests for control of liver function.
Croatian: Bolesnici s kroničnim hepatitisom B ili C koji se liječe antiretrovirusnim lijekovima izloženi su povećanom riziku za razvoj ozbiljnih jetrenih nuspojava s mogućim smrtnim ishodom te će im možda trebati provoditi krvne pretrage radi kontrole jetrene funkcije.
English: - Grapefruit juice (single dose) (unboosted saquinavir)
Croatian: - Sok od grejpa (pojedinačna doza) (nepojačani sakvinavir)
English: The metabolism of saquinavir is mediated by cytochrome P450, with the specific isoenzyme CYP3A4 responsible for 90 % of the hepatic metabolism.
Croatian: Metabolizam sakvinavira posredovan je citokromom P450, pri čemu je specifičan izoenzim CYP3A4 odgovoran za 90% metabolizma u jetri.
English: Similarly, saquinavir might also modify the pharmacokinetics of other medicinal products that are substrates for CYP3A4 or P-gp.
Croatian: Jednako tako, i sakvinavir može promijeniti farmakokinetiku drugih lijekova koji su supstrati za CYP3A4 ili P-gp.
English: Nefazodone inhibits CYP3A4.
Croatian: - Nefazodon inhibira CYP3A4.
English: Paediatric population: The safety and activity of saquinavir boosted with ritonavir in HIV-infected patients less than 2 years have not been established.
Croatian: Pedijatrijska populacija: Sigurnost i djelotvornost sakvinavira pojačanoga ritonavirom u bolesnika mlađih od 2 godine zaraženih HIV-om nisu ustanovljene.
English: No studies on the effects on the ability to drive and use machines have been performed.
Croatian: Nisu provedena ispitivanja o učincima lijeka na sposobnost upravljanja vozilima i strojevima.
English: Patients switching immediately from treatment with another protease inhibitor taken with ritonavir or from a non-nucleoside reverse transcriptase inhibitor based regimen, except rilpivirine (see section 4.5), without a wash-out period, should however initiate and continue Invirase at the standard recommended dose of 1000 mg two times daily with ritonavir 100 mg two times daily.
Croatian: Međutim, bolesnici koji prelaze na liječenje ovim lijekom neposredno nakon liječenja drugim inhibitorom proteaze i ritonavirom ili nakon režima liječenja koji se temeljio na nenukleozidnom inhibitoru reverzne transkriptaze, osim rilpivirina (vidjeti dio 4.5), bez perioda ispiranja (“wash-out”), trebaju započeti i nastaviti uzimati Invirase u standardnoj preporučenoj dozi od 1000 mg dvaput na dan uz ritonavir u dozi od 100 mg dvaput na dan.
English: Baseline saquinavir phenotype (shift in susceptibility relative to reference, PhenoSense Assay) was shown to be a predictive factor of virological outcome.
Croatian: Pokazalo se da je početni fenotip sakvinavira (pomak osjetljivosti u odnosu na referentne vrijednosti, metodom PhenoSense) pretkazatelj virološkog ishoda.
English: Also contains lactose (monohydrate) 38.5 mg, colourants (titanium dioxide E 171, iron oxide E 172) and other constituents.
Croatian: Također sadrži 38,5 mg laktoze (hidrata), bojila (titanijev dioksid E171, željezov oksid E172) i druge sastojke.
English: If a patient is already taking St. John's wort, stop St. John's wort, check viral levels and if possible saquinavir levels.
Croatian: Ako bolesnik već uzima gospinu travu, treba prestati s njezinom primjenom, provjeriti koncentraciju virusa i, po mogućnosti, koncentraciju sakvinavira.
English: The primary study variable was maximal change from dense predose baseline in QTcF (ΔQTcFdense).
Croatian: Primarna varijabla ispitivanja bila je maksimalna promjena QTcF u odnosu na prosječnu uzastopnu početnu vrijednost prije doziranja (ΔQTcFdense).
English: • certain medicines for depression - amitriptyline, imipramine, trazodone, maprotiline
Croatian: • nekih lijekova za liječenje depresije - amitriptilina, imipramina, trazodona, maprotilina
English: Also included are serious and non-serious adverse reactions from post-marketing spontaneous reports for which a causal relationship to saquinavir cannot be excluded.
Croatian: U tablici se navode i ozbiljne nuspojave te nuspojave koje nisu klasificirane kao ozbiljne, a koje su spontano prijavljene nakon stavljanja lijeka u promet i za koje se ne može isključiti uzročna povezanost s primjenom sakvinavira.
English: Continuous declines in HIV-RNA were observed in all treatment-naïve patients receiving the modified Invirase/ritonavir dosing regimen over the 2-week treatment period, suggesting HIV viral suppression during the time of the study.
Croatian: Stalna smanjenja HIV-RNK primijećena su u svih prethodno neliječenih bolesnika koji su primali modificirani režim doziranja lijekova Invirase/ritonavir tijekom 2-tjednog razdoblja liječenja, što ukazuje na virusnu supresiju za vrijeme ispitivanja.
English: • certain medicines used to treat the symptoms of Benign Prostatic Hyperplasia (an increase in size of the prostate) such as alfuzosin
Croatian: • nekih lijekova koji se koriste za liječenje simptoma benigne hiperplazije prostate (povećane prostate), poput alfuzozina
English: Mean ± SD Saquinavir (%CV) Pharmacokinetic Parameters*
Croatian: Srednja vrijednost ± standardna devijacija farmakokinetičkih parametara* sakvinavira (%CV)
English: Weight and levels of blood lipids and glucose may increase during antiretroviral therapy (see section
Croatian: Tjelesna težina i razina lipida i glukoze u krvi mogu se povećati tijekom antiretrovirusne terapije (vidjeti dio 4.4).
English: Other reported side effects (in more than one in a hundred but less than one in ten persons), which may occur are: rash, itching, eczema and dry skin, hair loss, dry mouth, headache, peripheral neuropathy (a disturbance of the nerves in the feet and hands that may take the form of numbness, pins and needles, shooting or burning pain), weakness, dizziness, libido problems, taste alteration, mouth ulcers, dry lips, abdominal discomfort, indigestion, weight loss,constipation, increased appetite, muscle spasms and shortness of breath.
Croatian: Ostale prijavljene nuspojave (u više od jedne na sto, ali manje od jedne na deset osoba) koje se mogu javiti su: osip, svrbež, ekcem i suha koža, opadanje kose, suhoća usta, glavobolja, periferna neuropatija (poremećaj u živcima stopala i šaka koji se javlja kao utrnulost, trnci i žmarci, probadajuća bol ili žarenje), slabost, omaglica, poteškoće s libidom, promjena okusa, vrijedovi u ustima, suhe usne, osjećaj nelagode u trbuhu, probavne tegobe, gubitak tjelesne težine, zatvor, pojačan tek, grčevi u mišićima i nedostatak zraka.
English: Kidney disease: Consult your doctor if you have a history of kidney disease.
Croatian: Bolest bubrega: Posavjetujte se s liječnikom ako ste imali bolest bubrega.
English: Liver disease: The safety and efficacy of saquinavir/ritonavir has not been established in patients with significant underlying liver disorders, therefore saquinavir/ritonavir should be used cautiously in this patient population.
Croatian: Bolest jetre: Sigurnost i djelotvornost kombinacije sakvinavir/ritonavir nije utvrđena u bolesnika s postojećim značajnim poremećajima jetrene funkcije te se stoga sakvinavir/ritonavir moraju primjenjivati uz oprez u ovoj populaciji bolesnika.
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: U bolesnika s postojećim oštećenjem jetrene funkcije, uključujući kronični aktivni hepatitis, su tijekom kombiniranog antiretrovirusnog liječenja učestaliji poremećaji jetrene funkcije te ih stoga treba nadzirati u skladu s uobičajenom praksom.
English: Glucocorticoids: Concomitant use of boosted saquinavir 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 4.5).
Croatian: Glukokortikoidi: Ne preporučuje se istodobna primjena sakvinavira pojačanog potpornim lijekom i flutikazona ili drugih glukokortikoida koji se metaboliziraju putem CYP3A4, osim ako potencijalna korist liječenja ne nadmašuje rizike od sustavnih učinaka kortikosteroida, uključujući Cushingov sindrom i supresiju nadbubrežnih žlijezda (vidjeti dio 4.5).
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 infkecija, nakon što započnete uzimati lijekove za liječenje HIV infekcije mogu se javiti i autoimuni poremećaji (stanja do kojih dolazi kada imunološki sustav napada zdravo tkivo u tijelu).
English: In case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant product information for these medicinal products.
Croatian: U slučaju istodobnog uzimanja antiretrovirusnih lijekova za liječenje hepatitisa B ili C, treba proučiti i sažetke opise svojstava lijeka za te lijekove.
English: Autoimmune disorders (such as Graves'disease and autoimmune hepatitis) have also been reported; 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 okolnostima imunološke reaktivacije prijavljena je i pojava autoimunih poremećaja (poput Gravesove bolesti i autoimunog hepatitisa); međutim, prijavljeno vrijeme do njihova nastupa je varijabilnije i mogu se pojaviti i više mjeseci nakon započinjanja liječenja (vidjeti dio 4.4).
English: Tacrolimus is a substrate of CYP3A4 and P-glycoprotein.
Croatian: Takrolimus je supstrat CYP3A4 i P-glikoproteina.
English: Increased plasma concentrations of quetiapine may lead to coma (see sectin 4.3).
Croatian: Povećane koncentracije kvetiapina u plazmi mogu dovesti do kome (vidjeti dio 4.3).
English: Mean ddQTcS
Croatian: Prosječna vrijednost ddQTcS
English: A limited number of studies have been completed with ritonavir boosted Invirase or ritonavir boosted saquinavir soft capsules.
Croatian: Ograničen broj ispitivanja proveden je s lijekom Invirase pojačanim ritonavirom ili s mekim kapsulama sakvinavira pojačanima ritonavirom.
English: Steady state saquinavir exposures observed in paediatric trials were substantially higher than historical data in adults where dose- and exposure-dependent QTc and PR prolongation were observed (see section 4.4).
Croatian: Izloženosti sakvinaviru u stanju dinamičke ravnoteže primijećene u ispitivanjima s pedijatrijskim bolesnicima bile su značajno više od onih na koje ukazuju podaci iz prethodnih ispitivanja u kojima je primijećeno produljenje QTc i PR-intervala ovisno o dozi i izloženosti (vidjeti dio 4.4).
English: Cardiac conduction and repolarisation abnormalities:
Croatian: Poremećaji srčane provodljivosti i repolarizacije:
English: Concomitant administration of Invirase and quetiapine is contraindicated as it may increase quetiapine-related toxicity.
Croatian: Istodobna primjena lijeka Invirase i kvetiapina je kontraindicirana jer može povećati toksičnost povezanu s kvetiapinom.
English: * Sum of rifabutin + 25-O-desacetyl rifabutin metabolite
Croatian: * Zbroj rifabutina i metabolita 25-Odesacetilrifabutina
English: Table 5: Virological response to saquinavir/ritonavir stratified by the number of baseline saquinavirassociated resistance mutations
Croatian: Tablica 5: Virološki odgovor na sakvinavir/ritonavir prema broju početnih mutacija povezanih s otpornošću na sakvinavir
English: Proportion with VL < 50 copies/ml at week 48, On Treatment
Croatian: Udio bolesnika s količinom virusa < 50 kopija/ml u 48. tjednu, na liječenju
English: • medicines for erectile dysfunction - sildenafil, vardenafil, tadalafil
Croatian: • lijekova za liječenje erekcijske disfunkcije - sildenafila, vardenafila, tadalafila
English: Oral contraceptives: Because concentration of ethinyl estradiol may be decreased when coadministered with Invirase/ritonavir, alternative or additional contraceptive measures should be used when oestrogen-based oral contraceptives are co-administered (see section 4.5).
Croatian: Oralni kontraceptivi: Budući da se koncentracije etinilestradiola mogu sniziti kad se primjenjuje istodobno s kombinacijom Invirase/ritonavir, u slučaju istodobne primjene estrogenskih oralnih kontraceptiva moraju se koristiti alternativne ili dodatne metode kontracepcije (vidjeti dio 4.5).
English: Saquinavir AUC ↓ 15% Saquinavir Cmax ↓ 9% Saquinavir Cmin ↓ 24% (remained above the target threshold for effective therapy.)
Croatian: Sakvinavir AUC ↓ 15% Sakvinavir Cmax ↓ 9% Sakvinavir Cmin ↓ 24% (ostao je iznad ciljnog praga za djelotvorno liječenje)
English: No dose recommendations for paediatric patients ≥2 years of age could be established that are both effective and below thresholds of concern for QT and PR interval prolongation.
Croatian: Nije moguće dati preporuke za doziranje u djece u dobi između ≥ 2 godine koje bi ujedno bile pouzdano djelotvorne i ispod sigurnosnoga praga za produljenje QT i PR intervala.
English: Corticosteroids - Dexamethasone
Croatian: Kortikosteroidi - Deksametazon
English: Patients with chronic hepatitis B or C and treated with combination antiretroviral therapy are at an increased risk for severe and potentially fatal hepatic adverse events.
Croatian: Bolesnici s kroničnim hepatitisom B ili C koji se liječe kombiniranom terapijom antiretrovirusnim lijekovima izloženi su povećanom riziku za razvoj ozbiljnih jetrenih nuspojava, s mogućim smrtnim ishodom.