FrancophonIA/ELRC3.0 huggingface dataset:
English: Halofantrine Pentamidine Sparfloxacin (saquinavir/ritonavir)
Croatian: - Halofantrin Pentamidin Sparfloksacin (sakvinavir/ritonavir)
English: Flurazepam (saquinavir/ritonavir)
Croatian: Flurazepam (sakvinavir/ritonavir)
English: Efavirenz 600 mg qd (saquinavir/ritonavir 1600/200 mg qd, or saquinavir/ritonavir 1000/100 mg bid, or saquinavir/ritonavir 1200/100 mg qd)
Croatian: Efavirenz 600 mg jedanput na dan (sakvinavir/ritonavir 1600/200 mg jedanput na dan, ili sakvinavir/ritonavir 1000/100 mg dvaput na dan, ili sakvinavir/ritonavir 1200/100 mg jedanput na dan)
English: • Contact your doctor immediately, if you get palpitations or an irregular heart beat during treatment.
Croatian: • Osjetite li tijekom liječenja palpitacije ili nepravilno kucanje srca, odmah se javite svom liječniku.
English: 6.4 Special precautions for storage This medicinal product does not require any special storage conditions.
Croatian: Lijek ne zahtijeva posebne uvjete čuvanja.
English: In the MaxCmin2 study, the safety and efficacy of saquinavir soft capsules/ritonavir 1000/100 mg twice daily plus 2 NRTIs/NNRTIs was compared with lopinavir/ritonavir 400/100 mg twice daily plus 2 NRTIs/NNRTIs in 324 (both protease inhibitor treatment naïve and experienced) subjects.
Croatian: U ispitivanju MaxCmin2 uspoređena je sigurnost i djelotvornost mekih kapsula sakvinavira/ritonavira u dozi od 1000/100 mg dvaput na dan uz dva NRTI-ja/NNRTI-ja s lopinavirom/ritonavirom u dozi od 400/100 mg dvaput na dan uz dva NRTI-ja/NNRTI-ja u 324 ispitanika (neliječenih i liječenih inhibitorom proteaze).
English: Others
Croatian: Drugo
English: Monitoring of neutropenia and liver enzyme levels is recommended due to an expected increase in exposure to rifabutin.
Croatian: Budući da se očekuje povećana izloženost rifabutinu, preporučuje se praćenje zbog mogućega razvoja neutropenije te nadzor razina jetrenih enzima.
English: The pharmacokinetics, safety and activity of saquinavir have been evaluated in an open label, multicenter study in 18 children aged 4 months to less than 6 years old in which saquinavir (50 mg/kg bid up to the adult dose of 1000 mg bid) was administered in combination with ritonavir oral solution (3 mg/kg bid for body weight from 5 to <15 kg, 2.5 mg/kg bid for body weight from 15 to 40 kg and
Croatian: Farmakokinetika, sigurnost i aktivnost sakvinavira ispitani su u otvorenom, multicentričnom ispitivanju provedenom na 18 djece u dobi od četiri mjeseca do manje od šest godina, kojima se sakvinavir (50 mg/kg dvaput na dan do doze za odrasle od 1000 mg dvaput na dan) davao u kombinaciji s oralnom otopinom ritonavira (3 mg/kg dvaput na dan za tjelesnu težinu od 5 do < 15 kg, 2,5 mg/kg dvaput na dan za tjelesnu težinu od 15 do 40 kg i 100 mg dvaput na dan za tjelesnu težinu >40 kg) i još ≥ 2 antiretrovirusna lijeka u osnovnoj terapiji.
English: Effect of food: In a cross-over study in 22 HIV-infected patients treated with Invirase/ritonavir 1000 mg/100 mg twice daily and receiving three consecutive doses under fasting conditions or after a high-fat, high-calorie meal (46 g fat, 1,091 Kcal), the AUC0-12, Cmax and Ctrough values of saquinavir under fasting conditions were about 70 per cent lower than with a high-fat meal.
Croatian: Utjecaj hrane: u ukriženom su ispitivanju 22 bolesnika zaražena HIV-om liječena lijekovima Invirase/ritonavir u dozi od 1000 mg/100 mg dvaput na dan te su primili tri uzastopne doze natašte ili nakon visokokaloričnog obroka s visokim udjelom masnoća (46 g masti, 1091 kcal).
English: One film-coated tablet of Invirase contains 500 mg of saquinavir as saquinavir mesilate.
Croatian: Jedna Invirase filmom obložena tableta sadrži 500 mg sakvinavira u obliku sakvinavirmesilata.
English: Invirase/ritonavir is contraindicated in patients with decompensated hepatic impairment (see sections 4.3 and 4.4).
Croatian: Invirase/ritonavir su kontraindicirani u bolesnika s dekompenziranim oštećenjem jetrene funkcije (vidjeti dijelove 4.3 i 4.4).
English: Alternative or additional contraceptive measures should be used when oestrogen-based oral contraceptives are co-administered (see section 4.4).
Croatian: Kad se istodobno primjenjuju estrogenski oralni kontraceptivi, moraju se koristiti alternativne ili dodatne metode kontracepcije (vidjeti dio 4.4).
English: Limited data is available from two clinical studies where the safety of saquinavir soft capsule (1000 mg twice daily) used in combination with low dose ritonavir (100 mg twice daily) for at least 48 weeks was studied in 311 patients.
Croatian: Dostupni su malobrojni podaci iz dvaju kliničkih ispitivanja u kojima je na uzorku od 311 bolesnika ispitivana sigurnost primjene meke kapsule sakvinavira (1000 mg dvaput na dan) u kombinaciji s niskom dozom ritonavira (100 mg dvaput na dan) tijekom najmanje 48 tjedana.
English: There have been reports of increased bleeding, including spontaneous skin haematomas and haemarthroses, in haemophilic patients type A and B treated with protease inhibitors (see section 4.4).
Croatian: A i B liječenima inhibitorima proteaze prijavljeno je pojačano krvarenje, uključujući spontane kožne hematome i hemartrozu (vidjeti dio 4.4).
English: In a mass balance study using 600 mg 14C-saquinavir (n = 8), 88 % and 1 % of the orally administered radioactivity, was recovered in faeces and urine, respectively, within 4 days of dosing.
Croatian: C-sakvinavira (n = 8), 88% peroralno primijenjene radioaktivnosti ponovno je detektirano u fecesu, a 1% u urinu u roku od četiri dana nakon doziranja.
English: Benzodiazepines Midazolam 7.5 mg single dose (oral) (saquinavir/ritonavir 1000/100 mg bid)
Croatian: Benzodiazepini Midazolam 7,5 mg jednokratna doza (peroralno) (sakvinavir/ritonavir 1000/100 mg dvaput na dan)
English: Saquinavir ↔
Croatian: Sakvinavir ↔
English: The following adverse events with an at least possible relationship to ritonavir boosted saquinavir (i.e. adverse reactions) were reported most frequently: nausea, diarrhoea, fatigue, vomiting, flatulence, and abdominal pain.
Croatian: Najčešće prijavljeni neželjeni događaji koji se mogu povezati s primjenom sakvinavira pojačanog ritonavirom (tj. nuspojave) su: mučnina, proljev, umor, povraćanje, flatulencija i bol u abdomenu.
English: Clarithromycin is a CYP3A4 substrate and is associated with QT prolongation.
Croatian: Klaritromicin je supstrat CYP3A4 i povezuje se s produljenjem QT intervala.
English: - For treatment-naïve patients initiating treatment with Invirase/ritonavir 500/100 mg two times daily for the first 7 days of treatment followed by Invirase 1000 mg two times daily with ritonavir 100 mg two times daily after 7 days and with a baseline QT interval < 450 msec, an on-treatment ECG is suggested after approximately 10 days of therapy.
Croatian: - U prethodno neliječenih bolesnika koji započinju liječenje lijekovima Invirase/ritonavir u dozi od 500/100 mg dvaput na dan tijekom prvih 7 dana liječenja, a nakon toga prelaze na dozu lijeka Invirase od 1000 mg dvaput na dan uz 100 mg ritonavira dvaput na dan, i u kojih je početni QT-interval < 450 ms, preporučuje se napraviti EKG tijekom liječenja nakon približno 10 dana terapije.
English: ΔQTcFdense ms (SD)
Croatian: Srednji maksimalni ΔQTcFdense ms (SD)
English: Anaemia, decreased haemoglobin, decreased lymphocyte count, decreased white blood cell count
Croatian: Poremećaji krvi i limfnog sustava vrlo često smanjen broj trombocita često anemija, snižene vrijednosti hemoglobina, smanjen broj limfocita, smanjen broj bijelih krvnih stanica manje često neutropenija
English: However, dizziness, fatigue and visual impairment have been reported during treatment with Invirase.
Croatian: Međutim, tijekom liječenja lijekom Invirase prijavljeni su omaglica, umor i vidne smetnje.
English: Saquinavir is essentially completely metabolised by CYP3A4.
Croatian: Sakvinavir se u osnovi potpuno metabolizira putem izoenzima CYP3A4.
English: Pimozide is a CYP3A4 substrate and is associated with QT prolongation,
Croatian: Pimozid je supstrat CYP3A4 i povezuje se s produljenjem QT intervala.
English: Fluvastatin (saquinavir/ritonavir)
Croatian: Fluvastatin (sakvinavir/ritonavir)
English: Vomiting, abdominal distension, abdominal pain, upper abdominal pain, constipation, dry mouth, dyspepsia, eructation, flatulence, lip dry, loose stools
Croatian: Poremećaji probavnog sustava vrlo često proljev, mučnina često povraćanje, abdominalna distenzija, bol u abdomenu, bol u gornjem dijelu abdomena, konstipacija, suha usta, dispepsija, podrigivanje, flatulencija, suhe usne, mekana stolica manje često pankreatitis
English: Dexamethasone induces CYP3A4 and may decrease saquinavir concentrations.
Croatian: - Deksametazon inducira aktivnost CYP3A4 te može sniziti koncentracije sakvinavira.
English: Increased alanine aminotransferase, increased aspartate aminotransferase, increased low density lipoprotein
Croatian: Poremećaji jetre i žuči vrlo često povišene vrijednosti alanin aminotransferaze, povišene vrijednosti aspartat aminotransferaze, povišene vrijednosti lipoproteina niske gustoće često povišene vrijednosti bilirubina u krvi, povišene vrijednosti amilaze u krvi manje često hepatitis, žutica
English: Close monitoring of safety (including signs of cardiac arrhythmia) and of virologic response is recommended due to increased variability of the exposure in this population (see sections 4.2 and 5.2).
Croatian: Zbog veće varijabilnosti izloženosti u ovoj populaciji bolesnika, preporučuje se poman nadzor sigurnosti primjene (uključujući znakove srčane aritmije) i virološkog odgovora (vidjeti dijelove 4.2 i 5.2).
English: NAME OF THE MEDICINAL PRODUCT INVIRASE 500 mg film-coated tablets.
Croatian: NAZIV LIJEKA INVIRASE 500 mg filmom obložene tablete
English: Glycerol triacetate, Iron oxide yellow and red (E172).
Croatian: Ovojnica tablete: hipromeloza, titanijev dioksid (E171), talk, glicerol triacetat, željezov oksid žuti i crveni (E172).
English: Tablet core:
Croatian: Oštećenje jetrene funkcije:
English: HIV fusion inhibitor Enfuvirtide (saquinavir/ritonavir 1000/100 mg bid)
Croatian: Inhibitor fuzije HIV-a Enfuvirtid (sakvinavir/ritonavir 1000/100 mg dvaput na dan)
English: (90 % CI 44-131 %) Saquinavir Cmax ↑ 75% (90 % CI 38-123 %) Ritonavir ↔
Croatian: Sakvinavir AUC ↑ 82% (90% CI 44-131%) Sakvinavir Cmax ↑ 75% (90% CI 38-123%) Ritonavir ↔
English: Erythromycin 250 mg qid (unboosted saquinavir 1200 mg tid)
Croatian: - Eritromicin 250 mg četiri puta na dan (nepojačani sakvinavir 1200 mg triput na dan)
English: • a history of an irregular heart beat (arrhythmias)
Croatian: • ako imate nepravilne otkucaje srca (aritmije) u povijesti bolesti
English: Concomitant use of alfuzosin and saquinavir/ritonavir is expected to increase plasma levels of alfuzosin.
Croatian: Očekuje se da će istodobna primjena alfuzozina i sakvinavira/ritonavira povećati koncentracije alfuzozina u plazmi.
English: In this study, PR interval of > 200 msec was also observed in 40% and 47% of subjects receiving Invirase/ritonavir 1000/100 mg twice daily and 1500/100 mg twice daily, respectively, on Day 3.
Croatian: U ovom je ispitivanju trećeg dana opažen i PR-interval > 200 ms u 40% ispitanika koji su primali lijekove Invirase/ritonavir u dozi od 1000/100 mg dvaput na dan te u 47% ispitanika koji su te lijekove primali u dozi od 1500/100 mg dvaput na dan.
English: The maximum mean PR interval changes relative to the pre-dose baseline value were 25 msec and 34 msec in the two ritonavir-boosted Invirase treatment groups, 1000/100 mg twice daily and 1500/100 mg twice daily, respectively (also see section 4.4).
Croatian: Najveće prosječne promjene PR-intervala u odnosu na početne vrijednosti prije prve doze iznosile su 25 ms u skupini koja je primala Invirase uz potpornu terapiju ritonavirom u dozi od 1000/100 mg dvaput na dan, a 34 ms u skupini koja je primala Invirase uz potpornu terapiju ritonavirom u dozi od 1500/100 mg dvaput na dan (vidjeti i dio 4.4).
English: Close monitoring of safety (including signs of cardiac arrhythmia) and of virologic response is recommended due to increased variability of the exposure in this population (see sections 4.2 and 4.4).
Croatian: Zbog veće varijabilnosti izloženosti u ovoj populaciji bolesnika preporučuje se poman nadzor sigurnosti primjene (uključujući znakove srčane aritmije) i virološkog odgovora (vidjeti dijelove 4.2 i 4.4).
English: Male
Croatian: Muškarci
English: Respiratory, thoracic and mediastinal disorders Common
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja često dispneja
English: Dose-dependent prolongations of QT and PR intervals have been observed in healthy volunteers receiving ritonavir-boosted Invirase (see section 5.1).
Croatian: U zdravih dobrovoljaca koji su primali Invirase pojačan ritonavirom, opažena su o dozi ovisna produljenja QT i PR-intervala (vidjeti dio 5.1).
English: In an additional four subjects administered 10.5 mg 14C-saquinavir intravenously, 81 % and 3 % of the intravenously administered radioactivity was recovered in faeces and urine, respectively, within 4 days of dosing.
Croatian: C-sakvinavira, 81% intravenski primijenjene radioaktivnosti ponovno je detektirano u fecesu, a 3% u urinu u roku od četiri dana nakon primjene.
English: However, so far the available data are insufficient and do not identify specific risks for the unborn child. Saquinavir should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus (see section 5.3).
Croatian: Sakvinavir se tijekom trudnoće smije koristiti samo ako moguća korist liječenja opravdava mogući rizik za fetus (vidjeti dio 5.3).
English: However, patients with severe renal impairment have not been studied and caution should be exercised when prescribing saquinavir/ritonavir in this population.
Croatian: No, kako nisu provedena klinička ispitivanja u bolesnika s teškim oštećenjem bubrežne funkcije, sakvinavir/ritonavir u toj populaciji treba primjenjivati uz oprez.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Croatian: Lijek se izdaje na ograničeni recept (vidjeti Prilog I.: Sažetak opisa svojstava lijeka, dio 4.2)
English: Co-administration of fusidic acid and Invirase/ritonavir can cause increased plasma concentration of both fusidic acid and saquinavir/ritonavir.
Croatian: Istodobna primjena fusidatne kiseline i lijekova Invirase/ritonavir može povećati koncentracije fusidatne kiseline i sakvinavira/ritonavira u plazmi
English: Erythromycin is a CYP3A4 substrate and is associated with QT prolongation.
Croatian: Eritromicin je supstrat CYP3A4 i povezuje se s produljenjem QT intervala.
English: Co-administration of Invirase/ritonavir with orally administered midazolam is contraindicated (see section 4.3).
Croatian: Istodobna primjena lijekova Invirase/ritonavir s peroralno primijenjenim midazolamom je kontraindicirana (vidjeti dio 4.3).
English: Roche Pharma AG Emil-Barell-Str. 1, 79639 Grenzach-Wyhlen, Germany.
Croatian: Roche Pharma AG Emil-Barell-Strasse 1 79639 Grenzach-Wyhlen Njemačka
English: Note: QTcS in this study was QT/RR0.319 for males and QT/RR0.337 for females, which are similar to Fridericia's correction (QTcF=QT/RR0.333).
Croatian: Napomena: u ovom je ispitivanju QTcS za muškarce bio QT/RR
English: • certain heart medicines - amiodarone, bepridil, disopyramide, dofetilide, flecainide,
Croatian: • nekih lijekove za liječenje srčanih bolesti - amiodarona, bepridila, dizopiramida, dofetilida,
English: Caution should be exercised in patients with severe renal impairment (see section 4.4).
Croatian: U bolesnika s teškim oštećenjem bubrežne funkcije potreban je oprez (vidjeti dio 4.4).
English: (90% CI 98%-167%) Rifabutin AUC0-72 ↑ 53% (90% CI 36%-73%) Rifabutin Cmax ↑ 86% (90% CI 57%-119%)
Croatian: Rifabutin djelatna komponenta* AUC0-72 ↑ 134% (90% CI 109%-162%) Rifabutin djelatna komponenta* Cmax ↑ 130% (90% CI 98%-167%) Rifabutin AUC0-72 ↑ 53% (90% CI 36%-73%) Rifabutin Cmax ↑ 86% (90% CI 57%-119%)
English: Ciclosporin Rapamycin (saquinavir/ritonavir)
Croatian: Ciklosporin Rapamicin (sakvinavir/ritonavir)
English: Concentrations of these medicinal products increase several fold when co-administered with Invirase/ritonavir.
Croatian: Koncentracije ovih lijekova višestruko se povećavaju kad se primjenjuju istodobno s lijekovima Invirase/ritonavir.
English: Clarithromycin 500 mg bid (unboosted saquinavir 1200 mg tid)
Croatian: - Klaritromicin 500 mg dvaput na dan (nepojačani sakvinavir 1200 mg triput na dan)
English: Invirase has not been tested for its effect on your ability to drive a car or operate machinery.
Croatian: Nije ispitan utjecaj lijeka Invirase na sposobnost upravljanja vozilima i rada na strojevima.
English: Other proton pump inhibitors (saquinavir/ritonavir 1000/100 mg bid)
Croatian: Ostali inhibitori protonske pumpe (sakvinavir/ritonavir 1000/100 mg dvaput na dan)
English: Narcotic analgesics Methadone 60-120 mg qd (saquinavir/ritonavir 1000/100 mg bid)
Croatian: Opijatni analgetici Metadon 60-120 mg jedanput na dan (sakvinavir/ritonavir 1000/100 mg dvaput na dan)
English: Atorvastatin is less dependent on CYP3A4 for metabolism.
Croatian: Metabolizam atorvastatina je manje ovisan o CYP3A4.
English: No dosage adjustment is necessary for patients with mild to moderate renal impairment.
Croatian: Nije potrebna prilagodba doze u bolesnika s blagim do umjerenim oštećenjem bubrežne funkcije.
English: 1000/100 mg (n=21)
Croatian: 10. dan 1000/100 mg (n=21)
English: • severe liver problems such as jaundice, hepatitis or liver failure - where your belly fills with fluid,
Croatian: • ako imate teške tegobe s jetrom, poput žutice, hepatitisa ili zatajenja jetre - kod njih dolazi do nakupljanja tekućine u trbuhu, smetenosti ili krvarenja iz vena jednjaka (cjevčice koja vodi od usta do želuca)
English: HIV protease inhibitors (PIs) Atazanavir 300 mg qd (saquinavir/ritonavir 1600/100 mg qd)
Croatian: Inhibitori HIV proteaze (PI) Atazanavir 300 mg jedanput na dan (sakvinavir/ritonavir 1600/100 mg jedanput na dan)
English: Oral contraceptives Ethinyl estradiol (saquinavir/ritonavir)
Croatian: Oralni kontraceptivi Etinilestradiol (sakvinavir/ritonavir)
English: - Nelfinavir 1250 mg bid (saquinavir/ritonavir 1000/100 mg bid)
Croatian: - Nelfinavir 1250 mg dvaput na dan (sakvinavir/ritonavir 1000/100 mg dvaput na dan)
English: Simvastatin Lovastatin (saquinavir/ritonavir)
Croatian: Simvastatin Lovastatin (sakvinavir/ritonavir)
English: These medicinal products are contraindicated for use with Invirase/ritonavir (see section 4.3).
Croatian: Istodobna primjena ovih lijekova s lijekovima Invirase/ritonavir je kontraindicirana (vidjeti dio 4.3).
English: HIV CCR5 antagonist Maraviroc 100 mg bid (saquinavir/ritonavir 1000/100 mg bid)
Croatian: Antagonisti HIV CCR5 receptora Maravirok 100 mg dvaput na dan (sakvinavir/ritonavir 1000/100 mg dvaput na dan)
English: Switching directly from a rilpivirine containing regimen to Invirase/ritonavir is contraindicated as is concomitant use due to the potential for life threatening cardiac arrhythmia (see sections 4.3 and 4.4).
Croatian: Kontraindiciran je izravan prelazak s režima koji sadrži rilpivirin na Invirase/ritonavir kao i istodobna primjena ovih lijekova zbog moguće po život opasne srčane aritmije (vidjeti dijelove 4.3 i 4.4).
English: 500/100 mg (n=21)
Croatian: 4. dan 500/100 mg (n=21)
English: Dizziness, fatigue and visual impairment have been reported during treatment with Invirase.
Croatian: Tijekom liječenja lijekom Invirase prijavljeni su omaglica, umor i vidne smetnje.
English: Concomitant use of salmeterol and saquinavir/ritonavir is expected to increase plasma levels of salmeterol.
Croatian: Očekuje se da će istodobna primjena salmeterola i sakvinavira/ritonavira povećati koncentracije salmeterola u plazmi.
English: Interaction with Invirase/ritonavir not studied
Croatian: Interakcija s lijekovima Invirase/ritonavir nije ispitivana
English: - Grapefruit juice (saquinavir/ritonavir)
Croatian: - Sok od grejpa (sakvinavir/ritonavir)
English: Fluconazole/miconazole (saquinavir/ritonavir)
Croatian: Flukonazol/mikonazol (sakvinavir/ritonavir)
English: Itraconazole (saquinavir/ritonavir)
Croatian: Itrakonazol (sakvinavir/ritonavir)
English: No dosage adjustment seems warranted for patients with moderate hepatic impairment based on limited data.
Croatian: Na temelju ograničenih podataka čini se da nije opravdana prilagodba doze u bolesnika s umjerenim oštećenjem jetrene funkcije.
English: Maprotiline
Croatian: Maprotilin
English: Interaction with Invirase/ritonavir not studied.
Croatian: Interakcija s lijekovima Invirase/ritonavir nije ispitana.
English: ΔQTcFdense ≥ 30 ms (%)
Croatian: Bolesnici s maksimalnim ΔQTcFdense ≥ 30 ms
English: Immune System Disorders Common
Croatian: Poremećaji imunološkog sustava često preosjetljivost
English: See table 1, section 4.5, for drugs known and/or having the potential to interact with saquinavir and specific recommendations.
Croatian: Za lijekove za koje se zna da ulaze i/ili koji bi mogli ulaziti u interakcije sa sakvinavirom i specifične preporuke vidjeti Tablicu 1 u dijelu 4.5.
English: (saquinavir/ritonavir)
Croatian: (sakvinavir/ritonavir)
English: Day 3 mg (n=22)
Croatian: 3. dan mg (n=22)
English: Tadalafil (saquinavir/ritonavir)
Croatian: Tadalafil (sakvinavir/ritonavir)
English: Streptogramin antibiotics (saquinavir/ritonavir)
Croatian: - Streptograminski antibiotici (sakvinavir/ritonavir)
English: Concentrations of these medicinal products may be increased when coadministered with Invirase/ritonavir.
Croatian: Koncentracije ovih lijekova mogu se povisiti kad se primjenjuju istodobno s lijekovima Invirase/ritonavir.
English: Antifungals Ketoconazole 200 mg qd (saquinavir/ritonavir 1000/100 mg bid)
Croatian: Antimikotici Ketokonazol 200 mg jedanput na dan (sakvinavir/ritonavir 1000/100 mg dvaput na dan)
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 500 mg of saquinavir as saquinavir mesilate.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna filmom obložena tableta sadrži 500 mg sakvinavira u obliku sakvinavirmesilata.
English: Anticoagulant Warfarin (saquinavir/ritonavir)
Croatian: Antikoagulansi Varfarin (sakvinavir/ritonavir)
English: Patients with haemophilia: There have been reports of increased bleeding, including spontaneous skin haematomas and haemarthroses, in haemophiliac patients type A and B treated with protease inhibitors.
Croatian: A i B liječenima inhibitorima proteaze prijavljeno je pojačano krvarenje, uključujući spontane kožne hematome i hemartrozu.
English: midazolam suggest a possible 34 fold increase in midazolam plasma levels.
Croatian: Ispitivanja drugih modulatora CYP3A i intravenski primijenjenog midazolama ukazuju na moguć porast koncentracije midazolama u plazmi za 3-4 puta.
English: 1000/100 mg bid)
Croatian: 1000/100 mg dvaput na dan)
English: NAME OF THE MEDICINAL PRODUCT Invirase 500 mg film-coated tablets Saquinavir
Croatian: Uputa o lijeku: Informacije za korisnika Invirase 500 mg filmom obložene tablete sakvinavir
English: Concentration of ethinyl estradiol may be decreased when coadministered with Invirase/ritonavir.
Croatian: Koncentracije etinilestradiola mogu se sniziti kad se primjenjuje istodobno s lijekovima Invirase/ritonavir.
English: Close monitoring of safety (including signs of cardiac arrhythmia) and of virologic response is recommended due to increased variability of the exposure in this population.
Croatian: Zbog veće varijabilnosti izloženosti u ovoj populaciji bolesnika preporučuje se poman nadzor sigurnosti primjene (uključujući znakove srčane aritmije) i virološkog odgovora.
English: mesoridazine, phenothiazines, sertindole, sultopride, thioridazine, ziprasidone
Croatian: • lijekova koji se koriste za liječenje teških psihičkih poremećaja - poput klozapina, haloperidola, mesoridazina, fenotiazina, sertindola, sultoprida, tioridazina, ziprazidona
English: Increased CPK, myalgia, myositis and rarely, rhabdomyolysis have been reported with protease inhibitors, particularly in combination with nucleoside analogues.
Croatian: Pri primjeni inhibitora proteaze, osobito u kombinaciji s analozima nukleozida, prijavljene su povišena razina kreatinin fosfokinaze, mialgija, miozitis te rijetko rabdomioliza.