FrancophonIA/ELRC3.0 huggingface dataset:
English: ISENTRESS is also available in a 400 mg tablet for use in adults, adolescents and children weighing at least 25 kg and able to swallow a tablet.
Croatian: ISENTRESS je dostupan i u obliku tablete od 400 mg za primjenu u odraslih, adolescenata i djece tjelesne težine najmanje 25 kg koja mogu progutati tabletu.
English: In some studies, co-administration of raltegravir 400 mg tablets twice daily with darunavir resulted in a modest but clinically insignificant decrease in darunavir plasma concentrations.
Croatian: U nekim je ispitivanjima istodobna primjena raltegravir tableta od 400 mg dvaput na dan i darunavira dovela do blagog, ali ne i klinički značajnog sniženja koncentracija darunavira u plazmi.
English: • acne; unusual hair loss or thinning; redness of skin; unusual distribution of fat on the body, this may include loss of fat from legs, arms, and face, and increase in abdomen fat; excessive sweating; night sweats; thickening and itching of the skin due to repeated scratching; skin lesion; dry skin
Croatian: • akne; neuobičajeno opadanje ili prorjeđivanje kose; crvenilo kože; promjena u raspodjeli masnog tkiva u tijelu, što može uključivati gubitak masnog tkiva na nogama, rukama i licu i nakupljanje masti na trbuhu; pojačano znojenje; noćno znojenje; zadebljanje i svrbež kože zbog učestalog češanja; oštećenja kože; suha koža
English: There are no data to guide co-administration of raltegravir with rifampicin in patients below 18 years of age (see section 4.5).
Croatian: Nema podataka na temelju kojih bi se mogle dati smjernice za istodobnu primjenu raltegravira s rifampicinom u bolesnika mlađih od 18 godina (vidjeti dio 4.5).
English: To monitor maternal-foetal outcomes in patients inadvertently administered raltegravir while pregnant, an Anti-retroviral Pregnancy Registry has been established.
Croatian: Registar trudnica koje su u trudnoći liječene antiretrovirusnim lijekovima Radi praćenja ishoda trudnoća za majku i fetus u bolesnica kojima je tijekom trudnoće nepažnjom primijenjen raltegravir uspostavljen je Registar trudnica koje su u trudnoći liječene antiretrovirusnim lijekovima.
English: • If you are allergic to raltegravir or to any of the other ingredients in this medicine (listed in section 6).
Croatian: Nemojte uzimati Isentress: • ako ste alergični na raltegravir ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: The 400 mg tablet should not be used to administer the 1,200 mg once daily regimen.
Croatian: Tableta od 400 mg ne smije se koristiti u režimu liječenja dozom od 1200 mg jedanput na dan.
English: Administration of a high fat meal resulted in a 1.9% increase in AUC0-last, 28% decrease in Cmax, and 12% decrease in C24 hr.
Croatian: Primjena obroka s vidokim udjelom masti dovela je do povećanja AUC0-last za 1,9%, smanjenja Cmax za 28% i smanjenja C24h za 12%.
English: The treatment difference (raltegravir 1,200 mg once daily-raltegravir 400 mg twice daily) was 0.5 % with an associated 95 % CI of (-4.2, 5.2) establishing that raltegravir 1,200 mg once daily is non-inferior to raltegravir 400 mg twice daily.
Croatian: Razlika između liječenja (raltegravir 1200 mg jedanput na danraltegravir 400 mg dvaput na dan) iznosila je 0,5% uz pripadajući 95%-tni CI (-4,2; 5,2), što dokazuje da raltegravir u dozi od 1200 mg jedanput na dan nije inferioran raltegraviru u dozi od 400 mg dvaput na dan.
English: • Do not use this medicine after the expiry date which is stated on the carton and sachet after
Croatian: • Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i vrećici iza oznake "EXP".
English: Randomisation was stratified by screening HIV RNA level (≤ 50,000 copies/mL; and > 50,000 copies/mL) and by hepatitis B or C status (positive or negative).
Croatian: Randomizacija je bila stratificirana probirom na temelju razine HIV-RNK (≤ 50 000 kopija/ml i > 50 000 kopija/ml) i statusa hepatitisa B ili C (pozitivan ili negativan).
English: In adults, there were no clinically important pharmacokinetic differences between patients with severe renal insufficiency and healthy subjects (see section 4.2 of the 400 mg twice daily SmPC).
Croatian: U odraslih nije bilo klinički značajne razlike u farmakokinetici lijeka između bolesnika s teškom insuficijencijom bubrega i zdravih ispitanika (vidjeti dio 4.2 u sažetku opisa svojstava lijeka za tablete od 400 mg dvaput na dan).
English: Administration of raltegravir following a high-fat meal increased AUC and Cmax by approximately 2-fold and increased C12 hr by 4.1-fold.
Croatian: Primjena raltegravira nakon obroka s visokim udjelom masti dovela je do približno dvostrukog povećanja AUC-a i Cmax, dok je C12h porastao 4,1 puta.
English: No dose adjustment required for raltegravir or tenofovir disoproxil fumarate.
Croatian: Nije potrebno prilagođavati dozu raltegravira ili tenofovirdizoproksilfumarata.
English: Non-nucleoside reverse transcriptase inhibitors (NNRTIs) efavirenz (raltegravir 400 mg Single Dose)
Croatian: Nenukleozidni inhibitori reverzne transkriptaze (NNRTI) efavirenz (raltegravir jednokratna doza od 400 mg)
English: > 200 cells/mm
Croatian: > 200 stanica/mm
English: Tap it with your finger to move any air bubbles up.
Croatian: Nježno lupnite štrcaljku prstom kako bi se mjehurići zraka, ako ih ima, podigli na vrh.
English: The length of combination anti-retroviral therapy, corticosteroid use, alcohol consumption, severe reduction of the activity of the immune system, higher body mass index, among others, may be some of the many risk factors for developing this disease.
Croatian: Neki od mnogih rizičnih čimbenika za razvoj ove bolesti mogu biti, između ostalog, trajanje liječenja kombiniranom antiretrovirusnom terapijom, uzimanje kortikosteroida, konzumiranje alkohola, ozbiljno smanjenje aktivnosti imunološkog sustava te povišen indeks tjelesne mase.
English: You can take this medicine with or without food or drink.
Croatian: Ovaj lijek možete uzimati s hranom i pićem ili bez njih.
English: Therefore, raltegravir should be used with caution in patients with severe hepatic impairment (see sections 4.2 and 5.2).
Croatian: Stoga raltegravir treba primjenjivati uz oprez u bolesnika s teškim oštećenjem funkcije jetre (vidjeti dijelove 4.2 i 5.2).
English: • lymph node pain; low count of white blood cells that fight infection; swollen glands in the neck, armpit and groin
Croatian: • bol u limfnim čvorovima, snižen broj bijelih krvnih stanica koje se bore protiv infekcije; otečene žlijezde na vratu, pazuhu i preponama
English: ONCEMRK Study
Croatian: Ispitivanje ONCEMRK
English: Uncommon immune reconstitution syndrome, drug hypersensitivity, hypersensitivity
Croatian: Poremećaji imunološkog sustava manje često sindrom imunološke rekonstitucije, preosjetljivost na lijekove, preosjetljivost
English: Table 1 Pharmacokinetic Interaction Data
Croatian: Tablica 1 Podaci o farmakokinetičkim interakcijama
English: Skin problems
Croatian: Kožne tegobe
English: Renal impairment No dosage adjustment is required for patients with renal impairment (see section 5.2).
Croatian: Nije potrebno prilagođavati dozu u bolesnika s oštećenjem funkcije bubrega (vidjeti dio 5.2).
English: Raltegravir achieved virologic responses (using Not Completer=Failure approach) of HIV RNA < 50 copies/mL in 61.7 % of patients at Week 16, in 62.1 % at Week 48 and in 57.0 % at Week 96.
Croatian: Virološki odgovor na raltegravir od < 50 HIV-RNK kopija/ml (primjena pristupa "prerani prekid = neuspjelo liječenje") postignut je u 61,7% bolesnika nakon 16 tjedana, u 62,1% bolesnika nakon 48 tjedana i u 57,0% bolesnika nakon 96 tjedana liječenja.
English: Prior to randomisation, OBT were selected by the investigator based on the patient's prior treatment history, as well as baseline genotypic and phenotypic viral resistance testing.
Croatian: Prije randomizacije ispitivač je svakom bolesniku odredio OBT na temelju prethodnog liječenja i rezultata početnih genotipskih i fenotipskih testova rezistencije virusa.
English: Uncommon hepatitis, hepatic steatosis, hepatitis alcoholic, hepatic failure
Croatian: Poremećaji jetre i žuči manje često hepatitis, hepatička steatoza, alkoholni hepatitis, zatajenje jetre
English: However, if co-administration with rifampicin is unavoidable, a doubling of the dose of raltegravir can be considered in adults.
Croatian: Međutim, ako je istodobna primjena s rifampicinom neizbježna, može se razmotriti udvostručenje doze raltegravir u odraslih.
English: What Isentress is
Croatian: Što je Isentress
English: The rates of discontinuation of raltegravir due to adverse reactions were 5% or less in clinical trials.
Croatian: U kliničkim su ispitivanjima stope prekida liječenja raltegravirom zbog nuspojava iznosile 5% ili manje.
English: The effect of severe hepatic insufficiency on the pharmacokinetics of raltegravir has not been studied (see sections 4.2 and 4.4 of the 400 mg twice daily SmPC).
Croatian: Učinak teške insuficijencije jetre na farmakokinetiku raltegravira nije ispitan (vidjeti dijelove 4.2 i 4.4 u sažetku opisa svojstava lijeka za tablete od 400 mg dvaput na dan).
English: See the instructions for use booklet for the right way to dispose of your leftover medicine.
Croatian: Pogledajte knjižicu s uputama za primjenu za informacije o pravilnom načinu zbrinjavanja preostalog lijeka.
English: • certain kinds of kidney problems
Croatian: • određene vrste bubrežnih tegoba
English: ISENTRESS 25 mg - bottle labeling
Croatian: ISENTRESS 25 mg - naljepnica boce
English: At 96-weeks, in treatment-experienced patients, Grade 2 or higher laboratory abnormalities that represent a worsening Grade from baseline of AST, ALT or total bilirubin occurred in 29 %, 34 % and 13 %, respectively, of co-infected patients treated with raltegravir as compared to 11 %, 10 % and 9 % of all other patients treated with raltegravir.
Croatian: Nakon 96 tjedana su u prethodno liječenih bolesnika odstupanja u laboratorijskim nalazima AST-a, ALT-a i ukupnog bilirubina 2. ili višeg stupnja koja su predstavljala pogoršanje u odnosu na početne vrijednosti zabilježena u 29%, 34% odnosno 13% bolesnika s istodobnom infekcijom koji su liječeni raltegravirom, u usporedbi s 11%, 10% odnosno 9% svih ostalih bolesnika koji su liječeni raltegravirom.
English: In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, titanium dioxide, polyethylene glycol 3350, talc, red iron oxide and black iron oxide.
Croatian: Osim toga, film ovojnica sadrži sljedeće pomoćne tvari: poli(vinilni alkohol), titanijev dioksid, polietilenglikol 3350, talk, crveni željezov oksid i crni željezov oksid.
English: gastric pH altering agents: proton pump inhibitors (e.g. omeprazole), H2 blockers (e.g. famotidine, ranitidine, cimitedine)
Croatian: lijekovi koji mijenjaju želučani pH: inhibitori protonske pumpe (npr. omeprazol), blokatori H2-receptora (npr. famotidin, ranitidin, cimitedin) (raltegravir 1200 mg)
English: Depression, including suicidal thoughts and behaviours, has been reported in some patients taking this medicine, particularly in patients with a prior history of depression or psychiatric illness.
Croatian: U nekih bolesnika koji su uzimali ovaj lijek prijavljena je depresija, uključujući misli o samoubojstvu i samoubilačko ponašanje, osobito u bolesnika koji su ranije imali depresiju ili psihijatrijsku bolest.
English: ISENTRESS 100 mg - bottle labeling
Croatian: ISENTRESS 100 mg - naljepnica boce
English: A moderate amount of data on pregnant women (between 300 - 1,000 pregnancy outcomes from first trimester exposure) indicate no malformative or feto/neonatal toxicity of raltegravir 400 mg film-coated tablets twice daily.
Croatian: Umjerena količina podataka o trudnicama (između 300 i 1000 ishoda trudnoće uz izloženost tijekom prvog tromjesečja) ne ukazuje na malformativnu ili feto/neonatalnu toksičnost raltegravira u obliku filmom obloženih tableta primijenjenog u dozi od 400 mg dvaput na dan.
English: Film-coating - Polyvinyl alcohol - Titanium dioxide - Polyethylene glycol 3350 - Talc - Red iron oxide - Black iron oxide
Croatian: Film ovojnica - poli(vinilni alkohol) - titanijev dioksid - polietilenglikol 3350 - talk - željezov oksid, crveni - željezov oksid, crni
English: With respect to the primary efficacy endpoint, the proportion of patients achieving HIV RNA < 50 copies/mL at Week 48 was 241/280 (86.1 %) in the group receiving raltegravir and 230/281 (81.9 %) in the group receiving efavirenz.
Croatian: Što se tiče primarnog ishoda djelotvornosti, udio bolesnika u kojih je u 48. tjednu postignuta koncentracija < 50 HIV-RNK kopija/ml iznosio je 241/280 (86,1%) u skupini koja je primala raltegravir i 230/281 (81,9%) u skupini koja je primala efavirenz.
English: Because the formulations have different pharmacokinetic profiles neither the chewable tablets nor the granules for oral suspension should be substituted for the 400 mg tablet or 600 mg tablet (see section 5.2).
Croatian: S obzirom da oblici imaju različite farmakokinetičke profile, ni tablete za žvakanje ni granule za oralnu suspenziju ne smiju se zamijeniti tabletom od 400 mg ili tabletom od 600 mg (vidjeti dio 5.2).
English: Two pack sizes are available: packs containing 1 bottle with 60 tablets, and multipacks comprising 3 bottles, each containing 60 tablets.
Croatian: Dostupne su dvije veličine pakiranja: pakiranje od 1 boce sa 60 tableta i višestruko pakiranje koje sadrži 3 boce sa po 60 tableta.
English: Give Isentress to your baby
Croatian: 12. korak: Dajte Isentress djetetu
English: EU/1/07/436/006 EU/1/07/436/007 180 film-coated tablets (3 bottles of 60)
Croatian: EU/1/07/436/006 EU/1/07/436/007 180 filmom obloženih tableta (3 boce sa 60)
English: How should I store Isentress?
Croatian: Kako trebam čuvati Isentress?
English: How Isentress works
Croatian: Kako djeluje Isentress
English: • drug ingestion in quantities greater than recommended
Croatian: • uzimanje većih količina lijeka od preporučenih.
English: • allergic rash
Croatian: • alergijski osip
English: efavirenz (raltegravir 1,200 mg single dose)
Croatian: efavirenz (raltegravir jednokratna doza od 1200 mg)
English: Because the formulations have different pharmacokinetic profiles neither the granules for oral suspension nor the chewable tablets should be substituted for the 400 mg tablet or 600 mg tablet (see section 5.2).
Croatian: S obzirom da oblici imaju različite farmakokinetičke profile, ni granule za oralnu suspenziju ni tablete za žvakanje ne smiju se zamijeniti tabletom od 400 mg ili tabletom od 600 mg (vidjeti dio 5.2).
English: atazanavir (raltegravir 1,200 mg single dose)
Croatian: atazanavir (raltegravir jednokratna doza od 1200 mg)
English: • Be sure you understand these instructions before you start.
Croatian: • Prije nego što počnete, obavezno s razumijevanjem pročitajte ove upute za primjenu.
English: Comprehensive drug interaction studies were performed with raltegravir 400 mg twice daily and a limited number of drug interaction studies were performed for raltegravir 1,200 mg once daily.
Croatian: Provedena su opsežna ispitivanja interakcija s raltegravirom u dozi od 400 mg dvaput na dan, dok je s raltegravirom u dozi od 1200 mg jedanput na dan proveden ograničen broj ispitivanja interakcija.
English: ANTIMICROBIALS Antimycobacterial rifampicin (raltegravir 400 mg Single Dose)
Croatian: ANTIMIKROBNI LIJEKOVI Antimikobakterijski lijekovi rifampicin (raltegravir jednokratna doza od 400 mg)
English: Therefore, co administration of emtricitabine/tenofovir disaproxil fumarate and raltegravir 1,200 mg once daily ispermitted.
Croatian: Stoga je dopuštena istodobna primjena emtricitabina/tenofovirdizoproksilfumarata i raltegravira u dozi od 1200 mg jedanput na dan.
English: Nucleoside/tide reverse transcriptase inhibitors tenofovir disoproxil fumarate (raltegravir 400 mg Twice Daily)
Croatian: Nukleozidni/nukleotidni inhibitori reverzne transkriptaze tenofovirdizoproksilfumarat (raltegravir 400 mg dvaput na dan)
English: If it is not mixed, swirl it some more.
Croatian: Ako nisu, vrtite čašu još neko vrijeme.
English: Each single-use sachet of granules for oral suspension contains 100 mg of raltegravir (as potassium).
Croatian: Jedna vrećica granula za oralnu suspenziju za jednokratnu primjenu sadrži 100 mg raltegravira (u obliku raltegravirkalija).
English: The impact of other strong inducers of drug metabolizing enzymes, such as phenytoin and phenobarbital, on UGT1A1 is unknown; therefore, co-administration with raltegravir 1,200 mg once daily is not recommended.
Croatian: Nije poznat utjecaj drugih snažnih induktora enzima koji sudjeluju u metabolizmu lijekova, poput fenitoina i fenobarbitala, na UGT1A1 pa se njihova istodobna primjena s raltegravirom u dozi od 1200 mg jedanput na dan ne preporučuje.
English: Keep the drying agent in the bottle to protect from moisture.
Croatian: Ostavite sredstvo za sušenje u boci radi zaštite od vlage.
English: No data are available in pre-term neonates.
Croatian: Nema dostupnih podataka u nedonoščadi.
English: For analysis by prognostic factors, virologic failures were carried forward for percent < 40 copies/mL.
Croatian: Za analizu prema prognostičkim faktorima, neuspjeli virološki odgovori preneseni su za postotak < 40 kopija/ml.
English: In studies of raltegravir 400 mg twice daily, cancers were reported in treatment-experienced and treatment-naïve patients who initiated raltegravir in conjunction with other antiretroviral agents.
Croatian: U ispitivanjima primjene raltegravira u dozi od 400 mg dvaput na dan provedenima u prethodno liječenih i još neliječenih bolesnika, koji su započeli liječenje raltegravirom u kombinaciji s drugim antiretrovirusnim lijekovima, prijavljeni su slučajevi raka.
English: In adults and paediatric patients (weighing at least 40 kg), the recommended dosage is 1,200 mg (two 600 mg tablets) once daily for treatment-naïve patients or patients who are virologically suppressed on an initial regimen of ISENTRESS 400 mg twice daily.
Croatian: U odraslih i pedijatrijskih bolesnika (tjelesne težine od najmanje 40 kg) preporučena doza je 1200 mg (dvije tablete od 600 mg) jedanput na dan za liječenje bolesnika koji prethodno nisu bili liječeni ili bolesnika koji su uz inicijalni režim liječenja lijekom ISENTRESS 400 mg dvaput na dan ostvarili virusnu supresiju.
English: Muscle problems
Croatian: Mišićne tegobe
English: Contains fructose, sorbitol and sucrose.
Croatian: Sadrži fruktozu, sorbitol i saharozu.
English: At 240-weeks, in treatment-naïve patients, Grade 2 or higher laboratory abnormalities that represent a worsening Grade from baseline of AST, ALT or total bilirubin occurred in 22 %, 44 % and 17 %, respectively, of co-infected patients treated with raltegravir as compared to 13 %, 13 % and 5 % of all other patients treated with raltegravir.
Croatian: Nakon 240 tjedana su, u bolesnika koji do tada nisu bili liječeni, odstupanja u laboratorijskim nalazima AST-a, ALT-a i ukupnog bilirubina 2. ili višeg stupnja koja su predstavljala pogoršanje u odnosu na početne vrijednosti zabilježena u 22%, 44% odnosno 17% bolesnika s istodobnom infekcijom koji su liječeni raltegravirom, u odnosu na 13%, 13% odnosno 5% svih ostalih bolesnika liječenih raltegravirom.
English: Table 3 Pharmacokinetic Interaction Data
Croatian: Tablica 3 Podaci o farmakokinetičkim interakcijama
English: ISENTRESS is also available for adults and paediatric patients (weighing at least 40 kg), as a 600 mg tablet to be administered as 1,200 mg once daily (two 600 mg tablets) for treatment-naïve patients or patients who are virologically suppressed on an initial regimen of ISENTRESS 400 mg twice daily.
Croatian: ISENTRESS je za odrasle i pedijatrijske bolesnike (tjelesne težine od najmanje 40 kg) dostupan i u obliku tablete od 600 mg, koja se primjenjuje u dozi od 1200 mg jedanput na dan (dvije tablete od 600 mg) za liječenje bolesnika koji prethodno nisu bili liječeni ili bolesnika koji su uz inicijalni režim liječenja lijekom ISENTRESS 400 mg dvaput na dan ostvarili virusnu supresiju.
English: Co-administration of raltegravir 1,200 mg once daily with aluminium/magnesium and calcium carbonate containing antacids are likely to result in clinically meaningful reductions in the plasma trough levels of raltegravir.
Croatian: Istodobna primjena raltegravira u dozi od 1200 mg jedanput na dan s antacidima koji sadrže aluminij/magnezij i kalcijev karbonat vjerojatno će dovesti do klinički značajnog sniženja najnižih koncentracija raltegravira u plazmi.
English: Table 1 Recommended Dose
Croatian: Preporučena doza
English: Uncommon dizziness, headache, psychomotor hyperactivity amnesia, carpal tunnel syndrome, cognitive disorder, disturbance in attention, dizziness postural, dysgeusia, hypersomnia, hypoaesthesia, lethargy, memory impairment, migraine, neuropathy peripheral, paraesthesia, somnolence, tension headache, tremor, poor quality sleep
Croatian: Poremećaji živčanog sustava često manje često omaglica, glavobolja, psihomotorička hiperaktivnost amnezija, sindrom karpalnog kanala, kognitivni poremećaj, poremećaj pažnje, posturalna omaglica, disgeuzija, hipersomnija, hipoestezija, letargija, poremećaj pamćenja, migrena, periferna neuropatija, parestezija, somnolencija, tenzijska glavobolja, tremor, loša kvaliteta sna
English: In vitro studies indicate that raltegravir is not a substrate of cytochrome P450 (CYP) enzymes, does not inhibit CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 or CYP3A, does not inhibit UDP glucuronosyltransferases (UGTs) 1A1 and 2B7, does not induce CYP3A4 and is not an inhibitor of P-glycoprotein (P-gp), breast cancer resistance protein (BCRP), organic anion-transporting polypeptides (OATP) 1B1, OATP1B3, organic cation transporters (OCT)1 and OCT2, or multidrug and toxin extrusion proteins (MATE)1 and MATE2-K. Based on these data, raltegravir is not expected to affect the pharmacokinetics of medicinal products that are substrates of these enzymes or transporters.
Croatian: Ispitivanja in vitro pokazuju da raltegravir nije supstrat enzima citokroma P450 (CYP), ne inhibira CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 ili CYP3A, ne inhibira UDP glukuronoziltransferaze (UGT) 1A1 i 2B7, ne inducira CYP3A4 niti je inhibitor P-glikoproteina (P-gp), proteina koji uzrokuje rezistenciju raka dojke na liječenje (engl. breast cancer resistance protein, BCRP), polipeptidnih transportera organskih aniona (engl. organic anion-transporting polypeptides, OATP) OATP1B1, OATP1B3, transportera organskih kationa (engl. organic cation transporters, OCT) OCT1 i OCT2, ili proteina za izlučivanje više lijekova i toksina (engl. multidrug and toxin extrusion protein, MATE)1 i MATE2-K.
English: ANTI-RETROVIRAL Protease inhibitors (PI) atazanavir /ritonavir (raltegravir 400 mg Twice Daily)
Croatian: Inhibitori proteaze (IP) atazanavir/ritonavir (raltegravir 400 mg dvaput na dan)
English: Geometric Mean (%CV AUC (mg*hr/L)
Croatian: Geometrijska srednja vrijednost (%CV AUC (mg*h/l)
English: No dosage adjustment required for raltegravir (400 mg twice daily and 1,200 mg once daily) or hormonal contraceptives (estrogen- and/or progesterone-based).
Croatian: Nije potrebno prilagođavati dozu raltegravira (400 mg dvaput na dan i 1200 mg jedanput na dan) ili hormonskih kontraceptiva (na bazi estrogena i/ili progesterona).
English: EU/1/07/436/001 EU/1/07/436/002 180 film-coated tablets (3 bottles of 60)
Croatian: EU/1/07/436/001 EU/1/07/436/002 180 filmom obloženih tableta (3 boce sa 60)
English: In addition, the film coating contains the following inactive ingredients: lactose monohydrate, hypromellose 2910, titanium dioxide, triacetin, iron oxide yellow and black iron oxide.
Croatian: Osim toga, film ovojnica sadrži sljedeće pomoćne tvari: laktozu hidrat, hipromelozu 2910, titanijev dioksid, triacetin, žuti željezov oksid i crni željezov oksid.
English: When Isentress should be used
Croatian: Kada treba primijeniti Isentress
English: See section 4.2 for dosing recommendations.
Croatian: Za upute o doziranju vidjeti dio 4.2.
English: The chewable tablets are available in 25 mg and scored 100 mg strengths.
Croatian: Tablete za žvakanje dostupne su u jačinama od 25 mg i 100 mg s razdjelnom crtom.