FrancophonIA/ELRC3.0 huggingface dataset:
English: No dosage adjustment required for raltegravir or hormonal contraceptives (estrogenand/or progesterone-based).
Slovenian: Odmerka raltegravirja ali hormonskih kontraceptivov (estrogenskih in/ali progesteronskih) ni treba prilagajati.
English: Take 1 sachet of ISENTRESS and shake the granules to the bottom of the sachet.
Slovenian: Vzemite 1 vrečico zdravila ISENTRESS in zrnca stresite, da bodo na dnu vrečice.
English: The recommended dose is 1 tablet (400 mg) by mouth twice a day.
Slovenian: Priporočeni odmerek je 1 tableta (400 mg) skozi usta dvakrat na dan.
English: Raltegravir 400 mg twice daily should be used during pregnancy only if the expected benefit justifies the potential risk to the foetus.
Slovenian: Raltegravir 400 mg dvakrat na dan se lahko med nosečnostjo uporablja samo, če pričakovana korist upravičuje morebitno tveganje za plod.
English: Of the 126 patients, 96 received the recommended dose of raltegravir twice daily.
Slovenian: Izmed 126 bolnikov jih je 96 prejelo priporočeni odmerek raltegravirja dvakrat na dan.
English: See section 4.2 for dosing recommendations.
Slovenian: Za priporočila o odmerjanju glejte poglavje 4.2.
English: Given that raltegravir is metabolised primarily via UGT1A1, caution should be used when co-administering raltegravir with strong inducers of UGT1A1 (e.g., rifampicin).
Slovenian: Glede na to, da se raltegravir v glavnem presnavlja preko UGT1A1, je pri sočasni uporabi raltegravirja in močnih induktorjev UGT1A1 (npr. rifampicina) potrebna previdnost.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Slovenian: Bolniki z redko dedno intoleranco za galaktozo, laponsko obliko pomanjkanja laktaze ali malabsorpcijo glukoze/galaktoze ne smejo jemati tega zdravila.
English: Isentress must be used in combination with other medicines for HIV.
Slovenian: Zdravilo Isentress je treba uporabljati skupaj z drugimi zdravili za zdravljenje okužbe z virusom HIV.
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.
Slovenian: Pred randomizacijo so raziskovalci določili OBT na osnovi bolnikovega predhodnega zdravljenja in na osnovi testiranja genotipske in fenotipske odpornosti virusa.
English: Extrapolated from 400 mg twice daily study
Slovenian: ekstrapolirano iz študije 400 mg dvakrat na dan
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.
Slovenian: Pri s HIV okuženih bolnikih s hudo imunsko pomanjkljivostjo lahko ob uvedbi kombiniranega protiretrovirusnega zdravljenja (CART - combination antiretroviral therapy) nastane vnetna reakcija na asimptomatične ali rezidualne oportunistične patogene in povzroči resno klinično stanje ali poslabšanje simptomov.
English: Rifampicin reduces plasma levels of raltegravir.
Slovenian: Rifampicin zmanjša plazemske koncentracije raltegravirja.
English: Read all of this leaflet carefully before you start giving this medicine to your child because it contains important information.
Slovenian: Pred začetkom dajanja zdravila otroku natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
English: Isentress stops this enzyme from working.
Slovenian: Zdravilo Isentress prepreči delovanje tega encima.
English: Baseline Characteristics and Efficacy Outcomes at Weeks 24 and 48 from IMPAACT P1066 (2 to 18 years of age)
Slovenian: Izhodiščne značilnosti in rezultati učinkovitosti v 24. in 48. tednu v študiji IMPAACT P1066 (od 2 do 18 let starosti)
English: Adults, children and adolescents weighing at least 40 kg The recommended dose is 1,200 mg taken as two 600 mg tablets taken by mouth once a day.
Slovenian: Odrasli, otroci in mladostniki s telesno maso najmanj 40 kg Priporočeni odmerek je 1.200 mg v obliki dveh 600 mg tablet skozi usta enkrat na dan.
English: In interaction studies, raltegravir did not have a clinically meaningful effect on the pharmacokinetics of etravirine, maraviroc, tenofovir disoproxil fumarate, hormonal contraceptives, methadone, midazolam or boceprevir.
Slovenian: V študijah medsebojnega delovanja raltegravir ni klinično pomembno vplival na farmakokinetiko etravirina, maraviroka, tenofovirdizoproksil fumarata, hormonskih kontraceptivov, metadona, midazolama ali boceprevirja.
English: For raltegravir 1,200 mg (2 x 600 mg) once daily, population PK analysis also demonstrated that the impacts of gender, race, ethnicity and body weight are not clinically meaningful.
Slovenian: Tudi za 1.200 mg raltegravirja (2 x 600 mg) enkrat na dan populacijska farmakokinetična analiza ni pokazala klinično pomembnega vpliva spola, rase, etnične pripadnosti ali telesne mase.
English: • erectile dysfunction; breast enlargement in men; menopausal symptoms
Slovenian: • motnje erekcije, povečanje prsi pri moških, menopavzalni simptomi
English: What Isentress looks like and contents of the pack
Slovenian: Izgled zdravila Isentress in vsebina pakiranja
English: One patient experienced a Grade 3 serious drug related allergic rash that resulted in treatment discontinuation.
Slovenian: Pri enem bolniku se je pojavil resen, z zdravilom povezan, alergijski izpuščaj 3. stopnje, zaradi katerega je bilo zdravljenje prekinjeno.
English: Do not pour it into the sink.
Slovenian: Ne vlijte ga v vodovodni odtok.
English: ISENTRESS granules for oral suspension can be administered with or without food (see section 5.2).
Slovenian: Zdravilo ISENTRESS zrnca za peroralno suspenzijo se lahko jemlje s hrano ali brez (glejte poglavje 5.2).
English: Skin problems
Slovenian: Težave s kožo
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines with or without a prescription.
Slovenian: Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo na recept ali brez recepta.
English: If you are the parent of a child taking Isentress, please read this information carefully with your child.
Slovenian: Če ste starš otroka, ki jemlje zdravilo Isentress, natančno preberite navodilo skupaj s svojim otrokom.
English: Fill a glass with water
Slovenian: 2. korak Kozarec napolnite z vodo
English: Dose adjustment is not considered necessary in subjects with reduced UGT1A1 activity due to genetic polymorphism.
Slovenian: Pri osebah z zmanjšano aktivnostjo UGT1A1 zaradi genetskega polimorfizma odmerka ni treba prilagajati.
English: Isentress is used to treat those who are infected by HIV.
Slovenian: Zdravilo Isentress se uporablja za zdravljenje okuženih z virusom HIV.
English: One pack size is available: 1 bottle with 60 tablets.
Slovenian: Na voljo je ena velikost pakiranja: 1 plastenka s 60 tabletami.
English: 2 blue (10 mL) syringes
Slovenian: 2 modri (10-ml) brizgi
English: Raltegravir 600 mg tablets (2 x 600 mg once daily) may be administered with or without food.
Slovenian: 600 mg tablete raltegravirja (2 x 600 mg enkrat na dan) se lahko jemljejo s hrano ali brez.
English: • tiredness, unusual tiredness or weakness; fever
Slovenian: • utrujenost, neobičajna utrujenost ali oslabelost, zvišana telesna temperatura
English: Muscle problems
Slovenian: Težave z mišicami
English: 0.7 mL (7 mg) once daily
Slovenian: 0,7 ml (7 mg) enkrat na dan
English: While the magnitudes of change on raltegravir exposure from raltegravir 400 mg twice daily by ritonavir, boceprevir or etravirine were small, the impact from tipranavir/ritonavir was greater (GMR Ctrough=0.45, GMR AUC=0.76).
Slovenian: Velikost spremembe izpostavljenosti raltegravirju (uporabljenem kot 400 mg raltegravirja dvakrat na dan) z ritonavirjem, boceprevirjem ali etravirinom je bila majhna, vpliv tipranavirja/ritonavirja pa je bil večji (razmerje geometričnih sredin Ctrough = 0,45, razmerje geometričnih sredin AUC = 0,76).
English: Raltegravir 1,200 mg is not recommended during pregnancy.
Slovenian: Uporaba raltegravirja 1.200 mg med nosečnostjo ni priporočljiva.
English: Viral Subtype Clade B
Slovenian: virusni podtip B
English: Table 3 Pharmacokinetic Interaction Data in Adults
Slovenian: Preglednica 3 Podatki o farmakokinetičnih interakcijah pri odraslih
English: The chewable tablets and the granules for oral suspension have not been studied in HIV-infected adolescents (12 to 18 years) or adults.
Slovenian: Žvečljivih tablet in zrnc za peroralno suspenzijo niso preučevali pri mladostnikih (od 12 do 18 let) ali odraslih, okuženih z virusom HIV.
English: Each chewable tablet contains approximately 0.46 mg fructose, approximately 0.05 mg phenylalanine (as a component of aspartame) and approximately 1.4 mg sorbitol.
Slovenian: Ena žvečljiva tableta vsebuje približno 0,46 mg fruktoze, približno 0,05 mg fenilalanina (kot del aspartama) in približno 1,4 mg sorbitola.
English: As demonstrated in healthy volunteers administered single oral doses of raltegravir in the fasted state, raltegravir is rapidly absorbed with a tmax of approximately 3 hours postdose.
Slovenian: Pri zdravih prostovoljcih je bila absorpcija raltegravirja po enkratnem peroralnem odmerku na tešče hitra, tmax je bil dosežen približno 3 ure po zaužitju odmerka.
English: Children at least 11 kg: weight based dose of the chewable tablet to a maximum dose of 300 mg, twice daily as specified in Tables 1 and 2.
Slovenian: Otroci s telesno maso najmanj 11 kg: Odmerjanje žvečljivih tablet temelji na telesni masi do največjega odmerka 300 mg dvakrat na dan, kot kažeta preglednici 1 in 2.
English: The recommended dosage for paediatric patients of at least 25 kg body weight is 400 mg (one tablet) twice daily.
Slovenian: Priporočeni odmerek za pediatrične bolnike s telesno maso najmanj 25 kg je 400 mg (ena tableta) dvakrat na dan.
English: Excipients with known effect Each sachet contains approximately: 0.5 mg fructose, 1.5 mg sorbitol and 4.7 mg sucrose.
Slovenian: Pomožne snovi z znanim učinkom Ena vrečica vsebuje približno 0,5 mg fruktoze, 1,5 mg sorbitola in 4,7 mg saharoze.
English: The doctor will work out the right dose of granules for oral suspension based on the age and weight of the infant or toddler.
Slovenian: Zdravnik bo določil ustrezen odmerek zrnc za peroralno suspenzijo glede na starost in telesno maso dojenčka ali malčka.
English: Raltegravir is approximately 83 % bound to human plasma protein over the concentration range of 2 to 10 µM.
Slovenian: Pri koncentracijah od 2 do 10 µM je vezava raltegravirja na plazemske proteine približno 83 %.
English: There are no data to guide co-administration of raltegravir with rifampicin in patients below 18 years of age (see section 4.4).
Slovenian: Na voljo ni nobenih podatkov za navodila pri sočasni uporabi raltegravirja z rifampicinom pri bolnikih, mlajših od 18 let (glejte poglavje 4.4).
English: ISENTRESS film-coated tablets contain lactose.
Slovenian: Zdravilo ISENTRESS filmsko obložene tablete vsebuje laktozo.
English: Population PK analysis showed that the effect of emtricitabine/tenofovir disaproxil fumarate on raltegravir pharmacokinetics was minimal (12% increase in relative bioavailability), and was not statistically or clinically significant.
Slovenian: Populacijska farmakokinetična analiza je pokazala, da je vpliv emtricitabina/tenofovirdizoproksil fumarata na farmakokinetiko raltegravirja minimalen (12 % zvišanje relativne biološke uporabnosti); ta vpliv ni statistično značilen in tudi ne klinično pomemben.
English: One patient experienced drug related laboratory abnormalities, Grade 4 AST and Grade 3 ALT, which were considered serious.
Slovenian: Pri enem bolniku so se pojavile z zdravilom povezane nenormalne laboratorijske vrednosti AST (4. stopnje) in ALT (3. stopnje), ki so veljale za resne.
English: There are no data to guide co-administration of raltegravir with rifampicin in patients below 18 years of age (see section 4.5).
Slovenian: Na voljo ni nobenih podatkov za navodila pri sočasni uporabi raltegravirja z rifampicinom pri bolnikih, mlajših od 18 let (glejte poglavje 4.5).
English: Patients should be instructed to keep scheduled appointments because the ISENTRESS dosage should be adjusted as the child grows.
Slovenian: Bolnikom je treba naročiti, naj se držijo dogovorjenih obiskov, ker je treba odmerek zdravila ISENTRESS prilagajati tekom otrokove rasti.
English: The doctor will tell you how much of the oral suspension the infant or toddler must take.
Slovenian: Zdravnik vam bo povedal, koliko peroralne suspenzije morate dati dojenčku ali malčku.
English: Add the 10 mL of water to the mixing cup
Slovenian: 5. korak 10 ml vode dodajte v posodico za mešanje
English: Infants and toddlers 4 weeks to less than 2 years of age IMPAACT P1066 also enrolled HIV-infected, infants and toddlers 4 weeks to less than 2 years of age who had received prior antiretroviral therapy either as prophylaxis for prevention of mother to child transmission (PMTCT) and/or as combination antiretroviral therapy for treatment of HIV infection.
Slovenian: Dojenčki in malčki, stari od 4 tedne do manj kot 2 leti Študija IMPAACT P1066 je vključevala tudi z virusom HIV okužene dojenčke in malčke, stare od 4 tedne do manj kot 2 leti, ki so se predhodno že zdravili s protiretrovirusnimi zdravili, in sicer preventivno za preprečevanje prenosa okužbe z matere na otroka (PMTCT) in/ali s kombiniranim protiretrovirusnim zdravljenjem za zdravljenje okužbe z virusom HIV.
English: If unable to swallow a tablet, consider the chewable tablet.
Slovenian: Če bolnik tablete ne more pogoltniti, je treba razmisliti o uporabi žvečljive tablete.
English: ISENTRESS 400 mg tablets can be administered with or without food.
Slovenian: Zdravilo ISENTRESS 400 mg tablete se lahko jemlje s hrano ali brez.
English: For patients weighing between 11 and 20 kg, either the chewable tablet or oral suspension can be used, as specified in Table 2.
Slovenian: Pri bolnikih s telesno maso med 11 in 20 kg se lahko uporabljajo žvečljive tablete ali peroralna suspenzija, kot kaže preglednica 2.
English: The 400 mg tablet should not be used to administer 1,200 mg once daily regimen (please refer to the 400 mg Summary of Product Characteristics).
Slovenian: 400 mg tablet se ne sme uporabljati za dajanje odmerka 1.200 mg enkrat na dan (glejte povzetek glavnih značilnosti zdravila za 400 mg tablete).
English: • Prior to breaking the seal, this product does not require any special storage conditions.
Slovenian: • Pred pretrganjem tesnila za shranjevanje zdravila niso potrebna posebna navodila.
English: For patients weighing between 11 and 20 kg, either the granules for oral suspension or the chewable tablet can be used as specified in Table 1 (see section 5.2).
Slovenian: Pri bolnikih s telesno maso med 11 in 20 kg se lahko uporabljajo zrnca za peroralno suspenzijo ali žvečljive tablete, kot kaže preglednica 1 (glejte poglavje 5.2).
English: Based on the magnitude of effect seen with raltegravir 400 mg tablets twice daily, it is expected that the effect of raltegravir 1,200 mg once daily on darunavir plasma concentrations is likely to be not clinically meaningful.
Slovenian: Glede na velikost učinka, opaženega pri uporabi 400 mg tablet raltegravirja dvakrat na dan, je mogoče pričakovati, da vpliv 1.200 mg raltegravirja enkrat na dan na koncentracijo darunavirja v plazmi verjetno ni klinično pomemben.
English: • NEW Syringe sizes to measure the dose
Slovenian: • NOVO Velikost brizg za odmerjanje odmerka
English: HCV ANTIVIRALS NS3/4A protease inhibitors (PI) boceprevir (raltegravir 400 mg Single Dose)
Slovenian: PROTIVIRUSNA ZDRAVILA PROTI HCV Zaviralci NS3/4A proteaz (PI) boceprevir (raltegravir 400 mg enkratni odmerek)
English: • decreased white blood cell count; decreased count of platelets in blood (a kind of cell that helps blood clot); blood test showing reduced kidney function; high blood sugar level; increased muscle enzyme in blood; sugar present in urine; red blood cells present in urine; weight gain; increase in waist size; decreased blood protein (albumin); increase in time for blood to clot
Slovenian: • zmanjšano število belih krvnih celic, zmanjšano število trombocitov (vrste krvnih celic, ki pomagajo pri strjevanju krvi), rezultati preiskav krvi, ki kažejo na zmanjšano delovanje ledvic, visok krvni sladkor, zvišani mišični encimi v krvi, sladkor v urinu, rdeče krvne celice v urinu, povečanje telesne mase, povečanje obsega pasu, znižana vrednost beljakovin (albuminov) v krvi, podaljšan čas strjevanja krvi
English: The granules for oral suspension and the chewable tablets have not been studied in HIV-infected adolescents (12 to 18 years) or adults.
Slovenian: Zrnc za peroralno suspenzijo in žvečljivih tablet niso preučevali pri mladostnikih (od 12 do 18 let) ali odraslih, okuženih z virusom HIV.
English: The 100 mg chewable tablet can be divided into equal halves.
Slovenian: 100 mg žvečljivo tableto se lahko razdeli na dve enaki polovici.
English: If co-administration with rifampicin is unavoidable, a doubling of the dose of raltegravir can be considered (see section 4.4).
Slovenian: Če je sočasna uporaba rifampicina nujna, je treba razmisliti o podvojitvi odmerka raltegravirja (glejte poglavje 4.4).
English: No evidence of mutagenicity or genotoxicity was observed in in vitro microbial mutagenesis (Ames) tests, in vitro alkaline elution assays for DNA breakage and in vitro and in vivo chromosomal aberration studies.
Slovenian: Pri in vitro testih mutageneze na mikrobih (Amesov test), in vitro testih alkalne elucije za ugotavljanje poškodb DNA in študijah kromosomskih aberacij in vitro ter in vivo niso odkrili znakov mutagenosti ali genotoksičnosti.
English: A single dose food effect study demonstrated that the 1,200 mg once daily had similar or smaller food effects when studied under high-fat and low-fat meal conditions when compared to the 400 mg twice daily.
Slovenian: Študija vpliva hrane z enkratnim odmerkom je pokazala, da je bil učinek hrane pri odmerku 1.200 mg enkrat na dan po obroku z veliko vsebnostjo maščob in obroku z majhno vsebnostjo maščob podoben ali manjši kot pri odmerku 400 mg dvakrat na dan.
English: Isentress granules for oral suspension contain fructose, sorbitol and sucrose If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicine.
Slovenian: Isentress zrnca za peroralno suspenzijo vsebujejo fruktozo, sorbitol in saharozo Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, se pred uporabo tega zdravila posvetujte z zdravnikom.
English: Recommended Dose* for ISENTRESS Granules For Oral Suspension and Chewable Tablets in Paediatric Patients at least 4 weeks of age and weighing 3 to 25 kg
Slovenian: Priporočeni odmerek* zdravila ISENTRESS zrnca za peroralno suspenzijo in žvečljive tablete pri pediatričnih bolnikih, starih vsaj 4 tedne in s telesno maso od 3 do 25 kg
English: Baseline Characteristics and Efficacy Outcomes at Weeks 24 and 48 from IMPAACT P1066 (4 weeks to less than 2 years of age)
Slovenian: Izhodiščne značilnosti in rezultati učinkovitosti v 24. in 48. tednu v študiji IMPAACT P1066 (od 4 tedne do manj kot 2 leti starosti)
English: ISENTRESS is indicated in combination with other anti-retroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection (see sections 4.2, 4.4, 5.1 and 5.2).
Slovenian: Zdravilo ISENTRESS je v kombinaciji z drugimi protiretrovirusnimi zdravili indicirano za zdravljenje okužbe z virusom humane imunske pomanjkljivosti (HIV-1) (glejte poglavja 4.2, 4.4, 5.1 in 5.2).
English: Fructose/Sucrose
Slovenian: Fruktoza/saharoza
English: Raltegravir Pharmacokinetic Parameters IMPAACT P1066 Following Administration of Doses in Section 4.2
Slovenian: Farmakokinetični parametri raltegravirja v študiji IMPAACT P1066 po aplikaciji odmerkov, navedenih v poglavju 4.2
English: No studies have been conducted to evaluate the drug interactions of ritonavir, tipranavir/ritonavir, boceprevir or etravirine with raltegravir 1,200 mg (2 x 600 mg) once daily.
Slovenian: Študij za ovrednotenje medsebojnega delovanja ritonavirja, tipranavirja/ritonavirja, boceprevirja ali etravirina in 1.200 mg (2 x 600 mg) raltegravirja enkrat na dan niso izvedli.
English: Your child can take this medicine with or without food or drink.
Slovenian: Otrok lahko zdravilo vzame skupaj s hrano ali pijačo ali brez.
English: ISENTRESS 600 mg film-coated tablets is indicated in combination with other anti-retroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in adults, and paediatric patients weighing at least 40 kg (see sections 4.2, 4.4, 5.1 and 5.2).
Slovenian: Zdravilo ISENTRESS 600 mg filmsko obložene tablete je v kombinaciji z drugimi protiretrovirusnimi zdravili indicirano za zdravljenje okužbe z virusom humane imunske pomanjkljivosti (HIV-1) pri odraslih in pediatričnih bolnikih s telesno maso najmanj 40 kg (glejte poglavja 4.2, 4.4, 5.1 in 5.2).
English: Following reconstitution the oral suspension has a concentration of 10 mg per mL.
Slovenian: Po pripravi ima peroralna suspenzija koncentracijo 10 mg/ml.
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).
Slovenian: Vpliva hude jetrne insuficience na farmakokinetiko raltegravirja niso raziskovali (glejte poglavji 4.2 in 4.4 v SmPCju za 400 mg dvakrat na dan).
English: One pack size is available: 1 carton with 60 sachets, two 10 mL syringes, two 3 mL syringes, two 1 mL syringes, two mixing cups, this package leaflet and booklet with instructions for use.
Slovenian: Na voljo je ena velikost pakiranja: 1 škatla s 60 vrečicami, dvema 10-ml brizgama, dvema 3-ml brizgama, dvema 1-ml brizgama, dvema posodicama za mešanje; v pakiranju sta tudi to navodilo za uporabo in knjižica z navodili za uporabo.
English: In drug interaction studies, efavirenz did not have a clinically meaningful effect on the pharmacokinetics of raltegravir 1,200 mg once daily; therefore, other less potent inducers (e.g., efavirenz, nevirapine, rifabutin, glucocorticoids, St. John's wort, pioglitazone) may be used with the recommended dose of raltegravir.
Slovenian: V študijah medsebojnega delovanja efavirenz ni klinično pomembno vplival na farmakokinetiko 1.200 mg raltegravirja enkrat na dan, zato je skupaj s priporočenim odmerkom raltegravirja mogoče uporabljati druge, manj močne induktorje (npr. efavirenz, nevirapin, rifabutin, glukokortikoide, šentjanževko, pioglitazon).
English: Mental health problems
Slovenian: Duševne težave
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 does not inhibit P-glycoprotein-mediated transport.
Slovenian: Študije in vitro kažejo, da raltegravir ni substrat za encime citokroma P450 (CYP), ne zavira CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 ali CYP3A, ne zavira UDP glukuronoziltransferaz (UGT) 1A1 in 2B7, ne inducira CYP3A4 in ne zavira s P-glikoproteinom posredovanega transporta.
English: Population PK analysis showed that the effect of gastric pH altering agents on raltegravir pharmacokinetics was minimal (8.8% decrease in relative bioavailability), and was not statistically or clinically significant.
Slovenian: Populacijska farmakokinetična analiza je pokazala, da učinkovine, ki spreminjajo pH v želodcu, minimalno vplivajo na farmakokinetiko raltegravirja (8,8 % zmanjšanje relativne biološke uporabnosti); ta vpliv ni statistično značilen in tudi ne klinično pomemben.
English: The maximum dose of the chewable tablet is 300 mg twice daily.
Slovenian: Največji odmerek žvečljivih tablet je 300 mg dvakrat na dan.