FrancophonIA/ELRC3.0 huggingface dataset:
English: Read the package leaflet and booklet before use.
Slovenian: Pred uporabo preberite priloženo navodilo za uporabo in knjižico z navodili!
English: At the NOAEL, systemic exposure was similar to that at the clinical dose of 1,200 mg once daily.
Slovenian: Pri odmerkih, kjer ni opaziti neželenih učinkov (NOAEL), je bila sistemska izpostavljenost podobna kot pri kliničnem odmerku 1.200 mg enkrat na dan.
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.
Slovenian: Pri upoštevanju učinkovitosti kot primarnega opazovanega dogodka je bil delež bolnikov, ki so dosegli HIV RNA < 50 kopij/ml v 48. tednu, v skupini, ki je prejemala raltegravir 241/280 (86,1 %), v skupini, ki je prejemala efavirenz pa 230/281 (81,9 %).
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).
Slovenian: Pri odraslih bolnikih s hudo ledvično insuficienco se farmakokinetika klinično ni pomembneje razlikovala od farmakokinetike pri zdravih osebah (glejte poglavje 4.2 v SmPCju za 400 mg dvakrat na dan).
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.
Slovenian: V študijah z raltegravirjem 400 mg dvakrat na dan pri predhodno zdravljenih in nezdravljenih bolnikih, pri katerih je bilo uvedeno zdravljenje z raltegravirjem v kombinaciji z drugimi protiretrovirusnimi zdravili, so poročali o pojavu rakavih obolenj.
English: Film-coating - Lactose monohydrate - Hypromellose 2910 - Titanium dioxide - Triacetin - Iron oxide yellow - Black iron oxide
Slovenian: Filmska obloga - laktoza monohidrat - hipromeloza 2910 - titanov dioksid - triacetin - rumeni železov oksid - črni železov oksid
English: UGT1A1 Polymorphism
Slovenian: Polimorfizem UGT1A1
English: EU/1/07/436/006 EU/1/07/436/007 180 film-coated tablets (3 bottles of 60)
Slovenian: EU/1/07/436/006 EU/1/07/436/007 180 filmsko obloženih tablet (3 plastenke po 60)
English: Taking an aluminium and magnesium antacid within 6 hours of raltegravir administration significantly decreased raltegravir plasma levels.
Slovenian: Jemanje aluminijevih in magnezijevih antacidov v roku 6 ur pred ali po zaužitju raltegravirja pomembno zmanjša plazemsko koncentracijo raltegravirja.
English: ISENTRESS is also available as a 400 mg tablet for twice daily use in HIV infected adults or children and adolescents at least 25 kg.
Slovenian: Na voljo so tudi dodatne farmacevtske oblike in jakosti Zdravilo ISENTRESS je na voljo tudi v obliki 400 mg tablet za uporabo dvakrat na dan pri odraslih ali otrocih in mladostnikih s telesno maso najmanj 25 kg, okuženih s HIV.
English: The orange-banana flavoured chewable tablet is round and pale yellow, marked with the MSD corporate logo on one side and “473” on the other side.
Slovenian: Žvečljiva tableta z okusom po pomaranči in banani je okrogla in bledo rumene barve, označena z logotipom podjetja MSD na eni in oznako "473" na drugi strani.
English: Therefore, raltegravir should be used with caution in patients with severe hepatic impairment (see sections 4.2 and 5.2).
Slovenian: Pri bolnikih s hudo okvaro jeter je zato treba raltegravir uporabljati previdno (glejte poglavji 4.2 in 5.2).
English: Give Isentress to your baby
Slovenian: 12. korak Zdravilo Isentress dajte otroku
English: for 1 mL or less for 1.5 mL to 3 mL
Slovenian: za 1 ml ali manj za 1,5 ml do 3 ml za 3,5 ml do 10 ml premaknite ta del bata do prave oznake na brizgi
English: This helps the virus to multiply in the cells in your body.
Slovenian: Virus izloča encim HIV integrazo, ki virusu pomaga, da se razmnožuje v telesnih celicah.
English: At the NOAEL, systemic exposure was similar to that at the clinical dose of 400 mg twice daily.
Slovenian: Pri odmerkih, kjer ni opaziti neželenih učinkov (NOAEL), je bila sistemska izpostavljenost podobna kot pri kliničnem odmerku 400 mg dvakrat na dan.
English: 1 to 4 Weeks - Twice daily dosing
Slovenian: Od 1 do 4 tedne - Odmerjanje dvakrat na dan od 2 do manj kot 3
English: Do not switch with other strengths or formulations of Isentress without first talking with your doctor, pharmacist or nurse.
Slovenian: Različnih jakosti in farmacevtskih oblik zdravila Isentress ne smete medsebojno menjavati, ne da bi se o tem prej posvetovali z zdravnikom, farmacevtom ali medicinsko sestro.
English: Caution should be used when co-administering raltegravir with strong inducers of uridine diphosphate glucuronosyltransferase (UGT) 1A1 (e.g., rifampicin).
Slovenian: Pri sočasni uporabi raltegravirja in močnih induktorjev uridin-difosfat-glukuronoziltransferaze (UGT) 1A1 (npr. rifampicin) je potrebna previdnost.
English: • Isentress chewable tablets are not recommended in pregnancy because they have not been studied in pregnant women.
Slovenian: • Uporaba zdravila Isentress žvečljive tablete med nosečnostjo ni priporočljiva, saj uporabe tega zdravila pri nosečnicah niso raziskovali.
English: Co-administration of raltegravir (1,200 mg once daily) is not recommended.
Slovenian: Sočasna uporaba raltegravirja (1.200 mg enkrat na dan) ni priporočljiva.
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.
Slovenian: Za odrasle in pediatrične bolnike (s telesno maso najmanj 40 kg) je priporočeni odmerek 1.200 mg (dve 600 mg tableti) enkrat na dan, za zdravljenje predhodno nezdravljenih bolnikov ali bolnikov z virološko supresijo med začetnim zdravljenjem z zdravilom ISENTRESS 400 mg dvakrat na dan.
English: What Isentress looks like and contents of the pack The banana flavoured granules for oral suspension is a white to off-white powder that may contain yellow or beige to tan particles in a single-use sachet.
Slovenian: Zrnca za peroralno suspenzijo z okusom banane so bel do sivo bel prašek, ki lahko vsebuje rumene ali bež do rumeno rjave delce, v vrečici za enkratno uporabo.
English: Reducing the amount of HIV in the blood may improve the functioning of your immune system.
Slovenian: Z zmanjšanjem količine virusa HIV se lahko izboljša delovanje imunskega sistema, kar pomeni, da se bo telo lahko bolje branilo pred okužbo.
English: Uncommon visual impairment
Slovenian: Očesne bolezni občasni motnje vida
English: • joint pain; painful joint disease; back pain; pain in bone/muscle; muscle tenderness or weakness; neck pain; pain in arms or legs; inflammation of the tendons; decrease in the amount of minerals in the bone
Slovenian: • bolečine v sklepih, boleča bolezen sklepov, bolečine v hrbtu, bolečine v kosteh/mišicah, občutljivost ali šibkost mišic, bolečina v vratu, bolečine v rokah ali nogah, vnetje tetiv, zmanjšanje količine mineralov v kosteh
English: Raltegravir 1,200 mg QD and raltegravir 400 mg BID were administered with emtricitabine (+) tenofovir disoproxil fumarate.
Slovenian: Shemi 1.200 mg raltegravirja enkrat na dan in 400 mg raltegravirja dvakrat na dan sta bili uporabljeni z emtricitabinom (+) tenofovirdizoproksil fumaratom.
English: In adults, there were no clinically important pharmacokinetic differences between patients with severe renal insufficiency and healthy subjects (see section 4.2).
Slovenian: Pri odraslih bolnikih s hudo ledvično insuficienco se farmakokinetika klinično ni pomembneje razlikovala od farmakokinetike pri zdravih osebah (glejte poglavje 4.2).
English: 1.5 x 100 mg † twice daily
Slovenian: 1,5 x 100 mg † dvakrat na dan
English: The other ingredients are: microcrystalline cellulose, hypromellose 2910, croscarmellose sodium and magnesium stearate.
Slovenian: Druge sestavine zdravila so: mikrokristalna celuloza, hipromeloza 2910, premrežen natrijev karmelozat in magnezijev stearat.
English: Uncommon erectile dysfunction, gynaecomastia, menopausal symptoms
Slovenian: Motnje reprodukcije in dojk občasni erektilna disfunkcija, ginekomastija, menopavzalni simptomi
English: Tablet core - Microcrystalline cellulose - Hypromellose 2910 - Magnesium stearate - Croscarmellose sodium
Slovenian: Jedro tablete - mikrokristalna celuloza - hipromeloza 2910 - magnezijev stearat - premrežen natrijev karmelozat
English: EU/1/07/436/001 EU/1/07/436/002 180 film-coated tablets (3 bottles of 60)
Slovenian: EU/1/07/436/001 EU/1/07/436/002 180 filmsko obloženih tablet (3 plastenke po 60)
English: Children should keep scheduled doctor's visits because their Isentress dosage should be adjusted as they get older, grow or gain weight.
Slovenian: Otroka morate redno voditi na preglede k zdravniku, saj je odmerek zdravila Isentress treba prilagajati glede na otrokovo starost, rast ali telesno maso.
English: Inhibitors of UGT1A1
Slovenian: Zaviralci UGT1A1
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.
Slovenian: Nekateri od številnih dejavnikov tveganja za pojav te bolezni so trajanje kombiniranega protiretrovirusnega zdravljenja, zdravljenje s kortikosteroidi, uživanje alkohola, močno zmanjšano delovanje imunskega sistema in višji indeks telesne mase.
English: • feeling dizzy; headache
Slovenian: • omotica, glavobol
English: • See the instructions for use in the booklet for how to prepare and give a dose of Isentress.
Slovenian: • Za navodila, kako pripraviti in dati odmerek zdravila Isentress, glejte navodila za uporabo v knjižici.
English: ISENTRESS 100 mg - bottle labeling
Slovenian: ISENTRESS 100 mg - označevanje na plastenki
English: Co-administration of raltegravir with other agents that increase gastric pH (e.g., omeprazole and famotidine) may increase the rate of raltegravir absorption and result in increased plasma levels of raltegravir (see Table 1).
Slovenian: Pri sočasni uporabi raltegravirja z drugimi zdravili, ki zvišujejo želodčni pH (npr. omeprazol in famotidin), se lahko poveča delež absorpcije raltegravirja in lahko pride do povečane plazemske koncentracije raltegravirja (glejte preglednico 1).
English: Co-administration of raltegravir with other agents that increase gastric pH (e.g., omeprazole and famotidine) may increase the rate of raltegravir absorption and result in increased plasma levels of raltegravir (see Table 3).
Slovenian: Pri sočasni uporabi raltegravirja z drugimi zdravili, ki zvišujejo želodčni pH (npr. omeprazol in famotidin), se lahko poveča delež absorpcije raltegravirja in lahko pride do zvišane plazemske koncentracije raltegravirja (glejte preglednico 3).
English: What Isentress contains
Slovenian: Kaj vsebuje zdravilo Isentress
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).
Slovenian: Odmerka raltegravirja (400 mg dvakrat na dan in 1.200 mg enkrat na dan) ali hormonskih kontraceptivov (estrogenskih in/ali progesteronskih) ni treba prilagajati.
English: • antacids (an agent that counteracts or neutralises the acid in the stomach to relieve indigestion and heartburn)
Slovenian: • antacide (zdravila, ki nevtralizirajo kislo vsebino želodca in tako lajšajo prebavne težave in zgago)
English: Caution should be used in patients with a pre-existing history of depression or psychiatric illness.
Slovenian: Pri bolnikih z depresijo ali psihiatrično boleznijo v anamnezi je potrebna previdnost.
English: • Store in the original package with the bottle tightly closed.
Slovenian: • Tesno zaprto plastenko shranjujte v originalni ovojnini.
English: Thus, the data indicate that the major mechanism of clearance of raltegravir in humans is UGT1A1-mediated glucuronidation.
Slovenian: Ti podatki kažejo, da glukuronidacija z UGT1A1 pri človeku predstavlja glavni mehanizem očistka raltegravirja.
English: Tablet core - Microcrystalline cellulose - Lactose monohydrate - Calcium phosphate dibasic anhydrous - Hypromellose 2208 - Poloxamer 407 - Sodium stearyl fumarate - Magnesium stearate
Slovenian: Jedro tablete - mikrokristalna celuloza - laktoza monohidrat - brezvodni kalcijev hidrogenfosfat - hipromeloza 2208 - poloksamer 407 - natrijev stearilfumarat - magnezijev stearat
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.
Slovenian: Filmska obloga vsebuje še naslednje pomožne snovi: polivinilalkohol, titanov dioksid, polietilenglikol 3350, smukec, rdeči železov oksid in črni železov oksid.
English: ISENTRESS 25 mg - bottle labeling
Slovenian: ISENTRESS 25 mg - označevanje na plastenki
English: Talk to your doctor about other antacids you can take.
Slovenian: Glede uporabe drugih antacidov, ki jih lahko jemljete, se posvetujte z zdravnikom.
English: How Isentress works
Slovenian: Kako deluje zdravilo Isentress
English: tipranavir /ritonavir (raltegravir 400 mg Twice Daily)
Slovenian: tipranavir/ritonavir (raltegravir 400 mg dvakrat na dan)
English: • Antacids (an agent that counteracts or neutralises the acid in the stomach to relieve indigestion and heartburn).
Slovenian: • antacide (zdravila, ki nevtralizirajo kislo vsebino želodca in tako lajšajo prebavne težave in zgago).
English: CCR5 inhibitors maraviroc (raltegravir 400 mg Twice Daily)
Slovenian: Inhibitorji CCR5 maravirok (raltegravir 400 mg dvakrat na dan)
English: Sixteen (16) neonates received 2 doses of ISENTRESS in first 2 weeks of life, and 26 neonates received 6 weeks of daily dosing; all were followed for 24 weeks.
Slovenian: V študiji IMPAACT P1110 (glejte poglavje 5.2) so bili primerni dojenčki gestacijske starosti vsaj 37 tednov in s telesno maso vsaj 2 kg. Šestnajst (16) novorojenčkov je v prvih 2 tednih življenja prejelo 2 odmerka zdravila Isentress, 26 novorojenčkov pa je 6 tednov prejemalo odmerke vsak dan; vse novorojenčke so spremljali 24 tednov.
English: maraviroc AUC  14 % maraviroc C12hr  10 % maraviroc Cmax ↓ 21 %
Slovenian: maravirok AUC  14 % maravirok C12ur  10 % maravirok Cmax ↓ 21 %
English: Remember that Isentress is not a cure for HIV infection.
Slovenian: Zavedati se morate, da zdravilo Isentress okužbe z virusom HIV ne more pozdraviti.
English: The virus produces an enzyme called HIV integrase.
Slovenian: Integraza je encim virusa HIV, ki je potreben za razmnoževanje virusa HIV.
English: High density polyethylene (HDPE) bottle with a child-resistant polypropylene closure.
Slovenian: Plastenke iz polietilena visoke gostote (HDPE) z za otroke varno polipropilensko zaporko.
English: At Week 96, the proportion of patients achieving HIV RNA < 40 copies/mL was 433/531(81.5 %) in the group receiving raltegravir 1,200 mg once daily and 213/266 (80.1 %) in the group receiving raltegravir 400 mg twice daily.
Slovenian: V 96. tednu je bil delež bolnikov, ki so dosegli HIV RNA < 40 kopij/ml, v skupini, ki je prejemala 1.200 mg raltegravirja enkrat na dan, 433/531 (81,5 %) in v skupini, ki je prejemala 400 mg raltegravirja dvakrat na dan, 213/266 (80,1 %).
English: Weight based dosing, see dosing Table 1
Slovenian: Za odmerjanje glejte preglednico 1.
English: The safety and efficacy of raltegravir have not been established in patients with severe underlying liver disorders.
Slovenian: Pri bolnikih s hudo boleznijo jeter varnosti in učinkovitosti raltegravirja niso dokazali.
English: Hold the syringe with tip up.
Slovenian: Brizgo držite tako, da je njena konica obrnjena navzgor.
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.
Slovenian: Filmska obloga vsebuje še naslednje pomožne snovi: laktoza monohidrat, hipromeloza 2910, titanov dioksid, triacetin, rumeni železov oksid in črni železov oksid.
English: Contains fructose, sorbitol and sucrose.
Slovenian: Vsebuje fruktozo, sorbitol in saharozo.
English: Co-administration of atazanavir with raltegravir 1,200 mg once daily significantly increased plasma levels of raltegravir; therefore, co-administration of raltegravir 1,200 mg once daily and atazanavir is not recommended.
Slovenian: Sočasna uporaba atazanavirja s 1.200 mg raltegravirja enkrat na dan je značilno povečala koncentracijo raltegravirja v plazmi, zato sočasna uporaba 1.200 mg raltegravirja enkrat na dan in atazanavirja ni priporočljiva.
English: How to take Isentress
Slovenian: Kako jemati zdravilo Isentress
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.
Slovenian: Na voljo so tudi dodatne farmacevtske oblike in jakosti Zdravilo ISENTRESS je na voljo tudi v obliki 400 mg tablet za uporabo pri odraslih, mladostnikih in otrocih, s telesno maso najmanj 25 kg, ki tableto lahko pogoltnejo.
English: See the instructions for use booklet for the right way to dispose of your leftover medicine.
Slovenian: Za pravilno odstranjevanje preostalega zdravila glejte knjižico z navodili za uporabo zdravila.
English: Uncommon cachexia, diabetes mellitus, dyslipidaemia, hypercholesterolaemia, hyperglycaemia, hyperlipidaemia, hyperphagia, increased appetite, polydipsia, body fat disorder
Slovenian: občasni kaheksija, sladkorna bolezen, dislipidemija, hiperholesterolemija, hiperglikemija, hiperlipidemija, hiperfagija, povečan apetit, polidipsija, motnja prerazporeditve telesnega maščevja
English: No dose adjustment required for raltegravir or boceprevir.
Slovenian: Odmerka raltegravirja ali boceprevirja ni treba prilagajati.
English: Each single-use sachet of granules for oral suspension contains 100 mg of raltegravir (as potassium).
Slovenian: Ena vrečica z zrnci za peroralno suspenzijo za enkratno uporabo vsebuje 100 mg raltegravirja (v obliki kalijeve soli).
English: Therefore, co-administration of raltegravir with aluminium and/or magnesium containing antacids is not recommended.
Slovenian: Zato sočasna uporaba raltegravirja z antacidi, ki vsebujejo aluminij in/ali magnezij, ni priporočljiva.
English: Raltegravir 400 mg twice daily (N = 281)
Slovenian: raltegravir 400 mg dvakrat na dan (n = 281)
English: ISENTRESS chewable tablets can be administered with or without food (see section 5.2).
Slovenian: Način uporabe peroralna uporaba Zdravilo ISENTRESS žvečljive tablete se lahko jemlje s hrano ali brez (glejte poglavje 5.2).
English: With respect to the primary efficacy endpoint, the proportion of patients achieving HIV RNA < 40 copies/mL at Week 48 was 472/531(88.9 %) in the group receiving raltegravir 1,200 mg once daily and 235/266 (88.3 %) in the group receiving raltegravir 400 mg twice daily.
Slovenian: Glede na primarni opazovani dogodek učinkovitosti je bil delež bolnikov, ki so 48. teden dosegli HIV RNA < 40 kopij/ml, v skupini, ki je prejemala 1.200 mg raltegravirja enkrat na dan, 472/531 (88,9 %) in v skupini, ki je prejemala 400 mg raltegravirja dvakrat na dan, 235/266 (88,3 %).
English: High density polyethylene (HDPE) bottle with a child-resistant polypropylene closure, induction seal and silica gel dessicant.
Slovenian: Plastenke iz polietilena visoke gostote (HDPE) z za otroke varno polipropilensko zaporko, z indukcijskim tesnilom in sušilnim sredstvom iz silikagela.
English: Raltegravir 400 mg twice daily (N = 266)
Slovenian: raltegravir 400 mg dvakrat na dan (n = 266)
English: This may mean that the HIV virus will develop resistance to Isentress and become harder to treat.
Slovenian: Med kratkotrajnim obdobjem brez jemanja zdravila se lahko količina virusa v krvi poveča, kar lahko pomeni, da bo virus HIV postal odporen na zdravilo Isentress, okužbo pa bo nato težje zdraviti.
English: Co-administration of raltegravir with aluminium and magnesium antacids resulted in reduced raltegravir plasma levels.
Slovenian: Pri sočasni uporabi raltegravirja z aluminijevimi in magnezijevimi antacidi je prišlo do zmanjšanja plazemske koncentracije raltegravirja.
English: No dose adjustment required for raltegravir or etravirine.
Slovenian: Odmerka raltegravirja ali etravirina ni treba prilagajati.
English: No renal impairment study was conducted with raltegravir 1,200 mg once daily however, based on results with the 400 mg twice daily tablet, no clinically meaningful effect is anticipated.
Slovenian: S 1.200 mg raltegravirja enkrat na dan niso izvedli študij pri bolnikih z okvaro ledvic, vendar glede na rezultate s 400 mg tabletami dvakrat na dan klinično pomembnega učinka ni pričakovati.
English: Ethinyl Estradiol AUC  2 % Ethinyl Estradiol Cmax ↑ 6 % Norelgestromin AUC ↑ 14 % Norelgestromin Cmax ↑ 29 %
Slovenian: etinilestradiol AUC  2 % etinilestradiol Cmax ↑ 6 % norelgestromin AUC ↑ 14 % norelgestromin Cmax ↑ 29 %
English: Therefore, ISENTRESS should be used with caution in patients with severe hepatic impairment (see sections 4.4 and 5.2).
Slovenian: Pri bolnikih s hudo okvaro jeter je treba zdravilo ISENTRESS zato uporabljati previdno (glejte poglavji 4.4 in 5.2).
English: PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
English: The other ingredients are: lactose monohydrate, microcrystalline cellulose, calcium phosphate dibasic anhydrous, hypromellose 2208, poloxamer 407, sodium stearyl fumarate, and magnesium stearate.
Slovenian: Druge sestavine zdravila so: laktoza monohidrat, mikrokristalna celuloza, brezvodni kalcijev hidrogenfosfat, hipromeloza 2208, poloksamer 407, natrijev stearilfumarat in magnezijev stearat.
English: The orange-banana flavoured chewable tablet is oval-shaped, pale orange coloured, scored on both sides with the MSD corporate logo and "477" on one side and without inscription on the other side.
Slovenian: Bledo oranžna, ovalna žvečljiva tableta, z okusom po pomaranči in banani, z razdelilno zarezo na obeh straneh, označena z logotipom podjetja MSD in oznako "477" na eni strani in brez oznak na drugi strani.
English: Table 1 Pharmacokinetic Interaction Data
Slovenian: Preglednica 1 Podatki o farmakokinetičnih interakcijah
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
Slovenian: Bolezni živčevja pogosti omotica, glavobol, psihomotorična hiperaktivnost občasni amnezija, sindrom karpalnega kanala, kognitivne motnje, motnje pozornosti, posturalna omotica, motnje okušanja, hipersomnija, hipestezija, letargija, motnje spomina, migrena, periferna nevropatija, parestezija, zaspanost, tenzijski glavobol, tremor, slaba kakovost spanca
English: There is little to no accumulation in AUC and Cmax and evidence of slight accumulation in C12 hr.
Slovenian: Akumulacija AUC in Cmax je majhna ali je ni.
English: Uncommon hepatitis, hepatic steatosis, hepatitis alcoholic, hepatic failure
Slovenian: Bolezni jeter, žolčnika in žolčevodov občasni hepatitis, jetrna steatoza, alkoholni hepatitis, odpoved jeter
English: Step 7.
Slovenian: Preglednica 7
English: Inducers of drug metabolizing enzymes
Slovenian: Induktorji encimov, ki presnavljajo zdravila
English: • This product does not require any special storage conditions.
Slovenian: • Za shranjevanje zdravila niso potrebna posebna navodila.
English: Unit dose sachet for ISENTRESS 100 mg granules for oral suspension - foil sachet
Slovenian: Enoodmerna vrečica za ISENTRESS 100 mg zrnca za peroralno suspenzijo - folija vrečice
English: Baseline Characteristic HIV-RNA > 100,000 copies/mL
Slovenian: HIV-RNA > 100,000 kopij/ml