natgillin/translations-raw huggingface dataset:
Discontinue raltegravir and other suspect agents immediately if signs or symptoms of severe skin reactions or hypersensitivity reactions develop (including, but not limited to, severe rash or rash accompanied by fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, facial oedema, hepatitis, eosinophilia, angioedema).
Odmah obustavite primjenu raltegravira i drugih suspektnih lijekova ako se pojave znakovi ili simptomi teških kožnih reakcija ili reakcija preosjetljivosti (primjerice, ali ne i jedino, teški osip ili osip praćen vrućicom, opća malaksalost, umor, bolovi u mišićima ili zglobovima, mjehurići, oralne lezije, konjunktivitis, edem lica, hepatitis, eozinofilija, angioedem).
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.
U ispitivanjima interakcija raltegravir nije imao klinički značajan učinak na farmakokinetiku etravirina, maraviroka, tenofovirdizoproksilfumarata, hormonskih kontraceptiva, metadona, midazolama ili boceprevira.
• increased appetite; diabetes; increased blood cholesterol and lipids; high sugar levels in the blood; excessive thirst; severe weight loss; high levels of fat (such as cholesterol and triglycerides) in the blood; body fat disorder
• pojačan tek; šećerna bolest; povišen kolesterol i lipidi u krvi; visoka razina šećera u krvi; prekomjerna žeđ; značajan gubitak tjelesne težine, visoke razine masnoća u krvi (kao što su kolesterol i trigliceridi); poremećaj masnog tkiva
The expiry date is printed on the carton and the Isentress sachets.
Rok valjanosti otisnut je na kutiji i vrećicama lijeka Isentress.
There were no clinically important pharmacokinetic differences due to gender, race or body mass index (BMI) in adults.
Nije bilo klinički važnih razlika u farmakokinetici lijeka s obzirom na spol, rasu i indeks tjelesne mase u odraslih.
In rats, tumours (squamous cell carcinoma) of the nose/nasopharynx were identified at 300 and 600 mg/kg/day in females and at 300 mg/kg/day in males.
Kod štakora su utvrđeni tumori (planocelularni karcinom) nosa/nazofarinksa, i to kod primjene doza od 300 i 600 mg/kg/dan kod ženki te 300 mg/kg na dan kod mužjaka.
The treatment difference (raltegravir - efavirenz) was 4.2 % with an associated 95 % CI of (-1.9, 10.3) establishing that raltegravir is non-inferior to efavirenz (pvalue for non-inferiority < 0.001).
Razlika u odgovoru na liječenje (raltegravir - efavirenz) iznosila je 4,2% uz pripadajući 95%-tni CI (-1,9; 10,3), što pokazuje da raltegravir nije inferioran efavirenzu (p-vrijednost za neinferiornost < 0,001).
The recommended dose is 1 tablet (400 mg) by mouth twice a day.
Preporučena doza je 1 tableta (400 mg) kroz usta, dvaput na dan.
Your child can take this medicine with or without food or drink.
Vaše dijete može uzeti ovaj lijek s hranom i pićem ili bez njih.
One patient experienced drug related laboratory abnormalities, Grade 4 AST and Grade 3 ALT, which were considered serious.
U jednog su bolesnika zabilježena odstupanja laboratorijskih vrijednosti povezanih s primjenom lijeka, AST-a 4. stupnja i ALT-a 3. stupnja, koja su se smatrala ozbiljnima.
Administration of multiple doses of raltegravir following a moderate-fat meal did not affect raltegravir AUC to a clinically meaningful degree with an increase of 13 % relative to fasting.
Primjena višekratnih doza raltegravira nakon umjereno masnog obroka nije klinički značajno utjecala na AUC raltegravira koji je porastao za 13% u odnosu na primjenu lijeka natašte.
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.
Populacijska farmakokinetička analiza pokazala je da je učinak emtricitabina/tenofovir dizoproksilfumarata na farmakokinetiku raltegravira bio minimalan (12% veća relativna bioraspoloživost) te nije bio statistički ni klinički značajan.
Uncommon: the following may affect up to 1 in 100 people
Manje česte: sljedeće nuspojave se mogu javiti u do 1 na 100 osoba:
• 60 sachets of Isentress granules
• 60 vrećica Isentress granula
What Isentress contains The active substance is raltegravir.
Što Isentress sadrži Djelatna tvar je raltegravir.
Viral Subtype Clade B
Podtip virusa skupine B
ISENTRESS chewable tablets contain fructose and sorbitol.
ISENTRESS tablete za žvakanje sadrže fruktozu i sorbitol.
Less potent inducers (e.g., efavirenz, nevirapine, etravirine, rifabutin, glucocorticoids, St. John's wort, pioglitazone) may be used with the recommended dose of raltegravir.
Manje potentni induktori (npr. efavirenz, nevirapin, etravirin, rifabutin, glukokortikoidi, gospina trava, pioglitazon) mogu se primjenjivati s preporučenom dozom raltegravira.
Raltegravir 1,200 mg once daily is also rapidly absorbed with median Tmax ~1.5 to 2 hours in the fasted state and generates a sharper absorption peak with a tendency to higher Cmax in comparison to raltegravir twice daily (1 x 400 mg tablet twice daily).
Raltegravir u dozi od 1200 mg jedanput na dan također se brzo apsorbira, uz medijan Tmax ~1,5 do 2 sata nakon primjene natašte, te ima oštriju krivulju apsorpcije s tendencijom za postizanje višeg Cmax u usporedbi s raltegravirom primijenjenim dvaput na dan (1 x 400 mg dvaput na dan).
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).
ISENTRESS je u kombinaciji s drugim antiretrovirusnim lijekovima indiciran za liječenje infekcije virusom humane imunodeficijencije (HIV-1) (vidjeti dijelove 4.2, 4.4, 5.1 i 5.2).
Fructose/Sucrose
Fruktoza/saharoza
Effect of raltegravir on the pharmacokinetics of other medicinal products
Učinak raltegravira na farmakokinetiku drugih lijekova
In clinical studies of treatment-experienced patients, rash, irrespective of causality, was more commonly observed with regimens containing raltegravir and darunavir compared to those containing raltegravir without darunavir or darunavir without raltegravir.
U kliničkim ispitivanjima u prethodno liječenih bolesnika osip je, bez obzira na uzrok, češće zapažen u bolesnika čija je terapija uključivala raltegravir i darunavir nego u onih koji su primali raltegravir bez darunavira ili darunavir bez raltegravira.
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.
S obzirom na opseg učinka zapaženog kod primjene raltegravir tableta od 400 mg dvaput na dan, očekuje se da učinak raltegravira u dozi od 1200 mg jedanput na dan na koncentracije darunavira u plazmi vjerojatno neće biti klinički značajan.
Use with caution in patients who have had myopathy or rhabdomyolysis in the past or have any predisposing issues including other medicinal products associated with these conditions (see section 4.8).
Primjenjivati uz oprez u bolesnika koji su ranije imali miopatiju ili rabdomiolizu ili imaju neki od predisponirajućih čimbenika, uključujući primjenu drugih lijekova povezanih s tim stanjima (vidjeti dio 4.8).
Patients should be instructed to keep scheduled appointments because the ISENTRESS dosage should be adjusted as the child grows.
Bolesnike treba uputiti da redovito dolaze na dogovorene kontrole jer se doza lijeka ISENTRESS mora prilagođavati kako dijete raste.
The dosing recommendations are based on approximately: 3 mg/kg/dose.
Preporuke za doziranje temelje se na približnoj dozi od 3 mg/kg.
* for ISENTRESS Granules For Oral Suspension and Chewable Tablets in Paediatric Patients at least 4 weeks of age and weighing 3 to 25 kg
* ISENTRESS granula za oralnu suspenziju i tableta za žvakanje za pedijatrijske bolesnike u dobi od najmanje 4 tjedna i tjelesne težine od 3 do 25 kg
The recommended dose of Isentress is 400 mg by mouth, twice a day for adolescents and children weighing at least 25 kg.
Preporučena doza lijeka Isentress je 400 mg kroz usta, dvaput na dan za adolescente i djecu koja imaju najmanje 25 kg.
In these 26 infants and toddlers, the frequency, type and severity of drug related adverse reactions through Week 48 were comparable to those observed in adults.
U tih su 26 dojenčadi i male djece učestalost, vrsta i težina nuspojava povezanih s primjenom lijeka tijekom 48 tjedana bile usporedive s onima opaženima u odraslih.
Emtricitabine/tenofovir disaproxil fumarate was identified to increase raltegravir 1,200 mg once daily bioavailability by 12%, however its impact is not clinically meaningful.
Utvrđeno je da kombinacija emtricitabin/tenofovirdizoproksilfumarat povećava bioraspoloživost raltegravira u dozi od 1200 mg jedanput na dan za 12%, no njezin utjecaj nije klinički značajan.
Rash occurred more commonly in treatment-experienced patients receiving regimens containing raltegravir and darunavir compared to patients receiving raltegravir without darunavir or darunavir without raltegravir (see section 4.8).
Osip se češće javljao u prethodno liječenih bolesnika čije je liječenje uključivalo raltegravir i darunavir u usporedbi s bolesnicima koji su primali raltegravir bez darunavira ili darunavir bez raltegravir (vidjeti dio 4.8).
One patient experienced a Grade 3 serious drug related allergic rash that resulted in treatment discontinuation.
Jedan je bolesnik imao ozbiljan alergijski osip 3. stupnja povezan s primjenom lijeka, koji je doveo do prekida liječenja.
Raltegravir 600 mg (1,200 mg once daily)
Raltegravir 600 mg (1200 mg jedanput na dan)
Cohort 1 (N=16, 10 exposed and 6 unexposed to raltegravir in utero) received 2 single doses of raltegravir GFS (within 48 hours and 7 - 10 days after birth); Cohort 2 (N=26, all raltegravir unexposed in utero) received raltegravir GFS for 6 weeks: 1.5 mg/kg once daily starting within 48 hours of birth through Week 1; 3 mg/kg twice daily Weeks 2 to 4; and 6 mg/kg twice daily Weeks 5 and 6.
Novorođenčad u Kohorti 1 (N=16, od kojih je 10 bilo izloženo raltegraviru in utero, a 6 nije bilo izloženo raltegraviru in utero) primila je 2 pojedinačne doze raltegravir granula za oralnu suspenziju (unutar 48 sati od rođenja te od 7 do 10 dana nakon rođenja); novorođenčad u Kohorti 2 (N=26, nijedno novorođenče nije bilo izloženo raltegraviru in utero) primala je dozu raltegravir granula za oralnu suspenziju tijekom 6 tjedana: 1,5 mg/kg jedanput na dan, počevši unutar 48 sati od rođenja pa do 1. tjedna; 3 mg/kg dvaput na dan od 2. do 4. tjedna; te 6 mg/kg dvaput na dan u 5. i 6. tjednu.
HCV ANTIVIRALS NS3/4A protease inhibitors (PI) boceprevir (raltegravir 400 mg Single Dose)
ANTIVIROTICI PROTIV HCV-a Inhibitori NS3/4A proteaze (IP) boceprevir (raltegravir jednokratna doza od 400 mg)
WHITE
BIJELA
Raltegravir 400 mg twice daily should be used during pregnancy only if the expected benefit justifies the potential risk to the foetus.
Raltegravir u dozi od 400 mg dvaput na dan smije se primjenjivati tijekom trudnoće samo ako očekivana korist opravdava potencijalni rizik za fetus.
Comparable efficacy and safety results were obtained in the absence or presence of these gastric pH-altering agents.
Dobiveni su usporedivi rezultati za djelotvornost i sigurnost u prisustvu tih lijekova koji mijenjaju želučani pH i bez njih.
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.
Jedna tableta za žvakanje sadrži približno 0,46 mg fruktoze, približno 0,05 mg fenilalanina (kao sastavnice aspartama) i približno 1,4 mg sorbitola.
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.
Populacijska farmakokinetička analiza pokazala je da je utjecaj lijekova koji mijenjaju želučani pH na farmakokinetiku raltegravira bio minimalan (8,8% manja relativna bioraspoloživost) te nije bio statistički ni klinički značajan.
In both studies at Week 24, suppression of HIV RNA to less than 50 copies/mL was maintained in 84.4 % of the raltegravir group versus 90.6 % of the lopinavir (+) ritonavir group, (Non-completers = Failure).
U oba je ispitivanja supresija HIV-RNK u 24. tjednu održana na manje od 50 kopija/ml u 84,4% bolesnika u skupini koja je primala raltegravir naspram 90,6% bolesnika u skupini koja je primala lopinavir (+) ritonavir ("prerani prekid = neuspjelo liječenje").
Based on these data, proton pump inhibitors and H2 blockers may be co-administered with raltegravir 1,200 mg once daily.
Temeljem tih podataka, inhibitori protonske pumpe i blokatori H2-receptora mogu se primjenjivati istodobno s raltegravirom u dozi od 1200 mg jedanput na dan.
There was no clinically meaningful effect of age on raltegravir pharmacokinetics in healthy subjects and patients with HIV-1 infection over the age range studied (19 to 84 years, with few individuals over the age of 65).
Dob nije imala klinički značajnog učinka na farmakokinetiku raltegravira u zdravih ispitanika i bolesnika s infekcijom virusom HIV-1 u ispitanom dobnom rasponu (od 19 do 84 godine uz nekoliko pojedinaca starijih od 65 godina).
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.
Odrasli, djeca i adolescenti tjelesne težine od najmanje 40 kg Preporučena doza je 1200 mg (dvije tablete od 600 mg) primijenjene kroz usta jedanput na dan.
Previous studies of raltegravir 400 mg twice daily showed that co-administration of tenofovir disoproxil fumarate (a component of emtricitabine/tenofovir disaproxil fumarate) increased raltegravir exposure.
Prethodna ispitivanja raltegravira u dozi od 400 mg dvaput na dan pokazala su da je istodobna primjena tenofovirdizoproksilfumarata (sastavnice kombinacije emtricitabin/ tenofovirdizoproksilfumarat) povećala izloženost raltegraviru.
The granules for oral suspension and the chewable tablets have not been studied in HIV-infected adolescents (12 to 18 years) or adults.
Granule za oralnu suspenziju i tablete za žvakanje nisu ispitivane u adolescenata (u dobi od 12 do 18 godina) ili odraslih inficiranih HIV-om.
Of the 126 patients, 96 received the recommended dose of raltegravir twice daily.
Od 126 bolesnika 96 ih je primalo preporučenu dozu raltegravira dvaput na dan.
Baseline Characteristics and Efficacy Outcomes at Weeks 24 and 48 from IMPAACT P1066 (2 to 18 years of age)
Početne karakteristike bolesnika i ishodi djelotvornosti u 24. i 48. tjednu iz ispitivanja IMPAACT P1066 (dob: 2 do 18 godina)
ISENTRESS film-coated tablets contain lactose.
ISENTRESS filmom obložene tablete sadrže laktozu.
In some studies, co-administration of raltegravir with darunavir resulted in a modest decrease in darunavir plasma concentrations; the mechanism for this effect is unknown.
U nekim je ispitivanjima istodobna primjena raltegravira i darunavira dovela do blagog sniženja koncentracija darunavira u plazmi; mehanizam u pozadini tog učinka nije poznat.
Instructions for Use Bring this booklet to your child's appointments.
Upute za primjenu Ponesite ovu knjižicu s uputama za primjenu na sve djetetove liječničke preglede
Of the 126 patients, 96 received the recommended dose of raltegravir.
Od 126 bolesnika 96 ih je primalo preporučenu dozu raltegravira.
Factors associated with failure include high baseline viral load and OBT that did not include at least one potent active agent.
Faktori povezani s neuspjelim odgovorom na liječenje uključuju visoko virusno opterećenje na početku liječenja i OBT u koju nije uključen najmanje jedan potentni aktivni lijek.
Rash considered by the investigator to be drug-related occurred at similar rates.
Stope osipa za koje je ispitivač smatrao da su povezane s primjenom lijeka bile su slične.
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.
Isentress granule za oralnu suspenziju sadrže fruktozu, sorbitol i saharozu Ako Vam je liječnik rekao da ne podnosite neke šećere, savjetujte se s liječnikom prije uzimanja ovog lijeka.
No dosage adjustment is required for patients with mild to moderate hepatic impairment.
Nije potrebno prilagođavati dozu u bolesnika s blagim do umjerenim oštećenjem funkcije jetre.
Based on these findings, co-administration of aluminium/magnesium and calcium carbonate containing antacids with raltegravir 1,200 mg once daily is not recommended.
S obzirom na ove nalaze, istodobna primjena antacida koji sadrže aluminij/magnezij i kalcijev karbonat s raltegravirom u dozi od 1200 mg jedanput na dan se ne preporučuje.
Raltegravir granules for oral suspension should be used during pregnancy only if the expected benefit justifies the potential risk to the foetus.
Raltegravir granule za oralnu suspenziju smiju se primjenjivati tijekom trudnoće samo ako očekivana korist opravdava potencijalni rizik za fetus.
Isentress might interact with other medicines.
Moguće je međusobno djelovanje lijeka Isentress i drugih lijekova.
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.
Ispitivanje učinka hrane uz primjenu jedne doze lijeka pokazalo je da su učinci hrane kod primjene doze od 1200 mg jedanput na dan uz obrok s visokim odnosno niskim udjelom masti bili slični ili manji u usporedbi s primjenom doze od 400 mg dvaput na dan.
Push the plunger of the blue syringe into the syringe as far as it goes.
Gurnite klip plave štrcaljke u tijelo štrcaljke sve do kraja.
Caution is recommended when co-administering raltegravir 1,200 mg once daily with sensitive OAT1 and/or OAT3 substrates.
Potreban je oprez pri istodobnoj primjeni raltegravira u dozi od 1200 mg jedanput na dan s osjetljivim OAT1 i/ili OAT3 supstratima.
Contents of the pack and other information Instructions for use - see the booklet for how to prepare and give the medicine
Upute za primjenu - pogledajte knjižicu s uputama o tome kako pripremiti i primijeniti ovaj lijek
The chewable tablets and the granules for oral suspension have not been studied in HIV-infected adolescents (12 to 18 years) or adults.
Tablete za žvakanje i granule za oralnu suspenziju nisu ispitivane u adolescenata (u dobi od 12 do 18 godina) ili odraslih inficiranih HIV-om.
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).
ISENTRESS 600 mg filmom obložene tablete su u kombinaciji s drugim antiretrovirusnim lijekovima indicirane za liječenje infekcije virusom humane imunodeficijencije (HIV-1) u odraslih i pedijatrijskih bolesnika tjelesne težine od najmanje 40 kg (vidjeti dijelove 4.2, 4.4, 5.1 i 5.2).
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines with or without a prescription.
Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove, uključujući i one koje ste nabavili bez recepta.
Inhibitors of UGT1A1
Inhibitori UGT1A1
Administration of a low fat meal with raltegravir 1,200 mg once daily resulted in a 42% decrease in AUC0-last, 52% decrease in Cmax, and 16% decrease in C24hr.
Primjena obroka s niskim udjelom masti s raltegravirom u dozi od 1200 mg jedanput na dan dovela je do smanjenja AUC0-last za 42%, smanjenja Cmax za 52% i smanjenja C24h za 16%.
There are no data for the use of raltegravir 1,200 mg once daily in pregnant women.
Nema podataka o primjeni raltegravira u dozi od 1200 mg jedanput na dan u trudnica.
Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported to occur in the setting of immune reactivation: however, the reported time to onset is more variable and these events can occur many months after initiation of treatment.
U uvjetima imunološke reaktivacije prijavljeni su i autoimuni poremećaji (kao npr. Gravesova bolest i autoimuni hepatitis); međutim, prijavljeno vrijeme do pojave je različito i ti se događaji mogu javiti više mjeseci nakon uvođenja liječenja.
Neonates, Infants and Toddlers
Novorođenčad, dojenčad i mala djeca
Based on a formulation comparison study in healthy adult volunteers, the chewable tablet and granules for oral suspension have higher oral bioavailability compared to the 400 mg tablet.
Na temelju ispitivanja usporedbe oblika lijeka u zdravih odraslih dobrovoljaca, utvrđeno je da tableta za žvakanje i granule za oralnu suspenziju imaju veću bioraspoloživost od tablete od 400 mg nakon peroralne primjene.
Isentress 600 mg film-coated tablets is used to treat adults and paediatric patients weighing at least 40 kg who are infected by HIV.
Isentress 600 mg filmom obložene tablete primjenjuju se za liječenje odraslih i pedijatrijskih bolesnika tjelesne težine od najmanje 40 kg koji su zaraženi HIV-om.
• Isentress chewable tablets are not recommended in pregnancy because they have not been studied in pregnant women.
• Primjena Isentress tableta za žvakanje u trudnoći se ne preporučuje jer nije ispitana u trudnica.
Following administration of an oral dose of radiolabeled raltegravir, approximately 51 and 32 % of the dose was excreted in faeces and urine, respectively.
Nakon primjene oralne doze raltegravira označenog radioizotopom oko 51% doze izlučilo se fecesom, a oko 32% urinom.
Raltegravir was administered with an optimised background regimen.
Raltegravir se primjenjivao s optimiziranom osnovnom terapijom.
In some patients with advanced HIV infection and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started.
U nekih bolesnika s uznapredovalom HIV infekcijom koji su već imali oportunističke infekcije mogu se ubrzo nakon početka primjene lijeka protiv HIV-a pojaviti znakovi i simptomi upale od prijašnjih infekcija.
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.
U bolesnika inficiranih virusom HIV-a s teškim imunološkim deficitom u trenutku uvođenja kombinirane antiretrovirusne terapije može se razviti upalna reakcija na asimptomatske ili rezidualne oportunističke patogene te uzrokovati ozbiljna klinička stanja ili pogoršanje simptoma.
• Keep the bottle tightly closed, with the desiccant in order to protect from moisture.
• Bocu čuvati čvrsto zatvorenu, sa sredstvom za sušenje radi zaštite od vlage.
Raltegravir 400 mg twice daily + OBT (N = 462)
Raltegravir 400 mg dvaput na dan + OBT (N=462)
Results 48-week and 240-week analyses
Rezultati analiza 48. i 240. tjedna
500 cells/mm
500 stanica/mm
Raltegravir Pharmacokinetic Parameters IMPAACT P1066 Following Administration of Doses in Section 4.2
Farmakokinetički parametri raltegravira u ispitivanju IMPAACT P1066 nakon primjena doza navedenih u dijelu 4.2
2 blue (10 mL) syringes
2 plave (10 ml) štrcaljke
In drug interaction studies performed using raltegravir 400 mg twice daily, raltegravir did not have a clinically meaningful effect on the pharmacokinetics of etravirine, maraviroc, tenofovir disoproxil fumarate, hormonal contraceptives, methadone, midazolam or boceprevir.
U ispitivanjima interakcija s raltegravirom u dozi od 400 mg dvaput na dan raltegravir nije imao klinički značajan učinak na farmakokinetiku etravirina, maraviroka, tenofovirdizoproksilfumarata, hormonskih kontraceptiva, metadona, midazolama ili boceprevira.