natgillin/translations-raw huggingface dataset:
darunavir/cobicistat (anti-HIV medicine) - carbamazepine, phenobarbital, phenytoin (medicines to prevent seizures) - rifampicin, because it is contraindicated with boosted protease inhibitors, and rifapentine
darunavir/kobicistat (lijekovi protiv HIV-a) - karbamazepin, fenobarbital, fenitoin (lijekovi za sprječavanje napadaja) - rifampicin, budući da je kontraindiciran s pojačanim inhibitorima proteaze i rifapentin (lijekovi za liječenje nekih infekcija poput tuberkuloze) - pripravci koji sadrže gospinu travu (Hypericum perforatum) (biljni pripravak koji se koristi za depresiju) - daklatasvir, simeprevir (lijekovi za liječenje hepatitis C infekcije).
If you notice within 6 hours of the time you usually take INTELENCE, you must take the tablet as soon as possible.
Ukoliko primijetite da niste uzeli lijek unutar 6 sati od vremena kada obično uzimate INTELENCE, tabletu uzmite što je prije moguće, uvijek nakon obroka.
INTELENCE contains sodium
INTELENCE sadrži natrij
The bottle contains 2 little pouches (desiccants) to keep the tablets dry.
Boca sadrži 2 male vrećice (sredstvo za sušenje) kako bi se tablete očuvale suhima.
Rifampicin and rifapentine are expected to decrease plasma concentrations of etravirine.
Očekuje se da će rifampicin i rifapentin smanjiti koncentracije etravirina u plazmi.
Change from baseline in CD4 cell count (x 10
Promjena u odnosu na početnu vrijednost broja stanica CD4 (x 10
INTELENCE and these antifungals can be used without dose adjustments.
INTELENCE i ovi antimikotici mogu se primjenjivati bez prilagodbe doze.
Simultaneously, plasma concentrations of itraconazole or ketoconazole may be decreased by etravirine.
Istovremeno, etravirin može smanjiti koncentracije itrakonazola ili ketokonazola u plazmi.
Tablet White to off-white, oval tablet debossed with “T125” on one side and “100” on the other side.
Bijela do bjelkasta ovalna tableta s utisnutim natpisom „T125“ na jednoj strani i „100“ na drugoj strani.
INTELENCE can be used with these NRTIs without dose adjustment.
INTELENCE se može primjenjivati s ovim NRTI bez prilagodbe doze.
Your doctor will have to check your blood - fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole (medicines to treat fungal infections) - clarithromycin, rifabutin (antibiotics) - artemether/lumefantrine (a medicine to treat malaria) - diazepam (medicines to treat trouble with sleeping and/or anxiety) - dexamethasone (a corticosteroid used in a variety of conditions such as inflammation and allergic reactions) - boceprevir (a medicine to treat hepatitis C infection) - atorvastatin, fluvastatin, lovastatin, rosuvastatin, simvastatin (cholesterol-lowering medicines) - cyclosporine, sirolimus, tacrolimus (immunosuppressants - medicines used to dampen down your immune system) - sildenafil, vardenafil, tadalafil (medicines to treat erectile dysfunction and/or pulmonary arterial hypertension) - clopidogrel (a medicine to prevent blood clots).
- flukonazol, itrakonazol, ketokonazol, posakonazol, vorikonazol (lijekovi za liječenje gljivičnih infekcija) - klaritromicin, rifabutin (antibiotici) - artemeter/lumefantrin (lijek za liječenje malarije) - diazepam (lijekovi za liječenje problema sa spavanjem i/ili tjeskobu) - deksametazon (kortikosteroid koji se primjenjuje kod različitih stanja kao što su upala i alergijske reakcije) - boceprevir (lijek za liječenje hepatitis C infekcije) - atorvastatin, fluvastatin, lovastatin, rozuvastatin, simvastatin (lijekovi koji snizuju kolesterol) - ciklosporin, sirolimus, takrolimus (imunosupresivi - lijekovi koji se koriste za prigušivanje
Co-administration of etravirine with atazanavir/cobicistat or darunavir/cobicistat may decrease plasma concentrations of the PI and/or cobicistat, which may result in loss of therapeutic effect and development of resistance.
Istodobna primjena etravirina s atazanavirom/kobicistatom ili darunavirom/kobicistatom može sniziti koncentracije inhibitora proteaze i/ili kobicistata u plazmi, što može dovesti do gubitka tearpijskog učinka i razvoja rezistencije.
R(-) methadone AUC ↔ 1.06 (0.99-1.13) Cmin ↔ 1.10 (1.02-1.19) Cmax ↔ 1.02 (0.96-1.09) S(+) methadone AUC ↔ 0.89 (0.82-0.96) Cmin ↔ 0.89 (0.81-0.98) Cmax ↔ 0.89 (0.83-0.97) etravirine
R(-) metadon AUC ↔ 1,06 (0,99-1,13) Cmin ↔ 1,10 (1,02-1,19) Cmax ↔ 1,02 (0,96-1,09) S(+) metadon AUC ↔ 0,89 (0,82-0,96) Cmin ↔ 0,89 (0,81-0,98) Cmax ↔ 0,89 (0,83-0,97) etravirin
Clarithromycin 500 mg twice daily clarithromycin AUC ↓ 0.61 (0.53-0.69) Cmin ↓ 0.47 (0.38-0.57) Cmax ↓ 0.66 (0.57-0.77) 14-OH-clarithromycin AUC ↑ 1.21 (1.05-1.39) Cmin ↔ 1.05 (0.90-1.22) Cmax ↑ 1.33 (1.13-1.56) etravirine
Klaritromicin 500 mg dva puta dnevno klaritromicin AUC ↓ 0,61 (0,53-0,69) Cmin ↓ 0,47 (0,38-0,57) Cmax ↓ 0,66 (0,57-0,77) 14-OH-klaritromicin AUC ↑ 1,21 (1,05-1,39) Cmin ↔ 1,05 (0,90-1,22) Cmax ↑ 1,33 (1,13-1,56) etravirin
The trial population included PI-naïve, NNRTI-experienced patients with evidence of NNRTI resistance.
Populacija u ispitivanju obuhvaćala je bolesnike koji prethodno nisu primali inhibitore proteaze, ali su liječeni s NNRTI i imali su dokazanu rezistenciju na NNRTI.
Common side effects (may affect up to 1 in 10 people) - allergic reactions (hypersensitivity); - diabetes, decrease of appetite; - anxiety, sleepiness, sleeplessness, sleep disorders; - tingling or pain in hands or feet, numbness, loss of skin sensibility, loss of memory tiredness; - blurred vision; - kidney failure, high blood pressure, heart attack, shortness of breath when exercising; - vomiting, heartburn, abdominal pain, distension of the abdomen, inflammation of the stomach,
Česte nuspojave (mogu se javiti u do 1 na 10 osoba) - alergijske reakcije (preosjetljivost); - šećerna bolest, smanjenje apetita; - tjeskoba, pospanost, nesanica, poremećaji spavanja; - trnci ili bol u šakama ili stopalima, utrnulost, gubitak osjeta kože, gubitak pamćenja, umor ; - zamagljen vid; - zatajenje bubrega, visoki krvni tlak, srčani udar, nedostatak zraka pri vježbanju; - povraćanje, žgaravica, bol u trbuhu, nadimanje trbuha, upala želuca,vjetrovi, zatvor, upala usta,
Co-administration of etravirine and medicinal products that inhibit CYP3A4, CYP2C9 or CYP2C19 may decrease the clearance of etravirine and may result in increased plasma concentrations of etravirine.
Istovremena primjena etravirina i lijekova koji inhibiraju CYP3A4, CYP2C9 ili CYP2C19 može smanjiti klirens etravirina, što može rezultirati povećanom koncentracijom etravirina u plazmi.
These adverse reactions have been identified through postmarketing experience with etravirine.
Ove nuspojave bile su zabilježene tijekom razdoblja nakon stavljanja etravirina u promet.
INTELENCE should be used in combination with a boosted PI. Rifampicin is contraindicated in combination with boosted PIs.
Rifampicin je kontraindiciran u kombinaciji s pojačanim IP.
The bottle contains 3 little pouches (desiccants) to keep the tablets dry.
Boca sadrži 3 male vrećice (sredstvo za sušenje) kako bi se tablete očuvale suhima.
Voriconazole 200 mg twice daily voriconazole AUC ↑ 1.14 (0.88-1.47) Cmin ↑ 1.23 (0.87-1.75) Cmax ↓ 0.95 (0.75-1.21) etravirine
Vorikonazol 200 mg dva puta dnevno vorikonazol AUC ↑ 1,14 (0,88-1,47) Cmin ↑ 1,23 (0,87-1,75) Cmax ↓ 0,95 (0,75-1,21) etravirin
Etravirine 200 mg twice daily postpartum N = 10
Etravirin 200 mg dva puta dnevno postpartalno N = 10
There is limited information regarding the use of INTELENCE in patients > 65 years of age (see section 5.2), therefore caution should be used in this population.
Za primjenu lijeka INTELENCE kod populacije bolesnika starijih od 65 godina potreban je oprez s obzirom na to da su dostupni ograničeni podaci (vidjeti dio 5.2).
Each tablet contains 160 mg of lactose monohydrate.
Jedna tableta sadrži 160 mg laktoze hidrata.
The patient should be instructed to do the following: - place the tablet(s) in 5 ml (1 teaspoon) of water, or at least enough liquid to cover the medicine, - stir well until the water looks milky, - if desired, add more water or alternatively orange juice or milk (patients should not place the tablets in orange juice or milk without first adding water), - drink it immediately, - rinse the glass several times with water, orange juice, or milk and completely swallow the rinse each time to make sure the patient takes the entire dose.
Ako ne možete progutati cijele tabletu(e) lijeka INTELENCE, možete napraviti sljedeće: tabletu(e) možete staviti u 5 ml (1 čajnu žličicu) vode, ili barem dovoljno tekućine da pokrije lijek, dobro promiješajte dok voda ne poprimi mliječni izgled, ako želite, dodajte još vode ili alternativno sok od naranče ili mlijeko (nemojte staviti tablete u sok od naranče ili mlijeko), odmah ju popijte, isperite čašu nekoliko puta s vodom, sokom od naranče ili mlijekom i svaki put popijte cijeli sadržaj do kraja kako biste bili sigurni da ste uzeli cijelu dozu.
It is not recommended to co-administer INTELENCE with other NNRTIs.
Ne preporučuje se istodobno primjenjivati INTELENCE i drugi NNRTI.
Furthermore, the presence of this mutation alone did not affect the response in the etravirine arm. Additional data is required to conclude on the influence of K103N when associated with other NNRTIs mutations.
Za zaključak o utjecaju K103N kada je povezan s drugim mutacijama NNRTI, potrebni su dodatni podaci.
A plastic bottle containing 60 tablets and 3 pouches to keep the tablets dry.
Plastična boca sadrži 60 tableta i 3 vrećice kako bi se tablete očuvale suhima.
Removing the child resistant cap
Otvaranje sigurnosnog zatvarača za djecu
Rash has been reported with etravirine.
Uz primjenu etravirina bio je prijavljen osip.
The combination of INTELENCE and ribavirin can be used without dose adjustments.
Kombinacija lijeka INTELENCE i ribavirina može se primijeniti bez prilagodbe doze.
Concomitant use of etravirine with simeprevir may decrease plasma concentrations of simeprevir.
Istodobna primjena etravirina sa simeprevirom može sniziti koncentracije simeprevira u plazmi.
Each tablet contains 40 mg of lactose monohydrate.
Jedna tableta sadrži 40 mg laktoze hidrata.
Tablet White to off-white, biconvex, oblong tablet debossed with “T200” on one side.
Tableta Bijela do bjelkasta, bikonveksna, duguljasta tableta s utisnutim natpisom „T200“ na jednoj strani.
Each tablet contains 160 mg lactose (as monohydrate).
Jedna tableta sadrži 160 mg laktoze (u obliku hidrata).
INTELENCE 25 mg tablets
INTELENCE 25 mg tablete
INTELENCE and raltegravir can be used without dose adjustments.
INTELENCE i raltegravir mogu se primjenjivati bez prilagodbe doze.
Co-administration of INTELENCE with atazanavir/cobicistat or darunavir/cobicistat is not recommended.
Ne preporučuje se istodobna primjena lijeka INTELENCE s atazanavirom/kobicistatom ili darunavirom/kobicistatom.
Fluvastatin, and rosuvastatin are metabolised by CYP2C9 and co-administration with etravirine may result in higher plasma concentrations of the HMG Co-A reductase inhibitor.
Fluvastatin i rosuvastatin metabolizira enzim CYP2C9 i njihova istovremena primjena s etravirinom može rezultirati višim koncentracijama inhibitora HMG Co-A reduktaze u plazmi.
INTELENCE and atazanavir/ritonavir can be used without dose adjustment.
INTELENCE i atazanavir/ritonavir mogu se primjenjivati bez prilagodbe doze.
Each tablet contains 40 mg lactose (as monohydrate).
Jedna tableta sadrži 40 mg laktoze (u obliku hidrata).
AUC ↑ 1.10 (0.94-1.28) Cmax ↑ 1.10 (0.94-1.29) Cmin ↓ 0.88 (0.66-1.17) etravirine
AUC ↑ 1,10 (0,94-1,28) Cmax ↑ 1,10 (0,94-1,29) Cmin ↓ 0,88 (0,66-1,17) etravirin
AUC ↔ 0.99 (0.79-1.25) Cmin ND
AUC ↔ 0,99 (0,79-1,25) Cmin NP
AUC12h (ng•h/ml) Geometric Mean ± Standard Deviation Median (Range) C0h (ng/ml) Geometric Mean ± Standard Deviation Median (Range) * All HIV-1 infected subjects enrolled in Phase III clinical trials received darunavir/ritonavir 600/100 mg twice daily as part of their background regimen.
* Svi ispitanici zaraženi HIVom-1 uključeni u klinička ispitivanja faze III primili su darunavir/ritonavir 600/100 mg dva puta dnevno kao dio osnovnog liječenja.
AUC ↔ 0.87 (0.83-0.92) Cmin ↓ 0.80 (0.73-0.88) Cmax ↔ 0.89 (0.82-0.96) etravirine
AUC ↔ 0.87 (0.83-0.92) Cmin ↓ 0,80 (0,73-0,88) Cmax ↔ 0,89 (0,82-0,96) etravirin
Gastrointestinal very common diarrhoea, nausea disorders common gastrooesophageal reflux disease, vomiting, abdominal pain, abdominal distension, flatulence, gastritis, constipation, dry mouth, stomatitis, lipase increased, blood amylase increased uncommon pancreatitis, haematemesis, retching Hepatobiliary disorders common increased alanine aminotransferase (ALT), increased aspartate aminotransferase (AST) uncommon hepatitis, hepatic steatosis, cytolytic hepatitis, hepatomegaly
Poremećaji probavnog sustava vrlo često proljev, mučnina često gastroezofagealna refluksna bolest, povraćanje, abdominalna bol, abdominalna distenzija, flatulencija, gastritis, konstipacija, suha usta, stomatitis, povišena lipaza, povišena amilaza u krvi manje često pankreatitis, hematemeza dizanje želuca
BENZODIAZEPINES Diazepam
BENZODIAZEPINI
A plastic bottle containing 120 tablets and 2 pouches to keep the tablets dry.
Plastična boca sadrži 120 tableta i 2 vrećice kako bi se tablete očuvale suhima.
INTELENCE and tenofovir can be used without dose adjustments.
INTELENCE i tenofovir mogu se primjenjivati bez prilagodbe doze.
If you notice after 6 hours, then skip the intake and take the next doses as usual.
Ako primijetite da ste propustili uzeti lijek nakon 6 sati, preskočite propuštenu dozu i uzmite iduću dozu u slijedećem redovnom terminu za uzimanje lijeka.
AUC ↔ 1.15 (1.05-1.26) Cmin ↔ 1.02 (0.90-1.17) Cmax ↔ 1.11 (1.01-1.22) etravirine
AUC ↔ 1.15 (1.05-1.26) Cmin ↔ 1.02 (0.90-1.17) Cmax ↔ 1.11 (1.01-1.22) etravirin
INTELENCE can be co-administered with paroxetine without dose adjustments.
INTELENCE se može primjenjivati istodobno s paroksetinom bez prilagodbe doze.
SELECTIVE SEROTONIN REUPTAKE INHIBITORS (SSRIS) Paroxetine
SELEKTIVNI INHIBITORI PONOVNE POHRANE SEROTONINA (SSRI) Paroksetin 20 mg jedanput dnevno paroksetin
INTELENCE 100 mg tablets
INTELENCE 100 mg tablete
INTELENCE and digoxin can be used without dose adjustments.
INTELENCE i digoksin mogu se primjenjivati bez prilagodbe doze.
dolutegravir AUC↔ 1.11(1.02-1.20) Cmin ↑ 1.28 (1.13-1.45) Cmax ↔ 1.07 (1.02-1.13) etravirine
dolutegravir AUC↔ 1,11(1,02-1,20) Cmin ↑ 1,28 (1,13-1,45) Cmax ↔ 1,07 (1,02-1,13) etravirin
Saquinavir/ritonavir 1,000/100 mg twice daily saquinavir
Sakvinavir/ritonavir 1000/100 mg dva puta dnevno sakvinavir
After administration of a radiolabeled
Nakon primjene doze radioaktivno obilježenog C
INTELENCE and didanosine can be used without dose adjustments.
INTELENCE i didanozin mogu se primjenjivati bez prilagodbe doze.
INTELENCE 200 mg tablets
INTELENCE 200 mg tablete
AUC ↑ 1.69 (1.53-1.86) Cmin ↑ 1.77 (1.39-2.25) Cmax ↑ 1.62 (1.47-1.79) etravirine
AUC ↑ 1,69 (1,53-1,86) Cmin ↑ 1,77 (1,39-2,25) Cmax ↑ 1,62 (1,47-1,79) etravirin
ANTICOAGULANTS Warfarin
Disopiramid Flekainid
AUC ↔ 1.06 (0.99-1.14) Cmin ↔ 1.08 (0.98-1.19) Cmax ↔ 1.05 (0.95-1.17) maraviroc*
AUC ↔ 1,06 (0,99-1,14) Cmin ↔ 1,08 (0,98-1,19) Cmax ↔ 1,05 (0,95-1,17) maravirok*
AUC ↓ 0.62 (0.48-0.80) Cmin ↓ 0.82 (0.67-1.01) Cmax ↓ 0.72 (0.55-0.94) dihydroartemisinin AUC ↓ 0.85 (0.75-0.97) Cmin ↓ 0.83 (0.71-0.97) Cmax ↓ 0.84 (0.71-0.99) lumefantrine AUC ↓ 0.87 (0.77-0.98) Cmin ↔ 0.97 (0.83-1.15) Cmax ↔ 1.07 (0.94-1.23) etravirine
AUC ↓ 0,62 (0,48-0,80) Cmin ↓ 0,82 (0,67-1,01) Cmax ↓ 0,72 (0,55-0,94) dihidroartemisinin AUC ↓ 0,85 (0,75-0,97) Cmin ↓ 0,83 (0,71-0,97) Cmax ↓ 0,84 (0,71-0,99) lumefantrin
Instructions for taking INTELENCE for all patients It is important that you take INTELENCE following a meal.
Upute za uzimanje lijeka INTELENCE za sve bolesnike
Respiratory, thoracic and mediastinal disorders common exertional dyspnoea uncommon bronchospasm
Poremećaji dišnog sustava, prsišta i sredoprsja često dispneja pri naporu manje često bronhospazam
A plastic bottle containing 120 tablets and 3 pouches to keep the tablets dry.
Plastična boca sadrži 120 tableta i 3 vrećice kako bi se tablete očuvale suhima.
INTELENCE and fluconazole can be used without dose adjustments.
INTELENCE i flukonazol mogu se primjenjivati bez prilagodbe doze.
The bottle is a high-density polyethylene (HDPE) plastic bottle containing 60 tablets and 3 desiccant pouches, fitted with a polypropylene (PP) child resistant closure.
Plastična boca od polietilena visoke gustoće (HDPE) sa 60 tableta i 3 vrećice sa sredstvom za sušenje, zatvorena polipropilenskim (PP) sigurnosnim zatvaračem za djecu.
AUC ↑ 1.18 (1.03-1.36) Cmin ↑ 1.24 (0.96-1.59) Cmax ↑ 1.14 (1.02-1.27) etravirine
AUC ↑ 1,18 (1,03-1,36) Cmin ↑ 1,24 (0,96-1,59) Cmax ↑ 1,14 (1,02-1,27) etravirin
It is therefore possible that etravirine may inhibit the metabolism of clopidogrel to its active metabolite by such inhibition of CYP2C19 in vivo.
Kroz takvu inhibiciju CYP2C19 in vivo postoji mogućnost inhibicije metabolizma klopidogrela u njegov aktivni metabolit etravirinom.
TMC125-C227 was an exploratory, randomised, active-controlled open-label trial, which investigated the efficacy and safety of etravirine in a treatment regimen, which is not approved under the current indication.
Eksploratorna (engl. head to head) usporedba s inhibitorom proteaze kod bolesnika koji prethodno njima nisu bili liječeni (ispitivanje TMC125-C227) Ispitivanje TMC125-C227 bilo je eksplorativno, randomizirano, otvoreno ispitivanje s aktivnom kontrolom kojim se ispitivala djelotvornost i sigurnost primjene etravirina u liječenju izvan odobrenih indikacija.
INTELENCE 25 mg tablets etravirine
INTELENCE 25 mg tablete etravirin
INTELENCE and azithromycin can be used without dose adjustments.
INTELENCE i azitromicin mogu se primjenjivati bez prilagodbe doze.
Each tablet contains less than 1 mmol sodium (23 mg), and is essentially sodium-free.
Jedna tableta sadrži manje od 1 mmol (23 mg) natrija, tj. zanemarive količine natrija.
6 cells/l), mean (SE) and median (range) Change from baseline in CD4 percentage, median (range)
6 stanica/l), srednja vrijednost (SE) i medijan (raspon)
Etravirine is expected to increase plasma concentrations of warfarin.
Očekuje se da etravirin povećava koncentracije varfarina u plazmi.
INTELENCE and lopinavir/ritonavir can be used without dose adjustments.
INTELENCE i lopinavir/ritonavir mogu se primjenjivati bez prilagodbe doze.
The bottle is a high-density polyethylene (HDPE) plastic bottle containing 120 tablets and 2 desiccant pouches, fitted with a polypropylene (PP) child resistant closure.
Plastična boca od polietilena visoke gustoće (HDPE) sa 120 tableta i 2 vrećice sa sredstvom za sušenje, zatvorena polipropilenskim (PP) sigurnosnim zatvaračem za djecu.
AUC ↔ 0.94 (0.88-1.01) Cmin ↔ 0.91 (0.84-0.98) Cmax ↔ 0.92 (0.85-1.00) etravirine
AUC ↔ 0,94 (0,88-1,01) Cmin ↔ 0,91 (0,84-0,98) Cmax ↔ 0,92 (0,85-1,00) etravirin
Co-administration of Intelence and simeprevir is not recommended.
Ne preporučuje se istodobna primjena lijeka Intelence i simeprevira.
Etravirine is expected to increase nelfinavir plasma concentrations.
Očekuje se da će etravirin povećati koncentracije nelfinavira u plazmi.
Renal and urinary disorders common renal failure, blood creatinine increased
Poremećaji bubrega i mokraćnog sustava često zatajenje bubrega,, povišen kreatinin u krvi
AUC ↔ 1.15 (1.09-1.21) Cmin ↑ 1.19 (1.13-1.26) Cmax ↑ 1.15 (1.04-1.27) etravirine
AUC ↔ 1,15 (1,09-1,21) Cmin ↑ 1,19 (1,13-1,26) Cmax ↑ 1,15 (1,04-1,27) etravirin
200 mg twice daily eight 25 mg tablets twice daily or two 100 mg tablets twice daily or one 200 mg tablet twice daily
200 mg dva puta dnevno osam tableta od 25 mg dva puta dnevno ili dvije tablete od 100 mg dva puta dnevno ili jedna tableta od 200 mg dva puta dnevno
Do not use after 6 weeks of first opening the bottle.
Rok valjanosti Nemojte koristiti nakon što prođe 6 tjedana od prvog otvaranja boce.
See leaflet for further information.
Za više informacija vidjeti uputu o lijeku.
AUC ↔ 0.95 (0.64-1.42) Cmin ↓ 0.80 (0.46-1.38) Cmax ↔ 1.00 (0.70-1.42) etravirine
AUC ↔ 0,95 (0,64-1,42) Cmin ↓ 0,80 (0,46-1,38) Cmax ↔ 1,00 (0,70-1,42) etravirin
Sími: +354 535 7000 janssen@vistor.is
Janssen-Cilag AB IS-210 Garðabær Sími: +354 535 7000 janssen@vistor.is
Daclatasvir
Daklatasvir
dolutegravir AUC↓ 0.75 (0.69-0.81) Cmin ↓ 0.63 (0.52-0.77) Cmax ↓ 0.88 (0.78-1.00) etravirine
dolutegravir AUC↓ 0,75 (0,69-0,81) Cmin ↓ 0,63 (0,52-0,77) Cmax ↓ 0,88 (0,78-1,00) etravirin
Each tablet contains 25 mg etravirine.
Jedna tableta sadrži 25 mg etravirina.
The bottle is a high-density polyethylene (HDPE) plastic bottle containing 120 tablets and 3 desiccant pouches, fitted with a polypropylene (PP) child resistant closure.
Plastična boca od polietilena visoke gustoće (HDPE) sa 120 tableta i 3 vrećice sa sredstvom za sušenje, zatvorena polipropilenskim (PP) sigurnosnim zatvaračem za djecu.
Each tablet of INTELENCE contains 25 mg of etravirine.
Jedna tableta lijeka INTELENCE sadrži 25 mg etravirina.
Etravirine is expected to increase plasma concentrations of diazepam.
Očekuje se da će etravirin povećati koncentracije diazepama u plazmi.
ANTI-INFECTIVES Antiretrovirals NRTIs
NNRTI (nenukleozidni inhibitori reverzne transkriptaze) Efavirenz
INTELENCE 100 mg tablets etravirine
INTELENCE 100 mg tablete etravirin
Hypromellose Microcrystalline cellulose Colloidal anhydrous silica Croscarmellose sodium Magnesium stearate Lactose monohydrate
Celuloza, mikrokristalična Silicijev dioksid, koloidni, bezvodni Karmelozanatrij, umrežena Magnezijev stearat Laktoza hidrat
INTELENCE 200 mg tablets etravirine
INTELENCE 200 mg tablete etravirin
White to off-white, oval, scored tablet, debossed with “TMC” on one side.
Bijela do bjelkasta ovalna tableta s urezom i utisnutim natpisom „TMC“ na jednoj strani.
Fusion Inhibitors Enfuvirtide 90 mg twice daily etravirine*
90 mg dva puta dnevno etravirin*
Each tablet of INTELENCE contains 100 mg of etravirine.
Jedna tableta lijeka INTELENCE sadrži 100 mg etravirina.
AUC ↔ 1.03 (0.90-1.18) Cmin ↓ 0.87 (0.75-1.02) Cmax ↔ 1.06 (0.95-1.20) etravirine
AUC ↔ 1.03 (0,90-1,18) Cmin ↓ 0,87 (0,75-1,02) Cmax ↔ 1,06 (0,95-1,20) etravirin
Each tablet contains 100 mg etravirine.
Jedna tableta sadrži 100 mg etravirina.
Proportion of subjects with HIV-1 RNA < 50 copies/ml at week 48
Postotak ispitanika s HIV-1 RNK < 50 kopija/ml u 48. tjednu etravirin + BR N = 599
AUC ↓ 0.90 (0.68-1.18) Cmin ↓ 0.66 (0.34-1.26) Cmax ↓ 0.89 (0.68-1.15) etravirine
AUC ↓ 0,90 (0,68-1,18) Cmin ↓ 0,66 (0,34-1,26) Cmax ↓ 0,89 (0,68-1,15) etravirin
Each tablet of INTELENCE contains 200 mg of etravirine.
Jedna tableta lijeka INTELENCE sadrži 200 mg etravirina.
No data other than drug-drug interaction data (see section 4.5) are available when etravirine is combined with raltegravir or maraviroc.
Kada se etravirin kombinira s raltegravirom ili maravirokom, nisu dostupni drugi podaci osim podataka o interakciji lijekova (vidjeti dio 4.5).
Each tablet contains 200 mg etravirine.
Jedna tableta sadrži 200 mg etravirina.
In the evening, take two 100 milligram INTELENCE tablets, following a meal.
Navečer, nakon obroka uzmite dvije tablete lijeka INTELENCE od 100 miligrama.
Dexamethasone is expected to decrease plasma concentrations of etravirine
Očekuje se da će deksametazon smanjiti koncentracije etravirina u plazmi.
AUC ↓ 0.86 (0.79-0.93) Cmin ↓ 0.62 (0.55-0.71) Cmax ↔ 0.97 (0.89-1.05) etravirine
AUC ↓ 0,86 (0,79-0,93) Cmin ↓ 0,62 (0,55-0,71) Cmax ↔ 0,97 (0,89-1,05) etravirin
In the morning, take two 100 milligram INTELENCE tablets, following a meal.
Ujutro, nakon obroka uzmite dvije tablete lijeka INTELENCE od 100 miligrama.
Sirolimus
Takrolimus
Eye disorders common blurred vision
Poremećaji oka često zamagljen vid
Nervous system disorders very common headache common peripheral neuropathy, paraesthesia, hypoaesthesia,
Poremećaji živčanog sustava vrlo često glavobolja česte periferna neuropatija, parestezija, hipoestezija, amnezija, somnolencija manje često konvulzije, sinkopa, tremor, hipersomnija, poremećaj pažnje
150 mg twice daily six 25 mg tablets twice daily or one 100 mg tablet and two 25 mg tablets twice daily
≥ 25 do < 30 kg 150 mg dva puta dnevno šest tableta od 25 mg dva puta dnevno ili jedna tableta od 100 mg i dvije tablete od 25 mg dva puta dnevno
Recommendations concerning co-administration
Preporuke vezane uz istovremenu primjenu