natgillin/translations-raw huggingface dataset:
Sirolimus 2 mg was dosed alone, 0.5 mg administered with dasabuvir + ombitasvir/paritaprevir/ritonavir.
Sirolimus se u dozi od 2 mg primjenjivao sam, a u dozi od 0,5 mg s dasabuvirom + ombitasvir/paritaprevir/ritonavir.
• Monitoring should be performed for clinical signs and symptoms of hepatic decompensation (such as ascites, hepatic encephalopathy, variceal haemorrhage).
• Potreban je nadzor zbog moguće pojave kliničkih znakova i simptoma dekompenzacije jetre
CYP3A/efflu x transporters by lopinavir and higher dose of ritonavir.
povećanje izloženosti paritaprevir u moglo bi biti posljedica inhibicije CYP3A/eflu ksnih prijenosnika koju uzrokuju lopinavir i viša doza ritonavira.
Frequency dasabuvir and ombitasvir/paritaprevir/ritonavir + ribavirin* N = 2,044
Učestalost dasabuvir i ombitasvir/paritaprevir/ritonavir + ribavirin* N = 2044
TURQUOISE II (open-label)
ribavirin, s kompenziranom cirozom TURQUOISE II (otvoreno ispitivanje)
The activity of dasabuvir was reduced by 5- and 11-fold by C316N and S556G, respectively; 46-fold by M414T or Y448H; and 1569-fold by the C316Y substitutions in the genotype 1b replicon.
U replikonu genotipa 1b, supstitucija C316N smanjila je aktivnost dasabuvira 5 puta, supstitucija S556G 11 puta, supstitucije M414T i Y448H 46 puta, a supstitucija C316Y 1569 puta.
Dabigatran etexilate Mechanism: Intestinal Pgp inhibition by paritaprevir and ritonavir.
Mehanizam: crijevna Pgp inhibicija paritaprevir om i ritonavirom.
Treated subjects (N=380) had a median age of 58 years (range: 21 to 71); 42.1% were treatment-naïve, 36.1% were prior pegIFN/RBV null responders; 8.2% were prior pegIFN/RBV partial responders, 13.7% were prior pegIFN/RBV relapsers; 70.3% were male; 3.2% were Black; 14.7% had platelet counts of less than 90 x 109/L; 49.7% had albumin less than 40 g/L; 86.1% had baseline HCV RNA levels of at least 800,000 IU/mL; 24.7% had a history of depression or bipolar disorder; 68.7% had HCV genotype 1a infection, 31.3% had HCV genotype 1b infection.
Medijan dobi liječenih ispitanika (N=380) iznosio je 58 godina (raspon: 21 do 71); 42,1% prethodno nije bilo liječeno; 36,1% nije ostvarilo odgovor na prethodno liječenje kombinacijom pegIFN/RBV; 8,2% ostvarilo je djelomičan odgovor na prethodno liječenje kombinacijom pegIFN/RBV; 13,7% doživjelo je relaps nakon prethodnog liječenja kombinacijom pegIFN/RBV; 70,3% ispitanika bili su muškarci; 3,2% bili su crnci; 14,7% imalo je broj trombocita manji od 90 x 109/l, 49,7% imalo je razinu albumina manju od 40 g/l; 86,1% imalo je početne razine HCV RNK od najmanje 800 000
The adverse reactions are listed below by system organ class and frequency.
Nuspojave u nastavku razvrstane su prema organskim sustavima i učestalosti.
0.75 mg single dose
Everolimus 0,75 mg pojedinačna doza Mehanizam:
global multicentre, open-label
globalno, multicentrično, otvoreno ispitivanje
Dose normalized tacrolimus ratios are shown for interaction with dasabuvir + ombitasvir/paritaprevir/ritonavir.
Omjeri normalizirani za dozu takrolimusa prikazani su za interakciju s dasabuvirom + ombitasvir/paritaprevir/ritonavir.
TURQUOISE-III: treatment-naïve or pegIFN + RBV-experienced with compensated cirrhosis
TURQUOISE-III: ispitanici s kompenziranom cirozom, prethodno neliječeni ili prethodno liječeni kombinacijom pegIFN + RBV
Treated subjects (N = 63) had a median age of 51 years (range: 31 to 69); 24% were Black; 19% had compensated cirrhosis; 67% were treatment-naïve; 33% had failed prior treatment with pegIFN/RBV; 89% had HCV genotype 1a infection.
(raspon: 31 do 69); 24% bili su crnci; 19% imalo je kompenziranu cirozu; 67% prethodno nije bilo liječeno; 33% nije ostvarilo odgovor na prethodno liječenje kombinacijom pegIFN/RBV; 89% imalo je infekciju HCV-om genotipa 1a.
PEARL-II - genotype 1b, pegIFN+RBV-experienced, without cirrhosis Design:
PEARL-II - ispitanici s infekcijom genotipom 1b prethodno liječeni kombinacijom pegIFN+RBV, bez ciroze
Ciclosporin 100 mg dosed alone and 30 mg administered with dasabuvir + ombitasvir/paritaprevir/ritonavir.
Samostalna doza od 100 mg ciklosporina ili doza od 30 mg ciklosporina primijenjena s dasabuvirom + ombitasvir/paritaprevir/ritonavir.
DIURETICS Furosemide 20 mg single dose
20 mg pojedinačna doza
Prior pegIFN/RBV null responder Prior pegIFN/RBV partial responder Prior pegIFN/RBV relapser Outcome for subjects without SVR12 On-treatment VF
Relaps nakon prethodnog liječenja kombinacijom pegIFN/RBV Ishodi za ispitanike bez SVR12
The highest documented single dose of dasabuvir administered to healthy volunteers was 2 g. No study drug-related adverse reactions or clinically significant laboratory abnormalities were observed.
2 g. Nisu zabilježene nuspojave povezane s primjenom ispitivanoga lijeka ni klinički značajna odstupanja u laboratorijskim vrijednostima..
Mechanism: possibly due to UGT1A1 inhibition by paritaprevir, ombitasvir and dasabuvir.
Mehanizam: mogao bi biti posljedica inhbicije UGT1A1 koju uzrokuju paritaprevir, ombitasvir i dasabuvir.
Methadone
Metformin
Genotype-specific activity
Aktivnost protiv pojedinih genotipova
Mechanism: OATP1B inhibition by paritaprevir and BCRP inhibition by dasabuvir paritaprevir, and ritonavir.
Mehanizam: paritaprevir inhibira OATP1B, a dasabuvir, paritaprevir, ritonavir inhibiraju BCRP.
Resistance-associated variants at amino acid positions R155 and D168 in NS3 were rarely observed (less than 1%) at baseline.
Varijante na aminokiselinskim položajima R155 i D168 u NS3,
dasabuvir and ombitasvir/paritaprevir/ritonavir without ribavirin for 12 weeks
dasabuvir i ombitasvir/paritaprevir/ritonavir tijekom 12 tjedana, bez ribavirina
randomised, global multicentre, open-label, regimen-controlled
randomizirano, globalno, multicentrično, otvoreno ispitivanje kontrolirano terapijskim režimom
Mechanism: possibly due to UGT inhibition by paritaprevir, ombitasvir and dasabuvir.
Mehanizam: mogao bi biti posljedica inhibicije UGT-a koju uzrokuju paritaprevir, ombitasvir i dasabuvir.
800/160 mg twice daily dasabu vir +
800/160 mg dvaput na dan
ANTIMYCOBACTERIALS Rifampicin
ANTIKONVULZIVI karbamazepin
Tacrolimus 2 mg was dosed alone and 2 mg was administered with dasabuvir + ombitasvir/paritaprevir/ritonavir.
Samostalna doza od 2 mg takrolimusa i doza od 2 mg primijenjena s dasabuvirom + ombitasvir/paritaprevir/ritonavir.
Paritaprevir treatment-emergent variants V36A/M, R155K or D168V were observed in NS3 in 47 subjects.
R155K ili D168V u NS3 nastale tijekom primjene paritaprevira primijećene su u 47 ispitanika.
Mechanism: CYP3A4 inhibition by ritonavir and UGT inhibition by paritaprevir, ombitasvir and dasabuvir.
Mehanizam: ritonavir inhibira CYP3A4 a paritaprevir, ombitasvir i dasabuvir inhibiraju UGT.
↑ fluvastatin ↑ pitavastatin ↔ dasabuvir ↔ ombitasvir ↔ paritaprevir
↑ darunavir ↓ dasabuvir ombitasvir
HCV Genotype 1a dasabuvir and ombitasvir/paritaprevir/ritonavir with RBV
HCV genotipa 1a dasabuvir i ombitasvir/paritaprevir/ritonavir
Mechanism: CYP3A4/Pgp inhibition by ketoconazole and paritaprevir/ ritonavir/ ombitasvir aprevir/ ritonavi r ombitasvir
Mehanizam: CYP3A4 inhibicija ritonavirom ombitasvir/p aritaprevir/ri tonavir
Poly(vinyl alcohol) (E 1203) Titanium dioxide (E 171) Macrogol (3350) Talc (E 553b)
poli(vinilni alkohol) (E 1203) titanijev dioksid (E 171) makrogol (3350) talk (E 553b) željezov oksid, žuti (E 172) željezov oksid, crveni (E 172) željezov oksid, crni (E 172)
Treated subjects (N=179) had a median age of 57 years (range: 26 to 70); 35.2% were prior pegIFN/RBV null responders; 28.5% were prior pegIFN/RBV partial responders; and 36.3% were prior pegIFN/RBV relapsers; 54.2% were male; 3.9% were Black; ; 12.8% had a history of depression or bipolar disorder; 87.7% had baseline HCV RNA levels of at least 800,000 IU/mL; 17.9% had portal fibrosis (F2) and 14.0% had bridging fibrosis (F3).
Medijan dobi liječenih ispitanika (N=179) iznosio je 57 godina (raspon: 26 do 70); 35,2% nije ostvarilo odgovor na prethodno liječenje kombinacijom pegIFN/RBV, 28,5% ostvarilo je djelomičan odgovor na prethodno liječenje kombinacijom pegIFN/RBV, a 36,3% doživjelo je relaps nakon prethodnog liječenja kombinacijom pegIFN/RBV; 54,2% ispitanika bili su muškarci; 3,9% bili su crnci; 12,8% imalo je depresiju ili bipolarni poremećaj u anamnezi; 87,7% imalo je početne razine
Pravastatin 10 mg once daily
10 mg jedanput na dan
Tell your doctor or pharmacist if you notice any of the following side effects: Side effects when taking Exviera with ombitasvir/paritaprevir/ritonavir:
Recite svom liječniku ako imate sljedeće simptome tijekom uzimanja lijeka Exviera i ombitasvira/paritaprevira/ritonavira jer oni mogu biti znakovi pogoršanja jetrenih tegoba:
TURQUOISE-II - treatment-naïve or pegIFN + RBV-experienced with compensated cirrhosis
TURQUOISE-II - ispitanici s kompenziranom cirozom, prethodno neliječeni ili prethodno liječeni kombinacijom pegIFN + RBV
Overall SVR12 HCV genotype 1a HCV genotype 1b Outcome for subjects without SVR12 On-treatment VFa Relapse Otherb a. Confirmed HCV ≥ 25 IU/mL after HCV RNA < 25 IU/mL during treatment, confirmed 1 log10 IU/mL
Ukupan SVR12 HCV genotipa 1a HCV genotipa 1b Ishodi za ispitanike bez SVR12
randomised, global multicentre, open-label
randomizirano, globalno, multicentrično, otvoreno ispitivanje
250 mg single dose
karisoprodo l 250 mg pojedinačna doza
ombitasvir/paritaprevir/ritonavir with or without dasabuvir coadminstered with or without weight-based ribavirin for 12 or 24 weeks
ombitasvir/paritaprevir/ritonavir s dasabuvirom ili bez njega tijekom 12 ili 24 tjedna, u kombinaciji s ribavirinom doziranim prema tjelesnoj težini ili bez njega
Phenobarbita l
Fenobarbita l
Film-coating
Film ovojnica:
Caution should be used when sulfasalazine is co-administered with dasabuvir + ombitasvir/paritaprevir/ ritonavir.
Sulfasalazin se mora primjenjivati s oprezom istodobno s dasabuvirom + ombitasvir/paritaprevir/rito navir.
Without cirrhosis
Bez ciroze
Purpose of the medicine carbamazepine, phenytoin, phenobarbital for epilepsy efavirenz, etravirine, nevirapine for HIV infection
Namjena lijeka karbamazepin, fenitoin, fenobarbital za liječenje epilepsije efavirenz, etravirin, nevirapin za liječenje HIV infekcije apalutamid, enzalutamid za rak prostate lijekovi koji sadrže etinilestradiol, poput većine lijekova za sprječavanje začeća i vaginalni kontracepcijski prstenovi.
SAPPHIRE-I - genotype 1, treatment-naïve, without cirrhosis
SAPPHIRE-I - prethodno neliječeni ispitanici s infekcijom genotipom 1, bez ciroze Dizajn:
Dasabuvir was not carcinogenic in a 6-month transgenic mouse study up to the highest dosage tested (2 g/kg/day), resulting in dasabuvir AUC exposures approximately 19-fold higher than those in humans at the recommended dose of 500 mg (250 mg twice daily).
6-mjesečnom istraživanju na transgeničnim miševima, dasabuvir nije bio kancerogen ni pri najvišoj ispitivanoj dozi (2 g/kg/dan), koja je dovela do približno 19 puta veće izloženosti dasabuviru
Hepatic impairment
Dabigatrane teksilat
Refer to the tacrolimus or sirolimus Summary of Product Characteristics for additional dosing and monitoring instructions.
Za dodatne upute o doziranju i praćenju, pročitajte sažetak opisa svojstava lijeka za takrolimus ili sirolimus.
dasabuvir and ombitasvir/paritaprevir /ritonavir
dasabuvir i ombitasvir/paritaprevir/ritonavir
Mechanism: CYP3A4 induction by phenytoin.
Mehanizam: indukcija CYP3A4 fenobarbital om.
Hepatic decompensation and hepatic failure, including liver transplantation or fatal outcomes, have been reported post-marketing in patients treated with dasabuvir with ombitasvir/paritaprevir/ritonavir with and without ribavirin.
Nakon stavljanja lijeka u promet, u bolesnika liječenih dasabuvirom u kombinaciji s ombitasvirom/ paritaprevirom /ritonavirom te u kombinaciji s ribavirinom ili bez njega prijavljeni su dekompenzacija jetre i zatajenje jetre, uključujući slučajeve koji su završili transplantacijom jetre ili smrtnim ishodom.
SVR12 for genotype 1b-infected treatment-naïve subjects in PEARL III
SVR12 za prethodno neliječene ispitanike s infekcijom genotipom 1b u ispitivanju
Prior pegIFN/RBV relapser
Djelomičan odgovor na prethodno liječenje kombinacijom pegIFN/RBV
No dose adjustment is necessary for methadone and dasabuvir + ombitasvir/paritaprevir/ ritonavir.
Nije potrebno prilagođavati dozu za metadon i dasabuvir + ombitasvir/paritaprevir/rito
↑ hydrocod one
↑ hidrokodon 1,27
CYP3A4 inhibition by ritonavir.
učinak na takrolimus posljedica je inhibicije CYP3A4 ritonavirom.
Medicinal products transported by Pgp in the intestine While dasabuvir is an in vitro inhibitor of P-gp, no significant change was observed in the exposure of the P-gp substrate, digoxin, when administered with dasabuvir with ombitasvir/paritaprevir/ritonavir.
Iako je dasabuvir in vitro inhibitor P-gp-a, nije primijećena značajna promjena izloženosti digoksinu,
aprevir/ ritonavi r ombitasvir with dasabuvir and ombitasvir/paritaprevir/r itonavir due to increase in paritaprevir exposures (see Summary of Product Characteristics of ombitasvir/paritaprevir/r itonavir).
paritaprevir om/ritonavirom zbog povišenja izloženosti paritapreviru (vidjeti sažetak opisa svojstava lijeka ombitasvir/paritaprevir/rito navir ).
Endpoint dasabuvir and ombitasvir/paritaprevir/ritonavir with or without ribavirin for 12 or 24 Weeks N = 200a
Mjera ishoda dasabuvir i ombitasvir/paritaprevir/ritonavir u kombinaciji s ribavirinom ili bez njega tijekom 12 ili 24 tjedna N = 200a
NA No dose adjustment needed for abacavir or lamivudine when administered with dasabuvir + ombitasvir/paritaprevir/ ritonavir.
NP Nije potrebno prilagođavati dozu abakavira ili lamivudina kada se primjenjuju s dasabuvirom + ombitasvir/paritaprevir/rito navir.
Exviera contains lactose.
Exviera sadrži laktozu.
Mechanism: increase in dasabuvir possibly due to CYP2C8 inhibition by trimethoprim ombitasvir
povećanje izloženosti dasabuviru kao moguća posljedica inhibicije CYP2C8 trimetoprim om dasabuvir ombitasvir/p aritaprevir/ri tonavir
Baseline platelet count, median (× 109/L) < 90, n (%) ≥ 90, n (%) Pooled analyses of clinical trials Durability of response Overall, 660 subjects in Phase 2 and 3 clinical trials had HCV RNA results for both the SVR12 and SVR24 time points.
Postojanost odgovora Ukupno je 660 ispitanika u kliničkim ispitivanjima faze 2 i 3 postiglo željene razine HCV RNK i u trenutku određivanja SVR12 i u trenutku određivanja SVR24.
No dose adjustment is necessary for emtricitabine/tenofovir and dasabuvir + ombitasvir/paritaprevir/ ritonavir.
Nije potrebno prilagođavati dozu za emtricitabin/tenofovir i dasabuvir +
Apalutamide
lamivudin
Dasabuvir and ombitasvir/paritaprevir/ritonavir in combination with ribavirin is recommended for 24 weeks in liver transplant recipients.
U bolesnika s transplantiranom jetrom preporuča se primjena dasabuvira i ombitasvira/paritaprevira/ritonavira u kombinaciji s ribavirinom tijekom 24 tjedna.
Mechanism: Unknown dasabu vir + ombitas vir/parit aprevir/ ritonavi r
Mehanizam: nepoznat dasabuvir ombitasvir/ paritaprevir /ritonavir
PEARL-IV - genotype 1a, treatment-naïve, without cirrhosis
PEARL-IV - prethodno neliječeni ispitanici s infekcijom genotipom 1a, bez ciroze Dizajn:
Metabolism and nutrition disorders Uncommon Dehydration Psychiatric disorders Very common Insomnia Gastrointestinal disorders Very common Nausea, Diarrhoea Common
Poremećaji jetre i žuči nepoznata učestalost dekompenzacija jetre i zatajenje jetre dekompenzacija jetre i zatajenje jetre
↓ dasabuvir ↓ paritaprevir ↓ ombitasvir
↓ dasabuvir ↓ ombitasvir
Mechanism: BCRP and Pgp inhibition by paritaprevir, ritonavir and dasabuvir dasabu vir +
Mehanizam: BCRP i Pgp inhibicija paritaprevir om, ritonavirom i dasabuviro m dasabuvir ombitasvir/ paritaprevir /ritonavir
Treated subjects (N=394) had a median age of 54 years (range: 19 to 71); 49.0% were prior pegIFN/RBV null responders; 21.8/% were prior pegIFN/RBV partial responders; and 29.2% were prior pegIFN/RBV relapsers; 57.6% were male; 8.1% were Black; 20.6% had a history of depression or bipolar disorder; 87.1% had baseline HCV RNA levels of at least 800,000 IU per mL; 17.8% had portal fibrosis (F2) and 14.5% had bridging fibrosis (F3); 58.4% had HCV genotype 1a infection; 41.4% had HCV genotype 1b infection.
Medijan dobi liječenih ispitanika (N=394) iznosio je 54 godine (raspon: 19 do 71); 49,0% nije ostvarilo odgovor na prethodno liječenje kombinacijom pegIFN/RBV, 21,8% ostvarilo je djelomičan odgovor na prethodno liječenje kombinacijom pegIFN/RBV, a 29,2% doživjelo je relaps nakon prethodnog liječenja kombinacijom pegIFN/RBV; 57,6% ispitanika bili su muškarci; 8,1% bili su crnci; 20,6% imalo je depresiju ili bipolarni poremećaj u anamnezi; 87,1% imalo je početnu razinu
Treated subjects (N=631) had a median age of 52 years (range: 18 to 70); 54.5% were male; 5.4% were Black; 15.2% had a history of depression or bipolar disorder; 79.1% had baseline HCV RNA levels of at least 800,000 IU/mL; 15.4% had portal fibrosis (F2) and 8.7% had bridging fibrosis (F3); 67.7% had HCV genotype 1a infection; 32.3% had HCV genotype 1b infection.
imalo je početne razine HCV RNK od najmanje 800 000 IU/ml; 15,4% imalo je portalnu fibrozu (F2), a 8,7% premoštavajuću fibrozu (F3); 67,7% imalo je infekciju HCV-om genotipa 1a; 32,3% imalo je infekciju HCV-om genotipa 1b.
open-label, single-arm, global multicentre
otvoreno, globalno, multicentrično ispitivanje s jednom skupinom
- Notice yellowing of your skin or eyes.
- primjetite žutilo kože ili očiju - mokraća Vam je tamnija nego inače - smetenost
Mechanism: OATP1B1 inhibition by paritaprevir.
Mehanizam: paritaprevir inhibira OATP1B1
A reduction of hydrocodone dose by 50% and/or clinical monitoring should be considered when administered with dasabuvir + ombitasvir/paritaprevir /ritonavir.
Promjene za dasabuvir i ombitasvir, paritaprevir su iste kao što je prikazano iznad za paracetamol hidrokodona za 50% i/ili kliničko praćenje kada se primjenjuje s dasabuvirom ombitasvir/paritaprevir/rito navir.
No dose adjustment is necessary for norethindrone or dasabuvir + ombitasvir/paritaprevir/ ritonavir.
Nije potrebno prilagođavati dozu noretindrona ili dasabuvira ombitasvir/paritaprevir/rito navir.
Posology
Pravastatin
Tel.: +48 22 372 78 00
AbbVie Polska Sp. z o.o. Tel.: +48 22 372 78 00
For contra-indications with ombitasvir/ paritaprevir /ritonavir refer to the Summary of Product Characteristics.
Za kontraindikacije ombitasvira/ paritaprevira /ritonavira vidjeti njihov sažetak opisa svojstava lijeka.
SVR12, n/N (%) [95% CI] Outcome for subjects not achieving SVR12 On-treatment virologic failure Post-treatment relapse Otherb a. Includes all HCV GT1 subjects in Part 2 excluding Arm G subjects that did not receive recommended regimen.
SVR12, n/N (%) [95% CI] Ishod za ispitanike koji nisu postigli SVR12
Mechanism: decrease possibly due to CYP1A2 induction by ritonavir dasabu vir +
Mehanizam: smanjenje kao moguća posljedica indukcije CYP1A2 ritonavirom dasabuvir ombitasvir/p aritaprevir/ri tonavir ciklobenzapri n
SVR12 for genotype 1a-infected treatment-naïve subjects in PEARL IV
Tablica 9. SVR12 za prethodno neliječene ispitanike s infekcijom genotipom 1a u ispitivanju
• Vomiting
• povraćanje.
↑ naloxone
Lanzoprazol
Hepatic decompensation and hepatic failure
Virološki neuspjeh tijekom liječenja
9% had advanced fibrosis (F3) and 98.2% had HCV genotype 1b infection (one subject each had genotype 1a, 1d, and 6 infection).
HCV-om genotipa 1a; 31,3% imalo je infekciju HCV-om genotipa 1b.
30 mg once daily single dose3
Ciklosporin 30 mg jednom dnevno u pojednačnoj dozi3 Mehanizam:
↔ R
(INR).
Sirolimus
Dojenje
Immune system disorders Frequency unknown
Poremećaji imunološkog sustava nepoznata učestalost anafilaktičke reakcije anafilaktičke reakcije
For interactions with ombitasvir/ paritaprevir /ritonavir refer to the Summary of Product Characteristics.
Za interakcije s ombitasvirom/ paritaprevirom/ritonavirom vidjeti sažetak opisa svojstava lijeka.
No dose adjustment is necessary for buprenorphine/naloxon e and dasabuvir + ombitasvir/paritaprevir/ ritonavir.
Nije potrebno prilagođavati dozu za buprenorfin/nalokson i dasabuvir + ombitasvir/paritaprevir/rito navir.
Angioedema
DIURETICI Furosemid
Treatment outcome dasabuvir and ombitasvir/paritaprevir/ritonavir for 12 weeks
dasabuvir i ombitasvir/paritaprevir/ritonavir tijekom 8 tjedana
Upon completion of dasabuvir and ombitasvir/paritaprevir/ ritonavir treatment, the appropriate dose and dosing frequency of tacrolimus should be guided by assessment of tacrolimus blood concentrations.
odgovarajuću dozu i učestalost primjene takrolimusa treba odrediti na temelju koncentracija takrolimusa u krvi.
Mechanism: possibly due to UGT1A1 inhibition by paritaprevir, dasabuvir and ombitasvir and CYP3A4 inhibition by ritonavir dasabuvi r + ombitas vir/parit aprevir/r itonavir dolutegravir
Mehanizam: inhibicija Pgp-a koju uzrokuju dasabuvir, paritaprevir i ritonavir dasabuvir ombitasvir/ paritaprevir /ritonavir
No dose adjustment is necessary for raltegravir or dasabuvir ombitasvir/paritaprevir/ ritonavir.
Nije potrebno prilagođavati dozu za raltegravir ili dasabuvir + ombitasvir/paritaprevir/rito navir.
↑ levothyroxine
↑ fluvastatin ↑ pitavastatin
SVR12 for genotype 1-infected treatment-naïve subjects in SAPPHIRE-I
SVR12 za prethodno neliječene ispitanike s infekcijom genotipom 1 u ispitivanju
dasabuvir and ombitasvir/paritaprevir/ritonavir with or without RBV for 12 or 24 weeks
dasabuvir i ombitasvir/paritaprevir/ritonavir u kombinaciji s ribavirinom ili bez njega tijekom 12 ili 24 tjedna
↑ norbu prenorphine
↑ norbupre norfin
CYP2C8 inhibition and increase in paritaprevir is possibly due to
povećanje izloženosti dasabuviru posljedica je inhibicije CYP2C8 a povećanje izloženosti paritaprevir u moglo bi biti posljedica inhibicije OATP1B1 gemfibrozil om.
With RBV
RMP-a.
Treatment-naïve and peginterferon+ribavirin-experienced, with compensated cirrhosis
Prethodno neliječeni ispitanici i ispitanici prethodno liječeni kombinacijom peginterferon +
Laboratory abnormalities
Odstupanja u laboratorijskim vrijednostima
0.5 mg single dose5
Sirolimus 0,5 mg pojedinačna doza5 Mehanizam:
Mechanism: OATP1B inhibition by paritaprevir.
Mehanizam: paritaprevir inhibira OATP1B
↔ S
U
NA No dose adjustment needed for sofosbuvir when administered with dasabuvir + ombitasvir/paritaprevir /ritonavir.
NP Nije potrebno prilagođavati dozu sofosbuvira kada se primjenjuje s dasabuvirom ombitasvir/paritaprevir/rito navir.
Emtricitabine/ tenofovir 200 mg once daily/300 mg once daily dasabu vir + ombitas vir/parit aprevir/ ritonavi r
300/100 mg jedanput na dan dasabuvir ombitasvir/ paritaprevir /ritonavir
tenofovir dasabuvir ombitasvir paritaprevir
Emtricitabin / tenofovir dasabuvir ombitasvir/ paritaprevir emtricitabin
Mechanism: CYP2C19 induction by ritonavir dasabu vir +
Mehanizam: CYP2C19 indukcija ritonavirom dasabuvir ombitasvir/p aritaprevir/ri tonavir
Arm A: dasabuvir and ombitasvir/paritaprevir/ritonavir + RBV (12 weeks)
skupina A: dasabuvir i ombitasvir/paritaprevir/ritonavir + RBV (12 tjedana) skupina B: dasabuvir i ombitasvir/paritaprevir/ritonavir + RBV (24 tjedna)
paritaprevir the same time as dasabuvir +ombitasvir/paritaprevi r/ritonavir.
Učinak na dasabuvir ombitasvir/ paritaprevi r/ ritonavir
Retreatment
KONTRACEPTIVI
↔ digoxin 1.15
↔ R-metadon 1,04
ANTICOAGULANTS Warfarin
ANTIKOAGULANSI
No dose adjustment needed for dasabuvir + ombitasvir/paritaprevir/ ritonavir.
Nije potrebno prilagođavati dozu za dasabuvir + ombitasvir/paritaprevir/rito navir.
Axumin fluciclovine (
Axumin fluciklovin (
The side effects seen with the product are mild and rare, and there are no serious safety risks.
Nuspojave proizvoda rijetke su i blage i ne postoje nikakvi ozbiljni sigurnosni rizici.
The full EPAR for Axumin can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Cjelovito europsko javno izvješće o ocjeni dokumentacije o lijeku (EPAR) za lijek Axumin nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
What measures are being taken to ensure the safe and effective use of Axumin?
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Axumin?
Other information about Axumin
Ostale informacije o lijeku Axumin