natgillin/translations-raw huggingface dataset:
These medicines may be available without a prescription atorvastatin, lovastatin, simvastatin to lower blood cholesterol carbamazepine, phenytoin, phenobarbital for epilepsy cisapride for relieving certain stomach problems clarithromycin, fusidic acid, rifampicin, telithromycin for bacterial infections colchicine in patients who have severe problems with their liver or kidneys for treating gout attacks conivaptan for making the sodium levels in the blood normal efavirenz, etravirine, lopinavir/ritonavir, saquinavir, tipranavir, nevirapine, indinavir, cobicistat for HIV infection enzalutamide for prostate cancer ergotamine, dihydroergotamine for migraine headaches ergonovine, methylergometrine used in childbirth ethinylestradiol-containing medicines such as those contained in most contraceptive pills and vaginal rings used for contraception for contraception itraconozole, ketoconozole, posaconazole, voriconazole for fungal infections midazolam, triazolam (when taken by mouth) for anxiety or trouble sleeping mitotane for symptoms of malignant tumours of the adrenal glands pimozide, lurasidone for schizophrenia quetiapine for schizophrenia, bipolar disorder and major depressive disorder quinidine for abnormal heart rhythms or malaria ranolazine for chronic angina (chest pain)
atorvastatin, lovastatin, simvastatin za snižavanje razine kolesterola u krvi karbamazepin, fenitoin, fenobarbital za liječenje epilepsije cisaprid za ublažavanje određenih želučanih tegoba klaritromicin, fusidatna kiselina, rifampicin, telitromicin za liječenje bakterijskih infekcija kolhicin u bolesnika koji imaju teške tegobe s jetrom ili bubrezima za liječenje napadaja gihta konivaptan za reguliranje razine natrija u krvi efavirenz, etravirin, lopinavir/ritonavir, sakvinavir, tipranavir, nevirapin, indinavir, kobicistat za liječenje HIV infekcije enzalutamid za liječenje karcinoma prostate ergotamin, dihidroergotamin za liječenje migrenskih glavobolja ergonovin, metilergometrin lijekovi koji se koriste pri porodu lijekovi koji sadrže etinilestradiol koji se nalazi u većini kontracepcijskih tableta i vaginalnim prstenovima koji se koriste za kontracepciju za kontracepciju itrakonazol, ketokonazol, posakonazol, vorikonazol za liječenje gljivičnih infekcija midazolam, triazolam (kada se uzimaju kroz usta)
Purpose of the medicine
UPUTA O LIJEKU
Mechanism: CYP3A4/OA TP1B inhibition
Mehanizam: CYP3A4/ OATP1B inhibicija
In TURQUOISE-I, the SVR12 rates in HCV/HIV-1 co-infected subjects were consistent with SVR12 rates in the phase 3 trials of HCV mono-infected subjects.
U ispitivanju TURQUOISE-I stopa SVR12 u ispitanika s kroničnom infekcijom hepatitisom C i istodobnom infekcijom HIV-om tipa 1 odgovarala je stopi SVR12 u ispitivanjima faze III u ispitanika s infekcijom samo HCV-om.
Vitamin E polyethylene glycol succinate Propylene glycol monolaurate Sorbitan monolaurate Colloidal anhydrous silica (E551) Sodium stearyl fumarate
Jezgra tablete: kopovidon vitamin E polietilenglikolsukcinat propilenglikolmonolaurat sorbitanmonolaurat silicijev dioksid, koloidni, bezvodni (E551) natrijev stearilfumarat
Viekirax + dasabuvir duloxetine
Viekirax bez dasabuvira duloksetin
Viekirax and dasabuvir without ribavirin for 12 weeks
Viekirax i dasabuvir tijekom 12 tjedana bez ribavirina
Effect of dasabuvir on paritaprevir/ritonavir and ombitasvir In the presence of dasabuvir, paritaprevir exposures increased by 50% to 65% while there was no change in ombitasvir exposures.
U prisutnosti dasabuvira, izloženost paritapreviru se povećala za 50 do 65%, dok nije bilo promjene u izloženosti ombitasviru.
This is due to liver function changes during treatment with Viekirax ± dasabuvir.
To je posljedica promjene funkcije jetre prilikom liječenja lijekom Viekirax, s dasabuvirom ili bez njega.
Viekirax is an antiviral medicine used to treat adults with chronic (long-term) hepatitis C (an infectious disease that affects the liver, caused by the hepatitis C virus).
Viekirax je antivirusni lijek koji se koristi za liječenje odraslih koji boluju od kroničnog (dugotrajnog)
OATP1B1/3 substrates evaluated in drug interaction studies include pravastatin and rosuvastatin (see Table 2).
OATP1B1/3 supstrati ocijenjeni u ispitivanjima inaterakcija uključuju pravastatin i rosuvastatin
Monitor tacrolimus levels and adjust dose and/or dosing frequency as needed.
Pratiti razine takrolimusa te po potrebi prilagoditi dozu i/ili učestalost primjene.
Viekirax is not recommended in patients with moderate hepatic impairment (Child-Pugh B).
Ne preporučuje se primjena lijeka Viekirax u bolesnika s umjerenim oštećenjem funkcije jetre (ChildPugh stadij B).
In patients with renal or hepatic impairment, use of colchicine with Viekirax with or without dasabuvir is contraindicated (see section 4.3 and 4.5).
Kod bolesnika s oštećenjem funkcije bubrega ili jetre je kontraindicirana istodobna primjena kolhicina i lijeka Viekirax s dasabuvirom ili bez njega (vidjeti dijelove 4.3 i 4.5).
For patients that require ribavirin, refer to the ribavirin Summary of Product Characteristics for information regarding use in patients with renal impairment.
U bolesnika u kojih je potrebna primjena ribavirina, za informacije o primjeni kod bolesnika s oštećenjem funkcije bubrega vidjeti Sažetak opisa svojstava lijeka za ribavirin.
↑ fluvastatin ↑ pitavastatin
↑ kvetiapin ↑ lurasidon
Mechanism: CYP3A4/Pgp inhibition by erythromycin, paritaprevir, ritonavir and dasabuvir.
Mehanizam: CYP3A4/Pgp inhibicija erithromicin om, paritaprevir om, ritonavirom i dasabuviro m.
Viekirax 12.5 mg/75 mg/50 mg film-coated tablets ombitasvir/paritaprevir/ritonavir
Viekirax 12,5 mg / 75 mg / 50 mg filmom obložene tablete ombitasvir / paritaprevir / ritonavir
Pharmacokinetics of the combination of ombitasvir 25 mg, paritaprevir 200 mg, and ritonavir 100 mg, with dasabuvir 400 mg were evaluated in subjects with mild (Child-Pugh A), moderate (Child-Pugh B) and severe (Child-Pugh C) hepatic impairment.
Farmakokinetika kombinacije ombitasvira u dozi od 25 mg, paritaprevira u dozi od 200 mg i ritonavira u dozi od 100 mg s dasabuvirom u dozi od 400 mg ocijenjena je u ispitanika s blagim (Child-Pugh stadij A), umjerenim (Child-Pugh stadij B) i teškim (Child-Pugh stadij C) oštećenjem funkcije jetre.
Mechanism: CYP3A inhibition by ritonavir
Mehanizam: CYP3A inhibicija ritonavirom
SVR12 for genotype 1-infected peginterferon+ribavirin-experienced subjects in SAPPHIRE-II
SVR12 za ispitanike prethodno liječene peginterferonom i ribavirinom s infekcijom genotipom 1 u ispitivanju SAPPHIRE-II
ANTIPSYCHOTICS Lurasidone
ANTIPSIHOTICI lurasidon pimozid kvetiapin
Similar effect expected as observed with Viekirax + dasabuvir.
Očekuje se učinak sličan onome primijećenom kod primjene kombinacije Viekirax + dasabuvir.
Thirty four subjects (29 with HCV genotype 1a infection and 5 with HCV genotype 1b infection) were enrolled who had not received treatment for HCV infection after transplantation and had a METAVIR fibrosis score of F2 or less.
Uključeno je 34 ispitanika (29 s infekcijom HCV-om genotipa 1a i 5 s infekcijom HCV-om genotipa
increase in HCV RNA from nadir, or HCV RNA persistently ≥ 25 IU/mL with at least 6 weeks of treatment.
HCV RNK od ≥ 25 IU/ml uz najmanje 6 tjedana liječenja.
Treatment-naïve pegIFN + RBV experienced Prior relapse Prior partial response Prior null response 100% (32/32) Other pegIFN/RBV failures TOTAL +Other types of pegIFN/RBV failure include less well documented non-response, relapse/breakthrough or other pegIFN failure.
UKUPNO +Ostale vrste neuspjeha liječenja kombinacijom pegIFN/RBV uključuje manji precizno dokumentirani izostanak odgovora, relaps/proboj ili druge oblike neuspjeha liječenja kombinacijom pegIFN/RBV.
Mechanism: CYP3A4 induction by rifampicin.
Mehanizam: CYP3A4 indukcija rifampicino m.
Viekirax with or without dasabuvir ethinylestradiol
Viekirax s dasabuvirom ili bez njega etinilestradiol
If you are not sure, talk to your doctor or pharmacist before taking Viekirax.
razgovarajte sa svojim liječnikom ili ljekarnikom prije nego uzmete lijek Viekirax.
SVR12 for genotype 1-infected subjects with compensated cirrhosis who were treatmentnaïve or previously treated with pegIFN/RBV
Tablica 12. SVR12 za ispitanike s infekcijom genotipom 1 i kompenziranom cirozom koji prethodno nisu bili liječeni ili su primali pegIFN/RBV Ishod liječenja
Increase in raltegravir exposures may be due to UGT1A1 inhibition by paritaprevir, ombitasvir.
Povećanje izloženosti raltegraviru moglo bi biti posljedica inhibicije UGT1A1 koju uzrokuju paritaprevir, ombitasvir i dasabuvir.
SVR12 for genotype 4-infected, subjects who were treatment-naïve or previously treated with pegIFN/RBV in PEARL I
Tablica 17. Stope SVR12 za ispitanike s infekcijom genotipom 4, prethodno neliječene ili prethodno liječene pegIFN/RBV-om u ispitivanju PEARL I
GT1b Arm A: Viekirax and dasabuvir + RBV Arm B: Viekirax and dasabuvir Treatment-naïve and peginterferon+ribavirin -experienced, with compensated cirrhosis
GT1a skupina A: Viekirax i dasabuvir + RBV skupina B: Viekirax i dasabuvir Ispitanici prethodno liječeni peginterferonom i ribavirinom, bez ciroze SAPPHIRE II
CONTRACEPTIVES Ethinylestradiol/ norgestimate
KONTRACEPTIVI etinilestradiol/ norgestimat mg jedanput na dan
Increase in paritaprevir exposures may be due to inhibition of OATP1B1/B3 and CYP3A by atazanavir.
Povećanje izloženosti paritaprevir u moglo bi biti posljedica inhibicije OATP1B1/ B3 i
Mechanism: CYP2C19 induction by ritonavir.
Mehanizam: CYP2C19 indukcija ritonavirom.
Mechanism: CYP2C19 induction by ritonavir
Mehanizam: CYP2C19 indukcija ritonavirom
Resistance to paritaprevir and ombitasvir conferred by variants in NS3 and NS5A respectively, selected in cell culture or identified in Phase 2b and 3 clinical trials were phenotypically characterised in the appropriate genotype 1a or 1b replicons.
NS3 ili NS5A izdvojenima u staničnoj kulturi ili identificiranima u kliničkim ispitivanjima faze 2b i 3,
Mechanism: Intestinal Pgp inhibition by paritaprevir and ritonavir.
Mehanizam: inhibicija crijevnog Pgp paritaprevir om i ritonavirom.
Clinical monitoring and dose reduction is recommended for angiotensin receptor blockers when coadministered with Viekirax with or without dasabuvir.
Preporučuje se kliničko praćenje i smanjenje doze za blokatore angiotenzinskih receptora kada se primjenjuju istodobno s lijekom
ANTIHISTAMINES Astemizole
ANTIHISTAMINICI astemizol terfenadin
Mechanism: CYP3A4/Pgp inhibition by conivaptan and paritaprevir/ ritonavir/ombi tasvir
Mehanizam: CYP3A4/Pgp inhibicija konivaptano m i paritaprevir om/ritonavir om/ombitas virom
S-warfarin paritaprevir ombitasvir
S-varfarin paritaprevir ombitasvir dabigatran eteksilat
Viekirax and dasabuvir without ribavirin or with weight-based ribavirin for 12 weeks Treated subjects (N=419) had a median age of 50 years (range: 19 to 70), 45.8% were male; 4.8% were Black; 9.3% had a history of depression or bipolar disorder; 73.3% had baseline HCV RNA of at least 800,000 IU/mL; 20.3% had portal fibrosis (F2) and 10.0% had bridging fibrosis (F3).
Viekirax i dasabuvir tijekom 12 tjedana bez ribavirina ili s ribavirinom čija je doza temeljena na težini Medijan dobi liječenih ispitanika (N=419) iznosio je 50 godina (raspon: 19 do 70); 45,8% bili su muškarci; 4,8% bili su crnci;; 9,3% imalo je depresiju ili bipolarni poremećaj u anamnezi; 73,3%
For patients coadministered ribavirin refer to the Summary of Product Characteristics of ribavirin.
Za bolesnice koje istodobno primaju ribavirin, pročitajte i Sažetak opisa svojstava lijeka za ribavirin.
Mechanism: CYP3A4 inhibition by ritonavir and UGT inhibition by paritaprevir, ombitasvir and dasabuvir.
Mehanizam: inhibicija CYP3A4 ritonavirom te inhibicija UGT-a koju uzrokuju paritaprevir, ombitasvir i dasabuvir.
Outcome for subjects without SVR12 On-treatment virologic failure Post-treatment relapse Other
Virološki neuspjeh tijekom liječenja Relaps nakon liječenja
Ethinylestradiol-containing oral contraceptives are contraindicated (see section 4.3).
Oralni kontraceptivi koji sadrže etinilestradiol su kontraindicirani (vidjeti dio
Viekirax and dasabuvir with investigator chosen ribavirin dose for 24 weeks
Viekirax i dasabuvir tijekom 24 tjedna s ribavirinom čiju je dozu odredio ispitivač
Mechanism: UGT1A1 inhibition by paritaprevir, ombitasvir and dasabuvir.
Mehanizam: UGT1A1 inhibicija paritaprevir om, ombitasviro m i dasabuviro m.
Viekirax safety and efficacy have been established in combination with dasabuvir and/or ribavirin.
Istodobna primjena s drugim antiviroticima koji djeluju izravno na HCV Ustanovljene su sigurnost i djelotvornost lijeka Viekirax u kombinaciji s dasabuvirom i/ili ribavirinom.
CYP3A4 inhibition by ritonavir and increase in paritaprevir exposures may be due to OATP/BCRP/ P-gp inhibition by ciclosporin.
Učinak na ciklosporin posljedica je inhibicije CYP3A4 ritonavirom, dok bi povećanje izloženosti paritaprevir u moglo biti posljedica inhibicije OATPa/BCRP
Decrease digoxin dose by 30-50%.
NP Dozu pravastatina treba smanjiti za 50%.
SVR12 for genotype 1b-infected peginterferon+ribavirin-experienced subjects in PEARL II
Tablica 11. SVR12 za ispitanike prethodno liječene peginterferonom i ribavirinom s infekcijom genotipom 1b u ispitivanju PEARL II
↔ es citalopram
Sdezmetilcitalopram
Posology
buprenorfin
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 HCV RNK od najmanje 800 000 IU po ml; 17,8% imalo je portalnu fibrozu (F2), a 14,5%
300 mg single dose
300 mg pojedinačna doza paracetamol
Treated subjects (N = 63) had a median age of 51 years (range: 31 to 69); 24% of subjects were Black; 19% of subjects had compensated cirrhosis; 67% of subjects were HCV treatment-naïve; 33% of subjects had failed prior treatment with pegIFN/RBV; 89% of subjects had HCV genotype 1a infection.
19% ispitanika imalo je kompenziranu cirozu, 67% nije bilo prethodno liječeno, 33% ispitanika bilo je prethodno neuspješno liječeno pegIFN/RBV-om, 89% ispitanika imalo je infekciju HCV-om genotipa 1a.
↑ telithromycin ↑ paritaprevir
↑ vorikonazol ↑ dasabuvir ↑ paritaprevir
MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U PROMET
↑ naloxone
↑ dronedaron
Buprenorphine / naloxone
buprenorfin/ nalokson
No dose adjustment needed for Viekirax with ombitasvir paritaprevir
Nije potrebna prilagodba doze lijeka Viekirax primijenjenog s ombitasvir paritaprevir dasabuvir
Mechanism: OATP1B inhibition by paritaprevir and BCRP inhibition by paritaprevir, ritonavir or dasabuvir.
Mehanizam: paritaprevir inhibira OATP1B, a paritaprevir, ritonavir ili dasabuvir inhibiraju BCRP.
SAPPHIRE II
SAPPHIRE-I
NAME OF THE MEDICINAL PRODUCT Viekirax 12.5 mg / 75 mg / 50 mg tablets ombitasvir / paritaprevir / ritonavir
Viekirax 12,5 mg / 75 mg / 50 mg tablete ombitasvir / paritaprevir / ritonavir
In a phase 2, multicentre, open-label, single arm study, 38 treatment-naïve or pegIFN/RBV treatment experienced, non-cirrhotic subjects with genotype 1 infection who were on stable doses of methadone (N=19) or buprenorphine +/- naloxone (N=19) received 12 weeks of Viekirax and dasabuvir with ribavirin.
om genotipa 1 koji su bili na ustaljenim dozama metadona (N=19) ili buprenorfina +/- nalokson (N=19) primalo je Viekirax i dasabuvir s ribavirinom tijekom 12 tjedana.
300/100 mg once daily (administered 12 hours apart)
Kliničke napomene jedanput na dan (primijenjen u razmaku od 12 sati)
CYP3A4 induction by phenobarbital.
Mehanizam: Indukcija CYP3A4 fenobarbital om.
Diltiazem Verapamil
Kliničke napomene diltiazem verapamil
Hepatic decompensation and hepatic failure, including liver transplantation or fatal outcomes, have been reported postmarketing in patients treated with Viekirax with and without dasabuvir and with and without ribavirin.
Nakon stavljanja lijeka u promet, u bolesnika liječenih lijekom Viekirax u kombinaciji s dasabuvirom ili bez njega te u kombinaciji s ribavirinom ili bez njega prijavljeni su dekompenzacija jetre i zatajenje jetre, uključujući slučajeve koji su završili presađivanjem jetre ili smrtnim ishodom.
While no change to the pharmacokinetics of warfarin is expected, close
Iako nije očekivana promjena farmakokinetike varfarina, preporučuje se pomni nadzor INR-a kod primjene svih antagonista vitamina K.
Patients who are taking ethinylestradiol-containing medicinal products (i.e. most combined oral contraceptives or contraceptive vaginal rings) must switch to an alternative method of contraception (e.g., progestin only contraception or non-hormonal methods) prior to initiating Viekirax and dasabuvir therapy (see sections 4.3 and 4.5).
kontracepcija samo progestinom ili nehormonske metode) prije započinjanja liječenja lijekom Viekirax i dasabuvirom (vidjet dijelove 4.3 i 4.5).
Mechanism: CYP2C19 induction and CYP3A4 inhibition by ritonavir
Mehanizam: ritonavir inducira CYP2C19 i inhibira CYP3A4
Arm A: Viekirax and dasabuvir + RBV (12 weeks)
skupina A: Viekirax i dasabuvir + RBV (12 tjedana) skupina B: Viekirax i dasabuvir + RBV (24 tjedna)
Very common: may affect more than 1 in 10 people
• Rijetke: mogu se javiti u do 1 na 1000 osoba
and dasabuvir
dasabuvira
TURQUOISE-I: treatment-naïve or pegIFN + RBV-experienced with HIV-1 co-infection, without cirrhosis or with compensated cirrhosis
TURQUOISE-I: ispitanici bez ciroze ili s kompenziranom cirozom, prethodno neliječeni ili prethodno liječeni pegIFN i RBV s istodobnom infekcijom HIV-om tipa 1 Dizajn:
If the combination is used, repeated ECG-monitoring should be done, see section 4.4.
Ako se primjenjuje kombinacija, potrebno je redovito EKG
Baseline platelet count, median (× 109/L)
Početni broj trombocita, medijan (× 109/L) < 90, n (%)
2a
Ostalo a.
STATEMENT OF ACTIVE SUBSTANCE(S) Each film coated tablet contains 12.5 mg of ombitasvir, 75 mg of paritaprevir and 50 mg of ritonavir.
Jedna filmom obložena tableta sadrži 12,5 mg ombitasvira, 75 mg paritaprevira i 50 mg ritonavira.
The mean EC50 of paritaprevir against replicons containing NS3 from a panel of treatment-naïve genotype 1a and 1b isolates in the HCV replicon cell culture assay was 0.86 nM (range 0.43 to 1.87 nM; n=11) and 0.06 nM (range 0.03 to 0.09 nM; n=9), respectively.
0,43 do 1,87 nM; n=11) odnosno 0,06 nM (raspon: 0,03 do 0,09 nM; n=9).
CYP3A4/Pgp inhibition.
CYP3A4 inhibicija
Pitavastatin Mechanism: OATP1B inhibition by paritaprevir
Mehanizam: paritaprevir inhibira OATP1B
NAME OF THE MEDICINAL PRODUCT Viekirax 12.5 mg / 75 mg / 50 mg film-coated tablets ombitasvir / paritaprevir / ritonavir
Uputa o lijeku: Informacija za bolesnika Viekirax 12,5 mg/75 mg/50 mg filmom obložene tablete ombitasvir/paritaprevir/ritonavir
Mechanism: P-gp inhibition by paritaprevir, ritonavir and dasabuvir.
Mehanizam: inhibicija Pgp-a paritaprevir om, ritonavirom i dasabuviro m
Mechanism: CYP3A4 inhibition by cobicistat
Mehanizam: CYP3A4 inhibicija kobicistato m
• Monitor 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
Paritaprevir had an EC50 value of 5.3 nM against the 2a-JFH-1 replicon cell line, and EC50 values of 19, 0.09, and 0.68 nM against replicon cell lines containing NS3 from a single isolate each of genotype 3a, 4a, and 6a, respectively
Vrijednost EC50 paritaprevira protiv stanične linije replikona 2a-JFH-1 iznosila je 5,3 nM, dok su vrijednosti EC50
Mechanism: CYP3A4 induction by phenytoin.
Mehanizam: Indukcija CYP3A4 fenitoinom
SVR12 % (n/N)
SVR12 % (n/N) Ishodi za ispitanike bez SVR12
Expected: ↑ sildenafil
↑ sildenafil
Viekirax and dasabuvir with RBV 12 weeks
Viekirax i dasabuvir s RBV-om
Clinical trials in subjects with genotype 4 chronic hepatitis C PEARL- I- genotype 4, treatment-naïve or pegIFN + RBV experienced without cirrhosis Design:
PEARL- I - ispitanici s infekcijom genotipom 4, prethodno neliječeni ili prethodno liječeni pegIFN i RBV bez ciroze
Expected
Vidjeti
Co-administration of Viekirax with or without dasabuvir with medicinal products that are primarily metabolized by UGT1A1 result in increased plasma concentrations of such medicinal products; routine clinical monitoring is recommended for narrow therapeutic index medicinal products (i.e. levothyroxine).
povećava koncentracije tih lijekova u plazmi; preporuča se rutinsko kliničko praćenje za lijekove s uskim terapijskim indeksom (tj. levotirkosin).
Viekirax and dasabuvir without ribavirin or with weight-based ribavirin for 12 weeks Treated subjects (N=305) had a median age of 54 years (range: 19 to 70); 65.2% were male; 11.8% were Black; 20.7% had a history of depression or bipolar disorder; 86.6% had baseline HCV RNA levels of at least 800,000 IU/mL; 18.4% had portal fibrosis (F2) and 17.7% had bridging fibrosis (F3).
Viekirax i dasabuvir tijekom 12 tjedana s ribavirinom čija je doza temeljena na težini Medijan dobi liječenih ispitanika (N=631) iznosio je 52 godine (raspon: 18 do 70); 54,5% bili su muškarci; 5,4% bili su crnci; 15,2% imalo je depresiju ili bipolarni poremećaj u anamnezi; 79,1%
ANTIFUNGALS Ketoconazole 400 mg once daily
IMUNOSUPRESIVI ciklosporin 30 mg jedanput na dan pojedinačna doza Mehanizam:
Mechanism: CYP3A4 induction by carbamazepine
Mehanizam: Indukcija CYP3A4 karbamazep inom.
Mechanism: OATP1B/BC RP inhibition by paritaprevir
Mehanizam: paritaprevir inhibira OATP1B/ BCRP
TURQUOISE-III: treatment-naïve or pegIFN + RBV-experienced with compensated cirrhosis
TURQUOISE-III: ispitanici s kompenziranom cirozom, prethodno neliječeni ili prethodno liječeni pegIFN i RBV Dizajn:
↑ dabigatran etexilate
↑ dabigatran eteksilat
OPIOIDS Methadone
ANTITUMORSKI LIJEKOVI enzalutamid mitotan
Cyclobenzapr ine 5 mg single dose
Očekuje se sličan učinak kao kod primjene kombinacije ciklobenzap rin 5 mg pojedinačna doza
↑ digoxin
↑ nalokson
Duloxetine 60 mg single dose
DIURETICI furosemid pojedinačna doza od 20 mg
20-120 mg once daily
OPIOIDI metadon 20-120 mg jedanput na dan5
Quetiapine
pitavastatin
↑ repaglinide
↑ amlodipin
Viekirax without dasabuvir atazanavir
Viekirax bez dasabuvira escitalopram
Efavirenz/ emtricitabine/ tenofovir disoproxil fumarate mg once daily
Očekuje se sličan učinak kao kod primjene kombinacije efavirenz/ emtricitabin /tenofovir dizoproksil fumarat
Retreatment
Supstitucija
Mechanism: CYP3A4 and/or P-gp inhibition by itraconazole, posaconazole and paritaprevir/ ritonavir/ombi tasvir
Mehanizam: itrakonazol, posakonazol i paritaprevir/ ritonavir/om bitasvir inhibiraju CYP3A4 i/ili P-gp.
TURQUOISE-II - treatment-naïve or pegIFN + RBV-experienced with compensated cirrhosis
TURQUOISE-II - ispitanici s kompenziranom cirozom, prethodno neliječeni ili prethodno liječeni pegIFN i RBV
Trazodone
paritaprevir trazodon