natgillin/translations-raw huggingface dataset:
Ombitasvir and paritaprevir do not inhibit organic anion transporter (OAT1) in vivo and are not expected to inhibit organic cation transporters (OCT1 and OCT2), organic anion transporters (OAT3), or multidrug and toxin extrusion proteins (MATE1 and MATE2K) at clinically relevant concentrations.
Prav tako ni pričakovati, da bi v klinično pomembnih koncentracijah zavirala prenašalce organskih kationov (OCT1 in OCT2 - organic cation transporters), prenašalec organskih anionov (OAT3) ali ekstruzijske beljakovine več zdravil in toksinov (MATE1 in MATE2K - multidrug and toxin extrusion proteins).
Geometric mean Cmax, AUC of multiple doses of Viekirax 150 mg/100 mg/25 mg once daily with dasabuvir 250 mg twice daily with food in healthy volunteers
150 mg/100 mg/25 mg enkrat na dan in dasabuvirja 250 mg dvakrat na dan, s hrano, pri zdravih prostovoljcih.
Concomitant use is contraindicated (see section 4.3).
Sočasna uporaba je kontraindicirana (glejte poglavje 4.3).
Mechanism: possibly due to UGT1A1 inhibition by paritaprevir, dasabuvir and ombitasvir and CYP3A4 inhibition by ritonavir
Morda zavrtje UGT1A1 s paritaprevirjem, dasabuvirjem in ombitasvirjem ter zavrtje CYP3A4 z ritonavirjem.
Viekirax and dasabuvir in combination with ribavirin is recommended for 24 weeks in liver transplant recipients with genotype 1 HCV infection.
Zdravilo Viekirax in dasabuvir sta skupaj z ribavirinom pri prejemnikih presajenih jeter, okuženih s HCV
NA Concomitant use of Viekirax with dasabuvir is contraindicated (see section 4.3).
NP Sočasna uporaba z zdravilom Viekirax in dasabuvirjem je kontraindicirana (glejte poglavje 4.3).
Viekirax may be administered with or without dasabuvir.
Zdravilo Viekirax se lahko uporablja z dasabuvirjem ali brez njega.
These medicines may be available without a prescription atorvastatin, lovastatin, simvastatin, lomitapide 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 apalutamide,enzalutamide for prostate cancer ergotamine, dihydroergotamine for migraine headaches ergonovine, methylergometrine used in childbirth ethinyloestradiol-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)
Apalutamid, enzalutamid pri raku prostate ergotamin, dihidroergotamin pri migrenskih glavobolih ergonovin, metilergometrin uporaba pri porodu zdravila, ki vsebujejo etinilestradiol, kot je večina kontracepcijskih tablet in vaginalnih obročkov, ki se uporabljajo kot kontracepcija kontracepcija itrakonazol, ketokonazol, posakonazol, vorikonazol pri glivičnih okužbah midazolam, triazolam (če se jemlje skozi usta) pri občutku tesnobe ali težavah s spanjem mitotan pri simptomih malignih tumorjev nadledvičnih žlez pimozid, lurasidon pri shizofreniji kvetiapin pri shizofreniji, bipolarni motnji in veliki depresivni motnji kinidin pri nerednem srčnem utripu ali malariji ranolazin pri kronični angini pektoris (bolečine v prsnem košu)
Rilpivirine exposure is substantially increased (3-fold) when rilpivirine is given in combination with Viekirax and dasabuvir, with a consequent potential for QT-prolongation.
Če je rilpivirin uporabljen v kombinaciji z zdravilom Viekirax in dasabuvirjem, se izpostavljenost rilpivirinu bistveno poveča (3-krat) in interval QT se lahko podaljša.
SVR12 for genotype 1b-infected peginterferon+ribavirin-experienced subjects in PEARL II
Preglednica 12: SVR12 pri preiskovancih, že zdravljenih s peginterferonom + ribavirinom, okuženih z genotipom 1b, v preskušanju PEARL II
CORAL-I: treatment-naïve or pegIFN + RBV-experienced, at least 3 months post liver transplant or 12 months post renal transplant
ugotovljenimi v preskušanjih 3. faze pri preiskovancih, okuženih samo s HCV. CORAL-I: še nezdravljeni ali že zdravljeni s pegIFN + RBV, vsaj 3 mesece po presaditvi jeter ali 12 mesecev po presaditvi ledvic
Mechanism: CYP3A4 induction by rifampicin.
Mehanizem: Indukcija CYP3A4 z rifampicinom.
No dose adjustment needed for Viekirax.
Odmerka zdravila Viekirax ni treba prilagoditi.
Although some cases had previous history of depression, psychiatric illness and/or substance abuse, a causal relation with Viekirax with or without dasabuvir treatment cannot be excluded.
Čeprav so nekateri primeri vključevali predhodno zgodovino depresije, psihiatričnih bolezni in/ali zlorabe snovi,
Tacrolimus 2 mg was dosed alone, 0.5 mg administered with Viekirax and 2 mg was administered with Viekirax + dasabuvir.
Odmerek 2 mg takrolimusa je bil uporabljen sam, odmerek 0,5 mg z zdravilom Viekirax in odmerek 2 mg z zdravilom Viekirax + dasabuvirjem.
Mechanism: OATP1B inhibition by paritaprevir and BCRP inhibition by paritaprevir, ritonavir or dasabuvir.
OATP1B s paritaprevirjem in zavrtje BCRP s paritaprevirjem, ritonavirjem ali dasabuvirjem.
Medicinal products metabolised by glucuronidation (UGT1A1) Paritaprevir, ombitasvir and dasabuvir are inhibitors of UGT1A1.
Paritaprevir, ombitasvir in dasabuvir zavirajo UGT1A1.
In the genotype 1b replicon, the activity of paritaprevir was reduced 76- and 159-and 337- fold by D168A, D168H, D168V, and D168Y respectively.
V replikonu genotipa 1b so D168A, D168H, D168V in D168Y zmanjšale aktivnost paritaprevirja za 76-krat,159-krat oziroma 337-krat.
Viekirax and dasabuvir with or without RBV for 12 or 24 weeks
Zdravljenje: zdravilo Viekirax in dasabuvir z ali brez RBV 12 ali 24 tednov
In subjects with severe hepatic impairment, paritaprevir mean Cmax and AUC values increased by 3.2-to 9.5-fold; ritonavir mean Cmax values were 35% lower and AUC values were 13% higher and ombitasvir mean Cmax and AUC values decreased by 68% and 54%, respectively, compared to subjects with normal hepatic function, therefore, Viekirax must not be used in patients with severe hepatic impairment (see sections 4.2 and 4.4).
Pri preiskovancih s hudo okvaro jeter so bile v primerjavi s preiskovanci z normalnim delovanjem jeter vrednosti naslednje: povprečni Cmax in AUC paritaprevirja sta bili za 3,2- do 9,5-krat večji, povprečna Cmax ritonavirja je bila za 35 % manjša in njegova povprečna AUC za 13 % večja, povprečna Cmax ombitasvirja je bila za 68 % manjša in njegova povprečna AUC za 54 % manjša.
In the genotype 1a replicon, the activity of paritaprevir was reduced 20-, 37-, and 17-fold by the F43L, R155K and A156T substitutions, respectively.
V replikonu genotipa 1a so substitucije F43L, R155K oziroma A156T zmanjšale aktivnost paritaprevirja za 20-, 37- in 17-krat.
NA ↔ ombitasvir/paritaprevir/dasabuvir (based on the crossstudy comparison)
NP ↔ ombitasvir/paritaprevir/dasabuvir (na podlagi primerjave med študijami)
Mechanism: CYP3A4/Pgp inhibition by erythromycin, paritaprevir, ritonavir and dasabuvir.
CYP3A4/P-gp z eritromicinom, paritaprevirjem, ritonavirjem in dasabuvirjem.
Ombitasvir has EC50 values of 12, 4.3, 19, 1.7, 3.2, and 366 pM against replicon cell lines constructed with NS5A from single isolates representing genotypes 2a, 2b, 3a, 4a, 5a, and 6a, respectively.
ki so predstavljali genotipe 2a, 2b, 3a, 4a, 5a in 6a, je bila EC50 ombitasvirja 12, 4,3, 19, 1,7, 3,2 in 366 pM.
HCV Genotype 1b Viekirax and dasabuvir
HCV Genotip 1b Viekirax in dasabuvir
These metabolites are not expected to have antiviral activity.
Ni pričakovati, da bi ti presnovki delovali protivirusno.
General disorders and administration and administration site conditions Very common
Splošne težave in spremembe na mestu aplikacije Zelo pogosti astenija utrujenost
PEARL- I- genotype 4, treatment-naïve or pegIFN + RBV experienced without cirrhosis
PEARL- I- genotip 4, še nezdravljeni ali že zdravljeni s kombinacijo pegIFN + RBV, brez ciroze
AGATE-1 -treatment-naïve or pegIFN +RBV experienced patients with compensated cirrhosis
AGATE-1 - še nezdravljeni ali že zdravljeni s kombinacijo pegIFN + RBV, s kompenzirano cirozo
GT1b Arm A: Viekirax and dasabuvir + RBV Arm B: Viekirax and dasabuvir
GT1b Skupina A: Viekirax in dasabuvir+ RBV Skupina B: Viekirax in dasabuvir
SVR12 for genotype 4-infected, subjects who were treatment-naïve or previously treated with pegIFN/RBV in PEARL I
Preglednica 18: SVR12 pri še nezdravljenih preiskovancih ali takih, ki so bili predhodno zdravljeni s pegIFN/RBV, okuženih z genotipom 4, v preskušanju PEARL I
↑ fusidic acid
fusidna kislina
• Each tablet contains 12.5 mg of ombitasvir, 75 mg of paritaprevir and 50 mg of ritonavir.
• Ena tableta vsebuje 12,5 mg ombitasvirja, 75 mg paritaprevirja in 50 mg ritonavirja.
Mechanism: possible CYP3A4 induction by efavirenz.
Mehanizem: morda indukcija CYP3A4 z efavirenzom.
Co-administration of Viekirax with or without dasabuvir with medicinal products that are strong inhibitors of CYP3A4 is expected to increase paritaprevir plasma concentrations and must not be co-administered with Viekirax (see section 4.5).
Sočasno z zdravilom Viekirax z ali brez dasabuvirja se ne sme uporabljati zdravil, ki so močni zaviralci CYP3A4, za katere se pričakuje da povečajo plazemske koncentracije peritaprevirja (glejte poglavje 4.5).
GT1a Arm A: Viekirax and dasabuvir + RBV Arm B: Viekirax and dasabuvir
GT1a Skupina A: Viekirax in dasabuvir+ RBV Skupina B: Viekirax in dasabuvir
Following administration of Viekirax
Po uporabi zdravila Viekirax
Patients who are taking ethinyloestradiol-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 with or without dasabuvir therapy (see sections 4.3 and 4.5).
Bolnice, ki uporabljajo zdravila z etinilestradiolom (takšna je večina kombiniranih peroralnih kontraceptivov ali kontracepcijskih vaginalnih obročkov), jih morajo prenehati uporabljati ali preiti na drugačen način kontracepcije (npr. na samo progestinsko kontracepcijo ali na nehormonske načine),
Efavirenz/ emtricitabine/ tenofovir disoproxil fumarate mg once daily
efavirenz/emtri citabin/dizopro ksiltenofovirat fumarat
↑ pimozide ↑ quetiapine ↑ lurasidone
↑ kvetiapin ↑ lurasidon
Caution should be used when sulfasalazine is coadministered with Viekirax with or without dasabuvir.
Previdnost je priporočljiva pri sočasni uporabi feksofenadina z zdravilom Viekirax z dasabuvirjem ali brez njega.
No dose adjustment needed for Viekirax with dasabuvir.
Odmerka zdravila Viekirax z dasabuvirjem ni treba prilagoditi.
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).
Zdravljenje: Viekirax in dasabuvir brez ribavirina ali z ribavirinom, odvisnim od telesne mase, 12 tednov Zdravljeni preiskovanci (N = 419) so bili mediano stari 50 let (razpon: od 19 do 70), 45,8 % je bilo moških; 4,8 % je bilo črncev; 9,3 % jih je imelo v anamnezi depresijo ali bipolarno motnjo; 73,3 % jih je imelo izhodiščno koncentracijo HCV RNA vsaj 800.000 i. e./ml; 20,3 % jih je imelo portalno fibrozo (F2) in 10,0 % jih je imelo fibrozo z mostiči (F3).
Clinical efficacy and safety
Zdravilo ali učinkovina
Mechanism: CYP2C19 induction by ritonavir
Mehanizem: Indukcija CYP2C19 z ritonavirjem
• fusidic acid
• fusidna kislina
A reduction in colchicine dosage or an interruption of colchicine treatment is recommended in patients with normal renal or hepatic function if treatment with Viekirax with or without dasabuvir is required (see section 4.5).
Če je potrebno zdravljenje z zdravilom Viekirax z dasabuvirjem ali brez njega, je pri bolnikih z normalnim delovanjem ledvic ali jeter priporočljivo zmanjšati odmerek kolhicina ali zdravljenje s kolhicinom prekiniti (glejte poglavje 4.5).
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).
Sočasna uporaba zdravila Viekirax z dasabuvirjem ali brez njega skupaj z zdravili, ki se presnavljajo predvsem z UGT1A1, lahko poveča koncentracijo takšnih zdravil v plazmi; med uporabo zdravil z ozkim terapevtskim indeksom (npr.
Mechanism: CYP3A4 induction by carbamazepine
Mehanizem: Indukcija CYP3A4 s karbamazepino m.
No subjects with HCV genotype 1b infection experienced on-treatment virologic failure and 2 subjects with HCV genotype 1b infection experienced relapse.
Virusna neodzivnost med zdravljenjem se ni pojavila pri nobenem preiskovancu, okuženem s HCV genotipa 1b, recidiv pa se je pojavil pri 2 takšnih preiskovancih.
SEDATIVES / HYPNOTICS Zolpidem
SEDATIVI / HIPNOTIKI zolpidem enkraten odmerek 5 mg
Baseline platelet count, median (× 109/L)
≥ 35, n (%) Izhodiščno število trombocitov, mediano (× 109/L) 132.0
Subjects had a median age of 56 years (range: 32 to 81); 50% were treatment-naïve, 28% were prior pegIFN/RBV null responders; 10% were prior pegIFN/RBV partial responders, 13% were prior pegIFN/RBV relapsers; 70% were male; 17% were Black; 73% had baseline HCV RNA levels of at least 800,000 IU per mL; 17% had platelet counts of less than 90 x 109 per L; and 4% had albumin less than 3.5 mg per dL.
Preiskovanci so bili mediano stari 56 let (razpon: 32 do 81); 50 % jih še ni bilo zdravljenih, 28 % se jih predhodno ni odzvalo na pegIFN/RBV; 10 % se jih je predhodno delno odzvalo na pegIFN/RBV, 13 % se je predhodno pojavil recidiv s pegIFN/RBV; 70 % je bilo moških; 17 % je bilo črncev; 73 % jih je imelo izhodiščno koncentracijo HCV RNA vsaj 800.000 i.e./ml; 17 % jih je imelo število trombocitov manj kot 90 x 109/l; in 4 % jih je imelo albumin manj kot 3,5 mg/dl.
The pharmacokinetic properties of the combination of Viekirax with dasabuvir have been evaluated in healthy adult subjects and in subjects with chronic hepatitis C. Table 20 shows mean Cmax and AUC of Viekirax 25 mg/150 mg/100 mg once daily with dasabuvir 250 mg twice daily following multiple doses with food in healthy volunteers.
Farmakokinetične lastnosti kombinacije zdravila Viekirax in dasabuvirja so ocenili pri zdravih odraslih in pri bolnikih s kroničnim hepatitisom C. Preglednica 20 prikazuje povprečni Cmax in AUC za zdravilo
Treatment with darunavir + Viekirax without dasabuvir is not recommended-(↑ paritaprevir).
Zdravljenje z darunavirjem in zdravilom Viekirax brez dasabuvirja ni priporočljivo -(↑
↔ darunavir ombitasvir
↔ atazanavir ↔ ombitasvir
Viekirax with weight-based ribavirin for 12 or 16 weeks
Zdravljenje: zdravilo Viekirax z ribavirinom, odvisnim od telesne mase, 12 do 16 tednov
Mechanism: P-gp inhibition by paritaprevir, ritonavir and dasabuvir.
Zavrtje P-gp s paritaprevirjem, ritonavirjem in dasabuvirjem.
Indinavir Saquinavir Tipranavir
Klinične opombe indinavir sakvinavir tipranavir
CYP2D6 substrates (e.g. desipramine, metoprolol and dextromethorphan) are not expected to require dose adjustments.
metoprolol in dekstrometorfan) ni pričakovati, da bi bila potrebna prilagoditev odmerka.
Mechanism: CYP3A4/Pgp inhibition by clarithromyci n and ritonavir.
CYP3A4/P-gp s klaritromicinom in ritonavirjem.
Co-administration of Viekirax with or without dasabuvir can decrease exposures of medicinal products that are metabolized by CYP2C19 (e.g. lansoprazole, esomeprazole, s-mephenytoin), which may require dose adjustment/clinical monitoring.
ki se presnavljajo s CYP2C19 (npr. lansoprazol, esomeprazol, s-mefenitoin), zaradi česar bo morda potrebna prilagoditev odmerka in klinično spremljanje.
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.
Zdravljeni preiskovanci (N = 394) so bili mediano stari 54 let (razpon: od 19 do 71); 49,0 % jih predhodno ni imelo odziva na pegIFN/RBV; 21,8 % jih je predhodno imelo delen odziv na pegIFN/RBV in 29,2 % jih je predhodno imelo recidiv ob pegIFN/RBV; 57,6 % je bilo moških; 8,1 % je bilo črncev; 20,6 % jih je imelo v anamnezi depresijo ali bipolarno motnjo; 87,1 % jih je imelo izhodiščno koncentracijo HCV RNA vsaj 800,000 i.e./ml; 17,8 % jih je imelo portalno fibrozo (F2) in 14,5 % jih je imelo fibrozo z mostiči (F3); 58,4 % jih je imelo okužbo s HCV genotipa 1a; 41,4 % jih je imelo okužbo s HCV genotipa 1b.
Subjects (N=135) had a median age of 51 years (range: 19 to 70); 63,7% were treatment-naïve, 17.0% were prior pegIFN/RBV null responders, 6.7% were prior pegIFN/RBV partial responders, 12.6% were prior pegIFN/RBV relapsers; 65.2%were male; 8.9% were Black, 69.6% had baseline HCV RNA levels at least 800,000 IU/mL; 6.7% had bridging fibrosis (F3).
Preiskovanci (N = 135) so bili mediano stari 51 let (razpon: od 19 do 70); 63,7 % jih še ni bilo zdravljenih, 17,0 % se jih predhodno ni odzvalo na pegIFN/RBV, 6,7 % se jih je predhodno delno odzvalo na pegIFN/RBV, 12,6 % se je predhodno pojavil recidiv s pegIFN/RBV; 65,2 % je bilo moških; 8,9 % je bilo črncev; 69,6 % jih je imelo izhodiščno koncentracijo HCV RNA vsaj 800.000 i.e./ml; 6,7 % jih je imelo fibrozo z mostiči (F3).
This medicine is available without a prescription ticagrelor stops blood from clotting
To zdravilo je na voljo brez recepta.
CYP3A4 inhibitors:
Zaviralci CYP3A4:
In the presence of ombitasvir, paritaprevir exposures were minimally affected (5% to 27% change) while dasabuvir exposures increase by approximately 30%.
Vpliv ombitasvirja na paritaprevir/ritonavir in dasabuvir Prisotnost ombitasvirja je minimalno vplivala na izpostavljenost paritaprevirju (sprememba za 5 do 27 %),
↑ ombitasvir ↑ paritaprevir ↑ dasabuvir
Pričakovano: ↑ konivaptan ↑ paritaprevir ↑ dasabuvir
Mechanism: CYP2C19 induction and CYP3A4 inhibition by ritonavir
Mehanizem: Indukcija CYP2C19 in indukcija CYP3A4 z ritonavirjem.
Viekirax and dasabuvir without ribavirin or with weight-based ribavirin for 12 weeks
Zdravljenje: Viekirax in dasabuvir brez ribavirina ali z ribavirinom, odvisnim od telesne mase, 12 tednov
Viekirax and dasabuvir with RBV 12 weeks
Viekirax in dasabuvir z RBV 12 tednov
Adverse drug reactions identified with Viekirax in combination with dasabuvir with and without ribavirin
Preglednica 3: Neželeni učinki zdravila ugotovljeni z zdravilom Viekirax v kombinaciji z dasabuvirjem ter z ribavirinom ali brez njega
500 mg single dose
Posamezni odmerek 500 mg
Drug interactions were evaluated for the Viekirax and dasabuvir regimen, but not for the Viekirax without dasabuvir, with carbamazepine, furosemide, zolpidem, darunavir twice daily, darunavir (evening administration), atazanavir (evening administration), rilpivirine, abacavir/lamivudine, dolutegravir, metformin, sulfamethoxazole/trimethoprim, cyclobenzaprine, carisoprodol, hydrocodone/
(uporaba zvečer), rilpivirinom, abakavir/lamivudinom, dolutegravirjem, metforminom, sulfametoksazol/trimetoprimom, ciklobenzaprinom, karisoprodolom, hidrokodon/paracetamolom ali diazepamom.
Expected in CYP2C19 Extensive Metabolisers:
Pričakovano pri učinkovinah, ki se v veliki meri presnavljajo preko CYP2C19:
ANTICONVULSANTS Carbamazepine
ANTIEPILEPTIKI karbamazepin
Potential for other medicinal products to affect the pharmacokinetics of ombitasvir, paritaprevir, and dasabuvir
Možnost vpliva drugih zdravil na farmakokinetiko ombitasvirja, paritaprevirja in dasabuvirja Zdravila, ki zavrejo CYP3A4
400/100 mg twice daily1
lopinavir / ritonavir 400/100 mg dvakrat na dan1 Mehanizem:
If rosuvastatin treatment is required during the treatment period, the maximum daily dose of rosuvastatin should be 5 mg (see section 4.5, Table 2).The increase in rosuvastatin when combined with Viekirax without dasabuvir is less pronounced.
Če je med obdobjem zdravljenja potrebno zdravljenje z rosuvastatinom, sme biti največji dnevni odmerek rosuvastatina 5 mg (glejte poglavje 4.5, preglednico 2).
Medicinal products that are highly dependent on CYP3A for clearance and for which elevated plasma levels are associated with serious events must not be co-administered with Viekirax (see section 4.5).
Sočasno z zdravilom Viekirax se ne sme uporabljati zdravil, ki so zelo odvisna od očistka s CYP3A in katerih povečana koncentracija v plazmi je povezana z resnimi učinki (glejte poglavje 4.5).
CYP3A substrates evaluated in drug interaction studies which may require dose adjustment and/or clinical monitoring include (see Table 2) ciclosporin, sirolimus, tacrolimus, amlodipine, rilpivirine and alprazolam.
Med substrati CYP3A, ki so bili ocenjeni v študijah medsebojnega delovanja zdravil in pri katerih je lahko potrebna prilagoditev odmerka, klinično spremljanje ali oboje (glejte preglednico 2) so ciklosporin,
A majority (86.8%) had baseline HCV RNA levels of at least 800,000 IU/mL and a majority (84.2%) had genotype 1a infection; 15.8% had portal fibrosis (F2) and 5.3% had bridging fibrosis (F3); and 94.7% were naïve to prior HCV treatment.
1a; 15,8 % jih je imelo portalno fibrozo (F2) in 5,3 % jih je imelo fibrozo z mostiči (F3); 94,7 % jih predhodno še ni bilo zdravljenih za HCV.
For patients coadministered ribavirin refer to the Summary of Product Characteristics of ribavirin.
Pri bolnicah, ki sočasno prejemajo ribavirin, je treba upoštevati tudi povzetek glavnih značilnosti ribavirina.
In genotype 4a, resistance to paritaprevir or ombitasvir by variants in NS3 or NS5A, respectively, selected in cell culture were phenotypically characterised.
Genotip 4 Pri genotipu 4a so fenotipsko opredelili odpornost proti paritaprevirju ali ombitasvirju zaradi variant NS3
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).
Zdravljeni preiskovanci (N = 179) so bili mediano stari 57 let (razpon: od 26 do 70); 35,2 % jih predhodno ni imelo odziva na pegIFN/RBV; 28,5 % jih je predhodno imelo delen odziv na pegIFN/RBV in 36,3 % jih je predhodno imelo recidiv ob pegIFN/RBV; 54,2 % je bilo moških; 3,9 % je bilo črncev; 12,8 % jih je imelo v anamnezi depresijo ali bipolarno motnjo; 87,7 % jih je imelo izhodiščno koncentracijo HCV RNA vsaj 800.000 i. e./ml; 17,9 % jih je imelo portalno fibrozo (F2) in 14,0 % jih je imelo fibrozo z mostiči (F3).
The maximum daily dose of rosuvastatin should be 5 mg (see section 4.4).
Največji dnevni odmerek rosuvastatina sme biti 5 mg (glejte poglavje
TURQUOISE-III: treatment-naïve or pegIFN + RBV-experienced with compensated cirrhosis Design:
TURQUOISE-II - še nezdravljeni ali že zdravljeni s pegIFN + RBV, s kompenzirano cirozo
Expected: ↓ombitasvir ↓ paritaprevir ↓ dasabuvir
Pričakovano: ↓ ombitasvir ↓ paritaprevir ↓ dasabuvir
ANTICANCER AGENTS Encorafenib
ZDRAVILA PROTI RAKU enkorafenib