natgillin/translations-raw huggingface dataset:
No relevant inhibition by telaprevir of the organic cation transporter (OCT) OCT2 was observed in vitro.
In vitro študije niso pokazale pomembnega zaviranja organskega kationskega prenašalca OCT2 (OCT - organic cation transporter) s telaprevirjem.
Table 13: SVR rates by week 4 response (< 1 log10 or ≥ 1 log10 reduction) in the T12(DS)/PR48
Preglednica 13: stopnje SVR ob odgovoru v 4. tednu (zmanjšanje za < 1 log10 ali ≥ 1 log10) v skupini T12(DS)/PR48: študija C216
Ribavirin may be restarted per the dosing modification guidelines for ribavirin.
Ribavirin lahko tudi ponovno uvedete, skladno z navodili za prilagajanje njegovega odmerka.
In a follow-up study of 98 treatment-naïve and prior treatment-failure patients who were treated with a INCIVO regimen in a Phase 2 or Phase 3study and did not achieve SVR, telaprevir-resistant variants were no longer detected in 85% (83/98) of patients (median follow-up of 27.5 months).
V študiji spremljanja 98 predhodno nezdravljenih bolnikov in bolnikov, pri katerih je bilo predhodno zdravljenje neuspešno in so bili zdravljeni s shemo zdravila INCIVO v študiji faze II ali III ter niso dosegli trajnega virološkega odziva, na telaprevir rezistentnih variant niso več našli pri 85% (83/98) bolnikov (mediani čas spremljanja 27,5 mesecev).
Gastric lavage should only be performed if this can be done within one hour after ingestion.
Izpiranje želodca lahko uporabite samo kadar ga lahko opravite v času ene ure po zaužitju.
Tell your health care provider if you have problems swallowing whole tablets.
Zdravniku morate povedati, če težko pogoltnete celo tableto.
168 film-coated tablets (4 bottles containing 42 tablets each) The bottles are not to be distributed individually.
168 filmsko obloženih tablet (4 plastenke, ena plastenka vsebuje 42 filmsko obloženih tablet)
After repeated oral administration, R-diastereomer of telaprevir (30-fold less active), pyrazinoic acid, and a metabolite that underwent reduction at the α-ketoamide bond of telaprevir (not active) were found to be the predominant
Po večkratnih peroralnih odmerkih so ugotovili, da sta glavna presnovka telaprevirja njegov R-diastereoizomer (ki je 30-krat manj aktiven), pirazinoična kislina in presnovek, ki je reduciran na α-ketoamidni vezi telaprevirja (in ni aktiven).
The concomitant use of rifabutin and telaprevir is not recommended.
Sočasna uporaba rifabutina in telaprevirja ni priporočljiva.
Common side effects (affects less than 1 in 10 people):
Pogosti neželeni učinki (pojavijo se pri manj kot 1 od 10 bolnikov)
Table 8 shows SVR rates for patient subgroups.
V preglednici 8 so podane stopnje virološkega odziva za podskupine bolnikov.
INCIVO 375 mg film-coated tablets
INCIVO 375 mg filmsko obložene tablete
(2.0-2.4 mEq/l)
(2,0-2,4 mmol/l)
HCV/Human immunodeficiency virus type (HIV)-1 co-infection HCV/HIV-1 co-infected patients should be treated in the same way as HCV mono-infected patients.
Sočasna okužba s HCV/virusom humane imunske pomanjkljivosti-1 (HIV-1) Bolnike s sočasno okužbo s HCV in HIV-1 je treba zdraviti enako kot bolnike, ki so okuženi samo s HCV.
)/PR] in combination with peginterferon alfa-2a and ribavirin.
)/PR] v kombinaciji s peginterferonom alfa-2a in ribavirinom.
The efficacy and safety of INCIVO in patients with genotype 1 chronic hepatitis C were evaluated in four Phase 3 studies: 3 in treatment-naïve patients and 1 in previously treated patients (relapsers, partial responders, and null responders).
Učinkovitost in varnost zdravila INCIVO pri bolnikih z genotipom 1 kroničnega hepatitisa C sta bili ovrednoteni v štirih študijah faze III - tri so bile opravljene pri nezdravljenih bolnikih, ena pa pri predhodno zdravljenih bolnikih (tistih, pri katerih se je bolezen ponovila, tistih, ki so se le delno odzvali na zdravljenje, in tistih, ki se sploh niso odzvali nanj).
HCV/HBV (hepatitis B virus) co-infection There are no data on the use of INCIVO in patients with HCV/HBV co-infection.
Sočasna okužba z virusoma HCV in HBV (virus hepatitisa B) Ni podatkov o uporabi zdravila INCIVO pri bolnikih, ki imajo sočasno okužbo s HCV in HBV.
- swollen veins in the rectum or anus (haemorrhoids), pain in the anus or rectum;
- otekle vene v danki ali zadnjiku (hemoroidi), bolečine v danki ali zadnjiku,
(12.1-15.0 mg/dl)
(121-150 mg/l)
oral triazolam
peroralno uporabljen triazolam
Based on population sequencing analyses of HCV in these 215 patients, the emergence of telaprevir-resistant HCV variants was detected in 105 (84%) virologic failures and in 55 (61%) relapsers, and wild-type virus was detected in 15 (12%) virologic failures and in 24 (27%) relapsers.
Na podlagi populacijskih sekvencijskih analiz HCV pri teh 215 bolnikih so ugotovili pojav za telaprevir rezistentnih variant HCV pri 105 (84%) primerih virološke neuspešnosti in pri 55 (61%) preiskovancih, pri katerih se je bolezen ponovila, divji tip virusa so ugotovili pri 15 (12%) primerih virološke neuspešnosti in pri 24 (27%) preiskovancih, pri katerih se je bolezen ponovila, medtem ko podatki o sekvencioniranju HCV niso bili na voljo za 16 (7%) bolnikov.
Telaprevir may be less effective due to decreased concentrations.
Zaradi zmanjšane koncentracije je lahko telaprevir manj učinkovit.
If the rash does not improve within 7 days following INCIVO discontinuation, ribavirin should be interrupted.
Če se izpuščaj v 7 dneh po ukinitvi zdravila INCIVO ne izboljša je treba prekiniti zdravljenje z ribavirinom.
Consultation with a specialist in dermatology is recommended.
Posvet z dermatologom je priporočen.
All rashes should be monitored for progression and until the rash is resolved.
Napredovanje vseh izpuščajev je treba spremljati, dokler izpuščaji ne izginejo.
These active substances include alfuzosin, amiodarone, bepridil, quinidine, astemizole, terfenadine, cisapride, pimozide, ergot derivatives (dihydroergotamine, ergonovine, ergotamine, methylergonovine), lovastatin, simvastatin, atorvastatin, sildenafil or tadalafil (only when used for treatment of pulmonary arterial hypertension), quetiapine and orally administered midazolam or triazolam (see section 4.5).
Med te zdravilne učinkovine sodijo na primer alfuzosin, amiodaron, bepridil, kinidin, astemizol, terfenadin, cisaprid, pimozid, ergot alkaloidi (dihidroergotamin, ergonovin, ergotamin, metilergonovin), lovastatin, simvastatin, atorvastatin, sildenafil ali tadalafil (samo pri uporabi za zdravljenje pljučne arterijske hipertenzije), kvetiapin ter peroralno uporabljen midazolam ali triazolam (glejte poglavje 4.5).
A lower ribavirin dose (600 mg/day) at initiation of INCIVO treatment is recommended (see section 5.1).
Ob uvedbi zdravljenja z zdravilom INCIVO je priporočljiva uporaba manjšega odmerka ribavirina (600 mg/dan) (glejte poglavje 5.1).
The incidence of adverse drug reactions (ADRs) of at least moderate intensity (≥ Grade 2) was higher in the INCIVO group than in the placebo group.
Pogostnost neželenih učinkov zdravila najmanj zmerne jakosti (≥ 2. stopnje) je bila višja v skupini, ki je prejemala zdravilo INCIVO, kot v skupini, ki je prejemala placebo.
21.6% of patients receiving INCIVO combination treatment required ribavirin dose reduction for anaemia compared to 9.4% of patients receiving peginterferon alfa and ribavirin alone.
Pri 21,6% bolnikov, ki so prejemali kombinirano zdravljenje z zdravilom INCIVO, je bilo potrebno zmanjšanje odmerka ribavirina zaradi anemije za razliko od 9,4% bolnikov, ki so prejemali samo peginterferon alfa in ribavirin.
Patients receiving cyclosporine A N = 24 % (n/N)
Bolniki, ki so prejemali ciklosporin A N = 24 % (n/N)
Each bottle contains one pouch or two pouches of desiccant to keep the tablets dry.
Vsaka plastenka vsebuje eno ali dve vrečki s sušilnim sredstvom, ki zagotavlja, da so tablete suhe.
Study C211 was a randomised, open-label, Phase 3 study conducted in treatment-naïve patients who were randomised to one of two treatment groups: INCIVO 750 mg every 8 hours [T12(q8h)/PR] or INCIVO 1,125 mg twice daily [T12(b.i.d.
Študija C211 je bila randomizirana, odprta študija faze III pri še nezdravljenih bolnikih, ki so bili naključno razdeljeni v eno izmed dveh skupin: INCIVO 750 mg na 8 ur [T12(q8h)/PR] ali INCIVO 1.125 mg dvakrat na dan [T12(b.i.d.
There are limited clinical data on the use of INCIVO in HCV patients aged ≥ 65 years.
Na voljo je le malo farnakokinetičnih podatkov o uporabi zdravila INCIVO pri bolnikih s HCV, starih ≥ 65 let.
The exposure (AUC) to telaprevir increased slightly greater than proportionally to the dose after single-dose administration of 375 up to 1,875 mg with food, possibly due to saturation of metabolic
Stopnja izpostavljenosti (AUC) telaprevirju po jemanju enkratnega odmerka od 375 do 1.875 mg s hrano je naraščala nekoliko več kot premosorazmerno odmerku, morda zaradi nasičenja presnovnih
Mild rash: localised skin eruption and/or a skin eruption with a limited distribution (up to several isolated sites on the body)
Blag izpuščaj: lokaliziran izpuščaj in/ali omejen izpuščaj (nekaj izoliranih mest na telesu)
Your doctor will do blood tests before starting treatment and regularly during your treatment: - to see how much virus is in your blood and to determine if you have the type of virus (genotype 1) that can be treated with INCIVO.
- spremljal, koliko virusa je v vaši krvi in ugotovil, ali ste okuženi s tipom virusa (genotipom 1), ki ga lahko zdravimo z zdravilom INCIVO.
- painful inflammation of the joints most commonly in the foot (gout);
- boleče vnetje sklepov (največkrat na nogi) (protin)
Figure 2: Duration of treatment for previously treated patients with prior partial or prior
Slika 2: trajanje zdravljenja pri predhodno zdravljenih bolnikih z delnim odzivom na
You must not reduce your dose of INCIVO.
Odmerka zdravila INCIVO ne smete zmanjšati.
In the description of the Phase 3 study outcomes for Study C211, HPC3008 and HPC3006, SVR12, considered virologic cure, was defined based on HCV RNA below the limit of quantification (25 IU/ml) using the last measurement in the visit window 12 weeks after the planned end of
V opisu izidov študij faze III za študiji C211, HPC3008 in HPC3006 je bil SVR12 (virološka ozdravljenost) določen na osnovi ocene HCV RNK pod mejo kvantifikacije (25 i.e./ml) 12. tednov po načrtovanem zaključku zdravljenja, z uporabo zadnje meritve v tem obdobju.
On-treatment-virologic failure includes patients who met a protocol-defined virologic stopping rule and/or had viral
Virološki neuspeh med zdravljenjem vključuje bolnike, ki so ustrezali v protokolu določenim kriterijem za prekinitev zdravljenja in/ali so imeli virusni preboj.
INCIVO has not been studied in HCV-infected patients with moderate hepatic impairment (Child-Pugh B, score 7-9).
Zdravila INCIVO niso preučevali pri s HCV okuženih bolnikih z zmerno okvaro jeter (razred B po Child-Pughu, ocena 7-9).
Do not drive or operate machines if you feel faint or have problems with your vision while taking INCIVO.
Med jemanjem zdravila INCIVO ne vozite in ne upravljajte s stroji, če čutite, da boste omedleli
Signs might be yellowing of the skin or eyes (jaundice), swelling of the stomach (ascites) or legs due to fluid, and bleeding from swollen veins (varices) in the gullet (oesophagus).
Med njihove znake lahko sodijo porumenelost kože ali oči (zlatenica), otekanje trebuha (ascites) ali nog zaradi kopičenja tekočin in krvavitev iz oteklih ven (varic) požiralnika.
See also the Summary of Product
Preberite si tudi Povzetek glavnih značilnosti zdravila
Following administration of a single oral dose of 750 mg
Izločanje Po jemanju enkratnega peroralnega 750 mg odmerka s C
DRESS presents as a rash with eosinophilia associated with one or more of the following features: fever, lymphadenopathy, facial oedema, and internal organ involvement (hepatic, renal, pulmonary).
Sindrom DRESS vključuje izpuščaj z eozinofilijo, povezan z enim ali več izmed naslednjih simptomov: zvišana telesna temperatura, limfadenopatija, edem obraza in prizadetost notranjih organov (jetra, ledvica, pljuča).
It is recommended that the international normalised ratio (INR) be monitored when warfarin is co-administered with telaprevir.
Priporočljivo je, da med sočasno uporabo varfarina s telaprevirjem spremljate vrednost mednarodnega normaliziranega količnika (INR).
The recommended total duration of treatment for patients who have received a liver transplant is 48 weeks.
Pri bolnikih s presajenimi jetri je priporočeno celotno trajanje zdravljenja 48 tednov.
For patients receiving a total of 48 weeks of treatment, peginterferon alfa and ribavirin should be discontinued if HCV RNA is detectable at week 24 or week 36.
Pri bolnikih, ki so se zdravili vseh 48 tednov, je treba zdravljenje s peginterferonom alfa, in ribavirinom ukiniti, če je koncentracija HCV RNK zaznavna v 24. ali 36. tednu.
Plasma concentrations with the telaprevir 1,875 mg every 8 hours dose used in this trial were comparable to those observed in studies in HCV-infected patients who received telaprevir 750 mg every 8 hours in combination with peginterferon alfa-2a and ribavirin.
Plazemske koncentracije pri odmerku telaprevirja 1.875 mg na vsakih 8 ur, ki je bil uporabljen v tem preskušanju, so bile podobne kot pri tistih, ki so jih opažali v študijah pri s HCV okuženih bolnikih, ki so prejemali telaprevir v odmerku 750 mg na vsakih 8 ur, v kombinaciji s peginterferonom alfa-2a in
Severe, potentially life-threatening and fatal skin reactions have been reported with INCIVO combination treatment, including DRESS, SJS, and TEN (see section 4.4).
Pri zdravljenju z zdravilom INCIVO so poročali o hudih, lahko življenju nevarnih in smrtnih kožnih reakcijah, vključno s sindromom DRESS, SJS in TEN (glejte poglavje 4.4).
At the initiation and discontinuation of INCIVO treatment, doses of co-administered tacrolimus or cyclosporine A need to be markedly adjusted (see sections 4.4 and 4.5, Immunosuppressants).
Ob uvedbi in zaključku zdravljenja z zdravilom INCIVO je treba ustrezno prilagoditi odmerke sočasno uporabljenega takrolimusa ali ciklosporina A (glejte poglavji 4.4 in 4.5 Imunosupresivi).
Patients in these studies, 108, 111 and C216, had compensated liver disease, detectable HCV RNA, and liver histopathology consistent with chronic hepatitis C. Unless otherwise indicated, INCIVO was administered at a dosage of 750 mg every 8 hours (q8h); the peginterferon alfa-2a dose was 180 µg/week, and the ribavirin dose was 1,000 mg/day (patients weighing < 75 kg) or 1,200 mg/day (patients weighing ≥ 75 kg).
Bolniki v teh študijah (108, 111 in C216) so imeli kompenzirano jetrno bolezen, merljive vrednosti HCV RNK in histopatološki izvid jeter, ki je kazal na kronični hepatitis C. Če ni drugače navedeno, so ti bolniki prejemali zdravilo INCIVO v odmerku 750 mg na vsakih 8 ur, odmerek peginterferona alfa-2a je bil 180 µg/teden in odmerek ribavirina 1.000 mg/dan (za bolnike s telesno maso < 75 kg) ali 1.200 mg/dan (za bolnike s telesno maso ≥ 75 kg).
The highest documented INCIVO dose administered is 1,875 mg every 8 hours for 4 days in healthy volunteers.
Največji dokumentirani odmerek zdravila INCIVO, ki je bil dan pri zdravih prostovoljcih, je bil 1.875 mg na 8 ur, 4 dni.
- low blood platelet count, decrease in lymphocytes (a type of white blood cell), decrease in thyroid gland activity, increase in uric acid in your blood, decrease in potassium in your blood,
- nizko število krvnih ploščic, zmanjšanje števila limfocitov (vrsta belih krvničk), zmanjšano delovanje žleze ščitnice, povečanje vrednosti sečne kisline v krvi, zmanjšanje vrednosti kalija v krvi, povečanje vrednosti bilirubina v krvi
The resistance profile observed in Study HPC3008 in HCV/HIV-1 co-infected patients was similar to the resistance profile in mono-infected HCV patients.
Profil odpornosti opažen v študiji HPC3008 pri bolnikih s sočasno okužbo s HCV/HIV-1 je bil podoben profilu pri bolnikih, ki so bili okuženi samo s HCV.
Patients were randomised to 12 weeks of INCIVO (750 mg every 8 hours if taken in combination with atazanavir/ritonavir, tenofovir disoproxil fumarate, and emtricitabine or lamivudine OR 1,125 mg every 8 hours if taken in combination with efavirenz, tenofovir disoproxil fumarate, and emtricitabine) or placebo.
Bolnike so randomizirali na 12 tedensko zdravljenje z zdravilom INCIVO (750 mg na 8 ur v kombinaciji s shemo atazanavir/ritonavir, dizoproksiltenofovirat fumaratom in emtricitabinom ali lamivudinom ALI 1.125 mg na 8 ur v kombinaciji z efavirenzom, dizoproksiltenofovirat fumaratom in emtricitabinom) ali s placebom.
In one of those studies, a telaprevir 1,875 mg every 8 hours regimen was evaluated and the placebo-adjusted maximum mean increase in QTcF was 8.0 msec (90% CI: 5.1-10.9).
V eni od teh študij so ovrednotili shemo odmerjanja telaprevirja 1.875 mg na vsakih 8 ur in je največje srednje povečanje vrednosti QTcF, korigirano glede na placebo, znašalo 8,0 msek (90% IZ: 5,1-10,9).
TSH levels should be determined before and during the course of INCIVO combination treatment and treated as clinically appropriate, including potential adjustment of thyroid replacement therapy in patients with pre-existing hypothyroidism (see section 4.4,
Koncentracije TSH je treba določiti pred in med kombiniranim zdravljenjem z zdravilom INCIVO in ustrezno zdraviti, vključno z morebitnim prilagajanjem nadomestnega zdravljenja s ščitničnimi hormoni pri bolnikih z obstoječim hipotiroidizmom (glejte poglavje 4.4 Laboratorijske preiskave).
Telaprevir is approximately 59% to 76% bound to plasma proteins.
Telaprevir je približno 59% do 76% vezan na plazemske beljakovine, veže pa se predvsem na alfa-1 kisli glikoprotein in na albumin.
Moderate rash: Diffuse rash ≤ 50% of body surface area
Zmeren izpuščaj: difuzen izpuščaj ≤ 50 telesne površine
Because of the potential for adverse reactions in breastfed infants, due to the combined treatment of INCIVO with peginterferon alfa and ribavirin, breast-feeding must be discontinued prior to initiation of therapy.
Zaradi nevarnosti pojava neželenih učinkov pri dojenčkih zaradi kombiniranega zdravljenja s peginterferonom alfa in ribavirinom je treba pred uvedbo zdravljenja dojenje prekiniti.
• Rash and Severe Cutaneous Adverse Reactions safety data from Phases 2 and 3
• podatke o varnosti iz študij faze II in III o izpuščaju in hudih kožnih reakcijah
Increased clinical and laboratory monitoring are warranted (see section 4.4).
Potrebno je okrepljeno klinično in laboratorijsko spremljanje bolnika (glejte poglavje 4.4).
If indicated, elimination of unabsorbed active substance may be achieved by emesis or gastric lavage.
Če je to indicirano, lahko neabsorbirano zdravilno učinkovino odstranite iz telesa s sprožanjem bruhanja ali z izpiranjem želodca.
The overall safety profile of INCIVO is based on Phase 2 and 3 clinical trial data (both controlled and uncontrolled) containing 3,441 patients who received INCIVO combination treatment and on
Celokupni varnostni profil zdravila INCIVO temelji na podatkih iz kliničnih preskušanj faze II in III (nadzorovanih in nenadzorovanih), v katera je bilo vključenih 3.441 bolnikov, ki so prejemali kombinirano zdravljenje z zdravilom INCIVO in na spontanih poročilih iz obdobja trženja zdravila.
domperidone to treat vomiting and nausea (antiemetics)
domperidon za zdravljenje bruhanja in slabosti (antiemetiki)
INCIVO should be used with caution with Class Ic antiarrhythmics propafenone and flecainide, including appropriate clinical and ECG monitoring.
Pri bolnikih, ki jemljejo antiaritmika razreda Ic propafenon in flekainid je potrebna previdnost, vključno z ustreznim kliničnim spremljanjem in spremljanjem EKG.
ECG should be monitored at baseline and regularly during telaprevir treatment.
Pred začetkom in nato redno med zdravljenjem s telaprevirjem je treba spremljati EKG.
INCIVO, 1,125 mg (three 375 mg film-coated tablets) should be taken orally twice daily (b.i.d.)
Zdravilo INCIVO v odmerku 1.125 mg (tri 375 mg filmsko obložene tablete) je treba jemati peroralno dvakrat na dan, s hrano.
Suppression by telaprevir and VRT-127394 of CYP enzymes regulated via CAR, PXR and Ah nuclear receptors was observed in vitro in human hepatocytes.
V in vitro študijah na humanih hepatocitih so opazili s telaprevirjem in VRT-127394 povzročeno supresijo encimov citokroma, ki je bila regulirana preko jedrnih receptorjev CAR, PXR in Ah.
Fertility INCIVO had no effects on fertility or fecundity when evaluated in rats.
Zdravilo INCIVO ni vplivalo na plodnost ali rodnost pri podganah.
Increased dose of zolpidem may be required to maintain efficacy.
Za vzdrževanje učinka, bo morda potrebno zvečati odmerek zolpidema.
Co-administration of rifampicin with telaprevir is contraindicated.
Sočasna uporaba rifampicina s telaprevirjem je kontraindicirana.
HCV RNA levels should be monitored at weeks 4 and 12.
Koncentracijo HCV RNK je treba določati v 4. in 12. tednu.
INCIVO is a strong, time-dependent inhibitor of CYP3A4 and also markedly inhibits P-gp.
Zdravilo INCIVO je močan, časovno odvisen zaviralec encima CYP3A4, ki izrazito zavira tudi P-gp.
If a patient achieved undetectable HCV RNA (target not detected) at week 4, the total treatment duration was 24 weeks.
Če je po 4 tednih bolnik dosegel nezaznavno koncentracijo HCV RNK (nezaznaven analit), je zdravljenje trajalo 24 tednov.
INCIVO, in combination with peginterferon alfa and ribavirin, is indicated for the treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease (including cirrhosis):
Zdravilo INCIVO je v kombinaciji s peginterferonom alfa in ribavirinom indicirano za zdravljenje kroničnega hepatitisa C z genotipom 1 pri odraslih bolnikih s kompenzirano boleznijo jeter (vključno s
3 and/or albumin < 3.3 g/dl.
3 in/ali koncentracijo albumina < 33 g/l ni priporočena.
Mild and moderate CYP3A inducers should be avoided, particularly in patients who are prior non-responders (partial or null responders for peginterferon alfa/ribavirin), unless specific dose recommendations are given (refer to table 2).
Uporabi blagih in zmernih induktorjev CYP3A se je treba izogibati, še posebno to velja pri bolnikih, ki se predhodno niso odzvali na zdravljenje (bolniki z delnim odzivom in bolniki, ki se niso odzvali na zdravljenje s peginterferonom alfa/ribavirinom), razen, če so podana specifična priporočila za
Patients on an efavirenz-based regimen must receive INCIVO 1,125 mg every 8 hours.
Bolniki na osnovni shemi z efavirenzom morajo prejeti 1,125 mg zdravila INCIVO na 8 ur.
The Division of AIDS Table for Grading the Severity of Adult and Paediatric Adverse Events (DAIDS, version 1.0, December 2004) was used in the pooled laboratory datasets.
Pri združenih podatkih je bila uporabljena preglednica za ocenjevanje stopnje jakosti neželenih učinkov pri odraslih in pediatričnih bolnikih, imenovana The Division of AIDS (DAIDS, različica 1.0, december 2004).
Alternatively, 750 mg (two 375 mg tablets) can be taken orally every 8 hours (q8h) with food.
Zdravilo se lahko jemlje tudi po 750 mg (dve 375 mg tableti) peroralno na vsakih 8 ur, s hrano.
Co-administration of sildenafil or tadalafil and telaprevir in the treatment of pulmonary arterial hypertension is contraindicated (see section 4.3).
Sočasna uporaba sildenafila ali tadalafila (za zdravljenje pljučne arterijske hipertenzije) in telaprevirja je kontraindicirana (glejte poglavje 4.3).
If the HCV RNA concentration is > 1,000 IU/ml, INCIVO, peginterferon alfa, and ribavirin should be discontinued.
Če je koncentracija HCV RNK > 1.000 i.e./ml, je treba zdravljenje z zdravili INCIVO, peginterferon alfa, in ribavirin ukiniti.
INCIVO is available in packs containing 1 bottle (total of 42 film-coated tablets) or 4 bottles (total of
Zdravilo INCIVO je na voljo v škatli z 1 plastenko (vsebuje 42 filmsko obloženih tablet) ali v škatli s 4 plastenkami (skupaj 168 filmsko obloženih tablet).
INCIVO is available in packs containing one bottle or 4 bottles per carton.
Zdravilo INCIVO je na voljo v škatlah, ki vsebujejo 1 ali 4 plastenke.
Patients taking INCIVO frequently get an itchy skin rash.
Pri bolnikih, ki jemljejo zdravilo INCIVO se pogosto pojavi srbeč kožni izpuščaj.
Excipient: 2.3 mg of sodium per film-coated tablet.
Pomožna snov: 2,3 mg natrija na filmsko obloženo tableto
↑ triazolam inhibition of CYP3A
↑ triazolam zaviranje CYP3A