natgillin/translations-raw huggingface dataset:
A treatment cycle comprises 28 days.
Cikel zdravljenja traja 28 dni.
• peeling skin, increased skin sensitivity to sunlight, change in skin colour, increased sweating
• luščenje kože, povečana občutljivost kože za sončno svetlobo, spremembe barve kože, povečano znojenje
If you are taking Temozolomide Accord in combination with radiotherapy (newly diagnosed patients):
Če jemljete zdravilo Temozolomid Accord v kombinaciji z radioterapijo (na novo diagnosticirani bolniki):
Special populations Paediatric population
Posebne populacije Pediatrična populacija
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
PRILOGA 1 POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
What you need to know before you take Temozolomide Accord
Kaj morate vedeti, preden boste vzeli zdravilo Temozolomid Accord
• frequent urination, difficulty with holding your urine or urine leakage
• pogosto uriniranje, težave z zadrževanjem urina ali uhajanje urina
The following side effects may occur if you are taking only temozolomide (patients treated for brain tumours that have come back or that have spread)
Naslednji neželeni učinki se lahko pojavijo, če jemljete samo temozolomid (bolniki, ki se zdravijo zaradi možganskih tumorjev, ki so se ponovno pojavili ali pa so se razširili).
Each carton contains 5 or 20 sachets.
Škatla vsebuje 5 ali 20 vrečk.
What Temozolomide Accord is and what it is used for What you need to know before you take Temozolomide Accord How to take Temozolomide Accord Possible side effects
Kaj je zdravilo Temozolomid Accord in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Temozolomid Accord Kako jemati zdravilo Temozolomid Accord Možni neželeni učinki
Patients usually present with shortness of breath and cough.
Bolniki ponavadi razvijejo kratko sapo in kašelj.
Pharmacotherapeutic group: Antineoplastic agents - Other alkylating agents, ATC code: L01A X03
Farmakoterapevtska skupina: Antineoplastična zdravila - Drugi alkilirajoči citostatiki, oznaka ATC: L01A X03
What Temozolomide Accord is and what it is used for
Kaj je zdravilo Temozolomid Accord in za kaj ga uporabljamo
Rats appear to be particularly sensitive to oncogenic effects of TMZ, with the occurrence of first tumours within 3 months of initiating dosing.
Zdi se, da so podgane posebej občutljive na onkogene učinke TMZ, prvi tumorji pa se pojavijo v 3 mesecih po začetku odmerjanja.
In some cases, your temozolomide dose will be reduced or discontinued.
V nekaterih primerih je treba zmanjšati ali ukiniti odmerek temozolomida.
Older patients are more prone to infections, increased bruising or bleeding.
Starejši bolniki so bolj dovzetni za okužbe, tvorbo modric ali pojav krvavitev.
Temozolomide Accord may cause permanent infertility.
Zdravilo Temozolomid Accord lahko povzroči trajno neplodnost.
This may cause you to have increased bruising or bleeding, anaemia (a shortage of red blood cells), fever, and/or a reduced resistance to infections.
To lahko poveča nagnjenost k nastanku modric, anemije (pomanjkanja rdečih krvnih celic), vročine in/ali manjše odpornosti na okužbe.
Store in the original bottle.
Shranjujte v originalni steklenici.
For all patients, liver function tests should be checked after each treatment cycle.
Pri vseh bolnikih je treba funkcijske preiskave delovanja jeter opraviti po vsakem ciklu zdravljenja.
Co-administration with valproic acid was associated with a small but statistically significant decrease in clearance of TMZ.
Sočasno jemanje z valproično kislino je bilo povezano z majhnim, a statistično pomembnim zmanjšanjem očistka TMZ.
In some cases, exposure to concomitant medicinal products associated with aplastic anaemia, including carbamazepine, phenytoin, and sulfamethoxazole/trimethoprim, complicates assessment.
V nekaterih primerih izpostavljenost sočasno jemanim zdravilom, ki jih povezujejo z aplastično anemijo, vključno s karbamezapinom, fenitoinom in sulfametoksazolom/trimetoprimom, otežuje oceno.
Dose-limiting toxicity was haematological and was reported with any dose but is expected to be more severe at higher doses.
Toksični učinki za omejitev odmerka so bili hematološki in so jih poročali pri vseh odmerkih, vendar je pričakovati, da bo toksičnost izrazitejša pri večjih odmerkih.
Very rarely, patients taking temozolomide and medicines like it may have a small risk of other changes in blood cells, including leukaemia.
Bolniki, ki jemljejo temozolomid in podobna zdravila, zelo redko razvijejo manjše tveganje za druge spremembe krvnih celic, vključno z levkemijo.
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Od zdravstvenih delavcev se zahteva, da poročajo o katerem koli domnevnem neželenem učinku zdravila na nacionalni center za poročanje, ki je naveden v Prilogi V*
TMZ administration can be continued throughout the 42 day concomitant period (up to 49 days) if all of the following conditions are met:
Jemanje odmerkov TMZ se lahko nadaljuje ves čas 42-dnevnega obdobja sočasnega zdravljenja (do 49 dni), če so izpolnjeni vsi od naslednjih pogojev:
Temozolomide Accord should not be administered to pregnant women.
Zdravila Temozolomid Accord se ne sme dajati nosečim ženskam.
Your doctor may need to reduce the dose of your medicine or interrupt your treatment, or you may need other treatment.
Vaš zdravnik bo moral morda zmanjšati odmerek vašega zdravila ali prekiniti zdravljenje oziroma ga spremeniti.
Patients who have experienced severe (Grade 3 or 4) vomiting in previous treatment cycles may require anti-emetic therapy.
Bolniki, pri katerih je v prejšnjih ciklih zdravljenja prišlo do hudega bruhanja (stopnja 3 ali 4), je potrebno antiemetično zdravljenje.
It is not known whether TMZ is excreted in human milk; thus, breast-feeding should be discontinued while receiving treatment with TMZ.
Ni znano ali se TMZ izloča v materino mleko, zato je treba med zdravljenjem s TMZ prenehati z dojenjem.
Each sachet contains 1 hard capsule.
Vsaka vrečka vsebuje 1 trdo kapsulo.
Tolerance to TMZ is similar to adults.
TMZ so bolniki prenašali podobno kot odrasli.
No evidence of cumulative myelosuppression was observed.
Dokazov kumulativne mielosupresije niso opazili.
Polyester/aluminium/polyethylene (PET/alu/PE) sachet.
Vrečka iz poliestra/aluminija/polietilena (PET/alu/PE).
Temozolomide is an anti-cancer medicine.
Temozolomid je zdravilo za zdravljenje raka..
Depending on your blood test results, your doctor may adjust your dose for the next cycle.
Zdravnik bo na osnovi rezultatov krvnih preiskav morda prilagodil vaš odmerek za naslednji cikel.
Frequency groupings are defined according to the following convention: Very Common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very rare (<1/10,000).
Pogostnostne skupine so opredeljene po naslednjem načelu: zelo pogosti (≥1/10); pogosti (≥1/100 do <1/10); občasni (≥1/1.000 to <1/100); redki (≥1/10.000 do <1/1.000); zelo redki (<1/10.000).
There is limited information in patients over 3 years of age who have taken Temozolomide Accord.
Število podatkov pri bolnikih, starejših od 3 let, ki so jemali zdravilo Temozolomid Accord, je omejeno.
For patients with significant liver function abnormalities, physicians should assess the benefit/risk of continuing treatment.
Pri bolnikih s signifikantno nenormalnimi rezultati funkcijski preiskav delovanja jeter morajo zdravniki oceniti razmerje med koristnostjo zdravljenja in tveganjem, povezanim z nadaljevanjem zdravljenja.
Relative to the AUC of TMZ, the exposure to MTIC and AIC is ~ 2.4% and 23%, respectively.
za TMZ je izpostavljenost MTIC in AIC ~ 2,4 % oziroma 23 %.
Patients will be carefully checked by their doctor for signs of this infection before treatment.
Pred začetkom zdravljenja bo zdravnik bolnike skrbno pregledal glede znakov te okužbe.
Following oral administration, approximately 5% to 10% of the dose is recovered unchanged in the urine over 24 hours, and the remainder excreted as temozolomide acid, 5-aminoimidazole-4carboxamide (AIC) or unidentified polar metabolites.
Po peroralni uporabi se v 24 urah v nespremenjeni obliki v urin izloči približno 5 % do 10 % odmerka, preostanek pa se izloči kot temozolomidna kislina, 5-aminoimidazol-4-karboksamid (AIC) ali nedoločeni polarni presnovki.
Plasma concentrations increase in a dose-related manner.
Plazemske koncentracije se povečajo v odvisnosti od povečanja odmerka.
Use of TMZ in combination with other myelosuppressive agents may increase the likelihood of myelosuppression.
Uporaba TMZ v kombinaciji z drugimi mielosupresivnimi učinkovinami lahko poveča verjetnost pojava mielosupresije.
In the non-comparative trial, the PFS at 6 months was 19%, the median progression-free survival was 2.1 months, and the median overall survival 5.4 months.
V neprimerjalnem preskušanju je bil PFS po 6 mesecih 19 %, mediana vrednost PFS 2,1 meseca in mediana vrednost celotnega preživetja 5,4 mesecev.
Anti-emetic therapy may be administered (see section 4.4).
Lahko se predpiše tudi antiemetično zdravljenje (glejte poglavje 4.4).
Elderly patients appear to be at increased risk of neutropenia and thrombocytopenia, compared with younger patients.
Zdi se, da je pri starejših bolnikih tveganje za pojav nevtropenije in trombocitopenije večje, kot pri mlajših bolnikih.
If you vomit after your dose, do not take a second dose on the same day.
Če bruhate po zaužitju odmerka, v istem dnevu ne vzemite drugega odmerka.
• loss of hearing, ringing noise in the ear
• izguba sluha, zvonjenje v ušesu
Very rare cases of rash with skin swelling, including on the palms of the hands and soles of the feet, or painful reddening of the skin and/or blisters on the body or in the mouth have been observed.
Zelo redko so opazili izpuščaj z oteklinami na koži, ki zajema tudi dlani in podplate, ali pa bolečo pordelost kože in/ali mehurje na telesu oziroma v ustih.
A treatment cycle with Temozolomide Accord comprises 28 days.
Cikel zdravljenja z zdravilom Temozolomid Accord traja 28 dni.
Temozolomide Accord capsules are taken to treat specific forms of brain tumours: - adults with newly diagnosed specific form of brain tumour (glioblastoma multiforme).
Kapsule Temozolomid Accord se uporabljajo za zdravljenje posebnih oblik možganskih tumorjev: - Odraslih bolnikov s posebno obliko novo diagnosticiranega možganskega tumorja (multiformni glioblastom).
In a population pharmacokinetics analysis of clinical trial experience there were 101 female and 169 male subjects for whom nadir neutrophil counts were available and 110 female and 174 male subjects for whom nadir platelet counts were available.
V analizi populacijske farmakokinetike, na osnovi izkušenj iz kliničnih preskušanj, so bili zajeti podatki 101 bolnice in 169 bolnikov, pri katerih je bil na voljo podatek o najmanjšem številu nevtrofilcev, ter podatki 110 bolnic in 174 bolnikov, pri katerih je bil na voljo podatek o najmanjšem številu trombocitov.
If you are a newly-diagnosed patient (glioblastoma multiforme) you may be receiving temozolomide for 42 days in combination with radiotherapy.
Če ste na novo odkrit bolnik (multiformni glioblastom), boste temozolomid morda prejemali 42 dni v kombinaciji z radioterapijo.
Liver toxicity may occur several weeks or more after the last treatment with temozolomide.
Hepatotoksičnost se lahko pojavi nekaj tednov po zadnjem zdravljenju s temozolomidom ali še pozneje.
Pack-size of 5 or 20 hard capsules individually sealed in sachets.
Pakiranja po 5 ali 20 trdih kapsul, posamezno zaprtih v vrečkah.
However, caution should be exercised when TMZ is administered in these patients.
Vendar pa je pri uporabi TMZ pri teh bolnikih potrebna previdnost.
Changes in blood cells
Spremembe krvnih celic.
Allergic reactions, including anaphylaxis, angioedema
alergijske reakcije, vključno z anafilakso in angioedemom
Pancytopenia, anaemia (grade 3-4), leukopenia
pancitopenija, anemija (stopnje 3-4), levkopenija,
Keep the bottle tightly closed in order to protect from moisture.
Steklenico shranjujte tesno zaprto za zagotovitev zaščite pred vlago.
Patients treated with TMZ may experience myelosuppression, including prolonged pancytopenia, which may result in aplastic anaemia, which in some cases has resulted in a fatal outcome.
Pri bolnikih, zdravljenih s TMZ lahko pride do mielosupresije , vključno s podaljšano pancotopenijo, kar lahko povzroči aplastično anemijo, ki se je v nekaterih primerih končala s smrtnim izidom.
If use during pregnancy must be considered, the patient should be apprised of the potential risk to the foetus.
Če je treba pretehtati možnost o uporabi zdravila med nosečnostjo, je treba bolnico obvestiti o morebitnih tveganjih za plod.
MTIC is spontaneously hydrolyzed to 5-amino-imidazole-4carboxamide (AIC), a known intermediate in purine and nucleic acid biosynthesis, and to methylhydrazine, which is believed to be the active alkylating species.
MTIC spontano hidrolizira v 5-amino-imidazol-4-karboksamid (AIC), ki je znan intermediat v biosintezi purinov in nukleinskih kislin, in v metilhidrazin, za katerega se domneva, da je aktivni alkilirajoči presnovek.
Plasma clearance, volume of distribution and half-life are independent of dose.
Plazemski očistek, porazdelitveni volumen in razpolovni čas so odvisni od odmerka.
The results from the trial were not consistent in the subgroup of patients with a poor performance status (WHO PS=2, n=70), where overall survival and time to progression were similar in both arms.
Rezultati preskušanja niso bili konsistentni v podskupini bolnikov s slabo telesno zmogljivostjo (WHO PS - »performance status« =2, n=70), kjer sta bila skupno preživetje in čas do napredovanja podobna v obeh krakih.
Patients taking temozolomide in combination with radiation therapy may experience different side effects than patients taking temozolomide alone.
Bolniki, ki jemljejo temozolomid v kombinaciji z radioterapijo, imajo lahko drugačne neželene učinke kot tisti, ki jemljejo samo temozolomid.
Most of the toxicity showed evidence of reversibility, except for adverse reactions on the male reproductive system and retinal degeneration.
Pri večini toksičnih učinkov je bila opažena reverzibilnost, z izjemo neželenih reakcij na moške reproduktivne organe in degeneracijo mrežnice.
In both trials, the primary endpoint was progression-free survival (PFS) defined by MRI scans or neurological worsening.
V obeh preskušanjih je bila primarna končna točka preskušanja čas preživetja brez napredovanja bolezni (PFS - »progression-free survival«), ugotovljen na podlagi NMR posnetkov, ali poslabšanje nevrološkega statusa bolnika.
Reduce TMZ by 1 dose levela
Zmanjšajte odmerek TMZ za 1 raven odmerkaa
Data on clinical efficacy in patients with glioblastoma multiforme (Karnofsky performance status [KPS] ≥70), progressive or recurrent after surgery and RT, were based on two clinical trials with oral TMZ.
Podatki o klinični učinkovitosti pri bolnikih z multiformnim glioblastomom (stanje telesne zmogljivosti po lestvici Karnofsky [KPS] ≥70), ki je napredoval ali se je ponovil po operaciji in RT, so bili pridobljeni iz dveh kliničnih preskušanj o peroralni uporabi TMZ.
The estimated probability of surviving 2 years or more (26% vs 10%) is higher for the RT + TMZ arm.
Ocenjena verjetnost preživetja 2 let ali več je večja za krak TMZ + RT (26 % proti 10 %).
Patients in the control arm received RT only.
Bolniki v kontrolnem kraku so prejeli samo radioterapije.
How to store Temozolomide Accord Contents of the pack and other information
Shranjevanje zdravila Temozolomid Accord Vsebina pakiranja in dodatne informacije
During treatment a complete blood count should be obtained on Day 22 (21 days after the first dose of TMZ).
Med zdravljenjem je treba 22. dan cikla preveriti celotno krvno sliko (21 dni po prvem odmerku TMZ).
In vivo, the t1/2 of MTIC was similar to that of TMZ, 1.8 hr.
In vivo je t1/2 MTIC podoben kot pri TMZ, t. j. 1,8 ur.
Dose level
Stopnja odmerka
Infections including agents causing pneumonia.
Okužbe, ki vključujejo povzročitelje pljučnice.
- if you feel sick or vomit, which are very common side effects of Temozolomide (see section 4).
- Če vam je slabo ali bruhate, kar je zelo pogost neželeni učinek temozolomida (glejte poglavje 4).
• flu-like symptoms, red spots under the skin
• gripi podobni simptomi, rdeče lise pod kožo
- if you have anaemia, low blood count (such as white blood cell count and platelet count), or blood clotting problems before treatment, or develop them during treatment.
- Če imate anemijo, majhno število krvnih celic (npr. majhno število belih krvničk ali krvnih ploščic) ali težave s strjevanjem krvi že pred začetkom zdravljenja ali pa se pojavijo med njim.
Herpes simplex, Herpes zoster, influenza-like symptoms
herpes simplex, herpes zoster, gripi podobni simptomi
Analysis of population-based pharmacokinetics of TMZ revealed that plasma TMZ clearance was independent of age, renal function or tobacco use.
Analiza populacijske farmakokinetike TMZ je pokazala, da je plazemski očistek TMZ neodvisen od starosti, delovanja ledvic ali uporabe tobaka.
Experts in liver disease should be consulted before treatment is initiated in patients with positive hepatitis B serology (including those with active disease).
Pred začetkom zdravljenja bolnikov s pozitivno serologijo na hepatitis B (vključno s tistimi, ki imajo aktivno bolezen) se je treba posvetovati s strokovnjaki za jetrne bolezni.
Signs of allergic reaction include feeling itchy, breathlessness or wheezing, swelling of the face, lips, tongue or throat.
Znaki alergijske reakcije vključujejo občutek srbenja, sopenje ali piskajoče dihanje, otekanje obraza, ustnic, jezika ali žrela.
The cytotoxicity of MTIC is thought to be primarily due to alkylation of DNA mainly at the O6 and N7 positions of guanine.
Domneva se, da je cititoksičnost MTIC večinoma posledica alkilacije DNA, predvsem gvanina na položajih O6 in N7 gvanina.
- Be sure you understand exactly how many capsules you need to take of each strength.
- Prepričajte se, da res razumete, koliko kapsul kakšne jakosti morate vzeti.
Skin redness, an itchy rash with raised yellow or white lumps that are surrounded by red inflammation, skin eruption, allergic reactions.
Rdečica kože, srbeč izpuščaj z rumenimi ali belimi izboklinami, ki jih obdaja rdeče vneto območje, izpuščaj na koži, alergijske reakcije.
• abnormal or blurred vision, double-vision
• nenormalen ali zamegljen vid, dvojni vid
One was a non-comparative trial in 138 patients (29% received prior chemotherapy), and the other was a randomised active-controlled trial of TMZ vs. procarbazine in a total of 225 patients (67% received prior treatment with nitrosourea based chemotherapy).
Prvo je bilo neprimerjalno preskušanje pri 138 bolnikih (29 % jih je prej prejelo kemoterapijo), drugo pa je bilo randomizirano, z učinkovino nadzorovano preskušanje TMZ in prokarbazina pri skupaj 225 bolnikih (67 % jih je prej prejelo kemoterapijo na osnovi nitrozouree.)
In a separate phase I study, administration of TMZ with ranitidine did not result in alterations in the extent of absorption of temozolomide or the exposure to its active metabolite monomethyl triazenoimidazole carboxamide (MTIC).
V ločeni študiji I. faze dajanje TMZ z ranitidinom ni povzročilo sprememb v obsegu absorpcije temozolomida ali izpostavljenosti njegovemu aktivnemu presnovku monometil triazenoimidazol karboksamidu (MTIC).
TMZ administration should be temporarily interrupted or permanently discontinued during the concomitant phase according to the haematological and non-haematological toxicity criteria as noted in Table 1.
Jemanje TMZ je treba začasno prekiniti ali popolnoma prenehati med fazo sočasnega zdravljenja v skladu s hematološkimi in nehematološkimi kriteriji toksičnosti, kot je prikazano v preglednici 1.
• feeling and/or being sick
• občutek slabosti in/ali bruhanje
- as you should be observed closely for the development of a serious form of chest infectioncalled Pneumocystis jirovecii pneumonia (PCP).
- Pozorni morajo biti na morebiten pojav resne oblike okužbe dihal, imenovane pljučnica Pneumocystis jirovecii (PCP- Pneumocystis jirovecii pneumonia).
Anti-emetic prophylaxis is recommended prior to the initial dose of concomitant phase and it is strongly recommended during the monotherapy phase.
Antiemetična profilaksa je priporočljiva pred prvim odmerkom temozolomida v sočasnem zdravljenju in je zelo priporočljiva med fazo monoterapije.
Depending on the dose of temozolomide that your doctor prescribes, you may have to take several capsules on each dosing day of the treatment cycle.
Odvisno od odmerka, ki ga bo predpisal vaš zdravnik, boste morda morali vsak dan jemanja v ciklu zdravljenja vzeti več kapsul naenkrat.
Clinical trial experience
Izkušnje iz kliničnih preskušanj
Cases of sepsis (when bacteria and their toxins circulate in the blood and start to damage the organs) have been uncommonly reported.
Občasno so poročali o primerih sepse (kadar so v krvi prisotne bakterije in njihovi toksini in pričnejo povzročati poškodbe na organih).
The hard capsules are dispensed in sachet containing 1 capsule.
Trde kapsule so na voljo v vrečkah, ki vsebujejo po 1 kapsulo.
Do not take Temozolomide Accord - if you are allergic to temozolomide or any of the other ingredients of this medicine (listed in section 6).
- če ste alergični na temozolomid ali katero koli sestavino zdravila (navedeno v poglavju 6).
20 hard capsules
20 trdih kapsul
CTC Grade 3
SMT stopnje 3
While the radiotherapy is ongoing your doctor will start temozolomide at a dose of 75 mg/m² and the actual daily dose you take will depend on your height and weight.
Med radioterapijo vam bo zdravnik predpisal začetni odmerek 75 mg/m² temozolomida, dejanski dnevni odmerek pa bo odvisen od vaše višine in telesne mase.
PET studies in humans and preclinical data suggest that TMZ crosses rapidly the blood-brain barrier and is present in the CSF.
Študije z uporabo PET pri ljudeh in predklinični podatki nakazujejo, da TMZ hitro prehaja krvnomožgansko pregrado in je prisoten v cerebrospinalni tekočini.
The cytotoxicity of MTIC is thought to be due primarily to alkylation at the O6 position of guanine with additional alkylation also occurring at the N7 position.
Cititoksičnost MTIC je verjetno večinoma posledica alkiliranja gvanina na položaju O6, z dodatnim alkiliranjem na položaju N7.
Cases of fatal respiratory failure have been reported in patients using TMZ, in particular in combination with dexamethasone or other steroids.
Poročali so o respiratorni odpovedi s smrtnim izidom pri bolnikih, ki so jemali TMZ, zlasti v kombinaciji z deksametazonom ali drugimi steroidi.
- if you have a reduced number of blood cells, such as your white blood cell count and platelet count.
- če imate zmanjšano število krvnih celic, na primer belih krvnih celic ali krvnih ploščic.
For patients on a 42 day treatment cycle liver function tests should be repeated midway during this cycle.
Pri bolnikih, ki se zdravijo z 42-dnevnim ciklom jemanja zdravila, je treba funkcijske preiskave delovanja jeter opraviti sredi tega cikla.
Rash, pruritus, alopecia
izpuščaj, pruritus, alopecija,
Effective contraceptive precautions must be taken by both male and female patients who are taking Temozolomide Accord (see also “Male fertility” below).
Bolnice in bolniki, ki jemljejo zdravilo Temozolomid Accord, morajo uporabljati učinkovito kontracepcijsko metodo (glejte tudi poglavje »Plodnost pri moških«).
No dose reductions are recommended, but delay or discontinuation of TMZ administration should be decided weekly according to haematological and non-haematological toxicity criteria.
Zmanjševanje odmerka ni priporočljivo, vendar je treba zamik ali prenehanje jemanja TMZ odločati tedensko, glede na hematološke in nehematološke kriterije toksičnosti.
In a separate pharmacokinetic study, plasma pharmacokinetic profiles in patients with mild to moderate hepatic impairment were similar to those observed in patients with normal hepatic function.
V ločeni farmakokinetični študiji so bili plazemski farmakokinetični profili pri bolnikih z blago do zmerno okvaro jeter podobni kot pri bolnikih z normalnim delovanjem jeter.