natgillin/translations-raw huggingface dataset:
Age greater than 75 years was a significant predictor of carboxy- and desmethyl-dabrafenib plasma concentrations with a 40% greater exposure in subjects ≥75 years of age, relative to subjects <75 years old.
Starost nad 75 let je bila pomemben napovednik koncentracije karboksi- in dezmetildabrafeniba v plazmi; pri bolnikih v starosti ≥ 75 let je bila izpostavljenost 40 % večja kot pri bolnikih, starih < 75 let.
In a study in dogs in which trametinib and dabrafenib were given in combination for 4 weeks, signs of gastrointestinal toxicity and decreased lymphoid cellularity of the thymus were observed at lower exposures than in dogs given trametinib alone.
V študiji na psih, ki so jim 4 tedne dajali trametinib in dabrafenib v kombinaciji, so opažali znake gastrointestinalne toksičnosti in zmanjšano število limfatičnih celic v timusu pri izpostavljenostih, ki so bile nižje kot pri psih, ki so jim dajali samo trametinib.
• some medicines that reduce cholesterol levels, such as atorvastatin and simvastatin
• nekatera zdravila za zniževanje holesterola, npr. atorvastatin in simvastatin
3) The following adverse reaction has occurred in MEK116513 and BRF115532 but not in MEK115306 and BRF113928: rhabdomyolysis (uncommon)
3. naslednji neželeni učinek se je pojavljal v študijah MEK116513 in BRF115532, ni pa se pojavljal v študijah MEK115306 in BRF113928: rabdomioliza (občasni).
The efficacy of the combination with trametinib was superior when indirectly compared to dabrafenib monotherapy in Cohort A.
Pri posredni primerjavi je bila učinkovitost kombinacije s trametinibom večja kot pri dabrafenibu v monoterapiji v kohorti A.
The median time to onset of the first occurrence of cuSCC in the combination arm of the adjuvant treatment study was approximately 18 weeks and was 33 weeks in the placebo arm.
Mediani čas do prvega pojava ploščatoceličnega karcinoma kože je bil v skupini, ki je prejemala kombinirano adjuvantno zdravljenje, približno 18 tednov in v skupini, ki je prejemala placebo, 33 tednov.
The majority of subjects had Stage IVM1c disease (67%).
Pri večini preiskovancev je bil stadij bolezni IVM1c (67 %).
Grade 1 or Grade 2 (Tolerable)
1. in 2. stopnja (znosni)
Tell your doctor, pharmacist or nurse if you get any of the signs and symptoms listed.
Zdravniku, farmacevtu ali medicinski sestri povejte, če se vam pojavi kateri od naštetih znakov in simptomov.
In some cases, people with fever may develop low blood pressure and dizziness.
V nekaterih primerih se lahko osebam z zvišano telesno temperaturo pojavita nizek krvni tlak in omotica.
Do not make up for missed doses and just take your next dose at your regular time: o If it is less than 6 hours to your next scheduled dose of Tafinlar, which is taken twice daily.
Izpuščenega odmerka pa ne nadomeščajte in vzemite samo naslednji odmerek po razporedu, če: o je manj kot 6 ur do naslednjega rednega odmerka zdravila Tafinlar, ki ga jemljete dvakrat na dan; o je manj kot 12 ur do naslednjega rednega odmerka trametiniba, ki ga jemljete enkrat na dan.
The most commonly observed BRAF mutation is V600E which accounts for approximately 90% of the BRAF mutations that are seen in melanoma.
Najpogosteje opažena mutacija BRAF je V600E; ta predstavlja ~90 % mutacij BRAF pri melanomu.
Based on updated data with an additional 10 months of follow-up compared to the primary analysis (minimum follow-up of 40 months), the RFS benefit was maintained with an estimated HR of 0.49 [95% CI: (0.40, 0.59)] (Figure 4).
Po analizi posodobljenih podatkov z dodatnimi 10 meseci spremljanja glede na primarno analizo (najkrajši čas spremljanja je bil 40 mesecev), se je izboljšanje RFS ohranilo z ocenjenim razmerjem ogroženosti 0,49 [95-odstotni IZ: (0,40; 0,59)] (slika 4).
• Dehydration (low levels of water or fluid)
• dehidracija (zmanjšana količina vode oziroma tekočin v telesu)
Medicinal products that are strong inhibitors or inducers of CYP2C8 or CYP3A4 are therefore likely to increase or decrease, respectively, dabrafenib concentrations.
Zato je verjetno, da zdravila, ki močno zavirajo ali inducirajo CYP2C8 ali CYP3A4, povečajo oziroma zmanjšajo koncentracijo dabrafeniba.
Included in these clinical trials were in total 402 subjects with BRAF V600E and 49 subjects with BRAF V600K mutation.
V te klinične študije je bilo skupaj vključenih 402 bolnikov z mutacijo BRAF V600E in 49 bolnikov z mutacijo BRAF V600K.
Administration of dabrafenib with food reduced the bioavailability (Cmax and AUC decreased by 51% and 31% respectively) and delayed absorption of dabrafenib capsules when compared to the fasted state.
Uporaba dabrafeniba s hrano je zmanjšala biološko uporabnost (Cmax za 51 % in AUC za 31 %) ter je upočasnila absorpcijo iz kapsul dabrafeniba v primerjavi z uporabo na tešče.
• Reddening and swelling of the palms, fingers and soles of the feet (see “Changes in your skin”
• rdečina in otekanje dlani, prstov rok in podplatov (glejte "Spremembe na koži" zgoraj v
Taking Tafinlar with trametinib: trametinib may impair fertility in both men and women.
Jemanje zdravila Tafinlar skupaj s trametinibom: Trametinib lahko poslabša plodnost pri moških in ženskah.
Neoplasms benign, malignant and unspecified (including cysts and polyps)
Benigne, maligne in neopredeljene neoplazme (vključno s cistami in polipi)
Table 4 Adverse reactions reported in the integrated safety population of dabrafenib in combination with trametinib in the studies MEK115306, MEK116513
Preglednica 4 Neželeni učinki, o katerih so poročali pri skupini za vrednotenje varnosti zdravila, zdravljeni z dabrafenibom v kombinaciji s trametinibom v študijah MEK115306, MEK116513
The onset of these serious non-infectious febrile events was typically within the first month of therapy.
Ti resni neinfekcijski febrilni pojavi so se praviloma začeli v prvem mesecu zdravljenja.
These include:
Med takšna spadajo:
One of the events occurred on the first day of dabrafenib dosing of a metastatic melanoma patient and recurred following re-challenge at a reduced dose.
En primer se je pojavil prvi dan uporabe dabrafeniba pri bolniku z metastatskim melanomom in se je ponovil po ponovni uvedbi zdravljenja z znižanim odmerkom.
Dabrafenib related material is excreted primarily in faeces, with 71% of an oral dose recovered in faeces; 23% of the dose was recovered in urine in the form of metabolites only.
Z dabrafenibom povezane snovi se v prvi vrsti izločijo v blato: 71 % peroralnega odmerka so našli v blatu, 23 % odmerka v urinu, in sicer samo v obliki presnovkov.
• dark urine due to kidney damage
• temno obarvan urin zaradi okvare ledvic.
Eye problems
Težave z očmi
57 patients had 1-3 lines of previous systemic treatment for their metastatic disease.
57 bolnikov je že prej prejelo 1-3 linije sistemskega zdravljenja metastatske bolezni.
Effect of food on dabrafenib
Vpliv hrane na dabrafenib
The bottles are opaque white plastic with threaded plastic closures.
Plastenke so iz motno bele plastike s plastično navojno zaporko.
If creatinine increases, dabrafenib may need to be interrupted as clinically appropriate.
Če se vrednost kreatinina zviša, je morda treba začasno prekiniti uporabo dabrafeniba, če je to klinično primerno.
Renal failure, acute renal failure Nephritis
Občasni odpoved ledvic, akutna odpoved ledvic nefritis
Renal failure due to pyrexia-associated pre-renal azotaemia or granulomatous nephritis was uncommon; however dabrafenib has not been studied in patients with renal insufficiency (defined as creatinine >1.5 x ULN).
Ledvična odpoved zaradi predledvične azotemije zaradi pireksije ali granulomatoznega nefritisa je bila občasna, vendar pa dabrafenib ni raziskan pri bolnikih, ki so imeli ledvično insuficienco (definirano kot kreatinin > 1.5 x ZNM).
The primary endpoint was ORR using the RECIST 1.1 assessed by the investigator.
Primarni cilj opazovanja je bila stopnja celokupnega odziva (ORR) po kriterijih RECIST 1.1, kot so jih ocenili raziskovalci.
Dabrafenib is an inhibitor of RAF kinases.
Dabrafenib je zaviralec RAF-kinaz.
• Decrease in number of red blood cells (anaemia), blood platelets (cells that help blood to clot),
• znižano število rdečih krvnih celic (anemija), krvnih ploščic (celice, ki omogočajo strjevanje krvi) in vrste belih krvnih celic (levkopenija)
Avoid co-administration of dabrafenib with potent inducers (e.g. rifampicin, phenytoin, carbamazepine, phenobarbital, or St John's wort (Hypericum perforatum)) of CYP2C8 or CYP3A4.
Izogibajte se sočasni uporabi dabrafeniba z močnimi induktorji (npr. rifampicinom, fenitoinom, karbamazepinom, fenobarbitalom ali šentjanževko (Hypericum perforatum)) CYP2C8 ali CYP3A4.
• loss of vision
• izguba vida
Take your morning and evening doses of Tafinlar at the same times every day.
Jutranji in večerni odmerek zdravila Tafinlar vzemite vsak dan ob istem času.
Survival estimates at 1 and 2 years from randomisation were 97% and 91% in the combination arm and 94% and 83% in the placebo arm, respectively).
Ocenjeno preživetje po 1 oziroma 2 letih od randomizacije je bilo v skupini s kombiniranim zdravljenjem 97 % oziroma 91 %, v skupini s placebom pa 94 % oziroma 83 %.
Male patients taking dabrafenib as monotherapy or in combination with trametinib should be informed of the potential risk for impaired spermatogenesis, which may be irreversible.
Moške bolnike, ki jemljejo dabrafenib, bodisi v monoterapiji ali v kombinaciji s trametinibom, je treba seznaniti z možnim tveganjem za motnje spermatogeneze, ki so lahko ireverzibilne.
When dabrafenib and trametinib are taken in combination, the once-daily dose of trametinib should be taken at the same time each day with either the morning dose or the evening dose of dabrafenib.
Pri jemanju dabrafeniba in trametiniba v kombinaciji je treba vzeti dnevni odmerek trametiniba enkrat na dan vsak dan ob istem času skupaj z bodisi jutranjim ali večernim odmerkom dabrafeniba.
BRF115532 (n=1076)
a, BRF113928 in BRF115532 (n = 1076)
78 patients had previous systemic treatment for their metastatic disease.
78 bolnikov je že prej prejemalo sistemsko zdravljenje metastatske bolezni.
• Anticoagulants (e.g. acenocoumarol, warfarin, see section 4.4)
• antikoagulansi (npr. acenokumarol, varfarin, glejte poglavje 4.4)
In clinical trials in unresectable or metastatic melanoma,these cases were identified within the first 5 months of dabrafenib as monotherapy.
V kliničnih preskušanjih inoperabilnega ali metastatskega melanoma so te primere odkrili v prvih 5 mesecih zdravljenja z dabrafenibom v monoterapiji.
Although limited by the low number of patients, median OS appeared consistent with data in patients with BRAF V600E positive tumours.
Kljub omejitvi zaradi majhnega števila bolnikov se mediana za celokupno preživetje po vsem sodeč sklada s podatki bolnikov z BRAF V600E pozitivnimi tumorji.
At 1 year
Po 1 letu
If your doctor decides that you will receive treatment with the combination of Tafinlar and trametinib, read the trametinib leaflet carefully as well as this leaflet.
Če se zdravnik odloči, da vas bo zdravil s kombinacijo zdravila Tafinlar in trametiniba, pozorno preberite navodilo za uporabo za trametinib in to navodilo za uporabo.
Grade (CTC-AE)* Recommended dabrafenib dose modifications Used as monotherapy or in combination with trametinib
Stopnja (CTC-AE)* Priporočena prilagoditev odmerka dabrafeniba pri uporabi v monoterapiji ali v kombinaciji s trametinibom
Median OS and estimated 1-year, 2-year, 3-year, 4 year and 5-year survival rates are presented in Table 8.
Mediana celokupnega preživetja (OS) in ocene 1-letnega, 2-letnega, 3-letnega, 4-letnega ter 5-letnega preživetja so predstavljene v preglednici 8.
Based on 153 events (60 [14%] in the combination arm and 93 [22%] in the placebo arm) corresponding to a 26% information fraction of the total target of 597 OS events, the estimated hazard ratio for OS was 0.57 (95% CI: 0.42, 0.79; p=0.0006).
Na osnovi 153 dogodkov (60 [14 %] v skupini s kombiniranim zdravljenjem in 93 [22 %] v skupini s placebom), ki predstavljajo 26 % celotnega števila podatkov, pridobljenih pri doseženenem cilju 597 dogodkov za oceno celokupnega preživetja, je ocenjeno razmerje ogroženosti 0,57 (95-odstotni IZ: 0,42; 0,79; p = 0,0006).
A population pharmacokinetic analysis indicates that mildly elevated bilirubin and/or AST levels (based on National Cancer Institute [NCI] classification) do not significantly affect dabrafenib oral clearance.
Populacijska farmakokinetična analiza kaže, da blago zvišanje bilirubina in/ali AST (po klasifikaciji NCI [National Cancer Institute]) ne vpliva pomembno na peroralni očistek dabrafeniba.
• Inflammation of the eye (uveitis, see “Eye problems” earlier in section 4))
• vnetje očesa (uveitis, glejte "Težave z očmi" zgoraj v 4. poglavju)
Median OS and estimated 1-year, 2-year, 3-year, 4 year and 5-year survival rates are presented in Table 6.
Mediana celokupnega preživetja (OS) in ocene 1-letnega, 2-letnega, 3-letnega, 4-letnega ter 5-letnega preživetja so predstavljene v preglednici 6.
• some medicines to lower fat (lipids) in the blood stream, such as gemfibrozil
• nekatera zdravila za zmanjševanje maščob (lipidov) vkrvnem obtoku, kot npr. gemfibrozil
However, in repeat dose studies, testicular degeneration/depletion was seen in rats and dogs (≥0.2 times the human clinical exposure based on AUC).
Toda v študijah ponavljajočih se odmerkov so pri podganah in psih opažali degeneracijo/deplecijo testisov (≥ 0,2-kratna klinična izpostavljenost pri človeku na podlagi AUC).
NA = Not applicable
NA = ni relevantno
• change of a mole in size or colour
• spremembo velikosti ali barve materinega znamenja
In some cases, people with fever may develop low blood pressure, dizziness or other symptoms.
V nekaterih primerih lahko pri bolnikih z zvišano telesno temperaturo pride tudi do znižanja krvnega tlaka, omotice ali drugih simptomov.
Mean accumulation AUC Day 18/Day 1 ratios was 0.73.
Razmerje povprečne AUC kopičenja 18. dan/1.
Some people taking Tafinlar may also notice that new melanomas have appeared.
Nekaterim bolnikom, ki jemljejo zdravilo Tafinlar, se lahko pojavijo novi melanomi.
Signs that your liver may not be working properly may include: - loss of appetite - feeling sick (nausea) - being sick (vomiting) - pain in your stomach (abdomen) - yellowing of your skin or the whites of your eyes (jaundice) - dark-coloured urine - itching of your skin
Znaki nezadostnega delovanja jeter lahko vključujejo: - izgubo apetita, - občutek slabosti, - bruhanje, - bolečine v trebuhu, - porumenelost kože ali beločnic (zlatenica), - temno obarvan urin, - srbenje kože.
At 5 years
Po 5 letih
Tafinlar in combination with trametinib can cause problems with your liver which may develop into serious conditions such as hepatitis and liver failure, which may be fatal.
Zdravilo Tafinlar lahko v kombinaciji s trametinibom povzroči težave z jetri, ki se lahko razvijejo v resno bolezen, kot sta hepatitis ali odpoved jeter, ki se lahko konča s smrtjo.
Patients with a history of prior malignancy, if disease-free for at least 5 years, were eligible.
Bolniki z anamnezo predhodne maligne bolezni so bili primerni za vključitev, če so bili brez znakov bolezni že najmanj 5 let.
• passing blood in the stools or passing black stools
• prisotnost krvi v blatu ali izločanje črnega blata
Upon discontinuation of dabrafenib offset of induction is gradual, concentrations of sensitive CYP3A4, CYP2B6, CYP2C8, CYP2C9 and CYP2C19, UDP glucuronosyl transferase (UGT) and transporter substrates (e.g. Pgp or MRP-2) may increase and patients should be monitored for toxicity and dose of these agents may need to be adjusted.
Koncentracije občutljivih CYP3A4, CYP2B6, CYP2C8, CYP2C9 in CYP2C19, UDP glukuronozil-transferaze (UGT) in substratov prenašalcev (npr. Pgp ali MRP-2) se lahko povečajo in bolnike je treba spremljati glede toksičnih učinkov; potrebna je lahko prilagoditev odmerkov teh zdravil.
Although dabrafenib and its metabolites, hydroxy-dabrafenib, carboxy-dabrafenib and desmethyl-dabrafenib, were inhibitors of human organic anion transporter (OAT) 1 and OAT3 in vitro, and dabrafenib and its desmethyl metabolite were found to be inhibitors of organic cation transporter 2 (OCT2) in vitro, the risk of a drug-drug interaction at these transporters is minimal based on clinical exposure of dabrafenib and its metabolites.
Čeprav dabrafenib in njegovi presnovki hidroksidabrafenib, karboksidabrafenib in desmetildabrafenib in vitro zavirajo humani prenašalec organskih anionov (OAT) 1 in OAT3, ter sta se dabrafenib in njegov desmetilni presnovek pokazala kot zaviralca prenašalca organskih kationov 2 (OCT2) in vitro, je tveganje za medsebojno delovanje zdravil zaradi navedenih prenašalcev, glede na klinično izpostavljenost dabrafenibu in njegovim presnovkom, zelo majhno.
d a - Progression-free survival (investigator assessed) b - Overall Response Rate = Complete Response + Partial Response c - Duration of response d - At the time of the reporting the majority (59% of dabrafenib+trametinib and 42% of vemurafenib) of investigator-assessed responses were still ongoing NR = Not reached
7,5d a - preživetje brez napredovanja (kot ga oceni raziskovalec) b - celokupni odziv = popoln odziv + delen odziv c - trajanje odziva d - v času poročanja je večina odzivov (59 % pri dabrafenibu + trametinibu in 42 % pri vemurafenibu), kot jih je ocenil raziskovalec, še trajala ND = ni doseženo
Tell your doctor immediately if you get the following symptoms of eye problems: blurred vision, loss of vision or other vision changes, coloured dots in your vision or halos (seeing blurred outline around objects) during your treatment.
Zdravniku morate takoj povedati, če se vam med zdravljenjem pojavijo naslednji očesni simptomi: zamegljen vid, izguba vida ali spremembe vida, pojav barvastih pik v vašem vidu ali odsevi (zamegljeni obrisi okoli predmetov).
The side effects that you may see when you take Tafinlar in combination with trametinib are as follows:
Neželeni učinki, ki jih lahko opazite v času jemanja zdravila Tafinlar v kombinaciji s trametinibom, so naslednji:
Sixty percent of patients were male and 99.6% were Caucasian; the median age was 52 years with 21% of patients being ≥65 years, 98.4% had ECOG status of 0 or 1, and 97% of patients had metastatic disease.
Mediana starost je bila 52 let; 21 % bolnikov je bilo starih ≥ 65 let, 98,4 jih je imelo stanje zmogljivosti po lestvici ECOG 0 ali 1 in 97 % bolnikov je imelo metastatsko bolezen.
• Inflammation of the fatty layer under the skin (panniculitis)
• vnetje maščobne plasti pod kožo (panikulitis)
Cohorts were enrolled sequentially:
Bolnike so zaporedno vključevali v naslednje kohorte:
How to take Tafinlar
Kako jemati zdravilo Tafinlar
Dry mouth Stomatitis
Pogosti suha usta stomatitis
Results for the primary analysis of RFS are presented in Table 14.
V preglednici 14 so prikazani rezultati primarne analize RFS.
• coughing up of blood or blood clots
• izkašljevanje krvi ali krvnih strdkov
Enzymes that may be induced include CYP3A in the liver and gut, CYP2B6, CYP2C8, CYP2C9, CYP2C19, and UGTs (glucuronide conjugating enzymes).
Med encimi, ki so lahko inducirani, so CYP3A v jetrih in črevesu, CYP2B6, CYP2C8, CYP2C9, CYP2C19 in UGT-ji (encimi, ki konjugirajo glukuronide).
Deep vein thrombosis/Pulmonary embolism
Globoka venska tromboza/pljučna embolija
Recommended dose level reductions and recommendations for dose modifications are provided in Tables 1 and 2, respectively.
Priporočena znižanja odmerka so prikazana v preglednici 1, priporočila za prilagajanje odmerka pa v preglednici 2.
Trametinib is not recommended if you have ever had a blockage of the vein draining the eye (retinal vein occlusion).
Trametiniba ni priporočljivo uporabljati, če ste kdaj imeli zaporo vene, po kateri kri odteka iz očesa (zaporo mrežnične vene).
Dabrafenib is an enzyme inducer and increases the synthesis of drug-metabolising enzymes including CYP3A4, CYP2Cs and CYP2B6 and may increase the synthesis of transporters.
Dabrafenib je induktor encimov in poveča sintezo encimov, ki presnavljajo zdravila, med njimi CYP3A4, CYP2C in CYP2B6, in lahko poveča sintezo prenašalcev.
New primary melanoma
Nov primarni melanom
Concomitant administration of dabrafenib with digoxin may result in decreased digoxin exposure.
Sočasna uporaba dabrafeniba in digoksina lahko zmanjša izpostavljenost digoksinu.
In addition, mild hepatic impairment as defined by bilirubin and AST did not have a significant effect on dabrafenib metabolite plasma concentrations.
Poleg tega blaga okvara jeter (opredeljena z bilirubinom in AST) ni pomembno vplivala na koncentracijo presnovkov dabrafeniba v plazmi.
There are no clinical data in subjects with severe renal impairment and the potential need for dose adjustment cannot be determined (see section 5.2).
Kliničnih podatkov za bolnike s hudo okvaro ledvic ni in morebitne potrebe po prilagoditvi odmerka ni mogoče opredeliti (glejte poglavje 5.2).
The Tafinlar doses should be about 12 hours apart.
Presledek med odmerkoma zdravila Tafinlar naj bo približno 12 ur.
As of 25 June 2012 cut-off, thirty five subjects (55.6%) of the 63 randomised to DTIC had crossed over to dabrafenib and 63% of subjects randomised to dabrafenib and 79% of subjects randomised to DTIC had progressed or died.
Do presečnega datuma 25. junija 2012 je 35 od 63 bolnikov (55,6 %) randomiziranih na DTIC, prešlo na dabrafenib; napredovanje bolezni ali smrt so zabeležili pri 63 % bolnikov, randomiziranih na dabrafenib, in pri 79 %, randomiziranih na DTIC.
Upon resolution of pyrexia dabrafenib should be restarted with appropriate anti-pyretic prophylaxis, either 1) at the same dose level, or 2) reduced by one dose level if the pyrexia is recurrent and/or was accompanied by other severe symptoms including dehydration, hypotension or renal failure.
Ko zvišana telesna temperatura mine, je treba ob sočasni antipiretični profilaksi zdravljenje z dabrafenibom ponovno uvesti, bodisi 1) v enakem odmerku ali 2) v odmerku, ki je za eno odmerno raven nižji, če se zvišana telesna temperatura ponavlja in/ali jo spremljajo hudi simptomi, ki vključujejo dehidracijo, hipotenzijo ali odpoved ledvic.
• Inflamed, flaky skin (exfoliative dermatitis)
• vnetje kože z luščenjem (eksfoliativni dermatitis)
Based on exposure, relative potency, and pharmacokinetic properties, both hydroxy- and desmethyl-dabrafenib are likely to contribute to the clinical activity of dabrafenib while the activity of carboxy-dabrafenib is not likely to be significant.
Na podlagi izpostavljenosti, relativne jakosti in farmakokinetičnih lastnosti verjetno h kliničnemu delovanju prispevata tako hidroksi- kot dezmetildabrafenib, medtem ko za delovanje karboksidabrafeniba ni verjetno, da bi bilo pomembno.
Following administration of 150 mg twice daily, geometric mean Cmax, AUC(0-) and predose concentration (C) were 1478 ng/ml, 4341 ng*hr/ml and 26 ng/ml, respectively.
Po uporabi 150 mg dvakrat na dan so bila geometrična povprečja Cmax 1478 ng/mL, AUC(0-) 4341 ng*h/mL in koncentracije pred odmerkom (C) 26 ng/mL.
Groups of medicinal products that can be affected include, but are not limited to:
To lahko velja za, vendar ni omejeno na, spodaj naštete skupine zdravil:
separation of the light-sensitive membrane in the back of the eye (the retina) from its supporting layers (retinal detachment) and swelling around the eyes
odstop membrane, ki je občutljiva za svetlobo in leži na očesnem ozadju (mrežnice) od spodaj ležeče plasti (odstop mrežnice) in oteklina okrog oči
In juvenile toxicity studies in rats, effects on growth (shorter long bone length), renal toxicity (tubular deposits, increased incidence of cortical cysts and tubular basophilia and reversible increases in urea and/or creatinine concentrations) and testicular toxicity (degeneration and tubular dilation) were observed (≥0.2 times adult human clinical exposure based on AUC).
V študijah juvenilne toksičnosti pri podganah so opažali učinke na rast (krajša dolžina dolgih kosti), ledvično toksičnost (tubularni depoziti, večja incidenca kortikalnih cist in tubularna bazofilija ter reverzibilno zvišanje koncentracije sečnine in/ali kreatinina) in testikularno toksičnost (degeneracija in dilatacija tubulov) (≥ 0,2-kratna klinična izpostavljenost pri odraslem človeku na podlagi AUC).