natgillin/translations-raw huggingface dataset:
Similar results were obtained in the 2 smaller ankylosing spondylitis trials.
Podobni rezultati so bili dobljeni pri 2 manjših raziskavah ankilozirajočega spondilitisa.
In a fourth study, the safety and efficacy of 50 mg Enbrel (two 25 mg SC injections) administered once weekly vs 25 mg Enbrel administered twice weekly were evaluated in a double-blind, placebo-controlled study of 356 patients with active ankylosing spondylitis.
V četrti, dvojno slepi in s placebom nadzorovani študiji so pri 356 bolnikih z aktivnim ankilozirajočim spondilitisom vrednotili varnost in učinkovitost dajanja zdravila Enbrel v odmerku 50 mg enkrat na teden (dve 25 mg subkutani injekciji) v primerjavi z dajanjem zdravila Enbrel v odmerku 25 mg dvakrat na teden.
The safety and efficacy profiles of the 50 mg once weekly and 25 mg twice weekly regimens were similar.
Profil varnosti in učinkovitosti je bil pri režimu dajanja 50 mg enkrat na teden enak kot pri režimu dajanja 25 mg dvakrat na teden.
Enbrel is recommended for use in patients as defined in section 4.1.
Zdravilo Enbrel se uporablja pri bolnikih, kot je priporočeno v poglavju 4. 1.
Patients who “ failed to respond to ” in the target population is defined by insufficient response (PASI < 50 or PGA less than good), or worsening of the disease while on treatment, and who were adequately dosed for a sufficiently long duration to assess response with at least each of the three major systemic therapies as available.
Skupina bolnikov v ciljni populaciji “ ki se ne odzove ” je opredeljena glede na nezadostni odziv (PASI < 50 ali PGA – Physician Global Assesment - manj kot dober) ali glede na poslabšanje bolezni tekom zdravljenja, ko je bolnik prejemal najmanj vsako od treh glavnih razpoložljivih sistemskih zdravljenj v zadostnem odmerku in dovolj časa, da se je lahko ocenilo odziv.
The efficacy of Enbrel versus other systemic therapies in patients with moderate to severe psoriasis (responsive to other systemic therapies) has not been evaluated in studies directly comparing Enbrel with other systemic therapies.
Učinkovitosti zdravila Enbrel v primerjavi z drugimi sistemskimi zdravljenji pri bolnikih z zmerno do hudo psoriazo (ki se odzivajo na drugo sistemsko zdravljenje) niso neposredno preučevali v primerjalnih raziskavah zdravila Enbrel in drugih sistemskih terapij.
Instead, the safety and efficacy of Enbrel were assessed in four randomised, double-blind, placebo-controlled studies.
Varnost in učinkovitost zdravila Enbrel so ocenili v štirih randomiziranih, dvojno slepih, s placebom kontroliranih raziskavah.
The primary efficacy endpoint in all four studies was the proportion of patients in each treatment group who achieved the PASI 75 (i. e. at least a 75% improvement in the Psoriasis Area and Severity Index score from baseline) at 12 weeks.
Primarni opazovani dogodek učinkovitosti v vseh štirih raziskavah je bil tisti delež bolnikov v vsaki terapevtski skupini, ki je po 12 tednih dosegel PASI 75 (tj. vsaj 75- odstotno izboljšanje indeksa PASI – Psoriasis Area and Severity Index; indeks površine in izrazitosti psoriaze - v primerjavi z izhodiščem).
22 Study 1 was a Phase 2 study in patients with active but clinically stable plaque psoriasis involving  10% of the body surface area that were  18 years old.
Raziskava 1 je bila raziskava 2. faze pri bolnikih, starih ≥ 18 let, z aktivno, a klinično stabilno psoriazo v plakih, ki je zajemala ≥ 10% površine telesa.
One hundred and twelve (112) patients were randomised to receive a dose of 25 mg of Enbrel (n=57) or placebo (n=55) twice a week for 24 weeks.
112 naključno izbranih bolnikov je 24 tednov dvakrat na teden dobivalo 25- mg odmerek zdravila Enbrel (n=57) ali placebo (n=55).
Study 2 evaluated 652 patients with chronic plaque psoriasis using the same inclusion criteria as study 1 with the addition of a minimum psoriasis area and severity index (PASI) of 10 at screening.
Raziskava 2 je ocenila 652 bolnikov s kronično psoriazo v plakih in je imela enaka vključitvena merila kot raziskava 1, le da so imeli bolniki ob presejanju indeks PASI vsaj 10.
After 12 weeks of treatment, patients in the placebo group began treatment with blinded Enbrel (25 mg twice a week); patients in the active treatment groups continued to week 24 on the dose to which they were originally randomised.
Po 12 tednih zdravljenja so bolniki v placebni skupini začeli slepo zdravljenje z zdravilom Enbrel (25 mg dvakrat na teden), bolniki v skupinah z aktivnim zdravljenjem pa so do 24. tedna nadaljevali z odmerkom, na katerega so bili prvotno randomizirani.
Study 3 evaluated 583 patients and had the same inclusion criteria as study 2.
Raziskava 3 je ocenila 583 bolnikov in je imela enaka vključitvena merila kot raziskava 2.
Patients in this study received a dose of 25 mg or 50 mg Enbrel, or placebo twice a week for 12 weeks and then all patients received open-label 25 mg Enbrel twice weekly for an additional 24 weeks.
Bolniki v tej raziskavi so dobivali odmerek 25 mg ali 50 mg zdravila Enbrel ali placebo dvakrat na teden 12 tednov, potem pa so vsi bolniki v odprtem delu dobivali 25 mg zdravila Enbrel dvakrat na teden dodatnih 24 tednov.
Study 4 evaluated 142 patients and had similar inclusion criteria to studies 2 and 3.
Raziskava 4 je ocenila 142 bolnikov in je imela podobna vključitvena merila kot raziskavi 2 in 3.
Patients in this study received a dose of 50 mg Enbrel or placebo once weekly for 12 weeks and then all patients received open- label 50 mg Enbrel once weekly for an additional 12 weeks.
Bolniki v tej raziskavi so dobivali odmerek 50 mg zdravila Enbrel ali placebo enkrat na teden 12 tednov, potem pa so vsi bolniki v odprtem delu dobivali 50 mg zdravila Enbrel enkrat na teden dodatnih 12 tednov.
In study 1, the Enbrel-treated group had a significantly higher proportion of patients with a PASI 75 response at week 12 (30%) compared to the placebo-treated group (2%) (p < 0.0001).
V raziskavi 1 je bil v 12. tednu delež bolnikov z odzivom PASI 75 pomembno večji v skupini, zdravljeni z zdravilom Enbrel (30%), kot v skupini, ki je dobivala placebo (2%) (p < 0, 0001).
At 24 weeks, 56% of patients in the Enbrel-treated group had achieved the PASI 75 compared to 5% of placebo-treated patients.
V 24. tednu je PASI dosegel vrednost 75 pri 56% bolnikov v skupini, zdravljeni z zdravilom Enbrel, in pri 5% bolnikov, ki so dobivali placebo.
Key results of studies 2, 3 and 4 are shown below.
Ključni rezultati raziskav 2, 3 in 4 so prikazani spodaj.
RESPONSES OF PATIENTS WITH PSORIASIS IN STUDIES 2, 3 AND 4 ------------------Study 2--------------- ---------------Study 3------------- ---------------Study 4-------------
22 ODZIVI BOLNIKOV S PSORIAZO V RAZISKAVAH 2, 3 IN 4
--------Enbrel--------- --------Enbrel-------
------------------- Raziskava 2 ---------------- -------- Zdravilo Enbrel -------- 25 mg 50 mg
-------Enbrel------
-------------- Raziskava 3 ------------ -------------- Raziskava 4 ------------ --- Zdravilo Enbrel ---- ---- Zdravilo Enbrel ---- 25 mg 50 mg 50 mg 50 mg
25 mg
placebo
50 mg 25 mg 50 mg 50 mg
2x/ teden 2x/ teden
50 mg
placebo 2x/ teden 2x/ teden placebo 1x/ teden 1x/ teden
Placebo
n = 166
QW
n=
n =
n= n= n=
166 n = n = n = n = n = 193 n = 196 n = 196 n = 46
n = 193 n = 196 n = 196 n = 46
wk
162
12 162 162 164 164 wk 12 wk wk wk wk 12 24a 12 24a
162
wk 12 wk 12 wk
12. teden 24. tedena
12
24.
wk 12
12. a
wk 24a
teden
PASI 50 PASI 75 DSGA b, clear or almost
PASI 50 PASI 75
clear
49 *
5 34* 39 49* 55 4 39*
4
No statistical comparisons to placebo were made at week 24 in studies 2 and 4 because the original placebo group began receiving Enbrel 25 mg BIW or 50 mg once weekly from week 13 to week 24. b.
V raziskavah 2 in 4 po 24 tednih niso opravili statističnih primerjav s placebom, ker je skupina, ki je prvotno dobivala placebo, začela dobivati 25 mg zdravila Enbrel dvakrat na teden ali 50 mg enkrat na teden od 13. do 24. tedna. b.
Dermatologist Static Global Assessment.
Dermatološka statistična globalna ocena.
23 Study 2 also had a drug withdrawal period during which patients who achieved a PASI improvement of at least 50% at week 24 had treatment stopped.
Raziskava 2 je vključevala tudi obdobje odtegnitve zdravila, med katerim so zdravljenje prekinili bolniki, ki so 24. teden dosegli izboljšanje PASI za vsaj 50%.
Patients were observed off treatment for the occurrence of rebound (PASI  150% of baseline) and for the time to relapse (defined as a loss of at least half of the improvement achieved between baseline and week 24).
Bolnike so brez terapije spremljali glede preobratnih znakov (PASI ≥ 150% izhodiščnega) in časa do recidiva (opredeljenega kot izginotje vsaj polovice izboljšanja, doseženega med izhodiščem in 24. tednom).
No rebound flare of disease and no psoriasis-related serious adverse events were observed.
Opazili niso nobenega preobratnega poslabšanja bolezni in nobenih s psoriazo povezanih resnih neželenih učinkov.
In study 3, the majority of patients (77%) who were initially randomised to 50 mg twice weekly and had their Enbrel dose decreased at week 12 to 25 mg twice weekly maintained their PASI 75 response through week 36.
V raziskavi 3 je večina bolnikov (77%), ki so bili uvodoma randomizirani na 50 mg dvakrat na teden in so jim odmerek zdravila Enbrel po 12 tednih znižali na 25 mg dvakrat na teden, odziv PASI 75 ohranila do 36. tedna.
For patients who received 25 mg twice weekly throughout the study, the PASI 75 response continued to improve between weeks 12 and 36.
Pri štirih bolnikih, ki so dobivali 25 mg dvakrat na teden ves čas raziskave, se je PASI 75 med 12. in 36. tednom še naprej izboljševal.
In study 4, the Enbrel-treated group had a higher proportion of patients with PASI 75 at week 12 (38%) compared to the placebo-treated group (2%) (p < 0.0001).
V raziskavi 4 je bil v 12. tednu delež bolnikov z odzivom PASI 75 večji v skupini, zdravljeni z zdravilom Enbrel (38%), kot v skupini, ki je dobivala placebo (2%) (p < 0, 0001).
For patients who received 50 mg once weekly throughout the study, the efficacy responses continued to improve with 71% achieving PASI 75 at week 24.
Pri bolnikih, ki so dobivali 50 mg enkrat na teden ves čas raziskave, so se učinkovitostni odzivi še naprej izboljševali, tako da jih je v 24. tednu 71% doseglo PASI 75.
The efficacy of Enbrel was assessed in a randomised, double-blind, placebo-controlled study in 211 paediatric patients aged 4 to 17 years with moderate to severe plaque psoriasis (as defined by a sPGA score ≥ 3, involving ≥ 10% of the BSA, and PASI ≥ 12).
Učinkovitost zdravila Enbrel so ugotavljali v randomizirani, dvojno slepi, s placebom kontrolirani študiji pri 211 pediatričnih bolnikih, starih 4 do 17 let, z zmerno do težko psoriazo v plakih (definirano z oceno sPGA ≥ 3, ki zajema ≥ 10% telesne površine (BSA – body surface area), in PASI ≥ 12).
Eligible patients had a history of receiving phototherapy or systemic therapy, or were inadequately controlled on topical therapy.
Bolniki, primerni za vključitev v študijo, so imeli v anamnezi bodisi fototerapijo bodisi sistemsko terapijo ali pa z lokalno terapijo njihove bolezni ni bilo mogoče zadostno obvladati.
Patients received Enbrel 0.8 mg/ kg (up to 50 mg) or placebo once weekly for 12 weeks.
Bolniki so 12 tednov enkrat na teden prejemali zdravilo Enbrel v odmerku 0, 8 mg/ kg (do 50 mg) ali placebo.
At week 12, more patients randomised to Enbrel had positive efficacy responses (e. g.
V 12. tednu je imelo pozitivne učinkovitostne odzive (npr.
Paediatric Plaque Psoriasis Outcomes at 12 Weeks Enbrel 0.8 mg/ kg Once
23 Rezultati po 12 tednih pri otrocih s psoriazo v plakih Enbrel 0, 8 mg/ kg enkrat na
Weekly
teden
Abbreviation: sPGA-static Physician Global Assessment. a. p < 0.0001 compared with placebo.
sPGA “ čisto ” ali “ minimalno ”, n (%) Okrajšava: sPGA- statična zdravnikova globalna ocena. a. p < 0, 0001 v primerjavi s placebom.
After the 12-week double-blind treatment period, all patients received Enbrel 0.8 mg/ kg (up to 50 mg) once weekly for additional 24 weeks.
Po 12- tedenskem obdobju dvojno slepega zdravljenja so vsi bolniki prejemali zdravilo Enbrel v odmerku 0, 8 mg/ kg (do 50 mg) enkrat na teden še dodatnih 24 tednov.
During a randomised withdrawal period, significantly more patients re-randomised to placebo experienced disease relapse (loss of PASI 75 response) compared with patients re-randomised to Enbrel.
Med obdobjem randomiziranega ukinjanja zdravila se je recidiv bolezni (izguba odziva PASI 75) pojavil pri statistično značilno več bolnikih, ki so bili ponovno v skupini s placebom, kot pri bolnikih, ki so bili ponovno v skupini z zdravilom Enbrel.
24 Antibodies to Enbrel
Protitelesa proti zdravilu Enbrel
These antibodies have all been non-neutralising and are generally transient.
Nobeno od teh protiteles ni bilo nevtralizirajoče, ta protitelesa so na splošno začasna.
There appears to be no correlation between antibody development and clinical response or adverse events.
Zdi se, da med nastajanjem protiteles na eni strani in kliničnim odzivom ali neželenimi učinki na drugi ni nikakršne korelacije.
In subjects treated with approved doses of etanercept in clinical trials for up to 12 months, cumulative rates of anti-etanercept antibodies were approximately 6% of subjects with rheumatoid arthritis, 7.5% of subjects with psoriatic arthritis, 2% of subjects with ankylosing spondylitis, 7% of subjects with psoriasis, 9.7% of subjects with paediatric psoriasis, and 3% of subjects with juvenile idiopathic arthritis.
Pri bolnikih, ki so jih v kliničnih preskušanjih zdravili z etanerceptom v odobrenih odmerkih do 12 mesecev, je bila kumulativna pogostnost protiteles proti etanerceptu približno 6% pri bolnikih z revmatoidnim artritisom, 7, 5% pri bolnikih s psoriatičnim artritisom, 2% pri bolnikih z ankiloznim spondilitisom, 7% pri bolnikih s psoriazo, 9, 7% pri bolnikih z otroško psoriazo in 3% pri bolnikih z juvenilnim idiopatičnim artritisom.
The proportion of subjects who developed antibodies to etanercept in longer-term trials (of up to 3.5 years) increases over time, as expected.
Delež bolnikov, pri katerih so se pojavila protitelesa proti etanerceptu v dolgoročnejših preskušanjih (do 3, 5 let), se po pričakovanjih sčasoma zvečuje.
However, due to their transient nature, the incidence of antibodies detected at each assessment point was typically less than 7% in rheumatoid arthritis subjects and psoriasis subjects.
Vendar je bila incidenca protiteles, odkritih ob vsakem periodičnem določanju zaradi njihove začasne narave pri bolnikih z revmatoidnim artritisom in bolnikih s psoriazo manjša od 7%.
In a long-term psoriasis study in which patients received 50 mg twice weekly for 96 weeks, the incidence of antibodies observed at each assessment point was up to approximately 9%.
V dolgoročni študiji psoriaze, v kateri so bolniki dobivali po 50 mg dvakrat na teden 96 tednov dolgo, je bila incidenca protiteles, ki so jih našli pri posameznem periodičnem določanju, do približno 9%.
Etanercept serum values were determined by an ELISA method, which may detect ELISA-reactive degradation products as well as the parent compound.
Koncentracije etanercepta v serumu so bile določene z metodo ELISA, ki zazna tako ELISA reaktivne razpadne produkte kot samo učinkovino.
Etanercept is slowly absorbed from the site of subcutaneous injection, reaching maximum concentration approximately 48 hours after a single dose.
Etanercept se počasi absorbira z mesta subkutane injekcije in doseže najvišjo koncentracijo po enkratnem odmerku po približno 48 urah.
The absolute bioavailability is 76%.
Absolutna biološka uporabnost etanercepta je 76%.
With twice weekly doses, it is anticipated that steady-state concentrations are approximately twice as high as those observed after single doses.
Pričakovati je, da bodo koncentracije v stanju dinamičnega ravnovesja po odmerjanju 2- krat tedensko približno dvakrat višje od tistih, ki jih izmerimo po enkratnem odmerku.
After a single subcutaneous dose of 25 mg Enbrel, the average maximum serum concentration observed in healthy volunteers was 1.65  0.66  g/ ml, and the area under the curve was 235  96.6  g hr/ ml.
Proporcionalnosti
Dose proportionality has not been formally evaluated, but there is no apparent saturation of clearance across the dosing range.
24 serumskih koncentracij v odvisnosti od odmerka niso formalno preverjali, vendar po v razponu terapevtskih odmerkov ni bilo opaziti nasičenja očistka zdravila.
The central volume of distribution of etanercept is 7.6 l, while the volume of distribution at steady-state is 10.4 l.
Osrednji porazdelitveni volumen etanercepta je 7, 6 l, porazdelitveni volumen v stanju dinamičnega ravnovesja pa je 10, 4 l.
Etanercept is cleared slowly from the body.
Etanercept se počasi izloča iz telesa.
Clearance is approximately 0.066 l/ hr in patients with rheumatoid arthritis, somewhat lower than the value of 0.11 l/ hr observed in healthy volunteers.
Očistek pri bolnikih z revmatoidnim artritisom je približno 0, 066 l/ h, nekoliko nižji kot pri zdravih prostovoljcih, pri katerih znaša 0, 11 l/ h.
Mean serum concentration profiles at steady state in treated RA patients were Cmax of 2.4 mg/ l vs 2.6 mg/ l, Cmin of 1.2 mg/ l vs 1.4 mg/ l, and partial AUC of 297 mgh/ l vs 316 mgh/ l for 50 mg Enbrel once weekly (n=21) vs 25 mg Enbrel twice weekly (n=16), respectively.
Pri zdravljenih bolnikih z revmatoidnim artritisom so bili parametri srednje koncentracije v serumu v stanju dinamičnega ravnovesja naslednji: z zdravilom Enbrel 50 mg enkrat na teden (n = 21) so bile Cmax 2, 4 mg/ l, Cmin 1, 2 mg/ l in delna AUC 297 mg. h/ l, z zdravilom Enbrel 25 mg dvakrat na teden (n = 16) pa Cmax 2, 6 mg/ l, Cmin 1, 4 mg/ l in delna AUC 316 mg. h/ l.
In an open-label, single-dose, two- treatment, crossover study in healthy volunteers, etanercept administered as a single 50 mg/ ml injection was found to be bioequivalent to two simultaneous injections of 25 mg/ ml.
V odprti, enoodmerni, navzkrižni raziskavi pri zdravih prostovoljcih z dvema oblikama zdravljenja so ugotovili, da je enkratna injekcija po 50 mg/ ml etanercepta bioekvivalentna dvema hkratnima injekcijama po 25 mg/ ml.
In a population pharmacokinetics analysis in ankylosing spondylitis patients the etanercept steady state AUCs were 466  g hr/ ml and 474  g  hr/ ml for 50 mg Enbrel once weekly (N= 154) and 25 mg twice weekly (N = 148), respectively.
Analize farmakokinetike pri posameznih skupinah bolnikov kažejo, da so bile pri bolnikih z ankilozirajočim spondilitisom pri režimu odmerjanja zdravila Enbrel 50 mg enkrat na teden (N = 154) vrednosti AUC etanercepta v stanju dinamičnega ravnovesja 466 μg* ur/ ml, pri režimu odmerjanja 25 mg dvakrat na teden (N = 148) pa 474 μg* ur/ ml.
25 Although there is elimination of radioactivity in urine after administration of radiolabelled etanercept to patients and volunteers, increased etanercept concentrations were not observed in patients with acute renal or hepatic failure.
Čeprav se pri prostovoljcih in pri bolnikih po prejemu radioaktivno označenega etanercepta le- ta izloča v urinu, ni zaznati povečanih koncentracij etanercepta pri bolnikih z akutno odpovedjo ledvic ali jeter.
The presence of renal and hepatic impairment should not require a change in dosage.
Pri bolnikih z ledvično ali jetrno okvaro zato ni treba prilagajati odmerkov.
Methotrexate has no effect on the pharmacokinetics of etanercept.
Metotreksat ne vpliva na farmakokinetiko etanercepta.
The effect of Enbrel on the human pharmacokinetics of methotrexate has not been investigated.
Učinka zdravila Enbrel na farmakokinetiko metotreksata pri človeku niso preučevali.
Paediatric patients with polyarticular juvenile idiopathic arthritis
Otroci s poliartikularnim juvenilnim idiopatskim artritisom
In a polyarticular juvenile idiopathic arthritis trial with Enbrel, 69 patients (aged 4 to 17 years) were administered 0.4 mg Enbrel/ kg twice weekly for three months.
V klinični raziskavi pri 69 bolnikih s poliartikularnim juvenilnim idiopatskim artritisom, starih od 4 do 17 let, so injicirali 0, 4 mg zdravila Enbrel/ kg 2- krat tedensko v obdobju 3 mesecev.
The youngest children (4 years of age) had reduced clearance (increased clearance when normalised by weight) compared with older children (12 years of age) and adults.
Pri najmlajših bolnikih (4 leta) so opazili zmanjšan očistek (povečan, če je bil normaliziran s težo) v primerjavi s starejšimi otroci (12 let) in odraslimi.
Simulation of dosing suggests that while older children (10-17 years of age) will have serum levels close to those seen in adults, younger children will have appreciably lower levels.
Simulacija odmerjanja kaže, da bodo imeli starejši otroci (med 10. in 17. letom) podobne serumske koncentracije kot odrasli, mlajši otroci pa znatno nižje.
Patients with paediatric plaque psoriasis (aged 4 to 17 years) were administered 0.8 mg/ kg (up to a maximum dose of 50 mg per week) of etanercept once weekly for up to 48 weeks.
Bolniki z otroško psoriazo v plakih (stari 4 do 17 let) so prejemali po 0, 8 mg/ kg (do največjega odmerka 50 mg na teden) etanercepta enkrat na teden do 48 tednov dolgo.
The mean serum steady state trough concentrations ranged from 1.6 to 2.1 mcg/ ml at weeks 12, 24, and 48.
Povprečne najnižje serumske koncentracije v stanju dinamičnega ravnovesja so se v 12., 24. in 48. tednu gibale med 1, 6 in 2, 1 µg/ ml.
These mean concentrations in patients with paediatric plaque psoriasis were similar to the concentrations observed in patients with juvenile idiopathic arthritis (treated with 0.4 mg/ kg etanercept twice weekly, up to maximum dose of 50 mg per week).
Te povprečne koncentracije pri bolnikih s pediatrično psoriazo v plakih so bile podobne koncentracijam, ki so jih opazili pri bolnikih z juvenilnim idiopatskim artritisom (zdravljenih z 0, 4 mg/ kg etanercepta dvakrat na teden, do največjega odmerka 50 mg na teden).
5.3 Preclinical safety data
25 5. 3 Predklinični podatki o varnosti
In the toxicological studies with Enbrel, no dose-limiting or target organ toxicity was evident.
V raziskavah toksičnosti zdravila Enbrel ni bilo opaziti toksičnosti, ki bi omejevala odmerjanje, niti posebne toksičnosti za tarčne organe.
Enbrel was considered to be non-genotoxic from a battery of in vitro and in vivo studies.
Zdravilo Enbrel se ni izkazalo za genotoksičnega v vrsti in vivo in in vitro raziskav.
Carcinogenicity studies, and standard assessments of fertility and postnatal toxicity, were not performed with Enbrel due to the development of neutralising antibodies in rodents.
Raziskav kancerogenosti in standardnih raziskav plodnosti in postnatalne toksičnosti niso opravili zaradi tvorbe nevtralizirajočih protiteles pri glodalcih.
Enbrel did not induce lethality or notable signs of toxicity in mice or rats following a single subcutaneous dose of 2000 mg/ kg or a single intravenous dose of 1000 mg/ kg.
Zdravilo Enbrel ni povzročilo smrtnosti ali pomembne toksičnosti pri miškah ali podganah po enkratnem subkutanem odmerku 2. 000 mg/ kg ali enkratnem intravenskem odmerku 1. 000 mg/ kg.
Enbrel did not elicit dose-limiting or target organ toxicity in cynomolgus monkeys following twice weekly subcutaneous administration for 4 or 26 consecutive weeks at a dose (15 mg/ kg) that resulted in AUC-based serum drug concentrations that were over 27-fold higher than that obtained in humans at the recommended dose of 25 mg.
Ti odmerki so povzročili 27- krat višje serumske koncentracije (na podlagi AUC), kot jih običajno izmerimo pri človeku po priporočenem odmerku 25 mg.
Mannitol Sucrose Trometamol.
Prašek: manitol saharoza trometamol.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Zaradi pomanjkanja študij kompatibilnosti, tega zdravila ne smemo mešati z drugimi zdravili.
After reconstitution, immediate use is recommended.
Priporočeno je, da se po pripravi zdravilo uporabi takoj.
Chemical and physical stability has been demonstrated for 48 hours at 2 C – 8 C.
Dokazano je bilo, da je pripravljeno zdravilo kemijsko in fizikalno stabilno 48 ur pri temperaturi od 2 °C do 8 °C.