FrancophonIA/ELRC3.0 huggingface dataset:
English: D-79639 Grenzach-Wyhlen GERMANY
Slovenian: D-79639 Grenzach-Wyhlen NEMČIJA
English: Please read the section below on breast-feeding.
Slovenian: Prosimo, preberite odstavek o dojenju.
English: The overall prenatal losses for the entire gestational period ranged from 20% to 45%.
Slovenian: Celokupna prenatalna izguba za celotno gestacijsko obdobje je bila 20- do 45-%.
English: There are limited data from the use of daclizumab in pregnant women.
Slovenian: O uporabi daclizumaba pri nosečnicah so na voljo le omejeni podatki.
English: • CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND
Slovenian: ● POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO
English: You may receive subsequent infusions within a day before or after the scheduled administration.
Slovenian: Naslednje infuzije lahko prejmete en dan pred načrtovanim dajanjem ali en dan po njem.
English: A maximum tolerated dose has not been determined in patients and could not be achieved in animals that received Zenapax.
Slovenian: Maksimalen dovoljen odmerek pri bolnikih ni bil določen, pri živalih, ki so prejemale Zenapax, pa ni bil dosežen.
English: Therapy with medicines which help to suppress the body's natural defence mechanisms can increase the risk for developing malignancies or infections.
Slovenian: Zdravljenje z zdravili, ki pomagajo zavreti naraven obrambni mehanizem telesa, lahko poveča tveganje za razvoj malignosti ali okužb.
English: Within the system organ classes, undesirable effects are listed under headings of frequency, using the following categories: 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), not known (cannot be estimated from the available data).
Slovenian: Neželeni učinki so znotraj organskih sistemov razvrščeni po pogostnosti v naslednje skupine: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do ≤ 1/100), redki (≥ 1/10.000 do ≤1/1.000), zelo redki (≤ 1/10.000), z neznano pogostnostjo (iz podatkov, ki so na voljo določitev ni mogoča).
English: Adverse events occurring with a frequency of ≥2% in patients in either group during the first 3 months post-transplant are listed below.
Slovenian: Neželeni učinki, ki so se pojavili z ≥ 2-% pogostnostjo pri bolnikih v katerikoli skupini v prvih 3 mesecih po presaditvi, so našteti spodaj.
English: Care must be taken to assure sterility of prepared solution, since the drug product does not contain any antimicrobial preservative or bacteriostatic agents.
Slovenian: Za zagotovitev sterilnosti pripravljene raztopine je potrebna pazljivost, ker zdravilo ne vsebuje antimikrobnih ali bakteriostatičnih sredstev.
English: ● CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON
Slovenian: • POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, PREDPISANI IMETNIKU
English: Chemical and physical in-use stability has been demonstrated for 24 hours at 2 °C - 8 °C or for 4 hours at 25 °C.
Slovenian: Kemična in fizikalna stabilnost po pripravi je dokazana do 24 ur pri 2 °C - 8 °C ali 4 ure pri 25 °C.
English: Take special care with Zenapax - if you have ever had an allergic reaction to other immunosuppressive medicines, which help to suppress the body's natural defence mechanisms.
Slovenian: Bodite posebno pozorni pri uporabi zdravila Zenapax - če ste kadar koli imeli alergijsko reakcijo na druga imunosupresivna zdravila, ki pomagajo zatreti naravni obrambni mehanizem telesa.
English: Zenapax is NOT for direct injection.
Slovenian: Zenapax NI namenjen neposrednemu injiciranju.
English: Daclizumab belongs to a group of medicines called immunosuppressants.
Slovenian: Daclizumab spada v skupino zdravil, ki jo imenujemo imunosupresivi.
English: Zenapax is available in pack sizes of 1 or 3 vials.
Slovenian: Zenapax je v pakiranju po 1 ali 3 viale.
English: The identified body weight influence on systemic clearance supports the dosing of Zenapax on a mg/kg basis and maintains drug exposure within 30% of the reference exposure for patient groups with wide range of demographic characteristics.
Slovenian: Ugotovljen vpliv telesne mase na sistemski očistek podpira odmerjanje Zenapaxa na podlagi mg/kg in vzdržuje izpostavljenost zdravila v okviru 30-% referenčne izpostavljenosti za skupine bolnikov s širokim obsegom demografskih lastnosti.
English: However, the data show considerable inter-animal variation and were within the historical control range for this species.
Slovenian: Vendar so podatki pokazali precejšnjo razliko med posameznimi živalmi in so bili v pričakovanih okvirih za to živalsko vrsto.
English: Daclizumab is excreted in cynomolgus monkey milk (see section 5.3).
Slovenian: Daclizumab se izloča v mleko opic Cynomolgus (glejte poglavje 5.3).
English: Paediatric patients: The safety profile for the use of Zenapax in paediatric patients was shown to be comparable to that in adult patients.
Slovenian: Pediatrični bolniki: varnostni profil uporabe Zenapaxa pri pediatričnih bolnikih je bil podoben kot pri odraslih.
English: The data from the four studies (O14392, O14393, O14874 and O15301) showed that the incidence and types of adverse events were similar in both placebo-treated and Zenapax-treated patients.
Slovenian: Podatki iz štirih študij (O14392, O14393, O14874 in O15301) so pokazali, da so bili incidenca in tipi neželenih učinkov podobni pri bolnikih, ki so prejemali placebo in pri bolnikih, ki so prejemali Zenapax.
English: - The active substance is daclizumab.
Slovenian: - Zdravilna učinkovina je daclizumab.
English: THE MARKETING AUTHORISATION HOLDER Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Slovenian: DOVOLJENJA ZA PROMET Z ZDRAVILOM Izdaja zdravila je le pod omejenimi pogoji in na recept (glejte Dodatek I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
English: Three year graft survival rates were significantly higher among those patients who did not experience acute rejection within the first year posttransplant (n=345) compared with those who experienced acute rejection during the first year (n=190) regardless of treatment.
Slovenian: Triletno preživetje presadka je bilo značilno višje med bolniki, pri katerih se v prvem letu po presaditvi ni pojavila akutna zavrnitev (n = 345) v primerjavi z bolniki, pri katerih se je akutna zavrnitev presadka pojavila v prvem letu po presaditvi (n = 190), ne glede na zdravljenje.
English: Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Slovenian: Pred začetkom zdravljenja se prepričajte, da sta vaš zdravnik ali farmacevt seznanjena s tem, ali jemljete oziroma če ste pred kratkim jemali katerakoli druga zdravila, tudi tista, ki ste jih dobili brez recepta.
English: Patients on immunosuppressive therapy following transplantation are at increased risk for developing lymphoproliferative disorders (LPDs) and opportunistic infections.
Slovenian: Pri bolnikih, ki so na imunosupresivnem zdravljenju po transplantaciji, obstaja večje tveganje za razvoj limfoproliferativnih bolezni (LPD) in oportunističnih okužb.
English: The first dose is given within 24 hours before your transplant.
Slovenian: Prvi odmerek se daje 24 ur pred presaditvijo.
English: One of 18 monkeys had an anaphylactic reaction to daclizumab.
Slovenian: Ena od osemnajstih opic je imela anafilaktično reakcijo na daclizumab.
English: Antibodies to daclizumab developed in approximately 9% of Zenapaxtreated patients in clinical studies but did not appear to affect efficacy, safety, serum daclizumab levels, or any other clinically relevant parameter examined.
Slovenian: Protitelesa proti daclizumabu so se v kliničnih študijah pojavila pri približno 9 % bolnikov, zdravljenih z Zenapaxom, vendar niso vplivala na učinkovitost, varnost, serumske vrednosti daclizumaba ali katerikoli drugi klinično pomemben preiskovan parameter.
English: Appreciable daclizumab serum levels were maintained except in 2 out of 18 monkeys that developed anti-daclizumab antibodies.
Slovenian: Precejšnji serumski nivoji daclizumaba so bili vzdrževani pri vseh opicah, razen pri dveh od 18, ki sta razvili protitelesa proti daclizumabu.
English: Renal function evaluated by serum creatinine and GFR was similar in both groups at three years posttransplant.
Slovenian: Renalna funkcija, ki so jo določali s serumskim kreatininom in GFR 3 leta po presaditvi, je bila podobna v obeh skupinah.
English: A health care professional will give you a suitable dose (normally 1 mg/kg of body weight) in the form of an intravenous infusion over a 15- minute period.
Slovenian: Zdravnik vam bo dal ustrezen odmerek (običajno 1 mg/kg telesne mase) v obliki intravenske infuzije v 15 minutah.
English: Very common side effects (occurring in 1 or more patients out of 10) are: - difficulty sleeping - shaking (tremor) - headache - high blood pressure (hypertension)
Slovenian: Zelo pogosti neželeni učinki (ki se pojavijo pri 1 ali več bolnikih od 10) so: - težave pri spanju, - tresenje (tremor), - glavobol, - visok krvni tlak (hipertenzija),
English: The Tac subunit of the IL-2 receptor was saturated immediately after the first dose of 1.0 mg/kg of daclizumab and remained saturated for at least the first three months post-transplant.
Slovenian: Tac podenota receptorja IL-2 je bila nasičena takoj po prvem odmerku 1,0 mg/kg daclizumaba in je ostala nasičena najmanj prve tri mesece po presaditvi.
English: For mixing the solution, do not shake, gently invert the bag in order to avoid foaming.
Slovenian: Za mešanje raztopine vrečke ne stresamo, rahlo jo obrnemo, tako da preprečimo penjenje.
English: Daclizumab was not genotoxic in standard tests.
Slovenian: V standardnih testih daclizumab ni bil genotoksičen.
English: 5 ml in a vial (Type I glass).
Slovenian: 5 ml viala (steklo tipa I).
English: Zenapax has no influence on the ability to drive and use machines.
Slovenian: Zenapax nima vpliva na sposobnost vožnje in upravljanja s stroji.
English: Therefore, Zenapax should not be used with other drugs without your doctor's consent.
Slovenian: Zato ne uporabljajte Zenapaxa sočasno z drugimi zdravili brez privolitve vašega zdravnika.
English: Combination Therapy in Renal Allograft Recipients
Slovenian: Kombinirano zdravljenje pri prejemnikih ledvičnega presadka
English: Tell your doctor immediately if you notice any of the following side effects occur: cough and shortness of breath, including when laying flat, vomiting, confusion or passing less urine then normal.
Slovenian: Nemudoma povejte svojemu zdravniku, če opazite katerega od naštetih neželenih učinkov: kašelj in zasoplost, tudi kadar ležite, bruhanje, zmedenost ali manjše izločanje urina kot ponavadi.
English: Tell your doctor straightaway if you are pregnant, breast-feeding, become pregnant or plan to start a family in the near future.
Slovenian: Zdravniku takoj povejte, če ste noseči, če dojite, zanosite ali nameravate zanositi v bližnji prihodnosti.
English: Zenapax is contraindicated in patients with known hypersensitivity to daclizumab or to any excipients of this product (see section 6.1).
Slovenian: Zenapax je kontraindiciran pri bolnikih z znano preobčutljivostjo za daclizumab ali katerokoli sestavino tega zdravila (glejte poglavje 6.1).
English: Of these 14 Zenapax patients, 4 died more than 90 days after receiving their last dose of Zenapax, making it unlikely that Zenapax had a role in the infection related death.
Slovenian: Od 14 bolnikov, ki so jemali Zenapax, so 4 bolniki umrli pozneje kot 90 dni po prejetju zadnjega odmerka Zenapaxa, zato ni verjetno, da bi bil Zenapax povezan s smrtjo zaradi okužbe.
English: A non-clinical reproduction toxicity study with daclizumab has shown an increased risk of early prenatal loss in cynomolgus monkeys compared to placebo.
Slovenian: Predklinična študija reproduktivne toksičnosti z daclizumabom je pokazala povečano tveganje za zgodnje prenatalne izgube pri opicah Cynomolgus v primerjavi s placebom.
English: The recommended dose for Zenapax in adult and paediatric patients is 1 mg/kg.
Slovenian: Priporočen odmerek Zenapaxa pri odraslih in otrocih je 1 mg/kg.
English: Like all medicines, Zenapax can cause side effects, although not everybody gets them.
Slovenian: Kot vsa zdravila ima lahko tudi zdravilo Zenapax neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: After dilution an immediate use is recommended.
Slovenian: Po razredčitvi priporočamo takojšnjo uporabo.
English: Pregnancy and breast-feeding You must not use this medicine if you are breast-feeding.
Slovenian: Nosečnost in dojenje Tega zdravila med dojenjem ne smete uporabljati.
English: From pooled data the difference in biopsy-proven acute rejection remained statistically different at one-year posttransplant (43% as compared with 28%).
Slovenian: Iz združenih podatkov je razlika akutne zavrnitve, potrjene z biopsijo, ostala statistično različna 1 leto po transplantaciji (43 % v primerjavi z 28 %).
English: Population pharmacokinetic analysis showed that the systemic clearance of daclizumab was influenced by total body weight, age, gender, proteinuria, and race.
Slovenian: Farmakokinetične populacijske analize so pokazale, da na sistemski očistek daclizumaba vplivajo telesna masa, starost, spol, proteinurija in rasa.
English: Daclizumab saturates the Tac receptor for approximately 90 days at the recommended dosage regimen for the majority of patients.
Slovenian: Daclizumab zasiti Tac receptor za približno 90 dni pri priporočenem režimu odmerjanja pri večini bolnikov.
English: The next and each subsequent dose should be given at intervals of fourteen days, for a total of five doses.
Slovenian: Naslednji odmerek in vsi nadaljnji odmerki se dajejo v 14-dnevnih intervalih do skupno pet odmerkov.
English: However, the following adverse events occurred more frequently in paediatric patients: diarrhoea (41%), postoperative pain (38%), fever (33%), vomiting (33%), hypertension (28%), pruritus (21%) and infections of the upper respiratory tract (20%) and urinary tract (18%).
Slovenian: Naslednji neželeni učinki pa so se pri pediatričnih bolnikih pojavili pogosteje: driska (41 %), postoperativna bolečina (38 %), zvišana telesna temperatura (33 %), bruhanje (33 %), zvišan krvni tlak (28 %), pruritus (21 %), okužbe zgornjega respiratornega trakta (20 %) in okužbe urinarnega trakta (18 %).
English: Common side effects (occurring in between 1 and 10 patients out of 100) are inflammation of the throat (pharyngitis); runny nose (rhinitis); diabetes mellitus; high blood sugar (hyperglycaemia); fluid overload; dehydration; anxiety; depression; dizziness; sensation of pins and needles; blurred vision; fast heart rate (tachycardia); bleeding (haemorrhage); blood clot (thrombosis); low blood pressure (hypotension); accumulation of lymph fluid in one part of the body (lymphocele); severe shortness of breath, including when laying flat at night (pulmonary oedema); fluid on the lungs (pleural effusion); collapsed lung (atelectasis); lack of oxygen in the body (hypoxia); congestion; cough; noisy or abnormal breath sounds, including crackling breath sounds (rales); bloated stomach; stomach pain or discomfort; flatulence; haemorrhoids; rash; itchy skin; acne; night sweats; increased sweating; excessive hair growth (hirsutism); back pain; muscle cramps, particularly in the legs; pain in the joints (arthralgia); pain in the muscles (myalgia); chest pain; pain in general; tiredness; skin irritation at the site of injection; fever; chills; general weakness; pain in the loins and changes or difficulty in passing urine (hydronephrosis); blood in the urine; pain on passing urine (dysuria); reduced urine output (oliguria); pain following surgery.
Slovenian: Pogosti neželeni učinki (ki se pojavijo pri več kot 1 in manj kot 10 bolnikih od 100) so vnetje žrela (faringitis), smrkav nos (rinitis), sladkorna bolezen, povišan sladkor v krvi (hiperglikemija), presežek tekočine, dehidracija, tesnoba, depresija, omotica, občutek zbadanja, zamegljen vid, hitro utripanje srca (tahikardija), krvavitev (hemoragija), krvni strdek (tromboza), nizek krvni tlak (hipotenzija), kopičenje limfe v določenem delu telesa (limfokela), huda zasoplost, tudi ponoči ko ležimo (pljučni edem), tekočina na pljučih (plevralni izliv), kolaps pljuč (atelektaza), pomanjkanje kisika v telesu (hipoksija), kongestija, kašelj, glasno dihanje ali nenormalen zvok dihanja, vključno s pokanjem (rales), napihnjen želodec, bolečina ali neugodje v želodcu, napenjanje, hemoroidi, kožni izpuščaj, srbeča koža, akne, nočno potenje, povečano potenje, povečana rast dlak (hirzutizem), bolečina v hrbtu, mišični krči, posebno v nogah, bolečina v sklepih (artralgija), bolečina v mišicah (mialgija), bolečina v prsnem košu, bolečina, utrujenost, vnetje kože na mestu injiciranja, povišana telesna temperatura, mrazenje, splošna oslabelost, bolečina v ledjih in spremenjeno ali oteženo uriniranje (hidronefroza), kri v urinu, bolečina pri uriniranju (dizurija), zmanjšano izločanje urina (oligurija), bolečina po operaciji.
English: WHAT ZENAPAX IS AND WHAT IT IS USED FOR
Slovenian: KAJ JE ZDRAVILO ZENAPAX IN ZA KAJ GA UPORABLJAMO
English: The estimate terminal elimination half-life of daclizumab ranged from 270 to 919 hours (average 480 hours) in renal allograft patients and is equivalent to that reported for human IgG which ranged from 432 to 552 hours (average 480 hours).
Slovenian: Ocenjen končni eliminacijski razpolovni čas daclizumaba pri bolnikih z ledvičnim presadkom je znašal od 270 do 919 ur (povprečje 480 ur) in je enakovreden eliminacijskemu razpolovnemu času za humani IgG, ki je bil v območju 432 do 552 ur (povprečje 480 ur).
English: Zenapax is contraindicated during lactation (see section 4.6).
Slovenian: Zenapax je kontraindiciran med dojenjem (glejte poglavje 4.6).
English: A study in cynomolgus monkeys has not shown teratogenic effects but did show an increase of early prenatal loss which remains in the historical spontaneous abortion rate (see section 5.3).
Slovenian: Študija pri opicah Cynomolgus ni pokazala teratogenih učinkov, ampak povečanje zgodnjih prenatalnih izgub, ki so v okviru pričakovane pogostnosti spontanih abortusov pri tej živalski vrsti (glejte poglavje 5.3).
English: Clear to slightly opalescent, colourless to slightly yellowish liquid.
Slovenian: Bistra do rahlo opalescenčna, brezbarvna do rahlo rumenkasta tekočina.
English: There was no cross reactivity in-vitro between daclizumab and human cryosections (28 organs) at concentrations up to 56 mg/ml, demonstrating the absence of non-specific binding.
Slovenian: Med daclizumabom in humanimi kriosekcijami (28 organov) in vitro ni bilo križne reaktivnosti pri koncentracijah do 56 mg/ml, kar kaže na odsotnost nespecifične vezave.
English: Zenapax should not be used in pregnant women unless it is clearly necessary.
Slovenian: Zdravila Zenapax ne smete uporabljati med nosečnostjo, razen če je nujno potrebno.
English: Addition of Zenapax did not increase the number of post-transplant lymphomas, which occurred with a frequency of 1.5% in the placebotreated group and 0.7% in the Zenapax-treated group.
Slovenian: Dodatek Zenapaxa ni povečal števila posttransplantacijskih limfomov, ki so se pojavili s frekvenco 1,5 % v placebo skupini in v 0,7 % v skupini, zdravljeni z Zenapaxom.
English: Experience with Zenapax in elderly patients (older than 65 years) is limited because of the small number of older patients who undergo renal transplantation, but there is no evidence that elderly patients require a different dosage from younger patients.
Slovenian: Izkušnje z Zenapaxom pri ostarelih bolnikih (nad 65 let) so omejene zaradi majhnega števila starejših bolnikov, ki prejmejo ledvični presadek.
English: Serum levels of 0.5 to 0.9 µg/ml are needed to saturate the IL-2 receptor and levels of 5-10 µg/ml are needed to inhibit IL-2 mediated biologic activity.
Slovenian: Za zasičenje receptorjev IL-2 so potrebni serumski nivoji od 0,5 do 0,9 µg/ml, za zaviranje z IL-2 vodene biološke aktivnosti pa nivoji od 5-10 µg/ml.
English: Zenapax should be prescribed only by physicians who are experienced in the use of immunosuppressive therapy following organ transplantation.
Slovenian: Zenapax lahko predpišejo le zdravniki z izkušnjami pri uporabi imunosupresivnega zdravljenja pri transplantaciji organov.
English: Parenteral drug products should be inspected visually for particulate matter and discoloration before administration.
Slovenian: Parenteralna zdravila je treba pred dajanjem vizualno podrobno preveriti glede prisotnosti delcev in obarvanosti.
English: Allergic reactions following the infusion of Zenapax have been reported rarely.
Slovenian: Alergijske reakcije, ki sledijo infuziji Zenapaxa, so se pojavile redko.
English: In the same non-clinical reproduction toxicity study with daclizumab, four out of seven lactating cynomolgus monkeys given a 5 - 10 fold multiple (10 mg/kg) of the normal human dose were found to secrete very low levels of daclizumab (0.17 - 0.28% of maternal serum levels) in breast milk.
Slovenian: V isti predklinični študiji reproduktivne toksičnosti z daclizumabom so štiri od sedmih opic Cynomolgus v laktaciji, ki so prejele 5- do 10-kratni (10 mg/kg) običajni odmerek za ljudi, v mleko izločale zelo majhne vrednosti daclizumaba (0,17 do 0,28 % maternalnih serumskih vrednosti).
English: Both trials showed a statistically significant superiority to placebo in reducing the rate of acute renal allograft rejection at six months post-transplant as confirmed by biopsy.
Slovenian: V obeh preskušanjih je Zenapax pokazal statistično značilno prednost pred placebom v zmanjšanju stopnje akutne zavrnitve ledvičnega presadka v šestih mesecih po transplantaciji, kot je potrdila biopsija.
English: Infectious episodes, including viral infections, fungal infections, bacteraemia and septicaemia, and pneumonia, were reported in 72% of the placebo-treated patients and in 68% of Zenapax-treated patients.
Slovenian: Primeri okužb, vključno z virusnimi in glivičnimi okužbami, bakteriemijo in septikemijo ter pljučnico, so se pojavili pri 72 % bolnikov v placebo skupini in pri 68 % bolnikov, zdravljenih z Zenapaxom.
English: Manufacturer Roche Pharma AG Emil-Barell-Strasse 1, D-79639 Grenzach-Wyhlen Germany
Slovenian: Roche Pharma AG Emil-Barell-Strasse 1 D- 79639 Grenzach-Wyhlen Nemčija
English: In Phase III trials Zenapax was added to a standard immunosuppressive regimen of cyclosporine (5 mg/kg) and steroids (prednisone or methylprednisolone), with or without addition of azathioprine (4 mg/kg).
Slovenian: V fazi III kliničnih preskušanj so Zenapax dodali standardnemu imunosupresivnemu režimu ciklosporina (5 mg/kg) in steroidov (prednizon ali metilprednizolon) z dodatkom azatioprina (4 mg/kg) ali brez njega.
English: The recommended regimen of daclizumab will maintain serum concentrations sufficient to saturate IL-2R alpha receptors on activated T lymphocytes for more than 90 days post transplantation in the majority of patients.
Slovenian: Priporočen način dajanja daclizumaba vzdržuje serumske koncentracije, ki so potrebne za nasičenje alfa receptorjev IL2R na aktiviranih T-limfocitih za več kot 90 dni po presaditvi pri večini bolnikov.
English: The beneficial effect of Zenapax prophylaxis upon the incidence of acute rejection after renal transplantation was not associated with adverse clinical sequelae, including the development of PostTransplant Lymphoproliferative Disease (PTLD), at 3 years posttransplant.
Slovenian: Dobrodejen učinek profilakse z Zenapaxom 3 leta po presaditvi na osnovi incidence akutne zavrnitve po presaditvi ledvic ni bil povezan z neželenimi kliničnimi posledicami, vključno z razvojem posttransplantacijske limfoproliferativne bolezni (PTLD - Post-Transplant Lymphoproliferative Disease).
English: Saturation of the Tac subunit of the IL-2 receptor was similar to that observed in adult patients receiving the same dose regimen.
Slovenian: Nasičenje Tac podenote receptorja IL-2 je bilo podobno nasičenju, opaženemu pri odraslih bolnikih, ki so prejemali daclizumab po enakem sistemu odmerjanja.