natgillin/translations-raw huggingface dataset:
Results from two pivotal 12-month multicentre studies (722 patients in total) comparing basiliximab with placebo show that basiliximab, used concomitantly with ciclosporin for microemulsion and corticosteroids, significantly reduces the incidence of acute rejection episodes both within 6 (31% vs. 45%, p<0.001) and 12 (33% vs. 48%, p<0.001) months after transplantation. 
Rezultati dveh ključnih 12-mesečnih multicentričnih raziskav (s skupno 722 bolniki), v katerih je bil baziliksimab primerjan s placebom, so pokazali, da baziliksimab, če je uporabljen sočasno s ciklosporinom v mikroemulziji in s kortikosteroidi, pomembno zmanjša pogostnost akutnih zavrnitvenih reakcij tako v 6 (31 % proti 45 %, p < 0,001) kot v 12 (33 % proti 48 %, p < 0,001) mesecih po presaditvi.
It is to be used concomitantly with ciclosporin for microemulsion- and corticosteroid-based immunosuppression, in patients with panel reactive antibodies less than 80%, or in a triple maintenance immunosuppressive regimen containing ciclosporin for microemulsion, corticosteroids and either azathioprine or mycophenolate mofetil. 
Namenjeno je sočasni uporabi s ciklosporinom v mikroemulziji in kortikosteroidi za imunosupresijo pri bolnikih, ki imajo manj kot 80 % PRA (panel reactive antibodies), ali v trotirni vzdrževalni imunosupresivni shemi s ciklosporinom v mikroemulziji, kortikosteroidi in bodisi azatioprinom ali mofetilmikofenolatom.
In paediatric patients weighing less than 35 kg, the recommended total dose is 20 mg, given in two doses of 10 mg each. 
Pri pediatričnih bolnikih, ki tehtajo manj od 35 kg, je priporočeni celotni odmerek 20 mg, ki ga prejmejo v dveh odmerkih po 10 mg.
It also contains potassium dihydrogen phosphate; disodium phosphate, anhydrous; sodium chloride; sucrose; mannitol (E421); glycine. 
Vsebuje tudi kalijev dihidrogenfosfat; natrijev hidrogenfosfat, brezvodni; natrijev klorid; saharozo; manitol (E421); glicin.
In paediatric patients weighing 35 kg or more, the recommended dose is the adult dose, i.e. a total dose of 40 mg, given in two doses of 20 mg each. 
Pri pediatričnih bolnikih, ki tehtajo 35 kg ali več, je priporočen odmerek za odrasle, tj. celotni odmerek 40 mg, dan v dveh odmerkih po 20 mg.
Peak serum concentration following intravenous infusion of 20 mg over 30 minutes is 7.15.1 mg/l. 
Kumulativni odmerki so znašali od 20 mg do 60 mg. Največja serumska koncentracija po 30-minutni intravenski infuziji 20 mg je 7,1 ± 5,1 mg/l.
* recombinant murine/human chimeric monoclonal antibody directed against the interleukin-2 receptor -chain (CD25 antigen) produced in a mouse myeloma cell line by recombinant DNA technology. 
* rekombinantno glodalsko/človeško himerno monoklonalno protitelo, usmerjeno proti  verigi receptorja za interlevkin-2 (antigen CD25), ki ga s tehnologijo rekombinantne DNA izdelujejo v kulturi mielomskih celic miši.
In a clinical trial with 172 patients receiving basiliximab, the incidence of human antimurine antibody (HAMA) in renal transplantation patients treated with basiliximab was 2/138 in patients not exposed to muromonab-CD3 and 4/34 in patients who received muromonab-CD3 concomitantly. 
Pri klinični raziskavi na 172 bolnikih, ki so dobivali baziliksimab, je bila incidenca človeškega protiglodalskega protitelesa (HAMA) pri bolnikih z ledvičnimi presadki, zdravljenih z baziliksimabom, 2/138 pri bolnikih, ki niso bili izpostavljeni muromonabu-CD3, in 4/34 pri bolnikih, ki so sočasno dobili muromonab-CD3.
Caution should be exercised when patients previously given Simulect are re-exposed to a subsequent course of therapy with this medicinal product. 
Kadar bolnike, ki so prej prejemali zdravilo Simulect, pozneje ponovno izpostavimo zdravljenju s tem zdravilom, je potrebna previdnost.
In the original phase III studies during the first 3 months post-transplantation, 14% of patients in the basiliximab group and 27% of patients in the placebo group had an acute rejection episode treated with antibody therapy (OKT 3 or antithymocyte globulin/antilymphocyte globulin [ATG/ALG]), with no increase in adverse events or infections in the basiliximab group as compared to placebo. 
V originalnih raziskavah faze III v prvih treh mesecih po presaditvi je imelo 14 % bolnikov v skupini z baziliksimabom in 27 % bolnikov v skupini s placebom akutno zavrnitveno reakcijo, ki so jo zdravili s protitelesi (OKT 3 ali antitimocitnim globulinom/antilimfocitnim globulinom [ATG/ALG]).
Simulect 10 mg must not be administered unless it is absolutely certain that the patient will receive the graft and concomitant immunosuppression. 
Zdravila Simulect 10 mg ne smemo uporabiti, če ni popolnoma gotovo, da bo bolnik dobil presadek in spremljajočo imunosupresijo.
What Simulect contains - The active substance is basiliximab. 
Kaj vsebuje zdravilo Simulect - Učinkovina je baziliksimab.
The first dose is given just before the transplant operation, and the second dose 4 days after the operation. 
Prvi odmerek prejmete tik pred presaditveno operacijo, drugega pa 4 dni po operaciji.
You must not be given Simulect - if you are allergic (hypersensitive) to basiliximab or any of the other ingredients of Simulect listed in section 6 under “What Simulect contains”. 
Zdravila Simulect ne smete dobiti - če ste alergični (preobčutljivi) na baziliksimab ali katero koli sestavino zdravila Simulect,
The most commonly reported (> 20%) events following dual therapy in both (< 35 kg vs.  35 kg weight) cohorts were urinary tract infection, hypertrichosis, rhinitis, pyrexia, hypertension, upper respiratory tract infection, viral infection, sepsis and constipation. 
Dogodki, o katerih so najpogosteje poročali (> 20 %) po dvotirnem zdravljenju v obeh (< 35 kg proti  35 kg telesne teže) kohortah, so bili okužbe sečil, hipertrihoza, rinitis, zvišana telesna temperatura, hipertenzija, okužba zgornjih dihal, virusna okužba, sepsa in zapeka.
Nevertheless, live vaccines are not recommended for immunosuppressed patients. 
Kljub temu pri bolnikih z zmanjšanim imunskim odzivom uporaba živih cepiv ni priporočena.
Do not use after the expiry date stated on the pack. 
Zdravila se ne sme uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini.
If a severe hypersensitivity reaction occurs, therapy with Simulect must be permanently discontinued and no further dose be administered. 
Če se pojavi težka preobčutljivostna reakcija, je treba zdravljenje s z zdravilom Simulect za stalno opustiti in bolnik ne sme prejeti nobenega odmerka več.
Basiliximab is a murine/human chimeric monoclonal antibody (IgG1) that is directed against the interleukin-2 receptor -chain (CD25 antigen), which is expressed on the surface of T-lymphocytes in response to antigenic challenge. 
Baziliksimab je glodalsko/človeško himerno monoklonalno protitelo (IgG1), usmerjeno proti verigi  receptorja za interlevkin-2 (antigen CD25), ki je izražen na površini limfocitov T kot odgovor na antigenski izziv.
When borderline rejections were included, the rates were 20.8% and 19.6%, respectively (HR: 1.01, 90% CI: [0.59; 1.72]). 
Če so zraven šteli tudi mejne zavrnitve, sta ustrezna deleža znašala 20,8 % in 19,6 % (razmerje tveganj: 1,01; 90-odstotni IZ: [0,59; 1,72]).
The second 20 mg dose should be given 4 days after transplantation. 
Drugi 20miligramski odmerek je treba bolniku dati 4 dni po presaditvi.
5.2 Pharmacokinetic properties 
5.2 Farmakokinetične lastnosti Odrasli
If you notice sudden signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, fast heart beat, dizziness, light headedness, shortness of breath, sneezing, wheezing or trouble breathing, severely decreased urine output, or fever and flu-like symptoms, tell your doctor or nurse immediately. 
Če opazite nenadne znake alergije, na primer izpuščaj, srbenje ali koprivnico na koži, otekanje obraza, ustnic, jezika ali drugih delov telesa, hiter srčni utrip, vrtoglavost, omotičnost, kratko sapo, kihanje, sopenje ali oteženo dihanje, zelo zmanjšano izločanje urina ali zvišano telesno temperatuo in podobne simptome kot pri gripi, o tem nemudoma obvestite svojega zdravnika ali medicinsko sestro.
The first 20 mg dose should be given within 2 hours prior to transplantation surgery. 
Prvi 20-miligramski odmerek naj dobi največ dve uri pred presaditveno operacijo.
Shake the vial gently to dissolve the powder, avoiding foaming. 
Stekleničko previdno stresite, da se prašek raztopi, ne da bi se spenil.
There is no evidence to indicate that Simulect has an effect on your ability to drive a car or use machines. 
Vpliv na sposobnost upravljanja vozil in strojev Ni znakov, ki bi kazali, da bi zdravilo Simulect vplivalo na vašo sposobnost upravljanja vozil in strojev.
The rates of BPAR were 9.4% in the basiliximab group and 17.4% in the placebo group (HR: 0.50, 90% CI: [0.25; 0.99]). 
Med bolniki z baziliksimabom je do akutne z biopsijo dokazane zavrnitvene epizode prišlo pri 9,4 %, med tistimi s placebom pa pri 17,4 % (razmerje tveganj: 0,50; 90-odstotni IZ: [0,25; 0,99]).
In adults, the most commonly reported side effects were constipation, nausea, diarrhoea, weight increase, headache, pain, swelling of hands, ankles or feet, high blood pressure, anaemia, changes in blood chemistry (e.g. potassium, cholesterol, phosphate, creatinine), surgical wound complications, and various kinds of infections. 
Pri odraslih so najpogosteje poročani neželeni učinki zapeka, slabost s siljenjem na bruhanje (navzea), driska, povečanje telesne teže, glavobol, bolečine, otekanje dlani, gležnjev ali stopal, zvišan krvni tlak, slabokrvnost, spremembe biokemijskih izvidov krvi (na primer kalija, holesterola, fosfatov, kreatinina), zapleti kirurške rane in različne vrste okužb.
Results from two multicentre double-blind studies comparing basiliximab with placebo (463 patients in total) show that basiliximab significantly reduces the incidence of acute rejection episodes within 6 months after transplantation when used concomitantly with ciclosporin for microemulsion, corticosteroids, and either azathioprine (21% vs. 35%) or mycophenolate mofetil (15% vs. 27%). 
Rezultati dveh multicentričnih dvojno slepih raziskav, v katerih je bil baziliksimab primerjan s placebom (skupno 463 bolnikov), kažejo, da baziliksimab statistično značilno zmanjša pogostnost akutnih zavrnitvenih reakcij v 6 mesecih po presaditvi, če je uporabljen sočasno s ciklosporinom v mikroemulziji, kortikosteroidi in bodisi azatioprinom (21 % proti 35 %) ali mofetilmikofenolatom (15 % proti 27 %).
Adults The standard total dose is 40 mg, given in two doses of 20 mg each. 
Odrasli Standardni celotni odmerek je 40 mg, ki ga bolnik prejme v dveh odmerkih po 20 mg.
The solvent ampoule contains 5 ml water for injections. 
Ampula z vehiklom vsebuje 5 ml vode za injekcije.
A 12-month, randomised, placebo-controlled, double-blind, multicentre study investigated basiliximab in combination with ciclosporin for microemulsion, mycophenolate mofetil and steroids in paediatric renal allograft recipients. 
V 12-mesečni, randomizirani, s placebom kontrolirani, dvojno slepi, multicentrični študiji so pri pediatričnih prejemnikih alogenih ledvičnih presadkov proučevali uporabo baziliksimaba v kombinaciji s ciklosporinom v mikroemulziji, z mofetilmikofenolatom in s steroidi.
No data are available on either the effects of live and inactive vaccination or the transmission of infection by live vaccines in patients receiving Simulect. 
Pri bolnikih, ki prejemajo zdravilo Simulect, ni na voljo nobenih podatkov o učinkovitosti cepljenja z bodisi živimi ali inaktiviranimi cepivi in možnosti prenosa okužbe z živimi cepivi.
Reconstituted Simulect can be administered as an intravenous bolus injection or as an intravenous infusion over 20-30 minutes. 
Pripravljeno zdravilo Simulect lahko dajemo bodisi kot intravensko injekcijo v bolusu bodisi kot intravensko infuzijo v trajanju 20 do 30 minut.
If you are unsure about anything, ask your doctor, nurse or pharmacist. 
Če ste glede česarkoli negotovi, vprašajte svojega zdravnika, medicinsko sestro ali farmacevta.
Elimination half-life was not influenced by age, gender, or race. 
Starost, spol ali rasa nimajo vpliva na razpolovni čas odstranjevanja iz telesa.
Simulect must not be administered unless it is absolutely certain that the patient will receive the graft and concomitant immunosuppression. 
Zdravila Simulect ne smemo uporabiti, če ni popolnoma gotovo, da bo bolnik dobil presadek in spremljajočo imunosupresijo.
The most commonly reported (> 20%) events following dual or triple therapy in both treatment groups (basiliximab vs. placebo) were constipation, urinary tract infection, pain, nausea, peripheral oedema, hypertension, anaemia, headache, hyperkalaemia, hypercholesterolaemia, postoperative wound complication, weight increase, increase in blood creatinine, hypophosphataemia, diarrhoea and upper respiratory tract infection. 
Učinki, o katerih so najpogosteje (> 20 %) poročali po dvotirnem ali trotirnem zdravljenju v obeh tretiranih skupinah (baziliksimab proti placebu), so bili zapeka, okužbe sečil, bolečina, navzea, periferni edemi, hipertenzija, anemija, glavobol, hiperkaliemija, hiperholesterolemija, pooperativni zapleti ran, povečanje telesne teže, zvišana vrednost kreatinina v krvi, hipofosfatemija, driska in okužbe zgornjih dihal.
You must not be given Simulect if you are pregnant. 
Če ste noseči, ne smete prejemati zdravila Simulect.
This solvent is used to dissolve the powder before it is given to you. 
V tem topilu se pred uporabo raztopi prašek.
There is a proportional increase in Cmax and AUC from 20 mg to 60 mg, the range of single-dose administrations tested. 
Pri odmerkih med 20 mg in 60 mg, tj. v razponu posameznih testnih odmerkov, se Cmax in AUC povečujeta sorazmerno z odmerkom.
Simulect is to be used concomitantly with ciclosporin for microemulsion- and corticosteroid-based immunosuppression. 
Zdravilo Simulect naj se uporablja za imunosupresijo sočasno s ciklosporinom v mikroemulziji in kortikosteroidi.
Hypersensitivity/anaphylactoid reactions such as rash, urticaria, pruritus, sneezing, wheezing, bronchospasm, dyspnoea, pulmonary oedema, cardiac failure, hypotension, tachycardia, respiratory failure, capillary leak syndrome (see section 4.4). 
Preobčutljivostne/anafilaktične reakcije, kot so izpuščaj, urtikarija, srbenje, kihanje, piskanje, bronhospazem, dispneja, pljučni edem, popuščanje srca, hipotenzija, tahikardija, insuficienca dihanja, sindrom zvečane prepustnosti kapilar (glejte poglavje 4.4).
Colourless type I glass vial, grey fluor-resin coated butyl rubber stopper, held in place by a flanged aluminium band, blue polypropylene flip-off cap, containing 20 mg basiliximab as powder for solution for injection or infusion. 
Viala iz neobarvanega stekla tipa I, siv zamašek iz butilne gume, prevlečen s fluorjevo smolo, pritrjen z zarobljenim aluminijastim trakom, modra zaporka iz polipropilena, ovojnina vsebuje 20 mg baziliksimaba v obliki praška za raztopino za injiciranje ali infundiranje.
Tell your doctor or nurse as soon as possible if you get any unexpected symptoms while you are being given Simulect, or during the 8 weeks afterwards, even if you do not think that they are related to the medicine. 
Če se v času prejemanja zdravila Simulect ali v sledečih 8 tednih pojavijo kakšni nepričakovani simptomi, tudi če jih ne povezujete z zdravilom, o tem čimprej obvestite zdravnika ali medicinsko sestro.
Simulect is given twice, in hospital, either slowly through a needle in your vein as an infusion lasting 20-30 minutes or as an intravenous injection using a syringe. 
Zdravilo Simulect boste v bolnišnici dobili samo ob presaditvi nove ledvice, in sicer dvakrat, skozi iglo v veno bodisi v obliki infuzije, trajajoče 20-30 minut ali naenkrat v obliki intravenske injekcije z brizgalko.
Colourless type I glass vial, grey fluor-resin coated butyl rubber stopper, held in place by a flanged aluminium band, blue polypropylene flip-off cap, containing 10 mg basiliximab as powder for solution for injection or infusion. 
Viala iz neobarvanega stekla tipa I, siv zamašek iz butilne gume, prevlečen s fluorjevo smolo, pritrjen z zarobljenim aluminijastim trakom, modra zaporka iz polipropilena, ovojnina vsebuje 10 mg baziliksimaba v obliki praška za raztopino za injiciranje ali infundiranje.
Chemical and physical stability of the reconstituted solution is demonstrated for 24 hours at 2°C - 8°C or for 4 hours at room temperature (see section 6.6). 
Kemijska in fizikalna stabilnost pripravljene raztopine je dokazana za 24 ur pri 2 C - 8 C ali za 4 ure pri sobni temperaturi (glejte poglavje 6.6).
It is supplied in a pack with a colourless glass ampoule containing 5 ml sterile water for injections. 
Pakirana je skupaj s prozorno stekleno ampulo, ki vsebuje 5 ml sterilne vode za injekcije.
- If you have any further questions, ask your doctor, nurse or pharmacist. 
- Če imate dodatna vprašanja, se posvetujte z zdravnikom, medicinsko sestro ali farmacevtom.
Human antimurine antibody (HAMA) responses were reported in a clinical trial of 172 patients treated with basiliximab, without predictive value for clinical tolerability. 
V klinični raziskavi na 172 bolnikih, zdravljenih z baziliksimabom, so poročali o odzivih humanih protiglodalskih protiteles (HAMA), kar pa nima napovedne vrednosti za klinično prenašanje zdravila.
The second dose should be withheld in the event of a severe hypersensitivity reaction to Simulect or post-operative complications such as graft loss (see section 4.4). 
V primeru hude preobčutljivostne reakcije na zdravilo Simulect ali pooperativnih zapletov, na primer izguba presadka bolnik ne sme dobiti drugega odmerka (glejte poglavje 4.4).
Sudden severe allergic reactions have been reported in patients treated with Simulect. 
Pri bolnikih, zdravljenih z zdravilom Simulect, poročajo o nenadnih težkih alergijskih reakcijah.
Colourless glass ampoule, type I glass, containing 5 ml water for injections. 
Ampula iz neobarvanega stekla tipa I, vsebuje 5 ml vode za injekcije.
No toxicity was observed when rhesus monkeys received intravenous doses of either up to 5 mg/kg basiliximab twice weekly for 4 weeks followed by an 8-week withdrawal period or 24 mg/kg basiliximab weekly for 39 weeks followed by a 13-week withdrawal period. 
Ko so opicam rezus dvakrat tedensko dajali intravenske odmerke bodisi do 5 mg/kg telesne mase baziliksimaba 4 tedne zapored čemur je sledilo 8-tedensko obdobje brez zdravila, bodisi 24 mg/kg telesne mase baziliksimaba 39 tednov, čemur je sledilo 13-tedensko obdobje brez zdravila, niso opazili toksičnosti.
The body's immune system thinks a transplanted organ is a foreign body and will try to reject it. Simulect works by stopping the immune cells that attack transplanted organs. 
Imunski sistem prepozna presajeni organ kot tujek in ga poskuša zavrniti.
The first dose should be given within 2 hours before transplantation surgery, and the second dose 4 days after transplantation. 
Prvi odmerek je bolniku treba dati največ dve uri pred presaditveno operacijo, drugi odmerek pa 4 dni po presaditvi.
INSTRUCTIONS FOR RECONSTITUTION AND ADMINISTRATION 
NAVODILA ZA PRIPRAVO IN UPORABO
Store and transport refrigerated (2°C - 8°C). 
Zdravilo shranjujte in prevažajte na hladnem (2 C - 8 C).
Acute hypersensitivity reactions were observed on re-administration of Simulect for a subsequent transplantation in some of these patients. 
Pri nekaterih od teh bolnikov so ob ponovni uporabi zdravila Simulect zaradi poznejše presaditve opazili akutne preobčutljivostne reakcije.
Reconstituted Simulect is administered as an intravenous infusion over 20 to 30 minutes or as a bolus injection. 
Pripravljeno zdravilo Simulect lahko dajemo v obliki intravenske infuzije, trajajoče 20 do 30 minut ali v obliki bolusne injekcije.
Since no data are available on the compatibility of Simulect with other intravenous substances, Simulect should not be mixed with other medications/substances and should always be given through a separate infusion line. 
Ker ni podatkov o združljivosti zdravila Simulect z drugimi zdravili za intravensko uporabo, zdravila Simulect ne smemo mešati z drugimi zdravili/snovmi in ga moramo vedno dajati po ločenem infuzijskem kanalu.
Use immediately after reconstitution (chemically and physically stable at 2°C - 8°C for 24 hours or at room temperature for 4 hours). 
Uporabite takoj po pripravi (kemijsko in fizikalno stabilno 24 ur pri temperaturi 2 °C - 8 C ali 4 ure pri sobni temperaturi).
It can be used in a ciclosporin for microemulsion- and corticosteroid-based triple immunosuppressive regimen including azathioprine or mycophenolate mofetil. 
Lahko se uporablja v trotirni vzdrževalni imunosupresivni shemi s ciklosporinom v mikroemulziji, kortikosteroidi in bodisi azatioprinom ali mofetilmikofenolatom.
These included anaphylactoid-type reactions such as rash, urticaria, pruritus, sneezing, wheezing, hypotension, tachycardia, dyspnoea, bronchospasm, pulmonary oedema, cardiac failure, respiratory failure and capillary leak syndrome. 
Te so obsegale reakcije anafilaktoidnega tipa, na primer izpuščaj, urtikarijo, pruritus, kihanje, piskanje, hipotenzijo, tahikardijo, dispnejo, bronhospazem, pljučni edem, popuščanje srca, insuficienco dihanja in sindrom zvečane prepustnosti kapilar.
The primary efficacy endpoint, time to first biopsy-proven acute rejection (BPAR) episode or treatment failure defined as graft loss, death or presumptive rejection within the first 6 months post transplantation, occurred in 16.7% of basiliximab-treated patients and 21.7% of placebo-treated patients. 
Primarni cilj opazovanja glede učinkovitosti je bil čas do prve akutne z biopsijo dokazane zavrnitvene epizode ali do neuspeha zdravljenja, ki je bil opredeljen kot izguba presadka, smrt bolnika ali domnevna zavrnitev presadka v prvih 6 mesecih po presaditvi.
Since no data are available on the compatibility of Simulect with other medicinal products intended for intravenous administration, Simulect should not be mixed with other medicinal products and should always be given through a separate infusion line. 
Ker ni na voljo nobenih podatkov o združljivosti zdravila Simulect z drugimi zdravili za intravensko uporabo, se zdravila Simulect ne sme mešati z drugimi zdravili in se mora vselej dati po posebnem infuzijskem sistemu.
One ml of the reconstituted solution contains 4 mg basiliximab. 
En mililiter pripravljene raztopine vsebuje 4 mg baziliksimaba.
Discard the reconstituted solution if not used within that time. 
Če pripravljene raztopine v tem času ne porabimo, jo zavržemo.
You must not breast-feed after being given Simulect or up to 4 months after the second dose. 
Po prejetju zdravila Simulect in do 4 mesece po drugem odmerku ne smete dojiti.
Simulect is also available in vials with 20 mg basiliximab. 
Zdravilo Simulect je na voljo tudi v vialah z 20 mg baziliksimaba.
How to store Simulect 
Kako boste prejeli zdravilo Simulect
To prepare the solution for infusion or injection, take 2.5 ml water for injections out of the accompanying 5 ml ampoule aseptically and add this 2.5 ml of water for injections aseptically to the vial containing the Simulect powder. 
Za pripravo infuzijske ali injekcijske raztopine aseptično odvzamite 2,5 ml vode za injekcije iz priložene 5-mililitrske ampule in ta 2,5 ml vode za injekcije aseptično dodajte v vialo s praškom Simulect.
Simulect is also available in vials with 10 mg basiliximab. 
Zdravilo Simulect je na voljo tudi v vialah z 10 mg baziliksimaba.
1 vial with 10 mg powder 1 ampoule with 5 ml solvent 
1 ampula s 5 ml vehikla
After reconstitution, chemical and physical in-use stability has been demonstrated for 24 hours at 2°C - 8°C or for 4 hours at room temperature. 
Kemijska in fizikalna stabilnost pripravljene raztopine je dokazana za 24 ur pri 2 °C - 8 °C ali 4 ure pri sobni temperaturi.
Reconstitution 
Odmerjanje
Single-dose and multiple-dose pharmacokinetic studies have been conducted in adult patients undergoing kidney transplantation. 
Pri odraslih bolnikih s presajeno ledvico so bile narejene farmakokinetične raziskave z enim odmerkom in z več odmerki.
One vial contains 20 mg of basiliximab. 
1 viala vsebuje 20 mg baziliksimaba.