natgillin/translations-raw huggingface dataset:
If any of the side effects gets serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
59 Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
Silgard is available in packs of 1, 10, or 20 pre-filled syringes with a needle guard (safety) device.
Cepivo Silgard je na voljo v pakiranjih z 1, 10 ali 20 napolnjenimi injekcijskimi brizgami z varovalom (zaščito) za iglo.
Marketing Authorisation Holder:
60 Imetnik dovoljenja za promet z zdravilom:
Ireland Merck Sharp & Dohme Ireland (Human Health) Limited, Tel: +353 (0)1 2998771 medinfo_ireland@merck. com
Merck Sharp & Dohme Ireland (Human Health) Tel: +386. 1. 520. 4201 Limited, msd_ slovenia@ merck. com Tel: +353 (0) 1 2998771 medinfo_ ireland@ merck. com
Tel: +386.1.520.4201 msd_slovenia@merck. com
Slovenská republika Ísland Merck Sharp & Dohme IDEA, Inc.
60 Ísland Icepharma hf.
Icepharma hf.
Sími: +354 540 8000 ISmail@merck. com
Tel: +421. 2. 58282010 Sími: +354 540 8000 msd_ sk@ merck. com ISmail@ merck. com
• Silgard is available in a pre-filled syringe, with needle guard (safety device) ready to use for intramuscular injection (IM), preferably in the deltoid area of the upper arm. • If 2 needles of different lengths are provided in the pack, choose the appropriate needle to ensure an IM administration depending on your patient’ s size and weight. • Parenteral drug products should be inspected visually for particulate matter and discolouration prior to administration.
• Če sta v škatli 2 različno dolgi igli, izberite tisto, ki je najprimernejša za bolnika, glede na njegovo višino in telesno maso.
Note:
62 Opomba:
61 Shake well before use.
Pred uporabo dobro pretresite.
Pull on the coloured tab while continuing to rotate the plunger as needed.
Medtem, ko vlečete za obarvano oznako, obračajte bat in odlepite nalepko.
Silgard, suspension for injection in a pre-filled syringe Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed)
Silgard suspenzija za injiciranje v napolnjeni injekcijski brizgi Adsorbirano rekombinantno cepivo proti humanim papilomavirusom [tipom 6, 11, 16 in 18]
Silgard produces type-specific antibodies and has been shown in clinical trials to prevent these HPV 6-, 11-, 16-, and 18-related diseases in adult women 16-26 years of age.
Silgard povzroči nastanek tipsko specifičnih protiteles in je v kliničnih študijah preprečil s HPV 6, 11, 16 in 18 povezane bolezni pri odraslih ženskah, starih 16 do 26 let.
You should tell your doctor if the person to be vaccinated:
65 Bodite posebno pozorni pri cepljenju s cepivom Silgard
66 If any of the side effects gets serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
67 Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
Marketing Authorisation Holder:
68 Imetnik dovoljenja za promet z zdravilom:
67 Manufacturer:
Izdelovalec:
68 Ísland Icepharma hf.
Icepharma hf.
• Silgard is available in a pre-filled syringe ready to use for intramuscular injection (IM), preferably in the deltoid area of the upper arm. • If 2 needles of different lengths are provided in the pack, choose the appropriate needle to ensure an IM administration depending on your patient’ s size and weight. • Parenteral drug products should be inspected visually for particulate matter and discolouration prior to administration.
• Če sta v škatli 2 različno dolgi igli, izberite tisto, ki je najprimernejša za bolnika, glede na njegovo višino in telesno maso.
Simulect is given into a vein, either as a ‘ bolus’ injection (given all at once) or as an infusion over 20 to 30 minutes.
Zdravilo Simulect se daje v veno bodisi kot „ bolusna “ injekcija (bolnik prejme celo injekcijo naenkrat) ali kot infuzija, ki traja 20 do 30 minut.
By binding to CD25, basiliximab blocks the activity of interleukin-2, reducing the rate at which the
Učinkovina baziliksimab je bila zasnovana tako, da se veže na antigen, imenovan CD25, ki je prisoten na površini limfocitov T (vrste belih krvničk, ki sodeluje pri zavrnitvi presajenih organov).
This reduces the number of activated T-lymphocytes, lowering the risk of the transplant being rejected.
CD25 je receptor za sporočilno molekulo interlevkin- 2, ki spodbuja limfocite T k razmnoževanju.
In the first two studies, most of the 722 patients were also taking ciclosporin and corticosteroids (‘ dual therapy’), with some patients also taking azathioprine or mycophenolate mofetil.
V prvih dveh študijah je večina od 722 bolnikov jemala tudi ciklosporin in kortikosteroide (dvotirno zdravljenje), nekateri bolniki pa so jemali tudi azatioprin ali mofetilmikofenolat.
In the third study, all 345 adults were taking ciclosporin, steroids and azathioprine (‘ triple therapy’).
V tretji študiji je vseh 345 odraslih jemalo ciklosporin, steroide in azatioprin (trotirno zdravljenje).
Looking at the results of the first two studies taken together, 40% of the patients receiving Simulect in addition to dual therapy failed treatment over six months (145 out of 363), compared with 56% of the patients receiving placebo (201 out of 359).
Iz rezultatov prvih dveh študij skupaj je razvidno, da zdravljenje v šestih mesecih ni uspelo pri 40% bolnikov, ki so zdravilo Simulect prejemali poleg dvotirnega zdravljenja (145 od 363), v primerjavi s 56% bolnikov, ki so prejemali placebo (201 od 359).
In the third study, fewer patients receiving Simulect with triple therapy failed treatment (26%) than those receiving placebo (40%).
V tretji študiji je bilo število bolnikov, pri katerih je bilo zdravljenje neuspešno, manjše pri bolnikih, ki so prejemali zdravilo Simulect sočasno s trotirnim zdravljenjem (26%), kot pri bolnikih, ki so prejemali placebo (40%).
In adults, the most common side effects (seen in more than 20% of patients) were constipation, urinary tract infections (infection of the structures that carry urine), pain, nausea (feeling sick), peripheral oedema (swelling), hypertension (high blood pressure), anaemia (low red blood cell counts), headache, hyperkalaemia (high blood potassium levels), hypercholesterolaemia (high blood cholesterol levels), surgical wound complication, weight increase, increased serum creatinine (a marker of kidney problems), hypophosphataemia (low blood phosphate levels), diarrhoea and upper respiratory tract infection (colds).
Najpogostejši neželeni učinki pri odraslih (opaženi pri več kot 20% bolnikov) so bili zapeka, okužbe sečil (okužbe struktur, po katerih se prenaša urin), bolečine, občutek slabosti, periferni edem (oteklina), hipertenzija (povišan krvni tlak), anemija (majhno število rdečih krvnih celic), glavobol, hiperkaliemija (visoke ravni kalija v krvi), hiperholesterolemija (visoke ravni holesterola v krvi), pooperativni zapleti ran, povečanje telesne mase, zvišana vrednost kreatinina v krvi (označevalec ledvičnih težav), hipofosfatemija (nizke ravni fosfata v krvi), driska in okužbe zgornjih dihal (prehladi).
In children, the side effects seen in more than 20% of patients were urinary tract infections, hypertrichosis (excess body hair), rhinitis (stuffy and runny nose), pyrexia (fever), hypertension, upper respiratory tract infection, viral infection, sepsis (blood infection) and constipation.
Pri otrocih so bili neželeni učinki, opaženi pri več kot 20% bolnikov, okužbe sečil, hipertrihoza (čezmerna poraščenost telesa), rinitis (zamašen nos ter izcedek iz nosu), zvišana telesna temperatura, hipertenzija, okužba zgornjih dihal, virusna okužba, sepsa (okužba krvi) in zapeka.
The Committee for Medicinal Products for Human Use (CHMP) decided that Simulect’ s benefits are greater than its risks for the prophylaxis of acute organ rejection in de novo allogeneic renal transplantation in adult and paediatric patients.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Simulect za zaščito pred akutno zavrnitvijo organa pri de novo alogeni presaditvi ledvice pri odraslih bolnikih in otrocih večje od z njim povezanih tveganj.
Each vial contains 20 mg basiliximab*.
Vsaka viala vsebuje 20 mg baziliksimaba *.
* recombinant murine/ human chimeric monoclonal antibody directed against the interleukin-2 receptor α -chain (CD25 antigen) produced in a mouse myeloma cell line by recombinant DNA technology.
* rekombinantno glodalsko/ človeško himerno monoklonalno protitelo, usmerjeno proti α verigi receptorja za interlevkin- 2 (antigen CD25), ki ga s tehnologijo rekombinantne DNA izdelujejo v kulturi mielomskih celic miši.
White powder
Bel prašek
Simulect is indicated for the prophylaxis of acute organ rejection in de novo allogeneic renal transplantation in adult and paediatric patients (1-17 years) (see section 4.2).
Simulect je indiciran za profilakso akutne zavrnitve organa pri de novo alogeni presaditvi ledvice pri odraslih in pediatričnih bolnikih (1- 17 let) (glejte poglavje 4. 2).
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.
Namenjen 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.
Posology Adults The standard total dose is 40 mg, given in two doses of 20 mg each.
Odmerjanje Odrasli Standardni celotni odmerek je 40 mg, ki ga bolnik prejme v dveh odmerkih po 20 mg.
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.
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 Simulect ali pooperativnih zapletov, na primer izgube presadka, bolnik ne sme dobiti drugega odmerka (glejte poglavje 4. 4).
2 Children and adolescents (1– 17 years) In paediatric patients weighing less than 35 kg, the recommended total dose is 20 mg, given in two doses of 10 mg each.
2 Otroci in mladostniki (1– 17 let) Pri pediatričnih bolnikih, ki tehtajo manj od 35 kg, je priporočeni celotni odmerek 20 mg, ki ga prejmejo v dveh odmerkih po 10 mg.
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.
The second dose should be given 4 days after transplantation.
Prvi odmerek je bolniku treba dati največ dve uri pred presaditveno operacijo, drugi odmerek pa 4 dni po presaditvi.
Elderly (≥ 65 years) There are limited data available on the use of Simulect in the elderly, but there is no evidence that elderly patients require a different dosage from younger adult patients.
Starostniki (≥ 65 let) Glede zdravljenja starejših s Simulectom je na voljo malo podatkov, vendar ni dokazov, ki bi narekovali pri starejših bolnikih drugačne odmerke kot pri mlajših odraslih bolnikih.
Method of administration Reconstituted Simulect can be administered as an intravenous bolus injection or as an intravenous infusion over 20– 30 minutes.
Način dajanja Pripravljeni Simulect lahko dajemo bodisi kot intravensko injekcijo v bolusu bodisi kot intravensko infuzijo v trajanju 20 do 30 minut.
For information on reconstitution, see section 6.6.
Za informacije o pripravi glejte poglavje 6. 6.
Pregnancy and lactation (see section 4.6).
Nosečnost in dojenje (glejte poglavje 4. 6).
Hypersensitivity Severe acute (less than 24 hours) hypersensitivity reactions have been observed both on initial exposure to Simulect and on re-exposure to a subsequent course of therapy.
Preobčutljivost Hude akutne preobčutljivostne reakcije (v manj kot 24 urah) so opažali tako pri prvi izpostavljenosti Simulectu kot pri ponovni izpostavljenosti ob kasnejši ponovitvi zdravljenja.
These included anaphylactoid-type reactions such as urticaria, pruritus, sneezing, hypotension, tachycardia, dyspnoea, bronchospasm, pulmonary oedema and respiratory failure.
Te so obsegale reakcije anafilaktoidnega tipa, na primer urtikarijo, pruritus, kihanje, hipotenzijo, tahikardijo, dispnejo, bronhospazem, pljučni edem in insuficienco dihanja.
There have been rare reports of such reactions in patients receiving Simulect (< 1/ 1,000 patients).
Pri bolnikih, ki so prejemali Simulect, so o teh reakcijah redko poročali (< 1/ 1. 000 bolnikov).
In a pooled analysis of two
V združeni analizi dveh petletnih podaljšanih raziskav niso našli nobenih razlik v pogostnosti malignih
3 five-year extension studies, no differences were found in the incidence of malignancies and LPDs between immunosuppressive regimens with or without combination of basiliximab (see section 4.8).
3 in limfoproliferativnih bolezni med imunosupresivnimi shemami s kombinacijo z baziliksimabom v primerjavi s kombinacijami brez njega (glejte poglavje 4. 8).
The incidence was 2/ 138 in patients not exposed to muromonab-CD3 (OKT3) and 4/ 34 in patients who received muromonab-CD3 concomitantly.
Incidenca je bila 2/ 138 pri bolnikih, ki niso bili izpostavljeni muromonabu- CD3 (OKT3), in 4/ 34 pri bolnikih, ki so sočasno dobili muromonab- CD3.
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.
Pri tem se v skupini, ki je dobila baziliksimab, v primerjavi s placebom, ni povečal obseg neželenih dogodkov ali okužb.
The total body clearance of basiliximab was reduced by an average 22% when azathioprine was added to a regimen consisting of ciclosporin for microemulsion and corticosteroids.
Če so kombinaciji ciklosporina v mikroemulziji in kortikosteroidov dodali azatioprin, se je celotni telesni očistek baziliksimaba zmanjšal za povprečno 22%.
The total body clearance of basiliximab was reduced by an average 51% when mycophenolate mofetil was added to a regimen consisting of ciclosporin for microemulsion and corticosteroids.
Če so kombinaciji ciklosporina v mikroemulziji in kortikosteroidov dodali mofetilmikofenolat, se je celotni telesni očistek baziliksimaba zmanjšal za povprečno 51%.
The use of basiliximab in a triple therapy regimen including azathioprine or mycophenolate mofetil did not increase adverse events or infections in the basiliximab group as compared to placebo (see section 4.8).
Uporaba baziliksimaba v programu trotirnega zdravljenja skupaj z azatioprinom ali mofetilmikofenolatom ni povečala obsega neželenih dogodkov ali okužb v skupini z baziliksimabom v primerjavi s placebom (glejte poglavje 4. 8).
Simulect is contraindicated in pregnancy and lactation (see section 4.3).
Zdravilo Simulect je kontraindicirano med nosečnostjo in dojenjem (glejte poglavje 4. 3).
Basiliximab has been tested in four randomised, double-blind, placebo-controlled studies in renal transplant recipients as an induction agent in combination with the following immunosuppressive regimens: ciclosporin for microemulsion and corticosteroids in two studies (346 and 380 patients), ciclosporin for microemulsion, azathioprine and corticosteroids in one study (340 patients), and ciclosporin for microemulsion, mycophenolate mofetil and corticosteroids in another study (123 patients).
Baziliksimab je bil kot uvodna učinkovina preizkušen v štirih randomiziranih, dvojno slepih, s placebom kontroliranih raziskavah pri prejemnikih ledvičnih presadkov in sicer v kombinaciji z naslednjimi imunosupresivnimi shemami: ciklosporin v mikroemulziji in kortikosteroidi v dveh raziskavah (346 in 380 bolnikov), ciklosporin v mikroemulziji, azatioprin in kortikosteroidi v eni raziskavi (340 bolnikov) ter ciklosporin v mikroemulziji, mofetilmikofenolat in kortikosteroidi v drugi
4 Incidence of adverse events:
Incidenca neželenih učinkov:
In the above four placebo-controlled trials, the pattern of adverse events in 590 patients treated with the recommended dose of basiliximab was comparable to that observed in 595 patients treated with placebo.
V zgoraj navedenih štirih raziskavah, kontroliranih s placebom, je bil vzorec neželenih učinkov pri 590 bolnikih, zdravljenih s priporočenim odmerkom baziliksimaba, primerljiv z vzorcem, opaženim pri 595 bolnikih, ki so dobili placebo.
The overall incidence of treatment-related adverse events among all patients in the individual studies was not significantly different between the basiliximab (7.1% - 40%) and the placebo (7.6% - 39%) treatment groups.
Celotna incidenca neželenih učinkov v zvezi z zdravljenjem se med vsemi bolniki v posameznih raziskavah ni bistveno razlikovala med skupino, zdravljeno z baziliksimabom (7, 1% - 40%), in skupino, ki je dobivala placebo (7, 6% - 39%).
Adult patients 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.
Odrasli bolniki 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.
Paediatric patients 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.
Pediatrični bolniki 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.
Incidence of malignant neoplasms:
Incidenca malignih neoplazem:
The overall incidence of malignancies among all patients in the individual studies was similar between the basiliximab and the comparator treatment groups.
Celotna incidenca malignih bolezni med vsemi bolniki v posameznih raziskavah je bila podobna v skupinah z baziliksimabom in v skupinah s primerjanimi načini zdravljenja.
Overall, lymphoma/ lymphoproliferative disease occurred in 0.1% (1/ 701) of patients in the basiliximab group compared with 0.3% (2/ 595) of patients receiving placebo, both in combination with dual and triple immunosuppressive therapy.
Limfomi oziroma limfoproliferativne bolezni so se pojavili pri 0, 1% bolnikov (1/ 701) v skupini z baziliksimabom in pri 0, 3% bolnikov (2/ 595), ki so prejemali placebo, tako v kombinaciji z dvotirnim kot s trotirnim imunosupresivnim zdravljenjem.
Other malignancies were reported among 1.0% (7/ 701) of patients in the basiliximab group compared with 1.2% (7/ 595) of placebo patients.
O drugih malignih boleznih so poročali pri 1, 0% bolnikov (7/ 701) v skupini z baziliksimabom v primerjavi z 1, 2% bolnikov (7/ 595) v skupini s placebom.
In a pooled analysis of two five- year extension studies, the incidence of LPDs and cancer was found to be equal with basiliximab 7% (21/ 295) and placebo 7% (21/ 291) (see section 4.4).
V združeni analizi dveh petletnih podaljšanih raziskav so ugotovili, da je bila pogostnost limfoproliferativnih bolezni in raka enaka pri baziliksimabu (7% - 21/ 295) in placebu (7% - 21/ 291) (glejte poglavje 4. 4).
Incidence of infectious episodes:
Incidenca okužb:
The overall incidence and profile of viral, bacterial and fungal infections among patients treated with basiliximab or placebo in combination with dual and triple immunosuppressive therapy was comparable between the groups.
Celotna incidenca in profil virusnih, bakterijskih in glivičnih okužb pri bolnikih, ki so bili zdravljeni z baziliksimabom ali s placebom v kombinaciji z dvotirnim ali tritirnim imunosupresivnim zdravljenjem, je bila primerljiva med obema skupinama.
The overall incidence of infections was 75.9% in the basiliximab group and 75.6% in the placebo group and the incidence of serious infections was 26.1% and 24.8%, respectively.
Celotna incidenca okužb je bila 75, 9% v skupini z baziliksimabom in 75, 6% v skupini s placebom; incidenca hudih okužb je bila 26, 1% v skupini s Simulectom in 24, 8% v skupini s placebom.
17.3%), following either dual or triple therapy regimen (see section 4.4).
Incidenca okužb s citomegalovirusom (CMV) je bila podobna v obeh skupinah (14, 6% v primerjavi s 17, 3%) tako po dvotirnem kot po tritirnem zdravljenju (glejte poglavje 4. 4).
The incidence and causes of deaths following dual or triple therapy were similar in basiliximab (2.9%) and placebo groups (2.6%), with the most common cause of deaths in both treatment groups being infections (basiliximab = 1.3%, placebo = 1.4%).
Incidenca smrtnih izidov in vzrokov smrti po dvotirnem ali tritirnem zdravljenju je bila v skupini z baziliksimabom (2, 9%) in placebom (2, 6%) podobna; najpogostejši vzrok smrti v obeh tretiranih skupinah so bile okužbe (baziliksimab = 1, 3%, placebo = 1, 4%).
In a pooled analysis of two five-year extension studies the incidence and cause of death remained similar in both treatment groups, (basiliximab 15%, placebo 11%), the primary cause of death being cardiac-related disorders (basiliximab 5%, placebo 4%).
V združeni analizi dveh petletnih podaljšanih raziskav so pogostnost in vzroki smrti ostali podobni v obeh tretiranih skupinah (baziliksimab 15%, placebo 11%), primarni vzrok smrti pa so bile bolezni, povezane s srcem (baziliksimab 5%, placebo 4%).
Post-marketing adverse reactions Hypersensitivity/ anaphylactoid reactions such as rash, urticaria, sneezing, wheezing, bronchospasm, pulmonary oedema, cardiac failure, respiratory failure and capillary leak syndrome (see section 4.4), and cytokine release syndrome have been reported during post-marketing experience with Simulect.
Postmarketinški neželeni učinki V obdobju postmarketinških izkušenj s Simulectom so poročali o preobčutljivostnih/ anafilaktoidnih reakcijah, kot so izpuščaj, urtikarija, kihanje, piskanje, bronhospazem, pljučni edem, popuščanje srca, insuficienca dihanja in sindrom zvečane prepustnosti kapilar (glejte poglavje 4. 4), ter o sindromu sproščanja citokinov.
The frequency is not known (cannot be estimated from the available data).
Njihova pogostnost ni znana (je ni mogoče oceniti iz razpoložljivih podatkov).
For information on preclinical toxicology see section 5.3.
5 Za podatke o predklinični toksikologiji glejte poglavje 5. 3.
Interleukin inhibitors, ATC code:
Farmakoterapevstka skupina: zaviralci interlevkinov, oznaka ATC:
Mechanism of action Basiliximab is a murine/ human chimeric monoclonal antibody (IgG1 κ) that is directed against the interleukin-2 receptor α -chain (CD25 antigen), which is expressed on the surface of T-lymphocytes in response to antigenic challenge.
Mehanizem delovanja Baziliksimab je glodalsko/ človeško himerno monoklonalno protitelo (IgG1κ), usmerjeno proti verigi α receptorja za interlevkin- 2 (antigen CD25), ki je izražen na površini limfocitov T kot odgovor na antigenski izziv.