natgillin/translations-raw huggingface dataset:
Women of childbearing potential must use an effective contraceptive method during Zenapax therapy and continue its use for an additional 4 months following the last dose of Zenapax.
me kontracepcijsko metodo in z njo nadaljevati še dodatne 4 mesece po prejemu zadnjega odmerka zdravila Zenapax.
ed Lactation Daclizumab is excreted in cynomolgus monkey milk (see section 5.3).
p ro Dojenje Daclizumab se izloča v mleko opic Cynomolgus (glejte poglavje 5. 3).
However due to potential harmful effects for the newborn, breast-feeding is
Ni znano, ali se zdravilo Zenapax izloča v humano mleko.
ori contraindicated during the treatment and up to 4 months following the last dose of Zenapax.
Zaradi možnega škodljivega učinka na novorojenčka je dojenje med zdravljenjem in 4 mesece po zadnjem odmerku zdravila Zenapax kontraindicirano.
4.7 Effects on ability to drive and use machines
za 4. 7 Vpliv na sposobnost vožnje in upravljanja s stroji
uth Zenapax has no influence on the ability to drive and use machines.
Zenapax nima vpliva na sposobnost vožnje in upravljanja s stroji.
ra 4.8 Undesirable effects
nja 4. 8 Neželeni učinki
The safety profile of Zenapax was studied in comparison to placebo in patients who concomitantly ge received immunosuppressive regimens containing cyclosporine and corticosteroids alone, with the addition of azathioprine or with the addition of mycophenolate mofetil.
Varnostni profil Zenapaxa so primerjali s placebom pri bolnikih, ki so sočasno prejemali lje imunosupresivna zdravila, ki so vključevala ciklosporin in kortikosteroide same ali sočasno z azatioprinom ali mofetilmikofenolatom.
The data from the four studies lon (O14392, O14393, O14874 and O15301) showed that the incidence and types of adverse events were similar in both placebo-treated and Zenapax-treated patients.
Podatki iz štirih študij (O14392, O14393, O14874 in O15301) vo so pokazali, da so bili incidenca in tipi neželenih učinkov podobni pri bolnikih, ki so prejemali placebo in pri bolnikih, ki so prejemali Zenapax.
Adverse events were reported by 95% of placebo and 96% of daclizumab treated patients.
Neželeni učinki so se pojavili pri 95% bolnikov, zdravljenih s placebom, in pri 96% bolnikov, zdravljenih z daclizumabom.
Serious adverse events were reported by 44.4% of the patients in the placebo-treated group and 39.9% of the patients in the Zenapax-treated group. no
44, 4% bolnikov, zdravljenih s placebom, in pri 39, 9% bolnikov, zdravljenih z Zenapaxom.
Adverse events occurring with a frequency of ≥ 2% in patients in either group during the first 3 months post-transplant are listed below. t uc
Neželeni učinki, ki so se pojavili z ≥ 2 -% pogostnostjo pri bolnikih v katerikoli skupini v prvih 3 mesecih po presaditvi, so našteti spodaj. eā
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 rod
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 av
< 1/ 100); rare (≥ 1/ 10,000 to < 1/ 1,000); very rare (< 1/ 10,000), not known (cannot be estimated from the available data).
≤1/ 1. 000), zelo redki (≤ 1/ 10. 000), z neznano pogostnostjo (iz podatkov, ki so na voljo določitev ni mogoča).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. lp
V razvrstitvah pogostnosti so neželeni učinki navedeni po padajoči resnosti. nim
Zenapax (%)
Zenapax (%) n = 336
Placebo (%)
placebo (%) n = 293
Pharyngitis Rhinitis
faringitis rinitis
Metabolism and dic
Presnovne in ilo
nutrition disorders
prehranske motnje rav
Fluid overload Dehydration
preobremenitev s tekočino dehidracija
3.3 3.0
3, 3 3, 0
5.8 3.1
5, 8 3, 1
Psychiatric disorders Me
Psihiatrične motnje
13.7
13, 7
Depression Anxiety
depresija tesnoba
3.3 2.1
3, 3 2, 1
2.0 5.5
2, 0 5, 5
Nervous system disorders
Bolezni živčevja Zd
Tremor Headache Dizziness Paraesthesia
omotica parestezija
Eye disorders Cardiac disorders Vascular disorders
Očesne bolezni Srčne bolezni Žilne bolezni
Common Common Very common Common
pogosti pogosti zelo pogosti pogosti
Vision blurred Tachycardia Hypertension(incl. aggravated) Hypotension Haemorrhage
zamegljen vid tahikardija hipertenzija (vključno s poslabšanjem) hipotenzija krvavitev
2.7 6.5 32.1 8.6 7.4
2, 7 6, 5 32, 1 8, 6 7, 4
4.4 6.8 27.7 10.2 10.6
4, 4 6, 8 27, 7 10, 2 10, 6
Zenapax (%) n=336
Zenapax (%) n = 336
Lymphocele Thrombosis
limfokela tromboza
7.4 5.4
7, 4 5, 4
6.5 4.4
6, 5 4, 4
Dyspnoea Pulmonary oedema Pleural effusion Atelectasis Hypoxia
dispneja pljučni edem
11.9 6.3 2.1 3.3 2.7
2, 1
15.4 4.4 1.4 3.8 3.1
1, 4
Respiratory tract congestion Rales
atelektaza hipoksija kongestija dihal pokanje
3.3 3.3
3, 3 2, 7 3, 3 3, 3
3.8 1.4
3, 8 3, 1 3, 8 1, 4
s
p ro
Cough Breath sounds abnormal
kašelj nenormalen zvok dihanja
5.1 2.7
4, 8 1, 7
ori Gastrointestinal disorders
Bolezni prebavil
Constipation Diarrhoea
konstipacija diareja bruhanje
34.8 15.2
34, 8 15, 2 14, 9
37.9 16.4
37, 9 16, 4 14, 3
uth
za
Vomiting Nausea Dyspepsia (incl. pyrosis)
navzea dispepsija (vključno z zgago)
14.9 27.4 15.1
27, 4 15, 1
14.3 25.9 14.7
25, 9 14, 7
Gastritis Abdominal pain Abdominal pain upper (epigastric pain) Haemorrhoids Flatulence
gastritis abdominalna bolečina bolečina v zgornjem delu trebuha (epigastrična bolečina) lje
2.4 9.8 5.4
2, 4 9, 8 5, 4
0.7 13.0 3.8
0, 7 13, 0 3, 8
ge lon
hemoroidi napenjanje
Rash Acne Pruritus Night sweats no
kožni izpuščaj vo
Hyperhidrosis Hirsutism
hiperhidroza hirzutizem
Musculoskeletal, connective tissue and
Bolezni mišično - skeletnega sistema in
Very common Common
zelo pogosti pogosti eā
Musculoskeletal pain Back pain
mišično- skeletna bolečina bolečina v hrbtu
12.3 6.5
12, 3 6, 5
12.5 8.2
12, 5 8, 2
bone disorders uc
vezivnega tkiva
rod
av
Muscle spasms Arthralgia Myalgia
mišični krči artralgija mialgija
2.4 2.7 2.1
2, 4 2, 7 2, 1
1.4 2.7 1.0
1, 4 2, 7 1, 0
Very common Common lp
zelo pogosti
Oedema Oedema peripheral Impaired healing (without infection) Chest pain
edem periferni edem slabše celjenje (brez okužbe)
18.4 30.0 10.2 8.9
15, 8 28, 0 12, 2
Pain Fatigue
18, 4 30, 0 10, 2
dic
ilo
i
pogosti
Application site reaction Pyrexia Asthenia
bolečina v prsnem košu bolečina utrujenost reakcije na mestu aplikacije pireksija astenija
4.8 5.4 3.3
8, 6 7, 1 7, 4 4, 8 5, 4 3, 3
5.1 10.2 2.7
8, 9 8, 2 9, 6 5, 1 10, 2 2, 7
5.1
3, 0
3.6 7.4 2.1
5, 1
Renal disorder (damage) Haemorrhage urinary tract Urinary retention Urinary tract disorder Oliguria Dysuria
zastoj urina bolezni sečil oligurija disuruja
4.5 2.1 2.1 2.7 9.5 6.0
2, 1 2, 7 9, 5 6, 0
7.8 3.4 3.1 2.4 10.6 12.3
3, 1 2, 4 10, 6 12, 3
Three years after treatment, the incidence of malignancies was 7.8% in the placebo group compared with 6.4% in the Zenapax group.
Incidenca malignih obolenj: tri leta po zdravljenju je bila incidenca malignih obolenj 7, 8 -% v placebo skupini in 6, 4 -% v skupini, zdravljeni z Zenapaxom.
Addition of Zenapax did not increase the
Dodatek Zenapaxa ni povečal števila
5 number of post-transplant lymphomas, which occurred with a frequency of 1.5% in the placebo- treated group and 0.7% in the Zenapax-treated group.
5 posttransplantacijskih limfomov, ki so se pojavili s frekvenco 1, 5% v placebo skupini in v 0, 7% v skupini, zdravljeni z Zenapaxom.
No differences in abnormal haematologic or chemical laboratory test results were seen between placebo-treated and Zenapax-treated groups with the exception of fasting blood glucose.
Hiperglikemija: med patološkimi hematološkimi ali kemičnimi laboratorijskimi testnimi rezultati ni bilo razlik med skupino, ki je jemala placebo in skupino, ki je jemala Zenapax, razen pri vrednostih krvnega sladkorja na tešče.
A total of 16% (10 of 64 patients) of placebo-treated and 32% (28 of 88 patients) of Zenapax-treated patients had high fasting blood glucose values.
t bolnikov (10 od 64 bolnikov) v placebo skupini in 32% (28 od 88 bolnikov) bolnikov, zdravljenih z
ed Deaths occurring during the first 6 months post-transplant were reported in 3.4% of the placebo- and in 0.6% of the Zenapax-treated groups.
p ro Prvih šest mesecev po transplantaciji je bilo v placebo skupini 3, 4% smrtnih primerov, v skupini, zdravljeni z Zenapaxom pa 0, 6%.
The twelve months mortality was 4.4% in the placebo- and
Po dvanajstih mesecih je bilo v placebo skupini 4, 4% smrtnih primerov, v skupini, zdravljeni z Zenapaxom pa 1, 5%.
s 1.5% in the Zenapax-treated groups.
Primeri okužb, vključno z virusnimi in glivičnimi okužbami, bakteriemijo in septikemijo ter pljučnico,
ori 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
za so se pojavili pri 72% bolnikov v placebo skupini in pri 68% bolnikov, zdravljenih z Zenapaxom.
Cytomegalovirus infection was reported in 16% of the patients in the placebo group and in 13% of the patients in the Zenapax group.
Okužbe s citomegalovirusom so se pojavile pri 16% bolnikov v placebo skupini in pri 13% bolnikov v skupini, zdravljenih z Zenapaxom.
The safety profile for the use of Zenapax in paediatric patients was shown to be lon comparable to that in adult patients.
nja V redkih primerih so se po dajanju Zenapaxa pojavile resne preobčutljivostne reakcije (glejte poglavje 4. 4). lje Pediatrični bolniki: varnostni profil uporabe Zenapaxa pri pediatričnih bolnikih je bil podoben kot pri odraslih.
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%). no
Naslednji neželeni učinki pa so se pri pediatričnih bolnikih pojavili pogosteje: driska (41%), vo 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%). do
4.9 Overdose t
4. 9 Preveliko odmerjanje
A maximum tolerated dose has not been determined in patients and could not be achieved in animals uc
Maksimalen dovoljen odmerek pri bolnikih ni bil določen, pri živalih, ki so prejemale Zenapax, pa ni eā
that received Zenapax.
bil dosežen.
A dose of 1.5 mg/ kg has been administered to bone marrow transplant recipients without any associated adverse events.
Pri odmerku 1, 5 mg/ kg, ki je bil dan prejemnikom transplantata kostnega mozga, ni bilo nobenih škodljivih učinkov.
In a single dose toxicity study a dose of 125 mg/ kg rod
V preskušanju toksičnosti enkratnega odmerka so miši intravensko dali odmerek 125 mg/ kg in pri tem niso opazili znakov toksičnosti. av
PHARMACOLOGICAL PROPERTIES lp
FARMAKOLOŠKE LASTNOSTI nim
5.1 Pharmacodynamic properties na
5. 1 Farmakodinamične lastnosti
Pharmacotherapeutic group: selective immunosuppressive agents ATC code:
Oznaka ATC:
L04A A08 i dic
L04A A08. ilo
Clinical Pharmacology Zenapax contains daclizumab, a recombinant, humanized IgG1 anti-Tac antibody, and functions as an Me
Klinična farmakologija Zenapax vsebuje daclizumab, rekombinantno humanizirano IgG1 anti- Tac protitelo in ima funkcijo rav
interleukin 2 (IL-2) receptor antagonist.
interlevkin 2 (IL- 2) receptorskega antagonista.
Daclizumab binds with high specificity to the alpha or Tac subunit of the high affinity IL-2 receptor complex (expressed on activated T cells), and inhibits IL-2 binding and biological activity.
Daclizumab se veže visoko specifično na alfa ali Tac podenoto visoko afinitetnega IL- 2 receptorskega kompleksa (izražen na aktiviranih T- celicah) in zavira vezavo ter biološko aktivnost IL- 2.
Administration of Zenapax inhibits IL-2-mediated activation of lymphocytes, a critical pathway in the cellular immune response involved in allograft rejection.
Daclizumab zasiti Tac Zd
Daclizumab saturates the Tac receptor for approximately 90 days at the recommended dosage regimen for the majority of patients.
receptor za približno 90 dni pri priporočenem režimu odmerjanja pri večini bolnikov.
Antibodies to daclizumab developed in approximately 9% of Zenapax- treated patients in clinical studies but did not appear to affect efficacy, safety, serum daclizumab levels, or any other clinically relevant parameter examined.
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.
6 No gross changes to circulating lymphocyte numbers or cell phenotypes were observed by fluorescence-activated cell sorter (FACS) analysis other than the expected transient decrease in Tac+ cells.
6 Z analizo FACS (s fluorescenco aktivirano celično razvrščevanje) niso opazili nobenih drugih očitnih sprememb v številu krožečih limfocitov ali celičnih fenotipih, kot pričakovano prehodno znižanje Tac+ celic.
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).
V fazi III kliničnih preskušanj so Zenapax dodali standardnemu imunosupresivnemu režimu
ed 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.
t ciklosporina (5 mg/ kg) in steroidov (prednizon ali metilprednizolon) z dodatkom azatioprina
From pooled data the
me (4 mg/ kg) ali brez njega.
s difference in biopsy-proven acute rejection remained statistically different at one-year posttransplant
V obeh preskušanjih je Zenapax pokazal statistično značilno prednost pred placebom v zmanjšanju
ori (43% as compared with 28%).
Iz združenih podatkov je razlika akutne zavrnitve, potrjene z biopsijo, ostala statistično različna 1 leto po transplantaciji (43% v primerjavi z 28%).
The
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
uth three year graft survival was not significantly different between placebo and daclizumab in the triple immunosuppressant trial (83% Vs.
za presaditvi (n = 190), ne glede na zdravljenje.
84%) or the double immunosuppressant trial (78% Vs.
Triletno preživetje presadka ni bilo statistično različno med placebom in daclizumabom v trojnem preskušanju imunosupresivov (83% placebo, 84% daclizumab) ali v dvojnem preskušanju imunosupresivov (78% placebo, 82% daclizumab).
82%).
Triletna
92%).
nja stopnja preživetja bolnikov je bila signifikatno različna med placebom in daclizumabom v dvojnem preskušanju imunosupresivov (88% placebo, 96% daclizumab; p = 0, 017), v trojnem preskušanju imunosupresivov pa ne (94% placebo, 92% daclizumab). lje Renalna funkcija, ki so jo določali s serumskim kreatininom in GFR 3 leta po presaditvi, je bila podobna v obeh skupinah. vo 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 do
ge Renal function evaluated by serum creatinine and GFR was similar in both groups at three years posttransplant. lon 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 Post- Transplant Lymphoproliferative Disease (PTLD), at 3 years posttransplant. no
posttransplantacijske limfoproliferativne bolezni (PTLD – Post- Transplant Lymphoproliferative Disease).
5.2 Pharmacokinetic properties t
5. 2 Farmakokinetične lastnosti eā
In clinical trials involving renal allograft patients-treated with 1 mg/ kg of Zenapax every 14 days for a uc
V kliničnih preskušanjih, ki so vključevale bolnike z ledvičnim presadkom, zdravljene z 1 mg/ kg Zenapaxa vsakih 14 dni, do skupno pet odmerkov, je povprečni vrh serumske koncentracije (srednja av
total of 5 doses, average peak serum concentrations (mean ± standard deviation) rose between the first dose (21 ± 14 µg/ ml) and fifth doses (32 ± 22 µg/ ml).
Srednja vrednost ± standardna deviacija najnižjih serumskih koncentracij pred petim odmerkom je bila 7, 6 ± 4, 0 µg/ ml.
The mean ± standard deviation trough serum rod
Za zasičenje receptorjev IL- 2 so potrebni serumski nivoji od 0, 5 do nim
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.
0, 9 µg/ ml, za zaviranje z IL- 2 vodene biološke aktivnosti pa nivoji od 5- 10 µg/ ml.
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 lp
Priporočen način dajanja daclizumaba vzdržuje serumske koncentracije, ki so potrebne za nasičenje alfa receptorjev IL - 2R na aktiviranih T- limfocitih za več kot 90 dni po presaditvi pri večini bolnikov.
This first three months, is the most critical period post-transplantation. na
Prvi trije meseci so najbolj kritično obdobje po presaditvi. ilo
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).
To pripisujejo humanizaciji rav
This is attributable to the humanisation of the protein. i dic
Farmakokinetične populacijske analize so pokazale, da na sistemski očistek daclizumaba vplivajo Zd
Me
telesna masa, starost, spol, proteinurija in rasa.
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.
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.
Pharmacokinetic and pharmacodynamic properties were evaluated in 61 paediatric patients treated with 1 mg/ kg IV dose of Zenapax every 14 days for a total of 5 doses.
7 Pediatrični bolniki: farmakokinetične in farmakodinamične lastnosti so ocenjevali pri 61 pediatričnih bolnikih, ki so prejemali Zenapax intravensko v odmerku 1 mg/ kg vsakih 14 dni, skupno 5 odmerkov.
Peak serum concentrations (peak + SD) rose between the first dose (16 + 12 µg/ ml) and the fifth dose (21 + 14 µg/ ml).
Najvišje serumske koncentracije (vrh ± standardna deviacija) so naraščale med prvim (16 ± 12 µg/ ml) in petim odmerkom (21 ± 14 µg/ ml).
The Tac
Pred petim odmerkom je bila srednja serumska koncentracija 5, 0 ± 2, 7 µg/ ml.
7 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.
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.
Saturation of the Tac subunit of the IL-2 receptor was similar to that observed in adult patients receiving the same dose regimen.
Nasičenje Tac podenote receptorja IL- 2 je bilo podobno nasičenju, opaženemu pri odraslih bolnikih, ki so prejemali
There is no pharmacokinetic interaction between Zenapax and mycophenolic acid, the active metabolite of mycophenolate mofetil (CellCept).
me Med Zenapaxom in mikofenolno kislino, aktivnim presnovkom mofetilmikofenolata (CellCept®), ni farmakokinetičnih interakcij.
5.3 Preclinical safety data
p ro 5. 3 Predklinični podatki o varnosti
ed Daclizumab was well tolerated after single bolus intravenous or subcutaneous doses ranging from 50 to 125 mg/ kg in mice, rats, and rabbits and after 28 days administration of 15 mg/ kg to monkeys.
Po enkratnih intravenskih bolusih ali subkutanih odmerkih v obsegu od 50 do 125 mg/ kg pri miših, podganah in kuncih in po 28- dnevnem dajanju 15 mg/ kg pri opicah so ugotovili dobro prenašanje
Appreciable daclizumab serum levels
Precejšnji serumski nivoji daclizumaba so bili vzdrževani pri vseh opicah, razen pri dveh od 18, ki sta razvili protitelesa proti daclizumabu.
There was
Med daclizumabom in humanimi kriosekcijami (28 organov) in vitro ni
ori 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.
nja bilo križne reaktivnosti pri koncentracijah do 56 mg/ ml, kar kaže na odsotnost nespecifične vezave.
However, the data show considerable
Predklinična študija reproduktivne toksičnosti z daclizumabom je pokazala povečano tveganje za lje zgodnje prenatalne izgube pri opicah Cynomolgus v primerjavi s placebom.
ra inter-animal variation and were within the historical control range for this species.
Vendar so podatki pokazali precejšnjo razliko med posameznimi živalmi in so bili v pričakovanih okvirih za to živalsko vo vrsto.
The overall prenatal losses for the entire gestational period ranged from 20% to 45%.
Celokupna prenatalna izguba za celotno gestacijsko obdobje je bila 20 - do 45 -%.
The incidence of stillbirth, caesarean section and breech delivery were comparable between the control and treatment groups. ge In the same non-clinical reproduction toxicity study with daclizumab, four out of seven lactating lon 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. no
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). eā
PHARMACEUTICAL PARTICULARS
FARMACEVTSKI PODATKI av
6.1 List of excipients t uc
6. 1 Seznam pomožnih snovi nim
Polysorbate 80 Sodium chloride rod
polisorbat 80 natrijev klorid brezvodni natrijev dihidrogenfosfat brezvodni natrijev hidrogenfosfat koncentrirana klorovodikova kislina ilo
Sodium dihydrogen phosphate anhydrous Disodium phosphate anhydrous Hydrochloric acid, concentrated Sodium hydroxide lp
natrijev hidroksid voda za injekcije rav
No incompatibility between Zenapax and polyvinyl chloride bags or infusion sets has been observed. i dic
Zd
6.3 Shelf life Me
6. 3 Rok uporabnosti
If not used immediately, in use storage times and conditions prior to use are the responsibility of the user.
Zdravilo ni namenjeno shranjevanju po razredčitvi, razen če je razredčitev
8
8 potekala pod nadzorovanimi in validiranimi aseptičnimi pogoji.
- Store in a refrigerator (2 °C – 8 °C).
Shranjujte v hladilniku (2 °C - 8 °C).
6.5 Nature and contents of container
me 6. 5 Vrsta ovojnine in vsebina
5 ml in a vial (Type I glass).
p ro 5 ml viala (steklo tipa I).
ed 6.6 Special precautions for disposal
6. 6 Posebni varnostni ukrepi za odstranjevanje
s Any unused product or waste material should be disposed of in accordance with local requirements.
za Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
ori Instructions for use and handling
nja Navodila za pripravo in ravnanje
uth Zenapax is NOT for direct injection.
Zenapax NI namenjen neposrednemu injiciranju.
It should be diluted in 50 ml of sterile 0.9% sodium chloride solution before intravenous administration to the patients.
Pred intravensko administracijo bolnikom ga moramo razredčiti v 50 ml sterilne raztopine 0, 9 -% natrijevega klorida.
For mixing the solution, do not shake, gently invert the bag in order to avoid foaming.
Za mešanje raztopine vrečke lje ne stresamo, rahlo jo obrnemo, tako da preprečimo penjenje.