natgillin/translations-raw huggingface dataset:
47 Do not stop taking Zeffix without instruction from your doctor, as there is a small risk of your hepatitis getting worse.
Ne prenehajte z jemanjem zdravila Zeffix, ne da vam bi tako naročil vaš zdravnik, obstaja namreč manjše tveganje za poslabšanje hepatitisa.
If you are already taking this medicinal product for HIV infection, your doctor will continue to treat you with the higher dose, usually 150 mg twice a day, as the lower dose of 100 mg of lamivudine is insufficient to treat HIV infection.
Če to zdravilo že jemljete zaradi okužbe z virusom HIV, vas bo vaš zdravnik še naprej zdravil z večjim, običajno 150 mg, odmerkom dvakrat dnevno, saj manjši 100 mg odmerek lamivudina ne zadostuje za zdravljenje okužbe z virusom HIV.
If you are a diabetic, please note that each dose of Zeffix (100 mg = 20 ml) contains 4 g sugar.
Če imate sladkorno bolezen, prosimo, upoštevajte, da vsak odmerek Zeffixa (100 mg = 20 ml) vsebuje 4 g sladkorja.
Taking Zeffix with food and drink:
Jemanje zdravila Zeffix skupaj s hrano in pijačo:
Zeffix can be taken with food or on an empty stomach.
Zeffix se lahko jemlje s hrano ali na prazen želodec.
Do not stop treatment with Zeffix without your doctor’s advice.
Ne prekinjajte zdravljenja z Zeffixom, ne da bi se prej posvetovali z zdravnikom.
E216 and methyl parahydroxybenzoate:
Pomembne informacije o nekaterih sestavinah zdravila Zeffix To zdravilo vsebuje propilparahidroksibenzoat (E216) in metilparahidroksibenzoat (E218).
E218) which may cause allergic reactions (possibly delayed).
Ti dve pomožni snovi lahko povzročita alergijske reakcije (še posebno odložen tip reakcij).
This medicinal product contains sucrose.
To zdravilo vsebuje tudi saharozo.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Če so vam povedali, da nekaterih sladkorjev ne prenašate, se preden vzamete to zdravilo, posvetujte s svojim zdravnikom.
Always take Zeffix exactly as your doctor has told you.
Pri jemanju zdravila Zeffix natančno upoštevajte zdravnikova navodila.
The recommended dose of Zeffix is 20 ml (100 mg lamivudine) once a day.
Priporočeni odmerek zdravila Zeffix je 20 ml (100 mg lamivudina) enkrat dnevno.
It can be taken with food or on an empty stomach.
Lahko se ga vzame skupaj s hrano ali na prazen želodec.
Your doctor will advise you on how long you will need to take the medicine for.
47 Vaš zdravnik vam bo povedal, kako dolgo boste morali jemati zdravilo.
48 To measure your dose of medicine accurately use the oral dosing syringe supplied with the pack as follows:
Da boste natančno odmerili odmerek vašega zdravila, uporabite ovojnini priloženo peroralno odmerno brizgo, tako kot sledi:
Remove the bottle cap 2.
Odstranite zamašek plastenke 2.
Push the plastic adapter into the neck of the bottle, while holding the bottle firmly 3.
Medtem ko trdno držite plastenko, potisnite plastični nastavek v vrat plastenke 3.
Insert the syringe firmly into the adapter 4.
Odmerno brizgo trdno vstavite v nastavek 4.
Turn the bottle upside down 5.
Obrnite zgornjo stran plastenke navzdol 5.
Turn the bottle the correct way up and remove the syringe from the adapter 7.
Obrnite plastenko v pravilen pokončen položaj in odstranite odmerno brizgo iz nastavka 7.
After use the syringe must not be left in the bottle.
Po uporabi odmerne brizge ne smete pustiti pritrjene na plastenko.
Take off the syringe and adapter and wash them thoroughly in clean water.
Odmerno brizgo in plastični nastavek odstranite in ju temeljito sperite s čisto vodo.
Replace and tighten the bottle cap
Plastenko dobro zaprite s pokrovčkom.
If you take more Zeffix than you should Accidentally taking too much of your medicine is unlikely to cause any serious problems.
Če ste vzeli večji odmerek zdravila Zeffix, kot bi smeli Če po nesreči vzamete prevelik odmerek zdravila, je malo verjetno, da bi prišlo do kakršnih koli resnih težav.
Like all medicines, Zeffix can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Zeffix neželene učinke.
The most commonly reported were tiredness, respiratory tract infections, throat discomfort, headache, stomach discomfort and pain, nausea, vomiting and diarrhoea.
Ti neželeni učinki so bili običajno blagi.
Common side effects (in more than 1 in 100 patients)
48 Pogosti neželeni učinki (pri več kot 1 od 100 bolnikov)
Very Rare side effects (in less than 1 in 10,000 patients)
Zelo redki neželeni učinki (pri manj kot 1 od 10. 000 bolnikov)
Cramps, muscle pains and breakdown of muscle
Krči, bolečine v mišicah in oslabelost mišic.
Marked worsening of liver disease after Zeffix is stopped or during treatment if resistance develops.
Značilno poslabšanje jetrnih bolezni v primeru prekinitve jemanja zdravila Zeffix ali med zdravljenjem, če se razvije rezistenca.
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
Če kateri koli neželeni učinek postane resen ali opazite kateri koli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
Do not use Zeffix after the expiry date which is stated on the bottle and the carton.
Zdravila Zeffix ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem omotu.
Sucrose, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), citric acid, propylene glycol, sodium citrate, artificial strawberry flavour, artificial banana flavour, purified water.
Pomožne snovi so: saharoza, metilparahidroksibenzoat (E218), propilparahidroksibenzoat (E216), citronska kislina, propilenglikol, natrijev citrat, umetna aroma jagode, umetna aroma banane, prečiščena voda.
Zeffix oral solution is supplied in tamper evident cartons containing a white polyethylene bottle, with a child resistant cap.
Zeffix peroralna raztopina je na voljo v škatlicah, z zaščito, ki dokazuje, da še niso bile odprte, v katerih je bela polietilenska plastenka, z za otroke varno zaporko.
The solution is clear, colourless to pale yellow in colour with strawberry/banana flavouring.
Peroralna raztopina je bistra, brezbarvna do bledo rumena raztopina z aromo jagode/ banane.
The bottle contains 240 ml of lamivudine solution (5 mg/ml).
Plastenka vsebuje 240 ml raztopine lamivudina (5 mg/ ml).
The pack includes an oral dosing syringe and a syringe-adapter for the bottle.
Škatlici je priložena peroralna odmerna brizga in nastavek za brizgo.
Marketing Authorisation Holder and Manufacturer
49 Imetnik dovoljenja za promet z zdravilom in izdelovalec
Glaxo Group Ltd Greenford Road Greenford Middlesex UB6 0NN United Kingdom
Greenford Road Greenford Middlesex UB6 0NN Velika Britanija
50 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom.
France Laboratoire GlaxoSmithKline Tél.: + 33 (0)1 39 17 84 44 diam@gsk.com
50 France Laboratoire GlaxoSmithKline Tél: + 33 (0) 1 39 17 84 44 diam@ gsk. com
ZENAPAX
t me ZENAPAX
ed EPAR summary for the public
Povzetek EPAR za javnost
s ori This document is a summary of the European Public Assessment Report (EPAR).
p ro Ta dokument je povzetek Evropskega javnega poročila o oceni zdravila (EPAR).
uth reach their recommendations on how to use the medicine.
za katerih je oblikoval priporočila glede uporabe zdravila.
If you want more
Če želite več informacij, ki temeljijo na priporočilih CHMP, preberite znanstveno razpravo (ki je
ra information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
nja prav tako del EPAR).
What is Zenapax?
lje Kaj je zdravilo Zenapax?
Zenapax is a concentrate to be made up into a solution for infusion (drip lon active substance daclizumab (5 mg/ ml).
Vsebuje zdravilno učinkovino daclizumab (5 mg/ ml). vo
It is used together no
Uporablja se skupaj z do
with other immunosuppressive (anti-rejection) medicines including ciclosporin and corticosteroids.
drugimi imunosupresivnimi učinkovinami (učinkovinami za preprečevanje zavrnitve), vključno s ciklosporinom in kortikosteroidi.
It is used in patients who do not have high levels of antibodies against ‘ foreign’ cells from other people.
Uporablja se pri bolnikih, ki nimajo visokih ravni protiteles proti „ tujim “ celicam drugih ljudi.
These antibodies can develop following blood transfusion, pregnancy or previous organ t
Ta protitelesa se lahko tvorijo po transfuzijah krvi, nosečnosti ali eā
transplantation. uc
predhodni presaditvi organa.
How is Zenapax used? rod
Kako se zdravilo Zenapax uporablja? av
The recommended dose for adults and children is 1 mg per kilogram body weight, diluted in 50 ml sterile saline solution and given over 15 lp
Priporočeni odmerek za odrasle in otroke je 1 mg na kilogram telesne mase, ki se razredči v 50 ml sterilne fiziološke raztopine ter daje v obdobju 15 minut.
The subsequent doses should be given every 14 days for a total of five doses. na
Skupno je treba nim
A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and bind to a specific structure (called i dic
Monoklonsko protitelo je protitelo (vrsta beljakovine), ki prepoznava in se veže na specifično strukturo (imenovano ilo
an antigen) that is found on certain cells in the body.
antigen), ki se nahaja na določenih celicah v telesu.
Daclizumab has been designed to bind to the receptor for interleukin-2 on the surface of white blood cells called T-lymphocytes.
Daclizumab je zasnovan tako, da se veže na receptor za interlevkin- 2, ki se nahaja na površini belih krvničk, ki jim pravimo limfociti T.
By binding to and blocking Me
Te celice rav
the receptor, daclizumab prevents interleukin-2 activating the T-lymphocytes, reducing the chance that the transplanted kidney will be rejected.
Zd
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged azathioprine.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged prednizon in azatioprin.
In this study, Zenapax was added to the children ’ s existing immunosuppressive medicines.
V tej študiji so zdravilo Zenapax dodajali obstoječim imunosupresivnim zdravilom.
Zenapax was more effective than placebo in reducing the rate of rejection when added to immunosuppressive therapy.
Dodajanje zdravila Zenapax imunosupresivnim zdravilom je bilo glede stopnje zavrnitve učinkovitejše
In the second study, 39 (28%) of the 141 adults adding Zenapax to ciclosporin, prednisone and
me V prvi študiji je do zavrnitve prišlo pri 28 (22%) od 126 odraslih bolnikov, pri katerih so zdravilo Zenapax dodajali ciklosporinu in prednizonu, in pri 47 (35%) od 134 odraslih bolnikov, pri katerih so ciklosporinu in prednizonu dodajali placebo.
s azathioprine experienced rejection of the kidney, compared with 63 (47%) of the 134 adding placebo.
p ro V drugi študiji je do zavrnitve ledvice prišlo pri 39 (28%) od 141 odraslih bolnikov, pri katerih so zdravilo Zenapax dodajali ciklosporinu, prednizonu in azatioprinu, in pri 63 (47%) od 134 odraslih bolnikov, pri katerih so ciklosporinu, prednizonu in azatioprinu dodajali placebo.
ori In the study of children, five (8%) experienced rejection in the first six months after the transplant.
V študiji pri otrocih je prišlo do zavrnitve v prvih šestih mesecih po presaditvi pri 5 (8%) otrocih.
What is the risk associated with Zenapax?
za Kakšna tveganja so povezana z zdravilom Zenapax?
The most common side effects (seen in more than 1 patient in 10) were insomnia (difficulty sleeping), tremor (shaking), headache,
V študijah so ugotovili, da se neželeni učinki pri bolnikih, ki so jemali zdravilo Zenapax v kombinaciji z imunosupresivnimi zdravili, pojavljajo s podobno pogostostjo kot pri bolnikih, katerim so dodajali
Zenapax should not be used in people who may be hypersensitive (allergic) to daclizumab or any of lon the other ingredients.
Najpogostejši neželeni učinki (opaženi pri več kot 1 bolniku od 10) so bili nespečnost (težave pri spanju), tremor (tresenje), glavobol, hipertenzija (visok krvni tlak), dispneja (oteženo dihanje), zaprtje, driska, bruhanje, slabost, dispepsija (zgaga), mišično- skeletne bolečine (bolečine v mišicah in sklepih), edem (otekanje), slabše celjenje in posttravmatske bolečine (bolečine po kirurškem posegu). lje Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Zenapax, glejte Navodilo za uporabo. vo Zdravila Zenapax se ne sme uporabljati pri osebah, ki utegnejo biti preobčutljive za (alergične na) daclizumab ali katerokoli drugo sestavino zdravila.
Zenapax must not be used in women who are breast feeding.
Zdravila Zenapax ne smejo uporabljati doječe matere. do
The Committee for Medicinal Products for Human Use (CHMP) decided that Zenapax’ s benefits are no
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristni učinki zdravila Zenapax pri preprečevanju akutne zavrnitve organa pri de novo alogeni ledvični transplantaciji pri eā
greater than its risks for the prophylaxis of acute organ rejection in de novo allogenic renal transplantation, used concomitantly with an immunosuppressive regimen, including ciclosporin and corticosteroids in patients who are not highly immunised.
bolnikih, ki niso visoko senzibilizirani, ob sočasnem režimu imunosupresivnih zdravil, vključno s ciklosporinom in kortikosteroidi, večji od z njim povezanih tveganj.
The Committee recommended that Zenapax t
Odbor je priporočil odobritev dovoljenja za promet z zdravilom Zenapax. av
The European Commission granted a marketing authorisation valid throughout the European Union rod
Evropska komisija je dovoljenje za promet z zdravilom Zenapax, veljavno po vsej Evropski uniji, nim
for Zenapax to Roche Registration Limited on 26 February 1999.
odobrila družbi Roche Registration Limited dne 26. februarja 1999.
The marketing authorisation was renewed on 26 February 2004. lp
Dovoljenje za promet z zdravilom je bilo podaljšano 26. februarja 2004.
The full EPAR for Zenapax can be found here. na
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Zenapax je na voljo tukaj. ilo
This summary was last updated in 10-2007. i dic Me
Povzetek je bil nazadnje posodobljen 10- 2007. rav Zd
ori uth ra ANNEX I ge lon SUMMARY OF PRODUCT CHARACTERISTICS tno uc rod lp nai dic Me
t me p ro za nja lje DODATEK I vo POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA do eā av nim ilo rav Zd
Zenapax 5 mg/ ml concentrate for solution for infusion
Zenapax 5 mg/ ml koncentrat za raztopino za infundiranje
Daclizumab*………… 5 mg per 1 ml infusion
t daclizumab * ………… 5 mg v 1 ml infuzije
ed One vial of 5 ml contains 25 mg of daclizumab* (5 mg/ ml).
me Ena 5 ml viala vsebuje 25 mg daclizumaba * (5 mg/ ml).
s a glutamine synthetase (GS) expression system (NS_GSO) by recombinant DNA technology
p ro * Rekombinantno humanizirano IgG1 anti- Tac protitelo, pridobljeno s tehnologijo rekombinantne DNA iz celične kulture mieloma NSO glodalcev s pomočjo ekspresijskega sistema glutamin sintetaze (NS_ GSO, glutamin synthetase expression system).
ori Excipients:
Pomožne snovi:
For a full list of excipients, see section 6.1.
za Za celoten seznam pomožnih snovi glejte poglavje 6. 1.
uth 3.
nja 3.
ge Clear to slightly opalescent, colourless to slightly yellowish liquid. lon 4.
Koncentrat za raztopino za infundiranje. lje Bistra do rahlo opalescenčna, brezbarvna do rahlo rumenkasta tekočina. vo 4.
CLINICAL PARTICULARS
KLINIČNI PODATKI do
4.1 Therapeutic indications no
4. 1 Terapevtske indikacije
Zenapax is indicated for the prophylaxis of acute organ rejection in de novo allogenic renal transplantation and is to be used concomitantly with an immunosuppressive regimen, including t
Uporablja se skupaj z imunosupresivnimi učinkovinami, vključno s ciklosporinom in eā
cyclosporine and corticosteroids in patients who are not highly immunised. uc
kortikosteroidi pri bolnikih, ki niso visoko senzibilizirani.
4.2 Posology and method of administration rod
4. 2 Odmerjanje in način uporabe av
Zenapax should be prescribed only by physicians who are experienced in the use of immunosuppressive therapy following organ transplantation. lp
Zenapax lahko predpišejo le zdravniki z izkušnjami pri uporabi imunosupresivnega zdravljenja pri transplantaciji organov. nim
The recommended dose for Zenapax in adult and paediatric patients is 1 mg/ kg.
Priporočen odmerek Zenapaxa pri odraslih in otrocih je 1 mg/ kg.
The volume of Zenapax containing the appropriate dose is added to 50 ml of sterile 0.9% saline solution and is na
Volumen Zenapaxa, ki vsebuje ustrezen odmerek, dodamo k 50 ml sterilne 0, 9 -% raztopine natrijevega klorida in apliciramo intravensko v obdobju 15 minut.
administered intravenously over a 15 minute period.
Lahko ga apliciramo v periferno ali centralno veno. ilo
subsequent dose should be given at intervals of fourteen days, for a total of five doses.
Naslednji odmerek in vsi nadaljnji odmerki se dajejo v 14- dnevnih intervalih do skupno pet odmerkov. rav
Elderly Me
Starejši bolniki
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.
Ni podatkov, ki bi kazali, da je pri starejših bolnikih Zd
Patients with severe renal impairment
odmerjanje drugačno kot pri mlajših.
2 No data are available for patients with severe hepatic impairment.
2 Za bolnike s hudo jetrno okvaro ni podatkov.
Instructions for the preparation of Zenapax infusions are described in section 6.6.
Navodila za pripravo infuzije zdravila Zenapax so opisana v poglavju 6. 6.
Zenapax is contraindicated in patients with known hypersensitivity to daclizumab or to any excipients of this product (see section 6.1).
t Zenapax je kontraindiciran pri bolnikih z znano preobčutljivostjo za daclizumab ali katerokoli
ed Zenapax is contraindicated during lactation (see section 4.6).
me sestavino tega zdravila (glejte poglavje 6. 1).
4.4 Special warnings and precautions for use
p ro 4. 4 Posebna opozorila in previdnostni ukrepi
s ori There is no experience of the use of Zenapax in patients who are highly immunised.
Za uporabo Zenapaxa pri visoko senzibiliziranih bolnikih ni izkušenj.
Severe, acute (onset within
za Lahko se pojavijo anafilaktične reakcije, ki sledijo aplikaciji beljakovin.
uth 24 hours) hypersensitivity reactions on both initial and subsequent exposure to Zenapax have been reported rarely.
Hude akutne (nastop v 24 urah) preobčutljivostne reakcije po prvi in po naslednjih izpostavitvah zdravilu Zenapax so se pojavile redko.
The clinical manifestations of these reactions include hypotension, tachycardia, hypoxia, dyspnoea, wheezing, laryngeal oedema, pulmonary oedema, flushing, diaphoresis,
Klinični znaki teh reakcij so vključevali hipotenzijo, tahikardijo, hipoksijo, dispnejo, sopenje,
Medications for the treatment of severe hypersensitivity reactions should therefore be available for immediate use.
nja edem grla, pljučni edem, rdečico, diaforezo, porast telesne temperature, izpuščaj in koprivnico.
ge Patients on immunosuppressive therapy following transplantation are at increased risk for developing lymphoproliferative disorders (LPDs) and opportunistic infections.
Zdravila za zdravljenje resnih preobčutljivostnih reakcij morajo biti na razpolago za takojšnjo uporabo. lje Pri bolnikih, ki so na imunosupresivnem zdravljenju po transplantaciji, obstaja večje tveganje za razvoj limfoproliferativnih bolezni (LPD) in oportunističnih okužb.
While Zenapax is an lon immunosuppressive drug, to date no increase in LPDs or opportunistic infections have been observed in patients treated with Zenapax.
Od začetka uporabe Zenapaxa kot vo imunosupresivnega zdravila, pri bolnikih zdravljenih z Zenapaxom, niso opazili porasta LPD ali oportunističnih okužb. do
In transplant recipients there is no experience of exposure to second or subsequent treatment courses no
Pri prejemnikih presadkov do zdaj še ni izkušenj z dvakratnim ali večkratnim zdravljenjem z Zenapaxom.
In a single randomized controlled clinical trial in cardiac transplant recipients which compared t
V randomiziranem nadziranem kliničnem preskušanju so pri prejemnikih srčnega presadka primerjali eā
Zenapax to placebo, each used in combination with mycophenolate mofetil (CellCept 1.5 g bid), uc
Zenapax in placebo v kombinaciji z mofetilmikofenolatom (CellCept 1, 5 g dvakrat na dan), ciklosporinom in kortikosteroidi.
cyclosporine, and corticosteroids, there were more infection related deaths among patients who received Zenapax.
Pri bolnikih, ki so prejemali Zenapax, so opazili večje število smrti, povezanih z okužbami.
At 1 year post-transplant 14 of 216 patients (6.5%) who received Zenapax and 4 of rod
1 leto po prejetju presadka je pri 14 od 216 (6, 5%) bolnikov, ki so jemali av
207 (1.9%) patients who received placebo died of an infection, a difference of 4.6% (95% CI:
Zenapax in pri 4 od 207 (1, 9%) bolnikov, ki so prejemali placebo, nastopila smrt zaradi okužbe (razlika 4, 6%; 95 -% interval zaupanja:
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.
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 nim
received Zenapax and in patients who received placebo, 18.5% and 17.9%, respectively.
V splošnem je zdravljenje s poliklonskimi antilimfocitnimi protitelesi (OKT3, ATG, ATGAM) prejelo podobno število bolnikov, ki so jemali Zenapax (18, 5%) ali placebo (17, 9%).
However, of the 40 patients who received both Zenapax and antilymphocyte therapy, 8 (20.0%) died whereas of the na
Od 40 bolnikov, ki so prejemali Zenapax in antilimfocitno zdravljenje, jih je 8 (20%) umrlo.
37 patients who received both placebo and antilymphocyte therapy, 2 (5.4%) died.
Od 37 bolnikov, ki so prejemali placebo in antilimfocitno zdravljenje, sta umrla 2 (5, 4%).
Concomitant use of Zenapax with another antilymphocyte antibody therapy in the context of intensive immunosuppression with cyclosporine, mycophenolate mofetil and corticosteroids may be a factor leading to fatal i dic
Sočasna uporaba Zenapaxa z drugim zdravljenjem z antilimfocitnimi protitelesi lahko v ilo
infection.
smislu intenzivne imunosupresije s ciklosporinom, mofetilmikofenolatom in kortikosteroidi privede do smrtne okužbe. rav
4.5 Interaction with other medicinal products and other forms of interaction Me
4. 5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
Because Zenapax is an immunoglobulin, no metabolic drug-drug interactions are to be expected.
Zd
The following transplant medications have been administered in clinical trials with Zenapax without any interactions: cyclosporine, mycophenolate mofetil, gancyclovir, acyclovir, tacrolimus, azathioprine, antithymocyte immune globulin, muromonab-CD3 (OKT3), and corticosteroids.
Pri kliničnih preskušanjih z Zenapaxom ni bilo medsebojnih delovanj z naslednjimi zdravili za transplantacijo: ciklosporinom, mofetilmikofenolatom, ganciklovirjem, aciklovirjem, takrolimusom, azatioprinom, antitimocitnim imunoglobulinom, muromonabom- CD3 (OKT3) in kortikosteroidi.
3 There are limited data from the use of daclizumab in pregnant women.
3 O uporabi daclizumaba pri nosečnicah so na voljo le omejeni podatki.
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).
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).