natgillin/translations-raw huggingface dataset:
Population pharmacokinetic analyses suggest that while low albumin, higher body weight and prior treatment with anti-TNF drugs may increase vedolizumab clearance, the magnitude of their effects is not considered to be clinically relevant. 
Analize populacijske farmakokinetike kažejo, da lahko nizka raven albumina, večja telesna masa in predhodno zdravljenje z zaviralci tumorje nekrotizirajočega faktorja (TNF) povečajo očistek vedolizumaba, vendar pa obseg njihovih učinkov ne velja za klinično pomembnega.
Vedolizumab did not affect immune surveillance and inflammation of the central nervous system in Experimental Autoimmune Encephalomyelitis in non-human primates, a model of multiple sclerosis. 
Vedolizumab ni vplival na imunski nadzor in vnetje osrednjega živčevja pri eksperimentalnem avtoimunskem encefalomielitisu pri nečloveških primatih, modelu multiple skleroze.
Induction of remission in Crohn's disease may take up to 14 weeks in some patients. 
Pri nekaterih bolnikih lahko indukcija remisije Crohnove bolezni traja do 14 tednov.
Once dissolved, gently invert vial 3 times. 
Ko se zdravilo raztopi, vialo 3-krat nežno obrnite.
Entyvio is used to treat the signs and symptoms in adults of: 
Zdravilo Entyvio uporabljamo pri odraslih za zdravljenje znakov in simptomov:
Given the lack of binding of vedolizumab to male reproductive tissue in monkey and human, and the intact male fertility observed in β7 integrin-knockout mice, it is not expected that vedolizumab will affect male fertility. 
Zaradi odsotnosti vezave vedolizumaba na moško reproduktivno tkivo pri opicah in človeku in ohranjeni plodnosti samcev, opaženi pri miših z izbitim genom za integrin β7 (“β7 integrin-knockout mice”), vpliva vedolizumaba na moško plodnost ne pričakujemo.
As noted in Table 4, although the primary endpoint was not met, exploratory analyses show that clinically meaningful results were observed. 
Primarni opazovani dogodek sicer ni bil dosežen, vendar pa eksplorativne analize kažejo klinično pomembne rezultate, kot je razvidno iz preglednice 4.
Further treatments 
Nadaljnja zdravljenja
Therefore, the use of Entyvio in such patients is not recommended. 
Uporaba zdravila Entyvio pri teh bolnikih tako ni priporočljiva.
A small number of patients have felt dizzy after receiving Entyvio. 
Pri majhnem številu bolnikov se je po prejemu zdravila Entyvio pojavila omotica.
By binding to α4β7 on certain lymphocytes, vedolizumab inhibits adhesion of these cells to mucosal addressin cell adhesion molecule-1 (MAdCAM-1), but not to vascular cell adhesion molecule-1 (VCAM-1). 
Z vezavo na α4β7 na nekaterih limfocitih vedolizumab zavira adhezijo teh celic na mukozno adresinsko celično adhezijsko molekulo-1 (MAdCAM-1-“mucosal addressin cell adhesion molecule-1”), vendar ne za žilno celično adhezijsko molekulo-1 (VCAM-1-“vascular cell adhesion molecule-1”).
If you stop using Entyvio You should not stop using Entyvio without talking with your doctor first. 
Zdravljenja z zdravilom Entyvio ne smete prekiniti, ne da bi se o tem prej posvetovali s svojim zdravnikom.
Therefore, this medicine is not recommended for use during pregnancy unless you and your doctor decide that the benefit to you clearly outweighs the potential risk to yourself and your baby. 
Uporaba tega zdravila med nosečnostjo tako ni priporočljiva, razen če skupaj z zdravnikom presodite, da je korist zdravljenja za vas nedvomno večja od možnega tveganja tako za vas kot nerojenega otroka.
Vedolizumab did not affect immune responses to antigenic challenge in the dermis and muscle (see section 4.4). 
Vedolizumab ni vplival na imunski odziv na antigenski izziv v dermisu in mišici (glejte poglavje 4.4).
• sudden, severe allergic reaction which can cause breathing difficulty, swelling, fast heartbeat, sweating, drop in blood pressure, light-headedness, loss of consciousness and collapse (anaphylactic reaction and anaphylactic shock) 
• nenadna, huda alergijska reakcija, ki lahko povzroči težave z dihanjem, otekanje, hiter srčni utrip, znojenje, padec krvnega tlaka, omotico, izgubo zavesti in kolaps (anafilaktična reakcija in anafilaktični šok).
The European Medicines Agency has deferred the obligation to submit the results of studies with vedolizumab in one or more subsets of the paediatric population in ulcerative colitis and Crohn's disease (see section 4.2 for information on paediatric use). 
Pediatrična populacija Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z vedolizumabom za eno ali več podskupin pediatrične populacije z ulceroznim kolitisom in s Crohnovo boleznijo (za informacije o pediatrični uporabi glejte poglavje 4.2).
Entyvio treatment should be initiated and supervised by specialist healthcare professionals experienced in the diagnosis and treatment of ulcerative colitis or Crohn's disease (see section 4.4). 
Zdravljenje z zdravilom Entyvio mora uvesti in nadzirati zdravnik specialist, ki ima izkušnje z diagnostiko in zdravljenjem ulzeroznega kolitisa ali Crohnove bolezni (glejte poglavje 4.4).
Reconstituted solution with uncharacteristic colour or containing particulates must not be administered. 
Rekonstituirane raztopine z neznačilno barvo ali vsebnostjo trdnih delcev ne smete aplicirati.
Given the known risk of PML development in patients with previous natalizumab exposure, physicians should normally wait 12 weeks after the last natalizumab dose prior to initiating Entyvio treatment. 
Glede na to, da pri bolnikih, ki so se predhodno zdravili z natalizumabom, obstaja znano tveganje za razvoj progresivne multifokalne levkoencefalopatije (PML), je pri takšnih bolnikih običajno treba počakati 12 tednov po zadnjem odmerku natalizumaba pred uvedbo zdravljenja z zdravilom Entyvio.
If you have any further questions on the use of this medicine, ask your doctor or nurse. 
Če imate kakršna koli dodatna vprašanja o uporabi tega zdravila, se posvetujte z zdravnikom ali medicinsko sestro.
The effects of Entyvio in pregnant women are not known. 
Učinki zdravila Entyvio pri nosečnicah niso znani.
There are limited amount of data from the use of vedolizumab in pregnant women. 
Nosečnost Podatki o uporabi vedolizumaba pri nosečnicah so omejeni.
These data are consistent with investigations in nonhuman primates which did not detect effects on immune surveillance of the CNS. 
Ti podatki se skladajo z rezultati preskušanj pri nečloveških primatih, pri katerih niso ugotovili učinkov na imunski nadzor v osrednjem živčevju.
As a precautionary measure, it is preferable to avoid the use of Entyvio during pregnancy unless the benefits clearly outweigh any potential risk to both the mother and foetus. 
Iz previdnostnih razlogov se je med nosečnostjo uporabi zdravila Entyvio bolje izogibati, razen če koristi zdravljenja jasno prevladajo nad kakršnim koli možnim tveganjem tako za mater kot za plod.
No definitive conclusion can be drawn on the male reproductive organs in cynomolgus monkey repeated dose toxicity study. 
Dokončnega zaključka o vplivu na moške reproduktivne organe na osnovi študije toksičnosti pri ponavljajočih odmerkih pri opicah Cynomolgus ni mogoče podati.
Within the system organ classes, adverse reactions are listed under headings of the following frequency categories: very common (≥ 1/10), common (≥ 1/100 to < 1/10), 
Pogostnost neželenih učinkov je navedena v skladu z naslednjimi kategorijami pogostnosti: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100) in zelo redki
The two primary endpoints were the proportion of patients in clinical remission (defined as CDAI score ≤ 150 points) at week 6 and the proportion of patients with enhanced clinical response (defined as a ≥ 100-point decrease in CDAI score from baseline) at week 6 (see Table 4). 
Primarna opazovana dogodka sta bila delež bolnikov v klinični remisiji (opredeljeno kot indeks CDAI ≤ 150 točk) v 6. tednu in delež bolnikov z okrepljenim kliničnim odzivom (opredeljeno kot zmanjšanje indeksa CDAI za ≥ 100 točk od izhodišča) v 6. tednu (glejte preglednico 4).
In controlled and open-label studies in adults with vedolizumab, serious infections have been reported, which include tuberculosis, sepsis (some fatal), salmonella sepsis, listeria meningitis, and cytomegaloviral colitis. 
V nadzorovanih in odprtih študijah uporabe vedolizumaba pri odraslih so poročila o resnih okužbah vključevala tuberkulozo, sepso (tudi posamezni smrtni primeri), salmonelozno sepso, listeriozni meningitis in citomegalovirusni kolitis.
0 weeks 
0. teden
If this is not possible, reconstituted solution in the vial can be stored for up to 8 hours at 2 °C-8 °C. 
Če to ni mogoče, lahko rekonstituirano raztopino v viali shranite do 8 ur pri temperaturi 2 °C-8 °C.
Prior and concurrent use of biological products 
Predhodna in sočasna uporaba bioloških zdravil
Exploratory subgroup analyses from the clinical trials in Crohn's disease suggested that vedolizumab administered in patients without concomitant corticosteroid treatment may be less effective for induction of remission in Crohn's disease than in those patients already receiving concomitant corticosteroids (regardless of use of concomitant immunomodulators; see section 5.1). 
Eksplorativne analize podskupin iz kliničnih preskušanj pri Crohnovi bolezni kažejo, da je indukcija remisije Crohnove bolezni z vedolizumabom pri bolnikih, ki se sočasno ne zdravijo s kortikosteroidi, lahko manj učinkovita kot pri bolnikih, ki se sočasno že zdravijo s kortikosteroidi (ne glede na sočasno zdravljenje z imunomodulatorji, glejte poglavje 5.1).
Do not use this medicine if you notice any particles in the liquid or discolouration prior to administration. 
Ne uporabljajte tega zdravila, če v tekočini pred aplikacijo opazite kakršne koli trdne delce ali spremembo barve.
• shingles (herpes zoster) 
• okužba nožnice, • pasovec (herpes zoster).
The GEMINI III Study was a second randomised, double-blind, placebo-controlled study that evaluated efficacy at week 6 and week 10 in the subgroup of patients defined as having failed at least one conventional therapy and failed TNFα antagonist therapy (including primary non-responders) as well as the overall population, which also included patients who failed at least one conventional therapy and were naïve to TNFα antagonist therapy. 
Študija GEMINI III je bila druga randomizirana, dvojno slepa, s placebom nadzorovana študija, ki je vrednotila učinkovitost v 6. tednu in 10. tednu v podskupini bolnikov, ki se niso odzvali vsaj na eno ustaljeno zdravljenje in na zdravljenje z zaviralcem TNFα (vključno s primarnim neodzivom) pa tudi v celotni populaciji, ki je prav tako vključevala bolnike, ki se niso odzvali na vsaj eno ustaljeno zdravljenje in se predhodno še niso zdravili z zaviralcem TNFα.
For all subsequent infusions (after the first two), you will be monitored during the infusion and for approximately 1 hour after you have completed the infusion. 
Pri vseh nadaljnjih infuzijah zdravila (po prvih dveh) vas bodo nadzirali med infundiranjem in še približno 1 uro po končanem infundiranju zdravila.
Exploratory analyses examined the effects of concomitant corticosteroids and immunomodulators on induction of remission with vedolizumab. 
Z eksplorativnimi analizami so raziskali učinke sočasnega zdravljenja s kortikosteroidi in z imunomodulatorji na indukcijo remisije z vedolizumabom.
Vedolizumab is a therapeutic monoclonal antibody and is not expected to bind to plasma proteins. 
Vedolizumab je terapevtsko monoklonsko protitelo zato vezava na plazemske proteine ni pričakovana.
• if you experience signs of an allergic reaction or other reaction to the infusion such as wheezing, difficulty breathing, hives, itching, swelling or dizziness. 
• če se pojavijo znaki alergijske reakcije ali druge reakcije na infuzijo, kot so sopenje, težko dihanje, koprivnica, srbenje, otekanje ali omotica.
The single and multiple dose pharmacokinetics of vedolizumab have been studied in healthy subjects and in patients with moderate to severely active ulcerative colitis or Crohn's disease. 
Farmakokinetiko enkratnega in ponavljajočih se odmerkov vedolizumaba so raziskali pri zdravih osebah in bolnikih z zmerno do močno aktivnim ulceroznim kolitisom ali Crohnovo boleznijo.
Each pack contains 1 vial. 
Pakiranje: škatla z 1 vialo.
Your doctor may decide to alter this treatment schedule depending on how well Entyvio works for you. 
Zdravnik lahko to shemo zdravljenja spremeni, odvisno od odziva na zdravljenje z zdravilom Entyvio.
What Entyvio is and what it is used for What you need to know before you are given Entyvio How Entyvio will be given Possible side effects 
Kaj je zdravilo Entyvio in za kaj ga uporabljamo Kaj morate vedeti, preden boste prejeli zdravilo Entyvio Kako boste prejeli zdravilo Entyvio
Population pharmacokinetic analyses suggest that co-administration of such agents did not have a clinically meaningful effect on vedolizumab pharmacokinetics. 
Analize populacijske farmakokinetike kažejo, da sočasna uporaba teh zdravil ni imela klinično pomembnega vpliva na farmakokinetiko vedolizumaba.
MAdCAM-1 is mainly expressed on gut endothelial cells and plays a critical role in the homing of T lymphocytes to tissues within the gastrointestinal tract. 
MAdCAM-1 je izražen predvsem na črevesnih endotelijskih celicah in ima pomembno vlogo pri nastanitvi limfocitov T v tkiva v prebavnem traktu.
Warnings and precautions Talk to your doctor or nurse before being given Entyvio. 
Opozorila in previdnostni ukrepi Pred začetkom uporabe zdravila Entyvio se posvetujte z zdravnikom ali medicinsko sestro.
• acne (pimples) 
• akna (mozoljavost).
• if you experience blurred, loss of or double vision, difficulty speaking, weakness in an arm or a leg, a change in the way you walk or problems with your balance, persistent numbness, decreased sensation or loss of sensation, memory loss or confusion. 
• če se pojavijo težave, kot so zamegljen vid, dvojen vid ali izguba vida, težave pri govoru, oslabelost v roki ali nogi, sprememba v načinu hoje ali težave z ravnotežjem, trdovratna odrevenelost, zmanjšanje ali popolna izguba čutnih zaznav, izguba spomina ali zmedenost.
Doses up to 10 mg/kg (approximately 2.5 times the recommended dose) have been administered in clinical trials. 
V kliničnih preskušanjih so aplicirali odmerke do 10 mg/kg (približno 2,5-kratni priporočeni odmerek).
If a severe IRR, anaphylactic reaction, or other severe reaction occurs, administration of Entyvio must be discontinued immediately and appropriate treatment initiated (e.g., epinephrine and antihistamines) (see section 4.3). 
V primeru pojava hude reakcije, povezane z infundiranjem, anafilaktične reakcije ali druge resne reakcije, je treba infundiranje zdravila Entyvio nemudoma prekiniti in uvesti ustrezno zdravljenje (npr. adrenalin in antihistaminiki) (glejte poglavje 4.3).
In clinical trials with vedolizumab at doses ranging from 2 to 10 mg/kg, > 95% saturation of α4β7 receptors on subsets of circulating lymphocytes involved in gut immune surveillance was observed in patients. 
V kliničnih preskušanjih so pri odmerkih vedolizumaba v razponu od 2 do 10 mg/kg pri bolnikih opazili > 95 % nasičenost α4β7 receptorjev pri podskupini limfocitov v obtoku, vključenih v črevesni imunski nadzor.
In healthy subjects, ulcerative colitis patients, or Crohn's disease patients, vedolizumab does not elevate neutrophils, basophils, eosinophils, B-helper and cytotoxic T lymphocytes, total memory T helper lymphocytes, monocytes or natural killer cells, in the peripheral blood with no leukocytosis observed. 
Vedolizumab pri zdravih osebah, bolnikih z ulceroznim kolitisom ali bolnikih s Crohnovo boleznijo ne zviša števila nevtrofilcev, bazofilcev, eozinofilcev, B-pomagalk in citotoksičnih limfocitov T, ter skupnega števila spominskih celic T pomagalk, monocitov ali naravnih celic ubijalk v periferni krvi brez opažene levkocitoze.
What Entyvio contains 
Kaj vsebuje navodilo
The efficacy and safety of vedolizumab for the treatment of adult patients with moderately to severely active ulcerative colitis (Mayo score 6 to 12 with endoscopic sub score ≥ 2) was demonstrated in a randomised, double-blind, placebo-controlled study evaluating efficacy endpoints at week 6 and week 52 (GEMINI I). 
Učinkovitost in varnost vedolizumaba pri zdravljenju odraslih bolnikov z zmerno do močno aktivnim ulceroznim kolitisom (ocena Mayo od 6 do 12, endoskopska podocena ≥ 2) so dokazali v randomizirani, dvojno slepi, s placebom nadzorovani študiji, ki je vrednotila opazovane dogodke učinkovitosti v 6. in 52. tednu (GEMINI I).
• For your first 2 infusions, your doctor or nurse will monitor you closely during the infusion and for approximately 2 hours after you have completed the infusion. 
• Pri prvih 2 infuzijah zdravila vas bo zdravnik ali medicinska sestra skrbno nadziral(-a) med infundiranjem in še približno 2 uri po končanem infundiranju zdravila.
Vedolizumab is a humanised IgG1 monoclonal antibody that binds to the human α4β7 integrin and is produced using recombinant DNA technology in Chinese hamster ovary (CHO) cells. 
Vedolizumab je humanizirano IgG1 monoklonsko protitelo, ki se veže na humani integrin α4β7, proizvedeno z uporabo tehnologije rekombinantne DNA na ovarijskih celicah kitajskega hrčka
*The placebo group includes those subjects who received vedolizumab at week 0 and week 2, and were randomised to receive placebo from week 6 through week 52. 
* Skupina s placebom vključuje tiste osebe, ki so prejele vedolizumab na 0. teden in 2. teden, in so bile nato randomizirane na placebo od 6. tedna do 52. tedna.
In contrast, vedolizumab inhibited an immune response to a gastrointestinal antigenic challenge in healthy human volunteers (see section 4.4). 
V nasprotju s tem pa vedolizumab zavira imunski odziv na gastrointestinalni antigenski izziv pri zdravih prostovoljcih (glejte poglavje 4.4).
12 hours2 
12 ur2
Population pharmacokinetic analyses showed no effect of age (see section 5.2). 
Pri analizah populacijske farmakokinetike vpliva starosti niso ugotovili (glejte poglavje 5.2).
Observed IRRs generally resolved with no or minimal intervention following the infusion. 
Opažene reakcije, povezane z infundiranjem, so običajno izzvenele brez ukrepanja ali z minimalnim ukrepanjem po infundiranju.
3 This period may include up to 12 hours at 20 °C-25 °C. 
3 V ta čas se šteje največ 12 ur pri temperaturi 20 °C-25 °C.
No dose recommendations can be made. 
Priporočil za odmerjanje tako ne moremo navesti.
Entyvio may affect the way you respond to a vaccination. 
Zdravilo Entyvio lahko vpliva na odziv telesa na cepljenje.
Patients receiving vedolizumab treatment may continue to receive non-live vaccines. 
Med zdravljenjem z vedolizumabom lahko bolniki še naprej prejemajo mrtva cepiva.
Insert the needle into the vial through the centre of the stopper and direct the stream of liquid to the wall of the vial to avoid excessive foaming. 
Injekcijsko iglo zabodite skozi osrednji del zamaška viale in tok tekočine usmerite na steno viale, da preprečite prekomerno penjenje.
Exploratory analysis show clinically meaningful improvements were observed for vedolizumab groups, and the improvements were significantly greater as compared with the placebo group at week 6 and week 52 on EQ-5D and EQ-5D VAS scores, all subscales of IBDQ (bowel symptoms, systemic function, emotional function and social function), and all subscales of SF-36 including the Physical Component Summary (PCS) and Mental Component Summary (MCS). 
V primerjavi s skupino, ki je prejemala placebo, so v 6. tednu in 52. tednu opazili pomembno večja izboljšanja pri ocenah EQ-5D in EQ-5D VAS, vseh podlestvicah IBDQ (črevesni simptomi, sistemsko funkcioniranje, čustveno funkcioniranje in socialno funkcioniranje) in vseh podlestvicah SF-36, vključno s skupno oceno s področja telesnega (PCS-“Physical Component Summary”) in duševnega (MCS-“Mental Component
The α4β7 integrin is expressed on a discrete subset of memory T helper lymphocytes which preferentially migrate into the gastrointestinal (GI) tract and cause inflammation that is characteristic of ulcerative colitis and Crohn's disease, both of which are chronic inflammatory immunologically mediated conditions of the GI tract. 
Integrin α4β7 je izražen na posebni podskupini spominskih celic T pomagalk, ki migrirajo predvsem v gastrointestinalni (GI) trakt in povzročajo vnetje, značilno za ulcerozni kolitis in Crohnovo bolezen, imunološko pogojeni kronični vnetni bolezni gastrointestinalnega trakta.
Enrolled patients had failed at least one conventional therapy, including corticosteroids, immunomodulators, and/or the TNFα antagonist infliximab (including primary non-responders). 
Vključeni bolniki se niso odzivali na vsaj eno ustaljeno zdravljenje, vključno s kortikosteroidi, imunomodulatorji in/ali zaviralcem TNFα infliksimabom (vključno s primarnim neodzivom).
Patients with Crohn's disease, who have not shown a response may benefit from a dose of Entyvio at week 10 (see section 4.4). 
Bolnikom s Crohnovo boleznijo brez odziva na zdravljenje morda lahko koristi odmerek zdravila Entyvio v 10. tednu (glejte poglavje 4.4).
• There is no clinical trial experience with Entyvio in patients previously treated with natalizumab. 
• Izkušnje iz kliničnega preskušanja zdravila Entyvio pri bolnikih, ki so se predhodno zdravili z natalizumabom, niso na voljo.
Each vial is for single-use only. 
Ena viala je namenjena le za enkratno uporabo.
In a pharmacologically responsive species (cynomolgus monkeys), there was no evidence of cellular hyperplasia or systemic immunomodulation that could potentially be associated with oncogenesis in 13- and 26-week toxicology studies. 
Pri 13- in 26-tedenskih toksikoloških študijah pri farmakološko odzivnih vrstah (opice Cynomolgus) niso opazili znakov celične hiperplazije ali sistemske imunomodulacije, ki bi potencialno lahko bila povezana z onkogenezo.
• Any patients with new onset or worsening signs and symptoms suggestive of PML should be considered for neurological referral at a center equipped to diagnose PML. 
• Pri vsakem bolniku, pri katerem se pojavijo novi ali poslabšajo že prisotni znaki in simptomi, ki kažejo na možnost razvoja PML, je treba razmisliti o napotitvi na specialistični nevrološki pregled v ustanovo, ustrezno opremljeno za diagnostiko PML.
If you forget or miss an appointment to receive the infusion, make another appointment as soon as possible. 
Če niste prejeli predvidene infuzije zdravila Entyvio Če ste pozabili ali zamudili predvideno infuzijo, se čim prej dogovorite za naslednji termin.
Women of childbearing potential should use adequate contraception to prevent pregnancy and to continue its use for at least 18 weeks after the last treatment. 
Ženske v rodni dobi naj uporabljajo učinkovito kontracepcijo med zdravljenjem in do 18 tednov po prejemu zadnjega odmerka.
In GEMINI II, 
Študija GEMINI II
M anufacture r Delpharm Novara S.r.l. 
Izde lovale c Delpharm Novara S.r.l.
Healthcare professionals should monitor patients on vedolizumab for any new onset or worsening of neurological signs and symptoms as outlined in physician education materials, and consider neurological referral if they occur. 
Zdravstveni delavci morajo bolnike nadzirati glede pojava kakršnih koli novih ali poslabšanja že prisotnih nevroloških znakov in simptomov, kot je opisano v izobraževalnem gradivu za zdravnike, in bolnike po potrebi napotiti na specialistični nevrološki pregled.
Inhibiting the interaction of α4β7 with MAdCAM-1 with vedolizumab prevents transmigration of gut-homing memory T helper lymphocytes across the vascular endothelium into parenchymal tissue in nonhuman primates and induced a reversible 3-fold elevation of these cells in peripheral blood. 
Pri nečloveških primatih vedolizumab z zaviranjem interakcije med α4β7 in MAdCAM-1 prepreči transmigracijo v črevesu prisotnih celic T pomagalk preko žilnega endotelija v parenhimsko tkivo in povzroči reverzibilno 3-kratno zvišanje teh celic v periferni krvi.
Do not freeze the reconstituted solution in the vial or the diluted solution in the infusion bag. 
Ne zamrzujte rekonstituirane raztopine v viali ali rekonstituirane raztopine v infuzijski vrečki.