natgillin/translations-raw huggingface dataset:
However, results from a repeat dose toxicity study suggest there is a potential for aflibercept to impair reproductive function and fertility.
Toda rezultati študije toksičnosti ponavljajočih se odmerkov kažejo, da aflibercept lahko okvari reproduktivno funkcijo in plodnost.
PlGF is also linked to pathological neovascularisation and recruitment of inflammatory cells into tumours.
PlGF je povezan tudi s patološko neovaskularizacijo in novačenjem vnetnih celic v tumorjih.
• Posterior reversible encephalopathy syndrome (PRES) (also known as reversible posterior leukoencephalopathy syndrome (RPLS))
• sindroma posteriorne reverzibilne encefalopatije (PRES - posterior reversible encephalopathy syndrome), znanega tudi kot sindrom reverzibilne posteriorne levkoencefalopatije (RPLS
Baseline and periodic evaluations of left ventricular function should be considered while the patient is receiving Zaltrap.
Treba je razmisliti o izhodiščni in nato periodičnih ocenah funkcije levega prekata, medtem ko bolnik prejema zdravilo Zaltrap.
• you have ever had any allergies - serious allergic reactions can happen during treatment with ZALTRAP (see section 4).
• če ste kdaj imeli kakšne alergije - med zdravljenjem z zdravilom ZALTRAP se lahko pojavijo resne alergijske reakcije (glejte poglavje 4).
As with other large proteins, both free and bound aflibercept, are expected to be cleared, more slowly, by other biological mechanisms, such as proteolytic catabolism.
Tako kot za druge velike beljakovine je mogoče pričakovati, da se tako prosti kot vezani aflibercept odstranita počasneje tudi z drugimi biološkimi mehanizmi, npr. s proteolitičnim katabolizmom.
ZALTRAP has no or negligible influence on the ability to drive and use machines.
Zdravilo ZALTRAP nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
Infection (1)
okužba (1)
Hypersensitivity to aflibercept or to any of the excipients listed in section 6.1.
Preobčutljivost na aflibercept ali katero koli pomožno snov, navedeno v poglavju 6.1.
Aflibercept is expected to degrade to small peptides and individual amino acids.
Pričakovati je, da se aflibercept razgradi v majhne peptide in posamezne aminokisline.
There was no margin of exposure to patients in relation to these effects.
Glede teh učinkov ni bilo nobene meje izpostavljenosti v razmerju do bolnikov.
Stratified log-rank test p-value
Vrednost p za stratificirani log-rang test
• The active substance is aflibercept.
• Zdravilna učinkovina je aflibercept.
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Od zdravstvenih delavcev se zahteva, da poročajo o katerem koli domnevnem neželenem učinku zdravila na nacionalni center za poročanje, ki je naveden v Prilogi 5.
In the event of hypertension on aflibercept treatment, blood pressure should be controlled with appropriate anti-hypertensive therapy and blood pressure should be monitored regularly.
V primeru hipertenzije med zdravljenjem z afliberceptom je treba krvni tlak urediti z ustreznim antihipertenzivnim zdravljenjem in krvni tlak redno kontrolirati.
Gender was the most significant covariate for explaining the interindividual variability of free aflibercept clearance and volume with a 15.5 % higher clearance and a 20.6 % higher volume of distribution in males than in females.
Spol je bil najpomembnejša sospremenljivka za pojasnitev interindividualne variabilnosti očistka prostega aflibercepta in volumna porazdelitve: očistek je bil pri moških 15,5 % večji kot pri ženskah, volumen pa 20,6 % večji kot pri ženskah.
• difficulty when breathing
• težko dihanje
Caution should be exercised when handling ZALTRAP, taking into account the use of containment devices, personal protective equipment (e.g. gloves), and preparation procedures.
Pri ravnanju z zdravilom ZALTRAP je potrebna previdnost; uporabiti je treba naprave za prestrezanje, osebno zaščitno opremo (npr. rokavice) in upoštevati je treba postopke priprave.
Most findings were considered to be related to the pharmacological activity of aflibercept.
Večina izsledkov velja za povezano s farmakološko aktivnostjo aflibercepta.
• polyvinyl chloride (PVC) containing bis(2-ethylhexyl) phthalate (DEHP)
• polivinilklorida (PVC), ki vsebuje bis(2-etilheksil)ftalat (DEHP)
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C unless dilution has taken place in controlled and validated aseptic conditions.
Če ni uporabljena takoj, so čas shranjevanja med uporabo in pogoji pred uporabo odgovornost uporabnika; čas običajno ne sme presegati 24 ur pri temperaturi od 2 do 8 °C, razen če je bilo razredčenje opravljeno v nadzorovanih in preverjenih aseptičnih pogojih.
Patients were treated until disease progression or unacceptable toxicity.
Bolniki so bili zdravljeni do napredovanja bolezni ali nesprejemljivih toksičnih učinkov.
Talk to your doctor straight away, if you notice any of the following serious side effects - you may need urgent medical treatment:
Takoj se posvetujte z zdravnikom, če opazite katerega od naslednjih resnih neželenih učinkovmorda boste potrebovali nujno zdravniško pomoč:
This is because it is not known if the medicine passes into breast milk.
Ne ve se namreč, ali to zdravilo prehaja v mleko.
Store in a refrigerator (2°C - 8°C).
Shranjujte v hladilniku ( 2 - 8 °C).
More than one vial could be needed for the preparation of the infusion solution.
Za pripravo raztopine za infundiranje je lahko potrebna več kot ena viala.
Aflibercept, also known as VEGF TRAP in the scientific literature, is a recombinant fusion protein consisting of VEGF-binding portions from the extracellular domains of human VEGF receptors 1 and 2 fused to the Fc portion of the human IgG1.
Aflibercept, v znanstveni literaturi znan tudi kot VEGF TRAP, je rekombinantna fuzijska beljakovina, sestavljena iz VEGF-vežočih delov zunajceličnih območij humanih receptorjev VEGF 1 in 2, vezanih na Fc-del človeškega IgG1.
For these reasons, comparison of the incidence of antibodies to ZALTRAP with the incidence of antibodies to other products may be misleading.
Primerjava incidence protiteles proti zdravilu ZALTRAP z incidenco protiteles proti drugim zdravilom je zato lahko zavajajoča.
At doses greater than 2 mg/kg, free aflibercept clearance was approximately 1.0L/day with a terminal half-life of 6 days.
Ob odmerkih, večjih od 2 mg/kg, je bil očistek prostega aflibercepta približno 1,0 l/dan in s terminalnim razpolovnim časom 6 dni.
Free aflibercept is primarily cleared by binding to endogenous VEGF to form a stable, inactive complex.
Prosti aflibercept se v prvi vrsti odstrani z vezavo na endogeni VEGF, s čimer nastane stabilen, neaktiven kompleks.
• blood clot in very small blood vessels (also called ‘thrombotic microangiopathy').
• krvni strdki v zelo majhnih žilah (to imenujemo tudi "trombotična mikroangiopatija").
ZALTRAP will be given to you by a doctor or a nurse that is experienced in the use of ‘chemotherapy'.
Zdravilo ZALTRAP vam bo dal zdravnik ali medicinska sestra, ki ima izkušnje s »kemopterapijo«.
Information about storage and the time to use ZALTRAP, after it has been diluted and is ready to use, is described in the ‘Practical information for healthcare professionals on preparation and handling of ZALTRAP 25 mg / ml concentrate for solution for infusion' at the end of this leaflet.
Informacije o shranjevanju in času uporabe zdravila ZALTRAP po njegovem redčenju in ko je pripravljeno za uporabo najdete pod naslovom "Praktične informacije za zdravstveno osebje o pripravi in ravnanju z zdravilom ZALTRAP 25 mg/ml koncentrat za raztopino za infundiranje" na koncu tega navodila.
Other medicines and ZALTRAP
Druga zdravila in zdravilo ZALTRAP
Patients with Grade 3 DVT should be treated with anticoagulation as clinically indicated, and aflibercept therapy should be continued.
Bolnike z GVT 3. stopnje je treba zdraviti z antikoagulansi, kot je klinično indicirano, zdravljenje z afliberceptom pa je treba nadaljevati.
No specific studies with aflibercept have been conducted in animals to evaluate the effect on fertility.
Pri živalih niso izvedli specifičnih študij z afliberceptom za oceno vpliva na plodnost.
Careful monitoring is recommended in order to rapidly detect and treat signs and symptoms of diarrhoea and dehydration and to minimize potential risk (see section 4.8).
Priporočljivo je skrbno nadziranje, da bi hitro odkrili in zdravili znake in simptome driske in dehidracije in da bi tako čim bolj zmanjšali možno tveganje (glejte poglavje 4.8).
Aflibercept is a dimeric glycoprotein with a protein molecular weight of 97 kilodaltons (kDa) and contains glycosylation, constituting an additional 15 % of the total molecular mass, resulting in a total molecular weight of 115 kDa.
Aflibercept je dimeren glikoprotein z beljakovinsko molekulsko maso 97 kilodaltonov (kDa) in vsebuje glikozilate, ki pomenijo dodatnih 15 % celotne molekulske mase, tako da je skupna molekulska masa 115 kDa.
No dose adjustment is required for aflibercept (see sections 4.2, 4.8 and 5.2).
Odmerka aflibercepta ni treba prilagoditi (glejte poglavja 4.2. 4.8 in 5.2).
ZALTRAP should be administered under the supervision of a physician experienced in the use of antineoplastic medicinal products.
Zdravilo ZALTRAP je treba dajati pod nadzorom zdravnika, ki ima izkušnje z uporabo antineoplastičnih zdravil.
VTE include deep venous thrombosis and pulmonary embolism.
VTE vključujejo globoko vensko trombozo in pljučno embolijo.
In the few patients with severe renal impairment, drug exposure was similar to that observed in patients with normal renal function.
Pri maloštevilnih bolnikih s hudo okvaro ledvic je bila izpostavljenost zdravilu podobna kot pri bolnikih z normalnim delovanjem ledvic.
Treatment with anti-diarrhoeal medicinal products and rehydration can be used as needed.
Uporabiti je mogoče antidiaroike in rehidracijo, kot je potrebno.
Administration of aflibercept to mice bearing xenotransplant or allotransplant tumours inhibited the growth of various cancer types.
Uporaba aflibercepta pri miših, ki so imele ksenotransplantate ali alotransplantate tumorjev, je zavrla rast različnih vrst raka.
Observed effects included decreases in maternal body weights, an increased number of foetal resorptions, and an increased incidence of external, visceral, and skeletal foetal malformations.
Med opaženimi učinki so bili zmanjšanje materine telesne mase, večje število resorpcij ploda ter večja incidenca zunanjih, visceralnih in skeletnih malformacij pri plodu.
Additionally, the observed incidence of antibody positivity in an assay may be influenced by several factors, including sample handling, timing of sample collection, concomitant medicinal products, and underlying disease.
Poleg tega lahko na opaženo incidenco pozitivnih protiteles v preskusu vpliva več dejavnikov, med drugim ravnanje z vzorcem, čas odvzema vzorca, sočasno uporabljana zdravila in osnovna bolezen.
It is unknown whether aflibercept is excreted in human milk.
Ni znano, ali se aflibercept pri človeku izloča v materino mleko.
Patients with a dipstick of ≥ 2+ for protein or a UPCR > 1 or a protein/creatinine ratio (PCR)> 100 mg/mmol should undergo a 24-hour urine collection.
Bolniki z vrednostjo proteinov na urinskem testnem traku ≥2+ ali UPCR >1 ali razmerjem protein/kreatinin (PCR) >100 mg/mmol morajo opraviti 24-urno zbiranje urina.
You should take your temperature often during treatment with this medicine.
Med zdravljenjem s tem zdravilom si morate pogosto izmeriti telesno temperaturo.
Race No effect of race was identified in the population analysis.
Rasa Populacijska analiza ni pokazala vpliva rase.
If your white blood cells are low, your doctor may need to delay your treatment.
Če imate majhno število belih krvnih celic, bo zdravnik morda moral odložiti vaše zdravljenje.
Irinotecan dose should be reduced by 15-20 %.
Odmerek irinotekana je treba zmanjšati za 15 do 20 %.
• drop in the number of white blood cells (leucopenia)
• zmanjšanje števila belih krvnih celic (levkopenija)
Immunogenicity As with all therapeutic proteins, there is a potential for immunogenicity with ZALTRAP.
Tako kot pri vseh terapevtskih beljakovinah tudi pri zdravilu ZALTRAP obstaja možnost imunogenosti.
Increased AST (2) Increased ALT (2)
Pogosti zvišanje AST (2) zvišanje ALT (2)
Exploratory biomarker analyses were undertaken in the VELOUR trial including analyses of RAS mutational status in 482 of 1,226 patients (n = 240 aflibercept; 242 placebo).
V preskušanju VELOUR so izvedli eksplorativne analize bioloških označevalcev, vključno z analizami mutacijskega stanja RAS, pri 482 od 1226 bolnikov (n = 240 aflibercept, 242 placebo).
• you experience signs of a blood clot (see section 4).
• če se vam pojavijo znaki krvnega strdka (glejte poglavje 4).
It is recommended to monitor blood pressure every two weeks, including before each administration or as clinically indicated during treatment with aflibercept.
Krvni tlak je priporočljivo kontrolirati na dva tedna, vključno pred vsako uporabo zdravila, ali kot je klinično indicirano med zdravljenjem z afliberceptom.
If hypertension cannot be adequately controlled, treatment with aflibercept should not be initiated.
Če hipertenzije ni mogoče ustrezno urediti, se zdravljenja z afliberceptom ne sme začeti.
Most aflibercept-related findings were noted from the lowest dose tested corresponding to plasma exposures close to those in patients at the therapeutic dose.
Večino z afliberceptom povezanih izsledkov so ugotovili pri najmanjšem testiranem odmerku, ki ustreza plazemski izpostavljenosti, blizu tisti pri bolnikih med uporabo terapevtskega odmerka.
The pharmacokinetic properties described below have to a large extent been derived from a population pharmacokinetic analysis with data from 1,507 patients with various types of advanced malignancies.
Spodaj opisane farmakokinetične lastnosti v veliki meri izvirajo iz populacijske farmakokinetične analize podatkov 1507 bolnikov z različnimi vrstami napredovalih malignomov.
Aflibercept should be permanently discontinued if hypertension cannot be adequately managed with appropriate anti-hypertensive therapy or aflibercept dose reduction, or if hypertensive crisis or hypertensive encephalopathy occurs (see section 4.2).
Zdravljenje z afliberceptom je treba za stalno končati, če hipertenzije ni mogoče ustrezno obvladati z ustreznim antihipertenzivnim zdravljenjem ali zmanjšanjem odmerka aflibercepta, ali če se pojavita hipertenzivna kriza ali hipertenzivna encefalopatija (glejte poglavje 4.2).
Do not re-enter the vial after the initial puncture.
Po prvem prebadanju v vialo ne posegajte več.
Aflibercept should be suspended for at least 4 weeks prior to elective surgery.
Uporabo zdravila aflibercept je treba prekiniti vsaj 4 tedne pred elektivno operacijo.
While being treated with ZALTRAP, you should maintain good oral hygiene (including regular teeth brushing) and receive routine dental check-ups.
V času zdravljenja z zdravilom ZALTRAP morate skrbeti za dobro ustno higieno (kar vključuje redno čiščenje zob) in redno hoditi na rutinske preglede k zobozdravniku.
Results by prior bevacizumab exposure are summarised in Table 3.
Rezultati glede na predhodno izpostavljenost bevacizumabu so povzeti v preglednici 3.
Analysis for OS and PFS by ECOG PS was also performed.
Opravljeni sta bili tudi analizi OS in PFS glede na stanje zmogljivosti po ECOG.
Dehydration (1) Decreased appetite Weight loss
dehidracija (1) zmanjšanje apetita hujšanje
Patients with NYHA class III or IV congestive heart failure should not be treated with ZALTRAP.
Bolnikov s kongestivnim srčnim popuščanjem v razredu III ali IV po NYHA III se ne sme zdraviti z zdravilom ZALTRAP.
Caution should be used when retreating patients with prior hypersensitivity reactions as recurrent hypersensitivity reactions have been observed in some patients despite prophylaxis, including corticosteroids.
Previdnost je potrebna pri ponovnem zdravljenju bolnikov, ki so predhodno imeli preobčutljivostne reakcije, kajti pri nekaterih bolnikih so opažali ponavljajoče se preobčutljivostne reakcije kljub profilaksi, vključno s kortikosteroidi.
Your doctor will stop this medicine for at least 4 weeks before planned surgery and until the wound is fully healed.
Zdravnik bo prekinil vaše zdravljenje s tem zdravilom najmanj 4 tedne pred načrtovano operacijo; zdravila ne boste prejemali, dokler se vam rana povsem ne zaceli.
• DEHP free PVC containing trioctyl-trimellitate (TOTM)
• PVC, ki ne vsebuje DEHP, vsebuje pa trioktil-trimelitat (TOTM)
• Allergic reactions: Common (may affect up to 1 in 10 people) - these may happen within a few minutes after your infusion.
• Alergijske reakcije: pogosto (pojavijo se lahko pri največ 1 od 10 oseb) - Pojavijo se lahko v nekaj minutah po infundiranju zdravila.
Warnings and precautions Talk to your doctor, pharmacist or nurse before you are given ZALTRAP and during your treatment if:
Opozorila in previdnostni ukrepi Posvetujte se s svojim zdravnikom, s farmacevtom ali z medicinsko sestro, preden dobite zdravilo ZALTRAP in med zdravljenjem:
Aflibercept binds to human VEGF-A (equilibrium dissociation constant KD of 0.5 pM for VEGF-A165 and 0.36 pM for VEGF-A121), to human PlGF (KD of 39 pM for PlGF-2), and to human VEGF-B (KD of 1.92 pM) to form a stable, inert complex which has no detectable biological activity.
Aflibercept se veže na človeški VEGF-A (ravnotežna konstanta disociacije KD je 0,5 pM za VEGF-A 165 in 0,36 pM za VEGF-A 121), človeški PlGF (KD je 39 pM za PlGF-2) in človeški VEGF-B (KD je 1,92 pM) ter tvori stabilen, inerten kompleks brez zaznavne biološke aktivnosti.
If recurrence after irinotecan and 5-FU dose reductions, reduction of ZALTRAP dose to 2 mg/kg could be considered.
Če pride do ponovitve po zmanjšanju odmerkov irinotekana in 5-FU, pride v poštev zmanjšanje odmerka zdravila ZALTRAP na 2 mg/kg.
Dose modification of FOLFIRI regimen (see section 4.2), anti-diarrhoeal medicinal products, and rehydration as needed should be instituted.
Odmerek sheme FOLFIRI je treba prilagoditi (glejte poglavje 4.2) ter uvesti antidiarioike in rehidracijo, kot je potrebno.
ZALTRAP/FOLFIRI should be discontinued and appropriate medical therapy should be administered.
Uporabo sheme ZALTRAP/FOLFIRI je treba prekiniti in uporabiti je treba ustrezno zdravljenje.
Diarrhoea and dehydration
Driska in dehidracija
Figure 1 - Overall survival (months) - Kaplan-Meier curves by treatment group - ITT population
Slika 1 - Celokupno preživetje (meseci) - Kaplan-Meierjevi krivulji po terapevtski skupinipopulacija ZNZ
The efficacy and safety of ZALTRAP were evaluated in a randomised, double-blind, placebo-controlled study in patients with metastatic colorectal cancer who had previously been treated with an oxaliplatin-based treatment with or without prior bevacizumab.
Učinkovitost in varnost zdravila ZALTRAP so ocenili v randomizirani, dvojno slepi, s placebom kontrolirani študiji pri bolnikih z metastatskim kolorektalnim rakom, predhodno zdravljenih s terapijo na podlagi oksaliplatina, s predhodno uporabo bevacizumaba ali brez nje.
ZALTRAP should be used only if the potential benefit justifies the potential risk during pregnancy.
Zdravilo ZALTRAP se sme med nosečnostjo uporabiti le, če morebitna korist upravičuje možno tveganje.
• you have any problems with your mouth or teeth such as poor dental health, gum disease, or a planned tooth extraction and especially if you have previously been treated with a bisphosphonate (used to treat or prevent bone disorders).
• če imate kakršne koli težave v ustih ali z zobmi, kot je bolezen zob, bolezen dlesni ali predvideno izdrtje zob in še posebej, če ste že bili zdravljeni z difosfonatom (uporablja se za zdravljenje ali preprečevanje bolezni kosti).
The treatment cycles on both arms were repeated every 2 weeks.
Cikluse zdravljenja so v obeh terapevtskih krakih ponavljali na 2 tedna.
Carcinogenesis and mutagenesis No studies have been conducted to evaluate carcinogenicity or mutagenicity of aflibercept.
Kancerogenost in mutagenost Študij za oceno kancerogenosti in mutagenosti aflibercepta niso izvedli.
ZALTRAP is a sterile, preservative-free and non-pyrogenic concentrate, therefore the solution for infusion should be prepared by a healthcare professional using safe-handling procedures and aseptic technique.
Zdravilo ZALTRAP je sterilen in apirogen koncentrat brez konzervansov, zato mora raztopino za infundiranje pripraviti zdravstveni delavec, ki uporablja varne postopke ravnanja in aseptično tehniko.
It is recommended that aflibercept not be initiated for at least 4 weeks following major surgery and not until the surgical wound is fully healed.
Priporočljivo je, da se zdravljenje z afliberceptom ne začne prej kot vsaj 4 tedne po večji operaciji in da se ne začne, dokler se rana povsem ne zaceli.
Aflibercept blocks the activation of VEGF receptors and the proliferation of endothelial cells, thereby inhibiting the growth of new vessels that supply tumours with oxygen and nutrients.
Aflibercept blokira aktivacijo receptorjev VEGF in proliferacijo endotelijskih celic; tako zavre rast novih žil, ki oskrbujejo tumorje s kisikom in hranili.
Oxaliplatin-based regimens were administered in combination with bevacizumab in 373 patients (30.4 %).
Sheme na osnovi oksaliplatina so v kombinaciji z bevacizumabom uporabili pri 373 bolnikih (30,4 %).
Women of childbearing potential / Contraception in males and females Women of childbearing potential should be advised to avoid becoming pregnant while on ZALTRAP, and should be informed of the potential hazard to the foetus.
Ženske v rodni dobi/kontracepcija pri moških in ženskah Ženskam v rodni dobi je treba svetovati, naj med zdravljenjem z zdravilom ZALTRAP ne zanosijo, in jih je treba obvestiti o možnih nevarnostih za plod.
If you are uncertain contact your doctor.
Če ste negotovi, se posvetujte z zdravnikom.
There are no data available for patients with severe hepatic impairment (total bilirubin > 3 x ULN and any AST).
Podatkov za bolnike s hudo okvaro jeter (celokupni bilirubin > 3-kratna ZNM in kateri koli AST) ni.
Your doctor should check your blood pressure throughout your treatment.
Zdravnik vam mora ves čas zdravljenja kontrolirati krvni tlak.
Seventeen (17) patients treated with ZALTRAP (1.6 %) and two (2) placebo-treated patients (0.2 %) were also positive in the neutralising antibody assay.
Sedemnajst (17) prejemnikov zdravila ZALTRAP (1,6 %) in dva (2) prejemnika placeba (0,2 %) so imeli tudi pozitiven preskus na nevtralizirajoča protitelesa.
For minor surgery such as central venous access port placement, biopsy, and tooth extraction, aflibercept may be initiated/restarted once the surgical wound is fully healed.
Po manjših posegih, kot so npr. namestitev centralnega venskega dostopa, biopsija ali izdrtje zoba, je mogoče zdravljenje z afliberceptom začeti oz. ga znova uvesti, ko se kirurška rana popolnoma zaceli.
Pharmacotherapeutic group: Antineoplastic agents, other antineoplastic agents, ATC code: L01XX44
Farmakoterapevtska skupina: Zdravila z delovanjem na novotvorbe, druga zdravila z delovanjem na novotvorbe, oznaka ATC: L01XX44
What ZALTRAP is and what it is used for
Kaj je zdravilo ZALTRAP in za kaj ga uporabljamo
High molecular weight proteins are not cleared by the renal route, therefore renal elimination of aflibercept is expected to be minimal.
Beljakovine z veliko molekulsko maso se ne odstranjujejo skozi ledvice, zato je mogoče pričakovati, da je izločanje aflibercepta skozi ledvice minimalno.
Practical information for handling and administration of ZALTRAP for doctors, nurses and pharmacists when using this medicine is provided with this leaflet.
To navodilo obsega praktične informacije za ravnanje z zdravilom ZALTRAP in za njegovo dajanje, namenjene zdravnikom, medicinskim sestram in farmacevtom pri uporabi tega zdravila.
The medicine must be diluted before it is given.
Zdravilo je treba pred uporabo razredčiti.