FrancophonIA/ELRC3.0 huggingface dataset:
English: COMP opinions in 2004 on designation of orphan medicinal products
Slovenian: Priloga 11 Mnenja COMP v letu 2004 o določitvi zdravil sirot
English: Significant variations/new treatment options for patients suffering from cancer
Slovenian: Pomembne spremembe/nove možnosti zdravljenja za bolnike z rakom
English: Fees
Slovenian: Panos
English: 297 days
Slovenian: 215 days 297 days
English: Validation Assessment
Slovenian: Potrditev Ocena
English: 289 days
Slovenian: 197 days 289 days
English: Members of the Committee for Medicinal Products for Human Use
Slovenian: Priloga 2 Člani Odbora za zdravila za uporabo v humani medicini
English: Treatment of patients with
Slovenian: Skupina za sodelovanje z organizacijami bolnikov
English: 213 days
Slovenian: 182 days 213 days
English: • David LYONS (EMEA representative) • Henri METZ (Luxembourg)
Slovenian: • David LYONS (predstavnik EMEA)
English: Salaries
Slovenian: Pristojbine
English: Adopted in March 2004
Slovenian: Sprejeto marca 2004
English: 154 days
Slovenian: 184 days 154 days
English: Consultation ended in October
Slovenian: Posvetovanje zaključeno oktobra
English: There were no negative CHMP opinions in 2004.
Slovenian: V letu 2004 CHMP ni izdal negativnih mnenj.
English: 173 days
Slovenian: 60 days 173 days
English: Summaries of COMP opinions are published on the EMEA website once a decision on designation has been taken.
Slovenian: Ko je sprejeta odločitev o določitvi zdravila kot zdravila sirote, se povzetki mnenj COMP objavijo na spletni strani EMEA.
English: Art. 31 of Directive 2001/83/EC (previously Art. 12 of Directive 75/319/EEC)
Slovenian: Člen 31 Direktive št. 2001/83/ES (prej člen 12 Direktive 75/319/EGS
English: Adopted in October 2004
Slovenian: Sprejeto oktobra 2004
English: Slovakia
Slovenian: SLOVAŠKA
English: Finalisation expected in 1st quarter
Slovenian: Dokončno oblikovanje se pričakuje v prvem četrtletju leta 2005
English: Haematology
Slovenian: Hematologija
English: Therapeutic area EMEA/CHMP European Commission
Slovenian: EMEA/CHMP Odobritev Mnenje
English: 236 days
Slovenian: 194 days 236 days
English: 129 days
Slovenian: 181 days 129 days
English: This document provides the procedures to implement Article 58 of Regulation (EC) No 726/2004 and was released for external consultation in November 2004.
Slovenian: • "Smernice o postopkovnih vidikih glede znanstvenega mnenja CHMP v okviru sodelovanja s Svetovno zdravstveno organizacijo (WHO) za vrednotenje zdravil, namenjenih izključno trgom zunaj Skupnosti": ta dokument zagotavlja postopke za izvajanje člena 58 Uredbe (ES) št. 726/2004 in je bil predstavljen za javno posvetovanje novembra 2004. Člen 58 Uredbe odseva potrebo po znanstveni pomoči državam nečlanicam v okviru sodelovanja s WHO, hkrati pa tem državam omogoča hiter dostop do pomembnih novih zdravil.
English: Line-extension applications Type-II variations Type-I variations
Slovenian: Vloge za razširitev indikacij Vloge za spremembo tipa II Vloge za spremembo tipa I
English: Consultation ended in August 2004
Slovenian: Posvetovanje zaključeno avgusta
English: Gunar ALVÁN (Alternate: Anders BROSTRÖM) United Kingdom Kent WOODS (Alternate: Steve DEAN)
Slovenian: Gunar ALVÁN (namestnik: Anders BROSTRÖM)
English: 356 days
Slovenian: 228 days 356 days
English: Operational expenditure
Slovenian: Odhodki Osebje Plače
English: Commission !
Slovenian: Odbor
English: Released for consultation in November 2004
Slovenian: Predstavljeno za posvetovanje novembra 2004
English: Release for consultation expected in 2nd quarter 2005
Slovenian: Predstavitev za posvetovanje se pričakuje v drugem četrtletju leta
English: Felin Interferon !
Slovenian: Virbagen Omega Felin Interferon Part A
English: 185 days
Slovenian: 202 days 185 days
English: Applications received 2002-2004
Slovenian: Prejete vloge v letih 2002-2004
English: Biosimilar Medicinal Products Working Party (formerly Ad hoc Working Group on (Pre-) Clinical Comparability of Biotechnology Products)
Slovenian: Delovna skupina za biološko podobna zdravila (prej Ad hoc delovna skupina za (pred)klinično primerljivost biotehnoloških izdelkov) Predsednik: Pekka KURKI Kontaktna oseba EMEA: Marisa PAPALUCA AMATI
English: 303 days
Slovenian: 183 days 303 days
English: 363 days
Slovenian: 168 days 363 days
English: • Ján MAZÁG3 (Slovakia) Alternate: Leila FARAH
Slovenian: • Ján MAZÁG3 (Slovaška)
English: Significant variations/new treatment options for patients suffering from diabetes
Slovenian: Pomembne spremembe/nove možnosti zdravljenja za bolnike s sladkorno boleznijo
English: Pre-submission meetings
Slovenian: Sestanki pred oddajo vloge
English: Consultation ended in December
Slovenian: Posvetovanje zaključeno decembra
English: Liechtenstein
Slovenian: Lihtenštajn
English: LIECHTENSTEIN
Slovenian: LIHTENŠTAJN
English: Release for consultation expected in 1st quarter 2005
Slovenian: Predstavitev za posvetovanje se pričakuje v prvem četrtletju leta
English: Acting Head of Sector for safety and efficacy of medicines
Slovenian: Vršilka dolžnosti vodje Sektorja za varnost in učinkovitost zdravil
English: Summary of indication
Slovenian: Vloge za razširitev indikacij
English: 148 days
Slovenian: 183 days 148 days
English: Alimentary tract
Slovenian: Prebavni trakt
English: 155 days
Slovenian: 210 days 155 days
English: 120 days
Slovenian: 203 days 120 days
English: • Gene Therapy Working Party
Slovenian: • Delovna skupina za gensko zdravljenje
English: Truvada !
Slovenian: THIRSTRUPA.
English: • Psoriasis
Slovenian: • luskavica
English: 279 days
Slovenian: 206 days 279 days
English: Art. 36 of Directive 2001/83/EC (previously Art. 15(a) of Directive 75/319/EEC)
Slovenian: Člen 36 Direktive št. 2001/83/ES (prej člen 12 Direktive 75/319/EGS
English: • Juris POKROTNIEKS (Latvia) Alternate: Indulis PURVINS
Slovenian: • Juris POKROTNIEKS (Latvija)
English: 208 days !
Slovenian: 208 days 180 days
English: Release for consultation expected in 3rd quarter 2005
Slovenian: Predstavitev za posvetovanje se pričakuje v tretjem četrtletju leta
English: Head of Sector for pharmacovigilance and post-authorisation safety and efficacy of medicines
Slovenian: Tony HUMPHREYS Vodja Sektorja za farmakovigilanco, varnost in učinkovitost zdravil po izdaji dovoljenja za promet
English: Post-authorisation applications
Slovenian: Vloge po izdaji dovoljenja za promet
English: TOTAL REVENUE
Slovenian: PRIHODKI SKUPAJ
English: 153 days
Slovenian: 172 days 153 days
English: Part B Extension
Slovenian: Xagrid anagrelide Part B
English: Gene Therapy Working Party (formerly Ad hoc Expert Group on Gene Therapy)
Slovenian: Delovna skupina za gensko zdravljenje (prej Ad hoc strokovna skupina za gensko zdravljenje)
English: EMEA/COMP !
Slovenian: Povzetek indikacij EMEA/COMP Predložitev
English: 284 days
Slovenian: 181 days 284 days
English: Service or project Description of measure Details of progress Videoconferencing and audiovisual
Slovenian: Videokonference in avdiovizualna tehnologija
English: MRA
Slovenian: ZK
English: insulin glulisine !
Slovenian: Apidra insulin glulisine Part A
English: (see section 5.1).
Slovenian: (glejte poglavje 5.1).
English: • if you think you may need any vaccinations in the near future, including those needed to travel to other countries.
Slovenian: • če menite, da boste v bližnji prihodnosti potrebovali kakršna koli cepljenja, vključno s takšnimi, ki so potrebna za potovanje v druge države.
English: Date of first authorisation: 23 November 2015 Date of last renewal: 19 April 2018
Slovenian: Datum prve odobritve: 23. november 2015 Datum zadnjega podaljšanja: 19. april 2018
English: • if you have an active infection.
Slovenian: • če imate kakšno aktivno okužbo.
English: Currently available data in children are described in section 4.8 and 5.1.
Slovenian: Podatki, ki so trenutno razpoložljivi pri otrocih, so opisani v poglavjih 4.8 in 5.1.
English: Health related quality of life
Slovenian: Z zdravjem povezana kakovost življenja
English: These changes reversed after cessation of treatment.
Slovenian: Te spremembe so po prenehanju zdravljenja izginile.
English: • allergic reaction
Slovenian: • alergijska reakcija
English: (stabiliser).
Slovenian: (stabilizatorjem).
English: • difficulty in speaking
Slovenian: • težave z govorjenjem.
English: Kaplan-Meier curve of overall survival
Slovenian: Kaplan-Meierjeva krivulja celokupnega preživetja
English: • Do not open the package.
Slovenian: • Ne odpirajte pakiranja.
English: The clinical significance of these imaging changes is unknown.
Slovenian: Klinični pomen teh sprememb na slikanjih ni znan.
English: Because the health-related quality of life results are based on a post-hoc sensitivity analysis, the results should be interpreted with caution.
Slovenian: Ker rezultati z zdravjem povezane kakovosti življenja temeljijo na post hoc analizi občutljivosti, je treba rezultate interpretirati previdno.
English: Your doctor will check if you should have the vaccination.
Slovenian: Zdravnik bo preveril, če potrebujete cepljenje.
English: 100-day mortality after alloHSCT
Slovenian: 100-dnevna umrljivost po alloHSCT
English: • confusion, disorientation
Slovenian: • zmedenost, dezorientiranost
English: BLINCYTO may not be suitable for you:
Slovenian: Zdravilo BLINCYTO morda ne bo primerno za vas:
English: Some of these side effects may be serious.
Slovenian: Nekateri od teh neželenih učinkov so lahko resni.
English: Special instructions to support accurate preparation
Slovenian: Posebna navodila za podporo točni pripravi
English: Your doctor will talk to you about precautions in using vaccinations for your baby.
Slovenian: Zdravnik se bo z vami pogovoril o previdnostnih ukrepih pri uporabi cepiv za vašega otroka.
English: N = total number of patients in the specified subgroup.
Slovenian: N = celotno število bolnikov v opredeljeni podskupini.
English: Body surface area, gender and age
Slovenian: Telesna površina, spol in starost
English: The type and frequency of adverse events were similar across different paediatric sub-groups (gender, age, geographic region).
Slovenian: Vrsta in pogostnost neželenih dogodkov sta bili podobni pri različnih pediatričnih podskupinah (spol, starost, geografska regija).
English: From a microbiological point of view, the prepared infusion bags should be used immediately.
Slovenian: Z mikrobiološkega stališča je treba pripravljene infuzijske vrečke uporabiti takoj.
English: Additionally, the side effects that happened more often in adolescents and children include:
Slovenian: Neželeni učinki, ki so se pogosteje pojavili pri mladostnikih in otrocih, poleg teh vključujejo:
English: 6.1 months
Slovenian: 6,1 mesecev
English: Efficacy results from other key endpoints in the study are summarised in table 2.
Slovenian: Rezultati učinkovitosti drugih ključnih opazovanih dogodkov v študiji so povzeti v preglednici 2.
English: The median time to onset was 7.5 days.
Slovenian: Mediana časa do pojava je bila 7,5 dni.
English: Elastomeric pumps should not be used.
Slovenian: Ne sme se uporabljati elastomernih črpalk.
English: These supplies are also required, but not included in the package
Slovenian: Potrebna je tudi naslednja oprema, ki pa ni vključena v pakiranju
English: If not diluted immediately, in-use storage times and conditions are the responsibility of the user.
Slovenian: Če ni razredčena takoj, so časi shranjevanja in pogoji med uporabo odgovornost uporabnika.
English: b MedDRA high level group terms (MedDRA version 18.1).
Slovenian: Krovna skupina izrazov po MedDRA (MedDRA različica 18.1).
English: You may also be given medicines to reduce fever.
Slovenian: Morda boste dobili tudi zdravila za znižanje zvišane telesne temperature.
English: • if the infusion pump stops unexpectedly.
Slovenian: • se infuzijska črpalka nepričakovano ustavi.
English: If you respond to this treatment, your doctor may decide to give you up to 3 additional cycles of treatment.
Slovenian: Če se odzovete na to zdravljenje, se zdravnik lahko odloči, da boste dobili še 3 dodatne cikluse zdravljenja.
English: Your doctor will discuss with you how long your treatment will last.
Slovenian: Zdravnik se bo z vami pogovoril o tem, koliko časa bo trajalo zdravljenje.
English: The infusion rate may be faster or slower depending on how often the bag is changed.
Slovenian: Infundiranje lahko poteka hitreje ali počasneje, odvisno od tega, kako pogosto se zamenja vrečko.
English: • increased bilirubin in the blood
Slovenian: • zvišan bilirubin v krvi
English: Your doctor will discuss with you if you can continue treatment at home after your initial hospital stay.
Slovenian: Zdravnik se bo z vami pogovoril, ali lahko po uvodnem bivanju v bolnišnici zdravljenje nadaljujete doma.
English: • high levels of some enzymes including blood enzymes
Slovenian: • visoka raven nekaterih encimov, vključno s krvnimi encimi
English: BLINCYTO should not be used in children below 1 year of age.
Slovenian: Zdravila BLINCYTO se ne sme uporabljati pri otrocih, mlajših od 1 leta.
English: The dose of the concomitant medicinal product should be adjusted as needed.
Slovenian: Odmerek sočasno uporabljanega zdravila je treba prilagoditi, kot je potrebno.
English: Treatment may include a bag change by a nurse.
Slovenian: Zdravljenje lahko obsega menjavo vrečke, ki jo opravi medicinska sestra.
English: Aseptic preparation
Slovenian: Aseptična priprava
English: Below lower limit of quantification Unknown
Slovenian: Pod spodnjo mejo količinske določljivosti Ni znano
English: • Water for injections
Slovenian: • voda za injekcije
English: d. n1: number of patients who achieved MRD response and the respective remission status; n2: number of patients who achieved the respective remission status.
Slovenian: d. n1: število bolnikov, ki so dosegli MRD odziv in ustrezno stanje remisije; n2: število bolnikov, ki so dosegli ustrezno stanje remisije.
English: ≥50% to <75%
Slovenian: ≥ 50 % do < 75 %
English: The demographics and baseline characteristics were well-balanced between the two arms (see table 1).
Slovenian: Demografske in izhodiščne značilnosti so bile med obema skupinama dobro uravnotežene (glejte preglednico 1).
English: Your doctor or nurse will monitor you for signs and symptoms of these reactions.
Slovenian: Zdravnik ali medicinska sestra vas bosta spremljala glede znakov in simptomov teh reakcij.
English: Caution should be exercised as cases of late occurrence of first neurological events have been observed.
Slovenian: Potrebna je previdnost, saj so opazili primere poznega pojava prvih nevroloških dogodkov.
English: Non-interventional post-authorisation safety study (PASS): Study 20150136: an observational study of blinatumomab safety and effectiveness, utilisation, and treatment practices*
Slovenian: Neintervencijska študija o varnosti zdravila po pridobitvi dovoljenja za promet z zdravilom (PASS): Študija 20150136: Opazovalna študija o varnosti in učinkovitosti blinatumomaba, uporabi in praksah zdravljenja*
English: • Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Slovenian: • Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
English: Do not use BLINCYTO: - if you are allergic to blinatumomab or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Ne uporabljajte zdravila BLINCYTO: - če ste alergični na blinatumomab ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Survival Probability
Slovenian: Verjetnost preživetja
English: • if you have ever had an infusion reaction after previously using BLINCYTO.
Slovenian: • če ste kdaj imeli infuzijsko reakcijo po predhodni uporabi zdravila BLINCYTO.
English: This is particularly important when using an ambulatory infusion pump.
Slovenian: To je posebej pomembno, če je uporabljena mobilna (ambulantna) infuzijska črpalka.
English: Contact your doctor or nurse immediately if:
Slovenian: Nemudoma se obrnite na zdravnika ali medicinsko sestro, če:
English: Number of subjects at Risk
Slovenian: Število preiskovancev, izpostavljenih tveganju
English: Leukoencephalopathy including progressive multifocal leukoencephalopathy
Slovenian: Levkoencefalopatija, vključno s progresivno multifokalno levkoencefalopatijo
English: The primary endpoint was overall survival (OS).
Slovenian: Primarni opazovani dogodek je bilo celokupno preživetje (OS - overall survival).
English: Results suggest that age (7 months to 80 years) and gender do not influence the pharmacokinetics of blinatumomab.
Slovenian: Rezultati kažejo, da starost (od 7 mesecev do 80 let) in spol ne vplivata na farmakokinetiko blinatumomaba.
English: This medicine works by enabling your immune system to attack and destroy these abnormal white blood cancer cells.
Slovenian: To zdravilo deluje tako, da telesnemu imunskemu sistemu omogoči, da napade in uniči te nenormalne rakave bele krvne celice.
English: Final interpretation of MRD results followed EuroMRD Consortium guidelines.
Slovenian: Pri končni interpretaciji rezultatov MRD so bile upoštevane smernice združenja EuroMRD.
English: * Centrally assessed in an assay with minimum sensitivity of 10-4
Slovenian: * Centralno ocenjeno s preiskavo z minimalno občutljivostjo 10
English: The infusion reactions were generally rapid, occurring within 48 hours after initiating infusion.
Slovenian: Infuzijske reakcije so bile na splošno hitre in so se pojavile v 48 urah po začetku infundiranja.
English: In the event of overdose, the infusion should be temporarily interrupted and patients should be monitored.
Slovenian: V primeru prevelikega odmerjanja je treba infundiranje začasno prekiniti, bolnika pa spremljati.
English: *, 1 patient had progressive disease (OS 2.3 months) and 2 were non-responders (OS 1.1 months and 8.7 months, respectively).
Slovenian: *, 1 bolnik je imel progresivno bolezen (OS 2,3 meseca), dva pa sta bila neodzivna na zdravljenje (OS 1,1 meseca oziroma 8,7 meseca).
English: • increased levels of liver enzymes (ALT, AST, GGT)
Slovenian: • zvišana koncentracija jetrnih encimov (ALT, AST, GGT)
English: * The study protocol needs to be developed and presented for PRAC review within 2 months after the EU Commission Decision.
Slovenian: * Protokol študije je potrebno izdelati in predstaviti za pregled pri PRAC v roku 2 mesecev po odločbi EU komisije.
English: You should not use BLINCYTO during pregnancy, unless your doctor thinks that it is the best medicine for you.
Slovenian: Zdravila BLINCYTO ne smete uporabljati med nosečnostjo, razen če zdravnik meni, da je to za vas najprimernejše zdravilo.
English: ≥75% to <90%
Slovenian: ≥ 75 % do < 90 %
English: You will then have a 2-week break where you will not be given the infusion.
Slovenian: Potem boste imeli 2-tedenski premor; v teh dveh tednih ne boste dobivali infuzij.
English: If you have a catheter for infusion, it is very important to keep the area around the catheter clean; otherwise you could get an infection.
Slovenian: Če imate infuzijski kateter, je zelo pomembno, da vzdržujete predel okoli katetra čist, sicer se lahko pojavi okužba.
English: A central laboratory subsequently confirmed MRD levels by PCR.
Slovenian: Naknadno je centralni laboratorij potrdil vrednosti MRD s PCR.
English: Following continuous intravenous infusion, the steady state serum concentration (Css) was achieved within a day and remained stable over time.
Slovenian: Po stalni intravenski infuziji je bila koncentracija v stanju dinamičnega ravnovesja (Css) dosežena v enem dnevu in je skozi čas ostala stabilna.
English: Infusion duration (hours)
Slovenian: Trajanje infuzije (ure)
English: Reconstituted BLINCYTO (number of packages)
Slovenian: Rekonstituirano zdravilo BLINCYTO (število pakiranj)
English: Do not try to restart your pump.
Slovenian: Ne poskušajte znova pognati črpalke.
English: 250 mL (usual overfill volume of 265 to 275 mL)
Slovenian: 250 ml (običajni volumen prepolnitve od 265 do 275 ml)
English: Other special populations
Slovenian: Druge posebne populacije
English: Cycle 1
Slovenian: 1. ciklus
English: Non-interventional post-authorisation safety study (PASS): The applicant should submit the final results of a follow-up observational study to further characterise the long-term safety of BLINCYTO including developmental aspects, HSCT and secondary malignancy in high-risk paediatric patients enrolled in Study 20120215*.
Slovenian: Neintervencijska študija o varnosti zdravila po pridobitvi dovoljenja za promet z zdravilom (PASS): Predlagatelj mora predložiti končne rezultate nadaljnje opazovalne študije, da bi dodatno opredelil dolgoročno varnost zdravila BLINCYTO, vključno z vidiki razvoja, HSCT in sekundarnimi malignomi pri pediatričnih bolnikih z visokim tveganjem, ki so vključeni v študijo 20120215*.
English: Patients should be observed closely for infusion reactions, especially during the initiation of the first and second treatment cycles and treated appropriately.
Slovenian: Bolnike je treba skrbno opazovati glede infuzijskih reakcij, zlasti na začetku prvega in drugega ciklusa zdravljenja, in jih ustrezno zdraviti.
English: * The study protocol needs to be developed and presented for PRAC review within 3 months after the EU Commission Decision.
Slovenian: * Protokol študije je potrebno izdelati in predstaviti za pregled pri PRAC v roku 3 mesecev po odločbi EU komisije.
English: Consistency in OS results was shown in subgroups by stratification factors.
Slovenian: Konsistentnost rezultatov celokupnega preživetja se je izkazala v podskupinah po randomizacijskih faktorjih.
English: • The entire volume of the reconstituted and diluted BLINCYTO will be more than the volume to be administered to the patient (240 mL).
Slovenian: • Celotna količina rekonstituiranega in razredčenega zdravila BLINCYTO bo večja od količine, ki bo dana bolniku (240 ml).
English: Confusion and disorientation, coordination and balance disorders, risk of seizures and disturbances in consciousness can occur (see section 4.4).
Slovenian: Pojavijo se lahko zmedenost in dezorientiranost, motnje koordinacije in ravnotežja, tveganje za konvulzije in motnje zavesti (glejte poglavje 4.4).
English: This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Slovenian: Zdravila ne smemo mešati z drugimi zdravili, razen s tistimi, ki so omenjena v poglavju 6.6. 6.3 Rok uporabnosti
English: • low levels of antibodies called “immunoglobulins” which help the immune system fight infection (decreased immunoglobulins)
Slovenian: • nizke ravni protiteles, imenovanih "imunoglobulini", ki imunskemu sistemu pomagajo premagovati okužbe (znižanje imunoglobulinov)
English: • Management of neurotoxicity (including dose adjustment and dose interruption)
Slovenian: • Obvladovanje nevrotoksičnosti (vključno s prilagoditvijo odmerka in prekinitvi odmerjanja).
English: • Data from clinical trials, frequency and severity (grade 3 and 4 neurological toxicities were observed)
Slovenian: • Podatki iz kliničnih preskušanj, pogostnost in resnost (opazili so stopnji 3 in 4 nevrološke toksičnosti).
English: Based on its pharmacological properties, a risk to the suckling child cannot be excluded.
Slovenian: Na podlagi njegovih farmakoloških lastnosti, tveganja za dojenega otroka ne moremo izključiti.
English: 0/12, 0.0% (0.0, NE)
Slovenian: 0/12, 0,0 % (0,0; NO)
English: Subgroup
Slovenian: Podskupina
English: There is a possibility of a higher risk of neurologic events in this population.
Slovenian: V tej populaciji je tveganje za nevrološke učinke morda večje.
English: Patients received up to 4 cycles of treatment.
Slovenian: Bolniki so dobili do 4 cikluse zdravljenja.
English: Aseptic handling must be ensured when preparing the infusion.
Slovenian: Pri pripravi infuzije je treba zagotoviti aseptično ravnanje.
English: Demographics and baseline characteristics in phase III study
Slovenian: Demografske in izhodiščne značilnosti v študiji III. faze
English: Less than 45 kg (BSA-based dose)
Slovenian: Manj kot 45 kg (odmerek glede na BSA)
English: Overall survival
Slovenian: Celokupno preživetje
English: • Use the specific volumes described in the reconstitution and dilution instructions below to minimise errors in calculation.
Slovenian: • Uporabite specifične količine, opisane v navodilih za rekonstitucijo in razredčenje (spodaj), da bi zmanjšali napake pri izračunu.