FrancophonIA/ELRC3.0 huggingface dataset:
English: infections, or at a thrombocyte count below 25,000 cells/mm3, which is not caused by the disease.
Slovenian: Poleg tega je treba odmerek prilagoditi, če se pojavijo zvišana telesna temperatura, okužbe ali če je število trombocitov nižje od 25.000 celic/mm3 razen v primeru, ko je število celic zmanjšano zaradi same bolezni.
English: ETOPOPHOS and associated names is indicated in combination with other approved chemotherapeutic agents for the treatment of small-cell lung cancer in adults.
Slovenian: Zdravilo ETOPOPHOS in povezana imena je, v kombinaciji z drugimi odobrenimi kemoterapevtiki, indicirano za zdravljenje drobnoceličnega pljučnega raka pri odraslih.
English: See Annex I - To be completed nationally
Slovenian: Glejte Prilogo I - izpolni država članica.
English: The recommended dose of ETOPOPHOS and associated names in adult patients is 50 to 100 mg/m2/day (etoposide equivalent) on days 1 to 5 or 100 to 120 mg/m2 on days 1, 3, and 5 every 3 to 4
Slovenian: Priporočeni odmerek zdravila ETOPOPHOS in povezana imena pri odraslih bolnikih je 50 do 100 mg/m2/dan (ekvivalent etopozida), 1. do 5. dan ali 100 do 120 mg/m2, 1., 3. in 5. dan na vsake 3 do 4 tedne v kombinaciji z drugimi zdravili, odobreni za uporabo pri zdravljeni bolezni.
English: You must not breastfeed while you are receiving ETOPOPHOS and associated names.
Slovenian: Med jemanjem zdravila ETOPOPHOS in povezana imena ne smete dojiti.
English: ETOPOPHOS and associated names is used in the treatment of certain types of cancers in adults:
Slovenian: Zdravilo ETOPOPHOS in povezana imena uporabljamo za zdravljenje določenih vrst raka pri odraslih: - rak mod
English: After reconstitution, the solution can be administered without further dilution or it can be further diluted with 5% glucose solution or 0.9% sodium chloride solution to obtain concentrations as low as 0.1 mg/ml etoposide.
Slovenian: Raztopino lahko tudi nadalje razredčite z glukozo 50 mg/ml (5 %) raztopina ali natrijevim kloridom 9 mg/ml (0,9 %), da boste dobili nizke koncentracije 0,1 mg/ml etopozida.
English: Uncommon side effects (affecting between 1 in 100 and 1 in 1000 people) • tingling or numbness in hands and feet
Slovenian: Pogosti neželeni učinki (pojavijo se pri manj kot 1 od 10 bolnikov in več kot 1 od 100 bolnikov) • akutna levkemija
English: ETOPOPHOS and associated names 100mg Powder for Solution for Infusion ETOPOPHOS and associated names 1000mg Powder for Solution for Infusion [See Annex I - To be completed nationally]
Slovenian: ETOPOPHOS in povezana imena 100 mg prašek za raztopino za infundiranje ETOPOPHOS in povezana imena 1000 mg prašek za raztopino za infundiranje [Glejte Prilogo I - izpolni država članica.]
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION ETOPOPHOS and associated names 100 mg powder for solution for infusion [See Annex I - To be completed nationally]
Slovenian: IME ZDRAVILA IN POT(I) UPORABE ETOPOPHOS in povezana imena 100 mg prašek za raztopino za infundiranje [Glejte Prilogo I - izpolni država članica.]
English: ETOPOPHOS and associated names is indicated in combination with other approved chemotherapeutic agents for the treatment of acute myeloid leukaemia in adult and paediatric patients.
Slovenian: Zdravilo ETOPOPHOS in povezana imena je, v kombinaciji z drugimi odobrenimi kemoterapevtiki, indicirano za zdravljenje akutne mieloblastne levkemije pri odraslih in pri pediatričnih bolnikih.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION ETOPOPHOS and associated names 1000 mg powder for solution for infusion [See Annex I - To be completed nationally]
Slovenian: IME ZDRAVILA IN POT(I) UPORABE ETOPOPHOS in povezana imena 1000 mg prašek za raztopino za infundiranje [Glejte Prilogo I - izpolni država članica.]
English: Sodium citrate
Slovenian: SEZNAM POMOŽNIH SNOVI natrijev citrat dekstran 40
English: ETOPOPHOS and associated names is indicated in combination with other approved chemotherapeutic agents for the treatment of non-Hodgkin's lymphoma in adult and paediatric patients.
Slovenian: Zdravilo ETOPOPHOS in povezana imena je, v kombinaciji z drugimi odobrenimi kemoterapevtiki, indicirano za zdravljenje ne-Hodgkinovega limfoma pri odraslih in pri pediatričnih bolnikih.
English: Administration and Dosage
Slovenian: Dajanje in odmerjanje
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial Label (1000 mg)
Slovenian: Nalepka na viali (1000 mg)
English: ETOPOPHOS and associated names is indicated for first line and second line therapy in combination with other approved chemotherapeutic agents for the treatment of high risk gestational trophoblastic neoplasia in adults.
Slovenian: Zdravilo ETOPOPHOS in povezana imena je, v kombinaciji z drugimi odobrenimi kemoterapevtiki, indicirano za prvo in drugo linijo zdravljenja visokotvegane gestacijske trofoblastne neoplazije.
English: ETOPOPHOS and associated names is indicated in combination with other approved chemotherapeutic agents for the treatment of Hodgkin's lymphoma in adult and paediatric patients.
Slovenian: Zdravilo ETOPOPHOS in povezana imena je, v kombinaciji z drugimi odobrenimi kemoterapevtiki, indicirano za zdravljenje Hodgkinovega limfoma pri odraslih in pri pediatričnih bolnikih.
English: What ETOPOPHOS and associated names is and what it is used for
Slovenian: Kaj je zdravilo ETOPOPHOS in povezana imena in za kaj ga uporabljamo To zdravilo se imenuje ETOPOPHOS in povezana imena.
English: ETOPOPHOS and associated names is indicated in combination with other approved chemotherapeutic agents for the treatment of non-epithelial ovarian cancer in adults.
Slovenian: Zdravilo ETOPOPHOS in povezana imena je, v kombinaciji z drugimi odobrenimi kemoterapevtiki, indicirano za zdravljenje neepitelijskega raka jajčnikov pri odraslih.
English: Nadirs tend to occur earlier with intravenous administration compared to oral administration.
Slovenian: Najnižje vrednosti se običajno pojavijo prej v primeru intravenske kot v primeru peroralne uporabe.
English: The usual dose, based on etoposide, is 50 to100mg/m2 body surface area, daily for 5 days in a row or 100 to 120 mg/ m2 body surface area on days 1, 3 and 5.
Slovenian: Običajni odmerek, ki temelji na etopozidu, je 50 do 100 mg/m2 telesne površine dnevno, 5 dni zapored ali 100 do 120 mg/m2 telesne površine 1., 3. in 5. dan. Cikel zdravljenja se nato lahko ponovi glede na rezultate krvnih preiskav, vendar ne prej kot 21 dni po zaključku prvega cikla zdravljenja.
English: Date
Slovenian: DRUGI PODATKI
English: Reports of fever and infection were also very common in patients with neutropenia treated with etoposide phosphate.
Slovenian: Pri bolnikih z nevtropenijo, ki so se zdravili z etopozid fosfatom, so zelo pogosto poročali o zvišani telesni temperaturi in okužbah.
English: ETOPOPHOS and associated names contains
Slovenian: ETOPOPHOS in povezana imena.
English: • constipation
Slovenian: • krvavitev
English: - if you are taking any drugs with a similar mechanism of action as ETOPOPHOS and associated names.
Slovenian: - Če jemljete katera koli zdravila s podobnim načinom delovanja, kot ga ima zdravilo
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains etoposide 100 mg (as phosphate) Each vial contains etoposide 1000 mg (as phosphate)
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena viala vsebuje 100 mg etopozida (v obliki fosfata).
English: Each vial contains etoposide phosphate equivalent to etoposide 100 mg or 1000 mg as the active ingredient.
Slovenian: Ena viala vsebuje 100 mg ali 1000 mg etopozida v obliki etopozid fosfata.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial Label (100 mg)
Slovenian: Nalepka na viali (100 mg)
English: How to store ETOPOPHOS and associated names
Slovenian: Kaj vsebuje zdravilo ETOPOPHOS in povezana imena
English: Fatal myelosuppression has been reported following etoposide phosphate administration.
Slovenian: Po dajanju etopozid fosfata so poročali o smrti zaradi mielosupresije.
English: Myelosuppression (see section 4.4) with fatal outcome has been reported following administration of etoposide phosphate.
Slovenian: Po uporabi etopozid fosfata so poročali o smrti zaradi mielosupresije (glejte poglavje 4.4).
English: December 2025
Slovenian: decembra 2025
English: June 2020
Slovenian: junija 2020
English: Aseptic technique must be used.
Slovenian: Uporabiti je treba aseptično tehniko.
English: Adults >21 years
Slovenian: Odrasli, stari > 21 let
English: t1/2 (day)
Slovenian: t1/2 (dni)
English: Ask your doctor for advice on the best contraceptive method that you can use.
Slovenian: Posvetujte se z zdravnikom o najboljši kontracepcijski metodi, ki jo lahko uporabite.
English: Asparagine (µM)
Slovenian: Asparagin (µM)
English: There are no data available for elderly patients.
Slovenian: Podatki za starejše bolnike niso na voljo.
English: 8 months.
Slovenian: 8 mesecev
English: It should only be given in a hospital setting where appropriate resuscitation equipment is available.
Slovenian: Zdravilo se lahko daje samo v bolnišnici, kjer je na voljo primerna oprema za oživljanje.
English: CA Papaellinas Ltd.
Slovenian: Papaellinas Ltd.
English: Your physician will decide whether your disease requires treatment.
Slovenian: Zdravnik bo presodil, ali je treba vašo bolezen zdraviti.
English: Therapeutic efficacy was defined as a clinical improvement which did not meet the criteria for other beneficial outcomes.
Slovenian: Terapevtska učinkovitost je bila opredeljena kot klinično izboljšanje, ki ne izpolnjuje meril za druge ugodne izide.
English: In very rare cases, mild tremor in the fingers has been described.
Slovenian: V zelo redkih primerih je bil opisan blag tremor v prstih.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 14 January 2016
Slovenian: Datum prve odobritve: 14. januar 2016
English: Alteration of liver parameters is common.
Slovenian: Spremembe jetrnih parametrov so pogoste.
English: Medical equipment to treat allergic reactions will be available nearby.
Slovenian: V bližini bo na voljo medicinska oprema za zdravljenje alergijskih reakcij.
English: Specific populations
Slovenian: Specifične populacije
English: Patients should be monitored for changes in liver function parameters.
Slovenian: Bolnike moramo spremljati za spremembe v parametrih jetrne funkcije.
English: Not known: Pyrexia
Slovenian: Neznana: pireksija
English: Staff should be trained in how to handle and transfer the medicinal product (pregnant staff should be excluded from working with this medicinal product).
Slovenian: Osebje je treba usposobiti za ravnanje z zdravilom in njegov prenos (nosečnice s tem zdravilom ne smejo delati).
English: If higher volume is given, the dose should be divided and given at several injection sites.
Slovenian: Če dajemo večji volumen, moramo odmerek razdeliti in ga dati na več mestih injiciranja.
English: All items for administration or cleaning, including gloves, should be placed in high-risk waste disposal bags for high-temperature incineration.
Slovenian: Vse predmete, namenjene dajanju ali čiščenju, vključno z rokavicami, je treba odložiti v vreče za odpadke z visokim tveganjem, namenjene sežiganju pri visokih temperaturah.
English: In general, incidence and type of adverse reactions Grade 3 and 4 were similar between the two treatment groups.
Slovenian: Na splošno sta bili pojavnost in vrsta neželenih učinkov 3. in 4. stopnje podobni v obeh skupinah zdravljenja.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.
Slovenian: Nosečnost in dojenje Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden uporabite to zdravilo.
English: The proportion of patients with this level of depletion was similar between the 2 study arms during all 3 phases of treatment at the protocol-specified time points.
Slovenian: Delež bolnikov s takšnim upadom je bil podoben v obeh skupinah študije v vseh 3 fazah zdravljenja ob časovnih točkah, opredeljenih v protokolu.
English: Tell your doctor if any of these conditions apply to you.
Slovenian: Obvestite zdravnika, če kaj od navedenega velja za vas.
English: ALL is a white blood cell cancer type in which certain immature white cells (named lymphoblasts) start growing out of control thus preventing the production of functional blood cells.
Slovenian: ALL je vrsta raka belih krvnih celic, pri katerem se začne število določenih nezrelih belih krvnih celic (imenovanih limfoblasti) nenadzorovano povečevati in s tem prepreči nastajanje delujočih krvnih celic.
English: This can promote the tendency to bleeding and/or thrombosis.
Slovenian: To lahko spodbuja nagnjenost h krvavitvam in/ali k trombozi.
English: During Oncaspar administration you will be closely watched for an hour after the start of treatment for any signs of serious allergic reactions.
Slovenian: Med dajanjem zdravila Oncaspar vas bodo eno uro po začetku zdravljenja natančno spremljali glede morebitnih znakov resne alergijske reakcije.
English: This leaflet was last revised in
Slovenian: Navodilo je bilo nazadnje revidirane dne
English: You should not use Oncaspar if you are pregnant because its effects during pregnancy have not been studied.
Slovenian: Zdravila Oncaspar ne smete uporabljati, če ste noseči, ker njegovih učinkov med nosečnostjo niso preučevali.
English: Normal cells can make asparagine for themselves, while some cancer cells cannot.
Slovenian: Normalne celice lahko same proizvajajo asparagin, nekatere rakave celice pa ga ne morejo.
English: Men must also use effective contraception while they or their partners are treated with Oncaspar.
Slovenian: Tudi moški morajo uporabljati učinkovito kontracepcijo, medtem ko se sami ali njihove partnerice zdravijo z zdravilom Oncaspar.
English: If symptoms of hyperammonaemia exist, ammonia levels should be monitored closely.
Slovenian: Če se pojavijo simptomi hiperamoniemije, moramo ravni amoniaka natančno spremljati.
English: - vincristine, another cancer medicine.
Slovenian: - vinkristin (drugo zdravilo za raka).
English: In case of overdose, patients must be carefully monitored for signs and symptoms of adverse reactions, and appropriately managed with symptomatic and supportive treatment.
Slovenian: V primeru prevelikega odmerjanja moramo bolnike skrbno spremljati glede znakov in simptomov neželenih učinkov in jih ustrezno obravnavati s simptomatskim in podpornim zdravljenjem.
English: Cmax (mU/mL)* Tmax (hr)*
Slovenian: Cmax (me./ml)* Tmax (h)*
English: Warning: special handling instructions (see package leaflet)
Slovenian: Opozorilo: posebna navodila za ravnanje (glejte navodilo za uporabo).
English: Elderly There are limited data available for patients older than 65 years.
Slovenian: Starejši bolniki Podatkov pri bolnikih, starejših od 65 let, je malo.
English: In severe cases, encephalopathy can develop with or without hepatic impairment, especially in older adults, which can be life-threatening or fatal.
Slovenian: V hudih primerih se lahko pojavi encefalopatija z jetrno okvaro ali brez nje, zlasti pri starejših bolnikih, ki je lahko življenjsko nevarna ali smrtna.
English: The controlled studies were not designed to formally evaluate the pharmacokinetics of Oncaspar in specific populations.
Slovenian: Nadzorovane študije niso bile načrtovane za formalno ocenjevanje farmakokinetike zdravila Oncaspar v specifičnih populacijah.
English: Investigations of the effect on fertility and peri- and postnatal development were not conducted.
Slovenian: Raziskave učinkov na plodnost in peri-/postnatalni razvoj niso bile opravljene.
English: Therefore, vincristine should be given at least 12 hours prior to administration of Oncaspar in order to minimise toxicity.
Slovenian: Zato je treba vinkristin dati vsaj 12 ur pred dajanjem zdravila Oncaspar, da se toksičnost zmanjša na najmanjšo možno mero.
English: Due to the risk of hyperbilirubinaemia, it is recommended to monitor bilirubin levels at baseline and prior to each dose.
Slovenian: Zaradi tveganja za hiperbilirubinemijo je priporočljivo spremljati ravni bilirubina na začetku in pred vsakim odmerkom.
English: If these substances are given subsequently, the effect of pegaspargase can be weakened antagonistically.
Slovenian: Če ti učinkovini damo naknadno, je lahko učinek pegaspargaze antagonistično oslabljen.
English: In the unlikely event of accidental overdose, you will be monitored carefully by medical staff and treated appropriately.
Slovenian: V malo verjetnem primeru nenamernega prevelikega odmerjanja vas bo zdravstveno osebje skrbno spremljalo in ustrezno zdravilo.
English: Severe hepatic impairment (bilirubin >3 times upper limit of normal [ULN]; transaminases >10 times ULN).
Slovenian: Huda jetrna okvara (bilirubin > 3-kratna zgornja meja normalnih vrednosti [ULN]; transaminaze > 10-kratna ULN).
English: Reduced splenic weight might be a sign of potential immunosuppressant effect of the treatment.
Slovenian: Zmanjšana masa vranice je lahko znak potencialnega imunosupresivnega učinka zdravljenja.
English: Oncaspar is used together with other medicines.
Slovenian: Zdravilo Oncaspar se uporablja skupaj z drugimi zdravili.
English: Oncaspar contains pegaspargase, which is an enzyme (asparaginase) that breaks down asparagine, an important building block of proteins without which cells cannot survive.
Slovenian: Zdravilo Oncaspar vsebuje pegaspargazo, encim (asparaginazo), ki razgrajuje asparagin, pomemben gradnik beljakovin, brez katerih celice ne morejo preživeti.
English: Based on its pharmacological properties, any risk to the breast-fed newborns/infants cannot be excluded.
Slovenian: Zaradi farmakoloških lastnosti zdravila tveganja za dojenega novorojenca/otroka ne moremo izključiti.
English: - medicines which require cell division for their effect, for example, methotrexate (a medicine used for cancer as well as arthritis treatment) may have a decrease in its effect.
Slovenian: - zdravila, ki za svoje delovanje zahtevajo celično delitev, npr. metotreksat (zdravilo, ki se uporablja za zdravljenje raka in artritisa), imajo lahko manjši učinek;
English: Grade 3 or higher febrile neutropenia was 15.4%.
Slovenian: Febrilne nevtropenije 3. stopnje ali višje je bilo 15,4 %.
English: When there is a marked decrease in fibrinogen or antithrombin III (ATIII) deficiency, consider appropriate replacement therapy.
Slovenian: V primeru izrazitega znižanja ravni fibrinogena ali pomanjkanja antitrombina III (ATIII) moramo razmisliti o ustreznem nadomestnem zdravljenju.
English: AUC0-t (mUday/mL)* AUC0-∞ (mUday/mL)
Slovenian: AUC0-t (me.dan/ml)* AUC0-∞ (me.dan/ml)
English: Treatment may be monitored based on the trough serum asparaginase activity measured before the next administration of pegaspargase.
Slovenian: Zdravljenje se lahko spremlja na podlagi aktivnosti serumske asparaginaze, izmerjene pred naslednjim dajanjem pegaspargaze.
English: Neutralising antibodies reducing clinical efficacy were also recorded.
Slovenian: Zaznali so tudi nevtralizirajoča protitelesa, ki so zmanjšala klinično učinkovitost.
English: The protocol-specified goal was achievement of asparagine depletion to a serum concentration of ≤1 µM.
Slovenian: Cilj, opredeljen v protokolu, je bil doseči upad ravni asparagina na serumsko koncentracijo ≤ 1 µM.
English: Arithmetic Mean (SD)
Slovenian: Aritmetična sredina (SD)
English: Days After First Dose of L-Asparaginase
Slovenian: Dni po prvem odmerku L-asparaginaze
English: Carcinogenicity, mutagenicity, fertility
Slovenian: Karcinogenost, mutagenost, plodnost
English: The decrease in serum proteins caused by pegaspargase can increase the toxicity of other medicinal products that are protein bound.
Slovenian: Znižanje ravni serumskih beljakovin, ki jih povzroči pegaspargaza, lahko poveča toksičnost drugih zdravil, ki se vežejo na beljakovine.
English: A pilot study was conducted for newly diagnosed patients from 1 to <31 years of age with high risk B-precursor ALL (Study AALL07P4).
Slovenian: Opravljena je bila pilotna študija pri bolnikih, starih od 1 do < 31 let, z novo diagnozo ALL B-prekurzorjev z visokim tveganjem (študija AALL07P4).
English: It is not known whether pegaspargase is excreted into the breast milk.
Slovenian: Ni znano, ali se pegaspargaza izloča v materino mleko.
English: For storage conditions of the reconstituted and diluted medicinal product, see section 6.3.
Slovenian: Za pogoje shranjevanja rekonstituiranega in razredčenega zdravila glejte poglavje 6.3.
English: Treatment was administered during Induction (Day 7), and then every 2 weeks for a total of 30 weeks post-Induction therapy.
Slovenian: Zdravljenje so dali med indukcijo (7. dan) in nato vsake 2 tedna skupno 30 tednov po indukcijskem zdravljenju.
English: This medicine can lead to fluctuations in clotting factors and may increase the risk of bleeding and/or clotting.
Slovenian: To zdravilo lahko povzroči nihanja ravni faktorjev strjevanja krvi in poveča tveganje za krvavitve in/ali strjevanje krvi.
English: The decrease in the number of circulating lymphoblasts is often quite marked, and normal or too low leukocyte counts are often seen in the first days after the start of therapy.
Slovenian: Zmanjšanje števila limfoblastov v obtoku je zelo izrazito in v prvih dneh po začetku zdravljenja je pogosto opaziti normalno ali prenizko število levkocitov.
English: Therefore, use of Oncaspar could increase the risk of infections.
Slovenian: Zato lahko uporaba zdravila Oncaspar poveča tveganje za okužbe.
English: A rise in serum urea occurs regularly, is dose-independent and nearly always a sign of pre-renal metabolic imbalance.
Slovenian: Zvišanje ravni sečnine v serumu se pojavlja redno, je neodvisno od odmerka in skoraj vedno znak predledvičnega presnovnega neravnovesja.
English: The vial should be gently swirled until the powder is reconstituted.
Slovenian: Vialo je treba narahlo vrteti, dokler se prašek ne raztopi.
English: Not known: Confusional state
Slovenian: Neznana: stanje zmedenosti
English: If not used immediately, in-use storage times and conditions are the responsibility of the user.
Slovenian: Če se zdravilo ne uporabi takoj, je za čase shranjevanja in pogoje pred uporabo odgovoren uporabnik.
English: In such cases, a switch to a different asparaginase preparation should be considered.
Slovenian: V takšnih primerih je treba razmisliti o prehodu na drugo zdravilo z asparaginazo.
English: Asparagine concentration fell to <3 µM when asparaginase activity was >0.1 U/mL.
Slovenian: Raven asparagina je upadla za < 3 µM, če je bila aktivnost asparaginaze > 0,1 e./ml.
English: For instructions on reconstitution and dilution of this medicinal product before administration, see section 6.6.
Slovenian: Za navodila glede rekonstitucije in redčenja tega zdravila pred dajanjem glejte poglavje 6.6.
English: There is no specific pharmacological treatment for the overdose.
Slovenian: Specifičnega farmakološkega zdravljenja za preveliko odmerjanje ni.
English: Simultaneous vaccination with live vaccines may increase the risk of severe infections attributable to the immunosuppressive activity of pegaspargase, the presence of the underlying disease and combination chemotherapy (see section 4.4).
Slovenian: Sočasno cepljenje z živimi cepivi lahko poveča tveganje za hude okužbe, kar je posledica imunosupresivne aktivnosti pegaspargaze, prisotnosti osnovne bolezni in kombinirane kemoterapije (glejte poglavje 4.4).
English: Common: Hypoxia
Slovenian: Pogosti: hipoksija
English: It should be explained to patients that Oncaspar should not be used at the same time as other medicines associated with an increased risk of bleeding (see section 2 “Other medicines and Oncaspar”).
Slovenian: Bolnikom moramo pojasniti, da se zdravilo Oncaspar ne sme uporabljati sočasno z drugimi zdravili, povezanimi s povečanim tveganjem za krvavitev (glejte poglavje 2 Druga zdravila in zdravilo Oncaspar).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1070/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1070/001
English: Table 2: Event-free survival rate at 3, 5 and 7 years (Study CCG-1962)
Slovenian: Preglednica 2: Preživetje brez dogodkov po 3, 5 in 7 letih (študija CCG-1962)