FrancophonIA/ELRC3.0 huggingface dataset:
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]
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA ETOPOPHOS i pridružena imena 1000 mg prašak za otopinu za infuziju [Vidjeti Prilog I.
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]
Croatian: ETOPOPHOS i pridružena imena 100 mg prašak za otopinu za infuziju ETOPOPHOS i pridružena imena 1000 mg prašak za otopinu za infuziju [Vidjeti Prilog I.
English: ETOPOPHOS and associated names is indicated in combination with other approved chemotherapeutic agents for the treatment of non-epithelial ovarian cancer in adults.
Croatian: ETOPOPHOS i pridružena imena indiciran je u kombinaciji s drugim odobrenim kemoterapeuticima za liječenje neepitelnog raka jajnika u odraslih.
English: ETOPOPHOS and associated names (see Annex 1) 100 mg powder for solution for infusion ETOPOPHOS and associated names (see Annex 1) 1000 mg powder for solution for infusion [See Annex I - To be completed nationally]
Croatian: ETOPOPHOS i pridružena imena (vidjeti Prilog I.) 100 mg prašak za otopinu za infuziju ETOPOPHOS i pridružena imena (vidjeti Prilog I.) 1000 mg prašak za otopinu za infuziju [Vidjeti Prilog I.
English: Administration and Dosage
Croatian: Primjena i doziranje
English: PHARMACEUTICAL FORM AND CONTENTS [To be completed nationally]
Croatian: 14. NAČIN IZDAVANJA LIJEKA [Ispunjava država članica]
English: Bacterial infections should be brought under control before treatment with ETOPOPHOS and associated names.
Croatian: Prije liječenja ETOPOPHOSOM i pridruženim imenima, bakterijske infekcije treba dovesti pod kontrolu.
English: • infertility
Croatian: • proljev
English: doses) for these findings at the no-observed adverse-effect-level in the preclinical studies were ≥ approximately
Croatian: Višekratnik doze (na osnovu doza u mg/m 2) za te nalaze pri razini bez opaženog štetnog učinka u pretkliničkim ispitivanjima iznosio je ≥ približno 0,05 puta u usporedbi s najvišom kliničkom dozom.
English: You must not breastfeed while you are receiving ETOPOPHOS and associated names.
Croatian: Tijekom uzimanja ETOPOPHOSA i pridruženih imena, ne smijete dojiti.
English: Frequency Adverse Reaction (MedDRA Terms)
Croatian: Poremećaji imunološkog sustava često anafilaktičke reakcije**
English: December 2025
Croatian: prosinac 2025.
English: Ask your doctor for advice on the best contraceptive method that you can use.
Croatian: Upitajte liječnika za savjet o najboljoj metodi kontracepcije koju možete upotrijebiti.
English: 8 months.
Croatian: 8 mjeseci.
English: Aseptic technique must be used.
Croatian: Mora se koristiti aseptička tehnika.
English: In very rare cases, mild tremor in the fingers has been described.
Croatian: U vrlo rijetkim slučajevima opisan je blagi tremor u prstima.
English: It should only be given in a hospital setting where appropriate resuscitation equipment is available.
Croatian: Smije se davati samo u bolničkom okruženju u kojem je dostupna odgovarajuća oprema za oživljavanje.
English: Your physician will decide whether your disease requires treatment.
Croatian: Vaš će liječnik odlučiti treba li Vašu bolest liječiti.
English: Asparagine (µM)
Croatian: Asparagin (µM)
English: There have been isolated reports of formation of pseudocysts (up to four months after the last treatment).
Croatian: Postoje izolirana izvješća o stvaranju pseudocista (do četiri mjeseca nakon posljednje terapije).
English: PK Parameters
Croatian: PK parametri
English: CA Papaellinas Ltd.
Croatian: Papaellinas Ltd.
English: Therapeutic efficacy was defined as a clinical improvement which did not meet the criteria for other beneficial outcomes.
Croatian: Terapijska djelotvornost definirana je kao kliničko poboljšanje koje nije ispunilo kriterije ostalih blagotvornih ishoda.
English: For more information, see section 5.1.
Croatian: Za dodatne informacije, vidjeti dio 5.1.
English: Allergic reactions can manifest in the skin.
Croatian: Alergijske reakcije mogu se manifestirati na koži.
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).
Croatian: Osoblje treba obučiti o načinu rukovanja i prijenosu lijeka (trudnice treba izuzeti od rada s ovim lijekom).
English: Medical equipment to treat allergic reactions will be available nearby.
Croatian: Medicinska oprema za liječenje alergijskih reakcija bit će odmah dostupna.
English: This will increase the risk of severe infections.
Croatian: To će povećati rizik od teških infekcija.
English: No statistically significant differences in PK characteristics between male and female subjects were identified in this analysis.
Croatian: U ovoj analizi nisu identificirane statistički značajne razlike u PK karakteristikama između muškaraca i žena.
English: t1/2 (day)
Croatian: t1/2 (dan)
English: There are no data available for elderly patients.
Croatian: Nema podataka koji se odnose na starije bolesnike.
English: Your doctor will decide what dose of the medicine is needed and how often, based on your age and body surface area which is calculated from your height and weight.
Croatian: Vaš će liječnik odlučiti koja je doza lijeka potrebna i koliko često, na temelju vaše dobi i površine tijela što se izračunava na temelju
English: In case of contact, irrigate with plenty of water for at least 15 minutes.
Croatian: U slučaju kontakta ispirite s puno vode najmanje 15 minuta.
English: Elderly There are limited data available for patients older than 65 years.
Croatian: Dostupni podaci koji se odnose na bolesnike starije od 65 godina su ograničeni.
English: * N=47 evaluable subjects.
Croatian: * N=47 ocjenjivih ispitanika.
English: - if you have had poor liver function or are using other medicines which may harm the liver.
Croatian: - ako imate slabu jetrenu funkciju ili koristite druge lijekove koji možda štete jetri.
English: Not known: Pyrexia
Croatian: Nepoznato: pireksija
English: If higher volume is given, the dose should be divided and given at several injection sites.
Croatian: Ako se daje veći volumen, dozu treba podijeliti i injicirati na nekoliko mjesta.
English: - vincristine, another cancer medicine.
Croatian: - vinkristin, drugi lijek protiv raka.
English: Oncaspar is used together with other medicines.
Croatian: Oncaspar se koristi zajedno s drugim lijekovima.
English: Talk to your doctor before you are given Oncaspar.
Croatian: Obratite se svojem liječniku prije nego što primite Oncaspar.
English: As your doctor will administer the medicine, it is very unlikely you will be given more than you need.
Croatian: Budući da će lijek primjenjivati liječnik, malo je vjerojatno da ćete primiti više lijeka nego što trebate.
English: During Oncaspar administration you will be closely watched for an hour after the start of treatment for any signs of serious allergic reactions.
Croatian: Tijekom primjene lijeka Oncaspar, pozorno će vas se promatrati tijekom sat vremena nakon početka liječenja radi mogućih znakova ozbiljnih alergijskih reakcija.
English: You should not use Oncaspar if you are pregnant because its effects during pregnancy have not been studied.
Croatian: Ne biste smjeli primiti Oncaspar ako ste trudni jer njegovo djelovanje tijekom trudnoće nije proučavano.
English: In the unlikely event of accidental overdose, you will be monitored carefully by medical staff and treated appropriately.
Croatian: U malo vjerojatnom događaju slučajnog predoziranja, pažljivo će vas nadzirati medicinsko osoblje i odgovarajuće liječiti.
English: The clinical study report should be submitted by:
Croatian: Izvješće kliničkog ispitivanja treba dostaviti do datuma:
English: Additional monitoring tests
Croatian: Dodatni testovi praćenja
English: Not known: Confusional state
Croatian: Nepoznato: konfuzno stanje
English: Increased serum glutamic pyruvic transaminase activity also occurred in one out of four dogs.
Croatian: Povećana aktivnost serumske glutamat-piruvat transaminaze također se pojavila u jednog od četiri psa.
English: Reduced splenic weight might be a sign of potential immunosuppressant effect of the treatment.
Croatian: Smanjena težina slezene može biti znak potencijalno imunosupresivnog učinka liječenja.
English: Treatment was administered during Induction (Day 7), and then every 2 weeks for a total of 30 weeks post-Induction therapy.
Croatian: Terapija je primijenjena tijekom indukcije (7. dan) i svaka 2 tjedna u ukupno 30 tjedana postindukcijske terapije.
English: Tell your doctor if any of these conditions apply to you.
Croatian: Obratite se svom liječniku ako se neki od ovih uvjeta odnose na vas.
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.
Croatian: Smanjenje broja cirkulirajućih limfoblasta često je prilično izraženo, a normalni ili preniski broj leukocita često se primjećuju u prvim danima nakon početka terapije.
English: The vial should be gently swirled until the powder is reconstituted.
Croatian: Bočicu treba nježno vrtjeti dok se prašak ne rekonstituira.
English: Do not drive or use machines when using this medicine because it may make you feel drowsy, tired or confused.
Croatian: Nemojte upravljati vozilima niti koristiti strojeve kada primjenjujete ovaj lijek jer se zbog njega možete osjećati omamljeno, umorno ili smeteno.
English: June 2020
Croatian: lipanj 2020.
English: There is no specific pharmacological treatment for the overdose.
Croatian: Nema specifičnog farmakološkog liječenja za predoziranje.
English: Blood and urine sugar levels, liver and pancreas function and other tests will be carried out regularly to monitor your health during and after treatment because this medicine can affect your blood and other organs.
Croatian: Razina šećera u krvi i urinu, funkcije jetre i gušterače i ostale pretrage redovito će se provoditi kako bi se pratilo vaše zdravlje tijekom i nakon liječenja jer ovaj lijek može utjecati na vašu krv i ostale organe.
English: In general, incidence and type of adverse reactions Grade 3 and 4 were similar between the two treatment groups.
Croatian: Općenito je incidencija i vrsta nuspojava 3. i 4. stupnja bila slična između dvije liječene skupine.
English: The potency of this medicinal product should not be compared to the one of another pegylated or non-pegylated protein of the same therapeutic class.
Croatian: Jačina ovog lijeka ne smije se uspoređivati s nekim od drugih pegiliranih ili nepegiliranih proteina iste terapijske skupine.
English: Asparagine concentration fell to <3 µM when asparaginase activity was >0.1 U/mL.
Croatian: Koncentracija asparagina pala je na <3 µM kada je aktivnost asparaginaze iznosila >0,1 U/ml.
English: Days After First Dose of L-Asparaginase
Croatian: Dani nakon prve doze L-asparaginaze
English: AUC0-t (mUday/mL)* AUC0-∞ (mUday/mL)
Croatian: AUC0-t (mUdan/ml)* AUC0-∞ (mUdan/ml)
English: ǂ N= 46 evaluable subjects.
Croatian: N= 46 ocjenjivih ispitanika.
English: Oncaspar is for single use only.
Croatian: Oncaspar je samo za jednokratnu uporabu.
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.
Croatian: ALL je vrsta raka bijelih krvnih stanica u kojem pojedine nezrele bijele krvne stanice (nazvane limfoblasti) počinju nekontrolirano rasti čime sprječavaju proizvodnju funkcionalnih krvnih stanica.
English: In such cases, a switch to a different asparaginase preparation should be considered.
Croatian: U tim slučajevima treba se razmotriti prebacivanje na drugi pripravak asparaginaze.
English: Randomisation of patients was stratified based on risk group (standard/high/very high risk), including both B- and T-cell ALL.
Croatian: Randomizacija bolesnika stratificirana je na temelju rizične skupine (standardni/visok/vrlo visok rizik), uključujući B- i T-stanični ALL.
English: Adverse reactions were loss of body weight, piloerection and reduced activity.
Croatian: Nuspojave su bile gubitak tjelesne težine, piloerekcija i smanjena aktivnost.
English: If these substances are given subsequently, the effect of pegaspargase can be weakened antagonistically.
Croatian: Ako se te tvari daju naknadno, djelovanje pegaspargaze može se antagonistički oslabiti.
English: All items for administration or cleaning, including gloves, should be placed in high-risk waste disposal bags for high-temperature incineration.
Croatian: Sve stavke za primjenu ili čišćenje, uključujući rukavice, trebaju se staviti u vrećice za zbrinjavanje otpada visokog rizika za spaljivanje pri visokim temperaturama.
English: The controlled studies were not designed to formally evaluate the pharmacokinetics of Oncaspar in specific populations.
Croatian: Kontrolirana ispitivanja nisu ustrojena za formalno ocjenjivanje farmakokinetike lijeka Oncaspar u posebnim populacijama.
English: If you are the parent of a child being treated with Oncaspar, tell the doctor if any of the above conditions apply to your child.
Croatian: Ako ste roditelj djeteta koje se liječi lijekom Oncaspar, recite liječniku ako se neko od gore navedenih stanja odnosi na Vaše dijete.
English: Multiple malformations and embryolethal effects were observed with doses in the therapeutic range.
Croatian: Višestruke malformacije i embrioletalni učinci zabilježeni su pri dozama u terapijskom rasponu.
English: This medicine can lead to fluctuations in clotting factors and may increase the risk of bleeding and/or clotting.
Croatian: Ovaj lijek može uzrokovati fluktuacije faktora zgrušavanja i može povećati rizik od krvarenja i/ili zgrušavanja.
English: What you need to know before you are given Oncaspar
Croatian: Što morate znati prije nego što počnete primati Oncaspar
English: Oncaspar has major influence on the ability to drive and use machines.
Croatian: Oncaspar značajno utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Normal cells can make asparagine for themselves, while some cancer cells cannot.
Croatian: Normalne stanice mogu same proizvesti asparagin, ali neke stanice raka to ne mogu.
English: Therefore, vincristine should be given at least 12 hours prior to administration of Oncaspar in order to minimise toxicity.
Croatian: Stoga, vinkristin treba primijeniti najmanje 12 sati prije primjene lijeka Oncaspar radi smanjenja toksičnosti na najmanju moguću mjeru.
English: Oncaspar contains pegaspargase, which is an enzyme (asparaginase) that breaks down asparagine, an important building block of proteins without which cells cannot survive.
Croatian: Oncaspar sadrži pegaspargazu, enzim (asparginaza) koji razgrađuje asparagin, važan gradivni element proteina bez kojeg stanice ne mogu preživjeti.
English: Patients should be informed of the signs and symptoms of pancreatitis which, if left untreated, could become fatal.
Croatian: Bolesnike treba obavijestiti o znakovima i simptomima pankreatitisa koji, u slučaju neliječenja, može biti smrtonosan.
English: Asparaginase facilitates the rapid conversion of asparagine and glutamine to aspartic acid and glutamic acid, with ammonia as the shared by-product of both reactions (see section 5.1).
Croatian: Asparaginaza omogućuje brzu konverziju asparagina i glutamina u aspartatnu kiselinu i glutamatnu kiselinu, uz amonijak kao zajednički nusprodukt obje reakcije (vidjeti dio 5.1).
English: This should be taken into account when considering the use of Oncaspar in these patient populations.
Croatian: To treba uzeti u obzir pri razmatranju primjene lijeka Oncaspar u populaciji tih bolesnika.
English: The medicine is given as a solution by injection into a muscle or, if more suitable, into a vein.
Croatian: Lijek se daje kao otopina injekcijom u mišić ili, ako je prikladnije, u venu.
English: Carcinogenicity, mutagenicity, fertility
Croatian: Karcinogenost, mutagenost, plodnost
English: If symptoms of hyperammonaemia exist, ammonia levels should be monitored closely.
Croatian: Ako postoje simptomi hiperamonemije, pažljivo treba pratiti razine amonijaka.
English: When there is a marked decrease in fibrinogen or antithrombin III (ATIII) deficiency, consider appropriate replacement therapy.
Croatian: Kada dođe do izrazitog smanjenja fibrinogena ili nedostatka antitrombina III (ATIII), razmotrite odgovarajuću nadomjesnu terapiju.
English: In addition, it is especially important to tell your doctor if you are also using any of the following medicines: - immunisation with live vaccines within three months of completing your leukaemia treatment.
Croatian: Pored toga, jako je važno da liječniku kažete ako koristite i bilo koji od sljedećih lijekova: - cijepljenje živim cjepivom unutar tri mjeseca nakon dovršetka liječenja leukemije.
English: Based on its pharmacological properties, any risk to the breast-fed newborns/infants cannot be excluded.
Croatian: Na temelju farmakoloških svojstava lijeka, nije moguće isključiti rizik za dojenu novorođenčad/dojenčad.
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.
Croatian: U slučaju predoziranja bolesnici se moraju pažljivo nadzirati radi znakova i simptoma nuspojava, te odgovarajuće liječiti simptomatskom i suportivnom terapijom.
English: Patients should be monitored for changes in liver function parameters.
Croatian: Potrebno je pratiti bolesnike kako bi se uočile promjene u parametrima funkcije jetre.
English: Neutralising antibodies reducing clinical efficacy were also recorded.
Croatian: Također su zabilježena neutralizirajuća protutijela koja smanjuju kliničku djelotvornost.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 14 January 2016
Croatian: Datum prvog odobrenja: 14. siječnja 2016.
English: Oncaspar can also cause changes in liver function which can affect the way other medicines work.
Croatian: Oncaspar može također uzrokovati promjene u funkciji jetre koje mogu utjecati na način djelovanja drugih lijekova.
English: Warning: special handling instructions (see package leaflet)
Croatian: Upozorenje: posebne upute za rukovanje (vidjeti uputu o lijeku)
English: This can promote the tendency to bleeding and/or thrombosis.
Croatian: To može pojačati sklonost krvarenju i/ili trombozi.
English: The powder must be reconstituted with 5.2 ml water for injections prior to administration (see section 4.2).
Croatian: Prašak se mora rekonstituirati s 5,2 ml vode za injekcije prije primjene (vidjeti dio 4.2).
English: Investigations of the effect on fertility and peri- and postnatal development were not conducted.
Croatian: Nisu provedena istraživanja o učinku na plodnost te perinatalni i postnatalni razvoj.
English: Serum asparagine concentrations of approximately 1 µM persisted for approximately 3 weeks.
Croatian: Serumske koncentracije asparagina od približno 1 µM održale su se približno 3 tjedna.
English: What Oncaspar is and what it is used for
Croatian: Što je Oncaspar i za što se koristi
English: Overall, from five studies analysed based on 65 ALL patients exposed to Oncaspar using the highest therapeutic response during the entire study, complete remission was observed in 30 patients (46%), partial remission in 7 patients (11%) and haematological improvement in 1 patient (2%).
Croatian: Sveukupno, iz pet analiziranih ispitivanja temeljenih na 65 bolesnika oboljelih od ALL-a izloženih lijeku Oncaspar na temelju najvećeg terapijskog odgovora tijekom cijelog ispitivanja, u 30 je bolesnika primijećena potpuna remisija (46%), u 7 bolesnika djelomična remisija (11%) a hematološka poboljšanja kod 1 bolesnika (2%).
English: Impaired protein synthesis can lead to a decline in the serum proteins.
Croatian: Oštećena sinteza proteina može dovesti do smanjenja serumskih proteina.
English: No reproduction studies in animals with pegaspargase were performed but studies in animals with L-asparaginase have shown teratogenicity (see section 5.3).
Croatian: Nisu provedena ispitivanja reprodukcije s pegaspargazom kod životinja, no ispitivanja u životinja s L-asparaginazom pokazala su teratogenost (vidjeti dio 5.3).
English: Frequencies are defined by the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
Croatian: Učestalosti su definirane sljedećom konvencijom: vrlo često (≥1/10), često (≥1/100 i <1/10), manje često (≥1/1000 i <1/100), rijetko (≥1/10 000 i <1/1000), vrlo rijetko (<1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Your treatment with Oncaspar has been prescribed by a doctor experienced in medicines used to treat cancer.
Croatian: Vaše liječenje lijekom Oncaspar propisao je liječnik s iskustvom u lijekovima koji se koriste za liječenje raka.
English: Serum amylase can rise during and also after the conclusion of Oncaspar therapy.
Croatian: Serumska amilaza može se povećati tijekom i nakon završetka liječenja lijekom Oncaspar.
English: Grade 3 or higher febrile neutropenia was 15.4%.
Croatian: Stopa učestalost febrilne neutropenije 3. stupnja ili većeg bila je 15,4%.
English: Overall, in the group receiving Oncaspar, the rate of all grade hypersensitivity was 5.8%, anaphylactic reactions was 19.2%, and pancreatitis 7.7%.
Croatian: Sveukupno, u skupini koja je primala Oncaspar stopa učestalosti reakcija preosjetljivosti svih stupnjeva bila je 5,8%, anafilaktičkih reakcija 19,2% i pankreatitisa 7,7%.
English: 5.2 ml water for injections are injected into the vial using a syringe and 21 gauge needle.
Croatian: 5,2 ml vode za injekcije injicira se u bočicu pomoću štrcaljke i igle od 21 gauge.
English: From a microbiological point of view, the product should be used immediately.
Croatian: S mikrobiološkog gledišta, lijek treba odmah upotrijebiti.
English: Oncaspar should be discontinued in patients with serious hypersensitivity reactions (see sections 4.3 and 4.8).
Croatian: Oncaspar treba prekinuti u bolesnika s ozbiljnim reakcijama preosjetljivosti (vidjeti dio 4.3 i 4.8).
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.
Croatian: Udio bolesnika s ovom razinom pada bio je sličan u dvije ispitivane skupine tijekom sve 3 faze liječenja u vremenskim točkama određenima u planu ispitivanja.
English: The mean half-life after absorption from the injection site was 1.7 days and the elimination half-life was 5.5 days.
Croatian: Srednja vrijednost poluvijeka nakon apsorpcije iz mjesta injekcije iznosila je 1,7 dana, a poluvijek eliminacije 5,5 dana.
English: In severe cases, encephalopathy can develop with or without hepatic impairment, especially in older adults, which can be life-threatening or fatal.
Croatian: U teškim slučajevima, moguć je razvoj encefalopatije uz oštećenje ili bez oštećenja funkcije jetre, posebno u starijih odraslih bolesnika, a to može ugroziti život ili biti smrtonosno.
English: Only very high doses of pegaspargase given to mice intraperitoneally as a single dose (25,000100,000 U/kg body weight) caused the death of 14% of all treated mice.
Croatian: Samo su vrlo visoke doze pegasparaze koje su davane miševima intraperitonealno kao jedna doza (25000 - 100000 U/kg tjelesne težine) uzrokovale smrt 14% svih tretiranih miševa.
English: For instructions on reconstitution and dilution of this medicinal product before administration, see section 6.6.
Croatian: Za upute o rekonstituciji i razrjeđivanju ovog lijeka prije primjene vidjeti dio 6.6.
English: What Oncaspar looks like and contents of the pack Oncaspar is a clear, colourless solution for injection contained in a glass vial.
Croatian: Kako Oncaspar izgleda i sadržaj pakiranja Oncaspar je bistra, bezbojna otopina za injekciju sadržana u staklenoj bočici.