FrancophonIA/ELRC3.0 huggingface dataset:
English: A decision must be made whether to discontinue breastfeeding or to discontinue VEPESID and associated names, taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman (see section 4.3).
Croatian: Potrebno je odlučiti hoće li se prekinuti dojenje ili prekinuti liječenje VEPESIDOM i pridruženim imenima, uzimajući pritom u obzir korist dojenja za dijete i korist terapije za majku (vidjeti dio 4.3).
English: Etoposide has been shown to be teratogenic in mice and rats (see section 5.3).
Croatian: Pokazalo se da je etopozid teratogen u miševa i štakora (vidjeti dio 5.3).
English: Pharmacotherapeutic group: Cytostatics, plant alkaloids and other natural products, podophyllotoxin derivatives, ATC code: L01CB01
Croatian: Farmakoterapijska skupina: Citostatici, biljni alkaloidi i drugi prirodni pripravci, derivati podofilotoksina, ATK oznaka: L01CB01
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Croatian: Od zdravstveni radnika se traži da prijave svaku sumnju na nuspojavu lijeka putem nacionalnog sustava prijave nuspojava: navedenog u Dodatku V.
English: • serious reactions of the skin and/or mucous membranes which may include painful blisters and fever, including extensive detachment of the skin (Stevens-Johnson syndrome and toxic epidermal necrolysis)
Croatian: • ozbiljne reakcije na koži i/ili sluznicama koje mogu uključiti bolne mjehure i vrućicu, uključujući opsežno ljuštenje kože (Stevens-Johnsonov sindrom i toksična epidermalna nekroliza)
English: At decreased creatinine clearance of 15 to 50 mL/min a dose reduction by 25% is recommended.
Croatian: Kod sniženog klirensa kreatinina od 15 do 50 ml/min, preporučuje se smanjenje doze za 25%.
English: Talk to your doctor or pharmacist before taking VEPESID and associated names
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete VEPESID i pridružena imena
English: Glucuronide and/or sulfate conjugates of etoposide are also excreted in human urine.
Croatian: Glukuronid i/ili sulfatni konjugati etopozida se također izlučuju u ljudskom urinu.
English: • convulsions (seizure)
Croatian: • konvulzije (napadaji)
English: If clinically significant hypertension occurs in patients receiving etoposide, appropriate supportive therapy should be initiated.
Croatian: Ako dođe do klinički značajne hipertenzije u bolesnika koji primaju etopozid, treba započeti odgovarajuću suportivnu terapiju.
English: This course of treatment may then be repeated, depending on the results of blood tests, but this will not be for at least 7 days after the first course of treatment.
Croatian: Ovakav ciklus liječenja tada se može ponoviti ovisno o nalazima krvnih pretraga, no to se neće dogoditi najmanje 7 dana nakon prvog ciklusa liječenja.
English: In clinical studies in which VEPESID and associated names was administered as a single agent either orally or by injection the most frequent adverse reactions of any severity were leucopenia (60 to 91%), thrombocytopenia (22 to 41%), nausea and/or vomiting (31 to 43%), and alopecia (8 to 66%).
Croatian: U kliničkim ispitivanjima u kojima se VEPESID i pridružena imena primjenjivao kao monoterapija, ili peroralno ili putem injekcije, najčešće nuspojave bilo kojeg stupnja težine bile su leukopenija (60 do 91 %), trombocitopenija (22 do 41 %), mučnina i/ili povraćanje (31 do 43 %), te alopecija (8 do 66 %).
English: On intravenous administration, the disposition of etoposide is best described as a biphasic process with a distribution half-life of about 1.5 hours and terminal elimination half-life ranging from 4 to 11 hours.
Croatian: Nakon intravenske primjene, dispozicija etopozida najbolje je opisana kao proces koji se odvija u dvije faze, s poluvijekom distribucije od oko 1,5 sata i terminalnim poluvijekom eliminacije u rasponu od 4 do 11 sati.
English: This course of treatment may then be repeated, depending on the results of blood tests, but this will not be for at least 21 days after the first course of treatment.
Croatian: Ovakav ciklus liječenja tada se može ponoviti ovisno o nalazima krvnih pretraga, no to se neće dogoditi najmanje 21 dan nakon prvog ciklusa liječenja.
English: The capsules should be taken with a glass of water on an empty stomach.
Croatian: Kapsule treba uzimati na prazan želudac s čašom vode.
English: • irregular heart beat (arrhythmia), or a heart attack (myocardial infarction)
Croatian: • nepravilan srčani ritam (aritmija) ili srčani udar (infarkt miokarda)
English: However, if you feel tired, sick to your stomach, dizzy or light-headed you should not do so until you have discussed it with your doctor.
Croatian: Međutim, ako se osjećate umorno, mučno Vam je, osjećate omaglicu ili ošamućenost, ne biste smjeli upravljati vozilima i strojevima prije nego o tome ne razgovarate sa svojim liječnikom.
English: Women of childbearing potential should use appropriate contraceptive measures to avoid pregnancy during etoposide therapy.
Croatian: Žene u reproduktivnoj dobi trebaju koristiti odgovarajuće kontracepcijske mjere za izbjegavanje trudnoće tijekom terapije etopozidom.
English: There are no or limited amount of data from the use of etoposide in pregnant women.
Croatian: Ne postoje ili su ograničeni podaci o primjeni etopozid u trudnica.
English: Close monitoring of patients is needed to detect early signs of tumour lysis syndrome, especially in patients with risk factors such as bulky treatmentsensitive tumours, and renal insufficiency.
Croatian: Potreban je poman nadzor bolesnika kako bi se otkrili rani znakovi sindroma lize tumora, pogotovo u bolesnika s faktorima rizika poput masivnih tumora osjetljivih na liječenje, i insuficijencijom bubrega.
English: Very common side effects (affecting more than 1 in 10 people)
Croatian: Vrlo česte nuspojave (mogu se javiti u više od 1 na 10 osoba)
English: The hydroxyacid metabolite [4' dimethyl-epipodophyllic acid-9-(4,6 0-ethylidene-β-Dglucopyranoside)], formed by opening of the lactone ring, is found in the urine of adults and children.
Croatian: Metabolit hidroksi kiseline [4'-dimetil- epipodofilna kiselina-9-(4,6-0-etiliden-β-D-glukopiranozid)], nastao otvaranjem laktonskog prstena, nađen je u urinu odraslih i djece.
English: Dosage should be modified to take into account the myelosuppressive effects of other drugs in the combination or the effects of prior radiotherapy or chemotherapy (see section 4.4), which may have compromised bone marrow reserve.
Croatian: Dozu treba modificirati kako bi se uzeli u obzir mijelosupresivni učinci drugih lijekova u kombinaciji ili učinci prethodne radioterapije ili kemoterapije (vidjeti dio 4.4), koji su mogli oštetiti rezervu koštane srži.
English: No evidence exists for any other differences in etoposide metabolism and excretion after administration of oral capsules as compared to intravenous infusion.
Croatian: Ne postoje dokazi za bilo koju drugu razliku u metabolizmu etopozida i izlučivanju nakon peroralne primjene kapsula u odnosu na intravensku infuziju.
English: Acute fatal reactions associated with bronchospasm have been reported with etoposide.
Croatian: Akutne smrtonosne reakcije povezane s bronhospazmom, prijavljene su s etopozidom.
English: • tumour lysis syndrome (complications of substances released from treated cancer cells entering the blood)
Croatian: • sindrom lize tumora (komplikacije uzrokovane tvarima koje se otpuštaju iz liječenih stanica raka i ulaze u krvotok)
English: If radiotherapy or chemotherapy has been given prior to starting etoposide treatment, an adequate interval should be allowed to enable the bone marrow to recover.
Croatian: Ako je prije početka liječenja etopozidom primjenjivana radioterapija ili kemoterapija, treba omogućiti odgovarajući vremenski interval za oporavak koštane srži.
English: In clinical studies involving etoposide, episodes of hypertension have been reported.
Croatian: U kliničkim ispitivanjima koja uključuju etopozid, prijavljene su epizode hipertenzije.
English: Severe liver, kidney or heart damage from a condition called tumour lysis syndrome, caused by harmful amounts of substances from the cancer cells getting into the blood stream, has been seen sometimes when VEPESID is taken along with other drugs used to treat cancer.
Croatian: Teško oštećenje jetre, bubrega ili srca uzrokovano stanjem pod nazivom sindrom lize tumora, nastalog pod utjecajem štetnih količina tvari iz stanica raka koje uđu u krvotok, ponekad je opaženo kada se VEPESID uzima zajedno s drugim lijekovima za liječenje raka.
English: In vitro, etoposide is highly protein bound (97%) to human plasma proteins.
Croatian: In vitro, etopozid je velikim dijelom vezan za proteine ljudske plazme (97 %).
English: Patients with impaired hepatic function should regularly have their hepatic function monitored due to the risk of accumulation.
Croatian: Bolesnici s oštećenom funkcijom jetre redovito trebaju kontrolirati funkciju jetre zbog opasnosti od nakupljanja.
English: Over the same dose range, the areas under the plasma concentration vs. time curves (AUC) and the maximum plasma concentration (Cmax) values increase linearly with dose.
Croatian: U tom rasponu doza, površina ispod krivulje koncentracije u plazmi/vrijeme (AUC) i vrijednosti maksimalne koncentracije u plazmi (Cmax) povećavaju se linearno s dozom.
English: What VEPESID looks like and contents of the pack
Croatian: Kako VEPESID izgleda i sadržaj pakiranja
English: • a sunburn-like rash that may occur on skin that has previously been exposed to radiotherapy and can be severe (radiation recall dermatitis)
Croatian: • osip sličan opeklinama koji se može pojaviti na koži koja je prethodno bila izložena zračenju i može biti težak (upalna reakcija ozračenog područja)
English: Testicular atrophy, spermatogenesis arrest, and growth retardation were reported in rats and mice.
Croatian: Atrofija testisa, zastoj spermatogeneze i usporen rast prijavljeni su kod štakora i miševa.
English: LABELLING
Croatian: OZNAČIVANJE
English: Both male patients and female patients of child-bearing age should use an effective contraceptive method (e.g., the barrier method or condoms) during treatment and for at least 6 months after the end of treatment with VEPESID and associated names.
Croatian: I muški i ženski bolesnici u reproduktivnoj dobi trebaju uzimati učinkovitu kontracepciju (npr. barijerna metoda ili kondomi) tijekom liječenja i najmanje 6 mjeseci nakon kraja liječenja VEPESIDOM i pridruženim imenima.
English: The coefficient of variation is around 30% after oral administration versus 10% after intravenous administration (between-patient variability is similar after intravenous or oral administration, i.e. 30 to 40%).
Croatian: Koeficijent varijacije je oko 30 % nakon peroralne primjene naspram 10% nakon intravenske primjene (varijabilnost između bolesnika slična je nakon intravenske ili peroralne primjene, tj. 30 do 40%).
English: Gastrointestinal Toxicity
Croatian: Gastrointestinalna toksičnost
English: As with all medicines used to treat cancer, care must be taken when handling VEPESID and associated names capsules.
Croatian: Kao i sa svim lijekovima koji se koriste za liječenje raka, nužan je oprez kod rukovanja kapsulama VEPESIDA i pridruženim imenima.
English: Etoposide belongs to the group of medicines called cytostatics which are used in the treatment of cancer.
Croatian: Etopozid spada u skupinu lijekova pod nazivom citostatici koji se koriste u liječenju raka.
English: In animal studies etoposide was associated with dose-related embryotoxicity and teratogenicity.
Croatian: U ispitivanjima na životinjama etopozid je bio povezan s embriotoksičnošću i teratogenošću povezanima s dozom.
English: Low serum albumin
Croatian: Niska koncentracija albumina u serumu
English: Another characteristic that has been associated with secondary leukaemia in patients who have received epipodophyllotoxins appears to be a short latency period, with average median time to development of leukaemia being approximately 32 months.
Croatian: Čini se da je druga karakteristika povezana sa sekundarnom leukemijom u bolesnika koji su primali epipodofilotoksine, kratko razdoblje latencije, s medijanom vremena do razvoja leukemije od približno 32 mjeseca.
English: The available efficacy data for etoposide in the different indications are generally based on studies in which etoposide was used intravenously.
Croatian: Raspoloživi podaci o djelotvornosti etopozida kod različitih indikacija općenito se temelje na ispitivanjima kod kojih je etopozid primjenjivan intravenski.
English: The roles of both administration schedules and cumulative doses of etoposide have been suggested, but have not been clearly defined.
Croatian: Smatra se da ulogu mogu imati i raspored primjene i kumulativne doze etopozida, ali nije jasno definirano.
English: If you forget to take VEPESID and associated names If you miss or forget to take a dose of this medicine, DO NOT WORRY - just take the next dose when it is due.
Croatian: Ako propustite ili zaboravite uzeti dozu ovog lijeka, NE BRINITE - jednostavno uzmite sljedeću dozu u planirano vrijeme.
English: In patients with moderate (CrCl =15 to 50 mL/min), or severe (CrCl <15ml/min) renal impairment undergoing haemodialysis, etoposide should be administered at a reduced dose (see section 4.2).
Croatian: Bolesnicima s umjerenim (CrCl = 15 do 50 ml/min) ili teškim (CrCl < 15ml/min) oštećenjem bubrega koji su na dijalizi, etopozid treba davati u smanjenoj dozi (vidjeti dio 4.2).
English: In patients with impaired renal function, the following initial dose modification should be considered based on measured creatinine clearance.
Croatian: Kod bolesnika s oštećenom funkcijom bubrega, treba uzeti u obzir sljedeću modifikaciju početne doze na osnovi izmjerenog klirensa kreatinina.
English: Daily doses greater than 200 mg should be divided and given twice per day.
Croatian: Dnevne doze veće od 200 mg primjenjuju se podijeljene u dvije doze.
English: If etoposide should contact the skin, mucosa or eyes, immediately wash the skin with soap and water and flush the mucosa or eyes with water.
Croatian: U slučaju kontakta etopozida s kožom, sluznicama ili očima, odmah operite kožu sapunom i vodom i isperite sluznicu ili oči vodom.
English: - if you are being treated with cisplatin (a medicine used to treat cancer).
Croatian: - ako se liječite cisplatinom (lijekom koji se primjenjuje u liječenju raka).
English: Phenylbutazone, sodium salicylate, and aspirin may displace etoposide from plasma protein binding.
Croatian: Fenilbutazon, natrijev salicilat i aspirin mogu istisnuti etopozid s proteina plazme.
English: Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru nakon oznake Rok valjanosti ili EXP.
English: Two dose-dependent responses are seen: At high concentrations (10 mcg/mL or more), cells entering mitosis are lysed; at low concentrations (0.3 to 10 mcg/mL), cells are inhibited from entering prophase.
Croatian: Zabilježena su dva odgovora ovisna o dozi: U visokim koncentracijama (10 µg/ml ili više), dolazi do lize stanica koje ulaze u mitozu; u niskim koncentracijama (0,3 do 10 µg/ml), stanicama je zapriječen ulazak u profazu.
English: Women of childbearing potential should be advised to avoid becoming pregnant.
Croatian: Žene u reproduktivnoj dobi treba savjetovati da izbjegavaju trudnoću.
English: Ovarian cancer
Croatian: Rak jajnika
English: OUTER CARTON AND BOTTLE LABEL TEXT
Croatian: TEKST NA KUTIJI I NALJEPNICI BOČICE
English: Haematological parameters should be measured and dose adjustments in subsequent cycles considered based on haematological toxicity and clinical effect in moderate and severe renal impaired patients.
Croatian: Treba izmjeriti hematološke parametre i prilagoditi dozu u uzastopnim ciklusima na temelju hematološke toksičnosti i kliničkog učinka kod bolesnika s umjerenim i teškim oštećenjem bubrega.
English: The oral bioavailability is variable but averages 76% at the 100 mg oral dose and 48% at the 400 mg oral dose.
Croatian: Oralna bioraspoloživost je varijabilna, ali je u prosjeku 76% kod oralne doze od 100 mg, a 48% kod oralne doze od 400 mg.
English: Male patients treated with VEPESID and associated names are advised not to father a child during treatment and for up to 6 months after treatment.
Croatian: Muškim bolesnicima liječenima VEPESIDOM i pridruženim imenima, savjetuje se da ne začnu dijete tijekom liječenja i do 6 mjeseci nakon liječenja.
English: • high blood pressure • sore lips, mouth or throat ulcers
Croatian: • visok krvni tlak • bolne usne, ranice u ustima ili grlu
English: Since etoposide and its metabolites are not dialyzable, it can be administered pre- and post-haemodialysis (see section 4.9).
Croatian: Budući da se etopozid i njegovi metaboliti ne mogu dijalizirati, može se primijeniti prije i nakon hemodijalize (vidjeti dio 4.9).
English: No correlation exists between the absolute oral bioavailability of etoposide capsules and non-renal clearance.
Croatian: Ne postoji korelacija između apsolutne oralne bioraspoloživosti kapsula etopozida i nerenalnog klirensa.
English: Total doses of 2.4 g/m2 to 3.5 g/m2 administered intravenously over three days have resulted in severe mucositis and myelotoxicity.
Croatian: Ukupne doze od 2,4 g/m2 do 3,5 g/m2 primijenjene intravenski tijekom tri dana uzrokovale su teški mukozitis i mijelotoksičnost.
English: The main effect of etoposide appears to be at the late S and early G2 portion of the cell cycle in mammalian cells.
Croatian: Čini se da se glavni učinak etopozida odvija u kasnoj S i ranoj G2 fazi staničnog ciklusa u stanicama sisavaca.
English: The dose of VEPESID and associated names capsules is based on the recommended intravenous dose taking into account the dose-dependent bioavailability of VEPESID and associated names capsules.
Croatian: Doza kapsula VEPESID i pridružena imena temelji se na preporučenoj intravenskoj dozi, uzimajući u obzir o dozi ovisnu bioraspoloživost kapsula VEPESID i pridruženih imena.
English: Alternative dosage schedule
Croatian: Alternativni raspored doziranja
English: Co-administration of antiepileptic drugs and VEPESID and associated names can lead to decreased seizure control due to pharmacokinetic interactions between the drugs.
Croatian: Istodobna primjena antiepileptičkih lijekova i VEPESIDA i pridruženih imena može dovesti do smanjenja kontrole napadaja zbog farmakokinetičkih interakcija između tih lijekova.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: {DD month YYYY}
Croatian: DATUM PRVOG ODOBRENJA / DATUM OBNOVE ODOBRENJA
English: VEPESID and associated names is used in the treatment of certain types of cancers in adults:
Croatian: VEPESID i pridružena imena koristi se u liječenju određenih vrsta raka u odraslih:
English: If you take more VEPESID and associated names than you should If you take too many capsules go to your nearest hospital emergency department or tell your doctor immediately.
Croatian: Ako uzmete previše kapsula, odmah otiđite na hitnu službu najbliže bolnice ili odmah obavijestite svog liječnika.
English: In all instances where the use of VEPESID and associated names is considered for chemotherapy, the physician must evaluate the need and usefulness of the drug against the risk of adverse reactions.
Croatian: U svim slučajevima kada se za kemoterapiju razmatra primjena VEPESIDA i pridruženih imena, liječnik mora procijeniti potrebu i korist lijeka u odnosu na rizik od nuspojava.
English: Effect of etoposide on the pharmacokinetics of other drugs
Croatian: Učinak etopozida na farmakokinetiku drugih lijekova
English: Historically, preclinical species have been more sensitive compared to humans towards cytotoxic agents.
Croatian: Povijesno gledano, pretkliničke vrste bile su osjetljivije na citotoksična sredstva u usporedbi s ljudima.
English: Therefore patients with low serum albumin may be at increased risk for etoposide-associated toxicities.
Croatian: Zato bolesnici s niskom koncentracijom albumina u serumu mogu imati veći rizik od toksičnosti povezane s etopozidom.
English: testicular cancer small cell lung cancer cancer of the blood (acute myeloid leukaemia) tumour in the lymphatic system (Hodgkin's lymphoma, non-Hodgkin's lymphoma) ovarian cancer
Croatian: - rak testisa - rak pluća malih stanica - rak krvi (akutna mijeloična leukemija) - tumor limfnog sustava (Hodgkinov limfom, non-Hodgkinov limfom) - rak jajnika
English: Subsequent dosing in moderate and severe renal impairment should be based on patient tolerance and clinical effect (see section 4.4).
Croatian: Naknadno doziranje kod umjerenog i teškog oštećenja bubrega treba temeljiti na podnošljivosti i kliničkom učinku u pojedinog bolesnika (vidjeti dio 4.4).
English: Concomitant phenytoin therapy is associated with increased etoposide clearance and reduced efficacy, and other enzyme-inducing antiepileptic therapy may be associated with increased VEPESID and associated names clearance and reduced efficacy.
Croatian: Istodobno liječenje fenitoinom povezano je s povećanim klirensom etopozida i smanjenom djelotvornošću, a liječenje drugim antiepilepticima koji induciraju enzime može biti povezano s povećanjem klirensa VEPESIDA i pridruženih imena te smanjenom djelotvornošću.
English: Etoposide binding ratio correlates directly with serum albumin in cancer patients and normal volunteers (see section 4.4).
Croatian: Omjer vezanja etopozida izravno korelira s razinom albumina u serumu u bolesnika s rakom i zdravih dobrovoljaca (vidjeti dio 4.4).
English: High dose ciclosporin, resulting in plasma concentrations above 2000 ng/mL, administered with oral etoposide has led to an 80% increase in etoposide exposure (AUC) with a 38% decrease in total body clearance of etoposide compared to etoposide alone.
Croatian: Visoka doza ciklosporina koja uzrokuje koncentracije u plazmi iznad 2000 ng/ml, primijenjena s oralnim etopozidom, dovela je do 80%-tnog povećanja izloženosti etopozidu (AUC) s 38% -tnim smanjenjem ukupnog tjelesnog klirensa etopozida u usporedbi s monoterapijom etopozidom.
English: The occurrence of acute leukaemia, which can occur with or without myelodysplastic syndrome, has been described in patients that were treated with etoposide containing chemotherapeutic regimens.
Croatian: Pojava akutne leukemije do koje može doći sa ili bez mijelodisplastičnog sindroma, opisana je kod bolesnika liječenih kemoterapijskim režimima koji sadrže etopozid.
English: An alternative dosage schedule for VEPESID and associated names capsules is 50 mg/m2/day for 2 to 3 weeks, with courses repeated after a one week rest period or upon recovery from myelosuppression.
Croatian: Alternativni raspored doziranja kapsula VEPESID i pridruženih imena sastoji se od primjene doze od 50 mg/m2/dan tijekom 2 do 3 tjedna, s time da se ti ciklusi ponavljaju nakon jednog tjedna odmora ili nakon oporavka od mijelosupresije.
English: Concomitant use of yellow fever vaccine or other live vaccines is contraindicated in immunosuppressed patients (see section 4.5).
Croatian: Istodobna primjena cjepiva protiv žute groznice ili drugih živih cjepiva kontraindicirana je u imunosuprimiranih bolesnika (vidjeti dio 4.5).
English: As etoposide may decrease male fertility, preservation of sperm may be considered for the purpose of later fatherhood.
Croatian: Budući da etopozid može smanjiti plodnost kod muškaraca, potrebno je razmotriti pohranu sperme u svrhu kasnijeg očinstva.
English: UNIQUE IDENTIFIER - 2D BARCODE <2D barcode carrying the unique identifier included.>
Croatian: 17. JEDINSTVENI IDENTIFIKATOR - 2D BARKOD <Sadrži 2D barkod s jedinstvenim identifikatorom.> 18. JEDINSTVENI IDENTIFIKATOR - PODACI ČITLJIVI LJUDSKIM OKOM PC: {broj}
English: After either intravenous infusion or oral capsule administration, the Cmax and AUC values exhibit marked intra- and inter-subject variability.
Croatian: Bilo nakon intravenske infuzije ili peroralne primjene kapsule, vrijednosti Cmax i AUC pokazuju značajnu varijabilnost unutar pojedinog bolesnika i među različitim bolesnicima.