FrancophonIA/ELRC3.0 huggingface dataset:
English: Responses were observed in 13/18 (72%, 95% confidence intervals: 47, 90) of DepoCyte patients versus 3/17 (18% patients, 95% confidence intervals: 4, 43) in the unencapsulated cytarabine arm. A statistically significant association between treatment and response was observed (Fisher's exact test p-value = 0.002).
Croatian: Odgovor je zabilježen u 13/18 (72%, 95% interval pouzdanosti: 47, 90) bolesnika koji su dobivali DepoCyte, naspram 3/17 (18%, 95% interval pouzdanosti: 4, 43) u skupini bolesnika koji su primali neinkapsulirani citarabin.
English: − The active substance is cytarabine.
Croatian: Djelatna tvar je citarabin.
English: Symptoms and signs of peripheral neuropathy, such as pain (1%), numbness (3%), paresthesia (3%), hypoaesthesia (2%), weakness (13%), and impaired bowel (3%) and bladder control (incontinence) (1%), have also been observed and in some cases this combination of neurological signs and symptoms has been reported as Cauda equina syndrome (3%).
Croatian: Također su opisani i simptomi i znakovi periferne neuropatije, poput boli (1%), utrnutosti (3%), parestezije (3%), hipoestezije (2%), slabosti (13%) i poremećaja kontrole sfinktera crijeva (3%) i mokraćnog mjehura (inkontinencija) (1%), a u nekim slučajevima ovi su simptomi i znakovi opisani kao sindrom kaude ekvine (3%).
English: Systemic toxicity due to intravenous administration of cytarabine consists primarily of bone marrow suppression with leucopenia, thrombocytopenia and anaemia.
Croatian: Sistemska toksičnost kod intravenske primjene citarabina sastoji se prvenstveno od supresije koštane srži s posljedičnom leukopenijom, trombocitopenijom i anemijom.
English: No formal assessments of pharmacokinetic drug-drug interactions between DepoCyte and other agents have been conducted.
Croatian: Formalna ispitivanja farmakokinetičkih interakcija između DepoCytea i drugih lijekova nisu provedena.
English: Since DepoCyte's particles are similar in size and appearance to white blood cells, care must be taken in interpreting CSF examination following administration.
Croatian: Budući da su čestice DepoCytea veličinom i oblikom nalik bijelim krvnim stanicama, nakon njegove primjene treba biti pažljiv prilikom tumačenja nalaza pregleda cerebrospinalne tekućine.
English: Psychiatric disorders
Croatian: Psihijatrijski poremećaji DepoCyte
English: The active ingredient, cytarabine, was mutagenic in in vitro tests and was clastogenic in vitro (chromosome aberrations and sister chromatid exchange in human leukocytes) and in vivo (chromosome aberrations and sister chromatid exchange assay in rodent bone marrow, mouse micronucleus assay).
Croatian: Djelatna tvar citarabin, pokazala se mutagenom u in vitro testovima, a pokazala se klastogenom u in vitro (aberacija kromosoma i zamjena sestrinske kromatide u humanim leukocitima) i u in vivo testovima (aberacija kromosoma i zamjena sestrinske kromatide u ispitivanoj koštanoj srži glodavaca, ispitanom mikronukleusu miša).
English: The following regimen of induction, consolidation and maintenance therapy is recommended: Induction therapy: 50 mg administered every 14 days for 2 doses (weeks 1 and 3).
Croatian: Preporučuje se sljedeći režim indukcijske terapije, konsolidacijske terapije, te terapije održavanja: Indukcijska terapija: 50 mg se primjenjuje svakih 14 dana, 2 doze (1. i 3. tjedan).
English: Table 3: Adverse reactions possibly reflecting meningeal irritation in Phase II, III, and IV patients
Croatian: Tablica 3: Nuspojave koje moguće ukazuju na iritaciju moždanih ovojnica bolesnika, u fazi II, III i IV
English: DepoCyte 50 mg suspension for injection Cytarabine
Croatian: DepoCyte 50 mg suspenzija za injekciju citarabin
English: AUCs of free and encapsulated cytarabine after ventricular injection of DepoCyte appeared to increase linearly with increasing dose, indicating that the release of cytarabine from DepoCyte and the pharmacokinetics of cytarabine are linear in human CSF.
Croatian: Nakon intraventrikularnog injiciranja DepoCytea čini se da područja ispod krivulje (AUC) za slobodni i inkapsulirani citarabin rastu linearno s dozom, ukazujući na to da se otpuštanje citarabina iz DepoCytea i farmakokinetika citarabina u cerebrospinalnoj tekućini ljudi kreću linearno.
English: In contrast with systemically administered cytarabine which is rapidly metabolised to ara-U, conversion to ara-U in the CSF is negligible after intrathecal administration because of the significantly lower cytidine deaminase activity in the CNS tissues and CSF.
Croatian: Dok se sistemski primijenjen citarabin brzo metabolizira u ara-U, konverzija citarabina u ara-U u cerebrospinalnoj tekućini nakon intratekalne primjene je zanemariva, zbog značajno niže aktivnosti citidin deaminaze u tkivima središnjeg živčanog sustava i cerebrospinalnoj tekućini.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Croatian: DATUM PRVOG ODOBRENJA ZA STAVLJANJE GOTOVOG LIJEKA U PROMET/DATUM OBNOVE ODOBRENJA ZA STAVLJANJE GOTOVOG LIJEKA U PROMET
English: In the event of accidental contact with the mucous membranes, treat immediately by copious washing with water; medical attention should be sought.
Croatian: U slučaju nehotičnog kontakta sa sluznicama, odmah obilno isprati vodom; treba potražiti medicinski savjet.
English: The CSF clearance rate of cytarabine is similar to the CSF bulk flow rate of 0.24 ml/min.
Croatian: Klirens citarabina u cerebrospinalnoj tekućini sličan je općem protoku cerebrospinalne tekućine od 0,24 ml/min.
English: The systemic exposure to free cytarabine following intrathecal treatment with DepoCyte was negligible.
Croatian: Sistemska izloženost slobodnom citarabinu nakon intratekalne primjene DepoCytea je zanemariva.
English: • Convulsion
Croatian: • Konvulzije
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA
Croatian: JEDINSTVENI IDENTIFIKATOR - PODACI ČITLJIVI LJUDSKIM OKOM < PC: {broj} [oznaka lijeka]
English: Mundipharma Gesellschaft m.b.H., Austria Tel: +40 751 121 222 office@mundipharma.ro
Croatian: Gesellschaft m.b.H., Austria Tel: +40 751 121 222 office@mundipharma.ro
English: The results suggest that the lipid components undergo hydrolysis and are largely incorporated in the tissues following breakdown in the intrathecal space.
Croatian: Dobiveni rezultati upućuju da se lipidne komponente nakon razgradnje u intratekalnom prostoru hidroliziraju i obilno inkorporiraju u tkiva.
English: Following administration by lumbar puncture, the patient should be instructed to lie flat for one hour.
Croatian: Nakon primjene lumbalnom punkcijom, bolesnik treba ležati na ravnom sat vremena.
English: • Headaches
Croatian: • Glavobolja
English: DepoCyte is administered directly into the CSF via an intraventricular reservoir or by direct injection into the lumbar sac.
Croatian: DepoCyte se primjenjuje izravno u cerebrospinalnu tekućinu putem intraventrikularnog rezervoara, ili izravnim injiciranjem u lumbalnu vreću.
English: Ear and labyrinth disorders
Croatian: Poremećaji uha i labirinta DepoCyte
English: Common: cauda equina syndrome, convulsions, cranial nerve palsies, hypoesthesia, myelopathy, paresthesia, hemiplegia, numbness
Croatian: Često: sindrom kaude ekvine, konvulzije, paraliza moždanih živaca, hipoestezija, mijelopatija, parestezija, hemiplegija, utrnutost Često: sindrom kaude ekvine, konvulzije, paraliza moždanih živaca, hipoestezija, mijelopatija, parestezija, hemiplegija, utrnutost
English: • Hearing loss
Croatian: • Gubitak sluha
English: Following intrathecal administration of DepoCyte, serious central nervous system toxicity, including persistent convulsions (7%), extreme somnolence (3%), hemiplegia (1%), visual disturbances including blindness (1%), deafness (3%) and cranial nerve palsies (3%) have been reported.
Croatian: Nakon intratekalne primjene DepoCytea opisani su slučajevi ozbiljnih toksičnih oštećenja središnjeg živčanog sustava, uključujući perzistirajuće konvulzije (7%), ekstremnu somnolenciju (3%), hemiplegiju (1%), smetnje vida uključujući sljepoću (1%), gluhoću (3%) i paralizu moždanih živaca (3%).
English: Methotrexate (n = 258 cycles)
Croatian: Metotreksat (n = 258 ciklusa)
English: All patients should be started on dexamethasone 4 mg twice daily either orally or intravenously for 5 days beginning on the day of injection of DepoCyte.
Croatian: Kod svih bolesnika treba započeti s primjenom deksametazona, 4 mg dva puta dnevno kroz 5 dana, bilo peroralno ili intravenski, počevši s danom kada se DepoCyte injicirao.
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Croatian: Ova uputa je zadnji puta revidirana u MM/GGGG Detaljne informacije o ovom lijeku dostupne su na web stranici Europske agencije za lijekove: http://www.ema.europa.eu.
English: Analysis of the available pharmacokinetic data shows that following intrathecal DepoCyte administration in patients, either via the lumbar sac or by intraventricular reservoir, peaks of free cytarabine were observed within 5 hours in both the ventricle and lumbar sac.
Croatian: Analiza dostupnih farmakokinetičkih podataka pokazuje da nakon intratekalne primjene DepoCytea, bilo lumbalnom punkcijom, bilo preko intraventrikularnog rezervoara, vršna razina slobodnog citarabina nastupa unutar 5 sati, kako nakon ventrikularne tako i nakon lumbalne primjene.
English: In Phase 1-4 studies the most commonly reported adverse reactions associated with DepoCyte were headache (23%), arachnoiditis (16%), pyrexia (14%), weakness (13%), nausea (13%), vomiting (12%), confusion (11%), diarrhoea (11%), thrombocytopenia (10%), and fatigue (6%).
Croatian: U fazama 1-4 kliničih ispitivanja najčešće navedene nuspojave povezane s DepoCyteom bile su glavobolja (23%), arahnoiditis (16%), pireksija (14%), opća slabost (13%), mučnina (13%), povraćanje (12%), konfuzija (11%), proljev (11%), trombocitopenija (10%) i umor (6%).
English: The incidence of these adverse reactions, possibly reflecting meningeal irritation, are headache (24%), nausea (18%), vomiting (17%), pyrexia (12%), neck stiffness (3%), neck pain (4%), back pain (7%), meningism (<1%), convulsions (6%), hydrocephalus (2%), and CSF pleocytosis with or without altered state of consciousness (1%).
Croatian: Učestalost ovih nuspojava, koje vjerojatno odražavaju nadražaj moždanih ovojnica, je: glavobolja (24%), mučnina (18%), povraćanje (17%), pireksija (12%), zakočenost vrata (3%), bol u vratu (4%), bol u leđima (7%), meningizam (<1%), konvulzije (6%), hidrocefalus (2%), i pleocitoza cerebrospinalne tekućine, s ili bez promjene stanja svijesti (1%).
English: EU/1/01/187/001
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/01/187/001
English: Because the systemic exposure to free cytarabine following intrathecal treatment with DepoCyte was negligible, the risk of impaired fertility is likely to be low.
Croatian: Budući da je sistemska izloženost slobodnom citarabinu nakon intratekalne primjene DepoCytea bila zanemariva, rizik njegovog utjecaja na plodnost vjerojatno je nizak.
English: Intrathecal co-administration of cytarabine with other cytotoxic agents may increase the risk of neurotoxicity.
Croatian: Istovremena intratekalna primjena citarabina i drugih citotoksičnih tvari može povećati rizik neurotoksičnosti.
English: Mundipharma Oy Puh/Tel: +358 (0)9 8520 2065 info@mundipharma.fi
Croatian: Suomi/Finland Mundipharma Oy Puh/Tel: +358 (0)9 8520 2065 info@mundipharma.fi
English: − The other ingredients are cholesterol, triolein, dioleoylphosphatidylcholine, dipalmitoylphosphatidylglycerol, sodium chloride, and water for injections.
Croatian: Drugi sastojci su kolesterol, triolein, dioleilfosfatidilkolin, dipalmitoilfosfatidilglicerol, natrijev klorid i voda za injekcije.
English: Cytarabine and methotrexate patients not completing all 4 doses are counted as a fraction of a cycle.
Croatian: Pacijenti koji nisu primili sve 4 doze citarabina odnosno metotreksata, računali su se kao dio ciklusa.
English: • Pain, numbness or tingling (feeling of sensation of pins and needles)
Croatian: • Bol, utrnutost ili mravinjanje (osjećaj bockanja iglica)
English: Cholesterol Triolein Dioleoylphosphatidylcholine (DOPC) Dipalmitoylphosphatidylglycerol (DPPG) Sodium chloride Water for injections
Croatian: Dioleoilfosfatidilkolin (DOPC) Dipalmitoilfosfatidilglicerol (DPPG) Natrijev klorid
English: Common: visual disturbances, blindness Common: visual disturbances, blindness
Croatian: Često: smetnje vida, sljepoća Često: smetnje vida, sljepoća
English: DepoCyte is a sustained-release formulation of cytarabine, designed for direct administration into the cerebrospinal fluid (CSF).
Croatian: DepoCyte je pripravak citarabina sa kontinuiranim otpuštanjem, namijenjen izravnoj primjeni u cerebrospinalnu tekućinu.
English: Cytarabine was clastogenic to meiotic cells; a dose-dependent increase in sperm-head abnormalities and chromosomal aberrations occurred in mice given intraperitoneal (i.p.)
Croatian: Citarabin je djelovao klastogeno na stanice u mejozi; u miševa kod kojih je citarabin dan intraperitonealno (i.p.) nastupili su porast abnormalnosti glava spermatozoida i aberacije kromosoma ovisni o dozi.
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING
Croatian: DODATAK II A. PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U PROMET B. UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I PRIMJENU C. OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET D.
English: Pacira Limited, Wessex House, Marlow Road, Bourne End, Buckinghamshire, SL8 5SP, United Kingdom.
Croatian: Pacira Limited, Wessex House, Marlow Road, Bourne End, Buckinghamshire, SL8 5SP, Ujedinjeno Kraljevstvo.
English: Cytarabine is cytotoxic to a wide variety of proliferating mammalian cells in culture.
Croatian: Citarabin je citotoksičan za čitav niz proliferirajućih stanica sisavaca u staničnim kulturama.
English: Concern for foetal harm following intrathecal DepoCyte administration however, is low because systemic exposure to cytarabine is negligible.
Croatian: Mogućnost oštećenja ploda nakon intratekalne primjene je niska, jer je izloženost sistemskom djelovanju citarabina zanemariva.
English: For Phase 1-4 studies in patients with lymphomatous meningitis receiving either DepoCyte or cytarabine adverse reactions are listed by MedDRA body system organ class and by frequency (Very common (≥1/10); and 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)) in Table 1 below.
Croatian: Nuspojave u fazama 1-4 kliničih ispitivanja u pacijenata s limfomatoznim meningitisom koji su primali ili DepoCyte ili citarabin navedene su prema MedDRA klasifikaciji organskih sustava i učestalosti nuspojava (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)) u tablici 1.
English: Very common: headache Common: convulsions, meningism
Croatian: Vrlo često: glavobolja Često: konvulzije, meningizam
English: Institute of Innovative Biomedical Technology Tel: +371 7 800810 info@ibti.lvoffice
Croatian: Tel: +371 7 800810 info@ibti.lvoffice
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.
Croatian: Moguće nuspojave Kao i svi drugi lijekovi, ovaj lijek može uzrokovati nuspojave.
English: Justification for not including Braille accepted.
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Prihvaćeno obrazloženje za ne navođenje Brailleovog pisma.
English: Transient elevations in CSF protein and white blood cells have been observed in patients following DepoCyte administration, and have also been noted after intrathecal treatment with methotrexate or cytarabine.
Croatian: U pacijenata koji su primili DepoCyte primijećeno je prolazno povišenje razine proteina i povišenje broja bijelih krvnih stanica u cerebrospinalnoj tekućini, a isto je primijećeno i nakon intratekalne primjene metotreksata i citarabina.
English: DepoCyte (n = 929 cycles) Methotrexate (n = 258 cycles) Cytarabine (n = 99 cycles)
Croatian: DepoCyte (n = 929 ciklusa) Metotreksat (n = 258 ciklusa) Citarabin (n = 99 ciklusa)
English: DepoCyte 50 mg suspension for injection
Croatian: NAZIV LIJEKA DepoCyte 50 mg suspenzija za injekciju
English: Also contains: cholesterol, triolein, dioleoylphosphatidylcholine, dipalmitoylphosphatidylglycerol, sodium chloride, water for injections.
Croatian: POPIS POMOĆNIH TVARI Sadrži također: kolesterol, triolein, dioleilfosfatidilkolin, dipalmitoilfosfatidilglicerol, natrijev klorid, vodu za injekcije.
English: Consolidation therapy: 50 mg administered every 14 days for 3 doses (weeks 5, 7 and 9) followed by an additional dose of 50 mg at week 13.
Croatian: Konsolidacijska terapija: 50 mg se primjenjuje svakih 14 dana, 3 doze (5., 7. i 9. tjedna) nakon čega slijedi dodatna doza od 50 mg u 13. tjednu.
English: C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING
Croatian: OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
English: Maintenance therapy: 50 mg administered every 28 days for 4 doses (weeks 17, 21, 25 and 29).
Croatian: Terapija održavanja: 50 mg se primjenjuje svakih 28 dana, 4 doze (17., 21., 25. i 29. tjedna).
English: DepoCyte must not be administered by any other way.
Croatian: DepoCyte se ne smije primijeniti niti jednim drugim putem.
English: Patients with active meningeal infection.
Croatian: Bolesnici s aktivnom infekcijom moždanih ovojnica.
English: The recommended dose will be given to you by the doctor or physician as necessary.
Croatian: Ako ste primili više DepoCytea nego što ste trebali Preporučenu dozu dat će Vam liječnik kako je potrebno.
English: The primary route of elimination of cytarabine is metabolism to the inactive compound ara-U, (1-β-Darabinofuranosyluracil or uracil arabinoside) followed by urinary excretion of ara-U.
Croatian: Metabolizira se do neaktivnog spoja ara-U, (1-β-Darabinofuranoziluracil ili uracil arabinozida), nakon čega se ara-U izlučuje urinom.
English: België/Belgique/Belgien
Croatian: België/Belgique/Belgien Mundipharma Comm VA.
English: Very common: diarrhoea, vomiting, nausea Very common: diarrhoea, vomiting, nausea
Croatian: Vrlo često: proljev, povraćanje, mučnina Vrlo često: proljev, povraćanje, mučnina
English: Adverse reactions possibly reflecting neurotoxicity are listed in Table 2 by MedDRA body system organ class and by frequency: Very common (_≥1/10); Common (≥1/100 to < 1/10); and Uncommon (≥ 1/1,000 to < 1/100).
Croatian: Nuspojave koje moguće ukazuju na neurotoksičnost prikazane su u tablici 2 prema MedDRA klasifikaciji organskih sustava i učestalosti nuspojava: vrlo često (≥1/10); često (≥1/100 i < 1/10); i manje često (≥1/1000 i <1/100).
English: The importance of concurrent dexamethasone administration should be emphasised at the initiation of each cycle of DepoCyte treatment.
Croatian: Kod započinjanja svakog ciklusa liječenja DepoCyteom treba naglasiti važnost istovremene primjene deksametazona.
English: DepoCyte is used to treat lymphomatous meningitis.
Croatian: Što je DepoCyte i za što se primijenjuje DepoCyte se koristi za liječenje limfomatoznog meningitisa.
English: DepoCyte administration
Croatian: Primjena DepoCytea
English: Pacira Limited Wessex House Marlow Road Bourne End Buckinghamshire SL8 5SP United Kingdom
Croatian: Pacira Limited Wessex House Marlow Road Bourne End Buckinghamshire SL8 5SP
English: Very common: headache Common: convulsions, hydrocephalus acquired, CSF pleocytosis
Croatian: Često: konvulzije, stečeni hidrocefalus, pleocitoza cerebrospinalne tekućine
English: Each 5 ml vial contains 50 mg cytarabine.
Croatian: Jedna bočica od 5 ml sadrži 50 mg citarabina.
English: DepoCyte must not be administered by any other route of administration.
Croatian: DepoCyte se ne smije primijeniti niti jednim drugim putem primjene.
English: Intrathecal use
Croatian: Intratekalna primjena
English: Very common: vomiting, nausea Very common: vomiting, nausea Very common: vomiting, nausea
Croatian: Vrlo često: povraćanje, mučnina Vrlo često: povraćanje, mučnina Vrlo često: povraćanje, mučnina
English: Start-up treatment: one vial of DepoCyte (50 mg) administered every 14 days for 2 doses (weeks 1 and 3).
Croatian: Započinjanje terapije: jednu bočicu DepoCytea (50 mg) primijeniti svakih 14 dana, 2 doze (1. i 3. tjedan).
English: Cytarabine
Croatian: Citarabin
English: • Fever
Croatian: • Vrućica
English: Incorporation into DNA and RNA may also contribute to cytarabine cytotoxicity.
Croatian: Ugradnja citarabina u DNA i RNA može pridonijeti njegovoj citotoksičnosti.
English: DepoCyte must only be administered by the intrathecal route.
Croatian: DepoCyte se smije primijeniti samo intratekalno.
English: • in the event of accidental contact with the mucous membranes, exposed areas should be treated immediately by copious lavage with water; medical attention should be sought.
Croatian: • u slučaju nehotičnog kontakta sa sluznicama, izložena područja treba odmah obilno isprati vodom;
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA BOČICE
English: Adverse reactions are listed by MedDRA body system organ class and by frequency: Very common (_≥1/10); Common (≥1/100 to < 1/10); and Uncommon (≥ 1/1,000 to < 1/100).
Croatian: Nuspojave su prikazane prema MedDRA klasifikaciji organskih sustava i učestalosti nuspojava: vrlo često (≥1/10); često (≥1/100 i < 1/10); i manje često (≥1/1000 i <1/100).
English: Mundipharma Comm VA. Tél: +32 (0) 15 45 11 80 info@mundipharma.be
Croatian: Luxembourg/Luxemburg Mundipharma Comm VA. Tél: +32 (0) 15 45 11 80 info@mundipharma.be
English: • Back pain
Croatian: • Bol u leđima
English: KBM Pharma OÜ Tel. +372 733 8080 kbmpharma@kbmpharma.eu
Croatian: +372 733 8080 kbmpharma@kbmpharma.eu
English: Very common: Thrombocytopenia Very common: Thrombocytopenia
Croatian: Vrlo često: trombocitopenija
English: DepoCyte Cytarabine
Croatian: Poremećaji oka DepoCyte Citarabin
English: Maintenance treatment: one vial of DepoCyte (50 mg) administered every 28 days for 4 doses (weeks 17, 21, 25 and 29).
Croatian: Terapija održavanja: jednu bočicu DepoCytea (50 mg) primijeniti svakih 28 dana, 4 doze (17., 21., 25. i 29. tjedan).
English: DepoCyte should not be given to pregnant women as it may harm an unborn child. Women of childbearing potential should use a reliable contraceptive method to avoid pregnancy whilst being treated with DepoCyte.
Croatian: Žene reproduktivne dobi trebaju koristiti učinkovitu metodu kontracepcije kako ne bi zatrudnjele dok se liječe DepoCyteom.
English: Follow-up treatment: one vial of DepoCyte (50 mg) administered every 14 days for 3 doses (weeks 5, 7 and 9) followed by an additional dose at week 13.
Croatian: Nastavak terapije: jednu bočicu DepoCytea (50 mg) primijeniti svakih 14 dana, 3 doze (5., 7. i 9. tjedan) nakon čega slijedi dodatna doza od 50 mg u 13. tjednu.
English: − If you get any side effects, talk to your doctor.
Croatian: Ako se primijetite bilo koju nuspojavu, obavijestite o tome svoga liječnika.
English: - o.z Tel: +421 2 63811611 mundipharma@mundipharma.sk
Croatian: Slovenská republika Mundipharma Ges.m.b.H. - o.z Tel: +421 2 63811611 mundipharma@mundipharma.sk
English: • Confusion
Croatian: • Smetenost
English: One 5 ml vial.
Croatian: Jedna bočica od 5 ml.
English: Slight to moderate inflammation of the meninges in the spinal cord and brain and/or astrocytic activation were observed in animals receiving intrathecal DepoCyte.
Croatian: U životinja koje su intratekalno primale DepoCyte primijećena je lagana do umjerena upala meningealnih ovojnica leđne moždine i mozga i/ili aktivacija astrocita.
English: Marketing Authorisation Holder
Croatian: NOSITELJ ODOBRENJA
English: Тел.
Croatian: C.
English: Mundipharma Pharmaceuticals, S.L.
Croatian: Mundipharma Pharmaceuticals B.V.
English: White to off-white suspension.
Croatian: Bijele do gotovo bijele boje.
English: Napp Pharmaceuticals Limited Tel: +44 (0) 1223 424444
Croatian: United Kingdom Napp Pharmaceuticals Limited Tel: +44 (0) 1223 424444 oncologymedinfo@napp.co.uk
English: It should not be shaken vigorously.
Croatian: Bočicu se ne bi smjelo žustro mućkati.