FrancophonIA/ELRC3.0 huggingface dataset:
English: - Low number of special white blood cells (neutrophils and leukocytes) - Nausea (feeling sick).
Croatian: Nizak broj posebnih bijelih krvnih stanica (neutrofila i leukocita).
English: - Infections of the urinary tract.
Croatian: - Infekcije mokraćnog sustava.
English: The recommended dosage for remission induction is 12 mg/m2 of body surface area, given as a single intravenous dose daily for five consecutive days (total of 60 mg/m2).
Croatian: Preporučeno doziranje za indukciju remisije iznosi 12 mg/m površine tijela, koji se dnevno daju kao jednokratna intravenska doza tijekom pet uzastopnih dana (ukupno 60 mg/m2).
English: Mitoxantrone should be administered under the supervision of a physician experienced in the use of cytotoxic chemotherapy agents.
Croatian: Mitoksantron je potrebno primijeniti pod nadzorom liječnika s iskustvom u primjeni citotoksičnih kemoterapeutika.
English: Novantrone and associated names (see Annex I) 2 mg/ml concentrate for solution for infusion [See Annex I - To be completed nationally] Mitoxantrone
Croatian: Novantrone i pridružena imena (vidjeti Prilog I.) 2 mg/ml koncentrat za otopinu za infuziju
English: The recommended dosage for remission induction is 12 mg/m2 of body surface area, given as a single intravenous dose daily for five consecutive days (total of 60 mg/m2 per 5 days).
Croatian: Preporučeno doziranje za indukciju remisije iznosi 12 mg/m2 površine tijela, koji se dnevno daju kao jednokratna doza u venu tijekom pet uzastopnih dana (ukupno 60 mg/m2 na 5 dana).
English: A neutropenia can occur after each administration.
Croatian: Hematološka toksičnost Neutropenija se može pojaviti nakon svake primjene lijeka.
English: Novantrone is used in combination with other medicinal products in this indication; pain caused by prostate cancer at an advanced stage of prostate cancer in combination with corticosteroids; highly active relapsing multiple sclerosis associated with rapidly evolving disability where no alternative therapeutic options exist (see sections 2 and 3).
Croatian: Novantrone se primjenjuje u kombinaciji s drugim lijekovima u ovoj indikaciji; - bol uzrokovana rakom prostate u uznapredovalom stadiju raka prostate u kombinaciji s kortikosteroidima;
English: Novantrone concentrate also can be administered as a short infusion (15 to 30 minutes) diluted in 50 to 100 ml isotonic saline or 5% glucose solution.
Croatian: Novantrone koncentrat također se može primijenjivati kao kratka infuzija (15 do 30 minuta) razrijeđen u
English: Elevated serum creatinine Elevated blood urea nitrogen levels
Croatian: Povišene razine kreatinina u serumu
English: STATEMENT OF ACTIVE SUBSTANCE(S) Mitoxantrone [To be completed nationally]
Croatian: POPIS POMOĆNIH TVARI [Ispunjava država članica]
English: If WBC nadir < 1,000 µl or platelet nadir < 25,000 µl
Croatian: Ako najniža vrijednost broja bijelih krvnih stanica iznosi < 1000 µl ili najniža vrijednost broja krvnih pločica < 25 000 µl
English: Arrhythmia
Croatian: Letargija
English: Constipation Diarrhoea Stomatitis
Croatian: Konstipacija Dijareja Stomatitis
English: (anaemia).
Croatian: (intraarterijski).
English: Nephropathy toxic Urine discolouration
Croatian: Diskoloracija urina
English: 21 days, in combination with low oral doses of corticosteroids (hormonal medicines that suppress the immune system).
Croatian: Preporučeno doziranje Novantrona iznosi 12 do 14 mg/m2 danih kao kratka infuzija u venu svakih 21 dan u kombinaciji s niskim oralnim dozama kortikosteroida (hormonalnim lijekovima koji suprimiraju imunološki sustav).
English: - Bruising.
Croatian: - Proljev.
English: WBC and platelet nadir
Croatian: Sinusna bradikardija
English: Haematological toxicity
Croatian: Toksična nefropatija
English: PHARMACEUTICAL FORM Concentrate for solution for infusion [To be completed nationally]
Croatian: NAČIN PRIMJENE LIJEKA [Ispunjava država članica]
English: Evaluation of the left-ventricular ejection fraction (LVEF) by echocardiogram or multiple-gated acquisition (MUGA) is recommended prior to administration of the initial dose of mitoxantrone in cancer patients.
Croatian: Prije primjene početne doze mitoksantrona u bolesnika oboljelih od raka preporučuje se procjena istisne frakcije lijeve klijetke (LVEF) putem ehokardiograma ili radionuklidne ventrikulografije (eng. multiple-gated acquisition,
English: What Novantrone contains
Croatian: Sadržaj pakiranja i druge informacije Što Novantrone sadrži
English: Myelosuppression Bone marrow failure White blood cell count
Croatian: Zatajenje koštane srži Abnormalan broj bijelih krvnih stanica
English: Novantrone will be given to you under supervision of a doctor experienced in the use of cytotoxic chemotherapy agents.
Croatian: Doziranje i način primjene Novantrone će Vam se dati pod nadzorom liječnika s iskustvom u primjeni citotoksičnih kemoterapeutika.
English: Urinary tract infection Upper respiratory tract infection
Croatian: Infekcija gornjeg dišnog sustava
English: - Diarrhoea.
Croatian: - Infekcije.
English: The safety and efficacy of mitoxantrone have not been studied after treatment with natalizumab, fingolimod, alemtuzumab, dimethyl fumarate, or teriflunomide.
Croatian: Primjena nakon drugih liječenja specifičnih za MS Sigurnost i djelotvornost mitoksantrona nisu ispitani nakon liječenja natalizumabom, fingolimodom,
English: Women of childbearing potential should be informed about increased risk of transitory or persistent amenorrhoea (see section 4.6).
Croatian: Potrebno je informirati žene u reproduktivnoj dobi o povećanom riziku od prolazne ili trajne amenoreje
English: If WBC nadir < 1,500 µl or platelet nadir < 50,000 µl
Croatian: Ako najniža vrijednost broja bijelih krvnih stanica iznosi < 1500 µl ili najniža vrijednost broja krvnih pločica < 50 000 µl
English: In metastatic breast cancer, combinations of mitoxantrone with other cytotoxic agents including cyclophosphamide and 5-fluorouracil or methotrexate and mitomycin C have been shown to be effective.
Croatian: U metastatskom raku dojke pokazale su se učinkovitima kombinacije mitoksantrona s drugim citotoksičnim lijekovima uključujući ciklofosfamid i
English: Nail disorders Rash
Croatian: Inhibitori prijenosnika BCRP
English: Very Common (may affect more than 1 in 10 people) - Infections.
Croatian: Za bolesnike koji se liječe od multiple skleroze: Vrlo često (može se javiti u više od 1 na 10 osoba) - Infekcije, uključujući infekcije gornjih dišnih putova i mokraćnog sustava.
English: - Urine discolouration.
Croatian: - Promjena boje urina.
English: INSTRUCTIONS ON USE [To be completed nationally]
Croatian: POSEBNE MJERE ČUVANJA [Ispunjava država članica]
English: - Inflammation of the pancreas.
Croatian: - Upala pluća (pneumonija).
English: Cancer patients who received cumulative doses of 140 mg/m2 either alone or in combination with other chemotherapeutic agents had a cumulative
Croatian: Bolesnici oboljeli od raka koji su primili kumulativne doze od 140 mg/m2 ili u monoterapiji ili u kombinaciji s drugim kemoterapeuticima imali su kumulativnu vjerojatnost od 2,6% za kliničko kongestivno zatajenje srca.
English: Cardiac disorders Common
Croatian: Kongestivno zatajenje srca
English: Thrombocytopenia Neutropenia
Croatian: Monoterapija u relapsu
English: Scleral discolouration
Croatian: Diskoloracija bjeloočnice
English: If WBC nadir > 1,500 µl and platelet nadir > 50,000 µl
Croatian: Ako najniža vrijednost broja bijelih krvnih stanica iznosi > 1500 µl i najniža vrijednost broja krvnih pločica >50 000 µl
English: - Skin discolouration.
Croatian: - Nastanak modrica.
English: It is particularly important that you mention any of the following medicines.
Croatian: Odmah obavijestite liječnika ako se dogodi išta od sljedećeg:
English: Excipient(s) with known effect:
Croatian: (ekstravazacija) tijekom primjene.
English: Constipation Diarrhoea Stomatitis Vomiting
Croatian: Kongestivno zatajenje srca Kardiomiopatija
English: Repeat this cleaning process 3 times.
Croatian: Postupak ispiranja ponovite 3 puta.
English: The following side effects can be very serious.
Croatian: Sljedeće nuspojave mogu biti vrlo ozbiljne.
English: There is no known specific antidote.
Croatian: Ne postoji poznati specifični antidot.
English: After first opening: 2 months
Croatian: Nakon prvog otvaranja: 2 mjeseca.
English: Suicidal ideation
Croatian: Suicidalne ideacije
English: If this happens to you, do not drive or use any tools or machines.
Croatian: Ako se ovo pojavi kod Vas, nemojte voziti niti koristiti alate ili strojeve.
English: Your doctor will decide whether you will be given this dose for one or two weeks.
Croatian: Vaš liječnik će odlučiti, hoćete li ovu dozu uzimati jedan ili dva tjedna.
English: These could be signs of an allergic reaction.
Croatian: Ovo bi mogli biti znakovi alergijske reakcije.
English: It may harm them,
Croatian: poremećaji hoda,
English: It is important that your treatment is completed as advised by your doctor or your symptoms may get worse.
Croatian: Važno je završiti liječenje kako je odredio Vaš liječnik ili se simptomi mogu pogoršati.
English: Do not stop taking your oral suspension suddenly.
Croatian: Nemojte iznenada prestati uzimati oralnu suspenziju.
English: If you do, you are at risk of having more seizures.
Croatian: Ako to učinite, izloženi ste riziku pojavljivanja više napadaja.
English: The need for antiepileptic therapy should be reviewed when a woman is planning to become pregnant.
Croatian: Potrebu za antiepileptičkom terapijom treba preispitati kad žena planira zatrudniti.
English: After first opening, oral suspension may be used for up to 2 months Open date: ---/---/--
Croatian: Nakon prvog otvaranja oralna se suspenzija smije upotrebljavati najviše 2 mjeseca Datum otvaranja: ---/---/--
English: At this age the intrinsic activity of the elimination process has not yet reached maturation.
Croatian: U toj dobi intrinzička aktivnost procesa eliminacije još nije dozrela.
English: Do not stop taking your tablets suddenly.
Croatian: Nemojte iznenada prestati uzimati tablete.
English: However, due to inter-individual variability, the effect may be clinically relevant in some individuals.
Croatian: Međutim, zbog interindividualne varijabilnosti, u nekih pojedinaca učinak može biti klinički relevantan.
English: Once you have opened the bottle, you must not use it longer than 2 months
Croatian: Nakon otvaranja boce, lijek ne smijete uzimati duže od 2 mjeseca.
English: Elderly (over 65 years of age)
Croatian: Starije osobe (iznad 65 godina starosti)
English: • Ringing in the ears;
Croatian: • Zvonjenje u ušima;
English: NN: (only for outer packaging)
Croatian: NN: (samo za vanjsko pakiranje)
English: Folic acid supplementation is recommended before and during pregnancy.
Croatian: Dodatak folne kiseline se preporučuje prije i tijekom trudnoće.
English: See ‘Pregnancy and breast-feeding' section for advice about contraception.
Croatian: Pogledajte dio „Trudnoća i dojenje“ za savjet o kontracepciji.
English: • if you suffer from seizures that begin with a widespread electric discharge that involves both sides of the brain.
Croatian: • ako bolujete od napadaja, koji započinju sa široko rasprostranjenim električnim pražnjenjem koje uključuje obje strane mozga.
English: In the double-blind period of the phase II study, evaluation of efficacy was a secondary objective.
Croatian: U dvostruko slijepom razdoblju ispitivanja faze II ocjena djelotvornosti bila je sekundarni cilj ispitivanja.
English: Your doctor may need to adjust the dose.
Croatian: Možda će Vaš liječnik morati prilagoditi dozu.
English: Doses could be adjusted based on tolerability and treatment response.
Croatian: Doze su se mogle prilagođavati na temelju podnošljivosti i odgovora na liječenje.
English: • Sweating or having dry skin;
Croatian: • Znojenje ili suha koža;
English: Swallow the tablet with a glass of water.
Croatian: Progutajte tabletu uz čašu vode.
English: Juvenile animals studies
Croatian: Ispitivanja na juvenilnim životinjama
English: However, based on individual response, the dose may be increased.
Croatian: Međutim, na temelju individualnog odgovora, doza se može povećati.
English: Talk to your doctor or pharmacist before taking Zebinix.
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete Zebinix.
English: If you accidently take more Zebinix than you should, you are potentially at risk of having more seizures; or you may feel like your heart beat is irregular or faster.
Croatian: Ako ste greškom uzeli više Zebinixa nego što ste trebali, za Vas postoji rizik da dobijete više napadaja; ili možete osjećati da Vam srce udara nepravilno ili brže.
English: Date of first authorisation: 21.04.2009 Date of latest renewal: 22.01.2014
Croatian: Datum posljednje obnove odobrenja: 22.01.2014.
English: The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for eslicarbazepine acetate.
Croatian: Mehanizam ovog rizika nije poznat, a dostupni podaci ne isključuju mogućnost povećanog rizika za eslikarbazepinacetat.
English: Currently available data are described in sections 4.8, 5.1 and 5.2 but no recommendation on a posology can be made.
Croatian: Trenutno dostupni podaci opisani su u dijelovima 4.8, 5.1 i 5.2 ali ne mogu se dati preporuke o doziranju.
English: Ask your doctor or pharmacist.
Croatian: Upitajte svog liječnika ili ljekarnika.
English: • Inability to speak or write or understand spoken or written language;
Croatian: • Nesposobnost govora ili pisanja ili razumijevanja govornog ili pisanog jezika; • Uznemirenost;
English: Minimum effective doses should be given, and monotherapy whenever possible should be preferred at least during the first three months of pregnancy.
Croatian: Treba dati minimalnu učinkovitu dozu, a kad god je to moguće treba preferirati monoterapiju, barem tijekom prva tri mjeseca trudnoće.
English: Elderly (over 65 years of age) If you are elderly and taking Zebinix on its own the dose of 1,600 mg is not a suitable dose for you.
Croatian: Starije osobe (starije od 65 godina) Ako ste osoba starije dobi i uzimate Zebinix sam, doza od 1600 mg za Vas nije prikladna.
English: Palpitations, bradycardia
Croatian: Palpitacije, bradikardija
English: Check with your doctor or pharmacist, if you are on long-term antiepileptic treatment, have a history of osteoporosis, or take steroids.
Croatian: Provjerite sa svojim liječnikom ili ljekarnikom ako ste na dugotrajnom liječenju antiepilepticima, a imate osteoporozu u povijesti bolesti ili uzimate steroide.
English: If you are not sure if the medicines you are taking could have this effect, discuss with your doctor.
Croatian: Ako niste sigurni da li lijekovi koje uzimate mogu imati ovaj učinak, razgovarajte s Vašim liječnikom.
English: • Decrease of appetite;
Croatian: • Smanjenje apetita;
English: Of the 183 patients who completed parts I and II of the study, 152 patients were enrolled into part III.
Croatian: Od 183 bolesnika koji su dovršili dio I i dio II ispitivanja, 152 ih je bilo uključeno u dio III.
English: Your doctor will decide how long you should take Zebinix.
Croatian: Vaš liječnik će odlučiti koliko dugo trebate uzimati Zebinix.
English: (only for outer packaging)
Croatian: (samo za vanjsko pakiranje)
English: Gently pull the plunger back downwards to the dose prescribed by your doctor.
Croatian: Nježno povucite klip prema nazad do doze koju Vam je propisao liječnik.
English: Not to be sold separatley.
Croatian: Ne prodaje se zasebno.
English: Apart from this, sodium levels should be determined during routine laboratory examination.
Croatian: Osim toga serumsku razinu natrija treba odrediti tijekom rutinskih laboratorijskih pretraga.
English: In repeat-dose studies in juvenile dogs, the toxicity profile was comparable to that observed in adult animals.
Croatian: U ispitivanjima ponovljene doze na mladim psima, profil toksičnosti bio je usporediv s onim primijećenim kod odraslih životinja.
English: Valproate and levetiracetam
Croatian: Valproat i levetiracetam
English: The mechanism by which bone metabolism is affected has not been identified.
Croatian: Mehanizam kojim utječe na metabolizam kostiju nije identificiran.
English: Since the relationship between exposure and drug activity is unclear, the monitoring of response to therapy (e.g., cholesterol levels) is recommended.
Croatian: Budući da je odnos između izloženosti lijeku i njegove aktivnosti nejasan, preporučuje se pratiti odgovor na terapiju (npr. razine kolesterola).
English: • Attention deficit/ hyperactivity disorder;
Croatian: • Smanjenje pozornosti/poremećaj hiperaktivnosti;
English: • Difficulty in sleeping;
Croatian: • Poteškoće u spavanju;
English: Hyponatraemia, decreased appetite
Croatian: Hiponatrijemija, smanjeni apetit
English: Step 10: Rinse the empty oral syringe after each use into a glass of clean water.
Croatian: 10. korak: Praznu štrcaljku za usta isperite nakon svake uporabe u čaši čiste vode.
English: Contents of the pack and other information What Zebinix contains
Croatian: Sadržaj pakiranja i druge informacije Što Zebinix sadrži
English: Monitoring and prevention
Croatian: Praćenje i prevencija
English: • Difficulty in coordinating movements (ataxia);
Croatian: • Poteškoće u koordinaciji pokreta (ataksija);
English: Specialist advice should be given to women who are likely to become pregnant or who are of child-bearing potential.
Croatian: Treba dati specijalistički savjet ženama koje mogu zatrudniti ili su u generativnoj dobi.
English: Your doctor will work out the correct dose for you.
Croatian: Vaš liječnik će Vam odrediti točnu dozu.
English: If you take more Zebinix than you should
Croatian: Ako uzmete više Zebinixa nego što ste trebali
English: All subjects were randomized to the lowest dose level and only if a seizure occurred subjects were to be escalated to the next dose level.
Croatian: Svi su ispitanici bili randomizirani na najnižu razinu doze i samo ako su imali napadaj, doza bi im se povećala na sljedeću razinu.
English: Read all of this leaflet carefully before you or your child start taking this medicine because it contains important information for you.
Croatian: Vi ili Vaše dijete počnete uzimati ovaj lijek jer sadrži Vama važne podatke
English: Interactions with other antiepileptic medicinal products
Croatian: Interakcije s drugim antiepileptičkim lijekovima
English: • if you suffer from a certain type of heart rhythm disorder (second or third degree atrioventricular (AV) block).
Croatian: • imate određenu vrstu poremećaja srčanog ritma (atrioventrikularni (AV) blok drugog ili trećeg stupnja).
English: In children from 2 to 6 years of age, the use of eslicarbazepine acetate is not recommended.
Croatian: U djece u dobi od 2 do 6 godina ne preporučuje se primjena eslikarbazepinacetata.
English: • if you suffer from a heart disease such as heart failure or heart attack, or have any heart rhytm disorder.
Croatian: • ako bolujete od bolesti srca, kao što je zatajenje srca ili srčani udar ili imate bilo kakav poremećaj srčanog ritma.
English: Zebinix has been given to you by your doctor to reduce your number of seizures.
Croatian: Zebinix Vam je propisao Vaš liječnik da bi se smanjio broj napadaja.
English: As the efficacy of this supplementation is not proven, a specific antenatal diagnosis can be offered even for women with a supplementary treatment of folic acid.
Croatian: S obzirom da djelotvornost ovog dodatka nije dokazana, specifična prenatalna dijagnoza se može ponuditi čak i ženama sa liječenjem dodatkom folne kiseline.
English: Step 6: If you see any air bubbles in the oral syringe, push the plunger upwards just far enough to completely push out any large air bubbles.
Croatian: 6. korak: Ako u štrcaljki za usta primijetite mjehuriće zraka, potisnite klip prema gore tek toliko da potpuno istisnete veće mjehuriće zraka.
English: This is just in case any of them interfere with how Zebinix works or how Zebinix interferes with their effect.
Croatian: To je za slučaj da neki od njih djeluju na učinak Zebinixa ili da Zebinix djeluje na njihov učinak.
English: • if you suffer from confusion, worsening of seizures or decreased consciousness which can be signs of low blood salt levels.
Croatian: • ako bolujete od smetenosti, pogoršanja napadaja ili smanjene svijesti, koji mogu biti znakovi smanjene razine soli u krvi.
English: The data shows that the incidence of adverse reactions in this population (65.3 %) is similar to the general population enrolled in the double-blind epilepsy studies (66.8%).
Croatian: Podaci pokazuju da je incidencija nuspojava u toj populaciji (65,3%) slična onoj u općoj populaciji uključenoj u dvostruko slijepa ispitivanja epilepsije (66,8%).
English: Based on comparative bioavailability data for the tablet and the suspension formulations, switching patients from one formulation to the other can be done.
Croatian: Na temelju komparativnih podataka o bioraspoloživosti za formulacije lijeka u obliku tablete i suspenzije, moguće je prebacivanje bolesnika s jedne formulacije lijeka na drugu.
English: Multiple antiepileptic medicinal product therapy may be associated with a higher risk of congenital malformations than monotherapy, therefore it is important that monotherapy is practised whenever possible.
Croatian: Višestruka terapija antiepileptičkim lijekovima može biti povezana s većim rizikom od kongenitalnih malformacija nego monoterapija, stoga je važno da se monoterapija prakticira kad god je to moguće.
English: This time delay must be taken into account when Zebinix is being used just prior to or in combination with other medicinal products that require dose adjustment when co-administered with Zebinix.
Croatian: Ta odgoda mora se uzeti u obzir kada se Zebinix koristi neposredno prije ili u kombinaciji s drugim lijekovima koji zahtijevaju prilagodbu doze kada se primjenjuju s Zebinixom.
English: Push the plunger all the way down.
Croatian: Pritisnite klip do kraja prema dolje.
English: The majority of adverse reactions were reported in <3% of subjects in any treatment group.
Croatian: Većina nuspojava zabilježena je u <3% ispitanika svake ispitivane skupine.
English: Multipack: 180 (2 packs of 90) tablets
Croatian: Višestruko pakiranje: 180 (2 pakiranja od 90) tableta.
English: Studies in animals have shown reproductive toxicity (see Fertility).
Croatian: Ispitivanja na životinjama pokazala su reproduktivnu toksičnost (vidjeti odlomak Plodnost).
English: You may need to apply some pressure to insert it securely.
Croatian: Može će biti potrebno primijeniti pritisak kako bi se nastavak čvrsto umetnuo.
English: • rosuvastatin, a medicine used to lower cholesterol level;
Croatian: • rosuvastatin, lijek koji se koristi za smanjenje razine kolesterola.
English: Based on this outcome, update of section 4.9 to reflect new information from overdose cases is recommended.
Croatian: Na temelju navedenoga, preporučuje se ažurirati dio 4.9 kako bi se navele nove informacije iz slučajeva predoziranja.
English: The score line is only there to help you break the tablet if you have difficulty swallowing it whole.
Croatian: Razdjelna crta služi samo da Vam pomogne prelomiti tabletu ako je ne možete progutati cijelu.
English: Safety margins based on comparative exposure have thus not been established.
Croatian: Stoga, na temelju komparativne izloženosti, granice sigurnosti još nisu utvrđene.
English: Research has shown an increased risk of birth defects in children of women taking antiepileptic medicines.
Croatian: Ispitivanja su pokazala povećani rizik od urođenih mana u djece žena koje su uzimale lijekove protiv epilepsije.
English: Shake the bottle for at least 10 seconds and remove the child resistant closure by pushing it down and turning it counter-clockwise (to the left).
Croatian: 2. korak: Protresite bocu najmanje 10 sekundi i skinite zatvarač siguran za djecu tako da ga pritisnete prema dolje i zakrenete u smjeru suprotnom od kazaljke na satu (na lijevo).
English: • Difficulty in concentration;
Croatian: • Poteškoće koncentracije;
English: Zebinix may be taken as monotherapy or added to existing anticonvulsant therapy.
Croatian: Zebinix se može uzimati kao monoterapija ili kao dodatak već postojećoj antikonvulzivnoj terapiji.