FrancophonIA/ELRC3.0 huggingface dataset:
English: Approximately 60-70% of a total dose is excreted in the urine in 96 hours and about 10% as respiratory CO2.
Croatian: Približno 60 do 70 % ukupne doze izlučuje se u urinu tijekom 96 sati, a otprilike 10 % kao izdahnuti CO2 Razgradnja preostalog lijeka nije poznata.
English: Carmustine Obvius contains ethanol (alcohol)
Croatian: Carmustine Obvius sadrži etanol (alkohol)
English: The duration of the treatment is determined by the doctor and may vary for each patient.
Croatian: Trajanje liječenja određuje liječnik i može se razlikovati od bolesnika do bolesnika.
English: Because of the good lipid solubility and the lack of ionisation at the physiological pH, carmustine is very well transferred through the blood-brain barrier.
Croatian: Zbog dobre topljivosti u lipidima i manjka ionizacije te fiziološkog pH, karmustin vrlo dobro prolazi kroz krvno-moždanu barijeru.
English: In patients having received carmustine in childhood or adolescence, cases of extremely delayedonset pulmonary fibrosis (up to 17 years after treatment) have been described.
Croatian: Kod bolesnika koji su primali karmustin u djetinjstvu ili adolescenciji, opisani su slučajevi jako odgođenih nastupa plućne fibroze (do 17 godina nakon liječenja).
English: Interstitial fibrosis (with lower doses).
Croatian: Intersticijska fibroza (s nižim dozama).
English: There are no limits for the period of application of carmustine therapy.
Croatian: Nema ograničenja za trajanje razdoblja primjene terapije karmustinom.
English: Doses will be adjusted according to how you respond to the treatment.
Croatian: Doze će se prilagoditi prema vašoj reakciji na liječenje.
English: When placebo-controlled trials are available, adverse reactions are included if the incidence is ≥ 5% higher in the treatment group.
Croatian: Kad su dostupna placebom kontrolirana klinička ispitivanja, nuspojave su uključene ako je incidencija za ≥ 5% viša u skupini za liječenje.
English: Talk to your doctor, pharmacist or nurse before using Carmustine Obvius.
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primite Carmustine
English: During administration of the medicinal product, the container shall be of suitable glass ware.
Croatian: Tijekom primjene lijeka, spremnik mora biti od prikladnog staklenog materijala.
English: Tell you doctor or nurse if you have any concern about the amount of medicine that you received.
Croatian: Obratite se svom liječniku ili medicinskoj sestri ako imate bojazni oko količine lijeka koju primate.
English: Ethanol.
Croatian: Etanol.
English: The carbamoylating activity of carmustine is generally considered less significant than the alkylating activity in its action on tumors, but carbamoylation may serve to inhibit DNA repair.
Croatian: Karbamilacijska aktivnost karmustina općenito se smatra manje značajnom od njegove alkilirajuće aktivnosti u djelovanju na tumor, ali karbamilacija može služiti za inhibiciju popravka DNK.
English: In case the tumor remains incurable or some serious or intolerable adverse reactions appear, the carmustine therapy must be terminated.
Croatian: U slučaju da tumor ostane neizlječiv te kod pojave ozbiljnih ili nepodnošljivih nuspojava, potrebno je prekinuti terapiju karmustinom.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness:
Croatian: Unutar svake skupine učestalosti nuspojave su prikazane u redoslijedu prema sve manjoj ozbiljnosti:
English: If used during pregancy, the patient must be aware of the potential risk to the unborn baby.
Croatian: Ako se koristi tijekom trudnoće, bolesnica mora biti svjesna potencijalnog rizika za nerođeno dijete.
English: The following table includes adverse reactions of carmustine listed by MedDRA system organ class and frequency convention presented in order of decreasing seriousness: 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), not known (frequency cannot be estimated from the available data).
Croatian: U sljedećoj tablici nuspojave karmustina su navedene sukladno MedDRA klasifikaciji organskih sustava i učestalosti, a poredane prema sve manjoj ozbiljnosti: 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: A specialized antidote is not available.
Croatian: Nema specifičnog antidota.
English: You must not breast-feed while taking this medicine and up to 7 days after treatment.
Croatian: Ne smijete dojiti dok uzimate ovaj lijek te do 7 dana nakon liječenja.
English: In cases where pulmonary toxicity started early (within 3 years of treatment), pulmonary infiltrates and/or pulmonary fibrosis occurred, some of which were fatal.
Croatian: U slučajevima gdje je plućna toksičnost počela rano (unutar 3 godine od liječenja), pojavili su se plućni infiltrati i/ili plućna fibroza pri čemu su neki slučajevi bili smrtonosni.
English: Carmustine Obvius has no or negligible influence on the ability to drive and use machines.
Croatian: Carmustine Obvius ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: However, opinion is divided over the role of the carbamoylating intermediates as mediators of the biological effects of the nitrosoureas.
Croatian: mišljenja su podijeljena oko uloge karbamilirajućih intermedijera kao posrednika bioloških učinaka nitrozoureja.
English: Tell your doctor immediately if you experience any of the following symptoms: shortness of breath, persistent cough, chest pain, persistent weakness/tiredness.
Croatian: Odmah recite svom liječniku ako iskusite bilo koji od sljedećih simptoma: nedostatak zraka, ustrajni kašalj, bol u prsima, ustrajna slabost/umor.
English: Melphalan Concomitant use with melphalan leads to increased risk of pulmonary toxicity.
Croatian: Istodobna primjena s melfalanom vodi do povećanog rizika od plućne toksičnosti.
English: The table includes adverse reactions that were presented during treatment with this medicinal product but may not necessarily have a causal relationship with the medicinal product.
Croatian: Tablica uključuje nuspojave koje su bile prisutne tijekom liječenja ovim lijekom, ali možda nisu nužno uzročno povezane s lijekom.
English: What Carmustine Obvius looks like and contents of the pack
Croatian: Kako Carmustine Obvius izgleda i sadržaj pakiranja
English: The dosage will be confirmed with the blood count.
Croatian: Doza se potvrđuje krvnom slikom.
English: Direct administration of carmustine into the carotid artery is regarded as experimental and has been associated with ocular toxicity.
Croatian: Izravna primjena karmustina u karotidnu arteriju smatra se eksperimentalnom i povezana je s okularnom toksičnošću.
English: May cause birth defects.
Croatian: Može uzrokovati urođene mane.
English: The main symptom of intoxication is myelosuppression.
Croatian: Glavni simptom intoksikacije je mijelosupresija.
English: During treatment, lung function tests (FVC, DLCO) should be performed regularly.
Croatian: Tijekom terapije treba redovito provoditi testove plućne funkcije (FVC, DLCO).
English: Your blood count will be monitored frequently to avoid toxicity in your bone marrow and the dose adjusted if necessary.
Croatian: Vaša krvna slika često će se pratiti kako bi se izbjegla toksičnost za Vašu koštanu srž te po potrebi prilagodila doza.
English: Such products are not accepted for use due to the risk of temperature excursions to more than 30°C.
Croatian: Takvi proizvodi nisu prihvatljivi za uporabu zbog rizika od odstupanja temperature na više od 30°C.
English: Blood counts should be monitored frequently and repeat courses should not be given before six weeks because of delayed haematologic toxicity.
Croatian: Krvnu sliku treba često nadzirati, a ponovljene cikluse lijeka ne treba davati prije 6 tjedana zbog odgođene hematološke toksičnosti.
English: Males should be advised of potential risk of infertility and to seek fertility/family planning counselling prior to therapy with carmustine .
Croatian: Muške bolesnike treba savjetovati o potencijalnom riziku od neplodnosti te da potraže savjet specijalista za plodnost/planiranje obitelji prije terapije karmustinom.
English: Leucocytes/mm3
Croatian: Leukociti/mm3
English: Pharmacotherapeutic group: Antineoplastic agents, alkylating agents, nitrosoureas, ATC code: L01AD01
Croatian: Farmakoterapijska skupina: Antineoplastici, alkilirajući lijekovi, nitrozoureje, ATK oznaka: L01AD01
English: The lyophilisate can appear as a fine powder, however handling can cause it to appear as a more heavy and lumpy lyophilisate than as a powdery lyophilisate due to the mechanical instability of the freeze drying cake.
Croatian: Liofilizat može izgledati kao fini prašak, međutim rukovanje njime može uzrokovati da izgleda teži i grudičastiji od praškastog liofilizata zbog mehaničke nestabilnosti suho zamrznutog kolačića.
English: What Carmustine Obvius is and what it is used for What you need to know before Carmustine Obvius is given to you How to use Carmustine Obvius
Croatian: Što je Carmustine Obvius i za što se koristi Što morate znati prije nego što počnete primati Carmustin Obvius Kako primjenjivati Carmustine Obvius
English: Concomitant use with digoxin leads to delayed, moderate, suspected, decreased effect of digoxin (due to the decreased digoxin absorption).
Croatian: Istodobna uporaba digoksina vodi ka odgođenom, umjerenom, suspektnom, smanjenom učinku digoksina (zbog smanjene apsorpcije digoksina).
English: Carmustine must be completely dissolved in ethanol before sterile water for injections is added.
Croatian: Karmustin se mora otopiti do kraja u etanolu prije dodavanja sterilne vode za injekcije.
English: Carmustine crosses the blood-brain barrier readily because of its lipophilic nature.
Croatian: Karmustin lako prolazi kroz krvno-moždanu barijeru zbog svoje lipofilne prirode.
English: In case of a decreased number of circulating platelets, leucocytes or erythrocytes either from previous chemotherapy or other cause the dose should be adjusted, see Table 1, section 4.2.
Croatian: U slučaju smanjenog broja cirkulirajućih trombocita, leukocita ili eritrocita bilo zbog prethodne kemoterapije ili drugih uzroka, dozu treba prilagoditi, vidjeti tablicu 1, dio 4.2.
English: Severe bone marrow depression.
Croatian: Teška depresija koštane srži.
English: Phenytoin and dexamethasone
Croatian: Fenitoin i deksametazon
English: The antineoplastic and toxic activities of carmustine may be due to its metabolites.
Croatian: Antineoplastično i toksično djelovanje karmustina može biti uzrokovano njegovim metabolitima.
English: Pulmonary fibrosis (with fatal outcome), pulmonary infiltration
Croatian: Plućna fibroza (sa smrtnim ishodom), plućna infiltracija
English: Carmustine and related nitrosoureas are unstable in aqueous solutions and degrade spontaneously to reactive intermediates that are capable of alkylation and carbamoylation.
Croatian: Karmustin i srodne nitrozoureje nisu stabilne u vodenim otopinama te se spontano raspadaju na reaktivne intermedijere koji mogu alkilirati i karbamilirati.
English: Hypersensitivity to the active substance, to other nitrosoureas or to any of the excipients listed in section 6.1.
Croatian: Preosjetljivost na djelatnu tvar, druge nitrozoureje ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: Carmustine, at clinically relevant dose levels, was carcinogenic in rats and mice.
Croatian: Karmustin je pri klinički relevantnim razinama doze bio kancerogen u štakora i miševa.
English: if you suffer from suppression of blood cell formation in the bone marrow and the number of your platelets, white blood cells (leucocytes), or red blood cells (erythrocytes) is therefore reduced, either as a result of chemotherapy or other causes.
Croatian: ako patite od supresije (potisnutog) stvaranja krvnih stanica u koštanoj srži i broj vaših trombocita, bijelih krvnih stanica (leukocita) ili crvenih krvnih stanica (eritrocita) je stoga smanjen bilo kao rezultat kemoterapije ili zbog drugih uzroka.
English: Carmustine Obvius is a medicine which contains carmustine.
Croatian: Carmustine Obvius je lijek koji sadrži karmustin.
English: Myelosuppression is very common and begins 7-14 days of administration with recovery 4256 days of administration.
Croatian: Mijelosupresija je vrlo česta i počinje 7. do 14. dana primjene s oporavkom 42. do 56. dana primjene.
English: - Secondary therapy in non-Hodgkin's lymphoma and Hodgkin's disease
Croatian: - Sekundarna terapija kod ne-Hodgkinova limfoma i Hodgkinove bolesti
English: Powder: white to almost white powder or lyophilisate.
Croatian: Prašak: bijeli do gotovo bijeli prašak liofilizata.
English: The powder is white to almost white powder supplied in a brown glass vial.
Croatian: Prašak je bijeli do gotovo bijeli prašak koji dolazi u smeđoj staklenoj bočici.
English: Not known Infertility, teratogenesis.
Croatian: Nepoznato Neplodnost, teratogeneza.
English: The bone marrow toxicity of carmustine is cumulative and therefore the dosage adjustment must be considered on the basis of nadir blood counts from prior doses (see section
Croatian: Toksičnost karmustina za koštanu srž je kumulativna i stoga je potrebno razmotriti prilagodbu doze na temelju najnižih vrijednosti krvne slike kod prethodnih doza (vidjeti dio 4.2.).
English: Posology and laboratory investigations
Croatian: Doziranje i laboratorijske pretrage
English: Common Alopecia, flushing (due to alcohol content of solvent; increased with administration times <1-2 h), injection site reaction.
Croatian: Alopecija, navale crvenila (zbog alkoholnog sadržaja otapala; povećano s vremenima primjene <1-2 sata), reakcija na mjestu primjene.
English: Pulmonary toxicity also manifested in the post-marketing phase as pneumonitis and interstitial lung disease.
Croatian: Plućna toksičnost također se manifestira u fazi nakon davanja odobrenja kao pneumonitis i intersticijska bolest pluća.
English: Emetogenic potential The emetogenic potential is high at doses >250 mg/m2 and high to moderate in doses
Croatian: Emetogeni potencijal Emetogeni potencijal je visok pri visokim dozama >250 mg/m2 te visok do umjeren u dozama
English: Veno-occlusive disease (high-dose therapy).
Croatian: Vensko-okluzivna bolest (terapija visokom dozom).
English: By following the recommended storage conditions it is possible to avoid any decomposition of the unopened vial until the date of expiry mentioned on the packaging.
Croatian: Slijedeći preporučene uvjete čuvanja moguće je izbjeći bilo kakvu razgradnju lijeka u neotvorenoj bočici sve do datuma isteka roka valjanosti navedenog na pakiranju.
English: In addition, the following serious adverse reactions may occur: liver necrosis, interstitial pneumonitis, encephalomyelitis.
Croatian: Pored toga, mogu se javiti sljedeće ozbiljne nuspojave: nekroza jetre, intersticijski pneumonitis, encefalomijelitis.
English: Secondary therapy in non-Hodgkin's lymphoma and Hodgkin's disease
Croatian: Sekundarna terapija kod ne-Hodgkinova limfoma i Hodgkinove bolesti
English: As an alkylating agent, it can alkylate reactive sites on nucleoproteins, thus interfering with DNA and RNA synthesis and DNA repair.
Croatian: Kao alkilirajuća tvar, može alkilirati reaktivna mjesta na nukleoproteinima, interferirajući tako sa sintezom DNK i RNK te popravkom RNK.
English: Therefore this medicine should not normally be administered to pregnant women.
Croatian: Stoga se ovaj lijek inače ne smije primjenjivati u trudnica.
English: All plastic coming into contact with the carmustine solution for infusion (e.g. infusion set, etc.) should be PVC-free polyethylene plastic, otherwise glass ware should be used.
Croatian: Sva plastika koja dolazi u doticaj s otopinom karmustina za infuziju (npr. set za infuziju itd.) mora biti polietilenska plastika bez PVC-a, inače treba koristiti staklene spremnike.
English: Common Anorexia, constipation, diarrhoea, stomatitis.
Croatian: Anoreksija, konstipacija, proljev, stomatitis.
English: Not known Extravasation hazard: vesicant
Croatian: Nepoznato Opasnost od ekstravazacije: vezikant
English: In combination with chemotherapeutic medicinal products reduced activity of antiepileptic medicinal products must be anticipated.
Croatian: U kombinaciji s kemoterapeuticima mora se očekivati smanjena aktivnost antiepileptika.
English: Repeat doses of Carmustine Obvius should not to be given more frequently than every six weeks.
Croatian: Ponovljene doze lijeka Carmustine Obvius ne treba davati češće od svakih 6 tjedana.
English: Pneumonitis is seen for doses >450 mg/m2 and interstitial lung disease is seen with prolonged therapy and cumulative dose > 1,400 mg/m2.
Croatian: Pneumonitis je zabilježen kod doza >450 mg/m2, a intersticijska bolest pluća zabilježena je kod produljene terapije i kumulativne doze > 1 400 mg/m2
English: After reconstitution Carmustine Obvius is stable for 3 hours, stored in a glass container and protected from light.
Croatian: Nakon rekonstitucije lijek Carmustine Obvius stabilan je tijekom 3 sata kada je pohranjen u staklenom spremniku te zaštićen od svjetlosti.
English: Patients with a baseline below 70% of the predicted forced vital capacity (FVC) or carbon monoxide diffusing capacity (DLCO) are particularly at risk.
Croatian: Bolesnici s početnim vrijednostima ispod 70 % predviđenog forsiranog vitalnog kapaciteta (FVC) ili kapaciteta difuzije ugljikova monoksida (DLCO) posebno su izloženi riziku.
English: Carmustine Obvius must not be used in children and adolescents aged <18 years.
Croatian: Carmustine Obvius se ne smije koristiti u djece i adolescenata mlađih od 18 godina.
English: Concomitant use with cimetidine leads to delayed, major, suspected, increased carmustine toxic effect (due to the inhibition of carmustine metabolism).
Croatian: Istodobna uporaba s cimetidinom vodi do odgođenog, većeg, suspektnog, povećanog toksičnog učinka karmustina (zbog inhibicije metabolizma karmustina).
English: Carmustine Obvius is contraindicated during breastfeeding and up to seven days post-treatment (see section 4.3).
Croatian: Carmustine Obvius je kontraindiciran tijekom dojenja, a dojenje do sedam dana nakon liječenja (vidjeti dio 4.3.).
English: When Carmustine Obvius is used in combination with other myelosuppressive medicinal products or in patients in whom bone marrow reserve is depleted, the doses should be adjusted according to the haematologic profile of the patient as shown below.
Croatian: Kad se Carmustine Obvius koristi u kombinaciji s drugim mijelosupresivnim lijekovima ili u bolesnika sa smanjenom rezervom koštane srži, doze treba prilagoditi u skladu s hematološkim profilom bolesnika kako je prikazano u nastavku.
English: The 530 ml diluted solution (i.e. the ready-to-use solution) should be mixed for at least 10 seconds before administration.
Croatian: Dobivenih 530 ml razrijeđene otopine (tj. otopine spremne za uporabu) treba miješati barem 10 sekundi prije primjene.
English: In addition, carmustine is known to carbamoylate lysine residues on proteins causing irreversible inactivation of enzymes including glutathione reductase.
Croatian: Pored toga, poznato je da karmustin karbamilira ostatke lizina na proteinima uzrokujući ireverzibilnu inaktivaciju enzima uključujući glutation reduktazu.
English: The alkylating intermediates are believed to be responsible for the antitumor effect of carmustine.
Croatian: Pretpostavlja se da su alkilirajući intermedijeri odgovorni za antitumorski učinak karmustina.
English: The myelosuppression is dose and cumulative dose related, and often biphasic.
Croatian: Mijelosupresija je povezana s dozom i kumulativnom dozom te je često bifazična.
English: Each ampoule of solvent contains 3 ml ethanol anhydrous (that is equivalent to 2.37 g).
Croatian: Jedna ampula otapala sadrži 3 ml bezvodnog etanola (što odgovara količini od 2,37 g).
English: This may be given as a single dose or divided into daily infusions such as 75 to 100 mg/m2 on two successive days.
Croatian: Može se dati kao jedna doza ili podijeljena doza u dnevnim infuzijama poput 75 do 100 mg/m2 na dva uzastopna dana.
English: To be taken into account in high-risk groups such as patients with liver disease or epilepsy.
Croatian: O tome treba voditi računa u visokorizičnih skupina ljudi poput bolesnika s bolešću jetre ili epilepsijom.
English: Very common Hypotension, due to the alcohol content of the solvent (high-dose therapy).
Croatian: Vrlo često Hipotenzija, zbog sadržaja alkohola u otapalu (terapija visokom dozom).
English: Carmustine Obvius must be administered only by specialists experienced in the field of chemotherapy and under appropriate medical supervision
Croatian: Carmustine Obvius smiju primjenjivati samo zdravstveni radnici iskusni u primjeni kemoterapije i samo pod odgovarajućim nadzorom liječnika.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Croatian: Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP), koji se nalazi u modulu 1.8.2
English: It is able to form interstrand crosslinks in DNA, which prevents DNA replication and transcription.
Croatian: Može stvarati ukrižene veze između lanaca uzvojnice DNK, što sprječava njenu replikaciju i transkripciju.
English: Intravenously administered carmustine is rapidly degraded, with no substance intact detectable after 15 minutes.
Croatian: Intravenski primijenjeni karmustin brzo se raspada te se nakon 15 minuta ne može detektirati nikakva intaktna tvar.
English: You must check with your doctor before driving or operating any tools or machines because the amount of alcohol in this medicine may impair your ability to drive or use machines.
Croatian: Prije upravljanja vozilima ili rada sa strojevima morate konzultirati svog liječnika jer količina alkohola u ovom lijeku može djelovati na vašu sposobnost upravljanja vozilima ili strojevima.
English: This can result in increased liver enzymes and bilirubin (detected by blood tests); - Alopecia (loss of hair); - Flushing of the skin; - Reactions on the injection site
Croatian: To može rezultirati povišenim jetrenim enzimima i bilirubinom (vidljivo na krvnoj slici); - Alopecija (gubitak kose); - Navala crvenila u koži; - Reakcije na mjestu infuzije
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without prescription, such as: Phenytoin, used in epilepsy
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove, uključujući one koji se dobivaju bez recepta:
English: Therefore your doctor will monitor blood counts weekly for at least 6 weeks after a dose.
Croatian: Stoga će vam liječnik pratiti krvnu sliku barem 6 tjedana nakon primanja doze.
English: Carmustine Obvius will always be given to you by a healthcare professional with experience in the use of anticancer medicines.
Croatian: Carmustine Obvius uvijek će Vam primjenjivati zdravstveni radnik iskusan u primjeni lijekova protiv raka.
English: How to store Carmustine Obvius
Croatian: Kako primjenjivati Carmustine Obvius
English: In cases where the nadir after initial dose does not fall in the same row for leucocytes and platelets (e.g. leucocytes >4,000 and platelets <25,000) the value given the lowest percentage of prior dose should be used (e.g. platelets <25,000 then a maximum of 50% of prior dose should be given).
Croatian: U slučajevima gdje najniža vrijednost nakon početne doze nije u istom redu kao za leukocite i trombocite (npr. leukociti > 4000 te trombociti < 25 000) potrebno je koristiti onaj postotak prethodne doze koji je niži (npr. trombociti < 25 000 potrebno je dati najviše 50 % prethodne doze).
English: Infusion of Carmustine Obvius over shorter periods of time may produce intense pain and burning at the site of injection.
Croatian: Infuzija lijeka Carmustine Obvius tijekom kraćih razdoblja može uzrokovati intenzivnu bol i žarenje na mjestu infuzije.