FrancophonIA/ELRC3.0 huggingface dataset:
English: Nausea and vomiting are severe and begins within 2-4 h of administration and lasts for 4-6 h.
Croatian: Mučnina i povraćanje su teški i počinju unutar 2 do 4 sata od primjene te traju 4
English: Common Acute leukaemia, bone marrow dysplasia - following long-term use.
Croatian: Akutna leukemija, displazija koštane srži - nakon dugoročne primjene
English: The amount of alcohol in this medicinal product may alter the effects of other medicines, and may impair your ability to drive or use machines.
Croatian: Količina alkohola u ovom lijeku može promijeniti učinke drugih lijekova i može umanjiti vašu sposobnost upravljanja vozilima ili rada sa strojevima.
English: C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Croatian: OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE U PROMET
English: Dermatitis with topical use improves with reduced concentration of compounded product, hyperpigmentation, transient, with accidental skin contact.
Croatian: Dermatitis se kod topikalne primjene poboljšava smanjenjem koncentracije sadržanog lijeka, hiperpigmentacija, prolazna kod slučajnog doticaja s kožom.
English: Then aseptically add 27 ml of sterile water for injection to the alcohol solution.
Croatian: Potom na aseptički način dodajte 27 ml sterilne vode za injekciju u alkoholnu otopinu.
English: Since the use of Carmustine Obvius can lead to lung damage, an X-ray of the chest region and lung function tests will be conducted before treatment is started (please also see the section “Possible side effects”).
Croatian: S obzirom na to da Carmustine Obvius može uzrokovati oštećenje pluća, prije početka liječenja će se obaviti rendgensko snimanje prsnog koša i ispitivanje funkcije pluća (vidjeti također dio „Moguće nuspojave”).
English: Obvius Investment B.V. De Cuserstraat 93
Croatian: De Cuserstraat 93
English: Paediatric population Carmustine must not be used in children aged <18 years because of safety concerns.
Croatian: Karmustin se ne smije koristiti u djece mlađe od 18 godina zbog sigurnosnih bojazni.
English: Carmustine belongs to a group of anticancer medicines known as nitrosourea that act by slowing the growth of cancer cells.
Croatian: Karmustin pripada skupini lijekova protiv raka zvanih nitrozoureje, a koje djeluju tako što usporavaju rasta stanica raka.
English: The major side effect of this medicine is delayed bone marrow suppression, which may show as tiredness, bleeding from the skin and mucous membranes as well as infections and fever due to changes in the blood.
Croatian: Glavna je nuspojava ovog lijeka odgođena supresija koštane srži što se može očitovati kao umor, krvarenje iz kože i sluznica kao i infekcije i vrućica zbog promjena u krvi.
English: Nadir after prior dose
Croatian: Najniža vrijednost nakon prethodne doze
English: Carmustine is carcinogenic in rats and mice at doses less than the recommended human dose based on body surface area.
Croatian: Karmustin je kancerogen u štakora i miševa pri dozama manjim od preporučene doze za ljude na temelju tjelesne površine.
English: Pulmonary toxicity characterised by pulmonary infiltrates and/or fibrosis has been reported to occur with a frequency ranging up to 30%.
Croatian: Prijavljena je plućna toksičnost okarakterizirana plućnim infiltratima i/ili fibrozom s učestalošću do 30 %.
English: HUNGARY
Croatian: Mađarska
English: Table 1
Croatian: Tablica 1.
English: This may occur within 3 years of therapy and appears to be dose related with cumulative doses of 1,200-1,500 mg/m2 being associated with increased likelihood of lung fibrosis.
Croatian: To se može dogoditi unutar 3 godine od terapije i čini se da je ovisna o dozi pri čemu su kumulativne doze od 1200-1500 mg/m2 povezane s povećanom vjerojatnošću plućne fibroze.
English: Solvent: colourless clear liquid.
Croatian: Otapalo: bezbojna bistra tekućina.
English: This medicinal product contains 0.57 vol% ethanol (alcohol), i.e. up to 7.62 g per dose, equivalent to 11.2 ml beer or 4.65 ml wine per dose.
Croatian: Ovaj lijek sadrži 0,57 vol % etanola (alkohola), tj. do 7,62 g po dozi što odgovara količini od 11,2 ml piva ili 4,65 ml vina po dozi.
English: Infusion of Carmustine Obvius in less than one hour may produce intense pain and burning at the site of injection (see section 4.2).
Croatian: Infuzija lijeka Carmustine Obvius trajanja kraćeg od jednog sata može uzrokovati intenzivnu bol i žarenje na mjestu primjene infuzije (vidjeti dio 4.2).
English: For patients with renal impairment the dose of Carmustine Obvius should be reduced if the glomerular filtration rate is reduced.
Croatian: Za bolesnike s oštećenjem funkcije bubrega dozu lijeka Carmustine Obvius treba smanjiti ako je smanjena brzina glomerularne filtracije.
English: Dexamethasone, used as an anti-inflammatory and immunosuppressive agent Cimetidine, used for stomach problems like indigestion Digoxin, used if you have abnormal heart rhythm Melphalan, an anticancer medicine
Croatian: fenitoin, koji se koristi kod epilepsije deksametazon, koji se koristi kao protuupalni i imunosupresivni lijek cimetidin, koji se koristi za probleme sa želucem poput loše probave digoksin, koji se koristi ako imate poremećen srčani ritam melfalan, lijek protiv raka
English: For storage conditions after reconstitution and further dilution of the medicinal product, see section 6.3.
Croatian: Uvjete čuvanja nakon rekonstitucije i daljnjeg razrjeđivanja lijeka vidjeti u dijelu 6.3.
English: The reconstituted and diluted solution (i.e. ready-to-use solution) must be given intravenously and should be administered by intravenous drip over a one- to two-hour period and administration should be finalised within 3 hours from reconstitution/dilution of the medicinal product.
Croatian: Način primjene Rekonstituirana i razrijeđena otopina (tj. otopina spremna za uporabu) mora se dati intravenski i treba je primijeniti putem intravenskog dripa tijekom razdoblja od jednog do dva sata, a primjenu treba dovršiti unutar 3 sata od rekonstitucije/razrjeđenja lijeka.
English: Platelets/mm3
Croatian: Trombociti/mm3
English: Adverse reactions are generally included if they were reported in more than 1% of patients in the product monograph or pivotal trials,
Croatian: Nuspojave se općenito navode ako su zabilježene u više od 1 % bolesnika u monografiji lijeka ili u pivotalnim ispitivanjima/ili se odredi da su klinički važne.
English: For dissolving purposes only
Croatian: Samo u svrhu otapanja
English: At the recommended dosage, courses of Carmustine Obvius would not be given more frequently than every 6 weeks.
Croatian: Pri preporučenom doziranju, ciklusi lijeka Carmustine Obvius ne bi se smjeli davati češće od svakih 6 tjedana.
English: Carmustine affected the fertility of male rats at doses higher than the human dose.
Croatian: Karmustin je utjecao na plodnost mužjaka štakora pri dozama višim od doza u ljudi.
English: Doses subsequent to the initial dose should be adjusted according to the haematologic response of the patient to the preceding dose in both monotherapy as well as in combination therapy with other myelosuppressive medicinal products.
Croatian: Doze nakon početne treba prilagoditi u skladu s hematološkom reakcijom bolesnika na prethodnu dozu u monoterapiji kao i u kombiniranoj terapiji s drugim mijelosupresivnim lijekovima.
English: - The active substance is carmustine.
Croatian: - Djelatna tvar je karmustin.
English: This information is a short description of preparation and/or handling, incompatibilities, posology of the medicine, overdose or monitoring measures and laboratory investigations based on the current SmPC.
Croatian: Ove informacije sadrže kratki opis pripreme i rukovanja, inkompatibilnosti, doziranja i predoziranja lijeka, mjera praćenja te laboratorijskih pretraga koje se temelje na postojećem sažetku opisa svojstava lijeka.
English: However, the possibility will have to be taken into consideration, that the alcohol quantity in these pharmaceutical medicines can impair the ability to drive and use machines.
Croatian: Međutim, potrebno je razmotriti mogućnost da količina alkohola u ovim lijekovima može narušiti mogućnost upravljanja vozilima i rada sa strojevima.
English: - Brain tumours (glioblastoma, Brain-stem gliomas, medulloblastoma, astrocytoma and ependymoma), brain metastases
Croatian: Tumori na mozgu (glioblastom, gliomi moždanog debla, meduloblastom, astrocitom i ependimom), metastaze u mozgu
English: It is unknown whether carmustine/metabolites are excreted in human milk.
Croatian: Nije poznato izlučuju li se karmustin ili njegovi metaboliti u majčino mlijeko.
English: The incidence of adverse reactions is probably doserelated; cumulative doses of 1200-1500 mg/m2 have been associated with an increased likelihood of pulmonary fibrosis.
Croatian: Incidencija nuspojava je vjerojatno povezana s dozom; kumulativne doze od 1200-1500 mg/m2 su povezane s povećanom vjerojatnošću od plućne fibroze.
English: Biotransformation It is presumed that the metabolites of carmustine cause its antineoplastic and toxic activity.
Croatian: Pretpostavlja se da metaboliti karmustina uzrokuju njegovu antineoplastičnu i toksičnu aktivnost.
English: Ataxia, dizziness, headache.
Croatian: Ataksija, omaglica, glavobolja.
English: The intravenous solution is unstable in polyvinyl chloride containers.
Croatian: Intravenska otopina nije stabilna u spremnicima od polivinilkorida.
English: The 30 ml stock solution needs to be mixed thoroughly.
Croatian: Trideset ml koncentrirane otopine treba temeljito promiješati.
English: The dry frozen product does not contain any preservatives and is suitable only for one use.
Croatian: Liofilizat ne sadrži nikakve konzervanse te je prikladan samo za jednokratnu primjenu.
English: For verification, hold the vial in bright light.
Croatian: Da biste to provjerili, držite bočice prema izvoru jasne svjetlosti.
English: The solution should be protected from light until the end of administration.
Croatian: Otopinu treba zaštititi od svjetlosti sve do kraja primjene.
English: Paediatric population Carmustine is contraindicated in children and adolescents aged <18 years (see section 4.3)
Croatian: Karmustin je kontraindiciran u djece i adolescenata u dobi od <18 godina (vidjeti dio 4.3) Starije osobe
English: Pulmonary toxicity, interstitial fibrosis (with prolonged therapy and cumulative dose)
Croatian: Vrlo često Plućna toksičnost, intersticijska fibroza (uz produljenu terapiju i kumulativnu dozu) Pneumonitis.
English: Method of administration Carmustine Obvius is for intravenous use after reconstitution and further dilution.
Croatian: Carmustine Obvius namijenjen je za intravensku primjenu nakon rekonstitucije i daljnjeg razrjeđivanja.
English: Male patients should use adequate contraceptive measures while on treatment with Carmustine Obvius and for at least 6 months after treatment to prevent their partners becoming pregnant.
Croatian: Muški bolesnici trebaju upotrebljavati odgovarajuće mjere kontracepcije dok traje liječenje lijekom Carmustine Obvius i najmanje 6 mjeseci nakon liječenja da bi spriječili da njihove partnerice zatrudne.
English: Guidelines for the safe handling and disposal of antineoplastic agents must be observed.
Croatian: Potrebno je pridržavati se smjernica za sigurno rukovanje i zbrinjavanje antineoplastičnih lijekova.
English: Before treatment, your liver, lung and kidney function will be tested and observed regularly during treatment.
Croatian: Prije liječenja napravit će se testovi funkcije vaše jetre, pluća i bubrega te će se ona redovito pratiti tijekom liječenja.
English: The Ready-to-Use solution should be administered over 1-2 hours and administration should be finalised within 3 hours from reconstitution of the product.
Croatian: Otopinu spremnu za uporabu treba primjenjivati tijekom 1 do 2 sata, a primjenu treba dovršiti unutar 3 sata od rekonstitucije lijeka.
English: it has been speculated that the carbamoylating species may mediate some of toxic effects of carmustine.
Croatian: S druge strane, nagađalo se da karbamilirajuće skupine mogu posredovati neke toksične učinke karmustina.
English: Brown type I hydrolytic glass vial (50 ml) with light grey 20 mm bromobutyl rubber stopper and sealed with a dark red aluminium flip-off cap.
Croatian: I (50 ml) sa svijetlosivim čepom od bromobutilne gume dimenzija 20 mm zatvorena tamnocrvenom aluminijskom kapicom.
English: This medicine will be stored by your doctor or health care professional.
Croatian: Kako čuvati Carmustine Obvius Ovaj lijek će čuvati vaš liječnik ili zdravstveni radnik.
English: Use of carmustine in children and adolescents < 18 years is contraindicated, see section 4.3.
Croatian: Primjena karmustina u djece i adolescenata < 18 godina kontraindicirana je, vidjeti dio
English: Severe (end-stage) renal impairment.
Croatian: Teško (završni stadij) oštećenje bubrega.
English: Not known Muscular pain, status epilepticus, seizure, grand mal seizure.
Croatian: Nepoznato Bol u mišićima, status epilepticus, napadaj,
English: Guidelines for the safe disposal of antineoplastic agents must be observed.
Croatian: Potrebno je pridržavati se smjernica za sigurno zbrinjavanje antineoplastičnih lijekova.
English: Gynecomastia.
Croatian: Ginekomastija.
English: Risk factors include smoking, respiratory disease, existing radiographic abnormalities, sequential or concomitant thoracic radiation, as well as combination with other active substances that can cause lung damage.
Croatian: Čimbenici rizika uključuju pušenje, prisutnost respiratorne bolesti, postojeće radiografske abnormalnosti, naknadno ili istodobno zračenje prsnog koša kao i kombinaciju s drugim djelatnim tvarima koje mogu uzrokovati oštećenje pluća.
English: The duration of infusion should not be less than one hour, otherwise it leads to burning and pain in the injected area.
Croatian: Trajanje infuzije ne smije biti manje od sat vremena, inače može doći do opeklina i boli na mjestu primjene.
English: After reconstitution and dilution (se section 6.6), one mL of solution contains 3.3 mg carmustine.
Croatian: Nakon rekonstitucije i razrjeđivanja (vidjeti dio 6.6) jedan ml otopine sadrži 3,3 mg karmustina.
English: Complete blood count should be monitored frequently for at least six weeks after a dose.
Croatian: Kompletnu krvnu sliku treba pratiti učestalo najmanje šest tjedana nakon primanja doze.
English: The resulting ready-to-use solution for infusion should then be administered immediately by intravenous drip over a one- to two-hour period protected from light.
Croatian: Rezultirajuća otopina spremna za infuziju potom se mora odmah primijeniti intravenskim dripom tijekom razdoblja od jednog do dva sata i zaštićena od svjetlosti.
English: Following reconstitution and dilution Carmustine Obvius is given into a vein by a drip (intravenously) over a one- to two-hour period protected from light.
Croatian: Nakon rekonstitucije i razrjeđivanja, lijek Carmustine Obvius daje se u venu (intravenski) infuzijom (kap po kap) tijekom razdoblja od sat ili dva, zaštićen od svjetlosti.
English: Liver, kidney and lung function should be checked and monitored regularly during therapy (see section 4.8).
Croatian: Tijekom terapije potrebno je redovito provjeravati funkciju jetre, bubrega i pluća (vidjeti dio 4.8).
English: - Solvent: Ethanol, anhydrous.
Croatian: - Otapalo: etanol, bezvodni.
English: Myelosuppression.
Croatian: Mijelosupresija.
English: The recommended dose of Carmustine Obvius as a single agent in previously untreated patients is 150 to 200 mg/m2 intravenously every 6 weeks.
Croatian: Preporučena doza lijeka Carmustine Obvius kada se primjenjuje sam kod prethodno neliječenih bolesnika je 150 do 200 mg/m2 intravenski svakih 6 tjedana.
English: Common Encephalopathy (high-dose therapy and dose-limiting).
Croatian: Encefalopatija (terapija visokom dozom i ograničenja doze zbog toksičnosti).
English: What you need to know before you use Carmustine Obvius Do not use Carmustine Obvius:
Croatian: Što morate znati prije nego što počnete primati Carmustine Obvius
English: Solvent for Carmustine Obvius ethanol anhydrous IV
Croatian: Otapalo za Carmustine Obvius bezvodni etanol, i.v.
English: Ocular toxicities, transient conjunctival flushing and blurred vision due to retinal haemorrhages.
Croatian: Očne toksičnosti, naleti crvenila konjuktive i zamućeni vid zbog krvarenja u mrežnici.
English: Renal toxicity Renal toxicity is rare, but occurs for cumulative doses < 1,000 mg/m2.
Croatian: Bubrežna toksičnost je rijetka, ali se javlja kod kumulativnih doza manjih od 1000 mg/m2
English: Carmustine is a cell-cycle phase nonspecific antineoplastic agent of the nitrosourea type, which exerts tumor cytotoxicity via multiple mechanisms.
Croatian: Mehanizam djelovanja Karmustin je antineoplastični lijek iz skupine nitrozoureja i nije fazno specifičan s obzirom na stanični ciklus te iskazuje tumorsku citotoksičnost putem višestrukih mehanizama.
English: Not known (frequency cannot be estimated from the available data) - Muscular pain; - Seizures (fits) including status epilepticus; - Tissue damage due to leakage in injection area; - Infertility; - Carmustine has been shown to adversely affect the development of unborn babies
Croatian: Nepoznato (učestalost se ne može procijeniti na temelju dostupnih podataka) - Bol u mišićima; - Napadaji, uključujući status epilepticus; - Oštećenje tkiva zbog curenja lijeka u području davanja lijeka;
English: Carmustine should not be administered to patients who are pregnant.
Croatian: Karmustin se ne smije primjenjivati u trudnica.
English: Powder for concentrate for solution for infusion 100 mg
Croatian: Prašak za koncentrat za otopinu za infuziju 100 mg
English: Risk factors include smoking, the presence of a respiratory condition, pre-existing radiographic abnormalities, sequential or concomitant thoracic irradiation and association with other agents that cause lung damage.
Croatian: Čimbenici rizika uključuju pušenje, prisutnost respiratorne bolesti, prethodno postojeće radiografske abnormalnosti, sljedeće ili istodobno zračenje prsnog koša i povezanost s drugim tvarima koje uzrokuju oštećenje pluća.
English: Administration of the infusion should be performed using a PVC free PE infusion set.
Croatian: Infuziju treba dati kroz polietilenski set za infuziju koji ne sadrži PVC.
English: Cytotoxic: Handle with caution.
Croatian: Citotoksično: oprezno rukovati.
English: Patients showing a baseline value of <70% of expected forced vital capacity or carbon monoxide diffusion capacity in these tests are at particular risk.
Croatian: Bolesnici kod kojih je vrijednost tih testova prije početka terapije manja od 70 % očekivanog forsiranog vitalnog kapaciteta ili kapaciteta difuzije ugljikovog monoksida pod posebnim su rizikom.
English: Do not use this medicine after the expiry date which is stated on the label and carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici bočice i ampule i kutiji iza oznake „Rok valjanosti”.
English: Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and the glomerular filtration rate should be monitored and the dose reduced according to this.
Croatian: S obzirom na veću vjerojatnost toga da će stariji bolesnici imati smanjenu bubrežnu funkciju, potreban je oprez kod odabira doza, Brzinu glomerularne filtracije treba nadzirati te dozu shodno tome smanjivati.
English: Male patients should be advised to use adequate contraceptive measures while on treatment with carmustine and for at least 6 months after treatment.
Croatian: Muške bolesnike treba savjetovati da koriste odgovarajuće mjere kontracepcije dok traje liječenje karmustinom i najmanje 6 mjeseci nakon liječenja.
English: Keep the vial in the outer carton in order to protect from light.
Croatian: Bočicu čuvati u vanjskom pakiranju radi zaštite od svjetla.
English: One pack of Carmustine Obvius contains one vial with 100 mg of powder and one ampoule with 3 ml of solvent.
Croatian: Jedno pakiranje lijeka Carmustine Obvius sadrži jednu bočicu sa 100 mg praška i jednu ampulu s 3 ml otapala.
English: One pack contains one vial with 100 mg of powder for concentrate for solution for infusion and one ampoule with 3 ml of solvent.
Croatian: Jedno pakiranje sadrži jednu bočicu sa 100 mg praška za koncentrat za otopinu za infuziju i jednu ampulu s 3 ml otapala.
English: The carmustine powder for concentrate for solution for infusion contains no preservative and is not intended as a multiple dose vial.
Croatian: Karmustin prašak za koncentrat za otopinu za infuziju ne sadrži konzervanse i nije namijenjen za višedoznu bočicu.
English: Keep the vial and ampoule in the outer carton in order to protect from light.
Croatian: Bočicu i ampulu čuvati u vanjskom pakiranju radi zaštite od svjetla.
English: Rare (may affect up to 1 in 1,000 people) - Veno-occlusive disease (progressive blockage of the veins) where very small (microscopic) veins in the liver are blocked.
Croatian: - Venookluzivna bolest (progresivno začepljenje vena) pri čemu su začepljene vrlo male (mikroskopske) vene u jetri.
English: Carmustine is effective in the following malignant neoplasms as a single agent or in combination with other antineoplastic agents and/or other therapeutic measures (radiotherapy, surgery):
Croatian: Karmustin je učinkovit kod sljedećih zloćudnih novotvorina kao lijek koji se primjenjuje sam ili u kombinaciji s drugim antineoplastičnim lijekovima i/ili drugim terapijskim mjerama
English: Avoid skin contact with concentrate for solution for infusion.
Croatian: Izbjegavajte doticaj koncentrata za otopinu za infuziju s kožom.
English: in children and adolescents if you are breast-feeding.
Croatian: Djeca i adolescenti Dojenje.
English: Symptoms may include muscle weakness in one area, poor decision-making or concentration, involuntary twitching, trembling, difficulty speaking or swallowing, seizures; - Anorexia; - Constipation; - Diarrhoea; - Inflammation of the mouth and lips; - Reversible liver toxicity in high-dose therapy.
Croatian: Simptomi mogu uključivati slabost mišićima jednog područja, manjkavo odlučivanje ili koncentraciju, nenamjerno trzanje, drhtavicu, poteškoće u govorenju ili gutanju, napadaje; - Gubitak teka; - Zatvor; - Proljev; - Upala usta i usana;
English: A repeat course of Carmustine Obvius should not be given until circulating blood elements have returned to acceptable levels (platelets above 100,000/mm3, leukocytes above 4,000/mm3), and this is usually in six weeks.
Croatian: Praćenje i naknadne doze Ponovljeni ciklus lijeka Carmustine Obvius ne treba davati sve dok se cirkulirajuće krvne komponente ne povrate na prihvatljive razine (trombociti iznad 100 000/mm3, leukociti iznad
English: Baseline pulmonary function studies and chest X-ray should be conducted along with frequent pulmonary function tests during treatment.
Croatian: Potrebno je provesti ispitivanja plućne funkcije i rendgenska snimanja prsnog koša prije početka terapije te često provoditi testove plućne funkcije tijekom terapije.
English: In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dose range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and take into consideration concomitant disease or therapy with other medicinal products.
Croatian: Općenito odabir doze za starije bolesnike treba biti oprezan, a obično se počinje s najnižom vrijednošću raspona doziranja s obzirom na veću učestalost smanjene jetrene, bubrežne ili srčane funkcije te je potrebno uzeti u obzir istodobnu bolest ili terapiju drugim lijekovima.
English: Women of childbearing potential are advised to use effective contraception to avoid becoming pregnant whilst being treated with this medicine and for at least 6 months after treatment.
Croatian: Ženama reproduktivne dobi savjetuje se da koriste učinkovitu kontracepciju kako bi izbjegle trudnoću dok se liječe ovim lijekom i najmanje 6 mjeseci nakon liječenja.