FrancophonIA/ELRC3.0 huggingface dataset:
English: c of reconstituted CANCIDAS to an IV bag (or bottle) containing 250 ml of 0.9 %, 0.45 %, or 0.225 % Sodium Chloride Injection, or Lactated Ringers Injection.
Croatian: c rekonstituiranog lijeka CANCIDAS u vrećicu (ili bocu) za i.v. primjenu, koja sadrži 250 ml 0,9%, 0,45% ili 0,225% otopine natrijevog klorida za injekciju ili Ringerovu otopinu s laktatom za injekciju.
English: CANCIDAS 70 mg powder for concentrate for solution for infusion Each vial contains 70 mg caspofungin (as acetate).
Croatian: CANCIDAS 70 mg prašak za koncentrat za otopinu za infuziju Jedna bočica sadrži 70 mg kaspofungina (u obliku kaspofunginacetata).
English: CANCIDAS 50 mg powder for concentrate for solution for infusion Each vial contains 50 mg caspofungin (as acetate).
Croatian: CANCIDAS 50 mg prašak za koncentrat za otopinu za infuziju Jedna bočica sadrži 50 mg kaspofungina (u obliku kaspofunginacetata).
English: In young children and toddlers (ages 12 to 23 months) receiving caspofungin at 50 mg/m2 daily (maximum 70 mg daily), the caspofungin plasma AUC0-24 hr after multiple doses was comparable to that seen in adults receiving caspofungin at 50 mg daily and to that in older children (2 to 11 years of age) receiving the 50 mg/m2 daily dose.
Croatian: U male djece (u dobi od 12 do 23 mjeseca), koja su primala kaspofungin u dozi od 50 mg/m2 na dan (maksimalno 70 mg na dan), AUC0-24 h kaspofungina u plazmi nakon višekratnih doza bila je usporediva s onom izmjerenom u odraslih koji su primali kaspofungin u dozi od 50 mg na dan i onom u starije djece (u dobi od 2 do 11 godina) koja su primala dozu od 50 mg/m2 na dan.
English: Limited data suggest that caspofungin at 25 mg/m2 daily in neonates and infants (less than 3 months of age)
Croatian: Ograničeni podaci pokazuju da se može uzeti u obzir primjena kaspofungina u dozi od 25 mg/m2 jedanput na dan u novorođenčadi i dojenčadi (mlađih od 3 mjeseca) i 50 mg/m2 jedanput na dan u male djece (u dobi od 3 do 11 mjeseci) (vidjeti dio 5.2).
English: Calculation of Body Surface Area (BSA) for paediatric dosing Before preparation of infusion, calculate the body surface area (BSA) of the patient using the following formula: (Mosteller2 Formula)
Croatian: Izračun površine tijela (PT) za doziranje u pedijatrijskih bolesnika Prije pripreme infuzije, izračunajte površinu tijela (PT) bolesnika pomoću sljedeće formule: (Mostellerova2 formula)
English: Calculation of Body Surface Area (BSA) for paediatric dosing Before preparation of infusion, calculate the body surface area (BSA) of the patient using the following formula: (Mosteller3 Formula)
Croatian: Izračun površine tijela (PT) za doziranje u pedijatrijskih bolesnika Prije pripreme infuzije izračunajte površinu tijela (PT) bolesnika pomoću sljedeće formule: (Mostellerova formula)
English: INSTRUCTIONS FOR USE IN ADULT PATIENTS (50 mg vial)
Croatian: UPUTE ZA UPORABU U ODRASLIH BOLESNIKA (bočica od 50 mg)
English: CANCIDAS 50 mg powder for concentrate for solution for infusion CANCIDAS 70 mg powder for concentrate for solution for infusion
Croatian: CANCIDAS 50 mg prašak za koncentrat za otopinu za infuziju CANCIDAS 70 mg prašak za koncentrat za otopinu za infuziju
English: Merck Sharp & Dohme B. V.
Croatian: Merck Sharp & Dohme B.
English: INSTRUCTIONS FOR USE IN ADULT PATIENTS (70 mg vial)
Croatian: UPUTE ZA UPORABU U ODRASLIH BOLESNIKA (bočica sa 70 mg)
English: In children (ages 2 to 11 years) receiving caspofungin at 50 mg/m2 daily (maximum 70 mg daily), the caspofungin plasma AUC0-24 hr after multiple doses was comparable to that seen in adults receiving caspofungin at 50 mg/day.
Croatian: U djece (u dobi od 2 do 11 godina), koja su primala kaspofungin u dozi od 50 mg/m2 na dan (maksimalno 70 mg na dan), AUC0-24 h kaspofungina u plazmi nakon višekratnih doza bila je usporediva s onom u odraslih koji su primali kaspofungin u dozi od 50 mg/dan.
English: c. CANCIDAS is formulated to provide the full labelled vial dose (70 mg) when 10 ml is withdrawn from the vial.
Croatian: CANCIDAS je pripravljen tako da se izvlačenjem 10 ml iz bočice sigurno dobije puna doza navedena na naljepnici bočice (70 mg).
English: Paediatric Patients: In adolescents (ages 12 to 17 years) receiving caspofungin at 50 mg/m2 daily (maximum 70 mg daily), the caspofungin plasma AUC0-24 hr was generally comparable to that seen in adults receiving caspofungin at 50 mg daily.
Croatian: U adolescenata (u dobi od 12 do 17 godina), koji su primali kaspofungin u dozi od 50 mg/m2 na dan (maksimalno 70 mg na dan) AUC0-24 h kaspofungina u plazmi bila je općenito usporediva s onom kakva je uočena u odraslih osoba koje su primale kaspofungin u dozi od 50 mg na dan.
English: c CANCIDAS is formulated to provide the full labelled vial dose (50 mg) when 10 ml is withdrawn from the vial.
Croatian: CANCIDAS je pripravljen tako da se izvlačenjem 10 ml iz bočice sigurno dobije puna doza navedena na naljepnici bočice (50 mg).
English: Cancidas 70 mg powder for concentrate for solution for infusion Each vial of Cancidas contains 70 mg of caspofungin.
Croatian: Cancidas 70 mg prašak za koncentrat za otopinu za infuziju Jedna bočica lijeka Cancidas sadrži 70 mg kaspofungina.
English: INSTRUCTIONS FOR USE IN PAEDIATRIC PATIENTS (70 mg vial)
Croatian: UPUTE ZA UPORABU U PEDIJATRIJSKIH BOLESNIKA (bočica od 70 mg)
English: When caspofungin is co-administered to paediatric patients (12 months to 17 years of age) with these same inducers of metabolic enzymes (see
Croatian: Kad se kaspofungin primjenjuje u pedijatrijskih bolesnika (u dobi od 12 mjeseci do 17 godina) istodobno s induktorima klirensa lijekova, kao što su rifampicin, efavirenz, nevirapin,
English: Day 1 [not to exceed 70 mg daily]) to liposomal amphotericin B (3 mg/kg IV daily) in a 2:1 treatment fashion (56 on caspofungin, 26 on liposomal amphotericin B) as empirical therapy in paediatric patients with persistent fever and neutropenia.
Croatian: Prvo ispitivanje, koje je uključivalo 82 bolesnika u dobi od 2 do 17 godina, bilo je randomizirano, dvostruko slijepo ispitivanje u kojem se kaspofungin (50 mg/m2 i.v. jedanput na dan nakon udarne doze od 70 mg/m2 prvog dana [doza nije smjela biti veća od 70 mg na dan]) uspoređivao s liposomalnim amfotericinom B (3 mg/kg i.v. na dan) u omjeru 2:1 (56 bolesnika primalo je kaspofungin, a 26 liposomalni amfotericin B) u empirijskom liječenju pedijatrijskih bolesnika s perzistentnom vrućicom i neutropenijom.
English: Cancidas 50 mg powder for concentrate for solution for infusion Each vial of Cancidas contains 50 mg of caspofungin.
Croatian: Cancidas 50 mg prašak za koncentrat za otopinu za infuziju Jedna bočica lijeka Cancidas sadrži 50 mg kaspofungina.
English: CANCIDAS 50 mg powder for concentrate for solution for infusion 10 ml Type I glass vial with a grey butyl stopper and a plastic cap with a red aluminium band.
Croatian: I volumena 10 ml s čepom od sive butil gume i plastičnim zatvaračem te crvenim aluminijskim prstenom.
English: INSTRUCTIONS FOR USE IN PAEDIATRIC PATIENTS (50 mg vial)
Croatian: UPUTE ZA UPORABU U PEDIJATRIJSKIH BOLESNIKA (bočica od 50 mg)
English: CANCIDAS 70 mg powder for concentrate for solution for infusion Caspofungin
Croatian: CANCIDAS 70 mg prašak za koncentrat za otopinu za infuziju kaspofungin
English: CANCIDAS 50 mg powder for concentrate for solution for infusion Caspofungin
Croatian: CANCIDAS 50 mg prašak za koncentrat za otopinu za infuziju kaspofungin
English: CANCIDAS 50 mg powder for concentrate for solution for infusion
Croatian: CANCIDAS 50 mg prašak za koncentrat za otopinu za infuziju
English: CANCIDAS 70 mg powder for concentrate for solution for infusion
Croatian: CANCIDAS 70 mg prašak za koncentrat za otopinu za infuziju
English: IV bag (or bottle) containing 250 ml of 0.9 %, 0.45 %, or 0.225 % Sodium Chloride Injection, or Lactated Ringers Injection.
Croatian: i.v. primjenu koja sadrži 250 ml 0,9%, 0,45% ili 0,225% otopine natrijevog klorida za injekciju ili Ringerovu otopinu s laktatom za injekciju.
English: c of reconstituted CANCIDAS to an
Croatian: c rekonstituiranog lijeka CANCIDAS u vrećicu (ili bocu) za
English: Preparation of the 50 mg/m infusion for paediatric patients >3 months of age (using a 70-mg vial) Determine the actual daily maintenance dose to be used in the paediatric patient by using the patient's BSA (as calculated above) and the following equation: BSA (m2) X 50 mg/m2 = Daily Maintenance Dose
Croatian: 70 mg) Odredite stvarnu dnevnu dozu održavanja koja će se primjenjivati u pedijatrijskog bolesnika koristeći površinu tijela bolesnika (izračunate prema gornjoj formuli) i sljedeću jednadžbu: PT (m 2) × 50 mg/m 2 = dnevna doza održavanja
English: Pharmacokinetic data from one 10-month old child receiving the 50 mg/m2 daily dose indicated an AUC0-24 hr within the same range as that observed in older children and adults at the
Croatian: Farmakokinetički podaci jednog djeteta u dobi od 10 mjeseci, koje je primalo dozu od 50 mg/m2 na dan pokazali su da je AUC0-24 h bila u istom rasponu kao i u starije djece koja su primala 50 mg/m 2 i odraslih koji su primali dozu od 50 mg, dok je u jednog šestomjesečnog djeteta, koje je primalo dozu od 50 mg/m 2, AUC0-24 h bila nešto veća.
English: CANCIDAS 70 mg powder for concentrate for solution for infusion 10 ml Type I glass vial with a grey butyl stopper and a plastic cap with an orange aluminium band.
Croatian: I volumena 10 ml s čepom od sive butil gume i plastičnim zatvaračem te narančastim aluminijskim prstenom.
English: When caspofungin is co-administered to paediatric patients (12 months to 17 years of age) with inducers of drug clearance, such as rifampicin, efavirenz, nevirapine, phenytoin, dexamethasone, or carbamazepine, a caspofungin dose of 70-mg/m2 daily (not to exceed an actual daily dose of 70 mg) should be considered.
Croatian: Kad se kaspofungin u pedijatrijskih bolesnika (u dobi od 12 mjeseci do 17 godina) istodobno primjenjuje s istim induktorima metaboličkih enzima (vidjeti dio 4.5) potrebno je razmotriti primjenu doze kaspofungina od 70 mg/m dnevno (ne smije biti viša od 70 mg na dan).
English: Preparation of the 50 mg/m infusion for paediatric patients >3 months of age (using a 50-mg vial) Determine the actual daily maintenance dose to be used in the paediatric patient by using the patient's BSA (as calculated above) and the following equation: BSA (m2) X 50 mg/m2 = Daily Maintenance Dose
Croatian: Odredite stvarnu dnevnu dozu održavanja koja će se primjenjivati u pedijatrijskog bolesnika koristeći površinu tijela bolesnika (izračunatu prema gornjoj formuli) i sljedeću jednadžbu: PT (m2) × 50 mg/m2 = dnevna doza održavanja
English: c of reconstituted CANCIDAS can be added to a reduced volume of 0.9 %, 0.45 %, or 0.225 % Sodium Chloride Injection or Lactated Ringers
Croatian: Alternativno možete dodati volumen (ml) rekonstituiranog lijeka CANCIDAS u smanjeni volumen 0,9%, 0,45% ili 0,225% otopine
English: b This will give a final caspofungin concentration in the vial of
Croatian: b Na ovaj ste način u bočici dobili završnu koncentraciju kaspofungina od 5,2 mg/ml.
English: Oral use blister (alu/alu)
Croatian: Blister (Al/Al)
English: It is used to treat the following diseases:
Croatian: Koristi se za liječenje sljedećih bolesti:
English: The dose depends on the age and condition of the patient, and the response to treatment, but it should not exceed 800 mg a day.
Croatian: Doza ovisi o dobi i stanju bolesnika, te reakciji na liječenje, no ne smije premašiti 800 mg na dan.
English: It is available as capsules (100 and 400 mg) and tablets (100 and 400 mg) and is given by mouth with a meal and a large glass of water to reduce the risk of irritation of the stomach and gut.
Croatian: Dostupan je u obliku kapsula (od 100 i 400 mg) i tableta (od 100 i 400 mg) te se uzima na usta uz obrok i veliku čašu vode kako bi se smanjila iritacija želudca i crijeva.
English: The full EPAR for Imatinib Teva can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Imatinib Teva nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This means that Imatinib Teva is similar to a ‘reference medicine' already authorised in the European Union (EU) called Glivec.
Croatian: To znači da je lijek Imatinib Teva sličan „referentnom lijeku” koji je već odobren u Europskoj uniji (EU) pod nazivom Glivec.
English: Imatinib Teva imatinib
Croatian: Teva imatinib
English: The European Commission granted a marketing authorisation valid throughout the European Union for Imatinib Teva on 8 January 2013.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Imatinib Teva na snazi u Europskoj uniji od 8. siječnja 2013.
English: It is also used in adults and children in the ‘chronic phase' of the disease if it is not responding to interferon alpha (another cancer medicine), and in more advanced phases of the disease (‘accelerated phase' and ‘blast crisis');
Croatian: Lijek se također koristi u odraslih i djece u „kroničnoj fazi” bolesti nakon neuspješne terapije interferonom alfa (drugi lijek protiv raka), te u uznapredovanim fazama bolesti („u ubrzanoj fazi” ili „u blastičnoj krizi”);
English: What measures are being taken to ensure the safe and effective use of Imatinib Teva?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Imatinib Teva?
English: These enzymes can be found in certain receptors in cancer cells, including the receptors that are involved in stimulating the cells to divide uncontrollably.
Croatian: Ti se enzimi nalaze u određenim receptorima na površini stanica raka, uključujući i na receptorima uključenim u stimulaciju stanica za nekontrolirano dijeljenje.
English: By blocking these receptors, Imatinib Teva helps to control cell division.
Croatian: Blokirajući te receptore, lijek Imatinib Teva pomaže u kontroli podjele stanica.
English: What are the benefits and risks of Imatinib Teva?
Croatian: Koje su koristi i rizici lijeka Imatinib Teva?
English: This is a summary of the European public assessment report (EPAR) for Imatinib Teva.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Imatinib Teva.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Imatinib Teva has been shown to have comparable quality and to be bioequivalent to Glivec.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji zaključio je kako je u skladu sa zahtjevima EUa potvrđeno da Imatinib Teva posjeduje usporedivu kakvoću i da je bioekvivalentan lijeku Glivec.
English: The active substance in Imatinib Teva, imatinib, is a protein-tyrosine kinase inhibitor.
Croatian: Djelatna tvar lijeka Imatinib Teva, imatinib, je inhibitor protein-tirozin kinaze.
English: What is Imatinib Teva and what is it used for?
Croatian: Što je Imatinib Teva i za što se koristi?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Imatinib Teva have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Imatinib Teva nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: Other information about Imatinib Teva
Croatian: Ostale informacije o lijeku Imatinib Teva
English: Therefore, the CHMP's view was that, as for Glivec, the benefit outweighs the identified risk.
Croatian: Stoga je stav CHMP-a da, kao i kod lijeka Glivec, koristi nadmašuju utvrđene rizike.
English: It is also used alone in adults to treat Ph+ ALL that has returned following previous treatment, or is not responding to other medicines;
Croatian: Koristi se također za samostalno za liječenje odraslih s Ph+ ALL-om nakon prethodnog liječenja ili u osoba koje ne reagiraju na druge lijekove;
English: Imatinib Teva is used to treat adults with DFSP that cannot be removed with surgery, and in adults who are not eligible for surgery when the cancer has returned after treatment or has spread to other parts of the body.
Croatian: Imatinib Teva koristi se za liječenje odraslih bolesnika s DFSP-om kojeg se ne može kirurški ukloniti i odraslih bolesnika koji ne mogu ići na kirurški zahvat u slučaju kada se rak ponovo razvio nakon prethodnog liječenja ili je metastazirao u druge dijelove tijela.
English: • dermatofibrosarcoma protuberans (DFSP), a type of cancer (sarcoma) in which cells in the tissue beneath the skin divide uncontrollably.
Croatian: • dermatofibrosarkomone protuberanse (DFSP), vrste raka (sarkoma) u kojem se stanice u tkivu ispod kože nekontrolirano dijele.
English: • myelodysplastic or myeloproliferative diseases (MD/MPD), a group of diseases in which the body produces large numbers of abnormal blood cells.
Croatian: • mijelodisplastičnih ili mijeloproliferativnih bolesti (MDS/MPD), skupine bolesti u kojima tijelo proizvodi veliki broj abnormalnih krvnih stanica.
English: For more information about treatment with Imatinib Teva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Imatinib Teva pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: Because Imatinib Teva is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Croatian: Budući da je lijek Imatinib Teva generički lijek te je bioekvivalentan referentnom lijeku, smatra se da su njegove koristi i rizici isti kao i kod referentnog lijeka.
English: Why is Imatinib Teva approved?
Croatian: Zašto je Imatinib Teva odobren?
English: Imatinib Teva is used in combination with other cancer medicines in adults and children who have been newly diagnosed with Ph+ ALL.
Croatian: Imatinib Teva koristi se zajedno s drugim lijekovima protiv raka u odraslih i djece s novodijagnosticiranim Ph+ ALL-om.
English: Imatinib Teva is used to treat adults with HES or CEL who have a specific re-arrangement of two genes called FIP1L1 and PDGFRα;
Croatian: Imatinib Teva koristi se za liječenje odraslih bolesnika s HES-om ili CEL-om sa specifičnom preraspodjelom dva gena naziva FIP1L1 i PDGFR;
English: It is not intended to provide practical advice on how to use Imatinib Teva.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Imatinib Teva.
English: Imatinib Teva is used when the patients are ‘Philadelphia chromosome positive' (Ph+).
Croatian: Lijek Imatinib Teva koristi se za liječenje bolesnika koji imaju „pozitivan Philadelphia kromosom” (Ph+).
English: Imatinib Teva is used to treat adults with MD/MPD who have re-arrangements of the gene for platelet-derived growth factor receptor (PDGFR);
Croatian: Imatinib Teva koristi se za liječenje odraslih bolesnika s MD/MPD-om s preraspodjelom gena za receptor faktora rasta koji potječe od trombocita (PDGFR);
English: The Committee recommended that Imatinib Teva be given marketing authorisation.
Croatian: Odbor je preporučio izdavanje odobrenja za stavljanje u promet lijeka Imatinib Teva.
English: Imatinib Teva can only be obtained with a prescription and treatment should be started by a doctor who has experience in the treatment of patients with cancers of the blood.
Croatian: Teva izdaje se samo na liječnički recept te liječenje mora započeti i nadzirati liječnik koji je iskusan u liječenju raka krvi.
English: For practical information about using Imatinib Teva, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Imatinib Teva bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svom liječniku ili ljekarniku.
English: Imatinib Teva is a cancer medicine.
Croatian: Teva je lijek protiv raka.
English: Imatinib Teva contains the active substance imatinib.
Croatian: Teva sadrži djelatnu tvar imatinib.
English: Because Imatinib Teva is a generic medicine, studies in patients have been limited to tests to determine that the tablets and capsules are bioequivalent to the reference medicine, Glivec.
Croatian: Budući da je lijek Imatinib Teva generički lijek, ispitivanja na bolesnicima bila su ograničena na utvrđivanje činjenice o tome je li riječ o bioekvivalentu referentnom lijeku Glivec.
English: • advanced hypereosinophilic syndrome (HES) or chronic eosinophilic leukaemia (CEL), diseases in which eosinophils (another type of white blood cell) start growing out of control.
Croatian: • uznapredovalog hipereozinofilnog sindroma (HES) ili kronične eozinofilne leukemije (KEL), bolesti u kojima eozinofili (drugi tip bijele krvne stanice) počinju nekontrolirano rasti.
English: • Ph+ acute lymphoblastic leukaemia (ALL), a type of cancer in which lymphocytes (another type of white blood cell) multiply too quickly.
Croatian: • akutne limfoblastične leukemije (ALL), vrste raka u kojem se limfociti (drugi tip bijele krvne stanice) prebrzo umnožavaju.
English: • chronic myeloid leukaemia (CML), a cancer of the white blood cells in which granulocytes (a type of white blood cell) start growing out of control.
Croatian: • kronične mijeloične leukemije (KML-a), raka bijelih krvnih stanica u kojem granulociti (tip bijele krvne stanice) počinju nekontrolirano rasti.
English: Imatinib Teva is used in adults and children who have been newly diagnosed with Ph+ CML and who are not eligible for a bone marrow transplant.
Croatian: Lijek Imatinib Teva koristi se u odraslih i djece s novodijagnosticiranim Ph+ KML-om te u kojih se transplantacija koštane srži ne smatra prvom linijom liječenja.
English: How has Imatinib Teva been studied?
Croatian: Kako je Imatinib Teva ispitivan?
English: How does Imatinib Teva work?
Croatian: Kako djeluje Imatinib Teva?
English: How is Imatinib Teva used?
Croatian: Kako se Imatinib Teva koristi?
English: Safety and efficacy were maintained throughout all cycles.
Croatian: Sigurnost i djelotvornost održale su se tijekom svih ciklusa.
English: It can be taken with or without food.
Croatian: Može se uzimati s hranom ili bez nje.
English: Additional interactions
Croatian: Dodatne interakcije
English: Akynzeo should not be taken by children and adolescents under 18 years.
Croatian: Akynzeo ne smiju uzimati djeca i adolescenti mlađi od 18 godina.
English: The effects were reversible or partially reversible after the recovery period.
Croatian: Učinci su bili reverzibilni ili djelomično reverzibilni nakon razdoblja oporavka.
English: The usual dose is 1 capsule.
Croatian: Uobičajena doza je 1 kapsula.
English: Akynzeo contains two medicines (‘active substances') called:
Croatian: Akynzeo sadrži dva lijeka (djelatne tvari) pod nazivom:
English: If you do not want to take Akynzeo, discuss this with your doctor.
Croatian: Ako ne želite uzimati Akynzeo, porazgovarajte o tome s liječnikom.
English: Therefore, use in these patients should be avoided.
Croatian: Stoga treba izbjegavati primjenu u tih bolesnika.
English: There was no pre-specified limit of the number of repeat consecutive cycles for any patient.
Croatian: Nije bilo unaprijed određene granice u broju ponavljanih uzastopnih ciklusa za bilo kojeg bolesnika.
English: The hard capsule should be swallowed whole.
Croatian: Tvrdu kapsulu treba progutati cijelu.
English: Women of childbearing potential/ contraception in females
Croatian: Žene reproduktivne dobi/kontracepcija u žena
English: • rifampicin - to treat tuberculosis (TB) and other infections.
Croatian: • rifampicin - za liječenje tuberkuloze (TB) i drugih infekcija.
English: Date of first authorisation: 27 May 2015 Date of latest renewal:
Croatian: Datum prvog odobrenja: 27. svibnja 2015.
English: • lack of energy (feeling weak)
Croatian: • manjak energije (osjećaj slabosti)
English: Approximately 62% of palonosetron is bound to plasma proteins.
Croatian: Približno 62% palonozetrona vezano je za proteine plazme.
English: • ring in the ear
Croatian: • zvonjava u ušima
English: A total of 724 patients (99.9%) were treated with cyclophosphamide.
Croatian: Ukupno 724 bolesnika (99,9%) liječeno je ciklofosfamidom.