FrancophonIA/ELRC3.0 huggingface dataset:
English: PFS (months; 95% CI) ORR, n (%); Odds ratio (95% CI) DOR (months; 95% CI) CBR, n (%); Odds ratio (95% CI)
Croatian: Preživljenje bez progresije bolesti (PFS) (mjeseci; 95 % CI) Ukupna stopa odgovora (ORR), n ( %); Omjer izgleda (95 % CI) Trajanje odgovora (DOR) (mjeseci; 95 % CI)
English: Type I colourless glass vial with a butyl rubber stopper covered with an aluminium flip-off seal containing 0.25 mg of trabectedin.
Croatian: I s čepom od butilne gume pokrivenim aluminijskim zaštitnim “flipoff” zatvaračem koja sadržava 0,25 mg trabektedina.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/417/001
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/07/417/001
English: Overall, 384 patients were randomized to the trabectedin group [1.5 mg/m once every 3 weeks (q3wk 24-h)] and
Croatian: Sveukupno, 384 bolesnika radnomizirana su u skupinu s trabektedinom [1,5 mg/m2 jednom svaka 3 tjedna (24 satne infuzije svaka 3 tjedna)], a 193 bolesnika u skupinu s dakarbazinom (1 g/m2 jednom svaka 3 tjedna).
English: A syringe is used to inject the correct amount of sterile water for injections into the vial.
Croatian: Štrcaljka se upotrebljava za ubrizgavanje točne količine sterilne vode za injekcije u bočicu.
English: 6.6 Special precautions for disposal and other handling
Croatian: 6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom Priprema za intravensku infuziju
English: Type I colourless glass vial with a butyl rubber stopper covered with an aluminium flip-off seal containing 1mg of trabectedin.
Croatian: I s čepom od butilne gume pokrivenim aluminijskim zaštitnim “flipoff” zatvaračem koja sadržava 1 mg trabektedina.
English: Of the 333 patients with ovarian cancer who received trabectedin in combination with PLD, 24% were 65 years of age or older and 6% were over 75 years.
Croatian: 333 bolesnice s rakom jajnika koje su primale trabektedin u kombinaciji s PLD-om, 24 % je imalo
English: If a diagnosis of CLS is confirmed after exclusion of other causes, the treating physician should discontinue trabectedin and initiate CLS treatment according to institutional guidelines (see sections 4.2 and 4.8).
Croatian: nadležni liječnik mora prekinuti liječenje trabektedinom i započeti liječenje sindroma kapilarnog curenja prema smjernicama ustanove (vidi odlomke 4.2 i 4.8).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton - 0.25 mg vial
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Vanjska kutija - bočica od 0,25 mg
English: Yondelis in combination with pegylated liposomal doxorubicin (PLD: another anti-cancer medicine) is used for the treatment of patients with ovarian cancer that has come back after at least 1 previous therapy and are not resistant to anti-cancer medicines containing platinum compounds.
Croatian: koristi za liječenje bolesnica s rakom jajnika koji se ponovno pojavio nakon najmanje jednog prethodnog liječenja te koji nije otporan na lijekove protiv raka koji sadrže spojeve platine.
English: These findings were secondary to severe local reaction at the administration site, and therefore uncertainly attributable to trabectedin; however, caution must be guaranteed in the interpretation of these renal findings, and treatment-related toxicity cannot be excluded.
Croatian: Ti su nalazi bili sekundarni u odnosu na tešku lokalnu reakciju na mjestu primjene i stoga ih se ne može zasigurno pripisati trabektedinu.
English: When Yondelis is used in combination with PLD, the intravenous line should be flushed well with 50 mg/ml (5%) glucose solution for infusion after administration of PLD and before administration of Yondelis.
Croatian: Kada se Yondelis primjenjuje u kombinaciji s PLD-om, intravenski kateter se mora dobro isprati s otopinom glukoze za infuziju od 50 mg/ml (5 %) nakon primjene PLD-a i prije primjene Yondelisa.
English: The analysis per cycle performed in patients treated with the monotherapy regimen showed neutropenia of grade 3 and 4 in approximately 19% and 8% of cycles respectively.
Croatian: Analiza izvršena po ciklusu kod bolesnika liječenih režimom monoterapije pokazala je neutropeniju 3. i 4. stupnja u približno 19 % odnosno 8 % ciklusa.
English: Cases of Capillary Leak Syndrome (CLS) have been reported with trabectedin (including cases with fatal outcomes).
Croatian: Nakon primjene trabektedina, prijavljeni su slučajevi sindroma kapilarnog curenja (uključujući slučajeve sa smrtnim ishodom).
English: Adverse reactions, included reversible elevation of liver enzymes and haematological events; in addition, fever, infection, dehydration and thrombosis/embolism were also reported.
Croatian: Također su se javljale vrućica, infekcija, dehidracija i tromboza/embolija.
English: In this case you may experience fever, difficulty in breathing, redness or flushing of the skin or a rash, feeling sick (nausea) or being sick (vomiting).
Croatian: U tom slučaju može Vam se javiti vrućica, otežano disanje, crvenilo kože ili navale crvenila, osip, mučnina ili povraćanje.
English: For the treatment of ovarian cancer, the usual dose is 1.1 mg/m2 body surface area after the administration of 30 mg/m2 body surface area of PLD.
Croatian: Za liječenje raka jajnika uobičajena je doza 1,1 mg/m2 površine tijela nakon primjene 30 mg/m2
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 0.25 mg trabectedin
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 0,25 mg trabektedina
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/417/002
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/07/417/002
English: Men in fertile age must use effective contraception during treatment and 5 months after treatment (see section 4.4).
Croatian: Muškarci u plodnoj dobi moraju primjenjivati učinkovitu kontracepciju tijekom liječenja i 5 mjeseci nakon liječenja (vidjeti dio 4.4).
English: Musculoskeletal and Connective Tissue Disorders
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva
English: Yondelis contains potassium
Croatian: Yondelis sadrži kalij
English: Weight decreased
Croatian: Smanjenje tjelesne težine
English: MARKETING AUTHORISATION NUMBER(S) Yondelis 0.25 mg
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Yondelis 0,25 mg
English: The geometric mean dose normalized trabectedin exposure (AUC) increased by 97% (90% CI: 20%, 222%) in 6 patients with moderate hepatic impairment (increased serum bilirubin levels from 1.5 to 3 x ULN and increase of aminotransferases (AST or ALT) < 8 x ULN) following administration of a single trabectedin dose of 0.58 mg/m2 (n=3) or 0.9 mg/m2 (n=3) compared to 9 patients with normal liver function following administration of a single trabectedin dose of 1.3 mg/m2 (see sections 4.2 and 4.4).
Croatian: 1,5 do 3 x GGN i porast aminotransferaza (AST ili ALT) < 8 x GGN) nakon primjene jedne doze trabektedina od 0,58 mg/m2 (n=3) ili 0,9 mg/m2 (n=3) u usporedbi s 9 bolesnika s normalnom jetrenom funkcijom nakon primjene jedne doze trabektedina od 1,3 mg/m2 (vidjeti dijelove 4.2 i 4.4).
English: Each vial of powder contains 0.25 mg of trabectedin.
Croatian: Svaka bočica praška sadržava 0,25 mg trabektedina.
English: Cardiac Dysfunction
Croatian: Srčani poremećaji
English: Yondelis 1 mg powder for concentrate for solution for infusion.
Croatian: Yondelis 1 mg prašak za koncentrat za otopinu za infuziju.
English: For storage conditions after reconstitution and dilution of the medicinal product, see the package leaflet.
Croatian: Za uvjete čuvanja pripremljenog i razrijeđenog lijeka pogledajte uputu o lijeku.
English: When used in combination with PLD the intravenous line should be flushed well with 50 mg/ml (5%) glucose solution for infusion after administration of PLD and before administration of Yondelis.
Croatian: Kada se primjenjuje u kombinaciji s PLD-om, intravenski kateter potrebno je dobro isprati otopinom glukoze za infuziju od 50 mg/ml (5 %) nakon primjene PLD-a i prije primjene Yondelisa.
English: Discard any unused product or waste material in accordance with local requirements.
Croatian: Neiskorišteni lijek ili otpadni materijal potrebno je zbrinuti sukladno nacionalnim propisima.
English: Liver Function Test (LFT) abnormalities
Croatian: Abnormalnosti testa jetrene funkcije
English: Yondelis must not be given to patients who are breast-feeding.
Croatian: Yondelis se ne smije davati bolesnicama koje doje.
English: Patients should seek advice on ovules or sperm conservation prior to treatment because of the risk of irreversible infertility due to therapy with Yondelis.
Croatian: Bolesnici bi prije liječenja Yondelisom morali zatražiti savjet o zamrzavanju jajašca ili sperme jer zbog liječenja Yondelisom postoji rizik od trajne neplodnosti.
English: A syringe is used to inject 5 ml of sterile water for injections into the vial.
Croatian: Štrcaljka se upotrebljava za injiciranje 5 ml sterilne vode za injekcije u bočicu.
English: - Hypersensitivity to trabectedin or to any of the excipients listed in section 6.1 - Concurrent serious or uncontrolled infection - Breast-feeding (see section 4.6) - Combination with yellow fever vaccine (see section 4.4)
Croatian: istodobna ozbiljna ili nekontrolirana infekcija dojenje (vidjeti dio 4.6) kombinacija s cjepivom protiv žute groznice (vidjeti dio 4.4) 4.4 Posebna upozorenja i mjere opreza pri uporabi Oštećenje funkcije jetre
English: A syringe is used to inject 20 ml of sterile water for injections into the vial.
Croatian: Štrcaljka se upotrebljava za injiciranje 20 ml sterilne vode za injekcije u bočicu.
English: Alanine aminotransferase increased
Croatian: Povišena alanin aminotransferaza Povišena aspartat aminotransferaza Povišena alkalna fosfataza u krvi
English: The analysis per cycle performed in patients treated with the monotherapy regimen showed grade 3 elevations of AST and ALT in 12% and 20% of cycles respectively.
Croatian: Analiza izvršena po ciklusu kod bolesnika liječenih režimom monoterapije pokazala je porast 3. stupnja AST-a u približno 12 % ciklusa odnosno ALT-a u 20 % ciklusa.
English: This reconstituted solution contains 0.05 mg/ml of trabectedin.
Croatian: Ta rekonstituirana otopina sadržava 0,05 mg/ml trabektedina.
English: Yondelis must be administered under the supervision of a physician experienced in the use of chemotherapy.
Croatian: 4.2 Doziranje i način primjene Yondelis se mora primijeniti pod nadzorom liječnika koji ima iskustva u primjeni kemoterapije.
English: The median survival for subjects with liposarcoma was 18.1 months [95% CI: 15.0, 26.4] and for subjects with leiomyosarcoma 16.2 months [95% CI: 11.7, 24.3].
Croatian: Medijan preživljenja za ispitanike s liposarkomom iznosio je 18,1 mjeseci [95 % CI: 15,0, 26,4], a za ispitanike s leiomiosarkomom 16,2 mjeseca [95 % CI: 11,7, 24,3].
English: If you get the above symptoms or signs, seek medical care immediately.
Croatian: Ako imate gore navedene simptome ili znakove, odmah zatražite medicinsku pomoć.
English: de los Reyes, 1 E-28770 Colmenar Viejo Madrid
Croatian: Polígono Industrial La Mina Avda. de los Reyes, 1 E-28770 Colmenar Viejo Madrid
English: You could experience general swelling or swelling of the limbs and a sensation of creeping on the skin.
Croatian: Može doći do sveopćeg oticanja ili oticanja udova te osjeta ježenja po koži.
English: Neutropenia Thrombocytopenia Anaemia
Croatian: Neutropenija Trombocitopenija Anemija
English: Extravasation Soft tissue necrosis
Croatian: Nekroza mekog tkiva
English: The most common adverse reactions of any severity grade were neutropenia, nausea, vomiting, increase in AST/ALT, anaemia, fatigue, thrombocytopenia, anorexia and diarrhoea.
Croatian: a/ALT-a, anemija, umor, trombocitopenija, anoreksija i proljev.
English: Breast-feeding
Croatian: Pireksija Edem
English: Placental transfer of trabectedin and fetal exposure to trabectedin were observed in a study in pregnant rats that received a single i.v.
Croatian: Prijenos trabektedina kroz placentu i fetalna izloženost trabektedinu promatrane su u ispitivanju na skotnim štakorima koji su primili jednu intravensku dozu 14C-trabektedina od 0,061 mg/kg.
English: If you get any of the previous described symptoms or signs, seek medical care immediately.
Croatian: Ako imate bilo koji od navedenih simptoma ili znakova, odmah zatražite medicinsku pomoć.
English: Like all medicines, this medicine or its combination with PLD can cause side effects, although not everybody gets them.
Croatian: Kao i svi lijekovi, ovaj lijek ili njegova kombinacija s pegiliranim liposomalnim doksorubicinom
English: 12 months PFS rate (95% CI) (%) Independent oncology review, all randomised n=336
Croatian: (95 % CI) ( %) Nezavisna onkološka procjena,
English: Abdominal pain Nausea
Croatian: Bol u abdomenu
English: One ml of reconstituted solution contains 0.05 mg of trabectedin.
Croatian: Jedan ml rekonstituirane otopine sadržava 0,05 mg trabektedina.
English: Vomiting Constipation Diarrhoea Stomatitis
Croatian: Konstipacija Proljev Stomatitis
English: Hypotension Flushing
Croatian: Hipotenzija Navale crvenila
English: Oedema
Croatian: Osip
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 0.25 mg of trabectedin.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Svaka bočica sadržava 0,25 mg trabektedina.
English: If intravenous administration is to be made via a central venous line, add the reconstituted solution to an infusion bag containing ≥ 50 ml of diluent (sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose 50 mg/ml (5%) solution for infusion), the concentration of trabectedin in the infusion solution being ≤ 0.030 mg/ml.
Croatian: Ako se intravenska primjena obavlja kroz središnji venski kateter, potrebno je dodati rekonstituiranu otopinu u infuzijsku vrećicu koja sadržava ≥ 50 ml otapala (otopinu natrijeva klorida za infuziju od 9 mg/ml (0,9 %) ili otopinu glukoze za infuziju od 50 mg/ml (5 %)), pri čemu je koncentracija trabektedina u infuzijskog otopini
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Yondelis 0.25 mg powder for concentrate for solution for infusion Trabectedin
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Yondelis 0,25 mg prašak za koncentrat za otopinu za infuziju trabektedin i.v. primjena
English: Capillary Leak Syndrome (CLS)
Croatian: Stopa kliničke koristi (CBR),
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 1 mg of trabectedin.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Svaka bočica sadržava 1 mg trabektedina.
English: Using the RECIST criteria the ORR among patients treated with trabectedin was 3 (8.1%; 95% CI: 1.7.21.9%) and 0 (0%, 95% CI: 0.0-9.7%) among patients treated with best supportive care, while the CBR was 24 (64.9%, 95% CI: 47.5-79.9%) versus 0 (0%, 95% CI: 0.0-9.7%), respectively.
Croatian: CI: 0,0-9,7 %), dok je stopa kliničke koristi (engl. clinical benefit rate, CBR) iznosila 24 (64,9 %, 95 % CI: 47,5-79,9 %) za bolesnike liječene trabektedinom odnosno 0 (0 %, 95 % CI: 0,0-9,7 %) za bolesnike koji su primali BSC.
English: Systemic exposure after intravenous administration as a constant rate infusion is dose proportional at doses up to and including 1.8 mg/m2.
Croatian: Distribucija Sistemska izloženost nakon intravenske primjene uz konstantnu brzinu infuzije proporcionalno je dozi,
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Yondelis 1 mg powder for concentrate for solution for infusion Trabectedin
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Yondelis 1 mg prašak za koncentrat za otopinu za infuziju trabektedin i.v.primjena
English: a
Croatian: Od
English: NAME OF THE MEDICINAL PRODUCT Yondelis 0.25 mg powder for concentrate for solution for infusion.
Croatian: Yondelis 0,25 mg prašak za koncentrat za otopinu za infuziju.
English: The primary efficacy endpoint of the study was OS, which included 381 death events (66% of all randomized patients): 258 (67.2%) deaths in the trabectedin group and 123 (63.7%) deaths in the dacarbazine group (HR 0.927 [95% CI: 0.748, 1.150; p=0.4920]).
Croatian: (67,2 %) smrti u skupini s trabektedinom i 123 (63,7 %) smrti u skupini s dakarbazinom (HR 0,927
English: Duration of the response was 6.5 months No responses were observed for Ewing sarcoma and NRSTS, [RR: 0% CI95% (0%-30.9%)].
Croatian: [RR: 0 % CI95 % (0 %-30,9 %)].
English: Both adverse reactions and laboratory values have been used to provide frequencies.
Croatian: . Pri određivanju učestalosti u obzir su uzete i nuspojave i laboratorijske vrijednosti.
English: Yondelis infusion may leak out of your vein while you are being given it, leading to damage and death of your tissue cells around the injection site (tissue necrosis, see also section 2 “Warnings and precautions”) which may require surgery.
Croatian: Infuzija Yondelisa može istjecati iz vene dok ju primate, što može prouzročiti oštećenje i odumiranje tkivnih stanica oko mjesta injiciranja
English: 1 ml of reconstituted solution contains 0.05 mg of trabectedin.
Croatian: 1 ml pripremljene otopine sadržava 0,05 mg trabektedina.
English: Yondelis 0.25 mg powder for concentrate for solution for infusion Yondelis 1 mg powder for concentrate for solution for infusion Trabectedin
Croatian: Uputa o lijeku: Informacije za bolesnika Yondelis 0,25 mg prašak za koncentrat za otopinu za infuziju Yondelis 1 mg prašak za koncentrat za otopinu za infuziju trabektedin
English: • You may notice that Yondelis infusion leaks out of your vein (extravasation) while you are being given it. Then you will notice some redness, swelling, itchiness and discomfort at the injection site.
Croatian: • Možda primijetite da infuzija Yondelisa istječe izvan vene (ekstravazacija) tijekom primanja infuzije.
English: NAME OF THE MEDICINAL PRODUCT Yondelis 0.25 mg powder for concentrate for solution for infusion Trabectedin
Croatian: Yondelis 0,25 mg prašak za koncentrat za otopinu za infuziju trabektedin
English: PHARMACEUTICAL FORM AND CONTENTS Powder for concentrate for solution for infusion 1 vial of 0.25 mg trabectedin
Croatian: Prašak za koncentrat za otopinu za infuziju 1 bočica s 0,25 mg trabektedina
English: However, fatigue and/or asthenia have been reported in patients receiving trabectedin.
Croatian: Međutim, kod bolesnika koji su primali trabektedin zabilježeni su umor i/ili astenija.
English: Dilute the reconstituted solution with sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose 50 mg/ml (5%) solution for infusion.
Croatian: (9 mg/ml (0,9 %) otopinu natrijeva klorida za infuziju ili 50 mg/ml (5 %) otopinu glukoze).
English: • If you notice unexplained partial or general swelling (oedema), with possible lightheadedness, dizziness or thirst (low blood pressure).
Croatian: • ako primijetite neobjašnjivo djelomično ili opće oticanje (edem), s mogućom ošamućenosti, omaglicom ili žeđi (nizak krvni tlak), to može biti znak poremećaja (sindrom kapilarnog curenja) koji uzrokuje pojačano nakupljanje tekućine u tkivima te zahtijeva hitan pregled liječnika.
English: - Increase of aminotransferases (AST or ALT) > 2.5 x ULN (monotherapy) or > 5 x ULN
Croatian: porast aminotransferaza (AST ili ALT) > 2,5 x GGN (monoterapija) ili > 5 x GGN (kombinirana terapija), koji traje do 21. dana bilo koje druge nuspojave 3. ili 4. stupnja (kao što su mučnina, povraćanje, umor).
English: PHARMACEUTICAL FORM AND CONTENTS Powder for concentrate for solution for infusion 1 vial of 1 mg trabectedin
Croatian: Prašak za koncentrat za otopinu za infuziju 1 bočica s 1 mg trabektedina
English: If central venous access is not feasible and a peripheral venous line has to be used, add the reconstituted solution to an infusion bag containing ≥ 1,000 ml of diluent (sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose 50 mg/ml (5%) solution for infusion).
Croatian: rekonstituiranu otopinu treba dodati u vrećicu za infuziju koja sadržava ≥ 1000 ml otapala (otopinu natrijeva klorida za infuziju od 9 mg/ml (0,9 %) ili otopinu glukoze za infuziju od 50 mg/ml (5 %)).
English: The use of any diluent other than 50 mg/ml (5%) glucose solution for infusion may cause precipitation of PLD.
Croatian: 50 mg/ml (5 %) otopinom glukoze za infuziju.
English: - if you have any serious infections.
Croatian: Ako imate probleme s jetrom,
English: NAME OF THE MEDICINAL PRODUCT Yondelis 1 mg powder for concentrate for solution for infusion Trabectedin
Croatian: Yondelis 1 mg prašak za koncentrat za otopinu za infuziju trabektedin
English: The reconstituted solution should be diluted with sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose 50 mg/ml (5%) solution for infusion.
Croatian: Rekonstituiranu otopinu treba razrijediti 9 mg/ml (0,9 %) otopinom natrijeva klorida za infuziju ili
English: The analysis per cycle performed in patients treated with the monotherapy regimen showed anaemia of grade 3 and 4 in approximately 3% and 1% of cycles respectively.
Croatian: Analiza izvršena po ciklusu kod bolesnika liječenih režimom monoterapije pokazala je anemiju 3. i 4.
English: There may be blistering, peeling and darkening of the skin over the site.
Croatian: Na mjestu injiciranja mogu se pojaviti mjehurići, ljuštenje i tamnjenje kože.
English: Nausea and vomiting
Croatian: Mučnina Povraćanje
English: You will be given a medicine before and as needed during the treatment with Yondelis in order to protect your liver and to reduce the risk of side effects such as feeling sick (nausea) and vomiting.
Croatian: Radi zaštite jetre te smanjivanja rizika od nuspojava poput mučnine i povraćanja dobit ćete odgovarajući lijek prije i po potrebi tijekom liječenja Yondelisom.
English: The final analysis showed no significant difference with a median survival follow-up of 21.2 months resulted in a median of 13.7 months (95% CI: 12.2, 16.0) for the trabectedin arm and 13.1 months [95% CI: 9.1, 16.2] for the dacarbazine arm.
Croatian: Završna analiza nije pokazala značajnu razliku u medijanu preživljenja u razdoblju praćenja od 21,2 mjeseca koji je rezultirao medijanom od 13,7 mjeseci
English: Phosphoric acid (for pH-adjustment)
Croatian: 6.1 Popis pomoćnih tvari saharoza kalijev dihidrogenfosfat fosfatna kiselina (za podešavanje pH) kalijev hidroksid (za podešavanje pH) 6.2 Inkompatibilnosti
English: Unopened vials
Croatian: Neotvorene bočice:
English: Tabulated summary of adverse reactions
Croatian: Prema RECIST kriterijima, stopa ukupnog odgovora
English: 16 November 2015
Croatian: 16. studenog 2015.
English: The safety and efficacy of Ebymect in children and adolescents aged 0 to < 18 years have not yet been established.
Croatian: Sigurnost i djelotvornost lijeka Ebymect u djece i adolescenata u dobi od 0 do < 18 godina još nisu ustanovljene.
English: • if you drink large amounts of alcohol, either every day or only from time to time (please see section “Ebymect with alcohol”).
Croatian: • ako pijete velike količine alkohola (bilo svakodnevno ili samo povremeno) (molimo pogledajte dio “Ebymect s alkoholom”).
English: Ebymect with alcohol
Croatian: Ebymect s alkoholom
English: Your doctor may decide to temporarily or permanently stop your treatment with Ebymect.
Croatian: Vaš liječnik može odlučiti privremeno ili trajno prekinuti Vaše liječenje lijekom Ebymect.
English: Ebymect is contraindicated in patients with:
Croatian: Ebymect je kontraindiciran u bolesnika:
English: Other medicines and Ebymect
Croatian: Drugi lijekovi i Ebymect
English: During treatment with Ebymect, your doctor will check your kidney function at least once every year or more frequently if you are elderly and/or if you have worsening kidney function.
Croatian: Tijekom liječenja lijekom Ebymect, liječnik će Vam provjeravati funkciju bubrega najmanje jedanput godišnje ili češće ako ste starija osoba i/ili ako Vam se funkcija bubrega pogoršava.
English: What Ebymect is and what it is used for
Croatian: Što je Ebymect i za što se koristi
English: What Ebymect looks like and contents of the pack
Croatian: Kako Ebymect izgleda i sadržaj pakiranja
English: There have been no therapeutic clinical trials conducted with Ebymect tablets.
Croatian: Nisu provedena terapijska klinička ispitivanja sa Ebymect tabletama.
English: Ebymect must be discontinued at the time of surgery with general, spinal or epidural anaesthesia.
Croatian: Ebymect se mora prekinuti u vrijeme kirurškog zahvata pod općom, spinalnom ili epiduralnom anestezijom.