FrancophonIA/ELRC3.0 huggingface dataset:
English: Pneumoniab
Croatian: Pneumonijab
English: Table 2: Recommended dosing schedule of Empliciti in combination with pomalidomide and dexamethasone
Croatian: Tablica 2: Preporučen raspored doziranja lijeka Empliciti u kombinaciji s pomalidomidom i deksametazonom
English: The active substance is elotuzumab.
Croatian: Djelatna tvar je elotuzumab.
English: Excipients: sucrose, sodium citrate, citric acid monohydrate, and polysorbate 80.
Croatian: Pomoćne tvari: saharoza, natrijev citrat, citratna kiselina hidrat i polisorbat 80.
English: The incidence of pneumonia was higher in the Empliciti combined with lenalidomide and dexamethasone arm compared to lenalidomide and dexamethasone arm reported at 15.1% vs. 11.7% with a fatal outcome at 0.6% vs. 0%, respectively.
Croatian: Incidencija pneumonije bila je viša u skupini liječenoj lijekom Empliciti u kombinaciji s lenalidomidom i deksametazonom nego u onoj koja je liječena lenalidomidom i deksametazonom (15,1% naspram 11,7%), a smrtni je ishod zabilježen u 0,6% odnosno 0% bolesnika.
English: Eighty-seven percent (87%) of the patients were refractory to lenalidomide, 80% refractory to a PI and 70% were refractory to both lenalidomide and a PI.
Croatian: Medijan broja prethodnih terapija iznosio je 3. Osamdeset i sedam posto (87%) bolesnika bilo je refraktorno na lenalidomid, 80% bolesnika bilo je refraktorno na inhibitor proteasoma, a 70% bolesnika bilo je refraktorno i na lenalidomid i na inhibitor proteasoma.
English: Very Good Partial Response (VGPR) n (%) Partial Response (RR/PR) n (%) Combined Responses (CR+sCR+VGPR) n (%) 12 (20.0)
Croatian: Vrlo dobar djelomičan odgovor (VGPR) n Djelomičan odgovor (RR/PR) n (%) Objedinjeni odgovori (CR+sCR+VGPR) n (%)
English: Empliciti + Lenalidomide and Dexamethasone N = 318
Croatian: Empliciti + lenalidomid i deksametazon N = 318
English: Empliciti is indicated in combination with pomalidomide and dexamethasone for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on the last therapy (see sections 4.2 and 5.1).
Croatian: Empliciti je indiciran u kombinaciji s pomalidomidom i deksametazonom za liječenje odraslih bolesnika s relapsirajućim i refraktornim multiplim mijelomom koji su prethodno primili najmanje dvije terapije, uključujući lenalidomid i inhibitor proteasoma, i koji su kod posljednje terapije doživjeli progresiju bolesti (vidjeti dijelove 4.2 i 5.1).
English: After reconstitution, the reconstituted solution should be transferred from the vial to the infusion bag immediately.
Croatian: Nakon pripreme za primjenu, pripremljenu otopinu treba odmah prenijeti iz bočice u infuzijsku vrećicu.
English: How to use Empliciti 4.
Croatian: Kako primjenjivati Empliciti 4. Moguće nuspojave
English: A total of 646 patients were randomised to receive treatment: 321 to Empliciti in combination with lenalidomide and dexamethasone and 325 to lenalidomide and dexamethasone.
Croatian: Ukupno je 646 bolesnika bilo randomizirano za primanje liječenja: 321 bolesnik za Empliciti u kombinaciji s lenalidomidom i deksametazonom te 325 bolesnika za lenalidomid i deksametazon.
English: The reconstituted solution should be diluted with sodium chloride 9 mg/mL (0.9%) solution for injection or 5% glucose injection to obtain a final infusion concentration range between 1 mg/mL and 6 mg/mL.
Croatian: Rekonstituiranu otopinu treba razrijediti 0,9%-tnom (9 mg/ml) otopinom natrijeva klorida (za injekcije ili 5%-tnom otopinom glukoze za injekcije da bi se dobila konačna koncentracija otopine za infuziju u rasponu od 1 mg/ml do 6 mg/ml.
English: You must use effective contraception while you are being treated with Empliciti, if there is any chance you could become pregnant.
Croatian: Ako postoji ikakva mogućnost da zatrudnite, morate koristiti učinkovitu kontracepciju dok se liječite lijekom Empliciti.
English: Elotuzumab is an immunostimulatory humanised, IgG1 monoclonal antibody that specifically targets the SLAMF7 (signaling lymphocyte activation molecule family member 7) protein.
Croatian: Elotuzumab je imunostimulirajuće humanizirano IgG1 monoklonsko protutijelo koje specifiično ciljano djeluje na protein SLAMF7 (član 7 obitelji signalnih molekula za aktivaciju limfocita [engl. signaling lymphocyte activation molecule family member 7]. SLAMF7 se u velikoj mjeri eksprimira na stanicama multiplog mijeloma neovisno o citogenetskim abnormalnostima.
English: Powder for concentrate for solution for infusion (powder for concentrate).
Croatian: 3. FARMACEUTSKI OBLIK Prašak za koncentrat za otopinu za infuziju (prašak za koncentrat).
English: HR (95.4% CI): 0.82 (0.68, 1.00) p-value: 0.0408
Croatian: HR (95,4% CI): 0,82 (0,68; 1,00) p-vrijednost: 0,0408
English: The effect of hepatic impairment on the clearance of Empliciti was evaluated by population PK analyses in patients with mild hepatic impairment (total bilirubin [TB] ≤ the upper limit of normal [ULN] and AST > ULN or TB < 1 to 1.5 × ULN and any AST; N = 33).
Croatian: Učinak oštećenja funkcije jetre na klirens lijeka Empliciti ocjenjivao se populacijskim farmakokinetičkim analizama u bolesnika s blagim oštećenjem funkcije jetre (ukupni bilirubin ≤ gornje granice normale [GGN] te AST > GGN ili ukupni bilirubin < 1 do 1,5 × GGN i bilo koja vrijednost AST-a; N = 33).
English: What Empliciti contains
Croatian: Što Empliciti sadrži
English: The chromosomal abnormalities as determined by the FISH of del(17p), t(4;14) and t(14;16) were present in 5%, 11%
Croatian: Vjerojatnost preživljenja abnormalnosti del(17p), t(4;14) i t(14;16) u 5%, 11% odnosno 7% bolesnika.
English: Elotuzumab will be given in combination with lenalidomide or pomalidomide and breast-feeding should be stopped because of the use of lenalidomide or pomalidomide.
Croatian: Elotuzumab će se primjenjivati u kombinaciji s lenalidomidom ili pomalidomidom, te se dojenje mora prekinuti zbog primjene lenalidomida ili pomalidomida.
English: Aseptically reconstitute each Empliciti vial with a syringe of adequate size and an 18 gauge or smaller needle as shown in Table 12.
Croatian: Koristeći aseptičnu tehniku, rekonstituirajte svaku bočicu lijeka Empliciti uz pomoć štrcaljke odgovarajuće veličine te igle veličine 18 G ili manje, kako je navedeno u Tablici 12.
English: Fatal infections (i.e. Grade 5 infections) were reported in 5% of Empliciti combined with pomalidomide and dexamethasone and 3.6% of pomalidomide and dexamethasone treated patients.
Croatian: Infekcije sa smrtnim ishodom (npr. infekcije 5. stupnja) prijavljene su u 5% bolesnika liječenih lijekom Empliciti u kombinaciji s pomalidomidom i deksametazonom te u 3,6% onih koji su liječeni pomalidomidom i deksametazonom.
English: Patients who have escalated to 5 mL/min at 10 mg/kg dose must decrease the rate to 3 mL/min at the first infusion at 20 mg/kg.
Croatian: U bolesnika kojima je brzina infuzije pri liječenju dozom od 10 mg/kg povećana na 5 ml/min ta se brzina mora smanjiti na 3 ml/min pri prvoj infuziji doze od 20 mg/ml.
English: Patients with cardiac amyloidosis or plasma cell leukemia were excluded from this study.
Croatian: U ovo ispitivanje nisu bili uključeni bolesnici sa srčanom amiloidozom niti oni s leukemijom plazmatskih stanica.
English: Patients with Grade 2 or higher peripheral neuropathy were excluded from the clinical studies with E-Pd.
Croatian: U klinička ispitivanja kombinacije E-Pd nisu bili uključeni bolesnici s perifernom neuropatijom 2. ili višeg stupnja.
English: Anaphylactic reaction Uncommon
Croatian: Anafilaktička reakcija Manje često
English: There was no clear causal evidence of altered pharmacokinetic, efficacy, or toxicity profiles with anti-product antibody development based on the population pharmacokinetic and exposure-response analyses.
Croatian: Populacijska farmakokinetička analiza i analiza odgovora na izloženost lijeku nisu pružile jasne dokaze uzročne povezanosti između izmijenjene farmakokinetike, djelotvornosti ili profila toksičnosti i razvoja protutijela na lijek.
English: Elotuzumab 10 mg/kg was administered intravenously each week for the first 2 cycles and every 2 weeks thereafter.
Croatian: Elotuzumab se primjenjivao u intravenskoj dozi od 10 mg/kg svaki tjedan tijekom prva 2 ciklusa, a zatim svaka 2 tjedna.
English: Table 1: Recommended dosing schedule of Empliciti in combination with lenalidomide and dexamethasone
Croatian: Tablica 1: Preporučen raspored doziranja lijeka Empliciti u kombinaciji s lenalidomidom i deksametazonom
English: In a clinical trial of patients with multiple myeloma that compared Empliciti combined with lenalidomide and dexamethasone treatment to lenalidomide and dexamethasone treatment (CA204004), the incidence of SPMs, and specifically of solid tumours and non-melanoma skin cancer, was higher in patient treated with Empliciti (see section 4.8).
Croatian: U kliničkom ispitivanju provedenom u bolesnika s multiplim mijelomom, u kojem se liječenje lijekom Empliciti u kombinaciji s lenalidomidom i deksametazonom uspoređivalo s liječenjem lenalidomidom i deksametazonom (CA204004), incidencija drugih primarnih zloćudnih bolesti, osobito solidnih tumora i nemelanomskih oblika raka kože, bila je viša u bolesnika liječenih lijekom Empliciti (vidjeti dio 4.8).
English: The administration of reconstituted and diluted solution must be initiated at an infusion rate of 3 mL/min.
Croatian: Primjena rekonstituirane i razrijeđene otopine mora se započeti brzinom od 3 ml/min.
English: a p-value based on the log-rank test stratified by B2 microglobulins (<3.5 mg/L versus ≥ 3.5 mg/L), number of prior lines of therapy (1 versus 2 or 3), and prior immunomodulatory therapy (no versus prior thalidomide only versus other).
Croatian: a p-vrijednost na temelju log-rang testa stratificiranog prema B2 mikroglobulinima (< 3,5 mg/l naspram ≥ 3,5 mg/l), broju prethodnih linija terapije (1 naspram 2 ili 3) i prethodnoj imunomodulacijskoj terapiji (bez terapije naspram prethodno samog talidomida naspram ostaloga).
English: Woman of childbearing potential/Contraception in the males and females Empliciti should not be used in women of childbearing potential, unless the clinical condition of the woman requires treatment with elotuzumab.
Croatian: Empliciti se ne smije primjenjivati u žena reproduktivne dobi, osim ako kliničko stanje žene ne zahtijeva liječenje elotuzumabom.
English: d p-value based on the Cochran-Mantel-Haenszel chi-square test stratified by B2 microglobulins (<3.5 mg/L versus ≥ 3.5 mg/L), number of prior lines of therapy (1 versus 2 or 3), and prior immunomodulatory therapy (no versus prior thalidomide only versus other).
Croatian: d p-vrijednost na temelju Cochran-Mantel-Haenzelova hi-kvadrat testa stratificiranog prema B2 mikroglobulinima (< 3,5 mg/l naspram ≥ 3,5 mg/l), broju prethodnih linija terapije (1 naspram 2 ili 3) i prethodnoj imunomodulacijskoj terapiji (bez terapije naspram prethodno samog talidomida naspram ostaloga).
English: Anti-product antibodies resolved by 2 to 3 months in 18 (95%) of these 19 patients.
Croatian: U 18 (95%) od tih 19 bolesnika protutijela na lijek povukla su se unutar 2 - 3 mjeseca.
English: The volume of sodium chloride 9 mg/mL (0.9%) solution for injection or 5% glucose injection should be adjusted so as to not exceed 5 mL/kg of patient weight at any given dose of Empliciti.
Croatian: Volumen 0,9%-tne (9 mg/ml) otopine natrijeva klorida za injekcije ili 5%-tne otopine glukoze za injekcije treba prilagoditi tako da ni kod jedne primijenjene doze lijeka Empliciti ne premaši vrijednost od 5 ml/kg bolesnikove tjelesne težine.
English: For men taking Empliciti
Croatian: Za muškarce koji primaju Empliciti
English: Table 8: CA204004 Efficacy results
Croatian: Tablica 8: Rezultati za djelotvornost u Ispitivanju CA204004
English: CA204125 is a randomised, open-label study conducted to evaluate the efficacy and safety of Empliciti in combination with pomalidomide and dexamethasone (E-Pd) in patients with refractory or relapsed and refractory multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor (PI) and had disease progression on or within 60 days of their last therapy.
Croatian: Empliciti u kombinaciji s pomalidomidom i deksametazonom (CA204125) CA204125 je randomizirano otvoreno ispitivanje provedeno tako da ispita djelotvornost i sigurnost lijeka Empliciti u kombinaciji s pomalidomidom i deksametazonom (E-Pd) u bolesnika s refraktornim ili relapsirajućim multiplim mijelomom koji su prethodno primili barem dvije terapije lenalinomidom i inhibitorima proteasoma (PI) i koji imaju progresiju bolesti na dan ili unutar 60 dana nakon zadnje terapije.
English: On days that Empliciti is not administered but a dose of dexamethasone is scheduled (Days 8, 15 and 22 of cycle 3 and all subsequent cycles), give 40 mg orally to patients ≤ 75 years old and 20 mg orally to patients > 75 years old.
Croatian: Onih dana kada se Empliciti ne primjenjuje, a predviđena je primjena doze deksametazona (8. , 15. i 22. dan 3. i svih sljedećih ciklusa), bolesnicima u dobi od 75 godina deksametazon treba davati peroralno u dozi od 40 mg, a onima u dobi od > 75 godina peroralno u dozi od 20 mg.
English: c p-value based on the Cochran-Mantel-Haenszel chi-square test stratified by stage of disease at study entry (International Staging System I-II vs III) and number of prior lines of therapy (2-3 vs ≥ 4) at randomization.
Croatian: c p-vrijednost na temelju Cochran-Mantel-Haenszelova hi-kvadrat testa stratificiranog prema stadiju bolesti pri uključivanju u ispitivanje (ISS I - II naspram III) i broju prethodnih linija terapije (2 - 3 naspram ≥ 4) pri randomizaciji.
English: Table 7: CA204125 Exposure-adjusted rates for adverse reactions for Empliciti-treated patients versus pomalidomide and dexamethasone-treated patients [includes multiple occurrences in all treated patients]
Croatian: Tablica 7: CA204125 - Stope nuspojava prilagođene za izloženost u bolesnika liječenih lijekom Empliciti naspram onih liječenih pomalidomidom i deksametazonom [uključuje višestruko pojavljivanje u svih liječenih bolesnika]
English: EU/1/16/1088/001-002
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/16/1088/001-002
English: Premedication consisting of dexamethasone, H1 blocker, H2 blocker, and paracetamol must be administered prior to Empliciti infusion (see section 4.2 Premedication).
Croatian: Bolesnicima se prije infuzije lijeka Empliciti mora primijeniti premedikacija koja se sastoji od deksametazona, blokatora H1 receptora, blokatora H2 receptora i paracetamola (vidjeti odlomak "Premedikacija" u dijelu 4.2).
English: If you are given too much Empliciti
Croatian: Ako primite previše lijeka Empliciti
English: The recommended dose of Empliciti is 10 mg/kg administered intravenously every week, on days 1, 8, 15, and 22 for the first two treatment cycles and every 2 weeks thereafter on days 1 and 15.
Croatian: Preporučena doza lijeka Empliciti je 10 mg/kg intravenski; tijekom prva dva ciklusa liječenja primjenjuje se svaki tjedan, tj. 1., 8., 15. i 22. dana, a nakon toga svaka 2 tjedna, tj. 1. i 15. dana.
English: In a clinical trial of patients with multiple myeloma (CA204125), infections were reported in 65% of patients in the Empliciti combined with pomalidomide and dexamethasone arm (N = 60) and 65.5% in the pomalidomide and dexamethasone arm (N = 55).
Croatian: U kliničkom ispitivanju provedenom u bolesnika s multiplim mijelomom (CA204125) infekcije su prijavljene u 65% bolesnika u skupini liječenoj lijekom Empliciti u kombinaciji s pomalidomidom i deksametazonom (N = 60) te u 65,5% bolesnika u skupini liječenoj pomalidomidom i deksametazonom (N = 55).
English: Elotuzumab 10 mg/kg was administered intravenously each week for the first 2 cycles and 20 mg/kg every 4 weeks thereafter.
Croatian: Elotuzumab se primjenjivao u intravenskoj dozi od 10 mg/kg svaki tjedan tijekom prva 2 ciklusa, a zatim u dozi od 20 mg/kg svaka 4 tjedna.
English: Among, patients treated with aspirin, deep vein thromboses were reported in 4.1% of patients treated with Empliciti combined with lenalidomide and dexamethasone (E-Ld) and 1.4% of patients treated with lenalidomide and dexamethasone (Ld).
Croatian: Među bolesnicima liječenima aspirinom, slučajevi duboke venske tromboze prijavljeni su u 4,1% bolesnika liječenih lijekom Empliciti u kombinaciji s lenalidomidom i deksametazonom (E-Ld) te 1,4% onih koji su liječeni lenalidomidom i deksametazonom (Ld).
English: Gently mix the infusion by manual rotation.
Croatian: Nježno promiješajte sadržaj infuzijske vrećice okrećući je u rukama.
English: Empliciti + Pomalidomide and Dexamethasone N = 60
Croatian: Empliciti + pomalidomid i deksametazon N = 60
English: On days that Empliciti is administered, patients ≤ 75 years old give dexamethasone 28 mg orally between 3 and 24 hours before Empliciti plus 8 mg intravenously between 45 and 90 minutes before Empliciti and for patients > 75 years old give dexamethasone 8 mg orally between 3 and 24 hours before Empliciti plus 8 mg intravenously between 45 and 90 minutes before Empliciti.
Croatian: Onih dana kada se primjenjuje i Empliciti, bolesnicima u dobi od ≤ 75 godina deksametazon treba dati peroralno u dozi od 28 mg 3 i 24 sata prije primjene lijeka Empliciti te intravenski u dozi od 8 mg 45 - 90 minuta prije primjene lijeka Empliciti, dok bolesnicima u dobi od > 75 godina deksametazon treba dati peroralno u dozi od 8 mg 3 i 24 sata prije primjene lijeka Empliciti te intravenski u dozi od 8 mg 45 i 90 minuta prije primjene lijeka Empliciti.
English: No dose adjustment for Empliciti is required for patients with mild hepatic impairment (total bilirubin [TB] ≤ to the upper limit of normal [ULN] and AST > ULN or TB < 1 to 1.5 × ULN and any AST).
Croatian: Nije potrebno prilagođavati dozu lijeka Empliciti u bolesnika s blagim oštećenjem funkcije jetre (ukupni bilirubin ≤ gornje granice normale [GGN] te AST > GGN ili ukupni bilirubin < 1 do 1,5 × GGN i bilo koja vrijednost AST-a).
English: The pharmacokinetics (PK) of elotuzumab was studied in patients with multiple myeloma.
Croatian: Farmakokinetika elotuzumaba ispitivala se u bolesnika s multiplim mijelomom.
English: Empliciti 400 mg powder for concentrate for solution for infusion Each vial contains 400 mg elotuzumab.
Croatian: Empliciti 400 mg prašak za koncentrat za otopinu za infuziju Jedna bočica sadrži 400 mg elotuzumaba.
English: Calculate the volume (mL) of diluent (either sodium chloride 9 mg/mL (0.9%) solution for injection or 5% glucose injection) needed to make up the solution for infusion for the patient.
Croatian: Izračunajte volumen 0,9%-tne (9 mg/ml) otopine natrijeva klorida(0,9%) za injekcije ili 5%-tne otopine glukoze za injekcije) koji je potreban da bi se pripremila otopina za infuziju za bolesnika.
English: Empliciti should be initiated at an infusion rate of 0.5 mL/min for 10 mg/kg dose and 3 mL/min for 20 mg/kg dose.
Croatian: Infuziju lijeka Empliciti treba započeti brzinom od 0,5 ml/min kod primjene doze od 10 mg/kg odnosno brzinom od 3 ml/min kod primjene doze od 20 mg/kg.
English: PHARMACEUTICAL PARTICULARS
Croatian: 6. FARMAKOLOŠKI PODACI
English: E-Ld 321 282 240 206 164 133 87 43 12 1
Croatian: E-Ld 321 282 240 206 164 133 87 43 12 1 Ld 325 262 204 168 130 97 53 24 7
English: Elotuzumab has not been studied in patients with moderate (TB > 1.5 to 3 × ULN and any AST) or severe hepatic impairment (TB > 3 × ULN and any AST) (see section 4.2).
Croatian: Elotuzumab se nije ispitivao u bolesnika s umjerenim (ukupni bilirubin > 1,5 do 3 × GGN i bilo koja vrijednost AST-a) ili teškim oštećenjem funkcije jetre (ukupni bilirubin > 3 × GGN i bilo koja vrijednost AST-a) (vidjeti dio 4.2).
English: How to use Empliciti
Croatian: Kako primjenjivati Empliciti
English: d The term herpes zoster is a grouping of the following terms: herpes zoster, oral herpes, and herpes virus infection.
Croatian: d Pojam "herpes zoster" obuhvaća sljedeće pojmove: herpes zoster, oralni herpes i infekciju virusom herpesa.
English: a p-value based on the log-rank test stratified by stage of disease at study entry (International Staging System I-II vs III) and number of prior lines of therapy (2-3 vs ≥ 4) at randomization.
Croatian: a p-vrijednost na temelju log-rang testa stratificiranog prema stadiju bolesti pri uključivanju u ispitivanje (ISS I - II naspram III) i broju prethodnih linija terapije (2 - 3 naspram ≥ 4) pri randomizaciji.
English: b The term pneumonia is a grouping of the following terms: pneumonia, atypical pneumonia, bronchopneumonia, lobar pneumonia, bacterial pneumonia, fungal pneumonia, pneumonia influenza, and pneumococcal pneumonia.
Croatian: b Pojam "pneumonija" obuhvaća sljedeće pojmove: pneumoniju, atipičnu pneumoniju, bronhopneumoniju, lobarnu pneumoniju, bakterijsku pneumoniju, gljivičnu pneumoniju, pneumoniju uzrokovanu virusom influence i pneumokoknu pneumoniju.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C − 8°C protected from light.
Croatian: Ako se ne primijeni odmah, trajanje i uvjeti čuvanja prije primjene odgovornost su korisnika te ne bi smjelo biti dulje od 24 sata na temperaturi od 2°C do 8°C zaštićen od svjetlosti.
English: Figure 2: CA204004 Overall survival
Croatian: Ukupno preživljenje u ispitivanju CA204004
English: c The term pneumonia is a grouping of the following terms: pneumonia, atypical pneumonia, bronchopneumonia, lobar pneumonia, bacterial pneumonia, fungal pneumonia, pneumonia influenza, and pneumococcal pneumonia.
Croatian: c Pojam "pneumonija" obuhvaća sljedeće pojmove: pneumoniju, atipičnu pneumoniju, bronhopneumoniju, lobarnu pneumoniju, bakterijsku pneumoniju, gljivičnu pneumoniju, pneumoniju uzrokovanu virusom influence i pneumokoknu pneumoniju.
English: Table 6: CA204004 Exposure-adjusted rates for adverse reactions for Empliciti-treated patients versus lenalidomide and dexamethasone-treated patients [includes multiple occurrences in all treated patients]
Croatian: Tablica 6: CA204004 - Stope nuspojava prilagođene za izloženost u bolesnika liječenih lijekom Empliciti naspram onih liječenih lenalidomidom i deksametazonom [uključuje višestruko pojavljivanje u svih liječenih bolesnika]
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C - 8°C protected from light.
Croatian: Ako se ne primijeni odmah, trajanje i uvjeti čuvanja prije primjene odgovornost su korisnika, te ne bi smjelo biti dulje od 24 sata na temperaturi od 2°C do 8°C, zaštićeno od svjetlosti.
English: Hypoaesthesia 25 4.9 Mood altered 23 4.5 Hypersensitivity 10 2.0
Croatian: Hipoestezija 25 4,9
English: The administration of the reconstituted and diluted solution must be initiated at an infusion rate of 0.5 mL/min.
Croatian: Infuzija rekonstituirane i razrijeđene otopine mora se započeti brzinom od 0,5 ml/min.
English: a The term cough includes the following terms: cough, productive cough, and upper airway cough syndrome.
Croatian: Pojam "kašalj" uključuje sljedeće pojmove: kašalj, produktivni kašalj i kašalj uzrokovan sindromom gornjih dišnih putova.
English: Overall survival (OS) was a key secondary study endpoint.
Croatian: Ključna sekundarna mjera ishoda u ispitivanju bilo je ukupno preživljenje (OS).
English: Empliciti 300 mg powder for concentrate for solution for infusion Empliciti 400 mg powder for concentrate for solution for infusion elotuzumab
Croatian: Empliciti 300 mg prašak za koncentrat za otopinu za infuziju Empliciti 400 mg prašak za koncentrat za otopinu za infuziju elotuzumab
English: d The term herpes zoster is a grouping of the following terms: herpes zoster, oral herpes, herpes virus infection and ophthalmic herpes zoster.
Croatian: Pojam "herpes zoster" obuhvaća sljedeće pojmove: herpes zoster, oralni herpes, infekciju virusom herpesa i oftalmički herpes zoster.
English: Empliciti at 10 mg/kg dose should be initiated at an infusion rate of 0.5 mL/min.
Croatian: Infuziju lijeka Empliciti u dozi od 10 mg/kg treba započeti brzinom od 0,5 ml/min.