FrancophonIA/ELRC3.0 huggingface dataset:
English: The medicinal product should not be administered or mixed with dextrose containing solutions.
Croatian: Lijek se ne smije primjenjivati niti miješati s otopinama koje sadrže glukozu.
English: Table 1 - Management recommendations for infusion-related reactions (IRRs)
Croatian: Tablica 1 - Preporuke za zbrinjavanje reakcija na infuziju
English: Parenteral medicines should be inspected visually for particulate matter prior to administration.
Croatian: Lijekove za parenteralnu primjenu treba prije primjene vizualno pregledati kako bi se utvrdila moguća prisutnost čestica.
English: Marketing Authorisation Holder Eli Lilly Nederland B.V.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet Eli Lilly Nederland B.V.
English: Concentrate for solution for infusion 190 mg/19 mL
Croatian: OBLIK I SADRŽAJ Koncentrat za otopinu za infuziju 190 mg/19 ml
English: Platelets help your blood to clot and a low platelet count may increase the risk of bleeding.
Croatian: Budući da trombociti pomažu u zgrušavanju krvi, nizak broj trombocita može povećati rizik od krvarenja.
English: Frequency overall Grade 3/4 frequency
Croatian: 3./4. stupnja
English: Known toxicities reported for doxorubicin, observed in the combination of olaratumab and doxorubicin include fatigue, anaemia, thrombocytopenia and alopecia.
Croatian: Poznate toksičnosti prijavljene kod primjene doksorubicina i primijećene kod liječenja kombinacijom olaratumaba i doksorubicina uključuju umor, anemiju, trombocitopeniju i alopeciju.
English: It is not known whether olaratumab gets into breast milk and if the breast-fed infant is at risk of harm.
Croatian: Nije poznato izlučuje li se olaratumab u majčino mlijeko i može li naškoditi dojenčetu.
English: To minimise doxorubicin-related cardiotoxicity, the use of appropriate cardioprotective measures (LVEF measurement, such as ECHO or MUGA scan, ECG monitoring, and/or use of cardioprotective agents) should be considered and planned in all patients before the start and throughout the treatment.
Croatian: Da bi se minimizirala kardiotoksičnost povezana s doksorubicinom, u svih bolesnika treba razmotriti i isplanirati primjenu odgovarajućih kardioprotektivnih mjera (određivanje ejekcijske frakcije lijeve klijetke [engl. left ventricular ejection fraction, LVEF], npr. ehokardiografijom ili radionuklidnom ventrikulografijom (MUGA), kontrola EKG-a i/ili primjena kardioprotektivnih lijekova) prije početka i tijekom trajanja liječenja.
English: Each 50 mL vial contains approximately 57 mg (2.5 mmol) sodium.
Croatian: Jedna bočica od 50 ml sadrži približno 57 mg (2,5 mmol) natrija.
English: In a dedicated DDI study, no pharmacokinetic interactions were observed in patients between olaratumab and doxorubicin.
Croatian: U posebnom ispitivanju interakcije između lijekova, u bolesnika nisu primijećene farmakokinetičke interakcije između olaratumaba i doksorubicina.
English: Your doctor will give you other medicines before you receive Lartruvo to reduce the risk of infusionrelated reactions.
Croatian: Prije nego što primite Lartruvo, liječnik će Vam dati druge lijekove kako bi smanjio rizik od reakcija na infuziju.
English: • Paracetamol, H1 antagonist and dexamethasone should be administered as needed (see premedication section)
Croatian: • Prema potrebi primijeniti paracetamol, antagonist H1 receptora i deksametazon (vidjeti odlomak o
English: Overall, a low incidence of both treatment emergent anti-drug antibodies and neutralising antibodies were detected in clinical trial samples.
Croatian: Sveukupno je u uzorcima iz kliničkog ispitivanja utvrđena niska incidencija i protutijela na lijek i neutralizirajućih protutijela nastalih tijekom liječenja.
English: Pack of 1 vial of 50 mL.
Croatian: Pakiranje s 1 bočicom od 50 ml.
English: Three Grade ≥3 events, including one fatal, have been reported across the clinical development programme of olaratumab (see section 4.4).
Croatian: U programu kliničkog razvoja olaratumaba prijavljena su tri događaja ≥ 3. stupnja, uključujući jedan sa smrtnim ishodom (vidjeti dio 4.4).
English: Olaratumab is an antagonist of platelet derived growth factor receptor-α (PDGFR-α), expressed on tumour and stromal cells.
Croatian: Olaratumab je antagonist α receptora za faktor rasta koji potječe od trombocita (engl. platelet-derived growth factor receptor-α, PDGFR-α), koji se eksprimira na tumorskim i stromalnim stanicama.
English: Concentrate for solution for infusion 500 mg/50 mL
Croatian: OBLIK I SADRŽAJ Koncentrat za otopinu za infuziju 500 mg/50 ml
English: For dosage adjustments related to neutropenia, refer to section 4.2.
Croatian: Za prilagodbu doze u slučaju neutropenije, vidjeti dio 4.2.
English: - The other ingredients are mannitol, glycine, L-histidine monohydrochloride monohydrate, L-histidine, sodium chloride (see section 2 “Lartruvo contains sodium”), polysorbate 20 and water for injections.
Croatian: - Drugi sastojci su: manitol, glicin, L-histidinklorid hidrat, L-histidin, natrijev klorid (pogledajte odlomak 'Lartruvo sadrži natrij' u dijelu 2.), polisorbat 20 i voda za injekcije.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One mL of concentrate for solution for infusion contains 10 mg of olaratumab.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedan ml koncentrata za otopinu za infuziju sadrži 10 mg olaratumaba.
English: Olaratumab may have minor influence on the ability to drive and use machines.
Croatian: 4.7 Utjecaj na sposobnost upravljanja vozilima i rada sa strojevima Olaratumab može malo utjecati na sposobnost upravljanja vozilima i rada sa strojevima.
English: Fertility There are no data on the effect of olaratumab on human fertility.
Croatian: Nema podataka o učinku olaratumaba na plodnost u ljudi.
English: Summary of survival data - ITT population Lartruvo plus doxorubicin (n = 66)
Croatian: Lartruvo plus doksorubicin (n = 66)
English: Gently invert the container to mix.
Croatian: Nježno preokrenite spremnik da biste promiješali lijek.
English: Refer to doxorubicin SmPC for appropriate monitoring of hepatic function and doxorubicin dose adjustments in patients with impaired liver function.
Croatian: Vidjeti Sažetak opisa svojstava lijeka za doksorubicin za odgovarajuće praćenje funkcije jetre i prilagodbu doze doksorubicina u bolesnika s oštećenjem funkcije jetre.
English: For subsequent cycles, premedication with an H1 antagonist (e.g., diphenhydramine) should be given intravenously 30-60 minutes prior to each dose of olaratumab.
Croatian: U sljedećim ciklusima treba intravenski primijeniti premedikaciju antagonistom H1 receptora (npr. difenhidraminom) 30 - 60 minuta prije svake doze olaratumaba.
English: The Phase 2 portion of the study was a randomised, open label study of olaratumab plus doxorubicin versus doxorubicin alone.
Croatian: Dio ispitivanja faze 2 bilo je randomizirano, otvoreno ispitivanje olaratumaba plus doksorubicina u odnosu na liječenje samo doksorubicinom.
English: If particulate matter or discolouration is identified, the vial must be discarded.
Croatian: Ako se utvrdi prisutnost čestica ili promjena boje, bočica se mora baciti.
English: As a result, in vitro olaratumab inhibits PDGFR-α pathway signalling in tumour and stromal cells.
Croatian: Zahvaljujući tome, olaratumab in vitro inhibira signalizaciju putem PDGFR-α u tumorskim i stromalnim stanicama.
English: Patients receiving olaratumab and doxorubicin are at risk of neutropenia (see section 4.8).
Croatian: U bolesnika koji primaju olaratumab i doksorubicin postoji rizik od neutropenije (vidjeti dio 4.8).
English: It is not known whether olaratumab is excreted in human milk.
Croatian: Nije poznato izlučuje li se olaratumab u majčino mlijeko.
English: All severe IRRs occurred during or immediately after the first administration of olaratumab.
Croatian: Sve teške reakcije na infuziju nastupile su tijekom ili neposredno nakon prve primjene olaratumaba.
English: Lartruvo is administered in combination with doxorubicin for up to 8 cycles of treatment, followed by Lartruvo monotherapy in patients whose disease has not progressed.
Croatian: Lartruvo se primjenjuje u kombinaciji s doksorubicinom tijekom najviše 8 ciklusa liječenja, nakon čega se Lartruvo primjenjuje u monoterapiji u bolesnika u kojih bolest nije uznapredovala.
English: Cardiac toxicity
Croatian: Toksičnost za srce
English: Any unused portion of olaratumab left in a vial should be discarded, as the product contains no antimicrobial preservatives.
Croatian: Sav neupotrijebljen olaratumab preostao u bočici mora se baciti jer lijek ne sadrži antimikrobne konzervanse.
English: Excipients: mannitol, glycine, sodium chloride, L-histidine monohydrochloride monohydrate, L-histidine, polysorbate 20 and water for injections.
Croatian: Pomoćne tvari: manitol, glicin, natrijev klorid, L-histidinklorid hidrat, L-histidin, polisorbat 20 i voda za injekcije.
English: Neutrophil count should be monitored during the treatment with olaratumab and doxorubicin and supportive care should be administered such as antibiotics or G-CSF as per local guidelines.
Croatian: Tijekom liječenja olaratumabom i doksorubicinom treba kontrolirati broj neutrofila te primijeniti potporno liječenje, poput antibiotika ili G-CSF-a, u skladu s nacionalnim smjernicama.
English: Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht The Netherlands
Croatian: Papendorpseweg 83, 3528 BJ Utrecht Nizozemska
English: Pack of 2 vials of 19 mL.
Croatian: Pakiranje s 2 bočice od 19 ml.
English: Table 2: Adverse reactions in patients receiving olaratumab plus doxorubicin for soft tissue sarcoma during the Phase 2 portion of a Phase 1b/2 study
Croatian: Tablica 2: Nuspojave u bolesnika koji su primali olaratumab plus doksorubicin za liječenje sarkoma mekog tkiva tijekom faze 2 u ispitivanju faze 1b/2 Organski sustav
English: Grade 3-4 • Immediately and permanently discontinue treatment with a Grade per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI
Croatian: • Odmah trajno obustaviti liječenje olaratumabom (vidjeti aStupanj prema verziji 4.03 Zajedničkih terminoloških kriterija za nuspojave Nacionalnog instituta za rak (engl.
English: Lartruvo and doxorubicin may decrease your platelet count.
Croatian: Lartruvo i doksorubicin mogu smanjiti broj krvnih pločica.
English: The concentrate is clear to slightly opalescent and colourless to slightly yellow solution without visible particles.
Croatian: Koncentrat je bistra do blago opalescentna i bezbojna do bljedožuta otopina koja ne sadrži vidljive čestice.
English: For patients who experience Grade 1 or 2 IRR, the infusion should be interrupted and paracetamol, H1 antagonist and dexamethasone (or equivalent medicinal products) administered as needed.
Croatian: U bolesnika u kojih nastupi reakcija na infuziju 1. ili 2. stupnja potrebno je privremeno prekinuti infuziju te prema potrebi primijeniti paracetamol, antagonist H1 receptora i deksametazon (ili ekvivalentne lijekove).
English: There are very limited data regarding olaratumab administration in patients with moderate hepatic impairment.
Croatian: Postoje vrlo ograničeni podaci o primjeni olaratumaba u bolesnika s umjerenim oštećenjem funkcije jetre.
English: If particulate matter is identified, discard the infusion solution.
Croatian: Ako primijetite čestice, bacite otopinu za infuziju.
English: Discard any unused portion of olaratumab left in a vial, as the product contains no antimicrobial preservatives.
Croatian: Bacite sav neupotrijebljen olaratumab preostao u bočici jer lijek ne sadrži antimikrobne konzervanse.
English: Ten patients in the olaratumab plus doxorubicin arm and 5 patients in the doxorubicin arm received post-study radiotherapy only.
Croatian: Deset bolesnika u skupini liječenoj olaratumabom plus doksorubicinom i 5 bolesnika u skupini liječenoj doksorubicinom je nakon ispitivanja primilo samo radioterapiju.
English: Patients with gastrointestinal stromal tumours (GIST) or Kaposi sarcoma were not enrolled.
Croatian: U ispitivanje nisu bili uključeni bolesnici s gastrointestinalnim stromalnim tumorima (GIST)
English: In addition, in vivo olaratumab has been shown to disrupt the PDGFR-α pathway in tumour cells and inhibit tumour growth.
Croatian: Osim toga, pokazalo se da olaratumab in vivo ometa signalizaciju putem PDGFR-α u tumorskim stanicama te inhibira rast tumora.
English: Infusion-related reactions (IRRs) Recommendations for the management of olaratumab IRRs are provided in table 1.
Croatian: Reakcije na infuziju Preporuke za zbrinjavanje reakcija na infuziju kod primjene olaratumaba navedene su u Tablici 1.
English: A statistically significant improvement in OS was seen in the olaratumab plus doxorubicin arm in comparison to treatment with doxorubicin alone in the overall population.
Croatian: U cjelokupnoj je populaciji primijećeno statistički značajno poboljšanje OS-a u skupini liječenoj olaratumabom plus doksorubicinom u odnosu na liječenje samo doksorubicinom.
English: Do not administer the solution if you notice any particulate matter or discoloration.
Croatian: Nemojte primijeniti otopinu ako primijetite da sadrži čestice ili da je promijenila boju.
English: Please refer to doxorubicin SmPC for recommendation on cardiac monitoring.
Croatian: Vidjeti Sažetak opisa svojstava lijeka za doksorubicin za preporuke za praćenje srčane funkcije.
English: Premedication with an H1 antagonist (e.g., diphenhydramine) and dexamethasone (or equivalent medicinal products) should be given, intravenously, 30-60 minutes prior to the olaratumab doses on days 1 and 8 of cycle 1 in all patients.
Croatian: U svih bolesnika treba intravenski primijeniti premedikaciju antagonistom H1 receptora (npr. difenhidraminom) i deksametazonom (ili ekvivalentnim lijekovima), 30 - 60 minuta prije doze olaratumaba 1. i 8. dana 1. ciklusa.
English: This product is preservative free.
Croatian: Ovaj lijek ne sadrži konzervanse.
English: Based on a PopPK analysis, no clinically meaningful differences in the clearance of olaratumab were observed in patients with mild (calculated creatinine clearance [CLcr] 60-89 mL/min, n = 43), or moderate (CLcr 30-59 mL/min, n = 15) renal impairment compared to patients with normal renal function (CLcr ≥90 mL/min, n = 85).
Croatian: [CLcr] 60 - 89 ml/min, n = 43) ili umjerenim (CLcr 30 - 59 ml/min, n = 15) oštećenjem funkcije bubrega i bolesnika s normalnom funkcijom bubrega (CLcr ≥ 90 ml/min, n = 85).
English: Please refer to the doxorubicin SmPC for complete descriptions of all adverse events associated with doxorubicin treatment
Croatian: Vidjeti Sažetak opisa svojstava lijeka za doksorubicin za cjelovit opis svih nuspojava povezanih s liječenjem doksorubicinom.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING
Croatian: UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I PRIMJENU
English: To be taken into consideration by patients on a controlled sodium diet.
Croatian: To treba uzeti u obzir u bolesnika na dijeti s ograničenim unosom natrija.
English: In the phase 2 trial, the frequency of haemorrhagic events considered related to any study drug was 3.1 % in either treatment arm. All of these events were Grade 1/2 and were confounded by multiple factors.
Croatian: U ispitivanju faze 2, učestalost slučajeva krvarenja za koje se smatralo da su povezani s bilo kojim lijekom koji se primjenjivao u ispitivanju iznosila je 3,1% u svakoj liječenoj skupini.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1143/001-003
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/16/1143/001-003
English: IRRs were reported in 12.5 % of patients and mainly present as chills, fever or dyspnoea.
Croatian: Reakcije na infuziju prijavljene su u 12,5% bolesnika, a uglavnom se manifestiraju kao zimica,
English: The rate of febrile neutropenia was 12.5 % in the olaratumab plus doxorubicin arm and 13.8 % in the doxorubicin alone arm. For dose adjustments, refer to section 4.2
Croatian: Stopa febrilne neutropenije iznosila je 12,5% u skupini liječenoj olaratumabom plus doksorubicinom te 13,8% u skupini liječenoj samo doksorubicinom.
English: Your doctor will check your platelet count prior to treatment with Lartruvo.
Croatian: Liječnik će provjeriti broj krvnih pločica prije liječenja lijekom Lartruvo.
English: The frequency of anaphylactic reactions/anaphylactic shock is already calculated as part of grade 3-4 infusion-related reactions in the table of Adverse Drug Reactions (ADRs) in the same section of the SmPC.
Croatian: Učestalost anafilaktičkih reakcija/anafilaktičkog šoka već je izračunata u sklopu učestalosti reakcija na infuziju 3./4. stupnja, u tablici nuspojava u istom dijelu sažetka opisa svojstava lijeka.
English: Rare (≥ 1/10,000 to < 1/1,000)
Croatian: često (≥ 1/100 i < 1/10) manje često (≥ 1/1000 i < 1/100) rijetko (≥ 1/10 000 i < 1/1000)
English: One vial of 50 mL contains 500 mg olaratumab.
Croatian: Jedna bočica od 50 ml sadrži 500 mg olaratumaba.
English: 50 mL solution in a vial (Type I glass) with a chlorobutyl elastomeric stopper, an aluminium seal and a polypropylene cap.
Croatian: 50 ml otopine u bočici (staklo tipa I) s čepom od klorbutilnog elastomera, aluminijskim zaštitnim zatvaračem i polipropilenskim zatvaračem.
English: For intravenous use after dilution.
Croatian: Za primjenu u venu nakon razrjeđivanja.
English: 19 mL solution in a vial (Type I glass) with a chlorobutyl elastomeric stopper, an aluminium seal and a polypropylene cap.
Croatian: 19 ml otopine u bočici (staklo tipa I) s čepom od klorbutilnog elastomera, aluminijskim zaštitnim zatvaračem i polipropilenskim zatvaračem.
English: Absorption Olaratumab is administered as an intravenous infusion only.
Croatian: Olaratumab se primjenjuje isključivo intravenskom infuzijom.
English: Figure 2.
Croatian: Pogledajte dio 4.
English: PopPK data suggest that no dose adjustments are required in patients with mild or moderate renal impairment.
Croatian: Podaci iz populacijske farmakokinetičke analize ukazuju na to da nije potrebno prilagođavati dozu u bolesnika s blagim ili umjerenim oštećenjem funkcije bubrega.
English: It is available in packs of: - 1 vial of 19 mL - 2 vials of 19 mL - 1 vial of 50 mL
Croatian: Dostupan je u pakiranjima od: - 1 bočice volumena 19 ml
English: 3 patients in the olaratumab plus doxorubicin arm and 1 patient in the doxorubicin arm had post-study surgery only.
Croatian: U 3 bolesnika u skupini liječenoj olaratumabom plus doksorubicinom i 1 bolesnika u skupini liječenoj doksorubicinom je nakon ispitivanja izvršen samo kirurški zahvat.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1143/001
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/16/1143/001
English: One vial of 19 mL contains 190 mg olaratumab.
Croatian: Jedna bočica od 19 ml sadrži 190 mg olaratumaba.
English: Vials contain 190 mg or 500 mg as a 10 mg/mL solution of olaratumab.
Croatian: Bočice sadrže 190 mg ili 500 mg olaratumaba u obliku otopine koncentracije 10 mg/ml.
English: For serious Grade ≥ 3 non-haematologic toxicity deemed related to olaratumab, the dose of olaratumab should be withheld until toxicity is ≤ Grade 1 or has returned to pretreatment baseline.
Croatian: primjenu doze olaratumaba treba odgoditi dok se toksičnost ne ublaži na ≤ 1. stupanj ili vrati na početnu vrijednost prije liječenja.
English: Pack of 1 vial of 19 mL.
Croatian: Pakiranje s 1 bočicom od 19 ml.
English: A separate infusion line must be used and the line must be flushed with sodium chloride 9 mg/mL (0.9 %) solution for injection at the end of the infusion.
Croatian: Za infuziju se mora upotrijebiti zasebna infuzijska linija, koja se po završetku infuzije mora isprati otopinom natrijeva klorida za injekciju od 9 mg/ml (0,9%).
English: Randomisation was stratified by PDGFR-α expression (positive versus negative), number of previous lines of treatment (0 versus 1 or more lines), histological tumour type (leiomyosarcoma, synovial sarcoma, and others) and ECOG performance status (0 or 1 versus 2).
Croatian: histološkom tipu tumora (lejomiosarkom, sinovijalni sarkom i drugi) te funkcionalnom ECOG statusu (0 ili 1 naspram 2).
English: No formal studies have been conducted to evaluate the effect of hepatic impairment on the PK of olaratumab.
Croatian: Nisu provedena formalna ispitivanja kojima bi se ocijenio učinak oštećenja funkcije bubrega na farmakokinetiku olaratumaba.
English: Age, sex, and race had no clinically meaningful effect on the PK of olaratumab based on a PopPK analysis.
Croatian: Prema populacijskoj farmakokinetičkoj analizi, dob, spol i rasa nisu imali klinički značajnog učinka na farmakokinetiku olaratumaba.
English: Very Common Common
Croatian: Ukupna učestalost
English: No other formal DDI studies with olaratumab and medicinal products commonly used in cancer patients, including those with STS (e.g. antiemetics, analgesics, anti-diarrheal drugs, oral contraceptives, etc.), have been performed.
Croatian: Nisu provedena druga formalna ispitivanja interakcija između olaratumaba i lijekova koji se često koriste u bolesnika oboljelih od raka, uključujući one sa sarkomom mekog tkiva (npr. antiemetici,
English: STATEMENT OF ACTIVE SUBSTANCE(S) One mL of concentrate contains 10 mg of olaratumab.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedan ml koncentrata sadrži 10 mg olaratumaba.
English: • Monitor patient for worsening of condition.
Croatian: • Nakon što se reakcije povuče, nastaviti infuziju 50% manjom • Nadzirati bolesnika zbog mogućeg pogoršanja stanja.
English: Infusion-related reactions may occur during treatment with Lartruvo.
Croatian: Tijekom liječenja lijekom Lartruvo mogu se javiti reakcije na infuziju.
English: To administer using pre-filled intravenous infusion containers Based on the calculated volume of olaratumab, aseptically remove the corresponding volume of sodium chloride 9 mg/mL (0.9 %) solution for injection from the prefilled 250 mL intravenous container and transfer the olaratumab medicine into the container to bring the final volume in the container back to 250 mL.
Croatian: Na temelju izračunatog volumena olaratumaba, aseptičnom tehnikom izvadite odgovarajući volumen otopine natrijeva klorida za injekciju od 9 mg/ml (0,9%) iz napunjenog spremnika za intravensku infuziju volumena 250 ml i zatim prenesite olaratumab u taj spremnik tako da konačan volumen u spremniku ponovno bude 250 ml.
English: If not used immediately, in-use storage times and conditions before use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8 ºC and up to an additional 8 hours at room temperature (below 25 ºC).
Croatian: Pripremljeni lijek ne smije se čuvati dulje od 24 sata na temperaturi od 2ºC do 8ºC i najviše 8 dodatnih sati na sobnoj temperaturi (25°C).
English: The concentrate for solution for infusion must be clear to slightly opalescent and colourless to slightly yellow prior to dilution.
Croatian: Koncentrat za otopinu za infuziju mora prije razrjeđivanja biti bistar do blago opalescentan te bezbojan do bljedožut.
English: Do not freeze or shake the vial.
Croatian: Bočica se ne smije zamrzavati ni tresti.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1143/002 - 1 vial of 19 mL.
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/16/1143/002 - 1 bočica od 19 ml
English: Progression free survival, months* Median (95 % CI) Hazard ratio (95 % CI) p-value Overall survival, months Median (95 % CI) Hazard ratio (95 % CI) p-value Abbreviations: CI = confidence interval * By investigator assessment **Met phase 2 protocol defined significance level of 0.19
Croatian: Ukupno preživljenje, mjeseci Medijan (95 % CI)
English: The calculated volume of olaratumab should be aseptically transferred to the intravenous container.
Croatian: Izračunati volumen olaratumaba treba aseptičnom tehnikom prenijeti u spremnik za intravensku primjenu.
English: - pain or sores in your mouth or throat (mucositis) - vomiting - diarrhoea - headache - infusion-related reactions
Croatian: - bol ili ranice u ustima ili grlu (mukozitis)
English: The drip lasts about 60 minutes.
Croatian: Ovaj se lijek primjenjuje infuzijom u venu kap po kap. Ukapavanje traje približno 60 minuta.