FrancophonIA/ELRC3.0 huggingface dataset:
English: The Phase 2 portion of the study was a randomised, open label study of olaratumab plus doxorubicin versus doxorubicin alone.
Slovenian: Faza 2 je bilo primerjalno randomizirano, odprto preskušanje za primerjavo kombinacije olaratumaba in doksorubicina ter doksorubicina samega.
English: For intravenous use after dilution.
Slovenian: Za intravensko uporabo po redčenju.
English: Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht The Netherlands
Slovenian: Papendorpseweg 83, 3528 BJ Utrecht Nizozemska
English: Sodium restricted diet
Slovenian: Dieta z omejitvijo vnosa natrija
English: E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE CONDITIONAL MARKETING AUTHORISATION
Slovenian: E. SPECIFIČNE ZAHTEVE ZA IZPOLNITEV UKREPOV PO PRIDOBITVI POGOJNEGA DOVOLJENJA ZA PROMET Z ZDRAVILOM IN DOVOLJENJA ZA PROMET Z ZDRAVILOM V IZJEMNIH OKOLIŠČINAH
English: Infusion-related reactions may occur during treatment with Lartruvo.
Slovenian: Med zdravljenjem z zdravilom Lartruvo lahko pride do reakcij, povezanih z infuzijo.
English: Sími + 354 540 8000
Slovenian: Icepharma hf. Sími + 354 540 8000
English: No clinically meaningful difference in doxorubicin-related cardiotoxicity was observed between the two treatment arms of the study.
Slovenian: Med obema zdravljenima skupinama študije ni bila opažena nobena klinično pomembna razlika v povezavi s kardiotoksičnostjo, povezano z doksorubicinom.
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.
Slovenian: Zdravilo Lartruvo se v kombinaciji z doksorubicinom uporablja v največ osmih ciklih zdravljenja, nato pa ga v monoterapiji uporabljajo le bolniki, pri katerih ni prišlo do napredovanja bolezni.
English: How to store Lartruvo
Slovenian: Shranjevanje zdravila Lartruvo
English: The concentrate is clear to slightly opalescent and colourless to slightly yellow solution without visible particles.
Slovenian: Koncentrat je prozorna do rahlo opalescentna, brezbarvna do nekoliko rumenkasta raztopina brez vidnih delcev.
English: In patients who have experienced a previous Grade 1 or 2 IRR, premedication with diphenhydramine hydrochloride (intravenously), paracetamol, and dexamethasone is recommended.
Slovenian: Pri bolnikih, pri katerih se je v preteklosti pojavila IRR stopnje 1 ali 2, se priporoča premedikacija z difenhidraminijevim kloridom (intravensko), paracetamolom in deksametazonom.
English: There are no data for the combination of olaratumab and doxorubicin in anthracycline pre-treated patients, including pre-treatment with doxorubicin (see section 4.1).
Slovenian: O uporabi kombinacije olaratumaba in doksorubicina pri bolnikih, ki so bili predhodno zdravljeni z antraciklini, ni podatkov (glejte poglavje 4.1).
English: Summary of survival data - ITT population Lartruvo plus doxorubicin (n = 66)
Slovenian: Zdravilo Lartruvo v kombinaciji z doksorubicinom (n = 66)
English: No animal studies have been performed to test olaratumab for potential of carcinogenicity, genotoxicity, or fertility impairment.
Slovenian: Za preskus karcinogenosti, genotoksičnosti in zmanjšane plodnosti zaradi uporabe olaratumaba ni bila izvedena nobena študija na živalih.
English: Anthracycline pre-treated patients
Slovenian: Bolniki, ki so bili predhodno zdravljeni z antraciklini
English: Kaplan-Meier curves of overall survival for Lartruvo plus doxorubicin versus doxorubicin alone
Slovenian: Kaplan-Meierjevi krivulji celokupnega preživetja skupine, zdravljene s kombinacijo zdravila Lartruvo in doksorubicina, in skupine, zdravljene samo z doksorubicinom
English: Vaccination with a live vaccine should be avoided in patients receiving olaratumab in combination with doxorubicin.
Slovenian: Pri bolnikih, ki prejemajo olaratumab v kombinaciji z doksorubicinom, se je treba izogibati cepljenju z živim cepivom.
English: Name and address of the manufacturer(s) responsible for batch release Lilly S.A.
Slovenian: Ime in naslov izdelovalca, odgovornega za sproščanje serij
English: There are no data regarding olaratumab administration in patients with severe renal impairment (calculated creatinine clearance < 30 mL/min) (see section 5.2).
Slovenian: O uporabi zdravila pri bolnikih s hudo ledvično okvaro (izračunani očistek kreatinina < 30 ml/min) (glejte poglavje 5.2) ni podatkov.
English: For all subsequent infusions, premedication with the following (or equivalent medicinal products) diphenhydramine hydrochloride (intravenously), paracetamol, and dexamethasone, should be given.
Slovenian: Pri vseh nadaljnjih infuzijah je potrebna premedikacija z difenhidraminijevim kloridom (intravensko), paracetamolom in deksametazonom (ali ekvivalentnimi zdravili).
English: 19 mL solution in a vial (Type I glass) with a chlorobutyl elastomeric stopper, an aluminium seal and a polypropylene cap.
Slovenian: 19 ml raztopine v viali (steklo vrste I) z zamaškom iz klorobutilnega elastomera, aluminijasto zaporko in polipropilenskim pokrovom.
English: 50 mL solution in a vial (Type I glass) with a chlorobutyl elastomeric stopper, an aluminium seal and a polypropylene cap.
Slovenian: 50 ml raztopine v viali (steklo vrste I) z zamaškom iz klorobutilnega elastomera, aluminijasto zaporko in polipropilenskim pokrovom.
English: How you are given Lartruvo
Slovenian: Kako boste prejemali zdravilo Lartruvo
English: Very Common None reported
Slovenian: Bolezni živčevja zelo pogosti ni bilo poročil
English: When olaratumab attaches to PDGFR-α it may prevent cancer cell growth and survival.
Slovenian: PDGFR-α, lahko prepreči rast in preživetje rakastih celic.
English: PopPK data suggest that no dose adjustments are required in patients with mild or moderate renal impairment.
Slovenian: Podatki PopPK kažejo, da odmerka pri bolnikih z blago do zmerno ledvično okvaro ni treba prilagajati.
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.
Slovenian: Hemoragični dogodki Pri preskušanju faze 2 je bila pogostnost hemoragičnih dogodkov v povezavi s katerim koli zdravilom v obeh skupinah zdravljenja 3,1 %.
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.
Slovenian: V celotni populaciji je bilo v skupini, ki je prejemala kombinacijo olaratumaba in doksorubicina, opaženo statistično značilno izboljšanje OS v primerjavi s skupino, ki je prejemala le doksorubicin.
English: In case of overdose, use supportive therapy.
Slovenian: Pri prevelikem odmerjanju zdravila Lartruvo uporabite podporno zdravljenje.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Slovenian: Preobčutljivost za učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1. 4.4 Posebna opozorila in previdnostni ukrepi Reakcije, povezane z infuzijo
English: There was a higher incidence of Grade ≥3 adverse reactions, adverse reactions leading to discontinuation and a higher rate of haematological toxicity in the elderly population compared to the overall study population (see section 4.2).
Slovenian: Toksičnost pri starejših Pri primerjavi s splošno proučevano populacijo so bili pri starejših pogostejši neželeni učinki stopnja ≥ 3, neželeni učinki, zaradi katerih je bilo zdravljenje ukinjeno, in hematološki toksični učinki (glejte poglavje 4.2).
English: The calculated volume of olaratumab should be aseptically transferred to the intravenous container.
Slovenian: Izračunano prostornino olaratumaba je treba aseptično prenesti v intravenski vsebnik.
English: This product is preservative free.
Slovenian: To zdravilo ne vsebuje konzervansov.
English: Vials contain 190 mg or 500 mg as a 10 mg/mL solution of olaratumab.
Slovenian: Viale vsebujejo 190 mg ali 500 mg olaratumaba v obliki 10 mg/ml raztopine.
English: PopPK data suggest that no dose adjustments are required in patients with mild hepatic impairment.
Slovenian: Podatki PopPK kažejo, da odmerka pri bolnikih z blago jetrno okvaro ni treba prilagoditi.
English: One vial of 50 mL contains 500 mg olaratumab.
Slovenian: Ena 50-ml viala vsebuje 500 mg olaratumaba.
English: Any unused medicine or waste material should be disposed of in accordance with local requirements.
Slovenian: Vse neporabljeno zdravilo in odpadni material je treba zavreči v skladu z lokalnimi predpisi.
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.
Slovenian: Uporabiti je treba ločeno intravensko linijo in po opravljeni infuziji je treba linijo sprati z 9 mg/ml (0,9 %) raztopino natrijevega klorida za injiciranje.
English: A doctor experienced in the use of anti-cancer medicines will supervise your Lartruvo therapy.
Slovenian: Vaše zdravljenje z zdravilom Lartruvo bo nadzoroval zdravnik z izkušnjami v uporabi zdravil proti raku.
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
Slovenian: Preglednica 2: Neželeni učinki pri bolnikih, pri katerih je bil sarkom mehkih tkiv v 2. delu študije faze 1b/2 zdravljen s kombinacijo olaratumaba in doksorubicina.
English: Ten patients in the olaratumab plus doxorubicin arm and 5 patients in the doxorubicin arm received post-study radiotherapy only.
Slovenian: Deset bolnikov iz skupine, zdravljene s kombinacijo olaratumaba in doksorubicina, in 5 bolnikov iz skupine, zdravljene z doksorubicinom, je bilo po koncu študije le obsevanih.
English: In case of prefilled intravenous infusion container usage Based on the calculated volume of olaratumab, the corresponding volume of sodium chloride 9 mg/mL (0.9 %) solution for injection should be removed from the prefilled 250 mL intravenous container.
Slovenian: Pri uporabi s predhodno napolnjenim vsebnikom za intravensko infuzijo Glede na izračunano prostornino olaratumaba je treba iz predhodno napolnjenega 250-ml intravenskega vsebnika odstraniti ustrezno prostornino 9 mg/ml (0,9-odstotne) raztopine natrijevega klorida za injiciranje.
English: The concentrate for solution for infusion must be clear to slightly opalescent and colourless to slightly yellow prior to dilution.
Slovenian: Koncentrat za raztopino za infundiranje mora biti pred redčenjem prozorna do rahlo opalescentna in brezbarvna do nekoliko rumenkasta raztopina.
English: Overall, a low incidence of both treatment emergent anti-drug antibodies and neutralising antibodies were detected in clinical trial samples.
Slovenian: V splošnem je bila v vzorcih, pridobljenih v kliničnih preskušanjih, zaznana nizka pogostnost ob zdravljenju nastalih protiteles proti zdravilu in nevtralizirajočih protiteles.
English: The most frequent ADRs associated with permanent treatment discontinuation occurred in 3 (4.7 %) patients of which the most frequent were infusion-related reactions (3.1 %) and mucositis (1.6 %).
Slovenian: Med temi so bile najpogostejše reakcije, povezane z infuzijo (3,1 %), in mukozitis (1,6 %).
English: This medicine is given as an infusion into a vein via a drip.
Slovenian: Zdravilo se daje v veno s kapalno infuzijo.
English: Administration of live or live-attenuated vaccines in patients immunocompromised by chemotherapeutic agents including doxorubicin may result in serious or fatal infections.
Slovenian: Uporaba živih ali živih oslabljenih cepiv pri bolnikih, imunsko oslabljenih zaradi kemoterapevtikov,
English: The content of the vials should be inspected for particulate matter and discolouration (the concentrate for solution for infusion should be clear to slightly opalescent and colourless to slightly yellow without visible particles) prior to administration.
Slovenian: Pred uporabo je treba preveriti, ali ni vsebina stekleničke morda obarvana in ali ne vsebuje delcev (koncentrat za raztopino za infundiranje mora biti prozorna do rahlo opalescentna in brezbarvna do nekoliko rumenkasta raztopina brez vidnih delcev).
English: Slovenská republika Eli Lilly Slovakia, s.r.o.
Slovenian: Eli Lilly Slovakia, s.r.o.
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.
Slovenian: Na podlagi izračunane prostornine olaratumaba iz predhodno napolnjenega 250-ml intravenskega vsebnika aseptično odstranite ustrezno prostornino 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje in prenesite zdravilo z olaratumabom v intravenski vsebnik, tako da bo končna prostornina spet dosegla 250 ml. Vsebnik nežno obračajte, da se vsebina ustrezno premeša.
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).
Slovenian: Shranjevanje ne sme trajati več kot 24 ur pri 2 do 8 ºC, z dodatnimi 8 urami pri sobni temperaturi (pod 25 ºC).
English: One vial of 19 mL contains 190 mg olaratumab.
Slovenian: Ena 19-ml viala vsebuje 190 mg olaratumaba.
English: Only use sodium chloride 9 mg/mL (0.9 %) solution for injection as a diluent.
Slovenian: Za redčenje uporabite le 9 mg/ml (0,9 %) raztopino natrijevega klorida za injiciranje.
English: If particulate matter is identified, discard the infusion solution.
Slovenian: Če opazite vidne delce, je treba raztopino za infundiranje zavreči.
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
Slovenian: Incidenca febrilne nevtropenije je bila 12,5 % v skupini, zdravljeni s kombinacijo olaratumaba in doksorubicina, in 13,8 % v skupini, zdravljeni samo z doksorubicinom.
English: Mannitol (E421)
Slovenian: 6.1 Seznam pomožnih snovi manitol (E421) glicin (E640) natrijev klorid
English: Grade 3-4 • Immediately and permanently discontinue treatment with a Grade per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI
Slovenian: Stopnja 3-4 • Zdravljenje z olaratumabom takoj in trajno ukinite (glejte a Stopnja, opredeljena po Skupnih terminoloških merilih za opredeljevanje neželenih dogodkov Nacionalnega onkološkega inštituta (NCI CTCAE, National Cancer Institute Common Terminology Criteria for Adverse Events), različica 4.03 b Po zmanjšanju hitrosti infuzije zaradi reakcije, povezane z infuzijo, stopnje 1 ali 2 se pri vseh nadaljnjih infuzijah priporoča uporaba manjše hitrosti infuzije.
English: You will be given medicines to reduce the risk of an infusion-related reaction before you receive Lartruvo.
Slovenian: Da bi se zmanjšalo tveganje reakcij, povezanih z infuzijo, vam bo zdravnik, preden boste prejeli zdravilo Lartruvo, dal druga zdravila.
English: Do not freeze or shake the vial.
Slovenian: Viale ne zamrzujte in ne pretresajte.
English: If a Grade 3 toxicity recurs despite the dose reduction, the dose should be reduced further to 10 mg/kg.
Slovenian: ponovno pojavi, je treba odmerek dodatno zmanjšati na 10 mg/kg.
English: Store in a refrigerator (2° C - 8° C).
Slovenian: 6.4 Posebna opozorila za shranjevanje Shranjujte v hladilniku (2-8 °C).
English: • Fever
Slovenian: • mrzlica,
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.
Slovenian: Za zmanjšanje toksičnosti, povezane z doksorubicinom, je treba pri vseh bolnikih pred začetkom in ves čas zdravljenja pretehtati in načrtovati ukrepe za varovanje srca
English: As a result, in vitro olaratumab inhibits PDGFR-α pathway signalling in tumour and stromal cells.
Slovenian: S tem in vitro v tumorskih in stromalnih celicah zavira s PDGFR-α posredovano signalno pot.
English: No formal studies have been conducted to evaluate the effect of renal impairment on the PK of olaratumab.
Slovenian: Formalne študije za ovrednotenje učinka ledvične okvare na farmakokinetiko olaratumaba niso bile izvedene.
English: Each millilitre of the concentrate for solution for infusion contains 10 mg of olaratumab.
Slovenian: En ml koncentrata za raztopino za infundiranje vsebuje 10 mg olaratumaba.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - 19 mL vial
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA ŠKATLA - 19-mililitrska viala
English: Age, sex, and race had no clinically meaningful effect on the PK of olaratumab based on a PopPK analysis.
Slovenian: Analiza PopPK ni pokazala klinično pomembnega vpliva starosti, spola ali rase na farmakokinetiko olaratumaba.
English: 3 patients in the olaratumab plus doxorubicin arm and 1 patient in the doxorubicin arm had post-study surgery only.
Slovenian: Trije bolniki v skupini, zdravljeni z olaratumabom in doksorubicinom, in 1 bolnik v skupini, zdravljeni samo z doksorubicinom, so bili po koncu študije le operirani.
English: No formal studies have been conducted to evaluate the effect of hepatic impairment on the PK of olaratumab.
Slovenian: Formalne študije za ovrednotenje učinka jetrne okvare na farmakokinetiko olaratumaba niso bile izvedene.
English: NAME OF THE MEDICINAL PRODUCT Lartruvo 10 mg/mL concentrate for solution for infusion
Slovenian: IME ZDRAVILA Lartruvo 10 mg/ml koncentrat za raztopino za infundiranje
English: What you need to know before you are given Lartruvo
Slovenian: Kaj morate vedeti, preden boste prejeli zdravilo Lartruvo Ne jemljite zdravila Lartruvo
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - 50 mL vial
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA ŠKATLA - 50-mililitrska viala
English: Your doctor will check your white blood cell counts prior to treatment with Lartruvo.
Slovenian: Pred začetkom zdravljenja z zdravilom Lartruvo bo zdravnik pri vas preveril število belih krvnih celic.
English: Infusion-related reactions (IRRs), including anaphylactic reactions, were reported in clinical trials with olaratumab.
Slovenian: V kliničnih preskušanjih olaratumaba so poročali o reakcijah, povezanih z infuzijo (IRR), vključno z anafilaktičnimi reakcijami.
English: Platelets help your blood to clot and a low platelet count may increase the risk of bleeding.
Slovenian: Nizko število trombocitov, ki so udeleženi pri strjevanju krvi, lahko poveča tveganje za krvavitve.
English: There have been no formal studies with olaratumab in patients with renal impairment.
Slovenian: Pri bolnikih z ledvično okvaro niso bile opravljene formalne študije olaratumaba.
English: 4.5 Interaction with other medicinal products and other forms of interaction
Slovenian: 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Olaratumab je humano monoklonsko protitelo.
English: Description of selected ADRs
Slovenian: Opis izbranih neželenih učinkov
English: Lartruvo 10 mg/mL concentrate for solution for infusion olaratumab
Slovenian: Lartruvo 10 mg/ml koncentrat za raztopino za infundiranje olaratumab
English: Please refer to the doxorubicin SmPC for complete descriptions of all adverse events associated with doxorubicin treatment
Slovenian: Za popoln opis vseh neželenih učinkov, povezanih z zdravljenjem z doksorubicinom, glejte povzetek glavnih značilnosti zdravila za doksorubicin.
English: - pain or sores in your mouth or throat (mucositis) - vomiting - diarrhoea - headache - infusion-related reactions
Slovenian: - bruhanje; - driska; - glavobol; - reakcije, povezane z infuzijo.
English: Patients receiving olaratumab and doxorubicin are at risk of haemorrhagic events (see section 4.8).
Slovenian: Hemoragični dogodki Bolnike, ki prejemajo olaratumab in doksorubicin, ogrožajo hemoragični dogodki (glejte poglavje
English: 2 patients in the olaratumab plus doxorubicin arm and none in the doxorubicin arm received both post-study radiotherapy and surgery.
Slovenian: Dva bolnika iz skupine, zdravljene z olaratumabom in doksorubicinom, sta bila po študiji obsevana in operirana, nihče pa ni bil po študiji obsevan in operiran iz skupine, zdravljene samo z doksorubicinom.
English: Refer to doxorubicin SmPC for appropriate monitoring of hepatic function and doxorubicin dose adjustments in patients with impaired liver function.
Slovenian: Za ustrezno spremljanje delovanja jeter in prilagajanje odmerka pri bolnikih z okvarjenim delovanjem jeter glejte povzetek glavnih značilnosti zdravila za doksorubicin.
English: There have been no formal studies with olaratumab in patients with hepatic impairment.
Slovenian: Pri bolnikih z jetrno okvaro niso bile opravljene formalne študije.
English: Ask your doctor if you can breast-feed during or after treatment with Lartruvo.
Slovenian: O tem, ali med zdravljenjem z zdravilom Lartruvo in po njem lahko dojite, se posvetujte z zdravnikom.
English: The final total volume in the container should be 250 mL.
Slovenian: Skupna končna prostornina v vsebniku mora znašati 250 ml. Vsebnik nežno obračajte, da se vsebina ustrezno premeša.
English: To administer using empty intravenous infusion containers Aseptically transfer the calculated volume of olaratumab into an empty intravenous infusion container.
Slovenian: Izračunano prostornino olaratumaba aseptično prenesite v prazen vsebnik za intravensko infundiranje.
English: Platelet counts should be checked prior to olaratumab dosing on Day 1 and Day 8 of each cycle.
Slovenian: Pred odmerkom olaratumaba 1. in 8. dan vsakega cikla je treba preveriti število trombocitov.
English: Please refer to doxorubicin SmPC for recommendation on cardiac monitoring.
Slovenian: Za priporočila o spremljanju delovanja srca glejte povzetek glavnih značilnosti zdravila za doksorubicin.
English: Neutrophil count should be checked prior to Olaratumab dosing on Day 1 and Day 8 of each cycle.
Slovenian: Pred odmerkom olaratumaba 1. in 8. dan vsakega ciklusa je treba preveriti število nevtrofilcev.
English: In case of empty intravenous infusion container usage The calculated volume of olaratumab should be aseptically transferred into an empty intravenous infusion container.
Slovenian: Izračunano prostornino olaratumaba je treba aseptično prenesti v prazen vsebnik za intravensko infuzijo.
English: Lartruvo and doxorubicin may decrease your platelet count.
Slovenian: - Krvavitev Zdravilo Lartruvo in doksorubicin lahko zmanjšata število trombocitov.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1143/001-003
Slovenian: EU/1/16/1143/001-003
English: Women of childbearing potential should be advised to use effective contraception during treatment and for at least 3 months following the last dose of olaratumab.
Slovenian: Med zdravljenjem in še vsaj tri mesece po zadnjem odmerku olaratumaba se ženskam v rodni dobi svetuje uporaba učinkovitih kontracepcijskih sredstev.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One mL of concentrate contains 10 mg of olaratumab.
Slovenian: En ml koncentrata vsebuje 10 mg olaratumaba.
English: DO NOT FREEZE OR SHAKE the infusion solution.
Slovenian: Raztopine za infuzijo NE ZAMRZUJTE IN NE PRETRESAJTE.
English: A sufficient quantity of sodium chloride 9 mg/mL (0.9 %) solution for injection should be added to the container to make the total volume 250 mL.
Slovenian: Vanj je treba dodati zadostno količino 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje, da dosežete skupno prostornino 250 ml. Vsebnik nežno obračajte, da se vsebina ustrezno premeša.
English: Handling instructions Lartruvo 10 mg/mL concentrate for solution for infusion olaratumab
Slovenian: Navodilo za ravnanje z zdravilom Lartruvo 10 mg/ml koncentrat za raztopino za infundiranje olaratumab