FrancophonIA/ELRC3.0 huggingface dataset:
English: The number of infusions that you receive will depend on how well and for how long treatment with Lartruvo works and how well you feel.
Croatian: Broj infuzija koje ćete primiti ovisit će o tome koliko dobro i koliko dugo liječenje lijekom Lartruvo djeluje i koliko se dobro osjećate.
English: Data on very elderly patients (> 75 years) are very limited (see sections 4.8 and 5.1).
Croatian: Podaci o primjeni u znatno starijih bolesnika (> 75 godina) vrlo su ograničeni (vidjeti dijelove 4.8 i 5.1).
English: Doxorubicin alone (n = 67)
Croatian: Samo doksorubicin (n = 67)
English: Toxicity in the elderly
Croatian: Toksičnost u starijih osoba
English: It is not known if Lartruvo will affect your ability to drive.
Croatian: Nije poznato hoće li Lartruvo utjecati na Vašu sposobnost upravljanja vozilima.
English: Doxorubicin can cause cardiotoxicity.
Croatian: Doksorubicin može uzrokovati kardiotoksičnost.
English: This leaflet was last revised in < {month YYYY}>.
Croatian: Ova uputa je zadnji puta revidirana u <{mjesec GGGG}>.
English: Clearance and volume of distribution had a positive correlation with body weight.
Croatian: Klirens i volumen distribucije bili su u pozitivnoj korelaciji s tjelesnom težinom.
English: If you get any symptoms that affect your ability to concentrate and react, such as tiredness, do not drive or use machines until the effect goes away.
Croatian: Ako primijetite bilo koji simptom koji utječe na Vašu sposobnost koncentracije i reagiranja, kao što je umor, nemojte upravljati vozilima niti raditi sa strojevima sve dok se taj učinak ne povuče.
English: Storage times include the duration of infusion.
Croatian: Vrijeme čuvanja uključuje i trajanje infuzije.
English: The final total volume in the container should be 250 mL.
Croatian: Konačan ukupni volumen u spremniku mora biti 250 ml.
English: Your doctor will discuss this with you.
Croatian: O tome ćete razgovarati sa svojim liječnikom.
English: The following convention has been used for classification of frequency: Very common (≥ 1/10)
Croatian: Za određivanje učestalosti korištene su sljedeće kategorije: vrlo često (≥ 1/10)
English: Detailed instructions for your doctor or your nurse on how to prepare Lartruvo infusion are included at the end of this package leaflet (see ‘Handling instructions').
Croatian: Detaljne upute za liječnika ili medicinsku sestru o tome kako pripremiti infuziju lijeka Lartruvo nalaze se na kraju ove upute (pogledajte odlomak 'Upute za rukovanje').
English: The majority of these reactions occurred during or following the first olaratumab infusion.
Croatian: Većina tih reakcija nastupila je tijekom ili nakon prve infuzije olaratumaba.
English: Efficacy results are shown in Table 3 and Figures 1 and 2.
Croatian: Rezultati za djelotvornost prikazani su u Tablici 3 te na Slikama 1 i 2.
English: What you need to know before you are given Lartruvo
Croatian: Što morate znati prije nego počnete primati Lartruvo
English: This medicine has been given ‘conditional approval'.
Croatian: Ovom lijeku izdano je 'uvjetno odobrenje'.
English: Non-clinical data reveal no special hazard for humans based on repeat dose toxicity studies in monkeys.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju ispitivanja toksičnosti ponovljenih doza u majmuna.
English: The following side effects have been reported:
Croatian: Prijavljene su sljedeće nuspojave:
English: The main analysis was performed in the following two subgroups: Leiomyosarcoma (LMS) and non-LMS (other).
Croatian: Glavna analiza provedena je u sljedeće dvije podskupine: lejomiosarkom (LMS) i ne-LMS (ostalo).
English: PFS according to a post-hoc, blinded, independent assessment was 8.2 months vs 4.4 months; HR = 0.670; p = 0.1208.
Croatian: PFS prema post-hoc ocjeni zaslijepljenog neovisnog povjerenstva iznosio je 8,2 mjeseca naspram 4,4 mjeseca; HR = 0,670;
English: Tell your doctor or nurse immediately if you feel unwell during infusion.
Croatian: Odmah obavijestite liječnika ili medicinsku sestru ako se tijekom infuzije osjećate loše.
English: See section 4 for more details about infusion-related reactions which may occur during or after the infusion.
Croatian: Pogledajte dio 4. za više informacija o reakcijama na infuziju koje se mogu javiti tijekom ili nakon infuzije.
English: Subgroups analysis of OS is shown in figure 2.
Croatian: OS-a prema podskupinama prikazana je na Slici 2.
English: • Additional risk minimisation measures
Croatian: • Dodatne mjere minimizacije rizika Nije primjenjivo.
English: In case of overdose, use supportive therapy.
Croatian: U slučaju predoziranja, uvesti potporno liječenje.
English: Ask your doctor if you can breast-feed during or after treatment with Lartruvo.
Croatian: Pitajte svog liječnika smijete li dojiti tijekom ili nakon liječenja lijekom Lartruvo.
English: Store in a refrigerator (2° C - 8° C).
Croatian: Čuvati u hladnjaku (2°C - 8°C).
English: Based on its mechanism of action (see section 5.1), olaratumab has the potential to cause foetal harm.
Croatian: S obzirom na mehanizam djelovanja (vidjeti dio 5.1), olaratumab može naškoditi plodu.
English: The container should be gently inverted to ensure adequate mixing.
Croatian: Spremnik treba nježno preokrenuti kako bi se osiguralo pravilno miješanje.
English: Due to frequent occurrence of fatigue, patients should be advised to use caution when driving or operating machinery.
Croatian: Zbog česte pojave umora, bolesnicima treba savjetovati da budu oprezni pri upravljanju vozilima ili radu sa strojevima.
English: Olaratumab therapy must be initiated and supervised by physicians experienced in oncology.
Croatian: Terapiju olaratumabom moraju započeti i nadzirati liječnici s iskustvom na području onkologije.
English: Administration of live or live-attenuated vaccines in patients immunocompromised by chemotherapeutic agents including doxorubicin may result in serious or fatal infections.
Croatian: Primjena živih ili živih atenuiranih cjepiva u bolesnika imunokompromitiranih kemoterapeuticima, uključujući doksorubicin, može dovesti do ozbiljnih ili smrtonosnih infekcija.
English: Name and address of the manufacturer(s) of the biological active substance(s) ImClone Systems LLC
Croatian: Naziv(i) i adresa(e) proizvođača biološke(ih) djelatne(ih) tvari ImClone Systems LLC
English: In order to accommodate larger infusion volumes that may be needed for patients requiring higher doses, the duration of infusion should be increased such that the maximum infusion rate of 25 mg/minute is not exceeded.
Croatian: Kako bi se prilagodilo većim infuzijskim volumenima koji bi mogli biti potrebni za bolesnike kojima trebaju veće doze, trajanje infuzije treba produljiti tako da maksimalna brzina infuzije ne prelazi 25 mg/min.
English: This medicinal product has been authorised under a so-called ‘conditional approval' scheme.
Croatian: Ovaj lijek je odobren po shemi takozvanog 'uvjetnog odobrenja'.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for olaratumab, the scientific conclusions of CHMP are as follows:
Croatian: Uzimajući u obzir PRAC-ovo izvješće o ocjeni periodičkog(ih) izvješća o neškodljivosti lijeka (PSUR) za olaratumab, znanstveni zaključci CHMP-a su sljedeći:
English: Other symptoms may occur as well (see section 2 “Warnings and precautions”).
Croatian: Mogu se javiti i drugi simptomi (pogledajte odlomak 'Upozorenja i mjere opreza' u dijelu 2.).
English: • For subsequent infusions, please see premedication section.
Croatian: • Za daljnje infuzije vidjeti odlomak o premedikaciji.
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.
Croatian: Ženama reproduktivne dobi treba savjetovati da koriste učinkovitu kontracepciju tijekom liječenja i još najmanje 3 mjeseca nakon posljednje doze olaratumaba.
English: What Lartruvo contains - The active substance is olaratumab.
Croatian: Što Lartruvo sadrži - Djelatna tvar je olaratumab.
English: As monoclonal antibodies are not metabolised by cytochrome P450 (CYP) enzymes or other drug metabolising enzymes, inhibition or induction of these enzymes by co-administered medicinal products is not anticipated to affect the pharmacokinetics of olaratumab.
Croatian: Budući da monoklonska protutijela ne metaboliziraju enzimi citokroma P450 (CYP) ni drugi enzimi koji metaboliziraju lijekove, ne očekuje se da će inhibicija ili indukcija tih enzima uzrokovana istodobnom primjenom drugih lijekova utjecati na farmakokinetiku olaratumaba.
English: The risk of cardiac toxicity rises with increasing cumulative doses of anthracyclines, including doxorubicin.
Croatian: Rizik od srčane toksičnosti povećava se s povećanjem kumulativnih doza antraciklina, uključujući doksorubicin.
English: Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies, ATC code: L01XC27
Croatian: Farmakoterapijska skupina: Antineoplastici, monoklonska protutijela, ATK oznaka: L01XC27 Mehanizam djelovanja
English: In case of recurrence of a Grade 4 toxicity, treatment with olaratumab should be permanently discontinued.
Croatian: U slučaju ponovne pojave toksičnosti 4. stupnja, liječenje olaratumabom mora se trajno obustaviti.
English: Patients had received 0-4 previous lines of therapy for treatment of advanced disease but had not previously received treatment with anthracyclines.
Croatian: Bolesnici su prethodno primili od 0 do 4 linije liječenja za uznapredovalu bolest, no nisu prethodno bili liječeni antraciklinima.
English: This medicine is for single use only.
Croatian: Ovaj lijek namijenjen je samo za jednokratnu uporabu.
English: Description of selected ADRs
Croatian: Opisa odabranih nuspojava
English: Infusion reactions Lartruvo has been associated with infusion reactions (see section 2 “Warnings and precautions”).
Croatian: Reakcije na infuziju Lartruvo se povezuje s reakcijama na infuziju (pogledajte odlomak 'Upozorenja i mjere opreza' u dijelu 2.).
English: Lartruvo contains sodium
Croatian: Lartruvo sadrži natrij
English: A low white blood cell count may increase your risk for infection.
Croatian: Nizak broj bijelih krvnih stanica može povećati rizik od infekcije.
English: From a microbiological point of view the prepared dosing solution should be used immediately.
Croatian: S mikrobiološkog stanovišta, pripremljenu otopinu treba odmah primijeniti.
English: Olaratumab is a human monoclonal antibody.
Croatian: Olaratumab je humano monoklonsko protutijelo.
English: DO NOT dilute with other solutions or co-infuse with other electrolytes or medicines.
Croatian: NE SMIJETE je razrjeđivati s drugim otopinama niti infundirati istodobno s drugim elektrolitima ili lijekovima.
English: When olaratumab attaches to PDGFR-α it may prevent cancer cell growth and survival.
Croatian: Kada se olaratumab pričvrsti za PDGFR-α, može spriječiti rast i preživljenje stanica raka.
English: Within each frequency grouping, ADRs are presented in order of decreasing seriousness.
Croatian: Unutar svake kategorije učestalosti, nuspojave su prikazane u padajućem nizu prema ozbiljnosti.
English: Avoid getting pregnant while receiving this medicine and for at least 3 months after the last dose of Lartruvo as this medicine may harm your unborn child. Talk to your doctor about the best contraception for you.
Croatian: Izbjegavajte trudnoću tijekom liječenja ovim lijekom i još najmanje 3 mjeseca nakon posljednje doze lijeka Lartruvo jer ovaj lijek može naškoditi Vašem nerođenom djetetu.
English: Doxorubicin is given on day 1 of each cycle following the Lartruvo infusion.
Croatian: Doksorubicin se primjenjuje 1. dana svakog ciklusa, nakon infuzije lijeka Lartruvo.
English: Severe IRRs, also including a fatal case (see section 4.4) were reported in 3.1 % of patients and mainly presented with shortness of breath, loss of consciousness and hypotension.
Croatian: Teške reakcije na infuziju, uključujući jedan slučaj sa smrtnim ishodom (vidjeti dio 4.4), prijavljene su u 3,1% bolesnika, a uglavnom su se manifestirale kao nedostatak zraka, gubitak svijesti i hipotenzija.
English: Other non-haematology toxicities
Croatian: Druge nehematološke toksičnosti
English: In the majority of patients the pain was related to the patients' underlying cancer or metastases or pre-existing or concomitant conditions.
Croatian: U većine je bolesnika bol bila povezana s podležećim rakom ili metastazama ili otprije postojećim ili popratnim bolestima.
English: You must not be given Lartruvo - if you are allergic to olaratumab or any of the other ingredients of this medicine (listed in section 6).
Croatian: - ako ste alergični na olaratumab ili neki drugi sastojak ovoga lijeka (naveden u dijelu 6.).
English: EU/1/16/1143/003 - 2 vials of 19 mL.
Croatian: EU/1/16/1143/003 - 2 bočice od 19 ml
English: This should be taken into consideration if you are on a controlled sodium diet.
Croatian: To treba uzeti u obzir ako ste na dijeti s ograničenim unosom natrija.
English: The primary efficacy outcome measure was progression free survival (PFS) by investigator assessment.
Croatian: Primarna mjera ishoda za djelotvornost bilo je preživljenje bez progresije bolesti (engl. progression-free survival, PFS) prema ocjeni ispitivača.
English: PDGFR-α is found in large amounts on some cancer cells where it stimulates the cells to grow and divide.
Croatian: PDGFR-α je u velikim količinama prisutan na nekim stanicama raka, gdje potiče rast i diobu tih stanica.
English: if you are receiving any treatment for heart disease or liver disease
Croatian: Trebate obavijestiti svog liječnika: - ako primate bilo kakvo liječenje za bolest srca ili bolest jetre
English: Olaratumab is not recommended during pregnancy and in women of childbearing potential not using contraception, unless the potential benefit justifies the potential risk to the foetus.
Croatian: Ne preporučuje se koristiti olaratumab tijekom trudnoće niti u žena reproduktivne dobi koje ne koriste kontracepciju, osim u slučajevima kada moguća korist opravdava mogući rizik za plod.
English: A total of 133 patients were randomised, of whom 129 received at least one dose of study treatment (64 in the olaratumab plus doxorubicin arm and 65 in the doxorubicin arm).
Croatian: Ukupno su randomizirana 133 bolesnika, od kojih je njih 129 primilo najmanje jednu dozu ispitivanog liječenja (64 u skupini liječenoj olaratumabom plus doksorubicinom i 65 u skupini liječenoj doksorubicinom).
English: How to store Lartruvo
Croatian: Kako čuvati Lartruvo
English: Difference in objective response rate [complete response (CR) + partial response (PR)] according to investigator assessment was not statistically significant (18.2 % vs 11.9 % in patients randomised to olaratumab plus doxorubicin compared to patients randomized to doxorubicin respectively).
Croatian: Razlika u stopi objektivnog odgovora (potpun odgovor [engl. complete response, CR] + djelomičan odgovor [engl. partial response, PR]) prema ocjeni ispitivača nije bila statistički značajna (18,2% u bolesnika randomiziranih za liječenje olaratumabom plus doksorubicinom naspram 11,9% u bolesnika randomiziranih za liječenje doksorubicinom).
English: Lartruvo contains the active substance olaratumab, which belongs to a group of medicines called monoclonal antibodies.
Croatian: Lartruvo sadrži djelatnu tvar olaratumab, koja pripada skupini lijekova koji se zovu monoklonska protutijela.
English: Administer via an infusion pump.
Croatian: Primijenite infuzijskom pumpom.
English: On the basis of the scientific conclusions for olaratumab the CHMP is of the opinion that the benefitrisk balance of the medicinal product(s) containing olaratumab is unchanged subject to the proposed changes to the product information.
Croatian: Na temelju znanstvenih zaključaka za olaratumab, CHMP smatra da je omjer koristi i rizika lijeka(ova) koji sadrži(e) olaratumab nepromijenjen, uz predložene izmjene informacija o lijeku.
English: Forest plot for subgroup analysis of overall survival (ITT population)
Croatian: Slika 2. Grafikon raspona pouzdanosti (engl. forest plot) za analizu ukupnog preživljenja po podskupinama (ITT populacija)
English: More than 25 different soft tissue sarcoma subtypes were represented in this trial, the most frequent being leiomyosarcoma (38.4 %), undifferentiated pleomorphic sarcoma (18.1 %) and liposarcoma (17.3 %).
Croatian: U tom je ispitivanju bilo zastupljeno više od 25 različitih podvrsta sarkoma mekog tkiva, od kojih su najčešći bili lejomiosarkom (38,4%), nediferencirani pleomorfni sarkom (18,1%) i liposarkom (17,3%).
English: In some patients there was a recurrence of pain .The pain did not worsen with time or during recurrence.
Croatian: Bol se nije pogoršala ni s vremenom ni kada se ponovno pojavila.
English: The rates of discontinuation were comparable between treatment arms across all age groups.
Croatian: Stope obustave liječenja bile su usporedive među liječenim skupinama u svim dobnim skupinama.
English: There is no known antidote to Lartruvo overdose.
Croatian: Nema poznatog protulijeka za predoziranje lijekom Lartruvo.
English: Vaccination with a live vaccine should be avoided in patients receiving olaratumab in combination with doxorubicin.
Croatian: Cijepljenje živim cjepivom treba izbjegavati u bolesnika koji primaju olaratumab u kombinaciji s doksorubicinom.
English: Scientific conclusions and grounds for the variation to the terms of the marketing
Croatian: Znanstveni zaključci i razlozi za izmjenu uvjeta odobrenja za stavljanje lijeka u promet
English: Infusion solution: After dilution and preparation, the medicine must be used immediately.
Croatian: Otopina za infuziju: Lijek se mora primijeniti odmah nakon razrjeđivanja i pripreme.
English: Kaplan-Meier curves of overall survival for Lartruvo plus doxorubicin versus doxorubicin alone
Croatian: Kaplan-Meierove krivulje ukupnog preživljenja za Lartruvo plus doksorubicin u odnosu na samo doksorubicin
English: Immunogenicity As with all therapeutic proteins, there is the potential for immunogenicity.
Croatian: Kao i svi terapijski proteini, ovaj lijek može imati imunogene učinke.
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 %).
Croatian: Najčešće nuspojave lijeka povezane s trajnom obustavom liječenja nastupile su u 3 (4,7%) bolesnika, a najčešće među njima bile u reakcije na infuziju (3,1%) i mukozitis (1,6%).
English: Patients in the olaratumab plus doxorubicin arm could continue on olaratumab monotherapy until disease progression, unacceptable toxicity or any other reason for treatment discontinuation occurred.
Croatian: Bolesnici u skupini liječenoj olaratumabom plus doksorubicinom mogli su nastaviti liječenje monoterapijom olaratumabom do progresije bolesti, pojave neprihvatljive toksičnosti ili nastupa bilo kojeg drugog razloga za obustavu liječenja.
English: For subsequent infusions, the dose should be reduced to 12 mg/kg for serious Grade 3 toxicities and to 10 mg/kg for Grade 4 toxicities.
Croatian: Kod svih sljedećih infuzija, dozu treba smanjiti na 12 mg/kg za ozbiljne toksičnosti 3. stupnja te na 10 mg/kg za toksičnosti 4. stupnja.
English: Other medicines and Lartruvo Tell your doctor if you are taking, have recently taken or might take any other medicines.
Croatian: Obavijestite svog liječnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: As doxorubicin is rapidly metabolised and predominantly eliminated by the biliary system, the toxicity of doxorubicin is enhanced in patients with hepatic impairment.
Croatian: Budući da se doksorubicin brzo metabolizira i prvenstveno eliminira putem žučnog sustava, toksičnost doksorubicina pojačana je u bolesnika s oštećenjem funkcije jetre.
English: Musculoskeletal pain
Croatian: Mišićno-koštana bol
English: In the event that intravenous administration of an H1 antagonist is not possible, equivalent alternative premedication should be given (e.g. oral diphenhydramine hydrochloride at least 90 minutes prior to the infusion).
Croatian: U slučaju da nije moguće intravenski primijeniti antagonist H1 receptora, treba dati neki drugi ekvivalentan lijek (npr. oralni difenhidraminklorid najmanje 90 minuta prije infuzije).
English: Key secondary efficacy outcome measures were overall survival (OS) and objective response rate (ORR) (see Table 3).
Croatian: (engl. overall survival, OS) i stopa objektivnog odgovora (engl. objective response rate, ORR) (vidjeti Tablicu 3).
English: Soft tissue sarcoma is a cancer that starts in the soft tissues, such as the muscles, fat, cartilage and blood vessels.
Croatian: Sarkom mekog tkiva je jedna vrsta raka koji se počne razvijati u mekim tkivima, kao što su mišići, masno tkivo, hrskavica i krvne žile.
English: If not used immediately, the dosing solution should be stored under refrigeration for up to 24 hours at 2 °C to 8 °C and up to an additional 8 hours at room temperature (up to 25 °C) assuming dilution has taken place in controlled and validated aseptic conditions.
Croatian: Ako se ne primijeni odmah, otopinu treba čuvati u hladnjaku do najviše 24 sata na temperaturi od 2°C do 8°C te do najviše dodatnih 8 sati na sobnoj temperaturi (do 25°C), pod uvjetom da je razrjeđivanje provedeno u kontroliranim i validiranim aseptičnim uvjetima.
English: Coagulation parameters should be monitored in patients with conditions predisposing to bleeding, such as anticoagulant use.
Croatian: Potrebno je kontrolirati parametre koagulacije u bolesnika sa stanjima koja predstavljaju predispoziciju za krvarenje, kao što je primjena antikoagulansa.
English: Olaratumab is a human IgG1 monoclonal antibody produced in murine (NS0) cells by recombinant DNA technology.
Croatian: Olaratumab je humano IgG1 monoklonsko protutijelo proizvedeno u mišjim (NS0) stanicama tehnologijom rekombinantne DNK.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 9 November 2016
Croatian: Datum prvog odobrenja: 9. studeni 2016.
English: The dose and volume of olaratumab needed should be calculated to prepare the infusion solution.
Croatian: Potrebno je izračunati potrebnu dozu i volumen olaratumaba kako bi se mogla pripremiti otopina za infuziju.
English: The median cumulative dose of doxorubicin was 487.6 mg/m2 in the olaratumab plus doxorubicin arm and 299.6 mg/m2 in the doxorubicin alone arm.
Croatian: Medijan kumulativne doze doksorubicina iznosio je 487,6 mg/m2 u skupini liječenoj olaratumabom plus doksorubicinom te 299,6 mg/m2 u skupini liječenoj samo doksorubicinom.
English: The number of patients receiving post-study systemic therapy was similar between arms.
Croatian: Broj bolesnika koji su nakon ispitivanja primili sistemsku terapiju bio je sličan u obje skupine.
English: Human IgG is excreted in human milk, therefore breast-feeding is not recommended during treatment with olaratumab and for at least 3 months following the last dose.
Croatian: Budući da se humani IgG izlučuje u majčino mlijeko, ne preporučuje se dojenje tijekom liječenja olaratumabom i još najmanje 3 mjeseca nakon posljednje doze.
English: - Reduction in the number of white blood cells Lartruvo and doxorubicin may decrease the number of white blood cells (including neutrophils).
Croatian: Lartruvo i doksorubicin mogu smanjiti broj bijelih krvnih stanica (uključujući neutrofile).
English: The risk of toxicity rises with increasing cumulative doses and is higher in individuals with a history of cardiomyopathy, mediastinal irradiation or pre-existing cardiac disease.
Croatian: Rizik od toksičnosti povećava se s povećanjem kumulativnih doza te je veći u osoba koje u anamnezi imaju kardiomiopatiju, zračenje sredoprsja ili otprije postojeću srčanu bolest.
English: Conversely, olaratumab is not anticipated to affect the pharmacokinetics of co-administered medicinal products.
Croatian: Isto tako, ne očekuje se da će olaratumab utjecati na farmakokinetiku istodobno primijenjenih lijekova.
English: Name and address of the manufacturer(s) responsible for batch release Lilly S.A.
Croatian: Naziv(i) i adresa(e) proizvođača odgovornog(ih) za puštanje serije lijeka u promet Lilly S.A.