FrancophonIA/ELRC3.0 huggingface dataset:
English: The safety profile of Herceptin subcutaneous formulation (evaluated in 298 and 297 patients treated with the intravenous and subcutaneous formulations respectively) from the pivotal trial in EBC was overall similar to the known safety profile of the intravenous formulation.
Croatian: Sigurnosni profil supkutane formulacije lijeka Herceptin (ocijenjen u 298 bolesnika liječenih intravenskom formulacijom i 297 bolesnika liječenih supkutanom formulacijom) iz pivotalnog ispitivanja u ranom raku dojke općenito je bio sličan poznatom sigurnosnom profilu intravenske formulacije lijeka.
English: 101 International Dr.
Croatian: Lonza Portsmouth 101 International Dr.
English: Not known +Acute respiratory distress syndrome Not known +Bronchospasm
Croatian: +akutni respiratorni distres sindrom nepoznato +bronhospazam nepoznato
English: Immune system disorders Hypersensitivity
Croatian: Poremećaji imunološkog sustava preosjetljivost
English: Herceptin is a powder for concentrate for solution for intravenous infusion, which is supplied in a glass vial with a rubber stopper containing 150 mg of trastuzumab.
Croatian: Herceptin je prašak za koncentrat za otopinu za intravensku infuziju, dostupan u staklenoj bočici s gumenim čepom te sadrži 150 mg trastuzumaba.
English: In the neoadjuvant setting, the experience of concurrent administration of Herceptin and low dose anthracycline regimen is limited (see section 4.4).
Croatian: U neoadjuvantnom liječenju, iskustvo s istodobnom primjenom lijeka Herceptin i niske doze antraciklina je ograničeno (vidjeti dio 4.4).
English: Do not use this medicine if you notice any particulate matter or discoloration prior to administration.
Croatian: Ovaj lijek se ne smije upotrijebiti ako primijetite bilo kakve čestice ili promjenu boje prije primjene.
English: The efficacy results from the BCIRG 006 are summarized in Tables 8 and 9.
Croatian: Rezultati djelotvornosti iz ispitivanja BCIRG 006 sažeto su prikazani u Tablicama 8 i 9.
English: In patients with lower body weights (<59 kg, the lowest body weight quartile) the fixed dose used in the Herceptin subcutaneous arm was not associated with an increased risk of cardiac events or significant drop in LVEF.
Croatian: U bolesnika manje tjelesne težine (<59 kg, najniži kvartil tjelesne težine), fiksna doza koja se primjenjivala u skupini liječenoj lijekom Herceptin za supkutanu primjenu nije bila povezana s povećanim rizikom od srčanih događaja niti značajnim padom LVEF-a.
English: In rare cases, a reduction in the amount of (amniotic) fluid that surrounds the developing baby within the womb has been observed in pregnant women receiving Herceptin.
Croatian: U rijetkim je slučajevima u trudnica koje primaju Herceptin primijećeno smanjenje količine (amnijske) tekućine koja okružuje bebu u razvoju unutar maternice.
English: Serious reactions have been treated successfully with supportive therapy such as oxygen, betaagonists, and corticosteroids.
Croatian: Ozbiljne reakcije uspješno su liječene potpornom terapijom, primjerice kisikom, beta-agonistima i kortikosteroidima.
English: In the joint analysis of the NSABP B-31 and NCCTG N9831 studies, EBC was limited to women with operable breast cancer at high risk, defined as HER2-positive and axillary lymph node positive or HER2 positive and lymph node negative with high risk features (tumor size > 1 cm and ER negative or tumor size > 2 cm, regardless of hormonal status).
Croatian: U skupnoj analizi ispitivanja NSABP B-31 i NCCTG N9831, rani rak dojke je bio ograničen isključivo na žene s operabilnim rakom dojke visokog rizika, definiranim kao HER2 pozitivan s pozitivnim aksilarnim limfnim čvorovima ili HER2 pozitivan s negativnim aksilarnim limfnim čvorovima sa značajkama visokog rizika (veličina tumora > 1 cm i ER negativan ili veličina tumora > 2 cm, bez obzira na hormonski status).
English: Currently no data from clinical trials are available on re-treatment of patients with previous exposure to Herceptin in the adjuvant setting.
Croatian: Trenutno nema dostupnih podataka dobivenih kliničkim ispitivanjima o ponovnom liječenju bolesnika koji su prethodno adjuvantno liječeni lijekom Herceptin.
English: One vial of 5 mL contains 600 mg of trastuzumab.
Croatian: Jedna bočica od 5 ml sadrži 600 mg trastuzumaba.
English: Reversibility of mild symptomatic and asymptomatic left ventricular dysfunction was demonstrated for 79.5 % of patients.
Croatian: Reverzibilnost blage simptomatske i asimptomatske disfunkcije lijeve klijetke dokazana je u 79,5% bolesnika liječenih lijekom Herceptin.
English: Pre-switching rates (Cycles 1-4) for serious adverse events, grade 3 adverse events and treatment discontinuations due to adverse events were low (<5%) and similar to post-switching rates (Cycles 58).
Croatian: Stope ozbiljnih štetnih događaja, štetnih događaja 3. stupnja i prekida liječenja zbog štetnih događaja zabilježene prije prelaska (1.-4. ciklus) bile su niske (<5%) i slične onima primijećenima nakon prelaska (5.-8. ciklus).
English: In patients receiving Herceptin after completion of adjuvant chemotherapy, the risk of cardiac dysfunction was associated with a higher cumulative dose of anthracycline given prior to initiation of Herceptin and a body mass index (BMI) >25 kg/m2.
Croatian: U bolesnika koji su Herceptin primali nakon završetka adjuvantne kemoterapije, rizik od disfunkcije srca povezivao se s većom kumulativnom dozom antraciklina primijenjenoga prije početka liječenja lijekom Herceptin te indeksom tjelesne mase (BMI) većim od 25 kg/m2.
English: Faint ⁄ barely perceptible membranous reactivity in ≥ 10 % of tumour cells; cells are reactive only in part of their membrane
Croatian: Vrlo slaba/jedva primjetna membranska reaktivnost u ≥ 10 % tumorskih stanica; stanice su reaktivne samo u dijelu membrane
English: The addition of Herceptin to paclitaxel chemotherapy also resulted in a 37 % decrease in the risk of death.
Croatian: Dodavanje lijeka Herceptin kemoterapiji paklitakselom rezultiralo je i smanjenjem rizika od smrti za 37%.
English: This dose should be administered subcutaneously over 2-5 minutes every three weeks.
Croatian: Dozu treba primijeniti supkutano tijekom 2-5 minute svaka tri tjedna.
English: In the final population PK model, in addition to primary tumor type, body-weight, serum aspartate aminotransferase and albumin were identified as a statistically significant covariates affecting the exposure of trastuzumab.
Croatian: U konačnom populacijskom farmakokinetičkom modelu, kao statistički značajne kovarijante koje utječu na izloženost trastuzumabu su, uz primarnu vrstu tumora, identificirane i tjelesna težina te razina aspartat aminotransferaze i albumina u serumu.
English: The 6-year EFS rate was 65% in both arms (ITT population: HR=0.98 [95% CI: 0.74;1.29]) and the OS rate, 84% in both arms (ITT population: HR=0.94 [95% CI: 0.61;1.45]).
Croatian: U obje je skupine 6-godišnja stopa EFS-a iznosila 65% (ITT populacija: HR=0,98 [95% CI: 0,74; 1,29]), dok je stopa OS-a u obje skupine iznosila 84% (ITT populacija: HR=0,94 [95% CI: 0,61; 1,45]).
English: In study BO16348, after a median follow-up of 8 years the incidence of severe CHF (NYHA Class III & IV) in the Herceptin 1 year treatment arm was 0.8 %, and the rate of mild symptomatic and asymptomatic left ventricular dysfunction was 4.6 %.
Croatian: U ispitivanju BO16348, nakon medijana praćenja od 8 godina, incidencija teškog kongestivnog zatajenja srca (NYHA klase III i IV) u skupini liječenoj 1 godinu lijekom Herceptin iznosila je 0,8%, dok je stopa blage simptomatske i asimptomatske disfunkcije lijeve klijetke iznosila
English: They can be treated with an analgesic/antipyretic such as meperidine or paracetamol, or an antihistamine such as diphenhydramine.
Croatian: One se mogu liječiti analgeticima/antipireticima, poput meperidina ili paracetamola, ili antihistaminicima, poput difenhidramina.
English: • the other is given as a subcutaneous injection over 2 to 5 minutes.
Croatian: • drugi se primjenjuje injekcijom pod kožu tijekom 2 do 5 minuta.
English: For the sequence IV→SC (SC vial and SC formulation in administration system cohorts combined), adverse event rates (all grades) were described preswitching (Cycles 1-4) and post-switching (Cycles 5-8) as 53.8% vs. 56.4%, respectively; for the sequence SC→IV (SC vial and SC formulation in administration system cohorts combined), adverse event rates (all grades) were described pre- and post-switching as 65.4% vs. 48.7%, respectively.
Croatian: → s.c. (objedinjene kohorte koje su primale s.c. formulaciju u bočici i s.c. formulaciju u sustavu za primjenu), stopa štetnih događaja (svih stupnjeva) prije prelaska (1.-4. ciklus) iznosila je 53,8%, a nakon prelaska (5.-8. ciklus) 56,4%; kod slijeda s.c. → i.v. (objedinjene kohorte koje su primale s.c. formulaciju u bočici i s.c. formulaciju u sustavu za primjenu), stopa štetnih događaja (svih stupnjeva) prije prelaska iznosila je 65,4%, a nakon prelaska 48,7%.
English: - as monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for their metastatic disease.
Croatian: - kao monoterapija u liječenju bolesnika koji su prošli najmanje dvije linije kemoterapije za metastatsku bolest.
English: The 600 mg dose should be administered as a subcutaneous injection only over 2-5 minutes every three weeks.
Croatian: Doza od 600 mg smije se primijeniti isključivo kao supkutana injekcija tijekom 2-5 minuta svaka tri tjedna.
English: In rare cases, these reactions were associated with a clinical course culminating in a fatal outcome.
Croatian: U rijetkim slučajevima klinički tijek tih reakcija doveo je do smrtnog ishoda.
English: If patients have a continued decrease in left ventricular function, but remain asymptomatic, the physician should consider discontinuing therapy if no clinical benefit of Herceptin therapy has been seen.
Croatian: Ako se u bolesnika primijeti kontinuirano smanjenje funkcije lijeve klijetke, koje ostaje asimptomatsko, potrebno je razmotriti prekid terapije lijekom Herceptin ako ona nije polučila nikakvu kliničku korist.
English: A single dose study in rabbits and a 13-week repeat dose toxicity study in Cynomolgus monkeys were conducted.
Croatian: Provedeno je ispitivanje jednokratne doze na kunićima i 13-tjedno ispitivanje toksičnosti ponovljenih doza na makaki majmunima.
English: In the clinical study comparing these two formulations, infections and cardiac events leading to hospitalisation were more frequent with the subcutaneous formulation.
Croatian: Pri usporedbi tih dvaju oblika u kliničkom ispitivanju infekcije i nuspojave koje utječu na srce i zahtijevaju bolničko liječenje bile su češće uz oblik za potkožnu primjenu.
English: In this trial, 87 % of patients entered had disease that was IHC3+, and 95 % of patients entered had disease that was IHC3+ and/or FISH-positive.
Croatian: U tom je ispitivanju 87 % bolesnica bilo IHC3+, a 95 % njih je bilo IHC3+ i/ili FISH pozitivno.
English: Study MO28048 investigating the safety and tolerability of Herceptin subcutaneous formulation as adjuvant therapy in HER2 positive EBC patients who were enrolled in either a Herceptin subcutaneous vial cohort (N=1868 patients, including 20 patients receiving neoadjuvant therapy) or a Herceptin subcutaneous administration system cohort (N=710 patients, including 21 patients receiving neoadjuvant therapy) resulted in no new safety signals.
Croatian: U ispitivanju MO28048, u kojem su se ocjenjivale sigurnost i podnošljivost supkutane formulacije lijeka Herceptin kao adjuvantne terapije u HER2 pozitivnih bolesnika s ranim rakom dojke uključenih ili u kohortu liječenu supkutanom formulacijom lijeka Herceptin u bočici (N=1868 bolesnika, uključujući 20 bolesnika koji su primali neoadjuvantnu terapiju) ili u kohortu koja je primala supkutanu formulaciju lijeka Herceptin u sustavu za primjenu (N=710 bolesnika, uključujući 21 bolesnika koji je primao neoadjuvantnu terapiju), nisu otkriveni novi sigurnosni signali.
English: Overall Survival, Median months Progression-Free Survival, Median months
Croatian: Preživljenje bez napredovanja bolesti, medijan u mjesecima Vrijeme do progresije bolesti, medijan u mjesecima
English: Trastuzumab washout period was assessed following subcutaneous administration using the population PK model.
Croatian: Razdoblje ispiranja trastuzumaba ocijenjeno je nakon supkutane primjene lijeka uz pomoć populacijskog farmakokinetičkog modela.
English: Serious reactions to intravenous Herceptin have been treated successfully with supportive therapy such as oxygen, beta-agonists, and corticosteroids.
Croatian: Ozbiljne reakcije na intravensku formulaciju lijeka Herceptin uspješno su liječene potpornom terapijom, primjerice kisikom, beta-agonistima i kortikosteroidima.
English: The pharmacokinetic results for the co primary endpoint, Ctrough pre dose Cycle 8, showed non-inferiority of the Herceptin subcutaneous compared to the Herceptin intravenous dose adjusted by body weight.
Croatian: Farmakokinetički rezultati za jednu od dvije primarne mjere ishoda, Ctrough prije primjene doze u 8. ciklusu, pokazali su neinferiornost supkutane doze lijeka Herceptin u usporedbi s intravenskom dozom lijeka Herceptin prilagođenom prema tjelesnoj težini.
English: Median duration of response (months) (range)
Croatian: Medijan trajanja odgovora (mjeseci) (raspon)
English: The rate of serious infections (most of which were identified because of in-patient hospitalisation or prolongation of existing hospitalisation) was 4.4 % in the Herceptin intravenous formulation arm and 8.1 % in the Herceptin subcutaneous formulation arm.
Croatian: Stopa ozbiljnih infekcija (većina ih je identificirana zahvaljujući hospitalizaciji ili produljenju postojeće hospitalizacije) iznosila je 4,4% u skupini koja je primala intravensku formulaciju lijeka Herceptin i 8,1% u skupini koja je primala Herceptin u supkutanoj formulaciji.
English: Although serious ARRs, including dyspnoea, hypotension, wheezing, bronchospasm, tachycardia, reduced oxygen saturation and respiratory distress, were not reported in the clinical trial with the Herceptin subcutaneous formulation, caution should be exercised as these have been associated with the intravenous formulation.
Croatian: Iako ozbiljne reakcije povezane s primjenom lijeka, uključujući dispneju, hipotenziju, piskanje, bronhospazam, tahikardiju, smanjenu zasićenost kisikom i respiratorni distres, nisu prijavljene u kliničkim ispitivanjima lijeka Herceptin u supkutanoj formulaciji, potreban je oprez jer su se te reakcije pojavile kod primjene intravenske formulacije lijeka.
English: Herceptin in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of adult patients with HER2 positive metastatic adenocarcinoma of the stomach or gastroesophageal junction who have not received prior anti-cancer treatment for their metastatic disease.
Croatian: Herceptin je u kombinaciji s kapecitabinom ili 5-fluorouracilom i cisplatinom indiciran u liječenju odraslih bolesnika s HER2 pozitivnim metastatskim adenokarcinomom želuca ili gastroezofagealnog spoja, koji nisu prethodno primali kemoterapiju za metastatsku bolest.
English: In the pivotal trials (H0648g, M77001), paclitaxel or docetaxel was administered the day following the first dose of Herceptin (for dose, see the Summary of Product Characteristics (SmPC) for paclitaxel or docetaxel) and immediately after the subsequent doses of Herceptin if the preceding dose of Herceptin was well tolerated.
Croatian: U pivotalnim kliničkim ispitivanjima (H0648g, M77001) paklitaksel ili docetaksel primjenjivan je dan nakon prve doze lijeka Herceptin (za dozu vidjeti Sažetak opisa svojstava lijeka za paklitaksel ili docetaksel) i neposredno nakon sljedećih doza lijeka Herceptin ako je bolesnik prethodnu dozu lijeka
English: From a microbiological point of view, the reconstituted solution and Herceptin infusion solution should be used immediately.
Croatian: S mikrobiološkog stajališta, rekonstituiranu otopinu i infuzijsku otopinu lijeka Herceptin potrebno je odmah primijeniti.
English: Patients should be observed for six hours after the first injection and for two hours after subsequent injections for signs or symptoms of administration-related reactions (see sections 4.4 and 4.8).
Croatian: Bolesnike treba promatrati najmanje šest sati nakon prve injekcije te dva sata nakon svake sljedeće injekcije kako bi se uočili mogući znakovi ili simptomi reakcija povezanih s primjenom lijeka (vidjeti dijelove 4.4 i 4.8).
English: Combination treatment with Herceptin and anastrozole Herceptin has been studied in combination with anastrozole for first line treatment of MBC in HER2 overexpressing, hormone-receptor (i.e. estrogen-receptor (ER) and/or progesterone-receptor (PR)) positive postmenopausal patients.
Croatian: Kombinirano liječenje lijekom Herceptin i anastrozolom Herceptin je ispitivan u kombinaciji s anastrozolom u prvoj liniji liječenja postmenopauzalnih bolesnica s metastatskim rakom dojke pozitivnim na povećanu ekspresiju HER2 i hormonske receptore (tj. estrogenske (ER) i/ili progesteronske receptore (PR)).
English: Details of risk minimisation measures that are consistent with the EU Risk Management Plan are presented in (section 4.4) Warnings and Precautions.
Croatian: Pojedinosti o mjerama za smanjenje rizika u skladu s Europskim planom upravljanja rizicima navedene su u dijelu Posebna upozorenja i mjere opreza pri uporabi (dio 4.4).
English: No reactivity or membranous reactivity in < 10 % of tumour cells
Croatian: Nema reaktivnosti ili membranske reaktivnosti u < 10 % tumorskih stanica
English: More patients treated with Herceptin and paclitaxel progressed in the central nervous system than those treated with paclitaxel alone (12.6 % versus 6.5 %; p=0.377).
Croatian: Pojava metastaza u središnjem živčanom sustavu bila je češća u bolesnica liječenih lijekom Herceptin i paklitakselom u odnosu na one liječene samo paklitakselom (12,6 % naspram 6,5 %; p=0,377).
English: Either of which was administered with: - cisplatin - 80 mg/m2 every 3 weeks for 6 cycles on day 1 of each cycle.
Croatian: Bilo koja od navedenih terapija primjenjivana je uz: - cisplatin - 80 mg/m2 svaka 3 tjedna u 6 ciklusa, 1. dan svakog ciklusa.
English: Cmin,ss*
Croatian: N Cmin,ss*
English: If left ventricular ejection fraction (LVEF) percentage drops ≥ 10 points from baseline AND to below
Croatian: Ako postotak ejekcijske frakcije lijeve klijetke (engl. left ventricular ejection fraction, LVEF) padne za ≥ 10 bodova od početne vrijednosti
English: Herceptin subcutaneous formulation is a ready to use solution which should not be mixed or diluted with other products.
Croatian: Herceptin u supkutanoj formulaciji je otopina spremna za primjenu koja se ne smije miješati ni razrjeđivati s drugim lijekovima.
English: Patients were treated with Herceptin until progression of disease.
Croatian: Bolesnice su primale Herceptin sve do progresije bolesti.
English: The results of these simulations indicate that at least 95% of patients will reach concentrations that are <1 μg/mL (approximately 3% of the population predicted Cmin,ss, or about 97%
Croatian: Rezultati tih simulacija pokazuju da će najmanje 95% bolesnika postići koncentracije <1 µg/ml (približno 3% vrijednosti Cmin,ss predviđene za populaciju ili ispiranje od približno 97%) do 7. mjeseca.
English: Congestive heart failure (NYHA Class II - IV) is a common adverse reaction associated with the use of Herceptin and has been associated with a fatal outcome (see section 4.4).
Croatian: Kongestivno zatajenje srca (NYHA klase II - IV), česta je nuspojava kod primjene lijeka Herceptin, ponekad povezana i sa smrtnim ishodom (vidjeti dio 4.4).
English: After reconstitution 1 ml concentrate contains 21 mg of trastuzumab
Croatian: Nakon rekonstitucije 1 ml koncentrata sadrži 21 mg trastuzumaba.
English: If the patient has missed a dose of Herceptin by more than one week, a re-loading dose of Herceptin should be administered over approximately 90 minutes (weekly regimen: 4 mg/kg; three-weekly regimen: 8 mg/kg) as soon as possible.
Croatian: Ako je bolesnik propustio primiti dozu lijeka Herceptin za više od tjedan dana, potrebno je što prije ponoviti udarnu dozu lijeka Herceptin u infuziji trajanja približno 90 minuta (tjedni ciklusi: 4 mg/kg; trotjedni ciklusi: 8 mg/kg).
English: The efficacy results from study BO16348 following 12 months* and 8 years** median follow-up are summarized in the Table 5:
Croatian: Rezultati djelotvornosti dobiveni ispitivanjem BO16348, nakon medijana praćenja od 12 mjeseci* i 8 godina**, sažeti su u Tablici 5:
English: Patients experiencing administration-related symptoms (see section 4.4) should be advised not to drive and use machines until symptoms abate.
Croatian: Bolesnicima u kojih su se razvili simptomi povezani s primjenom lijeka (vidjeti dio 4.4) potrebno je savjetovati da ne upravljaju vozilima niti rukuju strojevima dok se simptomi ne povuku.
English: Your doctor may prescribe Herceptin for the treatment of breast and gastric cancer when:
Croatian: Vaš liječnik Vam može propisati Herceptin za liječenje raka dojke i želuca ako:
English: In this final analysis, extending Herceptin treatment for a duration of two years did not show additional benefit over treatment for 1 year [DFS HR in the intent to treat (ITT) population of 2 years versus 1 year=0.99 (95 % CI: 0.87, 1.13), p-value=0.90 and OS HR=0.98 (0.83, 1.15); p-value= 0.78].
Croatian: U toj završnoj analizi produljenje liječenja lijekom Herceptin na dvije godine nije pokazalo dodatne korisne učinke u odnosu na jednogodišnje liječenje [omjer hazarda za preživljenje bez simptoma bolesti (DFS HR) u populaciji koju se namjeravalo liječiti (ITT) tijekom 2 godine naspram 1 godine = 0,99 (95% CI: 0,87; 1,13), p-vrijednost =0,90 i omjer hazarda za ukupno preživljenje (OS HR) = 0,98 (0,83; 1,15); p-vrijednost= 0,78].
English: Patients with HER2+ tumours were randomised to receive either neoadjuvant chemotherapy concurrently with neoadjuvant-adjuvant Herceptin, or neoadjuvant chemotherapy alone.
Croatian: Bolesnice s HER2+ tumorima randomizirane su da primaju bilo neoadjuvantnu kemoterapiju istodobno s neoadjuvantnim-adjuvantnim lijekom Herceptin ili samo neoadjuvantnu kemoterapiju.
English: More patients experienced at least one grade 3 or 4 adverse event in the 2-year treatment arm (20.4 %) compared with the 1-year treatment arm (16.3 %).
Croatian: Barem jedan štetan događaj stupnja 3 ili 4 pojavio se u više bolesnika u skupini liječenoj tijekom 2 godine (20,4%) u usporedbi sa skupinom liječenom tijekom 1 godine (16,3%).
English: There were no restrictions on the relative timing of Herceptin and anastrozole at administration (for dose, see the SmPC for anastrozole or other aromatase inhibitors).
Croatian: Nije bilo ograničenja vezanih za vrijeme primjene lijeka Herceptin i anastrozola (za dozu vidjeti Sažetak opisa svojstava lijeka za anastrozol ili ostale inhibitore aromataze).
English: 50 %, treatment should be suspended and a repeat LVEF assessment performed within approximately 3 weeks.
Croatian: I TAKOĐER na manje od 50 %, terapiju je potrebno prekinuti i ponoviti procjenu LVEF-a unutar otprilike 3 tjedna.
English: During the treatment course with Herceptin subcutaneous formulation other medicinal products for subcutaneous administration should preferably be injected at different sites.
Croatian: Tijekom ciklusa liječenja lijekom Herceptin u supkutanoj formulaciji druge lijekove za supkutanu primjenu treba po mogućnosti injicirati na druga mjesta.
English: The appropriate amount of solution should be withdrawn from the vial and added to a polyvinylchloride, polyethylene or polypropylene infusion bag containing 250 mL of 0.9 % sodium chloride solution.
Croatian: Odgovarajuću količinu otopine potrebno je izvući iz bočice i dodati u polivinilkloridnu, polietilensku ili polipropilensku infuzijsku vrećicu koja sadržava 250 ml otopine 0,9 %-tnog natrijevog klorida.
English: The appropriate amount of solution should be withdrawn from the vial and added to an infusion bag containing 250 mL of 0.9 % sodium chloride solution.
Croatian: Odgovarajuću količinu otopine potrebno je izvući iz bočice i dodati u infuzijsku vrećicu koja sadrži 250 ml otopine 0,9 %-tnog natrijevog klorida.
English: Polysorbate 20
Croatian: L-metionin polisorbat 20