FrancophonIA/ELRC3.0 huggingface dataset:
English: Prior to the intraperitoneal infusion, pre-medication with analgesic / antipyretic / non-steroidal antiphlogistic medicinal products is recommended (see section 4.4).
Croatian: Prije intraperitonealne primjene preporučuje se premedikacija analgetičkim / antipiretičkim / nesteroidnim antiflogističnim lijekovima (vidjeti dio 4.4).
English: Infection.
Croatian: - Infekcije
English: The results for puncture-free survival and time to first need for therapeutic ascites puncture in terms of medians and hazard ratios are presented in Table 3.
Croatian: Rezultati preživljenja bez punkcije i vremena do prve potrebne terapijske punkcije ascitesa s obzirom na medijane i omjere hazarda prikazani su u Tablici 3.
English: The in vivo anti-tumour activity of catumaxomab was confirmed in an immunologically compromised mouse model of ovarian carcinoma, where tumour development was delayed by an intraperitoneal treatment with catumaxomab and human peripheral blood mononuclear cells.
Croatian: In vivo antitumorska aktivnost katumaksomaba potvrđena je u imunološki kompromitiranom mišjem modelu karcinoma jajnika u kojem je rast tumora odgođen intraperitonealnom primjenom katumaksomaba i ljudskih perifernih mononuklearnih stanica.
English: Patients with hemodynamic insufficiency, oedema or hypoproteinaemia Blood volume, blood protein, blood pressure, pulse and renal function should be assessed before each Removab infusion.
Croatian: Bolesnici s hemodinamskom insuficijencijom, edemom ili hipoproteinemijom Prije svake infuzije Removaba potrebno je procijeniti volumen krvi, proteine u krvi, krvni tlak, puls i funkciju bubrega.
English: The primary efficacy endpoint, puncture-free survival, was a composite endpoint defined as the time to first need for therapeutic ascites puncture or death, whichever occurred first (identical to the pivotal study).
Croatian: Primarni ishod djelotvornosti, preživljenje bez punkcije, bio je složeni ishod definiran kao vrijeme do prve potrebne terapijske punkcije ascitesa ili smrti, što god se prvo dogodilo (identično ključnom ispitivanju).
English: Gastrointestinal reactions like abdominal pain, feeling sick, vomiting and diarrhoea occur in more than 1 in 10 patients (very common), but are mostly mild to moderate and respond well to additional treatment.
Croatian: Probavne reakcije kao što su bolovi u trbuhu, osjećaj mučnine, povraćanje i proljev pojavljuju se u više od 1 na 10 bolesnika (vrlo često), ali su većinom blage do umjerene i uspješno se rješavaju potpornim liječenjem.
English: Effective catumaxomab-mediated killing of tumour cells in vitro was observed for target cells with low and high expression of the EpCAM antigen, independent of the primary tumour type.
Croatian: Učinkovito uništavanje tumorskih stanica posredovano katumaksomabom in vitro zabilježeno je kod ciljnih stanica s niskom i visokom izraženošću EpCAM antigena, neovisno o primarnoj vrsti tumora.
English: - The other ingredients are sodium citrate, citric acid monohydrate, polysorbate 80 and water for injections.
Croatian: - Drugi sastojci su natrijev citrat, citratna kiselina hidrat, polisorbat 80 i voda za injekcije.
English: Abdominal pain was commonly reported as an adverse reaction.
Croatian: Bolovi u trbuhu često su prijavljivani kao nuspojava.
English: Appropriate medical management of ascites drainage is a prerequisite for Removab treatment in order to assure stable circulatory and renal functions.
Croatian: Odgovarajuća evakuacija ascitesa preduvjet je za liječenje Removabom kako bi se osigurala stabilnost cirkulacije i funkcije bubrega.
English: This study compared paracentesis plus catumaxomab versus paracentesis alone (control).
Croatian: U ovom ispitivanju uspoređena je paracenteza uz primjenu katumaksomaba sa samom paracentezom (u kontroloj skupini).
English: Standard therapy or premedication, e.g. analgesic / antipyretic / nonsteroidal antiphlogistic is appropriate to limit the risk.
Croatian: Standardno liječenje ili premedikacija, npr. analgetsko/antipiretsko/nesteroidno antiflogistično primjereno je za ograničavanje rizika.
English: Transient increase in hepatic enzymes was commonly observed after the administration of Removab.
Croatian: Često je zabilježen prolazni porast jetrenih enzima nakon primjene Removaba.
English: Removab must be administered intraperitoneally over an infusion time of at least 3 hours via a constant infusion pump system as described below:
Croatian: Removab se mora primjenjivati u trbušnu šupljinu infuzijom tijekom najmanje 3 sata putem sustava pumpe za kontinuiranu infuziju kao što je opisano u sljedećem tekstu:
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Croatian: • Plan upravljanja rizikom (RMP) Nositelj odobrenja obavljat će dodatne farmakovigilancijske aktivnosti i intervencije detaljno objašnjene u dogovorenom Planu upravljanja rizikom, a koji je opisan u Modulu 1.8.2.
English: The most common serious side effects of Removab are infusion-related side effects and side effects related to the gastrointestinal system (stomach and gut).
Croatian: Najčešće ozbiljne nuspojave Removaba su nuspojave vezane uz infuziju i nuspojave vezane uz probavni sustav (želudac i crijeva).
English: Cytokine release related symptoms with higher intensities In 5.1% of patients pyrexia reached an intensity of CTCAE grade 3 as it was the case with cytokine release syndrome (1.0%), chills (0.8%), nausea (3.4%), vomiting (4.4%), dyspnoea (1.6%) and hypo/hypertension (2.1% / 0.8%).
Croatian: U 5,1% bolesnika pireksija je dosegla je intenzitet CTCAE stupnja 3 kao i sindrom otpuštanja citokina (1,0%), zimica (0,8%), mučnina (3,4%), povraćanje (4,4%), dispneja (1,6%) i hipo/hipertenzija (2,1%/0,8%).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/512/001
Croatian: EU/1/09/512/001
English: • Uncertainty in the knowledge about the rare unfavourable effects since the safety database is still very limited due to the low number of patients treated with Removab.
Croatian: Removab pozitivan, ali vjeruje da je potrebno pozorno pratiti njegov sigurnosni profil zbog sljedećih razloga: • Nedovoljno poznavanje rijetkih nuspojava jer je baza sigurnosnih podataka još uvijek vrlo ograničena zbog malog broja bolesnika koji se liječe Removabom.
English: For information on dilution and administration of Removab please refer to section 6.6 of the Summary of Product Characteristics (SmPC) included in each package of Removab 10 micrograms and Removab 50 micrograms, respectively.
Croatian: Sljedeće informacije namijenjene su samo zdravstvenim djelatnicima: Za informacije o razrjeđivanju i primjeni Removaba molimo vidjeti dio 6.6 Sažetka opisa svojstava lijeka uključenog u svako pakiranje Removaba od 10 mikrograma odnosno Removaba od 50 mikrograma.
English: Sodium Chloride 9 mg/ml (0.9%)
Croatian: Natrijev klorid 9 mg/ml (0,9%)
English: Cytokine release related symptoms
Croatian: Simptomi povezani uz otpuštanje citokina
English: Do not use this medicine after the expiry date which is stated on the carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji iza Rok valjanosti.
English: • The 50 ml syringe is inserted in the infusion pump.
Croatian: • Štrcaljka od 50 ml umetne se u infuzijsku pumpu.
English: Systemic Inflammatory Response Syndrome (SIRS) In 3.8% of the patients symptoms of SIRS were observed within 24 hours after catumaxomab infusion.
Croatian: U 3,8% bolesnika simptomi sindroma sistemskog upalnog odgovora uočeni su unutar 24 sata nakon infuzije katumaksomaba.
English: Table 4 Overall survival of study IP-REM-AC-01 in post study phase Paracentesis + catumaxomab (N=170)
Croatian: Tablica 4 Ukupno preživljenje u ispitivanju IP-REM-AC-01 nakon njegovog završetka Paracenteza + katumaksomab (N=170)
English: Treatment of these patients with Removab should only be considered after a thorough evaluation of benefit / risk (see section 4.4).
Croatian: Liječenje ovih bolesnika Removabom dolazi u obzir samo nakon detaljne procjene koristi/rizika (vidjeti dio 4.4).
English: Gastrointestinal reactions like abdominal pain, nausea, vomiting and diarrhoea are very common and occur mostly with CTCAE grade 1 or 2, but were also observed in higher grades, and respond to adequate symptomatic treatment.
Croatian: Gastrointestinalne reakcije poput boli u trbuhu, mučnine, povraćanja i proljeva su vrlo česte i većinom su stupnja 1 i 2 prema CTCAE, ali također su zabilježeni i viši stupnjevi, a povlače se na simptomatsko liječenje.
English: As release of pro-inflammatory and cytotoxic cytokines is initiated by the binding of catumaxomab to immune and tumour cells, cytokine release related clinical symptoms such as fever, nausea, vomiting and chills have been very commonly reported during and after the Removab administration (see section 4.8).
Croatian: S obzirom da otpuštanje proupalnih i citotoksičnih citokina započinje vezanjem katumaksomaba na imunološke i tumorske stanice, simptomi vezani uz otpuštanje citokina kao što su vrućica, mučnina, povraćanje i zimica su vrlo često prijavljivani tijekom i nakon primjene Removaba (vidjeti dio 4.8).
English: Cytokine release syndrome*, hypersensitivity*.
Croatian: Sindrom otpuštanja citokina*, hipersenzitivnost*
English: Pharmacokinetics of catumaxomab during and after four intraperitoneal infusions of 10, 20, 50 and 150 micrograms catumaxomab were investigated in 13 patients with symptomatic malignant ascites due to EpCAM-positive carcinomas.
Croatian: Farmakokinetika katumaksomaba tijekom i nakon četiri infuzije intraperitonealne primijenjene od 10, 20, 50 i 150 mikrograma katumaksomaba ispitivana je u 13 bolesnika sa simptomatskim malignim ascitesom zbog EpCAM pozitivnog karcinoma.
English: Thereby, a concerted immunoreaction against tumour cells is induced which includes different mechanisms of action such as T-cell activation, antibody-dependent cell-mediated cytotoxicity (ADCC), complement-dependent cytotoxicity (CDC) and phagocytosis.
Croatian: Tako se potiče zajednička imunološka reakcija protiv tumorskih stanica koja uključuje različite mehanizme djelovanja kao što su aktivacija T-stanica, stanično posredovana citotoksičnost ovisna o protutijelima, citotoksičnost ovisna o komplementu i fagocitoza.
English: Cytokine-release related reactions: SIRS a potentially life-threatening combination of tachycardia, fever and/or dyspnoea, can develop within 24 hours after a catumaxomab infusion and resolves under symptomatic treatment.
Croatian: Reakcije vezane uz otpuštanje citokina: sindrom sistemskog upalnog odgovora, kombinacija tahikardije, vrućice i/ili dispneje potencijalno opasna po život, može se razviti unutar 24 sata nakon infuzije katumaksomaba i smiruje se simptomatskim liječenjem.
English: Dyspnoea*, pleural effusion*, cough.
Croatian: Dispneja*, pleuralni izljev*, kašalj
English: The diluted Removab solution for infusion is administered intraperitoneally as constant rate infusion using an adequate pump system.
Croatian: Razrijeđena infuzijska otopina Removaba primjenjuje se intraperitonealno konstantnom brzinom infuzije pomoću prikladne infuzijske pumpe.
English: Table 6 Overall survival of study IP-CAT-AC-03 in post study phase Catumaxomab (N=108)
Croatian: Tablica 6 Ukupno preživljenje u ispitivanju IP-CAT-AC-03 nakon njegovog završetka Katumaksomab (N=108)
English: A solid performance status expressed as Body Mass Index (BMI) > 17 (to be assessed after drainage of ascites fluid) and Karnofsky Index > 60 is required prior to Removab therapy.
Croatian: Za primjenu infuzije Removaba potrebno je solidno funkcionalno stanje karakterizirano indeksom tjelesne mase (ITM) > 17 (treba ocijeniti nakon evakuacije ascitesa) i Karnofsky indeksom > 60.
English: Treatment of these patients with Removab should only be considered after a thorough evaluation of benefit / risk.
Croatian: Liječenje ovih bolesnika Removabom dolazi u obzir samo nakon detaljne procjene koristi/rizika.
English: Table 5 Efficacy results (puncture-free survival and time to first need for therapeutic ascites puncture) of study IP-CAT-AC-03
Croatian: Tablica 5 Rezultati djelotvornosti (preživljenje bez punkcije i vrijeme do prve potrebne terapijske punkcije ascitesa) ispitivanja IP-CAT-AC-03
English: Based upon the data that have become available since the granting of the initial Marketing Authorisation, the CHMP considers that the benefit-risk balance of Removab remains positive, but considers that its safety profile is to be closely monitored for the following reasons:
Croatian: Temeljem podataka koji su postali dostupni od davanja prvog odobrenja za stavljanje gotovog lijeka u promet, Povjerenstvo za humane lijekove (CHMP) i dalje smatra da je odnos koristi i rizika lijeka
English: 95% CI for median (days) p-value (log-rank test)
Croatian: 95% CI za medijan (dani) p-vrijednost (log-rank test)
English: Description of selected adverse reactions
Croatian: “Opis odabranih nuspojava” Opis odabranih nuspojava
English: • The 50 ml syringe is closed with a cap and shaken gently to mix the solution.
Croatian: • Štrcaljka od 50 ml se zatvori zatvaračem i nježno protrese kako bi se otopina promiješala.
English: Figure 1 Kaplan-Meier estimates of time to first need for therapeutic ascites puncture of study IP-REM-AC-01
Croatian: Slika 1 Kaplan-Meierova procjena vremena do prve potrebne terapijske punkcije ascitesa u ispitivanju IP-REM-AC-01
English: Removab is given as 4 intraperitoneal infusions with increasing dose (10, 20, 50 and 150 micrograms), separated at least by 2 infusion-free calendar days (for example you will receive infusion on day 0, 3, 7, 10).
Croatian: Removab se primjenjuje u obliku 4 infuzije u trbušnu šupljinu s postupnim povećanjem doze (10, 20, 50 ili 150 mikrograma), a između svake infuzije moraju proći najmanje 2 kalendarska dana bez infuzije (na primjer, primit ćete infuziju na dan 0, 3, 7, 10).
English: • When the 50 ml syringe containing the diluted Removab solution for infusion is empty it is replaced with a 50 ml syringe containing 20 ml sodium chloride 9 mg/ml (0.9%) solution for injection until the end of the scheduled infusion time to clear the dead volume in the perfusion lead (approximately 2 ml) under unchanged conditions.
Croatian: • Kada je štrcaljka od 50 ml koja sadrži razrijeđenu Removab otopinu za infuziju prazna, zamijeni se štrcaljkom od 50 ml koja sadrži 20 ml 9 mg/ ml (0,9%) otopine natrijevog klorida za injekciju do kraja predviđenog vremena za infuziju kako bi se uklonio mrtvi volumen u perfuzijskoj cijevi (približno 2 ml) pod nepromijenjenim uvjetima.
English: • The perfusion tubing is connected to the Y-connection.
Croatian: • Perfuzijske cijevi spoje se u Y spoj.
English: An increased frequency of some adverse reactions was seen in relation to 3h administration including chills and hypotension (grades 1 / 2), diarrhoea (all grades) and fatigue (grade 1 / 2).
Croatian: Povećana učestalost nekih nuspojava uočena je pri trajanju infuzije od 3 sata uključujući zimicu i hipotenziju (stupnjevi 1/2), proljev (svi stupnjevi) i umor (stupnjevi 1/2).
English: You will be given Removab under the supervision of a doctor experienced in treating cancer.
Croatian: Removab će Vam primijeniti liječnik iskusan u liječenju raka.
English: This confirmatory two-arm, randomized, open label, phase IIIb study in 219 epithelial cancer patients with symptomatic malignant ascites requiring therapeutic ascites puncture investigated treatment with catumaxomab plus 25 mg prednisolone premedication vs. catumaxomab alone.
Croatian: Ovo potvrdno, randomizirano, otvoreno ispitivanje u fazi IIIb s dvije skupine ispitanika, na 219 bolesnika s epitelnim rakom i simptomatskim malignim ascitesom koji zahtijeva punkciju i evakuaciju ascitesa, uspoređivalo je liječenje katumaksomabom uz 25 mg prednizolona u premedikaciji naspram liječenja samim katumaksomabom.
English: Kaplan Meier estimates for time to first need for therapeutic ascites puncture are given in Figure 1.
Croatian: Kaplan-Meierova procjena vremena do prve potrebne terapijske punkcije ascitesa prikazana je na Slici 1.
English: WARNING TEXT FOR PEELABLE STICKER TO BE ATTACHED TO 50ml SYRINGE CONTAINING THE DILUTED REMOVAB SOLUTION FOR INFUSION
Croatian: TEKST UPOZORENJA ZA NALJEPNICU KOJU TREBA PRIČVRSTITI NA ŠTRCALJKU OD 50 ml KOJA SADRŽI RAZRIJEĐENU
English: • The 50 ml syringe containing the diluted Removab solution for infusion is installed in the precision pump.
Croatian: • Štrcaljka od 50 ml koja sadrži razrijeđenu Removab otopinu za infuziju namjesti se na preciznu pumpu.
English: Time to first need for therapeutic ascites puncture Median time to first need for therapeutic ascites puncture (days) 95% CI for median (days) p-value (log-rank test)
Croatian: Medijan vremena do prve potrebne terapijske punkcije ascitesa (dani) 95% CI za medijan (dani) p-vrijednost (log-rank test)
English: The patients remained ADA positive during treatment phase and follow-up.
Croatian: Bolesnici su ostali pozitivni na adenozin deaminazu tijekom liječenja i praćenja.
English: • The connected perfusion tubing equipment of the precision pump is prefilled with the diluted Removab solution for infusion.
Croatian: • Oprema perfuzijskih cijevi spojena s preciznom pumpom prethodno se napuni razrijeđenom Removab otopinom za infuziju.
English: LIST OF EXCIPIENTS Sodium citrate, citric acid monohydrate, polysorbate 80, water for injections
Croatian: natrijev citrat, citratna kiselina hidrat, polisorbat 80, voda za injekcije
English: Other cytokine-release related reactions such as fever, chills, nausea, and vomiting are very commonly reported reactions in intensity of CTCAE grade 1 and 2 (US National Cancer Institute, version 4.0).
Croatian: Ostale reakcije vezane uz otpuštanje citokina kao što su vrućica, zimica, mučnina i povraćanje 1. i 2. stupnja, prema CTCAE (američkog Nacionalnog instituta za rak, verziji 4.0) prijavljivane su vrlo često.
English: 4th infusion 150 micrograms
Croatian: 4. infuzija 150 mikrograma
English: Table 1 Adverse reactions reported from patients receiving catumaxomab treatment Infections and infestations
Croatian: Tablica 1 Nuspojave u bolesnika koji su primali liječenje katumaksomabom
English: 2nd infusion 20 micrograms
Croatian: 2. infuzija 20 mikrograma
English: The following components must be used for the dilution and administration of Removab as Removab is only compatible with:
Croatian: Sljedeće komponente moraju se koristiti za razrjeđivanje i primjenu Removaba jer je Removab kompatibilan samo s: • polipropilenskim štrcaljkama od 50 ml
English: Due to catumaxomab's binding properties, tumour cells, T-cells and accessory immune cells come in close proximity.
Croatian: Zbog sposobnosti vezivanja katumaksomaba, tumorske stanice, T-stanice i druge imunološke stanice približavaju se jedne drugima.
English: • Parallel to each Removab application 250 ml sodium chloride 9 mg/ml (0.9%) solution for injection are infused via an infusion valve / Y connection in the perfusion lead of the catheter.
Croatian: • Paralelno sa svakom primjenom Removaba primjenjuje se 250 ml 9 mg/ml (0,9%) otopine natrijevog klorida za injekciju putem infuzijskog ventila/Y spoja u perfuzijskoj cijevi katetera.
English: 20 micrograms on day 3
Croatian: 2. doza 20 mikrograma 3. dan
English: Removab has to be administered as constant rate intraperitoneal infusion with an infusion time of at least 3 hours.
Croatian: Removab je potrebno primjenjivati u obliku intraperitonealne infuzije konstantne brzine, u trajanju od najmanje 3 sata.
English: Table 3 Efficacy results (puncture-free survival and time to first need for therapeutic ascites puncture) of study IP-REM-AC-01
Croatian: Tablica 3 Rezultati djelotvornosti (preživljenje bez punkcije i vrijeme do prve potrebne terapijske punkcije ascitesa) ispitivanja IP-REM-AC-01
English: This is a precautionary measure to ensure that Removab is infused only via the intraperitoneal route of administration.
Croatian: Ovo je mjera opreza kako bi se osiguralo da se Removab primjeni isključivo u trbušnu šupljinu.
English: Any air bubble(s) from the 50 ml syringe is eliminated.
Croatian: Uklanjaju se svi mjehurići zraka iz štrcaljke od 50 ml.
English: • Based on the dose, the appropriate amount of sodium chloride 9 mg/ml (0.9%) solution for injection is extracted with a 50 ml syringe (Table 7).
Croatian: • S obzirom na dozu, potrebna količina 9 mg/ml (0,9%) otopine natrijevog klorida za injekciju izvlači se štrcaljkom od 50 ml (Tablica 7).
English: Puncture free survival
Croatian: Preživljenje bez punkcije
English: Side effects related to the gastrointestinal system
Croatian: Nuspojave vezane uz probavni sustav
English: 1st infusion 10 micrograms
Croatian: 1. infuzija 10 mikrograma
English: Uncommon Skin reaction*, dermatitis allergic*.
Croatian: - Kožna reakcija, teška alergijska kožna reakcija (dermatitis)
English: The catheter is used for ascites drainage and infusion of diluted Removab and sodium chloride 9 mg/ml (0.9%) solution for injection.
Croatian: Kateter se koristi za drenažu ascitesa i infuziju razrijeđenog Removaba i 9 mg/ml (0,9%) otopine natrijevog klorida za injekciju.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use.
Croatian: NAČIN I PUT(EVI) PRIMJENE Prije uporabe pročitajte Uputu o lijeku.
English: Removab must not be administered by intraperitoneal bolus or by any other route of administration.
Croatian: Removab se ne smije primjenjivati intraperitonealno u obliku bolusa ili nekim drugim putem primjene.
English: Catumaxomab (N=108)
Croatian: Katumaksomab (N=108)
English: 0.1 ml concentrate for solution for infusion in a pre-filled syringe (type I glass, siliconised) with plunger stopper (bromobutyl rubber) and luer lock system (polypropylene siliconised and polycarbonate) with tip cap (styrene butadiene rubber) with a cannula; pack size of 1.
Croatian: 0,1 ml koncentrata za otopinu za infuziju u napunjenoj štrcaljki (staklo tip I, silikonizirano) s čepom klipa (bromobutil guma) i luer lock sustavom (silikonizirani polipropilen i polikarbonat) sa zatvaračem vrha (stiren butadien guma) s cjevčicom; veličina pakiranja: 1. 6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom
English: The remaining sodium chloride 9 mg/ml (0.9%) solution for injection can be discarded.
Croatian: Preostala 9 mg/ml (0,9%) otopina natrijevog klorida za injekciju može se baciti.
English: Patients with hepatic impairment of a higher severity grade than moderate and / or with more than 70% of the liver metastasised and / or portal vein thrombosis / obstruction have not been investigated.
Croatian: U ispitivanja nisu uključivani bolesnici s oštećenjem funkcije jetre većeg stupnja od umjerenog i/ili s više od 70% tkiva jetre zauzetog metastazama i/ili trombozom/opstrukcijom portalne vene.
English: • The entire content of the syringe (Removab concentrate plus air buffer) is injected from the pre-filled syringe directly into the sodium chloride 9 mg/ml (0.9%) solution for injection.
Croatian: • Cijeli se sadržaj štrcaljke (Removab koncentrat zajedno s jastučićem zraka) ubrizga iz napunjene štrcaljke izravno u 9 mg/ml (0,9%) otopinu natrijevog klorida za injekciju.
English: 0.5 ml concentrate for solution for infusion in a pre-filled syringe (type I glass, siliconised) with plunger stopper (bromobutyl rubber) and luer lock system (polypropylene siliconised and polycarbonate) with tip cap (styrene butadiene rubber) with a cannula; pack size of 1.
Croatian: 0,5 ml koncentrata za otopinu za infuziju u napunjenoj štrcaljki (staklo tip I, silikonizirano) s čepom klipa (bromobutil guma) i luer lock sustavom (silikonizirani polipropilen i polikarbonat) sa zatvaračem vrha (stiren butadien guma) s cjevčicom; veličina pakiranja: 1. 6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom
English: Diluted Removab.
Croatian: (Dio vanjskog pakiranja) Razrijeđeni Removab.
English: In Table 1, adverse reactions are listed by organ class.
Croatian: U Tablici 1 nuspojave su navedene po organskim sustavima.
English: Dyspnoea and hypo-/ hypertension are commonly observed.
Croatian: Dispneja te hipo/hipertenzija bili su česti.