FrancophonIA/ELRC3.0 huggingface dataset:
English: Infusion-related side effects and abdominal pain are very common (see section 4).
Slovenian: Z infundiranjem povezani neželeni učinki in bolečine v trebuhu so zelo pogosti (glejte poglavje 4).
English: Catumaxomab was applied in patients where standard therapy was not available or no longer feasible and who had a Karnofsky performance status of at least 60.
Slovenian: Katumaksomab so dajali bolnikom, za katere standardne terapije ni bilo na voljo ali več ni bila smiselna, in katerih status telesne zmogljivosti izražen po Karnofskem je bil vsaj 60.
English: Fertility No data on the effect of catumaxomab on fertility are available.
Slovenian: Podatkov o učinkih katumaksomaba na plodnost ni.
English: The geometric mean plasma Cmax was approximately 0.5 ng/ml (range 0 to 2.3), and the geometric mean plasma AUC was approximately 1.7 day* ng/ml (range < LLOQ (lower limit of quantification) to 13.5).
Slovenian: Geometrično povprečje Cmax v plazmi je bilo približno 0,5 ng/ml (razpon 0 do 2,3) in geometrično povprečje AUC v plazmi je bilo približno 1,7 dan*ng/ml (razpon < LLOQ (spodnja meja kvantifikacije) do 13,5).
English: • polycarbonate infusion valves / Y connections
Slovenian: • polikarbonatnimi infuzijskimi ventili/Y-spoji
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/.
English: Paediatric population There is no relevant use of Removab in the paediatric population in the granted indication.
Slovenian: Zdravilo Removab ni primerno za uporabo pri pediatrični populaciji za odobreno indikacijo.
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%).
Slovenian: Pri 5,1 % bolnikov je pireksija dosegla intenzivnost 3. stopnje po CTCAE, prav tako kot pri sindromu sproščanja citokina (1,0 %), mrzlici (0,8 %), navzei (3,4 %), bruhanju (4,4 %), dispneji (1,6 %) in hipotenziji/hipertenziji (2,1 % / 0,8 %).
English: It is recommended that the catheter remains in the abdominal cavity during the entire treatment period.
Slovenian: Priporoča se, da ostane kateter v trebušni votlini ves čas zdravljenja.
English: This study compared paracentesis plus catumaxomab versus paracentesis alone (control).
Slovenian: V tej študiji so primerjali paracentezo in katumaksomab s samo paracentezo (kontrolna skupina).
English: Patients receiving a higher than recommended dose of catumaxomab experienced more severe (grade 3) adverse reactions.
Slovenian: Bolniki, ki so prejeli odmerek katumaksomaba, ki je bil višji od priporočenega, so imeli hujše neželene učinke (3. stopnje).
English: Prior to each Removab administration the ascites fluid must be drained until stop of spontaneous flow or symptom relief (see section 4.4).
Slovenian: Pred vsakim dajanjem zdravila Removab je potrebna drenaža tekočine iz ascitesa dokler ne preneha spontano teči ali do ublažitve simptomov (glejte poglavje 4.4).
English: The most common infusion-related side effects, which are mostly mild to moderate, are fever, chills, feeling sick and vomiting.
Slovenian: Najpogostejši z infundiranjem povezani neželeni učinki, ki so večinoma blagi do zmerni, so zvišana telesna temperatura, mrzlica, občutek slabosti in bruhanje.
English: Do not freeze.
Slovenian: Ne zamrzujte!
English: Intraperitoneal use only.
Slovenian: Samo za intraperitonealno uporabo.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.You should not use Removab if you are pregnant unless clearly necessary.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte s svojim zdravnikom, preden vzamete to zdravilo.
English: Patients who developed HAMAs 8 days after catumaxomab treatment showed better clinical outcome, as measured by puncture-free survival, time to next puncture and overall survival, compared with HAMA-negative patients.
Slovenian: Pri bolnikih, pri katerih so se razvila protitelesa HAMA 8 dni po zdravljenju s katumaksomabom, je bil klinični izid boljši v smislu meritev preživetja brez punktiranja, časa do naslednjega punktiranja in celokupnega preživetja, v primerjavi z bolniki, negativnimi na protitelesa HAMA.
English: The efficacy of the treatment with paracentesis and catumaxomab in patients with malignant ascites due to EpCAM-positive carcinomas was statistically significantly superior to that with paracentesis alone in terms of puncture-free survival and time to first need for therapeutic ascites puncture.
Slovenian: Učinkovitost zdravljenja s paracentezo in katumaksomabom pri bolnikih z malignim ascitesom zaradi karcinomov, pozitivnih na EpCAM, je bila statistično značilno boljša od zdravljenja samo s paracentezo v smislu preživetja brez punktiranja in časa do potrebe za terapevtskim punktiranjem ascitesa.
English: Cholangitis*, hyperbilirubinaemia.
Slovenian: Holangitis*, hiperbilirubinemija
English: It is unknown whether catumaxomab/metabolites are excreted in human milk.
Slovenian: Ni znano, ali se katumaksomab/presnovki izločajo v materino mleko.
English: Decreased appetite* / anorexia, dehydration*, hypokalaemia, hypoalbuminaemia, hyponatraemia*, hypocalcaemia*, hypoproteinaemia.
Slovenian: Zmanjšanje apetita* / anoreksija, dehidracija*, hipokaliemija, hipoalbuminemija, hiponatriemija*, hipokalciemija*, hipoproteinemija
English: Removab is used to treat malignant ascites, when standard treatment is not available or no longer feasible.
Slovenian: Zdravilo Removab se uporablja za zdravljenje malignega ascitesa, ko standardnega zdravljenja ni na voljo ali ni več smiselno.
English: Removab must be administered as an intraperitoneal infusion only.
Slovenian: Zdravilo Removab se mora dajati le kot intraperitonealna infuzija.
English: Altogether 45 out of 88 (51%) patients in the control arm crossed-over to achieve active treatment with catumaxomab.
Slovenian: Skupaj je prešlo na aktivno zdravljenje s katumaksomabom 45 od 88 (51 %) bolnikov iz kontrolne skupine.
English: Catumaxomab is a trifunctional rat-mouse hybrid monoclonal antibody that is specifically directed against the epithelial cell adhesion molecule (EpCAM) and the CD3 antigen.
Slovenian: Katumaksomab je trifunkcionalno monoklonsko protitelo hibrida podgane-miši, specifično usmerjeno proti adhezijski molekuli epitelijske celice (EpCAM) in antigenu CD3.
English: Due to catumaxomab's binding properties, tumour cells, T-cells and accessory immune cells come in close proximity.
Slovenian: Zaradi katumaksomabove sposobnosti vezave se celice tumorja, T-celice in dodatne imunske celice zelo približajo.
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.
Slovenian: In vivo dejavnost katumaksomaba proti tumorjem je bila potrjena na imunološko okrnjenem mišjem modelu raka jajčnikov, pri katerem je razvoj tumorja upočasnilo intraperitonealno zdravljenje s katumaksomabom in humanimi mononuklearnimi celicami periferne krvi.
English: Removab is not recommended during pregnancy and in women of childbearing potential not using contraception.
Slovenian: Zdravila Removab ne uporabljajte pri nosečnicah in pri ženskah v rodni dobi, ki ne uporabljajo učinkovite kontracepcije.
English: oedema peripheral*, general physical health deterioration*, chest pain, influenza-like illness, malaise*, catheter site erythema.
Slovenian: vključno s perifernim edemom*, splošno poslabšanje fizičnega zdravja*, bolečine v prsih, gripi podobna bolezen, slabo počutje*, eritem na mestu katetra
English: In this study, the primary efficacy endpoint was puncture-free survival, which was a composite endpoint defined as the time to first need for therapeutic ascites puncture or death, whichever occurred first.
Slovenian: V tej študiji je bila končna točka primarna učinkovitost preživetje brez punktiranja, ki je sestavljena končna točka, opredeljena kot čas do prve potrebe po terapevtskem punktiranju ascitesa ali smrti, kar je prej.
English: - If you have any further questions, ask your doctor or nurse.
Slovenian: - Če imate dodatna vprašanja, se posvetujte s svojim zdravnikom ali medicinsko sestro.
English: The induction of human anti-murine (rat and / or mouse) antibodies (HAMAs/HARAs) is an intrinsic effect of murine monoclonal antibodies.
Slovenian: Indukcija humanih protiteles proti glodavcem (podganam in/ali mišim) (HAMA/HARA) je učinek, lasten mišjim monoklonskim protitelesom.
English: An interval of at least two infusion free calendar days must elapse between infusion days.
Slovenian: Med dnevi infundiranja mora preteči interval vsaj dveh koledarskih dni brez infundiranja.
English: If you experience side effects such as dizziness or chills during or after administration, you should not drive or use machines until they disappear.
Slovenian: V primeru, da se med uporabo ali po njej pojavijo neželeni učinki, kot so omotičnost ali mrzlice, ne smete voziti ali uporabljati orodja ali strojev, dokler ne izzvenijo.
English: Catumaxomab was detectable in the ascites fluid and in plasma.
Slovenian: Katumaksomab je bil zaznaven v ascitesu in v plazmi.
English: The anti-tumour activity of catumaxomab has been demonstrated in vitro and in vivo.
Slovenian: Delovanje katumaksomaba proti tumorjem je bilo dokazano in vitro in in vivo.
English: Appropriate medical management of ascites drainage is a prerequisite for Removab treatment in order to assure stable circulatory and renal functions.
Slovenian: Predpogoj za zdravljenje z zdravilom Removab je ustrezna zdravstvena oskrba drenaže ascitesa, da se zagotovi stabilno delovanje obtočil in ledvic.
English: Prior to the intraperitoneal infusion, pre-medication with analgesic / antipyretic / non-steroidal antiphlogistic medicinal products is recommended (see section 4.4).
Slovenian: Pred intraperitonealnim infundiranjem se priporoča premedikacija z analgetiki/antipiretiki/nesteroidnimi antiflogistiki (glejte poglavje 4.4).
English: • 50 ml polypropylene syringes
Slovenian: • 50 ml polipropilenskimi brizgami
English: In three patients (0.4%) an intensity of CTCAE grade 4 was observed.
Slovenian: Pri treh bolnikih (0,4 %) so opazili CTCAE 4. stopnje.
English: There are no or limited amount of data from the use of catumaxomab in pregnant women.
Slovenian: Podatkov o uporabi katumaksomaba pri nosečnicah ni oziroma so omejeni.
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.
Slovenian: Bolniki s hemodinamsko insuficienco, edemom ali hipoproteinemijo Pred vsakim infundiranjem zdravila Removab je treba oceniti volumen krvi, beljakovine v krvi, krvni tlak, pulz in delovanje ledvic.
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.
Slovenian: Za informacije o redčenju in dajanju zdravila Removab glejte poglavje 6.6 Povzetka glavnih značilnosti zdravila (SmPC), ki je v vsakem pakiranju zdravila Removab 10 mikrogramov in zdravila Removab 50 mikrogramov.
English: Other or additional standard pre-medication with analgesic / antipyretic / nonsteroidal antiphlogistic medicinal products is recommended.
Slovenian: Priporoča se druga ali dodatna standardna premedikacija z analgetiki/antipiretiki/nesteroidnimi antiflogistiki.
English: Systemic Inflammatory Response Syndrome (SIRS), which may also occur commonly due to the mechanism of action of catumaxomab, develops, in general, within 24 hours after Removab infusion, showing symptoms of fever, tachycardia, tachypnoea and leucocytosis (see section 4.8).
Slovenian: Tudi sindrom sistemskega vnetnega odziva (SIRS - Systemic Inflammatory Response Syndrome), ki se lahko pogosto razvije zaradi mehanizma delovanja katumaksomaba, se običajno razvije v 24 urah po infundiranju zdravila Removab s simptomi zvišane telesne temperature, tahikardije, tahipneje in levkocitoze (glejte poglavje 4.8).
English: In the clinical studies in patients with malignant ascites, 1,000 mg paracetamol intravenously was routinely administered prior to Removab infusion for pain and pyrexia control.
Slovenian: V kliničnih študijah pri bolniki z malignim ascitesom so bolnikom pred uvedbo infundiranja zdravila Removab rutinsko invtravensko dali 1.000 mg paracetamola proti bolečini in za nadzor pireksije.
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.
Slovenian: Učinkovito smrt celic tumorja in vitro, ki jo posreduje katumaksomab, so opazili pri tarčnih celicah z malo in zelo izraženim antigenom EpCAM, neodvisno od primarne vrste tumorja.
English: Paracentesis + catumaxomab (N=170)
Slovenian: Paracenteza + katumaksomab (N = 170)
English: • polyethylene perfusion tubings with an inner diameter of 1 mm and a length of 150 cm
Slovenian: • polietilenskimi perfuzijskimi cevkami z notranjim premerom 1 mm in dolžino 150 cm
English: How to use Removab
Slovenian: Kako uporabljati zdravilo Removab
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.
Slovenian: • Ko je 50 ml injekcijska brizga, ki vsebuje razredčeno zdravilo Removab raztopino za infundiranje prazna, se nadomesti s 50 ml injekcijsko brizgo, ki vsebuje 20 ml raztopine natrijevega klorida 9 mg/ml (0,9 %) do konca načrtovanega časa infundiranja, da očistite mrtvi volumen v perfuzijskem vodu (približno 2 ml) pod nespremenjenimi pogoji.
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.
Slovenian: Gastrointestinalne reakcije, kot so bolečina v trebuhu, navzea, bruhanje in driska so zelo pogoste in se običajno pojavijo s 1. ali 2. stopnjo po CTCAE, pri čemer so opazili tudi reakcije višje stopnje, in se odzivajo na ustrezno simptomatsko zdravljenje.
English: Treatment of these patients with Removab should only be considered after a thorough evaluation of benefit / risk (see section 4.4).
Slovenian: Pred zdravljenjem teh bolnikov z zdravilom Removab je treba izčrpno analizirati razmerje med možnimi koristmi in možnimi tveganji (glejte poglavje 4.4).
English: As secondary efficacy endpoint overall survival (Table 6) was assessed.
Slovenian: Kot sekundarni opazovani dogodek so ocenili celokupno preživetje (Preglednica 6).
English: You are required to have a BMI above 17 (after drainage of the ascites fluid) and a Karnofsky Index above 60 to use this medicine.
Slovenian: Za uporabo tega zdravila mora biti vaš BMI nad 17 (po drenaži ascitesa) in indeks po Karnofskem nad 60.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/512/002
Slovenian: EU/1/09/512/002
English: Treatment of these patients with Removab should only be considered after a thorough evaluation of benefit / risk.
Slovenian: Pred zdravljenjem teh bolnikov z zdravilom Removab je treba izčrpno analizirati razmerje med možnimi koristmi in možnimi tveganji.
English: Removab must be administered under the supervision of a physician experienced in the use of anti-neoplastic medicinal products.
Slovenian: Zdravilo Removab se mora aplicirati pod nadzorom zdravnika, ki ima izkušnje z uporabo antineoplastičnih zdravil.
English: Figure 2 Illustration of the transfer of Removab from the pre-filled syringe to the 50 ml syringe
Slovenian: Slika 2 Slika prenosa zdravila Removab iz napolnjene injekcijske brizge v 50 ml brizgo
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).
Slovenian: Primarni opazovani dogodek učinkovitosti, preživetje brez punktiranja, je bil sestavljeni opazovani dogodek, opredeljen kot čas do prve potrebe po terapevtskem punktiranju ascitesa ali smrti, kar koli je nastopilo prej (identično s ključno študijo).
English: • An additional air buffer of at least 3 ml is included in the 50 ml syringe.
Slovenian: • 50 ml brizga vključuje vsaj dodatne 3 ml zračnega pufra.
English: Hypersensitivity to murine (rat and / or mouse) proteins.
Slovenian: Preobčutljivost za beljakovine glodavcev (podgan in/ali miši).
English: This is a precautionary measure to ensure that Removab is infused only via the intraperitoneal route of administration.
Slovenian: To je previdnostni ukrep, s katerim se zagotovi, da se zdravilo Removab infundira samo v obliki intraperitonealne infuzije.
English: Removab must be administered intraperitoneally over an infusion time of at least 3 hours via a constant infusion pump system as described below:
Slovenian: Zdravilo Removab se daje intraperitonealno v obliki vsaj 3-urne infuzije s sistemom stalne črpalke za infundiranje, kot je opisano spodaj:
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).
Slovenian: Najpogostejši resni neželeni učinki zdravila Removab so z infundiranjem povezani neželeni učinki in neželeni učinki, povezani s prebavili (želodec ali črevo).
English: • The catheter is kept closed until the next infusion.
Slovenian: • Do naslednje infuzije mora biti kateter zaprt.
English: Sodium Chloride 9 mg/ml (0.9%)
Slovenian: Natrijev klorid 9 mg/ml (0,9 %)
English: Uncommon Convulsion*.
Slovenian: Konvulzije*.
English: Anxiety, insomnia.
Slovenian: Anksioznost, nespečnost
English: Special populations No studies have been conducted.
Slovenian: Posebne skupine bolnikov Študij niso izvajali.
English: - The other ingredients are sodium citrate, citric acid monohydrate, polysorbate 80 and water for injections.
Slovenian: - Druge sestavine zdravila so natrijev citrat, citronska kislina monohidrat, polisorbat 80 in voda za injekcije.
English: Table 4 Overall survival of study IP-REM-AC-01 in post study phase Paracentesis + catumaxomab (N=170)
Slovenian: Preglednica 4 Celokupno preživetje študije IP-REM-AC-01 v fazi po študiji Paracenteza + katumaksomab (N = 170)
English: Back pain, myalgia, arthralgia.
Slovenian: Bolečine hrbta, mialgija, artralgija
English: Infection.
Slovenian: Okužba
English: Diluted Removab.
Slovenian: Razredčeno zdravilo Removab.
English: 95% CI for median (days) p-value (log-rank test)
Slovenian: 95 % IZ za mediano (dni) Vrednost p (test log-rank)
English: Pooled population (N=219)
Slovenian: Obe skupini bolnikov (N = 219)
English: Proteinuria.
Slovenian: Proteinurija
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.
Slovenian: Reakcije, povezane s sproščanjem citokina: sindrom sistemskega vnetnega odziva (SIRS - Systemic Inflammatory Response Syndrome), potencialno življenje ogrožajoča kombinacija tahikardije, zvišane telesne temperature in/ali dispneje, se lahko razvije v roku 24 ur od infundiranja katumaksomaba in izzveni s simptomatskim zdravljenjem.
English: Ascites drainage
Slovenian: Drenaža ascitesa
English: A third functional binding site in the Fc-region of catumaxomab enables interaction with accessory immune cells via Fcγ receptors.
Slovenian: Tretja površina funkcionalne vezave na območju Fc katumaksomaba omogoča medsebojno delovanje z dodatnimi imunskimi celicami prek receptorjev
English: After the Removab infusion you will be observed as decided by your doctor.
Slovenian: Po infundiranju zdravila Removab se bo zdravnik odločil o načinu, na katerega bodo vaše stanje spremljali.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/512/001
Slovenian: EU/1/09/512/001
English: Catumaxomab + prednisolone (N=111)
Slovenian: Katumaksomab + prednizolon (N = 111)
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).
Slovenian: Opazili so povečano pogostnost nekaterih neželenih učinkov pri 3-urnem dajanju, vključno z mrzlicami in hipotenzijo (stopnje 1 / 2), drisko (vseh stopenj) in utrujenostjo (stopnje 1 / 2).
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.
Slovenian: Pri bolnikih z okvaro delovanja jeter, ki presega zmerno, in/ali pri katerih je vsaj 70 % jeter metastaziranih in/ali s trombozo/obstrukcijo vene porte, raziskav niso opravili.
English: • The connected perfusion tubing equipment of the precision pump is prefilled with the diluted Removab solution for infusion.
Slovenian: • Povezana oprema s perfuzijsko cevko natančne črpalke je napolnjena z razredčeno raztopino zdravila Removab za infundiranje.
English: *rat-mouse hybrid IgG2 monoclonal antibody produced in a rat-mouse hybrid-hybridoma cell line For the full list of excipients, see section 6.1.
Slovenian: *monoklonsko protitelo hibrida podgane-miši IgG2, proizvedeno v celični liniji hibrid-hibridoma podgane-miši
English: 3 Perfusion Tubing (1 mm inner diameter, 150 cm length) 5 Perfusion Lead
Slovenian: infundiranje 3 Perfuzijska cev (1 mm notranji premer, 150 cm dolžine) 4 Infuzijski ventil
English: WARNING TEXT FOR PEELABLE STICKER TO BE ATTACHED TO 50ml SYRINGE CONTAINING THE DILUTED REMOVAB SOLUTION FOR INFUSION
Slovenian: OPOZORILNO BESEDILO ZA SAMOLEPILNO NALEPKO, KI SE PRILEPI NA 50 ml BRIZGO, KI VSEBUJE RAZREDČENO RAZTOPINO ZDRAVILA REMOVAB ZA INFUNDIRANJE
English: Removab is indicated for the intraperitoneal treatment of malignant ascites in adults with EpCAM-positive carcinomas where standard therapy is not available or no longer feasible.
Slovenian: Zdravilo Removab je indicirano za intraperitonealno zdravljenje malignega ascitesa pri odraslih s karcinomi, pozitivnimi na EpCAM, kjer standardne terapije ni ali ni več smiselna.
English: • The peelable sticker, which is provided on the inner side of the Removab carton box, displaying the text “Diluted Removab.
Slovenian: • Samolepilno nalepko na notranji strani škatle zdravila Removab z besedilom „Razredčeno zdravilo Removab.
English: Dyspnoea*, pleural effusion*, cough.
Slovenian: Dispneja*, plevralna efuzija*, kašelj
English: What you need to know before you use Removab
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Removab Ne uporabljajte zdravila Removab
English: Table 7 Preparation of Removab solution for intraperitoneal infusion Number of infusion / Dose
Slovenian: Preglednica 7 Priprava raztopine zdravila Removab za intraperitonealno infundiranje
English: Before you start using Removab your doctor will check your: - Body Mass Index (BMI), which depends on your height and weight - Karnofsky Index, a measure of your general performance status.
Slovenian: - vaš indeks telesne mase (BMI - Body Mass Index ), ki je odvisen od vaše višine in telesne mase, - indeks po Karnofskem, ki je merilo za vašo splošno sposobnost.
English: Systemic Inflammatory Response Syndrome (SIRS) In 3.8% of the patients symptoms of SIRS were observed within 24 hours after catumaxomab infusion.
Slovenian: Pri 3,8 % bolnikov so v 24 urah po infundiranju katumaksomaba opazili simptome SIRS.