FrancophonIA/ELRC3.0 huggingface dataset:
English: Uncommon Pulmonary embolism*, hypoxia*.
Slovenian: Pljučni embolizem*, hipoksija*
English: Table 5 Efficacy results (puncture-free survival and time to first need for therapeutic ascites puncture) of study IP-CAT-AC-03
Slovenian: Preglednica 5 Rezultati učinkovitosti (preživetje brez punktiranja in čas do prve potrebe po terapevtskem punktiranju ascitesa) študije IP-CAT-AC-03
English: Removab has to be administered as constant rate intraperitoneal infusion with an infusion time of at least 3 hours.
Slovenian: Zdravilo Removab se daje kot intraperitonealna infuzija s stalno hitrostjo s trajanjem infuzije vsaj 3 ure.
English: Figure 1 Kaplan-Meier estimates of time to first need for therapeutic ascites puncture of study IP-REM-AC-01
Slovenian: Slika 1 Ocena po Kaplan-Meierju za čas do prve potrebe po terapevtskem punktiranju ascitesa v študiji IP-REM-AC-01
English: Uncommon Extravasation*, application site inflammation*.
Slovenian: Ekstravazacija*, vnetje mesta aplikacije*
English: Intraperitoneal use only.” must be attached to the 50 ml syringe containing the diluted Removab solution for intraperitoneal infusion.
Slovenian: Samo za intraperitonealno uporabo.“ nalepite na 50 ml brizgo, ki vsebuje razredčeno raztopino zdravila Removab za intraperitonealno infundiranje.
English: Catumaxomab was administered as four 3-hour constant-rate i.p.
Slovenian: Katumaksomab so dajali v obliki štirih 3-urnih i.p.
English: Headache, dizziness.
Slovenian: Glavobol, omotičnost.
English: Anaemia*, lymphopenia, leukocytosis, neutrophilia.
Slovenian: Anemija*, limfopenija, levkocitoza, nevtrofilija
English: Hypotension*, hypertension*, flushing.
Slovenian: Hipotenzija*, hipertenzija*, oblivanje
English: Uncommon Gastrointestinal haemorrhage*, intestinal obstruction*.
Slovenian: Gastrointestinalne krvavitve*, obstrukcija črevesja*
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.
Slovenian: V tej potrditveni, dvokraki, randomizirani, odprti študiji faze IIIb z 219 bolniki z epitelnim rakom s simptomatičnim malignim ascitesom, ki so potrebovali terapevtsko punktiranje ascitesa, so raziskovali zdravljenje s premedikacijo s katumaksomabom in 25 mg prednizolona v primerjavi s samim katumaksomabom.
English: Removab has minor to moderate influence on the ability to drive and use machines.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Zdravilo Removab ima blag do zmeren vpliv na sposobnost vožnje in upravljanja s stroji.
English: Hepatic impairment or portal vein thrombosis / obstruction 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: Okvara delovanja jeter ali tromboza/obstrukcija vene porte 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: sinus tachycardia.
Slovenian: s sinusno tahikardijo
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.
Slovenian: 0,1 ml koncentrata za raztopino za infundiranje v napolnjeni injekcijski brizgi (steklo vrste I, silikonizirano) zamašek (bromobutilna guma) in sistem za zapiranje luer lock (silikoniziran polipropilen in polikarbonat) s pokrovom za konico (stiren-butadienska guma) s kanilo; velikost pakiranja po 1.
English: The remaining sodium chloride 9 mg/ml (0.9%) solution for injection can be discarded.
Slovenian: Preostanek natrijevega klorida 9 mg/ml (0,9 %) raztopine za injiciranje lahko zavržete.
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).
Slovenian: Ker povzroči vezava katumaksomaba na imunske celice in celice tumorja sproščanje vnetnih in citotoksičnih citokinov, so med in po uporabi zdravila Removab zelo pogosto poročali o kliničnih simptomih, povezanih s sproščanjem citokina, kot so zvišana telesna temperatura, navzea, bruhanje in mrzlice (glejte poglavje 4.8).
English: The following definitions of CTCAE criteria of the US National Cancer Institute (version 4.0) apply: CTCAE grade 1 = mild, CTCAE grade 2 = moderate, CTCAE grade 3 = severe, CTCAE grade 4 = life-threatening
Slovenian: 1. stopnje po CTCAE = blago, 2. stopnje po CTCAE = zmerno, 3. stopnje po CTCAE = resno,
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.
Slovenian: 0,5 ml koncentrata za raztopino za infundiranje v napolnjeni injekcijski brizgi (steklo vrste I, silikonizirano) zamašek (bromobutilna guma) in sistem za zapiranje luer lock (silikoniziran polipropilen in polikarbonat) s pokrovom za konico (stiren-butadienska guma) s kanilo; velikost pakiranja po 1.
English: In presence of factors interfering with the immune system, in particular acute infections, the administration of Removab is not recommended.
Slovenian: V prisotnosti dejavnikov, ki vplivajo na imunski sistem, še zlasti akutnih okužb, se uporaba zdravila
English: LIST OF EXCIPIENTS Sodium citrate, citric acid monohydrate, polysorbate 80, water for injections
Slovenian: Natrijev citrat, citronska kislina monohidrat, polisorbat 80, voda za injekcije
English: 4th infusion 150 micrograms
Slovenian: 4. infuzija 150 mikrogramov
English: What Removab looks like and contents of the pack Removab is presented as a clear and colourless concentrate for solution for infusion in a pre-filled syringe with a cannula.
Slovenian: Zdravilo Removab je bister in brezbarven koncentrat za raztopino za infundiranje v napolnjeni brizgi s kanilo.
English: Table 1 Adverse reactions reported from patients receiving catumaxomab treatment Infections and infestations
Slovenian: Preglednica 1 Neželeni učinki, o katerih so poročali pri bolnikih, zdravljenih s katumaksomabom
English: The safety profile of catumaxomab using a 3h versus a 6h infusion time is in general comparable in regards to nature, frequency and severity.
Slovenian: Varnostni profil katumaksomaba je po narav, pogostnosti in resnosti pri 3-urnem infundiranju primerljivi s 6-urnim.
English: Kaplan Meier estimates for time to first need for therapeutic ascites puncture are given in Figure 1.
Slovenian: Meierju za čas do prve potrebe po terapevtskem punktiranju ascitesa so predstavljene v Sliki 1.
English: A catheter will be placed in your abdominal space (intraperitoneal) for the whole treatment period, until the day after your last infusion.
Slovenian: Za ves čas trajanja postopka zdravljenja se v trebušno votlino (intraperitonealno) namesti kateter, do dneva zadnjega infundiranja.
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)
Slovenian: Čas od prve potrebe po terapevtskem punktiranju ascitesa Mediani čas do prve potrebe po terapevtskem punktiranju ascitesa (dni) 95 % IZ za mediano (dni) Vrednost p (test log-rank) Razmerje tveganja (RT) 95 % IZ za RT
English: Cytokine release related symptoms
Slovenian: Simptomi, povezani s sproščanjem citokina
English: 2nd infusion 20 micrograms
Slovenian: 2. infuzija 20 mikrogramov
English: 20 micrograms on day 3
Slovenian: 2. odmerek 20 mikrogramov na dan 3
English: 50 micrograms on day 7
Slovenian: 3. odmerek 50 mikrogramov na dan 7
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.
Slovenian: izražen kot indeks telesne mase (BMI - Body Mass Index) (oceni se po drenaži ascitesa) in > 17 indeks po Karnofskem > 60.
English: Table 3 Efficacy results (puncture-free survival and time to first need for therapeutic ascites puncture) of study IP-REM-AC-01
Slovenian: Preglednica 3 Rezultati učinkovitosti (preživetje brez punktiranja in čas do prve potrebe po terapevtskem punktiranju ascitesa) študije IP-REM-AC-01
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.
Slovenian: • Vzporedno z vsako aplikacijo zdravila Removab infundirajte še 250 ml raztopine natrijevega klorida 9 mg/ml (0,9 %) skozi infuzijski ventil/spoj Y v perfuzijski vod katetra.
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).
Slovenian: Zelo pogosto poročajo o drugih reakcijah, povezanih s sproščanjem citokina, kot so zvišana telesna temperatura, mrzlice, navzea in bruhanje, z intenzivnostjo 1. in 2. stopnje po Terminološko poenotenih kriterijih za neželene učinke (CTCAECommon Terminology Criteria for Adverse Events US National Cancer Institute, različica 4.0).
English: 1st infusion 10 micrograms
Slovenian: 1. infuzija 10 mikrogramov
English: Removab dosing schedule comprises the following four intraperitoneal infusions: 1st dose
Slovenian: Režim odmerjanja zdravila Removab sestavljajo naslednje štiri intraperitonealne infuzije:
English: 150 micrograms on day 10
Slovenian: 4. odmerek 150 mikrogramov na dan 10
English: Rash*, erythaema*, hyperhidrosis, pruritus.
Slovenian: Izpuščaj*, eritem*, hiperhidroza, pruritus
English: • polyurethane, polyurethane silicon coated catheters
Slovenian: • katetri iz poliuretana s silikonsko oblogo ali brez
English: Catumaxomab (N=108)
Slovenian: Katumaksomab (N = 108)
English: infusions in doses of 10, 20, 50 and 150 micrograms on day 0, 3, 7 and 10, respectively, in both groups.
Slovenian: infundiranj s stalno hitrostjo v odmerkih z 10 mikrogrami na dan 0, 20 mikrogrami na dan 3, 50 mikrogrami na dan 7 in 150 mikrogrami na dan 10 v obeh skupinah.
English: A pivotal, two-arm, randomised, open-label, phase II/III clinical trial in 258 patients with symptomatic malignant ascites due to EpCAM-positive carcinomas of whom 170 were randomised to catumaxomab treatment.
Slovenian: Ključno, dvokrako, randomizirano, odprto klinično preskušanje faze II/III z 258 bolniki s simptomatičnim malignim ascitesom zaradi karcinoma, pozitivnega na EpCAM, od katerih jih je bilo 170 naključno razvrščeno za zdravljenje s katumaksomabom v randomiziranem delu študije.
English: Uncommon Thrombocytopenia*, coagulopathy*.
Slovenian: Trombocitopenija*, koagulopatija*
English: Conditions such as hypovolaemia, hypoproteinaemia, hypotension, circulatory decompensation and acute renal impairment must be resolved prior to each Removab infusion.
Slovenian: Pred vsakim infundiranjem zdravila Removab je treba odpraviti stanja kot so hipovolemija, hipoproteinemija, hipotenzija, cirkulatorna dekompenzacija in okvara delovanja ledvic.
English: Endometrial *= lobular breast cancer
Slovenian: *= lobularni rak dojke
English: Catumaxomab was administered as four intraperitoneal infusions with increased doses of 10, 20, 50 and 150 micrograms on day 0, 3, 7 and 10, respectively (see section 4.2).
Slovenian: Katumaksomab so dajali kot štiri intraperitonealne infuzije z zvišanjem odmerkov z 10 mikrogrami na dan 0, 20 mikrogrami na dan 3, 50 mikrogrami na dan 7 in 150 mikrogrami na dan 10 (glejte poglavje 4.2).
English: • The 50 ml syringe containing the diluted Removab solution for infusion is installed in the precision pump.
Slovenian: • Namestite 50 ml brizgo, ki vsebuje razredčeno raztopino zdravila Removab za infundiranje, v natančno črpalko.
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).
Slovenian: • Glede na odmerek izvlecite ustrezno količino raztopine natrijevega klorida 9 mg/ml (0,9 %) za injekciranje v 50 ml brizgo (Preglednica 7).
English: In 43.7% of patients abdominal pain was reported as an adverse reaction reaching grade 3 in 8.2 % of patients, but it resolved under symptomatic treatment.
Slovenian: 3. stopnjo pri 8,2 % bolnikov, vendar so s simptomatskim zdravljenjem izzvenele.
English: • The 50 ml syringe is closed with a cap and shaken gently to mix the solution.
Slovenian: • 50 ml brizgo zaprite s pokrovom in zmešajte raztopino z nežnim pretresanjem.
English: Instructions for dilution prior to administration
Slovenian: Navodila za redčenje pred uporabo
English: In Table 1, adverse reactions are listed by organ class.
Slovenian: Seznam neželenih učinkov v obliki preglednice V Preglednici 1 so neželeni učinki našteti po organskih sistemih.
English: 2nd dose
Slovenian: PRILOGA II
English: Standard therapy or premedication, e.g. analgesic / antipyretic / nonsteroidal antiphlogistic is appropriate to limit the risk.
Slovenian: Za omejitev tveganja je ustrezna standardna terapija ali premedikacija, npr. z analgetiki/antipiretiki/nesteroidnimi antiflogistiki.
English: Abdominal pain was commonly reported as an adverse reaction.
Slovenian: Bolečina v trebuhu je neželeni učinek, o katerem so pogosto poročali.
English: The diluted Removab solution for infusion is administered intraperitoneally as constant rate infusion using an adequate pump system.
Slovenian: Razredčena raztopina se nato uporabi intraperitonealno z enakomerno hitrostjo infundiranja in s pomočjo ustreznega sistema črpalke.
English: • The 50 ml syringe is inserted in the infusion pump.
Slovenian: • 50 ml brizgo vstavite v črpalko za infundiranje.
English: Very common serious side effects (may affect more than 1 in 10 people): - Tiredness
Slovenian: Pogosti neželeni učinki (prizadenejo lahko do 1 od 10 bolnikov):
English: infusion cycle consisting of 10, 20, 50 and 150 micrograms of catumaxomab in 8 patients with malignant ascites due to carcinoma (IP-CAT-AC-04)
Slovenian: infundiranj, sestavljenem iz odmerkov z 10, 20, 50 in 150 mikrogrami katumaksomaba pri 8 bolnikih z malignim ascitesom zaradi karcinoma, (IP-CAT-AC-04), je bila adenozin deaminaza (ADA) pri presejalnem testiranju zaznavna v vseh razpoložljivih vzorcih ascitesa in plazme.
English: The infusion must be administered at constant rate with duration time of at least 3 hours.
Slovenian: Infuzijo se mora dajati s stalno hitrostjo s trajanjem infuzije vsaj
English: It is important to tell your doctor if you have any of the following: - undrained fluid in your abdominal cavity - cold hands and feet, light headedness, difficulty passing urine, increased heart rate, and weakness (symptoms of low blood volume) - weight gain, weakness, shortness of breath and fluid retention (symptoms of low blood protein levels) - feeling dizzy and faint (symptoms of low blood pressure) - problems with your heart and circulation - kidney or liver problems - an infection.
Slovenian: Pomembno je, da zdravnika obvestite, če imate katerega od znakov v nadaljevanju: - obstoječa tekočina v trebušni votlini, - hladne roke ali noge, omotica, težave pri uriniranju, zvišan srčni utrip, oslabelost (simptomi slabokrvnosti),
English: Precautions to be taken before administering the medicinal product Before administration of Removab the concentrate for solution for infusion is diluted in sodium chloride 9 mg/ml (0.9%) solution for injection.
Slovenian: Previdnostni ukrepi potrebni pred dajanjem zdravila Pred dajanjem se zdravilo Removab koncentrat za raztopino za infundiranje razredči v raztopini natrijevega klorida 9 mg/ml (0,9 %) za injiciranje.
English: Total volume of Removab concentrate for solution for infusion
Slovenian: Skupni volumen zdravila Removab koncentrata za raztopino za infundiranje
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.
Slovenian: • Injicirajte celotno vsebino brizge (koncentrat zdravila Removab z zračnim pufrom) iz napolnjene brizge neposredno v raztopino natrijevega klorida 9 mg/ml za injiciranje (0,9 %).
English: 1 pre-filled syringe.
Slovenian: 1 napolnjena injekcijska brizga
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).
Slovenian: 150 mikrogramov), med katerimi morata biti vsaj 2 koledarska dneva brez infundiranja (infuzijo boste na primer prejeli na dan 0, 3, 7, 10).
English: Talk to your doctor or nurse before using Removab.
Slovenian: Pred začetkom uporabe zdravila Removab se posvetujte s svojim zdravnikom ali medicinsko sestro.
English: Subsequently, prior to each Removab administration 500 ml sodium chloride 9 mg/ml (0.9%) solution for injection shall be infused to support distribution of the antibody in the abdominal cavity.
Slovenian: Nato se v trebušno votlino infundira 500 ml raztopine natrijevega klorida 9 mg/ml (0,9 %) za injiciranje za podporo porazdelitve protiteles.
English: Respiratory, thoracic and mediastinal disorders Common
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora
English: Puncture free survival
Slovenian: Preživetje brez punktiranja Mediano preživetje brez punktiranja
English: Transient increase in hepatic enzymes was commonly observed after the administration of Removab.
Slovenian: Po uporabi zdravila Removab so pogosto opažali prehodno zvišanje jetrnih encimov.
English: 50 ml Syringe
Slovenian: 50 ml brizga
English: In one patient (0.1%) dyspnoea and in 3 patients (0.4%) hypotension was reported in CTCAE grade 4 intensity.
Slovenian: 3 bolnikih (0,4 %) so poročali o hipotenziji 4. stopnje po CTCAE.
English: • The pre-filled syringe cannula is inserted through the 50 ml syringe opening so that the cannula is immersed in the sodium chloride 9 mg/ml (0.9%) solution for injection (Figure 2).
Slovenian: • Vstavite kanilo napolnjene injekcijske brizge skozi odprtino 50 ml brizge tako, da se kanila potopi v raztopino natrijevega klorida 9 mg/ml (0,9 %) za injiciranje (Slika 2).
English: gastric disorder, ileus*, gastroesophageal reflux disease, dry mouth.
Slovenian: Zaprtje*, dispepsija, trebušna distenzija, subileus*, flatulenca, želodčne motnje, ileus*, gastroezofagealna refluksna bolezen, suha usta
English: The catheter for intraperitoneal administration should be placed under ultrasound guidance by a physician experienced in intraperitoneal administration procedures.
Slovenian: Zdravnik z izkušnjami pri postopkih intraperitonealne uporabe zdravila nastavi kateter za intraperitonealno apliciranje pod ultrazvočnim vodenjem.
English: The catheter is used for ascites drainage and infusion of diluted Removab and sodium chloride 9 mg/ml (0.9%) solution for injection.
Slovenian: Kateter se uporablja za drenažo ascitesa in infundiranje zdravila Removab in raztopine natrijevega klorida 9 mg/ml (0,9 %).
English: Patients with renal impairment of a higher severity grade than mild have not been investigated.
Slovenian: Okvarjeno delovanje ledvic Pri bolnikih z okvaro delovanja ledvic, ki presega blago, raziskav niso opravili.
English: Do not use Removab - if you are allergic to catumaxomab or any of the other ingredients of this medicine (listed in section 6) - if you are allergic to murine proteins (from rat and / or mouse)
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Removab Ne uporabljajte zdravila Removab - če ste alergični na katumaksomab ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Intraperitoneal use only, after dilution.
Slovenian: Samo za intraperitonealno uporabo po razredčitvi.
English: Pain, asthenia*, Systemic inflammatory response syndrome*, oedema incl.
Slovenian: Bolečine, astenija*, sindrom sistemskega vnetnega odziva*, edem,
English: 3rd infusion 50 micrograms
Slovenian: 3. infuzija 50 mikrogramov
English: Removab must not be administered as a bolus or by any route other than intraperitoneally.
Slovenian: 4.4 Posebna opozorila in previdnostni ukrepi Zdravila Removab se ne sme uporabljati kot bolusni odmerek ali na kakršen koli drugačen način kot intraperitonealno.
English: Any air bubble(s) from the 50 ml syringe is eliminated.
Slovenian: Iz 50 ml brizge odstranite vse zračne mehurčke.
English: Removab must not be administered by intraperitoneal bolus or by any other route of administration.
Slovenian: Zdravila Removab se ne sme dati v obliki intraperitonealnega bolusnega odmerka ali na kak drugačen način.
English: Median overall survival (days) 95% CI for median (days) p-value (log-rank test) Hazard ratio (HR) (Catumaxomab versus Catumaxomab + Prednisolone) 95% CI for HR
Slovenian: 95 % IZ za mediano (dni) Vrednost p (test log-rank) Razmerje tveganja (RT) (katumaksomab v primerjavi s katumaksomabom + prednizolonom) 95 % IZ za RT
English: 95% CI for HR
Slovenian: Razmerje tveganja (RT) 95 % IZ za RT
English: Table 6 Overall survival of study IP-CAT-AC-03 in post study phase Catumaxomab (N=108)
Slovenian: Preglednica 6 Celokupno preživetje študije IP-CAT-AC-03 v fazi po študiji
English: How to store Removab
Slovenian: Shranjevanje zdravila Removab
English: Common serious side effects (may affect up to 1 in 10 people): - Loss of appetite - Dehydration - Reduction in red blood cells (anaemia) - Decreased blood levels of calcium and sodium - A very fast heart beat - High or low blood pressure - Abdominal pain accompanied by difficulty or blockage passing stools, constipation - Shortness of breath - Accumulation of fluid around the lungs which cause chest pain and breathlessness - Inflammation of the bile ducts - Skin redness, rash - Very fast heartbeat, fever, shortness of breath, feeling faint or light-headed - Complex of reactions due to the release of mediators of inflammation - Worsening of general state of health, generally feeling unwell and weak - Fluid retention - Hypersensitivity
Slovenian: - zastajanje tekočine okoli pljuč, kar povzroča bolečine v prsih in zasoplost, - vnetje žolčevodov, - pordelost kože, izpuščaj, - zelo hiter srčni utrip, zvišana telesna temperatura, zasoplost, občutek omedlevanja ali prazne glave, - kompleksna reakcija zaradi sproščanja mediatorjev vnetja,
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.
Slovenian: Pri 13 bolnikih s simptomatičnim malignim ascitesom zaradi karcinoma, pozitivnega na EpCAM, so raziskali farmakokinetiko katumaksomaba med štirimi intraperitonealnimi infuzijami s po 10, 20, 50 in 150 mikrogrami katumaksomaba in po njih.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton: Removab 10 micrograms
Slovenian: PODATKI NA ZUNANJI OVOJNINI Škatla: Removab 10 mikrogramov
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton: Removab 50 micrograms
Slovenian: PODATKI NA ZUNANJI OVOJNINI Škatla: Removab 50 mikrogramov
English: Plasma levels tended to decline after achieving a maximum after each dose.
Slovenian: Po doseženi največji vrednosti po vsakem odmerjanja so začele koncentracije v plazmi padati.
English: Paracentesis (control) (N=88)
Slovenian: skupina) (N = 88)
English: • The enclosed cannula is attached to the Removab pre-filled syringe.
Slovenian: • Priloženo kanilo nataknite na injekcijsko brizgo, napolnjeno z zdravilom Removab.
English: Very common Abdominal pain*, nausea*, vomiting*, diarrhoea*.
Slovenian: Bolečine v trebuhu*, navzea*, bruhanje*, driska*