FrancophonIA/ELRC3.0 huggingface dataset:
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).
Maltese: Il-medja ġeometrika tas-Cmax tal-plażma kienet ta' madwar 0.5 ng/ml (medda minn 0 sa 2.3) u l-medja ġeometrika tal-AUC tal-plażma kienet ta' madwar 1.7 jiem*ng/ml (medda ta' < LLOQ (il-limitu t'isfel tal-kwantifikazzjoni) sa 13.5).
English: In Table 1, adverse reactions are listed by organ class.
Maltese: F'Tabella 1, ir-reazzjonijiet avversi huma elenkati skont il-klassi tal-organi.
English: Sodium citrate Citric acid monohydrate Polysorbate 80
Maltese: Citric acid monohydrate
English: Rash*, erythaema*, hyperhidrosis, pruritus.
Maltese: Raxx*, eritema*, iperidrosi, ħakk.
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.
Maltese: Il-farmakokinetika ta' catumaxomab matul u wara erba' infużjonijiet ġol-peritonew ta' 10, 20, 50 u 150 mikrogramma ta' catumaxomab kienet investigata fi 13-il pazjent b'axxite malinna sintomatika minħabba karċinomi pożittivi għal EpCAM.
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.
Maltese: Fi 43.7% tal-pazjenti, l-uġigħ addominali kien irrappurtat bħala reazzjoni avversa, li laħaq grad 3 f'8.2% tal-pazjenti, iżda fieq wara kura sintomatika.
English: During and after infusion with Removab more than 1 in 10 patients (very common) will probably experience infusion-related side effects.
Maltese: Waqt u wara l-infużjoni b'Removab aktar minn pazjent 1 minn kull 10 (komuni ħafna) probabbilment ser ikollu xi effetti sekondarji marbuta mal-infużjoni.
English: 728 patients received catumaxomab intraperitoneally, 293 patients as 6 hour - and 435 patients as 3 hour infusions.
Maltese: 728 pazjent irċivew catumaxomab ġol-peritonew, 293 pazjent bħala infużjoni ta' 6 sigħat - u 435 pazjent bħala infużjoni ta' 3 sigħat.
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.
Maltese: 0.1 ml ta' konċentrat għal soluzzjoni għall-infużjoni f'siringa mimlija għal-lest (ħġieġ ta' tip I, siliconised) bi planġer-tapp (tal-lastku tal-bromobutyl) u sistema luer lock (polypropylene siliconised u polycarbonate) b'għatu tat-tarf (lastku tal-istyrene butadiene) b'kannula; daqs tal-pakkett ta' 1.
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).
Maltese: Catumaxomab ingħata bħala erba' infużjonijiet ġol-peritonew b'dożi li jiżdiedu ta' 10, 20, 50 u 150 mikrogramma f'jum 0, 3, 7 u 10 rispettivament (ara sezzjoni 4.2).
English: Musculoskeletal and connective tissue disorders Common
Maltese: Disturbi muskolu-skeletriċi u tat-tessuti konnetivi
English: infusions in doses of 10, 20, 50 and 150 micrograms on day 0, 3, 7 and 10, respectively, in both groups.
Maltese: Catumaxomab ingħata bħala erba' infużjonijiet i.p. ta' 3 sigħat f'dożi ta' 10, 20, 50 u 150 mikrogramma f'jiem 0, 3, 7, u 10 rispettivament fiż-żewġ gruppi.
English: N: number of patients in a treatment group.
Maltese: N: numru ta' pazjenti fi grupp ta' kura.
English: Despite this premedication, patients experienced the adverse reactions described above with an intensity of up to grade 3, according to the Common Terminology Criteria for Adverse Events (CTCAE) of the US National Cancer Institute, version 3.0.
Maltese: Minkejja din ilpremedikazzjoni, il-pazjenti kellhom ir-reazzjonijiet avversi deskritti hawn fuq b'intensità sa grad 3, skont il-Kriterji tat-Terminoloġija Komuni għal Avvenimenti Avversi (CTCAE) tal-US National Cancer Institute verżjoni 3.0.
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.
Maltese: Il-profil tas-sigurtà ta' catumaxomab bl-użu ta' ħin ta' infużjoni ta' 3 sigħat kontra 6 sigħat, hu b'mod ġenerali komparabbli fir-rigward tan-natura, frekwenza u severità.
English: The overall safety profile of Removab is characterised by cytokine-release related symptoms and gastrointestinal reactions.
Maltese: Il-profil globali tas-sigurtà ta' Removab huwa kkaratterizzat minn sintomi relatati ma' ħruġ ta' cytokines u ma' reazzjonijiet gastrointestinali.
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.
Maltese: 0.5 ml ta' konċentrat għal soluzzjoni għall-infużjoni f'siringa mimlija għal-lest (ħġieġ ta' tip I, siliconised) bi planġer-tapp (tal-lastku tal-bromobutyl) u sistema luer lock (polypropylene siliconised u polycarbonate) b'għatu tat-tarf (lastku tal-istyrene butadiene) b'kannula; daqs tal-pakkett ta' 1.
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).
Maltese: L-effetti sekondarji l-aktar komuni ta' Removab huma effetti sekondarji marbuta mal-infużjoni u effetti sekondarji marbuta mas-sistema gastrointestinali (l-istonku u l-imsaren)
English: Fertility No data on the effect of catumaxomab on fertility are available.
Maltese: Fertilità M'hemm l-ebda dejta dwar l-effett ta' catumaxomab fuq il-fertilità.
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.
Maltese: Sussegwentement, qabel kull għoti ta' Removab, 500 ml ta' soluzzjoni għall-injezzjoni ta' sodium chloride 9 mg/ml (0.9%) għandha tingħata permezz ta' infużjoni biex tappoġġja d-distribuzzjoni tal-antikorp fil-kavità addominali.
English: Common side effects (may affect up to 1 in 10 people): - Pain - Reduction or increase in number of white blood cells - Decreased blood levels of potassium - Decreased blood protein levels - Increase of bilirubin in blood - Spinning sensation - Indigestion, stomach problems, heartburn, feeling bloated, passing wind, dry mouth - Flu-like symptoms - Dizziness or headache - Chest pain - Increased sweating - Infections - Increased protein levels in urine - Back pain, aching muscles and joints - Feeling anxious and having difficulty sleeping - Itchy rash or hives - Redness of the skin in the area around the catheter - Flushing - Cough
Maltese: Effetti sekondarji komuni (jistgħu jaffettwaw sa persuna 1 f'10): - Uġigħ - Tnaqqis jew żieda fin-numru ta' ċelluli bojod tad-demm - Tnaqqis fil-livelli ta' potassium fid-demm - Tnaqqis fil-livelli tal-proteini fid-demm - Żieda tal-bilirubina fid-demm - Tħoss kollox idur bik - Indiġestjoni, problemi fl-istonku, qrusa fl-istonku, tħossok minfuħ, ikollok il-gass, ħalq xott - Sintomi bħall-influwenza - Sturdament jew uġigħ ta' ras - Uġigħ fis-sider - Żieda fl-ammont ta' għaraq - Infezzjonijiet - Żieda fil-livelli ta' proteini fl-awrina - Uġigħ fid-dahar, uġigħ fil-muskoli u fil-ġogi - Tħossok ansjuż u jkollok diffikultà biex torqod - Raxx bil-ħakk jew urtikarja - Ħmura tal-ġilda fiż-żona madwar il-kateter - Fwawar - Sogħla
English: In one patient (0.1%) dyspnoea and in 3 patients (0.4%) hypotension was reported in CTCAE grade 4 intensity.
Maltese: F'pazjent wieħed (0.1%) qtugħ ta' nifs u fi 3 pazjenti (0.4%) pressjoni baxxa, ġew irrapportati b'intensità ta' CTCAE ta' grad 4.
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).
Maltese: Removab jingħata bħala 4 infużjonijiet ġol-peritonew b'doża li tiżdied (10, 20, 50 u 150 mikrogramma), separata b'mill-inqas interval ta' jumejn mingħajr ebda infużjoni (pereżempju se tirċievi infużjoni f'jum 0, 3, 7, 10).
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.
Maltese: Catumaxomab ingħata f'pazjenti fejn it-terapija standard ma kinitx disponibbli jew ma kinitx iktar possibbli, u li kellhom stat tal-prestazzjoni ta' Karnofsky ta' mill-inqas 60.
English: Uncommon Erythaema induratum*, device-related infection*.
Maltese: Erythaema induratum*, infezzjoni relatata mat-tagħmir*.
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)
Maltese: Fi studju ta' vijabilità li evalwa ċiklu sekondarju tal-infużjoni i.p. li kien jikkonsisti minn 10, 20, 50 u 150 mikrogramma ta' catumaxomab fi 8 pazjenti b'axxite malinna minħabba karċinoma (IP-CAT-AC04)
English: 6.1 List of excipients
Maltese: FARMAĊEWTIKU 6.1 Lista ta' eċċipjenti Sodium citrate
English: • polyurethane, polyurethane silicon coated catheters
Maltese: • kateters tal-polyurethane bi jew mingħajr kisja tas-silicon
English: Very common Abdominal pain*, nausea*, vomiting*, diarrhoea*.
Maltese: Komuni ħafna Uġigħ addominali*, nawseja*, rimettar*, dijarea*.
English: Adverse reactions are derived from an integrated safety analysis including 12 clinical studies.
Maltese: Ir-reazzjonijiet avversi inkisbu minn analiżi integrata dwar is-sigurtà li tinkludi 12-il studju kliniku.
English: 3rd infusion 50 micrograms
Maltese: Removab 50 mikrogramma
English: 1st infusion 10 micrograms
Maltese: Removab 10 mikrogrammi
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.
Maltese: Il-qtil effettiv ta' ċelluli tattumur in vitro medjat minn catumaxomab, kien osservat għaċ-ċelluli fil-mira b'espressjoni għolja u baxxa tal-antiġen EpCAM, indipendentement mit-tip tat-tumur primarju.
English: • The peelable sticker, which is provided on the inner side of the Removab carton box, displaying the text “Diluted Removab.
Maltese: • L-isticker li jista' jitqaxxar, li hu pprovdut fuq in-naħa ta' ġewwa tal-kaxxa tal-kartun ta' Removab, li juri l-kitba “Removab dilwit.
English: Table 6 Overall survival of study IP-CAT-AC-03 in post study phase Catumaxomab (N=108)
Maltese: Tabella 6 Sopravivenza globali ta' studju IP-CAT-AC-03 fil-fażi ta' wara l-istudju Catumaxomab + prednisolone (N=111)
English: How to store Removab
Maltese: X'fih Removab
English: sinus tachycardia.
Maltese: Takikardija*, li tinkludi takikardija tas-sinus.
English: 50 ml Syringe
Maltese: Siringa ta' 50 ml
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.
Maltese: B'hekk, tiġi kkawżata immunoreazzjoni magħquda kontra ċċelluli tat-tumur, li tinkudi mekkaniżmi differenti ta' azzjoni, bħall-attivazzjoni taċ-ċelluli T, ċitotossiċità medjata miċ-ċelluli dipendenti fuq l-antikorpi (ADCC), ċitotossiċità dipendenti fuq ilkomplement (CDC) u fagoċitosi.
English: Headache, dizziness.
Maltese: Kolanġite*, iperbilirubinemja.
English: Ovarian
Maltese: Ovarju
English: Table 3 Efficacy results (puncture-free survival and time to first need for therapeutic ascites puncture) of study IP-REM-AC-01
Maltese: Tabella 3 Riżultati tal-effikaċja (sopravivenza mingħajr titqib u żmien għall-ewwel bżonn ta' titqiba terapewtika tal-axxite) ta' studju IP-REM-AC-01
English: OTHER
Maltese: Am
English: Treatment:
Maltese: Kura:
English: Table 2 EpCAM expression in most relevant ascites causing cancer types
Maltese: Tabella 2 Espressjoni EpCAM fl-iktar axxite rilevanti li tikkawża tipi ta' kanċer Dejta mil-Letteratura
English: Constipation*, dyspepsia, abdominal distension, sub-ileus*, flatulence,
Maltese: Stitikezza*, dispepsja, nefħa addominali, subileus*, gass, disturb gastriku, ileus*, mard tar-rifluss gastroesofagali, ħalq xott.
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.
Maltese: Stat tajjeb tal-prestazzjoni espress bħala l-Indiċi tal-Piż tal-Ġisem (BMI) ta' > 17 (biex ikun evalwat wara t-tneħħija tal-fluwidu tal-axxite) u Indiċi ta' Karnofsky ta' > 60, hu meħtieġ qabel it-terapija b'Removab.
English: Figure 2 Illustration of the transfer of Removab from the pre-filled syringe to the 50 ml syringe
Maltese: 2 Stampa li turi t-trasferiment ta' Removab mis-siringa mimlija għal-lest għassiringa ta' 50 ml
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.
Maltese: Dan l-istudju konfermatorju ta' fażi IIIb, b'żewġ partijiet, li fih il-parteċipanti ntgħażlu b'mod każwali, open label, li sar fuq 219-il pazjent b'kanċer epiteljali b'axxite malinna sintomatika, li kienu jeħtieġu titqiba terapewtika għal axxite, stħarreġ il-kura b'catumaxomab flimkien ma' 25 mg ta' prednisolone bħala premediċina vs. catamaxomab waħdu.
English: You will be given other medicines to reduce fever, pain or inflammation caused by Removab (see section 3).
Maltese: Se tingħata mediċini oħra biex tnaqqas id-deni, uġigħ jew infjammazzjoni kkawżati minn Removab (ara sezzjoni 3).
English: Hazard ratio (HR) 95% CI for HR 6 months survival rate 1 year survival rate Median overall survival (days) 95% CI for median (days) p-value (log-rank test)
Maltese: Rata ta' sopravivenza wara 6 xhur Rata ta' sopravivenza wara sena Medjan ta' sopravivenza totali (jiem) 95% CI għal medjan (jiem) valur p (log-rank test)
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.
Maltese: Fl-istudji kliniċi f'pazjenti b'axxite malinna, 1,000 mg ta' paracetamol ingħataw regolarment ġol-vina qabel l-infużjoni b'Removab għall-kontroll tal-uġigħ u d-deni.
English: Dyspnoea*, pleural effusion*, cough.
Maltese: Dispnea*, ħruġ ta' likwidu mill-plewra*, sogħla.
English: Altogether 45 out of 88 (51%) patients in the control arm crossed-over to achieve active treatment with catumaxomab.
Maltese: B'kollox, 45 minn 88 (51%) pazjent fil-parti tal-istudju dwar il-kontroll qalbu t-tip ta' kura biex jiksbu kura attiva b'catumaxomab.
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).
Maltese: Reazzjonijiet oħrajn relatati ma' ħruġ ta' cytokines bħal deni, tertir ta' bard, nawseja, u rimettar huma reazzjonijiet irrapportati b'mod komuni ħafna b'intensità ta' CTCAE ta' grad 1 u 2 (US National Cancer Institute, verżjoni 4.0).
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.
Maltese: • Flimkien ma' kull għoti ta' Removab, agħti infużjoni ta' soluzzjoni għall-injezzjoni ta' 250 ml sodium chloride 9 mg/ml (0.9%) permezz ta' valv tal-infużjoni/konnessjoni Y fil-lead talperfużjoni tal-kateter.
English: What Removab contains - The active substance is catumaxomab (50 micrograms in 0.5 ml, corresponding to 0.1 mg/ml).
Maltese: - Is-sustanza attiva hi catumaxomab (50 mikrogramma f'0.5 ml, li jikkorrispondu għal 0.1 mg/ml).
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.
Maltese: Catumaxomab hu antikorp trifunzjonali monoklonali ta' ibridu tal-firien-ġrieden li hu speċifikament dirett kontra l-molekula tal-adeżjoni taċ-ċelluli epiteljali (EpCAM) u l-antiġen CD3. L-antiġen EpCAM hu espress iżżejjed fuq il-biċċa l-kbira tal-karċinomi (Tabella 2).
English: Marketing Authorisation Holder and Manufacturer Neovii Biotech GmbH
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u l-Manifattur Neovii Biotech GmbH
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.
Maltese: Indeboliment epatiku jew trombożi/ostruzzjoni tal-vina portali Pazjenti b'indeboliment epatiku ta' severità ta' grad ogħla minn moderat u/jew b'iktar minn 70% talfwied li jkun metastasizzat u/jew trombożi/ostruzzjoni tal-vina portali, ma kinux investigati.
English: Figure 1 Kaplan-Meier estimates of time to first need for therapeutic ascites puncture of study IP-REM-AC-01
Maltese: Figura 1 Stimi Kaplan Meier għaż-żmien għall-ewwel ħtieġa għal titqiba terapewtika talaxxite ta' studju 1.IP-REM-AC-01
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.
Maltese: • Meta s-siringa ta' 50 ml li jkun fiha s-soluzzjoni għall-infużjoni dilwita ta' Removab tkun vojta, tinbidel ma' siringa ta' 50 ml li jkun fiha 20 ml ta' soluzzjoni għall-injezzjoni ta' sodium chloride 9 mg/ml (0.9%) sat-tmiem tal-ħin skedat tal-infużjoni biex ineħħu l-volum ‘mejjet' fillead tal-perfużjoni (madwar 2 ml) taħt kundizzjonijiet mhux mibdula.
English: 20.2 ml
Maltese: 20.2 ml et infużjoni
English: What Removab contains - The active substance is catumaxomab (10 micrograms in 0.1 ml, corresponding to 0.1 mg/ml).
Maltese: - Is-sustanza attiva hi catumaxomab (10 mikrogrammi f'0.1 ml, li jikkorrispondu għal 0.1 mg/ml).
English: Anaemia*, lymphopenia, leukocytosis, neutrophilia.
Maltese: Disturbi tad-demm u tas-sistema limfatika Komuni ħafna Anemija*, limfopenija, lewkoċitosi, newtrofilija.
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.
Maltese: L-attività in vivo ta' catumaxomab kontra t-tumur kienet ikkonfermata f'mudell tal-ġrieden kompromess b'mod immunoloġiku ta' karċinoma tal-ovarji, fejn l-iżvilupp tat-tumur kien ittardjat minn kura b'catumaxomab ġol-peritonew u ċelluli mononukleari fid-demm periferali uman.
English: Infusion-related side effects and abdominal pain are very common (see section 4).
Maltese: Effetti sekondarji relatati mal-infużjoni u mal-uġigħ addominali huma komuni ħafna (ara sezzjoni 4).
English: Paediatric population There is no relevant use of Removab in the paediatric population in the granted indication.
Maltese: M'hemm l-ebda użu rilevanti ta' Removab fil-popolazzjoni pedjatrika fl-indikazzjoni mogħtija.
English: • The perfusion tubing is connected to the Y-connection.
Maltese: • It-tubing tal-perfużjoni jitwaħħal mal-konnessjoni Y.
English: Removab must be administered under the supervision of a physician experienced in the use of anti-neoplastic medicinal products.
Maltese: Removab għandu jingħata taħt is-superviżjoni ta' tabib b'esperjenza fl-użu ta' prodotti mediċinali anti-neoplastiċi.
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.
Maltese: • Il-kontenut kollu tas-siringa (il-konċentrat ta' Removab flimkien mal-baffer tal-arja) jiġi injettat minn ġos-siringa mimlija għal-lest direttament għal ġos-soluzzjoni għall-injezzjoni tas-sodium chloride 9 mg/ml (0.9%).
English: Treatment of these patients with Removab should only be considered after a thorough evaluation of benefit / risk (see section 4.4).
Maltese: Il-kura ta' dawn ilpazjenti b'Removab għandha tkun ikkunsidrata biss wara evalwazzjoni bir-reqqa tal-benefiċċju/riskju (ara sezzjoni 4.4).
English: Current data on catumaxomab derived from the pivotal study show that only 5.6% of patients (7/124 patients) were HAMA positive before the 4th infusion.
Maltese: Dejta kurrenti dwar catumaxomab miksuba minn studju ta' importanza kbira turi li 5.6% biss tal-pazjenti (7/124 pazjenti) kienu pożittivi għal HAMA qabel ir-4
English: The median puncture-free survival time was 47.5 days, median time to first therapeutic puncture 60.0 days and median overall survival 406.5 days.
Maltese: 5 jiem, iż-żmien medjan għall-ewwel titqiba terapewtika 60 jum u ż-żmien medjan ta' sopravivenza globali 406.5 jiem.
English: Removab 50 micrograms concentrate for solution for infusion catumaxomab
Maltese: Removab 50 mikrogramma konċentrat għal soluzzjoni għall-infużjoni Catumaxomab
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).
Maltese: Żieda fil-frekwenza ta' xi reazzjonijiet avversi ġiet osservata fir-rigward tal-għoti ta' 3 sigħat, inklużi tertir ta' bard u pressjoni baxxa (gradi 1 / 2), dijarea (il-gradi kollha) u għeja (grad 1 / 2).
English: The catheter is used for ascites drainage and infusion of diluted Removab and sodium chloride 9 mg/ml (0.9%) solution for injection.
Maltese: Il-kateter jintuża għat-tneħħija ta' likwidu millaxxite u għall-infużjoni ta' Removab dilwit u soluzzjoni għall-injezzjoni ta' sodium chloride 9 mg/ml (0.9%).
English: • The 50 ml syringe is inserted in the infusion pump.
Maltese: • Is-siringa ta' 50 ml tiddaħħal fil-pompa tal-infużjoni.
English: One pre-filled syringe contains 50 micrograms catumaxomab in 0.5 ml solution, corresponding to 0.1 mg/ml.
Maltese: U KWANTITATTIVA Siringa mimlija għal-lest fiha 50 mikrogramma ta' catumaxomab* f'soluzzjoni ta' 0.5 ml li tikkorrispondi għal 0.1 mg/ml.
English: Name and address of the manufacturer of the biological active substance
Maltese: MANIFATTUR TAS-SUSTANZA BIJOLOĠIKA ATTIVA UMANIFATTUR RESPONSABBLI
English: Removab 10 micrograms concentrate for solution for infusion catumaxomab
Maltese: Removab 10 mikrogrammi konċentrat għal soluzzjoni għall-infużjoni catumaxomab
English: Ascites drainage
Maltese: Monitoraġġ
English: Administration of catumaxomab in animal models did not result in any signs of abnormal or drug-related acute toxicity or signs of local intolerance at the injection/infusion site.
Maltese: L-għoti ta' catumaxomab f'mudelli tal-annimali ma rriżulta fl-ebda sinjali ta' tossiċità akuta anormali jew relatata mal-mediċina, jew f'sinjali ta' intolleranza lokali fis-sit tal-injezzjoni/infużjoni.
English: These reactions resolved under symptomatic treatment.
Maltese: Dawn irreazzjonijiet fiequ wara kura sintomatika.
English: Infusion-related side effects
Maltese: Effetti sekondarji marbuta mal-infużjoni
English: Vertigo.
Maltese: Sturdament.
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).
Maltese: • Ibbażat fuq id-doża, l-ammont adattat ta' soluzzjoni ta' sodium chloride 9 mg/ml (0.9%) għallinjezzjoni jinġibed b'siringa ta' 50 ml (Tabella 7).