natgillin/translations-raw huggingface dataset:
Administration of prednisolone as premedication did not result in a reduction of these adverse reactions.
Uporaba prednizolona kot premedikacije ni povzročila zmanjšanja teh neželenih učinkov.
Symptoms of pain and pyrexia can be ameliorated or avoided by pre-medication (see sections 4.2 and 4.4).
Simptome bolečin in pireksije je mogoče omiliti ali preprečiti s premedikacijo (glejte poglavji 4.2 in 4.4).
This must at least include ascites drainage until stop of spontaneous flow or symptom relief, and, if appropriate, supportive replacement therapy with crystalloids and / or colloids.
Vključevati mora vsaj drenažo ascitesa, dokler ne preneha spontano teči ali do ublažitve simptomov, in podporno nadomestitveno terapijo s kristaloidi in/ali koloidi, če je ustrezno.
A complex of symptoms including very fast heartbeat, fever and shortness of breath can develop in up to 4 out of 100 patients.
Skupek simptomov, vključno z zelo hitrim srčnim utripom, zvišano telesno temperaturo in zasoplostjo, se lahko pojavi pri največ 4 od 100 bolnikov.
Figure 3 Schematic illustration of the infusion system
Slika 3 Shematski prikaz infuzijskega sistema
Adequate monitoring of the patient after end of Removab infusion is recommended.
Priporoča se ustrezno nadziranje bolnika po infundiranju zdravila Removab.
• The pump speed is adjusted according to the volume to be administered and the scheduled infusion time.
• Hitrost črpalke prilagodite glede na volumen, ki ga želite uporabiti, in načrtovani čas infundiranja.
You will be given other medicines to reduce fever, pain or inflammation caused by Removab (see section 3).
Dobili boste druga zdravila za znižanje telesne temperature, bolečine ali vnetja, ki jih povzroči zdravilo Removab (glejte poglavje 3).
A decision must be made whether to discontinue breast-feeding or to discontinue / abstain from Removab therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z zdravilom Removab, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
Patients of nonCaucasian origin have not been included in these clinical studies.
V tej klinični študiji niso bili vključeni bolniki, ki niso kavkaškega porekla.
Malignant ascites is an accumulation of fluid in the abdominal space (peritoneal cavity) resulting from certain types of cancer.
Maligni ascites je nabiranje tekočine v trebušni votlini (peritonealni votlini), ki jo povzročajo nekatere vrste raka.
The composite safety score evaluated the frequency and severity of the main known adverse reactions pyrexia, nausea, vomiting and abdominal pain in both treatment groups.
Sestavljena ocena varnosti je ovrednotila pogostnost in resnost glavnih znanih neželenih učinkov pireksije, navzee, bruhanja in bolečin v trebuhu v obeh skupinah zdravljenja.
CD3 is expressed on mature T-cells as a component of the T-cell receptor.
CD3 je izražen na zrelih Tcelicah kot sestavni del receptorja T-celice.
The prepared infusion solution should be used immediately.
Pripravljeno raztopino za infundiranje je treba takoj porabiti.
This transient effect is considered partially a consequence of the intraperitoneal route of administration.
Ta prehodni učinek je delno posledica intraperitonealnega načina uporabe.
Store in a refrigerator (2°C - 8°C).
Shranjujte v hladilniku (2 °C − 8 °C).
Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies, ATC code: L01XC09
Farmakoterapevtska skupina: Antineoplastična zdravila, monoklonska protitelesa, oznaka ATC: L01XC09
• The day after the last infusion a drainage of ascites until stop of spontaneous flow is performed.
• Na dan po zadnji infuziji opravite drenažo, da ascites spontano preneha teči.
What Removab is and what it is used for What you need to know before you use Removab How to use Removab
Kaj je zdravilo Removab in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Removab Kako uporabljati zdravilo Removab
Patients experiencing infusion-related symptoms should be advised not to drive and use machines until symptoms abate.
Bolnikom, ki imajo z infundiranjem povezane simptome, je treba odsvetovati vožnjo in upravljanje strojev, dokler simptomi ne izzvenijo.
Therefore, based upon the safety profile of Removab, which requires the submission of yearly PSURs, the CHMP concluded that the MAH should submit one additional renewal application in 5 years time.
Na podlagi varnostnega profila za zdravilo Removab, ki zahteva letno predložitev PSUR, je CHMP sklenil, da mora imetnik dovoljenja za promet z zdravilom vložiti eno dodatno vlogo za podaljšanje dovoljenja za promet z zdravilom v obdobju 5 let.
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.
Dajanje katumaksomaba na živalskih modelih ni povzročilo znakov abnormalne ali z zdravilom povezane akutne toksičnosti ali znakov lokalnega neprenašanja na mestu injiciranja/infundiranja.
The following components must be used for the dilution and administration of Removab as Removab is only compatible with:
Za redčenje in uporabo zdravila Removab je treba uporabiti naslednje dele, saj je zdravilo Removab združljivo le s:
No hypersensitivity reactions were observed.
Preobčutljivostnih reakcij niso opazili.
For any information about this medicine, please contact the Marketing Authorisation Holder.
Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom
The overall safety profile of Removab is characterised by cytokine-release related symptoms and gastrointestinal reactions.
Za splošni varnostni profil zdravila Removab so značilni simptomi in gastrointestinalna reakcije, povezani s sproščanjem citokina.
The geometric mean apparent terminal plasma elimination half-life (t1/2) was approximately 2.5 days (range 0.7 to 17).
Geometrično povprečje navidezne končne razpolovne dobe iz plazme (t1/2) je bilo približno 2,5 dni (razpon od 0,7 do 17 dni).
You will be given Removab under the supervision of a doctor experienced in treating cancer.
Zdravilo Removab boste prejeli pod nadzorom zdravnika z izkušnjami z zdravljenjem raka.
In order to assess the impact of prednisolone premedication on safety and efficacy the primary safety endpoint “composite safety score” and the co-primary efficacy endpoint “puncture-free survival” were investigated.
Da bi ocenili vpliv premedikacije s prednizolonom na varnost in učinkovitost, so raziskali primarni opazovani dogodek varnosti „sestavljena ocena varnosti“ in primarni opazovani dogodek učinkovitosti „preživetje brez punktiranja“.
During and after infusion with Removab more than 1 in 10 patients (very common) will probably experience infusion-related side effects.
Med infundiranjem zdravila Removab in po njem se bodo pri več kot 1 od 10 bolnikov (zelo pogosti) verjetno pojavili z infundiranjem povezani neželeni učinki.
Removab should be prepared by a healthcare professional using appropriate aseptic technique.
Zdravilo Removab mora pripraviti zdravstveni delavec z ustrezno aseptično tehniko.
All patients experienced symptoms related to catumaxomab mode of action with a safety profile comparable in nature to the first i.p.
Vsi bolniki so imeli simptome, povezane z načinom delovanja katumaksomaba, z varnostnim profilom po naravi primerljivim s prvim krogom i.p.
Cancer Type
Vrste raka
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.
Kljub taki premedikaciji so bolniki doživeli zgoraj opisane neželene učinke z intenzivnostjo do 3. stopnje po Terminološko poenotenih kriterijih za neželene učinke (CTCAE - Common Terminology Criteria for Adverse Events) Nacionalnega instituta za raka ZDA (US National Cancer Institute), različica 3.0.
• The plunger rod MUST NOT be drawn back to rinse the pre-filled syringe, in order to avoid contamination and to ensure that the correct volume is ejected.
• Bata NE SMETE potegniti nazaj zaradi spiranja napolnjene injekcijske brizge, da preprečite kontaminacijo in zagotovite vbrizganje pravilnega volumna.
Before starting and during treatment, you will be given other medicines to reduce fever, pain or inflammation caused by Removab.
Pred začetkom zdravljenja z zdravilom Removab in med njim boste dobili druga zdravila za znižanje telesne temperature, bolečine ali vnetja, ki jih povzroči zdravilo Removab.
• Precision perfusion pump
• natančna perfuzijska črpalka
The outer surface of the pre-filled syringe is not sterile.
Zunanja površina napolnjene injekcijske brizge ni sterilna.
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.
Zato se sproži usklajena imunska reakcija proti celicam tumorja, ki zajema različne mehanizme delovanja kot so aktiviranje T-celic, od protiteles odvisna celična citotoksičnost (antibody-dependent cell-mediated cytotoxicity - ADCC), komplementa odvisno citotoksičnost (complement-dependent cytotoxicity - CDC) in fagocitoza.
Table 2 EpCAM expression in most relevant ascites causing cancer types
Preglednica 2 Izraženost EpCAM pri večini pomembnih vrst raka, ki povzročajo ascites Podatki iz literature
It recognises a protein on the surface of cancer cells and recruits immune cells to destroy them.
Prepozna beljakovino na površini rakave celice in aktivira imunske celice, da jih uničijo.
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.
Gastrointestinalne reakcije, kot so bolečina v trebuhu, občutek slabosti, bruhanje in driska se običajno pojavijo pri več kot 1 od 10 bolnikov (zelo pogosti), vendar so večinoma blage do zmerne in se dobro odzivajo na dodatno zdravljenje.
Uncommon Skin reaction*, dermatitis allergic*.
Kožne reakcije*, alergijski dermatitis*
Repeated-dose toxicity, genotoxicity, carcinogenicity, reproductive and developmental toxicity studies have not been performed.
Študij toksičnosti pri ponavljajočih se odmerkih, genotoksičnosti, kancerogenega potenciala in vpliva na sposobnost razmnoževanja in razvoja niso opravili.
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.
Rezultati preživetja brez punktiranj in čas do prve potrebe po terapevtskem punktiranju ascitesa v smislu median in razmerij tveganja so predstavljeni v Preglednici 3.
Infusion-related side effects and abdominal pain are very common (see section 4).
Z infundiranjem povezani neželeni učinki in bolečine v trebuhu so zelo pogosti (glejte poglavje 4).
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.
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.
Fertility No data on the effect of catumaxomab on fertility are available.
Podatkov o učinkih katumaksomaba na plodnost ni.
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).
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).
• polycarbonate infusion valves / Y connections
• polikarbonatnimi infuzijskimi ventili/Y-spoji
Detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/.
Paediatric population There is no relevant use of Removab in the paediatric population in the granted indication.
Zdravilo Removab ni primerno za uporabo pri pediatrični populaciji za odobreno indikacijo.
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%).
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 %).
It is recommended that the catheter remains in the abdominal cavity during the entire treatment period.
Priporoča se, da ostane kateter v trebušni votlini ves čas zdravljenja.
This study compared paracentesis plus catumaxomab versus paracentesis alone (control).
V tej študiji so primerjali paracentezo in katumaksomab s samo paracentezo (kontrolna skupina).
Patients receiving a higher than recommended dose of catumaxomab experienced more severe (grade 3) adverse reactions.
Bolniki, ki so prejeli odmerek katumaksomaba, ki je bil višji od priporočenega, so imeli hujše neželene učinke (3. stopnje).
Prior to each Removab administration the ascites fluid must be drained until stop of spontaneous flow or symptom relief (see section 4.4).
Pred vsakim dajanjem zdravila Removab je potrebna drenaža tekočine iz ascitesa dokler ne preneha spontano teči ali do ublažitve simptomov (glejte poglavje 4.4).
The most common infusion-related side effects, which are mostly mild to moderate, are fever, chills, feeling sick and vomiting.
Najpogostejši z infundiranjem povezani neželeni učinki, ki so večinoma blagi do zmerni, so zvišana telesna temperatura, mrzlica, občutek slabosti in bruhanje.
Do not freeze.
Ne zamrzujte!
Intraperitoneal use only.
Samo za intraperitonealno uporabo.
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.
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte s svojim zdravnikom, preden vzamete to zdravilo.
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.
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.
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.
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.
Cholangitis*, hyperbilirubinaemia.
Holangitis*, hiperbilirubinemija
It is unknown whether catumaxomab/metabolites are excreted in human milk.
Ni znano, ali se katumaksomab/presnovki izločajo v materino mleko.
Decreased appetite* / anorexia, dehydration*, hypokalaemia, hypoalbuminaemia, hyponatraemia*, hypocalcaemia*, hypoproteinaemia.
Zmanjšanje apetita* / anoreksija, dehidracija*, hipokaliemija, hipoalbuminemija, hiponatriemija*, hipokalciemija*, hipoproteinemija
Removab is used to treat malignant ascites, when standard treatment is not available or no longer feasible.
Zdravilo Removab se uporablja za zdravljenje malignega ascitesa, ko standardnega zdravljenja ni na voljo ali ni več smiselno.
Removab must be administered as an intraperitoneal infusion only.
Zdravilo Removab se mora dajati le kot intraperitonealna infuzija.
Altogether 45 out of 88 (51%) patients in the control arm crossed-over to achieve active treatment with catumaxomab.
Skupaj je prešlo na aktivno zdravljenje s katumaksomabom 45 od 88 (51 %) bolnikov iz kontrolne skupine.
Catumaxomab is a trifunctional rat-mouse hybrid monoclonal antibody that is specifically directed against the epithelial cell adhesion molecule (EpCAM) and the CD3 antigen.
Katumaksomab je trifunkcionalno monoklonsko protitelo hibrida podgane-miši, specifično usmerjeno proti adhezijski molekuli epitelijske celice (EpCAM) in antigenu CD3.
Due to catumaxomab's binding properties, tumour cells, T-cells and accessory immune cells come in close proximity.
Zaradi katumaksomabove sposobnosti vezave se celice tumorja, T-celice in dodatne imunske celice zelo približajo.
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.
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.
Removab is not recommended during pregnancy and in women of childbearing potential not using contraception.
Zdravila Removab ne uporabljajte pri nosečnicah in pri ženskah v rodni dobi, ki ne uporabljajo učinkovite kontracepcije.
oedema peripheral*, general physical health deterioration*, chest pain, influenza-like illness, malaise*, catheter site erythema.
vključno s perifernim edemom*, splošno poslabšanje fizičnega zdravja*, bolečine v prsih, gripi podobna bolezen, slabo počutje*, eritem na mestu katetra
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.
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.
- If you have any further questions, ask your doctor or nurse.
- Če imate dodatna vprašanja, se posvetujte s svojim zdravnikom ali medicinsko sestro.
The induction of human anti-murine (rat and / or mouse) antibodies (HAMAs/HARAs) is an intrinsic effect of murine monoclonal antibodies.
Indukcija humanih protiteles proti glodavcem (podganam in/ali mišim) (HAMA/HARA) je učinek, lasten mišjim monoklonskim protitelesom.
An interval of at least two infusion free calendar days must elapse between infusion days.
Med dnevi infundiranja mora preteči interval vsaj dveh koledarskih dni brez infundiranja.
If you experience side effects such as dizziness or chills during or after administration, you should not drive or use machines until they disappear.
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.
Catumaxomab was detectable in the ascites fluid and in plasma.
Katumaksomab je bil zaznaven v ascitesu in v plazmi.
The anti-tumour activity of catumaxomab has been demonstrated in vitro and in vivo.
Delovanje katumaksomaba proti tumorjem je bilo dokazano in vitro in in vivo.
Appropriate medical management of ascites drainage is a prerequisite for Removab treatment in order to assure stable circulatory and renal functions.
Predpogoj za zdravljenje z zdravilom Removab je ustrezna zdravstvena oskrba drenaže ascitesa, da se zagotovi stabilno delovanje obtočil in ledvic.
Prior to the intraperitoneal infusion, pre-medication with analgesic / antipyretic / non-steroidal antiphlogistic medicinal products is recommended (see section 4.4).
Pred intraperitonealnim infundiranjem se priporoča premedikacija z analgetiki/antipiretiki/nesteroidnimi antiflogistiki (glejte poglavje 4.4).
• 50 ml polypropylene syringes
• 50 ml polipropilenskimi brizgami
In three patients (0.4%) an intensity of CTCAE grade 4 was observed.
Pri treh bolnikih (0,4 %) so opazili CTCAE 4. stopnje.
There are no or limited amount of data from the use of catumaxomab in pregnant women.
Podatkov o uporabi katumaksomaba pri nosečnicah ni oziroma so omejeni.
Patients with hemodynamic insufficiency, oedema or hypoproteinaemia Blood volume, blood protein, blood pressure, pulse and renal function should be assessed before each Removab infusion.
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.
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.
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.
Other or additional standard pre-medication with analgesic / antipyretic / nonsteroidal antiphlogistic medicinal products is recommended.
Priporoča se druga ali dodatna standardna premedikacija z analgetiki/antipiretiki/nesteroidnimi antiflogistiki.
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).
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).
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.
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.
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.
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.
Paracentesis + catumaxomab (N=170)
Paracenteza + katumaksomab (N = 170)
• polyethylene perfusion tubings with an inner diameter of 1 mm and a length of 150 cm
• polietilenskimi perfuzijskimi cevkami z notranjim premerom 1 mm in dolžino 150 cm
How to use Removab
Kako uporabljati zdravilo Removab