FrancophonIA/ELRC3.0 huggingface dataset:
English: • Risk of reactivation of latent tuberculosis and information about the screening for tuberculosis according to the local guidance;
Slovenian: • tveganju za reaktivacijo latentne tuberkuloze in, skladno z lokalnimi smernicami, podatki o testiranjih za tuberkulozo
English: The key messages and components included in the Healthcare Professional educational pack are defined as follows:
Slovenian: Ključna sporočila in sestavni deli programa za izobraževanje zdravnikov in ostalega zdravstvenega osebja so:
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
Slovenian: POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA, KI BODO UVELJAVLJENI V DRŽAVI ČLANICI
English: • Appropriate techniques for self administration of Stelara, including use of the prefilled syringes.
Slovenian: • pravilnem načinu samo-injiciranja zdravila Stelara in uporabi napolnjenih injekcijskih brizg.
English: The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented:
Slovenian: Država članica mora zagotoviti, da bodo uveljavljeni vsi spodaj opisani pogoji ali omejitve v zvezi z varno in učinkovito uporabo zdravila.
English: • Potential risk of malignancies;
Slovenian: • tveganju za malignome,
English: Time (days) to event
Slovenian: Čas (dnevi) do dogodka
English: The overall treatment period should not exceed 20 days.
Slovenian: Skupno obdobje zdravljenja naj ne traja več kot 20 dni.
English: Disposal No special requirements.
Slovenian: Odstranjevanje Ni posebnih zahtev.
English: N: number of patients in a treatment group.
Slovenian: Zdravljenje: N: število bolnikov v zdravljeni skupini.
English: • Grounds for one additional renewal
Slovenian: • Utemeljitev enega dodatnega podaljšanja
English: Estimated Probability of Being Puncture-free (%)
Slovenian: Ocenjena verjetnost biti brez punkcije (%)
English: It can be removed the day after the last infusion.
Slovenian: Odstranite ga lahko na dan po zadnji infuziji.
English: • Uncertainty in the knowledge about the rare unfavourable effects since the safety database is still very limited due to the low number of patients treated with Removab.
Slovenian: • negotovosti pri poznavanju redkih neugodnih učinkov, ker je podatkovna baza o varnosti še vedno zelo omejena zaradi majhnega števila bolnikov, zdravljenih z zdravilom Removab.
English: For each syringe a new cannula is used.
Slovenian: Za vsako brizgo se uporabi nova kanila.
English: Material and equipment required
Slovenian: Potrebni pripomočki in oprema
English: Only in case of clinically relevant or persisting increase further diagnostics or therapy should be considered.
Slovenian: Samo v primeru klinično pomembnega ali dlje časa trajajočega zvišanja je treba razmisliti o nadaljnji diagnostiki ali zdravljenju.
English: Adverse reactions are derived from an integrated safety analysis including 12 clinical studies.
Slovenian: Neželeni učinki so izpeljani iz integrirane analize varnosti, ki je vključevala 12 kliničnih študij.
English: Children and adolescents Removab should not be used in children and adolescents under 18 years of age.
Slovenian: Zdravila Removab ne smete uporabljati pri otrocih in mladostnikih, starih manj kot 18 let.
English: In the pivotal study IP-REM-AC-01 98.1% of patients were hospitalised for a median of 11 days.
Slovenian: V osrednji študiji IP-REM-AC-01 je bilo 98,1 % bolnikov hospitaliziranih za mediano 11 dni.
English: Despite pre-existing ADA values all patients received all 4 catumaxomab infusions.
Slovenian: Kljub že obstoječim vrednostim ADA so vsi bolniki prejeli vse 4 infuzije katumaksomaba.
English: Trion Pharma GmbH Frankfurter Ring 193a DE-80807 Munich Germany
Slovenian: Trion Pharma GmbH Frankfurter Ring 193a DE-80807 München
English: * were also reported as serious adverse reactions underlined: see section ‘Description of selected adverse reactions'
Slovenian: * o njih poročajo tudi kot o resnih neželenih učinkih podčrtano: glejte poglavje „Opis izbranih neželenih učinkov“
English: Some of these side effects may require medical treatment.
Slovenian: Nekateri od teh neželenih učinkov lahko zahtevajo zdravljenje.
English: The efficacy of catumaxomab was demonstrated in two phase III clinical studies.
Slovenian: Učinkovitost katumaksomaba so dokazali v dveh kliničnih študijah faze III.
English: For information on the perfusion system to be used see section 4.4.
Slovenian: Za informacije o perfuzijskem sistemu, ki ga je treba uporabiti, glejte poglavje 4.4.
English: (Part of the Outer Carton)
Slovenian: (del zunanje ovojnine)
English: For the first of the four doses an infusion time of 6 hours may be considered depending on the patient's health condition.
Slovenian: Za prvega od štirih odmerkov se lahko odločite za 6-urno infundiranje, odvisno od bolnikovega zdravstvenega stanja.
English: If such symptoms occur, speak to a doctor immediately, as these side effects require immediate attention and treatment.
Slovenian: Če se pojavijo taki simptomi, se nemudoma pogovorite z zdravnikom, saj ti neželeni učinki zahtevajo takojšnjo pomoč in zdravljenje.
English: In general, the changes in laboratory parameters were not clinically relevant and mostly returned to baseline after end of treatment.
Slovenian: Na splošno spremembe laboratorijskih parametrov niso bile klinično pomembne in so se po koncu zdravljenja večinoma vrnile na izhodiščno vrednost.
English: The patients remained ADA positive during treatment phase and follow-up.
Slovenian: Bolniki so ostali pozitivni za ADA med fazo zdravljenja in sledenjem.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20 April 2009
Slovenian: Datum prve odobritve: 20. april 2009 Datum zadnjega podaljšanja: 18. decembra 2013
English: Final volume for administration
Slovenian: Končni volumen za uporabo
English: These reactions resolved under symptomatic treatment.
Slovenian: Reakcije so s simptomatskim zdravljenjem izzvenele.
English: HAMAs were present in 94% of patients one month after the last catumaxomab infusion.
Slovenian: HAMA so bili prisotni pri 94 % bolnikov en mesec po zadnjem infundiranju katumaksomaba.
English: After completion of the study, patients were further observed until the end of their lifetime to assess overall survival (Table 4).
Slovenian: Po zaključku študije so bolnike spremljali do konca njihovega življenja, da bi ocenili celokupno preživetje (Preglednica 4).
English: Subsequently, the catheter can be removed.
Slovenian: Nato lahko kateter odstranite.
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.
Slovenian: Mediani čas preživetja brez punktiranja je bil 47,5 dni, mediani čas do prvega terapevtskega punktiranja 60,0 dni in mediani celokupni čas preživetja 406,5 dni.
English: Your doctor may consider reducing the infusion rate of Removab or giving you additional treatment to reduce these symptoms.
Slovenian: Vaš zdravnik bo morda razmislil o zmanjšanju hitrosti infundiranja zdravila Removab ali vam bo predpisal dodatno zdravljenje za zmanjšanje teh simptomov.
English: These symptoms reflect the mechanism of action of catumaxomab and are in general fully reversible.
Slovenian: Ti simptomi odražajo mehanizem delovanja katumaksomaba in so v glavnem povsem reverzibilni.
English: This results in destruction of tumour cells.
Slovenian: Posledica je uničenje celic tumorja.
English: However, these findings are of limited value due to the high species-specificity of catumaxomab.
Slovenian: Vendar pa je vrednost teh izsledkov omejena zaradi visoke specifičnosti katumaksomaba glede na vrsto.
English: In a feasibility study evaluating a second i.p.
Slovenian: V študiji izvedljivosti, kjer so ocenjevali drugi krog i.p.
English: Frequency groupings are defined as follows: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100).
Slovenian: Skupine pogostnosti so opredeljene kot sledi: zelo pogosti (≥1/10), pogosti (≥1/100 do <1/10), občasni (≥1/1.000 do <1/100).
English: Other medicines and Removab Tell your doctor if you are taking, have recently taken or might take any other medicines.
Slovenian: Druga zdravila in zdravilo Removab Obvestite svojega zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Slovenian: Če raztopine ne uporabimo takoj, je za čas hranjenja in za stanje pred uporabo odgovoren uporabnik, pri čemer čas hranjenja običajno ni več kot 24 ur pri 2 ºC do 8 ºC, razen če se je redčenje izvajalo pod nadziranimi in validiranimi aseptičnimi pogoji.
English: These symptoms occur mainly within 24 hours after a Removab infusion and can become life-threatening, but can be treated well with additional therapy.
Slovenian: Ti simptomi se v glavnem pojavijo v 24 urah po infundiranju zdravila Removab in lahko postanejo življenjsko nevarni, vendar se lahko uspešno zdravijo z dodatnim zdravljenjem.
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.
Slovenian: Razpoložljivi podatki o katumaksomabu, pridobljeni iz osrednje študije, kažejo, da je bilo le 5,6 % bolnikov (7/124 bolnikov) pozitivnih na HAMA pred 4. infundiranjem.
English: In clinical studies infusion times of 3 hours and 6 hours were investigated.
Slovenian: V kliničnih študijah so preučevali 3 in 6-urno trajanje infuzij.
English: In the pivotal study patients were monitored for 24 h after each infusion.
Slovenian: V osrednji študiji so bolnike nadzirali 24 ur po vsakem infundiranju.
English: Based upon the data that have become available since the granting of the initial Marketing Authorisation, the CHMP considers that the benefit-risk balance of Removab remains positive, but considers that its safety profile is to be closely monitored for the following reasons:
Slovenian: Na podlagi podatkov, dostopnih po pridobitvi osnovnega dovoljenja za promet z zdravilom, Odbor za zdravila za uporabo v humani medicini (CHMP) ocenjuje, da razmerje med tveganji in koristmi za zdravilo Removab ostaja pozitivno, vendar meni, da je potrebno njegov varnostni profil skrbno spremljati zaradi naslednjih razlogov:
English: The patient population was comparable to the pivotal study.
Slovenian: Skupina bolnikov je bila primerljiva s tisto v ključni študiji.
English: The prepared solution for infusion is physically and chemically stable for 48 hours at 2°C to 8°C and for 24 hours at a temperature not above 25°C.
Slovenian: Pripravljena raztopina za infundiranje je fizično in kemično stabilna 48 ur na 2 do 8 °C in 24 ur na temperaturi pod 25 °C.
English: Acute infections
Slovenian: Akutne okužbe
English: If such symptoms occur, please inform your doctor as soon as possible.
Slovenian: Če se pojavijo takšni simptomi, čim prej obvestite svojega zdravnika.
English: Percentage of EpCAM positive effusions
Slovenian: Odstotek efuzij, pozitivnih na EpCAM
English: The interval between the infusion days can be prolonged in case of relevant adverse reactions.
Slovenian: Interval med dnevi infundiranja se lahko zaradi pomembnih neželenih učinkov podaljša.
English: The EpCAM antigen is overexpressed on most carcinomas (Table 2).
Slovenian: Antigen EpCAM je pri večini karcinomov preveč izražen (Preglednica 2).
English: 728 patients received catumaxomab intraperitoneally, 293 patients as 6 hour - and 435 patients as 3 hour infusions.
Slovenian: 728 bolnikov je prejemalo katumaksomab intraperitonealno, 293 bolnikov v obliki 6-urne in 435 bolnikov v obliki 3-urne infuzije.
English: The concentrations increased with the number of infusions and the doses applied in most patients.
Slovenian: Koncentracije so se pri večini bolnikov s številom infuzij in uporabljenih odmerkom zvišale.
English: Pack size of 1.
Slovenian: Količina pakiranja je po 1.
English: The variability between subjects was high.
Slovenian: Med osebami so opazili veliko spremenljivost.
English: Administration of prednisolone as premedication did not result in a reduction of these adverse reactions.
Slovenian: Uporaba prednizolona kot premedikacije ni povzročila zmanjšanja teh neželenih učinkov.
English: Symptoms of pain and pyrexia can be ameliorated or avoided by pre-medication (see sections 4.2 and 4.4).
Slovenian: Simptome bolečin in pireksije je mogoče omiliti ali preprečiti s premedikacijo (glejte poglavji 4.2 in 4.4).
English: 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.
Slovenian: 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.
English: A complex of symptoms including very fast heartbeat, fever and shortness of breath can develop in up to 4 out of 100 patients.
Slovenian: Skupek simptomov, vključno z zelo hitrim srčnim utripom, zvišano telesno temperaturo in zasoplostjo, se lahko pojavi pri največ 4 od 100 bolnikov.
English: Figure 3 Schematic illustration of the infusion system
Slovenian: Slika 3 Shematski prikaz infuzijskega sistema
English: Adequate monitoring of the patient after end of Removab infusion is recommended.
Slovenian: Priporoča se ustrezno nadziranje bolnika po infundiranju zdravila Removab.
English: • The pump speed is adjusted according to the volume to be administered and the scheduled infusion time.
Slovenian: • Hitrost črpalke prilagodite glede na volumen, ki ga želite uporabiti, in načrtovani čas infundiranja.
English: 6 Catheter
Slovenian: 6 Kateter
English: You will be given other medicines to reduce fever, pain or inflammation caused by Removab (see section 3).
Slovenian: Dobili boste druga zdravila za znižanje telesne temperature, bolečine ali vnetja, ki jih povzroči zdravilo Removab (glejte poglavje 3).
English: 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.
Slovenian: 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.
English: Patients of nonCaucasian origin have not been included in these clinical studies.
Slovenian: V tej klinični študiji niso bili vključeni bolniki, ki niso kavkaškega porekla.
English: Malignant ascites is an accumulation of fluid in the abdominal space (peritoneal cavity) resulting from certain types of cancer.
Slovenian: Maligni ascites je nabiranje tekočine v trebušni votlini (peritonealni votlini), ki jo povzročajo nekatere vrste raka.
English: 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.
Slovenian: Sestavljena ocena varnosti je ovrednotila pogostnost in resnost glavnih znanih neželenih učinkov pireksije, navzee, bruhanja in bolečin v trebuhu v obeh skupinah zdravljenja.
English: CD3 is expressed on mature T-cells as a component of the T-cell receptor.
Slovenian: CD3 je izražen na zrelih Tcelicah kot sestavni del receptorja T-celice.
English: The prepared infusion solution should be used immediately.
Slovenian: Pripravljeno raztopino za infundiranje je treba takoj porabiti.
English: This transient effect is considered partially a consequence of the intraperitoneal route of administration.
Slovenian: Ta prehodni učinek je delno posledica intraperitonealnega načina uporabe.
English: Store in a refrigerator (2°C - 8°C).
Slovenian: Shranjujte v hladilniku (2 °C − 8 °C).
English: Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies, ATC code: L01XC09
Slovenian: Farmakoterapevtska skupina: Antineoplastična zdravila, monoklonska protitelesa, oznaka ATC: L01XC09
English: • The day after the last infusion a drainage of ascites until stop of spontaneous flow is performed.
Slovenian: • Na dan po zadnji infuziji opravite drenažo, da ascites spontano preneha teči.
English: What Removab is and what it is used for What you need to know before you use Removab How to use Removab
Slovenian: Kaj je zdravilo Removab in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Removab Kako uporabljati zdravilo Removab
English: Patients experiencing infusion-related symptoms should be advised not to drive and use machines until symptoms abate.
Slovenian: Bolnikom, ki imajo z infundiranjem povezane simptome, je treba odsvetovati vožnjo in upravljanje strojev, dokler simptomi ne izzvenijo.
English: 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.
Slovenian: 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.
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.
Slovenian: Dajanje katumaksomaba na živalskih modelih ni povzročilo znakov abnormalne ali z zdravilom povezane akutne toksičnosti ali znakov lokalnega neprenašanja na mestu injiciranja/infundiranja.
English: The following components must be used for the dilution and administration of Removab as Removab is only compatible with:
Slovenian: Za redčenje in uporabo zdravila Removab je treba uporabiti naslednje dele, saj je zdravilo Removab združljivo le s:
English: No hypersensitivity reactions were observed.
Slovenian: Preobčutljivostnih reakcij niso opazili.
English: For any information about this medicine, please contact the Marketing Authorisation Holder.
Slovenian: Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom
English: The overall safety profile of Removab is characterised by cytokine-release related symptoms and gastrointestinal reactions.
Slovenian: Za splošni varnostni profil zdravila Removab so značilni simptomi in gastrointestinalna reakcije, povezani s sproščanjem citokina.
English: The geometric mean apparent terminal plasma elimination half-life (t1/2) was approximately 2.5 days (range 0.7 to 17).
Slovenian: Geometrično povprečje navidezne končne razpolovne dobe iz plazme (t1/2) je bilo približno 2,5 dni (razpon od 0,7 do 17 dni).
English: You will be given Removab under the supervision of a doctor experienced in treating cancer.
Slovenian: Zdravilo Removab boste prejeli pod nadzorom zdravnika z izkušnjami z zdravljenjem raka.
English: 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.
Slovenian: 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“.
English: During and after infusion with Removab more than 1 in 10 patients (very common) will probably experience infusion-related side effects.
Slovenian: 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.
English: Removab should be prepared by a healthcare professional using appropriate aseptic technique.
Slovenian: Zdravilo Removab mora pripraviti zdravstveni delavec z ustrezno aseptično tehniko.
English: All patients experienced symptoms related to catumaxomab mode of action with a safety profile comparable in nature to the first i.p.
Slovenian: Vsi bolniki so imeli simptome, povezane z načinom delovanja katumaksomaba, z varnostnim profilom po naravi primerljivim s prvim krogom i.p.
English: Cancer Type
Slovenian: Vrste raka
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.
Slovenian: 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.
English: • 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.
Slovenian: • Bata NE SMETE potegniti nazaj zaradi spiranja napolnjene injekcijske brizge, da preprečite kontaminacijo in zagotovite vbrizganje pravilnega volumna.
English: Before starting and during treatment, you will be given other medicines to reduce fever, pain or inflammation caused by Removab.
Slovenian: 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.
English: • Precision perfusion pump
Slovenian: • natančna perfuzijska črpalka
English: OTHER Neovii Biotech GmbH
Slovenian: Neovii Biotech GmbH
English: The outer surface of the pre-filled syringe is not sterile.
Slovenian: Zunanja površina napolnjene injekcijske brizge ni sterilna.
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.
Slovenian: 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.
English: Table 2 EpCAM expression in most relevant ascites causing cancer types
Slovenian: Preglednica 2 Izraženost EpCAM pri večini pomembnih vrst raka, ki povzročajo ascites Podatki iz literature
English: It recognises a protein on the surface of cancer cells and recruits immune cells to destroy them.
Slovenian: Prepozna beljakovino na površini rakave celice in aktivira imunske celice, da jih uničijo.
English: Gastrointestinal reactions like abdominal pain, feeling sick, vomiting and diarrhoea occur in more than 1 in 10 patients (very common), but are mostly mild to moderate and respond well to additional treatment.
Slovenian: 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.
English: Uncommon Skin reaction*, dermatitis allergic*.
Slovenian: Kožne reakcije*, alergijski dermatitis*
English: Repeated-dose toxicity, genotoxicity, carcinogenicity, reproductive and developmental toxicity studies have not been performed.
Slovenian: Študij toksičnosti pri ponavljajočih se odmerkih, genotoksičnosti, kancerogenega potenciala in vpliva na sposobnost razmnoževanja in razvoja niso opravili.
English: The results for puncture-free survival and time to first need for therapeutic ascites puncture in terms of medians and hazard ratios are presented in Table 3.
Slovenian: Rezultati preživetja brez punktiranj in čas do prve potrebe po terapevtskem punktiranju ascitesa v smislu median in razmerij tveganja so predstavljeni v Preglednici 3.