FrancophonIA/ELRC3.0 huggingface dataset:
English: Caution is advised if duloxetine is co-administered with medicinal products that are predominantly metabolised by CYP2D6 (risperidone, tricyclic antidepressants [TCAs] such as nortriptyline, amitriptyline, and imipramine) particularly if they have a narrow therapeutic index (such as flecainide, propafenone and metoprolol).
Slovenian: Če duloksetin dajemo sočasno z zdravili, ki jih presnavlja predvsem CYP2D6 (risperidon, triciklični antidepresivi [tricyclic antidepressants, TCAs], kot so nortriptilin, amitriptilin in imipramin) in zlasti če imajo ozek terapevtski indeks (kot na primer s flekainidom, propafenonom in metoprololom), svetujemo previdnost.
English: Talk to your doctor before taking Duloxetine Zentiva if you:
Slovenian: Pred jemanjem zdravila Duloksetin Zentiva se posvetujte s svojim zdravnikom, če:
English: Also, you need to wait at least 5 days after you stop taking Duloxetine Zentiva before you take a MAOI.
Slovenian: Tudi po prenehanju jemanja zdravila Duloksetin Zentiva morate počakati vsaj 5 dni, preden lahko vzamete MAOI.
English: 5 Cases of suicidal ideation and suicidal behaviours have been reported during duloxetine therapy or early after treatment discontinuation (see section 4.4).
Slovenian: 5 Med zdravljenjem z duloksetinom ali kmalu po prekinitvi zdravljenja so poročali o primerih razmišljanja o samomoru in samomorilnem obnašanju (glejte poglavje 4.4).
English: Anaphylactic reaction Hyper-sensitivity
Slovenian: Bolezni imunskega sistema anafilaktična reakcija preobčutljivost
English: Inhibitors of CYP1A2
Slovenian: Zaviralci CYP1A2
English: Duloxetine Zentiva gastro-resistant hard capsules contain sucrose.
Slovenian: Duloksetin Zentiva trde gastrorezistentne kapsule vsebujejo saharozo.
English: 7 gastro-resistant hard capsules 28 gastro-resistant hard capsules 56 gastro-resistant hard capsules 84 gastro-resistant hard capsules 98 gastro-resistant hard capsules
Slovenian: 7 trdih gastrorezistentnih kapsul 28 trdih gastrorezstentnih kapsul 56 trdih gastrorezstentnih kapsul 84 trdih gastrorezstentnih kapsul 98 trdih gastrorezstentnih kapsul
English: The concomitant use of Duloxetine Zentiva with selective, reversible MAOIs, like moclobemide, is not recommended (see section 4.4).
Slovenian: Sočasno uporabo zdravila Duloksetin Zentiva s selektivnimi reverzibilnimi MAOI, kakršen je npr. moklobemid, odsvetujemo (glejte poglavje 4.4).
English: • constipation, diarrhoea, stomach pain, being sick (vomiting), heartburn or indigestion, breaking wind;
Slovenian: • zaprtje, driska, bolečina v trebuhu, slabost (bruhanje), zgaga ali slaba prebava, vetrovi
English: • have severe kidney disease;
Slovenian: • imate hudo obolenje ledvic;
English: Caution is advisable if duloxetine is used concomitantly with serotonergic agents like SSRIs, SNRIs, tricyclic antidepressants like clomipramine or amitriptyline, MAOIs like moclobemide or linezolid, St. John's wort (Hypericum perforatum) or triptans, tramadol, pethidine and tryptophan (see section 4.4).
Slovenian: Če duloksetin uporabljamo sočasno s serotonergičnimi zdravili, kot so SSRI, SNRI, s tricikličnimi antidepresivi, denimo, klomipraminom ali amitriptilinom, z MAOI, denimo moklobemidom ali linezolidom, s šentjanževko (Hypericum perforatum), triptani, tramadolom, petidinom in triptofanom, priporočamo previdnost (glejte poglavje 4.4).
English: Stomatitis Haematochezia Breath odour Microscopic colitis9
Slovenian: gastroenteritis kolcanje gastritis disfagija stomatitis hematohezija slab zadah mikroskopski kolitis9
English: • decreased thyroid gland activity which can cause tiredness or weight gain;
Slovenian: • zmanjšana aktivnost žleze ščitnice, kar lahko povzroči utrujenost ali zvečanje telesne mase
English: How to take Duloxetine Zentiva
Slovenian: Kako jemati zdravilo Duloksetin Zentiva
English: • are taking other medicines to treat depression (see ‘Other medicines and Duloxetine Zentiva');
Slovenian: • jemljete druga zdravila za zdravljenje depresije (glejte ‘Druga zdravila in zdravilo Duloksetin
English: Concomitant use of Duloxetine Zentiva with nonselective, irreversible monoamine oxidase inhibitors (MAOIs) is contraindicated (see section 4.5).
Slovenian: Zdravila Duloksetin Zentiva ne smemo uporabljati sočasno z neselektivnimi ireverzibilnimi zaviralci monoaminooksidaze - MAOI (glejte poglavje 4.5).
English: The use of Duloxetine Zentiva while breast-feeding is not recommended.
Slovenian: Uporabo zdravila Duloksetin Zentiva v času dojenja odsvetujemo.
English: Some fatalities have occurred, primarily with mixed overdoses, but also with duloxetine alone at a dose of approximately 1,000 mg. Signs and symptoms of overdose (duloxetine alone or in combination with other medicinal products) included somnolence, coma, serotonin syndrome, seizures, vomiting and tachycardia.
Slovenian: Znaki in simptomi prevelikega odmerjanja (duloksetina samega ali v kombinaciji z drugimi zdravili) so vključevali zaspanost, komo, serotoninski sindrom, epileptične napade, bruhanje in tahikardijo.
English: 28 gastro-resistant hard capsules 56 gastro-resistant hard capsules 84 gastro-resistant hard capsules 98 gastro-resistant hard capsules
Slovenian: 28 trdih gastrorezstentnih kapsul 56 trdih gastrorezstentnih kapsul 84 trdih gastrorezstentnih kapsul 98 trdih gastrorezstentnih kapsul
English: Duloxetine Zentiva 60 mg is available in packs of 28, 56, 84 and 98 capsules.
Slovenian: Duloksetin Zentiva 60 mg je na voljo v pakiranju po 28, 56, 84 in 98 kapsul.
English: Rare side effects (may affect up to 1 in 1,000 people):
Slovenian: Redki neželeni učinki (se lahko pojavijo pri največ 1 od 1.000 bolnikov):
English: Duloxetine Zentiva 30 mg is available in packs of 7, 28, 56, 84 and 98 capsules.
Slovenian: Duloksetin Zentiva 30 mg je na voljo v pakiranju po 7, 28, 56, 84 in 98 kapsul.
English: Very common side effects (may affect more than 1 in 10 people):
Slovenian: Zelo pogosti neželeni učinki (se lahko pojavijo pri več kot 1 od 10 bolnikov):
English: The pharmacokinetics of theophylline, a CYP1A2 substrate, were not significantly affected by coadministration with duloxetine (60 mg twice daily).
Slovenian: Sočasno dajanje duloksetina (60 mg dvakrat na dan) ni značilno vplivalo na farmakokinetiko teofilina, substrata CYP1A2.
English: Nervous system disorders Headache
Slovenian: vrtoglavica ušesna bolečina
English: Duloxetine Zentiva 60 mg gastro-resistant hard capsules Each capsule contains duloxetine hydrochloride equivalent to 60 mg duloxetine.
Slovenian: Duloksetin Zentiva 60 mg trde gastrorezistentne kapsule Ena kapsula vsebuje duloksetinijev klorid, kar ustreza 60 mg duloksetina.
English: Ear and labyrinth disorders Tinnitus1
Slovenian: Ušesne bolezni, vključno z motnjami labirinta tinitus1
English: • weight loss.
Slovenian: • izguba telesne mase
English: Duloxetine Zentiva 30 mg gastro-resistant hard capsules 7, 28, 56, 84 and 98 capsules
Slovenian: Duloksetin Zentiva 30 mg trde gastrorezistentne kapsule 7, 28, 56, 84 in 98 kapsul
English: Duloxetine Zentiva 60 mg gastro-resistant hard capsules 28, 56, 84 and 98 capsules
Slovenian: Duloksetin Zentiva 60 mg trde gastrorezistentne kapsule 28, 56, 84 in 98 kapsul
English: There have been reports of bleeding abnormalities, such as ecchymoses, purpura and gastrointestinal haemorrhage with selective serotonin reuptake inhibitors (SSRIs) and serotonin/noradrenaline reuptake inhibitors (SNRIs), including duloxetine.
Slovenian: Pri selektivnih zaviralcih prevzema serotonina (SSRI - selective serotonin reuptake inhibitors) in selektivnih zaviralcih prevzema noradrenalina (SNRI - selective noradrenaline reuptake inhibitors), vključno z duloksetinom, so poročali o nenormalnih krvavitvah, kot so ekhimoze, purpure in krvavitve iz prebavil.
English: Uncommon side effects (may affect up to 1 in 100 people):
Slovenian: Občasni neželeni učinki (se lahko pojavijo pri največ 1 od 100 bolnikov):
English: • Duloxetine Zentiva may cause effects that you may not be aware of, such as increases in liver enzymes or blood levels of potassium, creatine phosphokinase, sugar, or cholesterol.
Slovenian: kot povišanje jetrnih encimov ali krvnega nivoja kalija, kreatinske fosfokinaze, sladkorja ali holesterola
English: Hypromellose acetate succinate Triethyl citrate
Slovenian: Vsebina kapsule saharoza koruzni škrob hipromeloza smukec hipromeloza acetat sukcinat trietilcitrat
English: Duloxetine Zentiva 30 mg gastro-resistant hard capsules Hard opaque gelatin capsules of length approx. 15.9 mm with white opaque body and light-blue opaque cap which contain off-white to light-brown-yellow spherical pellets.
Slovenian: Duloksetin Zentiva 30 mg trde gastrorezistentne kapsule Trde, neprozorne kapsule iz želatine dolžine približno 15,9 mm z belim neprozornim telesom in svetlo modrim neprozornim pokrovčkom, ki vsebuje umazano bele do svetlo rjavo rumene okrogle pelete.
English: Caution should be exercised when duloxetine is combined with oral anticoagulants or antiplatelet agents due to a potential increased risk of bleeding attributable to a pharmacodynamic interaction.
Slovenian: Zaradi možnega povečanega tveganja za krvavitev, ki ga lahko pripišemo farmakodinamični interakciji, je potrebna previdnost pri kombinaciji duloksetina s peroralnimi antikoagulanti ali antitrombotičnimi zdravili.
English: Duloxetine Zentiva 60 mg gastro-resistant hard capsules Hard opaque gelatin capsules of length approx. 19.4 mm with ivory opaque body and light-blue opaque cap which contain off-white to light-brown-yellow spherical pellets.
Slovenian: Duloksetin Zentiva 60 mg trde gastrorezistentne kapsule Trde, neprozorne kapsule iz želatine dolžine približno 19,4 mm z neprozornim telesom v barvi slonovine in svetlo modrim neprozornim pokrovčkom, ki vsebuje umazano bele do svetlo rjavo rumene okrogle pelete.
English: Duloxetine Zentiva 30 mg gastro-resistant hard capsules Duloxetine Zentiva 60 mg gastro-resistant hard capsules
Slovenian: Duloksetin Zentiva 30 mg trde gastrorezistentne kapsule Duloksetin Zentiva 60 mg trde gastrorezistentne kapsule
English: What Duloxetine Zentiva contains
Slovenian: Kaj vsebuje zdravilo Duloksetin Zentiva
English: How to store Duloxetine Zentiva
Slovenian: Shranjevanje zdravila Duloksetin Zentiva
English: The 30 mg capsules are hard opaque gelatin capsules of length approx. 15.9 mm with white opaque body and light-blue opaque cap which contain off-white to light-brown-yellow spherical pellets.
Slovenian: 30 mg so trde, neprozorne kapsule iz želatine dolžine približno 15,9 mm z belim neprozornim telesom in svetlo modrim neprozornim pokrovčkom, ki vsebujejo umazano bele do svetlo rjavo rumene okrogle pelete.
English: Gynaecological haemorrhage Menstrual disorder Sexual dysfunction Testicular pain
Slovenian: Motnje reprodukcije in dojk erektilna disfunkcija motnje ejakulacije zapoznela ejakulacija ginekološka krvavitev motnje menstruacije spolna disfunkcija bolečina v testisih menopavzalni simptomi galaktoreja hiperprolaktinemija poporodna krvavitev6
English: Angio-neurotic oedema6
Slovenian: psihomotorični nemir6
English: General disorders and administration site conditions Falls8
Slovenian: Splošne težave in spremembe na mestu aplikacije
English: Duloxetine Zentiva 60 mg gastro-resistant hard capsules Capsule cap
Slovenian: Duloksetin Zentiva 60 mg trde gastrorezistentne kapsule Pokrovček kapsule
English: Adverse reactions may be more common during concomitant use of Duloxetine Zentiva and herbal preparations containing St. John's wort (Hypericum perforatum).
Slovenian: Ob sočasni uporabi zdravila Duloksetin Zentiva in pripravkov rastlinskega izvora, ki vsebujejo šentjanževko (Hypericum perforatum), so lahko neželeni učinki pogostejši.
English: The 60 mg capsules are hard opaque gelatin capsules of length approx. 19.4 mm with ivory opaque body and light-blue opaque cap which contain off-white to light-brown-yellow spherical pellets.
Slovenian: 60 mg so trde, neprozorne kapsule iz želatine dolžine približno 19,4 mm z neprozornim telesom v barvi slonovine in svetlo modrim neprozornim pokrovčkom, ki vsebuje umazano bele do svetlo rjavo rumene okrogle pelete.
English: Duloxetine Zentiva 30 mg gastro-resistant hard capsules Capsule cap
Slovenian: Duloksetin Zentiva 30 mg trde gastrorezistentne kapsule Pokrovček kapsule
English: • increased yawning;
Slovenian: • več zehanja
English: Duloxetine Zentiva is for oral use.
Slovenian: Zdravilo Duloksetin Zentiva jemljemo peroralno.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains duloxetine hydrochloride equivalent to 60 mg duloxetine.
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena kapsula vsebuje duloksetinijev klorid, kar ustreza 60 mg duloksetina.
English: • muscle pain, muscle spasm;
Slovenian: • mišična bolečina, mišični krč
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains duloxetine hydrochloride equivalent to 30 mg duloxetine.
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena kapsula vsebuje duloksetinijev klorid, kar ustreza 30 mg duloksetina.
English: • throat tightness, nose bleeds;
Slovenian: • napeto grlo, krvavitve iz nosu
English: • contraction of the jaw muscle;
Slovenian: • krčenje čeljustne mišice
English: Elevated liver enzymes (ALT, AST, alkaline phosphatase) Acute liver injury
Slovenian: zvišani jetrni encimi (ALT, AST, alkalna fosfataza) akutna okvara jeter odpoved jeter6 zlatenica6
English: Muscle tightness Muscle twitching
Slovenian: • mišična napetost, mišično trzanje
English: Duloxetine Zentiva contains sucrose
Slovenian: Zdravilo Duloksetin Zentiva vsebuje saharozo
English: NAME OF THE MEDICINAL PRODUCT Duloxetine Zentiva 30 mg gastro-resistant hard capsules Duloxetine
Slovenian: Duloksetin Zentiva 30 mg trde gastrorezistentne kapsule duloksetin
English: NAME OF THE MEDICINAL PRODUCT Duloxetine Zentiva 60 mg gastro-resistant hard capsules Duloxetine
Slovenian: Duloksetin Zentiva 60 mg trde gastrorezistentne kapsule duloksetin
English: Common side effects (may affect up to 1 in 10 people):
Slovenian: Pogosti neželeni učinki (se lahko pojavijo pri največ 1 od 10 bolnikov):
English: drowsiness, clumsiness, restlessness, feeling of being drunk, fever, sweating or rigid muscles),
Slovenian: • “serotoninski sindrom” (redka reakcija, ki lahko povzroči občutke velike sreče, zaspanost, okornost, nemir, občutek pijanosti, vročino, znojenje ali toge mišice), epileptični napadi
English: Skin and subcutaneous tissue disorders Sweating increased
Slovenian: Bolezni kože in podkožja povečano znojenje izpuščaj nočno znojenje urtikarija kontaktni dermatitis hladen znoj fotosenzitivnostne reakcije povečano nagnjenje k modricam
English: Breakable tablet
Slovenian: Lomljiva tableta
English: List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states
Slovenian: Dodatek I Seznam imen, farmacevtskih oblik, jakosti zdravila, poti uporabe zdravila,
English: 160 00 Praha 6 - Vokovice Czech Republic
Slovenian: Evropská 846/176a 160 00 Praha 6 - Vokovice Czech Republic
English: Farmaceutici Caber S.P.A. Viale Citta' D'Europa, 681 Rome
Slovenian: Viale Citta' D'Europa, 681 Rome
English: MYOPLEGE 4 mg, gélule
Slovenian: MYOPLEGE 4 mg, gélule 4mg
English: Acarpia Servicos Farmaceuticos Lda Rua dos Murcas, 88
Slovenian: Rua dos Murcas, 88
English: TIOCOLCHICOSIDE ZENTIVA 4mg
Slovenian: TIOCOLCHICOSIDE ZENTIVA
English: The overall treatment period should not be longer than 20 days.
Slovenian: Skupno obdobje zdravljenja naj ne traja več kot 20 dni.
English: It is used when standard treatment is not available or is no longer feasible.
Slovenian: Uporablja se, kadar standardno zdravljenje ni na voljo ali ni več izvedljivo.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Removab to Fresenius Biotech GmbH on 20 April 2009.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Removab, veljavno po vsej Evropski uniji, odobrila družbi Fresenius Biotech GmbH 20 aprila 2009.
English: It is usually given as four infusions in increasing doses from 10 to 150 micrograms over 11 days.
Slovenian: Zdravilo se običajno se daje v obliki štirih infuzij v naraščajočih odmerkih od 10 do 150 mg v obdobju 11 dni.
English: Other information about Removab:
Slovenian: Druge informacije o zdravilu Removab:
English: On average, patients who received Removab lived for 46 days without the need for further drainage.
Slovenian: V povprečju so bolniki, ki so prejeli zdravilo Removab, živeli 46 dni brez potrebe po nadaljnji drenaži.
English: There must be an interval of at least two days between infusions, but the interval can be increased if the patient has side effects.
Slovenian: Med infuzijami mora biti vsaj dvodnevni interval, ki se lahko podaljša, če ima bolnik neželene učinke.
English: Around 90% of patients treated with Removab have side effects.
Slovenian: Okoli 90 % bolnikov, ki so jih zdravili z zdravilom Removab, ima neželene učinke.
English: Removab is not recommended for use in patients below the age of 18 years because of a lack of information on safety and effectiveness in this age group.
Slovenian: Uporaba zdravila Removab pri bolnikih, mlajših od 18 let, zaradi pomanjkanja podatkov o varnosti in učinkovitosti v tej starostni skupini ni priporočljiva.
English: Removab must not be given all at once or by any other route.
Slovenian: Zdravilo Removab se ne sme dati v celoti naenkrat ali na kak drugačen način.
English: The Committee recommended that Removab be given marketing authorisation.
Slovenian: Odbor je priporočil, da se za zdravilo Removab odobri dovoljenje za promet.
English: Patients should be monitored after each infusion.
Slovenian: Po vsaki infuziji je treba bolnike nadzirati.
English: Before treatment, it is recommended that patients are given medicines to reduce pain, fever and inflammation.
Slovenian: Priporoča se, da bolniki pred zdravljenjem prejmejo zdravila za zmanjšanje bolečine, vročine in vnetja.
English: The main measure of effectiveness was how long patients lived without the need for further drainage.
Slovenian: Glavno merilo učinkovitosti je bilo, kako dolgo bolniki niso potrebovali nadaljnje drenaže.
English: The effects of Removab were first tested in experimental models before being studied in humans.
Slovenian: Učinki zdravila Removab so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
English: Removab treatment should only be given under the supervision of a doctor who has experience in the use of anticancer medicines.
Slovenian: Zdravljenje z zdravilom Removab mora potekati pod nadzorom zdravnika, ki ima izkušnje z uporabo zdravil proti raku.
English: Patients who have severe problems with their liver, or moderate or severe kidney problems should only be given Removab treatment after careful consideration of the medicine's benefits and risks.
Slovenian: Bolniki, ki imajo resne težave z jetri ali zmerne oziroma hude težave z ledvicami, naj začnejo zdravljenje z zdravilom Removab le po skrbni obravnavi koristi in tveganj zdravila.
English: What benefit has Removab shown during the studies?
Slovenian: Kakšne koristi je zdravilo Removab izkazalo med študijami?
English: This brings the cells close together so that the T-cells can kill the cancer cells.
Slovenian: S tem se te celice tesno približajo, tako da lahko T-celice ubijejo rakave celice.
English: The most common side effects with Removab (seen in more than 1 patient in 10) are lymphopenia (low level of lymphocytes, a type of white blood cell), abdominal (tummy) pain, nausea (feeling sick), vomiting, diarrhoea, pyrexia (fever), fatigue (tiredness), chills and pain.
Slovenian: Najpogostejši neželeni učinki zdravila Removab (opaženi pri več kot 1 bolniku izmed 10) so limfopenija (nizka raven limfocitov, vrste belih krvničk), bolečine v trebuhu, navzea (občutek slabosti), bruhanje, driska, pireksija (povišana telesna temperatura), utrujenost, mrzlica in bolečine.
English: T-cells are part of the immune system (the body's natural defences), and are involved in coordinating the death of infected and abnormal cells.
Slovenian: T-celice so del imunskega sistema (naravnega obrambnega mehanizma telesa) in so udeležene pri koordinaciji odmiranja okuženih in nenormalnih celic.
English: Removab was studied in one main study involving 258 patients with malignant ascites caused by an EpCAM-positive cancer and for which standard therapy was not available or was no longer feasible.
Slovenian: Zdravilo Removab so raziskali v eni glavni študiji, ki je vključevala 258 bolnikov z malignim ascitesom, ki ga je povzročil rak, pozitiven na EpCAM in za katerega standardna terapija ni bila na voljo ali ni bila več izvedljiva.
English: What is the risk associated with Removab?
Slovenian: Kakšna tveganja so povezana z zdravilom Removab?
English: Catumaxomab also attaches to a third substance called the Fc-gamma receptor, which also helps the body's immune system to target the cancer cells.
Slovenian: Katumaksomab se prav tako veže na tretjo snov, imenovano receptor Fc-gama, ki prav tako pomaga imunskemu sistemu telesa pri napadanju rakavih celic.
English: These are cancers where the tumour cells have large quantities of a molecule called EpCAM on their surface.
Slovenian: pri katerih imajo tumorske celice na površini velike količine molekul, imenovanih EpCAM.
English: By attaching to these two antigens, catumaxomab forms a bridge between the cancer cells and the T-cells.
Slovenian: Z vezavo na ta dva antigena katumaksomab ustvari most med rakavimi celicami in T-celicami.
English: Removab can only be used in patients with EpCAM-positive carcinomas.
Slovenian: Zdravilo Removab se uporablja le pri bolnikih s karcinomi, pozitivnimi na EpCAM.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) REMOVAB EPAR summary for the public
Slovenian: REMOVAB Povzetek EPAR za javnost
English: In patients with cancer, ascites forms because cancer cells develop on the peritoneum, the membrane around the peritoneal cavity, where they block the natural drainage of fluid from the abdomen.
Slovenian: Pri bolnikih z rakom ascites nastane, ker se rakave celice razvijejo na peritoneju, membrani, ki obdaja peritonealno votlino, in zavirajo naravno odtekanje tekočine iz trebuha.
English: For the full list of all side effects reported with Removab, see the Package Leaflet.
Slovenian: Za celoten opis neželenih učinkov, o katerih so poročali pri uporabi zdravila Removab, glejte navodilo za uporabo.
English: This compared with 11 days for patients who were treated with drainage alone.
Slovenian: V primerjavi z bolniki, ki so jih zdravili le z drenažo, je bil ta čas 11 dni.
English: It contains the active substance catumaxomab.
Slovenian: Vsebuje zdravilno učinkovino katumaksomab.
English: The active substance in Removab, catumaxomab, is a monoclonal antibody.
Slovenian: Zdravilna učinkovina zdravila Removab, katumaksomab, je monoklonsko protitelo.
English: Removab must be given as an intraperitoneal (into the peritoneal cavity) infusion using a pump system.
Slovenian: Zdravilo Removab se mora dajati le kot intraperitonealna infuzija (infuzija v trebušno votlino) z uporabo sistema črpalke.
English: Why has Removab been approved?
Slovenian: Zakaj je bilo zdravilo Removab odobreno?
English: A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure
Slovenian: Monoklonsko protitelo je protitelo (vrsta beljakovine), zasnovano tako, da prepozna in se veže na specifično strukturo (imenovano antigen), ki se nahaja na določenih celicah v telesu.
English: Removab with drainage was more effective at treating malignant acsites than drainage alone.
Slovenian: Zdravilo Removab v kombinaciji z drenažo je bilo pri zdravljenju malignega ascitesa učinkovitejše kot drenaža sama.
English: In this study, Removab used in combination with drainage of fluid from the abdomen was compared with drainage alone.
Slovenian: V tej študiji so primerjali uporabo zdravila Removab v kombinaciji z drenažo tekočine iz trebuha in drenažo samo.
English: Removab is used to treat malignant ascites, fluid accumulation in the peritoneal cavity (abdominal space) that is caused by a cancer.
Slovenian: Zdravilo Removab se uporablja za zdravljenje malignega ascitesa, nabiranja tekočine v peritonealni votlini (trebušni votlini) zaradi raka.