FrancophonIA/ELRC3.0 huggingface dataset:
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).
Icelandic: Vart varð við aukna tíðni tiltekinna aukaverkana í tengslum við 3 klst. lyfjagjöf, svo sem kuldahroll og lágþrýsting (stig 1 / 2), niðurgang (öll stig) og þreytu (stig 1 / 2).
English: Dyspnoea and hypo-/ hypertension are commonly observed.
Icelandic: Mæði og lág-/háþrýstingur koma oft fram.
English: The catheter is used for ascites drainage and infusion of diluted Removab and sodium chloride 9 mg/ml (0.9%) solution for injection.
Icelandic: Leggurinn er notaður fyrir frárennsli skinuholsvökva og innrennsli þynnts Removab og natríumklóríðlausnar 9 mg/ml (0,9%) lausnar.
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.
Icelandic: 0,1 ml af innrennslisþykkni, lausn í áfylltri sprautu (gler af gerð I, sílikonhúðað) með bullutappa (brómóbútýlgúmmí) og luer-læsingu (sílikonhúðað polýprópýlen og pólýkarbonat) totuloki (stýren-bútadíngúmmí) með dælu; pakkning með 1 einingu.
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.
Icelandic: Þrátt fyrir þessa forlyfjagjöf fundu sjúklingar fyrir aukaverkunum sem lýst er hér að framan í allt að 3. gráðu samkvæmt Algengum hugtökum um viðmið aukaverkana (CTCAE) hjá US National Cancer Institute, útgáfu 3.0. Mælt er með annarri eða aukalegri forlyfjagjöf verkjastillandi/hitalækkandi/bólgueyðandi (án stera) lyfja.
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.
Icelandic: Niðurstöður hvað varðar lifun án ástungu og tímann fram að fyrstu þörf fyrir ástungumeðferð vegna skinuholsvökva, með tilliti til miðgildis og áhættuhlutfalls, koma fram á töflu
English: Intraperitoneal use only.” must be attached to the 50 ml syringe containing the diluted Removab solution for intraperitoneal infusion.
Icelandic: Aðeins til notkunar í kviðarhol.“ skal festa við 50 ml sprautuna sem hefur að geyma þynntu Removab lausnina til innrennslis í kviðarhol.
English: 1 sterile cannula
Icelandic: 1 sæfð dæla
English: Removab is not recommended during pregnancy and in women of childbearing potential not using contraception.
Icelandic: Removab er ekki ætlað til notkunar á meðgöngu eða handa konum sem ekki nota getnaðarvarnir.
English: * were also reported as serious adverse reactions underlined: see section ‘Description of selected adverse reactions'
Icelandic: Undirstrikað: sjá kafla „Lýsing á völdum aukaverkunum“
English: 1st infusion 10 micrograms
Icelandic: 1. innrennsli 10 míkrógrömm
English: No hypersensitivity reactions were observed.
Icelandic: Engin ofnæmisviðbrögð sáust.
English: Malignant ascites is an accumulation of fluid in the abdominal space (peritoneal cavity) resulting from certain types of cancer.
Icelandic: Illkynja skinuholsvökvi vökvasöfnun í kvið (kviðarholi) af völdum tiltekinna gerða krabbameins.
English: • The 50 ml syringe is inserted in the infusion pump.
Icelandic: Setja skal 50 ml sprautuna inn í innrennslisdæluna.
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)
Icelandic: 95% CI fyrir HR 6 mánaða lifunarhlutfall 1 árs lifunarhlutfall Miðgildi heildarlifunar (dagar) 95% CI fyrir miðgildi (dagar) p-gildi (log-rank próf)
English: Removab has to be administered as constant rate intraperitoneal infusion with an infusion time of at least 3 hours.
Icelandic: Removab þarf að gefa með innrennsli í kviðarhol með stöðugum hraða í lágmark 3 klukkustundir.
English: Due to catumaxomab's binding properties, tumour cells, T-cells and accessory immune cells come in close proximity.
Icelandic: Vegna bindingareiginleika catumaxomab komast æxlisfrumur, t-frumur og ónæmisfrumur í mikið návígi.
English: Do not use Removab - if you are allergic to catumaxomab or any of the other ingredients of this medicine (listed in section 6) - if you are allergic to murine proteins (from rat and / or mouse)
Icelandic: Ekki má nota Removab - ef um er að ræða ofnæmi fyrir catumaxomab eða einhverju öðru innihaldsefni lyfsins (talin upp í kafla 6).
English: Administration of prednisolone as premedication did not result in a reduction of these adverse reactions.
Icelandic: Lyfjaforgjöf með prednisóloni dró ekki úr þessum aukaverkunum.
English: 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.
Icelandic: Við meðgöngu, brjóstagjöf, grun um þungun eða ef þungun er fyrirhuguð skal leita ráða hjá lækninum áður en lyfið er notað.
English: Anaemia*, lymphopenia, leukocytosis, neutrophilia.
Icelandic: Bakverkur, vöðvaþrautir, liðverkir.
English: Table 3 Efficacy results (puncture-free survival and time to first need for therapeutic ascites puncture) of study IP-REM-AC-01
Icelandic: Tafla 3 Verkunarniðurstöður (lifun án ástungu og tími fram að fyrstu þörf fyrir ástungumeðferð vegna skinuholsvökva) úr IP-REM-AC-01 rannsókninni Breyta
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton: Removab 50 micrograms
Icelandic: YTRI UMBÚÐUM Askja: Removab 50 míkrógrömm
English: What Removab looks like and contents of the pack Removab is presented as a clear and colourless concentrate for solution for infusion in a pre-filled syringe with a cannula.
Icelandic: Removab kemur fyrir sem tært og litlaust innrennslisþykkni, lausn í áfylltri sprautu með dælu.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton: Removab 10 micrograms
Icelandic: YTRI UMBÚÐUM Askja: Removab 10 míkrógrömm
English: Precautions to be taken before administering the medicinal product Before administration of Removab the concentrate for solution for infusion is diluted in sodium chloride 9 mg/ml (0.9%) solution for injection.
Icelandic: Varúðarráðstafanir sem þarf að gera áður en lyfið er gefið Fyrir lyfjagjöf skal þynna Removab innrennslisþykkni með 9 mg/ml (0,9%) natríumklóríð stungulyfi, lausn.
English: Removab must be administered as an intraperitoneal infusion only.
Icelandic: Removab á aðeins að gefa sem innrennsli í kviðarhol.
English: An updated RMP should be submitted:
Icelandic: eftirfarandi upptalningu:
English: In three patients (0.4%) an intensity of CTCAE grade 4 was observed.
Icelandic: Vart varð við CTCAE stig 4 hjá 3 sjúklingum (0,4%).
English: For each syringe a new cannula is used.
Icelandic: Nota skal nýja dælu fyrir hverja sprautu.
English: 3 Perfusion Tubing (1 mm inner diameter, 150 cm length) 5 Perfusion Lead
Icelandic: 2 Removab lausn fyrir innrennsli í kviðarhol 3 Gegnflæðisslöngur (1 mm að innra þvermáli, 150 cm að lengd)
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.
Icelandic: Öllu innihaldi sprautunnar (Removab þykkni auk loftstuðpúða) úr áfylltri sprautunni skal sprauta beint í natríumklóríð stungulyfi, lausn 9 mg/ml (0,9%).
English: Paracentesis (control) (N=88)
Icelandic: Ástunga (samanburður) (N=88)
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.
Icelandic: Samtímis hverri notkun Removab skal gefa innrennsli með 250 ml af 9 mg/ml (0,9%) natríumklóríðlausn með innrennslisventli/Y-tengi í gegnflæðisleiðslu leggjarins.
English: Patients with hemodynamic insufficiency, oedema or hypoproteinaemia Blood volume, blood protein, blood pressure, pulse and renal function should be assessed before each Removab infusion.
Icelandic: Meta skal blóðmagn, prótín í blóði, blóðþrýsting, púls og nýrnastarfsemi fyrir hvert innrennsli með Removab.
English: The EpCAM antigen is overexpressed on most carcinomas (Table 2).
Icelandic: Ofuráhersla er lögð á EpCAM CD3 mótefnavakann í tengslum við krabbamein (Tafla 2).
English: Removab contains the active substance catumaxomab, a monoclonal antibody.
Icelandic: Removab inniheldur virka innihaldsefnið catumaxomab sem er einstofna mótefni.
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.
Icelandic: Vega þarf og meta kosti brjóstagjafar fyrir barnið og ávinning meðferðar fyrir konuna og ákveða á grundvelli matsins hvort hætta eigi brjóstagjöf eða hætta/stöðva tímabundið meðferð með Removab.
English: Pre-filled syringe
Icelandic: Frárennsli skinuholsvökva
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.
Icelandic: Removab innrennslislausninni er tóm skal skipta henni út fyrir 50 ml sprautu með 20 ml af 9 mg/ml (0,9%) natríumklóríð, stungulyf, lausn, þar til tilætluðum innrennslistíma er lokið til að hreinsa út það sem eftir er í gegnflæðisleiðslunni (u.þ.b. 2 ml) við óbreyttar aðstæður.
English: Median puncture-free survival (days) 95% CI for median (days) p-value (log-rank test)
Icelandic: Miðgildi lifunar án ástungu (dagar) 95% CI fyrir miðgildi (dagar) p-gildi (log-rank próf)
English: Proteinuria.
Icelandic: Prótínmiga.
English: Only in case of clinically relevant or persisting increase further diagnostics or therapy should be considered.
Icelandic: Frekari sjúkdómsgreining eða meðferð er því aðeins nauðsynleg ef klínískt mikilvæg eða varanleg aukning kemur fram.
English: Store in a refrigerator.
Icelandic: Aðeins til notkunar í kviðarhol.
English: Removab dosing schedule comprises the following four intraperitoneal infusions: 1st dose
Icelandic: Removab skammtaáætlunin felur í sér fjögur skipti innrennslis í kviðarhol skv.
English: • The pump speed is adjusted according to the volume to be administered and the scheduled infusion time.
Icelandic: Stillið dæluhraðann til samræmis við það rúmmál lyfs sem gefa á og tilætlaðan innrennslistíma.
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.
Icelandic: Eftir það skal gefa innrennsli með 500 ml af 9 mg/ml (0,9%) natríumklóríðlausn fyrir hverja lyfjagjöf með Removab til að hjálpa til við dreifingu mótefnisins í kviðarholi.
English: Cytokine release syndrome*, hypersensitivity*.
Icelandic: Frumuboðalosunarheilkenni*, ofnæmi*.
English: PHARMACEUTICAL FORM Concentrate for solution for infusion.
Icelandic: Leiðbeiningar um þynningu fyrir lyfjagjöf.
English: LIST OF EXCIPIENTS Sodium citrate, citric acid monohydrate, polysorbate 80, water for injections
Icelandic: HJÁLPAREFNI Natríumsítrat, sítrínsýrueinhýdrat, pólýsorbat 80, vatn fyrir stungulyf
English: Respiratory, thoracic and mediastinal disorders Common
Icelandic: Öndunarfæri, brjósthol og miðmæti
English: Ascites drainage
Icelandic: - Vökvaskortur
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).
Icelandic: Í samræmi við skammtinn skal ná viðeigandi magni af natríumklóríð stungulyfi, lausn 9 mg/ml (0,9%) upp í 50 ml sprautu (Tafla 7).
English: The diluted Removab solution for infusion is administered intraperitoneally as constant rate infusion using an adequate pump system.
Icelandic: Þynnta lausnina skal svo gefa sem innrennsli í kviðarhol með stöðugu innrennsli og viðeigandi dælingarkerfi.
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)
Icelandic: Í frumathugun (feasibility study) þar sem lagt var mat á gjöf annarrar innrennslislotu í kviðarhol með 10, 20, 50 og 150 míkrógrömmum af catumaxomab hjá 8 sjúklingum með illkynja skinuholsvökva af völdum krabbameins (IP-CAT-AC-04) greindist mótefni gegn lyfinu í öllum fáanlegum vökvasýnum og blóðvökvasýnum við skimun.
English: • 50 ml polypropylene syringes
Icelandic: 50 ml pólýprópýlen sprautur
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Removab 10 micrograms concentrate for solution for infusion catumaxomab
Icelandic: HEITI LYFS OG ÍKOMULEIÐ(IR) Removab 10 míkrógrömm innrennslisþykkni, lausn catumaxomab
English: What you need to know before you use Removab
Icelandic: Áður en byrjað er að nota Removab
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Removab 50 micrograms concentrate for solution for infusion catumaxomab
Icelandic: HEITI LYFS OG ÍKOMULEIÐ(IR) Removab 50 míkrógrömm innrennslisþykkni, lausn catumaxomab
English: Sodium chloride 9 mg/ml (0.9%) solution for injection
Icelandic: 9 mg/ml (0,9%) natríumklóríð stungulyfi, lausn
English: 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.
Icelandic: EpCAM jákvæðs krabbameins með ástungu og catumaxomab skilaði tölfræðilega marktækt meiri árangri en meðferðin með ástungu einni saman, þegar átt er við lifun án ástungu og tímann þegar fyrst kemur fram þörf á læknismeðferð með ástungu vegna skinuholsvökva.
English: infusions in doses of 10, 20, 50 and 150 micrograms on day 0, 3, 7 and 10, respectively, in both groups.
Icelandic: Catumaxomab var gefið sem fjögur þriggja klukkustunda stöðug innrennsli í kviðarhol í skömmtunum 10, 20, 50 og 150 míkrógrömm á dögum 0, 3, 7 og 10, í þessari röð, í báðum hópum.
English: Dyspnoea*, pleural effusion*, cough.
Icelandic: Mæði*, fleiðruvökvi*, hósti.
English: In one patient (0.1%) dyspnoea and in 3 patients (0.4%) hypotension was reported in CTCAE grade 4 intensity.
Icelandic: Tilkynnt var um mæði hjá einum sjúklingi (0,1%) og lágþrýsting hjá 3 sjúklingum (0,4%) á CTCAE stigi 4. Unnt er að fyrirbyggja eða bæta úr einkennum um verki og sótthita með forlyfjagjöf (sjá kafla 4.2 og 4.4).
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.
Icelandic: Catumaxomab reyndist árangursríkt við eyðingu æxlisfrumna in vitro, bæði hvað varðar markfrumur með lága og háa tjáningu EpCAM mótefnavakans, óháð tegund upphaflegs æxlis.
English: • The pre-filled syringe cannula is inserted through the 50 ml syringe opening so that the cannula is immersed in the sodium chloride 9 mg/ml (0.9%) solution for injection (Figure 2).
Icelandic: Setja skal dælu áfylltu sprautunnar inn í opið á 50 ml gegnflæðissprautunni svo að nálin baðist í natríumklóríð stungulyfi, lausn 9 mg/ml (0,9%) (Mynd 2).
English: Infection.
Icelandic: - Ofnæmi
English: 10 micrograms pre-filled syringe
Icelandic: 10 míkrógrömm, áfyllt sprauta
English: • polyethylene perfusion tubings with an inner diameter of 1 mm and a length of 150 cm
Icelandic: • pólýetýlen gegnflæðisslöngubúnaður, 1 mm að innra þvermáli og 150 cm að lengd
English: • The perfusion tubing is connected to the Y-connection.
Icelandic: Tengið gegnflæðisslönguna við Y-tengið.
English: Headache, dizziness.
Icelandic: Blóð og eitlar
English: Some of these side effects may require medical treatment.
Icelandic: Hugsanlega þarf að meðhöndla þessar aukaverkanir.
English: Infusion-related side effects
Icelandic: Aukaverkanir sem tengjast meltingarfærum
English: Removab 50 micrograms concentrate for solution for infusion catumaxomab
Icelandic: Removab 50 míkrógrömm innrennslisþykkni, lausn catumaxomab
English: Common serious side effects (may affect up to 1 in 10 people): - Loss of appetite - Dehydration - Reduction in red blood cells (anaemia) - Decreased blood levels of calcium and sodium - A very fast heart beat - High or low blood pressure - Abdominal pain accompanied by difficulty or blockage passing stools, constipation - Shortness of breath - Accumulation of fluid around the lungs which cause chest pain and breathlessness - Inflammation of the bile ducts - Skin redness, rash - Very fast heartbeat, fever, shortness of breath, feeling faint or light-headed - Complex of reactions due to the release of mediators of inflammation - Worsening of general state of health, generally feeling unwell and weak - Fluid retention - Hypersensitivity
Icelandic: - Kviðverkur samfara erfiðleikum við hægðalosun eða hægðastíflu, hægðatregða - Mæði - Vökvasöfnun kringum lungu sem veldur brjóstverk og andnauð - Bólga í gallrásum - Húðroði, útbrot - Mjög hraður hjartsláttur, hiti, mæði, yfirliðs- eða vönkunartilfinning
English: Removab 10 micrograms concentrate for solution for infusion catumaxomab
Icelandic: Removab 10 míkrógrömm innrennslisþykkni, lausn catumaxomab
English: 50 ml Syringe
Icelandic: 50 ml sprauta
English: Uncommon Thrombocytopenia*, coagulopathy*.
Icelandic: Lungnasegarek*, vefildisskortur*.
English: Conditions such as hypovolaemia, hypoproteinaemia, hypotension, circulatory decompensation and acute renal impairment must be resolved prior to each Removab infusion.
Icelandic: Ráða verður bót á ástandi svo sem blóðþurrð, blóðpróteinskorti, lágþrýstingi, blóðrásarbilun og bráðri skerðingu á starfsemi nýrna fyrir hvert Removab innrennsli.
English: The overall safety profile of Removab is characterised by cytokine-release related symptoms and gastrointestinal reactions.
Icelandic: Heildaröryggisupplýsingar varðandi Removab greina frá einkennum tengdum frumuboðalosun og einkennum frá meltingarfærum.
English: As secondary efficacy endpoint overall survival (Table 6) was assessed.
Icelandic: Heildarlifun (tafla 6) var metin sem aukaendapunktur fyrir verkun.
English: Patients of nonCaucasian origin have not been included in these clinical studies.
Icelandic: Ekki hafa aðrir sjúklingar en hvítir einstaklingar verið teknir með í klínískum rannsóknum.
English: Renal and urinary disorders Common
Icelandic: Lifur og gall Algengar
English: What Removab contains - The active substance is catumaxomab (10 micrograms in 0.1 ml, corresponding to 0.1 mg/ml).
Icelandic: - Virka innihaldsefnið er catumaxomab (10 míkrógrömm í 0,1 ml, samsvarar 0,1 mg/ml).
English: 6 Catheter
Icelandic: 6.3 Geymsluþol
English: What Removab contains - The active substance is catumaxomab (50 micrograms in 0.5 ml, corresponding to 0.1 mg/ml).
Icelandic: - Virka innihaldsefnið er catumaxomab (50 míkrógrömm í 0,5 ml, samsvarar 0,1 mg/ml).
English: One pre-filled syringe contains 10 micrograms catumaxomab in 0.1 ml solution, corresponding to 0.1 mg/ml.
Icelandic: VIRK(T) EFNI Ein áfyllt sprauta inniheldur 10 míkrógrömm catumaxomab í 0,1 ml lausn, sem samsvarar 0,1 mg/ml.
English: 3rd dose
Icelandic: 3. skammtur
English: Removab must be administered intraperitoneally over an infusion time of at least 3 hours via a constant infusion pump system as described below:
Icelandic: Removab skal gefa í kviðarhol með innrennslistíma sem nemur minnst 3 klst.
English: The remaining sodium chloride 9 mg/ml (0.9%) solution for injection can be discarded.
Icelandic: Fleygja má því 9 mg/ml (0,9%) natríumklóríð stungulyfi, lausn sem eftir er.
English: One pre-filled syringe contains 50 micrograms catumaxomab in 0.5 ml solution, corresponding to 0.1 mg/ml.
Icelandic: VIRK(T) EFNI Ein áfyllt sprauta inniheldur 50 míkrógrömm catumaxomab í 0,5 ml lausn, sem samsvarar 0,1 mg/ml.
English: Hepatobiliary disorders
Icelandic: Margfeldismeðaltal
English: Gastric
Icelandic: Algengar
English: 3rd infusion 50 micrograms
Icelandic: 3. innrennsli 50 míkrógrömm
English: Uncommon serious side effects (may affect up to 1 in 100 people): - Lumps under the skin on the back of the legs that may become sores and leave scars - Inflammation and pain or burning and stinging in the area around the catheter - Reduction in number of blood platelets, blood clotting problems - Bleeding in the stomach or gut, shown by the vomiting of blood or the passage of red or black stools - Skin reaction, severe allergic skin reaction (dermatitis) - Fits - Lung problems including blood clot in the lungs - Low blood oxygen levels - Severe kidney problems - Extravasation (inadvertent leakage of administered medicinal product from the intraperitoneal catheter system into surrounding tissue)
Icelandic: - Blæðing í maga eða iðrum, kom fram í blóði í uppköstum eða sem rauðar eða svartar hægðir - Húðviðbrögð, alvarleg húðofnæmisviðbrögð (húðbólga) - Köst - Lungnavandamál, að meðtöldum blóðtappa í lungum
English: What is in this leaflet
Icelandic: á svæðinu kringum legginn
English: 50 micrograms pre-filled syringe
Icelandic: 50 míkrógrömm, áfyllt sprauta
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
Icelandic: - Lækkað magn próteina í blóði - Aukning gallrauða í blóði - Snúningstilfinning - Meltingartruflanir, magavandamál, brjóstsviði, uppþemba, vindgangur, munnþurrkur
English: Number of Removab pre-filled syringe(s)
Icelandic: Samantektir um öryggi lyfsins (PSUR)
English: These reactions resolved under symptomatic treatment.
Icelandic: Þessar aukaverkanir hjöðnuðu þegar einkennin voru meðhöndluð.
English: Colon
Icelandic: Bris
English: Paediatric population There is no relevant use of Removab in the paediatric population in the granted indication.
Icelandic: Börn Notkun Removab á ekki við hjá börnum við samþykkta ábendingu.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One pre-filled syringe contains 10 micrograms of catumaxomab* in 0.1 ml solution, corresponding to 0.1 mg/ml.
Icelandic: Ein áfyllt sprauta inniheldur 10 míkrógrömm af catumaxomab* í 0,1 ml lausn sem samsvarar 0,1 mg/ml.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One pre-filled syringe contains 50 micrograms of catumaxomab* in 0.5 ml solution, corresponding to 0.1 mg/ml.
Icelandic: Ein áfyllt sprauta inniheldur 50 míkrógrömm af catumaxomab* í 0,5 ml lausn sem samsvarar 0,1 mg/ml.
English: • The connected perfusion tubing equipment of the precision pump is prefilled with the diluted Removab solution for infusion.
Icelandic: Fyllið á tengdan gegnflæðisslöngubúnað á mælingardælunni með þynntri Removab innrennslislausninni.
English: The catheter for intraperitoneal administration should be placed under ultrasound guidance by a physician experienced in intraperitoneal administration procedures.
Icelandic: Legg fyrir lyfjagjöf í kviðarhol á að setja inn með aðstoð ómtækis í umsjón læknis með reynslu af framkvæmd lyfjagjafar í kviðarhol.
English: Table 7 Preparation of Removab solution for intraperitoneal infusion Number of infusion / Dose
Icelandic: Undirbúningur Removab lausnar fyrir innrennsli í kviðarhol Fjöldi innrennsla
English: General disorders and administration site conditions Very common Pyrexia*, fatigue*, chills*.
Icelandic: Almennar aukaverkanir og aukaverkanir á íkomustað Mjög algengar Sótthiti*, þreyta*, kuldahrollur*.