FrancophonIA/ELRC3.0 huggingface dataset:
English: • polypropylene
Danish: • polypropylen
English: versus 12.2 % Grades 3-4), increased AST (57.5 % versus 50.2 % all grades; 3.1 % versus 1.7% Grades 3-4), stomatitis (50.1 % versus 32.9 % all grades; 12.8 % versus 4.6 % Grades 3-4), fatigue (47.8 % versus 39.0 % all grades; 12.6 % versus 7.8 % Grade 3-4), thrombocytopenia (47.4 % versus 33.8 % all grades; 3.3 % versus 1.7 % Grades 3-4), increased ALT (47.3 % versus 37.1 % all grades; 2.7 % versus 2.2 % Grades 3-4), decreased appetite (31.9 % versus 23.8 % all grades; 3.4 % versus 1.8 % Grade 3-4), weight loss (31.9 % versus 14.4 % all grades; 2.6 % versus 0.8 % Grades 3-4), dysphonia (25.4 % versus 3.3 % all grades; 0.5 % versus 0 Grades 3-4), headache (22.3 % versus 8.8 % all grades; 1.6 % versus 0.3 % Grades 3-4), asthenia (18.3 % versus 13.2 % all grades; 5.1% versus 3.0 % Grades 3-4), Palmar- Plantar Erythrodysaesthesia syndrome (11.0 % versus 4.3 % all grades; 2.8 % versus 0.5 % Grades 3-4), and skin hyperpigmentation (8.2 % versus 2.8 % all grades; 0 versus 0 Grades 3-4).
Danish: Yderligere bivirkninger og laboratorieanomalier rapporteret med en ≥5 % forskel (alle grader) hos patienter behandlet med ZALTRAP/FOLFIRI-regimet versus placebo/FOLFIRI-regimet Følgende bivirkninger og unormale laboratorieværdier blev rapporteret med ≥5 % forskel (alle grader) hos patienterne i ZALTRAP-armen versus placeboarmen (sorteret efter faldende frekvens): leukopeni (78,3 % versus 72,4 % alle grader; 15,6 % versus 12,2 % grad 3-4), forhøjet ASAT (57,5 % versus 50,2 % alle grader; 3,1 % versus 1,7 % grad 3-4), stomatitis (50,1 % versus 32,9 % alle grader; 12,8 % versus 4,6 % grad 3-4), træthed (47,8 % versus 39,0 % alle grader; 12,6 % versus 7,8 % grad 3-4), trombocytopeni (47,4 % versus 33,8 % alle grader; 3,3 % versus 1,7 % grad 3-4), forhøjet ALAT (47,3 % versus 37,1 % alle grader; 2,7 % versus 2,2 % grad 3-4), nedsat appetit (31,9 % versus 23,8 % alle grader; 3,4 % versus 1,8 % grad 3-4), vægttab (31,9 % versus 14,4 % alle grader; 2,6 % versus 0,8 % grad 3-4), dysfoni (25,4 % versus 3,3 % alle grader; 0,5 % versus 0 grad 3-4), hovedpine (22,3 % versus 8,8 % alle grader; 1,6 % versus 0,3 % grad 3-4), asteni (18,3 % versus 13,2 % alle grader; 5,1 % versus 3,0 % grad 3-4), palmoplantar erytrodysæstesisyndrom (11,0 % versus 4,3 % alle grader; 2,8 % versus 0,5 % grad 3-4), hyperpigmentering af huden (8,2 % versus 2,8 % alle grader; 0 versus 0 grad 3-4).
English: Do not use this medicine after the expiry date which is stated on the outer carton and on the label of the vial after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen og på hætteglassets etiket efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: • you have or have had an aneurysm (enlargement and weakening of a blood vessel wall) or a tear in a blood vessel wall.
Danish: • du har eller har haft et aneurisme (udvidelse og svækkelse af en blodårevæg) eller en rift i en blodårevæg.
English: • pain in the mouth or throat
Danish: • smerter i munden eller halsen
English: If you experience changes in your vision or confusion, your doctor may stop your treatment with ZALTRAP.
Danish: Hvis du oplever ændringer på dit syn eller forvirring, kan lægen stoppe behandlingen med ZALTRAP.
English: Circulating concentrations of VEGF-bound aflibercept increase with the aflibercept dose until most available VEGF is bound.
Danish: Cirkulerende koncentrationer af VEGF-bundet aflibercept øges med afliberceptdosen indtil det meste tilgængelige VEGF er bundet.
English: Leucopenia (2) Neutropenia (2)
Danish: Leukopeni (2) Neutropeni (2)
English: Caution should be exercised when treating patients with history of clinically significant cardiovascular disease such as coronary artery disease, or congestive heart failure with ZALTRAP.
Danish: Der skal udvises forsigtighed ved behandling af patienter med klinisk signifikant kardiovaskulær sygdom, såsom koronararteriesygdom eller kongestiv hjerteinsufficiens, i anamnesen.
English: Patients treated with ZALTRAP have an increased risk of haemorrhage, including severe and sometimes fatal haemorrhagic events.
Danish: Patienter, som behandles med ZALTRAP, har en øget risiko for blødninger, inklusive alvorlige og undertiden dødelige blødningshændelser.
English: • Bleeding: Very common (may affect more than 1 in 10 people) - this includes bleeding from the nose, but may also include severe bleeding in your gut and other parts of the body, which may lead to death.
Danish: • Blødning: Meget almindeligt (kan påvirke mere end 1 ud af 10 personer) - dette omfatter blødning fra næsen, men kan også omfatte alvorlige blødninger i dine tarme og andre dele af kroppen, og de kan være dødelige.
English: FOLFIRI Dose modification when used in combination with ZALTRAP Severe stomatitis and Palmar-Plantar Erythrodysaesthesia syndrome
Danish: Dosisjustering ved anvendelse i kombination med ZALTRAP Svær stomatitis og palmoplantar erytrodysæstesisyndrom
English: sanofi-aventis groupe 54, rue La Boétie 75008 Paris France
Danish: sanofi-aventis groupe 54, rue La Boétie 75008 Paris Frankrig
English: In full-thickness excisional and incisional skin wound models, aflibercept administration reduced fibrous response, neovascularisation, epidermal hyperplasia/re-epithelialisation, and tensile strength.
Danish: I fuld-tykkelses excisions- og incisions-hudsårsmodeller reducerede aflibercept-administration fibrøs respons, neovaskulisering, epidermal hyperplasi/re-epitelisering og strækstyrke.
English: Seventeen (17) patients treated with ZALTRAP (1.6 %) and two (2) placebo-treated patients (0.2 %) were also positive in the neutralising antibody assay.
Danish: Sytten (17) patienter behandlet med ZALTRAP (1,6 %) og to (2) placebo-behandlede patienter (0,2 %) havde også positiv analyse for neutraliserende antistof.
English: Administration of the ZALTRAP/FOLFIRI should be delayed until platelet count is 75 x 10
Danish: Administration af ZALTRAP/FOLFIRI bør udsættes, indtil trombocyttallet er 75 x 10
English: • Pain in the mouth, teeth and/or jaw, swelling or non-healing sores in the mouth or jaw, discharge, numbness or a feeling of heaviness in the jaw, or loosening of a tooth: Uncommon (may affect up to 1 in 100 people) - These symptoms could be signs of bone damage in the jaw (osteonecrosis).
Danish: • Smerte i mund, tænder og/eller kæbe, hævelse eller sår der ikke vil hele i mund eller kæbe, udflåd, følelsesløshed eller en følelse af tyngde i kæben, eller løse tænder: Ikke almindelig (kan påvirke op til 1 ud af 100 personer) - Disse symptomer kan være tegn på knogleskade i kæben (osteonekrose).
English: Monitoring of complete blood count (CBC) with differential count is recommended at baseline and prior to initiation of each cycle of aflibercept.
Danish: Komplet blodtælling (CBC) med differentialtælling anbefales ved baseline og før initiering af hver cyklus med aflibercept.
English: ZALTRAP is a sterile, preservative-free and non-pyrogenic concentrate, therefore the solution for infusion should be prepared by a healthcare professional using safe-handling procedures and aseptic technique.
Danish: ZALTRAP er et sterilt, konserveringsmiddelfrit og nonpyrogent koncentrat, derfor bør infusionsopløsningen klargøres af sundhedspersonale under anvendelse af sikre håndteringsprocedurer og aseptisk teknik.
English: Aflibercept is produced by recombinant DNA technology in a Chinese hamster ovary (CHO) K-1 mammalian expression system.
Danish: Aflibercept fremstilles ved rekombinant DNA-teknologi i et kinesisk hamsterovarie (CHO) K-1 pattedyrs-ekspressionssystem.
English: Aflibercept should be permanently discontinued if hypertension cannot be adequately managed with appropriate anti-hypertensive therapy or aflibercept dose reduction, or if hypertensive crisis or hypertensive encephalopathy occurs (see section 4.2).
Danish: Aflibercept bør seponeres permanent, hvis hypertensionen ikke kan kontrolleres i tilstrækkelig grad med egnet antihypertensionsbehandling eller reduktion af afliberceptdosis, eller hvis der opstår hypertensiv krise eller hypertensiv encefalopati (se pkt.
English: In sexually mature male cynomolgus monkeys a decrease in sperm motility and an increase in incidence of morphological abnormalities of spermatozoa were observed.
Danish: Hos seksuelt modne han-cynomolgusaber observeredes der et fald i spermmotiliteten og en øget forekomst af morfologiske abnormaliteter i spermatozoer.
English: The European Medicines Agency has waived the obligation to conduct studies with ZALTRAP in all subsets of the paediatric population in adenocarcinoma of the colon and rectum (see section 4.2 for information on paediatric use).
Danish: Det europæiske lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med ZALTRAP i alle undergrupper af den pædiatriske population ved adenokarcinom i colon og rektum (se pkt.
English: ZALTRAP may affect male and female fertility.
Danish: ZALTRAP kan påvirke både mænds og kvinders frugtbarhed.
English: In these patients, non-renal events were generally comparable between patients with renal impairment and those without renal impairment, except a > 10 % higher incidence in dehydration (all grades) was noted (see section 4.4).
Danish: Hos disse patienter var ikke-renale bivirkninger generelt sammenlignelige hos patienter med nedsat nyrefunktion og patienter uden nedsat nyrefunktion bortset fra, at der blev set en >10 % højere forekomst af dehydrering (alle grader) (se pkt.
English: Posterior reversible encephalopathy syndrome (PRES) PRES was not reported in the pivotal phase III study of MCRC patients.
Danish: Posterior reversibelt encefalopatisyndrom (PRES) PRES blev ikke rapporteret i det pivotale fase III-studie med mCRC-patienter.
English: Treatment with ZALTRAP is associated with potential for compromised wound healing (wound dehiscence, anastomotic leakage).
Danish: Behandling med ZALTRAP er forbundet med risiko for kompromitteret sårheling (sårruptur, anastomotisk lækage).
English: • you have illnesses where your gut is inflamed, such as an infected section of the bowel wall (also called ‘diverticulitis'), stomach ulcers or colitis.
Danish: • du har en sygdom, der involverer betændelse i dine tarme, såsom infektion i en del af tarmvæggen (også kaldet ‘diverticulitis'), mavesår eller colitis.
English: In patients, ZALTRAP is administered at the dose of 4 mg/kg intravenously every two weeks for which there is an excess of circulating free aflibercept compared to VEGF-bound aflibercept.
Danish: Hos patienter administreres ZALTRAP i en dosis på 4 mg/kg intravenøst hver anden uge, for hvilken der er overskydende mængde cirkulerende frit aflibercept sammenlignet med VEGF-bundet aflibercept.
English: • you have had any abnormal tube-like connections or passageways inside the body between internal organs and skin or other tissues (also called ‘fistula').
Danish: • du har haft abnorme rørlignende forbindelser eller passager i kroppen mellem de indre organer og huden eller andre væv (også kaldet ‘fistler').
English: In the pivotal MCRC study, 28.2 % of patients were aged ≥ 65 and < 75 and 5.4 % of patients were aged ≥ 75.
Danish: I det pivotale mCRC-studie var 28,2 % af patienterne i alderen ≥65 og <75, og 5,4 % af patienterne var ≥75.
English: Patients should be monitored for signs and symptoms of GI bleeding and other severe bleeding.
Danish: Patienterne skal monitoreres for tegn og symptomer på GI-blødning og andre svære blødninger.
English: Patients should be monitored for signs and symptoms of GI perforation.
Danish: Patienterne bør monitoreres for tegn og symptomer på GI-perforation.
English: In the few patients with severe renal impairment, drug exposure was similar to that observed in patients with normal renal function.
Danish: Hos nogle få patienter med svært nedsat nyrefunktion svarede lægemiddeleksponeringen til det, der observeredes hos patienter med normal nyrefunktion.
English: Aflibercept should be suspended for at least 4 weeks prior to elective surgery.
Danish: Aflibercept bør seponeres i mindst 4 uger forud for elektiv kirurgi.
English: A side effect called osteonecrosis (bone damage in the jaw) has been reported in cancer patients treated with ZALTRAP.
Danish: En bivirkning kaldet osteonekrose (knogleskade i kæben) er rapporteret hos kræftpatienter behandlet med ZALTRAP.
English: High-titre antibody responses to aflibercept were not detected in any patients.
Danish: Højtiter antistofrespons på aflibercept blev ikke detekteret hos nogen patienter.
English: Dehydration (1)
Danish: Dehydrering (1)
English: • A side effect which affects your nervous system (called ‘posterior reversible encephalopathy syndrome' or PRES): Uncommon (may affect up to 1 in 100 people) - signs may include headache, sight changes, feeling confused or fits with or without high blood pressure.
Danish: • En bivirkning, der påvirker dit nervesystem (kaldet ‘posterior reversibelt encefalopatisyndrom' eller PRES): Ikke almindeligt (kan påvirke op til 1 ud af 100 personer)symptomerne kan omfatte hovedpine, synsforandringer, en følelse af forvirring eller anfald med eller uden forhøjet blodtryk.
English: Infection (1)
Danish: Infektion (1)
English: ZALTRAP should be discontinued in patients with life-threatening (Grade 4) thromboembolic events (including pulmonary embolism) (see section 4.2).
Danish: ZALTRAP bør seponeres hos patienter med livstruende (grad 4) tromboemboli (inklusive lungeemboli) (se pkt.
English: • PVC containing DEHP infusion bags or polyolefin infusion bags should be used.
Danish: • Der bør anvendes infusionsposer af PVC indeholdende DEHP eller polyolefin infusionsposer.
English: 11.1 (8.5 to 13.8)
Danish: 11,1 (8,5 til 13,8)
English: Disposal Any unused medicine or waste material should be disposed of in accordance with local requirements.
Danish: Bortskaffelse Ikke anvendt lægemiddel samt affald heraf skal bortskaffes i henhold til lokale retningslinjer.
English: In a population pharmacokinetic analysis with data from 1,507 patients with various types of advanced malignancies receiving ZALTRAP with or without chemotherapy, 63 patients with mild hepatic impairment (total bilirubin > 1.0 x - 1.5 x ULN and any AST) and 5 patients with moderate hepatic impairment (total bilirubin > 1.5 x - 3 x ULN and any AST) were treated with ZALTRAP.
Danish: I en populationsfarmakokinetisk analyse med data fra 1507 patienter med forskellige typer fremskredene maligniteter, som modtog ZALTRAP med eller uden kemoterapi, blev 63 patienter med mildt nedsat leverfunktion (totalt bilirubin >1,0 x - 1,5 x ULN og evt. ASAT) og 5 patienter med moderat nedsat leverfunktion (totalt bilirubin >1,5 x - 3 x ULN og evt. ASAT) blev behandlet med ZALTRAP.
English: It may also present itself as a sudden numb or weak feeling in the face, arms, or legs.
Danish: Det kan også vise sig som en pludselig følelsesløshed eller svaghedsfølelse i ansigt, arme eller ben.
English: Osteonecrosis of the jaw (ONJ) Cases of ONJ have been reported in cancer patients treated with Zaltrap, several of whom had received prior or concomitant treatment with intravenous bisphosphonates, for which ONJ is an identified risk.
Danish: Tilfælde af ONJ er rapporteret hos cancerpatienter behandlet med ZALTRAP, hvoraf flere havde fået tidligere eller samtidig behandling med intravenøse bisfosfonater, for hvilke ONJ er en kendt risiko.
English: Tell your doctor and dentist immediately if you experience such symptoms while being treated with ZALTRAP or after stopping treatment.
Danish: Fortæl det straks til din læge og tandlæge hvis du oplever disse symptomer, mens du behandles med ZALTRAP, eller efter behandlingen er ophørt.
English: Adverse reactions in Table 1 are defined as either any adverse clinical reaction or laboratory abnormality having ≥ 2 % greater incidence (all grades) in the aflibercept treatment group in comparison to the placebo treatment group in the MCRC study including those that do not meet this threshold but were consistent with the anti-VEGF class and were seen in any study with aflibercept.
Danish: Bivirkninger i Tabel 1 er defineret som enten en klinisk bivirkning eller laboratorieabnormitet med ≥2 % højere incidens (alle grader) i aflibercept-armen i forhold til placeboarmen i mCRC-studiet, inklusive dem, der ikke nåede denne grænse, men stemte overens med anti-VEGF-klassen og blev observeret i et studie med aflibercept.
English: • painful sores in the mouth
Danish: • smertende sår i munden
English: Corresponding data in patients with RAS mutant type tumours showed a HR for OS of 0.9 (0.7-1.2) with median 12.6 and 11.2 months for aflibercept and placebo, respectively.
Danish: Tilsvarende data hos patienter med RAS-muterede tumorer viste HR for OS på 0,9 (0,7-1,2) med en median på henholdsvis 12,6 og 11,2 måneder for aflibercept og placebo.
English: Neutropenic infection/sepsis (1) Urinary tract infection Nasopharyngitis
Danish: Neutropenisk infektion/sepsis (1) Urinvejsinfektion Nasofaryngitis
English: It is recommended that aflibercept not be initiated for at least 4 weeks following major surgery and not until the surgical wound is fully healed.
Danish: Det anbefales, at afliberceptbehandling ikke initieres i mindst 4 uger efter større indgreb, og ikke før operationssåret er fuldt ophelet.
English: ZALTRAP is given by a drip (infusion) into one of your veins (‘intra-venous') to treat advanced cancers of the colon or rectum.
Danish: ZALTRAP gives som et drop (infusion) i en af dine blodårer (‘intravenøst') for at behandle kræft i tyktarm eller endetarm.
English: A population pharmacokinetic analysis was conducted with data from 1,507 patients with various types of advanced malignancies receiving ZALTRAP with or without chemotherapy.
Danish: En populationsfarmakokinetisk analyse blev gennemført med data fra 1507 patienter med forskellige typer fremskredne maligniteter, som modtog ZALTRAP med eller uden kemoterapi.
English: If this should happen to you, your doctor will stop your treatment with ZALTRAP.
Danish: Hvis dette skulle ske for dig, vil lægen stoppe behandlingen med ZALTRAP.
English: Of the 611 patients treated with the ZALTRAP/FOLFIRI regimen in the pivotal study of MCRC patients, 172 (28.2 %) were aged ≥ 65 and < 75 and 33 (5.4 %) were age ≥ 75.
Danish: Ud af de 611 patienter, som blev behandlet med ZALTRAP/FOLFIRI-regimet i det pivotale studie med mCRC-patienter, var 172 (28,2 %) i alderen ≥65 og <75, og 33 (5,4 %) var ≥75.
English: For minor surgery such as central venous access port placement, biopsy, and tooth extraction, aflibercept may be initiated/restarted once the surgical wound is fully healed.
Danish: Ved mindre indgreb som anlæggelse af centralt venekateter, biopsi og tandudtrækning kan aflibercept initieres/genstartes, når operationssåret er fuldt ophelet.
English: PRES may present with altered mental status, seizure, nausea, vomiting, headache, or visual disturbances.
Danish: PRES kan præsentere sig med ændret mental status, kramper, kvalme, opkastning, hovedpine eller synsforstyrrelser.
English: There was no effect of age on the pharmacokinetics of free aflibercept.
Danish: Der var ingen aldersindvirkning på frit aflibercepts farmakokinetik.
English: Thrombotic and embolic events
Danish: Trombotiske og emboliske hændelser
English: NN:
Danish: SN: NN:
English: Very common (may affect more than 1 in 10 people)
Danish: Meget almindeligt (kan påvirke mere end 1 ud af 10 personer)
English: Adverse reactions and laboratory abnormalities reported in patients treated with the ZALTRAP/FOLFIRI regimen compared to patients treated with the placebo/FOLFIRI regimen are listed in Table 1 according to MedDRA system organ class and frequency categories.
Danish: Bivirkninger og unormale laboratorieværdier rapporteret hos patienter behandlet med ZALTRAP/FOLFIRI-regimet sammenlignet med patienter behandlet med placebo/FOLFIRI-regimet er angivet i Tabel 1 i henhold til MedDRA systemorganklasse og frekvenskategorier.
English: Other subgroup analyses for overall survival and progression free survival according to age (< 65; ≥ 65), gender, presence of liver metastasis only, history of prior hypertension, and number of organs involved, showed a treatment effect favouring the ZALTRAP/FOLFIRI regimen over the placebo/FOLFIRI regimen.
Danish: Andre subgruppeanalyser for samlet overlevelse og progressionsfri overlevelse i henhold til alder (<65; ≥65), køn, forudgående brug af bevacizumab, ECOG performance status 0 og 1, tilstedeværelse af metastaser begrænset til leveren, hypertension i anamnesen og antal involverede organer viste en behandlingseffekt til fordel for ZALTRAP/FOLFIRI-regimet i forhold til placebo/FOLFIRI-regimet.
English: • Fistula formation
Danish: • Fisteldannelse
English: • you experience fits (seizures).
Danish: • du oplever anfald (kramper).
English: It is recommended to monitor blood pressure every two weeks, including before each administration or as clinically indicated during treatment with aflibercept.
Danish: Under behandling med aflibercept anbefales det at monitorere blodtrykket hver anden uge, inklusive før hver administration, eller når det er klinisk indiceret.
English: • Grade 4 venous thromboembolic events (including pulmonary embolism)
Danish: • Grad 4 venøs tromboemboli (inklusive lungeemboli)
English: Citric acid monohydrate
Danish: Citronsyremonohydrat
English: • swelling and numbness of the hands and feet that happens with chemotherapy (called
Danish: • hævelse og følelsesløshed i hænder og fødder i forbindelse med kemoterapi (kaldet
English: • an enlargement and weakening of a blood vessel wall or a tear in a blood vessel wall (aneurysms and artery dissections)
Danish: • En udvidelse og svækkelse af en blodårevæg eller en rift i en blodårevæg (aneurismer og arterielle dissektioner).
English: Single-dose vial.
Danish: Enkeltdosis-hætteglas.
English: PRACTICAL INFORMATION FOR HEALTHCARE PROFESSIONALS ON PREPARATION AND HANDLING OF ZALTRAP 25 mg / ml CONCENTRATE FOR SOLUTION FOR INFUSION
Danish: PRAKTISKE OPLYSNINGER FOR SUNDHEDSPERSONALE VEDRØRENDE KLARGØRING OG HÅNDTERING AF ZALTRAP 25 mg/ml KONCENTRAT TIL INFUSIONSVÆSKE, OPLØSNING
English: 4.67 (4.21 to 5.36)
Danish: 4,67 (4,21 til 5,36)
English: Aflibercept administration should be suspended for ≥ 2 grams of proteinuria/24 hours and restarted when proteinuria is <2 grams/24 hours.
Danish: Aflibercept-administration bør suspenderes ved ≥2 gram proteinuri/24 timer og påbegyndes igen, når proteinurien er <2 gram/24 timer.
English: It will be given with other medicines called ‘chemotherapy', including ‘5-fluorouracil', ‘folinic acid', and ‘irinotecan'.
Danish: Det vil blive givet sammen med anden medicin kaldet ‘kemoterapi' herunder ‘5-fluoruracil', ‘folinsyre' og ‘irinotecan'.
English: Due to hyperosmolality (1000 mOsmol / kg) of the ZALTRAP concentrate, undiluted ZALTRAP concentrate must not be administered as an intravenous push or bolus.
Danish: På grund af hyperosmolalitet (1000 mOsmol/kg) af ZALTRAP-koncentratet må ufortyndet ZALTRAP ikke administreres som intravenøs indsprøjtning eller bolus.
English: For contraindications related to FOLFIRI components (irinotecan, 5-FU, and folinic acid), refer to the current respective summary of product characteristics.
Danish: For kontraindikationer relateret til FOLFIRI-komponenter (irinotecan, 5-FU og folinsyre ) henvises til de respektive produktresuméer.
English: • polyurethane
Danish: • polyurethan
English: Overall across all clinical oncology studies, similar incidence of low titre anti-drug antibody (ADA) responses (post baseline) in the ADA assay were observed in both patients treated with placebo and ZALTRAP (3.3 % and 3.8 %, respectively).
Danish: På tværs af alle kliniske onkologistudier blev der observeret samme hyppighed af lavtiter antilægemiddel-antistof (ADA) respons (post baseline) i ADA-analysen hos patienter behandlet med placebo og ZALTRAP (henholdsvis 3,3 % og 3,8 %).
English: In the event of a mild to moderate hypersensitivity reaction to ZALTRAP (including flushing, rash, urticaria, and pruritus), aflibercept should be temporarily suspended until the reaction is resolved.
Danish: I tilfælde af en let til moderat overfølsomhedsreaktion over for ZALTRAP (inklusive ansigtsrødme, udslæt, urticaria og pruritus) bør aflibercept seponeres midlertidigt, indtil reaktionen er forsvundet.