natgillin/translations-raw huggingface dataset:
• du har alvorlig eller langvarig diarré, føler dig dårlig tilpas (kvalme) eller kaster op - dette kan medføre alvorligt tab af væske (kaldet ‘dehydrering').
• you have severe or long-lasting diarrhoea, feel sick (nausea) or are being sick (vomiting) - these could cause severe loss of body fluids (called ‘dehydration').
Almene symptomer og reaktioner på administrationsstedet Meget almindelig Asteni
General disorders and administration site conditions Very common
I tilfælde af en svær overfølsomhedsreaktion (inklusive bronkospasme, dyspnø, angioødem og anafylaksi) bør aflibercept seponeres og passende medicinske foranstaltninger administreres (se pkt.
In the event of a severe hypersensitivity reaction (including bronchospasm, dyspnoea, angioedema, and anaphylaxis), aflibercept should be discontinued and appropriate medical measures should be administered (see section 4.2).
Pakningsstørrelse på 1 eller 3 hætteglas.
Pack size of 1 vial or 3 vials.
Infektioner forekom med større hyppighed hos patienterne i ZALTRAP-armen (46,2 %, alle grader; 12,3 %, grad 3-4), end hos patienterne i placeboarmen (32,7 %, alle grader; 6,9 %, grad 3-4), inklusive urinvejsinfektion, nasofaryngitis, infektion i de øvre luftveje, pneumoni, infektion af katederanlæggelsesstedet og tandinfektion.
Infections occurred at a higher frequency in patients receiving the ZALTRAP/FOLFIRI regimen (46.2 %, all grades; 12.3 %, grade 3-4) than in patients receiving the placebo/FOLFIRI regimen (32.7%, all grades; 6.9 %, grade 3-4), including urinary tract infection, nasopharyngitis, upper respiratory tract infection, pneumonia, catheter site infection, and tooth infection.
Blandt patienterne i ZALTRAP-armen som udviklede grad 3-4-hypertension, fik 54 % symptomer i løbet af de første to cykler af behandlingen (se pkt.
Among those patients treated with the ZALTRAP/FOLFIRI regimen developing grade 3-4 hypertension, 54 % had onset during the first two cycles of treatment (see section 4.4).
‘palmoplantar erytrodysæstesisyndrom')
‘Palmar-Plantar Erythrodysaesthesia syndrome')
I tilfælde af recidiverende signifikant eller svær hypertension, trods optimal behandling, bør aflibercept seponeres, indtil hypertensionen er under kontrol, og aflibercept-dosis reduceres til 2 mg/kg i efterfølgende cykler.
In case of recurrent medically significant or severe hypertension, despite optimal treatment, aflibercept should be suspended until the hypertension is controlled and the aflibercept dose should be reduced to 2 mg/kg for subsequent cycles.
Dehydrering (1) Nedsat appetit Vægttab
Dehydration (1) Decreased appetite Weight loss
Bestemt ved IVRS b Samlet overlevelse i ITT populationen, eksklusive patienter, som progredierede under eller indenfor 6 måneder efter adjuverende behandling, viste en HR (95 % CI) på 0,78 (0,68 til 0,90) [median OS (95 %) for placebo/FOLFIRI 11,9 måneder (10,88 til 13,01) og for ZALTRAP/FOLFIRI 13,8 måneder (12,68 til 15,44)].
OS in ITT population excluding patients who progressed during or within 6 months of adjuvant therapy demonstrated an HR (95 % CI) of 0.78 (0.68 to 0.90) [median OS (95 % CI) with Placebo/FOLFIRI 11.9 months (10.88 to 13.01) and with ZALTRAP/FOLFIRI 13.8 months (12.68 to 15.44)]
Blandt de 1226 randomiserede patienter fik henholdsvis 89,4 % og 90,2 % af de patienter, der behandledes med placebo/FOLFIRI og ZALTRAP/FOLFIRI-regimet, forudgående oxaliplatin-baseret kombinationskemoterapi i det metastaserende/avancerede miljø.
Among the 1,226 randomised patients, 89.4 % and 90.2 % of patients treated with the placebo/FOLFIRI and ZALTRAP/FOLFIRI regimens, respectively, received prior oxaliplatin-based combination chemotherapy in the metastatic/advanced setting.
I det pivotale mCRC-studie forekom anæmi, kvalme, opkastning, obstipation, alopeci, forhøjet basisk fosfatase og hyperbilirubinæmi hos ≥20 % af patienterne.
In the pivotal MCRC study, anaemia, nausea, vomiting, constipation, alopecia, increased alkaline phosphatase, and hyperbilirubinaemia occurred in ≥ 20 % of patients.
Cirka 10 % af patienterne (henholdsvis 10,4 % patienter behandlet med placebo/FOLFIRI-regimet og 9,8 % patienter behandlet med ZALTRAP/FOLFIRI-regimet) modtog forudgående oxaliplatin-baseret adjuverende kemoterapi og progredierede ved eller inden for 6 måneder fra gennemførelse af den adjuverende kemoterapi.
Approximately 10 % of patients (10.4 % and 9.8 % of patients treated with the placebo/FOLFIRI and ZALTRAP/FOLFIRI regimens, respectively) received prior oxaliplatin-based adjuvant chemotherapy and progressed on or within 6 months of completion of adjuvant chemotherapy.
Sanofi Aventis Deutschland GmbH Industriepark Hoechst 65926 Frankfurt am Main Tyskland
Sanofi-Aventis Deutschland GmbH Industriepark Hoechst 65926 Frankfurt am Main Germany
I tre placebo-kontrollerede kliniske fase III studier (N=352) var bivirkningerne hos ZALTRAPbehandlede patienter med let nedsat nyrefunktion ved baseline (N=352) sammenlignelige med bivirkningerne hos patienter uden nedsat nyrefunktion (N=642).
In patients receiving ZALTRAP, the adverse reactions in patients with mild renal impairment at baseline in three Phase III placebo-controlled clinical studies (N = 352) were comparable with those of patients without renal impairment (N = 642).
I tilfælde af recidiverende signifikant eller svær hypertension, trods optimal behandling, bør ZALTRAP seponeres, indtil hypertensionen er under kontrol, og dosis reduceres til 2 mg/kg i efterfølgende cykler.
In case of recurrent medically significant or severe hypertension, despite optimal treatment, ZALTRAP should be suspended until the hypertension is controlled and the dose reduced to 2 mg / kg for subsequent cycles.
Komplet blodtælling (CBC) inklusive trombocytter anbefales ved baseline, før initiering af hver cyklus med aflibercept og efter klinisk behov.
Monitoring of complete blood count (CBC) with platelets is recommended at baseline, prior to initiation of each cycle of aflibercept, and as clinically necessary.
ZALTRAP vil blive givet sammen med anden kemoterapi-medicin, herunder ‘5-fluoruracil', ‘folinsyre' og ‘irinotecan'.
ZALTRAP will be given with other chemotherapy medicines including ‘5-fluorouracil', ‘folinic acid', and ‘irinotecan'.
Febril neutropeni Trombocytopeni (2)
Febrile neutropenia Thrombocytopenia (2)
GI-perforation inklusive dødelig GI-perforation er blevet indberettet hos patienter, som blev behandlet med ZALTRAP.
GI perforation including fatal GI perforation has been reported in patients treated with ZALTRAP.
Tabel 1 - Bivirkninger rapporteret hos patienter behandlet med ZALTRAP/FOLFIRI-regimet i mCRCstudiet
Table 1 - Adverse reactions reported in patients treated with the ZALTRAP/FOLFIRI regimen from the MCRC study
Hvis det drejer sig en alvorlig blødning, vil lægen stoppe behandlingen med ZALTRAP.
If the bleeding is severe, your doctor will stop your treatment with ZALTRAP.
Hvis noget af ovenstående gælder for dig (eller du ikke er sikker), så tal med din læge, apotekspersonalet eller sundhedspersonalet, før du får ZALTRAP og under behandlingen.
If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before you are given ZALTRAP and during your treatment.
Patienten skal holdes under tæt overvågning for at monitorere eventuelle bivirkninger (se pkt.
The patient should remain under close medical supervision to monitor any adverse reactions (see section 4.8).
ZALTRAP må ikke administreres som intravitreal injektion (se punkt 2 i indlægssedlen).
ZALTRAP must not be administered as an intravitreal injection (see section 2 of the package leaflet).
5-FU-bolus bør reduceres og infusionsdosis reduceres med
5-FU bolus should be reduced and the infusion dose reduced by 20 %.
Kontakt lægen, hvis du er usikker på noget.
If you are uncertain contact your doctor.
Andre symptomer omfatter hævelse i det ene eller begge ben, smerter eller ømhed i det ene eller begge ben, når man står eller går, varme i huden på det berørte ben, rød eller misfarvet hud på det berørte ben eller synlige blodårer.
Other signs include swelling in one or both legs, pain or tenderness in one or both legs while standing or walking, warmth of the skin on the affected leg, red or discoloured skin in the affected leg or visible veins.
Symptomer på allergiske reaktioner kan omfatte udslæt eller kløe, rødmen af huden, følelse af svimmelhed eller besvimelse, stakåndethed, trykken for brystet, tillukning i halsen eller hævelse af ansigtet.
Signs of allergic reaction may include rash or itching, skin redness, feeling dizzy or faint, being short of breath, tight chest or throat, or swelling of the face.
Svær proteinuri, nefrotisk syndrom og trombotisk mikroangiopati (TMA) er observeret hos patienter behandlet med aflibercept (se pkt.
Severe proteinuria, nephrotic syndrome, and thrombotic microangiopathy (TMA) have been observed in patients treated with aflibercept (see section 4.8).
Hazard-ratio for progressionsfri overlevelse var 0,76 (0,63 til 0,91) for ECOG performance status 0 og 0,75 (0,61 til 0,92) for ECOG performance status 1.
The hazard ratio (95 % CI) of progression free survival was 0.76 (0.63 to 0.91) for ECOG performance status 0 and 0.75 (0.61 to 0.92) for ECOG performance status 1.
Før hver aflibercept-administration bør proteinuri monitoreres ved urinsticks-analyse og/eller bestemmelse af protein-kreatinin-forholdet i urinen (UPCR) for udvikling eller forværring.
Proteinuria should be monitored by urine dipstick analysis and/or urinary protein creatinine ratio (UPCR) for the development or worsening of proteinuria before each aflibercept administration.
Andre symptomer omfatter en følelse af forvirring, synsproblemer, gangproblemer, koordinationsproblemer eller balanceproblemer, problemer med at udtale ord eller sløret tale.
Other signs include feeling confused, problems with sight, walking, coordination or balance, problems in saying words or slurring of speech.
Bemærk: Bivirkninger er rapporteret ved hjælp af MedDRA version MEDDRA13.1 og gradueret ved hjælp af NCI CTC version 3.0 (1) Se "Beskrivelse af udvalgte bivirkninger" i dette afsnit (2) Baseret på laboratorieværdier (procentdele udledt på patienter med laboratorievurderinger) (3) Sammensat af kliniske data og laboratoriedata (4) Ikke rapporteret i mCRC-studiet; imidlertid blev PRES rapporteret hos patienter behandlet med aflibercept som monoterapi og i kombination med kemoterapi, som ikke var FOLFIRI, i andre studier.
Note: Adverse reactions are reported using MedDRA version MEDDRA13.1 and graded using NCI CTC version 3.0 (1) See “Description of selected adverse reactions” in this section (2) Based on laboratory values (percentages done on patients with laboratory assessments) (3) Compilation of clinical and laboratory data
• Forhøjet blodtryk (også kaldet ‘hypertension'): Meget almindeligt (kan påvirke mere end 1 ud af 10 personer) - dette kan udvikles eller forværres.
• High blood pressure (also called ‘hypertension'): Very common (may affect more than 1 in 10 people) - this may develop or get worse.
I andre studier blev PRES rapporteret hos patienter behandlet med aflibercept som monoterapi og i kombination med anden kemoterapi (se pkt.
In other studies, PRES was reported in patients treated with aflibercept as monotherapy and in combination with other chemotherapies (see section 4.8).
De fleste aflibercept-inducerede påvirkninger var reversible efter en 5-måneders medicinfri periode med undtagelse af fund i skelet og næsehule De fleste fund ansås at være relateret til aflibercepts farmakologiske aktivitet.
Most aflibercept-induced effects were reversible after a 5-month drug free period with the exception of skeletal and nasal cavity findings.
Almindeligt (kan påvirke op til 1 ud af 10 personer)
Common (may affect up to 1 in 10 people)
Kliniske data tyder på, at der ikke kræves ændring af aflibercept-dosis til patienter med let til moderat nedsat leverfunktion.
Clinical data suggest that no change in aflibercept dose is required in patients with mild to moderate hepatic impairment.
Hos patienter med RASvildtypetumor var HR (95 % CI) for samlet overlevelse (OS) 0,7 (0,5-1,0) med en median OS på 16,0 måneder for patienter, som fik aflibercept, og 11,7 måneder for patienter i placebogruppen.
In patients with RAS wild type tumours the HR (95 % CI) for OS was 0.7 (0.5-1.0) with a median OS of 16.0 months for patients treated with aflibercept, and 11.7 months for the patients treated with placebo.
Hos seksuelt modne huncynomolgusaber er der påvist tegn på hæmning af ovariefunktion og follikeludvikling.
In sexually mature female cynomolgus monkeys inhibition of ovarian function and follicular development was evidenced.
• Huller i tarmen (også kaldet ‘gastrointestinal perforation'): Ikke almindeligt (kan påvirke op til 1 ud af 100 personer) - dette er et hul i mavesækken, spiserøret eller tarmene.
• Holes in the gut (also called ‘gastro-intestinal perforation'): Uncommon (may affect up to 1 in 100 people) - this is a hole in the stomach, food pipe, gut or bowel.
Stratificeret Log-Rank test p-værdi Progressionsfri overlevelse (PFS)
Stratified log-rank test p-value
Efter fortynding i infusionsposen
After dilution in the infusion bag
Der er observeret ATE (inklusive transitorisk iskæmisk attak, cerebrovaskulær hændelse, angina pectoris, intrakardiel trombe, myokardieinfarkt, arteriel emboli og iskæmisk colitis) hos patienter behandlet med aflibercept (se pkt.
ATE (including transient ischaemic attack, cerebrovascular accident, angina pectoris, intracardiac thrombus, myocardial infarction, arterial embolism, and ischaemic colitis) have been observed in patients treated with aflibercept (see section 4.8).
• åndedrætsbesvær
• difficulty when breathing
Klargøring af infusionsopløsningen
Preparation of the infusion solution
200 mg/8 ml 1 hætteglas
200 mg / 8 ml 1 vial
11,7 (9,66 til 13,27) 13,8 (11,01 til 15,87)
11.7 (9.66 to 13.27) 13.8 (11.01 to 15.87)
Indeholder også saccharose, natriumchlorid, natriumcitratdihydrat, citronsyremonohydrat, polysorbat 20, dinatriumphosphatheptahydrat, natriumdihydrogenphosphatmonohydrat, natriumhydroxid og/eller saltsyre samt vand til injektionsvæsker.
Also contains sucrose, sodium chloride, sodium citrate dihydrate, citric acid monohydrate, polysorbate 20, sodium phosphate dibasic heptahydrate, sodium phosphate monobasic monohydrate, sodium hydroxide and/or hydrochloric acid and water for injections.
Grad 3 hypertension (der krævede justering af eksisterende antihypertensiv behandling eller behandling med mere end et lægemiddel) blev indberettet hos 1,5 % af patienterne i placeboarmen og hos 19,1 % i ZALTRAP-armen.
Grade 3 hypertension (requiring adjustment in existing anti-hypertensive therapy or treatment with more than one medicinal product) was reported in 1.5 % of patients treated with the placebo/FOLFIRI regimen and 19.1 % of patients treated with the ZALTRAP/FOLFIRI regimen.
0,817 (0,714 til 0,935)
0.817 (0.714 to 0.935)
Symptomer på infektion kan omfatte feber, kulderystelser, hoste, brændende fornemmelse, når du lader vandet, eller muskelsmerter.
Signs of infection may include fever, chills, cough, burning on passing water or muscle ache.
Ved recidiv bør behandlingen seponeres indtil <2 gram/24 timer, og derefter reduceres dosis til 2 mg/kg.
If recurrence, the treatment should be suspended until <2 grams per 24 hours and then the dose reduces to 2 mg/kg.
Der er observeret en højere forekomst af neutropeniske komplikationer (febril neutropeni og neutropenisk infektion) hos patienter behandlet med ZALTRAP/FOLFIRI-regimet (se pkt.
A higher incidence of neutropenic complications (febrile neutropenia and neutropenic infection) has been observed in patients treated with the ZALTRAP/FOLFIRI regimen (see section 4.8).
Reproduktions- og udviklingstoksikologi
Reproductive and developmental toxicology
Natriumcitratdihydrat
Sodium citrate dihydrate
Kompromitteret sårheling Aflibercept hæmmede sårhelingen i dyrestudier (se pkt.
Compromised wound healing Aflibercept impaired wound healing in animal models (see section 5.3).
Symptomerne kan omfatte smerter i brystet eller tung fornemmelse i brystet, pludselig følelsesløshed eller svaghedsfølelse i ansigt, arme eller ben.
Signs may include chest pain or heaviness in the chest, sudden numb or weak feeling in the face, arms, or legs.
Seponer ZALTRAP hos patienter, der oplever hjerteinsufficiens og nedsat ejektionsfraktion.
Discontinue ZALTRAP in patients who experience cardiac failure and ejection fraction decreased.
• Lavt antal hvide blodlegemer (også kaldet ‘neutropeni'): Meget almindeligt (kan påvirke mere end 1 ud af 10 personer) - dette kan medføre alvorlige infektioner.
• Low white blood cell count (also called ‘neutropenia'): Very common (may affect more than 1 in 10 people) - this can cause serious infections.
I andre studier er der forekommet svær intrakraniel blødning og pulmonal blødning/hæmoptyse inklusive dødelige hændelser hos patienter, der fik ZALTRAP (se pkt.
In other studies, severe intracranial haemorrhage and pulmonary haemorrhage/haemoptysis including fatal events have occurred in patients receiving ZALTRAP (see section 4.4).
Koncentratet er en klar, farveløs til lysegul opløsning.
The concentrate is a clear, colourless to pale yellow solution.
Dinatriumphosphatheptahydrat Natriumdihydrogenphosphatmonohydrat Natriumhydroxid og/eller saltsyre (til justering af pH) Vand til injektionsvæsker
Sodium phosphate dibasic heptahydrate Sodium phosphate monobasic monohydrate Sodium hydroxide and/or hydrochloric acid (for pH adjustment) Water for injections
12,06 (11,07 til 13,08) 13,50 (12,52 til 14,95)
12.06 (11.07 to 13.08) 13.50 (12.52 to 14.95)
90 minutter og folinsyre (dl racemisk) 400 mg/m² som intravenøs infusion over 2 timer på samme tidspunkt på dag 1 via en Y-linje, efterfulgt af 5-fluoruracil (5-FU) 400 mg/m² som intravenøs bolus, efterfulgt af 5-FU 2.400 mg/m² som kontinuerlig intravenøs infusion over 46 timer.
The FOLFIRI regimen to be used is irinotecan 180 mg/m intravenous infusion over 90 minutes and folinic acid (dl racemic) 400 mg/m² intravenous infusion over 2 hours at the same time on day 1 using a Y-line, followed by 5-fluorouracil (5-FU) 400 mg / m² intravenous bolus, followed by 5-FU 2400 mg / m² continuous intravenous infusion over 46 hours.
6.7 (5,75 til 8,21)
6.7 (5.75 to 8.21)
Infusionssættene skal være fremstillet af et af følgende materialer: • polyvinylchlorid (PVC) indeholdende bis(2-ethylhexyl)phthalat (DEHP)
• polyvinyl chloride (PVC) containing bis(2-ethylhexyl) phthalate (DEHP)
• hvis du er allergisk over for aflibercept eller et af de øvrige indholdsstoffer (angivet i punkt 6).
Do not use ZALTRAP: • if you are allergic to aflibercept or any of the other ingredients of this medicine (listed in section
Aneurismer og arterielle dissektioner Luftveje, thorax og mediastinum Meget almindelig Dyspnø Epistaxis
Respiratory, thoracic and mediastinal disorders Very common
0,812 (0,634 til 1,042)
0.812 (0.634 to 1.042)
Der er observeret en øget risiko for grad 3-4 hypertension (inklusive hypertension og et tilfælde af essentiel hypertension) hos patienter behandlet med ZALTRAP/FOLFIRI-regimet (se pkt.
An increased risk of grade 3-4 hypertension (including hypertension and one case of essential hypertension) has been observed in patients treated with the ZALTRAP/FOLFIRI regimen (see section
I subgruppeanalyse af samlet overlevelse hos patienter <65 år og ≥65 år der fik ZALTRAP/FOLFIRIregimet, observeredes en fordel svarende til den for den samlede population.
In sub-group analysis of overall survival, a benefit consistent with the overall population was observed in patients < 65 years old and ≥ 65 years old who received the ZALTRAP/FOLFIRI regimen.
Præmedicinering med kortikosteroider og/eller antihistaminer kan overvejes i de efterfølgende cykler.
Pre-treatment with corticosteroids and/or antihistamines may be considered in subsequent cycles.
Hjerteinsufficiens og nedsat ejektionsfraktion er blevet rapporteret hos patienter behandlet med ZALTRAP.
Cardiac failure and ejection fraction decreased have been reported in patients treated with ZALTRAP.
0,645 (0,498 til 0,835)
0.645 (0.498 to 0.835)
De hyppigst rapporterede grad 3-4 reaktioner (≥5 % forekomst) med mindst 2 % højere forekomst for ZALTRAP/FOLFIRI-regimet end for placebo/FOLFIRI-regimet var, med faldende frekvens: neutropeni, diarré, hypertension, leukopeni, stomatitis, træthed, proteinuri og asteni (se Tabel 1).
The most common reported grades 3-4 reactions ( ≥5 % incidence) reported at least 2 % greater incidence for the ZALTRAP/FOLFIRI regimen as compared to the placebo/FOLFIRI regimen in order of decreasing frequency, were neutropenia, diarrhoea, hypertension, leucopenia, stomatitis, fatigue, proteinuria, and asthenia (see Table 1).
Symptomer på blødning kan være træthed, svaghed og/eller svimmelhed eller ændringer i farven på din afføring.
Signs may include feeling very tired, weak, and/or dizzy, or having changes in the colour of your stool.
• Blokering af blodårerne på grund af en blodprop (også kaldet ‘venøse tromboemboliske hændelser'): Almindeligt (kan påvirke op til 1 ud af 10 personer) - dette kan omfatte en blodprop i lungerne eller benene.
• Blocking of the veins by a blood clot (also called ‘venous thrombo-embolic events'): Common (may affect up to 1 in 10 people) - this may include a blood clot in the lungs or legs.
Der foreligger ingen data vedrørende administration af aflilbercept til patienter med svært nedsat leverfunktion.
There are no data regarding the administration of aflibercept in patients with severe hepatic impairment.
Ialt 1226 patienter blev randomiseret (1:1) til at få enten ZALTRAP (N=612; 4 mg/kg som 1 times intravenøs infusion på dag 1) eller placebo (N=614), i kombination med 5-fluouracil plus irinotecan [FOLFIRI: irinotecan 180 mg/m2 intravenøs infusion over 90 minutter og folinsyre (dl racemisk) 400 mg/m²
A total of 1,226 patients were randomised (1:1) to receive either ZALTRAP (N = 612; 4 mg/kg as a 1 hour intravenous infusion on day 1) or placebo (N = 614), in combination with 5-fluouracil plus irinotecan [FOLFIRI: irinotecan 180 mg/m intravenous infusion over 90 minutes and folinic acid (dl racemic) 400 mg/m² intravenous infusion over 2 hours at the same time on day 1 using a Y-line, followed by 5-FU 400 mg/m² intravenous bolus, followed by 5-FU 2,400 mg /m² continuous intravenous infusion over 46-hours].
6,90 (6,51 til 7,20)
6.90 (6.51 to 7.20)
Denne population omfattede: 549 patienter med let nedsat nyrefunktion (CLCR mellem 50-80 ml/min.
This population included; 549 patients with mild renal impairment (CL CR between 50-80 ml/min), 96 patients with moderate renal impairment (CL CR between 30-50 ml/min), and 5 patients with severe renal impairment (CL CR < 30 ml/min).
ZALTRAP er et lægemiddel der bruges til at behandle fremskreden kræft i tyktarmen og endetarmen hos voksne.
ZALTRAP is a medicine used to treat advanced cancers of the colon or rectum (parts of the large intestine) in adults.
En ml koncentrat indeholder 25 mg aflibercept.
One ml of concentrate contains 25 mg aflibercept.
• Hjerteinsufficiens og nedsat ejektionsfraktion
• Cardiac failure and ejection fraction decreased
• fald i antallet af visse celler i blodet (blodplader), der hjælper det med at koagulere
• drop in the number of certain cells in the blood that help it to clot (thrombocytopenia)
Et 4 ml hætteglas indeholder 100 mg aflibercept (25 mg/ml).
One vial of 4 ml contains 100 mg of aflibercept (25 mg / ml).
• Hjertesvigt (også kaldet hjerteinsufficiens): Ikke almindeligt (kan påvirke op til 1 ud af 100 personer) - symptomerne kan omfatte åndenød når du ligger ned, eller når du anstrenger dig, overdreven træthed eller hævede ben.
• Heart failure (also called cardiac failure); Uncommon (may affect up to 1 in 100 people) - Signs may include shortness of breath when you lie down or when you exert yourself, excessive tiredness or leg swelling.