natgillin/translations-raw huggingface dataset:
Undersøgelser Psykiske forstyrrelser
Investigations Psychiatric disorders Injury, poisoning and
vægtforøgelse søvnmangel
weight increased insomnia
15 11
15 11
6 4
6 4
Traumer, forgiftninger negletoksisitet og behandlings - komplikationer 1
procedural complications 1
Antallet inkluderer patienter med foretrukne termer for ” febril
These numbers include patients with preferred terms of ‘ febrile neutropenia’, ‘ neutropenic sepsis’ or ‘ neutropenia’ that was associated with fever (and antibiotic use).
” neutropeni ”, der var forbundet med feber (og brug af antibiotika).
See also section 4.8 There was an increased incidence of SAEs (40% vs.
4. 8
31%) and Grade 4 AEs (34% vs.
Der var en øget forekomst af alvorlige bivirkninger (40% versus 31%) og grad 4 bivirkninger (34% versus 23%) i kombinationsarmen sammenlignet med docetaxel monoterapi.
23%) in the combination arm compared to docetaxel monotherapy.
I yderligere en randomiseret klinisk undersøgelse (BO16216) fik HER2- positive patienter og patienter med hormon- receptor positiv metastatisk brystkræft anastrozol med eller uden Herceptin.
In a further randomised clinical trial (BO16216), patients with HER2 positive and hormone receptor positive metastatic breast cancer received anastrozole with or without Herceptin.
I denne undersøgelse var der ingen ændring i sikkerhedsprofilen sammenlignet med tidligere undersøgelser hos den metastatiske population.
In this trial, there was no change in the safety profile compared with previous trials in the metastatic population.
Nedenstående tabel viser de uønskede hændelser, som blev rapporteret hos ≥ 10% af patienterne under behandlingen:
The following table displays adverse events which were reported in ≥ 10% of patients, by study treatment:
9 Tabel 2
9 Table 2
Oversigt over uønskede hændelser med en incidensrate på mindst 10% under behandlingen
Summary of Adverse Events with an Incidence Rate of at Least 10% by Trial Treatment
Uønsket hændelse
Adverse Event
Arimidex plus Herceptin N=103 Antal (%)
Arimidex Plus Herceptin Arimidex Alone N=103 N=104 No.
Arimidex alene N=104 Antal (%)
(%)
Træthed Diarré Opkastning Artralgi Pyreksi Rygsmerter Dyspnø Kvalme Hoste Hovedpine Nasopharyngitis Knoglesmerter Obstipation Kulderystelser Procentdelen er baseret på N.
Fatigue Diarrhoea Vomiting Arthralgia Pyrexia Back pain Dyspnoea Nausea Cough Headache Nasopharyngitis Bone pain Constipation Chills
Multiple forekomster af den samme uønskede hændelse hos samme person er kun talt en gang.
Multiple occurrences of the same adverse event in one individual counted only once.
For patienter i armen med arimidex alene, som skiftede til armen med Herceptin alene, er det kun uønskede hændelser før den første Herceptin- administration, der er angivet.
For patients from the Arimidex Alone arm who switched to Herceptin, only AEs before the 1st Herceptin administration are displayed
Der var en øget forekomst af alvorlige bivirkninger (23% versus 6%) og grad 4 bivirkninger (25% versus 15%) i kombinationsarmen sammenlignet med anastrozol monoterapi.
15%) in the combination arm compared to anastrozole monotherapy.
Tidlig brystkræft
EBC
5. 1 Farmakodynamiske egenskaber).
The HERA trial is a randomised, open label study in patients with HER2-positive early breast cancer (see section 5.1 Pharmacodynamic properties).
Tabel 3 viser bivirkninger, som blev rapporteret efter 1 år hos ≥ 1% af patienterne i undersøgelsen.
Table 3 displays adverse events which were reported at 1 year in ≥ 1% of patients, by study treatment.
Bivirkninger rapporteret efter 1 år hos ≥ 1% af patienterne i undersøgelsen.
Adverse Events Reported at 1 year in ≥ 1% of Patients, by Study Treatment
Bivirkninger
Observation Herceptin 1 Only year Adverse Event N = 1708 N = 1678
Kun observation N=1708 Antal (%)
Body System
Herceptin efter 1 år N=1678 Antal (%)
(%)
Samlede antal bivirkninger
Total Pts with at least one AE Total number of AEs
artralgi * rygsmerter * smerter i ekstremiteter myalgi *
arthralgia* back pain* pain in extremity
98 (6) 59 (3) 45 (3) 17 (< 1)
98 (6) 59 (3) 45 (3)
137 (8) 91 (5) 60 (4) 63 (4)
137 (8) 91 (5) 60 (4)
knoglesmerter skuldersmerter smerter i thoraxvæg muskelspasmer * smerter i bevægeapparatet
myalgia*
26 (2) 29 (2) 24 (1) 3 (< 1) 11 (< 1)
17 (< 1)
49 (3) 30 (2) 26 (2) 45 (3) 17 (1)
63 (4)
Infektioner og parasitære sygdomme
connective tissue disorders
nasopharynitis * influenza *
bone pain shoulder pain chest wall pain muscle spasms*
43 (3) 9 (< 1)
26 (2) 29 (2) 24 (1) 3 (< 1)
10
49 (3) 30 (2) 26 (2) 45 (3)
Organklasse
135 (8) 69 (4)
Kun observation N=1708 Antal (%)
Observation Only
Herceptin efter 1 år N=1678 Antal (%)
Herceptin 1 year
Samlede antal patienter med mindst én bivirkning
Body System
Samlede antal bivirkninger infektion i de øvre
Total Pts with at least one AE Total number of AEs
luftveje * urinvejsinfektion rhinitis sinuitis cystitis pharyngitis bronkitis herpes zoster
urinary tract infection rhinitis sinusitis cystitis pharyngitis bronchitis herpes zoster
20 (1) 13 (< 1) 6 (< 2) 5 (< 1) 11 (< 1) 9 (< 1) 9 (< 1) 9 (< 1)
13 (< 1) 6 (< 1) 5 (< 1) 11 (< 1) 9 (< 1) 9 (< 1) 9 (< 1)
46 (3) 39 (2) 36 (2) 26 (2) 19 (1) 20 (1) 18 (1) 17 (1)
39 (2) 36 (2) 26 (2) 19 (1) 20 (1) 18 (1) 17 (1)
Almene symptomer og
128 (8) 79 (5) 100 (6)
træthed * perifer ødem pyrexi * asteni *
asthenia* chills* chest pain* influenza illness oedema chest discomfort
44 (3) 38 (2) 6 (< 1) 30 (2)
30 (2) - 22 (1) 3 (< 1) 7 (< 1) 2 (< 1)
128 (8) 79 (5) 100 (6) 75 (4)
75 (4) 85 (5) 45 (3) 40 (2) 18 (1) 20 (1)
reaktioner på
Gastrointestinal
kulderystelser *
diarrhoea* nausea* vomiting* abdominal pain
-
16 (< 1) 19 (1) 10 (< 1) 16 (< 1)
85 (5)
123 (7) 108 (6) 58 (3) 40 (2)
administrationsstedet
disorders
brystsmerter *
constipation
22 (1)
17 (< 1)
45 (3)
33 (2)
influenzasygdom ødem ubehag i brystet
abdominal pain upper dyspepsia gastritis stomatitis headache*
3 (< 1) 7 (< 1) 2 (< 1)
15 (< 1) 9 (< 1) 11 (< 1) 1 (< 1) 49 (3)
40 (2) 18 (1) 20 (1)
29 (2) 30 (2) 20 (1) 26 (2) 161 (10)
diarre * kvalme * opkastning * abdominalsmerter obstipation øvre abdominalsmerter
dizziness* paraesthesia vertigo hot flush
16 (< 1) 19 (1) 10 (< 1) 16 (< 1) 17 (< 1) 15 (< 1)
29 (2) 11 (< 1) 7 (< 1) 84 (5)
123 (7) 108 (6) 58 (3) 40 (2) 33 (2) 29 (2)
60 (4) 29 (2) 25 (1) 98 (6)
dyspepsi gastritis stomatitis
Vascular disorders Skin and subcutaneous
9 (< 1) 11 (< 1) 1 (< 1)
hypertension* lymphoedema rash* pruritus
30 (2) 20 (1) 26 (2)
35 (2) 40 (2) 10 (< 1) 10 (< 1)
hovedpine * svimmelhed *
64 (4) 42 (3) 70 (4) 40 (2)
49 (3) 29 (2)
tissue
Nervesystemet
nail disorder*
paraestesi vertigo
-
11 (< 1) 7 (< 1)
43 (3)
29 (2) 25 (1)
Respiratory, thoracic
Vaskulære sygdomme
onychorrhexis erythema cough* dyspnoea
opblussen hypertension *
1 (< 1) 7 (< 1) 34 (2) 26 (2)
84 (5) 35 (2)
36 (2) 24 (1) 81 (5) 56 (3)
98 (6) 64 (4)
and
lymfeødem
pharyngolaryngeal pain
40 (2)
8 (< 1)
42 (3)
32 (2)
Hud og subkutane
mediastinal disorders
udslæt * kløe negleproblemer *
dyspnoea exertional
10 (< 1) 10 (< 1) -
15 (< 1)
70 (4) 40 (2) 43 (3)
21 (1)
væv
rhinorrhoea epistaxis
onychorrhexi
5 (< 1) 1 (< 1)
1 (< 1)
24 (1) 24 (1)
36 (2)
Reproductive system and breast disorders
erytem
breast pain
7 (< 1)
19 (1)
24 (1)
24 (1)
Samlede antal bivirkninger
Pts with at least one AE
15 (< 1) 5 (< 1) 1 (< 1)
Total number of AEs
søvnmangel depression
depression anxiety
39 (2)
51 (3) 39 (2)
Hjerte
palpitations*
12 (< 1) 5 (< 1)
12 (< 1)
48 (3) 30 (2)
48 (3)
Undersøgelser
Cardiac disorders Investigations
nedsat ejektionsfraktion *
cardiac failure congestive tachycardia ejection fraction decreased*
11 (< 1)
5 (< 1) 5 (< 1) 11 (< 1)
58 (3)
30 (2) 20 (1) 58 (3)
vægtforøgelse
weight increased
dysuri
dysuria
* Bivirkninger som blev rapporteret med en højere incidens (> 2% forskel) i Herceptin- gruppen sammenlignet med observationsgruppen og kan derfor være tilskrevet Herceptin.
* Adverse Events that were reported at higher incidence (> _2% difference) in the Herceptin group compared with the observation group and therefore may be attributable to Herceptin.
Følgende information er relevant for alle indikationer:
The following information is relevant to all indications:
Alvorlige bivirkninger I de kliniske undersøgelser eller efter markedsføring er der indtruffet mindst en af nedenstående alvorlige bivirkninger hos mindst en patient, som er behandlet med Herceptin alene eller i kombination med kemoterapi:
Serious Adverse Reactions At least one case of the following serious adverse reactions has occurred in at least one patient treated with Herceptin alone or in combination with chemotherapy in clinical trials or has been reported during post marketing experience:
Organklasse Hele kroppen
Body System Body as a Whole
Bivirkninger hypersensitiv reaktion, anafylaksi og anafylaktisk shock, angioødem, ataksi, sepsis, kulderystelser og feber, asteni, feber, rigor, hovedpine, pareser, brystsmerter, træthed, infusionsrelaterede symptomer, perifere ødemer, knoglesmerter, coma, meningitis, hjerneødem, abnorme tanker, progression af neoplasi
Adverse Event hypersensitivity reaction, anaphylaxis and anaphylactic shock, angioedema, ataxia, sepsis, chills and fever, asthenia, fever, rigor, headache, paresis, chest pain, fatigue, infusion-related symptoms, peripheral oedema, bone pain, coma, meningitis, cerebral oedema, thinking abnormal, progression of neoplasia
Kardiovaskulære
Cardiovascular
cardiomyopati, kongestiv hjerteinsufficiens, forværring af kongestiv hjerteinsufficiens, nedsat ejektionsfraktion, hypotension, perikardial effusion, bradykardi, cerebrovaskulær sygdom, hjerteinsufficiens, kardiogent shock, pericarditis
cardiomyopathy, congestive heart failure, increased congestive heart failure, decreased ejection fraction, hypotension, pericardial effusion, bradycardia, cerebrovascular disorder, cardiac failure, cardiogenic shock, pericarditis
Gastro- intestinale
Digestive Blood and Lymphatic
beskadigelse af leverceller, ømhed i leveren, diarré, kvalme og opkastning, pancreatitis, leverinsufficiens, ikterus
hepatocellular damage, liver tenderness, diarrhoea, nausea and vomiting, pancreatitis, hepatic failure, jaundice leukaemia, febrile neutropenia, neutropenia, thrombocytopenia, anaemia, hypoprothrombinemia
Blod og lymfe
Infections Metabolic Musculoskeletal Nervous Renal Respiratory
leukæmi, febril neutropeni, neutropeni, trombocytopeni, anæmi, hypoprotrombinæmi
cellulitis, erysipelas hyperkalaemia myalgia paraneoplastic cerebellar degeneration membranous glomerulonephritis, glomerulonephropathy, renal failure bronchospasm, respiratory distress, acute pulmonary oedema, respiratory insufficiency, dyspnoea, hypoxia, laryngeal oedema, acute respiratory distress, acute respiratory distress syndrome, Cheyne-Stokes breathing, pulmonary infiltrates, pneumonia, pneumonitis, pulmonary fibrosis.
Infektioner
Skin and appendages Special Senses
cellulitis, erysipelas
rash, dermatitis, urticaria, Stevens-Johnson syndrome papilloedema, abnormal lacrimation, retinal haemorrhage, deafness
12
12 Infusion-Related Symptoms During the first infusion of Herceptin chills and/ or fever are observed commonly in patients.
Andre tegn og/ eller symptomer kan omfatte kvalme, hypertension, opkastning, smerter, rigor, hovedpine, hoste, svimmelhed, udslæt og asteni.
Other signs and/ or symptoms may include nausea, hypertension, vomiting, pain, rigors, headache, cough, dizziness, rash, and asthenia.
Symptomerne er normalt lette til moderate og kommer kun sjældent under de efterfølgende infusioner med Herceptin.
These symptoms are usually mild to moderate in severity, and occur infrequently with subsequent Herceptin infusions.
Symptomerne kan behandles med et analgetikum/ antipyretikum såsom meperidin eller paracetamol eller et antihistaminikum såsom diphenhydramin (se 4. 2).
These symptoms can be treated with an analgesic/ antipyretic such as meperidine or paracetamol, or an antihistamine such as diphenhydramine (see 4.2).
Nogle bivirkninger ved Herceptin- infusionen, herunder dyspnø, hypotension, hiven efter vejret, bronkospasmer, supraventrikulær takyarytmi og nedsat oxygenmætning og åndedrætsbesvær, kan være alvorlige og potentielt fatale (se 4. 4).
Some adverse reactions to Herceptin infusion including dyspnoea, hypotension, wheezing, bronchospasm, supraventricular tachyarrythmia, reduced oxygen saturation and respiratory distress can be serious and potentially fatal (see 4.4).
Allergilignende reaktioner og overfølsomhedsreaktioner Allergiske reaktioner, anafylaksi og anafylaktisk chok, urtikaria og angioødem, som indtræffer under den første infusion med Herceptin, er sjældent rapporteret.
Allergic-like and hypersensitivity reactions Allergic reactions, anaphylaxis and anaphylactic shock, urticaria and angioedema occurring during the first infusion of Herceptin, have been reported rarely.
Mere end en tredjedel af disse patienter reagerede negativt ved genprovokation og fortsatte med Herceptin.
Over a third of these patients had a negative re- challenge and continued to receive Herceptin.
Nogle af disse reaktioner kan være alvorlige og potentielt fatale (se 4. 4).
Some of these reactions can be serious and potentially fatal (see 4.4).
Alvorlige pulmonale hændelser I sjældne tilfælde er der rapporteret om enkelttilfælde af lungeinfiltrater, pneumoni, pulmonal fibrose, pleural effusion, åndedrætsbesvær, akut lungeødem, akut respiratorisk distress syndrom (ARDS) og respirationsinsufficiens.
Serious pulmonary events Single cases of pulmonary infiltrates, pneumonia, pulmonary fibrosis, pleural effusion, respiratory distress, acute pulmonary oedema, acute respiratory distress syndrome (ARDS) and respiratory insufficiency have been reported rarely.
Disse bivirkninger er sjældent rapporteret med fatal udgang (se 4. 4).
These events have been reported rarely with fatal outcome (see 4.4).
Kardial toksicitet Der er observeret nedsat ejektionsfraktion og tegn og symptomer på hjerteinsufficiens såsom dyspnø, orthopnø, øget hoste, lungeødem og S3- gallop hos patienter, som har fået Herceptin (se 4. 4).
(see 4.4).
Incidensen af kardiale bivirkninger i en retrospektiv analyse af data fra undersøgelsen om kombinationsbehandling (Herceptin plus paclitaxel versus paclitaxel alene og fra undersøgelsen om Herceptin monoterapi fremgår af nedenstående tabel):
The incidence of cardiac adverse events from retrospective analysis of data from the combination therapy study (Herceptin plus paclitaxel versus paclitaxel alone and the Herceptin monotherapy study is shown in the following table:
Hyppighed af kardiale bivirkninger; n,% [95% konfidensinterval] Symptomatisk
Cardiac Adverse Event Incidence; n,% [95 %-confidence limits]
Herceptin plus paclitaxel N=91
Herceptin plus paclitaxel N=91
paclitaxel N=95
paclitaxel N=95
Herceptin N=213
Herceptin N=213
hjerteinsufficiens
Symptomatic heart failure
8; 8, 8%
8, 8.8% [3.9-16.6]
4; 4, 2%
4, 4.2% [1.2-10.4]
18; 8, 5%
18, 8.5% [5.1-13.0]
end hjerteinsufficiens
Cardiac diagnosis other
4; 4, 4%
4, 4.4%
7; 7, 4%
7, 7.4%
7; 3, 3%
7, 3.3%
[1, 2- 10, 9]
[1.2-10.9]
[3, 0- 14, 6]
[3.0-14.6]
[1, 3- 6, 7]
[1.3-6.7]
13 Incidensen af symptomatisk kongestiv hjerteinsufficiens i undersøgelsen med Herceptin plus docetaxel versus docetaxel alene (M77001) er vist i nedenstående tabel:
The incidence of symptomatic congestive heart failure in the study of Herceptin plus docetaxel versus docetaxel alone (M77001), is shown in the following table:
Herceptin plus docetaxel N=92
Herceptin plus docetaxel N = 92
docetaxel N=94
docetaxel N = 94
Symptomatisk hjerteinsufficiens
Symptomatic heart failure
I denne undersøgelse havde alle patienter en kardiel ejektionsfraktion ved baseline på større end 50%.
In this study, all patients had a baseline cardiac ejection fraction of greater than 50%.
I Herceptin plus docetaxel armen havde 64% tidligere fået anthracyklin sammenlignet med 55% i armen med docetaxel alene.
In the Herceptin plus docetaxel arm, 64% had received a prior anthracycline compared with 55% in the docetaxel alone arm.
Oversigt over patienter med et absolut fald i LVEF på mindst 15% fra baseline og en absolut LVEF- værdi under 50%, sikkerhedspopulation (før overkrydsning)
Summary of Patients with an LVEF Decrease by at least an Absolute 15% from Baseline and the Absolute LVEF Value below 50%, Safety Population (Before Crossover)
Anastrozol plus Herceptin N=103
Anastrozole plus Herceptin n=103
Anastrazol alene N=104
Anastrozole alone n=104
Symptomatisk CHF Bekræftet LVEF- fald på ≥ 15% fra baseline og under 50%
Symptomatic CHF Confirmed LVEF drops of ≥ 15% from Baseline and below 50%
0a 0b
0a 0b
Mindst et LVEF- fald på ≥ 15% fra baseline og under 50% a
At least one LVEF drop of ≥ 15% from baseline and below 50% a
1 patient oplevede symptomatisk CHF efter overkrydsning til regime med Herceptin efter progression b To patienter oplevede bekræftet LVEF- fald efter overkrydsning til regime med Herceptin efter progression c Fire patienter oplevede et LVEF- fald efter overkrydsning til regime med Herceptin efter progression
One patient experienced symptomatic CHF after cross over to Herceptin-containing regimen following progression b Two patients experienced confirmed LVEF drops after cross over to Herceptin-containing regimen following progression c Four patients experienced one LVEF drops after cross over to Herceptin-containing regimen following progression
I HERA- undersøgelsen blev der hos 0, 6% af patienterne i 1- års- armen observeret NYHA klasse III - IV hjerteinsufficiens.
In the HERA trial, NYHA class III-IV heart failure was observed in 0.6% of patients in the one-year arm.
Symptomfri eller mild symptomatisk NYHA klasse I- II objektive fund blev observeret hos 3, 0% af patienterne i Herceptin- armen, sammenlignet med 0, 5% af patienterne i kontrolarmen.
Asymptomatic or mildly symptomatic NYHA class I – II events were observed in 3.0% of patients in the Herceptin arm compared to 0.5% of patients in the observation arm.
Andelen af patienter med mindst et signifikant fald i LVEF (reduktion på ≥ 10 EF point til < 50%) var under behandlingen 7, 4% i 1- års Herceptin- armen versus 2, 3% i kontrolarmen.
The percentage of patients with at least one significant LVEF drop (decrease of ≥ 10 EF points and to < 50%) during the study was 7.4% in the 1 year Herceptin arm versus 2.3% in the observation arm.
Hæmatologisk toksicitet Hæmatologisk toksicitet var sjælden efter administration af Herceptin som enkeltstofbehandling i den metastatiske behandling, WHO grad 3 leukopeni, trombycytopeni og anæmi forekom hos < 1% af patienterne.
Haematological toxicity Haematological toxicity was infrequent following the administration of Herceptin as a single agent in the metastatic setting, WHO Grade 3 leucopenia, thrombocytopenia and anaemia occurring in < 1% of patients.
Der blev ikke set nogen WHO grad 4 toksicitet.
No WHO Grade 4 toxicities were observed.
Hos patienter der fik en kombination af Herceptin og paclitaxel var der en stigning i den hæmatologiske toksicitet WHO grad 3 eller 4 sammenlignet med patienter som fik paclitaxel alene (34% versus 21%).
There was an increase in WHO Grade 3 or 4 haematological toxicity in patients treated with the combination of Herceptin and paclitaxel compared with patients receiving paclitaxel alone (34% versus 21%).
Der var ligeledes en stigning i hæmatologisk toksicitet hos patienter, som fik Herceptin og docetaxel sammenlignet med docetaxel alene (32% grad 3⁄4 neutropeni versus 22%, under anvendelse af NCI- CTC kriterier).
Haematological toxicity was also increased in patients receiving Herceptin and docetaxel, compared with docetaxel alone (32% grade 3/ 4 neutropenia versus 22%, using NCI-CTC criteria).
Bemærk at dette sandsynligvis er underestimeret, idet docetaxel alene i en dosis på 100 mg/ m2 er kendt for at forårsage neutropeni hos 97% af patienterne, 76% grad 4, baseret på nadir blodtælling.
Note that this is likely to be an underestimate since docetaxel alone at a dose of 100mg/ m2 is known to result in neutropenia in 97% of patients, 76% grade 4, based on nadir blood counts.
Incidensen af febril neutropeni/ neutropenisk sepsis var også øget hos patienter behandlet med Herceptin plus docetaxel (23% versus 17% for patienter behandlet med docetaxel alene).
The incidence of febrile neutropenia/ neutropenic sepsis was also increased in patients treated with Herceptin plus docetaxel (23% versus 17% for patients treated with docetaxel alone).
I HERA- undersøgelsen oplevede 0, 4% af de Herceptin- behandlede patienter et skift på 3 eller 4 grader fra baseline sammenlignet med 0, 6% i kontrolarmen under anvendelse af NCI- CTC kriterier.
Using NCI-CTC criteria, in the HERA trial, 0.4% of Herceptin-treated patients experienced a shift of 3 or 4 grades from baseline, compared with 0.6% in the observation arm.
Hepatisk og renal toksicitet Hepatisk toksicitet WHO grad 3 eller 4 blev set hos 12% af patienterne efter administration af Herceptin som enkeltstof i den metastatiske behandling.
Hepatic and renal toxicity WHO Grade 3 or 4 hepatic toxicity was observed in 12% of patients following administration of Herceptin as single agent, in the metastatic setting.
Toksiciteten var ledsaget af sygdomsprogression i leveren hos 60% af disse patienter.
This toxicity was associated with progression of disease in the liver in 60% of these patients.
15%).
WHO Grade 3 or 4 hepatic toxicity was less frequently observed among patients receiving Herceptin and paclitaxel than among patients receiving paclitaxel (7% compared with 15%).
Der blev ikke observeret renal WHO grad 3 eller 4 toksicitet hos patienter behandlet med Herceptin.
No WHO Grade 3 or 4 renal toxicity was observed in patients treated with Herceptin.
Diarré 27% af de patienter, som fik Herceptin som enkeltstofbehandling i den metastatiske behandling, fik diarré.
Diarrhoea Of patients treated with Herceptin as a single agent in the metastatic setting, 27% experienced diarrhoea.
Der er også set en stigning i incidensen af diarré, primær let til moderat, hos patienter som fik Herceptin i kombination med paclitaxel eller docetaxel sammenlignet med patienter, der fik paclitaxel eller docetaxel alene.
An increase in the incidence of diarrhoea, primarily mild to moderate in severity, has also been observed in patients receiving Herceptin in combination with paclitaxel or docetaxel compared with patients receiving paclitaxel or docetaxel alone.
I HERA- undersøgelsen oplevede 7% af de Herceptin- behandlede patienter diarré.
In the HERA trial, 7% of Herceptin-treated patients had diarrhoea.
Infektioner Der er observeret en stigning i incidensen af infektioner, primært af øvre luftvejsinfektioner af mindre klinisk betydning eller af kateterinfektioner, først og fremmest hos patienter som blev behandlet med Herceptin plus paclitaxel eller docetaxel sammenlignet med patienter, som fik paclitaxel eller docetaxel alene.
14 An increased incidence of infections, primarily mild upper respiratory infections of minor clinical significance or catheter infections, has been observed primarily in patients treated with Herceptin plus paclitaxel or docetaxel compared with patients receiving paclitaxel or docetaxel alone.
Der er ikke rapporteret tilfælde af overdosering i humane kliniske undersøgelser.
There is no experience with overdosage in human clinical trials.
I de kliniske undersøgelser er der ikke givet enkeltdoser over 10 mg/ kg Herceptin.
Single doses of Herceptin alone greater than 10 mg/ kg have not been administered in the clinical trials.
Antineoplastiske stoffer, ATC- kode:
Antineoplastic agents, ATC code:
Trastuzumab er et rekombinant humant IgG1 monoklonalt antistof mod den humane epidermale vækstfaktor receptor 2 (HER2).
Trastuzumab is a recombinant humanised IgG1 monoclonal antibody against the human epidermal growth factor receptor 2 (HER2).
Der er observeret overekspression af HER2 hos 20- 30% af primær brystkræft.
Overexpression of HER2 is observed in 20 %-30% of primary breast cancers.
Undersøgelsen tyder på, at patienter med overekspression af HER2 har en kortere sygdomsfri overlevelse end patienter, hvis tumorer ikke har overekspression af HER2.
Studies indicate that patients whose tumours overexpress HER2 have a shortened disease-free survival compared to patients whose tumours do not overexpress HER2.