natgillin/translations-raw huggingface dataset:
Hjertestop Myokardie - infarkt Atrieflimmer Supraventrikulær takykardi Arytmi Bradykardi Abnormt EKG
Psychiatric disorders
Hypertension Vasospasmer Rødmen
Confusion Anxiety Depression Somnolence Insomnia
Sygdomme i åndedrætsorganer, brysthule og mediastinum
Depersonalisation Personality disorder Abnormal thinking Impotence Nervousness
Stridor Tæthed i halsen
Nervous system disorders
Bronkospasme
Headache
Pulmonal infiltration
Vertigo Dizziness Tremor Paresthesia Hypoesthesia Hyperkinesia Taste loss
Pleural effusion Nedsat åndedrætslyd Respiratorisk lidelse
Syncope Abnormal gait Dystonia Hyperesthesia Neuropathy Taste perversion
Gastro- intestinale
Eye disorders Ear and labyrinth disorders
Opkastning
Conjunctivitis
Gastro- intestinal blødning
Endophthalmitis Deafness Tinnitus
Gastroenteritis
Cardiac disorders
ORGANKLASSE MEDDRA
Palpitation Tachycardia
MEGET ALMINDELIG
Vascular disorders
ALMINDELIG
Hypotension
USÆDVANLIG
Dyspnoea
sygdomme
Gastrointestinal disorders
Ulcerøs stomatitis Stomatitits Abdominal- smerter Dyspepsi Konstipation Flatulens
Ulcerative stomatitis Stomatitis Abdominal pain Dyspepsia Constipation Flatulence
Tungeulceration Gingivitis Hikke Opstød Mundtørhed
Tongue ulceration Gingivitis Hiccup Eructation Dry mouth
Sygdomme i lever - og galdeveje
Hepatobiliary disorders
Makulo- papuløst udslæt
Maculo-papular rash
Urticaria Udslæt Hyperhidrose
Urticaria Rash Hyperhidrosis
Hudlidelser
Skin disorder
Artralgi Myalgi Knoglesmerter Rygsmerter
Arthralgia Myalgia Skeletal pain Back pain
Hæmaturi Urininkontinens Nedsat urinproduktion Polyuri Abnorm nyrefunktion
Haematuria Urinary incontinence Urine flow decreased Polyuria Renal function abnormal
Almene lidelser og reaktioner påindgivelsesstedet
General disorders and administration site conditions
Kulderystelser Feber
Chills Fever
Brystsmerter Influenza- lignende symptomer
Chest pain Influenza-like symptoms
Lungeødem Perifer ødem
Pulmonary oedema Peripheral oedema
Mucositis Ødem i munden Ødemer
Mucositis Oedema mouth Oedema Asthenia Malaise Temperature change sensation Infusion site reaction Pain
Periorbitalt ødem Mucosal ulceration Misfarvninger på infusionsstedet
Periorbital oedema Mucosal ulceration Infusion site bruising Infusion site dermatitis Infusion site pain
Bivirkninger indberettet efter markedsføringen
Undesirable Effects Observed During Post-Marketing Surveillance
Bivirkninger ved infusion:
Infusion reactions:
Der er indberettet alvorlige bivirkninger, som nogen gange har dødelig udgang, herunder bronkospasme, hypoksi, synkope, lungeinfiltrater, akut respiratorisk distress syndrom (ARDS), respirationsstop, myokardieinfarkt, arytmier, akut hjerteinsufficiens og hjertestop.
Serious and sometimes fatal reactions, including bronchospasm, hypoxia, syncope, pulmonary infiltrates, acute respiratory distress syndrome (ARDS), respiratory arrest, myocardial infarction, arrhythmias, acute cardiac insufficiency and cardiac arrest have been observed.
Alvorlige anafylaktiske og andre hypersensivitetsreaktioner, herunder anafylaktisk chok og angioødem, er indberettet efter MabCampath- behandling.
Severe anaphylactic and other hypersensitivity reactions, including anaphylactic shock and angioedema, have 10 been reported following MabCampath administration.
4. 4).
These symptoms can be ameliorated or avoided if premedication and dose escalation are utilised (see section 4.4).
Infektiøse og parasitære sygdomme:
Infections and infestations:
Alvorlige og sommetider fatale virale infectioner (f. eks. adenovirus, parainfluenza, hepatitis B, progressiv multifokal leukoencephalopati (PML)), bakterielle infektioner (herunder tuberkulose og atypiske mykobakterier, nokardiose) protozo - (f. eks. toxoplasma gondii) og svampeinfektioner (f. eks. rinocerebral mucormycose), herunder de der skyldes reaktivering af latente infektioner, er forekommet under post- marketing overvågning.
Serious and sometimes fatal viral (e. g. adenovirus, parainfluenza, hepatitis B, progressive multifocal leukoencephalopathy (PML)), bacterial (including tuberculosis and atypical mycobacterioses, nocardiosis), protozoan (e. g. toxoplasma gondii), and fungal (e. g. rhinocerebral mucormycosis) infections, including those due to reactivation of latent infections have occurred during post-marketing surveillance.
4. 4).
The recommended anti-infective prophylaxis treatment appears to be effective in reducing the risk of PCP and herpes infections (see section 4.4).
Der er indberettet EBV- relateret lymfoproliferativ sygdom.
EBV-associated lymphoproliferative disorder has been reported.
Der er indberettet alvorlige blødningsreaktioner.
Severe bleeding reactions have been reported.
Der er indberettet tilfælde af alvorlige autoimmune fænomener, nogen gange med dødelig udgang, herunder autoimmun hæmolytisk anæmi, autoimmun trombocytopeni, aplastisk anæmi, Guillain Barré- syndrom og dets kroniske form, kronisk inflammatorisk demyelinerende polyradiculoneuropati.
Serious and sometimes fatal autoimmune phenomena including autoimmune haemolytic anaemia, autoimmune thrombocytopenia, aplastic anaemia, Guillain Barré syndrome and its chronic form, chronic inflammatory demyelinating polyradiculoneuropathy have been reported.
En positiv Coombs 'test er også set.
A positive Coombs test has also been observed.
Stofskiftesygdomme og ernæringsbetingede sygdomme:
Metabolism and nutritional disorders:
Der er indberettet tilfælde af tumorlysesyndrom med dødelig udgang.
Tumour lysis syndrome with fatal outcome has been reported.
Der er set intrakraniel blødning med dødelig udgang hos patienter med trombocytopeni.
Intracranial haemorrhage has occurred with fatal outcome, in patients with thrombocytopenia.
Kongestiv hjerteinsufficiens, kardiomyopati og nedsat ejektionsfraktion er indberettet hos patienter, der tidligere er behandlet med potentielt kardiotoksiske midler.
Congestive heart failure, cardiomyopathy, and decreased ejection fraction have been reported in patients previously treated with potentially cardiotoxic agents.
Farmakoterapeutisk klassifikation: monoklonalt antistof, ATC- kode:
Pharmacotherapeutic group: monoclonal antibody, ATC code:
Alemtuzumab er et genetisk fremstillet humaniseret IgG1 kappa- monoklonalt antistof specifikt for et 21- 28 kD lymfocyt- celleoverfladeglykoprotein (CD 52) udskilt primært på overfladen af normale eller maligne perifere blod B - og T- celle lymfocytter.
Alemtuzumab is a genetically engineered humanised IgG1 kappa monoclonal antibody specific for a 21-28 kD lymphocyte cell surface glycoprotein (CD52) expressed primarily on the surface of normal and malignant peripheral blood B and T cell lymphocytes.
Alemtuzumab blev dannet ved at indsætte seks komplementaritets- bestemmende områder fra et IgG2a rotte monoklonalt antistof i et humant IgG1 immunglobulin- molekyle.
Alemtuzumab was generated by the insertion of six complementarity-determining regions from an IgG2a rat monoclonal antibody into a human IgG1 immunoglobulin molecule.
Alemtuzumab fremkalder lyse af lymfocytter ved at binde sig til CD52, stærkt udtrykt, ikke - modulerende antigen, som befinder sig på overfladen af i det væsentlige alle B - og T- celle- lymfocytter samt monocytter, thymocytter og makrofager.
Alemtuzumab causes the lysis of lymphocytes by binding to CD52, a highly expressed, non- modulating antigen which is present on the surface of essentially all B and T cell lymphocytes as well as monocytes, thymocytes and macrophages.
1. linje- B- CLL- patienter Sikkerhed og effektivitet for MabCampath blev evalueret i et Fase 3, open- label, randomiseret komparativt forsøg med 1. linje- patienter (tidligere ubehandlede) behandlingskrævende Rai- stadie I - IV B- CLL patienter (Undersøgelse 4).
11 First Line B-CLL Patients The safety and efficacy of MabCampath were evaluated in a Phase 3, open-label, randomized comparative trial of first line (previously untreated) Rai stage I-IV B-CLL patients requiring therapy (Study 4).
11 Figur 1:
Figure 1:
Undersøgelse af progressionsfri overlevelse hos 1. linje- patienter (efter behandlingsgruppe)
Progression Free Survival in First Line Study (by Treatment Group)
De sekundære mål omfattede komplet respons (CR) og samlet respons (CR eller delvis respons), grader ved anvendelse af 1996 NCIWG kriterierne, respons- varighed, tid til alternativ behandling og sikkerhed i de to behandlingsgrene.
The secondary objectives included complete response (CR) and overall response (CR or partial response) rates using the 1996 NCIWG criteria, the duration of response, time to alternative treatment and safety of the two treatment arms.
12 Resumé af 1. linje- patientpopulation og resultater
Summary of First-Line Patient Population and Outcomes
Uafhængig oversigt over grad og varighed
Independent Review of Response Rate and Duration
P- værdi
P value
Median for alder (år) RAI- stadium III/ IV sygdom
Median Age (Years) Rai Stage III/ IV Disease
Ikke aktuelt Ikke aktuelt
Not Applicable Not Applicable
Samlet respons- grad Komplet respons MRD negativ ****
Overall Response Rate Complete Response MRD negative****
Delvis respons Varighed af respons **, CR eller PR (måneder)
Partial Response Duration of Response**, CR or PR (Months)
K- M median (95% konfidensinterval)
K-M median (95% Confidence Interval)
Tid til alternativ behandling (måneder) K- M median (95% konfidensinterval) * Pearson chi- square test eller Exact test ** Varighed af bedst respons
Time to Alternative Treatment (Months) K-M median (95% Confidence Interval)
*** log- rank test stratificeret efter Rai gruppe (Stadium I- II vs III- IV) **** efter 4- farve flow
*Pearson chi-square test or Exact test ** Duration of best response *** log-rank test stratified by Rai group (Stage I-II vs III-IV) **** by 4-colour flow
Cytogene analyser hos 1. linje- B- CLL- patienter:
Cytogenetic Analyses in First Line B-CLL Patients:
Den cytogenetiske profil af B- CLL vinder stigende anerkendelse som givende vigtige prognostiske informationer, og den kan forudsige respons på visse behandlinger.
The cytogenetic profile of B-CLL has been increasingly recognized as providing important prognostic information and may predict response to certain therapies.
Ud af de 1. linje- patienter (n=282), hos hvem der var cytogene (FISH) data til rådighed ved udgangspunktet i undersøgelse 4, blev der detekteret kromosomale afvigelser hos 82%, mens normal karyotype blev detekteret hos 18%.
Of the first-line patients (n=282) in whom baseline cytogenetic (FISH) data were available in Study 4, chromosomal aberrations were detected in 82%, while normal karyotype was detected in 18%.
Kromosomale afvigelser blev kategoriseret efter Döhner’ s hierarkiske model.
Chromosomal aberrations were categorized according to Döhner’ s hierarchical model.
Hos 1. linje- patienter behandlet med enten MabCampath eller chlorambucil var der 21 patienter med 17 q deletion, 54 patienter med 11 q deletion, 34 patienter med trisomi 12, 51 patienter med normal karyotype og 67 patienter med kun 13 q deletion.
In first line patients, treated with either MabCampath or chlorambucil, there were 21 patients with the 17p deletion, 54 patients with 11q deletion, 34 patients with trisomy 12, 51 patients with normal karyotype and 67 patients with sole 13q deletion.
ORR var højere hos patienter med nogen 11 q deletion (87% v 29%; p < 0, 0001) eller kun 13 q deletion (91% v 62%; p=0, 0087) behandlet med MabCampath sammenlignet med chlorambucil.
ORR was superior in patients with any 11q deletion (87% v 29%; p < 0.0001) or sole deletion 13q (91% v 62%; p=0.0087) treated with MabCampath compared to chlorambucil.
Der observeredes en tendens til forbedret ORR hos patienter med 17p deletion behandlet med MabCampath (64% v 20%; p=0, 0805).
A trend toward improved ORR was observed in patients with 17p deletion treated with MabCampath (64% v 20%; p=0.0805).
Komplette remissioner var også højere hos patienter med kun 13p deletion behandlet med MabCampath (27% v 0%; p=0, 0009).
Complete remissions were also superior in patients with sole 13q deletion treated with MabCampath (27% v 0%; p=0.0009).
Median PFS var højere hos patienter med kun 13p deletion behandlet med MabCampath (24, 4 v 13, 0 måneder; p=0, 0170 stratificeret efter Rai- stadium).
Median PFS was superior in patients with sole 13q deletion treated with MabCampath (24.4 v 13.0 months; p=0.0170 stratified by Rai Stage).
13 Vurdering af CMV efter PCR:
Assessment of CMV by PCR:
I det randomiserede kontrollerede forsøg med 1. linje- patienter (Undersøgelse 4), blev patienter i MabCampath- grenen testet ugentligt for CMV ved hjælp af en PCR (polymerasekædereaktion) analyse fra indledning til afslutning af behandlingen, og hver 2. uge i de første to måneder efter behandlingen.
In the randomized controlled trial in first line patients (Study 4), patients in the MabCampath arm were tested weekly for CMV using a PCR (polymerase chain reaction) assay from initiation through completion of therapy, and every 2 weeks for the first 2 months following therapy.
I denne undersøgelse rapporterede asymptomatisk positive PCR alene for CMV hos 77/ 147 (52. 4%) af MabCampath- behandlede patienter; symptomatisk CMV- infektion blev rapporteret mindre hyppigt hos 23/ 147 MabCampath- behandlede patienter (16%).
In this study, asymptomatic positive PCR only for CMV was reported in 77/ 147 (52.4%) of MabCampath-treated patients; symptomatic CMV infection was reported less commonly in 23/ 147 MabCampath treated patients (16%).
I MabCampath- grenen fik 36/ 77 (46, 8%) af patienterne med asymptomatisk PCR positiv CMV antiviral behandling, og 47/ 77 (61%) af disse patienter fik seponeret MabCampath- behandlingen.
In the MabCampath arm 36/ 77 (46.8%) of patients with asymptomatic PCR positive CMV received antiviral therapy and 47/ 77 (61%) of these patients had MabCampath therapy interrupted.
Tilstedeværelsen af asymptomatisk positiv PCR for CMV eller symptomatisk PCR positiv CMV infektion under behandling med MabCampath havde ingen målbar invirkning på den progressionsfri overlevelse (PFS).
The presence of asymptomatic positive PCR for CMV or symptomatic PCR positive CMV infection during treatment with MabCampath had no measurable impact on progression free survival (PFS).
Tidligere behandlede B- CLL- patienter:
Previously treated B-CLL Patients:
Data, som er tilgængelige fra tre ukontrollerede studier af B- CLL, er opsummeret i følgende tabel:
Data available from three uncontrolled B-CLL studies are summarised in the following table:
Effektparametre
Efficacy Parameters
B- CLL- patienter, B- CLL- patienter, som havde fået et som ikke havde
B-CLL pts who had B-CLL pts who had
B- CLL (plus en med
B-CLL (plus a PLL)
ikke havde klaret fludarabin
received an alkylating agent and had failed fludarabine
fået recidiv efter behandling med konventionel kemoterapi
failed to respond or relapsed following treatment with conventional chemotherapy
patienter, som ikke havde responderet på eller som havde fået recidiv efter behandling med fludarabin
pts who had failed to respond or relapsed following treatment with fludarabine
Medianalder (år) Sygdomskarakteristika (%)
Median Age (years) Disease Characteristics (%)
Rai- stadium III/ IV B- symptom Tidligere behandlinger (%):
Rai Stage III/ IV B Symptoms Prior Therapies (%):
Alkylerende stoffer Fludarabin Antal tidligere behandlinger (område) Initialt doseringsregime
100 13
100 100 3 (2- 7) Gradvis øgning fra 3 til 10 til 30 mg
100
100 34 3 (1- 10) Gradvis øgning fra 10 til 30 mg
100
92 100 3 (1- 8) Gradvis øgning fra 10 til 30 mg
100
Afsluttende doseringsregime
Number of Prior Regimens (range)
30 mg iv 3 x ugentlig
3 (1-10)
30 mg iv 3 x ugentlig
3 (1-8)
30 mg iv 3 x ugentlig
Initial Dosing Regimen
Samlet målopfyldelse (%) (95% sikkerhedsinterval) Fuldstændig målopfyldelse Delvis målopfyldelse Median- varighed af målopfyldelse
Gradual escalation Gradual escalation
33 (23- 43) 2 31
from 3 to 10 to 30 mg
21 (8 - 33) 0 21
from 10 to 30 mg
29 (11- 47) 0 29
from 10 to 30 mg
(måneder) (95% sikkerhedsinterval) Median- tid til målopfyldelse
Final Dosing Regimen Overall Response Rate (%)
7 (5- 8)
30 mg iv
7 (5- 23)
3 x weekly 21
11 (6- 19)
30 mg iv 3 x weekly 29
(måneder) (95% sikkerhedsinterval) Progressionsfri overlevelse (måneder) (95% sikkerhedsinterval) Overlevelse (måneder):
(95% Confidence Interval) Complete Response Partial Response Median Duration of Response (months) (95% Confidence Interval) Median time to Response (months) (95% Confidence Interval) Progression-Free Survival (months) (95% Confidence Interval) Survival (months):
(95% sikkerhedsinterval)
(95% Confidence Interval)
2 (1- 2) 4 (3- 5)
(23-43) 2 31 7 (5-8) 2 (1-2) 4 (3-5)
4 (1- 5) 5 (3- 7)
(8-33) 0 21 7 (5-23) 4 (1-5) 5 (3-7)
4 (2- 4) 7 (3- 9)
(11-47) 0 29 11 (6-19) 4 (2-4) 7 (3-9)
Alle patienter Patienter, der responderer IN = ikke nået
All patients
16 (12- 22) 33 (26- IN)
16 (12-22)
26 (12- 44) 44 (28- IN)
26 (12-44)
28 (7- 33) 36 (19- IN)
33 (26-NR)
Farmakokinetikken blev beskrevet hos MabCampath- naive patienter med B- celle kronisk lymfatisk leukæmi (B- CLL), hvor tidligere behandling med purinanaloger havde slået fejl.
Pharmacokinetics were characterised in MabCampath-naive patients with B-cell chronic lymphocytic leukaemia (B-CLL) who had failed previous therapy with purine analogues.
MabCampath blev indgivet som en 2- timers intravenøs infusion efter anbefalet doseringsskema, startende med 3 mg og stigende til 30 mg 3 gange ugentlig i op til 12 uger.
MabCampath was administered as a 2 hour intravenous infusion, at the recommended dosing schedule, starting at 3 mg and increasing to 30 mg, 3 times weekly, for up to 12 weeks.
Farmakokinetikken for MabCambath fulgte en 2 - kompartmentmodel og udviste non- lineær eliminationskinetik.
MabCampath pharmacokinetics followed a 2-compartment model and displayed non-linear elimination kinetics.
Efter den sidste dosis på 30 mg var det mediane fordelingsvolumen ved steady state 0, 15 l/ kg (område:
After the last 30 mg dose, the median volume of distribution at steady-state was 0.15 l/ kg (range:
0, 1- 0, 4 l/ kg) tydende på, at fordelingen primært var til de ekstracellulære væske - og plasmakompartments.
0.1-0.4 l/ kg), indicating that distribution was primarily to the extracellular fluid and plasma compartments.
Systemisk clearance 15 faldt ved gentagen indgift på grund af nedsat receptormedieret clearance (dvs. tab af CD 52 receptorer i periferien).
Systemic clearance decreased with repeated administration due to decreased receptor-mediated clearance (i. e. loss of CD52 receptors in the periphery).
Ved gentagen indgift og deraf følgende plasmakoncentrationsakkumulation nærmede eliminationshastigheden sig nul- ordenskinetik.
With repeated administration and consequent plasma concentration accumulation, the rate of elimination approached zero-order kinetics.
Som sådan var halveringstiden 8 timer (område:
As such, half-life was 8 hours (range:
2- 32 timer) efter den første dosis på 30 mg og den var 6 dage (område:
2-32 hours) after the first 30 mg dose and was 6 days (range:
1- 14 dage) efter den sidste dosis på 30 mg.
1-14 days) after the last 30 mg dose.
6 ugers dosering.
Steady-state concentrations were reached after about 6 weeks of dosing.
5. 3 Prækliniske sikkerhedsdata
Preclinical safety data
Præklinisk vurdering af alemtuzumab hos dyr har været begrænset til cynomolgus- aben på grund af det manglende udtryk af CD52 antigenet hos ikke- primater.
Preclinical evaluation of alemtuzumab in animals has been limited to the cynomolgus monkey because of the lack of expression of the CD52 antigen on non-primate species.
Enkelte intravenøse doser på 10 og 30 mg/ kg fremkaldte moderat til alvorlig dosisrelateret hypotension ledsaget af let takykardi.
Single intravenous doses of 10 and 30 mg/ kg produced moderate to severe dose related hypotension accompanied by a slight tachycardia.
MabCampath Fab- binding blev observeret i lymfoide væv og det mononukleære fagocytsystem.
MabCampath Fab binding was observed in lymphoid tissues and the mononuclear phagocyte system.
Betydende Fab- binding blev også observeret i de mandlige forplantningsorganer (epididymis, sperma, vesicula seminalis) og huden.
Significant Fab binding was also observed in the male reproductive tract (epididymis, sperm, seminal vesicle) and the skin.
Der er ikke gennemført kort - eller langvarige dyrestudier med MabCampath m. h. p. at vurdere karcinogent eller mutagent potentiale.
14 No short or long term animal studies have been conducted with MabCampath to assess carcinogenic and mutagenic potential.
Natriumedetat Polysorbat 80 Kaliumklorid Kaliumdihydrogenfosfat Natriumklorid Dibasisk natriumfosfat Vand til injektionsvæsker
Disodium edetate Polysorbate 80 Potassium chloride Potassium dihydrogen phosphate Sodium chloride Dibasic sodium phosphate Water for injections
Andre lægemidler må dog ikke blandes med MabCampath- infusionen eller infunderes samtidigt gennem den samme intravenøse infusionsslange.
However, other medicinal products should not be added to the MabCampath infusion or simultaneously infused through the same intravenous line.
16 Fortyndet opløsning:
Reconstituted solution:
MabCampath indeholder intet antimikrobielt konserveringsmiddel.
MabCampath contains no antimicrobial preservative.
Opløsningen kan opbevares ved 15°C - 30°C eller opbevares i køleskab.
Solutions may be stored at 15°C-30°C or refrigerated.
Opbevares i køleskab (2°C- 8°C).
Store in a refrigerator (2°C-8°C).
5 ml ampul (klar glas, Type 1), som indeholder 3 ml koncentrat Pakningsstørrelse: æske med 3 ampuller.
Pack size: carton of 3 ampoules.
6. 6 Særlige forholdsregler for bortskaffelse og anden håndtering
6.6 Special precautions for disposal and other handling
Det anbefales derfor, at MabCampath tilberedes til intravenøs infusion ved anvendelse af aseptisk teknik og at den fortyndede infusionsopløsning indgives inden for 8 timer efter tilberedningen og beskyttes mod lys.
MabCampath contains no antimicrobial preservatives, therefore, it is recommended that MabCampath should be prepared for intravenous infusion using aseptic techniques and that the diluted solution for infusion should be administered within 8 hours after preparation and protected from light.
Den nødvendige mængde af ampullens indhold bør via et sterilt, fiberfrit, 5 μm filter med lav proteinbinding tilsættes til 100 ml 9 mg/ ml (0, 9%) natriumkloridopløsning til infusion eller 5% glukoseopløsning til infusion.
The 15 required amount of the ampoule contents should be added, via a sterile, low-protein binding, non-fibre 5 μ m filter, to 100 ml of sodium chloride 9 mg/ ml (0.9%) solution for infusion or glucose (5%) solution for infusion.
Andre lægemidler må ikke blandes med MabCampath infusionen eller infunderes samtidigt gennem den samme intravenøse infusionsslange.
Other medicinal products should not be added to the MabCampath infusion solution or simultaneously infused through the same intravenous line.
Genzyme Europe BV Gooimeer 10 1411 DD Naarden Holland
Genzyme Europe BV Gooimeer 10 1411 DD Naarden Netherlands
06/ 07/ 2001 Dato for seneste fornyelse:
06/ 07/ 2001 Date of latest renewal:
Yderligere information om dette lægemiddel er tilgængelig på Det europæiske Lægemiddelagenturs (EMEA) hjemmeside: http: // www. emea. europa. eu.
Detailed information on this product is available on the website of the European Medicines Agency (EMEA): http: / /www. emea. europa. eu.
MabCampath 30 mg/ ml koncentrat til infusionsvæske, opløsning.
MabCampath 30 mg/ ml concentrate for solution for infusion
En ml indeholder 30 mg alemtuzumab Hvert hætteglas indeholder 30 mg alemtuzumab.
Each vial contains 30 mg of alemtuzumab.
MabCampath er indiceret til behandling af patienter med kronisk lymfatisk B- celleleukæmi (B- CLL) for hvem fludarabin- kombinationskemoterapi ikke er hensigtsmæssig.
MabCampath is indicated for the treatment of patients with B-cell chronic lymphocytic leukaemia (B- CLL) for whom fludarabine combination chemotherapy is not appropriate.
Gennemsnitlig behandlingsvarighed var 11, 7 uger for 1. linje- patienter, og 9, 0 uger for tidligere behandlede patienter.
17 Median duration of treatment was 11.7 weeks for first line patients and 9.0 weeks for previously treated patients.