natgillin/translations-raw huggingface dataset:
19 Så snart en patient opfylder alle laboratoriemæssige og kliniske kriterier på en fuldstændigt respons, bør MabCampath seponeres og patienten kontrolleres.
Once a patient meets all laboratory and clinical criteria for a complete response, MabCampath should be discontinued and the patient monitored.
Patienter med nedsat nyre - og leverfunktion:
18 Patients with renal or hepatic impairment:
4. 4).
No studies have been conducted.
20 4. 3 Kontraindikationer
4.3 Contraindications
Akutte bivirkninger, som kan opstå i løbet af den initiale dosisoptrapning, og hvor nogle af dem kan skyldes cytokinfrigivelse, omfatter hypotension, kulderystelser, feber, åndenød og hududslæt.
Acute adverse reactions, which may occur during initial dose escalation and some of which may be due to the release of cytokines, include hypotension, chills/ rigors, fever, shortness of breath and rashes.
Der bør udvises forsigtighed ved behandling af patienter med iskæmisk hjertesygdom, angina og/ eller patienter, som behandles med antihypertensiva.
Caution should be used in treating patients with ischaemic heart disease, angina and/ or in patients receiving an antihypertensive medicincal product.
Vurdering og løbende overvågning af hjertefunktion (f. eks. ekkokardiografi, hjerterytme og kropsvægt) bør overvejes hos patienter, som tidligere er blevet behandlet med potentielt kardiotoksiske midler.
Assessment and ongoing monitoring of cardiac function (e. g. echocardiography, heart rate and body weight) should be considered in patients previously treated with potentially cardiotoxic agents.
Når dosis øges, og når det er klinisk indiceret, anbefales det, at patienterne præmedicineres med orale eller intravenøse steroider 30- 60 minutter før infusion med MabCampath.
It is recommended that patients be premedicated with oral or intravenous steroids 30-60 minutes prior to each MabCampath infusion during dose escalation and as clinically indicated.
Hos patienter, der får MabCampath som 1. linje- behandling, blev der opnået restitution af CD4+ tal til ≥200 celler/ µL på 6 måneder efter behandling, 2 måneder efter behandlingen var medianen dog 183 celler/ µl.
In patients receiving MabCampath as first line therapy, the recovery of CD4+ counts to ≥ 200 cells/ µl occurred by 6 months post-treatment, however, at 2 months post-treatment the median was 183 cells/μ l.
21 Asymptomatisk laboratorie- positiv Cytomegalovirus (CMV) viræmi bør ikke nødvendigvis betragtes som en alvorlig infektion, der kræver seponering af behandlingen.
19 Asymptomatic laboratory positive Cytomegalovirus (CMV) viraemia should not necessarily be considered a serious infection requiring interruption of therapy.
4. 2).
Since CLL occurs commonly in this older age group, these patients should be monitored carefully (see section 4.2).
22 skade på fosteret, hvis det gives til en gravid kvinde eller om det kan påvirke forplantningsevnen.
It is 20 not known whether MabCampath can cause foetal harm when administered to a pregnant woman or whether it can affect reproductive capacity.
Nedenstående tabeller rapporterer bivirkninger efter MEDDRA- systemets organklasser (MedDRA SOCs).
The tables below report adverse reactions by MedDRA system organ classes (MedDRA SOCs).
Hyppighederne er defineret som: meget almindelige (≥ 1/ 10), almindelige (≥ 1/ 100 til < 1/ 10), ikke - almindelige (≥ 1/ 1, 000 til < 1/ 100).
The frequencies are defined as: very common (≥ 1/ 10), common (≥ 1/ 100 to < 1/ 10), uncommon (≥ 1/ 1,000 to < 1/ 100).
97% af 1. linje- patienterne oplevede birvirkninger; de mest almindeligt indberettede bivirkninger hos 1. linje- patienterne forekom sædvanligvis i den første behandlingsuge.
Approximately 97% of first-line patients experienced adverse reactions; the most commonly reported reactions in first-line patients usually occurred in the first week of therapy.
Inden for hver frekvensgruppering præsenteres bivirkninger observeret under behandlingen eller inden for 30 dage efter gennemført behandling med MabCampath efter faldende grad.
Within each frequency grouping, undesirable effects observed during treatment or within 30 days following the completion of treatment with MabCampath, are presented in order of decreasing seriousness.
SystemOrgan- Klasse MEDDRA
SYSTEM ORGAN CLASS MEDDRA
Cytomegalovirus - infektion;
Cytomegalovirus infection
Stafylococ- baseret bakteriæmi Tuberkulose Bronkopneumoni Herpes ophthalmicus Beta- hæmolytisk streptococinfektion Candidiasis Genital candidiasis Urinvejsinfektion
Staphylococcal bacteraemia Tuberculosis Bronchopneumonia Herpes ophthalmicus Beta haemolytic streptococcal infection Candidiasis Genital candidiasis Urinary tract infection Cystitis Body tinea
MEGET ALMINDELIG
COMMON
IKKE- ALMINDELIG Cystitis Tinea corporis Nasofaryngit Rinit
UNCOMMON Nasopharyngitis Rhinitis
Tumorlysissyndrom Hyperglykæmi Nedsat total protein Anoreksi
Tumour lysis syndrome Hyperglycaemia Protein total decreased Anorexia
Hypoxi Pleural effusion Dysfoni Rinorré
Hypoxia Pleural effusion Dysphonia Rhinorrhoea
Sygdomme i mave - tarmkanalen
Gastrointestinal disorders
Opkastning Mavesmerter
Vomiting Abdominal pain
Ileus Oralt ubehag Maveubehag Diarré
Ileus Oral discomfort Stomach discomfort Diarrhoea
Udslæt, makuløst Udslæt, erytematøst Dermatit
Rash macular Rash erythematous Dermatitis
Knoglesmerter Artralgi Muskuloskeletale brystsmerter
Bone pain Arthralgia Musculoskeletal chest pain
24 SystemOrgan- Klasse MEDDRA
SYSTEM ORGAN CLASS MEDDRA
MEGET ALMINDELIG
VERY COMMON
IKKE- ALMINDELIG Muskelspasmer
UNCOMMON Muscle spasms
Bakterieinfektion
Bacterial infection
Pneumonitis Fungal infektion
Pneumonitis Fungal infection Candidiasis Herpes zoster Abscess Urinary tract infection Sinusitis Bronchitis Upper respiratory tract infection Pharyngitis Infection
Fungal dermatitis Laryngitis
Fungal dermatitis Laryngitis Rhinitis Onychomycosis
Candidiasis Herpes zoster Absces Urinvejsinfektion Sinusitis Bronkitis Infektion i øvre luftveje Faryngitis Infektion
Neoplasms, benign, malignant and unspecified (incl. cysts and polyps)
Rinitis Onykomykose
Lymphoma – like disorder
Lymfom- lignende sygdom
Blood and lymphatic system disorder
Sygdomme i blod - og lymfesystemet
Granulocytopenia Thrombocytopenia
Granulocytopeni Trombocytopeni
23
Febril neutropeni Pancytopeni
Febrile neutropenia Pancytopenia
Aplasi i knoglemarv Dissemineret intravaskulær koagulation
Aplasia bone marrow Disseminated intravascular coagulation
Hæmolytisk anæmi, Nedsat haptoglobin
Haemolytic anaemia, Decreased haptoglobin
Lymfopeni Purpura
Lymphopenia
25 SystemOrgan- Klasse MEDDRA
Bone marrow depression
ALMINDELIG
Purpura
IKKE- ALMINDELIG Gingiva blødning Hæmatologisk test abnorm
Epistaxis Gingival bleeding Haematology test abnormal
Allergisk reaktion Alvorlige anafylaktiske og andre overfølsomheds - reaktioner
Allergic reaction Severe anaphylactic and other hypersensitivity reactions
Stofskifte - og ernæringssyg- domme
Metabolic and nutrition disorders
Hyponatræmi Hypokalcæmi Vægttab Dehydrering Tørst
Hyponatraemia Hypocalcaemia Weight decrease Dehydration Thirst
Hypokalæmi Forværret diabetes mellitus
Hypokalaemia Diabetes mellitus aggravated
Konfusion Angst Depression Somnolens Insomni
Confusion Anxiety Depression Somnolence Insomnia
Depersonalisation Personlighedsforstyrrelse Abnorm tankegang Impotens Nervøsitet
Depersonalisation Personality disorder Abnormal thinking Impotence Nervousness
Vertigo Svimmelhed Tremor Paræstesi Hypoæstesi Hyperkinesi Smagstab
Vertigo Dizziness Tremor Paresthesia Hypoesthesia Hyperkinesia Taste loss
Synkope Abnorm gangart Dystoni Hyperæstesi Neuropati Smagsforvrængning
Syncope Abnormal gait Dystonia Hyperesthesia Neuropathy Taste perversion
Sygdomme i øjnene Øre - og labyrint- lidelser
Eye disorders Ear and labyrinth disorders
Endoftalmitis Døvhed Tinnitus
Endophthalmitis Deafness Tinnitus
Palpitation Takykardi
Palpitation Tachycardia
Hjertestop Myokardieinfarkt Atrieflimmer Supraventrikulær takykardi Arytmi Bradykardi Abnormt EKG
Cardiac arrest Myocardial infarction Atrial fibrillation Supraventricular tachycardia Arrhythmia Bradycardia Abnormal ECG
Hypertension Karspasme Rødmen
Hypertension Vasospasm Flushing
Hypoxi Hæmoptyse Bronkospasme Hoste
Hypoxia Haemoptysis Bronchospasm Coughing
Stridor Tæthed i halsen Pulmonal infiltration Pleural effusion Nedsatte respirationslyde Respiratorisk forstyrrelse
Stridor Throat tightness Pulmonary infiltration Pleural effusion Breath sounds decreased Respiratory disorder
Opkastning Kvalme Diarré
Vomiting
Gastrointestinal blødning Ulcerøs stomatitis Stomatitis Mavesmerter Dyspepsi Konstipation Flatulens
Gastrointestinal haemorrhage
Gastroenteritis Tungeulceration Gingivitis Hikke Opstød Mundtørhed
Gastroenteritis
26
Nausea Diarrhoea
SystemOrgan- Klasse MEDDRA Hepatobiliære lidelser
Ulcerative stomatitis Stomatitis Abdominal pain Dyspepsia Constipation Flatulence
MEGET ALMINDELIG
Tongue ulceration Gingivitis Hiccup Eructation Dry mouth
ALMINDELIG Abnorm leverfunktion
Hepatobiliary disorders
IKKE- ALMINDELIG
Hepatic function abnormal
Urtikaria Udslæt Hyperhidrose
Urticaria Rash Hyperhidrosis
Hudsygdom
Skin disorder
Artralgi Myalgi Skeletsmerter Rygsmerter
Arthralgia Myalgia Skeletal pain Back pain
Hæmaturi Urininkontinens Needsat urinudskillelse Polyuri Abnorm nyrefunktion
Haematuria Urinary incontinence Urine flow decreased Polyuria Renal function abnormal
Lungeødem Perifert ødem
Pulmonary oedema Peripheral oedema
Periorbitalt ødem Mucosal ulceration Misfarvning på infusionsstedet
Periorbital oedema Mucosal ulceration Infusion site bruising Infusion site dermatitis Infusion site pain
bivirkninger ved infusion:
Infusion reactions:
Alvorlige anafylaktiske og andre hypersensivitetsreaktioner, herunder anafylaktisk shock og angioødem, er indberettet efter MabCampath- behandling.
Severe anaphylactic and other hypersensitivity reactions, including anaphylactic shock and angioedema, have been reported following MabCampath administration.
Alvorlige og sommetider fatale virale infectioner (f. eks. adenovirus, parainfluenza, hepatitis B, progressiv multifokal leukoencephalopati (PML)), bakterielle infectioner (herunder tuberkulose og atypiske mykobakterier, nokardiose) protozo - (f. eks. toxoplasma gondii) og svampeinfektioner (f. eks. rinocerebral mucormycose), herunder dem 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.
27 Forstyrrelser i immunsystemet:
25 Immune system disorders:
Der er set intrakraniel blødning med ødelig udgang hos patienter med trombocytopeni.
Intracranial haemorrhage has occurred with fatal outcome, in patients with thrombocytopenia.
Kongestiv hjerteinsufficiens, kardiomyopati og nedsat ejektionsfraktion er indberettet i usædvanlige tilfælde 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.
28 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).
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).
Figur 1:
26 Figure 1:
Lymfom- lignende sygdom
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.
29 Resumé af 1. linje- patientpopulation og resultater
Summary of First-Line Patient Population and Outcomes
Median for alder (år) Rai- stadium III/ IV sygdom
Median Age (Years) Rai Stage III/ IV Disease
< 0. 0001 * < 0, 0001 * 0, 0008 *
< 0.0001* < 0.0001* 0.0008*
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) *Pearson chi-square test or Exact test ** Duration of best response
*** log- rank test stratificeret efter Rai gruppe (Stadium I- II vs III- IV) **** efter 4- farve flow
*** log-rank test stratified by Rai group (Stage I-II **** by 4-colour flow
Cytogene analyser hos 1. linje- B- CLL- patienter:
27 Cytogenetic Analyses in First Line B-CLL Patients:
Den cytogene 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%.
ORR var højere hos patienter med nogen 11q 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.
Komplette remissioner var også højere hos patienter med kun 13q 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 13q 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).
I denne undersøgelse rapporterede asymptomatisk positive PCR alene for CMV hos 77/ 147 (52. 4%) af MabCampath- behandlede patienter; symptomatisk CMV- infektion blev rapporteret
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%).
B- CLL- patienter, som B- CLL- patienter,
B-CLL pts who had B-CLL pts who had
responderet på eller som havde fået recidiv efter
received an alkylating agent and had failed fludarabine
(PLL)) patienter, som ikke havde responderet på eller
failed to respond or relapsed following treatment with conventional chemotherapy
som havde fået recidiv efter behandling med fludarabin
pts who had failed to respond or relapsed following treatment with fludarabine
Alkylerende stoffer Fludarabin
Alkylating Agents Fludarabine Number of Prior Regimens (range) Initial Dosing Regimen
100 100
100 100 3 (2-7) Gradual escalation from 3 to 10 to 30 mg
100 34
100 34 3 (1-10) Gradual escalation from 10 to 30 mg
Antal tidligere behandlinger (område)
92 100 3 (1-8) Gradual escalation from 10 to 30 mg
Initialt doseringsregime
Final Dosing Regimen
Gradvis øgning fra 10 til 30 mg
30 mg iv 3 x weekly
30 mg iv 3 x ugentlig 30 mg iv 3 x ugentlig 33 21 (23- 43) (8 - 33) 2 0 31 21
30 mg iv 3 x weekly
30 mg iv 3 x ugentlig 29 (11- 47) 0 29
30 mg iv 3 x weekly
11 (6- 19)
28
(måneder) (95% sikkerhedsinterval) Progressionsfri overlevelse
Overall Response Rate (%) (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):
(måneder) (95% sikkerhedsinterval) Overlevelse (måneder):
(95% Confidence Interval)
(95% sikkerhedsinterval)
33 (23-43) 2 31 7 (5-8) 2 (1-2) 4 (3-5)
4 5 (3- 5) (3- 7)
21 (8-33) 0 21 7 (5-23) 4 (1-5) 5 (3-7)
Alle patienter Patienter, der responderer IN = ikke nået
All patients Responders NR = not reached
16 (12- 22) 26 (12- 44) 33 (26- IN) 44 (28- IN)
26 (12-44) 44 (28-NR)
28 (7- 33) 36 (19- IN)
28 (7-33) 36 (19-NR)
Systemisk clearance
0.1-0.4 l/ kg), indicating that distribution was primarily to the extracellular fluid and plasma compartments.
32 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).
Der er ikke gennemført kort - eller langvarige dyrestudier med MabCampath m. h. p. at vurdere karcinogent eller mutagent potentiale.
No short or long term animal studies have been conducted with MabCampath to assess carcinogenic and mutagenic potential.
33 Fortyndet opløsning:
Reconstituted solution:
Opbevares i køleskab (2°C- 8°C) Må ikke nedfryses.
Do not freeze.
2 ml hætteglas (klar glas, Type 1), som indeholder 1 ml koncentrat
2 ml vial (clear type I glass) containing 1 ml of concentrate.
Pakningsstørrelse: æske med 3 hætteglas.
Pack size: carton of 3 vials.
Den nødvendige mængde af hætteglassets indhold bør tilsættes til 100 ml 9 mg/ ml (0, 9%) natriumklorid opløsning til infusion eller 5% glukoseopløsning til infusion.
The required amount of the vial contents should be added 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.
30 Other medicinal products should not be added to the MabCampath infusion solution or simultaneously infused through the same intravenous line.
35 BILAG II
31 ANNEX II
KG Birkendorfer Straße 65 D- 88397 Biberach an der Riss Tyskland
KG Birkendorfer Strasse 65 D-88397 Biberach an der Riss Deutschland
Bayer Schering Pharma AG Müllerstraße 178 D- 13342 Berlin Tyskland
Bayer Schering Pharma AG Müllerstrasse 178 D-13342 Berlin Deutschland
Lægemidlet må kun udleveres efter begrænset recept (jf. bilag I:
Medicinal product subject to restricted medical prescription (See Annex 1:
Indehaveren af markedsføringstilladelsen skal sammen med de lokale myndigheder. blive enige om indholdet i en informationsbrochure.
The MAH shall agree the details of an educational brochure with the National Competent Authorities.
Indehaveren af markedsføringstilladelsen skal sikre, at alle læger, der foreskriver MabCampath, modtager en informationspakke til sundhedspersonalet der indeholder følgende: ● Informationsbrochure ● Produktresumé (SPC) samt indlægsseddel og etikettering
The MAH shall ensure that all doctors who prescribe MabCampath are provided with a healthcare professional information pack containing the following: • Educational brochure • Summary of Product Characteristics (SPC) and Package Leaflet and Labelling
Informationsbrochuren skal indeholde følgende punkter: ● Risiko for opportunistiske infektioner, specielt CMV- viraemia ● Anbefaling om at undlade vaccination med levende vacciner i mindst 12 måneder efter MabCampath- behandlingen ● Risiko for infusionsreaktioner o Behov for præmedicinering o At behandling for hypersensitivitetsreaktioner, herunder forholdsregler for genoplivning, skal være tilgængelig under administration o At risikoen for infusionsreaktioner er højest i behandlingens første uge o At såfremt reaktionen er moderat eller alvorlig, bør dosering fortsætte på samme niveau (dvs. ingen dosisoptrapning), indtil hver dosis tolereres godt. o At såfremt behandlingen seponeres i mere end 7 dage, skal MabCampath genindsættes med gradvis dosisoptrapning
• The risk of opportunistic infections, in particular CMV viraemia • Recommendation to avoid vaccination with live vaccines for at least 12 months following MabCampath therapy • The risk of infusion reactions o Need for premedication o That treatment for hypersensitivity reactions, including measures for resuscitation should be available during administration o That the risk of infusion reactions is highest in first week of therapy o That if the reaction is moderate or severe dosing should continue at the same level (ie no dose escalation) until each dose is well tolerated o That if therapy is withheld for more than 7 days then MabCampath should be reinstituted with gradual dose escalation
37 Risikostyringsplan Indehaveren af markedsføringstilladelsen skal gennemføre undersøgelser og supplerende pharmacovigilance- aktiviteter, som angivet i Pharmacovigilance- planen i henhold til version 2. 0 i risikostyringsplanen i modul 1. 8. 2. i ansøgningen om markedsføringstilladelse og eventuelle senere opdateringer af planen, godkendt af CHMP.
33 Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 2.0 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
I henhold til CHMPs retningslinjer for risikostyringssystemer for lægemidler til humant brug,, skal den opdaterede risikostyringsplan indsendes samtidigt med næste PSUR- rapport (Periodic Safety Update Report).
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Herudover skal der indsendes en opdateret risikostyringsplan: • Når der modtages nye oplysninger, som kan påvirke den aktuelle sikkerhedsspecifikation, pharmacovigilance- plan eller de risikoforebyggende aktiviteter • Inden for 60 dage efter at en vigtig milepæl er nået inden for pharmacovigilance eller risikominimering • På forlangende af EMEA
In addition, an updated RMP should be submitted: • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
38 BILAG III
34 ANNEX III
40 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
36 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
MabCampath 10 mg/ ml, koncentrat til infusionsvæske, opløsning Alemtuzumab
MabCampath 10 mg/ ml concentrate for solution for infusion Alemtuzumab
1 ml indeholder 10 mg alemtuzumab Hver ampul indeholder 30 mg alemtuzumab
Each ampoule contains 30 mg of alemtuzumab.
3 x 3 ml ampuller 30 mg/ 3 ml
3 x 3 ml ampoules 30 mg/ 3 ml
Intravenøs anvendelse Læs indlægssedlen før brug
Read the package leaflet before use.
EXP Opbevaringstiden for det fortyndede lægemiddel er anført i indlægssedlen.
EXP Read the leaflet for the shelf life of the reconstituted product.
41 9.
37 9.
Må ikke nedfryses Opbevares i originalemballagen for at sikre beskyttelse mod lys.
Store in the original package in order to protect from light.
42 MINDSTEKRAV TIL MÆRKNING, DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER
38 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
MabCampath 10 mg/ ml, koncentrat til infusionsvæske, opløsning Alemtuzumab Til intravenøs brug
MabCampath 10 mg/ ml concentrate for solution for infusion Alemtuzumab Intravenous use
43 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
39 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
MabCampath 30 mg/ ml, koncentrat til infusionsvæske, opløsning Alemtuzumab
MabCampath 30 mg/ ml concentrate for solution for infusion Alemtuzumab
3 x 1 ml hætteglas 30 mg/ ml
3 x 1 ml vials 30 mg/ ml
Må ikke nedfryses Opbevares i originalemballagen for at sikre beskyttelse mod lys.
Store in the original package in order to protect from light,.