natgillin/translations-raw huggingface dataset:
Leukocytmigration over BBB involverer interaktion mellem adhæsionsmolekyler på de inflammatoriske celler og adhæsionsmolekylerne på karvæggens endotelceller.
The interaction between α 4β 1 and its targets is an important component of pathological inflammation in the brain and disruption of these interactions leads to reduced inflammation.
Under normale forhold udtrykkes VCAM- 1 ikke i hjerneparenkymet.
Under normal conditions, VCAM-1 is not expressed in the brain parenchyma.
Til gengæld opreguleres VCAM- 1 på endotelceller og muligvis på gliale celler tæt ved inflammationsstederne, når der er pro- inflammatoriske cytokiner tilstede.
However, in the presence of pro-inflammatory cytokines, VCAM-1 is upregulated on endothelial cells and possibly on glial cells near the sites of inflammation.
Når det drejer sig om inflammation i centralnervesystemet (CNS) ved MS, er det interaktionen mellem α4β1 og VCAM- 1, CS- 1 og osteopontin, der medierer den faste adhæsion og transmigration af leukocytter ind i hjerneparenkymet og dermed foranlediger den uophørlige inflammatoriske kaskade i CNS væv.
In the setting of central nervous system (CNS) inflammation in MS, it is the interaction of α 4β 1 with VCAM-1, CS-1 and osteopontin that mediates the firm adhesion and transmigration of leukocytes into the brain parenchyma and may perpetuate the inflammatory cascade in CNS tissue.
Blokaden hæmmer yderligere rekruttering af immunceller til inflammeret væv og reducerer derved nydannelse eller forstørrelse af MS- læsioner.
Blockade of the molecular interactions of α 4β 1 with its targets reduces inflammatory activity present in the brain in MS and inhibits further recruitment of immune cells into inflamed tissue, thus reducing the formation or enlargement of MS lesions.
TYSABRI er indiceret som en monoterapeutisk sygdomsmodificerende behandling hos patienter med relapsing- remitting multipel sklerose for at forhindre attakker og for at forsinke progression af handikapudvikling.
TYSABRI is indicated as a single disease modifying therapy in relapsing remitting multiple sclerosis to prevent relapses and delay progression of disability.
4. 4 og 4. 8) er behandlingen begrænset til følgende patientgrupper:
Due to safety concerns (see sections 4.4 and 4.8) treatment is restricted to the following patient groups:
• Patienter som ikke har responderet på et fuldstændigt og tilstrækkeligt behandlingsforløb af et beta- interferon.
• Patients who have failed to respond to a full and adequate course of a beta-interferon.
Patienter som har oplevet mindst 1 attak i det forudgående år, mens de var i behandling, og som har mindst 9 T2- hyperintense læsioner påvist ved kraniel MR- scanning eller mindst 1 gadolinium- forstærket læsion.
Patients should have had at least 1 relapse in the previous year while on therapy, and have at least 9 T2-hyperintense lesions in cranial MRI or at least 1 Gadolinium-enhancing lesion.
9 • Patienter med hurtigt udviklende svær relapsing- remitting multipel sklerose, defineret som 2 eller flere invaliderende attakker på ét år og med 1 eller flere Gadolinium forstærkede læsioner set ved MR hjernescanning eller en signifikant stigning i T2 læsionsbyrden sammenlignet med en tidligere nylig MR- scanning.
• Patients with rapidly evolving severe relapsing remitting multiple sclerosis, defined by 2 or more disabling relapses in one year, and with 1 or more Gadolinium enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI.
Effekten som monoterapi er blevet evalueret i et randomiseret, dobbeltblindet, placebokontrolleret studie over 2 år (AFFIRM studiet) med relapsing- remitting MS- patienter, der havde oplevet mindst ét klinisk attak i året forud for deres indtræden i forsøget, og som havde en score på mellem 0 og 5 på Kurtzke- skalaen (Expanded Disability Status Scale - EDSS).
Efficacy as monotherapy has been evaluated in one randomised, double-blind, placebo-controlled study lasting 2 years (AFFIRM study) in relapsing-remitting MS patients who had experienced at least 1 clinical relapse during the year prior to entry and had a Kurtzke Expanded Disability Status Scale (EDSS) score between 0 and 5.
Patienterne blev randomiseret i forholdet 2: 1 til at modtage TYSABRI 300 mg (n = 627) eller placebo (n = 315) hver 4. uge med op til 30 infusioner.
The patients were randomised with a 2:1 ratio to receive TYSABRI 300 mg (n = 627) or placebo (n = 315) every 4 weeks for up to 30 infusions.
Magnetisk resonans scanning (MR) evalueringer for T1- vægtede gadolinium (Gd) - forstærkede læsioner og T2 - hyperintense læsioner blev udført årligt.
MRI evaluations for T1-weighted gadolinium (Gd)-enhancing lesions and T2-hyperintense lesions were performed annually.
AFFIRM studiet:
9 AFFIRM study:
Overordnede rammer og resultater Monoterapi; randomiseret dobbeltblindet placebokontrolleret Design parallelgruppe forsøg over 120 uger Forsøgspersoner
Main features and results Monotherapy; randomised double-blind placebo-controlled Design parallel-group trial for 120 weeks Subjects
Behandling Endepunkt ved ét år Endepunkt ved to år
Treatment One year endpoint Two year endpoint
Placebo
Secondary endpoints
/ natalizumab 300 mg i. v. hver 4. uge Attakhyppighed Progression i EDSS
Relapse rate derived variables / MRI-derived variables Placebo Natalizumab 315 627
Sekundære endepunkter Afledte variabler fra attakhyppighed / afledte variabler fra MR Patienter Randomiseret Fuldførte 1 år Fuldførte 2 år
Completing 1 years Completing 2 years
Placebo 315 296 285
296 285
Natalizumab 627 609 589
609 589
Alder, år median (område) MS- anamnese, år, median
Age yrs, median (range) MS-history yrs, median (range) Time since diagnosis, yrs median
(område) Attakker i forudgående 12
(range) Relapses in previous 12 months,
måneder, median (område) EDSS- baseline, median
median (range) EDSS-baseline, median (range)
1, 0 (0- 5)
1.0 (0-5) 2 (0-6.0)
2 (0- 6, 0)
1.0 (0-12) 2 (0-6.0)
RESULTATER Årlig attakhyppighed Efter ét år (primært endepunkt) Efter to år
After one year (primary endpoint) After two years
0, 805 0, 733
0.805 0.733
0, 261 0, 235
0.261 0.235
Hyppighedsforhold 0, 33 CI95% 0, 26; 0, 41
Rate ratio 0.33 CI95% 0.26; 0.41
Hyppighedsforhold 0, 32 CI95% 0, 26; 0, 40
Rate ratio 0.32 CI95% 0.26; 0.40
Efter ét år Efter to år
After two years
Andel med progression1( 12 -
Proportion progressed1(12-week
ugers bekræftelse;
confirmation; primary outcome)
Hazard ratio 0, 58, CI95% 0, 43; 0, 73, p < 0, 001 1 Andel med progression (24 -
Hazard ratio 0.58, CI95% 0.43; 0.73, p < 0.001 Proportion progressed1(24-week
ugers bekræftelse)
confirmation)
Hazard ratio 0, 46, CI95% 0, 33; 0, 64, p < 0, 001 MR (0- 2 år)
Hazard ratio 0.46, CI95% 0.33; 0.64, p < 0.001 MRI (0-2 years)
Median% ændring i T2 -
Median% change in T2-
hyperintense læsioners volumen Gennemsnitligt antal nye eller
hyperintense lesion volume
(p < 0, 001) 1, 9
(p < 0.001)
nyligt forstørrede T2- hyperintense læsioner
Mean number of new or newly-
Gennemsnitligt antal T1 -
enlarging T2-hyperintense lesions Mean number of T1-hypointense
hypointense læsioner Gennemsnitligt antal Gd -
lesions Mean number of Gd-enhancing
forstærkede læsioner 1
lesions
Progression af handikapudvikling var defineret som mindst 1, 0 point stigning i EDSS fra en baseline EDSS > =1, 0 fortsat i 12 eller 24 uger eller mindst 1, 5 point stigning i EDSS fra en baseline EDSS =0 fortsat i 12 eller 24 uger.
Progression of disability was defined as at least a 1.0 point increase on the EDSS from a baseline EDSS > =1.0 sustained for 12 or 24 weeks or at least a 1.5 point increase on the EDSS from a baseline EDSS =0 sustained for 12 or 24 weeks.
I undergruppen af patienter, der var indiceret til behandling af hurtigt udviklende relapsing- remitting MS (patienter med 2 eller flere attakker eller 1 eller flere Gd+ læsioner), var den årlige attakhyppighed 0, 282 i den TYSABRI behandlede gruppe (n= 148) og 1, 455 i placebo- gruppen (n= 61) (p < 0, 001).
In the sub-group of patients indicated for treatment of rapidly evolving relapsing remitting MS (patients with 2 or more relapses and 1 or more Gd+ lesion), the annualised relapse rate was 0.282 in
Hazard ratio for progression af handikapudvikling var 0, 36 (95% CI:
Hazard ratio for disability progression was 0.36 (95% CI:
0, 17; 0, 76) p=0, 008.
0.17, 0.76) p = 0.008.
Efter gentagen intravenøs administration af en 300 mg dosis natalizumab til MS- patienter var den observerede middelværdi for den maksimale serumkoncentration 110 ± 52 μg/ ml.
Following the repeat intravenous administration of a 300 mg dose of natalizumab to MS patients, the mean maximum observed serum concentration was 110 ± 52 μ g/ ml.
Gennemsnitlig middelværdi for steady- state minimumskoncentrationer af natalizumab over behandlingsperioden lå mellem 23 μg/ ml og 29 μg/ ml.
Mean average steady-state trough natalizumab concentrations over the dosing period ranged from 23 μ g/ ml to 29 μ g/ ml.
Den forventede tid til steady- state var cirka 36 uger.
The predicted time to steady-state was approximately 36 weeks.
En populations- farmakokinetisk analyse blev gennemført med prøver fra mere end 1. 100 MS - patienter, som fik doser fra 3 til 6 mg/ kg natalizumab.
A population pharmacokinetics analysis was conducted on samples from over 1,100 MS patients receiving doses ranging from 3 to 6 mg/ kg natalizumab.
Middelværdi ± SD steady- state clearance var 13, 1 ± 5, 0 ml/ t, med en middelværdi ± SD halveringstid på 16 ± 4 dage.
The mean ± SD steady-state clearance was 13.1 ± 5.0 ml/ h, with a mean ± SD half-life of 16 ± 4 days.
Analysen så på virkninger på farmakokinetikken af udvalgte kovariater inklusive legemsvægt, alder, køn, nyre - og leverfunktion samt tilstedeværelse af anti- natalizumab antistoffer.
The analysis explored the effects of selected covariates including body weight, age, gender, hepatic and renal function, and presence of anti-natalizumab antibodies upon pharmacokinetics.
Kun legemsvægt og tilstedeværelse af anti- natalizumab antistoffer viste sig at påvirke natalizumab fordelingen.
Only body weight and the presence of anti-natalizumab antibodies were found to influence natalizumab disposition.
Legemsvægt viste sig at påvirke clearance på en mindre- end proportional måde, således at en 43% ændring i legemsvægt resulterede i en 31 til 34% ændring i clearance.
Body weight was found to influence clearance in a less-than-proportional manner, such that a 43% change in body weight resulted in a 31% to 34% change in clearance.
4. 8).
The presence of persistent anti-natalizumab antibodies increased natalizumab clearance approximately 3-fold, consistent with reduced serum natalizumab concentrations observed in persistently antibody-positive patients, (see section 4.8).
Farmakokinetikken af natalizumab hos pædiatriske MS- patienter eller hos patienter med nyre - eller leverinsufficiens er ikke blevet undersøgt.
The pharmacokinetics of natalizumab in paediatric MS patients or in patients with renal or hepatic insufficiency has not been studied.
Virkningen af plasmaferese på natalizumab- clearance og - farmakodynamik er evalueret i et forsøg med 12 MS- patienter.
The effect of plasma exchange on natalizumab clearance and pharmacodynamics was evaluated in a study of 12 MS patients.
Estimeringer af den totale fjernelse af stoffet efter tre plasmafereser (over en periode på 5- 8 dage) var cirka 70- 80% sammenlignet med 40% i tidligere forsøg, hvor målingerne blev foretaget efter afbrydelse af medicinen over en lignende observationsperiode.
This compares to approximately 40% seen in earlier studies in which measurements occurred after drug discontinuation over a similar period of observation.
I overensstemmelse med den farmakologiske aktivitet af natalizumab viste ændringer i transporten af lymfocytter sig som en forøgelse i antallet af hvide blodlegemer såvel som en forøget miltvægt i de fleste in vivo forsøg.
Consistent with the pharmacological activity of natalizumab, altered trafficking of lymphocytes was seen as white blood cell increases as well as increased spleen weights in most in vivo studies.
Natalizumab udviste ingen virkninger på in vitro prøver af α4 - integrin- positiv tumor linie proliferation eller cytotoksicitet.
Natalizumab showed no effects on in vitro assays of α 4-integrin-positive tumour line proliferation or cytotoxicity.
Natalizumab havde ingen effekt på fertiliteten hos hanner.
Reductions in female guinea pig fertility were observed in one study at doses in excess of the human dose; natalizumab did not affect male fertility.
I et forsøg med aber var antallet af aborter fordoblet hos natalizumab- behandlede (30 mg/ kg) grupper i forhold til matchende kontrolgrupper.
In a study in monkeys, the number of abortions was doubled in the natalizumab 30 mg/ kg treatment groups versus matching control groups.
Dette var resultatet af en høj incidens af aborter i de behandlede grupper i den første kohorte, og dette blev ikke observeret i den anden kohorte.
This was the result of a high incidence of abortions in treated groups in the
Der er ikke blevet observeret virkninger på abortraterne i noget andet forsøg.
11 first cohort that was not observed in the second cohort.
Et forsøg med drægtige cynomolgus aber påviste natalizumab relaterede ændringer på fostret.
No effects on abortion rates were noted in any other study.
Ændringerne omfattede mild anæmi, reduceret blodpladetal, øget miltvægt og reduceret lever - og thymusvægt.
A study in pregnant cynomolgus monkeys demonstrated natalizumab-related changes in the foetus that included mild anaemia, reduced platelet counts, increased spleen weights and reduced liver and thymus weights.
Der var derimod intet tegn på anæmi hos afkommet.
Platelet counts were also reduced in offspring born to mothers treated with natalizumab until parturition, however there was no evidence of anaemia in these offspring.
4. 6).
In cynomolgus monkeys treated with natalizumab until parturition, low levels of natalizumab were detected in the breast milk of some animals, indicating the possibility for transfer of natalizumab into breast milk in humans (see section 4.6).
Natriumfosfat, monobasisk, monohydrat Natriumfosfat, dibasisk, heptahydrat Natriumklorid Polysorbat 80 (E433) Vand til injektioner
Sodium phosphate, monobasic, monohydrate Sodium phosphate, dibasic, heptahydrate Sodium chloride Polysorbate 80 (E433) Water for Injections.
6. 6
TYSABRI must not be mixed with other medicinal products except those mentioned in section 6.6.
Hvis den fortyndede opløsning ikke anvendes omgående, skal den opbevares ved 2˚C - 8˚C og infunderes inden for 8 timer efter fortynding.
If not used immediately, the diluted solution must be stored at 2˚ C - 8˚ C and infused within 8 hours of dilution.
Opbevaringstid og - forhold inden anvendelse er brugerens ansvar.
In-use storage times and conditions prior to use are the responsibility of the user.
Opbevares i køleskab (2 °C – 8 °C).
Store in a refrigerator (2 ˚ C - 8˚ C).
15 ml TYSABRI i et hætteglas (Type I glas) med en prop (bromobutylgummi) og en forsegling (aluminium) med flip- off hætte.
15 ml TYSABRI in a vial (type I glass) with a stopper (bromobutyl rubber) and a seal (aluminium) with a flip-off cap.
Hvis der observeres partikler, og/ eller hvis væsken i hætteglasset ikke er farveløs, klar til let opaliserende, må hætteglasset ikke anvendes.
If particles are observed and/ or the liquid in the vial is not colourless, clear to slightly opalescent, the vial must not be used.
Brug aseptisk teknik, når TYSABRI opløsningen klargøres til intravenøs (i. v.) infusion.
Use aseptic technique when preparing TYSABRI solution for intravenous (IV) infusion.
Tag flip- off hætten af hætteglasset.
Remove flip-off cap from the vial.
Stik sprøjtenålen ind i hætteglasset gennem midten af gummiproppen, og udtræk 15 ml infusionsvæske- koncentrat.
Insert the syringe needle into the vial through the centre of the rubber stopper and remove 15 ml concentrate for solution for infusion.
Tilfør de 15 ml infusionsvæske- koncentrat til 100 ml natriumklorid 9 mg/ ml (0, 9%) injektionsopløsning.
Add the 15 ml concentrate for solution for infusion to 100 ml sodium chloride 9 mg/ ml (0.9%) solution for injection.
4 TYSABRI må ikke blandes med andre lægemidler eller opløsningsmidler.
TYSABRI must not be mixed with other medicinal products or diluents.
Undersøg det fortyndede produkt visuelt for partikler eller misfarvning inden administrationen.
5 Visually inspect the diluted product for particles or discolouration prior to administration.
Det fortyndede produkt skal anvendes så hurtigt som muligt og inden for 8 timer efter fortynding.
The diluted product is to be used as soon as possible and within 8 hours of dilution.
Hvis det fortyndede produkt opbevares ved 2˚C - 8˚C (må ikke nedfryses), skal man lade opløsningen få stuetemperatur inden infusionen.
If the diluted product is stored at 2˚ C - 8˚ C (do not freeze), allow the solution to warm to room temperature prior to infusion.
Den fortyndede opløsning skal infunderes intravenøst over 1 time med en hastighed på cirka 2 ml/ minut.
The diluted solution is to be infused intravenously over 1 hour at a rate of approximately 2 ml/ minute.
Efter at infusionen er gennemført, gennemskylles i. v. slangen med natriumklorid 9 mg/ ml (0, 9%) injektionsopløsning.
After the infusion is complete, flush the intravenous line with sodium chloride 9 mg/ ml (0.9%) solution for injection.
Hvert enkelt hætteglas er til engangsbrug.
Each vial is for single– use only.
Ikke anvendte lægemidler samt affald heraf bør destrueres i henhold til lokale retningslinjer.
Any unused product or waste material must be disposed of in accordance with local requirements.
Elan Pharma International Ltd., Monksland, Athlone, County Westmeath, Irland
Elan Pharma International Ltd., Monksland, Athlone, County Westmeath, Ireland
27. juni 2006
27th June 2006
Yderligere information om dette lægemiddel er tilgængelig på Det europæiske Lægemiddelagenturs (EMEAs) 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/.
14 BILAG II
14 A.
BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
Robijnlaan 8 NL- 2132 Hoofddorp Holland
Robijnlaan 8 NL-2132 Hoofddorp The Netherlands
Biogen Idec Denmark Manufacturing ApS Biogen Idec Allé 1 DK- 3400 Hillerød Danmark
Biogen Idec Denmark Manufacturing ApS Biogen Idec Allé 1 DK-3400 Hillerød Denmark
Indehaveren af markedsføringstilladelsen skal implementere nationalt, inden markedsføringen, og som aftalt med de kompetente myndigheder i medlemslandene, at alle læger, som påtænker at ordinere TYSABRI, skal forsynes med en lægepakke, der indeholder følgende: • Produktinformation • Information til lægen om TYSABRI • Patientinformationskort
The Marketing Authorisation Holder must implement nationally, prior to marketing, and as agreed with the competent authorities in the Member States that all physicians who intend to prescribe TYSABRI are provided with a physician pack containing the following elements: • Product information • Physician information about TYSABRI • Patient alert card.
Informationen til lægen om TYSABRI skal indeholde følgende hovedelementer: • Begrænset indikation • Atypiske/ opportunistiske infektioner især PML, herunder:
The physician information about TYSABRI shall contain the following key elements: • Restricted indication • Atypical/ opportunistic infections in particular PML including:
Diagnosticering af PML, herunder differentiering mellem PML og MS attak PML behandlingsalgoritme Mulighed for andre opportunistiske infektioner
Diagnosis of PML including differentiation between PML and MS relapse PML management algorithm Possibility of other opportunistic infections
• Infusionsreaktioner • Overfølsomhedsreaktioner • Antistofdannelse • Nødvendigheden af at informere patienterne om fordele og risici ved behandling med TYSABRI samt at forsyne patienterne med et patientinformationskort.
• Infusion reactions • Hypersensitivity reactions • Antibody formation
16 • ANDRE BETINGELSER
• OTHER CONDITIONS
Indehaveren af markedsføringstilladelsen skal sikre, at systemet til bivirkningsovervågning er på plads, og at det fungerer, inden produktet kommer på markedet, og så længe det markedsførte produkt stadig er i brug.
The MAH must ensure that the system of pharmacovigilance is in place and functioning before the product is placed on the market and for as long as the marketed product remains in use.
Indehaveren af markedsføringstilladelsen forpligter sig til at gennemføre studier og yderligere bivirkningsovervågningsaktiviteter, detaljeret beskrevet i bivirkningsovervågningsplanen.
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan.
En opdateret Risk Management Plan skal tilvejebringes som ifølge CHMP Guideline on Risk Management Systems for lægemiddelprodukter til human anvendelse.
An updated Risk Management Plan should be provided as per the CHMP Guideline on Risk Management Systems for medicinal products for human use.
Indehaveren af markedsføringstilladelsen skal hver 6. måned indsende periodiske sikkerhedsopdateringsrapporter (PSUR' er), indtil andet specificeres.
The MAH will submit PSURs on 6 monthly basis until otherwise specified.
ETIKETTERING
18 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Hvert 15 ml hætteglas med koncentrat indeholder 300 mg natalizumab (20 mg/ ml);
Each 15 ml vial of concentrate contains 300 mg natalizumab (20 mg/ ml);
natriumfosfat, monobasisk, monohydrat; natriumfosfat, dibasisk, heptahydrat; natriumklorid; polysorbat 80 (E433); og vand til injektioner.
sodium phosphate, monobasic, monohydrate; sodium phosphate, dibasic, heptahydrate; sodium chloride; polysorbate 80 (E433) and water for injections.
1 x 15 ml hætteglas
1 x 15 ml vial
Monksland Athlone County Westmeath Irland
Monksland Athlone County Westmeath Ireland
Begrundelse for ikke at inkludere Braille er accepteret.
Justification for not including Braille accepted.
Læs hele denne indlægsseddel omhyggeligt, inden De begynder at bruge dette lægemiddel.
Read all of this leaflet carefully before you start using this medicine.
Foruden denne indlægsseddel vil De modtage et patientinformationskort, der indeholder vigtig sikkerhedsinformation, som De bør kende til, inden De får TYSABRI (udtales ty- SA- bri), og som De bør være opmærksom på under behandlingen med TYSABRI.
In addition to this leaflet you will be given a Patient Alert Card, which contains important safety information that you need to know before you are given TYSABRI (pronounced tie-SA-bree) and during treatment with TYSABRI.
- Gem indlægssedlen og patientinformationskortet.
- Keep this leaflet and the Patient Alert Card.
igen.
You may need to read them again.
- Det er vigtigt, at De har patientinformationskortet på Dem under behandlingsforløbet og i 6
- It is important that you keep the Alert Card with you during treatment and for six months after
måneder efter den sidste dosis TYSABRI, da bivirkninger kan forekomme selv efter, at De er ophørt med behandlingen.
the last dose of TYSABRI, since side effects may occur even after you have stopped treatment.
- Denne indlægsseddel vil fortælle om bivirkninger, som nogle patienter oplever i forbindelse
If you
Hvis De får en alvorlig bivirkning, eller hvis De bemærker nogen form for bivirkninger, som ikke er nævnt i denne indlægsseddel, bør De fortælle det til Deres læge, sygeplejerske eller apotek.
have any worrying side effects, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.
Virkning og anvendelse 2.
What TYSABRI is and what it is used for 2.
Det skal De vide, før De begynder at bruge TYSABRI 3.
Before you use TYSABRI 3.
Sådan skal De bruge TYSABRI 4.
How to use TYSABRI 4.
Opbevaring 6.
How to store TYSABRI 6.
VIRKNING OG ANVENDELSE
WHAT TYSABRI IS AND WHAT IT IS USED FOR