natgillin/translations-raw huggingface dataset:
• Information that atypical/opportunistic infections, in particular PML, may occur with TYSABRI and include: o That the risk of PML increases with increasing duration of treatment and that treatment beyond 24 months carries additional risk and other factors associated with an increased risk for the development of PML 
• Informacijo, da se lahko pri uporabi zdravila TYSABRI pojavijo atipične/oportunistične okužbe, zlasti PML, vključno z: o Da tveganje PML narašča s trajanjem zdravljenja in da zdravljenje, ki traja dlje kot
Only body weight and the presence of anti-natalizumab antibodies were found to influence natalizumab disposition. 
Ugotovili so, da na izločevanje natalizumaba vpliva le telesna masa in prisotnost proti-natalizumabnih protiteles.
Following the repeat intravenous administration of a 300 mg dose of natalizumab to MS patients, the mean maximum observed serum concentration was 110 ± 52 μg/ml. 
Ugotovljena srednja najvišja koncentracija v serumu pri bolnikih z MS po ponavljajočem intravenskem dajanju 300 mg odmerka natalizumaba je bila 110 ± 52 μg/ml.
If PML or JCV GCN is suspected, further dosing must be suspended until PML has been excluded. 
Pri sumu na progresivno multifokalno levkoencefalopatijo (PML) ali JCV GCN morate s terapijo prenehati, dokler se PML ne izključi.
The nature of the infections was generally similar in natalizumab- and placebo-treated patients. 
Narava okužb bolnikov, zdravljenih z natalizumabom in tistih, zdravljenih s placebom, je bila na splošno podobna.
Patients who have all three risk factors for PML (i.e., are anti-JCV antibody positive and have received more than 2 years of TYSABRI therapy, and have received prior immunosuppressant therapy) have a significantly higher risk of PML. 
Pri bolnikih, ki imajo vse tri dejavnike tveganja za PML (tj. so pozitivni na protitelesa proti JCV in so se z zdravilom TYSABRI zdravili več kot 2 leti in so pred tem prejemali imunosupresive), je tveganje za PML značilno večje.
Symptoms can include; walking problems, numbness in the face, arms or legs, problems seeing things, tiredness, feeling off-balance or light headed, bladder and bowel problems, difficulty in thinking and concentrating, depression, acute or chronic pain, sexual problems, and stiffness and muscle spasms. 
utrujenost, občutek neuravnoteženosti ali slabotnosti, težave z mehurjem ali črevesjem, težave z razmišljanjem in koncentracijo, depresijo, akutne ali kronične bolečine, težave s spolnostjo, otrdelost mišic in mišične krče.
In anti-JCV antibody positive TYSABRI treated patients who have not used prior immunosuppressants the level of anti-JCV antibody response (index) is associated with the level of risk for PML. 
Pri bolnikih, zdravljenih z zdravilom TYSABRI, pozitivnih na protitelesa proti JCV, ki pred tem niso prejemali imunosupresivov, je raven odziva na protitelesa proti JCV (indeks) povezana z ravnijo tveganja za PML.
The symptoms of JCV GCN are similar to PML. 
Simptomi JCV GCN so podobni kot pri PML.
If there are signs of treatment-related abnormalities these must return to normal before treatment with natalizumab is started. 
Pri znakih bolezenskih sprememb, povezanih z zdravljenjem, se mora stanje bolnikov najprej vrniti na normalno raven pred zdravljenjem, preden se lahko daje natalizumab.
Progressive multifocal leukoencephalopathy (PML). 
Progresivna multifokalna levkoencefalopatija (PML).
• Severe anaemia (decrease in your red blood cells which can make your skin pale and can make you feel breathless or lacking energy) 
• neobičajne okužbe (tako imenovane »oportunistične okužbe«) • huda anemija (zmanjšanje števila rdečih krvnih celic, kar lahko povzroči bledo kožo in zasoplost ali pomanjkanje energije)
• The diluted medicinal product is to be used as soon as possible and within 8 hours of dilution. 
• Raztopino uporabite takoj, ko je mogoče in najpozneje 8 ur po razredčitvi.
TYSABRI must not be mixed with other medicinal products or diluents. 
Zdravila TYSABRI se ne sme mešati z drugimi zdravili ali topili.
Progressive Multifocal Leukoencephalopathy (PML) 
Progresivna multifokalna levkoencefalopatija (PML)
• Physician information about TYSABRI 
• Informacije o zdravilu TYSABRI za zdravnike
Hazard ratio for disability progression was 0.36 (95% CI: 0.17, 0.76) p = 0.008. 
Razmerje nevarnosti za napredovanje prizadetosti je bilo 0,36 (95-% IZ: 0,17; 0,76) p = 0,008.
LIST OF EXCIPIENTS sodium phosphate, monobasic, monohydrate; sodium phosphate, dibasic, heptahydrate; sodium chloride; polysorbate 80 (E433) and water for injections. 
Natrijev dihidrogenfosfat monohidrat; natrijev hidrogenfosfat heptahidrat; natrijev klorid; polisorbat 80 (E433) in voda za injekcije.
Continued therapy must be carefully reconsidered in patients who show no evidence of therapeutic benefit beyond 6 months 
Nadaljevanje zdravljenja pri bolnikih, ki po 6 mesecih ne kažejo znakov izboljšanja, je treba skrbno pretehtati.
Readministration 
Ponovna uporaba
Serious, life-threatening, and sometimes fatal cases have been reported in the postmarketing setting in multiple sclerosis patients receiving TYSABRI (see section 4.8). 
V obdobju po začetku trženja so poročali o resnih, življenjsko nevarnih in včasih smrtnih primerih pri bolnikih z multiplo sklerozo, ki so se zdravili z zdravilom TYSABRI (glejte poglavje 4.8).
• The diluted solution is to be infused intravenously over 1 hour at a rate of approximately 2 ml/minute. 
• Razporejeno na 1 uro infundirajte približno 2 ml razredčene raztopine na minuto.
Your doctor can decide whether TYSABRI is not working properly for you by testing your blood and will stop TYSABRI, if necessary. 
Zdravnik se lahko na podlagi rezultatov testiranja krvi odloči, ali zdravilo TYSABRI ne deluje pravilno, in po potrebi prekine zdravljenje z zdravilom TYSABRI.
MRI evaluations for T1-weighted gadolinium (Gd)-enhancing lesions and T2-hyperintense lesions were performed annually. 
Ocene lezij s slikanjem z magnetno resonance, vidnih z gadolinijem in obteženih s T1, in hiperintenzivnih lezij T2, so se izvajale letno.
Patients with a treatment history of immunosuppressant medicinal products are at increased risk for PML. 
Pri bolnikih z zgodovino zdravljenja z zaviralci imunskega odziva je tveganje PML večje.
If the diluted medicinal product is stored at 2°C - 8°C (do not freeze), allow the solution to warm to room temperature prior to infusion. 
Raztopina, ki se hrani pri 2 °C - 8 °C (ne zamrzujte), se mora pred infundiranjem segreti na sobno temperaturo.
Patients who have experienced a hypersensitivity reaction must be permanently discontinued from treatment with TYSABRI. 
Pri bolnikih, ki so doživeli preobčutljivostno reakcijo, je treba zdravljenje z zdravilom TYSABRI trajno prekiniti.
Patients can switch directly from beta interferon or glatiramer acetate to natalizumab providing there are no signs of relevant treatment-related abnormalities e.g. neutropenia. 
Na voljo morajo biti viri za upravljanje s preobčutljivostnimi reakcijami in dostop do MRS. Bolniki lahko direktno preidejo iz interferona beta ali glatiramer acetata na natalizumab, če ne kažejo znakov pomembnih bolezenskih sprememb, povezanih z zdravljenjem, npr. nevtropenije.
• If you have been treated for more than 2 years and you have a lower level of JCV antibodies in your blood. 
• nimate protiteles proti virusu JC v krvi ALI • če se zdravite dlje kot 2 leti in imate nižje ravni protiteles proti virusu JC v krvi.
• Swelling of your face, lips or tongue 
• oteklina obraza, ustnic ali jezika • težave pri dihanju
Studies have not been conducted to examine the effects of renal or hepatic impairment. 
Kliničnih študij, s katerimi bi raziskali učinke okvare ledvic ali jeter, niso izvedli.
6.6 Special precautions for disposal and other handling 
6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Navodila za uporabo:
• Patients who have all three risk factors for PML (i.e., are anti-JCV antibody positive and have received more than 2 years of TYSABRI therapy, and have received prior immunosuppressant therapy), 
To vključuje: • Bolnike, ki imajo vse tri dejavnike tveganja za PML (tj. so pozitivni na protitelesa proti JCV in so se z zdravilom TYSABRI zdravili več kot 2 leti in so pred tem prejemali imunosupresive),
• That TYSABRI therapy is to be initiated and continuously supervised by specialised physicians experienced in the diagnosis and treatment of neurological conditions, in centres with timely access to MRI. 
• Opozorilo, da naj zdravljenje z zdravilom TYSABRI uvede in neprestano nadzoruje zdravnik specialist z izkušnjami v diagnosticiranju in zdravljenju nevroloških bolezni, v centrih s hitrim dostopom do MRS.
TYSABRI therapy is to be initiated and continuously supervised by specialised physicians experienced in the diagnosis and treatment of neurological conditions, in centres with timely access to MRI. 
Zdravljenje z zdravilom TYSABRI mora uvesti in neprestano nadzorovati zdravnik specialist, izkušen v diagnosticiranju in zdravljenju nevroloških bolezni, v centrih s pravočasnim dostopom do MRS.
Musculoskeletal and connective tissue disorders 
Bolezni mišično-skeletnega sistema in vezivnega tkiva artralgija pogosti
JC virus also causes JCV granule cell neuronopathy (GCN) which has been reported in patients treated with TYSABRI. 
JCV nevropatijo zrnatih celic (JCV GCN, granule cell neuronopathy), o kateri so poročali pri bolnikih, zdravljenih z zdravilom TYSABRI.
If a patient develops PML the dosing of TYSABRI must be permanently discontinued. 
Če bolnik razvije PML med jemanjem zdravila TYSABRI, je treba zdravljenje trajno prekiniti.
Name and address of the manufacturers responsible for batch release 
Ime in naslov izdelovalca (izdelovalcev), odgovornega (odgovornih) za sproščanje serije
If the diluted medicinal product is stored at 2˚C - 8˚C (do not freeze), allow the solution to warm to room temperature prior to infusion. 
Raztopina, ki se hrani pri 2 ˚C - 8 ˚C (ne zamrzujte), se mora pred infundiranjem segreti na sobno temperaturo.
The efficacy of re-administration has not been established, for safety see section 4.4. 
Napotke v zvezi z varnostjo najdete v poglavju 4.4.
Concurrent use of these agents with TYSABRI may increase the risk of infections, including opportunistic infections, and is contraindicated (see section 4.3). 
Sočasno jemanje teh učinkovin z zdravilom TYSABRI lahko poveča tveganje okužb, vključno z oportunističnimi okužbami in je kontraindicirano
• Treatment discontinuation form 
• Obrazec za prekinitev zdravljenja
All changes in haematological variables returned to pre-treatment values, usually within 16 weeks of last dose of the medicinal product and the changes were not associated with clinical symptoms. 
Vse spremenjene vrednosti hematoloških spremenljivk so se vrnile na raven pred zdravljenjem, običajno
When diluted the solution for infusion contains approximately 2.6 mg/ml of natalizumab. 
Razredčena raztopina za infundiranje vsebuje približno 2,6 mg/ml natalizumaba.
As such, natalizumab may act to suppress inflammatory activity present at the disease site, and inhibit further recruitment of immune cells into inflamed tissues. 
Natalizumab lahko kot tak zavira vnetje na mestu bolezni in preprečuje nadaljnjo migracijo imunskih celic k vnetemu tkivu.
Rate ratio 0.32 CI95% 0.26 ; 0.40 
Razmerje stopnje 0,32 IZ95 % 0,26 ; 0,40
Since patients who have received an initial short exposure to TYSABRI and then had an extended period without treatment are at a higher risk of developing anti-natalizumab antibodies and/or hypersensitivity upon redosing, the presence of antibodies should be evaluated and if these remain positive in a confirmatory test after at least 6 weeks, the patient should not receive further treatment with TYSABRI. 
nato pa so za dalj časa prekinili zdravljenje, obstaja višje tveganje za razvoj protiteles proti natalizumabu in/ali preobčutljivostnih reakcij po ponovnem odmerjanju zdravila, je pri njih treba oceniti prisotnost protiteles in če potrditveni test po vsaj šestih tednih pokaže njihovo prisotnost, se bolnika ne sme več zdraviti z zdravilom TYSABRI.
No differences in incidence rates or the nature of malignancies between natalizumab- and placebo-treated patients were observed over 2 years of treatment. 
Malignosti V času 2-letnega zdravljenja ni bilo razlik v incidenci in v naravi malignosti med bolniki zdravljenimi z natalizumabom in tistimi, ki so prejemali placebo.
• Immunosuppressant use prior to receiving TYSABRI. 
• Uporaba imunosupresivov pred začetkom zdravljenja z zdravilom TYSABRI.
Do not use TYSABRI 
Ne uporabljajte zdravila TYSABRI:
Sodium content in TYSABRI 
Vsebnost natrija v zdravilu TYSABRI
• Visually inspect the diluted medicinal product for particles or discolouration prior to administration. 
• Pred dajanjem vizualno preverite razredčeno raztopino glede delcev ali obarvanja.
You should discuss with your doctor whether you choose to breast-feed or to use TYSABRI. 
Posvetujte se z zdravnikom, ali boste nehali dojiti ali uporabljati zdravilo TYSABRI.
Hazard ratio 0.46, CI95% 0.33; 0.64, p<0.001 
Razmerje nevarnosti 0,46, IZ95 % 0,33; 0,64, p<0,001
Events reported more commonly with natalizumab than with placebo included dizziness, nausea, urticaria and rigors. 
Dogodki, o katerih so v primerjavi z placebom pri natalizumabu pogosteje poročali, vključujejo omotičnost, slabost, urtikarijo in rigor.
Physicians should refer to the Physician Information and Management Guidelines for further information on managing the risk of PML in TYSABRI-treated patients. 
Zdravniki naj za več informacij o upravljanju tveganja za PML pri bolnikih, zdravljenih z zdravilom TYSABRI, preberejo Informacije za zdravnike in smernice za zdravljenje bolezni.
However, observation over longer treatment periods is required before any effect of natalizumab on malignancies can be excluded. 
Vendar pa je za izključitev vseh vplivov natalizumaba na malignosti potrebno daljše obdobje opazovanja.
Over the 2-year duration of the studies, 43.5% of patients treated with natalizumab reported adverse reactions (placebo: 39.6%). 
43,5 % bolnikov, zdravljenih z natalizumabom, poročalo o neželenih učinkih zdravila (placebo:
For the estimation of PML risk in the different patient subgroups, please refer to the Physician Information and Management Guidelines. 
Za oceno tveganja za PML pri različnih podskupinah bolnikov glejte
If you miss your dose of TYSABRI 
Če ste pozabili uporabiti zdravilo TYSABRI
The active substance is natalizumab. 
Zdravilna učinkovina je natalizumab.
Hazard ratio 0.58, CI95% 0.43; 0.73, p<0.001 
Razmerje nevarnosti 0,58, IZ95 % 0,43; 0,73, p<0,001
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. 
2 leti trajajoči študiji (študija AFFIRM) bolnikov z recidivno remitentno MS, ki so imeli najmanj 1 leto pred vključitvijo vsaj en klinični recidiv in po lestvici prizadetosti EDSS (Kurtzke Expanded Disability Status Scale) med 0 in 5 točkami.Povprečna starost je bila 37 let, povprečno trajanje bolezni pa 5 let.
A case of cryptosporidium diarrhoea was reported in MS clinical trials. 
Pri kliničnih preskušanjih v zvezi z MS so poročali o primeru diareje, povzročene s Cryptosporidiumom.
After dilution for use, this medicinal product contains 17.7 mmol (or 406 mg) sodium per dose. 
Po redčenju za uporabo vsebuje zdravilo 17,7 mmol (ali 406 mg) natrija na odmerek.
Always use this medicine exactly as described in this leaflet or as your doctor has told you. 
Pri uporabi tega zdravila natančno upoštevajte napotke v tem navodilu ali navodila svojega zdravnika.
Specifically, natalizumab binds to the α4β1 integrin, blocking the interaction with its cognate receptor, vascular cell adhesion molecule-1 (VCAM-1), and ligands osteopontin, and an alternatively spliced domain of fibronectin, connecting segment-1 (CS-1). 
adhezijsko molekulo-1 na žilnih celicah (VCAM-1) ter ligandi osteopontinom in fibronektinom oz. njegovo alternativno spojeno domeno t.i. spojnim segmentom-1 (CS-1).
In studies conducted in mice, growth and metastasis of melanoma and lymphoblastic leukaemia tumour cells was not increased by the administration of natalizumab. 
Pri študijan na miših dajanje natalizumaba ni vplivalo na rast in zasevke celic tumorja melanoma in limfoblastne levkemije.
Diluted solution: After dilution, immediate use is recommended. 
Priporoča se, da razredčeno raztopino takoj uporabite.
The diluted solution is to be infused intravenously over 1 hour at a rate of approximately 2 ml/minute. 
Razporejeno na 1 uro infundirajte približno 2 ml razredčene raztopine na minuto.
Patients should be monitored as appropriate for impaired liver function, and be instructed to contact their physician in case signs and symptoms suggestive of liver injury occur, such as jaundice and vomiting. 
Bolnike je treba poučiti, da morajo takoj obvestiti svojega zdravnika, če se pojavijo znaki, ki kažejo na okvaro jeter, kot sta zlatenica ali bruhanje.
Spontaneous cases of serious liver injuries, increased liver enzymes, hyperbilirubinaemia have been reported during the post marketing phase (see section 4.4). 
V obdobju trženja so poročali o primerih resnih okvar jeter, povišanih jetrnih encimih in hiperbilirubinemiji (glejte poglavje 4.4).
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. 
V okviru vnetja osrednjega živčnega sistema pri MS je interakcija α4β1 z VCAM-1, CS-1 in osteopontinom posrednik čvrste adhezije in transmigracije levkocitov v možganski parenhim in lahko ohranja vnetno kaskado v tkivu osrednjega živčnega sistema.
TYSABRI contains 2.3 mmol (or 52 mg) sodium per vial of medicinal product. 
Zdravilo TYSABRI vsebuje 2,3 mmol (ali 52 mg) natrija na vialo zdravila.
In post marketing experience,serious, life-threatening, and sometimes fatal cases of encephalitis and meningitis caused by herpes simplex or varicella zoster have been reported in multiple sclerosis patients receiving TYSABRI. 
V izkušnjah v obdobju po začetku trženja so pri bolnikih z multiplo sklerozo, zdravljenih z zdravilom TYSABRI, poročali o resnih, življenjsko nevarnih in včasih smrtnih primerih encefalitisa in meningitisa, ki ju povzročajo virusi herpes simplex ali virusi varicella zoster.
Spontaneous serious adverse reactions of liver injury have been reported during the post marketing phase. 
V obdobju trženja so poročali o spontanih hudih neželenih reakcijah zaradi okvare jeter.
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. 
V skladu s farmakološko aktivnostjo natalizumaba se je pokazala spremenjena izmenjava limfocitov tako, da je v večini študij in vivo poraslo število levkocitov, masa vranice pa se je povečala.
Do not use this medicine if you notice particles in the liquid and/or the liquid in the vial is discoloured. 
Če v tekočini opazite delce in/ali če je tekočina v viali obarvana, tega zdravila ne smete uporabiti.
Gently invert the TYSABRI solution to mix completely. 
Nežno obrnite raztopino zdravila TYSABRI, da se povsem premeša.
The diluted medicinal product is to be used as soon as possible and within 8 hours of dilution. 
Raztopino uporabite takoj, ko je mogoče, vendar najpozneje 8 ur po razredčitvi.
If a woman becomes pregnant while taking TYSABRI, discontinuation of the medicinal product should be considered. 
Ženske, ki zanosijo med jemanjem zdravila TYSABRI, morajo razmisliti o prekinitvi zdravljenja z zdravilom.
Patients are to be observed during the infusion and for 1 hour after the completion of the infusion (see section 4.8). 
Bolnika se v času infundiranja in 1 uro po končanem infundiranju opazuje za znake in simptome preobčutljivostnih reakcij (glejte poglavje 4.8).
Other medicines and TYSABRI Tell your doctor if you are taking or have recently taken or might take any other medicines. 
Obvestite svojega zdravnika, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli zdravilo.
Presence of anti-JC virus antibodies Level of the antibody response (index) for patients without a history of immunosuppressant treatment 
Raven odziva protiteles (indeks) za bolnike brez zdravljenja z imunopresivi v anamnezi
When diluted in 100 ml sodium chloride 9 mg/ml (0.9%) the medicinal product contains 17.7 mmol (or 406 mg) sodium. 
Pri redčenju s 100 ml natrijevega klorida 9 mg/ml (0,9 %) vsebuje zdravilo 17,7 mmol (ali 406 mg) natrija.
When diluted (see section 6.6), the solution for infusion contains approximately 2.6 mg/ml of natalizumab. 
Razredčena raztopina za infundiranje (glejte poglavje 6.6) vsebuje približno 2,6 mg/ml natalizumaba.
• Sore throat and runny or blocked up nose 
• vnetje žrela in zamašen nos ali nosni izcedek • tresavica
• Use aseptic technique when preparing TYSABRI solution for intravenous (IV) infusion. 
• Pri pripravi raztopine zdravila TYSABRI za intravensko infundiranje uporabite aseptično tehniko.
Rate ratio 0.33 CI95% 0.26 ; 0.41 
Razmerje stopnje 0,33 IZ95 % 0,26 ; 0,41
Visually inspect the diluted medicinal product for particles or discolouration prior to administration. 
Pred dajanjem vizualno preverite razredčeno raztopino glede delcev ali obarvanja.
TYSABRI 300 mg concentrate for solution for infusion natalizumab 
TYSABRI 300 mg koncentrat za raztopino za infundiranje natalizumab
For those with a lower risk of PML, your doctor may repeat the test regularly to check if anything has changed if: 
Zdravnik lahko teste pri bolnikih, pri katerih je tveganje za PML manjše, redno ponavlja, da ugotovi,
4.5 Interaction with other medicinal products and other forms of interaction TYSABRI is contraindicated in combination with beta-interferons or glatiramer acetate (see section 
Zdravilo TYSABRI je kontraindicirano v kombinaciji z interferoni beta ali glatiramer acetatom (glejte poglavje 4.3).
The anti-JCV antibody assay (ELISA) should not be used to diagnose PML. 
Za postavitev diagnoze PML ne uporabljajte testa protiteles proti JCV (ELISA).
There is no evidence of a specific pattern of birth defects with TYSABRI. 
Pri zdravilu TYSABRI ni dokazov o posebnem vzorcu prirojenih okvar.
NAME OF THE MEDICINAL PRODUCT TYSABRI 300 mg concentrate for solution for infusion 
IME ZDRAVILA TYSABRI 300 mg koncentrat za raztopino za infundiranje
When diluted in 100 ml sodium chloride 9 mg/ml (0.9%) this medicinal product contains 17.7 mmol (or 406 mg) sodium per dose. 
Pri redčenju s 100 ml natrijevega klorida 9 mg/ml (0,9 %) vsebuje zdravilo 17,7 mmol (ali 406 mg) natrija na odmerek.
TYSABRI contains sodium 
Zdravilo TYSABRI vsebuje natrij
This leaflet was last revised in {MM/YYYY}. 
DATUM ZADNJE REVIZIJE BESEDILA <{MM/LLLL}>
Add the 15 ml concentrate for solution for infusion to 100 ml sodium chloride 9 mg/ml (0.9%) solution for injection. 
15 ml koncentrata za raztopino za infundiranje dodajte 100 ml natrijevega klorida 9 mg/ml (0,9 %) raztopine za injiciranje.
• Patients with a high anti-JCV antibody index who have received more than 2 years of 
• Bolniki z visokim indeksom protiteles proti JCV, ki so se z zdravilom TYSABRI
Speak to your doctor or nurse immediately if you notice any of the following 
Če opazite kar koli od naslednjega, se takoj posvetujte z zdravnikom ali medicinsko sestro.
Relapse rate 
Stopnja recidivov
Cases of JCV GCN have also been reported during postmarketing use of TYSABRI. 
V obdobju po začetku trženja zdravila TYSABRI so poročali tudi o primerih JCV GCN.
After dilution with sodium chloride 9 mg/ml (0.9%) solution for injection, immediate use is recommended. 
Priporoča se, da z natrijevim kloridom 9 mg/ml (0,9 %) raztopino za injiciranje razredčeno raztopino takoj uporabite.