natgillin/translations-raw huggingface dataset:
Resources for the management of hypersensitivity reactions and access to MRI should be available.
Na voljo morajo biti viri za upravljanje s preobčutljivostnimi reakcijami in dostop do MRS.
Your doctor should do a blood test in order to test for abnormalities and whether you have antibodies to the JC virus.
Zdravnik mora narediti krvne preiskave, da ugotovi, ali obstajajo bolezenski znaki in ali imate protitelesa proti virusu JC.
• Present data from PK/PD/efficacy modelling from clinical trial data that suggests efficacy of 6 week dosing more similar to 4 weeks if occurs >1 year of 4 weekly treatment
• Trenutni podatki modeliranja FK/FD ter modeliranja učinkovitosti na podlagi podatkov kliničnih preskušanj kažejo, da je učinkovitost šesttedenskega odmerjanja bolj podobna štiritedenskemu odmerjanju, če štiritedensko odmerjanje traja več kot eno leto.
Acute retinal necrosis (ARN) is a rare fulminant viral infection of the retina caused by the family of herpes viruses (e.g. varicella zoster).
Akutna nekroza mrežnice (ARN-acute retinal necrosis) je redka fulminantna virusna okužba mrežnice, ki jo povzroči skupina virusov herpesa (npr. varicella zoster).
Package leaflet: Information for the patient TYSABRI 300 mg concentrate for solution for infusion natalizumab This medicine is subject to additional monitoring.
Navodilo za uporabo TYSABRI 300 mg koncentrat za raztopino za infundiranje natalizumab Za to zdravilo se izvaja dodatno spremljanje varnosti.
Following clinical diagnosis of ARN, discontinuation of TYSBABRI should be considered in these patients.
Po postavitvi klinične diagnoze ARN je pri teh bolnikih treba razmisliti o prekinitvi zdravljenja z zdravilom TYSABRI.
The limited sample size and shorter duration of TYSABRI exposure for this subgroup of patients should be considered when interpreting these data.
Pri razlagi teh podatkov moramo upoštevati omejeno velikost vzorca in krajše trajanje izpostavljenosti zdravilu TYSABRI pri tej podskupini bolnikov.
Consistent with efficacy results observed for patients switching from beta interferon or glatiramer acetate to TYSABRI, for patients switching from fingolimod (n=147) to TYSABRI, a significant decrease in annualised relapse rate (ARR) was observed, which remained stable over 2 years, and mean EDSS scores remained similar from baseline to Year 2.
Skladno z rezultati učinkovitosti, ugotovljenimi pri bolnikih, ki so prešli z interferona beta ali glatiramer acetata na zdravilo TYSABRI, so pri bolnikih, ki so prešli s fingolimoda (n = 147) na zdravilo TYSABRI, opazili pomembno zmanjšanje letne stopnje recidivov (ARR-annualised relapse rate), ki je ostala stabilna 2 leti, srednji rezultati EDSS pa so bili podobni od izhodišča do 2. leta.
Patients with increased risk for opportunistic infections, including immunocompromised patients (including those currently receiving immunosuppressive therapies or those immunocompromised by prior therapies (see sections 4.4 and 4.8).
Bolniki, pri katerih je povečano tveganje oportunističnih okužb, vključno z bolniki z oslabljenim imunskim sistemom (vključno s tistimi, ki so nedavno prejemali terapijo za zaviranje imunskega odziva ali tisti z oslabljenim imunskim sistemom zaradi prejšnjega zdravljenja) (glejte poglavji 4.4 in
• Reminder to keep the card with them for 6 months after the last dose of Tysabri
• Navodilo, da morajo imeti opozorilno kartico pri sebi še šest mesecev po zadnjem odmerku zdravila Tysabri.
The clinical worsening is a result of local inflammatory reaction, including oedema, and manifests as a worsening of neurological symptoms including hemiparesis, ataxia, speech abnormalities, visual disturbance, cognitive/behavioural changes and seizure (dependent on the site of IRIS).
Klinično poslabšanje je posledica lokalne vnetne reakcije, vključno z edemom, kar se kaže kot poslabšanje nevroloških simptomov, vključno s hemiparezo, ataksijo, motnjami govora, motnjami vida,
Irrespective of the presence or absence of PML risk factors, heightened clinical vigilance for PML should be maintained in all patients treated with TYSABRI and for 6 months following discontinuation of therapy.
Ne glede na prisotnost ali odsotnost dejavnikov tveganja za PML je še šest mesecev po prekinitvi zdravljenja treba zelo pozorno klinično spremljati vse bolnike, ki so se zdravili z zdravilom TYSABRI.
In 2-year controlled clinical trials in MS patients TYSABRI treatment was associated with increases in circulating lymphocytes, monocytes, eosinophils, basophils and nucleated red blood cells.
V dveletnih kontroliranih kliničnih preskušanjih pri bolnikih z MS je bilo zdravljenje z zdravilom TYSABRI povezano s povišanim obtokom limfocitov, monocitov, eozinofilcev, bazofilcev in eritrocitov z jedrom.
Each ml of concentrate contains 20 mg of natalizumab.
En ml koncentrata vsebuje 20 mg natalizumaba.
1 case of herpes meningitis was reported in the meta-analysis.
V metaanalizi so poročali o enem primeru herpetičnega meningitisa.
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 the TYSABRI treated group (n = 148) and 1.455 in the placebo group (n = 61) (p <0.001).
Pri podskupini bolnikov, pri katerih je bilo indicirano zdravljenje hitro razvijajoče se hude recidivne remitentne MS (bolniki z najmanj 2 recidivoma in vsaj 1 lezijo, vidno z gadolinijem), je letna stopnja recidivov pri skupini, ki je prejemala zdravilo TYSABRI (n = 148) znašala 0,282, pri skupini, ki je prejemala placebo (n = 61), pa 1,455 (p <0,001).
− A copy of the treatment initiation form
− kopijo obrazca za uvedbo zdravljenja,
• Inform about an ongoing study assessing the efficacy, tolerability and safety of switching to EID after at least 12 months on approved dosing.
• Seznanitev s potekajočo študijo za oceno učinkovitosti, prenašanja in varnosti prehoda na PIO
treatment stratified by prior treatment with immunosuppressants and JCV infection.
TYSABRI, razčlenjeno glede na predhodno zdravljenje z imunosupresivi in okužbo z JCV,
TYSABRI is a clear, colourless to slightly cloudy liquid.
Zdravilo TYSABRI je bistra, brezbarvna ali rahlo motna tekočina.
Other medicines and TYSABRI
Druga zdravila in zdravilo TYSABRI
What TYSABRI looks like and contents of the pack
Izgled zdravila TYSABRI in vsebina pakiranja
Physicians must discuss the benefits and risks of TYSABRI therapy with the patient and provide them with a Patient Alert Card.
Zdravnik se mora o koristih in tveganjih zdravljenja z zdravilom TYSABRI posvetovati z bolnikom in bolniku izročiti opozorilno kartico za bolnika.
Interim analysis of results (as of May 2015) from the ongoing TYSABRI Observational Program (TOP), a phase 4, multicentre, single-arm study (n=5770) demonstrated that patients switching from beta interferon (n= 3255) or glatiramer acetate (n= 1384) to TYSABRI showed a sustained, significant decrease in annualised relapse rate (p< 0.0001).
(TOP-TYSABRI Observational Program), multicentrične študije 4. faze z enim krakom (n = 5770), je pokazala, da so bolniki, ki so prešli z interferona beta (n = 3255) ali glatiramer acetata (n = 1384) na zdravilo TYSABRI, pokazali dolgotrajno pomembno zmanjšanje letne stopnje recidivov (p< 0,0001).
A Complete Blood Count (CBC, including lymphocytes) is recommended prior to initiating TYSABRI to ensure that immune effects of the previous therapy (i.e. cytopenia) have resolved.
Pred uvedbo zdravila TYSABRI je priporočljivo narediti kompletno krvno sliko (vključno z limfociti), da zagotovimo, da so imunski učinki predhodnega zdravljenja (npr. citopenija) izzveneli.
Patients should not be tested for anti-JCV antibodies within 2 weeks of PLEX due to removal of antibodies from the serum, or within 6 months of IVIg (i.e. 6 months = 5x half-life for immunoglobulins).
Bolnikov ne testirajte za serumska protitelesa proti JCV prej kot 2 tedna po PLEX zaradi odstranitve protiteles iz seruma ali prej kot 6 mesecev po IVIg (t.j.
TYSABRI will be given to you by a doctor experienced in the treatment of MS.
Zdravilo TYSABRI da zdravnik z izkušnjami v zdravljenju MS.
A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
A. PROIZVAJALEC (PROIZVAJALCI) BIOLOŠKE UČINKOVINE (UČINKOVIN) IN PROIZVAJALEC (PROIZVAJALCI), ODGOVOREN (ODGOVORNI) ZA
Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Predpisovanje in izdaja zdravila je le recept s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
How to use TYSABRI
Kako uporabljati zdravilo TYSABRI
o Description of MRI protocols for baseline, routine screening and in case of PML suspicion o Anti-JCV antibody testing, frequency of testing, interpretation of qualitative and quantitative results, seroprevalence of JCV-antibodies and seroconversion rate over time o Diagnosis and prognosis of symptomatic and asymptomatic PML
o Testiranje za protitelesa proti JCV, pogostnost testiranja, interpretacija kvalitativnih in kvantitativnih rezultatov, stopnja seroprevalence protiteles proti JCV in serokonverzije glede na čas.
A group of symptoms caused by a serious infection of the brain including:
- bolečino ali rdečino očes/-a Skupina simptomov, ki jih povzroča resna okužba možganov, vključno z/s:
It is unknown if patients switching from these therapies to TYSABRI have an increased risk of PML, therefore these patients should be monitored more frequently (i.e. similarly to patients switching from immunosuppressants to TYSABRI).
Ni znano, ali je pri bolnikih, ki prehajajo s teh zdravljenj na zdravilo TYSABRI, tveganje za PML povečano, zato je treba te bolnike pogosteje spremljati (tj.
When switching from dimethyl fumarate, the washout period should be sufficient for lymphocyte count to recover before treatment with TYSABRI is started.
Pri prehajanju z dimetilfumarata mora vmesno obdobje brez zdravljenja zadostovati, da se število limfocitov popravi, preden se začne zdravljenje z zdravilom TYSABRI.
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 trženja zdravila 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).
IRIS is generally suspected when patients with PML exhibit signs of clinical worsening usually, but not always, accompanied by gadolinium enhancement of PML lesions with or without mass effect on brain MRI.
IRIS večinoma obstaja pri bolnikih s PML, ki običajno kažejo znake kliničnega poslabšanja, kar se ne zgodi v vseh primerih, ter imajo lezije PML, vidne z gadolinijem, ki jih spremljajo velike spremembe na slikah možganov, pridobljenih z magnetno resonanco, ali pa so brez sprememb.
Relapse free
SPROŠČANJE SERIJ
• You must not use TYSABRI if you are being treated with other medicines to treat your MS disease
• Zdravila TYSABRI ne smete uporabljati, če se zdravite z drugimi zdravili za zdravljenje multiple skleroze.
In post-marketing experience, there have been reports of hypersensitivity reactions which have occurred with one or more of the following associated symptoms: hypotension, hypertension, chest pain, chest discomfort, dyspnoea, angioedema, in addition to more usual symptoms such as rash and urticaria.
V izkušnjah v obdobju trženja zdravila so poročali o preobčutljivostnih reakcijah, ki so se pojavile z enim ali več od naslednjih simptomov: hipotenzija, hipertenzija, bolečine v prsih, nelagodje v prsih, dispneja,
2) Intravenous methylprednisolone (1 g/d for 3 or 5 d) with oral taper over 2 months
2) Metilprednizolon, apliciran intravensko (1 g/dan tri ali pet dni) z dvomesečnim postopnim zmanjševanjem peroralnega odmerka.
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
1) Oral prednisone 1.5 mg/kg/d x 2 wks with taper over 2 months
1) Peroralni prednizon 1,5 mg/kg/dan dva tedna z dvomesečnim postopnim zmanjševanjem odmerka.
In postmarketing experience, rare cases of ARN have been observed in patients receiving TYSABRI.
V obdobju trženja zdravila so pri bolnikih, ki so prejemali zdravilo TYSABRI, opazili redke primere ARN.
• 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.
• Informacijo, da 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.
The washout period should be sufficient for lymphocyte count to recover before treatment with TYSABRI is started.
Vmesno obdobje brez zdravljenja mora zadostovati, da se število limfocitov popravi, preden se začne zdravljenje z zdravilom TYSABRI.
TYSABRI 300 mg concentrate for solution for infusion
TYSABRI 300 mg koncentrat za raztopino za infundiranje
Rate ratio 0.32 CI95% 0.26 ; 0.40
Razmerje stopnje 0,32 IZ95 % 0,26; 0,40
In Phase 3 MS clinical trials, concomitant treatment of relapses with a short course of corticosteroids was not associated with an increased rate of infection.
V kliničnih preskušanjih 3. faze MS ni bila ugotovljena povečana stopnja okužb pri sočasnem zdravljenju recidivov s kratkoročnim dajanjem kortikosteroidov.
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 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 shrani pri temperaturi 2 °C - 8 °C (ne zamrzujte), se mora pred infundiranjem segreti na sobno temperaturo.
o Information provided regarding - In all cases where further investigation of change in neurological status or change in brain MRI is indicated, TYSABRI must be suspended and not restarted until non MS pathology has been confidently excluded.
o Zagotovitev informacij - V vseh primerih, kjer je indicirano slikanje z magnetno resonanco za nadaljnje preiskave sprememb nevrološkega statusa ali sprememb v možganih, je treba zdravljenje z zdravilom TYSABRI prekiniti in se ga ne sme ponovno uvesti do prepričljive izključitve patologije MS. Ne pričakuje se, da bi kratkotrajna prekinitev zdravljenja z zdravilom TYSABRI (nekaj dni ali tednov) ogrozila terapevtsko učinkovitost, ki temelji na farmakodinamiki zdravila.
Common side effects that may affect up to 1 in 10 people:
Pogosti neželeni učinki, ki lahko prizadenejo največ 1 od 10 bolnikov:
o Description of PML and incidence.
o Opis in incidenca PML.
In anti-JCV antibody positive patients, extended interval dosing of TYSABRI (average dosing interval of approximately 6 weeks) is suggested to be associated with a lower PML risk compared to approved dosing.
Pri bolnikih, ki so pozitivni na protitelesa proti JCV, se predvideva, da je podaljšan interval odmerjanja zdravila TYSABRI (povprečni interval odmerjanja je bil približno 6 tednov) povezan s klinično pomembnim in statistično značilnim nižjim tveganjem za PML v primerjavi z odobrenim odmerjanjem.
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); voda za injekcije
o A stratification of the risk of developing PML based on the identified risk factors and presentation of the PML risk in a given time interval of treatment as well as the cumulative PML risk o PML risk estimates algorithm summarizes PML risk by anti- John Cunningham virus (JCV) antibody status, prior IS use and duration of treatment (by year of treatment) and stratifies this risk by index value when applicable.
o Algoritem za oceno tveganja za razvoj PML povzema tveganja za PML na podlagi statusa protiteles proti virusu John Cunningham (JCV), predhodne uporabe imunosupresivov (IS) in trajanja zdravljenja (v letih zdravljenja) ter razvršča tveganje glede na vrednost indeksa, če se uporablja.
For further information, refer to the Physician Information and Management Guidelines.
Za nadaljnje informacije glejte Informacije za zdravnike in smernice za zdravljenje bolezni.
• Reminder no to take any other long-term medicines for MS while receiving Tysabri
• Opomnik, da med prejemanjem zdravila Tysabri ni dovoljeno jemati drugih zdravil za dolgotrajno zdravljenje MS.
• You may not be able to use TYSABRI if you are currently receiving or have previously received medicines that affect your immune system
• Če trenutno jemljete ali ste predhodno prejemali zdravila, ki vplivajo na imunski sistem, morda ne boste mogli uporabljati zdravila TYSABRI.
The treatment discontinuation form • Inform patient that PML has been reported up to 6 months after stopping Tysabri
• Seznanitev bolnika, da so o PML poročali še do šest mesecev po prekinitvi zdravljenja z zdravilom Tysabri.
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
The pharmacokinetics of natalizumab in paediatric MS patients has not been established.
Farmakokinetika natalizumaba pri otrocih, obolelih za MS, ni bila ugotovljena.
EDSS-baseline, median (range)
Izhodišče na EDSS, mediana
o TYSABRI increases the risk of developing encephalitis, meningitis and acute retinal necrosis (ARN) caused by herpes simplex and varicella zoster viruses o Guidance on screening for ARN.
o Zdravilo TYSABRI poveča tveganje za razvoj encefalitisa, meningitisa in akutne retinalne nekroze (ARN), ki jih povzročata virusa herpes simplex in varicella zoster.
In studies conducted in mice, growth and metastasis of melanoma and lymphoblastic leukaemia tumour cells was not increased by the administration of natalizumab.
Pri študijah na miših dajanje natalizumaba ni vplivalo na rast in zasevke celic tumorja melanoma in limfoblastne levkemije.
Immunosuppressant treatment prior to the use of TYSABRI
zdravljenje z imunosupresivi pred začetkom uporabe zdravila TYSABRI.
Relapse rate derived variables / MRI-derived variables
Napredovanje po EDSS Sekundarni opazovani dogodki Iz stopnje recidivov izpeljane spremenljivke/iz MRT-izpeljane spremenljivke
o If treatment is to be continued for longer than 24 months, the need to inform patients about the increased risk of PML and provide them with a copy of the treatment continuation form o Description of Immune Reconstitution Inflammatory Syndrome (IRIS) is provided
o Če bo zdravljenje trajalo več kot 24 mesecev, je treba bolnike seznaniti s povečanim tveganjem za PML in jim zagotoviti kopijo obrazca za nadaljevanje zdravljenja.
Rate ratio 0.33 CI95% 0.26 ; 0.41
Razmerje stopnje 0,33 IZ95 % 0,26; 0,41
Cases of JCV GCN have also been reported during postmarketing use of TYSABRI.
V obdobju trženja zdravila TYSABRI so poročali tudi o primerih JCV GCN.
Concurrent treatment with immunosuppressants
Sočasno zdravljenje z imunosupresivi
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 trženja zdravila 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.
• Summary of Product Characteristics and Package Leaflet
• Povzetek glavnih značilnosti zdravila in Navodilo za uporabo
The active substance is natalizumab.
Učinkovina je natalizumab.
− differentiation between PML and MS
− diferenciacija PML in multiple skleroze,
During extended pre-registration trials, two cases of PML were reported in MS patients and a full safety evaluation revealed one further case in a clinical trial patient with Crohn's Disease.
Razprava o PML pri bolnikih, ki so se zdravili z zdravilom TYSABRI V podaljšanih preskušanjih pred pridobitvijo dovoljenja za promet z zdravilom so poročali o dveh primerih PML pri bolnikih z MS, popolna ocena varnosti pa je razkrila še en primer pri bolniku s
Patients with a treatment history of immunosuppressant medications are at increased risk for PML.
Predhodno zdravljenje z imunosupresivnimi ali imunomodulatornimi terapijami Pri bolnikih, ki so v preteklosti jemali imunosupresive, je tveganje za PML večje.
Therefore, following PLEX or IA, periodic clinical monitoring of patients, including MRI monitoring, may be useful for the early detection of IRIS.
PLEX ali IA, bo zato morda koristno redno klinično spremljanje bolnikov, vključno s slikanjem z magnetno resonanco.
• Reminder to show the card to any doctor involved with their treatment
Opozorilna kartica za bolnika • Navodilo, da je treba kartico pokazati vsem zdravnikom, ki so vključeni v zdravljenje.
• 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.
Within 3 months prior to starting TYSABRI Annually during treatment with TYSABRI More frequent MRIs (e.g. on a 3 to 6 monthly basis) for patients at high risk for PML.
enkrat letno med zdravljenjem z zdravilom TYSABRI, pogostejša MRS (npr. vsake 3 do 6 mesecev) za bolnike z velikim tveganjem za PML, ob prvih znakih kakršnih koli simptomov, ki kažejo na možnost pojava PML.
Diluted solution:
Razredčena raztopina:
Some cases have occurred in patients with central nervous system (CNS) herpes infections (e.g. herpes meningitis and encephalitis).
Nekateri primeri so se pojavili pri bolnikih z okužbami osrednjega živčnega sistema s herpesom
Diluted solution 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.
• Patients with a high anti-JCV antibody index who have received more than 2 years of
• Bolnike z visokim indeksom protiteles proti JCV, ki so se z zdravilom TYSABRI
The reactions are reported as MedDRA preferred terms under the MedDRA primary system organ class.
Neželeni učinki so navedeni z izrazi, ki jih priporoča MedDRA, in glede na MedDRA organske sisteme.
• Reminder of the approved dosing; cross reference to EU SmPC
Informacije o podaljšanem intervalu odmerjanja (PIO) • Opomnik glede odobrenega odmerka; navzkrižno sklicevanje na EU povzetek glavnih značilnosti zdravila.
Persistent anti-natalizumab antibodies (one positive test reproducible on retesting at least
Pri približno 6 % bolnikov so se razvila obstojna proti-natalizumabna protitelesa (en pozitivni test, potrjen pri ponovnem testiranju vsaj 6 tednov kasneje).
Serious adverse events were evaluated in 621 MS paediatric patients included in a meta-analysis (see also Section 5.1).
Pediatrična populacija Pri 621 pediatričnih bolnikih z MS, vključenih v metaanalizo, so ocenjevali resne neželene učinke
Contents of the pack and other information
Shranjevanje zdravila TYSABRI Vsebina pakiranja in dodatne informacije
and IRIS
Zaradi reakcije IRIS
Presence of anti-JC virus antibodies Level of the antibody response (index) for patients without a history of immunosuppressant treatment
Drugi dejavniki, povezani s povečanim tveganjem za razvoj PML: prisotnost protiteles proti JCV, raven odziva protiteles (indeks) za bolnike brez zdravljenja z imunopresivi v anamnezi,