natgillin/translations-raw huggingface dataset:
8 Natalizumab is a selective adhesion-molecule inhibitor and binds to the α 4-subunit of human integrins, which is highly expressed on the surface of all leukocytes, with the exception of neutrophils.
Natalizumab je selektivni zaviralec adhezijskih molekul in se veže na podenoto α4 humanega integrina, ki se v močno izraženem številu nahaja na površini vseh levkocitov razen nevtrofilcev.
Specifically, natalizumab binds to the α 4β 1 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).
Natalizumab se veže zlasti na α4β1 integrin in onemogoči interakcijo s sorodnim receptorjem, 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).
Natalizumab blocks the interaction of α 4β 7 integrin with the mucosal addressin cell adhesion molecule-1 (MadCAM-1).
Natalizumab onemogoči interakcijo integrina α4β7 z mukozno adresinsko celično adhezijsko molekulo- 1 (MadCAM- 1).
A further mechanism of action of natalizumab may be to suppress ongoing inflammatory reactions in diseased tissues by inhibiting the interaction of α 4-expressing leukocytes with their ligands in the extracellular matrix and on parenchymal cells.
Nadaljnji mehanizem delovanja natalizumaba je lahko zaviranje tekoče vnetne reakcije v obolelem tkivu s preprečevanjem interakcije levkocitov z izraženimi α4 integrini, z njihovimi ligandi v ekstracelularnem prostoru in na parenhimskih celicah.
In MS, lesions are believed to occur when activated T-lymphocytes cross the blood-brain barrier (BBB).
Predvideva se, da se lezije pri MS pojavljajo, ko aktivirani T- limfociti prodrejo skozi hematocefalno bariero (BBB).
Under normal conditions, VCAM-1 is not expressed in the brain parenchyma.
V normalnih pogojih molekule VCAM- 1 niso izražene v možganskem parenhimu.
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.
Vendar pa se lahko v prisotnosti provnetnih citokinov poveča število VCAM- 1 molekul na endotelijskih celicah, morda pa tudi na celicah glie blizu vnetnih žarišč.
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.
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.
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.
Blokada molekulske interakcije α4β1 s tarčnimi strukturami zmanjšuje vnetno aktivnost v možganih pri MS in preprečuje nadaljnje vključevanje imunskih celic v vnetno tkivo, kar zmanjšuje nastajanje ali povečevanje lezij zaradi MS.
TYSABRI is indicated as a single disease modifying therapy in relapsing remitting multiple sclerosis to prevent relapses and delay progression of disability.
Zdravilo TYSABRI je indicirano kot monoterapija, ki spreminja potek bolezni pri recidivni remitentni multipli sklerozi tako, da preprečuje recidive in odloži napredovanje prizadetosti.
Due to safety concerns (see sections 4.4 and 4.8) treatment is restricted to the following patient groups:
Zaradi skrbi glede varnosti (glejte poglavji 4. 4 in 4. 8) je zdravljenje omejeno na sledeči skupini bolnikov:
• Patients who have failed to respond to a full and adequate course of a beta-interferon.
• Bolniki, ki se niso odzivali na celoten in ustrezen potek zdravljenja z interferonom beta.
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.
Bolniki morajo imeti vsaj 1 recidiv v preteklem letu med terapijo in vsaj 9 T2- hiperintenzivnih lezij pri možganski MRS ali vsaj 1 lezijo, vidno z gadolinijem.
• 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.
• Bolniki s hitro razvijajočo se hudo recidivno remitentno multiplo sklerozo, ki se kaže z 2 ali več recidivi prizadetosti v enem letu ter z 1 ali več lezijami, vidnimi z gadolinijem na MRS možganov ali znatnim povečanjem površine lezij T2 v primerjavi s predhodno nedavno MRS.
Median age was 37 years, with a median disease duration of 5 years.
9 Učinkovitost monoterapije se je ocenjevala v randomizirani, dvojno slepi, s placebom kontrolirani, 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.
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.
Bolnike so randomizirali v razmerju 2: 1 za dajanje zdravila TYSABRI 300 mg (n = 627) ali placeba (n = 315) vsake 4 tedne do 30 infuzij.
Main features and results Monotherapy; randomised double-blind placebo-controlled Design parallel-group trial for 120 weeks Subjects
10 Študija AFFIRM: glavne značilnosti in rezultati Monoterapija; randomizirano, dvojno slepo, s placebom Zasnova kontrolirano, vzporedno, 120- tedensko preskušanje Bolniki z RRMS (recidivna remitentna multipla skleroza) Preizkušanci (McDonaldovi kriteriji) Zdravljenje Opazovani dogodek – eno leto Opazovani dogodek – dve leti
Placebo / Natalizumab 300 mg i. v. every 4 weeks Relapse rate Progression on EDSS
Placebo / natalizumab 300 mg i. v. vsake 4 tedne Stopnja recidivov Napredovanje po EDSS
Completing 1 years Completing 2 years
Iz stopnje recidivov izpeljane spremenljivke / iz MRT - Sekundarni opazovani dogodki izpeljane spremenljivke Predmeti Randomizirano Dopolnjeno 1 leto Dopolnjeni 2 leti
Age yrs, median (range) MS-history yrs, median (range) Time since diagnosis, yrs median
Starost v letih, mediana (razpon) Zgodovina obolelosti za MS v letih,
(range) Relapses in previous 12 months,
(razpon) Recidivi v preteklih 12 mesecih,
median (range) EDSS-baseline, median (range)
mediana (razpon) Izhodišče na EDSS,
RESULTS Annual relapse rate
mediana (razpon)
After one year (primary endpoint) After two years
2 (0- 6, 0)
0.261 0.235
dogodki)
One year
0, 805
Rate ratio 0.33 CI95% 0.26; 0.41
0, 261
Relapse free
Po dveh letih
Two years
0, 733
Rate ratio 0.32 CI95% 0.26; 0.40
0, 235
After one year
Brez recidiva
53%
Eno leto Dve leti
76%
Razmerje stopnje 0, 33 CI95% 0, 26; 0, 41 Razmerje stopnje 0, 32 CI95% 0, 26; 0, 40
After two years
Po enem letu Po dveh letih
Proportion progressed1(12-week
Delež napredovanja1 (potrditev po 12
confirmation; primary outcome)
tednih; primarni izid)
Hazard ratio 0.58, CI95% 0.43; 0.73, p < 0.001 Proportion progressed1(24-week
Razmerje nevarnosti 0, 58, CI95% 0, 43; 0, 73, p < 0, 001 Delež napredovanja1 (potrditev po 24
confirmation)
tednih)
Hazard ratio 0.46, CI95% 0.33; 0.64, p < 0.001 MRI (0-2 years)
Razmerje nevarnosti 0, 46, CI95% 0, 33; 0, 64, p < 0, 001 MRS (0- 2 let)
Median% change in T2-
Mediana% sprememba v obsegu
hyperintense lesion volume
hiperintenzivne lezije T2 (mm3)
Mean number of new or newly-
Povprečno število novih ali na novo
enlarging T2-hyperintense lesions Mean number of T1-hypointense
povečanih hiperintenzivnih lezij T2 Povprečno število hipointenzivnih
lesions Mean number of Gd-enhancing
lezij T1 Povprečno število lezij, vidnih z
lesions
gadolinijem
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.
11 1 Napredovanje prizadetosti je bilo definirano s povečanjem na EDSS za vsaj 1, 0 točke, od izhodiščne EDSS > =1, 0, v trajanju vsaj 12 ali 24 tednov, ali s povečanjem na EDSS za vsaj 1, 5 točke, od izhodiščne EDSS =0, v trajanju vsaj 12 ali 24 tednov.
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
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, in pri skupini, ki je prejemala placebo (n=61) 1, 455 (p < 0, 001).
Hazard ratio for disability progression was 0.36 (95% CI:
Razmerje nevarnosti za napredovanje prizadetosti je bilo 0, 36 (95% CI:
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.
Ugotovljena srednja najvišja koncentracija v serumu pri bolnikih z MS po ponavljajočem intravenskem dajanju 300 mg odmerka natalizumaba je bila 110 ± 52 μg/ ml.
Mean average steady-state trough natalizumab concentrations over the dosing period ranged from 23 μ g/ ml to 29 μ g/ ml.
Srednja povprečna koncentracija natalizumaba v stanju dinamičnega ravnovesja se je v obdobju dajanja gibala od 23 μg/ ml do 29 μg/ ml.
A population pharmacokinetics analysis was conducted on samples from over 1,100 MS patients receiving doses ranging from 3 to 6 mg/ kg natalizumab.
Analiza populacijske farmakokinetike se je izvajala na vzorcih več kot 1100 bolnikov z MS, ki so prejemali odmerke od 3 do 6 mg/ kg natalizumaba.
The mean ± SD steady-state clearance was 13.1 ± 5.0 ml/ h, with a mean ± SD half-life of 16 ± 4 days.
Srednji (± SD) očistek v stanju dinamičnega ravnovesja je bil 13, 1 ± 5, 0 ml/ h, s srednjim (± SD) razpolovnim časom 16 ± 4 dni.
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.
Analiza je raziskala učinke izbranih sospremenljivk, vključno s telesno maso, starostjo, spolom, jetrnim in ledvičnim delovanjem in prisotnostjo proti- natalizumabnih protiteles na farmakokinetiko.
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.
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.
Ugotovili so, da telesna masa vpliva na očistek manj kot sorazmerno, pri čemer povzroči 43% sprememba telesne mase 31% do 34% spremembo očistka.
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).
Prisotnost obstojnih proti- natalizumabnih protiteles je povečala očistek natalizumaba za približno trikrat, kar je v skladu z zmanjšanjem serumskih koncentracij natalizumaba, ugotovljenih pri bolnikih z obstojnimi proti- natalizumabnimi protitelesi (glejte poglavje 4. 8).
Estimates of the total drug removal after 3 plasma exchanges (over a 5-8 day interval) was approximately 70-80%.
Ocenjena celotna izločitev zdravila po 3 zamenjavah plazme (v intervalih 5- 8 dni) je bila približno 70- 80%.
This compares to approximately 40% seen in earlier studies in which measurements occurred after drug discontinuation over a similar period of observation.
To je primerljivo s približno 40% iz zgodnjih študij, v katerih so se meritve opravile po prekinitvi jemanja zdravila v podobnem opazovalnem obdobju.
Natalizumab showed no effects on in vitro assays of α 4-integrin-positive tumour line proliferation or cytotoxicity.
Natalizumab ni kazal učinkov v metodi in vitro α4- integrin - pozitivne proliferacije ali citotoksičnosti tumorske linije.
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.
12 Pri samicah budre so opazili zmanjšano plodnost v eni študiji pri odmerkih, ki presegajo odmerek za zdravljenje ljudi; natalizumab ni vplival na plodnost samcev.
This was the result of a high incidence of abortions in treated groups in the
V eni študiji z opicami se je število abortusov obravnavanih opic podvojilo pri dajanju 30 mg/ kg natalizumaba v primerjavi z ujemajočimi kontrolnimi skupinami.
11 first cohort that was not observed in the second cohort.
To je bila posledica visoke incidence abortusov v tretirani skupini prve kohorte, ki ni bila opažena v drugi kohorti.
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).
Pri opicah cynomolgus, tretiranih z natalizumabom do skotitve, so bile nizke ravni natalizumaba ugotovljene v opičjem mleku nekaterih živali, kar kaže na možnost prehoda natalizumaba v človeško mleko (glejte poglavje 4. 6).
Sodium phosphate, monobasic, monohydrate Sodium phosphate, dibasic, heptahydrate Sodium chloride Polysorbate 80 (E433) Water for Injections.
Natrijev dihidrogenfosfat monohidrat Natrijev hidrogenfosfat, heptahidrat Natrijev klorid Polisorbat 80 (E433) Voda za injekcije.
TYSABRI must not be mixed with other medicinal products except those mentioned in section 6.6.
Zdravila TYSABRI ne smemo mešati z drugimi zdravili, razen s tistimi, omenjenimi v poglavju 6. 6.
If not used immediately, the diluted solution must be stored at 2˚ C - 8˚ C and infused within 8 hours of dilution.
Razredčeno raztopino, ki je ne porabite takoj, morate hraniti na 2 ˚C do 8 ˚C in infundirati v roku 8 ur po razredčitvi.
Store in a refrigerator (2 ˚ C - 8˚ C).
Shranjujte v hladilniku (2 ˚C – 8 ˚C).
For storage conditions of the diluted medicinal product see section 6.3.
Za pogoje shranjevanja raztopljenega zdravila glejte poglavje 6. 3.
15 ml TYSABRI in a vial (type I glass) with a stopper (bromobutyl rubber) and a seal (aluminium) with a flip-off cap.
15 ml zdravila TYSABRI v viali (steklo vrste I) z brombutilnim gumijastim zamaškom in aluminijasto prekrivno zaporko s pokrovom „ flip- off “.
If particles are observed and/ or the liquid in the vial is not colourless, clear to slightly opalescent, the vial must not be used.
Če opazite delce in/ ali če raztopina v viali ni brezbarvna, bistra do rahlo opalescentna, viale ne smete uporabiti.
Remove flip-off cap from the vial.
Z viale odstranite pokrov „ flip- off “.
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.
5 Visually inspect the diluted product for particles or discolouration prior to administration.
Pred dajanjem vizualno preverite razredčeno raztopino glede delcev ali obarvanja.
The diluted 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.
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.
Raztopina, ki se hrani pri 2 ˚C - 8 ˚C (ne zamrzujte), se mora pred infundiranjem segreti na sobno temperaturo.
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.
After the infusion is complete, flush the intravenous line with sodium chloride 9 mg/ ml (0.9%) solution for injection.
Po končanem infundiranju sperite intravensko linijo z natrijevim kloridom 9 mg/ ml (0, 9%) 8. raztopino za injiciranje.
Each vial is for single– use only.
Vsaka viala je samo za enkratno uporabo.
Elan Pharma International Ltd., Monksland, Athlone, County Westmeath, Ireland
Elan Pharma International Ltd., Monksland, Athlone, County Westmeath, Irska
27th June 2006
27. junij 2006
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/.
14 Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http: // www. emea. europa. eu /.
13 ANNEX II
15 DODATEK II
Biogen Idec Inc 5000 Davis Drive Research Triangle Park NC 27709-4627 USA
Biogen Idec Inc 5000 Davis Drive Research Triangle Park NC 27709- 4627 ZDA
Robijnlaan 8 NL-2132 Hoofddorp The Netherlands
Robijnlaan 8 NL- 2132 Hoofddorp Nizozemska
Biogen Idec Denmark Manufacturing ApS Biogen Idec Allé 1 DK-3400 Hillerød Denmark
Biogen Idec Denmark Manufacturing ApS Biogen Idec Allé 1 DK- 3400 Hillerød Danska
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.
Imetnik dovoljenja za promet z zdravilom mora, pred prometom z zdravilom in skladno z dogovorom s pristojnimi organi v državah članicah, v nacionalnem okviru zagotoviti, da bodo vsi zdravniki, ki bodo predpisovali zdravilo TYSABRI, dobili informacije, ki bodo vključevale: • Podatke o zdravilu • Informacije o zdravilu TYSABRI za zdravnike • Kartico s posebnimi opozorili za bolnika
The physician information about TYSABRI shall contain the following key elements: • Restricted indication • Atypical/ opportunistic infections in particular PML including:
Informacije o zdravilu TYSABRI za zdravnike naj vsebujejo naslednje ključne elemente: • Omejitev indikacij • Atipične/ oportunistične okužbe, zlasti PML, vključno z:
• Infusion reactions • Hypersensitivity reactions • Antibody formation
Diagnozo PML, vključno z diferenciacijo PML in recidiva multiple skleroze o Algoritem upravljanja PML o Možnost drugih oportunističnih okužb o • Reakcije na infuzijo • Preobčutljivostne reakcije • Nastajanje protiteles
15 • Need to inform patients about the benefits and risk of TYSABRI and provide them with a patient alert card.
17 • Potreba, da se bolnike obvesti o koristih in tveganjih zdravljenja z zdravilom TYSABRI in se jim da kartico s posebnimi opozorili.
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.
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je sistem farmakovigilance, vzpostavljen in da deluje, preden da zdravilo na trg in toliko časa, kolikor bo zdravilo v uporabi.
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan.
Imetnik dovoljenja za promet z zdravilom se zavezuje, da bo opravil študije in dodatne farmakovigilančne aktivnosti, ki so podrobno opisane v načrtu farmakovigilance.
An updated Risk Management Plan should be provided as per the CHMP Guideline on Risk Management Systems for medicinal products for human use.
V skladu s smernicami CHMP o sistemih za obvladovanje tveganja pri zdravilih za humano uporabo mora biti predložen posodobljen načrt za obvladovanje tveganja.
The MAH will submit PSURs on 6 monthly basis until otherwise specified.
Imetnik dovoljenja za promet bo vsakih 6 mesecev predložil PSUR, dokler se ne določi drugače.
16 ANNEX III
18 DODATEK III
18 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
20 PODATKI NA ZUNANJI OVOJNINI
Each 15 ml vial of concentrate contains 300 mg natalizumab (20 mg/ ml);
Vsaka 15 ml viala koncentrata vsebuje 300 mg natalizumaba (20 mg/ ml);
1 x 15 ml vial
1 x 15 ml viala
Monksland Athlone County Westmeath Ireland
Monksland Athlone County Westmeath Irska
MARKETING AUTHORISATION NUMBER(S)
ŠTEVILK( E) DOVOLJENJA (DOVOLJENJ) ZA PROMET
20 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
22 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
INFORMATION FOR THE USER
24 NAVODILO ZA UPORABO
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.
Poleg teh navodil boste prejeli tudi kartico s posebnimi opozorili za bolnika, ki vsebuje pomembne informacije v zvezi z varnostjo, za katere morate vedeti, preden začnete z zdravljenjem z zdravilom TYSABRI (izgovor taj- se- bri) in med samim zdravljenjem s tem zdravilom.
- Keep this leaflet and the Patient Alert Card.
- Navodilo in kartico s posebnimi opozorili shranite.
- It is important that you keep the Alert Card with you during treatment and for six months after
- Pomembno je, da kartico s posebnimi opozorili med zdravljenjem in šest mesecev po zadnjem
the last dose of TYSABRI, since side effects may occur even after you have stopped treatment.
odmerku zdravila TYSABRI hranite pri sebi, ker se neželeni učinki lahko pojavijo celo po končanem zdravljenju.
If you
- V navodilu so opisani neželeni učinki, ki so jih nekateri bolniki doživeli ob jemanju zdravila
have any worrying side effects, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.
Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika, njegovo osebje ali farmacevta.
What TYSABRI is and what it is used for 2.
Kaj je zdravilo TYSABRI in za kaj ga uporabljamo 2.
Before you use TYSABRI 3.
Kaj morate vedeti, preden boste uporabili zdravilo TYSABRI 3.
How to use TYSABRI 4.
Kako uporabljati zdravilo TYSABRI 4.
How to store TYSABRI 6.
Shranjevanje zdravila TYSABRI 6.
WHAT TYSABRI IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO TYSABRI IN ZA KAJ GA UPORABLJAMO
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.
Simptomi lahko vključujejo: težave s hojo, odrevenelost obraza, rok ali nog, težave z gledanjem, 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 mišični krči.
In TYSABRI the active ingredient is natalizumab, a protein similar to your own antibodies.
Zdravilna učinkovina v zdravilu TYSABRI je natalizumab, beljakovina, podobna vašim lastnim protitelesom.
It stops the cells that cause inflammation from going into your brain.
Celicam, ki povzročajo vnetje, preprečuje vstop v možgane.
However, TYSABRI cannot repair the damage that has already been caused by MS.
Vendar pa zdravilo TYSABRI ne more popraviti škode, ki jo je MS že povzročila.
BEFORE YOU USE TYSABRI
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO TYSABRI
Do not use TYSABRI • If you are allergic (hypersensitive) to natalizumab or any of the other ingredients of TYSABRI (see section 6 for the ingredients).
Ne uporabljajte zdravila TYSABRI • Če ste alergični na (preobčutljivi za) natalizumab ali katerokoli sestavino zdravila TYSABRI (glejte poglavje 6 za sestavine).