natgillin/translations-raw huggingface dataset:
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.
Sodium phosphate, monobasic, monohydrate, Sodium phosphate, dibasic, heptahydrate, Sodium chloride (see section 2 ‘TYSABRI contains sodium'), Polysorbate 80 (E433)
Druge sestavine so: natrijev dihidrogenfosfat monohidrat natrijev hidrogenfosfat heptahidrat natrijev klorid (glejte poglavje 2 ‘Zdravilo TYSABRI vsebuje natrij') polisorbat 80 (E433) voda za injekcije
Each vial contains 2.3 mmol (or 52 mg) sodium.
Ena viala vsebuje 2,3 mmol (ali 52 mg) natrija.
Your doctor may test your blood to check if you have antibodies to the JC virus before you start treatment with TYSABRI.
Vaš zdravnik vam bo morda pred začetkom zdravljenja z zdravilom TYSABRI dal pregledati kri, da ugotovi morebitno prisotnost protiteles proti virusu JC.
If you miss your usual dose of TYSABRI, arrange with your doctor to receive it as soon as you can. You can then continue to receive your dose of TYSABRI every 4 weeks.
Če ste izpustili običajni odmerek zdravila TYSABRI, se z zdravnikom dogovorite, da ga boste prejeli čim prej.
What TYSABRI looks like and contents of the pack TYSABRI is a clear, colourless to slightly cloudy liquid.
Zdravilo TYSABRI je bistra, brezbarvna ali rahlo motna tekočina.
TYSABRI will be given to you by a doctor experienced in the treatment of MS.
Kako uporabljati zdravilo TYSABRI Zdravilo TYSABRI da zdravnik z izkušnjami v zdravljenju MS.
A condition called JCV GCN (JC virus granule cell neuronopathy) is also caused by JC virus and has occurred in some patients who have been given TYSABRI.
Virus JC lahko povzroči tudi bolezen, imenovano JCV GCN (JCV nevropatija zrnatih celic), o kateri so poročali pri nekaterih bolnikih, zdravljenih 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.
Some patients with a past medical history of an abnormal liver test have experienced an exacerbation of abnormal liver test while on TYSABRI.
Pri nekaterih bolnikih, katerih testi so v preteklosti pokazali nepravilnosti v delovanju jeter, so se vrednosti med jemanjem zdravila TYSABRI še poslabšale.
After dilution (see section 6.6), the infusion is to be administered over approximately 1 hour and patients are to be observed during the infusion and for 1 hour after the completion of the infusion for signs and symptoms of hypersensitivity reactions.
Bolnika se v času infundiranja in 1 uro po končanem infundiranju opazuje za znake in simptome preobčutljivostnih reakcij.
Breast-feeding should be discontinued during treatment with TYSABRI.
Med zdravljenjem z zdravilom TYSABRI je treba prenehati z dojenjem.
This is because patients who received one or two doses of TYSABRI and then had a gap in treatment of three months or more, were more likely to have an allergic reaction when resuming treatment.
TYSABRI, nato pa prekinili zdravljenje za tri mesece ali več, pogosteje pojavile alergije, ko so ponovno pričeli z zdravljenjem.
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
Each vial of TYSABRI contains 2.3 mmol (or 52 mg) of sodium.
Ena viala zdravila TYSABRI vsebuje 2,3 mmol (ali 52 mg) natrija.
• Feeling sick (nausea)
• huda alergija (preobčutljivost)
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 %) raztopino za injiciranje.
In 10% of patients antibodies against natalizumab were detected in 2-year controlled clinical trials in MS patients.
V dveletnih kontroliranih kliničnih preskušanjih pri bolnikih z MS so bila pri 10 % bolnikov odkrita protitelesa proti natalizumabu.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION TYSABRI 300 mg concentrate for solution for infusion natalizumab
IME ZDRAVILA IN POT(I) UPORABE TYSABRI 300 mg koncentrat za raztopino za infundiranje natalizumab intravenska uporaba
Continuous dosing with TYSABRI is important, especially during the first few months of treatment.
Neprekinjeno odmerjanje zdravila TYSABRI je pomembno še posebej prvih nekaj mesecev zdravljenja, zato ker so se pri bolnikih, ki so prejeli enega ali dva odmerka zdravila
Tell your doctor immediately if you have, or think you have, any sort of infection (see side effects).
Če imate ali mislite, da imate kakršno koli vrsto okužbe (glejte neželene učinke), o tem takoj obvestite zdravnika.
• Prescriber name, signature and date
• ime, podpis in datum zdravnika, ki predpisuje zdravilo
What TYSABRI contains
Kaj vsebuje zdravilo TYSABRI
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.
Potomci, rojeni materam, tretiranih z natalizumabom do skotitve, so imeli zmanjšano število trombocitov, vendar niso kazali znakov anemije.
In cases of significant liver injury TYSABRI should be discontinued.
V primeru hujših okvar jeter je treba zdravljenje z zdravilom TYSABRI prekiniti.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of concentrate contains 20 mg of natalizumab.
En ml koncentrata vsebuje 20 mg natalizumaba.
MedDRA System Organ Class Adverse reaction
Organski sistem po MedDRA Neželeni učinek
Discontinue administration of TYSABRI and initiate appropriate therapy at the first symptoms or signs of hypersensitivity.
Ob pojavu prvih simptomov ali znakov preobčutljivosti prenehajte z dajanjem zdravila TYSABRI in uvedite ustrezno zdravljenje.
• You may not be able to use TYSABRI if you are currently receiving or have previously received medicines that affect your immune system, e.g. mitoxantrone or cyclophosphamide.
• Če trenutno jemljete ali ste predhodno prejemali zdravila, ki vplivajo na imunski sistem, npr.
Relapse free
(ODGOVORNI) ZA SPROŠČANJE SERIJ
• 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 %)
• Being sick (vomiting)
• srbeč izpuščaj (koprivnica)
Randomised
Preizkušanci
Dilute before infusion.
Pred infundiranjem razredčite.
• 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
• Urinary tract infection
• okužbe sečil
Rare side effects that may affect up to 1 in 1,000 people:
• progresivna multifokalna levkoencefalopatija (PML) Redki neželeni učinki, ki lahko prizadenejo največ 1 od 1.000 bolnikov:
In patients considered at high risk treatment with TYSABRI should only be continued if the benefits outweigh the risks.
Pri bolnikih, pri katerih je tveganje veliko, se sme zdravljenje z zdravilom TYSABRI nadaljevati le,
In 2-year controlled clinical trials in MS patients, an infusion-related event was defined as an adverse event occurring during the infusion or within 1 hour of the completion of the infusion.
opredelili kot neželen dogodek, ki se pojavi med infundiranjem ali v eni uri od zaključenega infundiranja.
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.
TYSABRI povezano s povišanim obtokom limfocitov, monocitov, eozinofilcev, bazofilcev in eritrocitov z jedrom.
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.
Given that efficacy may be reduced or the incidence of hypersensitivity or infusion-related reactions may be increased in a patient with persistent antibodies, treatment should be discontinued in patients who develop persistent antibodies.
Ker se lahko pri bolnikih z obstojnimi protitelesi učinkovitost zmanjša ali poveča pojavnost preobčutljivosti ali z infuzijo povezanih reakcij,
How to store TYSABRI
Shranjevanje zdravila TYSABRI
• Information on PML and IRIS including the risk of developing PML during TYSABRI treatment stratified by prior treatment with immunosuppressants and JC virus infection.
• informacije o PML in IRIS, vključno s tveganjem za razvoj PML med zdravljenjem z zdravilom
TYSABRI therapy and without prior history of immunosuppressant therapy.
TYSABRI, opredeljeno glede na predhodno zdravljenje z imunosupresivi in okužbo z virusom JC
• Dizziness
• bruhanje
• TYSABRI must be diluted before it is given to you.
• Pred uporabo je treba zdravilo TYSABRI razredčiti.
Warnings and precautions Talk to your doctor before using TYSABRI.
Pred začetkom uporabe zdravila TYSABRI se posvetujte s svojim zdravnikom.
− Weight loss
Razredčena raztopina
Stopping TYSABRI therapy
Prenehanje zdravljenja z zdravilom TYSABRI
• Difficulty breathing
Težave z jetri
This includes:
ali se je kaj spremenilo, če:
Do not use if it is discoloured or if foreign particles are seen.
Obarvane raztopine ali raztopine, v kateri so delci, ne smete uporabiti.
In 2-year controlled clinical trials in MS patients, the rate of infection was approximately 1.5 per patient-year in both natalizumab- and placebo-treated patients.
Okužbe, vključno s PML in oportunističnimi okužbami V dveletnih kontroliranih kliničnih preskušanjih pri bolnikih z MS je bila stopnja okužbe približno 1,5
• Severe allergy (hypersensitivity) • Progressive multifocal leukoencephalopathy (PML)
Bolezni živčevja glavobol pogosti omotica pogosti progresivna multifokalna levkoencefalopatija (PML)
One year endpoint
Opazovani dogodek - eno leto
Rare, serious cases of anaemia and haemolytic anaemia have been reported in patients treated with TYSABRI in post-marketing observational studies.
V opazovalnih študijah po prihodu zdravila na trg so pri bolnikih, zdravljenih z zdravilom Tysabri,
Urinary tract infection
raztopino za injiciranje.
Vomiting
Imunogenost