natgillin/translations-raw huggingface dataset:
Non-clinical data reveal no special hazard for humans based on studies of repeated dose toxicity and toxicity to reproduction. 
Predklinični podatki na osnovi študije toksičnosti ponavljajočih se odmerkov in vpliva na sposobnost razmnoževanja ne kažejo posebnega tveganja za človeka.
Very common Bacterial infections, e.g. bronchitis, urinary tract infection 
Infekcijske in parazitske bolezni zelo pogosti bakterijske okužbe, npr. bronhitis,
The intravenous studies did not exclude patients with a history of psychiatric disorders. 
Bolniki z anamnezo psihiatričnih motenj v študijah intravenske uporabe niso bili izključeni.
Benlysta is supplied as a 1 ml colourless to slightly yellow solution in a single use pre-filled pen. 
Zdravilo Benlysta je na voljo kot 1 ml brezbarvna do rahlo rumenkasta raztopina v napolnjenem injekcijskem peresniku za enkratno uporabo.
The recommended injection sites are the abdomen or thigh. 
Priporočeni mesti injiciranja sta trebuh ali stegno.
Gauze pad or cotton wool ball 
Zloženec gaze ali kosem vate
Percent of patients with no worsening by BILAG index (%) Odds ratio (95% CI) vs placebo 
Odstotek bolnikov z zmanjšanjem SELENA-SLEDAI ≥ 4 (%) Razmerje obetov (95 % IZ) v primerjavi s placebom Odstotek bolnikov brez poslabšanja indeksa BILAG (%) Razmerje obetov (95 % IZ) v primerjavi s placebom Odstotek bolnikov brez poslabšanja po PGA (%)
• Dispose of the used pen and ring cap in a container with a tight-fitting lid. 
• Uporabljen injekcijski peresnik in okrogel pokrovček zavrzite v vsebnik z dobro prilegajočim se pokrovom.
Inject Benlysta Insert the needle 
Injicirajte zdravilo Benlysta Zabodite iglo
Benlysta 200 mg solution for injection in pre-filled syringe belimumab This medicine is subject to additional monitoring. 
Benlysta 200 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku belimumab Za to zdravilo se izvaja dodatno spremljanje varnosti.
The recommended dose regimen for children aged 5 years and older is 10 mg/kg Benlysta on Days 0, 14 and 28, and at 4-week intervals thereafter. 
Pediatrična populacija Priporočena shema odmerjanja za otroke, stare 5 let in več, je 10 mg/kg zdravila Benlysta na dan 0, 14
In patients with anti-dsDNA antibodies, 16% of patients treated with Benlysta converted to anti-dsDNA negative compared with 7% of the patients receiving placebo by Week 52. 
Med bolniki s protitelesi anti-dvDNK je do 52. tedna postalo negativnih 16 % bolnikov, zdravljenih z zdravilom Benlysta, in 7 % tistih, ki so prejemali placebo.
FACIT-fatigue score improvement from baseline at week-52 (mean) 
Izboljšanje rezultata FACIT-fatigue od izhodišča do 52. tedna (povprečje)
Benlysta significantly reduced circulating overall, transitional, naïve, and SLE B cells, as well as plasma cells at Week 52. 
Zdravilo Benlysta je po 52 tednih značilno zmanjšalo število vseh, tranzicijskih, naivnih in SLE celic B
BLyS levels are elevated in patients with SLE and other autoimmune diseases. 
Bolniki s SLE in drugimi avtoimunskimi boleznimi imajo večjo koncentracijo BLyS.
Delayed-type, non-acute hypersensitivity reactions have also been observed and included symptoms such as rash, nausea, fatigue, myalgia, headache, and facial oedema. 
Opazili so tudi reakcije pozne, neakutne preobčutljivosti, ki vključujejo simptome, kot so kožni izpuščaj, navzea, utrujenost, bolečine v mišicah, glavobol in edem obraza.
Benlysta 400 mg powder for concentrate for solution for infusion belimumab 
Benlysta 400 mg prašek za koncentrat za raztopino za infundiranje belimumab
In patients with anti-dsDNA antibodies at baseline, by Week 52, 18% of patients treated with Benlysta had converted to anti-dsDNA negative compared with 15% of the patients receiving placebo. 
Med bolniki, ki so izhodiščno imeli protitelesa anti-dvDNK, je do 52. tedna postalo negativnih 18 % bolnikov zdravljenih z zdravilom Benlysta in 15 % bolnikov, ki so prejemali placebo.
Solutions diluted in sodium chloride 9 mg/ml (0.9%), sodium chloride 4.5 mg/ml (0.45%), or Lactated Ringer's solution for injection may be stored at 2°C to 8°C or room temperature (15°C to 25°C). 
(0,45 %) raztopino natrijevega klorida ali raztopino Ringerjevega laktata za injiciranje, je lahko shranjena pri temperaturi od 2 °C do 8 °C ali pri sobni temperaturi (15 do 25 °C).
The reduction in systemic clearance estimated by population PK modelling for patients at the midpoints of the renal impairment categories relative to patients with median creatinine clearance in the PK population (79.9 ml/min) were 1.4% for mild (75 ml/min), 11.7% for moderate (45 ml/min) and 24.0% for severe (22.5 ml/min) renal impairment. 
Zmanjšanje sistemskega očistka, ocenjeno s populacijskim farmakokinetičnim modeliranjem za bolnike na srednji točki kategorije okvare ledvic glede na bolnike z medianim očistkom kreatinina v farmakokinetični populaciji (79,9 ml/min), je bilo
Leucopenia: The incidence of leucopenia reported as an adverse event was 3% in the group receiving Benlysta and 2% in the group receiving placebo. 
Benlysta, 3 % in v skupini, ki je prejemala placebo, 2 %.
• Do not remove the needle cap until just before the injection. 
• Pokrovček igle odstranite šele tik pred injiciranjem.
The intravenous pharmacokinetic parameters quoted below are based on population parameter estimates for the 563 patients who received Benlysta 10 mg/kg in the two Phase III studies. 
563 bolnikih, ki so prejemali 10 mg/kg zdravila Benlysta v dveh študijah III. faze.
Benlysta 120 mg powder for concentrate for solution for infusion belimumab 
Benlysta 120 mg prašek za koncentrat za raztopino za infundiranje belimumab
SRI response rate at week 52 (%) Observed treatment difference vs placebo (%) 
Delež odziva po SRI po 52 tednih (%) Opažena terapevtska razlika v prim.
Injecting Benlysta 
Injiciranje zdravila Benlysta
Preparation of 400 mg solution for infusion 
Priprava 400 mg raztopine za infundiranje Rekonstitucija
≤7.5 mg/day during Weeks 40 through 52, was 18.2% in the group receiving Benlysta and 11.9% in the group receiving placebo (p=0.0732). 
Benlysta 18,2 % in med prejemniki placeba 11,9 % (p = 0,0732).
• Do not remove the ring cap until just before the injection. 
• Okrogli pokrovček odstranite šele tik pred injiciranjem.
After reconstitution, a volume of 5 ml (corresponding to 400 mg belimumab) can be withdrawn from each 20 ml vial. 
Po rekonstituciji je mogoče iz ene 20-ml viale potegniti volumen 5 ml (to ustreza 400 mg belimumaba).
The reconstituted medicinal product is diluted to 250 ml with sodium chloride 9 mg/ml (0.9%), sodium chloride 4.5 mg/ml (0.45%), or Lactated Ringer's solution for injection. 
Pripravljeno zdravilo je treba razredčiti do 250 ml z 0,9 % (9 mg/ml) raztopino natrijevega klorida,
• Check the expiry date on the pre-filled pen. 
• Preverite rok uporabnosti na napolnjenem injekcijskem peresniku.
A single Benlysta pre-filled pen can be stored at room temperature (up to 25°C) for a maximum of 12 hours - as long as it is protected from light. 
25 °C) do največ 12 ur - dokler je zaščiten pred svetlobo.
After reconstitution, a volume of 1.5 ml (corresponding to 120 mg belimumab) can be withdrawn from each 5 ml vial. 
Po rekonstituciji je mogoče iz ene 5-ml viale potegniti volumen 1,5 ml (to ustreza 120 mg belimumaba).
The clinical status of the subject and the adverse reaction profile of Benlysta should be borne in mind when considering the patient's ability to perform tasks that require judgement, motor or cognitive skills. 
Pri ocenjevanju bolnikove zmožnosti za izvajanje opravil, ki zahtevajo presojo in motorične ali kognitivne sposobnosti, je treba upoštevati njegovo klinično stanje in profil neželenih učinkov zdravila Benlysta.
Injection site reactions: In the subcutaneous trial, the frequency of injection site reactions was 6.1% (34/556) and 2.5% (7/280) for patients receiving Benlysta and placebo, respectively. 
Reakcije na mestu injiciranja: V preskušanju s subkutano uporabo je bila pogostnost reakcij na mestu injiciranja v skupini bolnikov, ki je prejemala zdravilo Benlysta, 6,1 % (34/556) in v skupini bolnikov,
In a pooled analysis of the two studies, the percentage of patients receiving >7.5 mg/day prednisone (or equivalent) at baseline, whose average corticosteroid dose was reduced by at least 25% to a dose equivalent to prednisone ≤7.5 mg/day during Weeks 40 through 52, was 17.9% in the group receiving Benlysta and 12.3% in the group receiving placebo (p=0.0451). 
tedna zmanjšal za vsaj 25 % na odmerek, enakovreden ≤7,5 mg/dan prednizona, 17,9 % med prejemniki zdravila Benlysta in 12,3 % med prejemniki placeba (p = 0,0451).
After reconstitution, a volume of 5 ml (corresponding to 400 mg belimumab) can be withdrawn from each vial. 
Po rekonstituciji je mogoče iz ene viale potegniti volumen 5 ml (to ustreza 400 mg belimumaba).
The majority of patients were also receiving one or more of the following concomitant treatments for SLE: corticosteroids, immunomodulatory medicinal products, anti-malarials, non-steroidal anti-inflammatory medicinal products. 
Večina bolnikov je za SLE sočasno dobivala tudi eno ali več naslednjih zdravil: kortikosteroide,
After reconstitution, a volume of 1.5 ml (corresponding to 120 mg belimumab) can be withdrawn from each vial. 
Po rekonstituciji je mogoče iz ene viale potegniti volumen 1,5 ml (to ustreza 120 mg belimumaba).
Inspect the Benlysta solution 
Preglejte raztopino zdravila Benlysta
Follow these instructions on how to use the pre-filled syringe correctly. 
Za pravilno uporabo napolnjenega injekcijskega peresnika upoštevajte ta navodila.
Benlysta 10 mg/kg n=53 
Zdravilo Benlysta 10 mg/kg n = 53
EU/1/11/700/003 1 pre-filled pen EU/1/11/700/004 4 pre-filled pens 
EU/1/11/700/003 1 napolnjen injekcijski peresnik EU/1/11/700/004 4 napolnjeni injekcijski peresniki
Please refer to the Summary of Product Characteristics for Benlysta powder for concentrate for solution for infusion (section 4.4). 
Glejte povzetek glavnih značilnosti zdravila za zdravilo Benlysta prašek za koncentrat za raztopino za infundiranje
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON-VIAL 
PODATKI NA ZUNANJI OVOJNINI ŠKATLA- VIALA
Uncommon side effects 
Neželeni učinek/učinki
PARTICULARS TO APPEAR ON INTERMEDIATE PACKAGING CARTON -- PRE-FILLED PEN- Multipack containing 12 pre-filled pens (3 packs of 4 pre-filled pens)with out blue box 
PODATKI NA VMESNEM PAKIRANJU ŠKATLA - NAPOLNJEN INJEKCIJSKI PERESNIK - Skupno pakiranje vsebuje 12
These injection site reactions (most commonly pain, erythema, hematoma, pruritus and induration) were mild to moderate in severity. 
Te reakcije na mestu injiciranja (najpogosteje bolečine, eritem,
Subgroup analysis of the primary endpoint demonstrated that the greatest benefit was observed in patients with higher disease activity at baseline including patients with SELENA SLEDAI scores ≥ 10 or patients requiring steroids to control their disease or patients with low complement levels. 
Analiza primarnega opazovanega dogodka v podskupinah je pokazala največjo opaženo korist pri bolnikih z večjo izhodiščno aktivnostjo bolezni, vključno z bolniki, ki so imeli rezultat SELENA
The risk of severe flares was reduced by 49% during the 52 weeks of observation in the group receiving Benlysta compared with the group receiving placebo (hazard ratio=0.51; p=0.0004). 
Tveganje za huda poslabšanja se je med 52 tedni opazovanja v skupini, ki so prejemali zdravilo Benlysta zmanjšalo za 49 % v primerjavi s skupino, ki je prejemala placebo (razmerje ogroženosti =
Each 1 ml pre-filled syringe contains 200 mg belimumab. 
Ena 1-ml napolnjena injekcijska brizga vsebuje 200 mg belimumaba.
Pre-filled pen 
Okrogli pokrovček
However, higher rates of nausea, vomiting and diarrhoea were observed in obese patients. 
Vendar pa so pri debelih bolnikih ugotovili velike deleže navzee, bruhanja in driske.
Benlysta 200 mg injection belimumab 
Benlysta 200 mg injekcija belimumab s.c. subkutano
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - Multipack containing 12 pre-filled pens (3 packs of 4 pre-filled pens)-with blue box 
PODATKI NA ZUNANJI OVOJNINI ZUNANJA ŠKATLA - Skupno pakiranje vsebuje 12 napolnjenih injekcijskih peresnikov
The 400 mg single-use vial of Benlysta is reconstituted with 4.8 ml of water for injections to yield a final concentration of 80 mg/ml belimumab. 
400-mg vialo zdravila Benlysta za enkratno uporabo je treba pripraviti s 4,8 ml vode za injekcije, tako da je končna koncentracija belimumaba 80 mg/ml.
The 400 mg single-use vial of belimumab is reconstituted with 4.8 ml of water for injections to yield a final concentration of 80 mg/ml belimumab. 
400-mg vialo belimumaba za enkratno uporabo pripravite z 4,8 ml vode za injekcije, da nastane končna koncentracija belimumaba 80 mg/ml.
• Benlysta pre-filled syringe 
• napolnjena injekcijska brizga Benlysta
Benlysta 200 mg solution for injection in pre-filled syringe belimumab 
Benlysta 200 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku belimumab
• Do not put the ring cap back onto the pen. 
• Ne nameščajte okroglega pokrovčka nazaj na injekcijski peresnik.
Infections and infestations 
Nosečnost in dojenje
Observed treatment difference vs placebo (%) 
s placebom (%)
The 120 mg single-use vial of belimumab is reconstituted with 1.5 ml of water for injections to yield a final concentration of 80 mg/ml belimumab. 
120-mg vialo belimumaba za enkratno uporabo pripravite z 1,5 ml vode za injekcije, da nastane končna koncentracija belimumaba 80 mg/ml.
What Benlysta is and what it is used for Benlysta as a subcutaneous injection is a medicine used to treat lupus (systemic lupus erythematosus, SLE) 
Kaj je zdravilo Benlysta in za kaj ga uporabljamo Zdravilo Benlysta v obliki podkožne injekcije je zdravilo za zdravljenje lupusa (sistemskega eritematoznega lupusa, SLE) pri odraslih bolnikih (starih 18 let in več), pri katerih je bolezen kljub standardnemu zdravljenju še vedno zelo aktivna.
How Benlysta is used 
Kako uporabljati zdravilo Benlysta Koliko zdravila uporabiti
Pre-filled syringe Each 1-ml pre-filled syringe contains 200 mg of belimumab. 
Napolnjena injekcijska brizga Ena 1-ml napolnjena injekcijska brizga vsebuje 200 mg belimumaba.
The 120 mg single-use vial of Benlysta is reconstituted with 1.5 ml of water for injections to yield a final concentration of 80 mg/ml belimumab. 
120-mg vialo zdravila Benlysta za enkratno uporabo je treba pripraviti z 1,5 ml vode za injekcije, tako da je končna koncentracija belimumaba 80 mg/ml.
• If you become pregnant while being treated with Benlysta, tell your doctor. 
Preden dobite zdravilo Benlysta, se posvetujte s svojim zdravnikom.
Benlysta 10 mg/kg (n=53) 
Zdravilo Benlysta 10 mg/kg (n = 53)
How Benlysta is used How much to use Adults (18 years of age and older) 
Odrasli (stari 18 let in več)
How to reconstitute Benlysta 
Kako uporabljati zdravilo Benlysta
Benlysta 200 mg solution for injection in pre-filled syringe. 
Benlysta 200 mg raztopina za injiciranje v napolnjeni injekcijski brizgi belimumab
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - PRE-FILLED SYRINGE(S) 
PODATKI NA ZUNANJI OVOJNINI ŠKATLA - NAPOLNJENA INJEKCIJSKA BRIZGA
Pre-filled syringe 
Siv zamašek
Time (weeks) 
dni).
Components of SLE Responder Index Percent of patients with reduction in SELENA-SLEDAI ≥4 (%) Odds ratio (95% CI) vs placebo 
Razmerje obetov (95 % IZ) v primerjavi s placebom Elementi indeksa odziva SLE
Benlysta 400 mg powder for concentrate for solution for infusion. 
Benlysta 400 mg prašek za koncentrat za raztopino za infundiranje belimumab i.v.
Discard the solution if any particulate matter or discoloration is observed. 
Če opazite kakšne delce ali obarvanje, morate raztopino zavreči.
From a 250 ml (or 100 ml) infusion bag or bottle of sodium chloride 9 mg/ml (0.9%), sodium chloride 4.5 mg/ml (0.45%), or Lactated Ringer's solution for injection, withdraw and discard a volume equal to the volume of the reconstituted Benlysta solution required for the patient's dose. 
Iz 250-ml (ali 100-ml) vrečke ali steklenice 0,9 % (9 mg/ml) raztopine natrijevega klorida, 4,5 mg/ml
Inspect the Benlysta solution visually for particulate matter and discoloration prior to administration. 
Raztopino zdravila Benlysta morate pred uporabo pregledati in se prepričati, da ne vsebuje delcev in da ni obarvana.
Benlysta pre-filled syringe 
Benlysta napolnjena injekcijska brizga
at screening. 
s placebom
The systemic clearance was 215 ml/day (range: 69-622 ml/day). 
69-622 ml/dan).
Severe flares over 52 weeks Patients experiencing a severe flare (%) Observed treatment difference vs. placebo (%) Time to severe flare [Hazard ratio (95% CI)] 
Huda poslabšanja v 52 tednih Bolniki, ki se jim je pojavilo poslabšanje (%) Opažena terapevtska razlika v prim.
From a 250 ml infusion bag or bottle of sodium chloride 9 mg/ml (0.9%), sodium chloride 4.5 mg/ml (0.45%), or Lactated Ringer's solution for injection, withdraw and discard a volume equal to the volume of the reconstituted Benlysta solution required for the patient's dose. 
(0,45 %) raztopine natrijevega klorida ali raztopine Ringerjevega laktata za injiciranje izvlecite in zavrzite količino, ki je enaka količini pripravljene raztopine zdravila Benlysta, potrebni za bolnikov odmerek.
Benlysta 120 mg powder for concentrate for solution for infusion. 
Benlysta 120 mg prašek za koncentrat za raztopino za infundiranje belimumab i.v.
Reconstitution 
Redčenje
Check with your doctor if this may apply to you. 
→ Če bi to lahko veljalo za vas, se posvetujte z zdravnikom.
Observed difference vs placebo 
ki so prejemali placebo.
Pre-filled pen Each 1-ml pre-filled pen contains 200 mg of belimumab. 
Napolnjen injekcijski peresnik En 1-ml napolnjen injekcijski peresnik vsebuje 200 mg belimumaba.
OTHER 
Bat
Solution for injection in pre-filled pen. 
Raztopina za injiciranje v napolnjenem injekcijskem peresniku.
Angioedema, urticaria, rash 
občasni angioedem, urtikarija, izpuščaj
• Peel back the film of the tray and remove the pre-filled pen. 
• Odlepite folijo z embalaže in vzemite ven napolnjen injekcijski peresnik.
every 4 weeks 
vsake 4 tedne
• If you are under 18 years of age. 
• če ste stari manj kot 18 let.
Children and adolescents below the age of 18 years. 
Otroci in mladostniki, ki so mlajši od 18 let.
AFFIRM study: Main features and results 
Študija AFFIRM: glavne značilnosti in rezultati
These results were obtained from a post hoc analysis and should be interpreted cautiously. 
Ti rezultati so bili pridobljeni iz post hoc analize in jih je treba razlagati s previdnostjo.
Live vaccines have not been studied. 
Živih cepiv niso preučevali.
This takes about 1 hour. 
Infundiranje traja približno 1 uro.
Two years 
Dve leti
• Increase or decrease in your blood pressure (your doctor or nurse will notice this if they are monitoring your blood pressure). 
• zvišanje ali znižanje krvnega tlaka (zdravnik ali medicinska sestra bosta to opazila, ko bosta preverjala vaš krvni tlak)
Study features and results are presented in the table below. 
Značilnosti in rezultati študije so predstavljeni v spodnji tabeli.
Sixteen of the 29 were classified as major defects. 
Šestnajst od 29 je bilo razvrščenih med velike okvare.
Signs of a possible liver problem: 
Znaki morebitnih težav z jetri:
• Information about the following adverse reactions: 
• Informacije o naslednjih neželenih učinkih:
When a relapse occurs, you may notice the symptoms suddenly, within a few hours, or slowly progressing over several days. 
Pri recidivu lahko simptome opazite nenadno, v nekaj urah, ali počasi napredujoče nekaj dni.
It is important that you keep this Alert Card and show it to your partner or caregivers. 
Pomembno je, da to kartico shranite in jo pokažete svojemu partnerju ali negovalcu.
Unopened vial 4 years 
Neodprta viala 4 leta
Each carton contains one glass vial. 
Vsaka škatla vsebuje eno stekleno vialo.
• It is important to continue with your medicine for as long as you and your doctor decide that it is helping you. 
• Pomembno je, da z zdravljenjem nadaljujete tako dolgo, dokler vi in vaš zdravnik menita, da vam koristi.
• Treatment duration, especially beyond 2 years. 
• Trajanje zdravljenja, zlasti daljše kot 2 leti.
These medicines reduce the activity of your body's immune system. 
Ta zdravila zmanjšajo aktivnost imunskega sistema telesa.
Your symptoms will then usually improve gradually (this is called a remission). 
Običajno se simptomi postopoma izboljšujejo (to se imenuje remisija).
The treatment initiation form should contain the following elements: 
Obrazec za začetek zdravljenja naj vsebuje naslednje elemente:
After one year After two years 
Po enem letu Po dveh letih
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 27th June 2006 
Datum prve odobritve: 27. junij 2006
Progression on EDSS 
Napredovanje po EDSS
The predicted time to steady-state was approximately 36 weeks. 
Predvideni čas do stanja dinamičnega ravnovesja je bil približno 36 tednov.
What are the symptoms of multiple sclerosis? 
Kaj so simptomi multiple skleroze?
This was the result of a high incidence of abortions in treated groups in the 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.
No information on the severity of the relapses before inclusion of patients in the study is available. 
Informacije o resnosti recidivov, pred vključitvijo bolnikov v študijo, niso na voljo.
This compares to approximately 40% seen in earlier studies in which measurements occurred after natalizumab 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 natalizumaba v podobnem opazovalnem obdobju.
These antibodies are a sign that you have been infected by JC virus. 
Ta protitelesa so znak, da ste se okužili z virusom JC.
MARKETING AUTHORISATION NUMBER(S) EU/1/06/346/001 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/06/346/001
These antibodies work by binding to proteins in the body so that the harmful effect of that protein is removed. 
Ta protitelesa učinkujejo tako, da se vežejo na beljakovine v telesu, kar prepreči škodljive učinke teh beljakovin.
These changes were reversible and did not appear to have any adverse toxicological consequences. 
Za te reverzibilne spremembe ni bilo videti, da imajo neželene toksikološke posledice.
Antibodies were detected on only one occasion in an additional 4% of patients. 
Protitelesa so bila odkrita v le enem primeru od dodatnih 4 % bolnikov.
JC virus is a common virus which infects many people but does not normally cause noticeable illness. 
Virus JC je pogost virus, ki okuži številne ljudi, vendar običajno ne povzroči opazne bolezni.
PML is a rare infection of the brain. 
PML je redka okužba možganov.
• If you are allergic to natalizumab or any of the other ingredients of this medicine (listed in section 6). 
• če ste alergični na natalizumab ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
In other clinical trials, cases of additional opportunistic infections have been reported, some of which were fatal. 
V drugih kliničnih preskušanjih so poročali o primerih dodatnih oportunističnih okužb, med katerimi so bile nekatere smrtne.
Neurological evaluations were performed every 12 weeks and at times of suspected relapse. 
Nevrološke ocenitve so potekale vsakih 12 tednov in v primeru suma na recidiv.
• Each vial is for single-use only. 
• Vsaka viala je samo za enkratno uporabo.
• Do not use TYSABRI if you are pregnant unless you have discussed this with your doctor. 
• Ne uporabljajte zdravila TYSABRI, če ste noseči, razen če ste se tako dogovorili s svojim zdravnikom.
The following risk factors are associated with an increased risk of PML. 
Naslednji dejavniki tveganja so povezani z večjim tveganjem za PML.
The rate of defects corresponds to the defect rates reported in other pregnancy registries involving MS patients. 
Stopnja okvar ustreza stopnjam okvar, o katerih so poročali v drugih registrih nosečnosti, ki so vključevali bolnike z MS.
At the first sign of any symptoms indicative of the possibility of PML. 
ob prvih znakih kakršnih koli simptomov, ki kažejo na možnost pojava PML.