natgillin/translations-raw huggingface dataset:
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.
Do not use this medicine after the expiry date stated on the label and carton.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki in škatli.
After 2 years continued therapy should be considered only following a reassessment of the potential for benefit and risk.
Po 2 letih nadaljevanja zdravljenja se je treba odločati na podlagi ponovnega ovrednotenja potencialnih koristi in tveganj.
There were 316 live births, 29 of which were reported to have birth defects.
Živorojenih je bilo 316 otrok, od katerih so pri 29 poročali o prirojenih okvarah.
This should be carefully considered on a case-by-case basis, and a wash-out period of natalizumab might be appropriate.
O tem je treba razmisliti na osnovi vsakega primera posebej in morda bo primerno upoštevati dobo izpiranja natalizumaba.
• If you have an active cancer (unless it is a type of skin cancer called basal cell carcinoma).
• če imate aktivnega raka (razen v primeru tipa kožnega raka, ki se imenuje bazocelularni karcinom).
It is given as a drip into a vein (by intravenous infusion), usually in your arm.
Zdravilo se daje s kapljanjem v veno (z intravensko infuzijo), običajno v roko.
PML usually leads to severe disability or death (see section 4.4).
PML navadno vodi do hude prizadetosti ali smrti (glejte poglavje 4.4).
The completed prospective TYSABRI pregnancy registry contained 355 pregnancies with available outcomes.
V dokončan prospektivni register nosečnosti za zdravilo TYSABRI je bilo vključenih 355 nosečnosti z znanimi izidi.
PML and IRIS (Immune Reconstitution Inflammatory Syndrome)
PML in IRIS (Immune Reconstitution Inflammatory Syndrome - vnetni sindrom imunske obnove)
Some infections other than PML may also be serious and can be due to viruses, bacteria, or other causes.
Resne so lahko tudi nekatere okužbe, ki niso PML, in nastanejo zaradi virusov, bakterij ali drugih vzrokov.
Body weight was found to influence clearance in a less-thanproportional 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.
RESULTS Annual relapse rate After one year (primary endpoint) After two years One year
REZULTATI Letna stopnja recidivov Po enem letu (primarni opazovani dogodki) Po dveh letih Eno leto
• If you have previously taken a medicine called an immunosuppressant.
• Če ste pred tem jemali zdravilo, ki se imenuje imunosupresiv.
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, ki so omenjena v poglavju 6.6.
MS causes inflammation in the brain that damages the nerve cells.
MS povzroča vnetje v možganih, ki poškoduje živčne celice.
• The recommended dose for adults is 300 mg given once every 4 weeks.
• Priporočeni odmerek za odrasle je 300 mg na vsake štiri tedne.
TYSABRI is not recommended for use in patients aged over 65 due to a lack of data in this population.
Jemanje zdravila TYSABRI se ne priporoča pri bolnikih, starejših od 65 let, ker so podatki za to populacijo pomanjkljivi.
See section 4.3.
Glejte poglavje 4.3.
Data on the safety and efficacy of natalizumab at 2 years were generated from controlled, doubleblind studies.
Podatki o varnosti in učinkovitosti natalizumaba po 2 letih so bili pridobljeni v kontroliranih, dvojno slepih študijah.
Show the Alert Card and this package leaflet to any doctor involved with your treatment, not only to your neurologist.
Kartico pokažite vsem zdravnikom, ki sodelujejo pri vašem zdravljenju, ne samo vašemu nevrologu.
The risk of PML with TYSABRI is higher:
Tveganje PML z zdravilom TYSABRI je večje:
Under normal conditions, VCAM-1 is not expressed in the brain parenchyma.
V normalnih pogojih molekule VCAM-1 niso izražene v možganskem parenhimu.
Be sure to tell your doctor immediately if you are pregnant, think you may be pregnant, or if you are planning to become pregnant.
Svojega zdravnika nemudoma obvestite, če ste noseči, ali mislite, da ste noseči, ali če načrtujete nosečnost.
• If your doctor has told you that you have PML (progressive multifocal leukoencephalopathy).
• če vam je zdravnik povedal, da imate PML (progresivno multifokalno levkoencefalopatijo).
PML may lead to severe disability or death.
PML lahko povzroči hudo prizadetost ali smrt.
The symptoms of MS vary from patient to patient, and you may experience some or none of them.
Simptomi MS so različni pri različnih bolnikih, morda boste vi doživeli nekatere ali nobenega.
Patients should also be advised to inform their partner or caregivers about their treatment, since they may notice symptoms that the patient is not aware of.
Bolniku je treba svetovati naj svojega partnerja ali negovalca o zdravljenju obvesti, ker le-ta lahko opazi simptome, katerih se bolnik sam morda ne zaveda.
Estimates of the total natalizumab removal after 3 plasma exchanges (over a 5-8 day interval) was approximately 70-80%.
Ocenjena celotna izločitev natalizumaba po 3 zamenjavah plazme (v intervalih 5-8 dni) je bila približno 70-80 %.
Therefore, it is recommended that newborns of women exposed to the medicinal product during the third trimester of pregnancy are monitored for potential haematological abnormalities.
Zato se priporoča, da se novorojenčke žensk, ki so izpostavljene zdravilu v tretjem trimesečju nosečnosti, spremlja zaradi možnih hematoloških nenormalnosti.
The impact of plasma exchange on the restitution of lymphocyte migration and ultimately its clinical usefulness is unknown.
Vpliv zamenjave plazme na obnovitev migracije limfocitov in s tem njena klinična koristnost ni znana.
Proportion progressed1(24-week confirmation)
Delež napredovanja1 (potrditev po 24 tednih)
In clinical trials, TYSABRI approximately halved the progression of the disabling effects of MS and also decreased the number of MS attacks by about two-thirds.
Pri kliničnih preskušanjih je zdravilo TYSABRI približno prepolovilo napredovanje uničujočih učinkov MS in zmanjšalo tudi število zagonov MS za približno dve tretjini.
See section 4.8 for how to report adverse reactions
Glejte poglavje 4.8, kako poročati o neželenih učinkih.
The effect of natalizumab on newborn/infants is unknown.
Učinek natalizumaba na dojene novorojence/otroke ni znan.
If you have all three risks described above your chance of getting PML is higher.
Če imate vse tri zgoraj opisane dejavnike tveganja, so vaše možnosti, da dobite PML, večje.
However, the risk of hypersensitivity reactions should be considered for every infusion administered.
Kljub temu je treba tveganje preobčutljivostnih reakcij upoštevati pri vsaki dani infuziji.
TYSABRI is used to treat multiple sclerosis (MS).
Zdravilo TYSABRI se uporablja za zdravljenje multiple skleroze (MS).
• The symptoms of PML may be similar to an MS relapse (e.g. weakness or visual changes).
• Simptomi PML so lahko podobni simptomom recidiva MS (npr. šibkost ali spremembe vida).
A “non-responder” could also be defined as a patient with an unchanged or increased relapse rate or ongoing severe relapses, as compared to the previous year.
»Neodzivni bolnik« je lahko tudi bolnik z nespremenjenim ali povečanim številom recidivov ali neprestanimi hudimi recidivi, v primerjavi s prejšnjim letom.
This active ingredient is called a monoclonal antibody.
Ta zdravilna učinkovina se imenuje monoklonsko protitelo.
Relapses in previous 12 months, median (range)
Recidivi v preteklih 12 mesecih, mediana (razpon)
These liver injuries may occur at any time during treatment, even after the first dose.
Do okvare jeter lahko pride kadar koli med zdravljenjem, tudi po prvem odmerku.
The effect of natalizumab on reproduction was evaluated in 5 studies, 3 in guinea pigs and 2 in cynomolgus monkeys.
Učinek natalizumaba na razmnoževanje so ocenili v 5 študijah, 3 na budrah in 2 na opicah cynomolgus.
Each vial is for single-use only.
Vsaka viala je samo za enkratno uporabo.
Symptoms might arise that you might not become aware of by yourself, such as changes in mood or behaviour, memory lapses, speech and communication difficulties, which your doctor may need to investigate further to rule out PML.
Le-ta lahko opazi simptome, katerih se sami morda ne zavedate, kot so spremembe v razpoloženju ali vedenju, izguba spomina, težave z govorom in komuniciranjem, ki jih mora zdravnik podrobneje raziskati, da izključi PML.
The interaction between α4β1 and its targets is an important component of pathological inflammation in the brain and disruption of these interactions leads to reduced inflammation.
Interakcija med α4β1 in njegovimi tarčami je pomembna komponenta patološkega vnetja v možganih, zato prekinitev te interakcije zmanjša vnetje.
• That the aim of the treatment initiation form is to provide patients with information on PML and IRIS
• da je namen obrazca za začetek zdravljenja posredovati bolnikom informacije o PML in IRIS
Anaphylactic/anaphylactoid reactions occurred in less than 1% of patients receiving TYSABRI.
Anafilaktična/anafilaktoidna reakcija se je pojavila pri manj kot 1 % bolnikov, ki so prejemali zdravilo TYSABRI.
The majority of patients did not interrupt natalizumab therapy during infections and recovery occurred with appropriate treatment.
Večina bolnikov med okužbami ni prekinila zdravljenja z natalizumabom in je z ustreznim zdravljenjem okrevala.
Known active malignancies, except for patients with cutaneous basal cell carcinoma.
Znane aktivne maligne tvorbe razen pri bolnikih z bazocelularnim karcinomom kože.