natgillin/translations-raw huggingface dataset:
PHARMACEUTICAL FORM [To be completed nationally] <[Saroten and associated names 50 mg film-coated tablets] The tablet can be divided into 4 equal doses.>
<[Saroten in povezana imena 50 mg filmsko obložene tablete] Tableta se lahko deli na 4 enake odmerke.>
• medicine to treat high blood pressure for example calcium-channel blockers (e.g. diltiazem and verapamil), guanethidine, betanidine, clonidine reserpine and methyldopa
diltiazem in verapamil), gvanetidin, betanidin, klonidin, reserpin in metildopa
Your doctor will advise you whether to start/continue/stop breast-feeding, or stop using this medicine taking into account the benefit of breast-feeding for your child and the benefit of therapy for you.
Glede na razmerje med koristmi dojenja za vašega otroka in koristmi zdravljenja za vas vam bo zdravnik svetoval, ali naj začnete/nadaljujete/prenehate z dojenjem ali pa prenehate uporabljati to zdravilo.
Neuropathic pain, prophylactic treatment of chronic tension type headache and prophylactic treatment of migraine prophylaxis
Nevropatska bolečina, preprečevanje kroničnega glavobola tenzijskega tipa in preprečevanje migrene
Potential for amitriptyline to affect other medicinal products Contraindicated combinations
4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Možnost vpliva amitriptilina na delovanje drugih zdravil Kontraindicirane kombinacije
The duration of treatment is decided by your doctor.
Zdravnik se bo odločil, kako dolgo bo trajalo zdravljenje.
The dose may be increased depending on individual patient response and tolerability.
Glede na odziv posameznega bolnika in prenašanje zdravila, se odmerek lahko povečuje.
• shakiness of hands or other body parts
• zaspanost/dremavost • tresenje rok ali drugih delov telesa
Dose increase
Priporočeni odmerek
• fatigue
• omotico
Elderly (above 65 years of age) and patients with cardiovascular disease The recommended initial dose is 25 mg in the evening.
Starejši (stari več kot 65 let) in bolniki s srčno-žilno boleznijo Priporočeni začetni odmerek je 25 mg zvečer.
Elderly patients over 65 years of age and patients with cardiovascular disease Initially 25 mg in the evening.
Starejši bolniki, stari več kot 65 let in bolniki s srčno-žilno boleznijo Začetni odmerek je 25 mg zvečer.
Recommended doses are 25 mg - 75 mg daily in the evening.
Priporočeni odmerki so 25 mg - 75 mg na dan zvečer.
Elderly patients over 65 years of age and patients with cardiovascular disease Initially 10 mg - 25 mg daily.
Starejši bolniki, stari več kot 65 let in bolniki s srčno-žilno boleznijo Začetni odmerek je10 mg - 25 mg.
<[Saroten and associated names prolonged-release capsules, hard ] Excipients
<[Saroten in povezana imena trde kapsule s podaljšanim sproščanjem]
• thyroid medication.
• zdravila za zdravljenje bolezni ščitnice.
Very common Weight increased.
a so dosti bolj šibki.
• Chronic tension type headache prophylaxis in adults
• nevropatske bolečine pri odraslih • preprečevanje kroničnega glavobola tenzijskega tipa pri odraslih
If a dose of X is missed Make a new appointment for an injection with your physician.
metabolna acidoza, hipokaliemija Če je bil odmerek zdravila X izpuščen Z zdravnikom se dogovorite za nov datum za injiciranje zdravila.
STATEMENT OF ACTIVE SUBSTANCE(S)
NAVEDBA ENE ALI VEČ UČINKOVIN [izpolni država članica]
Adults The recommended initial dose is 10 mg - 25 mg in the evening.
Priporočeni začetni odmerek je 10 mg - 25 mg zvečer.
• Migraine prophylaxis
• preprečevanje migrene
Elderly patients over 65 years of age and patients with cardiovascular disease A starting dose of 10 mg - 25 mg in the evening is recommended.
Starejši bolniki, stari več kot 65 let in bolniki s srčno-žilno boleznijo Priporočeni začetni odmerek je 10 mg - 25 mg zvečer.
e.g.:
EKG).
What X contains
Zdravilo X vsebuje natrij
Cardiac symptoms: Arrhythmias (ventricular tachyarrhythmias, torsade de pointes, ventricular fibrillation).
Srčni simptomi: aritmije (ventrikularne tahiaritmije, torsade de pointes, ventrikularna fibrilacija), na EKG se vidi značilno podaljšanje intervala PR, razširitev kompleksa QRS, podaljšanje intervala QT,
Elderly (above 65 years of age) and patients with cardiovascular disease The recommended initial dose is 10 mg - 25 mg in the evening.
Starejši (stari več kot 65 let) in bolniki s srčno-žilno boleznijo Priporočeni začetni odmerek je 10 mg - 25 mg zvečer.
Depending on your response to the medicine, your doctor may increase the dose to 100 mg.
Glede na vaš odziv na zdravilo lahko zdravnik odmerek postopno poveča do 100 mg zvečer.
Dosage should be initiated at a low level and increased gradually, noting carefully the clinical response and any evidence of intolerability.
Pri tem je treba skrbno spremljati klinični odziv in znake morebitnega neprenašanja zdravila.
Amitriptyline
OVOJNINAH AMPULA
The effects in overdose will be potentiated by simultaneous ingestion of alcohol and other psychotropic.
Sočasno uživanje alkohola in drugih psihotropnih snovi okrepi učinke prevelikega odmerka.
Reproductive system and breast disorders
Organski sistemi po MedDRA
Carton/Label
PODATKI V BRAILLOVI PISAVI
• the prophylactic treatment of chronic tension type headache (CTTH) in adults
• preprečevanje kroničnega glavobola tenzijskega tipa pri odraslih • preprečevanje migrene pri odraslih
This product information is the outcome of the referral procedure to which this Commission decision relates.
Te spremembe zadevnih poglavij povzetka glavnih značilnosti zdravila in navodila za uporabo so izid postopka arbitraže.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI Škatla/nalepka
Micturition disorders.
- Navodilo shranite.
MARKETING AUTHORISATION NUMBER(S) [To be completed nationally] BATCH NUMBER
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM
PHARMACEUTICAL FORM [To be completed nationally] <[Saroten and associated names 75 mg, modified release tablets] The tablet can be divided into 3 equal doses .>
<[Saroten in povezana imena 75 mg tablete s prirejenim sproščanjem] Tableta se lahko deli na 3 enake odmerke.>
Weakened patients with cerebral or cardiac impairment, as well as patients with poor circulation, breathing problems, impaired liver function or advanced renal impairment a dose reduction is recommended.
težavami z dihanjem, okvaro jeter ali napredovalo okvaro ledvic se priporoča zmanjšanje odmerka.
• antidepressants (e.g SSRIs (fluoxetine, paroxetine, fluvoxamine), and bupropion)
• antidepresivi (npr. selektivni zaviralci ponovnega privzema serotonina (SSRI) (fluoksetin,
Common side effect, may affect up to 1 in 10 people.
Pogost neželeni učinek; pojavi se lahko pri največ 1 od 10 bolnikov.
Cardiomyopathies, torsades de pointes.
NMDA v osrednjem živčevju in hrbtenjači.
What X contains <[Saroten and associated names prolonged-release capsules, hard ] The active substance is amitriptyline.>
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo X <[Saroten in povezana imena trde kapsule s podaljšanim sproščanjem] Učinkovina je amitriptilin.> <[Saroten in povezana imena 75 mg tablete s prirejenim sproščanjem]
Antifungals such as fluconazole (CYP2C9 inhibitor) and terbinafine (CYP2D6 inhibitor) have been observed to increase serum levels of amitriptyline and nortriptyline.
(zaviralec CYP2D6), povečajo ravni amitriptilina in nortriptilina v serumu.
Heart rhythm disorders and hypotension may occur if you receive a high dosage of amitriptyline.
Če ste prejeli velike odmerke amitriptilina, se lahko pojavijo motnje srčnega ritma in hipotenzija.
Tricyclic antidepressants (TCA) including amitriptyline are primarily metabolised by the hepatic cytochrome P450 isozymes CYP2D6 and CYP2C19, which are polymorphic in the population.
CYP2D6 in CYP2C19 jetrnega citokroma P450, ki sta v populaciji polimorfna.
• the prophylactic treatment of migraine in adults
• zdravljenje hude depresije pri odraslih
Symptoms of overdose include: dilated pupils fast or irregular heartbeats difficulties passing water dry mouth and tongue intestinal blockage fits fever agitation confusion hallucinations uncontrolled movements low blood pressure, weak pulse, pallor difficulty breathing blue discolouration of the skin decreased heart rate drowsiness loss of consciousness coma various cardiac symptoms such as heart block, heart failure, hypotension, cardiogenic shock, metabolic acidosis, hypokalemia.
Srčne bolezni zelo pogosti palpitacije, tahikardija pogosti atrioventrikularni blok, kračni blok občasni kolaps, poslabšanje srčnega popuščanja redki aritmija zelo redki kardiomiopatije, torsade de pointes neznana pogostnost preobčutljivostni miokarditis
• liver function impairment (e.g. cholestatic liver disease).
• okvara jeter (npr. holestaza jeter)
• nausea
• kolaps
What X looks like and contents of the pack [To be completed nationally].
Izgled zdravila X in vsebina pakiranja
Saroten and associated names is indicated for: • the treatment of major depressive disorder in adults
Učinkovitost in varnost amitriptilina je bila dokazana pri zdravljenju naslednjih indikacij pri odraslih: • huda depresija
Uncommon Hepatic impairment (e.g. cholestatic liver disease).
Bolezni jeter, žolčnika in žolčevodov občasni okvara jeter (npr. holestaza jeter)
The CYP3A4 and CYP1A2 isozymes metabolise amitriptyline to a lesser extent.
Amitriptilin se v manjši meri presnavlja z izoencimoma CYP3A4 in CYP1A2.
This medicine is used to treat:
Zdravljenje naslednjih stanj se razlikuje od primera do primera:
Ear and labyrinth disorders
Ušesne bolezni, vključno z motnjami labirinta občasni tinitus
excitement, anxiety, difficulties sleeping, nightmares convulsions tinnitus increased blood pressure diarrhoea, vomiting skin rash, nettle rash (urticarial), swelling of the face and tongue difficulties passing urine increased production of breast milk or breast milk outflow without breast feeding increased pressure in the eye ball collapse conditions worsening of cardiac failure liver function impairment (e.g. cholestatic liver disease)
Psihiatrične motnje zelo pogosti agresivnost pogosti stanje zmedenosti, zmanjšan libido, agitacija občasni hipomanija, manija, anksioznost, nespečnost, nočne more redki delirij (pri starejših bolnikih), halucinacije (pri bolnikih s shizofrenijo), samomorilne misli ali vedenje*
Rare: may affect up to 1 in 1,000 people decreased appetite delirium (especially in elderly patients), hallucinations (especially in patients with schizophrenia), abnormality in the heart's rhythm, or heartbeat pattern swelling of the salivary glands hair loss increased sensitivity to sunlight breast enlargement in men fever weight loss abnormal results of liver function tests
Psihiatrične motnje zelo pogosti agresivnost pogosti stanje zmedenosti, zmanjšan libido občasni hipomanija, manija, anksioznost, nespečnost, nočne more redki delirij (pri starejših bolnikih), halucinacije (pri bolnikih s shizofrenijo), samomorilne misli ali vedenje*
Give 50 g of charcoal if within one hour of ingestion.
V prvi uri po zaužitju se da 50 g aktivnega oglja.
• absent sensation of appetite
• zmanjšanje apetita
What you need to know before you take X
Kaj je zdravilo X in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo X Kako jemati zdravilo X
Uncommon Collapse conditions, worsening of cardiac failure.
Samomorilne misli in poslabšanje depresije
Treatment 1.
dostopa.
Neuropathic pain, chronic tension type headache and migraine prophylaxis It might take a few weeks before your feel any improvement of your pain.
Nevropatska bolečina, preprečevanje kroničnega glavobola tenzijskega tipa in preprečevanje migrene pri odraslih Pri vsakem posameznem bolniku je treba odmerek titrirati do odmerka, ki zagotavlja ustrezno analgezijo z neželenimi učinki na zdravilo, ki jih še lahko prenaša.
• methylphenidate (used to treat ADHD)
• metilfenidat (uporablja se za zdravljenje motnje pomanjkanja pozornosti s hiperaktivnostjo (ADHD))
• children aged 6 to 10 years: 10 mg - 20 mg. A suitable dosage form should be used for this age group.
• otroci, stari od 6 do 10 let: 10 mg - 20 mg.
It is important that you read this card carefully.
Pomembno je, da kartico natančno preberete.
1 PRAC recommendations issued on 11 February 2016
1 Priporočila odbora PRAC, izdana 11. februarja 2016
Tysabri was authorised in the European Union in June 2006.
Zdravilo Tysabri je bilo v Evropski uniji odobreno junija 2006.
Healthcare professionals should follow these recommendations:
Zdravstveni delavci naj sledijo naslednjim priporočilom:
• If you have any questions or concerns, speak to your doctor, nurse or pharmacist.
• Če imate dodatna vprašanja ali pomisleke, se posvetujte z zdravnikom, medicinsko sestro ali farmacevtom.
The review of Tysabri was initiated on 7 May 2015 at the request of the European Commission, under Article 20 of Regulation (EC) No 726/2004.
Pregled zdravila Tysabri se je pričel 7. maja 2015 na zahtevo Evropske komisije v skladu s členom 20 Uredbe (ES) št. 726/2004.
Keep this card with you and make sure your partner or carer is aware of its content.
Kartico hranite in poskrbite, da vaš partner oz. negovalec pozna njeno vsebino.
Index 0.9 or less
Indeks 0,9 ali manj
• have been treated with Tysabri for more than 2 years, and
• so se več kot 2 leti zdravili z zdravilom Tysabri, in
No index value
Brez indeksne vrednosti
Considering these factors, your doctor will be able to advise you about your risk of developing PML.
Ob upoštevanju teh dejavnikov vam bo zdravnik svetoval glede vašega tveganja za razvoj PML.
In these patients, treatment with Tysabri should only be continued if benefits outweigh the risks.
Pri teh bolnikih je treba zdravljenje z zdravilom Tysabri nadaljevati le, če so koristi večje od tveganj.
PML is a rare brain infection caused by John Cunningham (JC) virus.
PML je redka možganska okužba, ki jo povzroča virus Johna Cunninghama (JC).
Your doctor will also check for signs and symptoms suggestive of PML.
Vaš zdravnik bo tudi preveril, ali so prisotni znaki in simptomi, ki kažejo na PML.
New recommendations have been issued which may help early detection of PML and improve patients' outcomes.
Izdana so bila nova priporočila, ki lahko pomagajo pri zgodnjem odkrivanju PML in izboljšajo bolnikovo prognozo.
EMA's recommendations are based on an initial review by its Pharmacovigilance Risk Assessment Committee (PRAC).
Priporočila agencije EMA temeljijo na začetnem pregledu, ki ga je opravil Odbor za oceno tveganja na področju farmakovigilance (PRAC).
In light of the new evidence, patients are considered at higher risk of developing PML if they:
Ob upoštevanju novih podatkov se šteje, da so bolniki s povečanim tveganjem za razvoj PML, če:
This protein is found on the surface of most leucocytes (the white cells in the blood that are involved in the inflammation process).
Ta se nahaja na površini večine levkocitov (belih krvnih celic v krvi, ki sodelujejo pri vnetju).
The CHMP's opinion was then sent to the European Commission, which issued a legally-binding decision valid throughout the EU.
Mnenje odbora CHMP je bilo nato poslano Evropski komisiji, ki je izdala pravno zavezujočo odločbo, ki je veljavna v vsej EU.
Patients should be instructed to seek medical advice if they think their disease is getting worse, or if they notice any new or unusual symptoms.
Bolnike je treba poučiti, naj v primeru slabšanja bolezni, ali kadar opazijo nov ali nenavaden simptom, poiščejo medicinsko pomoč.
It is used when the disease has failed to respond to treatment with a beta-interferon or glatiramer acetate (other types of medicines used in MS), or is severe and getting worse rapidly.
Uporablja se, kadar se bolezen ne odzove na zdravljenje z beta-interferonom in glatiramer acetatom (drugima vrstama zdravil za zdravljenje multiple skleroze), ali kadar je bolezen resna in se hitro poslabšuje.
The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States on 25/04/2016.
Mnenje odbora CHMP je bilo posredovano Evropski komisiji, ki je dne 25/04/2016 izdala končno pravno zavezujočo odločbo, ki velja za vse države članice EU.
The most common symptoms of PML are progressive weakness, speech and communication difficulties, vision changes, and sometimes changes in mood or behaviour.
Najpogostejši simptomi PML so napredujoča šibkost, težave pri govoru in komuniciranju, spremembe vida in včasih spremembe razpoloženja ali vedenja.
• Anti-JC virus antibody testing should be done every 6 months in antibody-negative patients.
• Testiranje na protitelesa proti virusu JC je treba pri bolnikih, ki so na protitelesa negativni, izvesti vsakih 6 mesecev.
Prior use of immunosuppressants
Predhodna uporaba imunosupresivov
If you believe your disease is getting worse or if you notice any new or unusual symptoms while using Tysabri and for up to 6 months after stopping Tysabri, speak to your doctor as soon as possible.
Če menite, da se vaša bolezen slabša, ali če pri jemanju zdravila Tysabri ali do 6 mesecev po prenehanju jemanja, opazite nove ali nenavadne simptome, se čim prej pogovorite s svojim zdravnikom.
• have tested positive for JC virus, and
• so bili njihovi testi za virus JC pozitivni,
On 25 February 2016, EMA completed its review of the known risk of progressive multifocal leukoencephalopathy (PML) with the multiple sclerosis medicine Tysabri (natalizumab), and confirmed initial recommendations1 aimed at minimising this risk.
Dne 25. februarja 2016 je agencija EMA zaključila pregled znanega tveganja za progresivno multifokalno levkoencefalopatijo (PML) pri uporabi zdravila Tysabri (natalizumab) za spreminjanje poteka multiple skleroze in potrdila začetna priporočila1, namenjena zmanjševanju tveganja.
• Symptoms of PML may be similar to those of a multiple sclerosis attack, and include progressive weakness, speech and communication difficulties, vision problems, and sometimes changes in mood or behaviour.
• Simptomi PML so lahko podobni simptomom napada multiple skleroze, in obsegajo napredujočo šibkost, težave pri govoru in komuniciranju, težave z vidom in včasih spremembo vedenja ali razpoloženja.
2 PML risk estimates were derived using the life table method based on the pooled cohort of 21,696 patients who participated in the STRATIFY-2, TOP, TYGRIS, and STRATA clinical studies.
Ocene tveganja za PML so bile izdelane po metodi življenjske preglednice na osnovi kohorte 21 696 bolnikov, ki so sodelovali v kliničnih raziskavah STRATIFY-2, TOP, TYGRIS in STRATA.
EMA confirms recommendations to minimise risk of brain infection PML with Tysabri
EMA potrjuje priporočila za zmanjševanje tveganja za možgansko okužbo PML pri uporabi zdravila Tysabri
Tysabri is a medicine used to treat adults with highly active multiple sclerosis (MS), a disease of the nerves in which inflammation destroys the protective sheath surrounding the nerve cells.
Zdravilo Tysabri je zdravilo, ki se uporablja za zdravljenje odraslih z zelo aktivno multiplo sklerozo (MS), boleznijo živcev, pri kateri vnetje uniči zaščitno ovojnico, ki obdaja živčne celice.
No prior use of immunosuppressants
Brez predhodne uporabe imunosupresivov
The PRAC recommendations were sent to the Committee for Medicinal Products for Human Use (CHMP), which confirmed them and adopted its final opinion.
Priporočila odbora PRAC so bila poslana Odboru za zdravila za uporabo v humani medicini (CHMP), ki jih je potrdil in sprejel svoje končno mnenje.
• Your risk of PML depends on several factors, such as whether you have antibodies against JC virus in your blood (a sign that you have been exposed to the virus that causes PML) and what their level is, how long you have been treated with Tysabri, and whether or not you were treated with medicines that suppress your immune system before starting Tysabri.
• Vaše tveganje za PML je odvisno od več dejavnikov, med drugim od tega, ali imate v krvi protitelesa proti virusu JC (znak, da ste bili izpostavljeni virusu, ki povzroča PML) in kolikšna je njihova raven, kako dolgo ste se zdravili z zdravilom Tysabri in ali ste se pred začetkom jemanja zdravila Tysabri zdravili z zdravili, ki zavirajo vaš imunski sistem.
• More information about the risk of PML with Tysabri is included in the Patient Alert Card you have been given by your doctor.
• Več informacij o tveganju za PML pri zdravilu Tysabri je vključenih na opozorilni kartici, ki vam jo je dal vaš zdravnik.
The updated risk estimates above show that the risk of developing PML is small, and lower than previously estimated, at antibody index values of 0.9 or less, and increases substantially in patients with index values above 1.5 who have been treated with Tysabri for longer than 2 years.
Navedene posodobljene ocene tveganja kažejo, da je tveganje za razvoj PML majhno in manjše od pričakovanega, z vrednostmi protitelesnega indeksa 0,9 ali manj, in z bistvenimi povečanji pri bolnikih z indeksnimi vrednostmi nad 1,5, ki se z zdravilom Tysabri zdravijo več kot 2 leti.
In patients who tested negative for JC virus antibodies, the PML risk estimate remains unchanged at 0.1 per 1,000 patients.
Pri bolnikih, pri katerih so bili testi za protitelesa proti virusu JC negativni, ostaja tveganje za PML nespremenjeno pri 0,1 od 1 000 bolnikov.
More detailed information on the risk stratification, diagnosis and treatment of PML will be included in the updated Physician Information and Management Guidelines for Tysabri.
Več podatkov o stratifikaciji tveganja, diagnozi in zdravljenju PML bo vključenih v posodobljenih Informacijah za zdravnike in smernicah za ravnanje z zdravilom Tysabri.
• During treatment with Tysabri, patients should be monitored at regular intervals for signs and symptoms of new neurological dysfunction, and a full brain MRI should be performed at least once a year for the duration of treatment.
• Med zdravljenjem z zdravilom Tysabri je treba bolnike redno spremljati za pojavljanje znakov in simptomov nove nevrološke disfunkcije, v času zdravljenja pa je treba vsaj enkrat letno izvesti tudi MRS celotnih možganov.
• PML should be considered in the differential diagnosis of any patient presenting with neurological symptoms and/or new brain lesions on MRI.
• PML je treba upoštevati v diferencialni diagnozi pri vsakem bolniku z nevrološkimi simptomi oz. novimi možganskimi lezijami pri MRS.
The active substance in Tysabri, natalizumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to a specific part of a protein called ‘α4β1 integrin'.
Zdravilna učinkovina zdravila Tysabri, natalizumab, je monoklonsko protitelo (vrsta beljakovine), zasnovano za prepoznavo in vezavo na specifičen del beljakovine α4β1-integrin.
• Before starting treatment with Tysabri, patients and carers should be advised about the risk of PML.
• Pred začetkom zdravljenja z zdravilom Tysabri je treba bolnike in negovalce seznaniti s tveganjem za PML.
The PRAC recommendations were then sent to the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which adopted the Agency's final opinion.
Priporočila odbora PRAC so bila poslana Odboru za zdravila za uporabo v humani medicini (CHMP), odgovornemu za vprašanja glede zdravil za uporabo v humani medicini, ki je sprejel končno mnenje agencije.
By attaching to the integrin, natalizumab stops the leucocytes from going from the blood into the brain, thereby reducing the inflammation and nerve damage caused by MS.
Natalizumab z vezavo na integrin levkocitom prepreči prehod iz krvi v možgane in s tem zmanjša vnetje in okvaro živcev, ki jo povzroča multipla skleroza.
• Progressive multifocal leukoencephalopathy (PML, a serious brain infection) is known to be an uncommon risk with the multiple sclerosis medicine Tysabri.
• Progresivna multifokalna levkoencefalopatija (PML, resna možganska okužba) je pri zdravilu za spreminjanje poteka multiple skleroze Tysabri redko tveganje.
• either have used an immunosuppressant before starting Tysabri, or have not used immunosuppressants and have a high JC virus antibody index.
• so jemali imunosupresiv pred začetkom zdravljenja z zdravilom Tysabri ali pa imunosupresivov niso jemali in imajo visok indeks protiteles proti virusu JC.