natgillin/translations-raw huggingface dataset:
Palonosetron was non-inferior versus the comparators in the acute phase of emesis both in moderately and highly emetogenic setting.
Palonosetron je bil v akutni fazi bruhanja enako učinkovit, tako pri zmerno kot visoko emetogeni kemoterapiji, kot primerjana zdravila.
Common: may affect up to 1 in 10 people
Pogosti: lahko se pojavijo pri največ 1 od 10 ljudi:
Talk to your doctor or nurse before you are given Aloxi if:
Pred začetkom prejemanja zdravila Aloxi se posvetujte z zdravnikom ali medicinsko sestro, če:
Urinary retention, glycosuria
Bolezni sečil retenca urina, glikozurija
No dosage adjustment is necessary based on gender.
Odmerka glede na spol bolnika ni potrebno prilagajati.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Aloxi 250 micrograms solution for injection
IME ZDRAVILA IN POT(I) UPORABE Aloxi 250 mikrogramov raztopina za injiciranje palonosetron
A lower bound greater that -15 % demonstrates noninferiority between Aloxi oral and comparator Aloxi intravenous c
Spodnja meja, višja od -15 %, dokazuje ne manjvrednost peroralnega zdravila Aloxi proti primerjanemu intravenskemu zdravilu Aloxi.
• the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy.
• preprečevanje slabosti in bruhanja, povezanih z zmerno emetogenimi kemoterapijami pri zdravljenju raka.
t½, hours
AUC0-∞, h·µg/l t½, ure
Single-dose i.v.
Farmakokinetične podatke o enkratnem odmerku i.v.
Anxiety, euphoric mood
Psihiatrične motnje anksioznost, evforija
No dosage adjustment is necessary in elderly patients.
Pri starejših bolnikih prilagajanje odmerka ni potrebno.
Aloxi contains the active substance palonosetron.
Zdravilo Aloxi vsebuje učinkovino palonosetron.
Palonosetron does not inhibit or induce cytochrome P450 isoenzymes at clinically relevant concentrations.
Palonosetron pri klinično pomembnih koncentracijah ne inhibira ali inducira citokrom P450 izoencimov.
Plain, light beige, opaque, round to oval, soft gelatine capsules, filled with a clear yellowish solution.
Neoznačene, svetlo sivkastorjave, neprozorne, okrogle do ovalne, mehke želatinske kapsule,
NAME OF THE MARKETING AUTHORISATION HOLDER Helsinn
IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Helsinn
No dose adjustment is necessary for the elderly.
Starejši ljudje Odmerjanja pri starejših ni potrebno prilagoditi.
You may feel dizzy or tired after taking this medicine.
Ko vzamete to zdravilo, se boste morda počutili omotične ali utrujene.
Aloxi Intravenous 250 micrograms (n=162)
Intravensko zdravilo Aloxi 250 mikrogramov (n=162)
Blood bilirubin increased
Preiskave zvišan bilirubin v krvi
Aloxi 250 micrograms solution for injection Palonosetron
Navodilo za uporabo Aloxi 250 mikrogramov raztopina za injiciranje palonosetron
Serotonergic Drugs (e.g. SSRIs and SNRIs) There have been reports of serotonin syndrome following concomitant use of 5-HT3 antagonists and other serotonergic drugs (including SSRIs and SNRIs).
Po sočasni uporabi antagonistov serotoninskih 5-HT3 receptorjev in drugih serotoninergičnih zdravil (vključno z SSRI in SNRI) so poročali o serotoninskem sindromu.
Glycerol Monocaprylocaproate (type I) Polyglycerol oleate
Vsebina kapsule: glicerol monokaprilat monokaprinat (tip I), poliglicerol oleat, glicerol,
Each vial of 5 ml of solution contains 250 micrograms palonosetron (as hydrochloride).
Ena viala (5 mililitrov raztopine) vsebuje 250 mikrogramov palonosetrona (v obliki palonosetronijevega klorida).
The study demonstrated no effect on QT/QTc interval duration as well as any other ECG interval at doses up to 2.25 mg. No clinically significant changes were shown on heart rate, atrioventricular (AV) conduction and cardiac repolarization.
Študija ni pokazala nikakršnega učinka na trajanje intervala QT/QTc ali na kakšen drug EKG interval v odmerkih do 2,25 mg.
Uncommon: may affect up to 1 in 100 people
Občasni: lahko se pojavijo pri največ 1 od 100 ljudi:
In a randomised, double-blind study with a total of 667 patients receiving highly emetogenic chemotherapy that included cisplatin ≥ 60 mg/m2, cyclophosphamide > 1,500 mg/m2 and dacarbazine,
V randomizirani, dvojno slepi študiji, v kateri je sodelovalo 667 bolnikov, ki so prejemali visoko emetogeno kemoterapijo, ki je vključevala cisplatin >60 mg/m2, ciklofosfamid >1500 mg/m2 in dakarbazin, so primerjali odmerka 250 mikrogramov in 750 mikrogramov palonosetrona v primerjavi z ondansetronom 32 mg, danim prvi dan kemoterapije.
NAME OF THE MEDICINAL PRODUCT Aloxi 250 micrograms solution for injection Palonosetron (as hydrochloride)
Aloxi 250 mikrogramov raztopina za injiciranje palonosetron (v obliki palonosetronijevega klorida)
Capsule content:
Pomožne snovi:
Eye irritation, amblyopia
Očesne bolezni draženje oči, ambliopija
Each capsule contains 500 micrograms palonosetron (as hydrochloride).
Ena kapsula vsebuje 500 mikrogramov palonosetrona (v obliki palonosetronijevega klorida).
Based on in vitro studies, palonosetron does not inhibit or induce cytochrome P450 isoenzyme at clinically relevant concentrations.
Glede na in vitro raziskave, palonosetron v klinično pomembnih koncentracijah ne inhibira ali inducira izoencima citokrom P450.
Disodium edetate
PRETISNI OMOT
• Single use only, any unused solution should be disposed of.
• Za enkratno uporabo, vso preostalo raztopino zavrzite.
In 36 healthy male and female subjects given a single oral dose of palonosetron capsules 500 micrograms, maximum plasma palonosetron concentration (Cmax) was 0.81 ± 0.17 ng/ml (mean ± SD) and time to maximum concentration (Tmax) was 5.1 ± 1.7 hours.
Pri 36 zdravih osebah obeh spolov, ki so prejele enkraten peroralni odmerek palonosetrona v obliki 500-mikrogramskih kapsul, je bila najvišja koncentracija palonosetrona v plazmi (Cmax) 0,81 ±
What Aloxi contains
Kaj vsebuje zdravilo Aloxi
a Intent-to-treat cohort.
Kohorta z namenom zdravljenja.
• constipation, diarrhoea.
• zaprtje, driska.
° From post-marketing experience
°Iz izkušenj po prihodu zdravila na trg.
After a single-dose of approximately 0.75 mg intravenous palonosetron, the total body clearance of palonosetron in healthy subjects was 160 ± 35 ml/h/kg (mean ± SD) and renal clearance was 66.5 ± 18.2 ml/h/kg.
Po enkratnem odmerku približno 0,75 mg intravenskega palonosetrona je bil celotni telesni očistek palonosetrona pri zdravih preiskovancih 160
A single-dose of 250 mcg, 500 mcg, or 750 mcg oral palonosetron capsules given one hour prior to moderately emetogenic chemotherapy was compared to a single-dose of 250 mcg intravenous Aloxi given 30 minutes prior to chemotherapy.
V multicentrični, randomizirani, dvojno slepi klinični študiji z aktivnimi kontrolami, v kateri je sodelovalo 635 bolnikov, ki naj bi dobili zmerno emetogeno kemoterapijo raka, so primerjali enkraten odmerek peroralnih kapsul palonosetrona 250 mikrogramov, 500 mikrogramov in 750 mikrogramov, eno uro pred zmerno emetogeno kemoterapijo, z enkratnim odmerkom 250 mikrogramov zdravila Aloxi, danega intravensko 30 minut pred kemoterapijo.
Cardiac disorders
Kortikosteroidi
Other side effects Tell your doctor if you notice any of the following side effects:
Obvestite zdravnika, če opazite katerega koli od naslednjih neželenih učinkov:
Sodium citrate
OVOJNINAH VIALA
Two cases of constipation with faecal impaction requiring hospitalisation have been reported in association with palonosetron 750 micrograms.
V povezavi z jemanjem palonosetrona 750 mikrogramov so poročali o dveh primerih s konstipacijo in zaprtjem z blatom, ki sta potrebovala hospitalizacijo.
Chemotherapeutic agents
Kemoterapevtiki
Nervous system disorders Headache Dizziness
Bolezni živčevja glavobol omotica, diskinezija
NAME OF THE MEDICINAL PRODUCT Aloxi 250 micrograms solution for injection.
IME ZDRAVILA Aloxi 250 mikrogramov raztopina za injiciranje
Dyspepsia, abdominal pain, abdominal pain upper, dry mouth, flatulence
Bolezni prebavil zaprtje driska dispepsija, bolečine v trebuhu, bolečine v zgornjem delu trebuha, suha usta, napihnjenost
Purified water
• oteženo odvajanje vode,
ANNEX II A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RETRICTIONS REGARDING SUPPLY AND USE
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA
Injection site reaction*
reakcija na mestu infuzije,
Table 1: Percentage of patients a responding by treatment group and phase in the Moderately
Preglednica 1: Odstotek bolnikova, ki reagirajo na zdravljenje, glede na vrsto zdravljenja in stopnjo zdravljenja v študiji zmerno emetogene kemoterapije v primerjavi z ondansetronom
MARKETING AUTHORISATION NUMBER(S) EU/1/04/306/001
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/04/306/003
Very rare: may affect up to 1 in 10,000 people • Burning, pain or redness at the injection site
Pogosti: lahko se pojavijo pri največ 1 od 10 ljudi: • glavobol.
MARKETING AUTHORISATION NUMBER(S) EU/1/04/306/002
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/04/306/002
You may feel dizzy or tired after being given this medicine.
Ko dobite to zdravilo, se boste morda počutili omotične ali utrujene.
Paediatric patients
Pediatrični bolniki z rakoma
No dose adjustment is necessary for patients with impaired hepatic function.
Jetrna okvara Pri bolnikih z jetrno okvaro odmerjanja ni potrebno prilagajati.
No dosage adjustment is necessary in patients with renal insufficiency.
Pri bolnikih z ledvično insuficienco ni potrebno prilagajati odmerka.
Following intravenous administration of palonosetron 0.25 mg once every other day for 3 doses in 11 testicular cancer patients, the mean (± SD) increase in plasma concentration from Day 1 to Day 5 was 42 ± 34 %.
bolnikih z rakom mod koncentracija v plazmi od 1. do 5. dne povprečno (± SD) zrasla za 42 ± 34 %.
PC:
vrednost pc
• shortness of breath
• slabost s siljenjem na bruhanje,
If you get any side effects, talk to your doctor or pharmacist.
Če ste negotovi, se posvetujte s svojim zdravnikom ali farmacevtom.
Table 3: Percentage of patients a responding by treatment group and phase in the Highly Emetogenic Chemotherapy study versus ondansetron Aloxi 250 micrograms (n= 223)
Preglednica 3: Odstotek bolnikova, ki reagirajo na zdravljenje, glede na vrsto zdravljenja in stopnjo zdravljenja v študiji visoko emetogene kemoterapije v primerjavi z ondansetronom
No dose adjustment is necessary for patients with impaired renal function.
Pri bolnikih z ledvično okvaro odmerjanja ni potrebno prilagajati.
Ask your doctor or pharmacist for advice before using this medicine if you are pregnant or think you might be.
Če ste noseči ali menite, da bi lahko bili noseči, se posvetujte z zdravnikom ali farmacevtom, preden uporabite to zdravilo.
Ask your doctor or nurse for advice before being given this medicine if you are pregnant or think you might be.
Če ste noseči ali menite, da bi lahko bili noseči, se posvetujte z zdravnikom ali medicinsko sestro, preden dobite to zdravilo.
Palonosetron
Odmerjanje
QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution contains 50 micrograms palonosetron (as hydrochloride).
En ml raztopine vsebuje 50 mikrogramov palonosetrona (v obliki palonosetronijevega klorida).
Package leaflet: Information for the patient
Shranjevanje zdravila Aloxi Vsebina pakiranja in dodatne informacije
Children and young people Common: may affect up to 1 in 10 people
Zelo redki: lahko se pojavijo pri največ 1 od 10.000 ljudi:
• motion sickness
• omotica,
Arthralgia
Plodnost
Skin and subcutaneous tissue disorders
Bolezni kože in podkožja alergični dermatitis, srbeč izpuščaj
The safety and efficacy of Palonosetron i.v at single doses of 3µg/kg and 10µg/kg was investigated in the first clinical study in 72 patients in the following age groups, >28 days to 23 months (12 patients), 2 to 11 years (31 patients), and 12 to 17 years of age (29 patients), receiving highly or moderately emetogenic chemotherapy.
pri enojnem odmerku 3 µg/kg in 10 µg/kg so raziskovali v prvi klinični študiji z 72 bolniki v naslednjih starostnih skupinah: >28 dni do 23 mesecev
QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 500 micrograms palonosetron (as hydrochloride).
Ena kapsula vsebuje 500 mikrogramov palonosetrona (v obliki klorida).
For how long?
Kako dolgo?
82.7% of these patients completed the study.
82,7 % teh bolnikov je dokončalo študijo.
It has not been determined whether they respond differently than younger patients.
Ni bilo ugotovljeno, ali se odzivajo drugače kot mlajši bolniki.
When?
Kdaj?
Each vial is intended for single use only.
Vsaka viala je namenjena samo enkratni uporabi.
However, in some cases ITP developed years later.
Vendar se je v nekaterih primerih ITP razvila leta kasneje.
Occasionally allergic reactions could occur.
Občasno se lahko pojavijo alergijske reakcije.
Classical biotransformation studies have not been conducted.
Klasičnih študij biotransformacije niso izvedli.
• Procedures for proper handling and disposal should be observed.
• Upoštevajte postopke pravilnega ravnanja in odstranjevanja.
It is important you understand these risks and how to monitor for them.
Pomembno je, da razumete ta tveganja in načine spremljanja njihove prisotnosti.
Not known (frequency cannot be estimated from the available data):
Neznana pogostnost (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov):
Therefore, it is important to tell your doctor about all medicines you are taking.
Zato je pomembno, da zdravniku navedete vsa zdravila, ki jih jemljete.
However, these changes did not affect fertility and were therefore considered to be non-adverse.
Vendar te spremembe niso vplivale na plodnost, zato se štejejo za neškodljive.
Two treatment courses may reduce MS activity for up to 6 years.
Dva postopka zdravljenja lahko zmanjšata aktivnost MS za do 6 let.
The maximum daily dose is one infusion.
Največji dnevni odmerek je ena infuzija.
These results were obtained from a post hoc analysis and should be interpreted cautiously.
Ti rezultati so bili dobljeni s post-hoc analizo, zato jih je treba tolmačiti previdno.
Educational Materials for Healthcare Providers are also available:
Na voljo so tudi izobraževalna gradiva za zdravstvene delavce:
What is multiple sclerosis?
Kaj je multipla skleroza?
Duration of extension
Trajanje podaljšanja
3 Estimated using a mixed model for repeated measures.
3 Ocenjeno z mešanim modelom za ponavljajoče se meritve.
Summary of the safety profile in clinical studies
Povzetek varnostnega profila v kliničnih študijah
It is also possible to develop a herpes infection for the first time.
Obstaja tudi možnost, da se herpesna okužba pojavi prvič.
This may be a serious medical condition that can be life threatening.
To je lahko resno zdravstveno stanje, ki lahko ogrozi življenje.
Testing is needed even if you are feeling well and your MS symptoms are under control.
Preiskave so potrebne tudi, če se počutite dobro in so simptomi MS obvladani.
88397 Biberach an der Riss GERMANY
88397 Biberach an der Riss NEMČIJA
• decreased/weak immune system
• zmanjšan/šibek imunski sistem
The benefits and risks of 5 or more treatment courses have not been established.
Koristi in tveganja 5 ali več stopenj zdravljenja niso povsem ugotovljeni.
In addition, these conditions may occur beyond 4 years, therefore, you must continue to look for signs and symptoms, even after you no longer need to do monthly blood and urine tests.
Poleg tega se lahko te bolezni pojavijo po več kot 4 letih, zato morate še naprej ostati pozorni na njihove znake in simptome tudi potem, ko ne potrebujete več mesečnih preiskav krvi in urina.
In general, the infections can be treated with standard medicines.
Na splošno se lahko okužbe zdravijo s standardnimi zdravili.
In 79.5% of cases, ITP onset occurred within 4 years after first exposure.
V 79,5 % primerih se je ITP pojavila v 4 letih po prvi izpostavljenosti.
Chemical and physical in-use stability has been demonstrated for 8 hours at 2°C - 8°C.
Kemijska in fizikalna stabilnost med uporabo je bila dokazana za 8 ur pri 2 C - 8 C.
Recommended laboratory tests for monitoring patients
Priporočene laboratorijske preiskave za spremljanje bolnikov
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines (including any vaccinations or herbal medecines).
Obvestite svojega zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali bi lahko jemali katero koli zdravilo (vključno s cepivi ali zdravili rastlinskega izvora).
The difference was statistically significant (p=0.0002).
Razlika je bila statistično značilna (p=0,0002).
Clinical studies did not include any patients aged over 61 years old.
V klinične študije niso bili vključeni bolniki, starejši od 61 let.
As with all therapeutic proteins, there is potential for immunogenicity.
Kot pri vseh terapevtskih proteinih obstaja možnost imunogenosti.
No characteristics at study entry identified patients who would later receive one or more additional courses.
Nobena značilnost ob vstopu v raziskavo ni identificirala bolnikov, ki bi pozneje prejeli enega ali več dodatnih ciklov.
These are conditions in which your immune system mistakenly attacks your body.
To so bolezni, pri katerih imunski sistem zmotno napade vaše telo.
It can also help to slow down or reverse some of the signs and symptoms of MS.
Pripomore tudi k upočasnitvi ali izginotju določenih znakov in simptomov MS.
Date of first authorisation: 12 September 2013 Date of latest renewal: 2 July 2018
Datum zadnjega podaljšanja: 2. Julij 2018
A risk to the suckling newborn/infant cannot be excluded.
Tveganja za novorojenčka/dojenčka ni možno izključiti.
In case of serious reactions, the infusion may be slowed down or even stopped.
V primeru resnih reakcij vam lahko infuzijo upočasnijo ali celo prekinejo.
Care should be taken to ensure the sterility of the prepared solution.
Potrebna je previdnost, da se zagotovi sterilnost pripravljene raztopine.
• In case of a severe adverse event
• v primeru hudega neželenega učinka,
Listeria infection can cause serious illness, including meningitis, but can be treated with appropriate medicines.
Okužba z listerijo lahko povzroči hudo bolezen, vključno z meningitisom, vendar jo je mogoče zdraviti z ustreznimi zdravili.
The antibody has an approximate molecular weight of 150 kD.
Protitelo ima približno molekulsko maso 150 kD.
Frequencies are defined according to the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).
Pogostnost je razvrščena po naslednjem dogovoru: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 to < 1/1.000); zelo redki (< 1/10.000); neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
If affected, stop these activities until you feel better.
Če zdravilo na vas deluje na tak način, prekinite te dejavnosti, dokler se ne počutite bolje.
There is 1 vial in each carton.
V vsaki škatli je ena viala.
These improvements were subsequently maintained, but no firm conclusions can be made with regards to the longer-term efficacy (e.g. 3 and 4 years after additional treatment courses) because many patients completed the study before reaching these time points.
Ta izboljšanja so se nato ohranila, toda glede dolgoročne učinkovitosti (npr. 3 in 4 leta po dodatnih ciklusih) ni mogoče narediti trdnih sklepov, ker so številni bolniki dokončali študijo, preden so dosegli te časovne točke.
Atrial fibrillation*
atrijska fibrilacija*
The safety and efficacy of LEMTRADA in children with MS aged 0 to 18 years have not yet been established.
Varnost in učinkovitost zdravila LEMTRADA pri otrocih z MS, starih od 0 do 18 let, še nista bili dokazani.
LEMTRADA is not intended to be used in children and adolescents below 18 years old as it has not been studied in MS patients below 18 years old.
Zdravilo LEMTRADA ni namenjeno uporabi pri otrocih in mladostnikih, mlajših od 18 let, saj ni bilo preučeno pri bolnikih z MS, mlajših od 18 let.
Initial treatment of 2 courses:
Začetno zdravljenje z 2 cikloma:
In order to reduce the chance of getting an infection, your doctor will check if other medicines you are taking might be affecting your immune system.
Da se zmanjša verjetnost okužbe, bo vaš zdravnik preveril, ali morda katero drugo zdravilo, ki ga jemljete, vpliva na vaš imunski sistem.
The incidence of antibodies is highly dependent on the sensitivity and specificity of the assay.
Pojavnost protiteles je zelo odvisna od občutljivosti in specifičnosti testa.
For further information on autoimmune reactions, infections and other information.
z dodatnimi informacijami o avtoimunskih reakcijah in okužbah ter drugimi informacijami.
Additional follow-up provided data through a median of 4.8 years (maximum 6.7).
Dodatno spremljanje je zagotovilo podatke za mediano 4,8 leta (največ 6,7 leta).
If severe infusion reactions occur, the intravenous infusion should be discontinued immediately.
Če se pojavijo hude z infuzijo povezane reakcije, je treba intravensko infundiranje nemudoma prekiniti.
There have been no studies to assess the carcinogenic or mutagenic potential of alemtuzumab.
Študij za oceno kancerogenega ali mutagenega potenciala alemtuzumaba niso opravili.
Long-term efficacy data
Podatki o dolgoročni učinkovitosti
Reactions have occurred following any of the doses and also after course number 2.
Reakcije so se pojavile po katerem koli odmerku in tudi po ciklusu številka 2.
To help you better understand the duration of the effects of treatment and the length of required follow-up, please refer to the diagram below.
Za boljše razumevanje trajanja učinkov zdravljenja in dolžine zahtevanega sledenja glejte spodnjo shemo.
If you cannot reach your doctor, you must seek immediate medical attention.
Če ne morete govoriti s svojim zdravnikom, morate poiskati nujno zdravniško oskrbo.
Figure 1: Time to 6 Month Confirmed Disability Worsening in Study 2
Slika 1: Čas do 6-mesečnega potrjenega poslabšanja prizadetosti v študiji 2
This must be diagnosed and treated early, as otherwise the effects can be serious or even fatal.
To bolezen je treba prepoznati in zdraviti čim prej, saj so lahko njeni učinki resni ali celo smrtno nevarni.
• You should monitor their test results and remain vigilant for symptoms of adverse events.
• Rezultate preiskav morate spremljati in biti pozorni na simptome neželenih učinkov.
• Other medicinal products should not be added to the LEMTRADA infusion solution or simultaneously infused though the same intravenous line.
• Druga zdravila se ne smejo dodajati infuziji zdravila LEMTRADA ali sočasno infundirati po isti intravenski liniji.
Up to two additional treatment courses, as needed, may be considered (see section 5.1):
Razmisliti je mogoče o največ dveh dodatnih ciklusih zdravljenja, kot je potrebno (glejte poglavje 5.1):
• It is extremely important that your patient understands the commitment to having periodic testing performed (for 4 years after last infusion) even if they are asymptomatic and their MS disease is well controlled.
• Izjemno pomembno je, da bolnik razume obveznost glede rednih preiskav (še štiri leta po zadnji infuziji), čeprav je asimptomatičen in je MS dobro obvladana.
It was often self-limiting and relatively mild, although severity and outcome was unknown in many cases.
Pogosto je bila samoomejujoča in razmeroma blaga, vendar njena izrazitost in izid v številnih primerih nista znana.
CDI is a measure for sustained disability improvement.
CDI je merilo trajnejšega zmanjšanja prizadetosti.
Safety profile in long-term follow-up
Varnostne značilnosti med dolgoročnim spremljanjem
Lymphocytes repopulate over time with B-cell recovery usually completed within 6 months.
Limfociti se sčasoma znova naselijo, pri čemer je obnovitev celic B običajno zaključena v 6 mesecih.
There are certain signs and symptoms that you should look out for yourself.
Na nekatere znake in simptome morate biti pozorni sami.
If you live in a region where tuberculosis infections are common, you may be at greater risk of infection with tuberculosis.
Če živite v področju, kjer je pogosta tuberkuloza, je pri vas lahko prisotno večje tveganje za tuberkulozo.