natgillin/translations-raw huggingface dataset:
Rare (affects 1 to 10 users in 10,000): palpitations, rapid heartbeat, difficulty to breathe, abnormal sensation of skin (for example pins and needles), hives, skin redness, pain in leg or arm, platelet deficiency, nerve inflammation, limb swelling and ankle swelling, taste disturbance, swelling of eyelid, fainting 
razbijanje srca, pospešen srčni utrip, težko dihanje, nenormalni občutek na koži (npr. zbadanje), koprivnica, rdečica, bolečine v nogi ali roki, pomanjkanje trombocitov, vneti živci, otekanje okončin in gležnjev, motnje okusa, otekanje vek, omedlevica
The safety profiles of IXIARO and the other studied vaccines were not compromised when administered concomitantly. 
Hkratno odmerjanje ni negativno vplivalo na varnostne profile cepiva IXIARO in drugih preučevanih cepiv.
In a phase 2 study in healthy Indian toddlers aged ≥1 year to <3 years, 24 children were vaccinated with 0.25 ml of IXIARO (the licensed dose for this age group) and 24 children received the adult 0.5 ml dose. 
0,25 ml cepiva IXIARO (odobreni odmerek za to starostno skupino) in 24 otrok je prejelo odmerek za odrasle 0,5 ml.
In children aged 2 months to <3 years, the following side effects have been observed more frequently compared to children aged 3 years to <12 years, adolescents and adults: Very common: fever (28.9%), diarrhoea (11.8%), influenza like illness (11.2%), irritability (11.0%) Common: loss of appetite, vomiting, skin rash 
Zelo pogosti: zvišana telesna temperatura (28,9 %), driska (11,8 %), gripi podobna bolezen (11,2 %), razdražljivost (11,0 %)
Pivotal immunogenicity trial (adults) 
Osrednje preskušanje imunogenosti (odrasli)
Frequency of adverse reactions observed in children given the 0.25 ml dose (2 months to <3 years of age) and in children and adolescents given the 0.5 ml dose (3 years to <18 years of age) 
(2 meseca do < 3 leta starosti), in pri otrocih in mladostnikih, ki so prejeli 0,5 ml odmerek (3 leta do < 18 let starosti)
Month 12 Month 24 
12. mesec 24. mesec
Respiratory, Thoracic and Medistinal Disorders 
Bolezni dihal, prsnega koša in mediastinalnega prostora kašelj
Seroconversion rates and geometric mean titer of JEV neutralizing antibody at Day 70 in the Intent-to-treat Population, for the entire study population and stratified by age 
Preglednica 9: Vrednosti serokonverzije in geometrični srednji titri nevtraliziranih protiteles proti virusu japonskega encefalitisa na dan 70 pri populaciji, namenjeni za obravnavo, in sicer za celotno populacijo študije, razvrščeno glede na starost
A study in rats did not indicate vaccine-related effects on female reproduction, foetal weight, survival and development of the off-spring. 
Študija pri podganah ni pokazala s cepivom povezanih učinkov na sposobnost razmnoževanja pri samicah,
The second injection 7 days after the first injection (Day 7). 
• prvo injiciranje na dan 0, • drugo injiciranje 7 dni po prvem injiciranju (7. dan).
General disorders and administration site conditions Very common: injection site pain, injection site tenderness, fatigue Common: influenza like illness, pyrexia, other injection site reactions e.g. redness, hardening, swelling, itching 
Zelo pogosti: bolečina na mestu injiciranja, občutljivost na mestu injiciranja, utrujenost Pogosti: gripi podobna bolezen, pireksija, druge reakcije na mestu injiciranja, npr. rdečica, zatrdline,
Rapid immunisation schedule (adults) 
Imunizacija po hitri shemi (odrasli)
Seroconversion rates and geometric mean titers of IXIARO and JE VAX in the Per Protocol Population. 
Preglednica 2: Odstotki serokonverzije in geometrični srednji titri cepiv IXIARO in JE-VAX v protokolni populaciji.
Shake to form a uniform suspension. 
intramuskularna uporaba Pretresite, da bi dobili enotno suspenzijo.
IXIARO suspension for injection Japanese encephalitis vaccine Intramuscular (IM) use 
IXIARO suspenzija za injiciranje cepivo proti virusu japonskega encefalitisa intramuskularna uporaba
VAX group (80.9 vs. 45.9, p=0.0236) but there was no significant difference at Day 56 for this treatment group. 
Geometrični srednji titri so bili znatno višji na 28. dan pri osebah, ki so bile mlajše od 50 let, kot pri tistih, ki so bile stare 50 let ali več, v skupini, ki je prejela cepivo JE-VAX (80,9 v primerjavi s 45,9, p = 0,0236), vendar na 56. dan v tej skupini ni bilo pomembnih razlik.
Table 12: Seroconversion rates and geometric mean titer of JEV neutralizing antibody by vaccine dose and age group. 
Preglednica 12: Stopnje serokonverzije in geometrični srednji titer protiteles, ki nevtralizirajo virus japonskega encefalitisa, glede na odmerek cepiva in starostno skupino.
Primary immunization should be completed at least one week prior to potential exposure to JEV. 
Prvo imunizacijo je treba končati vsaj en teden pred morebitno izpostavitvijo virusu japonskega encefalitisa.
0.25 ml N=783 2 months to <3 years 
0,25 ml n = 783
Rates of subjects with PRNT50≥1:10 and geometric mean titers (GMT) at Month 2, 6, 12, 24 and 36 after vaccination with IXIARO (ITT population) 
Preglednica 3: Odstotki oseb s PRNT50≥1:10 in geometrični srednji titri v 2., 6., 12., 24. in 36. mesecu po cepljenju s cepivom IXIARO (populacija ITT) Odstotek oseb s PRNT50≥1:10
Pre-booster, Day 0 (n=198) Day 28 (n=198) Month 6 (n=197) Month 12 (n=194) 
28. dan (n = 198)
For any information about this medicine, please contact the Marketing Authorization Holder by the following email-address: 
Za morebitne dodatne informacije o tem zdravilu se lahko obrnete na imetnika dovoljenja za promet z zdravilom na naslednjem e-poštnem naslovu: infoixiaro@valneva.com
GMT 
NP
Age Group ≥3 to <18 years 
Starostna skupina ≥ 3 leta do
In adults a seroconversion rate of 29.4 % has been observed 10 days after the first i.m. 
Pri odraslih je bila 10 dni po prvem intramuskularnem cepljenju opažena serokonverzija v višini 29,4 %, en teden po drugem intramuskularnem cepljenju pa serokonverzija v višini 97,3 % po običajni shemi.
Immunogenicity of the vaccine was evaluated in a randomized, active controlled, observer blinded, multicenter Phase 3 clinical trial including 867 healthy male and female subjects given IXIARO or the US licensed JEV vaccine JE VAX (on a 0, 7 and 28 day schedule by subcutaneous injection). 
Imunogenost cepiva je bila ovrednotena v randomiziranem, z učinkovino nadzorovanem, slepem, multicentričnem kliničnemu preskušanju 3. faze, v katerega je bilo vključenih 867 zdravih moških in žensk,
Ask your pharmacist how to throw away medicines you and/or your child no longer use. 
O načinu odstranjevanja zdravila, ki ga ne uporabljate več, se posvetujte s farmacevtom.
Nervous System Disorders 
Bolezni živčevja glavobol
Neutralising antibody titers against JEV were measured against the JEV strain SA14 
Titri nevtralizirajočih protiteles proti virusu japonskega encefalitisa so bili izmerjeni proti sevom virusa japonskega encefalitisa SA14-14-2.
Sodium chloride Potassium dihydrogen phosphate Disodium hydrogen phosphate Water for injections 
natrijev klorid, kalijev dihidrogen fosfat, natrijev hidrogen fosfat, vodo za injekcije.
Antibody persistence was evaluated for three years after the primary vaccination with IXIARO in an uncontrolled, open-label follow-up clinical trial conducted in the United States, Europe and Australia. 
odprti nadaljevalni klinični raziskavi v Združenih državah Amerike, Evropi in Avstraliji.
IXIARO suspension for injection Japanese encephalitis vaccine (inactivated, adsorbed) 
IXIARO suspenzija za injiciranje cepivo proti japonskemu encefalitisu z inaktiviranimi virusi (adsorbirano)
IXIARO is used to prevent infection with the Japanese encephalitis virus (JEV). 
Cepivo IXIARO se uporablja za preprečevanje okužbe z virusom japonskega encefalitisa.
Hence, primary immunisation should be completed at least one week prior to potential exposure to Japanese encephalitis virus (JEV). 
Zaradi tega je treba prvo imunizacijo končati vsaj en teden pred morebitno izpostavitvijo virusu japonskega encefalitisa.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Pre-filled syringe label 
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Seroconversion rates and geometric mean titer for JEV neutralizing antibody at Day 70 n / N 
Vrednosti serokonverzije in geometrični srednji titri za nevtralizirana protitelesa proti virusu japonskega encefalitisa na dan 70
150 children were followed-up for three years without booster, additional 150 children received a booster after 1 year (0.25 ml if aged <3 years at time of the booster, 0.5 ml if aged 3 years and above) and were followed-up for further two years. 
če so bili v času prejema obnovitvenega odmerka stari manj kot 3 leta; 0,5 ml, če so bili stari 3 leta ali več) ter so jih spremljali še dve leti.
What you need to know before you and/or your child receive IXIARO 3. 
Kaj je cepivo IXIARO in za kaj ga uporabljamo Kaj morate vedeti, preden boste vi in/ali vaš otrok prejeli cepivo IXIARO Kako uporabljati cepivo IXIARO
Month 24 
2. mesec
IXIARO Dose 
Izraz po MedDRA
Seroconversion rates and geometric mean titer of anti JEV neutralizing antibody at Day 56 and seroconversion rates and geometric mean titer for HAV antibody at Day 28 in the Per Protocol Population 
Preglednica 7: Odstotki serokonverzije in geometrični srednji titer nevtralizirajočih protiteles proti virusu japonskega encefalitisa 56. dne in odstotki serokonverzije ter geometrični srednji titer protiteles proti virusu hepatitisa A 28. dan glede na populacijo protokola
Rapid Schedule % (n/N) 
Hitra shema n/N (%)
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton 
PODATKI NA ZUNANJI OVOJNINI Zunanja škatla
GMT in these subjects was 16.2 (95% CI: 13.8, 19.0) at Month 24. 
Geometrični srednji titer v 24. mesecu je pri teh osebah znašal 16,2 (95-odstotni IZ:
Do not administer if particulate matter remains following shaking or if discoloration is observed or if the syringe appears to be physically damaged.. 
Če so prisotni delci ali če opazite, da cepivo spremeni barvo ali če je injekcijska brizga fizično poškodovana, cepivo zavrzite.
Common (affects 1 to 10 users in 100): Nausea, influenza like illness, fever, other injection site reactions (e.g. redness, hardening, swelling, itching) 
slabost, gripi podobna bolezen, vročina, druge reakcije na mestu vboda (npr. rdečica, zatrdline, otekanje, srbečica)
Lymphadenopathy 
Bolezni živčevja
Pyrexia Influenza like illness Irritability Fatigue Injection site redness Injection site pain Injection site tenderness Injection site swelling Injection site hardening Injection site itching 
Splošne težave in spremembe na mestu aplikacije pireksija gripi podobna bolezen razdražljivost utrujenost rdečina na mestu injiciranja bolečina na mestu injiciranja občutljivost na mestu injiciranja oteklina na mestu injiciranja otrdlina na mestu injiciranja srbenje na mestu injiciranja
For administration of a 0.25 ml dose in children aged 2 months to < 3 years, follow the steps below: 
Informacije o pripravi odmerka 0,25 ml cepiva IXIARO za uporabo pri otrocih, starih manj kot 3 leta Pri dajanju 0,25 ml odmerka otrokom, starim 2 meseca do < 3 leta, upoštevajte spodnje korake: 1.
IXIARO Day 0,7 Rabipur Day 0,3,7 
IXIARO, dan 0, 7 Rabipur, dan 0, 3,
The effect of age on the immune response to IXIARO and JE-VAX was assessed as a secondary endpoint in this active controlled study, comparing subjects aged ≥ 50 years of age (N=262, mean age 59.8) with those below 50 years of age (N=605, mean age 33.9). 
Vpliv starosti na odziv imunskega sistema na cepivo IXIARO in JE VAX je bil ocenjen kot sekundarni cilj študije v tej aktivni nadzorovani študiji, v kateri je bila opravljena primerjava oseb, starejših od 50 let (N =
Seroconversion rates and geometric mean titer for anti-JEV neutralizing antibody at Day 56 % with SCR 
Odstotki serokonverzije in geometrični srednji titer za nevtralizirajočo protitelo proti virusu japonskega encefalitisa na 56. dan % s stopnjo serokonverzije geometrični srednji titer
SCR and GMT at four weeks after a single 6 mcg booster dose administered to subjects with a PRNT50 <1:10 (PRNT50<1:10 means a subject is no longer seroprotected) at month 11 or month 23 after recommended primary immunization (2x 6 mcg) or incomplete (1x6 mcg) primary immunization with IXIARO (ITT population) 
ki ni več zaščitena s serumom) v 11. ali 23. mesecu po priporočeni primarni imunizaciji (2 x 6 mikrogram) ali nezaključeni (1 x 6 mikrogram) primarni imunizaciji s cepivom IXIARO
Booster immunisation (adults) 
Obnovitvena imunizacija (odrasli)
Attach a needle to the pre-filled syringe. 
Na napolnjeno injekcijsko brizgo namestite iglo.
The recommended dosage for babies and children aged 2 months to < 3 years is a total of 2 injections of 0.25 ml each: The first injection on Day 0 The second injection 28 days after the first injection (Day 28). 
Priporočeni odmerek za dojenčke in otroke, stare 2 meseca do < 3 leta, je skupaj 2 injekciji, vsaka po 0,25 ml:
Seroconversion rates and geometric mean titer for HAV antibody at Day 28 % with SCR 
Odstotki serokonverzije in geometrični srednji titer za protitelo proti virusu hepatitisa A na 28. dan
Respiratory, thoracic and mediastinal disorders Rare: dyspnoea 
Redki: palpitacija, tahikardija Bolezni dihal, prsnega koša in mediastinalnega prostora Redki: dispneja
Nervous system disorders Very common: headache Uncommon: migraine, dizziness Rare: paraesthesia, neuritis, dysgeusia, syncope* 
Redki: parestezija, nevritis, disgevzija, sinkopa*
GMT [95% CI] 
[95-odstotni IZ]
Table 13: Seroprotection rates and geometric mean titer of JEV neutralizing antibody by vaccine dose and age group. 
Preglednica 13: Stopnje serološke zaščite in geometrični povprečni titer nevtralizirajočih protiteles proti virusu japonskega encefalitisa glede na odmerek cepiva in starostno skupino Populacija z namenom zdravljenja
There was no significant difference between seroconversion rates in subjects aged <50 years compared to those aged ≥50 years at Day 28 or Day 56 for either treatment group. 
50. leta starosti v primerjavi s tistimi, starimi 50 let ali več, ni bilo pomembnih razlik v nobeni od obeh skupin.
Very common (affects more than 1 user in 10): headache, muscle pain, injection site pain, injection site tenderness, tiredness 
glavobol, bolečine v mišicah, bolečina na mestu injiciranja, občutljivost na mestu injiciranja, utrujenost
See section 6.6 for instructions on preparing a 0.25 ml dose for children aged 2 months to <3 years. 
Otroci, stari od 14 mesecev do < 3 let, naj bi prejeli enkratni obnovitveni odmerek 0,25 ml. Za navodila o pripravi odmerka 0,25 ml za otroke, stare od 2 mesecev do < 3 let, si oglejte poglavje 6.6.
Vaccination scheme IXIARO Day 0,7 Rabipur Day 0,3,7 
Cepitvena shema IXIARO, dan 0, 7 Rabipur, dan 0, 3,
NA 
V
There was no interference with the immune response to the JE virus and HAV, respectively. 
Vplivanja na imunski odziv na virus japonskega encefalitisa oziroma virus hepatitisa A ni bilo.
A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 
A. IZDELOVALEC (IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (UČINKOVIN)
Rapid Schedule (N) 
Hitra shema (N)
Uncommon: musculoskeletal stiffness, arthralgia Rare: pain in extremity 
Občasni: mrazenje, nelagodje, slabotnost Redki: periferni edem
Skin and subcutaneous tissue disorders Uncommon: rash, pruritus, hyperhidrosis Rare: urticaria, erythema 
Občasni: izpuščaji, pruritus, hiperhidroza
Keep this medicine out of the sight and reach of children. 
• Zdravilo shranjujte nedosegljivo otrokom.
Clear liquid with a white precipitate. 
suspenzija za injiciranje bistra tekočina z belo oborino
Table 10: Seroconversion rates, rates of subjects with at least 4-fold increase in JEV neutralizing antibody titers and Geometric Mean Titers at baseline, Day 56 and Month 7 stratified by age group, Intent To Treat Population Vaccine Dose 
Preglednica 10: Stopnje serokonverzije, delež oseb z vsaj 4-kratnim povečanjem titra protiteles, ki nevtralizira virus japonskega encefalitisa in geometrični srednji titer ob izhodišču, na 56.
), host cell protein. 
• Navodilo shranite.
Conventional Schedule % (n/N) 
Običajna shema n/N (%)
Concomitant administration of IXIARO with other vaccines: 
Hkratno odmerjanje cepiva IXIARO z deaktiviranim cepivom proti steklini (Rabipur):
The SPRs and GMTs are displayed in Table 13. 
Vrednosti stopnje serološke zaščite in geometričnega povprečnega titra so prikazane v preglednici 13.
Information on the administration of a 0.5 ml dose of IXIARO for persons 3 years of age and above 
Informacije o pripravi odmerka 0,5 ml cepiva IXIARO osebam, starim 3 leta in več Pri dajanju celega 0,5 ml odmerka upoštevajte spodnje korake:
<50 years compared to those aged ≥50 years at Day 28 or Day 56 following vaccination. 
Med odstotki serokonverzije na 28. ali 56. dan po cepljenju pri osebah do
SCR n / N 
n/N
The co-primary endpoint was seroconversion rate (anti JEV antibody titer ≥1:10) and geometric mean titers (GMT) at Day 56 
Sočasna primarna končna točka je bil odstotek serokonverzije (titer protiteles proti virusu japonskega encefalitisa ≥1:10) in geometrični srednji titri na 56. dan, ocenjeni s testom Plaque Reduction Neutralization Test (PRNT) za celotno študijsko populacijo.
Myalgia 
GEOMETRIČNI
Additional side effects in children aged 2 months to <3 years 
Dodatni neželeni učinki pri otrocih, starih 2 meseca do < 3 leta Pri otrocih, starih 2 meseca do < 3 leta, so pogosteje opazili naslednje neželene učinke v primerjavi z otroci,
Uncommon: chills, malaise, asthenia 
Občasni: migrena, omotica
The use of external filters is not required. 
Uporaba zunanjih filtrov ni potrebna.
Very common (may affect more than 1 in 10 people) 
Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 ljudi)
Very common ( ≥ 1/10) 
zelo pogosti (≥ 1/10)
Not known (frequency cannot be estimated from the available data) 
Neznana pogostnost (ni je mogoče oceniti iz razpoložljivih podatkov)
Information on long term efficacy of this medicinal product is not available. 
Podatki o dolgoročni učinkovitosti tega zdravila niso na voljo.
Patients were assessed over a 3 year treatment period. 
Bolnike so ocenjevali v 3-letnem obdobju zdravljenja.
6Nominal p value 
6Nominalna vrednost p.
These effects were observed within several hours post-dose and generally resolved within 48 hours. 
Te učinke so opazili znotraj več ur po odmerku in so na splošno izzveneli v 48 urah.
It may also weaken the muscles used for breathing and swallowing. 
Oslabijo lahko tudi mišice, ki se uporabljajo za dihanje in požiranje.
This reduces the loss of nerve cells and so may improve muscle strength. 
To zmanjša odmiranje živčnih celic, s čimer se lahko izboljša mišična moč.
An analysis of the subset of patients in the ITT population who had observed values at Month 15 demonstrated consistent, statistically significant results. 
Analiza podskupine bolnikov v populaciji ITT, ki so imeli ugotovljene vrednosti v 15. mesecu, je pokazala skladne, statistično značilne rezultate.
Do not use this medicine after the expiry date which is stated on the carton after “EXP”. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na kartonski škatli poleg oznake “EXP”.
6Based on log-rank test stratified by disease duration 
6Na podlagi testa log-rank, stratificiranega po trajanju bolezni.
The incidence and severity of these events were consistent with events expected to occur with lumbar puncture. 
Pogostnost in resnost teh dogodkov se je ujemala z dogodki, pričakovanimi pri lumbalni punkciji.
You or your child may also be given a medicine to make you relax or sleep during the procedure. 
Vam ali vašemu otroku bodo mogoče dali tudi zdravilo, ki bo vam/vašemu otroku pomagalo sprostiti se ali zaspati med postopkom.
Long-term studies in animals to evaluate the carcinogenic potential of nusinersen have not been performed. 
Dolgoročnih študij na živalih za oceno kancerogenega potenciala nusinersena niso izvedli.
Characteristics in specific patient populations 
Značilnosti v določenih populacijah bolnikov
The impact of immunogenicity on safety was not formally analysed as the number of patients with ADAs was low. 
Vpliv imunogenosti na varnost ni bil uradno analiziran, saj je bilo število bolnikov z ADA nizko.
Nusinersen demonstrated no evidence of genotoxicity. 
Nusinersen ni kazal znakov genotoksičnosti.
Each vial is for single use. 
Vsaka viala je namenjena za enkratno uporabo.
The 6MWT (six-minute walk test) was conducted for ambulatory patients only. 
6MWT (test 6-minutne hoje) so naredili samo pri pokretnih bolnikih.
The majority of patients studied were Caucasian. 
Večina proučevanih bolnikov je bila belcev.
Median plasma Tmax values ranged from 1.7 to 6.0 hours. 
Mediane plazemske vrednosti tmax so segale od 1,7 do 6,0 ur.
The frequency of these reactions is not known as they have been reported from the post marketing setting. 
Pogostnost teh reakcij ni znana, ker so o njih poročali v obdobju trženja zdravila.
This can include headaches, vomiting and back pain. 
Ti lahko vključujejo glavobole, bruhanje in bolečino v hrbtu.
These events can be considered manifestations of post-lumbar puncture syndrome. 
Ti dogodki se lahko upoštevajo kot manifestacija postpunkcijskega sindroma.
Four patients met the criteria for permanent ventilation and five patients died during the study. 
Štirje bolniki so izpolnili merila za prejemanje trajne ventilacije, pet bolnikov pa je umrlo med študijo.
These results are supported by 2 open label studies (study CS2 and study CS12). 
Te rezultate podpirata 2 odprti študiji (študija CS2 in študija CS12).
For persistent elevated urinary protein, further evaluation should be considered. 
Pri vztrajajočem zvišanju beljakovin v urinu je treba razmisliti o nadaljnji diagnostiki.
Prevention and treatment will be managed by routine clinical practice and no additional risk minimization measures or evaluations are required as part of the pharmacovigilance plan. 
Preprečevanje in zdravljenje bosta izvedena v okviru rutinske klinične prakse, v okviru načrta farmakovigilance pa niso potrebni dodatni ukrepi za zmanjševanje tveganja ali vrednotenje.
Any unused product or waste material must be disposed of in accordance with local requirements. 
Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
The mean terminal elimination half-life in CSF is estimated at 135 to 177 days. 
Ocenjujejo, da je srednji končni razpolovni čas izločanja v CSF 135 do 177 dni.
If particles are observed and/or the liquid in the vial is not clear and colourless, the vial must not be used. 
Če opazite delce in/ali če tekočina v viali ni bistra in brezbarvna, viale ne smete uporabiti.
There are no data available on the potential effects on fertility in humans. 
Podatki o možnih učinkih na plodnost pri ljudeh niso na voljo.
In the event of an overdose, supportive medical care should be provided including consulting with a healthcare professional and close observation of the clinical status of the patient. 
V primeru prevelikega odmerjanja je treba nuditi podporno medicinsko oskrbo, vključno s posvetom z zdravstvenim delavcem in z natančnim opazovanjem bolnikovega kliničnega stanja.
Nusinersen is not a substrate or inhibitor of human BCRP, P-gp, OAT1, OAT3, OCT1, OCT2, OATP1B1, OATP1B3, or BSEP transporters. 
Nusinersen ni niti substrat niti inhibitor humanih prenašalcev BCRP, P-gp, OAT1, OAT3, OCT1, OCT2, OATP1B1, OATP1B3 ali BSEP.
A second gene SMN2, located near SMN1, is responsible for a small amount of SMN protein production. 
Drug gen SMN2, ki je lociran blizu SMN1, je odgovoren za majhno količino nastanka beljakovine SMN.
Patients achieved milestones unexpected in Type I or II SMA and more consistent with normal development. 
Bolniki so dosegli mejnike, ki so bili pri SMA tipa I ali II nepričakovani in so se bolj skladali z normalnim razvojem.
Two previously non-independent ambulatory patients (Type III) achieved independent walking, and one non-ambulatory patient (Type II) achieved independent walking. 
Dva predhodno nesamostojno pokretna bolnika (tip III) sta dosegla samostojno hojo, en nepokreten bolnik (tip II) pa je dosegel samostojno hojo.