FrancophonIA/ELRC3.0 huggingface dataset:
English: Study CS3B (ENDEAR) was a Phase 3, randomized, double-blind, sham-procedure controlled study conducted in 121 symptomatic infants ≤ 7 months of age, diagnosed with SMA (symptom onset before 6 months of age).
Slovenian: Študija CS3B (ENDEAR) je bila randomizirana, dvojno slepa, s placebom kontrolirana študija 3. faze, opravljena pri 121 simptomatičnih dojenčkih, starih ≤ 7 mesecev, ki so jim postavili diagnozo SMA (nastop simptomov pred 6 meseci starosti).
English: Of the 20 subjects enrolled, 11 (55%) were alive and free of permanent ventilation at the last visit.
Slovenian: Od 20 vključenih preiskovancev je bilo ob zadnjem obisku živih 11 preiskovancev (55 %), ki niso prejemali trajne ventilacije.
English: Proportion achieving a 4-point worsening
Slovenian: Delež, ki se mu je bolezen poslabšala za 4 točke
English: In vitro studies indicated that nusinersen is not an inducer or inhibitor of CYP450 mediated metabolism.
Slovenian: Študije in vitro so pokazale, da nusinersen ni induktor ali inhibitor presnove preko presnovne poti CYP450.
English: Patients who first initiated Spinraza treatment in Study CS11 (n=24; sham control in Study CS3B) were of a median age of 17.8 months (range 10 - 23 months) and had a mean CHOP INTEND score of 17.25 (range 2.0 - 46.0) at baseline in Study CS11.
Slovenian: Mediana starosti bolnikov, ki so zdravljenje z zdravilom Spinraza prvič začeli v študiji CS11 (n = 24; kontrolni bolniki na placebu v študiji CS3B), je bila 17,8 meseca (razpon 10-23 mesecev), v izhodišču študije CS11 pa so imeli povprečni rezultat CHOP INTEND 17,25 (razpon 2,0-46,0).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA KARTONSKA ŠKATLA
English: Proportion with any improvement Proportion with any worsening p<0.0001
Slovenian: Delež, ki je dosegel izboljšanje za 4 točke p<0,0001
English: Patients in this study were deemed most likely to develop Type II or III SMA.
Slovenian: da se bo bolnikom v tej študiji razvil SMA tipa II ali III.
English: Intrathecal use
Slovenian: intratekalna uporaba
English: Displacement of these factors leads to retention of exon 7 in the SMN2 mRNA and hence when SMN2 mRNA is produced, it can be translated into the functional full length SMN protein.
Slovenian: v mRNA SMN2, zato se izdelana mRNA SMN2 lahko prevede v funkcionalno beljakovino SMN s polno dolžino.
English: Aseptic technique should be used when preparing Spinraza solution for intrathecal administration.
Slovenian: Pri pripravi raztopine zdravila Spinraza za intratekalno uporabo morate uporabljati aseptično tehniko.
English: At the final analysis, a statistically significant improvement in HFMSE score from baseline to Month 15 was seen in the Spinraza group compared to the sham-control group (Table 3, Figure 2).
Slovenian: Pri končni analizi so ugotovili statistično značilno izboljšanje rezultata HFMSE od izhodišča do 15. meseca v skupini z zdravilom Spinraza v primerjavi s skupino, ki je prejemala placebo (preglednica 3, slika 2).
English: The Spinraza vial should be inspected for particles prior to administration.
Slovenian: Vialo zdravila Spinraza morate pred uporabo pregledati za delce.
English: In patients with Type II SMA the Upper Limb Module test was conducted with mean improvement of 1.9 (SD 2.68, n=11) at Day 253 and 3.5 (SD 3.32, n=9) at Day 1050.
Slovenian: Pri bolnikih s SMA tipa II so opravili test modula zgornjih udov s povprečnim izboljšanjem 1,9 (SD 2,68, n=11) po 253 dneh in 3,5 (SD 3,32, n=9) po 1050 dneh.
English: In these patients, a mean improvement of 28.6 meters (SD 47.22, n=12) at Day 253 and 86.5 metres (SD 40.58, n=8) at Day 1050.
Slovenian: Pri teh bolnikih so ugotovili povprečno izboljšanje za 28,6 metra (SD 47,22, n=12) po 253 dneh in 86,5 metra (SD 40,58, n=8) po
English: In addition, no patients in the Spinraza or shamcontrol group required the use of permanent ventilation.
Slovenian: Poleg tega za nobenega bolnika v skupini bolnikov, zdravljenih z zdravilom Spinraza ali v kontrolni skupini bolnikov na placebu, ni bila potrebna trajna ventilacija.
English: Prior to administration, unopened vials of Spinraza can be removed from and returned to the refrigerator if necessary.
Slovenian: Pred uporabo lahko neodprte viale zdravila Spinraza vzamete iz hladilnika in jih spet daste nazaj v hladilnik, če je to potrebno.
English: Spinraza is for intrathecal use by lumbar puncture.
Slovenian: Zdravilo Spinraza se uporablja intratekalno z lumbalno punkcijo.
English: Further improvement in mean total motor milestone (HINE-Section 2) (2.1; SD 4.36; n=22) and CHOP INTEND (4.68; SD 3.993, n=22) scores were observed from baseline to Study Day 304 in Study CS11.
Slovenian: Nadaljnje izboljšanje povprečnega celotnega motoričnega mejnika (HINE - poglavje 2) (2,1; SD 4,36; n = 22) in rezultatov CHOP INTEND (4,68; SD 3,993; n = 22) so v študiji CS11 ugotavljali od izhodišča do 304. dne študije.
English: Sodium dihydrogen phosphate dihydrate, disodium phosphate, sodium chloride, potassium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate, sodium hydroxide, hydrochloric acid, water for injections.
Slovenian: Natrijev dihidrogenfosfat dihidrat, natrijev hidrogenfosfat, natrijev klorid, kalijev klorid, kalcijev klorid dihidrat, magnezijev klorid heksahidrat, natrijev hidroksid, klorovodikova kislina, voda za injekcije.
English: These results are supported by an open-label Phase 2 study in symptomatic patients diagnosed with SMA (CS3A).
Slovenian: Te rezultate podpira odprta študija 2. faze pri simptomatičnih bolnikih, ki so jim postavili diagnozo
English: Table 2: Primary and secondary endpoints at final analysis - Study CS3B Efficacy Parameter
Slovenian: Preglednica 2: Primarni in sekundarni končni opazovani dogodki v končni analizištudija CS3B
English: required respiratory intervention >6 hours/day continuously for ≥7 days, all of whom initiated ventilatory support during an acute reversible illness
Slovenian: Pri štirih bolnikih (s po 2 kopijama gena za SMN2) je bila potrebna respiratorna intervencija za > 6 ur/dan neprekinjeno ≥ 7 zaporednih dni, pri vseh pa je bila med akutno reverzibilno boleznijo potrebna ventilatorna podpora.
English: Post-authorisation efficacy study (PAES): In order to evaluate the long term efficacy and safety of nusinersen in symptomatic patients with spinal muscular atrophy, the MAH should conduct and submit the results of the Phase 3, open-label extension study (SHINE, CS11)
Slovenian: (PAES): Da bo imetnik dovoljenja za promet z zdravilom ocenil dolgoročno učinkovitost in varnost nusinersena pri simptomatičnih bolnikih s spinalno mišično atrofijo, mora izvesti odprto podaljšano študijo 3. faze (SHINE, CS11) in predložiti rezultate.
English: Proportion with improvement in total motor milestone score Proportion with worsening in total motor milestone score p<0.0001
Slovenian: Delež z izboljšanjem celotnega rezultata motoričnih mejnikov Delež s poslabšanjem celotnega rezultata motoričnih mejnikov
English: It is recommended that the volume of cerebral spinal fluid (CSF), equivalent to the volume of Spinraza to be injected, is removed prior to administration of Spinraza.
Slovenian: Priporočljivo je, da se pred injiciranjem zdravila Spinraza odstrani volumen cerebrospinalne tekočine (cerebral spinal fluid - CSF), ki je enak volumnu zdravila Spinraza, ki se ga injicira.
English: The mean total score was 49.8 (SD 12.46) at Day 253 and 52.6 (SD 12.78) at 1050 days.
Slovenian: Povprečni celotni rezultat je bil 49,8 (SD 12,46) po 253 dneh in 52,6 (SD 12,78) po 1050 dneh.
English: No cases of overdose associated with adverse reactions were reported in clinical studies.
Slovenian: V kliničnih študijah niso poročali o primerih prevelikega odmerjanja, povezanega z neželenimi učinki.
English: 26.3% (95% CI: 12.4,40.2)
Slovenian: 26,3 % (95-% IZ: 12,4,
English: Improvement in mean total motor milestone (HINE-Section 2) (1.2; SD 1.8; n=12) and CHOP INTEND (3.58; SD 7.051, n=12) scores were observed from baseline to Study Day 304 in Study CS11.
Slovenian: Izboljšanje povprečnega celotnega motoričnega mejnika (HINE - poglavje 2) (1,2; SD 1,8; n = 12) in rezultatov CHOP INTEND (3,58; SD 7,051; n = 12) so v študiji CS11 ugotavljali od izhodišča do 304. dne študije.
English: 5.9% (95% CI: 0.7,
Slovenian: 5,9 % (95-% IZ: 0,7,
English: The mean total score was 26.4 (SD 11.91) at Day 253 and 31.3 (SD 13.02) at Day 1050, no plateau was observed.
Slovenian: Povprečni celotni rezultat je bil 26,4 (SD 11,91) po 253 dneh in 31,3 (SD 13,02) po 1050 dneh zdravljenja, brez platoja.
English: The protocol-defined criteria for clinically manifested SMA included age-adjusted weight below the fifth WHO percentile, a decrease of 2 or more major weight growth curve percentiles, the placement of a percutaneous gastric tube, and/or the inability to achieve expected age-appropriate WHO milestones (sitting without support, standing with assistance, hands-and-knees crawling, walking with assistance, standing alone and walking alone).
Slovenian: zmanjšanje 2 ali več pomembnejših percentilov rastne krivulje telesne mase, vstavitev perkutane gastrostome in/ali nesposobnost doseči pričakovane, starosti primerne mejnike SZO (sedenje brez opore, stanje s pomočjo, plazenje po dlaneh in kolenih, hoja s pomočjo, samostojno stanje in samostojna hoja).
English: Of the 45 patients who had not met the definition of permanent ventilation in Study CS3B, 38 patients (84%) were alive without permanent ventilation in Study CS11 at the time of interim analysis.
Slovenian: Od 45 bolnikov, ki v študiji CS3B niso dosegli odzivnosti, opredeljene s trajno ventilacijo, je bilo v času vmesne analize študije CS11 živih 38 bolnikov (84 %), ki niso prejemali trajne ventilacije.
English: Patients in this study were deemed most likely to develop Type I or II SMA.
Slovenian: Smatrali so, da se bo pri bolnikih v tej študiji najverjetneje razvila SMA tipa I ali II.
English: Of these patients, stabilization or improvement in mean HFMSE (1.4; SD 4.02) and RULM (2.1; SD 2.56) scores were observed from baseline to Study Day 265 in Study CS11.
Slovenian: Pri teh bolnikih so stabilizacijo ali izboljšanje povprečnega rezultata HFMSE (1,4; SD 4,02) in rezultata RULM (2,1; SD 2,56) v študiji CS11 ugotavljali od izhodišča do
English: Proportion at Day 394
Slovenian: delež na 183. dan delež na 302. dan delež na 394. dan
English: Post-authorisation efficacy study (PAES): In order to evaluate the long term efficacy and safety of nusinersen in pre-symptomatic patients with spinal muscular atrophy, the MAH should conduct and submit the results of the Phase 2, open-label study (NURTURE (SM201))
Slovenian: (PAES): Da bo imetnik dovoljenja za promet z zdravilom ocenil dolgoročno učinkovitost in varnost nusinersena pri predsimptomatičnih bolnikih s spinalno mišično atrofijo, mora izvesti odprto študijo 2. faze (NURTURE (SM201)) in predložiti rezultate.
English: Each ml contains 2.4 mg of nusinersen.
Slovenian: En ml vsebuje 2,4 mg nusinersena.
English: - The other ingredients are sodium dihydrogen phosphate dihydrate, disodium phosphate, sodium chloride, potassium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate,
Slovenian: - Druge sestavine zdravila so natrijev dihidrogenfosfat dihidrat, natrijev hidrogenfosfat, natrijev klorid, kalijev klorid, kalcijev klorid dihidrat, magnezijev klorid heksahidrat, natrijev hidroksid, klorovodikova kislina, voda za injekcije.
English: Of patients who initiated Spinraza treatment in Study CS4 (n=39), stabilization or additional improvements in mean HFMSE (0.2; SD 3.06) and RULM (0.7; SD 2.69) scores were observed from baseline to Study Day 265 in Study CS11.
Slovenian: Pri bolnikih, pri katerih je bilo zdravljenje z zdravilom Spinraza uvedeno v študiji CS4 (n = 39), so stabilizacijo ali dodatna izboljšanja povprečnega rezultata HFMSE (0,2; SD 3,06) in rezultata RULM (0,7; SD 2,69) v študiji CS11 ugotavljali od izhodišča do 265. dne.
English: - Each ml contains 2.4 mg of nusinersen.
Slovenian: - En ml vsebuje 2,4 mg nusinersena.
English: 0.5 (95% CI: -0.6, 1.6)
Slovenian: 0,5 (95-% IZ: -0,6, 1,6)
English: HFMSE score
Slovenian: Icepharma hf
English: Symptomatic patients
Slovenian: Bolniki s
English: 4Assessed at the later of Day 183, Day 302, and Day 394 Study Visit 5According to Hammersmith Infant Neurological Examination (HINE) section 2: ≥2 point increase [or maximal score] in ability to kick, OR ≥1 point increase in the motor milestones of head control, rolling, sitting, crawling, standing or walking, AND improvement in more categories of motor milestones than worsening, defined as a responder for this primary analysis.
Slovenian: 5V skladu s preiskavo Hammersmith Infant Neurological Examination (HINE), 2. poglavje: bolnik, ki je pokazal zvečanje za ≥2 točki (ali maksimalni rezultat) pri sposobnosti brcanja, ALI zvečanje za ≥1 točko pri motoričnih mejnikih obvladovanja glave, zvijanja, sedenja, plazenja, stanja ali hoje IN izboljšanje pri več kategorijah motoričnih mejnikov kot poslabšanje, je bil za to primarno analizo opredeljen kot bolnik, ki se odziva na zdravljenje.
English: Thrombocytopenia and coagulation abnormalities
Slovenian: Trombocitopenija in abnormalnosti koagulacije krvi
English: - Each 5 ml vial contains nusinersen sodium equivalent to 12 mg nusinersen.
Slovenian: - Ena 5 ml viala vsebuje natrijev nusinersenat, ki ustreza 12 mg nusinersena.
English: It is recommended that the volume of CSF, equivalent to the volume of Spinraza to be injected, is removed prior to administration of Spinraza.
Slovenian: Priporočljivo je, da pred injiciranjem zdravila Spinraza odstranite volumen CSF, ki je enak volumnu zdravila Spinraza, ki ga boste injicirali.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Slovenian: Preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1. 4.4 Posebna opozorila in previdnostni ukrepi Postopek lumbalne punkcije
English: The mean total score was13.8 (SD 3.09) at Day 253 and 15.7 (SD 1.92) at Day 1050.
Slovenian: 13,8 (SD 3,09) po 253 dneh in 15,7 (SD 1,92) po 1050 dneh.
English: Spinraza 12 mg solution for injection
Slovenian: Spinraza 12 mg raztopina za injiciranje
English: Musculoskeletal and connective tissue disorders
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva bolečina v hrbtu*
English: Table 3: Primary and secondary endpoints at final analysis - Study CS41 Spinraza treated Patients
Slovenian: Preglednica 3: Primarni in sekundarni končni opazovani dogodki pri končni analizištudija CS41
English: In the efficacy set, 18 patients (25%) in the Spinraza group and 12 patients (32%) in the sham-control group required permanent ventilation.
Slovenian: V naboru za oceno učinkovitosti je 18 bolnikov (25 %) v skupini z zdravilom Spinraza in
English: Of the 13 patients with infantile-onset SMA, 7 of out 9 patients (78%; 95%CI: 45, 94) in the Spinraza group and 0 out of 4 patients (0%; 95%CI: 0, 60) in the sham group met the criteria for motor milestone response (according to HINE section 2: ≥2 point increase [or maximal score] in ability to kick OR ≥1 point increase in the motor milestones of head control, rolling, sitting, crawling, standing or walking and improvement in more categories of motor milestones than worsening) .
Slovenian: Od 13 bolnikov, ki so jim postavili diagnozo simptomatične SMA z nastopom pri dojenčku, je 7 od 9 bolnikov (78 %; 95-% IZ: 45, 94) v skupini bolnikov, zdravljenih z zdravilom Spinraza, in 0 od 4 bolnikov (0 %; 95-% IZ: 0, 60) v kontrolni skupini bolnikov na placebu izpolnilo merila za doseganje odzivnosti, opredeljene z motoričnimi mejniki (v skladu s HINE,
English: How Spinraza is given
Slovenian: Kako se daje zdravilo Spinraza
English: Pharmacotherapeutic group: Other drugs for disorders of the musculo-skeletal system, ATC code: M09AX07
Slovenian: oznaka ATC: M09AX07 Mehanizem delovanja
English: Each 5 ml vial contains nusinersen sodium equivalent to 12 mg nusinersen (2.4 mg/ml).
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena 5 ml viala vsebuje natrijev nusinersenat, ki ustreza 12 mg nusinersena (2,4 mg/ml).
English: Figure 1: Change in CHOP INTEND from Baseline to Later of Day 183, Day 302, and Day 394 Study Visit - Endear Study /CS3B (Efficacy Set, ES)
Slovenian: 183., 302. ali 394. dan) - študija Endear/CS3B (nabor za oceno učinkovitosti - Efficacy Set, ES)
English: България ТП ЕВОФАРМА
Slovenian: ТП ЕВОФАРМА Teл.
English: Reporting of side effects If you or your child get any side effects, talk to your doctor or nurse.
Slovenian: Če pri sebi ali svojem otroku opazite katerega koli izmed neželenih učinkov, se posvetujte zdravnikom ali medicinsko sestro.
English: 56.8% (95% CI:45.6, 68.1) P=0.00065
Slovenian: 56,8 % (95-% IZ: 45,6, 68,1)
English: Number of patients who died Hazard Ratio (95% CI) p-value6
Slovenian: Razmerje ogroženosti (95-% IZ) Vrednost p6
English: The primary endpoint was the proportion of patients who improved in one or more categories in motor milestones (according to HINE section 2: ≥2 point increase [or maximal score] in ability to kick or voluntary grasp OR ≥1 point increase in the motor milestones of head control, rolling, sitting, crawling, standing or walking).
Slovenian: Primarni končni opazovani dogodek je bil delež bolnikov, ki so se izboljšali v eni ali več kategorijah motoričnih mejnikov (v skladu s poglavjem 2 HINE: zvečanje za ≥ 2 točki (ali maksimalni rezultat)
English: Hepatic impairment
Slovenian: Bolezni živčevja glavobol*
English: Spinraza 12 mg solution for injection nusinersen
Slovenian: Spinraza 12 mg raztopina za injiciranje nusinersen
English: The use of ultrasound or other imaging techniques to assist with intrathecal administration of Spinraza, can be considered at the physician's discretion.
Slovenian: Po presoji zdravnika lahko pride v poštev uporaba ultrazvoka ali drugih tehnik slikanja kot pomoč pri intratekalnem dajanju zdravila
English: Statistically significant effects on event-free survival, overall survival, the proportion of patients achieving the definition of a motor milestone responder, and the percentage of patients with at least a 4-point improvement from baseline in Children's Hospital of Philadelphia
Slovenian: Statistično značilne učinke na preživetje brez dogodkov, stopnjo preživetja, delež bolnikov, ki so dosegli odzivnost, opredeljeno z motoričnimi mejniki in delež bolnikov z izboljšanjem za najmanj 4 točk od izhodišča v rezultatu testa za dojenčke za živčnomišične bolezni bolnišnice Children's Hospital of Philadelphia (Children's Hospital of Philadelphia Infant Test for Neuromuscular DiseaseCHOP INTEND) so ugotovili pri bolnikih v skupini z zdravilom Spinraza v primerjavi z rezultati kontrolne skupine na placebu (preglednica 2).
English: Calcium chloride dihydrate Magnesium chloride hexahydrate Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injections
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi natrijev dihidrogenfosfat dihidrat natrijev hidrogenfosfat natrijev klorid kalijev klorid kalcijev klorid dihidrat magnezijev klorid heksahidrat natrijev hidroksid (za uravnavanje pH) klorovodikova kislina (za uravnavanje pH) voda za injekcije
English: If you are not sure, talk to your doctor or nurse before you or your child are given Spinraza.
Slovenian: Če ste negotovi, se posvetujte z zdravnikom ali medicinsko sestro, preden prejmete ali preden vaš otrok prejme zdravilo Spinraza.
English: Spinraza treated Patients
Slovenian: Bolniki, zdravljeni z zdravilom Spinraza
English: There have been reports of communicating hydrocephalus not related to meningitis or bleeding in patients treated with nusinersen in the post-marketing setting.
Slovenian: Pri bolnikih, zdravljenih z nusinersenom v obdobju trženja, so poročali o komunikantnem hidrocefalusu, ki ni bil povezan z meningitisom ali krvavitvijo.
English: The median time to death or permanent ventilation was 50.9 weeks after initiation of Spinraza treatment in Study CS11.
Slovenian: Po uvedbi zdravljenja z zdravilom Spinraza v študiji CS11 je vrednost mediane časa do smrti ali trajne ventilacije znašala 50,9 tedna.
English: A sustained improvement was seen in patients with Type II SMA who experienced a mean improvement from baseline HFMSE score of 5.1 (SD 4.05, n=11) at Day 253, and 9.1(SD 6.61, n=9) at Day 1050.
Slovenian: Trajno izboljšanje so ugotovili pri bolnikih s SMA tipa II, ki so se povprečno izboljšali z izhodiščnega rezultata 5,1 (SD 4,05, n=11) po 253 dneh,
English: Thrombocytopenia and coagulation abnormalities, including acute severe thrombocytopenia, have been observed after administration of other subcutaneously or intravenously administered antisense oligonucleotides.
Slovenian: Po dajanju drugih subkutano ali intravensko apliciranih protismiselnih oligonukleotidov so opazili trombocitopenijo in abnormalnosti koagulacije krvi, vključno z akutno hudo trombocitopenijo.
English: Sham-control Patients
Slovenian: Kontrolni bolniki na placebu
English: Biogen Spain SL Tel: +34 91 310 7110
Slovenian: Tel: +34 91 310 7110
English: Sedation may be required to administer Spinraza, as indicated by the clinical condition of the patient.
Slovenian: Glede na klinično stanje bolnika bo za dajanje zdravila Spinraza mogoče potrebna sedacija.
English: Pharma MT limited Tel: +356 213 37008/9
Slovenian: Tel: +356 213 37008/9
English: Each 5 ml vial contains nusinersen sodium equivalent to 12 mg nusinersen.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena 5 ml viala vsebuje natrijev nusinersenat, ki ustreza 12 mg nusinersena.
English: Icepharma hf Sími: +354 540 8000
Slovenian: Sími: +354 540 8000
English: Adverse reactions associated with the administration of Spinraza by lumbar puncture have been observed.
Slovenian: Opazili so neželene učinke, povezane z lumbalno punkcijo ob uporabi zdravila Spinraza.
English: At the interim analysis, all 25 (100%) patients had achieved the WHO motor milestone of sitting without support, 22 (88%) patients were walking with assistance.
Slovenian: sedenja brez opore, 22 (88 %) bolnikov pa je hodilo s podporo.
English: The median age when patients received their first dose was 164.5 days for treated patients, and 205 days for sham-control.
Slovenian: 99 % bolnikov je imelo po 2 kopiji gena SMN2 in je bilo zato zanje najverjetneje, da se bo razvila SMA tipa I. Mediana starost, pri kateri so bolniki prejeli prvi odmerek, je bila pri zdravljenih bolnikih 164,5 dni, pri kontrolnih bolnikih na placebu pa 205 dni.
English: Change from baseline in total HFMSE score at 15 months1,2,3
Slovenian: Spremembe povprečja najmanjših kvadratov HFMSE od izhodišča meseci
English: Biogen Idec (Ireland) Ltd. Tel: +353 (0)1 463 7799
Slovenian: Tel: +353 (0)1 463 7799
English: Potassium chloride
Slovenian: Toksičnost za ledvice
English: April 2023.
Slovenian: 265. dne.
English: Spinraza has not been studied in patients with hepatic impairment.
Slovenian: Pri bolnikih z okvaro jeter zdravila Spinraza niso proučevali.
English: How to store Spinraza
Slovenian: Shranjevanje zdravila Spinraza
English: 3At the final analysis, CHOP INTEND and motor milestone analyses were conducted using the Efficacy Set (Spinraza n=73; Sham-control n=37).
Slovenian: 3V končni analizi so opravili analize CHOP INTEND in motoričnih mejnikov z uporabo nabora za oceno učinkovitosti
English: It is essentially ‘sodium-free' and can be used by people on a sodium-restricted diet.
Slovenian: To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni ‘brez natrija' in ga lahko uporabljajo ljudje, ki so na dieti z nadzorovanim vnosom natrija.
English: 19.7% (95% CI: 10.9, p=0.0811
Slovenian: 19,7% (95-% IZ: 10,9,
English: Side effects related to the lumbar puncture may occur while Spinraza is being given or afterwards.
Slovenian: Med dajanjem ali po dajanju zdravila Spinraza se lahko pojavijo neželeni učinki, povezani z lumbalno punkcijo.
English: Clinical efficacy and safety
Slovenian: Klinična učinkovitost in varnost Simptomatični bolniki Začetek bolezni pri dojenčkih
English: • Back pain
Slovenian: • bolečina v hrbtu
English: Talk to your doctor before you or your child are given Spinraza.
Slovenian: Preden vam ali vašemu otroku dajo zdravilo Spinraza, se posvetujte z zdravnikom.