natgillin/translations-raw huggingface dataset:
Renal and urinary disorders Caution should be used and close monitoring considered when administering interferon beta to patients with severe renal failure.
Bolezni sečil Pri uporabi interferona beta pri bolnikih s hudo ledvično odpovedjo, je treba biti previden, bolnike pa pozorno spremljati.
Cardiac disorders Extavia should also be used with caution in patients who suffer from pre-existing cardiac disorders.
Srčne bolezni Zdravilo Extavia je treba uporabljati previdno pri bolnikih, ki imajo že obstoječe bolezni srca.
4 While Extavia does not have any known direct-acting cardiac toxicity, symptoms of the flu-like syndrome associated with beta interferons may prove stressful to patients with pre-existing significant cardiac disease.
4 Zdravilo Extavia nima znane neposredne toksičnosti za srce, vendar je lahko kompleks gripi podobnih simptomov, povezan z uporabo interferonov, za bolnike z obstoječo pomembno boleznijo srca stresen.
During the post-marketing period very rare reports have been received of worsening of cardiac status in patients with pre-existing significant cardiac disease temporarily associated with the initiation of Extavia therapy.
V postmarketinškem obdobju so prejeli zelo redka poročila o poslabšanju bolezni srca pri bolnikih z obstoječo boleznijo srca, do katerega je prišlo na začetku zdravljenja z zdravilom Extavia.
General disorders and administration site conditions Serious hypersensitivity reactions (rare but severe acute reactions such as bronchospasm, anaphylaxis and urticaria) may occur.
Splošne težave in spremembe na mestu aplikacije Lahko pride do resnih preobčutljivostnih reakcij (redke, vendar hude akutne reakcije, kot je bronhospazem, anafilaksa in urtikarija).
Injection site necrosis has been reported in patients using Extavia (see section 4.8).
Pri bolnikih, ki prejemajo zdravilo Extavia, so poročali o nekrozi na mestu injiciranja (glejte poglavje 4. 8).
If the patient experiences any break in the skin, which may be associated with swelling or drainage of fluid from the injection site, the patient should be advised to consult with his/ her physician before continuing injections with Extavia.
Če bolnik opazi poškodbo kože, ki je lahko povezana z otekanjem ali vlaženje na mestu injiciranja, mu je treba svetovati, da se pred nadaljevanjem injiciranja zdravila Extavia posvetuje z zdravnikom.
To minimise the risk of injection site necrosis patients should be advised to: − use an aseptic injection technique, − rotate the injection sites with each dose.
Za zmanjšanje tveganja za nekrozo na mestu injiciranja, je treba bolnikom svetovati, da: − uporabljajo aseptično tehniko injiciranja, − pri vsakem odmerku zamenjajo mesto injiciranja.
Immunogenicity As with all therapeutic proteins, there is a potential for immunogenicity.
Imunogenost Kot pri vseh beljakovinskih zdravilih, obstaja možnost nastanka imunogenosti.
Serum samples in controlled clinical trials were collected every 3 months for monitoring of development of antibodies to Extavia.
Za spremljanje nastanka protiteles proti zdravilu Extavia so v nadzorovanih kliničnih preskušanjih vsake 3 mesece odvzeli vzorce seruma.
In the different controlled clinical trials, between 23% and 41% of the patients developed serum interferon beta-1b neutralising activity confirmed by at least two consecutive positive titres; of these patients, between 43% and 55% converted to a stable antibody negative status (based on two consecutive negative titres) during the subsequent observational period of the respective study.
43% do 55% teh bolnikov je med poznejšim opazovalnim obdobjem posameznih preskušanj prišlo do konverzije v stabilni antigensko negativni status (na osnovi dveh zaporednih negativnih titrov).
In the study of patients with a single clinical event suggestive of multiple sclerosis, neutralising activity measured every 6 months was observed at least once in 32% (88) of the patients treated immediately with Extavia; of these, 47% (41) returned to negative status over a 3-year period.
V študiji pri bolnikih z enim samim kliničnim dogodkom, ki kaže na multiplo sklerozo, so nevtralizacijsko aktivnost, izmerjeno vsakih 6 mesecev, opazili vsaj enkrat pri 32% (88) bolnikov, ki so takoj prejeli zdravilo Extavia;. med njimi se jih je v triletnem obdobju 47% (41) vrnilo na negativni
5 New adverse events have not been associated with the development of neutralising activity.
V tem obdobju razvoj nevtralizacijske aktivnosti ni bil povezan z zmanjšanjem klinične učinkovitosti (glede na čas do klinično dokončne multiple skleroze (clinically definite multiple sclerosis (CDMS) in čas do potrjenega napredovanja na lestvici EDSS).
It has been demonstrated in vitro that Extavia cross-reacts with natural interferon beta.
Pojav nevtralizacijske aktivnosti ni bil povezan z novimi neželenimi učinki.
However, this has not been investigated in vivo and its clinical significance is uncertain.
In vitro je dokazano, da zdravilo Extavia navzkrižno reagira z naravnim interferonom beta, vendar to ni raziskano in vivo; klinični pomen tega ni gotov.
The effect of alternate-day administration of 250 microgram (8.0 million IU) of Extavia on drug metabolism in multiple sclerosis patients is unknown.
Učinek uporabe 250 mikrogramov (8, 0 milijonov i. e.) zdravila Extavia vsak drugi dan na presnovo zdravil pri bolnikih z multiplo sklerozo ni znan.
Corticosteroid or ACTH treatment of relapses for periods of up to 28 days has been well tolerated in patients receiving Extavia.
ACTH, ki je trajalo do 28 dni.
Caution should be exercised when Extavia is administered in combination with medicinal products that have a narrow therapeutic index and are largely dependent on the hepatic cytochrome P450 system for clearance, e. g. anti-epileptics.
Previdnost je potrebna pri sočasni uporabi zdravila Extavia in zdravil, ki imajo ozek terapevtski indeks in katerih očistek je v največji meri odvisen od jetrnega citokromalnega sistema P450 npr.: antiepileptiki.
Pregnancy There is limited information on the use of Extavia in pregnancy.
Nosečnost Informacije o uporabi zdravila Extavia med nosečnostjo so pomanjkljive.
Women of child-bearing potential Women of child-bearing potential should take appropriate contraceptive measures.
Ženske v rodni dobi Ženske v rodni dobi morajo med zdravljenjem uporabljati kontracepcijo.
If the patient becomes pregnant or plans to become pregnant while taking Extavia, she should be informed of the potential hazards and discontinuation of therapy should be considered (see section 5.3).
Če bolnica med uporabo zdravila Extavia zanosi ali načrtuje nosečnost, jo je treba seznaniti s potencialnimi nevarnostmi, v poštev pride prekinitev zdravljenja (glejte poglavje 5. 3).
In patients with a high relapse rate before treatment started, the risk of a severe relapse following discontinuation of Extavia in the event of pregnancy should be weighed against a possible increased risk of spontaneous abortion.
Pri bolnicah z visoko stopnjo relapsa je tveganje za resen relaps po prekinitvi zdravljenja z zdravilom Extavia med nosečnostjo potrebno pretehtati glede na povečano tveganje za spontani splav.
Lactation It is not known whether interferon beta-1b is excreted in human milk.
Dojenje Ni znano, ali se interferon beta- 1b izloča v materinem mleku.
Central nervous system-related adverse events associated with the use of Extavia might influence the ability to drive and use machines in susceptible patients.
Z zdravilom Extavia povezani neželeni učinki na osrednje živčevje bi pri dovzetnih bolnikih lahko vplivali na sposobnost vožnje in upravljanja s stroji.
6 4.8 Undesirable effects
6 4. 8 Neželeni učinki
Redness, swelling, discoloration, inflammation, pain, hypersensitivity, necrosis and non-specific reactions were significantly associated with 250 microgram (8 million IU) Extavia treatment.
Z uporabo 250 mikrogramov (8 milijonov i. e.) zdravila Extavia so statistično pomembno povezane naslednje reakcije: rdečica, otekanje, sprememba barve, vnetje, bolečina, preobčutljivost, nekroza in nespecifične reakcije.
Generally, dose titration is recommended at the start of treatment in order to increase tolerability to Extavia (see section 4.2).
Na splošno se na začetku zdravljenja priporoča titracija odmerka, da bi povečali toleranco za zdravilo Extavia (glejte poglavje 4. 2).
Flu-like symptoms may also be reduced by administration of non- steroidal anti-inflammatory medicinal products.
Bolezenski znaki podobni gripi se lahko zmanjšajo z uporabo nesteroidnih protivnetnih zdravil.
b) The following adverse event listing is based on reports from clinical trials (Table 1, adverse events and laboratory abnormalities) and from the post-marketing surveillance (Table 2, reporting rates based on spontaneous adverse drug reaction reports classified as 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) of Extavia use.
b) Spodnja seznama neželenih učinkov temeljita na poročilih iz kliničnih raziskav (preglednica 1, neželeni učinki in nenormalni rezultati laboratorijskih preiskav) in iz postmarketinškega nadzora (preglednica 2, pogostnost navedb, ki temelji na spontanih prijavah neželenih učinkov zdravila; razvrstitev: zelo pogosto ≥1/ 10, pogosto ≥1/ 100 do < 1/ 10, občasno ≥1/ 1, 000 do < 1/ 100, redko ≥1/ 10, 000 do 1/ 1, 000, zelo redko < 1/ 10, 000)) uporabe zdravila Extavia.
Adverse events and laboratory abnormalities with incidence rates ≥ 10% and the respective percentages under placebo; significantly associated side effects < 10%
Neželeni učinki in nenormalni rezultati laboratorijskih preiskav s pogostnostjo ≥10% in ustrezni odstotki pri placebu; statistično značilno povezani neželeni učinki < 10%
Class Single Event Secondary Secondary suggestive of Progressive Progressive
dogodek, ki kaže sekundarno sekundarno recidivno - na multiplo progresivna progresivna remitentna sklerozo
Relapsing- Remitting
neželeni učinek in
Multiple Multiple Multiple Sclerosis Sclerosis Sclerosis
multipla multipla multipla (BENEFIT) skleroza skleroza skleroza
Multiple Sclerosis
nenormalen rezultat laboratorijske
Laboratory Abnormalities
(evropska raziskava)
American Study)
(severnoameriš - ka raziskava)
Extavia
preiskave
Infection Abscess
mikrogramov (placebo) n=124 (n=123)
6% (3%) 0% (1%)
6% (3%) 0% (1%) sistema
Blood and lymphatic system disorders Lymphocyte count decreased (< 1500/ mm³) × Λ °
zmanjšano število limfocitov (< 1500/ mm³) × Λ °
Absolute neutrophil count decreased (< 1500/ mm³) × Λ *°
zmanjšano absolutno število nevtrofilcev (< 1500/ mm³) × Λ * °
White blood cell count decreased (< 3000/ mm³) × Λ *°
zmanjšano število levkocitov (< 3000/ mm³) × Λ * °
Metabolism and nutrition disorders Blood glucose decreased (< 55 mg/ dl) ×
Presnovne in prehranske motnje
7 System Organ Class
7 recidivno - sekundarno sekundarno Organski sistem
Single Event suggestive of
dogodek, ki kaže na multiplo
Secondary Secondary Progressive Progressive
progresivna multipla
Relapsing- Remitting
progresivna multipla
Adverse Event and Laboratory Abnormalities
neželeni učinek in
Multiple Sclerosis (BENEFIT)
sklerozo (BENEFIT)
Multiple Multiple Sclerosis Sclerosis (European (North Study) American Study)
skleroza
Multiple Sclerosis
nenormalen rezultat
Extavia
(evropska
Extavia Extavia
laboratorijske
Extavia
raziskava)
Psychiatric disorders
ka raziskava)
44% (41%) 10% (11%)
% (41%)% (11%)
Headache Λ Dizziness Insomnia Migraine Paraesthesia Eye disorders
glavobol Λ omotica nespečnost migrena parestezija Očesne bolezni
55% (46%) 28% (26%) 26% (25%) 5% (4%) 40% (43%)
% (46%)% (26%)% (25%)% (4%)% (43%)
Conjunctivitis Λ
konjunktivitis Λ
6% (6%)
6
Abnormal vision
motnje vida
11% (15%)
11
11% (11%)
% (11%)
Ear and labyrinth disorders Ear pain Cardiac disorders
Ušesne bolezni, vključno z motnjami labirinta bolečine v ušesu Srčne bolezni
Respiratory, thoracic and mediastinal disorders Upper respiratory infection
hipertenzija ° Bolezni dihal, prsnega koša
Sinusitis Cough increased Dyspnoea * Gastrointestinal disorders
stopnjevanje kašlja dispneja * Bolezni prebavil
24% (18%) 48% (49%) 21% (19%) 32% (24%)
21% (19%)
Alanine aminotransferase increased (SGPT > 5 times baseline) × Λ * °
Bolezni hepatobiliarnega sistema zvišane vrednosti alanin aminotransferaze (SGPT > 5- kratna izhodiščna vrednost) × Λ * °
Aspartate aminotransferase increased (SGOT > 5 times baseline) × Λ * °
mikrogramov mikrogramov mikrogramov mikrogramov (placebo) (placebo) (placebo) (Placebo) n=124 n=317 n=360 n=292 (n=123) (n=308) (n=358) (n=176) zvišane vrednosti aspartat aminotransferaze (SGOT > 5- kratna izhodiščna vrednost) × Λ * ° Bolezni kože in podkožja
6% (1%)
% (1%)
4% (1%)
% (1%)
Skin disorder Λ
kožne motnje Λ
19% (17%)
% (17%)
Back pain
bolečine v hrbtu bolečine v okončinah Bolezni sečil
36% (37%)
36% 0%
0% (0%)
(37%) (0%)
Reproductive system and breast disorders Dysmenorrhoea
dismenoreja
Menstrual disorder *
menstruacijske motnje *
General disorders and administration site conditions Injection site reaction (various kinds) Λ * ° §
Splošne težave in spremembe na mestu aplikacije reakcija na injekcijskem mestu (različne vrste) Λ * ° §
* °
nekroza na injekcijskem mestu * °
Flu-like symptoms Fever Λ * ° Pain Chest pain ° Peripheral oedema Asthenia * Λ
gripi podobni simptomi & Λ * °
*°
13% (5%)
44% (18%) 13% (5%) 4% (4%) 1% (0%) 0% (0%) 22% (17%)
4% (4%) 1% (0%) 0% (0%) 22% (17%)
61% (40%) 40% (13%) 31% (25%) 5% (4%) 7% (7%) 63% (58%)
31% (25%) 5% (4%) 7% (7%) 63% (58%)
43% (33%) 29% (24%) 59% (59%) 15% (8%) 21% (18%) 64% (58%)
59% (59%) 15% (8%) 21% (18%) 64% (58%)
52% (48%) 59% (41%) 52% (48%) 15% (15%) 7% (8%) 49% (35%)
52% (48%) 15% (15%) 7% (8%) 49% (35%)
Chills * ° Sweating * Malaise * ×
dogodek, ki kaže na multiplo
Laboratory abnormality Λ Significantly associated with Extavia treatment for patients with first event suggestive of MS, p < 0.05 * Significantly associated with Extavia treatment for RRMS, p < 0.05 ° Significantly associated with Extavia treatment for SPMS, p < 0.05 § Injection site reaction (various kinds) comprises all adverse events occurring at the injection site, i. e. the following terms: injection site haemorrhage, injection site hypersensitivity, injection site inflammation, injection site mass, injection site necrosis, injection site pain, injection site reaction, injection site oedema, and injection site atrophy & “ Flu-like symptom complex” denotes flu syndrome and/ or a combination of at least two adverse events from fever, chills, myalgia, malaise, sweating.
nenormalen rezultat laboratorijske preiskave Λ pomembno povezano z zdravljenjem z zdravilom Extavia pri bolnikih s prvim dogodkom, ki kaže na MS, p < 0, 05 * statistično značilno povezano z uporabo zdravila Extavia pri RRMS, p < 0, 05 ° statistično značilno povezano z uporabo zdravila Extavia pri SPMS, p < 0, 05 § reakcije na mestu injiciranja (različne vrste) sestavljajo vsi neželeni učinki na mestu injiciranja, tj. naslednji učinki: krvavitev na mestu injiciranja, preobčutljivost na mestu injiciranja, vnetje na mestu injiciranja, masa na mestu injiciranja, nekroza na mestu injiciranja, bolečina na mestu injiciranja, reakcija na mestu injiciranja, edem na mestu injiciranja in atrofija na mestu injiciranja & “ kompleks gripi podobnih simptomov ” pomeni sindrom gripe in/ ali kombinacijo vsaj dveh izmed naslednjih neželenih učinkov: povišana telesna temperatura, mrzlica, mialgija, občutek neugodja, potenje.
9 The most appropriate MedDRA term is used to describe a certain reaction and its synonyms and related conditions.
Za opis določene reakcije je uporabljen najustreznejši izraz po MedDRA, njegove sopomenke in povezana stanja.
Reporting rates (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) based on spontaneous adverse drug reaction reports
Pogostnost navedb (zelo pogosto ≥1/ 10, pogosto ≥1/ 100 do < 1/ 10, občasno ≥1/ 1, 000 do < 1/ 100, redko ≥1/ 10, 000 do < 1/ 1, 000, zelo redko < 1/ 10, 000) temelji na spontanih prijavah neželenih učinkov zdravila.
Very common Common Uncommon Rare ≥ 1/ 10 ≥ 1/ 100 to < 1/ 10 ≥ 1/ 1,000 to < 1/ 100 ≥ 1/ 10,000 to < 1/ 1,000
Zelo pogosto Pogosto Občasno Redko ≥1/ 10 ≥1/ 100 do < 1/ 10 ≥1/ 1. 000 do ≥1/ 10. 000 do < 1/ 100 < 1/ 1000
Blood and
anemija, trombocitopenija, levkopenija
Anemia, Lymphadenopathy
10 Redko Organski sistem
lymphatic system disorders Immune system disorders Endocrine disorders
≥1/ 10
Thrombocytopenia, Leukopenia
≥1/ 100 do < 1/ 10
Anaphylactic reactions Hyperthyroidism, Hypothyroidism, Thyroid disorder
≥1/ 1. 000 do < 1/ 100
Metabolism and nutrition disorders
Psihiatrične motnje
Blood triglycerides increased, Anorexia
Depresija (glejte
Psychiatric disorders
Bolezni živčevja Srčne bolezni Žilne bolezni Bolezni dihal, prsnega koša in mediastinalnega prostora
Depression (see also section 4.4)
poglavje 4. 4) hipertenzija
Confusion, Anxiety, Emotional lability, Suicide attempt (see also section 4.4)
tesnoba, emocionalna labilnost, poskus samomora (glejte poglavje 4. 4) konvulzije kardiomiopatija, tahikardija, palpitacije bronhospazem, dispneja
Convulsion
bruhanje, navzeja
Cardiac disorders
pankreatitis
Cardiomyopathy, Tachycardia, Palpitation
Bolezni jeter,
Vascular disorders
povečane
Hypertension
povečane
Respiratory, thoracic and mediastinal disorders
žolčnika in
Bronchospasm, Dyspnoea
vrednosti amino
Gastrointestinal disorders
vrednosti
Vomiting, Nausea
žolčevodov
Pancreatitis
transferaze,
Hepatobiliary disorders
bilirubina v krvi,
Alanine amino- transferase increased, Aspartate amino- transferase increased
povečane vrednosti aspartat amino transferaze.
Blood bilirubin increased, Gamma-glutamyl- transferase increased, Hepatitis
povečane vrednosti gamaglutamil - transferaze, hepatitis
Skin and subcutaneous tissue disorders
Bolezni kože in podkožja Bolezni mišično - skeletnega sistema, vezivnega tkiva in kosti Motnje reprodukcije in dojk
Urticaria, Rash, Pruritus, Alopecia
razbarvanje kože menstrualne motnje
Skin discolouration
Splošne težave in
Musculoskeletal, connective tissue and bone disorders
znaki, podobni
Myalgia, Hypertonia
nekroza na mestu
10 System Organ Class
bolečine v prsnem
Very common ≥ 1/ 10
spremembe na
Common ≥ 1/ 100 to < 1/ 10
gripi *, mrzlica *,
Uncommon ≥ 1/ 1,000 to < 1/ 100
injiciranja *
Rare ≥ 1/ 10,000 to < 1/ 1,000
košu, splošno
Reproductive system and breast disorders
mestu aplikacije
Menstrual disorder
povečana telesna
General disorders and administration site conditions
slabo počutje,
Injection site necrosis*
Preiskave
Chest pain, Malaise, Sweating
temperatura *, reakcije na mestu injiciranja *, vnetje na mestu injiciranja *, bolečina na mestu injiciranja
Weight decrease
potenje Zmanjšanje telesne teže
* frequencies based on clinical trials
* pogostnost na temelju kliničnih preskušanj
Interferon beta-1b has been given without serious adverse events compromising vital functions to adult cancer patients at individual doses as high as 5,500 microgram (176 million IU) intravenously three times a week.
Interferon beta- 1b so brez resnih neželenih učinkov, ki bi ogrozili vitalne funkcije, dajali odraslim bolnikom z rakom v individualnih odmerkih do 5, 500 mikrogramov (176 milijonov i. e.) intravensko trikrat na teden.
Interferons, ATC Code:
Farmakoterapevtska skupina: interferoni, oznaka ATC:
The activities of interferon beta-1b are species-restricted and therefore, the most pertinent pharmacological information on interferon beta-1b is derived from studies of human cells in culture or in human in vivo studies.
Delovanje interferona beta- 1b je omejeno na vrsto, zato najrelevantnejše informacije o farmakologiji interferona beta- 1b izvirajo iz raziskav človeških celic v kulturah in iz in vivo študij pri ljudeh.
However, it is known that the biological response-modifying properties of interferon beta-1b are mediated through its interactions with specific cell receptors found on the surface of human cells.
Znano pa je, da se tiste lastnosti interferona beta - 1b, ki spreminjajo biološki odziv, posredujejo prek njegovih interakcij s specifičnimi celičnimi receptorji na površini človeških celic.
Interferon beta-1b both decreases the binding affinity and enhances the internalisation and degradation of the interferon-gamma receptor.
Interferon beta- 1b zmanjšuje vezavno afiniteto receptorja interferona gama in povečuje njegovo internalizacijo in degradacijo.
11 Clinical trials Relapsing-remitting multiple sclerosis (RR-MS) One controlled clinical trial with Extavia in patients with relapsing-remitting multiple sclerosis and able to walk unaided (baseline EDSS 0 to 5.5) was performed.
Recidivno- remitentna multipla skleroza (RRMS) Opravljena je bila ena kontrolirana klinična raziskava zdravila Extavia pri bolnikih z recidivno - remitentno multiplo sklerozo, ki so lahko hodili brez pomoči (izhodiščni EDSS 0 do 5, 5).
Patients receiving Extavia showed a reduction in frequency (30%) and severity of clinical relapses, as well as the number of hospitalisations due to disease.
Bolniki, ki so dobivali zdravilo Extavia, so imeli redkejše (30%) in manj hude klinične recidive in manj hospitalizacij zaradi bolezni.
There is no evidence of an effect of Extavia on the duration of relapses or on symptoms in between relapses, and no significant effect was seen on the progression of the disease in relapsing-remitting multiple sclerosis.
Ni dokazov, da bi zdravilo Extavia vplivalo na trajanje recidivov ali na simptome med recidivi, in opazili niso nobenega pomembnega vpliva na napredovanje bolezni pri recidivno- remitentni multipli sklerozi.
Secondary progressive multiple sclerosis (SP-MS) Two controlled clinical trials with Extavia involving a total of 1,657 patients with secondary progressive multiple sclerosis (baseline EDSS 3 to 6.5, i. e. patients were able to walk) were performed.
Sekundarno progresivna multipla skelroza (SPMS) Narejeni sta bili dve kontrolirani klinični raziskavi z zdravilom Extavia, ki sta skupaj zajeli 1. 657 bolnikov s sekundarno progresivno multiplo sklerozo (izhodiščni EDSS 3 do 6, 5, tj. bolniki so lahko hodili).
One of the two studies demonstrated a statistically significant delay in the time to disability progression (Hazard Ratio = 0.69, 95% confidence interval (0.55, 0.86), p=0.0010, corresponding to a 31% risk reduction due to Extavia) and in the time to becoming wheelchair-bound (Hazard Ratio = 0.61, 95% confidence interval (0.44, 0.85), p=0.0036, corresponding to a 39% risk reduction due to Extavia) in patients who received Extavia.
Prva od njiju je pri bolnikih, ki so dobivali zdravilo Extavia, ugotovila statistično značilen odlog do napredovanja invalidnosti (razmerje tveganja = 0, 69, 95% interval zaupanja (0, 55, 0, 86), p=0, 0010, kar ustreza 31% zmanjšanju tveganja zaradi zdravila Extavia) in do priklenjenosti na voziček (razmerje tveganja = 0, 61, 95% interval zaupanja (0, 44, 0, 85), p=0, 0036, kar ustreza 39% zmanjšanju tveganja zaradi zdravila Extavia).
In the second trial of Extavia in secondary progressive multiple sclerosis, no delay in the time to disability progression was observed.
12 V drugi raziskavi zdravila Extavia pri sekundarno progresivni multipli sklerozi niso opazili odloga do napredovanja invalidnosti.
In retrospective meta-analyses including the data of both studies, an overall treatment effect was found which was statistically significant (p=0.0076; 8 million IU Extavia versus all placebo patients).
Z retrospektivno metaanalizo podatkov obeh raziskav so ugotovili statistično značilen celotni učinek zdravljenja (p=0, 0076; 8 milijonov i. e. zdravila Extavia v primerjavi z vsemi bolniki na placebu).