natgillin/translations-raw huggingface dataset:
Hepatic injury including elevated serum hepatic enzyme levels, hepatitis, autoimmune hepatitis and hepatic failure has been reported with interferon beta in post-marketing (see section 4.8).
V okviru postmarketinških izkušenj (glejte poglavje 4. 8) so pri uporabi interferona beta poročali o poškodbah jeter, vključno z zvišanimi vrednostmi jetrnih encimov v serumu, hepatitisom, avtoimunskim hepatitisom in jetrno odpovedjo.
The potential of additive effects from multiple medicinal products or other hepatotoxic agents (e. g. alcohol) has not been determined.
Možnosti aditivnega delovanja večih zdravil ali drugih hepatotoksičnih snovi (npr. alkohola) niso ugotovili.
3 Patients with cardiac disease, such as angina, congestive heart failure or arrhythmia, should be closely monitored for worsening of their clinical condition during treatment with AVONEX.
3 Bolnike s srčnimi boleznimi, kot so npr. angina pektoris, srčno popuščanje ali aritmija, je potrebno natančno opazovati, da se jim klinično stanje med zdravljenjem z zdravilom AVONEX ne poslabša.
Therefore, in addition to those laboratory tests normally required for monitoring patients with MS, complete and differential white blood cell counts, platelet counts, and blood chemistry, including liver function tests, are recommended during AVONEX therapy.
Zato je med zdravljenjem z zdravilom AVONEX za spremljanje bolnikov z MS, poleg teh laboratorijskih testov, priporočeno opazovati še celotno in diferencialno krvno sliko, število trombocitov in teste krvne sestave, vključno s testi delovanja jeter.
Patients may develop antibodies to AVONEX.
Bolniki lahko razvijejo protitelesa za AVONEX.
The antibodies of some of those patients reduce the activity of interferon beta-1a in vitro (neutralising antibodies).
Protitelesa pri nekaterih bolnikih zmanjšujejo aktivnost interferona beta- 1a in vitro (nevtralizirajoča protitelesa).
Data from patients treated up to two years with AVONEX suggests that approximately 8% develop neutralising antibodies.
Podatki o bolnikih, zdravljenih z zdravilom AVONEX do dve leti, kažejo, da približno 8% teh bolnikov razvije nevtralizirajoča protitelesa.
The use of various assays to detect serum antibodies to interferons limits the ability to compare antigenicity among different products.
Uporaba raznih analiz, da bi odkrili serumska protitelesa za interferone, omejuje zmožnost za primerjavo antigenosti med različnimi zdravili.
No formal interaction studies have been performed in humans.
Pri ljudeh niso izvedli nobenih uradnih študij medsebojnega delovanja.
The effect of high-dose AVONEX administration on P450-dependent metabolism in monkeys was evaluated and no changes in liver metabolising capabilities were observed.
Sprememb pri presnovnih zmožnostih jeter ni bilo.
Caution should be exercised when AVONEX 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. antiepileptics and some classes of antidepressants.
Previdno je potrebno ravnati pri dajanju zdravila AVONEX v kombinaciji z zdravili, ki imajo ozek terapevtski indeks in so za odstranitev v veliki meri odvisni od sistema jetrnega citokroma P450, npr. antiepileptiki in nekatere vrste antidepresivov.
There is limited information on the use of AVONEX in pregnancy.
Ni zadostnih podatkov o uporabi zdravila AVONEX pri nosečnicah.
Initiation of treatment is contraindicated during pregnancy (see section 4.3).
Uvedba zdravljenja med nosečnostjo je kontraindicirana (glejte poglavje 4. 3).
If the patient becomes pregnant or plans to become pregnant while taking AVONEX she should be informed of the potential hazards and discontinuation of therapy should be considered (see section 5.3).
Bolnice, ki načrtujejo nosečnost, in tiste, ki zanosijo, je potrebno seznaniti z možnimi nevarnostmi in zdravljenje z zdravilom AVONEX po potrebi prekiniti (glejte poglavje 5. 3).
In patients with a high relapse rate before treatment started, the risk of a severe relapse following discontinuation of AVONEX in the event of pregnancy should be weighed against a possible increased risk of spontaneous abortion.
Pri bolnikih, ki se jim je bolezen pred začetkom zdravljenja velikokrat ponavljala, je treba pretehtati smiselnost uporabe zdravila AVONEX v nosečnosti, glede na tveganje spontanega abortusa ali hujše ponovitve bolezni po prekinitvi zdravljenja.
4 Lactation
4 Dojenje
It is not known whether AVONEX is excreted in human milk.
Ni znano, ali se AVONEX izloča v materino mleko.
Because of the potential for serious adverse reactions in nursing infants, a decision should be made either to discontinue breast-feeding or AVONEX therapy.
Zaradi možnosti resnih neželenih učinkov pri dojenih otrocih, se je potrebno odločiti za prekinitev dojenja ali zdravljenja z zdravilom AVONEX.
Central nervous system-related adverse reactions may have a minor influence on the ability to drive and use machines in susceptible patients (see section 4.8).
Neželene reakcije centralnega živčnega sistema lahko pri občutljivih bolnikih nekoliko vplivajo na njihovo sposobnost vožnje in upravljanja s stroji (glejte poglavje 4. 8).
Flu-like symptoms tend to be most prominent at the initiation of therapy and decrease in frequency with continued treatment.
Gripi podobni simptomi so običajno najbolj izraženi na začetku zdravljenja, z nadaljnjim zdravljenjem pa njihova pogostost upada.
Transient episodes of hypertonia and/ or severe muscular weakness that prevent voluntary movements may occur at any time during treatment.
Kadar koli v poteku zdravljenja lahko nastopijo tudi prehodne epizode oz. napadi hipertonije in/ ali hude mišične šibkosti, ki preprečujejo hotne gibe.
The frequencies of adverse reactions are expressed in patient-years, according to the following categories:
Pogostosti neželenih pojavov so izražene z enoto bolnikov- let, po naslednjih kategorijah:
Very common (≥ 1/ 10 patient-years); Common (≥ 1/ 100 to < 1/ 10 patient-years); Uncommon (≥ 1/ 1, 000 to < 1/ 100 patient-years); Rare (≥ 1/ 10, 000 to < 1/ 1,000 patient-years); Very rare (< 1/ 10,000 patient-years); Not known (cannot be estimated from the available data).
Zelo pogosti (≥1/ 10 bolnikov- let); Pogosti (≥1/ 100 do < 1/ 10 bolnikov- let); Občasni (≥1/ 1. 000 do < 1/ 100 bolnikov- let); Redki (≥1/ 10. 000 do < 1/ 1. 000 bolnikov- let); Zelo redki (< 1/ 10. 000 bolnikov- let); Neznana (ni mogoče oceniti iz razpoložljivih podatkov).
Adverse reactions identified from studies (clinical trials and observational studies, with a period of follow-up ranging from two years to six years) and other adverse reactions identified through spontaneous reporting from the market, with unknown frequency, are provided in the table below.
Neželeni učinki, ki so jih razkrile študije (klinična preskušanja in opazovalne študije z dolžino spremljanja bolnikov od dveh do šestih let), in drugi neželeni učinki, opredeljeni v spontanih poročilih s tržišča, z neznano pogostostjo, so navedeni v spodnji razpredelnici.
5 Investigations
5 Preiskave
lymphocyte count decreased, white blood cell count decreased, neutrophil count decreased, hematocrit decreased, blood potassium increased, blood urea nitrogen increased
zmanjšano število limfocitov, zmanjšano pogosti število levkocitov, zmanjšano število nevrofilcev, znižan hematokrit, povečana vsebnost kalija v krvi, povečana vsebnost dušika iz sečnine v krvi
uncommon
občasni
platelet count decreased
zmanjšano število trombocitov
weight decreased, weight increased, liver function tests abnormal
zmanjšanje telesne mase, povečanje telesne mase, nenormalni jetrni testi
cardiomyopathy, congestive heart failure (see section 4.4), palpitations, arrhythmia, tachycardia
kardiomiopatija, kongestivno srčno neznana popuščanje (glejte poglavje 4. 4), palpitacije, aritmija, tahikardija
pancytopenia, thrombocytopenia
pancitopenija, trombocitopenija neznana
very common
glavobol2 zelo pogosti
muscle spasticity, hypoesthesia
spastičnost mišic, hipestezija
rhinorrhoea
rinoreja pogosti
dyspnoea
dispneja redki
vomiting, diarrhoea, nausea2
bruhanje, driska, navzea2 pogosti
rash, sweating increased, contusion
izpuščaj, povečano znojenje, kontuzija pogosti
angioneurotic oedema, pruritus, rash vesicular, urticaria, aggravation of psoriasis
angionevrotski edem, pruritus, vezikularni izpuščaj, urtikarija, poslabšanje psoriaze
6 Musculoskeletal and connective tissue disorders
6 Bolezni mišično- skeletnega sistema in vezivnega tkiva
muscle cramp, neck pain, myalgia2, arthralgia, pain in extremity, back pain, muscle stiffness, musculoskeletal stiffness
mišični krči, bolečine v vratu, mialgija2, pogosti artralgija, bolečine v udih, bolečine v hrbtu, mišična togost, mišično- skeletna togost
hypothyroidism, hyperthyroidism
hipotiroidizem, hipertiroidizem neznana
anorexia
anoreksija pogosti
injection site abscess1
absces na mestu injiciranja1 neznana
common
navali vročine pogosti
flushing
neznana
not known
vazodilatacija
vasodilatation
Splošne težave in spremembe na mestu aplikacije
General disorders and administration site conditions
gripi podobni simptomi, pireksija2, mrzlica2, zelo pogosti znojenje2
very common
pogosti
injection site pain, injection site erythema,
bolečina na mestu injiciranja, eritem na mestu injiciranja, podplutba na mestu injiciranja, astenija2, bolečina, utrujenost2, občutek neugodja, nočno znojenje
common
občasni
injection site bruising, asthenia2, pain, fatigue2, malaise, night sweats
pekoč občutek na mestu injiciranja
injection site burning uncommon injection site reaction, injection site not known
neznana
inflammation, injection site cellulitis1, injection site necrosis, injection site bleeding, chest pain
reakcija na mestu injiciranja, vneto mesto injiciranja, celulitis na mestu injiciranja1, nekroza na mestu injiciranja, krvavitev na mestu injiciranja, bolečina v prsih
anaphylactic reaction, anaphylactic shock, hypersensitivity reactions (angioedema, dyspnoea, urticaria, rash, pruritic rash)
anafilaktična reakcija, anafilaktični šok, neznana preobčutljivostne reakcije (angioedem, dispneja, urtikarija, izpuščaj, srbeč izpuščaj)
7 Hepatobiliary disorders
7 Bolezni jeter, žolčnika in žolčevodov
hepatic failure (see section 4.4), hepatitis, autoimmune hepatitis
jetrna odpoved (glejte poglavje 4. 4), neznana hepatitis, avtoimunski hepatitis
metrorrhagia, menorrhagia
metroragija, menoragija občasni
depression (see section 4.4), insomnia
depresija (glejte poglavje 4. 4), nespečnost pogosti
not known
samomor, psihoza, anksioznost, zmedenost, neznana
suicide, psychosis, anxiety, confusion, emotional lability
čustvena nestabilnost
1 Injection site reactions including pain, inflammation and very rare cases of abscess or cellulitis that may require surgical intervention have been reported.
1 Poročali so o reakcijah na mestu injiciranja zdravila, vključno z bolečino, vnetjem in zelo redkimi primeri abscesa ali celulitisa, pri katerih je lahko potreben kirurški poseg.
2 The frequency of occurrence is higher at the beginning of treatment.
2 Pogostost pojavljanja je večja ob začetku zdravljenja.
3 A syncope episode may occur after AVONEX injection, it is normally a single episode that usually appears at the beginning of the treatment and does not recur with subsequent injections.
Običajno gre za enkraten pojav, navadno na začetku zdravljenja, ki se ne ponovi pri naslednjih injekcijah zdravila.
Interferons, ATC code:
Farmakoterapevtska skupina: interferoni, oznaka ATC:
Natural interferon beta and AVONEX (interferon beta-1a) are glycosylated and have a single N-linked complex carbohydrate moiety.
Naravni interferon beta in AVONEX (interferon beta- 1a) sta glikozilirana in imata en N- členski kompleksen ogljikovodikov del.
AVONEX exerts its biological effects by binding to specific receptors on the surface of human cells.
AVONEX doseže svoj biološki učinek s tem, da se veže na specifične receptorje na površini človeških celic.
These include MHC Class I, Mx protein, 2’ / 5’ -oligoadenylate synthetase, β 2-microglobulin, and neopterin.
Ti vključujejo MHC razreda I, protein Mx, 2 ’ / 5 ’ – oligoadenilat ligaza, β2 mikroglobulin in neopterin.
Some of these products have been 8 measured in the serum and cellular fractions of blood collected from patients treated with AVONEX.
Po enem samem
After a single intramuscular dose of AVONEX, serum levels of these products remain elevated for at least four days and up to one week.
8 intramuskularnem odmerku zdravila AVONEX so ostale ravni teh produktov v serumu dvignjene vsaj štiri dni in do enega tedna.
The effects of lyophilised AVONEX in the treatment of MS were demonstrated in a placebo- controlled study of 301 patients (AVONEX n=158, placebo n=143) with relapsing MS characterised by at least 2 exacerbations in the previous 3 years or at least one exacerbation per year prior to entry when the duration of the disease was less than 3 years.
Učinki liofiliziranega zdravila AVONEX pri zdravljenju MS so bili prikazani v s placebom kontrolirani študiji, opravljeni na 301 bolniku (AVONEX n=158, placebo n=143) s ponavljajočo se multiplo sklerozo, ki so preteklih treh let doživeli vsaj dva povratna napada nevrološke disfunkcije (relapsa) ali vsaj enim zagonom na leto pred vstopom v študijo, ce je cas trajanja bolezni krajši od treh let.
Patients with an EDSS of 1.0 to 3.5 at entry were included in the clinical trial.
V klinicno študijo so bili vkljuceni bolniki, ki so pri vstopu v študijo imeli EDSS od 1 do 3, 5..
150 AVONEX-treated patients completed one year on study and 85 completed two years on study.
Bolniki so pri študiji, zaradi njene oblike, sodelovali različno dolgo; 150 bolnikov, zdravljenih z zdravilom AVONEX je pri študiji sodelovalo eno leto, 85 bolnikov pa je pri študiji sodelovalo dve leti.
In the study, the cumulative percentage of patients who developed disability progression (by Kaplan-Meier life table analysis) by the end of two years was 35% for placebo-treated patients and 22% for AVONEX-treated patients.
Napredovanje prizadetosti pri bolnikih, zdravljenih z zdravilom AVONEX, se je pojavilo pri 22% bolnikov.
Disability progression was measured as an increase in the Expanded Disability Status Scale (EDSS) of 1.0 point, sustained for at least six months.
To stanje je moralo trajati vsaj šest mesecev.
A double-blind randomised dose comparison study of 802 relapsing MS patients (AVONEX 30 micrograms n=402, AVONEX 60 micrograms n=400) has shown no statistically significant differences or trends between the 30 micrograms and the 60 micrograms doses of AVONEX in clinical and general MRI parameters.
Randomizirana, dvojno slepa študija primerjave odmerkov, pri kateri sta sodelovala 802 bolnika s ponavljajočo se MS (AVONEX 30 mikrogramov n=402, AVONEX 60 mikrogramov n=400) pri kliničnih in splošnih MRI parametrih ni pokazala statistično pomembnih razlik ali trendov med 30 mikrogramskimi in 60 mikrogramskimi odmerki zdravila AVONEX.
The effects of AVONEX in the treatment of MS were also demonstrated in a randomised double-blind study performed with 383 patients (AVONEX n=193, placebo n=190) with a single demyelinating event associated with at least two compatible brain MRI lesions.
Učinki zdravila AVONEX pri zdravljenju MS so bili prikazani tudi na randomizirani, dvojno slepi študiji, opravljeni na 383 bolnikih (AVONEX n=193, placebo n=190), z enim demielinizirajočim napadom, povezanim z vsaj dvema kompatibilnima možganskima MRI poškodbama.
The estimated risk of a second event was 50% in three years and 39% in two years in the placebo group and 35% (three years) and 21% (two years) in the AVONEX group.
Ocenjeno tveganje drugega dogodka je bilo 50% v treh letih in 39% v dveh letih za bolnike, zdravljene s placebom, in 35% (tri leta) ter 21% (dve leti) za bolnike, zdravljene z zdravilom AVONEX.
In a post-hoc analysis, those patients with a baseline MRI with at least one Gd-enhancing lesion and nine T2 lesions had a two-year risk of suffering a second event of 56% in the placebo group and 21% in the AVONEX treatment group.
V post hoc analizi se je pri bolnikih z osnovno mejo MRI z vsaj enim Gd- stopnjevanjem poškodb in devetimi T2 poškodbami pokazala 56% možnost drugega napada pri bolnikih, zdravljenih s placebom, in 21% možnost drugega napada pri bolnikih, zdravljenih z zdravilom AVONEX.
Furthermore, for the time-being there is no well established definition of a high risk patient although a more conservative approach is to accept at least nine T2 hyperintense lesions on the initial scan and at least one new T2 or one new Gd-enhancing lesion on a follow-up scan taken at least three months after the initial scan.
Nadalje, trenutno ne obstaja nobena dobro osnovana definicija bolnika z visokim tveganjem, čeprav bolj konzervativen pristop dovoljuje vsaj devet T2 hiperintenzivnih poškodb pri prvem pregledu in vsaj eno novo T2 ali eno novo Gd- stopnjevano poškodbo na naslednjem pregledu, ki mora biti opravljen vsaj tri mesece po prvem pregledu.
With appropriate adjustment for the rate of absorption from the injection site, the calculated bioavailability is approximately 40%.
Ob ustreznem upoštevanju hitrosti absorpcije z mesta injiciranja znaša izračunana biološka uporabnost približno 40%.
Intramuscular bioavailability is three-fold higher than subcutaneous bioavailability.
Intramuskularna biološka uporabnost je trikrat večja kot subkutana.
9 5.3 Preclinical safety data
9 5. 3 Predklinični podatki o varnosti
No carcinogenicity data for interferon beta-1a are available in animals or humans.
Karcinogeneza: o karcinogenosti interferona beta- 1a pri ljudeh in živalih ni na voljo nobenih podatkov.
In a 26-week, repeated-dose toxicity study in rhesus monkeys by intramuscular route once per week, administered in combination with another immunomodulating agent, an anti CD40 ligand monoclonal antibody, no immune response toward interferon beta-1a and no signs of toxicity were demonstrated.
Rezultati študije kažejo, da ni imunskega odziva na interferon beta- 1a, niti se niso pokazali znaki toksičnosti.
Intramuscular irritation has not been evaluated in animals following repeated administration to the same injection site.
Lokalna toleranca: intramuskularna iritacija pri živalih po večkratni aplikaciji zdravila na isto mesto ni bila določena.
Limited but relevant mutagenesis tests have been carried out.
Mutageneza: izvedeni so bili omejeni, a pomembni testi mutageneze.
Impairment of Fertility:
Vpliv na plodnost:
Fertility and developmental studies in rhesus monkeys have been carried out with a related form of interferon beta-1a.
Študije plodnosti in razvoja so opravili pri opicah Rhesus s sorodno obliko interferona beta- 1a.
At very high doses, anovulatory and abortifacient effects in test animals were observed.
Pri zelo velikih odmerkih so pri poskusnih živalih opazili anovulacijske in abortivne učinke.
No teratogenic effects or effects on foetal development have been observed, but the available information on the effects of interferon beta-1a in the peri- and postnatal periods is limited.
Teratogenih učinkov in vpliva na razvoj fetusa ni bilo moč opaziti, a informacije, ki so na voljo o učinkih interferona beta- 1a v perinatalnem in postnatalnem obdobju, so skope.
No information is available on the effects of interferon beta-1a on male fertility.
Podatki o učinku interferona beta- 1a na plodnost moških niso na voljo.
Human serum albumin, Dibasic sodium phosphate, Monobasic sodium phosphate, Sodium chloride.
Humani serumski albumin, natrijev hidrogenfosfat, natrijev dihidrogenfosfat, natrijev klorid.
AVONEX should be administered as soon as possible after reconstitution.
AVONEX je treba aplicirati kar se da neposredno po rekonstituciji.
However, the reconstituted solution can be stored at 2 °C-8 °C for up to six hours, prior to injection.
Vendar pa lahko rekonstituirano raztopino shranjujemo pri temperaturi 2 °C – 8 °C do 6 ur pred injiciranjem.
For storage conditions of the reconstituted medicinal product see section 6.3.
Za pogoje shranjevanja rekonstituiranega zdravila glejte poglavje 6. 3.
10 Nature and contents of container
10 6. 5 Vrsta ovojnine in vsebina
AVONEX is available as a package of four individual doses.
AVONEX je na voljo v pakiranju s štirimi posameznimi odmerki.
Each dose is supplied in a 3 ml clear glass vial with BIO-SET device and a 13 mm bromobutyl rubber stopper.
Vsak odmerek je v 3 ml viali z BIO- SET nastavkom in s 13 mm brombutilovim gumijastim zamaškom.
Inject the content of the syringe into the vial of AVONEX by connecting the pre-filled syringe to the BIO-SET device.
Vsebino injekcijske brizge vbrizgajte v vialo zdravila AVONEX tako, da napolnjeno injekcijsko brizgo povežete z BIO- SET nastavkom.
Inspect the reconstituted product:
Rekonstituirano zdravilo preglejte.
If it contains particulate matter or is other than colourless to slightly yellow in colour, the vial must not be used.
Raztopina mora biti brezbarvna do rahlo rumene barve; če vsebuje delce snovi ali je kakšne druge barve, viale ne smete uporabiti.
After reconstitution, draw all the liquid (1 ml) from the vial back into the syringe for the administration of 30 micrograms AVONEX.
Za uporabo 30 μg zdravila AVONEX po rekonstituciji potegnite vso tekočino (1 ml) iz viale nazaj v injekcijsko brizgo (oznaka na napolnjeni injekcijski brizgi).
BIOGEN IDEC LIMITED Innovation House 70 Norden Road Maidenhead Berkshire SL6 4AY United Kingdom
BIOGEN IDEC LIMITED Innovation House 70 Norden Road Maidenhead Berkshire SL6 4AY Velika Britanija
13 March 1997 Date of latest renewal:
13. marec 1997 Datum zadnjega podaljšanja:
AVONEX 30 micrograms/ 0.5 ml solution for injection.
AVONEX 30 mikrogramov/ 0, 5 ml raztopina za injiciranje.
Each 0.5 ml pre-filled syringe contains 30 micrograms (6 million IU) of interferon beta-1a.
Vsaka 0, 5 ml napolnjena injekcijska brizga vsebuje 30 mikrogramov (6 milijonov i. e.) interferona beta- 1a.
The concentration is 30 micrograms per 0.5 ml.
Koncentracija je 30 mikrogramov na 0, 5 ml.
AVONEX is indicated for the treatment of
AVONEX je namenjen zdravljenju
In clinical trials, this was characterised by two or more acute exacerbations (relapses) in the previous three-years without evidence of continuous progression between relapses; AVONEX slows the progression of disability and decreases the frequency of relapses.
V kliničnih študijah so to opisali kot dva ali več akutnih poslabšanj (relapsov) v preteklih treh letih, brez dokazov o postopnem napredovanju med relapsi; AVONEX upočasnjuje napredovanje prizadetosti in zmanjšuje pogostost relapsov.
The recommended dosage for the treatment of relapsing MS is 30 micrograms (0.5 ml solution), administered by intramuscular (IM) injection once a week (see section 6.6).
Priporočen odmerek za zdravljenje ponavljajoče se MS je 30 mikrogramov (1 ml raztopine), injiciranih intramuskularno (i. m.) enkrat tedensko (glejte poglavje 6. 6).
At the initiation of treatment, patients may either be started on a full dose of 30 micrograms (0.5 ml solution) or on approximately half the dose once a week to help them to adjust to treatment and thereafter increased to the full dose of 30 micrograms (0.5 ml solution).
Ob začetku zdravljenja se lahko bolnikom začne enkrat tedensko odmerjati ali običajni odmerek 30 mikrogramov (0, 5 ml raztopine) ali približno pol odmerka za lažje prilagajanje na zdravljenje,
12 after the initial titration period.
12 zatem pa se odmerek poveča na običajni odmerek 30 mikrogramov (0, 5 ml raztopine).
A manual titration device to enable delivery of approximately half the dose is available for patients initiating AVONEX treatment.
Naprava za ročno titracijo, ki omogoča odmerjanje približno polovice odmerka je na voljo bolnikom, ki pričenjajo z zdravljenjem z zdravilom AVONEX.
However, limited published data suggest that the safety profile in adolescents from 12 to 16 years of age receiving AVONEX 30 micrograms IM once per week is similar to that seen in adults.
Omejeni objavljeni podatki kažejo, da je varnostni profil pri mladostnikih, starih od 12 do 16 let, ki so prejemali AVONEX 30 mikrogramov i. m. enkrat tedensko, podoben tistemu, ki so ga opazili pri odraslih.
- Patients with a history of hypersensitivity to natural or recombinant interferon-ß or to any
pri bolnikih, ki so že imeli preobčutljivostno reakcijo na naravni ali rekombinantni interferon- β ali