natgillin/translations-raw huggingface dataset:
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) BETAFERON EPAR summary for the public
EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR)
Betaferon is a powder and solvent, which is made into a solution for injection.
Zdravilo Betaferon je prašek in vehikel za pripravo raztopine za injiciranje.
It contains 250 micrograms (8 million international units - MIU) per ml of the active substance interferon beta-1b.
Zdravilo vsebuje 250 mikrogramov (8 milijonov mednarodnih enot – i. e.) / ml učinkovine interferon beta- 1b.
Betaferon is used to treat adult patients who have multiple sclerosis (MS).
Zdravilo Betaferon je namenjeno za zdravljenje bolnikov z multiplo sklerozo (MS).
It is used in patients: • who have experienced the signs of MS for the first time, and these are severe enough to justify treatment with injected corticosteroids (anti-inflammatory medicines).
Uporablja se pri bolnikih, ki: • so prvikrat doživeli znake MS, so pa le- ti dovolj resni, da upravičujejo zdravljenje z injiciranjem kortikosteroidov (protivnetnih zdravil).
Before using it, doctors need to exclude other causes for the symptoms. • who have MS of the type known as relapsing remitting, when the patient has attacks (relapses) within periods with no symptoms (remissions), in patients with at least 2 relapses within the last two years. • who have secondary progressive MS (the type of MS that comes after relapsing remitting MS), when their disease is active.
Pred samo uporabo zdravila morajo zdravniki izključiti druge možne razloge za simptome. • imajo tip MS, znan kot recidivno- remitentna MS, pri kateri ima bolnik napade (recidive), ki jim sledijo obdobja brez simptomov (izboljšanje), in sicer pri bolnikih z vsaj dvema napadoma v zadnjih dveh letih. • pri bolnikih s sekundarno progresivno MS (tip MS, ki sledi recidivno- remitentni MS), če je njihova bolezen aktivna.
Betaferon treatment should be started by a doctor who has experience in the treatment of MS.
Zdravljenje z zdravilom Betaferon mora uvesti zdravnik z izkušnjami z zdravljenjem MS.
The treatment should start with 62.5 micrograms (a quarter of the dose) every other day, increasing progressively over 2 and a half weeks to reach the recommended dose of 250 micrograms (8 MIU) given every other day.
Zdravljenje se mora pričeti z 62, 5 mikrogramskim odmerkom (četrtina odmerka) vsak drugi dan, postopoma povečujoč odmerek, ki naj v obdobju dveh in pol tednov doseže priporočeni odmerek 250 mikrogramov (8 milijonov mednarodnih enot - i. e.), ki ga bolnik prejme vsak drugi dan.
Betaferon is given by a subcutaneous (under the skin) injection.
Zdravilo Betaferon se daje s subkutano injekcijo (pod kožo).
The patients can inject Betaferon themselves, provided that they have been trained.
Bolniki si lahko zdravilo Betaferon injicirajo sami, pod pogojem, da so bili ustrezno usposobljeni.
MS is a disease of the nerves, where inflammation destroys the protective sheath around the nerves (demyelination).
MS je bolezen živčnega sistema, pri kateri vnetje poškoduje zaščitno ovojnico okrog živcev (demielinizacija).
The active substance in Betaferon, interferon beta-1b, belongs to the group of the interferons.
Učinkovina v zdravilu Betaferon, interferon beta- 1b, sodi v skupino interferonov.
The interferon beta-1b is made by a bacterium that has received a gene (DNA), which makes it able to produce it.
Interferoni so naravne spojine, ki jih proizvaja telo z namenom obrambe proti napadom kot so okužbe, ki jih povzročajo virusi.
The replacement interferon beta-1b acts in the same way as naturally produced interferon beta.
Natančen način delovanja zdravila Betaferon pri MS ni še popolnoma znan, toda zdi se, da interferon beta pomirja imunski sistem in preprečuje recidive MS.
(44-20) 74 18 84 00 Fax (44-20) 74 18 86 68 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged How has Betaferon been studied?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 86 68 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Interferon beta- 1b se proizvaja po metodi, imenovani » tehnologija rekombinantne DNK «.
Betaferon was studied over 2 years in 338 patients with relapsing remitting MS and able to walk unaided, where its effectiveness was compared to that of a placebo (dummy treatment.
Učinkovitost zdravila Betaferon so preučevali v obdobju dveh let pri 338 bolnikih z recidivno - remitentno MS, sposobnih hoje brez pomoči, pri čemer so njegovo učinkovitost primerjali z učinkovitostjo placeba (zdravila brez zdravilne učinkovine).
Betaferon has also been studied in 1,657 patients in two studies of secondary progressive MS patients who were able to walk, where it was compared with a placebo.
Zdravilo Betaferon so preučevali tudi v okviru dveh raziskav pri 1. 657 bolnikih s sekundarno progresivno MS, sposobnih hoje, pri čemer so ga primerjali s placebom.
The main measure of effectiveness was the delay to progression of disability.
Glavno merilo učinkovitosti je bila odložitev napredovanja invalidnosti.
The study of Betaferon in patients with a single demyelinating event involved 487 patients, who received either Betaferon or a placebo for two years.
Raziskava zdravila Betaferon pri bolnikih z enkratnim demielinizacijskim dogodkom je vključevala 487 bolnikov, ki so v obdobju dveh let prejemali zdravilo Betaferon ali placebo.
The study measured the time it took for a patient to develop clinically defined MS.
Raziskava je merila čas, v katerem se je pri bolniku razvila klinično definirana MS.
What benefit has Betaferon shown during the studies?
Kakšne koristi je zdravilo Betaferon izkazalo med raziskavami?
In patients with relapsing remitting MS, Betaferon was more effective than placebo in reducing the number of annual relapses: patients receiving the medicine had on average 0.84 relapses a year, when patients on placebo had 1.27.
Pri bolnikih z redicivno- remitentno MS je bilo pri zmanjševanju števila letnih recidivov zdravilo Betaferon bolj učinkovito od placeba: bolniki, ki so prejemali zdravilo, so v povprečju doživeli 0, 84 recidivov letno, bolniki, zdravljeni s placebom, pa 1, 27.
One of the two studies in patients with secondary progressive MS showed a significant delay in the time to disability progression (31% risk reduction due to Betaferon) and in the time to becoming wheelchair bound (39%).
Ena od dveh raziskav pri bolnikih s sekundarno progresivno MS je pokazala pomemben odlog do napredovanja invalidnosti (31% zmanjšanje tveganja zaradi zdravila Betaferon) in do priklenjenosti na voziček (39%).
In the second trial, no delay in the time to disability progression was seen.
V drugi raziskavi niso opazili odloga do napredovanja invalidnosti.
In both trials, Betaferon showed a reduction in the number (30%) of clinical relapses.
V obeh raziskavah so ugotovili zmanjšanje števila (30%) kliničnih recidivov pri uporabi zdravila Betaferon.
In the study of patients with a single demyelinating event, Betaferon was shown to reduce the risk of developing clinically defined MS:
V raziskavi z bolnikih z enkratnim demielinizacijskim dogodkom so ugotovili, da je zdravilo Betaferon zmanjšalo tveganje za razvoj klinično potrjene MS:
28% of the patients who received Betaferon developed MS, against 45% of those who received placebo.
MS se je razvila pri 28% bolnikov, ki so prejemali zdravilo Betaferon, v primerjavi s 45% tistih, ki so prejemali placebo.
Very common side effects are flu-like symptoms (fever, chills, arthralgia [joint pain, malaise [feeling ill], headache or myalgia [muscle pain]) and injection site reactions.
Zelo pogosti neželeni učinki so gripi podobni simptomi (zvišana telesna temperatura, mrzlica, artralgija (bolečina v sklepih), splošno slabo počutje, glavobol ali mialgija (bolečine v mišicah) in reakcije na mestu injiciranja.
For the full list of all side effects reported with Betaferon, see the Package Leaflet.
Celovit opis neželenih učinkov, o katerih so poročali pri uporabi zdravila Betaferon, najdete v Navodilih za uporabo.
Betaferon should not be used in people who have a history of hypersensitivity (allergy) to natural or recombinant interferon beta, human albumin or any of the other ingredients.
Zdravila Betaferon ne smejo uporabljati osebe, ki so preobčutljive za (alergični na) naravni ali rekombinantni interferon beta, humani albumin ali katero od drugih sestavin.
Betaferon treatment should not be started during pregnancy.
Zdravljenje z zdravilom Betaferon se ne sme pričeti med nosečnostjo.
Betaferon should not be used in patients who are currently suffering from severe depression and/ or have thoughts of suicide.
Zdravila Betaferon prav tako ne smejo uporabljati bolniki, ki trpijo za depresijo in/ ali imajo samomorilne misli.
Betaferon should not be used in patients who have decompensated liver disease (when the liver does not function normally).
Zdravila Betaferon ne smejo uporabljati bolniki z dekompenzirano boleznijo jeter (ko jetra ne delujejo normalno).
The Committee for Medicinal products for Human Use (CHMP) decided that Betaferon’ s benefits are greater than its risks for the treatment of patients with relapsing remitting multiple sclerosis, secondary progressive multiple sclerosis, and in patients with a single episode of demyelination, severe enough to justify treatment with injected corticosteroids.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila Betaferon pri zdravljenju multiple skleroze z recidivi, sekundarne progresivne multiple skleroze ter pri zdravljenju bolnikov, ki so doživeli enkraten demielinizacijski dogodek, je pa le- ta dovolj resen, da upravičuje zdravljenje z injiciranjem kortikosteroidov, večje od z njim povezanih tveganj.
They recommended that Betaferon be given marketing authorisation.
Zato so priporočili, da se za zdravilo Betaferon podeli dovoljenje za promet.
Betaferon was originally authorised under "Exceptional Circumstances", because, for scientific reasons, limited information was available at the time of approval.
Zdravilo Betaferon je bilo prvotno odobreno » v izjemnih okoliščinah «, saj so bile zaradi znanstvenih razlogov ob odobritvi na voljo le omejene informacije.
As the company had supplied the additional information requested, the "Exceptional Circumstances" ended on 3 April 2001.
Ker je družba posredovala zahtevane dodatne informacije, so » izjemne okoliščine « prenehale 3. aprila 2001.
Other information about Betaferon:
Druge informacije o zdravilu Betaferon:
The European Commission granted a marketing authorisation valid throughout the European Union, for Betaferon to Schering Aktiengesellschaft on 30 November 1995.
Evropska komisija je dovoljenje za promet z zdravilom Betaferon, veljavno po vsej Evropski uniji, odobrila družbi Schering Aktiengesellschaft dne 30. novembra 1995.
This was renewed on 30 November 2000 and 30 November 2005.
Dovoljenje za promet z zdravilom je bilo podaljšano 30. novembra 2000 in 30. novembra 2005.
The full EPAR for Betaferon is available here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Betaferon je na voljo tukaj.
©EMEA 2006
Ta povzetek je bil nazadnje posodobljen v 09- 2006.
EU/ 1/ 95/ 003/ 003
EU/ 1/ 95/ 003/ 003 Betaferon
Powder: vial (glass); solvent: pre-filled syringe (glass)
prašek: viala (steklo) vehikel: napolnjena injekcijska brizga (steklo)
solvent:
vehikel:
15 vials + 15 pre-filled syringes
15 vial + 15 napolnjenih injekcijskih brizg
EU/ 1/ 95/ 003/ 004
EU/ 1/ 95/ 003/ 004 Betaferon
5 vials + 5 pre-filled syringes
5 vial + 5 napolnjenih injekcijskih brizg
15 x (1 vial + 1 pre-filled syringe + 1 vial adapter with needle + 2 alcohol wipes)
15 x (1 viala + 1 napolnjena injekcijska brizga + 1 adapter za vialo z iglo + 2 alkoholni blazinici)
5 x (1 vial + 1 pre-filled syringe + 1 vial adapter with needle + 2 alcohol wipes)
5 x (1 viala + 1 napolnjena injekcijska brizga + 1 adapter za vialo z iglo + 2 alkoholni blazinici)
3 x 15 x (1 vial + 1 pre-filled syringe + 1 vial adapter with needle + 2 alcohol wipes)
3 x 15 x (1 viala + 1 napolnjena injekcijska brizga + 1 adapter za vialo z iglo + 2 alkoholni blazinici)
3 x 14 x (1 vial + 1 pre-filled syringe + 1 vial adapter with needle + 2 alcohol wipes)
3 x 14 x (1 viala + 1 napolnjena injekcijska brizga + 1 adapter za vialo z iglo + 2 alkoholni blazinici)
Betaferon 250 microgram/ ml, powder and solvent for solution for injection.
Betaferon 250 mikrogramov/ ml prašek in vehikel za raztopino za injiciranje
Recombinant interferon beta-1b * 250 microgram (8.0 million IU) per ml when reconstituted.
Rekombinantni interferon beta- 1b, * 250 mikrogramov (8 milijonov i. e.) na mililiter po pripravi
Betaferon contains 300 microgram (9.6 million IU) of recombinant interferon beta-1b per vial.
Zdravilo Betaferon vsebuje 300 mikrogramov (9, 6 milijonov i. e.) rekombinantnega interferona beta- 1b na vialo.
Sterile white to off-white powder.
Sterilni bel do belkast prašek
Betaferon is indicated for the treatment of • patients with a single demyelinating event with an active inflammatory process, if it is severe enough to warrant treatment with intravenous corticosteroids, if alternative diagnoses have been excluded, and if they are determined to be at high risk of developing clinically definite multiple sclerosis (see section 5.1). • patients with relapsing remitting multiple sclerosis and two or more relapses within the last two years, • patients with secondary progressive multiple sclerosis with active disease, evidenced by relapses.
Zdravilo Betaferon je indicirano za zdravljenje • bolnikov z enkratnim demielinizacijskim dogodkom, z aktivnim vnetnim procesom, če je dovolj resen, da je potrebno intravensko zdravljenje s kortikosteroidi, če je bila alternativna diagnoza izključena in če je ugotovljeno, da je tveganje za razvoj klinično potrjene multiple skleroze veliko (glejte poglavje 5. 1), • bolnikov z recidivno- remitentno multiplo sklerozo, ki so v zadnjih dveh letih doživeli dva recidiva ali več, • bolnikov s sekundarno progresivno multiplo sklerozo, pri katerih je bolezen aktivna, kar se kaže z recidivi.
The recommended dose of Betaferon is 250 microgram (8.0 million IU), contained in 1 ml of the reconstituted solution (see section 6.6), to be injected subcutaneously every other day.
Priporočeni odmerek zdravila Betaferon pri bolnikih je 250 mikrogramov (8 milijonov i. e.), kolikor ga vsebuje 1 ml pripravljene raztopine (glejte poglavje 6. 6), ki ga je treba injicirati subkutano vsak drugi dan.
However, limited published data suggest that the safety profile in adolescents from 12 to 16 years of age receiving Betaferon 8.0 million IU subcutaneously every other day is similar to that seen in adults.
Vendar omejeni objavljeni podatki kažejo, da je varnostni profil pri mladostnikih, starih od 12 do 16 let, ki so vsak drugi dan subkutano prejemali 8 milijonov i. e. zdravila Betaferon, podoben varnostnemu profilu pri odraslih.
There is no information on the use of Betaferon in children under 12 years of age and therefore Betaferon should not be used in this population.
Podatkov o uporabi zdravila Betaferon pri otrocih, mlajših od 12 let, ni, zato se ga pri tej populaciji ne sme uporabljati.
Generally, dose titration is recommended at the start of treatment.
* Pridobljen z genskim inženirstvom iz seva Escherichie coli.
* produced by genetic engineering from strain of Escherichia coli.
2 Na splošno se na začetku zdravljenja priporoča titriranje odmerka.
2 Patients should be started at 62.5 microgram (0.25 ml) subcutaneously every other day, and increased slowly to a dose of 250 microgram (1.0 ml) every other day (see Table A).
Zdravljenje je treba začeti z odmerkom 62, 5 mikrogramov (0, 25 ml) subkutano vsak drugi dan, nato pa ga počasi povečevati do odmerka 250 mikrogramov (1 ml) vsak drugi dan (glejte preglednico A).
Table A:
Preglednica A:
Schedule for dose titration*
Razpored titriranja odmerka *
dose
odmerek
62.5 microgram
62, 5 mikrogramov
187.5 microgram 250 microgram
187, 5 mikrogramov 250 mikrogramov
0.75 ml 1.0 ml
0, 75 ml 1 ml
* The titration period may be adjusted, if any significant adverse reaction occurs.
* Če se pojavijo resni neželeni učinki, se lahko obdobje titriranja prilagodi.
The optimal dose has not been fully clarified.
Optimalni odmerek še ni točno določen.
At the present time, it is not known for how long the patient should be treated.
Trenutno ni znano, kako dolgo naj traja zdravljenje.
There are follow-up data under controlled clinical conditions for patients with relapsing-remitting MS for up to 5 years and for patients with secondary progressive MS for up to 3 years.
Za bolnike z recidivno- remitentno multiplo sklerozo obstajajo podatki o spremljanju v kontroliranih kliničnih pogojih za obdobje do 5 let, za bolnike s sekundarno progresivno multiplo sklerozo za obdobje do 3 let.
For relapsing-remitting MS, efficacy has been demonstrated for therapy for the first two years.
Pri recidivno- remitentni multipli sklerozi je dokazana učinkovitost zdravljenja za prvi dve leti.
The available data for the additional three years are consistent with sustained treatment efficacy of Betaferon over the whole time period.
Razpoložljivi podatki o dodatnih treh letih se ujemajo z učinkovitostjo zdravljenja z zdravilom Betaferon v celotnem časovnem obdobju.
Treatment is not recommended in patients with relapsing-remitting multiple sclerosis who have experienced less than 2 relapses in the previous 2 years or in patients with secondary-progressive multiple sclerosis who have had no active disease in the previous 2 years.
Zdravljenje ni priporočljivo za bolnike z recidivno- remitentno multiplo sklerozo, ki so v zadnjih dveh letih doživeli manj kot dva recidiva, in bolnikov s sekundarno progresivno multiplo sklerozo, ki v zadnjih dveh letih niso imeli aktivne bolezni.
If the patient fails to respond, for example a steady progression in EDSS for 6 months occurs or treatment with at least 3 courses of ACTH or corticosteroids during a one year period is required despite Betaferon therapy, treatment with Betaferon should be stopped.
Zdravljenje z zdravilom Betaferon je treba prenehati, če se bolnik ne odzove na zdravljenje, npr. če kljub zdravljenju z zdravilom Betaferon stanje glede na EDSS (Expanded Disability Status Scale) 6 mesecev nenehno napreduje ali so v enoletnem obdobju kljub zdravljenju z zdravilom Betaferon potrebni vsaj 3 ciklusi zdravljenja z ACTH ali kortikosteroidi.
− Initiation of treatment in pregnancy (see section 4.6 Pregnancy and lactation). − Patients with a history of hypersensitivity to natural or recombinant interferon beta, human albumin or to any excipients. − Patients with current severe depression and/ or suicidal ideation (see section 4.4 Special warnings and special precautions for use and 4.8 Undesirable effects). − Patients with decompensated liver disease (see sections 4.4, 4.5, 4.8).
− uvajanje zdravljenja med nosečnostjo (glejte poglavje 4. 6 Nosečnost in dojenje) − bolniki z znano preobčutljivostjo za naravni ali rekombinantni interferon beta, humani albumin ali katerokoli pomožno snov − bolniki s hudimi oblikami depresije in/ ali samomorilnimi mislimi (glejte poglavji 4. 4 Posebna opozorila in previdnostni ukrepi in 4. 8 Neželeni učinki) − bolniki z dekompenzirano jetrno boleznijo (glejte poglavja 4. 4, 4. 5, 4. 8).
The administration of cytokines to patients with a pre-existing monoclonal gammopathy has been associated with the development of systemic capillary leak syndrome with shock-like symptoms and fatal outcome.
Uporaba citokinov pri bolnikih z monoklonsko gamopatijo je povezana z razvojem sindroma sistemske kapilarne krvavitve s simptomi, podobnimi šoku in smrtnim izidom.
3 Nervous system disorders
3 Bolezni živčevja
Betaferon should be administered with caution to patients with previous or current depressive disorders, in particular to those with antecedents of suicidal ideation (see section 4.3).
Zdravilo Betaferon je treba previdno uporabljati pri bolnikih s predhodnimi ali trenutnimi depresijami, zlasti pri tistih, ki so že imeli samomorilne misli (glejte poglavje 4. 3).
Depression and suicidal ideation are known to occur in increased frequency in the multiple sclerosis population and in association with interferon use.
Znano je, da so depresija in samomorilne misli med bolniki z multiplo sklerozo in v povezavi z uporabo interferona pogostejša.
Patients treated with Betaferon should be advised to immediately report any symptoms of depression and/ or suicidal ideation to their prescribing physician.
Bolnikom, ki prejemajo zdravilo Betaferon, je treba svetovati, naj o morebitnih simptomih depresije in/ ali samomorilnih mislih takoj obvestijo zdravnika, ki je predpisal zdravilo.
Patients exhibiting depression should be monitored closely during therapy with Betaferon and treated appropriately.
Depresivne bolnike je treba med zdravljenjem z zdravilom Betaferon natančno nadzorovati in ustrezno zdraviti.
Cessation of therapy with Betaferon should be considered (see also section 4.3 and section 4.8).
V poštev pride prekinitev zdravljenja z zdravilom Betaferon (glejte tudi poglavji 4. 3 in 4. 8).
Betaferon should be administered with caution to patients with a history of seizures, to those receiving treatment with anti-epileptics, particularly if their epilepsy is not adequately controlled with anti- epileptics (see section 4.5 and section 4.8).
Zdravilo Betaferon je treba previdno uporabljati pri bolnikih z anamnezo epileptičnih napadov in bolnikih, ki prejemajo antiepileptična zdravila, zlasti če njihova epilepsija z antiepileptičnimi zdravili ni ustrezno nadzorovana (glejte poglavji 4. 5 in 4. 8).
A risk for transmission of Creutzfeld-Jacob disease (CJD) cannot be excluded.
Tveganja za prenos Creutzfeld- Jakobove bolezni (CJD) ni možno izključiti.
Thyroid function tests are recommended regularly in patients with a history of thyroid dysfunction or as clinically indicated.
Pri bolnikih z anamnezo motenega delovanja ščitnice so priporočljive redne preiskave delovanja ščitnice, kot je klinično indicirano.
In addition to those laboratory tests normally required for monitoring patients with multiple sclerosis, complete blood and differential white blood cell counts, platelet counts, and blood chemistries, including liver function tests (e. g.
Poleg laboratorijskih preiskav, ki se običajno uporabljajo pri spremljanju bolnikov z multiplo sklerozo, je pred začetkom zdravljenja z zdravilom Betaferon, ob rednih presledkih med zdravljenjem ter, če ni kliničnih simptomov, občasno po zdravljenju, priporočljivo narediti celotno krvno sliko, diferencialno krvno sliko levkocitov, določiti število trombocitov in opraviti biokemične krvne preiskave, vključno z jetrnimi testi (npr.
AST (SGOT), ALT (SGPT) and γ -GT), are recommended prior to initiation and at regular intervals following introduction of Betaferon therapy, and then periodically thereafter in the absence of clinical symptoms.
AST (SGOT), ALT (SGPT) in γ- GT).
Patients with anemia, thrombocytopenia, leukopenia (alone or in any combination) may require more intensive monitoring of complete blood cell counts, with differential and platelet counts.
Pri bolnikih z anemijo, trombocitopenijo in levkopenijo (samo ali v katerikoli kombinaciji) bo morda potrebno pozornejše spremljanje celotne krvne slike, diferencialne krvne slike in števila trombocitov.
Patients who develop neutropenia should be monitored closely for the development of fever or infection.
Pri bolnikih, pri katerih pride do nevtropenije, je treba pozorno spremljati morebitno zvišanje telesne temperature ali pojav okužb.
Asymptomatic elevations of serum transaminases, in most cases mild and transient, occurred very commonly in patients treated with Betaferon during clinical trials.
Med kliničnimi preskušanji so se pri bolnikih, ki so prejemali zdravilo Betaferon, zelo pogosto asimptomatsko povečale vrednosti serumskih transaminaz, večinoma blago in prehodno.