natgillin/translations-raw huggingface dataset:
6 *Adverse reactions identified during post marketing surveillance (frequency not known)
* Neželeni učinki, opaženi v času spremljanja zdravila na trgu po pridobitvi dovoljenja za promet (pogostnost ni znana)
Interferon beta has a potential for causing severe liver injury.
Interferoni beta ima potencial za povzročanje hudih jetrnih poškodb.
The majority of the cases of severe liver injury occurred within the first six months of treatment.
Večina primerov s hudo jetrno poškodbo se je pojavila v prvih šestih mesecih zdravljenja.
No specific risk factors have been identified.
Nobenih specifičnih dejavnikov tveganja niso identificirali.
Treatment with Rebif should be stopped if icterus or other clinical symptoms of liver dysfunction appear (see section 4.4).
Zdravljenje z zdravilom Rebif se mora prekiniti, če se pojavi zlatenica ali drugi klinični znaki motenj delovanja jeter (glejte poglavje 4. 4).
The administration of interferons has been associated with anorexia, dizziness, anxiety, arythmias, vasodilation and palpitation, menorrhagia and metrorrhagia.
Uporabo interferonov povezujejo z anoreksijo, omotico, anksioznostjo, aritmijami, vazodilatacijo in palpitacijo, menoragijo in metroragijo.
Immunostimulants, Interferons, ATC code:
Farmakoterapevtska skupina: zdravila za spodbujanje imunske odzivnosti, interferoni, oznaka ATC:
Interferons (IFNs) are a group of endogenous glycoproteins endowed with immunomodulatory, antiviral and antiproliferative properties.
Interferoni (INFs) so skupina endogenih glikoproteinov z imunomodulatornimi, antivirusnimi in antiproliferativnimi lastnostmi.
Rebif (interferon beta-1a) shares the same amino acid sequence with endogenous human interferon beta.
Zdravilo Rebif (interferon beta- 1a) ima enako zaporedje aminokislin kot endogeni človeški interferon beta.
The safety and efficacy of Rebif has been evaluated in patients with relapsing-remitting multiple sclerosis at doses ranging from 11 to 44 micrograms (3-12 million IU), administered subcutaneously three times per week.
Varnost in učinkovitost zdravila Rebif je bila ocenjena pri bolnikih z recidivno- remitentno multiplo sklerozo, pri odmerkih v razponu od 11 do 44 mikrogramov (3- 12 milijonov i. e.), podkožno trikrat na teden.
At licensed posology, Rebif 22 micrograms has been demonstrated to decrease the incidence (approximately 30% over 2 years) and severity of clinical relapses in patients with at least 2 exacerbations in the previous 2 years and with an EDSS of 0-5.0 at entry.
Pri odobrenem odmerjanju zdravila Rebif 22 mikrogramov dokazano zmanjšuje pogostnost (približno 30% v dveh letih) in intenziteto kliničnih zagonov bolezni pri bolnikih, ki so imeli najmanj dva zagona v predhodnih dveh letih in izhodiščni EDSS 0 do 0, 5.
The proportion of patients with disability progression, as defined by at least one point increase in EDSS confirmed three months later, was reduced from 39% (placebo) to 30% (Rebif 22 micrograms).
Odstotek bolnikov z napredovanjem nesposobnosti, definiranim kot povečanje za najmanj eno točko po EDSS, potrjenim po 3 mesecih, se je zmanjšal iz 39% (placebo) na 30% (zdravilo Rebif 22 mikrogramov).
Over 4 years, the reduction in the mean exacerbation rate was 22% in patients treated with Rebif 22 micrograms, and 29% in patients treated with Rebif 44 micrograms group compared with a group of patients treated with placebo for 2 years and then either Rebif 22 or Rebif 44 micrograms for 2 years.
Tekom 4 let se je povprečna pogostnost zagonov zmanjšala za 22% pri bolnikih, ki so prejemali zdravilo Rebif 22 mikrogramov in za 29% pri bolnikih, ki so prejemali zdravilo Rebif 44 mikrogramov, v primerjavi s skupino bolnikov, ki so 2 leti prejemali placebo in nato še 2 leti zdravilo Rebif 22 mikrogramov ali zdravilo Rebif 44 mikrogramov.
In a 3-year study in patients with secondary progressive multiple sclerosis (EDSS 3-6.5) with evidence of clinical progression in the preceding two years and who had not experienced relapses in the preceding 8 weeks, Rebif had no significant effect on progression of disability, but relapse rate was reduced by approximately 30%.
7 V 3 letni študiji z bolniki, ki imajo sekundarno progresivno multiplo sklerozo (EDSS 3 do 6, 5) s potrjenim kliničnim napredovanjem bolezni v predhodnih dveh letih in brez zagonov v predhodnih osmih tednih, zdravilo Rebif ni imelo pomembnega učinka na napredovanje nesposobnosti, vendar pa je zmanjšalo delež zagonov bolezni za približno 30%.
If the patient population was divided into 2 subgroups (those with and those without relapses in the 2-year period prior to study entry), there was no effect on disability in patients without relapses, but in patients with relapses, the proportion with progression in disability at the end of the study was reduced from 70% (placebo) to 57% (Rebif 22 micrograms and 44 micrograms combined).
Če so razdelili populacijo bolnikov v dve podskupini (na bolnike z in brez pojava zagonov v 2 letih pred vključitvijo v študijo), ni bilo pomembnega učinka na razvoj nesposobnosti pri bolnikih brez zagonov, vendar pa se je pri bolnikih z zagoni delež tistih z napredovalo nesposobnostjo na koncu študije zmanjšal iz 70% (placebo) na 57% (zdravilo Rebif 22 mikrogramov v kombinaciji z Rebifom 44 mikrogramov).
Rebif has not yet been investigated in patients with primary progressive multiple sclerosis, and should not be used in such patients.
Uporaba zdravila Rebif pri bolnikih s primarno progresivno multiplo sklerozo še ni raziskana, zato se zdravila Rebif pri teh bolnikih ne sme uporabljati.
7 5.2 Pharmacokinetic properties
5. 2 Farmakokinetične lastnosti
In healthy volunteers after intravenous administration, interferon beta-1a exhibits a sharp multi-exponential decline, with serum levels proportional to the dose.
Pri zdravih prostovoljcih se po intravenskem dajanju interferona beta- 1a pokaže oster multieksponentni padec serumskih vrednosti, sorazmerno z odmerkom.
The initial half-life is in the order of minutes and the terminal half-life is several hours, with the possible presence of a deep compartment.
Začetni razpolovni čas je minutnega reda, končni razpolovni čas je reda nekaj ur, z možno prisotnostjo globokega porazdelitvenega prostora..
When administered by the subcutaneous or intramuscular routes, serum levels of interferon beta remain low, but are still measurable up to 12 to 24 hours post-dose.
Kadar se daje subkutano ali intramuskularno, ostanejo serumske vrednosti interferona beta nizke, vendar še vedno merljive v času od 12 do 24 ur po odmerku.
Following a single 60 microgram dose, the maximum peak concentration, as measured by immunoassay, is around 6 to 10 IU/ ml, occurring on average around 3 hours after the dose.
Po enkratnem odmerku 60 mikrogramov je največja koncentracija, merjena z imunskim testom, približno 6 do 10 i. e. / ml in je v povprečju dosežena približno tri ure po odmerku.
After subcutaneous administration at the same dose repeated every 48 hours for 4 doses, a moderate accumulation occurs (about 2.5 x for AUC).
Pri ponavljajočem dajanju enakega odmerka subkutano vsakih 48 ur, 4 odmerke, se pojavi zmerno kopičenje (približno 2, 5 x za AUC).
After a single dose, intracellular and serum activity of 2-5A synthetase and serum concentrations of beta-2 microglobulin and neopterin increase within 24 hours, and start to decline within 2 days.
Po enkratnem odmerku, se v 24 urah povečajo intracelularna in serumska aktivnost 2- 5A sintetaze in serumske koncentracije beta 2- mikroglobulina ter neopterina in pričnejo upadati v 2 dneh.
Interferon beta-1a is mainly metabolised and excreted by the liver and the kidneys.
Interferon beta- 1a se v glavnem presnavlja in izloča skozi jetra in ledvice.
Rebif has not been investigated for carcinogenicity.
Zdravila Rebif niso preiskušali na kancerogenost.
A study on embryo/ foetal toxicity in monkeys showed no evidence of reproductive disturbances.
Študija embrio/ fetalne toksičnosti pri opicah ni pokazala znakov reproduktivnih motenj.
No information is available on the effects of the interferon beta-1a on male fertility.
Ni podatkov o učinku interferona beta- 1a na moško plodnost.
Mannitol Poloxamer 188 L-methionine Benzyl alcohol Sodium acetate Acetic acid for pH adjustment Sodium hydroxide for pH adjustment Water for injections
manitol poloksamer 188 L- metionin benzilalkohol natrijev acetat ocetna kislina za uravnavanje pH natrijev hidroksid za uravnavanje pH voda za injekcije
6.2 Incompatibilities
8 6. 2 Inkompatibilnosti
One ml type 1glass syringe, with a stainless steel needle, containing 0.5 ml solution.
Enomililitrska tip I steklena injekcijska brizga, z iglo iz nerjavečega jekla, z 0, 5 ml raztopine.
Only clear to opalescent solution without particles should be used and without visible signs of deterioration.
Uporabiti smete samo bistro do opalescentno raztopino brez delcev in vidnih znakov kvarjenja.
Serono Europe Limited 56, Marsh Wall London E14 9TP United Kingdom
Serono Europe Limited 56, Marsh Wall London E14 9TP Velika Britanija
4th May 1998 Date of first renewal:
Datum prvega podaljšanja dovoljenja za promet:
4th May 2003 Date of latest renewal:
Datum zadnjega podaljšanja dovoljenja za promet:
20th May 2008
20. maj 2008.
Each pre-filled syringe (0.5 ml) contains 44 micrograms (12 MIU*) of interferon beta-1a**.
Ena napolnjena injekcijska brizga vsebuje 44 mikrogramov (12 milijonov i. e. *) interferona beta- 1a **.
* Million International Units, measured by cytopathic effect (CPE) bioassay against the in house IFN beta-1a standard which is calibrated against the current international NIH standard (GB-23-902-531). ** produced in Chinese hamster ovary Cells (CHO-K1) by recombinant DNA technology.
* milijon mednarodnih enot, merjeno z biološkim testom s citopatskim učinkom (CPE) po IFN beta- 1a standardu proizvajalca, ki je kalibriran po trenutnem mednarodnem NIH standardu (GB- 23- 902- 531). ** pridobljen s tehnologijo rekombinantne DNK na ovarijskih celicah kitajskega hrčka (CHO- K1).
Efficacy has not been demonstrated in patients with secondary progressive multiple sclerosis without ongoing relapsing activity (see section 5.1).
Učinkovitost ni bila ugotovljena pri bolnikih s sekundarno progresivno multiplo sklerozo, ki nimajo aktivnih zagonov (glejte poglavje 5. 1).
10 At the present time, it is not known for how long patients should be treated.
Zaenkrat ni znano, kako dolgo bi se bolniki morali zdraviti.
It is recommended that patients should be evaluated at least every second year in the 4-year period after initiation of treatment with Rebif and a decision for longer term treatment should then be made on an individual basis by the treating
Zato je se priporoča, da lečeči zdravnik bolnika pregleda najmanj vsako drugo leto v 4- letnem obdobju od začetka zdravljenja z zdravilom
However, limited published data suggest that the safety profile in adolescents from 12 to 16 years of age receiving Rebif 22 micrograms subcutaneous three times per week is similar to that seen in adults.
Vendar pa omejeni objavljeni podatki kažejo, da je varnostni profil za mladostnike, stare od 12 do 16 let, ki prejemajo subkutano zdravilo Rebif 22 mikrogramov trikrat na teden, podoben tistemu pri odraslih.
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 zmanjševanje tveganja nastanka nekroz na mestu injiciranja, moramo bolnikom svetovati da: • uporabljajo aseptično tehniko injiciranja • po vsakem odmerku zamenjajo mesto vboda.
Patients with single lesions may continue provided that the necrosis is not too extensive.
Bolniki, ki imajo eno samo lezijo, lahko z zdravljenjem nadaljujejo, pod pogojem, da nekroza ni preobširna.
11 In clinical trials with Rebif, asymptomatic elevations of hepatic transaminases (particularly alanine aminotransferase (ALT)) were common and 1-3% of patients developed elevations of hepatic transaminases above 5 times the upper limit of normal (ULN).
V kliničnih študijah z zdravilom Rebif je bilo pogosto asimptomatsko zvišanje jetrnih transaminaz (zlasti alanin- aminotransferaze (ALT)) in 1- 3% bolnikov je razvilo povečanje jetrnih transaminaz, ki 11 je preseglo 5- kratne vrednosti zgornje meje normalne ravni (ULN).
Rebif should be initiated with caution in patients with a history of significant liver disease, clinical evidence of active liver disease, alcohol abuse or increased serum ALT (> 2.5 times ULN).
Zdravljenje z zdravilom Rebif moramo uvajati previdno pri bolnikih s pomembnimi jetrnimi boleznimi v anamnezi, s klinično potrjeno aktivno jetrno boleznijo, zlorabo alkohola ali zvišano serumsko ravnjo ALT (> 2, 5 kratna ULN).
The overall incidence of these is slightly higher with Rebif 44 than Rebif 22 micrograms.
Celokupna incidenca le- teh je nekoliko višja pri zdravilu Rebif 44 mikrogramov kot pri zdravilu Rebif 22 mikrogramov.
Clinical data suggest that after 24 to 48 months of treatment with Rebif 44 micrograms, approximately 13 to 14% of patients develop persistent serum antibodies to interferon beta-1a.
Klinični podatki kažejo, da se po 24 do 48 mesecih zdravljenja z zdravilom Rebif 44 mikrogramov, približno pri 13 do 14% bolnikov razvije vztrajen pojav serumskih protiteles na interferon beta- 1a.
May cause toxic reactions and anaphylactoid reactions in infants and children up to 3 years old.
Lahko povzroči toksične reakcije in anafilaktoidne reakcije pri dojenčkih in otrocih, do 3 leta starosti.
No interaction studies have been performed with interferon beta-1a in humans.
Študij medsebojnega delovanja z drugimi zdravili za interferon beta- 1a pri človeku niso izvedli.
Caution should be exercised when administering Rebif in combination with
Previdnost se zahteva pri uporabi zdravila Rebif v kombinaciji z zdravili, ki imajo ozek terapevtski indeks in se v glavnem razgrajujejo preko jetrnega citokrom P450 sistema, npr.
12 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.
12 antiepileptiki in nekatere vrste antidepresivov.
Therefore initiation of treatment is contraindicated during pregnancy (see section 4.3).
Zato je začetek zdravljenja v nosečnosti kontraindiciran (glejte poglavje 4. 3).
Central nervous system-related adverse events associated with the use of interferon beta (e. g. dizziness) might influence the patient's ability to drive or use machines (see section 4.8).
Neželeni dogodki v povezavi z uporabo interferona beta, vezani na osrednji živčni sistem, lahko vplivajo na bolnikovo sposobnost za vožnjo ali upravljanje strojev (glejte poglavje 4. 8).
Very Common Common Uncommon Rare Very rare
Zelo pogosti Pogosti Občasni Redki Zelo redki Neznana
≥ 1/ 10 ≥ 1/ 100 to < 1/ 10 ≥ 1/ 1,000 to < 1/ 100 ≥ 1/ 10,000 to < 1/ 1,000 < 1/ 10,000
≥ 1/ 10 ≥ 1/ 100 do < 1/ 10 ≥1/ 1. 000 do < 1/ 100 ≥ 1/ 10. 000 do < 1/ 1. 000 < 1/ 10. 000 Ni mogoče oceniti iz razpoložljivih podatkov
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Predstavljeni podatki so zbrani iz kliničnih študij z multiplo sklerozo (placebo = 824 bolnikov; zdravilo Rebif 22 mikrogramov trikrat na teden (TIW) =398 bolnikov; zdravilo Rebif 44 mikrogramov TIW= 727 bolnikov) in kažejo pogostnost neželenih učinkov opaženih v šestih mesecih (presežek
13 The data presented is obtained from pooled clinical studies in multiple sclerosis (placebo=824 patients; Rebif 22 micrograms three times per week (TIW)=398 patients; Rebif 44 micrograms TIW=727 patients) and shows the frequency of adverse reactions observed at six months (excess over placebo).
13 glede na placebo).
System Organ Class Infections and infestations
Organski sistem Infekcijske in parazitske bolezni Bolezni krvi in limfatičnega sistema
Very common
Zelo pogosti nevtropenija, limfopenija, leukopenija, trombocitopen ija, anemija
Uncommon Injection site abscess
Občasni absces na mestu injiciranja
Not known* Injection site infections, including cellulitis
Neznana * okužbe mesta injiciranja, vključno s celulitisom
Thyroid dysfunction most often presenting as hypothyroidism or hyperthyroidism
motnje delovanja ščitnice, najpogosteje v obliki hipotiroidizma ali hipertiroidizma
Nervous system disorders
Bolezni živčevja Bolezni prebavil
Seizures
glavobol
Gastrointestinal disorders
driska, bruhanje, slabost
Diarrhoea, vomiting, nausea
epileptični napadi
Pruritus, rash, erythematous rash, maculo-papular rash
srbenje, izpuščaj, eritematozni izpuščaj, makulopapul ozni izpuščaj
Angioedema, urticaria, erythema multiforme, erythema multiforme-like skin reactions, Stevens-Johnson syndrome, hair loss
angioedem, urtikarija, multiformni eritem, multiformnemu eritemu podobne kožne reakcije, Stevens - Johnsonov sindrom, izguba las
Myalgia, arthralgia
mialgija, artralgija bolečina na
General disorders and administration site conditions
nekroza na mestu
Injection site inflammation, injection site reaction, influenza-like symptoms
Splošne težave in
Injection site pain, fatigue, rigors, fever
vnetje na mestu
Injection site necrosis, injection site mass
injiciranja, bula na
Investigations
spremembe na
Asymptomatic transaminase increase
injiciranja,
Respiratory, thoracic and mediastinal disorders
injiciranja,
Dyspnoea
mestu injiciranja
Immune system disorders
mestu aplikacije
Anaphylactic reactions
reakcija na mestu injiciranja, gripi podoben simptom
14 System Organ Class Vascular disorders
utrujenost, drgetanje, zvišana telesna temperatura
Very common
Preiskave
Common
Bolezni dihal, prsnega koša in mediastinalnega prostora
Uncommon
dispneja
Not known* Thromboembolic events
Bolezni imunskega sistema Žilne bolezni
*Adverse reactions identified during post marketing surveillance (frequency not known)
14 * Neželeni učinki, opaženi v času spremljanja zdravila na trgu po pridobitvi dovoljenja za promet (pogostnost ni znana)
Interferon beta has a potential for causing severe liver injury.
Interferon beta ima potencial za povzročanje hudih jetrnih poškodb.
At licensed posology, Rebif 44 micrograms has been demonstrated to decrease the incidence (approximately 30% over 2 years) and severity of clinical relapses in patients with at least 2 exacerbations in the previous 2 years and with an EDSS of 0-5.0 at entry.
Pri odobrenem odmerjanju, zdravilo Rebif 44 mikrogramov dokazano zmanjšuje pogostnost (približno 30% v dveh letih) in intenziteto kliničnih zagonov bolezni pri bolnikih, ki so imeli najmanj dva zagona v predhodnih dveh letih in izhodiščni EDSS 0 do 0, 5.
The proportion of patients with disability progression, as defined by at least one point increase in EDSS confirmed three months later, was reduced from 39% (placebo) to 27% (Rebif 44 micrograms).
Odstotek bolnikov z napredovanjem nesposobnosti, definiranim kot povečanje za najmanj eno točko po EDSS, potrjenim po 3 mesecih, se je zmanjšal iz 39% (placebo) na 27% (zdravilo Rebif 44 mikrogramov).
In a 3-year study in patients with secondary progressive multiple sclerosis (EDSS 3-6.5) with evidence of clinical progression in the preceding two years and who had not experienced relapses in the preceding 8 weeks, Rebif had no significant effect on progression of disability, but relapse rate was reduced by approximately 30%.
V 3 letni študiji z bolniki, ki imajo sekundarno progresivno multiplo sklerozo (EDSS 3 do 6, 5) s potrjenim kliničnim napredovanjem bolezni v predhodnih dveh letih in brez zagonov v predhodnih osmih tednih, zdravilo Rebif ni imelo pomembnega učinka na napredovanje nesposobnosti, vendar pa je zmanjšalo delež zagonov bolezni za približno 30%.
If the patient population was divided into 2 subgroups (those with and those without relapses in the 2-year period prior to study entry), there was no effect on disability in patients without relapses, but in patients with relapses, the proportion with progression in disability at the end of the study was reduced from 70% (placebo) to 57% (Rebif 22 micrograms and
Če so razdelili populacijo bolnikov v dve podskupini (na bolnike z in brez pojava zagonov v 2 letih pred vključitvijo v študijo), ni bilo pomembnega učinka na razvoj nesposobnosti pri bolnikih brez zagonov, vendar pa se je pri bolnikih z zagoni delež tistih z napredovalo nesposobnostjo na koncu študije zmanjšal iz 70% (placebo) na 57% (zdravilo Rebif 22 mikrogramov v kombinaciji z zdravilom Rebif 44 mikrogramov).
Rebif has not yet been investigated in patients with primary progressive multiple sclerosis, and should not be used in such patients.
15 Uporaba zdravila Rebif pri bolnikih s primarno progresivno multiplo sklerozo še ni raziskana, zato se zdravila Rebif pri teh bolnikih ne sme uporabljati.
In healthy volunteers after intravenous administration, interferon beta-1a exhibits a sharp multi- exponential decline, with serum levels proportional to the dose.
Pri zdravih prostovoljcih se po intravenskem dajanju interferona beta- 1a pokaže oster multieksponentni padec serumskih vrednosti, sorazmerno z odmerkom.
The initial half-life is in the order of minutes and the terminal half-life is several hours, with the possible presence of a deep compartment.
Začetni razpolovni čas je minutnega reda, končni razpolovni čas je reda nekaj ur, z možno prisotnostjo globokega porazdelitvenega prostora.
Following a single 60 microgram dose, the maximum peak concentration, as measured by immunoassay, is around 6 to 10 IU/ ml, occurring on average around 3 hours after the dose.
Po enkratnem odmerku 60 mikrogramov, je največja koncentracija, merjena z imunskim testom, približno 6 do 10 i. e. / ml in je v povprečju dosežena približno tri ure po odmerku.
After a single dose, intracellular and serum activity of 2-5A synthetase and serum concentrations of beta-2 microglobulin and neopterin increase within 24 hours, and start to decline within 2 days.
Po enkratnem odmerku se v 24 urah povečajo intracelularna in serumska aktivnost 2- 5A sintetaze in serumske koncentracije beta 2- mikroglobulina ter neopterina in pričnejo upadati v 2 dneh.
6.4 Special precautions for storage
16 6. 4 Posebna navodila za shranjevanje in ravnanje z zdravilom
One ml type 1 glass syringe, with a stainless steel needle, containing 0.5 ml solution.
Enomililitrska tip I steklena injekcijska brizga, z iglo iz nerjavečega jekla, z 0, 5 ml raztopine.
Rebif 8.8 micrograms solution for injection in pre-filled syringe Rebif 22 micrograms solution for injection in pre-filled syringe
Rebif 8, 8 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi Rebif 22 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi
Each pre-filled syringe (0.2 ml) contains 8.8 micrograms (2.4 MIU*) of interferon beta-1a**.
Ena napolnjena injekcijska brizga (0, 2 ml) vsebuje 8, 8mikrogramov (2, 4 milijonov i. e. *) interferona beta- 1a **.
*Million International Units, measured by cytopathic effect (CPE) bioassay against the in-house IFN beta-1a standard which is calibrated against the current international NIH standard (GB-23-902-531). ** produced in Chinese hamster ovary Cells (CHO-K1) by recombinant DNA technology.
* milijon mednarodnih enot, merjeno z biološkim testom s citopatskim učinkom (CPE) po IFN beta- 1a standardu proizvajalca, ki je kalibriran po trenutnem mednarodnem NIH standardu (GB- 23- 902- 531). ** pridobljen s tehnologijo rekombinantne DNK na ovarijskih celicah kitajskega hrčka (CHO- K1).
1.0 mg benzyl alcohol For a full list of excipients, see section 6.1.
1, 0 mg benzilalkohola Za celoten seznam pomožnih snovi glejte poglavje 6. 1.
Each pre-filled syringe (0.5 ml) contains 22 micrograms (6 MIU*) of interferon beta-1a**.
Vsaka napolnjena injekcijska brizga (0, 5 ml) vsebuje 22 mikrogramov (6 milijonov i. e. *) interferona beta- 1a **.
Efficacy has not been demonstrated in patients with secondary progressive multiple sclerosis without ongoing relapse activity (See section 5.1).
Učinkovitost ni bila ugotovljena pri bolnikih s sekundarno progresivno multiplo sklerozo, ki nimajo aktivnih zagonov (glejte poglavje 5. 1.).
Treatment should be initiated under supervision of a physician experienced in the treatment of the disease.
Zdravljenje se mora začeti pod nadzorom zdravnika izkušenega v zdravljenju te bolezni.