natgillin/translations-raw huggingface dataset:
Call a doctor immediately as they may be signs of a possible liver problem.
Nemudoma pokličite zdravnika, saj so lahko to znaki težav z jetri.
A large amount of data (more than 1000 pregnancy outcomes) from registries and post-marketing experience indicates no increased risk of major congenital anomalies after pre-conception exposure to interferon beta or such exposure during the first trimester of pregnancy.
Številni podatki (več kot 1.000 izidov nosečnosti) iz registrov in na podlagi izkušenj iz obdobja po prihodu zdravila na trg ne kažejo povečanega tveganja za večje kongenitalne anomalije pri izpostavljenosti interferonu beta pred zanositvijo ali v prvem trimesečju nosečnosti.
Whether the mechanism of action of AVONEX in MS is mediated by the same pathway as the biological effects described above is not known because the pathophysiology of MS is not well established.
Ni znano, ali mehanizem delovanja zdravila AVONEX poteka pri MS na enak način, kot je opisano zgoraj, ker patofiziologija MS ni dobro pojasnjena.
Biogen Inc., 5000 Davis Drive, POB 14627, Research Triangle Park, North Carolina, 27709, USA.
Biogen Inc., 250 Binney Street, Cambridge, Massachusetts 02142, ZDA Biogen Inc., 5000 Davis Drive, POB 14627, Research Triangle Park, North Carolina, 27709, ZDA
Avonex can help to reduce the number of relapses that you have and slow down the disabling effects of MS.
Zdravilo Avonex lahko pomaga zmanjšati število ponovitev, ki jih imate, in upočasniti onesposobljujoče učinke MS.
The clinical studies indicate that MS patients can receive AVONEX and corticosteroids or ACTH during relapses.
Klinične študije kažejo, da bolniki z MS med relapsi lahko jemljejo zdravilo AVONEX in kortikosteroide ali ACTH.
*Class label for interferon beta products (see section 4.4).
*Označevanje razreda zdravil, ki vsebujejo interferon beta (glejte poglavje 4.4).
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 pogostnostjo, so navedeni v spodnji razpredelnici.
You can get a larger print version of this leaflet by calling the local representatives.
Za večjo tiskano različico navodila pokličite svoje lokalno predstavništvo.
The liquid should be clear and colourless.
Tekočina mora biti bistra in brezbarvna.
At very high doses, anovulatory and abortifacient effects in test animals were observed.
Pri zelo visokih odmerkih so pri poskusnih živalih opazili anovulacijske in abortivne učinke.
This medicine is essentially ‘sodium-free'.
Zdravilo je pravzaprav »brez natrija«.
Periodic monitoring of early signs or symptoms, e.g. oedema, proteinuria and impaired renal function is recommended, especially in patients at higher risk of renal disease.
Priporoča se periodično spremljanje zgodnjih znakov ali simptomov, npr. edema, proteinurije in okvarjenega delovanja ledvic, zlasti pri bolnikih, pri katerih je tveganje za ledvične bolezni večje.
Interferons alpha and beta are classified as Type I interferons, and interferon gamma is a Type II interferon.
Interferoni alfa in beta so klasificirani kot interferoni tipa I, interferon gama pa je interferon tipa II.
Once the pen is sealed there is no risk of injury.
Ko je napolnjen injekcijski peresnik zaprt, ni več tveganja za poškodbo.
Continue injecting on this new day every week.
Z injiciranjem nadaljujte na ta nov dan v tednu.
Neutralising antibodies are associated with a reduction in the in vivo biological effects of AVONEX and may potentially be associated with a reduction of clinical efficacy.
Nevtralizirajoča protitelesa so povezana z zmanjševanjem in vivo bioloških učinkov zdravila AVONEX in so lahko povezana z zmanjševanjem klinične učinkovitosti.
5 Disposal
5 Odstranjevanje.
You may get a needle injury.
Obstaja možnost, da se poškodujete z iglo.
If you have depression, your doctor may still prescribe Avonex for you, but it's important to let your doctor know if you have had depression or any similar problems affecting your moods.
Če imate depresijo, vam lahko zdravnik sicer predpiše zdravilo Avonex, vendar je pomembno, da zdravnika obvestite, če ste imeli depresijo ali podobne težave, ki vplivajo na vaše razpoloženje.
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALCI BIOLOŠKE UČINKOVINE IN IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ
Sometimes you will need to remind other medical staff that you are being treated with Avonex.
Včasih boste morali drugo zdravstveno osebje opozoriti, da se zdravite 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.
Using the World Health Organisation (WHO) International Standard for Interferon, 30 micrograms of AVONEX contain 6 million IU of antiviral activity.
Po mednarodnem standardu Svetovne zdravstvene organizacije (SZO) za interferon, 30 mikrogramov zdravila AVONEX vsebuje 6 milijonov i.e. protivirusne aktivnosti.
Avonex may affect other medicines or be affected by them.
Zdravilo Avonex lahko vpliva na druga zdravila ali druga zdravila vplivajo nanj.
Avonex is used to treat Multiple Sclerosis (MS).
Zdravilo Avonex se uporablja za zdravljenje multiple skleroze (MS).
Name and address of the manufacturers responsible for batch release Biogen (Denmark) Manufacturing ApS, Biogen Allé 1, DK-3400 Hillerød, Denmark.
Ime in naslov izdelovalcev, odgovornih za sproščanje serij Biogen (Denmark) Manufacturing ApS, Biogen Allé 1, DK-3400 Hillerød, Danska
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 strojev (glejte poglavje 4.8).
Paediatric population: The safety and efficacy of AVONEX in adolescents aged 12 to 16 years have not yet been established.
Pediatrična populacija: Varnost in učinkovitost zdravila AVONEX pri otrocih, starih od 12 do 16 let, še nista bili dokazani.
These episodes are of limited duration, temporally related to the injections and may recur after subsequent injections.
Te epizode trajajo le nekaj časa - časovno so povezane z injekcijami zdravila in se lahko ponovno pojavijo po kasnejših injekcijah.
• Press the blue activation button with your thumb to start the injection.
• S palcem pritisnite modri sprožilni gumb, da začnete injicirati.
Limited information available on the transfer of interferon beta-1a into breast milk, together with the chemical / physiological characteristics of interferon beta, suggests that levels of interferon beta-1a excreted in human milk are negligible.
Omejeni podatki glede izločanja interferona beta-1a v materino mleko skupaj s kemijskimi/fiziološkimi lastnostmi interferona beta kažejo, da so ravni interferona beta-1a, ki se izloča v materino mleko, zanemarljive.
No additional benefit has been shown by administering a higher dose (60 micrograms) once a week.
Pri dajanju večjega odmerka (60 mikrogramov) enkrat tedensko se niso pokazale dodatne koristi.
If TMA is diagnosed, prompt treatment is required (considering plasma exchange) and immediate discontinuation of AVONEX is recommended.
Če je TMA diagnosticirana, je potrebno takojšnje zdravljenje (razmisliti o izmenjavi plazme), priporoča pa se tudi takojšnje prenehanje zdravljenja z zdravilom Avonex.
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. some classes of antiepileptics and 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. nekatere vrste antiepileptikov in antidepresivov.
If it looks like it has been opened, do not use that syringe.
Če izgleda, kot da je bil odprt, te injekcijske brizge ne uporabite.
Three major forms of interferons have been distinguished: alpha, beta, and gamma.
Poznamo tri glavne vrste interferonov: alfa, beta in gama.
150 AVONEX-treated patients completed one year on study and 85 completed two years on study.
bolnikov, zdravljenih z zdravilom AVONEX je pri študiji sodelovalo eno leto, 85 bolnikov pa je pri študiji sodelovalo dve leti.
The frequencies of adverse reactions are expressed in patient-years, according to the following categories:
Pogostnosti neželenih pojavov so izražene z enoto bolnikov-let, po naslednjih kategorijah:
Flu-like symptoms
Gripi podobni simptomi
1Injection site reactions including pain, inflammation and very rare cases of abscess or cellulitis that may require surgical intervention have been reported.
1Poročali 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.
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.
Bolnike s srčnimi boleznimi, kot so npr. angina pektoris, kongestivno srčno popuščanje ali aritmija, je potrebno natančno opazovati, da se jim klinično stanje med zdravljenjem z zdravilom AVONEX ne poslabša.
Marketing Authorisation Holder and Manufacturer The Marketing Authorisation Holder is:
Imetnik dovoljenja za promet z zdravilom in izdelovalec Imetnik dovoljenja za promet z zdravilom je:
Your doctor, nurse or pharmacist should provide you with instructions on how to dispose of your used Avonex Pen, for example into a sharps bin.
Zdravnik, medicinska sestra ali farmacevt vam bo dal navodila o odstranjevanju uporabljenega napolnjenega injekcijskega peresnika Avonex Pen, na primer v odpadke za ostre predmete.
It can be used to achieve the ¼ or ½ dose increments.
Uporablja se lahko za povečanja odmerka za ¼ ali ½.
However, in case of overdose, patients should be hospitalised for observation and appropriate supportive treatment given.
V primeru prevelikega odmerjanja je potrebno bolnika napotiti v bolnišnico na opazovanje in mu nuditi primerno zdravljenje.
Following intramuscular administration of AVONEX, serum antiviral activity levels peak between 5 and 15 hours post-dose and decline with a half-life of approximately 10 hours.
Po intramuskularni aplikaciji zdravila AVONEX doseže serumska protivirusna aktivnost vrh med 5 in 15 urami po odmerku in upada z razpolovnim časom približno 10 ur.
The small rectangular window area will disappear.
Predel z majhnim štirioglatim okencem bo izginil.
The unused portion of Avonex must not be used.
Neuporabljenega odmerka zdravila Avonex ne smete znova uporabiti.
This includes any medicines obtained without a prescription.
To vključuje tudi zdravila, ki ste jih dobili brez recepta.
Laboratory abnormalities are associated with the use of interferons.
Laboratorijske motnje so povezane z uporabo interferonov.
Try to use Avonex at the same time on the same day each week.
Poskusite uporabljati zdravilo Avonex ob istem času in na isti dan v tednu.
• Check the injector shield is fully extended.
• Preverite, ali je zaščita injektorja povsem razširjena.
┼ Class label for interferon products, see below Pulmonary arterial hypertension.
┼ Označevanje razreda zdravil, ki vsebujejo interferone - glejte Pljučna arterijska hipertenzija spodaj.
Tip: The needle cover will come off automatically during step 3, below.
Nasvet: Pokrovček igle se samodejno sname v 3. koraku,
Your doctor will advise you for how long you can use Avonex or when to stop.
Zdravnik vam bo svetoval, kako dolgo lahko uporabljate zdravilo Avonex in kdaj naj prenehate.
Tell your doctor you are using Avonex:
Povejte zdravniku, da uporabljate zdravilo Avonex:
• Apply pressure to the injection site for a few seconds.
• Še nekaj sekund pritiskajte na mesto injiciranja.
An alternative titration schedule can be achieved by initiating therapy on approximately a ½ dose of AVONEX once a week before increasing to the full dose.
Alternativen načrt titriranja lahko dosežete tako, da zdravljenje začnete s približno ½ odmerka zdravila AVONEX enkrat na teden, preden dosežete polni odmerek.
Avonex is not to be used in children below the age of 12 years.
Zdravilo Avonex se ne sme uporabiti pri otrocih, starih manj kot 12 let.
If you get any of these: - Swelling of the face, lips or tongue - Difficulty breathing
Če se pojavi kar koli od naslednjega: - oteklost obraza, ustnic ali jezika,
This includes any other medicines including medicines obtained without a prescription.
To vključuje vsa zdravila, vključno s tistimi, ki ste jih dobili brez recepta.
This makes the injection more comfortable than using straight from the refrigerator.
Tako bo injiciranje bolj prijetno, kot če uporabite injekcijo, takoj ko jo vzamete iz hladilnika.
The safety and efficacy of AVONEX in children below 12 years of age have not yet been established.
Varnost in učinkovitost zdravila AVONEX pri otrocih, mlajših od 12 let, še nista bili dokazani.
This assay is limited in that it is sensitive for interferon but lacks specificity for interferon beta.
Omejitev te analize je, da je sicer občutljiva na interferon, vendar ne na specifičnost interferona beta.
Please check every time you get your prescription refilled to see if the leaflet has been updated.
Prosimo, da ob vsakem novem receptu preverite, ali je morda navodilo dopolnjeno.
Carcinogenesis: 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.
The active substance in Avonex is a protein called interferon beta-1a.
Učinkovina v zdravilu Avonex je protein, ki se imenuje interferon beta-1a.
• Use your other hand, and with one quick motion pull up the injector shield (grooved area) over the needle until the needle is fully covered.
• S hitrim gibom druge roke potegnite zaščito injektorja navzgor (zgiban predel) nad iglo, dokler ni igla povsem prekrita.
These interferons have overlapping but clearly distinguishable biological activities.
Čeprav se biološke aktivnosti teh interferonov prekrivajo, so med njimi jasne razlike.
- If you notice any irritation or skin problems after an injection, talk to your doctor.
- Če opazite draženje kože ali težave z njo po injiciranju, se posvetujte z zdravnikom.
• After 10 seconds pull the pen straight out to remove the needle from the injection site.
• Po 10 sekundah izvlecite napolnjen injekcijski peresnik naravnost ven, da potegnete iglo iz mesta injiciranja.
Tip: Take care not to press the blue activation button too early.
Nasvet: pazite, da ne boste prezgodaj pritisnili modrega sprožilnega gumba.
• Avonex is injected into a muscle, the best area is the upper, outer thigh muscle as shown in the diagram opposite.
• Zdravilo Avonex se injicira v mišico, pri čemer je najboljši predel zgornja, zunanja stegenska mišica, kot prikazuje nasprotni diagram.
AVONEX 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 sections 4.5 and 4.8).
Previdnost je potrebna pri dajanju zdravila AVONEX bolnikom z znano nagnjenostjo h krčem, kot tudi tistim, ki se zdravijo z antiepileptiki, še zlasti, če se njihove epilepsije z antiepileptiki ne da ustrezno obvladovati (glejte poglavji 4.5 in 4.8).
Make the injection Insert the injection needle with a quick dart-like thrust at right angles to the skin, into the muscle.
Vbodite injekcijsko igro s hitrim sunkom pod pravim kotom na kožo, v mišico.
Avonex works best when you use it: - at the same time - once a week - on a regular basis
Zdravilo Avonex deluje najbolje, če ga uporabljate: - vedno ob istem času, - enkrat tedensko, - redno.
Patients may develop antibodies to AVONEX.
Bolniki lahko razvijejo protitelesa za zdravilo AVONEX.
You will be provided with an Avostartclip titration kit.
Prejeli boste komplet za titriranje Avostartclip.
Cessation of therapy with AVONEX should be considered (see also sections 4.3 and 4.8).
Po potrebi tudi ukinite terapijo z zdravilom AVONEX (glejte poglavji 4.3 in 4.8).
It contains less than 23 mg (1 mmol) sodium in each weekly dose.
Vsak tedenski odmerek vsebuje manj kot 23 mg (1 mmol) natrija.
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).
If you have used more than one injection of Avonex in a three-day period, contact your doctor or pharmacist straight away for advice.
Če ste si injicirali več kot eno injekcijo zdravila Avonex v obdobju treh dni, se nemudoma posvetujte z zdravnikom ali farmacevtom.
Titration using the pre-filled syringe can be achieved by initiating therapy on ¼ dose increments per week reaching the full dose (30 micrograms/week) by the fourth week.
Titriranje z uporabo napolnjene injekcijske brizge dosežete z uvedbo zdravljenja z večanjem odmerka po ¼ na teden, dokler v četrtem tednu ne dosežete polnega odmerka (30 mikrogramov/teden).
Titrating AVONEX at the initiation of therapy has demonstrated a reduction in the severity and incidence of flu-like symptoms.
Titriranje zdravila AVONEX ob uvedbi zdravljenja je pokazalo zmanjšanje resnosti in incidence gripi podobnih simptomov.
This means less risk of irritation to your skin and muscle.
S tem se tveganje za draženje kože in mišice zmanjša.
If you need to, use an alcohol wipe to clean the skin at the injection site you've chosen.
Če morate, z alkoholno blazinico očistite kožo na izbranem mestu injiciranja.
These are the side effects that people reported when Avonex was being tested.
To so neželeni učinki, o katerih so poročali med testiranjem zdravila Avonex.
- Just after an injection, your muscles may feel tense or very weak - as though you are having a relapse.
- Takoj po injiciranju boste morda občutili napetost ali izjemno slabotnost v mišicah - kot da se je bolezen ponovila.
This is what causes the symptoms of MS. Avonex seems to work by stopping your body's defence system from attacking the myelin.
Kaže, da zdravilo Avonex deluje tako, da onemogoči obrambnemu sistemu vašega telesa, da bi napadel mielin.
Excipient(s) with known effect For the full list of excipients, see section 6.1.
Pomožna(e) snov(i) z znanim učinkom: Za celoten seznam pomožnih snovi glejte poglavje 6.1.
With one hand, stretch the skin around the injection site.
Z eno roko napnite kožo okoli mesta injiciranja.
Make sure the cap is intact and has not been opened.
Preverite, da je pokrovček nepoškodovan in da ni bil odprt.
Patient-time is the sum of individual units of time that the patient in the study has been exposed to AVONEX before experiencing the adverse reaction.
Produkt števila bolnikov in časa je seštevek posameznih enot časa, ko je bil bolnik v študiji izpostavljen zdravilu AVONEX, preden je imel neželeni pojav.
Other medicines and AVONEX
Druga zdravila in zdravilo AVONEX
- Patients with a history of hypersensitivity to natural or recombinant interferon beta or to any excipients listed in section 6.1.
- Pri bolnikih, ki so že imeli preobčutljivostno reakcijo na naravni ali rekombinantni interferon-β ali katero koli pomožno snov, navedeno v poglavju 6.1.
The syringe will not empty.
Injekcijska brizga se ne bo izpraznila.
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);
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);
Check the blister tray contains one pre-filled syringe and one injection needle (see picture “Contents of the plastic tray”).
Preverite, ali ovoj vsebuje eno napolnjeno injekcijsko brizgo in eno injekcijsko iglo (glejte sliko „Vsebina plastičnega ovoja“).
3 Give the injection
3 Dajte injekcijo.
Keep the skin stretched tightly or squeeze the skin around the injection site, and pull out the needle.
Izvlecite iglo Držite kožo tesno napeto ali pa kožo okoli mesta vboda stiskajte in izvlecite iglo.
This is a specially designed holder to help you with injecting Avonex.
To je posebej zasnovano držalo, ki vam bo v pomoč pri injiciranju zdravila Avonex.
Your doctor may want to check your blood pressure, blood (platelet count) and the function of your kidneys.
Zdravnik bo morda želel spremljati vaš krvni tlak, krvno sliko (število krvnih ploščic) in delovanje vaših ledvic.
- Feeling faint: Your first injection of Avonex may be given by your doctor.
- Občutek šibkosti: Prvo injekcijo zdravila Avonex vam mora injicirati zdravnik.
• Use a different injection site each week.
• Vsak teden uporabite drugo mesto injiciranja.
Tip: Do not press the blue activation button at the same time.
Nasvet: modrega sprožilnega gumba ne pritisnite sočasno.
AVONEX 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).
Previdnost pri dajanju zdravila AVONEX je potrebna pri bolnikih s preteklimi ali trenutno prisotnimi depresivnimi motnjami, zlasti tistimi, ki so povezane s samomorilnimi nagnjenji (glejte poglavje 4.3).
Prompt treatment of nephrotic syndrome is required and discontinuation of treatment with AVONEX should be considered.
Zdravljenje nefrotskega sindroma je potrebno hitro začeti in razmisliti je potrebno o prenehanju zdravljenja z zdravilom AVONEX.
It is for a single use only.
Primeren je samo za enkratno uporabo.
Side effects seen in clinical trials
Neželeni učinki, opaženi v kliničnih preskušanjih
Interferons have been reported to reduce the activity of hepatic cytochrome P450-dependent enzymes in humans and animals.
Podatki kažejo, da interferoni zmanjšujejo aktivnost encimov, odvisnih od jetrnega citokroma P450, pri ljudeh in živalih.
Infections and infestations not known injection site abscess1
Infekcijske in parazitske bolezni neznana absces na mestu injiciranja1
If you use alcohol wipes, hold one on the injection site.
Če uporabljate alkoholno krpico, jo držite na mestu vboda.
Tell your doctor as they may be signs of a possible kidney problem.
To povejte zdravniku, saj so to lahko znaki težav z ledvicami.
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
If you have been told to gradually increase your dose of Avonex, you may need to use an Avostartclip titration kit provided by your doctor.
Če vam je bilo naročeno, da postopoma povečujete svoj odmerek zdravila Avonex, boste morda morali uporabiti komplet za titriranje Avostartclip, ki vam ga bo priskrbel zdravnik.
These include MHC Class I, Mx protein, 2' / 5'-oligoadenylate synthetase, β2-microglobulin, and neopterin.
I, protein Mx, 2' / 5' - oligoadenilat ligazo, β2 mikroglobulin in neopterin.
Where to inject
Kam injicirati