natgillin/translations-raw huggingface dataset:
Pharmacotherapeutic group: Cytokines, Interferons, ATC Code: L03 AB 08
Farmakoterapevtska skupina: citokini, interferoni; oznaka ATC: L03AB08 Mehanizem delovanja
If you become depressed while you are on Betaferon, you may need special treatment and your doctor will closely monitor you and may also consider stopping your treatment.
Če postanete med uporabo zdravila Betaferon depresivni, vas bo morda treba posebej zdraviti, zdravnik pa vas bo pozorno nadzoroval ali pretehtal možnost prenehanja zdravljenja.
If more than 3 hours pass, discard the reconstituted Betaferon solution and prepare a new injection.
Če mine več kot 3 ure, zavrzite rekonstituirano raztopino zdravila Betaferon in pripravite novo injekcijo.
Betaferon serum levels were followed in patients and volunteers by means of a not completely specific bioassay.
Koncentracijo zdravila Betaferon v serumu so pri bolnikih in prostovoljcih spremljali z ne povsem specifičnim biološkim preizkusom.
The risk of spontaneous abortions in pregnant women exposed to interferon beta cannot adequately be evaluated based on the currently available data, but the data do not suggest an increased risk so far.
Glede na podatke, ki so na voljo, se tveganja za spontane splave pri nosečnicah, ki so bile izpostavljene interferonu beta, ne da ustrezno oceniti, vendar pa podatki zaenkrat ne kažejo povečanega tveganja.
Do not inject a double dose to make up for a forgotten single dose.
Ne injicirajte si dvojnega odmerka, če ste pozabili uporabiti prejšnji odmerek.
As you get started, you may find the following helpful:
Na začetku vam bodo v pomoč naslednji koraki:
Within this period, the development of neutralising activity was associated with a significant increase in newly active lesions and T2 lesion volume on magnetic resonance imaging.
V tem obdobju je bil razvoj nevtralizacijske aktivnosti povezan s pomembnim povečanjem nove aktivne lezije in T2 lezije pri magnetnoresonančnem slikanju.
► Stop using Betaferon and tell your doctor immediately if any of these happens to you.
► Takoj prenehajte uporabljati zdravilo Betaferon in obvestite zdravnika, če se vam pojavi kar koli od naštetega.
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 se ne priporoča pri bolnikih z recidivno-remitentno multiplo sklerozo, ki so v zadnjih dveh letih imeli manj kot dva recidiva, in bolnikih s sekundarno progresivno multiplo sklerozo, ki v zadnjih dveh letih niso imeli aktivne bolezni.
This is called a Rotation Cycle.
To je t. i. rotacijski cikel.
This study consisted of two phases, a placebo-controlled phase followed by a pre-planned follow-up phase.
Preskušanje je imelo dve obdobji, s placebom nadzorovanem obdobju je sledilo vnaprej načrtovano obdobje spremljanja.
To minimise the risk of injection site necrosis patients should be advised to:
Za zmanjšanje tveganja za nekrozo na mestu injiciranja, je treba bolnikom svetovati, da:
If you know that you are allergic (hypersensitive) to any of the ingredients or if you become so, you must not use Betaferon.
Če veste, da ste alergični (preobčutljivi) na katero koli sestavino zdravila ali nanjo postanete preobčutljivi, zdravila Betaferon ne smete uporabljati.
In the absence of clinical evidence for liver damage and after normalisation of liver enzymes a reintroduction of therapy could be considered with appropriate follow-up of hepatic functions.
V odsotnosti kliničnih znakov jetrne okvare in po normalizaciji vrednosti jetrnih encimov se lahko ponovno uvede zdravljenje z ustreznim nadaljnjim spremljanjem delovanja jeter.
2 - Open the Betaferon vial and put it on the table.
2 - Odprite vialo z zdravilom Betaferon in jo položite na mizo.
List 1: Very common side effects which have occurred in clinical trials with Betaferon(at least 10% of the cases) and at a higher percentage than those observed with placebo.
Seznam 1: Zelo pogosti neželeni učinki, ki so se pojavili v kliničnih preskušanjih zdravila Betaferon (vsaj ≥ 10 % primerov) in v večjem odstotku kot pri placebu.
Experience with Betaferon in patients with MS is limited, consequently those adverse events which occur very rarely may not yet have been observed.
Izkušnje z zdravilom Betaferon so pri bolnikih z multiplo sklerozo omejene, zato je mogoče, da neželenih učinkov, ki se pojavljajo zelo redko, še niso opazili.
Furthermore, there was a prolongation of the relapse-free interval.
Poleg tega se je podaljšalo obdobje brez recidiva.
− Try to give your injection at the same time of day.
- Če je mogoče, si zdravilo injicirajte vedno ob istem času dneva.
− If you have ever had seizures or if you are taking medicines to treat epilepsy (antiepileptics), your doctor will monitor your treatment carefully (see also ‘Other medicines and Betaferon' and section 4.
- če ste imeli epileptične napade ali jemljete zdravila za zdravljenje epilepsije (antiepileptike), vas bo zdravnik skrbno nadzoroval (glejte tudi poglavji Druga zdravila in zdravilo Betaferon in poglavje 4.
Your doctor will closely monitor you during treatment.
Med zdravljenjem vas bo zdravnik pozorno nadzoroval.
Changes to the liver function values occurred in patients treated with Betaferon during clinical studies.
Spremembe v delovanju jeter so se pojavile pri bolnikih, ki so jih med kliničnimi študijami zdravili z zdravilom Betaferon.
Fertility No investigations on fertility have been conducted (see section 5.3).
Raziskav o vplivu zdravila na plodnost niso izvedli (glejte poglavje 5.3).
47% versus placebo
47 % v primerjavi s placebom
Please follow in detail the instructions for use below.
Upoštevajte navodila za uporabo, ki so opisana spodaj.
Multiple sclerosis (MS) is a long-term condition that affects the central nervous system (CNS), particularly the functioning of the brain and spinal cord.
Mutipla skleroza (MS) je dolgotrajno stanje, ki vpliva na osrednje živčevje, še zlasti na delovanje možganov in hrbtenjače.
Your doctor may find changes in your blood and the function of your kidneys.
Zdravnik bo morda ugotovil spremembe v vaši krvni sliki in delovanju vaših ledvic.
− During treatment with Betaferon your body may produce substances called neutralising antibodies, which may react with Betaferon (neutralising activity).
- Med zdravljenjem z zdravilom Betaferon lahko vaše telo izdela snovi, imenovane nevtralizacijska protitelesa, ki lahko reagirajo z zdravilom Betaferon (nevtralizacija).
# During the BENEFIT follow-up study, no change in the known risk profile of Betaferon was observed.
# V obdobju spremljanja v študiji BENEFIT niso ugotovili sprememb glede varnosti zdravila Betaferon.
Depression and suicidal ideation are known to occur with increased frequency in the multiple sclerosis population and in association with interferon use.
Znano je, da se depresija in samomorilne misli pogosteje pojavljajo pri bolnikih z multiplo sklerozo in tistih, ki uporabljajo interferon.
Do not use Betaferon if you notice it contains particles or is discoloured.
Ne uporabljajte zdravila Betaferon, če opazite, da vsebuje delce ali je obarvano.
If, for some reason, you are not able to inject the Betaferon immediately, you can keep the reconstituted solution in the syringe in a refrigerator for up to 3 hours before using.
Če si zaradi kakršnega koli razloga zdravila Betaferon ne morete vbrizgati takoj, lahko rekonstituirano raztopino v brizgi do 3 ure hranite v hladilniku.
Patients with mild disease and those unable to walk were not studied.
Bolnikov z blago boleznijo in bolnikov nezmožnih hoje, niso preučevali.
Secondary Progressive Multiple Sclerosis (European Study)
sekundarno progresivna multipla skleroza (evropska študija)
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).
From day 19 you are injecting the full dose 1.0 ml.
Od 19. dneva zdravljenja injicirajte celoten odmerek 1 ml.
- if you are allergic (hypersensitive) to natural or recombinant interferon beta, human albumin or any of the other ingredients of this medicine (listed in section 6).
- če ste alergični (preobčutljivi) na naravni ali rekombinantni interferon beta, humani albumin ali katero koli sestavino tega zdravila (navedeno v poglavju 6),
Betaferon is available in pack sizes of:
Zdravilo Betaferon je na voljo v pakiranjih, ki vsebujejo:
− Patients with decompensated liver disease (see sections 4.4, 4.5 and 4.8).
− bolniki z dekompenzirano jetrno boleznijo (glejte poglavja 4.4, 4.5 in 4.8)
If you stop using Betaferon
Če ste prenehali uporabljati zdravilo Betaferon
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.
A large amount of data (more than 1000 pregnancy outcomes) from interferon beta registries, national registries and post-marketing experience indicates no increased risk of major congenital anomalies after pre-conception exposure or exposure during the first trimester of pregnancy.
Večje število podatkov o uporabi interferona beta pri nosečnicah (več kot 1000 izpostavljenih nosečnosti) iz registrov uporabe interferona beta, nacionalnih registrov in izkušenj v obdobju trženja ne kaže povečanega tveganja za resne prirojene anomalije pri izpostavljenosti zdravilu pred oploditvijo ali izpostavljenosti v prvem trimesečju nosečnosti.
− if you feel noticeably more sad or hopeless than before the treatment with Betaferon, or if you develop thoughts of suicide.
- če se počutite izrazito bolj žalostni ali brezupno, kot ste se pred začetkom zdravljenja z zdravilom Betaferon, ali če se pojavijo samomorilne misli.
‘Possible side effects').
Možni neželeni učinki).
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 1 month after the initial scan.
Do danes dobro utemeljene opredelitve bolnika z velikim tveganjem še ni, vendar je bolj sprejemljiv konzervativen pristop, to pomeni vsaj 9 hiperintenzivnih lezij T2 v prvi preiskavi in vsaj ena nova T2 ali ena nova lezija po ojačanju z Gd v naslednji preiskavi, ki je izvedena vsaj 1 mesec po prvi preiskavi.
An abnormal response by the body's immune system is thought to play an important part in the process which damages the CNS.
Predvidevajo, da ima nenormalen odziv imunskega sistema telesa pomembno vlogo v procesu, ki uničuje osrednje živčevje.
Betaferon should be administered with caution to patients with a history of seizures and 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).
Zdravilo Betaferon je treba previdno uporabljati pri bolnikih z anamnezo epileptičnih napadov in bolnikih, ki prejemajo antiepileptična zdravila, zlasti če epilepsija pri njih ni ustrezno nadzorovana z antiepileptičnimi zdravili (glejte poglavji 4.5 in 4.8).
A titration pack composed of four triple packs is available for the titration period and the patient's initial treatment with Betaferon.
Set za titriranje je sestavljen iz štirih tridelnih pakiranj, ki so namenjena za obdobje titriranja in začetno zdravljenje bolnikov z zdravilom Betaferon.
No acute toxicity studies have been carried out.
Študij akutne toksičnosti niso izvedli.
− in the powder: mannitol and human albumin,
− v prašku: manitol in humani albumin,
In order to obtain adequate efficacy, a dose of 250 microgram (1.0 ml) every other day should be reached.
Za zagotovitev ustrezne učinkovitosti je treba doseči odmerek 250 mikrogramov (1 ml) vsak drugi dan.
At the present time, it is not known how long the patient should be treated for.
Trenutno ni znano, kako dolgo naj traja zdravljenje.
By following this schedule, you will come back to your first area (e.g. the right side of the abdomen) after 8 injections (16 days).
Če boste upoštevali takšen časovni razpored, boste prvi predel (npr. na desno stran trebuha) ponovno uporabili po 8 injekcijah (16 dneh).
An example of a medication record is also included (see Annex Part III).
Priložen je primer zapisovanja o uporabi zdravila (glejte Dodatek, del III).
7- Discard the syringe in the disposal unit.
7 - Brizgo zavrzite v posodo za odstranjevanje.
These may be symptoms of a fall in your blood cell count or in the number of platelets in your blood (cells, which help the blood to clot).
To so lahko simptomi zmanjšanja števila celic v krvi ali števila trombocitov v krvi (celice, ki pomagajo pri strjevanju krvi).
Betaferon is a type of medicine known as interferon used to treat multiple sclerosis.
Zdravilo Betaferon je vrsta zdravila, znanega kot interferon, za zdravljenje multiple skleroze.
The procedure for the self-administration by the patient should be reviewed periodically especially if injection site reactions have occurred.
Pri bolniku je treba redno nadzorovati postopek samoinjiciranja, zlasti če so se pojavile reakcije na mestu injiciranja.
Every other day (once every two days), 1.0 ml of the prepared Betaferon solution (see Annex ‘Selfinjection procedure' in the second part of this leaflet) injected under the skin (subcutaneously).
Vsak drugi dan (enkrat na dva dni) 1 ml pripravljene raztopine zdravila Betaferon (glejte Dodatek: Postopek samoinjiciranja v drugem delu tega navodila), injicirane pod kožo (subkutano).
The most serious were reported in patients taking other medicines or who were suffering from diseases that can affect the liver (e.g. alcohol abuse, severe infection).
O resnih neželenih učinkih so poročali pri bolnikih, ki so jemali še druga zdravila ali so imeli bolezni, ki vplivajo na jetra (npr. zloraba alkohola, resne okužbe).
Each cycle will be 8 injections (16 days), given in area 1 through to area 8 in turn.
Vsak cikel sestavlja 8 injekcij (16 dni), ki se zaporedoma dajejo v predele od 1 do 8.
This will be done before you start using Betaferon, regularly after treatment with Betaferon has been initiated and periodically whilst you are on it, even if you have no particular symptoms.
Betaferon, redno po začetku zdravljenja z zdravilom Betaferon in v presledkih med njegovo uporabo, tudi če nimate posebnih simptomov.
− if you notice any unusual bruising, excessive bleeding after injury or if you seem to be catching a lot of infections.
- če opazite kakršne koli nenavadne modrice, čezmerne krvavitve po poškodbi ali če se vam zdi, da pogosto zbolevate za okužbami.
A number of these products have been measured in the serum and cellular fractions of blood collected from patients treated with interferon beta-1b.
Številne od teh produktov so ugotovili v serumski in celični frakciji krvi bolnikov, zdravljenih z interferonom beta-1b.
Time to confirmed EDSS progression Kaplan-Meier estimates
Čas do potrjenega napredovanja glede na EDSS Ocena po Kaplan
• small amounts of mannitol, a naturally occurring sugar and human albumin, a protein.
• majhne količine manitola (naravni sladkor) in humanega albumina (beljakovina).
In the study of patients with a single clinical event suggestive of multiple sclerosis, neutralising activity measured every 6 months was observed at least once in 32% (89) of the patients treated immediately with Betaferon; of these, 60% (53) returned to negative status based on the last available assessment within the 5 year period.
V študiji pri bolnikih z enim samim kliničnim dogodkom, ki kaže na multiplo sklerozo, so nevtralizacijsko aktivnost, izmerjeno vsakih 6 mesecev, opazili vsaj enkrat pri 32 % (89) bolnikov, takoj zdravljenih z zdravilom Betaferon; glede na zadnje ocene, ki so bile na voljo, se jih je v petih letih 60 % (53) vrnilo na negativni status.
Patients with pre-existing significant cardiac disease, such as congestive heart failure, coronary artery disease or arrhythmia, should be monitored for worsening of their cardiac condition, particularly during initiation of treatment with Betaferon.
Bolnike s pomembnimi srčnimi boleznimi, kot so kongestivna srčna odpoved, bolezen koronarnih arterij ali aritmija, je treba spremljati zaradi možnega poslabšanja srčne bolezni, zlasti na začetku zdravljenja z zdravilom Betaferon.
Occasionally debridement and, less often, skin grafting are required and healing may take up to 6 months.
Manj pogosto je potrebna presaditev kože; celjenje lahko traja do 6 mesecev.
If TMA is diagnosed, prompt treatment is required (considering plasma exchange) and immediate discontinuation of Betaferon is recommended.
Če je TMA diagnosticirana, je potrebno takojšnje zdravljenje (razmisliti o izmenjavi plazme), priporoča pa se tudi takojšnje prenehanje zdravljenja z zdravilom Betaferon.
Dissolve the powder completely without shaking.
Prašek je treba popolnoma raztopiti, brez stresanja.
Central nervous system-related adverse events associated with the use of Betaferon might influence the ability to drive and use machines in susceptible patients.
Neželeni učinki na osrednje živčevje, povezani z uporabo zdravila Betaferon, lahko pri bolj občutljivih bolnikih vplivajo na sposobnost vožnje in upravljanja strojev.
Transitory hyperthermia was observed, as well as a significant rise in lymphocytes and a significant decrease in thrombocytes and segmented neutrophils.
Opažali so prehodno hipertermijo, pomembno povečanje števila limfocitov in pomembno zmanjšanje števila trombocitov in segmentiranih nevtrofilcev.
Secondary Progressive Multiple Sclerosis (North American Study)
sekundarno progresivna multipla skleroza (severno ameriška študija)
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 8,0 milijonov i.e. zdravila Betaferon, podoben varnostnemu profilu pri odraslih.
Thrombotic microangiopathy (TMA)
Trombotična mikroangiopatija (TMA)
Subgroup analyses according to baseline factors demonstrated evidence of efficacy on progression to CDMS in all subgroups evaluated.
Analiza podskupin glede na izhodiščne dejavnike je dokazala, da zdravljenje vpliva na napredovanje bolezni do CDMS v vseh preučevanih podskupinah.
In the pivotal study of patients with a single clinical event suggestive of multiple sclerosis an autoinjector was used in the majority of patients.
V ključni študiji pri bolnikih z enim samim kliničnim dogodkom, ki kaže na multiplo sklerozo, so avtoinjektor uporabili pri večini bolnikov.
Relapsing-remitting multiple sclerosis: People with relapsing-remitting MS have occasional attacks or relapses during which symptoms become noticeably worse.
Recidivno-remitentna multipla skleroza: bolniki z recidivno-remitentno MS imajo občasne zagone ali relapse, med katerimi se simptomi znatno poslabšajo.
Betaferon can be used during breast-feeding.
Zdravilo Betaferon se lahko uporablja med dojenjem.
Year 2 results Placebo-controlled phase
Izsledki v drugem letu s placebom nadzorovane faze
For the dose titration at the start of treatment, draw the respective volume as given in section 4.2.
Za titriranje odmerkov je treba na začetku zdravljenja potegniti ustrezno količino raztopine, kot je razloženo v poglavju 4.2.
The activities of interferon beta-1b are species-restricted and therefore, the most pertinent pharmacological information on interferon beta-1b is derived from studies of human cells in culture or in human in vivo studies.
Delovanje interferona beta-1b je omejeno na vrsto, zato najbolj ustrezni podatki o farmakologiji interferona beta1b izhajajo iz študij humanih celic v kulturah ali in vivo študij pri ljudeh.
In rare cases, pancreatitis was observed with Betaferon use, often associated with hypertriglyceridaemia.
V redkih primerih so pri uporabi zdravila Betaferon opazili pankreatitis, ki je bil pogosto povezan s hipertrigliceridemijo.
Absolute neutrophil count decreased (<1,500/mm³) × Λ * °
zmanjšano absolutno število nevtrofilcev (< 1.500/mm³) × Λ * °
Limited information available on the transfer of interferon beta-1b into breast milk, together with the chemical / physiological characteristics of interferon beta, suggests that levels of interferon beta-1b excreted in human milk are negligible.
Omejeni podatki o prehajanju interferona beta-1b v materino mleko, ki so na voljo, skupaj s kemijsko/fiziološkimi lastnostmi interferona beta, kažejo da so ravni interferona beta-1b, izločenega v humanem mleku neznatne.
Betaferon prolonged the time to CDMS by 363 days, from 255 days in the placebo group to 618 days in the Betaferon group (based on the 25th percentiles)
za 363 dni, od 255 dni v skupini, ki je dobivala placebo do 618 dni v skupini, ki je dobivala zdravilo Betaferon (glede na 25. percentil)
Your doctor will rule out any other reasons which could explain these symptoms before you are treated.
Zdravnik bo pred zdravljenjem izključil možnost kakršnega koli drugega vzroka za te simptome.
Any disease other than multiple sclerosis that could better explain signs and symptoms of the patient had to be excluded.
Izključiti je bilo treba kakršno koli bolezen, ki bi bolje ustrezala bolnikovim znakom in simptomom.
− 2 alcohol swabs to clean the skin and vial.
- 2 alkoholni blazinici za čiščenje kože in vial.
Do not attempt to inject yourself until you are sure that you understand how to prepare the injection solution and give the injection to yourself.
Zdravila si ne poskušajte dajati sami, če niste povsem prepričani, da razumete vse zahteve za pripravo raztopine za injiciranje in njeno samoinjiciranje.
The best places for injections are where the skin is loose and soft, and away from joints, nerves, or bones, for example the abdomen, arm, thigh or buttocks.
Najboljše mesto za injiciranje je predel, kjer je koža mlahava in mehka, ne v bližini sklepov, živcev in kosti, na primer trebuh, roka, stegno ali zadnjica.
In the second trial of Betaferon in secondary progressive multiple sclerosis, no delay in the time to disability progression was observed.
V drugem preskušanju zdravila Betaferon pri sekundarno progresivni multipli sklerozi niso opazili odložitve do napredovanja invalidnosti.
Using Betaferon with other medicines that modify the immune system response is not recommended, except anti-inflammatory medicines called corticosteroids or the adrenocorticotropic hormone (ACTH).
Uporaba zdravila Betaferon z drugimi zdravili, ki spreminjajo odziv imunskega sistema, ni priporočljiva; izjema so protivnetna zdravila imenovana kortikosteroidi in adrenokortikotropni hormon (ACTH).
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 prepustnosti s šoku podobnimi simptomi in smrtnim izidom.
− Patients with current severe depression and/or suicidal ideation (see sections 4.4 and 4.8).
− bolniki s hudimi oblikami depresije in/ali samomorilnimi mislimi (glejte poglavji 4.4 in 4.8)
To help you rotate the injection sites appropriately, we recommend that you keep a record of the date and location of your injection.
Da bi ustrezno menjavali mesta injiciranja, priporočamo, da si datum in mesto injiciranja zapišete.
Due to the lack of clinical experience in multiple sclerosis patients, the use of Betaferon together with immunomodulators other than corticosteroids or ACTH is not recommended.
Zaradi pomanjkanja kliničnih izkušenj z zdravilom Betaferon, se pri bolnikih z multiplo sklerozo ne priporoča uporaba skupaj z drugimi imunomodulatorji (razen kortikosteroidi ali ACTH).