natgillin/translations-raw huggingface dataset:
Talk to your doctor if you stop or wish to stop treatment.
Pogovorite se z zdravnikom, če ste prenehali ali želite prenehati z zdravljenjem.
In order to improve traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Z namenom izboljšanja sledljivosti bioloških zdravil je treba jasno zabeležiti ime in številko serije uporabljenega zdravila.
► Checking the content of the pack
► Preverjanje vsebine pakiranja
Moreover, an autoinjector was used by the majority of patients throughout the study.
Poleg tega so pri večini bolnikov ves čas trajanja študije uporabljali avtoinjektor.
This can lead to shock (collapse) and even be fatal.
To lahko povzroči šok (kolaps) in celo smrt.
Each triple pack contains the syringes you will require for preparing each dose.
Vsako tridelno pakiranje vsebuje tudi brizge, ki jih boste potrebovali za pripravo vsakega odmerka.
- medicines which affect the production of blood cells.
- zdravili, ki vplivajo na nastajanje krvnih celic.
Each single pack contains:
Vsako posamezno pakiranje vsebuje:
69% 85% No primary endpoint
69 % 85 % Ni primarnega končnega izida
If you are especially sensitive, this might affect your ability to drive or use machines.
Če ste posebno občutljivi, lahko to vpliva na vašo sposobnost upravljanja vozil ali strojev.
The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Zahteve glede predložitve PSUR za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
− Always use a sterile (aseptic) technique as described in here.
- Vedno uporabite sterilno (aseptično) tehniko, kot je opisano.
This is often associated with an increase of certain blood fats (triglycerides).
To je pogosto povezano s povečanjem vrednosti nekaterih maščob v krvi (trigliceridov).
No long-term studies have been conducted.
Dolgoročnih študij niso izvedli.
You will find that within a few weeks your treatment will become a natural part of your routine.
V nekaj tednih bo zdravljenje postalo rutinsko.
In one single genotoxicity study (Ames test), no mutagenic effect has been observed.
V eni sami študiji genotoksičnosti (Amesov test) niso opazili mutagenega učinka.
This will either be done by your doctor or nurse or by yourself after you have been carefully trained.
To bodo naredili bodisi zdravnik ali medicinska sestra bodisi vi sami, potem ko se boste za to zadostno usposobili.
Table 3: Primary efficacy results of the BENEFIT and the BENEFIT Follow-up study
Preglednica 3: Izsledki primarne učinkovitosti v študiji BENEFIT in nadaljevalni študiji BENEFIT
Experience with other interferons suggests a potential for impairment of male and female fertility.
Izkušnje z drugimi interferoni kažejo možnost vpliva na moško in žensko plodnost.
This medicinal product must not be mixed with other medicinal products except for the supplied solvent mentioned in section 6.6.
Zdravila ne smemo mešati z drugimi zdravili, razen s tistimi, ki so omenjena v poglavju 6.6.
You can use the following rotation schedule.
Lahko uporabite naslednji načrt.
Some analyses suggest that this effect might be larger in patients with higher titre levels of neutralising activity.
Nekatere analize kažejo, da bi bil ta učinek lahko večji pri bolnikih z večjim titrom nevtralizacijske aktivnosti.
* produced by genetic engineering from a strain of Escherichia coli.
* pridobljen z genskim inženirstvom iz seva Escherichie coli.
Keep a record of where and when you last gave yourself an injection.
Zapisujte si, kam in kdaj ste si nazadnje dali injekcijo.
Neutralising antibodies are not produced in all patients.
Nevtralizacijska protitelesa ne nastajajo pri vseh bolnikih.
The schedule shown in the diagram below will help you to vary the sites appropriately.
Razpored na diagramu vam bo pomagal ustrezno menjavati mesta.
No malformations have been observed in the surviving animals.
Med preživelimi živalmi niso opazili malformacij.
• Periodic safety update reports(PSURs)
• Redno posodobljena poročila o varnosti zdravila (PSUR)
These may be symptoms of a serious allergic reaction (hypersensitivity), which may become life threatening.
To so lahko simptomi resne alergiske reakcije (preobčutljivosti), ki lahko postane življenjsko nevarna.
The reconstituted product is colourless to light yellow and slightly opalescent to opalescent.
Rekonstituirano zdravilo je brezbarvno do svetlo rumeno in rahlo opalescentno do opalescentno.
There is no information on the use of Betaferon in children under 12 years of age.
Podatkov o uporabi zdravila Betaferon pri otrocih, mlajših od 12 let, ni.
Experience with exposure during the second and third trimester is very limited.
Izkušenj z izpostavljenostjo zdravilu v drugem in tretjem trimesečju nosečnosti je zelo malo.
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines, including medicines obtained without a prescription.
Obvestite zdravnika ali farmacevta, če uporabljate, ste pred kratkim uporabljali ali pa boste morda začeli uporabljati katero koli drugo zdravilo, tudi če ste ga dobili brez recepta.
Müllerstraße 178 13353 Berlin Germany
Müllerstraße 178 13353 Berlin
The triple packs are highlighted in different colours (see section 6.5).
Tridelna pakiranja so označena z različnimi barvami (glejte poglavje 6.5).
INSTRUCTIONS ON USE (text for inside the lid)
NAVODILA ZA UPORABO (besedilo na notranji strani pokrova)
This is a disorder of the immune system where an abnormal protein is found in the blood.
To je motnja imunskega sistema, pri kateri so v krvi prisotne nenormalne beljakovine.
19, 21, 23 et seq.
19, 21, 23 in naslednji
These blood tests will be in addition to the tests, which are normally done to monitor your MS.
Te krvne preiskave se opravijo poleg preiskav, ki so običajne za nadzor MS.
The development of neutralising activity in these studies is associated with a reduction in clinical efficacy only with regard to relapse activity.
Pojav nevtralizacijske aktivnosti v teh študijah je povezan z zmanjšanjem klinične učinkovitosti, ki se nanaša le na recidivno aktivnost.
► Get a good start!
► Dobro se pripravite!
Interferons are proteins produced by the body that help fight against attacks on the immune system such as viral infections.
Interferoni so beljakovine, ki jih proizvaja telo in pomagajo odvračati napade na imunski sistem, kot so virusne okužbe.
− Prepare each dose only when you are ready for an injection.
- Vsak odmerek pripravite šele, ko ste pripravljeni na injiciranje.
This applies also to the titration pack.
To se nanaša tudi na set za titriranje.
Date of last renewal: 31 January 2006
Datum prve odobritve: 30. november 1995 Datum zadnjega podaljšanja: 31. januar 2006
Single use.
Za enkratno uporabo.
If you have forgotten to give yourself an injection at the right time do it as soon as you remember and then follow on with the next one 48 hours later.
Če si zdravilo pozabite samoinjicirati ob določenem času, to storite takoj ko se spomnite in nato ponovno čez 48 ur.
Rare cases of cardiomyopathy have been reported.
Poročali so o redkih primerih kardiomiopatije.
New adverse events have not been associated with the development of neutralising activity.
Novi neželeni učinki niso bili povezani s pojavom nevtralizacijske aktivnosti.
The table also includes side effects which occurred in less than 10% but were significantly associated with the treatment.
V preglednici so tudi neželeni učinki, ki so se pojavili pri manj kot 10 % primerov, a so pomembno povezani z zdravljenjem.
Betaferon with food and drink
Zdravilo Betaferon skupaj s hrano in pijačo
− If you have had depression or are depressed or previously had thoughts of suicide.
- če ste že imeli depresijo, ste depresivni ali ste že kdaj imeli samomorilne misli.
The following instructions and pictures explain how to prepare Betaferon for injection and how to inject Betaferon yourself.
Naslednja navodila in slike pojasnjujejo, kako zdravilo Betaferon pripravite za injiciranje in kako si ga sami injicirate.
− Be consistent - use Betaferon as described in section 3.
- Bodite dosledni - zdravilo Betaferon uporabljajte, kot je opisano v poglavju 3.
These symptoms may suggest problems with your liver.
Ti simptomi morda kažejo na težave z jetri.
13 - If the plunger has moved back to its original position push it in again and hold it in place.
13 - Če se je bat vrnil v prvotni položaj, ga znova potisnite in držite v tem položaju.
These symptoms may be reduced by taking paracetamol or nonsteroidal anti-inflammatory medicines such as ibuprofen.
Te simptome je mogoče ublažiti z jemanjem paracetamola ali nesteroidnih protivnetnih zdravil, kot je na primer ibuprofen.
No influence on the monkey oestrous cycle has been observed.
Vpliva na estrusni ciklus opic niso ugotovili.
The available data for the additional three years are consistent with sustained treatment efficacy of Betaferon over the whole time period.
Podatki, ki so na voljo, o dodatnih treh letih se ujemajo z učinkovitostjo zdravljenja z zdravilom Betaferon v celotnem časovnem obdobju.
However, the duration of exposure during the first trimester is uncertain, because data were collected when interferon beta use was contraindicated during pregnancy, and treatment likely interrupted when pregnancy was detected and/or confirmed.
Vendar pa so podatki glede trajanja izpostavljenosti v prvem trimesečju negotovi, saj so bili podatki zbrani v obdobju, ko je bila uporaba interferona beta med nosečnostjo kontraindicirana, in je bilo zdravljenje po vsej verjetnosti prekinjeno, ko je bila nosečnost odkrita in/ali potrjena.
No individual sale.
Ne prodaja se posamezno.
The robustness of the treatment effect was also shown by the delay of progression to multiple sclerosis according to McDonald criteria (Table 3).
Robustnost učinka zdravljenja se je pokazala tudi kot odložitev napredovanja bolezni v multiplo sklerozo glede na merila po McDonaldu (preglednica 3).
An in vitro cell transformation test gave no indication of tumorigenic potential.
Test celične transformacije in vitro ni pokazal tumorogenega potenciala.
The syringes have special markings for this dose.
Brizge imajo posebne oznake za odmerke.
Additional caution should be exercised with any co-medication which has an effect on the haematopoietic system.
Dodatna previdnost je potrebna pri sočasni uporabi katerega koli zdravila, ki vpliva na hematopoetski sistem.
If the solution is discoloured or contains particles, discard it and start again with a new single pack of supplies.
Če je raztopina obarvana ali vsebuje delce, jo zavrzite in postopek začnite znova z novim paketom.
You should inject Betaferon into the fatty layer between the skin and muscle (that is, subcutaneously, about 8 to 12 mm under the skin).
Zdravilo Betaferon injicirajte v maščobno plast med kožo in mišico (to je subkutano, približno 8 do 12 mm pod kožo).
- Select an injection site for your first injection.
- Izberite mesto injiciranja za vašo prvo injekcijo.
The instructions include the following main steps:
Navodila obsegajo naslednje korake
*Betaferon is formulated to contain a calculated overfill of 20 %.
*Zdravilo Betaferon je pripravljeno tako, da vsebuje izračunan 20 % presežek.
► Talk to your doctor if you injected too much Betaferon or injected it too often.
► Posvetujte se z zdravnikom, če ste si injicirali preveč zdravila Betaferon ali če ste si ga injicirali prepogosto.
(Push the plunger all the way in until the syringe is empty.)
(Bat potisnite do konca, dokler ne izpraznite brizge.)
Carcinogenicity studies have not been performed.
Študije kancerogenosti niso izvedli.
Your doctor may decide, together with you, to change the time interval between increases in the dose depending on side effects you may experience at the start of treatment.
Zdravnik se lahko skupaj z vami odloči za spremembo presledka med povečanjem odmerkov glede na neželene učinke na začetku zdravljenja.
From these retrospective subgroup analyses there was evidence to suggest that relapses as well as pronounced EDSS progression (EDSS >1 point or >0.5 point for EDSS ≥6 in the previous two years) can help to identify patients with active disease.
Te retrospektivne analize podskupin so pokazale, da lahko poslabšanja in izrazito napredovanje glede na EDSS (EDSS > 1 točko ali > 0,5 točke pri EDSS ≥ 6 v zadnjih dveh letih) pripomorejo k odkritju bolnikov z aktivno boleznijo.
PHARMACEUTICAL FORM AND CONTENTS Triple pack 1
FARMACEVTSKA OBLIKA IN VSEBINA Tridelno pakiranje 1
Do not freeze the solution, and do not wait longer than 3 hours to inject it.
Raztopine ne zamrzujte, do injiciranja pa ne čakajte več kot 3 ure.
In addition you will need a disposal unit for used syringes and needles.
Dodatno boste potrebovali tudi posodo za odstranjevanje uporabljenih brizg in igel.
This makes it easier to remember and easier to plan a block of time when you will not be interrupted.
Tako si lažje zapomnite in načrtujete čas, ko ne želite, da vas med injiciranjem kdo prekine.
On our example schedule each area is split again into 6 injection sites (which adds up to 48 injection sites all together), left and right: upper, middle and lower part of each area.
V našem razporedu je vsak predel razdeljen na 6 mest injiciranja (kar skupno tvori 48 mest injiciranja): na zgornji, srednji in spodnji del na levi in desni strani.
If clinically needed, the use of Betaferon may be considered during pregnancy.
Če je klinično indicirano, se lahko razmisli o uporabi zdravila Betaferon med nosečnostjo.
Betaferon itself does not affect the heart directly.
Samo zdravilo Betaferon ne vpliva neposredno na srce.
- infection, abscess
- okužba, ognojek
You may need extra monitoring by your doctor.
Morda vas bo moral zdravnik posebej nadzorovati.
A risk for transmission of Creutzfeld-Jacob disease (CJD) cannot be excluded.
Tveganja za prenos Creutzfeld-Jakobove bolezni (CJD) ni mogoče izključiti.
For example, give the first injection into the right side of the abdomen, choose the left side for the second injection, then move to the right thigh for the third, and so on through the diagram until all suitable areas of the body have been used.
Če si npr. prvo injekcijo date v desno stran trebuha, izberite za drugo injekcijo levo stran, nato za tretjo injekcijo desno stegno in tako naprej po diagramu, dokler ne uporabite na telesu vseh primernih mest.
Interferons belong to the family of cytokines, which are naturally occurring proteins.
Interferoni spadajo v družino citokinov, ki so naravne beljakovine.
Your doctor or nurse will help you to learn the process of self-administration.
Zdravnik ali medicinska sestra vas bosta naučila postopka samoinjiciranja.
However, this did not seem to be associated with a reduction in clinical efficacy (with regard to time to clinically definite multiple sclerosis (CDMS), time to confirmed EDSS progression and relapse rate).
Vendar pa ta ni bil povezan z zmanjšanjem klinične učinkovitosti (glede na čas do klinično potrjene multiple skleroze (CDMS - clinically definite multiple sclerosis), časom do napredovanja potrjenega glede na EDSS in stopnjo recidiva).
Three major classes of interferons have been identified: alpha, beta, and gamma.
Znane so tri glavne skupine interferonov: alfa, beta in gama.
At present it is not known how long treatment with Betaferon should last.
Trenutno ni znano, kako dolgo mora trajati zdravljenje z zdravilom Betaferon.
There is evidence that the patients included in this study had overall less active disease than in the other study in secondary progressive multiple sclerosis.
Obstajajo dokazi, da so imeli bolniki, vključeni v to preskušanje, na splošno manj aktivno bolezen kot v omenjenem prvem preskušanju pri sekundarno progresivni multipli sklerozi.
Table A: Schedule for dose titration* treatment day dose volume
Preglednica A: Razpored titriranja odmerka* dan zdravljenja odmerek prostornina
However, if you are not able to do so, it will be suitable for use for 3 hours, if kept at 2-8 °C (in a refrigerator).
Če to ni mogoče, jo lahko hranite 3 ure na temperaturi od 2 do 8 °C (v hladilniku).
1 - Choose an area for the injection (see advice at the start and the diagrams at the end of this Annex), and make a note of it in your medication record.
1 - Izberite mesto injiciranja (glejte nasvet na začetku in diagrame na koncu tega dodatka) in dogodek zabeležite v kartici uporabe zdravila.
Inspection prior to use
Pregled pred uporabo
In any case, treatment should only be considered for patients classified as high risk.
V vsakem primeru je treba možnost zdravljenja upoštevati le pri bolnikih, pri katerih je tveganje veliko.
− Never re-use syringes or needles.
- Brizg ali igel nikoli ne uporabite dvakrat.
The decision to continue or discontinue treatment should be based on all aspects of the patient's disease status rather than on neutralising activity status alone.
Pri odločitvi o nadaljevanju ali prenehanju zdravljenja je treba upoštevati celoten status bolezni, ne le prisotnost nevtralizacijske aktivnosti.
Therapy with Betaferon was well accepted as indicated by a high rate of trial completion (93% in the Betaferon group).
Zdravljenje z zdravilom Betaferon je bilo dobro sprejeto, na kar kaže veliko število bolnikov, ki so zaključili preskušanje (93 % v skupini, ki je prejemala zdravilo Betaferon).
Injection site reactions usually become less frequent over time.
Reakcije na mestu injiciranja postanejo sčasoma manj pogoste.
INFORMATION IN BRAILLE Betaferon
PODATKI V BRAILLOVI PISAVI
The relation of multiple sclerosis disease activity as measured by MRI and clinical outcome is currently not fully understood.
Razmerje med aktivnostjo multiple skleroze, merjeno z MRS, in kliničnim izidom trenutno ni povsem jasno.
As rodents do not react to human interferon beta, repeated dose studies were carried out with rhesus monkeys.
Ker se glodalci ne odzovejo na humani interferon beta, so študije ponavljajočih odmerkov naredili na opicah rhesus.
4 - Gently pinch the skin together around the disinfected injection site (to raise it up a little).
4 - Kožo okoli dezinficiranega mesta nežno stisnite (da jo nekoliko dvignete).
Only hold the blue plastic adapter when removing.
Med odstranjevanjem držite le modri plastični adapter.
If you come back to an area after one Rotation Cycle, choose the most distant injection site within this area.
Če se po enem rotacijskem ciklu vrnete na isti predel, izberite mesto injiciranja znotraj tega predela, ki je najbolj oddaljeno od prejšnjega.
The treatment effect occurred in patients at all levels of disability investigated and independent of relapse activity.
Učinek zdravljenja se je pojavil pri bolnikih ne glede na preučevano stopnjo invalidnosti in neodvisno od recidivne aktivnosti.
The occurrence of elevations in serum transaminases should lead to close monitoring and investigation.
Pri povečanju vrednosti serumskih transaminaz so potrebni skrben nadzor in preiskave.
A risk of transmission of Creutzfeld-Jacob disease (CJD) cannot be ruled out.
Tveganja za prenos Creutzfeld-Jakobove bolezni (CJD) ni možno izključiti.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Odstranjevanje Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
No interaction studies with anti-epileptics have been carried out.
Študij medsebojnega delovanja z antiepileptiki niso izvedli.
Let the skin air-dry.
Pustite, da se posuši na zraku.
− Always place the used syringes in the proper disposal unit.
- Rabljeno brizgo vedno spravite v ustrezno posodo za odstranjevanje.
− If you have a heart disease, the flu-like symptoms, which often occur at the start of treatment, may prove stressful to you.
- Če imate bolezen srca vas bodo morda gripi podobni simptomi, ki se pogosto pojavijo na začetku zdravljenja, močno obremenjevali.
If you are injecting less than 1 ml with the titration pack there might not be any air bubbles, however for full dose injection some air bubbles might turn up.
Če ste pri titriranju injicirali manj kot 1 ml, zračni mehurčki verjetno niso prisotni, vendar se pri injiciranju celotnega odmerka zračni mehurčki lahko dvignejo.
Betaferon injections given every other day do not lead to serum level increases, and the pharmacokinetics does not seem to change during therapy.
Injiciranje zdravila Betaferon vsak drugi dan ne povzroči povečanja koncentracije v serumu in kot kaže, se farmakokinetika med zdravljenjem ne spremeni.
Secondary progressive multiple sclerosis: In some cases people with relapsing-remitting MS find that their symptoms increase and they progress to another form of MS called secondary progressive MS. With this, people find themselves becoming increasingly impaired, whether or not they have relapses.
Sekundarno progresivna multipla skleroza: V nekaterih primerih pri bolnikih z recidivnoremitentno MS ugotovijo večjo izraženost njihovih simptomov in napredovanje v drugo obliko MS, imenovano sekundarno progresivna MS. Bolniki s to obliko postajajo vedno bolj prizadeti, ne glede na to, ali imajo relapse ali ne.
This product contains human albumin and hence carries a potential risk for transmission of viral diseases.
Zdravilo vsebuje humani albumin in zato obstaja potencialno tveganje za prenos virusnih bolezni.
Betaferon can reduce the number and severity of the attacks, and slow the progression of disability.
Zdravilo Betaferon lahko zmanjša pogostnost in resnost zagonov ter upočasni napredovanje invalidnosti.
Patients should be monitored for signs of hepatic injury.
Bolnike je treba nadzorovati glede znakov jetrne okvare.
No formal clinical trials or pharmacokinetic studies have been conducted in children or adolescents.
Kliničnih preskušanj ali farmakokinetičnih študij pri otrocih ali mladostnikih niso izvedli.
Inspect the reconstituted product visually before use.
Rekonstituirano zdravilo je treba pred uporabo vizualno pregledati.
Boehringer Ingelheim RCV GmbH & Co KG Dr.-Boehringer-Gasse 5-11
Boehringer Ingelheim RCV GmbH & Co KG
Injection site reactions as well as injection site necroses were observed less frequently in this study than in the other pivotal studies.
Reakcije in nekroze na mestu injiciranja so v tej študiji opazili redkeje kot v drugih ključnih študijah.
Patients treated with Betaferon should be advised to report any symptoms of depression and/or suicidal ideation to their prescribing physician immediately.
Bolnikom, ki prejemajo zdravilo Betaferon, je treba svetovati, naj o morebitnih simptomih depresije in/ali samomorilnih mislih takoj obvestijo zdravnika, ki jim je predpisal zdravilo.
Do not shake the vial.
Ne stresajte viale.
If some areas are too difficult for you to reach, you may need a family member or friend to help you with these injections.
Če katera mesta težko dosežete, prosite za pomoč člana družine ali prijatelja, da vam pomaga pri injiciranju.
Reproduction studies with rhesus monkeys revealed maternal toxicity and an increased rate of abortion, resulting in prenatal mortality.
Reprodukcijske študije pri opicah rhesus so razkrile maternalno toksičnost in povečano pogostnost splavov, ki sta povzročila prenatalno umrljivost.
In the open-label follow-up phase, the treatment effect on CDMS was still evident after 3 and 5 years (Table 3) even though the majority of patients from the placebo-group were treated with Betaferon at least from the second year onwards.
V odprti fazi nadaljevanja študije so bili učinki zdravljenja na CDMS še vedno opazni po 3 in 5 letih (preglednica 3), čeprav je bila večina bolnikov iz skupine, ki je dobivala placebo, zdravljena z zdravilom Betaferon vsaj od drugega leta naprej.
Other things to consider when using Betaferon
Drugi dejavniki, ki jih je treba upoštevati pri uporabi zdravila Betaferon
Please refer to the rotation schedule at the end of this Annex to learn how to choose an injection site.
Oglejte si načrt menjavanja na koncu tega dodatka, da se naučite izbrati mesto injiciranja.