FrancophonIA/ELRC3.0 huggingface dataset:
English: 1 - Wash your hands thoroughly with soap and water before beginning this process.
Slovenian: 1 - Pred začetkom si temeljito umijte roke z milom in vodo.
English: Neutralising antibodies are not produced in all patients.
Slovenian: Nevtralizirajoča protitelesa ne nastajajo pri vseh bolnikih.
English: No long-term studies have been conducted.
Slovenian: Dolgoročnih študij niso izvajali.
English: There is no evidence for benefit in terms of confirmed disability progression in the majority of patients receiving “immediate” treatment.
Slovenian: Podatki ne dokazujejo koristi glede napredovanja invalidnosti pri večini bolnikov, ki so prejeli “takojšnje” zdravljenje.
English: Significant effects were also obtained in patients with less disseminated and less active disease at the time of the first event.
Slovenian: Pomembne učinke so dosegli tudi pri bolnikih z manj diseminirano in manj aktivno boleznijo v času prvega dogodka.
English: If more than 3 hours pass, discard the medicine and prepare a new injection.
Slovenian: Če mine več kot 3 ure, zdravilo zavrzite in pripravite novo injekcijo.
English: If you are especially sensitive, this might influence your ability to drive or use machines.
Slovenian: Če ste posebno občutljivi, lahko to vpliva na vašo sposobnost upravljanja vozil ali strojev.
English: No harmful effects on the breastfed newborn/infant are anticipated.
Slovenian: Škodljivih učinkov na dojenega novorojenčka/otroka ni pričakovati.
English: This is often associated with an increase in certain blood fats (triglycerides).
Slovenian: To je pogosto povezano z zvišanjem vrednosti nekaterih maščob v krvi (trigliceridov).
English: The length of treatment will be decided by your doctor together with you.
Slovenian: Trajanje zdravljenja boste določili skupaj z zdravnikom.
English: The available data for the additional three years are consistent with sustained treatment efficacy of Extavia over the whole time period.
Slovenian: Razpoložljivi podatki o dodatnih treh letih se skladajo s trajno učinkovitostjo zdravljenja z zdravilom Extavia v celotnem časovnem obdobju.
English: This medicinal product must not be mixed with other medicinal products except for the supplied solvent mentioned in section 6.6.
Slovenian: Zdravila ne smemo mešati z drugimi zdravili, razen s priloženim vehiklom, ki je omenjen v poglavju 6.6.
English: These blood tests will be in addition to the tests which are normally done to monitor your MS.
Slovenian: Te krvne preiskave se opravijo poleg testov, ki so običajni za nadzor MS.
English: Moreover, an autoinjector was used by the majority of patients throughout the study.
Slovenian: Poleg tega so pri večini bolnikov ves čas trajanja študije uporabili avtoinjektor.
English: Some analyses suggest that this effect might be more pronounced in patients with higher titre levels of neutralising activity.
Slovenian: Nekatere analize kažejo, da bi bil ta učinek lahko bolj izrazit pri bolnikih z višjim titrom nevtralizirajoče aktivnosti.
English: Rotation Cycle 1: Upper left section of each area Rotation Cycle 2: Lower right section of each area Rotation Cycle 3: Middle left section of each area Rotation Cycle 4 Upper right section of each area Rotation Cycle 5: Lower left section of each area Rotation Cycle 6:
Slovenian: Rotacijski cikel 1: Zgornji levi del vsakega predela Rotacijski cikel 2: Spodnji desni del vsakega predela Rotacijski cikel 3: Srednji levi del vsakega predela Rotacijski cikel 4: Zgornji desni del vsakega predela Rotacijski cikel 5: Spodnji levi del vsakega predela Rotacijski cikel 6: Srednji desni del vsakega predela
English: If you have already been using Extavia start with the area that has not been used during the last rotation cycle (i.e. the past 16 days).
Slovenian: Če ste že uporabljali zdravilo Extavia, začnite s predelom, ki ga v zadnjem rotacijskem ciklusu (tj. zadnjih 16 dni) niste uporabili.
English: The powder should dissolve completely without shaking.
Slovenian: Prašek je treba raztopiti popolnoma, brez pretresanja.
English: 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.
Slovenian: Če si zdravilo pozabite samoinjicirati ob določenem času, to storite takoj, ko se spomnite in nato ponovno čez 48 ur.
English: Note: If the solution is discoloured or contains particles, discard it and start again with a new syringe and vial from your package.
Slovenian: Pozor: Če je raztopina obarvana ali vsebuje delce, jo zavrzite in postopek začnite znova z novo brizgo in novo vialo iz paketa.
English: Do not use this medicine if you notice it contains particles or is discoloured.
Slovenian: Ne uporabljajte tega zdravila, če opazite, da vsebuje delce ali je obarvano.
English: 4 - Where possible gently pinch the skin together around the disinfected injection site (to raise it up a little).
Slovenian: 4 - Kjer je mogoče, kožo okoli dezinficiranega mesta nežno stisnite (da jo nekoliko dvignete).
English: You should inject this medicine into the fatty layer between the skin and muscle (that is, subcutaneously, about 8 mm to 12 mm under the skin).
Slovenian: To zdravilo injicirajte v maščobno plast med kožo in mišico (to je subkutano, približno 8 mm do 12 mm pod kožo).
English: Do not inject a double dose to make up for a forgotten individual dose.
Slovenian: Ne injicirajte si dvojnega odmerka, če ste pozabili vzeti posamezen odmerek.
English: - Try to give yourself the injection at the same time each day.
Slovenian: - Zdravilo si poskusite injicirati vedno ob istem času dneva.
English: The decision to continue or discontinue treatment should be based on clinical disease activity rather than on neutralising activity status.
Slovenian: Odločitev o nadaljevanju ali prekinitvi zdravljenja mora temeljiti na kliničnem poteku bolezni, ne pa na prisotnosti nevtralizirajoče aktivnosti.
English: If clinically needed, the use of Extavia may be considered during pregnancy.
Slovenian: Če je klinično potrebno, je mogoče razmisliti o uporabi zdravila Extavia v času nosečnosti.
English: You will also need a disposal unit for used syringes and needles.
Slovenian: Potrebovali boste tudi posodo za odstranjevanje uporabljenih brizg in igel.
English: Talk to your doctor if you stop or wish to stop treatment.
Slovenian: Pogovorite se s svojim zdravnikom, če želite prenehati z zdravljenjem.
English: 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.
Slovenian: Če npr. prvo injekcijo daste 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.
English: Detailed instructions for self-injection of Extavia under the skin are provided in the Annex at the back of this leaflet.
Slovenian: Podrobna navodila za samoinjiciranje zdravila Extavia pod kožo so navedena v Dodatku na hrbtni strani tega navodila.
English: Interferons are proteins produced by the body that help it fight against attacks on the immune system such as viral infections.
Slovenian: Interferoni so beljakovine, ki jih proizvaja telo in pomagajo odvračati napade na imunski sistem, kot so virusne okužbe.
English: - Never re-use syringes or needles.
Slovenian: - Brizg ali igel nikoli ne uporabite dvakrat.
English: - If you have had depression or are depressed or previously had thoughts of suicide.
Slovenian: - če ste že imeli depresije, ste depresivni ali ste že kdaj imeli samomorilne misli.
English: No investigations on fertility have been conducted (see section 5.3).
Slovenian: Raziskave o plodnosti niso bile izvedene (glejte poglavje 5.3).
English: ► Talk to your doctor if you inject too much Extavia or injected too often.
Slovenian: ► Pogovorite se z zdravnikom, če ste injicirali preveč zdravila Extavia ali če ste ga injicirali prepogosto.
English: Extavia itself does not affect the heart directly.
Slovenian: Samo zdravilo Extavia ne vpliva neposredno na srce.
English: Injection site reactions and necroses were observed less frequently in this study than in the other pivotal studies.
Slovenian: Reakcije na mestu injiciranja in nekroze so v tej študiji opazili redkeje kot v drugih ključnih študijah.
English: The robustness of the treatment effect was also shown by the delay of progression to multiple sclerosis according to the McDonald criteria.
Slovenian: Robustnost učinka zdravljenja je pokazala tudi upočasnitev napredovanja v multiplo sklerozo po merilih po McDonaldu.
English: However, there are some data available in adolescents aged from 12 to 17 years which suggest that the safety of Extavia in this group is the same as in adults.
Slovenian: Vendar je na voljo nekaj podatkov pri mladostnikih, starih od 12 do 17 let, ki nakazujejo, da je varnost uporabe zdravila Extavia pri tej skupini bolnikov enaka kot pri odraslih.
English: Push the plunger to the 1 ml mark (or to the volume prescribed by your doctor).
Slovenian: Bat potisnite do oznake za 1 ml (oziroma do prostornine, ki vam jo je predpisal zdravnik).
English: At present it is not known how long treatment with Extavia should last.
Slovenian: Trenutno ni znano, kako dolgo mora trajati zdravljenje z zdravilom Extavia.
English: Do not push the plunger.
Slovenian: Ne pritisnite bata.
English: The treatment effect occurred in patients at all levels of disability investigated and independent of relapse activity.
Slovenian: Učinek zdravljenja se je pojavil pri bolnikih z vsemi raziskovanimi stopnjami invalidnosti in neodvisno od recidivne aktivnosti.
English: These symptoms may be reduced by taking paracetamol or non-steroidal antiinflammatory medicines such as ibuprofen.
Slovenian: Te simptome je mogoče ublažiti z jemanjem paracetamola ali nesteroidnih protivnetnih zdravil, kot je ibuprofen.
English: Generally, dose titration is recommended at the start of treatment in order to increase tolerability to Extavia (see section 4.2).
Slovenian: Na splošno se na začetku zdravljenja priporoča titracija odmerka, da bi povečali toleranco za zdravilo Extavia (glejte poglavje 4.2).
English: The persistence of the treatment effect was observed although the majority of patients from the placebo-group was treated with Extavia in the third year of the study.
Slovenian: Ohranjen učinek zdravljenja so opažali kljub temu, da je večina bolnikov iz skupine s placebom v tretjem letu študije jemala zdravilo Extavia.
English: Cases of cardiomyopathy have been reported.
Slovenian: Poročali so o primerih kardiomiopatije.
English: * produced by genetic engineering from strain of Escherichia coli.
Slovenian: * Pridobljen z gensko tehnologijo iz seva bakterije Escherichia coli.
English: However, the long-term impact of early treatment with Extavia is unknown even in these high risk subgroups as this study was mainly designed to assess the time to CDMS rather than the long-term evolution of the disease.
Slovenian: Vendar je dolgotrajen učinek zgodnjega zdravljenja z zdravilom Extavia neznan tudi pri teh podskupinah z velikim tveganjem, kajti študija je bila namenjena ocenjevanju časa do CDMS, ne pa dolgotrajnega razvoja bolezni.
English: Interferons have molecular weights ranging from 15,000 to 21,000 Daltons.
Slovenian: Njihova molekulska masa je od 15.000 do 21.000 daltonov.
English: Note: Be careful not to touch the exposed end of the syringe.
Slovenian: Pozor: Ravnajte previdno, da se ne dotaknete izpostavljenega dela brizge.
English: If you are allergic to latex, talk to your doctor before using Extavia.
Slovenian: Če ste alergični na lateks, se posvetujte z zdravnikom, preden začnete uporabljati zdravilo Extavia.
English: 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.
Slovenian: Te retrospektivne analize podskupin so pokazale, da lahko recidivi in izrazito napredovanje EDSS (EDSS>1 točko ali >0,5 točke pri EDSS>=6 v zadnjih dveh letih) pomagajo odkriti bolnike z aktivno boleznijo.
English: Pharmacotherapeutic group: Immunostimulants, interferons, ATC Code: L03AB08
Slovenian: Farmakoterapevtska skupina: zdravila za spodbujanje imunske odzivnosti, interferoni, oznaka ATC: L03AB08
English: - If you have a heart disease, the flu-like symptoms which often occur at the start of treatment may prove stressful to you.
Slovenian: - Če imate bolezen srca vas bodo morda gripi podobni simptomi, ki se pogosto pojavijo ob začetku zdravljenja, močno obremenjevali.
English: Extavia can reduce the number and severity of the attacks, and slow the progression of disability.
Slovenian: Zdravilo Extavia lahko zmanjša pogostnost in resnost napadov ter upočasni napredovanje invalidnosti.
English: Other things to consider when using Extavia:
Slovenian: Drugi dejavniki, ki jih je treba upoštevati pri uporabi zdravila Extavia:
English: What Extavia is and what it is used for
Slovenian: Kaj je zdravilo Extavia in za kaj ga uporabljamo
English: - Always place the used syringes in the proper disposal unit.
Slovenian: - Rabljeno brizgo vedno spravite v ustrezno posodo za odstranjevanje.
English: However, if you are not able to do so, it will remain usable for a period of 3 hours, if kept in a refrigerator (2°C - 8°C).
Slovenian: Če to ni mogoče, bo raztopina ostala uporabna 3 ure v hladilniku (pri temperaturi 2 °C-8 °C).
English: An example of a medication record is also included (see Annex Part III).
Slovenian: Priložen je primer zapisovanja dajanja zdravila (glejte Priloga del III).
English: Additional caution should be exercised with any co-medication which has an effect on the haematopoetic system.
Slovenian: Dodatna previdnost je potrebna ob sočasni uporabi katerega koli zdravila, ki vpliva na hematopoetski sistem.
English: On our example schedule each area is split again into 6 injection sites (which adds up to 48 injection sites altogether), left and right: upper, middle and lower part of each area.
Slovenian: V našem primeru 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.
English: The occurrence of elevations in serum transaminases should lead to close monitoring and investigation.
Slovenian: Zvišanje serumskih transaminaz zahteva skrbno nadziranje in preiskavo.
English: If some areas are too difficult for you to reach, you may need a family member or friend to help you with these injections.
Slovenian: Če nekatera mesta težko dosežete, prosite za pomoč člana družine ali prijatelja, da vam pomaga pri injiciranju.
English: An abnormal response by the body's immune system is thought to play an important part in the process which damages the CNS.
Slovenian: Predvidevajo, da ima nenormalen odziv imunskega sistema telesa pomembno vlogo v procesu, ki uničuje OŽ.
English: Administration of Extavia injections every other day does not lead to serum level increase, and the pharmacokinetics do not seem to change during therapy.
Slovenian: Injiciranje zdravila Extavia vsak drugi dan ne povzroči povečanja koncentracije v serumu in kot kaže, se farmakokinetika med zdravljenjem ne spremeni.
English: - During treatment with Extavia your body may produce substances called neutralising antibodies, which may react with Extavia.
Slovenian: - Med zdravljenjem z zdravilom Extavia lahko vaše telo proizvede snovi, imenovane nevtralizirajoča protitelesa, ki lahko reagirajo z zdravilom Extavia.
English: The development of neutralising activity is associated with a reduction in clinical efficacy only with regard to relapse activity.
Slovenian: Pojav nevtralizirajoče aktivnosti je povezan z zmanjšanjem klinične učinkovitosti, le kar zadeva recidivno aktivnost.
English: Generally, dose titration is recommended at the start of treatment.
Slovenian: Na splošno se na začetku zdravljenja priporoča titracija odmerka.
English: As rodents do not react to human interferon beta, repeated dose studies were carried out with rhesus monkeys.
Slovenian: Ker se glodalci ne odzovejo na človeški interferon beta, so študije ponavljajočih odmerkov naredili na opicah rhesus.
English: No formal clinical trials or pharmacokinetic studies have been conducted in children or adolescents.
Slovenian: Formalnih kliničnih preskušanj ali farmakokinetičnih študij pri otrocih ali mladostnikih niso opravili.
English: Extavia should not be used in children under 12 years of age as there is no information available for this age group.
Slovenian: Zdravila Extavia ni dovoljeno uporabljati pri otrocih, starih manj kot 12 let, ker za to starostno skupino ni na voljo nobenih podatkov.
English: Interferon beta-1b has been given to adult cancer patients at individual doses as high as 5,500 microgram (176 million IU) intravenously three times a week without serious adverse events compromising vital functions.
Slovenian: Interferon beta-1b so dajali odraslim bolnikom z rakom v individualnih odmerkih do 5,500 mikrogramov (176 milijonov i.e.) intravensko trikrat na teden in pri tem ni prišlo do resnih neželenih učinkov, ki bi ogrožali vitalne funkcije.
English: Extavia is indicated for the treatment of:
Slovenian: Zdravilo Extavia je indicirano za zdravljenje:
English: • Vial adapters for use when reconstituting your medicine
Slovenian: • adapterje za vialo, ki jih potrebujete za rekonstitucijo zdravila
English: These will be performed before you start using Extavia, regularly after treatment with Extavia has been initiated and then periodically during treatment, even if you have no particular symptoms.
Slovenian: Preiskave je treba opraviti preden začnete jemati zdravilo Extavia, redno po začetku zdravljenja z zdravilom Extavia in nato v presledkih med zdravljenjem, tudi če nimate posebnih simptomov.
English: 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.
Slovenian: V odsotnosti kliničnih znakov okvare jeter in po normalizaciji jetrnih encimov je mogoče razmisliti o ponovni uvedbi zdravljenja z ustreznim nadaljnjim spremljanjem jetrnega delovanja.
English: Reproduction studies with rhesus monkeys revealed maternal toxicity and an increased rate of abortion, resulting in prenatal mortality.
Slovenian: Reprodukcijske študije pri opicah rhesus so razkrile maternalno toksičnost in povečano pogostost splavov, ki sta povzročila prenatalno umrljivost.
English: In-use stability demonstrated for 3 hours at 2°C - 8°C.
Slovenian: Stabilnost po pripravi je dokazana za 3 ure pri temperaturi od 2 °C do 8 °C.
English: Extavia is a type of medicine known as interferon used to treat multiple sclerosis.
Slovenian: Extavia je vrsta zdravila, znanega kot interferon, za zdravljenje multiple skleroze.
English: - disease of the heart muscle (cardiomyopathy), (rare).
Slovenian: - obolenje srčne mišice (kardiomiopatija) (redki).
English: The relation of multiple sclerosis disease activity as measured by MRI and clinical outcome is currently not fully understood.
Slovenian: Razmerje med bolezensko aktivnostjo multiple skleroze, merjeno z MRS, in kliničnim izidom trenutno ni povsem jasno.
English: • Patients with a single demyelinating event with an active inflammatory process, if it is severe enough to warrant treatment with intravenous corticosteroids, if alternative diagnoses have been excluded, and if they are determined to be at high risk of developing clinically definite multiple sclerosis (see section 5.1).
Slovenian: • bolnikov z enkratnim demielinizacijskim dogodkom, z aktivnim vnetnim procesom, če je dovolj resen, da je potrebno intravensko zdravljenje s kortikosteroidi, če je bila alternativna diagnoza izključena in če je ugotovljeno, da je tveganje za razvoj klinično dokončne multiple skleroze veliko (glejte poglavje 5.1);
English: 6 - Inject the medicine (by pushing the plunger slowly and steadily all the way in until the syringe is empty).
Slovenian: 6 - Injicirajte zdravilo (s počasnim in enakomernim potiskanjem bata do konca, dokler ne izpraznite brizge).
English: The list also includes side effects which occurred commonly (may affect up to 1 in 10 people) but were significantly associated with the treatment:
Slovenian: Seznam obsega tudi neželene učinke, ki so se pojavljali pogosto (lahko prizadenejo največ 1 od 10 bolnikov), a so pomembno povezani z zdravljenjem:
English: If you come back to an area after one Rotation Cycle choose the most distant injection site within this area.
Slovenian: Če se po enem rotacijskem ciklu vrnete na isti predel, izberite mesto injiciranja znotraj tega predela, ki je najbolj oddaljeno od prejšnjega.
English: Your doctor may decide together with you to change the time intervals for dose increase depending on side effects you may experience at the start of treatment.
Slovenian: Vaš zdravnik se lahko skupaj z vami odloči za spremembo presledka za povečanje odmerka glede na neželene učinke ob začetku zdravljenja.
English: No data are available on the use of Extavia in children under 12 years of age and therefore Extavia should not be used in this population.
Slovenian: Podatkov o uporabi zdravila Extavia pri otrocih, mlajših od 12 let, ni na voljo, zato se ga pri tej populaciji ne sme uporabljati.
English: This medicinal product contains human albumin and hence carries a potential risk for transmission of viral diseases.
Slovenian: Zdravilo vsebuje človeški albumin in zato obstaja potencialno tveganje za prenos virusnih bolezni.
English: You may need extra monitoring by your doctor.
Slovenian: Morda vas bo moral zdravnik posebej nadzirati.
English: C) Reconstituting and drawing up the solution for injection, step by step
Slovenian: C) Rekonstitucija in izvlek raztopine za injiciranje po korakih
English: Please refer to the rotation schedule at the end of this Annex to learn how to choose an injection site.
Slovenian: Oglejte si načrt menjavanja na koncu tega Dodatka, da se naučite izbrati mesto injiciranja.
English: No acute toxicity studies have been performed.
Slovenian: Študij akutne toksičnosti niso izvedli.
English: Note: It may be necessary to adjust the plunger position back and forth a few times to ensure the excess air bubbles are gone and there is 1 ml of solution in the syringe.
Slovenian: Pozor: Morda boste morali bat nekajkrat potisniti nazaj in naprej, da boste odstranili odvečne zračne mehurčke in zagotovili, da bo v brizgi 1 ml raztopine.
English: The following instructions and pictures explain how to prepare Extavia for injection and how to inject Extavia yourself.
Slovenian: Naslednja navodila in slike pojasnjujejo, kako zdravilo Extavia pripravite za injiciranje in kako si ga sami injicirate.
English: This study consisted of two phases, a placebocontrolled phase followed by a pre-planned follow-up phase.
Slovenian: Ta študija je imela dva dela: s placebom kontroliranemu prvemu delu je sledil vnaprej načrtovan kontrolni del študije.
English: Patients should be monitored for signs of hepatic injury.
Slovenian: Bolnike je treba nadzirati glede znakov okvare jeter.
English: The reconstituted product is colourless to light yellow and slightly opalescent to opalescent.
Slovenian: Pripravljeno zdravilo je brezbarvno do rumenkasto in rahlo opalescentno do opalescentno.
English: Patients with decompensated liver disease (see sections 4.4, 4.5 and 4.8).
Slovenian: Bolniki z dekompenzirano boleznijo jeter (glejte poglavja 4.4, 4.5 in 4.8).
English: 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.
Slovenian: Obstajajo dokazi, da so imeli bolniki v tej raziskavi v celoti manj aktivno bolezen kot v omenjeni prvi raziskavi pri sekundarno progresivni multipli sklerozi.