FrancophonIA/ELRC3.0 huggingface dataset:
English: Acrochordon, melanocytic naevus, seborrhoeic keratosis, skin papilloma
Slovenian: karcinom bazalnih celic fibroepitelialni polip, melanocitni nevusi, seboreična keratoza, kožni papilom
English: Nausea Constipation, dyspepsia, vomiting, dry mouth, diarrhoea, abdominal pain, gastritis, flatulence, abdominal distension,
Slovenian: Bolezni prebavil navzea zaprtje, dispepsija, bruhanje, suha usta, diareja, bolečina v trebuhu, gastritis, flatulenca, abdominalna distenzija, povečano izločanje sline, gastroezofagealna refluksna bolezen, aftozni stomatitis peptična razjeda, siljenje na bruhanje, krvavitev v zgornjih prebavilih
English: Xadago 50 mg film-coated tablets Xadago 100 mg film-coated tablets safinamide
Slovenian: Navodilo za uporabo Xadago 50 mg filmsko obložene tablete Xadago 100 mg filmsko obložene tablete Safinamid
English: Amblyopia, chromatopsia, diabetic retinopathy, erythropsia, eye haemorrhage, eye pain, eyelid oedema, hypermetropia, keratitis, lacrimation increased, night blindness, papilloedema, presbyopia, strabismus
Slovenian: Očesne bolezni katarakta zamegljen vid, skotom, diplopija, fotofobija, obolenje mrežnice, konjunktivitis, glavkom ambliopija, kromatopsija, diabetična retinopatija, eritropsija, očesna krvavitev, bolečina v očesu, edem očesne veke, hipermetropija, keratitis, povečano solzenje, nočna slepota, papiloedem, presbiopija,
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovanje in izdaja zdravila je le na recept.
English: Eosinophilia, lymphopenia
Slovenian: Bolezni jeter, žolčnika in žolčevodov hiperbilirubinemija
English: Dyskinesia was the most common adverse reaction reported in safinamide patients when used in combination with L-dopa alone or in combination with other PD treatments.
Slovenian: Pri bolnikih, zdravljenih s safinamidom, so ob uporabi zdravila v kombinaciji z L-dopo v monoterapiji ali v kombinaciji z drugimi zdravili za zdravljenje parkinsonove bolezni najpogosteje poročali o diskineziji.
English: OFF time (hrs) (c) Baseline (b)
Slovenian: Obdobje težav z gibanjem (»izklop«) (ure) (c) Izhodišče (b)
English: Back pain, arthralgia, muscle spasms, muscle rigidity, pain in extremity, muscular weakness, sensation of heaviness
Slovenian: Bolezni mišičnoskeletnega sistema in vezivnega tkiva bolečina v hrbtu, artralgija, mišični krči, mišična rigidnost, bolečine v udih, šibkost mišic, občutek teže ankilozni spondilitis, bolečina v ledvenem predelu, otekanje sklepov, mišično-skeletna bolečina, mialgija, bolečina v vratu, osteoartritis, sinovijska cista
English: Xadago 100 mg film-coated tablets safinamide
Slovenian: Xadago 100 mg filmsko obložene tablete safinamid
English: PD Duration (years) (b)
Slovenian: Trajanje obolelosti s parkinsonovo boleznijo(leta) (b)
English: There have been reports of medicinal product interactions with the concomitant use of dextromethorphan and non-selective MAO inhibitors.
Slovenian: O interakciji med zdravili so poročali tudi pri sočasni uporabi zaviralcev MAO in simpatomimetikov.
English: 95% CI p-value
Slovenian: Razlika LS v primerjavi s placebom 95 % IZ
English: Xadago 50 mg film-coated tablets safinamide
Slovenian: Xadago 50 mg filmsko obložene tablete safinamid
English: CARTON - film-coated tablets
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA - filmsko obložene tablete
English: What Xadago looks like and contents of the pack Xadago 50 mg are orange to copper, round, biconcave film-coated tablets of 7 mm diameter with metallic gloss, embossed with “50” on one side of the tablet.
Slovenian: Xadago 50 mg so oranžne do bakrene barve, okrogle, bikonkavne filmsko obložene tablete premera 7 mm s kovinskim sijajem in vtisnjeno jakostjo „50“ na eni strani tablete.
English: xadago 50 mg
Slovenian: PODATKI V BRAILLOVI PISAVI xadago 50 mg
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Slovenian: Izgled zdravila Xadago in vsebina pakiranja
English: Micturition urgency, polyuria, pyuria, urinary hesitation
Slovenian: nuja po uriniranju, poliurija, piurija, težave z začetkom mokrenja
English: Xadago 100 mg film-coated tablets
Slovenian: Xadago 100 filmsko obložene tablete
English: How to store Xadago
Slovenian: Shranjevanje zdravila Xadago
English: Bronchospasm, dysphonia, oropharyngeal pain, oropharyngeal spasm
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora kašelj, dispneja, rinoreja bronhospazem, disfonija, orofaringealna bolečina, orofaringealni spazem
English: Symptoms may disappear completely or partly.
Slovenian: Simptomi lahko popolnoma izginejo ali le delno.
English: The exact cause of MS is unknown.
Slovenian: Natančen vzrok za MS ni znan.
English: This effect continued over the observation period of up to 33 months.
Slovenian: Ta vpliv se je nadaljeval v obdobju spremljanja do 33 mesecev.
English: Please read the instructions carefully and follow them step by step.
Slovenian: Navodila natančno preberite in jim sledite korak za korakom.
English: A) General advice
Slovenian: A) Splošni nasveti
English: Currently it is not possible to predict which patients belong to this group.
Slovenian: Trenutno ni mogoče predvideti, kateri bolniki sodijo v to skupino.
English: This will help you to inject the required dose only.
Slovenian: To vam bo v pomoč, da boste injicirali samo zahtevani odmerek.
English: The length of treatment will be decided by your doctor together with you.
Slovenian: O trajanju zdravljenja se bo zdravnik odločil skupaj z vami.
English: However, there is some data available in children and adolescents from 12 to 16 years.
Slovenian: Vendar pa so za otroke in mladostnike, stare od 12 do 16 let, na voljo nekateri podatki.
English: Risk reduction
Slovenian: Zmanjšanje tveganja
English: Based on animal data (see section 5.3), there is a possibly increased risk for spontaneous abortion.
Slovenian: Glede na podatke iz študij na živalih (glejte poglavje 5.3), je možno povečano tveganje za spontani splav.
English: 18 - You are now ready to inject.
Slovenian: 18 - Sedaj ste pripravljeni na injiciranje.
English: Dear patient,
Slovenian: Dragi bolnik!
English: PART I: STEP BY STEP INSTRUCTIONS
Slovenian: DEL I: NAVODILA PO KORAKIH
English: ► Tell your doctor if any of the above applies to you.
Slovenian: ► Obvestite zdravnika, če kar koli od zgoraj navedenega velja za vas.
English: As with all therapeutic proteins, there is a potential for immunogenicity.
Slovenian: Kot pri vseh terapevtskih beljakovinah, obstaja možnost za razvoj imunogenosti.
English: Therefore Betaferon should not be used in this population.
Slovenian: Zato se ga pri tej populaciji ne sme uporabljati.
English: Robust evidence for benefit on this outcome parameter could not be demonstrated for 'immediate' treatment.
Slovenian: Robustnosti dokaza koristnosti učinka na ta parameter ni bilo mogoče prikazati za "takojšnje" zdravljenje.
English: No harmful effects on the breastfed newborn/infant are anticipated.
Slovenian: Škodljivih učinkov na dojene novorojenčke/dojenčke se ne pričakuje.
English: The optimal dose has not been fully clarified.
Slovenian: Optimalni odmerek še ni povsem določen.
English: Always double-check your dosage.
Slovenian: Vedno dvakrat preverite svoj odmerek.
English: This is called demyelination.
Slovenian: Proces se imenuje demielinizacija.
English: It is not yet clear whether these neutralising antibodies reduce the effectiveness of the treatment.
Slovenian: Ni še jasno, ali lahko nevtralizirajoča protitelesa zmanjšajo učinkovitost zdravljenja.
English: This package meets the patient's needs for the first 12 injections.
Slovenian: Ta pakiranja zadostujejo za potrebe bolnika za prvih 12 injekcij.
English: Talk to your doctor if you stop or wish to stop treatment.
Slovenian: Pogovorite se z zdravnikom, če ste prenehali ali želite prenehati z zdravljenjem.
English: In order to improve traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Slovenian: Z namenom izboljšanja sledljivosti bioloških zdravil je treba jasno zabeležiti ime in številko serije uporabljenega zdravila.
English: ► Checking the content of the pack
Slovenian: ► Preverjanje vsebine pakiranja
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 uporabljali avtoinjektor.
English: This can lead to shock (collapse) and even be fatal.
Slovenian: To lahko povzroči šok (kolaps) in celo smrt.
English: Each triple pack contains the syringes you will require for preparing each dose.
Slovenian: Vsako tridelno pakiranje vsebuje tudi brizge, ki jih boste potrebovali za pripravo vsakega odmerka.
English: - medicines which affect the production of blood cells.
Slovenian: - zdravili, ki vplivajo na nastajanje krvnih celic.
English: Each single pack contains:
Slovenian: Vsako posamezno pakiranje vsebuje:
English: 69% 85% No primary endpoint
Slovenian: 69 % 85 % Ni primarnega končnega izida
English: If you are especially sensitive, this might affect your ability to drive or use machines.
Slovenian: Če ste posebno občutljivi, lahko to vpliva na vašo sposobnost upravljanja vozil ali strojev.
English: 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.
Slovenian: 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.
English: − Always use a sterile (aseptic) technique as described in here.
Slovenian: - Vedno uporabite sterilno (aseptično) tehniko, kot je opisano.
English: This is often associated with an increase of certain blood fats (triglycerides).
Slovenian: To je pogosto povezano s povečanjem vrednosti nekaterih maščob v krvi (trigliceridov).
English: No long-term studies have been conducted.
Slovenian: Dolgoročnih študij niso izvedli.
English: You will find that within a few weeks your treatment will become a natural part of your routine.
Slovenian: V nekaj tednih bo zdravljenje postalo rutinsko.
English: In one single genotoxicity study (Ames test), no mutagenic effect has been observed.
Slovenian: V eni sami študiji genotoksičnosti (Amesov test) niso opazili mutagenega učinka.
English: This will either be done by your doctor or nurse or by yourself after you have been carefully trained.
Slovenian: To bodo naredili bodisi zdravnik ali medicinska sestra bodisi vi sami, potem ko se boste za to zadostno usposobili.
English: Table 3: Primary efficacy results of the BENEFIT and the BENEFIT Follow-up study
Slovenian: Preglednica 3: Izsledki primarne učinkovitosti v študiji BENEFIT in nadaljevalni študiji BENEFIT
English: Experience with other interferons suggests a potential for impairment of male and female fertility.
Slovenian: Izkušnje z drugimi interferoni kažejo možnost vpliva na moško in žensko plodnost.
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 tistimi, ki so omenjena v poglavju 6.6.
English: You can use the following rotation schedule.
Slovenian: Lahko uporabite naslednji načrt.
English: Some analyses suggest that this effect might be larger in patients with higher titre levels of neutralising activity.
Slovenian: Nekatere analize kažejo, da bi bil ta učinek lahko večji pri bolnikih z večjim titrom nevtralizacijske aktivnosti.
English: * produced by genetic engineering from a strain of Escherichia coli.
Slovenian: * pridobljen z genskim inženirstvom iz seva Escherichie coli.
English: Keep a record of where and when you last gave yourself an injection.
Slovenian: Zapisujte si, kam in kdaj ste si nazadnje dali injekcijo.
English: Neutralising antibodies are not produced in all patients.
Slovenian: Nevtralizacijska protitelesa ne nastajajo pri vseh bolnikih.
English: The schedule shown in the diagram below will help you to vary the sites appropriately.
Slovenian: Razpored na diagramu vam bo pomagal ustrezno menjavati mesta.
English: No malformations have been observed in the surviving animals.
Slovenian: Med preživelimi živalmi niso opazili malformacij.
English: • Periodic safety update reports(PSURs)
Slovenian: • Redno posodobljena poročila o varnosti zdravila (PSUR)
English: These may be symptoms of a serious allergic reaction (hypersensitivity), which may become life threatening.
Slovenian: To so lahko simptomi resne alergiske reakcije (preobčutljivosti), ki lahko postane življenjsko nevarna.
English: The reconstituted product is colourless to light yellow and slightly opalescent to opalescent.
Slovenian: Rekonstituirano zdravilo je brezbarvno do svetlo rumeno in rahlo opalescentno do opalescentno.
English: There is no information on the use of Betaferon in children under 12 years of age.
Slovenian: Podatkov o uporabi zdravila Betaferon pri otrocih, mlajših od 12 let, ni.
English: Experience with exposure during the second and third trimester is very limited.
Slovenian: Izkušenj z izpostavljenostjo zdravilu v drugem in tretjem trimesečju nosečnosti je zelo malo.
English: Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines, including medicines obtained without a prescription.
Slovenian: 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.
English: Müllerstraße 178 13353 Berlin Germany
Slovenian: Müllerstraße 178 13353 Berlin
English: The triple packs are highlighted in different colours (see section 6.5).
Slovenian: Tridelna pakiranja so označena z različnimi barvami (glejte poglavje 6.5).
English: INSTRUCTIONS ON USE (text for inside the lid)
Slovenian: NAVODILA ZA UPORABO (besedilo na notranji strani pokrova)
English: This is a disorder of the immune system where an abnormal protein is found in the blood.
Slovenian: To je motnja imunskega sistema, pri kateri so v krvi prisotne nenormalne beljakovine.
English: 19, 21, 23 et seq.
Slovenian: 19, 21, 23 in naslednji
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 preiskav, ki so običajne za nadzor MS.
English: The development of neutralising activity in these studies is associated with a reduction in clinical efficacy only with regard to relapse activity.
Slovenian: Pojav nevtralizacijske aktivnosti v teh študijah je povezan z zmanjšanjem klinične učinkovitosti, ki se nanaša le na recidivno aktivnost.
English: ► Get a good start!
Slovenian: ► Dobro se pripravite!
English: Interferons are proteins produced by the body that help 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: − Prepare each dose only when you are ready for an injection.
Slovenian: - Vsak odmerek pripravite šele, ko ste pripravljeni na injiciranje.
English: This applies also to the titration pack.
Slovenian: To se nanaša tudi na set za titriranje.
English: Date of last renewal: 31 January 2006
Slovenian: Datum prve odobritve: 30. november 1995 Datum zadnjega podaljšanja: 31. januar 2006
English: Single use.
Slovenian: Za enkratno uporabo.
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: Rare cases of cardiomyopathy have been reported.
Slovenian: Poročali so o redkih primerih kardiomiopatije.
English: New adverse events have not been associated with the development of neutralising activity.
Slovenian: Novi neželeni učinki niso bili povezani s pojavom nevtralizacijske aktivnosti.
English: The table also includes side effects which occurred in less than 10% but were significantly associated with the treatment.
Slovenian: V preglednici so tudi neželeni učinki, ki so se pojavili pri manj kot 10 % primerov, a so pomembno povezani z zdravljenjem.
English: Betaferon with food and drink
Slovenian: Zdravilo Betaferon skupaj s hrano in pijačo
English: − If you have had depression or are depressed or previously had thoughts of suicide.
Slovenian: - če ste že imeli depresijo, ste depresivni ali ste že kdaj imeli samomorilne misli.
English: The following instructions and pictures explain how to prepare Betaferon for injection and how to inject Betaferon yourself.
Slovenian: Naslednja navodila in slike pojasnjujejo, kako zdravilo Betaferon pripravite za injiciranje in kako si ga sami injicirate.
English: − Be consistent - use Betaferon as described in section 3.
Slovenian: - Bodite dosledni - zdravilo Betaferon uporabljajte, kot je opisano v poglavju 3.
English: These symptoms may suggest problems with your liver.
Slovenian: Ti simptomi morda kažejo na težave z jetri.
English: 13 - If the plunger has moved back to its original position push it in again and hold it in place.
Slovenian: 13 - Če se je bat vrnil v prvotni položaj, ga znova potisnite in držite v tem položaju.
English: These symptoms may be reduced by taking paracetamol or nonsteroidal anti-inflammatory medicines such as ibuprofen.
Slovenian: Te simptome je mogoče ublažiti z jemanjem paracetamola ali nesteroidnih protivnetnih zdravil, kot je na primer ibuprofen.
English: No influence on the monkey oestrous cycle has been observed.
Slovenian: Vpliva na estrusni ciklus opic niso ugotovili.
English: The available data for the additional three years are consistent with sustained treatment efficacy of Betaferon over the whole time period.
Slovenian: Podatki, ki so na voljo, o dodatnih treh letih se ujemajo z učinkovitostjo zdravljenja z zdravilom Betaferon v celotnem časovnem obdobju.
English: 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.
Slovenian: 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.
English: No individual sale.
Slovenian: Ne prodaja se posamezno.
English: The robustness of the treatment effect was also shown by the delay of progression to multiple sclerosis according to McDonald criteria (Table 3).
Slovenian: Robustnost učinka zdravljenja se je pokazala tudi kot odložitev napredovanja bolezni v multiplo sklerozo glede na merila po McDonaldu (preglednica 3).
English: An in vitro cell transformation test gave no indication of tumorigenic potential.
Slovenian: Test celične transformacije in vitro ni pokazal tumorogenega potenciala.
English: The syringes have special markings for this dose.
Slovenian: Brizge imajo posebne oznake za odmerke.
English: Additional caution should be exercised with any co-medication which has an effect on the haematopoietic system.
Slovenian: Dodatna previdnost je potrebna pri sočasni uporabi katerega koli zdravila, ki vpliva na hematopoetski sistem.
English: If the solution is discoloured or contains particles, discard it and start again with a new single pack of supplies.
Slovenian: Če je raztopina obarvana ali vsebuje delce, jo zavrzite in postopek začnite znova z novim paketom.
English: You should inject Betaferon into the fatty layer between the skin and muscle (that is, subcutaneously, about 8 to 12 mm under the skin).
Slovenian: Zdravilo Betaferon injicirajte v maščobno plast med kožo in mišico (to je subkutano, približno 8 do 12 mm pod kožo).
English: - Select an injection site for your first injection.
Slovenian: - Izberite mesto injiciranja za vašo prvo injekcijo.
English: The instructions include the following main steps:
Slovenian: Navodila obsegajo naslednje korake
English: *Betaferon is formulated to contain a calculated overfill of 20 %.
Slovenian: *Zdravilo Betaferon je pripravljeno tako, da vsebuje izračunan 20 % presežek.
English: ► Talk to your doctor if you injected too much Betaferon or injected it too often.
Slovenian: ► Posvetujte se z zdravnikom, če ste si injicirali preveč zdravila Betaferon ali če ste si ga injicirali prepogosto.
English: (Push the plunger all the way in until the syringe is empty.)
Slovenian: (Bat potisnite do konca, dokler ne izpraznite brizge.)
English: Carcinogenicity studies have not been performed.
Slovenian: Študije kancerogenosti niso izvedli.
English: 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.
Slovenian: Zdravnik se lahko skupaj z vami odloči za spremembo presledka med povečanjem odmerkov glede na neželene učinke na začetku zdravljenja.
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 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.
English: PHARMACEUTICAL FORM AND CONTENTS Triple pack 1
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA Tridelno pakiranje 1
English: Do not freeze the solution, and do not wait longer than 3 hours to inject it.
Slovenian: Raztopine ne zamrzujte, do injiciranja pa ne čakajte več kot 3 ure.
English: In addition you will need a disposal unit for used syringes and needles.
Slovenian: Dodatno boste potrebovali tudi posodo za odstranjevanje uporabljenih brizg in igel.
English: This makes it easier to remember and easier to plan a block of time when you will not be interrupted.
Slovenian: Tako si lažje zapomnite in načrtujete čas, ko ne želite, da vas med injiciranjem kdo prekine.
English: 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.
Slovenian: 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.
English: If clinically needed, the use of Betaferon may be considered during pregnancy.
Slovenian: Če je klinično indicirano, se lahko razmisli o uporabi zdravila Betaferon med nosečnostjo.
English: Betaferon itself does not affect the heart directly.
Slovenian: Samo zdravilo Betaferon ne vpliva neposredno na srce.
English: - infection, abscess
Slovenian: - okužba, ognojek
English: You may need extra monitoring by your doctor.
Slovenian: Morda vas bo moral zdravnik posebej nadzorovati.
English: A risk for transmission of Creutzfeld-Jacob disease (CJD) cannot be excluded.
Slovenian: Tveganja za prenos Creutzfeld-Jakobove bolezni (CJD) ni mogoče izključiti.
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 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.
English: Interferons belong to the family of cytokines, which are naturally occurring proteins.
Slovenian: Interferoni spadajo v družino citokinov, ki so naravne beljakovine.