FrancophonIA/ELRC3.0 huggingface dataset:
English: AUBAGIO should be used with caution in patients aged 65 years and over due to insufficient data on safety and efficacy.
Slovenian: Zdravilo AUBAGIO se mora uporabljati previdno pri bolnikih, starih 65 let in več, zaradi nezadostnih podatkov o varnosti in učinkovitosti.
English: • Requires concomitant use of effective contraception in women of child-bearing potential
Slovenian: • zahteva sočasno uporabo učinkovite kontracepcije pri ženskah v rodni dobi,
English: • To remind both patients and HCP about the Pregnancy Registry (in countries where pregnancy registry is on-going)
Slovenian: • opomniti bolnice in zdravstvene delavce o registru nosečnosti (v državah, kjer register nosečnosti obstaja).
English: The use of live attenuated vaccines may carry a risk of infections and should therefore be avoided.
Slovenian: Uporaba živih oslabljenih cepiv je lahko povezana s tveganjem za okužbe in se ji je treba izogniti.
English: • Talk with your doctor about the best method of contraception for you and any potential need for contraception change.
Slovenian: • S svojim zdravnikom se pogovorite o najboljši metodi kontracepcije za vas, pa tudi, če želite spremeniti obliko kontracepcije.
English: The mean duration of disease, since first symptoms, was 8.7 years.
Slovenian: Povprečno trajanje bolezni, od pojava prvih simptomov, je bilo 8,7 let.
English: The time can be reduced to a few weeks by taking certain medicines which speed up removal of AUBAGIO from your body.
Slovenian: Ta čas se lahko skrajša na nekaj tednov z uporabo določenih zdravil, ki pospešijo izločanje zdravila AUBAGIO iz vašega telesa.
English: • Summary of Product Characteristics (SmPC)
Slovenian: • Povzetek glavnih značilnosti zdravila (SmPC);
English: AUBAGIO can cause an increase in blood pressure.
Slovenian: Zdravilo AUBAGIO lahko povzroči povečanje krvnega tlaka.
English: • Educational material for Healthcare professionals
Slovenian: • Izobraževalno gradivo za zdravstvene delavce;
English: These effects are considered to be related to increase in renal tubular excretion and not related to changes in glomerular functions.
Slovenian: Ti učinki se štejejo za povezane s povečano ledvično tubularno sekrecijo in ne za povezane s spremembami glomerulne funkcije.
English: Frequencies were defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Slovenian: Pogostnosti so določene po naslednjem dogovoru: zelo pogosti (≥1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1000 do < 1/100); redki (≥ 1/10000 do < 1/1000); zelo redki (< 1/10000); neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: • Requires a pregnancy status check before treatment
Slovenian: • zahteva preverjanje nosečnosti pred uvedbo zdravljenja,
English: Information on the optional service of a periodic reminder to patients about the continued need for effective contraception during treatment.
Slovenian: Informacije o izbirnih storitvah, ki so na voljo kot redni opomniki bolnikov o stalni potrebi po učinkoviti kontracepciji med zdravljenjem.
English: Prior to launch in each Member State the Marketing Authorisation Holder (MAH) shall agree an educational programme with the National Competent Authority.
Slovenian: Pred prihodom zdravila na trg v vsaki državi članici se mora imetnik dovoljenja za promet z zdravilom (MAH) s pristojnim nacionalnim organom dogovoriti glede izobraževalnega programa.
English: Long term follow-up results from TEMSO long term extension safety study (overall median treatment duration approximately 5 years, maximum treatment duration approximately 8.5 years) did not present any new or unexpected safety findings.
Slovenian: Dolgoročno spremljanje rezultatov dolgoročne podaljšane varnostne študije TEMSO (skupna mediana trajanja zdravljenja je bila približno 5 let, pri čemer je bilo najdaljše trajanje zdravljenja približno 8,5 let) ni pokazalo nobenih novih ali nepričakovanih ugotovitev glede varnosti.
English: - you have severe skin reactions.
Slovenian: - če imate hudo kožno reakcijo.
English: You may experience side effects similar to those described in section 4 below.
Slovenian: Lahko se pojavijo neželeni učinki, podobni tistim, ki so opisani v poglavju 4.
English: The safety and efficacy of teriflunomide in children aged from 10 to less than 18 years has not yet been established.
Slovenian: Varnost in učinkovitost teriflunomida pri otrocih, starih od 10 do manj kot 18 let, nista bili dokazani.
English: - you have weakness, numbness and pain in the hands and feet.
Slovenian: - če občutite oslabelost, otrplost ali bolečine v rokah in nogah.
English: However, there was a wide variability in final outcome, i.e. in some patients the neuropathy resolved and some patients had persistent symptoms.
Slovenian: Vendar pa obstaja velika variabilnost v končnem izidu, tj. pri nekaterih bolnikih nevropatija izzveni, nekateri bolniki pa imajo stalne simptome.
English: The safety of teriflunomide in individuals with latent tuberculosis infection is unknown, as tuberculosis screening was not systematically performed in clinical studies.
Slovenian: Varnost teriflunomida pri osebah z latentno tuberkulozo ni znana, saj presejalni test za tuberkulozo ni bil sistematično opravljen v kliničnih študijah.
English: Gender, Elderly, Paediatric patients
Slovenian: Spol, starostniki, pediatrični bolniki
English: Teriflunomide 14 mg (N=1002)
Slovenian: teriflunomid 14 mg (N=1002)
English: The volume of distribution is 11 l after a single intravenous (IV) administration.
Slovenian: Volumen porazdelitve je 11 l po enkratnem intravenskem (i.v.)
English: However, there was no apparent impact of this increase in plasma rosuvastatin exposure on the HMG-CoA reductase activity.
Slovenian: Vendar ni bilo opaziti učinka tega povečanja plazemske izpostavitve rosuvastatinu na aktivnost HMG-CoA-reduktaze.
English: - you have high blood pressure (hypertension) whether it is controlled with medicines or not.
Slovenian: - če imate visok krvni tlak (hipertenzijo), ki ga obvladujete z zdravili ali ne.
English: Teriflunomide is extensively bound to plasma protein (>99%), probably albumin and is mainly distributed in plasma.
Slovenian: Teriflunomid je obsežno vezan na plazemske beljakovine (> 99 %), verjetno albumin, in se v glavnem porazdeljuje v plazmi.
English: AUBAGIO may be taken with or without food.
Slovenian: Zdravilo AUBAGIO se lahko jemlje s hrano ali brez nje.
English: ILD may occur acutely at any time during therapy with a variable clinical presentation.
Slovenian: ILD se lahko pojavi akutno, kadar koli med zdravljenjem in z raznoliko klinično sliko.
English: The tablets should be swallowed whole with some water.
Slovenian: Tablete je treba pogoltniti cele z nekaj vode.
English: The risk of malignancy, particularly lymphoproliferative disorders, is increased with use of some other agents that affect the immune system (class effect).
Slovenian: Tveganje za maligne bolezni, zlasti za limfoproliferativne bolezni, se poveča z uporabo nekaterih drugih snovi, ki vplivajo na imunski sistem (učinek razreda).
English: Teriflunomide is eliminated slowly from the plasma.
Slovenian: Teriflunomid se iz plazme izloča počasi.
English: Symptoms may disappear completely after the relapse is over, but over time, some problems may remain between relapses.
Slovenian: Simptomi lahko na koncu recidiva popolnoma izginejo, vendar se lahko sčasoma določene težave ohranijo med recidivi.
English: The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch
Slovenian: V natisnjenem navodilu za uporabo zdravila morata biti navedena ime in naslov proizvajalca, odgovornega za sprostitev zadevne serije.
English: Alternatively, activated charcoal may also be used (the 11 days do not need to be consecutive unless there is a need to lower teriflunomide plasma concentration rapidly).
Slovenian: V nasprotnem primeru se lahko uporabi aktivirano oglje (za 11 dni ni nujno, da so zaporedni dnevi, razen če je treba plazemsko koncentracijo teriflunomida znižati hitro).
English: • Affects blood cell counts and the immune system 2.
Slovenian: • vpliva na krvno sliko in imunski sistem.
English: The primary endpoint was time to a second clinical episode (relapse).
Slovenian: Primarni opazovani dogodek je bil čas do druge klinične epizode (recidiva).
English: Patients with severe renal impairment undergoing dialysis, because insufficient clinical experience is available in this patient group.
Slovenian: Bolniki s hudo ledvično okvaro, ki se zdravijo z dializo, ker je premalo kliničnih izkušenj v tej skupini bolnikov.
English: A reminder for both patients and all HCPs involved in their treatment that the patient is being treated with teriflunomide, a medicine which:
Slovenian: Opomnik za bolnike in vse zdravstvene delavce, ki sodelujejo pri njihovem zdravljenju, da se bolnik zdravi s teriflunomidom, zdravilom ki:
English: The frequency of elevations above 3-fold ULN and higher was balanced across treatment groups.
Slovenian: Pogostnost zvišanj nad 3-kratnik ULN ali višje je bila uravnotežena med zdravljenima skupinama.
English: People with relapsing form of multiple sclerosis will have repeated attacks (relapses) of physical symptoms caused by their nerves not working properly.
Slovenian: Ljudje z recidivno obliko multiple skleroze imajo ponavljajoče se napade (recidive) telesnih simptomov, ki so posledica nepravilnega delovanja živcev.
English: Excipient with known effect: each tablet contains 72 mg of lactose (as monohydrate).
Slovenian: Pomožne snovi z znanim učinkom: vsaka tableta vsebuje 72 mg laktoze (v obliki laktoze monohidrata).
English: Do not use this medicine after the expiry date which is stated on the carton, protective sleeve, and wallet after “EXP”.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli, zaščitnem ovoju in pretisni zgibanki poleg oznake “EXP''.
English: Tell your your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Slovenian: Obvestite svojega zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli zdravilo, tudi če gre za zdravila brez recepta.
English: • To remind both patients and HCPs about the accelerated elimination procedure
Slovenian: • opomniti bolnice in zdravstvene delavce na postopek pospešenega izločanja,
English: Animals are more sensitive to the pharmacology, and therefore toxicity, of teriflunomide than humans.
Slovenian: Živali so bolj občutljive za farmakologijo in posledično toksičnost teriflunomida kot človek.
English: This limits the inflammation that leads to nerve damage in MS.
Slovenian: To omejuje vnetje, ki vodi do poškodb živcev
English: Pregnancy must be excluded before start of treatment (see section 4.6).
Slovenian: Pred začetkom zdravljenja je treba izključiti nosečnost (glejte poglavje 4.6).
English: It is recommended that patients receiving teriflunomide are not treated with cholestyramine or activated charcoal because this leads to a rapid and significant decrease in plasma concentration unless an accelerated elimination is desired.
Slovenian: Priporočljivo je, da se bolniki, ki prejemajo teriflunomid, ne zdravijo s holestiraminom ali aktiviranim ogljem, ker to povzroči hiter in pomemben upad plazemske koncentracije, razen če je pospešeno izločanje zaželeno.
English: As a result, toxicity in animals was found at exposures equivalent or below human therapeutic levels.
Slovenian: Posledično so toksičnost pri živalih odkrili pri izpostavljenosti, ki je enakovredna ali manjša, kakor so terapevtske koncentracije pri človeku.
English: Immunosuppressive or immunomodulating therapies
Slovenian: Imunosupresivno ali imunomodulirajoče zdravljenje
English: These elevations in transaminase occurred mostly within the first 6 months of treatment and were reversible after treatment cessation.
Slovenian: Ta zvišanja transaminaz so se pojavljala zlasti v prvih 6 mesecih zdravljenja in so bila reverzibilna po prekinitvi zdravljenja.
English: Most patients improved after discontinuation of AUBAGIO.
Slovenian: Stanje večine bolnikov se je izboljšalo po prekinitvi jemanja zdravila AUBAGIO.
English: During this period women should discuss any plans to stop or change contraception with the treating physician.
Slovenian: V tem obdobju se morajo ženske o vseh načrtih za prekinitev ali spremembo kontracepcije posvetovati z lečečim zdravnikom.
English: Your doctor will carry out blood tests before and during treatment to check how well your liver is working.
Slovenian: Zdravnik bo opravil krvne preiskave pred in med zdravljenjem, da bi preveril delovanje vaših jeter.
English: Within each frequency grouping, adverse reactions are ranked in order of decreasing seriousness.
Slovenian: V vsaki skupini pogostnosti so neželeni učinki razvrščeni s padajočo resnostjo.
English: The film-coated tablets are for oral use.
Slovenian: Filmsko obložene tablete so za peroralno uporabo.
English: Over 21 days, 60.1% of the administered dose is excreted via feces (37.5%) and urine (22.6%).
Slovenian: V 21 dneh se 60,1 % vnesenega odmerka izloči v blatu (37,5 %) in urinu (22,6 %).
English: No similar subgroup analysis was performed in TOWER as no MRI data were obtained.
Slovenian: V študiji TOWER podobna analiza podskupin ni bila izvedena, ker ni bilo podatkov MRS.
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: Imetnik dovoljenja za promet z zdravilom mora PSUR za to zdravilo predložiti v skladu z zahtevami, določenimi v seznamu referenčnih datumov Unije (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES in objavljenem na evropskem spletnem portalu o zdravilih.
English: Two clinical studies have shown that vaccinations to inactivated neoantigen (first vaccination), or recall antigen (reexposure) were safe and effective during AUBAGIO treatment.
Slovenian: Dve klinični študiji sta pokazali, da sta bili cepljenji z inaktiviranim neoantigenom (prvo cepljenje) in priklicem antigena (ponovna izpostavljenost) med zdravljenjem z zdravilom AUBAGIO varni in učinkoviti.
English: For further information on the laboratory testing please contact your doctor.
Slovenian: Za več informacij o laboratorijski preiskavi se obrnite na svojega zdravnika.
English: Effect on renal tubular functions
Slovenian: Učinek na ledvične tubularne funkcije
English: Patients with severe hepatic impairment (Child-Pugh class C).
Slovenian: Bolniki s hudo okvarjenim delovanjem jeter (razred C lestvice po Child-Pugh-u).
English: AUBAGIO has no or negligible influence on the ability to drive and use machines.
Slovenian: Zdravilo AUBAGIO nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: • Complete blood cell counts should be performed based on clinical signs and symptoms (e.g. infections) during treatment.
Slovenian: • celotno krvno sliko, ki se izvaja glede na klinične znake in simptome (npr. okužbe) med zdravljenjem.
English: Table 1 - Main Results ( for the approved dose, ITT population) TEMSO-study
Slovenian: Preglednica 1 Glavni rezultati (za odobreni odmerek, populacija z namenom zdravljenja) študija TEMSO
English: Animal studies have shown excretion of teriflunomide in milk.
Slovenian: V študijah na živalih so dokazali izločanje teriflunomida v materino mleko.
English: • alternatively, 50 g of activated powdered charcoal is administered every 12 hours for a period of 11
Slovenian: • druga možnost je dajanje 50 g aktiviranega oglja v prahu vsakih 12 ur za obdobje 11 dni.
English: • Blood pressure o Check periodically
Slovenian: • krvni tlak o redno preverjanje
English: The elimination of the active substance may take up to 2 years to occur naturally.
Slovenian: Naravno izločanje učinkovine lahko traja do 2 let.
English: België/Belgique/Belgien
Slovenian: België/Belgique/Belgien Sanofi Belgium
English: Teriflunomide is a substrate of the efflux transporter BCRP, which could be involved in direct secretion.
Slovenian: Teriflunomid je substrat efluksnega transporterja BCRP, ki bi lahko sodeloval pri neposrednem izločanju.
English: Before you take AUBAGIO, your doctor will make sure you have enough white blood cells and platelets in your blood.
Slovenian: Preden začnete jemati zdravilo AUBAGIO, se bo vaš zdravnik prepričal, da imate v krvi dovolj belih krvničk in ploščic.
English: HCPs should discuss with their patients the specific safety concerns of AUBAGIO detailed below including the tests and precautions needed for safe use as follows:
Slovenian: Zdravstveni delavci se morajo posvetovati s svojimi bolniki o varnostnih tveganjih zdravila AUBAGIO, podrobno opisanih v nadaljevanju, vključno s preiskavami in previdnostnimi ukrepi, ki so potrebni za varno uporabo, kot sledi:
English: While this interaction of teriflunomide is not expected to adversely impact the efficacy of oral contraceptives, it should be considered when selecting or adjusting oral contraceptive treatment used in combination with teriflunomide.
Slovenian: Čeprav se ne pričakuje negativnega vpliva te interakcije s teriflunomidom na učinkovitost peroralnih kontracepcijskih sredstev, je to treba upoštevati ob izbiri ali prilagajanju zdravljenja s peroralnim kontraceptivom, uporabljenim v kombinaciji s teriflunomidom.
English: Interference with determination of ionised calcium levels
Slovenian: Moteno določanje koncentracije ioniziranega kalcija
English: In general, headache, diarrhoea, nausea and alopecia, were mild to moderate, transient and infrequently led to treatment discontinuation.
Slovenian: Na splošno so bile glavobol, driska, navzea in alopecija blage do zmerne, prehodne in so občasno privedle do prekinitve zdravljenja.
English: - you are due to have a specific blood test (calcium level).
Slovenian: - če imate predvideno posebno preiskavo krvi (meritev koncentracije kalcija).
English: The educational material for HealthCare Professionals (HCP) will include the following key elements:
Slovenian: Izobraževalno gradivo za zdravstvene delavce mora vključevati naslednje bistvene elemente:
English: The CNS is made up of the brain and spinal cord.
Slovenian: CŽS sestavljajo možgani in hrbtenjača.
English: Teriflunomide is an immunomodulatory agent with anti-inflammatory properties that selectively and reversibly inhibits the mitochondrial enzyme dihydroorotate dehydrogenase (DHO-DH), required for the de novo pyrimidine synthesis.
Slovenian: Teriflunomid je imunomodulatorno sredstvo s protivnetnimi lastnostmi, ki selektivno in reverzibilno zavira mitohondrijski encim dihidroorotat-dehidrogenazo (DHO-DH), ki je potreben za sintezo pirimidinov de novo.
English: EU/1/13/838/001 14 tablets EU/1/13/838/002 28 tablets EU/1/13/838/003 84 tablets EU/1/13/838/004 98 tablets EU/1/13/838/005 10x1 tablet
Slovenian: EU/1/13/838/001 14 tablet EU/1/13/838/002 28 tablet EU/1/13/838/003 84 tablet EU/1/13/838/004 98 tablet EU/1/13/838/005 10 x 1 tableta
English: At entry, patients had an Expanded Disability Status Scale (EDSS) score ≤5.5.
Slovenian: Ob vključitvi bolnikov v študiji je bilo stanje razširjene nezmožnosti (Expanded Disability Status Scale, EDSS) ≤ 5,5.
English: • Alanine aminotransferase/serum glutamic pyruvic transaminase (ALT/SGPT)
Slovenian: • raven alanin-aminotransferaze/serumske glutamat piruvat transaminaze (ALT/SGPT),
English: Co-administration with antineoplastic or immunosuppressive therapies used for treatment of MS has not been evaluated.
Slovenian: Sočasna uporaba z antineoplastičnimi ali imunosupresivnimi zdravljenji, ki se uporabljajo za zdravljenje MS, ni bila ocenjena.
English: In either case it should be confirmed by a blood test that the active substance has been sufficiently removed from your body and you need confirmation from your treating physician that the blood level of AUBAGIO is low enough to allow you to become pregnant.
Slovenian: V vsakem primeru je treba s krvno preiskavo potrditi, da se je učinkovina zadostno odstranila iz vašega telesa, zato mora vaš lečeči zdravnik potrditi, da so ravni zdravila AUBAGIO v vaši krvi dovolj nizke, da lahko zanosite.
English: In case of doubtful measurements, it is recommended to determine the total albumin adjusted serum calcium concentration.
Slovenian: V primeru negotovih meritev je priporočljivo določiti koncentracijo kalcija v serumu, prilagojeno na celokupni albumin.
English: Teriflunomide was embryotoxic and teratogenic in rats and rabbits at doses in the human therapeutic range.
Slovenian: Teriflunomid je bil embriotoksičen in teratogen pri podganah in kuncih v odmerkih v terapevtskem območju pri človeku.
English: After the rapid elimination procedure with cholestyramine, an additional 23.1% was recovered (mostly in feces).
Slovenian: Po postopku hitrega izločanja s holestiraminom so odkrili še dodatnih 23,1 % (največ v blatu).
English: Effect of teriflunomide on BCRP and /or organic anion transporting polypeptide B1 and B3 (OATP1B1/B3) substrates
Slovenian: Učinek teriflunomida na BCRP in/ali substrate transportnega polipeptida B1 in B3 za organske anione (OATP1B1/B3)
English: In MS patients, the median t1/2z was approximately 19 days after repeated doses of 14 mg.
Slovenian: Pri bolnikih z MS je povprečna vrednost t1/2z približno 19 dni po ponavljajočih se odmerkih 14 mg.
English: If the test confirms that you are pregnant, your doctor may suggest treatment with certain medicines to remove AUBAGIO rapidly and sufficiently from your body, as this may decrease the risk to your baby.
Slovenian: Če preiskava potrdi nosečnost, bo vaš zdravnik morda predlagal zdravljenje z določenimi zdravili, da se zdravilo AUBAGIO odstrani hitro in v zadostni meri iz vaše krvi, saj to lahko zmanjša tveganje za vašega otroka.
English: The recommended dose is one film-coated tablet (14 mg) daily.
Slovenian: Priporočeni odmerek je ena filmsko obložena tableta (14 mg) na dan.
English: Since teriflunomide is highly protein bound and as the binding is dependent upon the concentrations of albumin, unbound plasma teriflunomide concentrations are expected to be increased in patients with hypoproteinaemia, e.g. in nephrotic syndrome.
Slovenian: Ker je teriflunomid izrazito vezan na beljakovine in ker je vezava odvisna od koncentracije albumina, se pričakuje, da se plazemske koncentracije nevezanega teriflunomida zvišajo pri bolnikih s hipoproteinemijo, npr. pri nefrotskem sindromu.
English: Since AUBAGIO tablets contain lactose, patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption, should not take this medicinal product.
Slovenian: Ker tablete zdravila AUBAGIO vsebujejo laktozo, bolniki z redkimi dednimi boleznimi galaktozne intolerance, skupno zmanjšano aktivnostjo laktaze ali malabsorpcijo glukoze-galaktoze ne smejo jemati tega zdravila.
English: Tell your doctor if you plan to become pregnant after stopping treatment with AUBAGIO, as you need to ensure that most of this medicine has left your body before trying to become pregnant.
Slovenian: Zdravnika obvestite, če načrtujete zanositev po prekinitvi zdravljenja z zdravilom AUBAGIO, saj je treba zagotoviti, da se je večina tega zdravila izločila iz vašega telesa, preden poskusite zanositi.
English: You should swallow the tablet whole with some water.
Slovenian: Tableto morate pogoltniti celo z nekaj vode.
English: Hepatic effects During placebo-controlled studies the following was detected:
Slovenian: V s placebom kontroliranih študijah so ugotovili naslednje:
English: In addition, if required for tolerability reasons, administration of cholestyramine or activated charcoal does not need to occur on consecutive days (see section 5.2).
Slovenian: Če je potrebno zaradi prenašanja, ni obvezno, da se holestiramin oz. aktivirano oglje dajeta zaporedne dni (glejte poglavje 5.2).