FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore, the CHMP's view was that, as for MabThera, the benefits of Truxima outweigh the identified risks and it can be authorised for use in the EU.
Slovenian: Zato je odbor menil, da koristi zdravila Truxima enako kot pri zdravilu MabThera odtehtajo znana tveganja in da se zdravilo lahko odobri v EU.
English: Truxima is a ‘biosimilar medicine'.
Slovenian: Zdravilo Truxima je „podobno biološko zdravilo“.
English: For the full list of side effects of Truxima, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov zdravila Truxima glejte navodilo za uporabo.
English: In addition, a study comparing Truxima to MabThera in rheumatoid arthritis adult patients showed that both medicines are similarly effective.
Slovenian: Poleg tega je bilo v študiji, v kateri so pri odraslih bolnikih z revmatoidnim artritisom primerjali zdravilo Truxima z zdravilom MabThera, dokazano, da sta zdravili podobno učinkoviti.
English: It is available as a concentrate for making a solution that must be given by infusion (drip) into a vein.
Slovenian: Zdravilo je na voljo v obliki koncentrata za pripravo raztopine za infundiranje (kapalne infuzije) v veno.
English: How is Truxima used?
Slovenian: Kako se zdravilo Truxima uporablja?
English: Extensive laboratory studies comparing Truxima with MabThera have shown that rituximab in Truxima is highly similar to rituximab in MabThera in terms of chemical structure, purity and biological activity.
Slovenian: Obsežne laboratorijske študije, v katerih so zdravilo Truxima primerjali z zdravilom MabThera, so pokazale, da je rituksimab v zdravilu Truxima po zgradbi, čistosti in biološkem delovanju zelo podoben rituksimabu v zdravilu MabThera.
English: Truxima contains the active substance rituximab.
Slovenian: Zdravilo Truxima vsebuje učinkovino rituksimab.
English: Truxima has been compared with MabThera given into a vein in a study involving 372 patients with active rheumatoid arthritis.
Slovenian: Zdravilo Truxima so v študiji, v katero je bilo vključenih 372 bolnikov z aktivnim revmatoidnim artritisom, primerjali z zdravilom MabThera, infundiranim v veno.
English: • severe rheumatoid arthritis (an inflammatory condition of the joints)
Slovenian: • hudega revmatoidnega artritisa (vnetne bolezni sklepov);
English: Truxima can only be obtained with a prescription.
Slovenian: Predpisovanje in izdaja zdravila Truxima je le na recept.
English: The full EPAR and risk management plan summary for Budesonide/Formoterol Teva can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) in povzetek načrta obvladovanja tveganj za zdravilo Budesonide/Formoterol Teva sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that Budesonide/Formoterol Teva 160/4.5 microgram and 320/9 microgram have been shown to have comparable quality and to be equivalent to the corresponding strengths of Symbicort Turbohaler.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da ima zdravilo Budesonide/Formoterol Teva v jakostih 160/4,5 mikrograma in 320/9 mikrogramov primerljivo raven kakovosti kot zdravilo Symbicort Turbohaler ter da mu je pri ustrezajočih jakostih biološko enakovredno.
English: This means that it is similar to a ‘reference medicine' containing the same active substances, but Budesonide/Formoterol Teva is given using a different inhaler.
Slovenian: To pomeni, da je podobno referenčnemu zdravilu, ki vsebuje isti zdravilni učinkovini, vendar se zdravilo Budesonide/Formoterol Teva uporablja z drugačnim inhalatorjem.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Budesonide/Formoterol Teva on 19 November 2014.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Budesonide/Formoterol Teva, veljavno po vsej Evropski uniji, izdala 19. novembra 2014.
English: Studies were carried out to show that Budesonide/Formoterol Teva is bioequivalent to the reference medicine (i.e. produces the same level of the active substance in the body) and that the two medicines act in the same way.
Slovenian: Izvedene so bile študije, ki so pokazale, da je zdravilo Budesonide/Formoterol Teva biološko enakovredno referenčnemu zdravilu (tj. da dosega enako raven zdravilne učinkovine v telesu) in da obe zdravili enako delujeta.
English: Budesonide/Formoterol Teva is also used to relieve the symptoms of severe chronic obstructive pulmonary disease (COPD) in adults who have had exacerbations (flare-ups) of the disease in the past despite regular treatment.
Slovenian: Zdravilo Budesonide/Formoterol Teva se uporablja tudi za zdravljenje simptomov hude kronične obstruktivne pljučne bolezni (KOPB) pri odraslih s ponavljajočimi se poslabšanji simptomov bolezni v preteklosti kljub rednemu zdravljenju.
English: This is a summary of the European public assessment report (EPAR) for Budesonide/Formoterol Teva.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Budesonide/Formoterol Teva.
English: The benefits and risks of Budesonide/Formoterol Teva are therefore taken to be the same as those of the reference medicine.
Slovenian: Koristi in tveganja zdravila Budesonide/Formoterol Teva so torej enaki kot pri referenčnemu zdravilu.
English: What measures are being taken to ensure the safe and effective use of Budesonide/Formoterol Teva?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Budesonide/Formoterol Teva?
English: Budesonide/Formoterol Teva budesonide / formoterol
Slovenian: Budesonide/Formoterol Teva budezonid/formoterol
English: It works by attaching to receptors known as beta-2 receptors found in the muscles.
Slovenian: Deluje tako, da se veže na receptorje, imenovane adrenergični receptorji beta-2, ki so v dihalnih mišicah.
English: The reference medicine for Budesonide/Formoterol Teva is Symbicort Turbohaler.
Slovenian: Referenčno zdravilo za zdravilo Budesonide/Formoterol Teva je Symbicort Turbohaler.
English: It works in a similar way to naturally occurring corticosteroid hormones, reducing the activity of the immune system by attaching to receptors in various types of immune cells.
Slovenian: Deluje podobno kot kortikosteroidni hormoni, ki naravno nastajajo v telesu, pri čemer se veže na receptorje v različnih vrstah imunskih celic ter tako zmanjša dejavnost imunskega sistema.
English: The two active substances in Budesonide/Formoterol Teva are well known and are present in several medicines used to treat asthma and COPD, either alone or in combination with other medicines.
Slovenian: Zdravilni učinkovini v zdravilu Budesonide/Formoterol Teva sta dobro znani in sta prisotni v več zdravilih, ki se samostojno ali v kombinaciji z drugimi zdravili uporabljajo za zdravljenje astme in KOPB.
English: A risk management plan has been developed to ensure that Budesonide/Formoterol Teva is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Budesonide/Formoterol Teva je bil pripravljen načrt obvladovanja tveganj.
English: Budesonide/Formoterol Teva can be used for the regular treatment of asthma.
Slovenian: Zdravilo Budesonide/Formoterol Teva se lahko uporablja za redno zdravljenje astme.
English: For more information about treatment with Budesonide/Formoterol Teva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Budesonide/Formoterol Teva preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: For practical information about using Budesonide/Formoterol Teva, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Budesonide/Formoterol Teva naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: Other information about Budesonide/Formoterol Teva
Slovenian: Druge informacije o zdravilu Budesonide/Formoterol Teva
English: What are the benefits and risks of Budesonide/Formoterol Teva?
Slovenian: Kakšne so koristi in tveganja, povezani z zdravilom Budesonide/Formoterol Teva?
English: If patients need to take more than 8 reliever inhalations per day, it is recommended they speak to their doctor to have their asthma therapy reconsidered.
Slovenian: Pri olajševalnem zdravljenju astme morajo bolniki za lajšanje simptomov uporabiti ločen „inhalator z olajševalcem.“ Če bolniki potrebujejo več kot osem vpihov na dan, je priporočljivo, da se posvetujejo z zdravnikom, ki bo ponovno ocenil njihovo zdravljenje astme.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Budesonide/Formoterol Teva, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti tega zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: What is Budesonide/Formoterol Teva and what is it used for?
Slovenian: Kaj je zdravilo Budesonide/Formoterol Teva in za kaj se uporablja?
English: The Committee recommended that Budesonide/Formoterol Teva be given marketing authorisation.
Slovenian: Priporočil je, da se za zdravilo Budesonide/Formoterol Teva izda dovoljenje za promet.
English: Budesonide/Formoterol Teva is a medicine that contains the active substances budesonide and formoterol.
Slovenian: Budesonide/Formoterol Teva je zdravilo, ki vsebuje zdravilni učinkovini budezonid in formoterol.
English: Why is Budesonide/Formoterol Teva approved?
Slovenian: Zakaj je bilo zdravilo Budesonide/Formoterol Teva odobreno?
English: Budesonide/Formoterol Teva is a ‘hybrid medicine'.
Slovenian: Zdravilo Budesonide/Formoterol Teva je „hibridno zdravilo“.
English: How is Budesonide/Formoterol Teva used?
Slovenian: Kako se zdravilo Budesonide/Formoterol Teva uporablja?
English: How does Budesonide/Formoterol Teva work?
Slovenian: Kako zdravilo Budesonide/Formoterol Teva deluje?
English: SUMMARY OF PRODUCT CHARACTERISTICS (SmPC)
Slovenian: POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA (SmPC)
English: Section 4.2 • {(Invented) Name} is contraindicated in children less than 30 months (see section 4.3).
Slovenian: Poglavje 4.2 • {(Lastniško) ime} je kontraindicirano pri otrocih, mlajših od 30 mesecev (glejte poglavje 4.3).
English: • “If required, appropriate symptomatic treatment should be given in specialized care unit”.
Slovenian: • „Po potrebi je treba uvesti ustrezno simptomatsko zdravljenje v enotah za posebno nego.“
English: Section 5.1 • “Terpenic derivatives may lower the epileptogenous threshold.”
Slovenian: Poglavje 5.1 • „Derivati terpena lahko znižajo prag za nastanek epileptičnih napadov.“
English: {(Invented) Name} should not be used during breast-feeding.
Slovenian: Zdravilo {(Lastniško) ime} se med dojenjem ne sme uporabljati.
English: • “Do not use in children less than 30 months”
Slovenian: • „Zdravila ne uporabljajte priotrocih, mlajših od 30 mesecev.“
English: There is insufficient information on the excretion of {Active substance} in human milk.
Slovenian: Ni dovolj podatkov o izločanju {zdravilne učinkovine} v materino mleko.
English: AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE SUMMARY OF PRODUCTS CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
Slovenian: DOPOLNILA, KI SE VKLJUČIJO V USTREZNA POGLAVJA POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJA IN NAVODILA ZA UPORABO
English: • “Do not administer at a dose higher than recommended due to an increased risk of adverse drug reactions and disorders related to overdosage (see section 4.9).”
Slovenian: • „Ne uporabljajte odmerka, ki je večji od priporočenega, zaradi povečanega tveganja za neželene učinke in bolezni, povezane s prevelikim odmerjanjem (glejte poglavje 4.9).“
English: • “As this product is inflammable, do not go near a flame.”
Slovenian: • „Zdravilo je vnetljivo, zato ga ne uporabljajte v bližini ognja.“
English: • Removal of posology related to children less than 30 months.
Slovenian: • Odmerjanje v zvezi z otroki, mlajšimi od 30 mesecev, se izbriše.
English: Section 4.3 “Hypersensitivity to the active substances or to any of the excipients” “Children less than 30 months” “Children with a history of epilepsy or febrile convulsion” “Recent history of anorectal lesion”
Slovenian: Poglavje 4.3 - „Preobčutljivost za zdravilne učinkovine ali katero koli pomožno snov.“ - „Otroci, mlajši od 30 mesecev.“ - „Otroci z anamnezo epilepsije ali vročinskih krčev.“ - „Nedavna anamneza anorektalnih lezij.“
English: - Do not prolong the treatment over 3 days due to the possible risks related to the accumulation of terpenic derivatives (for example camphor, cineole, niaouli, wild thyme, terpineol, terpine, citral, menthol and essential oils of pine needle, eucalyptus and turpentine) in the body including the brain, in particular neuropsychological disorders; and the risk of rectal burning.” - “Do not administer at doses higher than recommended due to an increased risk of adverse drug reactions and overdosage related disorders.” - “As this product is inflammable, do not go near a flame.” “Pregnancy and breast-feeding: - Do not use during pregnancy or breast-feeding”
Slovenian: - Zdravljenje naj ne traja dlje kot tri dni zaradi možnih tveganj v zvezi s kopičenjem derivatov terpena (na primer kafra, cineol, niaouli, divji timijan, terpineol, terpin, citral, mentol ter eterična olja iz evkaliptusa, iglic bora in terpentina) v telesu, vključno z možgani, zlasti nevrofizioloških boleznih, ter tveganja za pekočo bolečino v danki.“ - „Ne uporabljajte odmerkov, ki so večji od priporočenih, zaradi povečanega tveganja za neželene učinke in bolezni, povezane s prevelikim odmerjanjem.“ - „Zdravilo je vnetljivo, zato ga ne uporabljajte v bližini ognja.“ „Nosečnost in dojenje: - Ne uporabljajte med nosečnostjo ali dojenjem.“
English: • “Do not use concomitantly with other products (medicinal or cosmetic) containing terpenic derivatives whatever the route of administration (oral, rectal, cutaneous, or pulmonary).”
Slovenian: • „Ne uporabljajte sočasno z drugimi izdelki (zdravili ali kozmetičnimi izdelki), ki vsebujejo derivate terpena, ne glede na pot uporabe (peroralno, rektalno, dermalno ali pljučno).“
English: Section 2 “Do not use {(Invented) Name} suppositories: - In children less than 30 months - In children with a history of epilepsy or febrile convulsion” - In children with a recent history of anorectal lesion “Take special care with {(Invented) Name} suppositories: - This product contains <name(s) of terpenic derivative(s)> which, at excessive dose, may lead to neurological disorders as convulsion, in infants and children.
Slovenian: Poglavje 2 „Ne uporabljajte zdravila {(Lastniško) ime} svečke: - pri otrocih, mlajših od 30 mesecev - pri otrocih z anamnezo epilepsije ali vročinskih krčev - pri otrocih z nedavno anamnezo anorektalnih lezij „Bodite posebno pozorni pri uporabi zdravila {(Lastniško) ime} svečke: - Zdravilo vsebuje <ime(-na) derivata(-ov) terpena>, ki lahko pri prevelikem odmerjanju pri dojenčkih in otrocih povzroči(-jo) nevrološke bolezni, kot so krči.
English: • “This product contains terpenic derivatives which, at excessive dose, may cause neurological disorders as convulsions in infants and children.”
Slovenian: • „Zdravilo vsebuje derivate terpena, ki lahko pri prevelikem odmerjanju pri dojenčkih in otrocih povzročajo nevrološke bolezni, kot so krči.“
English: There are no or limited amount of data from the use of {Active substance} in pregnant women.
Slovenian: Podatkov o uporabi {zdravilna učinkovina} pri nosečnicah ni oziroma so omejeni.
English: • “Do not prolong the treatment over 3 days due to the risks related to terpenic derivatives storage (because of their lipophilic properties, the rate of metabolism and elimination is unknown) in tissues and brain, in particular neuropsychological disorders; and the risk of rectal burning.”
Slovenian: • „Zdravljenje naj ne traja dlje kot 3 dni zaradi tveganja, povezanega s kopičenjem derivatov terpena (zaradi lipofilnih lastnosti ter neznane hitrosti presnavljanja in izločanja) v tkivih in možganih, zlasti nevrofizioloških bolezni, in zaradi tveganja za pekočo bolečino v danki.“
English: • “In case of accidental oral intake or administration error in infants and children, there is a risk of neurological disorders.”
Slovenian: • „V primeru nenamernega peroralnega zaužitja ali napačne uporabe pri dojenčkih in otrocih obstaja tveganje za nevrološke bolezni.“
English: {(Invented) Name} is not recommended during pregnancy <and in women of childbearing potential not using contraception.>
Slovenian: Zdravila{(Lastniško) ime} ne uporabljajte pri nosečnicah <in pri ženskah v rodni dobi, ki ne uporabljajo učinkovite kontracepcije>.
English: • “Due to the presence of <name(s) of terpenic derivative(s)> and in case of patients not complying with the recommended doses there is a risk of convulsions in children and infants”
Slovenian: • „Zaradi prisotnosti <ime(-na) derivata(-ov) terpena> in v primeru bolnikovega neupoštevanja priporočenih odmerkov obstaja tveganje za pojavljanje krčev pri otrocih in dojenčkih.“
English: • “Due to the presence of <name(s) of terpenic derivative(s)> and in case of non-adherence to the recommended doses, there is a risk of convulsions in children and infants”
Slovenian: • „Zaradi prisotnosti <ime(-na) derivata(-ov) terpena> in v primeru neupoštevanja priporočenih odmerkov pri otrocih in dojenčkih obstaja tveganje za pojavljanje krčev.“
English: The following wording should be included in the labelling of the marketing authorisations to be varied, as relevant:
Slovenian: Naslednje besedilo se ustrezno vključi v podatke o označevanju dovoljenj za promet z zdravilom, ki se spremenijo:
English: The following wording should be included in the package leaflet of the marketing authorisations to be varied, as relevant:
Slovenian: Naslednje besedilo se vključi v povzetek glavnih značilnosti zdravila dovoljenj za promet z zdravilom, ki se ustrezno spremenijo:
English: “Use with other medicines - Do not use {(Invented) Name} while also taking other products (medicinal or cosmetic) containing terpenic derivatives (for example camphor, cineole, niaouli, wild thyme, terpineol,
Slovenian: - Zdravila {(Lastniško) ime} ne uporabljajte, če sočasno jemljete druge izdelke (zdravila ali kozmetične izdelke), ki vsebujejo derivate terpena (na primer kafro, cineol, niaouli, divji timijan, terpineol, terpin, citral, mentol ter eterična olja iz evkaliptusa, iglic bora in terpentina), ne glede na pot uporabe (peroralno, rektalno, kožno ali pljučno).“
English: Section 4.9 • “Repeated and prolonged use may cause rectal burning.”
Slovenian: • „Večkratna ali podaljšana uporaba lahko povzroči pekočo bolečino v danki.“
English: The following wording should be included in the SmPC of the marketing authorisations to be varied, as relevant:
Slovenian: Naslednje besedilo se ustrezno vključi v navodilo za uporabo dovoljenj za promet z zdravilom, ki se spremenijo:
English: PACKAGE LEAFLET
Slovenian: NAVODILO ZA UPORABO
English: Conditions for the lifting of the suspension of the Marketing Authorisations
Slovenian: Pogoji za preklic začasnega umika dovoljenj za promet z zdravilom
English: Annex IV Conditions for the lifting of the marketing authorisation
Slovenian: Priloga IV Pogoji za preklic začasnega umika dovoljenja za promet z zdravilom
English: • women who are pregnant;
Slovenian: • nosečnice;
English: This overview was last updated in 04-2019.
Slovenian: Povzetek je bil nazadnje posodobljen 04-2019.
English: The company will also collect information on whether the medicine is used outside its approved indication.
Slovenian: Podjetje bo hkrati zbiralo informacije o tem, ali se zdravilo uporablja zunaj odobrene indikacije.
English: • patients who are unable to follow or to comply with the requirement to use contraceptives.
Slovenian: • bolniki, ki niso zmožni upoštevati zahtev po uporabi kontracepcijskih sredstev ali ravnati v skladu z njimi.
English: In patients over 75 years of age a starting dose of 100 mg (2 capsules) a day is recommended.
Slovenian: Pri bolnikih, starejših od 75 let, se priporoča začetni odmerek 100 mg (dve kapsuli) na dan.
English: This can help to slow down the progression of multiple myeloma.
Slovenian: To pripomore k upočasnitvi napredovanja multiplega mieloma.
English: It will also supply cards for patients to ensure that all appropriate safety measures are taken by each patient.
Slovenian: Prav tako bo izdalo kartice za bolnike ter tako zagotovilo, da vsak bolnik izpolnjuje vse ustrezne varnostne ukrepe.
English: • women who could become pregnant, unless they take all of the necessary steps to ensure that they are not pregnant before treatment and that they do not become pregnant during or soon after treatment;
Slovenian: • ženske, ki bi lahko zanosile, razen če naredijo vse potrebno, da ne zanosijo pred zdravljenjem, med samim zdravljenjem ali kmalu po njem;
English: Thalidomide Celgene received a marketing authorisation valid throughout the EU on 16 April 2008.
Slovenian: Za zdravilo Thalidomide Celgene je bilo 16. aprila 2008 izdano dovoljenje za promet, veljavno po vsej EU.
English: The company that markets Thalidomide Celgene will set up a pregnancy prevention programme in each Member State.
Slovenian: Podjetje, ki trži zdravilo Thalidomide Celgene, bo v vsaki državi članici vzpostavilo program za preprečevanje nosečnosti.
English: Thalidomide Celgene is available as capsules (50 mg).
Slovenian: Zdravilo Thalidomide Celgene je na voljo v obliki kapsul (50 mg).
English: Thalidomide Celgene can be used for a maximum of 12 treatment cycles, with each cycle lasting 6 weeks.
Slovenian: Zdravilo Thalidomide Celgene se lahko uporablja največ 12 ciklov zdravljenja, pri čemer vsak cikel traja šest tednov.
English: The European Medicines Agency concluded that, provided that very strict measures are put in place to avoid exposure of unborn children to thalidomide, Thalidomide Celgene's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je zaključila, da so pod pogojem, da se upoštevajo strogi ukrepi glede preprečevanja izpostavitve nerojenih otrok talidomidu, koristi zdravila Thalidomide Celgene večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: The doctor may delay, reduce or stop doses if the patient gets certain side effects, including blood clots, nerve damage, rash, low heart rate, fainting or sleepiness.
Slovenian: Zdravnik lahko odmerke odloži, zmanjša ali ukine, če se pri bolniku pojavijo določeni neželeni učinki, kot so npr. krvni strdki, poškodbe živčevja, izpuščaji, počasen utrip srca, omedlevica ali zaspanost.