FrancophonIA/ELRC3.0 huggingface dataset:
English: • Since improvement of acne usually requires at least 3 months of treatment with dienogest/ethinylestradiol and further improvement has been seen after 6 months, women should be assessed 3 to 6 months after treatment initiation and periodically thereafter to review the need for continuation of treatment.
Slovenian: • Ker izboljšanje aken običajno zahteva vsaj tri mesece zdravljenja z dienogestom/etinilestradiolom, nadaljnje izboljšanje pa je vidno po šestih mesecih, je treba ženske pregledati po treh do šestih mesecih zdravljenja in nato v rednih časovnih presledkih, da se oceni potreba po nadaljevanju zdravljenja.
English: • Taking into account the available evidence, and in order not to unnecessarily expose women to a potentially higher risk of VTE, use of dienogest/ethinylestradiol should be restricted to second line and to women who also choose oral contraception.
Slovenian: • Glede na razpoložljive dokaze, in da žensk ne bi po nepotrebnem izpostavljali morebitnemu večjemu tveganju za VTE, je treba uporabo dienogesta/etinilestradiola omejiti na drugo izbiro zdravljenja in na ženske, ki se odločijo za peroralno kontracepcijo.
English: They should only be used when treatments applied to the skin or an antibiotic taken by mouth have not worked.
Slovenian: Uporabljajo se lahko le takrat, kadar so zdravila za nanos na kožo ali peroralni antibiotiki neuspešni.
English: On 26 January 2016, the European Medicines Agency (EMA) recommended that medicines containing a combination of dienogest 2 mg and ethinylestradiol 0.03 mg can continue to be used to treat moderate acne when suitable treatments applied to the skin or antibiotics taken by mouth have not worked.
Slovenian: Evropska agencija za zdravila (EMA) je 26. januarja 2016 priporočila, da se zdravila, ki vsebujejo kombinacijo dienogesta 2 mg in etinilestradiola 0,03 mg, lahko še naprej uporabljajo za zdravljenje zmernih aken, ko so ustrezna zdravila za nanos na kožo ali peroralni antibiotiki neuspešni.
English: However, to date, there are insufficient data to accurately determine the relative risk of venous thromboembolism (VTE) with respect to other combined hormonal contraceptives containing other progestogens.
Slovenian: Vendar pa je do zdaj še premalo podatkov, da bi lahko natančno določili relativno tveganje za vensko trombembolijo (VTE) v primerjavi z drugimi kombiniranimi hormonskimi kontracepcijskimi sredstvi, ki vsebujejo druge progestogene.
English: Medicines containing dienogest 2 mg and ethinylestradiol 0.03 mg are used as oral contraceptives and for the treatment of moderate acne.
Slovenian: Zdravila, ki vsebujejo dienogest 2 mg in etinilestradiol 0,03 mg, se uporabljajo kot peroralna kontracepcijska sredstva in za zdravljenje zmernih aken.
English: Considering the observed benefits of dienogest/ethinylestradiol in the treatment of acne, the potential risk of VTE and the nature of the disease, the CHMP concluded that this combination should only be used after certain other treatments have failed, and only when oral contraception is chosen.
Slovenian: Odbor CHMP je glede na ugotovljene koristi dienogesta/etinilestradiola pri zdravljenju aken, potencialno tveganje za VTE in naravo bolezni zaključil, da se sme ta kombinacija uporabljati samo, kadar druge oblike zdravljenja niso bile uspešne, in le takrat, kadar se ženska odloči za peroralno kontracepcijo.
English: The CHMP also recommended that women should be assessed by their doctor 3 to 6 months after starting treatment and periodically thereafter to review the need for continuation of treatment.
Slovenian: Priporočil je tudi, da zdravnik ženske pregleda tri do šest mesecev po začetku zdravljenja in nato v rednih časovnih presledkih, da se oceni potreba po nadaljevanju zdravljenja.
English: While this risk is low, the data on the risk with dienogest/ethinylestradiol are still insufficient to accurately estimate how it compares with other contraceptives.
Slovenian: Čeprav je to tveganje majhno, podatki o tveganju pri dienogestu/etinilestradiolu še vedno niso zadostni, da bi lahko natančno ocenili, kakšno je to tveganje v primerjavi z drugimi kontracepcijskimi sredstvi.
English: • The combination dienogest/ethinylestradiol should be used for the treatment of moderate acne only after failure of suitable local therapies or oral antibiotic treatment in women who elect to use an oral contraceptive.
Slovenian: • Kombinacija dienogesta/etinilestradiola se sme uporabljati za zdravljenje zmernih aken samo takrat, kadar primerna lokalna zdravila ali peroralno antibiotično zdravljenje niso uspešna, in sicer pri ženskah, ki se odločijo za uporabo peroralnega kontracepcijskega sredstva.
English: • You should be aware that, as with other hormonal contraceptives, there is a risk of blood clots associated with the use of dienogest/ethinylestradiol.
Slovenian: • Zavedati se morate, da pri uporabi dienogesta/etinilestradiola obstaja tveganje za krvne strdke, tako kot pri drugih hormonskih kontracepcijskih sredstvih.
English: • Medicines containing dienogest and ethinylestradiol should only be used to treat moderate acne in women who also choose oral contraception.
Slovenian: • Zdravila, ki vsebujejo dienogest in etinilestradiol, smejo za zdravljenje zmernih aken uporabljati samo ženske, ki se odločijo za peroralno kontracepcijo.
English: However, the data on the risk with dienogest/ethinylestradiol are not sufficient to accurately estimate how it compares with other contraceptives and further data are still awaited.
Slovenian: Vendar podatki o tveganju z dienogestom/etinilestradiolom niso zadostni, da bi lahko natančno ocenili, kakšno je tveganje v primerjavi z drugimi kontracepcijskimi sredstvi.
English: Your doctor will assess whether you should continue treatment with this medicine 3 to 6 months after you have started treatment and regularly after that.
Slovenian: Zdravnik bo po treh do šestih mesecih zdravljenja in nato v rednih časovnih presledkih ocenjeval, ali boste zdravljenje s tem zdravilom nadaljevali.
English: It is available as tablets (20 mg).
Slovenian: Na voljo je v obliki tablet (20 mg).
English: Conbriza bazedoxifene
Slovenian: Conbriza bazedoksifen
English: The European Commission granted a marketing authorisation valid throughout the European Union for Conbriza on 17 April 2009.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Conbriza, veljavno po vsej Evropski uniji, izdala 17. aprila 2009.
English: The women were treated for two years and received calcium supplements.
Slovenian: Ženske so se zdravile dve leti in so prejemale dodatke kalcija.
English: The recommended dose of Conbriza is one tablet once a day.
Slovenian: Priporočeni odmerek zdravila Conbriza je ena tableta enkrat dnevno.
English: The difference was more relevant in the sub-group of women at higher risk of fractures before the study.
Slovenian: Razlika je bila večja v podskupini žensk z večjim tveganjem za zlome pred študijo.
English: The full EPAR for Conbriza 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) za zdravilo Conbriza je na voljo na spletni strani agencije ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Patients should also receive calcium and vitamin D supplements if they do not get enough from their diet.
Slovenian: Bolnice morajo jemati tudi dodatek kalcija in vitamina D, če ju ne dobijo dovolj s prehrano.
English: What measures are being taken to ensure the safe and effective use of Conbriza?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Conbriza?
English: What benefit has Conbriza shown during the studies?
Slovenian: Kakšne koristi je zdravilo Conbriza izkazalo med študijami?
English: This is a summary of the European public assessment report (EPAR) for Conbriza.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Conbriza.
English: A risk management plan has been developed to ensure that Conbriza is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Conbriza je bil pripravljen načrt obvladovanja tveganj.
English: After two years, the average bone density remained almost unchanged in women who received Conbriza, but in women who received placebo it was reduced by over 1%.
Slovenian: Po dveh letih je povprečna gostota kosti ostala skoraj nespremenjena pri ženskah, ki so prejemale zdravilo Conbriza, pri ženskah, ki so prejemale placebo, pa se je zmanjšala za več kot 1 %.
English: After three years, 2% of the patients receiving Conbriza (35 out of 1,724) had new fractures compared with 4% of those receiving placebo (59 out of 1,741).
Slovenian: Po treh letih je pri 2 % (35 od 1 724) bolnic, ki so prejemale zdravilo Conbriza, prišlo do novih zlomov v primerjavi s 4 % (59 od 1 741) tistih, ki so prejemale placebo.
English: For more information about treatment with Conbriza, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Conbriza preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: It must not be used in women with unexplained bleeding from the womb and women with signs or symptoms of endometrial cancer (a cancer of the lining of the womb).
Slovenian: Ne sme se uporabljati pri ženskah, ki imajo nepojasnjene krvavitve iz maternice in ženskah z znaki raka endometrija (rak maternične sluznice).
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Conbriza, 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: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Conbriza.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: The CHMP decided that Conbriza's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: CHMP je zaključil, da so koristi zdravila Conbriza večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
English: In both main studies the effects of Conbriza were similar to the effects of raloxifene.
Slovenian: V obeh glavnih študijah so bili učinki zdravila Conbriza podobni učinkom raloksifena.
English: The main measure of effectiveness was the change in bone density (a measure of how strong the bones are) in the spine after two years of treatment.
Slovenian: Glavno merilo učinkovitosti je bila sprememba gostote kosti (merilo trdnosti kosti) v hrbtenici po dveh letih zdravljenja.
English: Conbriza is only for use in women who have been through the menopause, so it must not be used in women who could become pregnant.
Slovenian: Zdravilo Conbriza se lahko uporablja samo pri ženskah v obdobju po menopavzi, zato se ne sme uporabljati pri ženskah, ki bi lahko zanosile.
English: Other information about Conbriza
Slovenian: Druge informacije o zdravilu Conbriza:
English: Conbriza was also compared with raloxifene and placebo in another main study involving 1,583 postmenopausal women who were considered to be at risk of osteoporosis.
Slovenian: Zdravilo Conbriza so z raloksifenom in placebom primerjali tudi v drugi glavni študiji, v katero je bilo vključenih 1 583 žensk v obdobju po menopavzi, za katere je obstajalo tveganje za osteoporozo.
English: Conbriza is a medicine that contains the active substance bazedoxifene.
Slovenian: Conbriza je zdravilo, ki vsebuje zdravilno učinkovino bazedoksifen.
English: Conbriza must not be used in women who have had venous thromboembolism events (problems due to the formation of blood clots in the veins) including deep vein thrombosis (a blood clot in a deep vein, usually in the leg), pulmonary embolism (a blood clot in the lungs) and retinal vein thrombosis (a blood clot at the back of the eye).
Slovenian: Zdravilo Conbriza se ne sme uporabljati pri bolnicah, ki so imele epizode, povezane z vensko tromboembolijo (težave zaradi nastanka krvnih strdkov v venah), vključno z globoko vensko trombozo (krvni strdek v globoki veni, navadno v nogah), pljučno embolijo (krvni strdek v pljučih) in trombozo ven mrežnice (krvni strdek v zadnjem delu očesa).
English: The active substance in Conbriza, bazedoxifene, is a selective oestrogen receptor modulator (SERM).
Slovenian: Zdravilna učinkovina zdravila Conbriza, bazedoksifen, je selektivni modulator estrogenskih receptorjev (SERM).
English: Why has Conbriza been approved?
Slovenian: Zakaj je bilo zdravilo Conbriza odobreno?
English: What is the risk associated with Conbriza?
Slovenian: Kakšna tveganja so povezana z zdravilom Conbriza?
English: Bazedoxifene acts as an ‘agonist' of the oestrogen receptor (a substance that stimulates the receptor for oestrogen) in some tissues in the body.
Slovenian: Bazedoksifen deluje kot agonist receptorjev estrogena (snovi, ki stimulira receptorje za estrogen) v nekaterih telesnih tkivih.
English: The most common side effects with Conbriza (seen in more than 1 patient in 10) are hot flushes, muscle spasms and peripheral oedema (swelling, especially of the ankles and feet).
Slovenian: Najpogostejša neželena učinka zdravila Conbriza (opažena pri več kot 1 bolniku od 10) sta omotica in periferni edem (otekanje, zlasti gležnjev in stopal).
English: Conbriza is used for the treatment of osteoporosis (a disease that makes bones fragile) in women who have been through the menopause.
Slovenian: Zdravilo Conbriza se uporablja za zdravljenje osteoporoze (bolezni, ki povzroča krhkost kosti) pri ženskah v obdobju po menopavzi.
English: It is used in women who are at risk of fracture (broken bones).
Slovenian: Uporablja se pri ženskah, pri katerih obstaja možnost zloma kosti.
English: For the full list of all side effects reported with Conbriza, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Conbriza, glejte navodilo za uporabo.
English: In the other study, Conbriza was also more effective than placebo at maintaining the bone density of the spine.
Slovenian: V drugi študiji je bilo zdravilo Conbriza prav tako učinkovitejše od placeba pri ohranjanju gostote kosti hrbtenice.
English: In the first study, Conbriza was more effective than placebo at reducing the number of new spine fractures.
Slovenian: V prvi študiji je bilo zdravilo Conbriza pri zmanjševanju števila novih zlomov hrbtenice učinkovitejše od placeba.
English: Conbriza has been shown to significantly reduce fractures in the spine but not in the hip.
Slovenian: Za zdravilo Conbriza je bilo dokazano, da občutno zmanjša število zlomov hrbtenice, vendar ne zlomov kolka.
English: Conbriza has been compared with raloxifene (another medicine used to treat osteoporosis) and placebo (a dummy treatment) in one main study involving about 7,500 women with osteoporosis who had been through the menopause.
Slovenian: Zdravilo Conbriza so primerjali z raloksifenom (drugim zdravilom za zdravljenje osteoporoze) in placebom (zdravilom brez zdravilne učinkovine) v eni glavni študiji, v katero je bilo vključenih 7 500 žensk z osteoporozo v obdobju po menopavzi.
English: Bazedoxifene has the same effect as oestrogen in the bone.
Slovenian: Na kost učinkuje enako kot estrogen.
English: What is Conbriza used for?
Slovenian: Za kaj se zdravilo Conbriza uporablja?
English: Conbriza was not shown to be effective at reducing the number of fractures outside the spine.
Slovenian: Ni bilo dokazano, da bi bilo zdravilo Conbriza učinkovito pri zmanjševanju števila zlomov drugod kot v hrbtenici.
English: How is Conbriza used?
Slovenian: Kako se zdravilo Conbriza uporablja?
English: All of the women in the study were also given calcium and vitamin D supplements.
Slovenian: Vse ženske v študiji so prejemale tudi dodatke kalcija in vitamina D. Glavno merilo učinkovitosti je bilo število novih zlomov hrbtenice v treh letih.
English: How has Conbriza been studied?
Slovenian: Kako je bilo zdravilo Conbriza raziskano?
English: How does Conbriza work?
Slovenian: Kako zdravilo Conbriza deluje?
English: What is Conbriza?
Slovenian: Kaj je zdravilo Conbriza?
English: This summary was last updated in February 2013.
Slovenian: Povzetek je bil nazadnje posodobljen februarja 2013.
English: This will help protect against the disease.
Slovenian: To pomaga zaščititi živali pred boleznijo.
English: The effectiveness of the vaccine was first studied in a number of laboratory studies in piglets.
Slovenian: Učinkovitost cepiva so najprej raziskali v več laboratorijskih študijah pri prašičkih.
English: Damage to the wall of small blood vessels in the brain results in characteristic nervous signs.
Slovenian: Zaradi poškodovanih sten malih krvnih žil v možganih se pojavijo značilni znaki živčnosti.
English: Oedema disease is found worldwide and usually occurs in the first two weeks after weaning of the piglets, and is an acute (short-term) condition which can lead to death within 24 to 48 hours.
Slovenian: Edemska bolezen je razširjena po vsem svetu in se običajno pojavi v prvih dveh tednih po odstavitvi prašičkov; je akutna (kratkotrajna) bolezen, ki lahko povzroči smrt v 24 do 48 urah.
English: Protection starts 21 days after vaccination and lasts for 105 days.
Slovenian: Imunost se razvije 21 dni po cepljenju in traja 105 dni.
English: In the future, if the animals are exposed to the bacteria producing the unmodified toxin, the immune system will be able to make antibodies against it more quickly.
Slovenian: Če so živali kasneje izpostavljene bakterijam, ki izločajo nemodificirani toksin, lahko imunski sistem hitreje tvori protitelesa proti njemu.
English: The vaccine is given as a single injection into a muscle, preferably the neck muscle behind the ear.
Slovenian: Cepivo se daje v enkratnem odmerku z injiciranjem v mišico, po možnosti v vratno mišico za ušesom.
English: The most common side effects after injection of Ecoporc Shiga (which may affect up to 1 in 10 animals) are mild swelling, lasting for up to 7 days, at the injection site and a slight rise in body temperature for up to two days after injection; both resolve without treatment.
Slovenian: Najpogostejša neželena učinka po injiciranju zdravila Ecoporc Shiga (ki se lahko pojavita pri 1 živali od 10) sta blaga oteklina na mestu injiciranja, ki traja največ sedem dni, in rahlo povišanje telesne temperature, ki traja največ dva dni po injiciranju; oba izzvenita brez zdravljenja.
English: The modified toxin in the vaccine is produced by a method known as ‘recombinant DNA technology': it is made by bacteria which have received a gene (DNA) that makes them produce the modified toxin.
Slovenian: Modificirani toksin v cepivu pridobivajo z metodo, znano kot „tehnologija rekombinantne DNK, pri kateri bakterije prejmejo gen (DNK), s katerim lahko tvorijo modificirani toksin.
English: The laboratory studies showed that the injection had its full effect by 21 days, and that protection lasted for at least 105 days after injection; protection was not affected by antibodies transmitted from the mother.
Slovenian: Laboratorijske študije so pokazale, da je imela injekcija polni učinek na 21. dan in da je zaščita trajala najmanj 105 dni po injiciranju; protitelesa, ki so jih prašički dobili od matere, niso vplivala na zaščito.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Ecoporc Shiga exceed the risks for the approved indications and recommended that Ecoporc Shiga be given a marketing authorisation.
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi zdravila Ecoporc Shiga večje od z njim povezanih tveganj za odobrene indikacije, in priporočil, da se zanj odobri dovoljenje za promet.
English: The field studies showed that the vaccine reduced the mortality and clinical signs of oedema disease compared with placebo: in all three studies no piglets receiving Ecoporc Shiga died, while up to 11% of piglets receiving placebo died.
Slovenian: Terenske študije so pokazale, da je cepivo zmanjšalo smrtnost in klinične znake edemske bolezni v primerjavi s placebom: v nobeni od treh študij ni poginil noben pujsek, cepljen z zdravilom Ecoporc Shiga, medtem ko je poginilo 11 % prašičkov, ki so prejemali placebo.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Ecoporc Shiga on 10 April 2013.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Ecoporc Shiga, veljavno po vsej Evropski uniji, odobrila dne 10/04/2013.
English: Ecoporc Shiga is used in pigs from the age of 4 days for active immunisation against oedema disease, which leads to fluids accumulating in the tissues of the stomach and gut.
Slovenian: Zdravilo Ecoporc Shiga se uporablja pri prašičih od starosti 4 dni za aktivno imunizacijo proti edemski bolezni, ki povzroča kopičenje tekočin v tkivih želodca in črevesja.
English: Other information about Ecoporc Shiga:
Slovenian: Druge informacije o zdravilu Ecoporc Shiga:
English: The purpose of the studies was to establish how long it took for piglets to be fully protected, the length of time protection lasts against oedema disease as well as the influence of maternal antibodies (transmitted from the mother) on the effectiveness of the vaccine.
Slovenian: Namen študij je bil ugotoviti, kdaj prašički postanejo popolnoma zaščiteni pred edemsko boleznijo in koliko časa ta zaščita traja ter kako na učinkovitost cepiva vplivajo maternalna protitelesa (ki so jih prašički dobili od matere).
English: In case of accidental self-injection, medical advice should be sought immediately and the package leaflet or label shown to the doctor.
Slovenian: V primeru nenamernega zaužitja zdravila se je treba takoj posvetovati z zdravnikom in mu pokazati navodila za uporabo ali ovojnino.
English: Ecoporc Shiga contains an adjuvant (aluminium hydroxide) to enhance the immune response.
Slovenian: Zdravilo Ecoporc Shiga vsebuje dodatek (aluminijev hidroksid), ki spodbuja imunski odziv.
English: Genetically modified recombinant Stx2e antigen
Slovenian: Ecoporc Shiga gensko modificirani rekombinantni antigen Stx2e
English: Ecoporc Shiga is a vaccine containing the modified toxin Stx2e.
Slovenian: Ecoporc Shiga je cepivo, ki vsebuje modificirani toksin Stx2e.
English: Ecoporc Shiga is a vaccine containing a form of Shiga toxin (Stx2e) that has been modified so that it can no longer cause disease.
Slovenian: Zdravilo Ecoporc Shiga je cepivo, ki vsebuje toksin Shiga (Stx2e) v obliki, ki je bila spremenjena tako, da ne more več povzročati bolezni.
English: It is caused by a bacterial toxin (poison) known as Shiga toxin 2e (Stx2e) that is produced by certain strains of Escherichia coli.
Slovenian: Bolezen povzroča bakterijski toksin (strup), imenovan toksin Shiga 2e (Stx2e), ki ga izločajo nekateri sevi bakterije Escherichia coli.
English: For a full list of all side effects reported with Ecoporc Shiga, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Ecoporc Shiga, glejte navodilo za uporabo.
English: What benefit has Ecoporc Shiga shown during the studies?
Slovenian: Kakšne koristi je zdravilo Ecoporc Shiga izkazalo med študijami?
English: When Ecoporc Shiga is given to pigs, the animal's immune system recognises the toxin contained in the vaccine as ‘foreign' and makes antibodies against it.
Slovenian: Ko prašiči prejmejo cepivo Ecoporc Shiga, njihov imunski sistem prepozna toksin v cepivu kot tujek in začne proti njemu tvoriti protitelesa.