FrancophonIA/ELRC3.0 huggingface dataset:
English: After this period, companies will have to demonstrate that their sartan products have no quantifiable levels of these impurities before they can be used in the EU.
Slovenian: Po tem obdobju bodo morala podjetja dokazati, da v njihovih zdravilih, ki vsebujejo sartane, ni zaznavnih ravni teh nečistot, preden se bodo ta zdravila lahko uporabljala v EU.
English: After the transition period, companies must exclude the presence of even lower levels of NDEA or NDMA in their products (< 0.03 parts per million).
Slovenian: Po prehodnem obdobju morajo podjetja v svojih zdravilih izključiti prisotnost tudi nižjih ravni NDEA ali NDMA (< 0,03 ppm).
English: Companies will have a transition period to make any necessary changes, during which strict temporary limits on levels of these impurities will apply.
Slovenian: Podjetjem bo omogočeno prehodno obdobje za izvedbo potrebnih sprememb, v katerem bodo veljale stroge začasne omejitve glede ravni teh nečistot.
English: • Ever since these impurities were first seen in some sartan medicines, regulatory authorities in the EU have been working to protect patients' health.
Slovenian: • Od prvega odkritja teh nečistot v zdravilih, ki vsebujejo sartane, se regulativni organi v EU ukvarjajo z zaščito zdravja bolnikov.
English: They work by blocking the action of angiotensin II, a hormone that constricts blood vessels and causes blood pressure to rise.
Slovenian: Delujejo tako, da zavirajo delovanje angiotenzina II, tj. hormona, ki zožuje krvne žile in povzroča dvig krvnega tlaka.
English: • Nitrosamines are potent carcinogens in animals and probable carcinogens in humans.
Slovenian: • Nitrozamini so močno rakotvorne snovi pri živalih in verjetno rakotvorne pri človeku.
English: The transition period, which will last for 2 years, will allow companies to make the necessary changes to their manufacturing processes and to put in place testing regimes able to detect the smallest amounts of these impurities.
Slovenian: Prehodno obdobje, ki bo trajalo dve leti, bo podjetjem omogočilo izvedbo potrebnih sprememb njihovih proizvodnih postopkov in uvedbo shem testiranja za odkrivanje najmanjših količin teh nečistot.
English: On 20 September 2018, the review was extended to include medicines containing candesartan, irbesartan, losartan and olmesartan.
Slovenian: Dne 20. septembra 2018 je bil pregled razširjen tako, da je zajel tudi zdravila, ki vsebujejo kandesartan, irbesartan, losartan in olmesartan.
English: The review concerns candesartan, irbesartan, losartan, olmesartan and valsartan, which belong to a class of medicines called sartans (also known as angiotensin-II-receptor antagonists).
Slovenian: Pregled zadeva kandesartan, irbesartan, losartan, olmesartan in valsartan, ki spadajo v razred zdravil, imenovanih sartani (znani tudi kot antagonisti receptorjev za angiotenzin II).
English: • You should not stop taking any sartan medicines without speaking to your doctor.
Slovenian: • Zdravil, ki vsebujejo sartane, ne prenehajte jemati, ne da bi se posvetovali z zdravnikom.
English: A similar step - involving diethylamine (DEA) - is linked to the presence of NDEA.
Slovenian: Podoben korak, ki vključuje dietilamin (DEA), je povezan s prisotnostjo NDEA.
English: It concluded that if 100,000 patients took valsartan from Zhejiang Huahai (where the highest levels of impurities were found) every day for 6 years at the highest dose, there could be 22 extra cases of cancer due to NDMA over the lifetimes of those 100,000 patients.
Slovenian: Ugotovili so, da bi, če bi 100 000 bolnikov vsak dan v obdobju šestih let jemalo valsartan proizvajalca Zhejiang Huahai (pri katerem so našli največje količine nečistot) v največjem odmerku, v celotnem življenjskem obdobju teh 100 000 bolnikov prišlo do 22 dodatnih primerov raka zaradi NDMA.
English: • There is a very low risk that nitrosamine impurities at the levels previously found in some sartan medicines could cause cancer in humans.
Slovenian: • Obstaja zelo majhno tveganje, da bi lahko nitrozaminske nečistote v količinah, ki so jih predhodno našli v nekaterih zdravilih, ki vsebujejo sartane, pri človeku povzročale raka.
English: Before June 2018, NDMA and NDEA were not among the impurities identified in sartan medicines and were therefore not detected by routine tests.
Slovenian: Pred junijem 2018 NDMA in NDEA nista bila med nečistotami, najdenimi v zdravilih, ki vsebujejo sartane, zato jih z rutinskimi testi niso odkrivali.
English: EMA and national authorities will continue investigating the presence of nitrosamine impurities in medicines, including other impurities such as N-nitrosoethylisopropylamine (EIPNA), Nnitrosodiisopropylamine (DIPNA) and N-nitroso-N-methylamino butyric acid (NMBA).
Slovenian: Agencija EMA in nacionalni organi bodo nadaljevali proučevanje prisotnosti nitrozaminskih nečistot v zdravilih, vključno z drugimi nečistotami, kot so N-nitrozoetilizopropilamin (EIPNA), Nnitrozodiizopropilamin (DIPNA) in N-nitrozo-N-metilaminomaslena kislina (NMBA).
English: • For NDMA, the key step involves dimethylamine (DMA) which forms the impurity in the presence of nitrites, usually under acidic conditions.
Slovenian: • Pri NDMA ključni korak vključuje dimetilamin (DMA), ki tvori nečistoto v prisotnosti nitritov, običajno v kislih pogojih.
English: On 31 January 2019, EMA recommended that companies making sartan blood pressure medicines (also known as angiotensin II receptor blockers) review their manufacturing processes so that they do not produce nitrosamine impurities.
Slovenian: Evropska agencija za zdravila (EMA) je 31. januarja 2019 priporočila, naj podjetja, ki izdelujejo zdravila za zniževanje krvnega tlaka, ki vsebujejo sartane (znana tudi kot zaviralci receptorjev angiotenzina II), pregledajo svoje proizvodne postopke, tako da v njih ne bodo nastajale nitrozaminske nečistote.
English: NDEA
Slovenian: Meja za NDEA
English: • EMA is now taking further action to prevent these impurities from being present in future batches of sartan medicines.
Slovenian: • Agencija EMA izvaja nadaljnje ukrepe za preprečevanje pojava teh nečistot v prihodnjih serijah zdravil, ki vsebujejo sartane.
English: While the goal is to have no quantifiable nitrosamine impurities in sartans, interim limits have been set for NDMA and NDEA in line with current international guidelines.2
Slovenian: Cilj je doseči odsotnost zaznavnih nitrozaminskih nečistot v sartanih, vendar so bile za NDMA in NDEA v skladu s trenutnimi mednarodnimi smernicami postavljene začasne meje2.
English: • These impurities can form during the production of sartans that contain a tetrazole ring when certain reaction conditions are met or when contaminated materials are used.
Slovenian: • Te nečistote lahko nastajajo med proizvodnjo sartanov, ki vsebujejo tetrazolni obroč, v določenih reakcijskih pogojih ali pri uporabi onesnaženih materialov.
English: Dividing these by the maximum daily dose for each active substance gives the limit in parts per million (see Table 1).
Slovenian: Če ti količini delimo z največjim dnevnim odmerkom posamezne učinkovine, dobimo mejo v ppm (glejte preglednico 1).
English: Temporary limits for NDMA and NDEA impurities
Slovenian: Začasne meje za nečistoti NDMA in NDEA Meja za NDMA
English: These sartan medicines have a specific ring structure (tetrazole) whose synthesis could potentially lead to the formation of nitrosamine impurities.
Slovenian: Ta zdravila, ki vsebujejo sartane, imajo posebno obročasto obliko (tetrazolno), pri sintezi katere lahko nastajajo nitrozaminske nečistote.
English: How impurities came to be present in sartans
Slovenian: Zakaj so v sartanih prisotne nečistote?
English: 1 The 6 and 4 years refer to the duration of time NDMA and NDEA are believed to have been present in valsartan from Zhejiang Huahai sartans because manufacturers had inadvertently used contaminated equipment or reagents in the manufacturing process.
Slovenian: 1 Šest- in štiriletno obdobje se nanašata na domnevni čas prisotnosti NDMA in NDEA v valsartanu proizvajalca Zhejiang Huahai.
English: It is now known that these impurities can form during the production of sartans that contain a specific ring structure known as a tetrazole ring under certain conditions and when certain solvents, reagents, and other raw materials are used.
Slovenian: Zdaj je znano, da lahko v določenih pogojih in ob uporabi določenih vehiklov, reagentov in drugih surovin ti nečistoti nastajata med proizvodnjo sartanov, ki imajo posebno obročasto obliko, znano kot tetrazolni obroč.
English: These recommendations follow EMA's review of N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA), which are classified as probable human carcinogens (substances that could cause cancer) and have been detected in some sartan medicines.
Slovenian: NDMA in NDEA sta razvrščena kot možni rakotvorni snovi za človeka (snovi, ki lahko povzročata raka) in so ju odkrili v nekaterih zdravilih, ki vsebujejo sartane.
English: 1 1 ml of solution contains 1.125 mg ibandronic acid, monosodium salt, monohydrate, corresponding to 1mg ibandronic acid.
Slovenian: 1 1 ml raztopine vsebuje 1,125 mg ibandronske kisline v obliki monohidrata natrijeve soli, kar ustreza 1 mg ibandronske kisline.
English: Pharmaceutical Form Route of Administration
Slovenian: Izmišljeno ime jakost farmacevtska oblika pot uporabe ovojnina vsebina (koncentracija)
English: Ref. EMEA/CHMP/512295/2008
Slovenian: EMEA/CHMP/511854/2008
English: The procedure started on 21 June 2007.
Slovenian: Postopek se je začel dne 21. junija 2007.
English: London, 24 September 2008 Doc.
Slovenian: London, 24. september 2008 Sklic na dok.
English: The Marketing Authorisation Holder provided supplementary information on 20 December 2007.
Slovenian: Imetnik dovoljenja za promet z zdravilom je priskrbel dodatne informacije dne 20. decembra 2007.
English: A Decision was issued by the European Commission on 23 September 2008.
Slovenian: Evropska komisija je odločbo izdala dne 23. septembra 2008.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 30 REFERRAL FOR Gemzar International Non-Proprietary Name (INN): gemcitabine
Slovenian: ODBOR ZA ZDRAVILA ZA UPORABO V HUMANI MEDICINI (CHMP) MNENJE V ZVEZI Z NAPOTITVIJO V SKLADU S ČLENOM 30 ZA ZDRAVILO Gemzar Mednarodno nelastniško ime (INN): gemcitabin
English: Gemzar, 200 mg, 1000 mg, powder for solution for infusion, is a pyrimidine antagonist and is given in the management of solid tumours.
Slovenian: Gemzar, 200 mg in 1000 mg, prašek za raztopino za injiciranje je antagonist pirimidina, ki se uporablja pri zdravljenju trdnih tumorjev.
English: It is indicated in bladder cancer, advanced non-small cell lung cancer, advanced pancreatic cancer, breast cancer and ovarian cancer.
Slovenian: Namenjen je za zdravljenje raka sečnega mehurja, napredovalega nedrobnoceličnega raka pljuč, napredovalega raka trebušne slinavke, raka dojk in raka jajčnikov.
English: The basis for referral was that there were divergences in the Summaries of Product Characteristics (SPC) including quality aspects of Gemzar approved across EU Member States, mainly with respect to the approved indications, the posology, the contra-indications and the warnings.
Slovenian: Temelj za napotitev so bila razhajanja v povzetkih glavnih značilnosti zdravila in vidikih kakovosti zdravila Gemzar, ki so bili odobreni v državah članicah EU ter so se večinoma nanašali na odobrene indikacije, odmerjanje, kontraindikacije in opozorila.
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II together with the amended SPC, Labelling and Package Leaflet in Annex III.
Slovenian: Seznam zadevnih imen zdravil je naveden v Dodatku I. Znanstveni zaključki so na voljo v Dodatku II, spremenjeni povzetek glavnih značilnosti zdravila, označevanje in navodila za uporabo pa v Dodatku III.
English: During its June 2008 meeting, the CHMP, in the light of the overall submitted data and the scientific discussion within the Committee, was of the opinion that the proposal for the harmonisation of the SPC, Labelling and Package leaflet including the quality aspects was acceptable and that they should be amended.
Slovenian: CHMP je med zasedanjem junija 2008 na podlagi vseh predloženih podatkov in znanstvene razprave v Odboru menil, da je predlog za uskladitev povzetkov glavnih značilnosti zdravila, označevanja in navodila za uporabo, vključno z vidiki kakovosti, sprejemljiv in da bi bilo treba navedene dokumente spremeniti.
English: The CHMP gave a positive opinion on 26 June 2008 recommending the harmonisation of the SPC, Labelling and Package Leaflet including quality aspects for Gemzar.
Slovenian: CHMP je dne 26. junija 2008 izdal pozitivno mnenje, s katerim priporoča uskladitev povzetkov glavnih značilnosti zdravila, označevanja in navodila za uporabo vključno z vidiki kakovosti za zdravilo Gemzar.
English: This medicinal product belongs to the list of products for SPC harmonisation.
Slovenian: Zdravilo spada na seznam zdravil, katerih povzetke glavnih značilnosti zdravila je treba uskladiti.
English: On 8 June 2007, the European Commission presented to the EMEA a referral under Article 30 of Directive 2001/83/EC, as amended, in order to harmonise the nationally authorised Summaries of Product Characteristics (SPC), Labelling and Package Leaflet including quality aspects of the medicinal product Gemzar.
Slovenian: Direktive 2001/83/ES, kakor je bila spremenjena, da bi uskladila nacionalno odobrene povzetke glavnih značilnosti zdravila, označevanje in navodilo za uporabo, vključno z vidiki kakovosti zdravila Gemzar.
English: 33 mg/g Granules
Slovenian: 33 mg/g Zrnca
English: Oral use bottle (HDPE) 1 x 60 g granules
Slovenian: Peroralna uporaba plastenka (HDPE) 1 x 60 g zrnc
English: The European Commission granted a marketing authorisation valid throughout the EU for Karvezide on 16 October 1998.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Karvezide, veljavno po vsej Evropski uniji, odobrila dne 16. oktobra 1998.
English: The full EPAR for Karvezide 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 Karvezide je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Karvezide.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Karvezide.
English: Other information about Karvezide
Slovenian: Druge informacije o zdravilu Karvezide
English: Karvezide irbesartan / hydrochlorothiazide
Slovenian: Karvezide irbesartan/hidroklorotiazid
English: What benefit has Karvezide shown during the studies?
Slovenian: Kakšne koristi je zdravilo Karvezide izkazalo med študijami?
English: The CHMP decided that Karvezide's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: CHMP je zaključil, da so koristi zdravila Karvezide večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
English: For more information about treatment with Karvezide, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Karvezide preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: What is the risk associated with Karvezide?
Slovenian: Kakšna tveganja so povezana z zdravilom Karvezide?
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 Karvezide.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Karvezide, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: The most common side effects with Karvezide (seen in between 1 and 10 patients in 100) are dizziness, nausea (feeling sick) or vomiting, abnormal urination, fatigue (tiredness), and increases in blood urea nitrogen (BUN, a breakdown product of protein), creatinine (a breakdown product of muscle) and creatine kinase (an enzyme found in muscles).
Slovenian: Najpogostejši neželeni učinki zdravila Karvezide (opaženi pri 1 do 10 bolnikih izmed 100) so omotica, navzeja (slabost) ali bruhanje, nenormalno uriniranje, utrujenost in povečane vrednosti dušika sečnine v krvi (BUN, produkta razgradnje beljakovin), kreatinina (produkta metabolizma mišic) in kreatin kinaze (encima, ki ga najdemo v mišicah).
English: The dose of Karvezide to be used depends on the dose of irbesartan or hydrochlorothiazide that the patient was taking before.
Slovenian: Odmerek zdravila Karvezide, ki ga naj bolnik jemlje, je odvisen od odmerka irbesartana ali hidroklorotiazida, ki ga je bolnik jemal prej.
English: Why has Karvezide been approved?
Slovenian: Zakaj je bilo zdravilo Karvezide odobreno?
English: Karvezide must not be used in people who are hypersensitive (allergic) to irbesartan, hydrochlorothiazide, sulfonamides, or any of the other ingredients.
Slovenian: Zdravila Karvezide ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) irbesartan, hidroklorotiazid, sulfonamide ali katero koli drugo sestavino zdravila.
English: Karvezide is used in adults who have essential hypertension (high blood pressure) that is not adequately controlled by irbesartan or hydrochlorothiazide alone.
Slovenian: Zdravilo Karvezide se uporablja pri odraslih z esencialno hipertenzijo (visokim krvnim tlakom), ki ni ustrezno uravnana z uporabo zgolj irbesartana ali zgolj hidroklorotiazida.
English: For the full list of all side effects reported with Karvezide, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Karvezide, glejte navodilo za uporabo.
English: Karvezide in combination with aliskiren-containing medicines (used to treat essential hypertension) must not be used in patients with diabetes, or moderate or severe kidney impairment.
Slovenian: Zdravilo Karvezide se v kombinaciji z zdravili, ki vsebujejo aliskiren (ki se uporablja za zdravljenje esencialne hipertenzije), ne sme uporabljati pri bolnikih s sladkorno boleznijo ali zmerno do hudo ledvično okvaro.
English: Care must be taken when using Karvezide with other medicines that have an effect on blood potassium levels.
Slovenian: Posebna previdnost je potrebna, če se zdravilo Karvezide jemlje sočasno z drugimi zdravili, ki vplivajo na koncentracijo kalija v krvi.
English: Karvezide is a medicine that contains two active substances, irbesartan and hydrochlorothiazide.
Slovenian: Karvezide je zdravilo, ki vsebuje dve zdravilni učinkovini, irbesartan in hidroklorotiazid.
English: Karvezide must also not be used in patients who have severe liver, kidney or bile problems, blood potassium levels that are too low or blood calcium levels that are too high.
Slovenian: Zdravila Karvezide prav tako ne smejo uporabljati bolniki s hudim obolenjem jeter, ledvic ali žolčnika ali bolniki s prenizko koncentracijo kalija v krvi ali s previsoko koncentracijo kalcija v krvi.
English: What is Karvezide used for?
Slovenian: Za kaj se zdravilo Karvezide uporablja?
English: How has Karvezide been studied?
Slovenian: Kako je bilo zdravilo Karvezide raziskano?
English: The studies of Karvea/Aprovel used with hydrochlorothiazide as separate tablets were used to support the use of Karvezide.
Slovenian: V podporo uporabi zdravila Karvezide so bile uporabljene študije z zdraviloma Karvea in Aprovel, uporabljenima skupaj z hidroklorotiazidom v ločenih tabletah.
English: Karvezide was more effective than placebo (a dummy treatment) and than hydrochlorothiazide alone in reducing diastolic blood pressure.
Slovenian: Zdravilo Karvezide je bilo pri zniževanju diastoličnega krvnega tlaka učinkovitejše od placeba (zdravila brez zdravilne učinkovine) in od hidroklorotiazida kot samostojnega zdravila.
English: What is Karvezide?
Slovenian: Kaj je zdravilo Karvezide?
English: How is Karvezide used?
Slovenian: Kako se zdravilo Karvezide uporablja?
English: Karvezide may be added to some other treatments for hypertension.
Slovenian: Zdravilo Karvezide se lahko uvede sočasno z nekaterimi drugimi zdravili za zdravljenje visokega krvnega tlaka.
English: Karvezide contains two active substances, irbesartan and hydrochlorothiazide.
Slovenian: Zdravilo Karvezide vsebuje dve zdravilni učinkovini, irbesartan in hidroklorotiazid.
English: How does Karvezide work?
Slovenian: Kako zdravilo Karvezide deluje?
English: The European Commission issued a decision on 2 June 2009.
Slovenian: Evropska komisija je odločbo izdala dne 2. junija 2009.
English: Ref. EMEA/403687/2009 EMEA/A-29/1094
Slovenian: EMEA/403708/2009 EMEA/A-29/1094
English: Dr. Karl Broich (Germany)
Slovenian: dr. Karl Broich (Nemčija)
English: The company wanted the authorisation to be recognised in Austria, Bulgaria, the Czech Republic, Hungary, Poland, Romania and Slovakia (the concerned Member States).
Slovenian: Družba je želela, da dovoljenje za promet z zdravilom priznajo tudi v Avstriji, Bolgariji, Češki republiki, Madžarski, Poljski, Romuniji in Slovaški (zadevne države članice).
English: London, 4 June 2009 Doc.
Slovenian: London, 4. junija 2009 Sklic dok.
English: Medicines are bioequivalent when they produce the same levels of active substance in the body.
Slovenian: Zdravila so biološko enakovredna, ko dosegajo enake ravni zdravilne učinkovine v telesu.
English: Questions and answers on the referral for Betavert N tablets containing betahistine dihydrochloride (8 or 16 mg)
Slovenian: Vprašanja in odgovori v zvezi z napotitvijo za zdravilo Betavert N tablete, ki vsebujejo betahistin dihidroklorid (8 ali 16 mg)
English: However, the member states were not able to reach an agreement and the German medicines regulatory agency referred the matter to the CHMP for arbitration on 30 October 2008.
Slovenian: Ker pa omenjene države članice niso dosegle soglasja, je nemški regulatorni organ dne 30. oktobra 2008 zadevo napotil na CHMP v arbitražo.
English: Patients with Menière's disease have vertigo (a spinning sensation), often associated with feeling sick or vomiting, tinnitus (ringing in the ear) and hearing loss.
Slovenian: Bolniki z Menierjevo boleznijo imajo vrtoglavico (občutek vrtenja), pogosto povezano s slabostjo ali bruhanjem, tinitusom (zvonjenjem v ušesu) in izgubo sluha.
English: This allows a dilation of the blood vessels in the inner ear, thus helping the pressure to drop and relieving the symptoms of the disease.
Slovenian: To omogoča razširitev krvnih žil v notranjem ušesu, kar povzroči padec pritiska in blaži simptome bolezni.
English: Why was Betavert N reviewed?
Slovenian: Zakaj je bilo zdravilo Betavert N pregledano?
English: Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP was of the opinion that bioequivalence between Betavert N and Betaserc 8 had been demonstrated.
Slovenian: Na podlagi ocene trenutno razpoložljivih podatkov in znanstvene razprave v okviru Odbora je CHMP menil, da je bila biološka enakovrednost med zdravilom Betavert N in Betaserc 8 dokazana.
English: Menière's disease is a disease where an accumulation of fluid in the inner ear causes a build-up of pressure.
Slovenian: Menierova bolezen je bolezen, pri kateri nabiranje tekočine v notranjem ušesu povzroča povečanje pritiska.
English: This means that Betavert N is similar to a ‘reference medicine' already authorised in the European Union (EU) called Betaserc 8.
Slovenian: To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Betaserc 8.
English: The active substance in Betavert N, betahistine, is an analogue of histamine, a naturally-occurring substance in the body that is involved in many processes.
Slovenian: Zdravilna učinkovina v zdravilu Betavert N, betahistin, je analog histamina, naravno prisotne snovi v telesu, ki je prisotna v številnih postopkih.