natgillin/translations-raw huggingface dataset:
The most common side effects with Emtriva (seen in more than 1 patient in 10) are headache, diarrhoea, nausea (feeling sick), and elevated creatine kinase levels in the blood (an enzyme found in muscles).
Najpogostejši neželeni učinki zdravila Emtriva (opaženi pri več kot 1 bolniku od 10) so glavobol, driska, navzeja (slabost) in povišane ravni kreatin kinaze v krvi (encima v mišicah).
For patients who have taken medicines to treat their HIV infection before and did not respond to that treatment, doctors should only prescribe Emtriva once they have looked at the antiviral medicines the patient has taken before and assessed the likelihood of the virus's response to any new antiviral medicines that might be prescribed.
Pri bolnikih, ki so že jemali zdravila za zdravljenje okužbe z virusom HIV, a se na to vrsto zdravljenja niso odzvali, lahko zdravniki predpišejo zdravilo Emtriva šele, ko preverijo, katera zdravila je bolnik jemal prej, in ocenijo verjetnost za odziv virusa na zdravljenje z novimi protivirusnimi zdravili, ki bi jih utegnili predpisati.
Emtriva, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Zdravilo Emtriva v kombinaciji z drugimi protivirusnimi zdravili zniža količino virusa HIV v krvi in jo vzdržuje na nizki ravni.
The active substance in Emtriva, emtricitabine, is a nucleoside reverse transcriptase inhibitor (NRTI).
Zdravilna učinkovina v zdravilu Emtriva, emtricitabin, je zaviralec nukleozidne reverzne transkriptaze (NRTI).
For practical information about using Emtriva, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Emtriva naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Studies have shown that Emtriva, in combination with other antiviral medicines, reduces viral loads in HIV-infected patients and compares well with other medicines used in combination.
Študije so pokazale, da zdravilo Emtriva v kombinaciji z drugimi protivirusnimi zdravili znižuje virusno breme pri bolnikih, okuženih z virusom HIV, in da je dobro primerljivo z drugimi zdravili, ki se uporabljajo v kombinaciji z njim.
Emtriva should only be started by a doctor experienced in managing HIV infections.
Zdravljenje z zdravilom Emtriva mora uvesti zdravnik z izkušnjami z zdravljenjem okužbe z virusom HIV.
The Committee noted that this indication is based on studies in patients who have not received HIV treatment before, or whose HIV is already well controlled with antiviral medicines, and that there was no experience of Emtriva in patients whose previous treatment for HIV was not working.
Ugotovil je, da ta indikacija temelji na študijah z bolniki, ki pred tem niso prejemali zdravljenja zaradi okužbe z virusom HIV ali katerih okužba s tem virusom je bila že prej dobro nadzorovana s protivirusnimi zdravili, medtem ko bolniki, ki se na prejšnje zdravljenje okužbe z virusom HIV niso odzivali, niso bili vključeni v študije zdravila Emtriva.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Emtriva's benefits are greater than its risks for the treatment of HIV-1 infected adults and children in combination with other antiretroviral agents.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Emtriva pri zdravljenju odraslih in otrok, okuženih z virusom HIV-1, v kombinaciji z drugimi protiretrovirusnimi zdravili večje od z njim povezanih tveganj.
• In a third study in 459 patients who had been taking three antiviral medicines (including lamivudine), the number of patients switching from lamivudine to Emtriva who had viral loads below 400 copies/ml after 48 weeks was similar to the number of those who continued taking lamivudine (73% and 82%, respectively).
• v tretji študiji, ki je vključevala 459 bolnikov, ki so prejemali tri protivirusna zdravila (vključno z lamivudinom), je bilo število tistih, ki so prešli z jemanja lamivudina na zdravilo Emtriva in pri katerih je bilo virusno breme po 48 tednih pod 400 kopijami/ml, podobno številu bolnikov, ki so še naprej jemali lamivudin (73 % oziroma 82 %).
Emtriva is used in combination with other antiviral medicines and contains the active substance emtricitabine.
Zdravilo Emtriva se uporablja v kombinaciji z drugimi protivirusnimi zdravili in vsebuje zdravilno učinkovino emtricitabin.
• In a study of 571 previously untreated adults, more patients taking Emtriva (in combination with didanosine and efavirenz) had viral loads below 50 copies/ml after 24 weeks of treatment than those taking stavudine (81% and 70%, respectively).
• v študiji, v katero je bilo vključenih 571 predhodno nezdravljenih odraslih bolnikov, je imelo po 24-tedenskem zdravljenju več bolnikov, ki so jemali zdravilo Emtriva (v kombinaciji z didanozinom in efavirenzom), virusno breme pod 50 kopij/ml v primerjavi s tistimi, ki so jemali stavudin (81 % oziroma 70 %).
The oral solution is for patients who weigh less than 33 kg, and those who cannot swallow the capsules.
Običajni odmerek zdravila Emtriva znaša za bolnike, ki so težki 33 kg ali več, eno kapsulo enkrat na dan. Peroralno raztopino lahko uporabljajo le bolniki, ki tehtajo manj kot 33 kg, in bolniki, ki kapsul ne morejo pogoltniti.
How is Emtriva used?
Kako se zdravilo Emtriva uporablja?
The dose may need to be adjusted in patients who have problems with their kidneys.
Pri bolnikih, ki imajo resne težave z ledvicami, je treba odmerek zdravila prilagoditi.
How does Emtriva work?
Kako zdravilo Emtriva deluje?
Because no agreement was reached at the Day 60, the procedure was referred to the CHMP.
Ker do 60. dne dogovor ni bil dosežen, je bil postopek napoten na CHMP.
Human plasma protein binding is under 5%.
Vezava na beljakovine človeške plazme je manjša od 5 %.
The mechanism of action of betahistine dihydrochloride is not compleately clear but the product has been on the EU market for a long time, therefore could be concluded that its use is well established and its efficacy is proven.
Mehanizem delovanja betahistin dihidroklorida ni povsem jasen, vendar pa je izdelek na trgu EU že dalj časa in zato lahko zaključimo, da je njegova uporaba dobro uveljavljena in učinkovitost dokazana.
No new safety data are provided or needed.
Novi podatki o varnosti niso priloženi in niso potrebni.
The analysis results show that the finished products meet the specifications proposed.
Rezultati analiz kažejo, da končni izdelki izpolnjujejo predlagane specifikacije.
The product specifications cover appropriate parameters for this dosage form.
Specifikacije izdelka pokrivajo ustrezne parametre za to obliko odmerka.
ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR POSITIVE OPINION
DODATEK II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA POZITIVNO MNENJE
The conditions used in the stability studies are according to the ICH stability guideline.
Pogoji, uporabljeni v študijah stabilnosti, so v skladu s smernicami stabilnosti Mednarodne konference o usklajevanju (ISH).
PK study, also, revealed no safety issues.
Študija farmakokinetike prav tako ni razkrila nikakršnih vprašanj glede varnosti.
Critical evaluation
Odločilno vrednotenje
Considering the dissolution test, both strengths of the test product can be classified as “very rapid dissolving tablets”.
Ob upoštevanju preskusa raztopitve lahko uvrstimo obe jakosti izdelka med „zelo hitro raztopljive tablete“.
The drug substance is completely and fast dissolved independent of the applied medium.
Zdravilo se popolnoma in hitro raztopi, ne glede na uporabljen medij.
Bioequivalence
Biološka enakovrednost
The CHMP assessed the dossier and the available data, including the issue raised by the objecting CMS.
CHMP je ocenil dokumentacijo in razpoložljive podatke, vključno s problematiko, ki so jo izrazile nasprotujoče zadevne države članice.
No significant changes were observed in 6 months accelerated stability study (40°C/ 75% RH) and up to 5 years controlled room temperature stability study.
V šestmesečni pospešeni študiji stabilnosti (40°C/75 % relativna vlažnosti) in v do 5 let trajajoči študiji stabilnosti pri nadzorovani sobni temperaturi bistvenih sprememb niso opazili.
Its exact biochemical mode of action as well as its receptor specificity and affinity has not been clarified until now.
Natančen biokemijski način delovanja ter njegova specifičnost in afiniteta za receptorje do sedaj niso bili razjasnjeni.
Validations of the analytical methods have been presented.
Predstavljene so bile potrditve analitičnih metod.
Analytical data were submitted and the choice of excipients was justified and their functions explained.
Predloženi so bili analitični podatki, izbira pomožnih snovi pa utemeljena in njihovo delovanje razloženo.
The valid Summary of Product Characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure.
Veljavni povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo so zadnje različice, ki so bile pripravljene v postopku koordinacijske skupine.
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF BETAVERT N AND ASSOCIATED NAMES (SEE ANNEX I)
SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA BETAVERT N IN Z NJIM POVEZANIH IMEN (GLEJTE DODATEK I)
Elimination: Excretion of Betahistine is almost entirely (85 % - 90 %) in the urine within 24 hours Betahistin is excreted almost completely as the major metabolite in the urine.
Izločanje: betahistin se skoraj v celoti (85 % - 90 %) izloči z urinom; v 24 urah se betahistin praktično popolnoma izloči kot glavni presnovek v urinu.
The conditions for the suitability of this biowaiver have been discussed taking into account: solubility, dissolution, and absorption/permeability.
Na posvetovanju o pogojih za primernost te bio-opustitve so upoštevali: topnost, raztopitev in absorpcijo/prepustnost.
The CHMP considered the chemicalpharmaceutical documentation and Expert Report, of Betahistine, of sufficient quality in view of the present European regulatory requirements.
CHMP je ocenil, da so kemijsko-farmacevtska dokumentacija in strokovno poročilo za betahistin zadovoljive kakovosti kar zadeva trenutne evropske zakonodajne zahteve.
Betavert N was approved in EU, on 18 April 2007, during a Mutual Recognition Procedure (MRP) with Germany as Reference Member State (RMS) plus 7 Concerned Member States (CMS): AT, BG, CZ, HU, PL, RO and SK.
Zdravilo Betavert N je bilo 18. aprila 2007 s postopkom medsebojnega priznavanja odobreno v EU, pri čemer je bila Nemčija referenčna država članica, sedem zadevnih držav članic pa Avstrija, Bolgarija, Češka republika, Madžarska, Poljska, Romunija in Slovaška.
Betahistine is a structural analogue of the endogenous histamine.
Betahistin je strukturni analog endogenega histamina.
The Benefit-Risk-Assessment is positive.
Ocena razmerja med koristmi in tveganji je pozitivna.
The MAH has provided documents that set out a detailed description of the system of pharmacovigilance.
Imetnik dovoljenja za promet je priložil dokumentacijo, ki natančno opisuje sistem farmakovigilance.
ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS / MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, PREDLAGATELJEV / IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
The product is considered as bioequivalent to the originator, and the benefit-risk balance is considered positive.
Izdelek je biološko enakovreden svojemu izvornemu zdravilu, razmerje med koristmi in tveganji pa se šteje kot pozitivno.
The Czech Republic came to the conclusion that the bioequivalence has not been properly demonstrated in vivo because of the choice of the analytical method.
Češka republika je prišla do sklepa, da biološka enakovrednost zaradi izbrane analitične metode ni bila primerno dokazana in vivo.
This procedure concerns Betavert N, a generic version of betahistine dihydrochloride tablets.
Ta postopek zadeva zdravilo Betavert N, generično različico tablet betahistin dihidroklorida.
Non clinical aspects
Neklinični vidiki
Metabolism: Betahistine dihydrochloride is rapidly metabolised in the liver to the inactive major metabolite, 2-pyridylacetic acid and to demethyl-betahistine [2-(2 aminoethylpyridine)].
Presnova: Betahistin dihidroklorid se v jetrih hitro pretvori v glavni neaktivni metabolit 2-piridil ocetno kislino in v demetil betahistin [2-(2 aminoetil piridin)].
GmbH & Co. KG Liebigstraße 1 - 2 65439 Flörsheim/Main Germany
KG Liebigstraße 1 - 2 65439 Flörsheim/Main Nemčija
Betahistine is excreted in breast milk in concentrations similar to those found in plasma.
Betahistin se izloča z materinim mlekom v koncentracijah, podobnih tistim v plazmi.
Biliary elimination is not a significant route of elimination for the active agent or any of its metabolites.
Izločanje z žolčem ne predstavlja bistvene poti izločanja zdravilne učinkovine ali katerega od njegovih presnovkov.
Peak plasma concentrations of C14-labelled betahistine dihydrochloride are reached approximately 1 hour after oral administration in fasting volunteers.
Najvišje plazemske koncentracije C14-označenega betahistin dihidroklorida so pri teščih prostovoljcih dosežene približno 1 uro po zaužitju.
Betahistine is an analogue of histamine, which is indicated in the treatment of vertigo associated with functional disorders of the vestibular apparatus in the context of Meniere's symptom complex.
Betahistin je analog histamina, ki je indiciran za zdravljenje vrtoglavice, povezane s funkcionalnimi motnjami vestibularnega aparata v okviru kompleksnih simptomov Menierjeve bolezni.
Absorption: following oral administration, betahistine dihydrochloride is rapidly and completely absorbed.
Absorpcija: po zaužitju se betahistin dihidroklorid hitro in v celoti absorbira.
This was done by a bioequivalence study investigating urine levels of the main metabolite and by supportive in vitro studies, performed in the course of the national authorisation procedure, leading to the conclusion that it is justified to waive for further bioequivalence studies in human volunteers.
To so dokazali v študiji biološke enakovrednosti, kjer so raziskovali ravni glavnega presnovka v urinu, in s podpornimi študijami in vitro, izvedenimi med nacionalnim postopkom za pridobitev dovoljenja, iz česar so zaključili, da je nadaljnje študije biološke enakovrednosti na prostovoljcih upravičeno opustiti.
The BCS-studies of betahistine substance and formulations presented herein along with the properties of the drug substance (therapeutic index, safety and complete absorption) and the formulations (composition) provided robust support for waiving in vivo BE studies for Betavert N. Moreover, betahistine fulfils the regulatory requirements for granting a biowaver, being assigned to the group of compounds with high solubility and complete absorption - accordant with Class I of BCS.
Na podlagi biofarmacevtskega klasifikacijskega sistema narejene študije učinkovine betahistina in formulacije betahistina, predstavljene tukaj poleg lastnosti zdravila (terapevtski indeks, varnost in popolna absorpcija) in formulacij (sestava), močno podpirajo opustitev in vivo študij biološke enakovrednosti za zdravilo Betavert N. Poleg tega betahistin izpolnjuje predpisane zahteve za odobritev bio-opustitve, saj spada v skupino visoko topnih in popolnoma absorbiranih spojin - v skladu z razredom I biofarmacevtskega klasifikacijskega sistema.
The CHMP agreed that there were no objections to approval of Betavert N 8 mg and Betavert N 16 mg from a nonclinical point of view.
CHMP se strinja, da z nekliničnega vidika ugovorov za odobritev zdravil Betavert N 8 mg and Betavert N 16 mg ni bilo.
As betathistine is a widely used, well-known active substance, no further studies are required and the MAH provides none.
Ker je betahistin široko uporabna, dobro znana zdravilna učinkovina, dodatne študije niso potrebne in jih imetnik dovoljenja za promet z zdravilom ni predložil.
The binding of Betahistine to human plasma proteins has been measured by equilibrium dialysis.
Vezavo betahistina na beljakovine človeške plazme so merili z ravnotežno dializo.
Efficacy and safety of betahistine dihydrochloride in the treatment of symptoms associated with Menière's disease have been demonstrated in preclinical-and clinical trials.
Klinična učinkovitost/varnost Učinkovitost in varnost betahistin dihidroklorida pri zdravljenju simptomov, povezanih z Menierjevo boleznijo, sta bili dokazani v predkliničnih in kliničnih preskušanjih.
The pure betahistine dihydrochloride could not reliably quantify in the human body.
Čistega betahistin dihidroklorida ne moremo zanesljivo oceniti v človeškem telesu.
The bioequivalence between Betavert N and the originator is based on Biopharmaceutics Classification System (BCS) approach (biowaiver).
Biološka enakovrednost med zdravilom Betavert N in izvornim zdravilom temelji na pristopu biofarmacevtskega klasifikacijskega sistema (bio-opustitev).
The preparation of Betahistine is not recommended for use in children and adolescents due to lack of data on safety and efficacy.
Zaradi pomanjkljivih podatkov o varnosti in učinkovitosti uporaba betahistina pri otrocih in mladostnikih ni priporočena.
The CHMP asked the MAH to clearly prove the bioequivalence between Betavert N and the originator.
CHMP je prosil imetnika dovoljenja za promet z zdravilom, naj jasno dokaže biološko enakovrednost med zdravilom Betavert N in njegovim izvornikom.
The RMS considers that the Pharmacovigilance system as described by the MAH fulfils the requirements as described in Volume 9A of the Rules Governing Medicinal Products in the European Union and provides adequate evidence that the MAH has the services of a qualified person responsible for pharmacovigilance and has the necessary means for the notification of any adverse reaction suspected of occurring either in the Community or in a third country.
Referenčna država članica je mnenja, da sistem farmakovigilance, ki ga je opisal imetnik dovoljenja za promet, izpolnjuje zahteve, opisane v zvezku 9A „Pravil, ki urejajo zdravila v Evropski uniji“, in zadostno dokazuje, da ima imetnik dovoljenja za promet z zdravilom storitve usposobljene osebe, odgovorne za farmakovigilanco, in ima potrebna sredstva za obveščanje o kakršnih koli neželenih učinkih, do katerih bi lahko prišlo v Skupnosti ali v tretji državi.
A statement signed by the MAH and the qualified person for pharmacovigilance, indicating that the MAH has the services of a qualified person responsible for pharmacovigilance and the necessary means for the notification of any adverse reaction occurring either in the Community or in a third country has been provided.
Priložena je bila tudi izjava, ki sta jo podpisala imetnik dovoljenja za promet z zdravilom in za farmakovigilanco usposobljena oseba, o tem, da ima imetnik dovoljenja za promet z zdravilom storitve usposobljene osebe, odgovorne za farmakovigilanco, in da so bila zagotovljena potrebna sredstva za obveščanje o kakršnih koli neželenih učinkih, ki bi se zgodili v Skupnosti ali v tretji državi.
The solubility of the drug substance and the fast dissolution rate of the drug product were already unquestionably proven.
Topnost učinkovine zdravila in velika hitrost raztopitve produkta zdravila sta že bili nesporno dokazani.
The determination of 2-Pyridylacetic acid (PAA), the active metabolite of betahistine, from urine samples was not considered as up-to-date method, the measurement of PAA in human plasmas would have considered more appropriate.
Določanje 2-piridil ocetne kisline, aktivnega presnovka betahistina iz vzorcev urina ne velja za sodobno metodo; merjenje 2-piridil ocetne kisline v človeški plazmi bi bilo bolj ustrezno.
Benefit Risk Assessment
Ocena razmerja med koristmi in tveganji
The originator product is Betaserc® 8 available in 8 mg tablets.
Izvorno zdravilo je Betaserc® 8, ki je na voljo kot 8-miligramske tablete.
Distribution: The human volume of distribution of betahistine dihydrochloride is not known.
Porazdelitev: Volumen porazdelitve betahistin dihidroklorida pri človeku ni znan.
The results of solubility study showed a high solubility of the active substance about a broad pH range.
Rezultati študije topnosti so pokazali visoko topnost zdravilne učinkovine prek širokega pH spektra.
The CHMP has recommended the granting of the Marketing Authorisation(s) for Betavert N and associated names (see Annex I).
CHMP je priporočil odobritev dovoljenj(a) za promet z zdravilom Betavert N in z njim povezanih imen (glejte Dodatek I).
Based on these, the CHMP proposed a re-test period of 5 years for betahistine hydrochloride.
Na podlagi tega je CHMP za betahistin hidroklorid predlagal ponovitev preskusov čez 5 let.
The Marketing Authorisation Holder of the originator is Solvay Pharma B.V. settled in Netherlands.
Imetnik dovoljenja za promet z izvornim zdravilom je družba Solvay Pharma B.V.
The control tests and specifications for drug product are adequately drawn up.
Kontrolni preskusi in specifikacije zdravila so bili zadostno predstavljeni.
65439 Flörsheim/Main
Liebigstraße 1 - 2 65439 Flörsheim/Main Nemčija
The evaluation of the permeability and the absorption of the active substance was derived from a bioequivalence and a mass balance study in vivo.
Vrednotenje prepustnosti in absorpcije zdravilne učinkovine je bilo povzeto iz študije biološke enakovrdnosti in študije masnega ravnotežja in vivo.
The Marketing Authorisation Holder of Betavert N is Hennig Arzneimittel GmbH & Co.KG
Imetnik dovoljenja za promet z zdravilom Betavert N je družba Hennig Arzneimittel GmbH & Co.KG.
Pharmacodynamic, pharmacokinetic and toxicological properties of betahistine are well known.
Farmakodinamične, farmakokinetične in toksikološke lastnosti betahistina so dobro znane.
The absolute bioavailability of betahistine dihydrochloride is not known.
Popolna biološka razpoložljivost betahistin dihidroklorida ni znana.
The MAH demonstrated the bioequivalence with two types of data: an in vivo BE-study (bioequivalence study) with urine measurement and in vitro studies on BA/BE based on Biopharmaceutics Classification System (BCS).
Imetnik dovoljenja za promet z zdravilom je dokazal biološko enakovrednost z dvema vrstama podatkov: z in vivo študijo biološke enakovrednosti z merjenjem urina in z in vitro študijami biološke uporabnosti/biološke enakovrednosti na podlagi biofarmacevtskega klasifikacijskega sistema.
Non-clinical pharmacodynamic, pharmacokinetic and toxicological properties of betahistine dihydrochloride are also well known.
Neklinične farmakodinamične, farmakokinetične in toksikološke lastnosti betahistin dihidroklorida so prav tako dobro znane.
The MAH has demonstrated that Betavert N (Hennig Arzneimittel GmbH, Germany) and the originator, Betaserc® 8 (Duphar, UK), are bioequivalent after single administration.
Imetnik dovoljenja za promet z zdravilom je dokazal, da sta po enkratni uporabi zdravili Betavert N (Hennig Arzneimittel GmbH, Nemčija) in izvorno zdravilo Betaserc® 8 (Duphar, VB) biološko enakovredni.
The control tests and specifications for drug substance product were adequately drawn up.
Kontrolni preskusi in specifikacije učinkovine zdravila so bile zadostno predstavljeni.
The solubility of the drug substance and the fast dissolution rate of the drug product have been proven.
Topnost učinkovine zdravila in velika hitrost raztopitve zdravila sta bili dokazani.
The active substance Betahistine hydrochloride is described in Ph.Eur.
Zdravilna učinkovina betahistin hidroklorid je opisana v Evropski farmakopeji.
The CHMP concluded that betahistine dihydrochloride can be classified as Class I according to Biopharmaceutics Classification System.
CHMP je sklenil, da se betahistin dihidroklorid lahko uvrsti v razred I po biofarmacevtskem klasifikacijskem sistemu.
Only traces of desmethylbetahistine dihydrochloride are recovered in the urine.
Desmetil betahistin dihidroklorid se v urinu nahaja le v sledovih.