FrancophonIA/ELRC3.0 huggingface dataset:
English: The study in support of the safety of furosemide (Dormans et al.1) presented by the applicant, was not considered as relevant by the CHMP, as furosemide in this study was used intravenously and Furosemide Vitabalans is intended to be used in oral administration as a 40mg tablet.
Slovenian: Študije v podporo varnosti furosemida (Dormans in sod.1), ki jo je predložil predlagatelj, odbor CHMP ni upošteval za ustrezno, saj je bil v tej študiji furosemid uporabljan intravensko, zdravilo Furosemide Viatabalans pa je namenjeno za peroralno uporabo v obliki 40 mg tablet.
English: In response to the CHMP, the applicant further referred to published pharmacokinetics data presenting PK parameters of similar tablets formulations to Furosemide Vitabalans as well as different formulations (e.g. tablet 20mg).
Slovenian: Kot odgovor odboru CHMP je predlagatelj nadalje navedel objavljene farmakokinetične podatke, ki predstavljajo farmakokinetične parametre tablet, podobnih zdravilu Furosemide Vitabalans, kot tudi drugačnih formulacij (npr. 20-miligramske tablete).
English: The pharmacokinetic parameters available in the literature are not sufficient to claim that Furosemide Vitabalans would have a similar bioavailability.
Slovenian: Farmakokinetični parametri, ki so na voljo v literaturi, niso zadostni za potrditev, da ima zdravilo Furosemide Vitabalans podobno biološko uporabnost.
English: The group considered that manufacturing methods or dissolution data could not predict how the product would behave in vivo.
Slovenian: Skupina je bila prav tako mnenja, da z metodami izdelave ali s podatki o raztapljanju ni mogoče predvideti obnašanja zdravila in vivo.
English: The CHMP is of the opinion that the applicant has not adequately demonstrated that the submitted published literature on furosemide was directly applicable to Furosemide Vitabalans.
Slovenian: Odbor CHMP meni, da predlagatelj ni ustrezno predstavil, da je mogoče predloženo objavljeno literaturo o furosemidu neposredno uporabiti za zdravilo Furosemide Vitabalans.
English: A judgement must be made whether the product studied can be considered as similar to the products, for which application for a marketing authorisation has been made in spite of the existing differences.
Slovenian: Presoditi je treba, ali je preučevano zdravilo mogoče obravnavati kot podobno zdravilu, za katerega je bila predložena vloga za pridobitev dovoljenja za promet kljub obstoječim razlikam.
English: As discussed previously, in vitro data demonstrating similarity of dissolution profiles between Furosemide Vitabalans and other products containing furosemide do not prove that the bioavailability of these products would be similar, in particular, with a BCS class IV drug substance (low solubility, low permeability).
Slovenian: Kot je bilo predhodno obravnavano, podatki in vitro za prikaz podobnosti profilov raztapljanja med zdravilom Furosemide Vitabalans z drugimi zdravili s furosemidom ne dokazujejo podobnosti biološke uporabnosti, zlasti z biofarmacevtskim zdravilom razreda IV (nizka topnost, nizka prepustnost).
English: The applicant also argued that dissolution behaviour together with evident pharmaceutical equivalence proves bridging between Furosemide Vitabalans and other authorised furosemide 40mg products.
Slovenian: Predlagatelj je prav tako trdil, da obnašanje pri raztapljanju skupaj z evidentno farmacevtsko enakovrednostjo dokazuje povezavo med zdravilom Furosemide Vitabalans z drugimi zdravili s 40 mg furosemida.
English: An ad-hoc expert meeting was convened on 13 February 2013 at the request of the applicant.
Slovenian: Na zahtevo predlagatelja je bila 13. februarja sklicana adhoc seja strokovnjakov.
English: The applicant's argument that traditional manufacturing methods as well as excipients widely used in tablet formulations would not cause potential lower or higher exposure to furosemide when Furosemide Vitabalans is used (compared to the exposure obtained following administration of other furosemide 40 mg tablets) cannot be considered as sufficient evidence to bridge the applied product and other furosemide described in the literature.
Slovenian: Predlagateljevega argumenta, da tradicionalne metode izdelave in pomožne snovi, ki jih široko uporabljajo v tabletah, ne povzročajo potencialno manjše ali večje izpostavljenosti furosemidu ob uporabi zdravila Furosemide Vitabalans (v primerjavi z izpostavljenostjo, ugotovljeno po dajanju drugih tablet s 40 mg furosemida), ni mogoče upoštevati kot zadostnega dokaza za povezavo zdravila, za katerega je vloga predložena, z drugimi oblikami furosemida, opisanimi v literaturi.
English: Indeed, it cannot be excluded that the formulation of the applied product would behave differently in terms of pharmacokinetics compared to the products containing furosemide included in the submitted literature.
Slovenian: Ni mogoče izključiti, da bi se oblika zdravila, za katerega je vloga predložena, v smislu farmakokinetike obnašala drugače kot zdravila s furosemidom, vključena v predloženo literaturo.
English: The ad-hoc expert group considered that the published literature and the dissolution data provided by the applicant were not sufficient to prove the safety and efficacy of Furosemide Vitabalans.
Slovenian: Ad-hoc skupina strokovnjakov je bila mnenja, da objavljena literatura in podatki o raztapljanju, ki jih je predložil predlagatelj, niso zadostni za dokaz varnosti in učinkovitosti zdravila Furosemide Vitabalans.
English: Additional data would be needed to support the relevance of the bibliographic data to demonstrate the safety and efficacy of Furosemide Vitabalans.
Slovenian: Potrebni bi bili dodatni podatki, da bi lahko predstavili pomen bibliografskih podatkov za prikaz varnosti in učinkovitosti zdravila Furosemide Vitabalans.
English: The dossier submitted by the applicant did not include any in vivo clinical data which could have demonstrated that pharmacokinetic profile of Furosemide Vitabalans is similar to the products containing furosemide included in the submitted literature.
Slovenian: Dokumentacija, ki jo je predložil predlagatelj, ni vključevala kliničnih podatkov in vivo, ki bi lahko prikazali podobnost farmakokinetičnega profila zdravila Furosemide Vitabalans z zdravili s furosemidom, vključenimi v predloženo literaturo.
English: Based only on published literature data, it is not possible to conclude that the pharmacokinetic parameters of Furosemide Vitabalans would be within the same range than other furosemide 40 mg tablets referred to.
Slovenian: Na osnovi podatkov iz objavljene literature ni mogoče sklepati, da bi bili farmakokinetični parametri zdravila Furosemide Vitabalans znotraj enakega območja kot druge omenjene tablete s 40 mg furosemida.
English: To support the efficacy and safety of Furosemide Vitabalans, the applicant only referred to published studies.
Slovenian: V podporo učinkovitosti in varnosti zdravila Furosemide Vitabalans je predlagatelj navedel le objavljene študije.
English: Therefore, the literature data submitted by the applicant to support the safety and efficacy of furosemide did not provide sufficient evidence that the pharmacokinetics of Furosemide Vitabalans allow its safe and effective use in the same dosage and indications applied for.
Slovenian: Zato podatki iz literature, ki jih je predložil predlagatelj v podporo varnosti in učinkovitosti furosemida, niso zagotovili zadostnih dokazov, da farmakokinetika zdravila Furosemide Vitabalans omogoča varno in učinkovito uporabo tega zdravila v odmerkih in indikacijah, za katere predlagatelj vlaga vlogo.
English: The applicant's argument that traditional manufacturing methods as well as excipients widely used are sufficient to demonstrate the bridging between Furosemide Vitabalans and other furosemide products cannot be accepted.
Slovenian: Predlagateljevega argumenta, da tradicionalne metode izdelave in pomožne snovi, ki jih široko uporabljajo, zadostujejo za povezavo zdravila Furosemide Vitabalans z drugimi izdelki s furosemidom, ni mogoče sprejeti.
English: The results of this study showing that Furosemide Vitabalans had a similar dissolution profile as the other furosemide presented were not considered sufficient by the CHMP to demonstrate efficacy and safety of the product applied for.
Slovenian: Rezultatov te študije, ki dokazuje, da je imelo zdravilo Furosemide Vitabalans podoben profil raztapljanja kot druge predstavljene oblike furosemida, odbor CHMP ni upošteval kot zadostnih za prikaz učinkovitosti in varnosti zdravila, za katerega predlagatelj predlaga vlogo za dovoljenje za promet z zdravilom.
English: A referral was thus triggered at the CMD(h) and the applicant was asked to justify that the literature provided in support of this application was applicable to the product applied for and to demonstrate that the potentially lower or higher exposure to furosemide, when Furosemide Vitabalans is used compared to the exposure obtained following administration of the product used in the pivotal clinical studies described in the submitted literature, would not influence efficacy or safety.
Slovenian: Zato je bil sprožen napotitveni postopek pri Usklajevalni skupini za postopek z medsebojnim priznavanjem in decentralizirani postopekzdravila za uporabo v humani medicini CMD(h), predlagatelj pa je bil pozvan k utemeljitvi, da literatura, ki jo je predložil v podporo tej vlogi, velja za zdravilo, za katerega je vloga predložena, in dokaže, da potencialno manjša ali večja izpostavljenost furosemidu ne vpliva na učinkovitost in varnost uporabe zdravila Furosemide Vitabalans v primerjavi z izpostavljenostjo, ugotovljeno po dajanju uporabljenega zdravila v ključnih kliničnih študijah, opisanih v predloženi literaturi.
English: On the basis of the bibliographic data submitted, taken together with additional pharmaceutical documentation, the applicant failed to establish the relevance of these data to demonstrate the safety and efficacy of Furosemide Vitabalans and associated names.
Slovenian: Na podlagi predloženih bibliografskih podatkov skupaj z dodatno farmacevtsko dokumentacijo predlagatelj ni uspešno predstavil pomena teh podatkov za prikaz varnosti in učinkovitosti zdravila Furosemide Vitabalans in povezanih imen.
English: The major concern raised by Poland and Lithuania could not be solved during the CMD(h) referral and the issue was therefore referred to the CHMP.
Slovenian: Ker glavnega zadržka, ki sta ga izpostavili Poljska in Litva, ni bilo mogoče razrešiti v času napotitvenega postopka pri Usklajevalni skupini za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v humani medicini, je bila zadeva napotena na odbor CHMP.
English: The applicant's arguments saying that there is no correlation between the absorbed amount of furosemide and the diuresis, and that controlled-released and immediate-released formulation produce almost as much diuresis, was not considered as sufficient to prove the efficacy of Furosemide Vitabalans.
Slovenian: Predlagateljevi argumenti, v katerih je navedel, da ni povezave med absorbirano količino furosemida in diurezo ter da imata oblika s kontroliranim sproščanjem in oblika s takojšnjim sproščanjem skoraj enako diurezo, niso bili upoštevani kot zadostni za dokaz učinkovitosti zdravila Furosemide Vitabalans.
English: The applicant's arguments that there is no correlation between the absorbed amount of furosemide and the diuresis, and that controlled-released and immediate-released formulation produce almost as much diuresis, were not considered as sufficient by the group to prove the safety and efficacy of Furosemide Vitabalans.
Slovenian: Predlagateljevih argumentov, da ni povezave med absorbirano količino furosemida in diurezo ter da imata oblika s kontroliranim sproščanjem in oblika s takojšnjim sproščanjem skoraj enako diurezo, skupina ni upoštevala kot zadostnih za dokaz o varnosti in učinkovitosti zdravila Furosemide Vitabalans.
English: On the basis of the bibliographic data submitted, taken together with the pharmaceutical data, the applicant failed to establish the relevance of these data to demonstrate safety and efficacy of Furosemide Vitabalans.
Slovenian: Na podlagi predloženih bibliografskih podatkov skupaj s farmacevtskimi podatki predlagatelj ni uspešno predstavil pomena teh podatkov za prikaz varnosti in učinkovitosti zdravila Furosemide Vitabalans.
English: • The provided data do not show that Furosemide Vitabalans is similar to the products described in the submitted literature.
Slovenian: • predloženi podatki ne kažejo na to, da je zdravilo Furosemide Vitabalans podobno zdravilom,
English: A scientifically valid approach such as the demonstration of comparable pharmacokinetics was considered necessary to bridge Furosemide Vitabalans to a similar product.
Slovenian: Za povezavo zdravila Furosemide Vitabalans s podobnimi zdravili je potreben znanstveno veljaven pristop, kot na primer predstavitev primerljive farmakokinetike.
English: • The Committee considered the notification of the referral triggered by Estonia under Article 29(4)
Slovenian: • je Odbor upošteval obvestilo o napotitvenem postopku, ki ga je sprožila Estonija skladno s členom 29(4) Direktive 2001/83/ES ter sta Poljska in Litva presodili, da izdaja dovoljenja za promet predstavlja potencialno resno tveganje za javno zdravje;
English: 360 ELISA Units
Slovenian: 360 ELISA enot
English: 10 micrograms
Slovenian: 10 mikrogramov
English: Hepatitis B surface antigen3,4
Slovenian: Površinski antigen virusa hepatitisa B
English: EMA procedure number
Slovenian: Številka EU
English: 1Produced on human diploid (MRC-5) cells 2Adsorbed on aluminium hydroxide, hydrated
Slovenian: Pridobljen na humanih diploidnih celicah (MRC-5) 2Adsorbiran na hidratirani aluminijev hidroksid
English: Content (concentration)
Slovenian: Pot uporabe Stična Ovojnina Vsebina (koncentracija)
English: 3Produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology 4Adsorbed on aluminium phosphate
Slovenian: Pridobljen s tehnologijo rekombinantne DNA na celični kulturi kvasovk (Saccharomyces cerevisiae) Adsorbiran na aluminijev fosfat
English: 1 dose (0.5 ml): Hepatitis A virus (inactivated)1,2
Slovenian: Virus hepatitisa A (inaktivirani)
English: 1 pre-filled syringe without needle
Slovenian: 1 napolnjena injekcijska brizga brez igle
English: This means it has a long duration of action.
Slovenian: To pomeni, da je njegovo delovanje dolgotrajno.
English: The study in children lasted 16 weeks.
Slovenian: Študije pri otrocih so trajale 16 tednov.
English: All the studies in adults lasted six months, but one was extended to one year.
Slovenian: Vse študije pri odraslih so trajale šest mesecev, eno od njih pa so podaljšali na eno leto.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Ryzodeg on 21 January 2013.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Ryzodeg, veljavno po vsej Evropski uniji, izdala 21. januarja 2013.
English: What measures are being taken to ensure the safe and effective use of Ryzodeg?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Ryzodeg?
English: The full EPAR for Ryzodeg 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 Ryzodeg je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Because the dose requirements in young children may not be stable and because they cannot express symptoms of hypoglycaemia, Ryzodeg is not suitable for children aged under 2 years.
Slovenian: Ker bi lahko bil zahtevani odmerek pri majhnih otrocih nestabilen in ker ne morejo izraziti simptomov hipoglikemije, zdravilo Ryzodeg ni primerno za otroke, mlajše od dveh let.
English: Other information about Ryzodeg
Slovenian: Druge informacije o zdravilu Ryzodeg
English: What benefit has Ryzodeg shown during the studies?
Slovenian: Kakšne koristi je zdravilo Ryzodeg izkazalo med študijami?
English: This is a summary of the European public assessment report (EPAR) for Ryzodeg.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Ryzodeg.
English: The dose of Ryzodeg is determined individually for each patient.
Slovenian: Ustrezen odmerek se določi za vsakega bolnika posebej.
English: For more information about treatment with Ryzodeg, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Ryzodeg preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ryzodeg have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Ryrzodeg upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: Ryzodeg insulin degludec / insulin aspart
Slovenian: Ryzodeg insulin degludek/insulin aspart
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 Ryzodeg.
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: Ryzodeg is injected once or twice a day, at mealtimes.
Slovenian: Zdravilo Ryzodeg se injicira enkrat ali dvakrat na dan ob obrokih.
English: The CHMP decided that Ryzodeg's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: CHMP je zaključil, da so koristi zdravila Ryzodeg večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
English: It is available as a solution for injection in a cartridge (100 units/ml) and in a pre-filled pen (100 units/ml).
Slovenian: Na voljo je kot raztopina za injiciranje v injekcijskem vložku (100 enot/ml) in v napolnjenem injekcijskem peresniku (100 enot/ml).
English: What is the risk associated with Ryzodeg?
Slovenian: Kakšna tveganja so povezana z zdravilom Ryzodeg?
English: The Committee concluded that Ryzodeg is generally safe and its side effects are comparable to those of other insulin analogues.
Slovenian: Odbor je ugotovil, da je zdravilo Ryzodeg na splošno varno in da so njegovi neželeni učinki primerljivi z neželenimi učinki drugih insulinskih analogov.
English: Meanwhile, insulin aspart is absorbed faster by the body than human insulin, and therefore it starts to work as soon as it is injected and has a short duration of action.
Slovenian: Po drugi strani se insulin aspart v telesu hitreje absorbira kot človeški insulin, zato začne delovati takoj ob injiciranju, njegovo delovanje pa je kratkotrajno.
English: The place for injection should be altered with each injection to reduce the risk of developing fatty lumps under the skin that can affect the amount of Ryzodeg absorbed into the blood.
Slovenian: Mesto injiciranja je treba menjati ob vsakem injiciranju, da se zmanjša tveganje za razvoj maščobnih bulic pod kožo, ki lahko vpliva na količino absorbiranega zdravila Ryzodeg.
English: In the study in children, the combined used of Ryzodeg and insulin aspart was at least as effective as insulin detemir and insulin aspart, with average HbA1c reductions of 0.27 and 0.23 percentage points respectively.
Slovenian: V študiji pri otrocih je bila kombinirana uporaba zdravila Ryzodeg in insulina asparta vsaj tako učinkovita kot insuin detemir in insulin aspart, pri tem pa so se ravni HbA1c povprečno znižale za 0,27 oziroma 0,23 odstotne točke.
English: The most frequently reported side effect during treatment with Ryzodeg is hypoglycaemia (low blood glucose levels).
Slovenian: Najpogosteje opisan neželeni učinek med zdravljenjem z zdravilom Ryzodeg je hipoglikemija (nizke ravni glukoze v krvi).
English: Ryzodeg has been studied in one main study involving 548 adults with type 1 diabetes and in four main studies involving 1,866 adults with type 2 diabetes.
Slovenian: Zdravilo Ryzodeg je bilo raziskano v eni glavni študiji, ki je vključevala 548 odraslih s sladkorno boleznijo 1, in v štirih glavnih študijah, ki so vključevale 1 866 odraslih s sladkorno boleznijo tipa 2.
English: All of the studies measured the level of glycosylated haemoglobin (HbA1c), which is the percentage of haemoglobin in the blood attached to glucose.
Slovenian: V vseh študijah so merili raven glikoziliranega hemoglobina (HbA1c) oziroma delež hemoglobina v krvi, vezanega na glukozo.
English: The replacement insulin acts in the same way as natural insulin, and helps glucose from the blood to enter cells.
Slovenian: Nadomestni insulin deluje na enak način kot naravno tvorjeni insulin in pomaga pri prehodu glukoze iz krvi v celice.
English: Why has Ryzodeg been approved?
Slovenian: Zakaj je bilo zdravilo Ryzodeg odobreno?
English: In the studies in type 2 diabetes, Ryzodeg was either given alone or in combination with other antidiabetes medicines.
Slovenian: V študijah pri sladkorni bolezni tipa 2 so zdravilo Ryzodeg dajali samostojno ali v kombinaciji z drugimi antidiabetiki.
English: The differences mean that insulin degludec is absorbed more slowly by the body.
Slovenian: Razlika je v tem, da telo insulin degludek počasneje absorbira.
English: Insulin degludec and insulin aspart are slightly different from human insulin.
Slovenian: Insulin degludek in insulin aspart se nekoliko razlikujeta od človeškega insulina.
English: The active substances in Ryzodeg, insulin degludec and insulin aspart, are produced by a method known as ‘recombinant DNA technology': they are made by a yeast that has received a gene (DNA), which makes the yeast able to produce them.
Slovenian: Zdravilni učinkovini v njem, insulin degludek in insulin aspart, se proizvedeta z metodo, znano kot „tehnologija rekombinantne DNK“: proizvede ju kvasovka, ki prejeme gen (DNK), s katerim lahko tvori te beljakovine.
English: Injecting Ryzodeg at a main meal provides long-acting insulin to control blood sugar until the next dose as well as short-acting insulin to help deal with the extra sugar from the meal.
Slovenian: Injiciranje zdravila Ryzodeg ob glavnem obroku zagotavlja dolgotrajno delovanje insulina za uravnavanje sladkorja v krvi do naslednjega odmerka in hitrodelujoči insulin, ki pomaga obvladovati dodatni sladkor iz obroka.
English: Ryzodeg is used to treat diabetes in adults, adolescents and children from 2 years of age.
Slovenian: Zdravilo Ryzodeg se uporablja za zdravljenje odraslih, mladostnikov in otrok, starejših od dveh let, ki imajo sladkorno bolezen.
English: Ryzodeg is a replacement insulin for the insulin normally made by the body.
Slovenian: Zdravilo Ryzodeg je nadomestni insulin za insulin, ki ga v normalnih pogojih proizvaja telo.
English: The reduction in HbA1c levels (in percentage points) was 0.7 in patients with type 1 diabetes and between 1 and 1.7 across the trials in patients with type 2 diabetes.
Slovenian: Ravni HbA1c so se pri bolnikih s sladkorno boleznijo tipa 1 znižale za 0,7 odstotne točke, pri bolnikih s sladkorno boleznijo tipa 2 pa so se v različnih preskušanjih znižale za od 1 do 1,7 odstotne točke.
English: It is given as an injection under the skin in the abdominal wall (at the front of the waist), upper arm or thigh.
Slovenian: Zdravilo se injicira pod kožo v trebušno steno (sprednji del pasu), nadlaket ali stegno.
English: It also noted that in the studies with adults Ryzodeg reduces the risk of hypoglycaemia during the night in patients with type 1 and type 2diabetes.
Slovenian: Prav tako je upošteval, da je v študijah pri odraslih zdravilo Ryzodeg zmanjšalo tveganje za pojav hipoglikemije ponoči pri bolnikih s sladkorno boleznijo tipa 1 in 2.