FrancophonIA/ELRC3.0 huggingface dataset:
English: In an add-on to insulin study up to 104 weeks, episodes of major hypoglycaemia were reported in 0.5 % and 1.0 % of subjects in dapagliflozin 10 mg plus insulin at Weeks 24 and 104, respectively, and in 0.5 % of subjects treated with placebo plus insulin groups at Weeks 24 and 104.
Slovenian: V študiji dodatka k insulinu do 104 tedne so hude hipoglikemije do 24. oziroma 104. tedna zabeležili pri 0,5 % oziroma 1,0 % prejemnikov kombinacije 10 mg dapagliflozina in insulina ter pri 0,5 % prejemnikov kombinacije placeba in insulina.
English: In subjects ≥ 65 years of age, adverse reactions of volume depletion, most commonly reported as hypotension, were reported in 1.7 % and 0.8 % of dapagliflozin-treated subjects and placebo-treated subjects, respectively (see section 4.4).
Slovenian: Pri preiskovancih, starih 65 let ali več, so neželeni učinek pomanjkanja volumna (najpogosteje opisan kot hipotenzija) zabeležili pri 1,7 % tistih, ki so prejemali dapagliflozin, in pri 0,8 % tistih, ki so prejemali placebo (glejte poglavje 4.4).
English: Reactions related to volume depletion (including, reports of dehydration, hypovolaemia or hypotension) were reported in 1.1 % and 0.7 % of subjects who received dapagliflozin 10 mg and placebo, respectively; serious reactions occurred in < 0.2 % of subjects balanced between dapagliflozin 10 mg and placebo (see section 4.4).
Slovenian: O učinkih, povezanih s pomanjkanjem volumna (vključno z dehidracijo, hipovolemijo ali hipotenzijo) so poročali pri 1,1 % oseb, ki so prejemale 10 mg dapagliflozina, in 0,7 % oseb, ki so prejemale placebo.
English: At Week 104, adjusted mean change from baseline in HbA1c was -0.32 % for dapagliflozin and -0.14 % for glipizide, respectively.
Slovenian: 104. teden je bila korigirana povprečna sprememba HbA1c od izhodišča z dapagliflozinom -0,32 % in z glipizidom -0,14 %.
English: Talc (E553b) Titanium dioxide (E171) Iron oxide yellow (E172) Iron oxide red (E172)
Slovenian: Polivinilalkohol (E1203) Makrogol 3350 (E1520(iii)) Smukec (E553b) Titanov dioksid (E171) Rumeni železov oksid (E172) Rdeči železov oksid (E172)
English: The following adverse reactions have been identified in the placebo-controlled dapagliflozin plus metformin clinical trials, dapagliflozin clinical trials and metformin clinical trials and post-marketing experience.
Slovenian: V s placebom kontroliranih kliničnih preskušanjih kombinacije dapagliflozina in metformina, kliničnih preskušanjih dapagliflozina, kliničnih preskušanjih metformina in med obdobjem po odobritvi dovoljenja za promet so ugotovili naslednje neželene učinke.
English: Fifty percent of subjects were on insulin monotherapy at baseline; 50 % were on 1 or 2 oral glucose-lowering medicinal product(s) in addition to insulin: Of this latter group, 80 % were on metformin alone, 12 % were on metformin plus sulphonylurea therapy, and the rest were on other oral glucose-lowering medicinal products.
Slovenian: Petdeset odstotkov bolnikov je bilo izhodiščno na monoterapiji z insulinom; 50 % jih je poleg insulina jemalo 1 ali 2 peroralna antidiabetika.
English: HbA1c (%) Baseline (mean) Change from baseline Difference from placebo c
Slovenian: HbA1c (%) Izhodišče (povprečje) Sprememba od izhodišča Razlika v primerjavi s placebom
English: Dapagliflozin as an add-on to metformin alone or metformin plus sitagliptin, sulphonylurea or insulin (with or without additional oral glucose-lowering medicinal products, including metformin) resulted in statistically significant body weight reduction up to 24 weeks (p < 0.0001, Tables 3, 4 and 5).
Slovenian: Dapagliflozin kot dodatek metforminu samemu ali metforminu v kombinaciji s sitagliptinom, sulfonilsečnino ali insulinom (z dodatnimi peroralnimi zdravili za znižanje glukoze (vključno z metforminom) ali brez njih) je do 24. tedna statistično značilno znižal telesno maso (p < 0,0001,
English: Lactic acidosis Vitamin B
Slovenian: pomanjkanje volumna b,e žeja diabetična ketoacidoza laktacidoza pomanjkanje vitamina B12
English: In patients with normal renal function or mild renal impairment (baseline eGFR ≥ 60 mL/min/1.73 m2) this grouping of reactions were reported in 1.3 % and 0.8 % of patients who received dapagliflozin 10 mg and placebo, respectively.
Slovenian: Pri bolnikih z normalnim delovanjem ledvic ali blago okvaro ledvic (izhodiščna ocenjena hitrost glomerularne filtracije [eGFR] ≥ 60 ml/min/1,73 m2) je bila ta skupina učinkov opisana pri 1,3 % bolnikov, ki so prejemali 10 mg dapagliflozina, in pri 0,8 % tistih, ki so prejemali placebo.Te reakcije so bile pogostejše pri bolnikih z izhodiščno ocenjeno hitrostjo glomerularne filtracije [eGFR] ≥ 30 in < 60 ml/min/1,73 m2 (18,5 % z 10 mg dapagliflozina in 9,3 % s placebom).
English: Mean daily insulin dose (IU) Baseline (mean) Change from baseline Difference from placebo c
Slovenian: Povprečni dnevni odmerek insulina (i.e.) Izhodišče (povprečje) Sprememba od izhodišča Razlika v primerjavi s placebom
English: In subjects ≥ 65 years of age, a higher proportion of subjects treated with dapagliflozin had adverse reactions related to volume depletion (see section 4.8).
Slovenian: Med preiskovanci, starimi 65 let ali več, je bil delež neželenih učinkov, povezanih s pomanjkanjem volumna, večji med prejemniki dapagliflozina (glejte poglavje 4.8).
English: What Xigduo contains • The active substances are dapagliflozin and metformin hydrochloride (metformin HCl).
Slovenian: • Zdravilni učinkovini sta dapagliflozin in metforminijev klorid.
English: Each Xigduo 5 mg/1,000 mg film-coated tablet (tablet) contains dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin and 1,000 mg metformin hydrochloride.
Slovenian: Ena filmsko obložena tableta (tableta) zdravila Xigduo 5 mg/1000 mg vsebuje dapagliflozinpropandiol monohidrat v količini, ki ustreza 5 mg dapagliflozina, in 1.000 mg metforminijevega klorida.
English: Bone mineral density measurements in patients with normal or mildly impaired renal function did not indicate bone loss over a treatment period of two years.
Slovenian: Opažali so majhna zvišanja koncentracije PTH v serumu; zvišanja so bila večja pri preiskovancih z večjo izhodiščno koncentracijo PTH. Merjenja mineralne gostote kosti pri bolnikih z normalno ali blago okvaro ledvic v dveletnem obdobju zdravljenja niso pokazala izgube kostne mase.
English: a) in an active-controlled study comparing dapagliflozin with glipizide as add-on to metformin
Slovenian: Rezultati z zdravilno učinkovino kontrolirane študije, ki je primerjala dapagliflozin z glipizidom kot dodatkom metforminu po 52 tednih (LOCF
English: a) placebo-controlled studies up to 24 weeks of dapagliflozin in add-on combination with metformin or metformin plus sitagliptin Add-on combination
Slovenian: Rezultati s placebom kontrolirane študije dapagliflozina kot dodatek metforminu samemu ali metforminu v kombinaciji s sitagliptinom po 24 tednih (LOCF
English: Urticaria Erythema Pruritus
Slovenian: *,f nikturija okvara ledvic
English: The maximum daily dose is 3000 mg metformin and should preferably be divided into 2 - 3 daily doses.
Slovenian: Zaželeno ga je razdeliti na 2 - 3 dnevne odmerke.
English: Cardiac failure
Slovenian: • mišične krče
English: Mean percent change from baseline for dapagliflozin 10 mg versus placebo, respectively, was: total cholesterol 2.5 % versus 0.0 %; HDL cholesterol 6.0 % versus 2.7 %; LDL cholesterol 2.9 % versus -1.0 %; triglycerides2.7 % versus -0.7 %.
Slovenian: Povprečni odstotek spremembe od izhodišča za 10 mg dapagliflozina v primerjavi s placebom je bil: celotni holesterol 2,5 % v prim.
English: Blood creatinine increased
Slovenian: Povečanje hematokrita
English: At Weeks 24, HbA1c change from baseline in subjects treated with dapagliflozin plus insulin with metformin was -0.93 %.
Slovenian: Po 24 tednih se je HbA1c pri preiskovancih, zdravljenih z dapagliflozinom v kombinaciji z insulinom in metforminom, v primerjavi z izhodiščem spremenil za
English: Change from baseline Difference from glipizide + metformin c
Slovenian: Izhodišče (povprečje) Sprememba od izhodišča Razlika v primerjavi s kombinacijo glipizid + metformin
English: Skin and subcutaneous tissue disorders
Slovenian: Bolezni jeter, žolčnika in žolčevodov motnje delovanja jeter hepatitis
English: For patients inadequately controlled on metformin monotherapy or metformin in combination with other glucose-lowering medicinal products including insulin The recommended dose is one tablet twice daily.
Slovenian: Bolniki, ki niso zadostno urejeni z metforminom v monoterapiji ali metforminom v kombinaciji z drugimi antidiabetiki, vključno z insulinom
English: OTHER
Slovenian: Redki
English: Baseline (mean) Change from Baseline Difference from Placebo c
Slovenian: Izhodišče (povprečje) Sprememba od izhodišča Razlika v primerjavi s placebom
English: The Committee retained its other concerns.
Slovenian: Ohranil pa je druge zadržke.
English: International non-proprietary name (INN): idebenone
Slovenian: Mednarodno nelastniško ime (INN): idebenon
English: It was to be available as tablets (150 mg).
Slovenian: Na voljo naj bi bilo v tabletah (150 mg).
English: It is usually fatal in adulthood.
Slovenian: V odrasli dobi je bolezen ponavadi smrtna.
English: The effectiveness of Sovrima was studied in one main study involving 48 patients.
Slovenian: Učinkovitost zdravila Sovrima je bila ocenjena v eni glavni študiji, ki je vključevala 48 bolnikov.
English: However, during the re-examination of the opinion, the intended use of the medicine was restricted to children only.
Slovenian: Vendar je bilo med ponovnim pregledom mnenja zdravilo namenjeno le za uporabo pri otrocih.
English: Questions and answers on recommendation for the refusal of the marketing authorisation for Sovrima
Slovenian: Vprašanja in odgovori v zvezi s priporočilom za zavrnitev vloge za dovoljenje za promet z zdravilom Sovrima
English: In the initial application, it was intended for use in children and young adults, as well as in adults whose disease had been diagnosed within the past five years and in adults with cardiomyopathy (harm to the heart muscle).
Slovenian: V prvotni vlogi je bilo namenjeno za uporabo pri otrocih in mladih odraslih kot tudi pri odraslih, pri katerih je bila bolezen ugotovljena v preteklih petih letih, ter pri odraslih z kardiomiopatijo (poškodbami srčne mišice).
English: Ref. EMEA/614926/2008
Slovenian: : EMEA/421324/2009 Error!
English: After having considered the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 20 November 2008.
Slovenian: Po proučitvi podlage za to zahtevo je CHMP ponovno pregledal prvotno mnenje in dne 20. novembra 2008 potrdil zavrnitev vloge za dovoljenje za promet.
English: There are no consequences on the use of idebenone in its existing indications, for which the balance of benefits and risks remains unchanged.
Slovenian: Umik nima nobenih posledic za uporabo zdravila idebenon za odobreno indikacijo, pri kateri ostaja razmerje med koristmi in tveganji nespremenjeno.
English: Frataxin plays a role in building the energy-producing parts of cells.
Slovenian: Frataksin pomaga pri tvorbi delov celic, ki proizvajajo energijo.
English: The active substance in Sovrima, idebenone, has been available in some countries in Europe since the 1990s for cognitive disorders (problems with thinking, learning and memory) and for Alzheimer's disease.
Slovenian: Zdravilna učinkovina zdravila Sovrima idebenon je na voljo v nekaterih evropskih državah od leta 1990 za zdravljenje kognitivnih motenj (težave z razmišljanjem, učenjem in spominom) in Alzheimerjeve bolezni.
English: These highly reactive forms of oxygen damage cells in the brain, the spinal cord and nerves, as well as in the heart and pancreas, causing the symptoms of the disease.
Slovenian: Te visoko reaktivne oblike kisika poškodujejo celice v možganih, hrbtenjači in živcih ter v srcu in trebušni slinavki, kar povzroča simptome te bolezni.
English: The company that applied for authorisation is Santhera Pharmaceuticals (Deutschland) GmbH.
Slovenian: Vlogo za dovoljenje je predložila družba Santhera Pharmaceuticals (Deutschland) GmbH.
English: In addition, the supporting information from the scientific literature was weak and did not demonstrate a consistent clinical benefit of Sovrima for this disease.
Slovenian: Poleg tega so bili podatki iz znanstvene literature, ki podpirajo študijo, šibki in niso dokazali stalne klinične koristi zdravila Sovrima za to bolezen.
English: It has a range of symptoms that gradually get worse, including difficulty walking, an inability to co-ordinate movements, muscle weakness, speech problems, damage to the heart muscle, and diabetes.
Slovenian: Zanjo je značilna vrsta simptomov, ki postopoma napredujejo, vključno s težavami pri hoji, nesposobnostjo usklajevanja gibov, šibkostjo mišic, govornimi težavami, poškodbami srčne mišice in sladkorno boleznijo.
English: The effects of Sovrima were first tested in experimental models before being studied in humans.
Slovenian: Učinki zdravila Sovrima so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
English: The CHMP noted that it would be useful to have more information on the effects of Sovrima on preventing heart disease getting worse in children.
Slovenian: CHMP je navedel, da bi bilo koristno imeti več informacij o učinkih zdravila Sovrima pri preprečevanju slabšanja bolezni srca pri otrocih.
English: The main measure of effectiveness was the change in the level of a substance in the blood called deoxyguanosine, which is a marker of cell damage caused by highly reactive forms of oxygen.
Slovenian: Glavno merilo učinkovitosti je bila sprememba koncentracije snovi v krvi, imenovane deoksigvanozin, ki je označevalec poškodb celic, ki jih povzročajo visoko reaktivne oblike kisika.
English: In July 2008, the CHMP was concerned that the effectiveness of Sovrima had not been demonstrated in the single study performed.
Slovenian: Julija 2008 je CHMP izrazil zaskrbljenost, da učinkovitost zdravila Sovrima z eno samo opravljeno študijo ni bila dokazana.
English: On 24 July 2008, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Sovrima 150 mg tablets, intended for the treatment of Friedreich's ataxia.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je v svojem negativnem mnenju z dne 24. julija 2008 priporočil zavrnitev vloge za dovoljenje za promet z zdravilom Sovrima, 150 mg tablete, namenjenim za zdravljenje Friedreichove ataksije.
English: Sovrima is a medicine that contains the active substance idebenone.
Slovenian: Sovrima je zdravilo, ki vsebuje zdravilno učinkovino idebenon.
English: What are the consequences of the refusal for patients in clinical trials or compassionate use programmes using Sovrima?
Slovenian: Kakšne so posledice zavrnitve za bolnike, ki sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila Sovrima?
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials.
Slovenian: Družba je obvestila CHMP, da umik nima nobenih posledic za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih.
English: It is expected to work by enhancing the production of energy within cells and possibly by neutralising the highly reactive forms of oxygen.
Slovenian: Delovalo naj bi s povečanjem tvorbe energije v celicah ter po možnosti z nevtraliziranjem visoko reaktivnih oblik kisika.
English: When frataxin is missing, the production of energy is severely impaired and highly reactive and toxic forms of oxygen are produced.
Slovenian: Ob pomanjkanju frataksina je tvorba energije resno okrnjena, nastajajo pa visoko reaktivne in toksične oblike kisika.
English: This was expected to protect cells from damage and to reduce the symptoms of Friedreich's ataxia.
Slovenian: To naj bi zaščitilo celice pred poškodbami in ublažilo simptome Fridreichove ataksije.
English: Friedreich's ataxia is an inherited disease.
Slovenian: Friedreichova ataksija je dedna bolezen.
English: What is happening with idebenone for cognitive disorders and Alzheimer's disease?
Slovenian: Kakšne so posledice za zdravilo idebenon za zdravljenje kognitivnih motenj in Alzheimerjeve bolezni?
English: The study looked also at the effectiveness of Sovrima in controlling movements, as measured on standard scales for ataxia symptoms, at its impact on daily activities as measured using a questionnaire, and at its effect on heart function.
Slovenian: V študiji so proučevali tudi učinkovitost zdravila Sovrima pri nadzoru gibov, ki je bila merjena s standardnimi lestvicami za simptome ataksije, vplive na vsakodnevne aktivnosti, ki so bili merjeni z vprašalnikom, in njegove vplive na delovanje srca.
English: Patients with Friedreich's ataxia do not have enough of a protein called frataxin.
Slovenian: Bolnikom s Friedreichovo ataksijo primanjkuje beljakovine, imenovane frataksin.
English: What is Sovrima?
Slovenian: Kaj je zdravilo Sovrima?
English: The CHMP also had concerns that there was no clear explanation for the fact that the intermediate dose of Sovrima seemed to be more effective than the higher dose.
Slovenian: CHMP je imel zadržke tudi zaradi pomanjkanja jasne razlage dejstva, da se je zdel srednji odmerek zdravila Sovrima učinkovitejši od višjega odmerka.
English: Sovrima did not show a significant improvement compared with placebo, with respect to the main measure of effectiveness, as well as to other evaluated parameters.
Slovenian: V primerjavi s placebom pri zdravljenju z zdravilom Sovrima ni bilo bistvenih izboljšanj niti pri merilu učinkovitosti niti pri drugih ocenjevanih parametrih.
English: In addition, the CHMP was concerned that the information provided by the company did not show that Sovrima was more effective in children than in the wider group of patients initially proposed.
Slovenian: Poleg tega je bil zaskrbljen, da podatki, ki jih je priskrbela družba, niso potrdili, da je zdravilo Sovrima bolj učinkovito pri otrocih kot pa pri širši skupini bolnikov, kot je bilo prvotno predlagano.
English: In November 2008, following the re-examination, the CHMP removed its concern over the intermediate dose of Sovrima.
Slovenian: Novembra 2008 je CHMP po ponovni proučitvi umaknil zadržke glede srednjega odmerka zdravila Sovrima.
English: Sovrima was designated as an orphan medicinal product on 8 March 2004 for Friedreich's ataxia.
Slovenian: Zdravilo Sovrima je bilo dne 8. marca 2004 določeno kot zdravilo sirota za zdravljenje Friedreichove ataksije.
English: The company also informed the CHMP that there are no consequences for the named patient programmes or compassionate use programmes with Sovrima.
Slovenian: Družba je CHMP obvestila tudi, da umik nima posledic za programe posamezno imenovanih bolnikov ali programe sočutne uporabe zdravila Sovrima.
English: The study compared the effectiveness of three different doses of Sovrima (5, 15 and 40 mg per kilogram body weight) with that of placebo (a dummy treatment) over six months.
Slovenian: V študiji so primerjali učinkovitost treh različnih odmerkov zdravila Sovrima (5, 15 in 40 mg na
English: Therefore, at that point in time, the CHMP was of the opinion that the benefits of Sovrima in the treatment of Friedreich's ataxia did not outweigh its risks.
Slovenian: CHMP je takrat menil, da koristi zdravila Sovrima pri zdravljenju Friedreichove ataksije ne odtehtajo z njim povezanih tveganj.
English: The active substance in Sovrima, idebenone, is an antioxidant agent.
Slovenian: Zdravilna učinkovina zdravila Sovrima idebenon je antioksidant.
English: What was Sovrima expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Sovrima uporabljalo?
English: Sovrima was expected to be used to treat Friedreich's ataxia.
Slovenian: Zdravilo Sovrima naj bi se uporabljalo za zdravljenje Friedreichove ataksije.
English: How is Sovrima expected to work?
Slovenian: Kako naj bi zdravilo Sovrima delovalo?
English: Hence, the CHMP recommended that Sovrima be refused marketing authorisation.
Slovenian: Zato je priporočil zavrnitev dovoljenja za promet z zdravilom Sovrima.
English: If protection against Rabies is required:
Slovenian: Če je potrebna zaščita pred steklino:
English: ATC vet code: QI07AI02.
Slovenian: Oznaka ATC vet: QI07AI02.
English: EU/2/14/164/002
Slovenian: EU/2/14/0164/001 EU/2/14/0164/002
English: VIAL (1 ML SUSPENSION)
Slovenian: VIALA (1 ML SUSPENZIJA)
English: Date of last renewal: 08/04/2019.
Slovenian: Datum zadnjega podaljšanja dovoljenja za promet: 08/04/2019.
English: The duration of immunity against CAV-2 was not established by challenge.
Slovenian: Trajanje imunosti proti CAV-2 ni bilo določeno s preizkusom.
English: * Tissue culture infectious dose 50%.
Slovenian: * 50 % infektivnega odmerka za tkivno kulturo.
English: Protective immune response against CAV-2 associated respiratory disease is considered to last at least 3 years.
Slovenian: Imunski odziv za zaščito proti CAV-2 pridruženi bolezni dihal naj bi trajal vsaj 3 leta.
English: Pharmacotherapeutic group: Immunologicals for canidae, live viral and inactivated bacterial vaccines.
Slovenian: Farmakoterapevtska skupina: Imunološka zdravila za pse (canidae) - živa virusna in inaktivirana bakterijska cepiva.
English: Suspension: whitish colour with fine sediment.
Slovenian: Suspenzija: belkasto obarvana s finim sedimentom.
English: However, in field studies 10% of sero-negative dogs did not show seroconversion (>0.1 IU/ml) 3-4 weeks after single primary vaccination against rabies.
Slovenian: Študije na terenu so pokazale, da pri 10 % serološko negativnih psov ne pride do serološke konverzije (> 0,1 i.e./ml) 3-4 tedne po enkratnem cepljenju proti steklini.
English: However, in a minority of animals pain was observed at the injection site immediately after administration of a 10-fold overdose of the vaccine.
Slovenian: Pri manjšem številu živali so opazili bolečino na mestu injiciranja takoj po dajanju 10- krat prevelikega odmerka cepiva.
English: Annual re-vaccination is required for Parainfluenza and Leptospira components, therefore a single dose of compatible vaccine Versican Plus Pi/L4 can be used annually as required.
Slovenian: Vsako leto je treba ponoviti cepljenje proti virusu parainfluence in komponentam Leptospire, za kar se lahko letno uporabi enkratni odmerek kompatibilnega cepiva Versican Plus Pi/L4.
English: EXPIRY DATE EXP {month/year}
Slovenian: EXP { mesec/leto }
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 07/05/2014.
Slovenian: Datum pridobitve dovoljenja za promet: 07/05/2014.
English: 1.8-2.2 mg. For the full list of excipients, see section 6.1.
Slovenian: Za celoten seznam pomožnih snovi, glejte poglavje 6.1.
English: Clinical signs of immune-mediated diseases, such as haemolytic anaemia, thrombocytopenia or polyarthritis have been reported in very rare cases.
Slovenian: Klinični znaki imunsko pogojenih bolezni kot so hemolitična anemija, trombocitopenija ali poliartritis so bili opaženi v zelo redkih primerih.
English: In case of need, dogs younger than 8 weeks can be vaccinated as safety of Versican Plus DHPPi/L4R has been demonstrated in 6 weeks old dogs.
Slovenian: Če je potrebno, lahko cepimo pse, mlajše od 8 tednov, saj je bila varnost cepiva Versican Plus DHPPi/L4R dokazana pri psih, starih 6 tednov.