FrancophonIA/ELRC3.0 huggingface dataset:
English: In addition, performing ECG or measurements of potassium or magnesium levels is neither considered proportionate in pre-treatment screening for a medicinal product solely used to treat benign symptoms of generally self-limiting conditions, nor feasible in clinical practice.
Slovenian: Poleg tega pri presejanju pred zdravljenjem z zdravilom, uporabljanim izključno za zdravljenje benignih simptomov stanj, ki so običajno samoomejujoča, izvedba EKG ali meritev ravni kalija ali magnezija ne velja za sorazmerno in tudi ne za izvedljivo v klinični praksi.
English: Further, the PRAC could not identify condition(s) which if fulfilled would demonstrate a positive benefitrisk balance for these products in a defined patient population.
Slovenian: Odbor tudi ni mogel določiti pogojev, ki bi ob izpolnitvi pri opredeljeni populaciji bolnikov dokazali pozitivno razmerje med tveganji in koristmi teh zdravil.
English: The PRAC noted that this conclusion was also reached by the MAH of the originator.
Slovenian: Navedel je, da je enako sklenil tudi imetnik dovoljenja za promet z zdravilom originatorja.
English: QT/QTc interval prolongation was not accompanied by any events of arrhythmia or contracture on the guinea pig heart model at any assay concentration.
Slovenian: Na modelu srca morskega prašička pri nobeni koncentraciji testa med podaljšanjem intervala QT/QTc ni bilo dogodkov aritmije ali kontrakture.
English: The marketing authorisation was renewed on 20 September 2001 and on 20 September 2006.
Slovenian: Dovoljenje za promet je bilo podaljšano 20. septembra 2001 in 20. septembra 2006.
English: The antibodies will help to protect against diseases caused by these viruses.
Slovenian: Protitelesa bodo pomagala ščititi proti boleznim, ki jih povzročata ta virusa.
English: This means that the viruses and surface antigens are fixed onto aluminium compounds, to stimulate a better response.
Slovenian: To pomeni, da so virusi in površinski antigeni vezani na aluminijeve spojine, da bi spodbudili boljši odziv.
English: In these cases, a fourth injection is recommended 12 months after the first dose.
Slovenian: V teh primerih je priporočena tudi četrta injekcijska brizga, 12 mesecev po prvem odmerku.
English: It should never be injected into a vein.
Slovenian: Zdravilo se ne sme nikoli injicirati v veno.
English: If exposed to the viruses in the future, the immune system will be able to make antibodies more quickly.
Slovenian: V primeru izpostavljenosti virusu v prihodnosti bo imunski sistem sposoben hitreje tvoriti protitelesa.
English: The additional studies showed that the presence of antibodies was maintained for up to five years.
Slovenian: Dodatne študije so pokazale, da ostanejo protitelesa v telesu prisotna do pet let.
English: Twinrix Adult has been studied in three main studies involving 843 healthy people aged between 18 and 60 years, most of whom were under 40 years of age.
Slovenian: Zdravilo Twinrix Adult so raziskovali v treh glavnih študijah, ki so vključevale 843 zdravih ljudi, starih med 18 in 60 let, od katerih jih je bila večina mlajših od 40 let.
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against a disease.
Slovenian: Cepiva delujejo tako, da imunski sistem (naravne obrambne mehanizme telesa) „učijo“, kako naj se brani proti bolezni.
English: It is used in adults and adolescents from 16 years of age who are not already immune to these two diseases and who are at risk of contracting both of them.
Slovenian: Uporablja se pri odraslih in mladostnikih, starih 16 let in več, ki še niso imuni na ta dva virusa in pri katerih obstaja tveganje, da se okužijo z obema.
English: The vaccine is injected into the muscle of the upper arm.
Slovenian: Cepivo se injicira v mišico nadlakti.
English: The three-week vaccination schedule also led to the production of antibodies in around 83% of patients, rising to around 89% after the booster dose at month 12.
Slovenian: Tri tedne trajajoče cepljenje je prav tako privedlo do tvorjenja protiteles pri približno 83 % bolnikov, ta delež pa se je po poživitvenem odmerku v 12. mesecu povzpel na približno 89 %.
English: Further studies looked at the persistence of antibodies after vaccination in adults and adolescents, and at the schedule for vaccinating adults over three weeks when rapid protection is required.
Slovenian: V drugih študijah so opazovali čas prisotnosti protiteles po cepljenju odraslih in mladostnikov in shemo cepljenja odraslih v času treh tednov, kadar je potrebna hitra zaščita.
English: The main measure of effectiveness was the proportion of the people who had developed antibodies against hepatitis A and B.
Slovenian: Glavno merilo učinkovitosti je bil delež ljudi, pri katerih so se razvila protitelesa proti virusu hepatitisa A in B.
English: Each person received Twinrix Adult doses at months 0, 1 and 6.
Slovenian: Vse osebe so odmerek zdravila Twinrix Adult prejele v 0., 1. in 6. mesecu.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) TWINRIX ADULT EPAR summary for the public
Slovenian: EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) TWINRIX ADULT Povzetek EPAR za javnost
English: It is recommended that individuals who receive the first dose should complete all doses of Twinrix Adult.
Slovenian: Priporočeno je, da posamezniki, ki prejmejo prvi odmerek, prejmejo vse odmerke zdravila Twinrix Adult.
English: The recommended vaccination schedule for Twinrix Adult is three doses, with a gap of one month between the first two doses and a gap of five months between the second and third.
Slovenian: Priporočena shema cepljenja z zdravilom Twinrix Adult vključuje tri odmerke, dane v presledku enega meseca med prvima dvema odmerkoma in presledku petih mesecev med drugim in tretjim odmerkom.
English: For hepatitis B, antibodies were detected in 71% of adults after the first dose, 97% after the second dose and 99.7% after the third dose.
Slovenian: Protitelesa proti hepatitisu B so opazili pri 71 % odraslih po prvem odmerku, pri 97 % po drugem odmerku in pri 99,7 % po tretjem odmerku.
English: The surface antigens of the hepatitis B virus are produced by a method known as ‘recombinant DNA technology': they are made by a yeast that has received a gene (DNA), which makes it able to produce the proteins.
Slovenian: Površinski antigeni virusa hepatitisa B se izdelujejo z metodo, ki se imenuje „tehnologija rekombinantne DNA“: proizvajajo jih kvasovke, ki so prejele gen (DNA), zaradi katerega lahko tvorijo beljakovine.
English: It should also not be used in people who have had an allergic reaction after being given hepatitis A or hepatitis B vaccines.
Slovenian: Zdravila prav tako ne smejo uporabljati ljudje, ki so imeli po prejetju cepiva proti hepatitisu A ali hepatitisu B alergično reakcijo.
English: Twinrix Adult should be postponed in patients with a severe sudden fever.
Slovenian: Dajanje zdravila Twinrix Adult je treba pri bolnikih s hudo nenadno vročino odložiti na pozneje.
English: The European Commission granted a marketing authorisation valid throughout the EU to GlaxoSmithKline Biologicals s.a. for Twinrix Adult on 20 September 1996.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Twinrix Adult, veljavno po vsej Evropski uniji, odobrila družbi GlaxoSmithKline Biologicals s.a. dne 20. septembra 1996.
English: Twinrix Adult is a vaccine, which is available as a suspension for injection.
Slovenian: Zdravilo Twinrix Adult je cepivo, ki je na voljo v obliki suspenzije za injiciranje.
English: Other information about Twinrix Adult:
Slovenian: Druge informacije o zdravilu Twinrix Adult:
English: The most common side effects with Twinrix Adult (seen in more than 1 in 10 doses of the vaccine) are headache, pain and redness at the injection site, and fatigue (tiredness).
Slovenian: Najpogostejši neželeni učinki, ki so povezani z zdravilom Twinrix Adult (opaženi pri več kot enem od 10 odmerkov cepiva) so glavobol, bolečina in rdečina na mestu injiciranja ter utrujenost.
English: The studies showed that for hepatitis A, antibodies were detected in 94% of adults after the first dose, 99.5% after the second dose and 100% after the third dose.
Slovenian: Študije so pokazale, da so protitelesa proti hepatitisu A opazili pri 94 % odraslih po prvem odmerku, pri 99,5 % po drugem odmerku in pri 100 % po tretjem odmerku.
English: Twinrix Adult should not be used in people who may be hypersensitive (allergic) to any of the active substances, to any of the other ingredients or to neomycin (an antibiotic).
Slovenian: Zdravilo Twinrix Adult ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) katero koli od zdravilnih učinkovin, katero koli od drugih sestavin zdravila ali neomicin (antibiotik).
English: In exceptional cases, the three injections can be given over three weeks for adults needing rapid protection before travelling.
Slovenian: V izjemnih primerih se lahko pri odraslih, ki potrebujejo hitro zaščito zaradi potovanja, tri injekcijske brizge injicirajo v obdobju treh tednov.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Twinrix Adult's benefits are greater than its risks for use in non-immune adults and adolescents of 16 years of age and above who are at risk of both hepatitis A and hepatitis B infection.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila Twinrix Adult pri uporabi pri neimunih odraslih in mladostnikih, starih 16 let ali več, pri katerih obstaja tveganje okužbe s hepatitisom A in hepatitisom B, večje od z njim povezanih tveganj.
English: The active substances in Twinrix Adult have been available in the European Union (EU) for a number of years in separate vaccines: Havrix Adult for protection against hepatitis A and Engerix-B for protection against hepatitis B.
Slovenian: Zdravilne učinkovine cepiva Twinrix Adult so v Evropski uniji (EU) na voljo že mnoga leta kot samostojna cepiva: Havrix Adult za zaščito proti virusu hepatitisa A in Engerix-B za zaščito proti virusu hepatitisa B.
English: Twinrix Adult is a vaccine.
Slovenian: Zdravilo Twinrix Adult je cepivo.
English: Twinrix Adult is used to protect against hepatitis A and hepatitis B infection (diseases that affect the liver).
Slovenian: Zdravilo Twinrix Adult se uporablja za zaščito pred okužbo z virusom hepatitisa A in hepatitisa B (bolezni, ki vplivata na jetra).
English: For the full list of all side effects reported with Twinrix Adult, see the Package Leaflet.
Slovenian: Za celoten opis neželenih učinkov, o katerih so poročali pri uporabi zdravila Twinrix Adult, glejte Navodilo za uporabo.
English: A booster dose of Twinrix Adult, or of a separate hepatitis A or B vaccine may be given, according to official recommendations.
Slovenian: Poživitveni odmerek zdravila Twinrix Adult ali ločenega cepiva proti virusu hepatitisa A ali B lahko zdravnik da skladno z uradnimi priporočili.
English: What benefit has Twinrix Adult shown during the studies?
Slovenian: Kakšne koristi je zdravilo Twinrix Adult izkazalo med študijami?
English: The Committee recommended that Twinrix Adult be given marketing authorisation.
Slovenian: Odbor je priporočil odobritev dovoljenja za promet z zdravilom Twinrix Adult.
English: What is the risk associated with Twinrix Adult?
Slovenian: Kakšna tveganja so povezana z zdravilom Twinrix Adult?
English: Why has Twinrix Adult been approved?
Slovenian: Zakaj je bilo zdravilo Twinrix Adult odobreno?
English: The full EPAR for Twinrix Adult can be found here.
Slovenian: Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Twinrix Adult je na voljo tukaj.
English: Twinrix Adult contains small amounts of inactivated hepatitis A viruses and the ‘surface antigen' (proteins from the surface) of the hepatitis B virus.
Slovenian: Zdravilo Twinrix Adult vsebuje majhne količine inaktiviranih virusov hepatitisa A in „površinskih antigenov“ (beljakovin iz površine) virusa hepatitisa B. Kadar oseba prejme cepivo, imunski sistem prepozna viruse in površinske antigene kot „tuje“ ter začne proti njim tvoriti protitelesa.
English: It contains inactivated (killed) hepatitis A viruses and parts of the hepatitis B virus as active substances.
Slovenian: Zdravilo kot zdravilno učinkovino vsebuje inaktivirane (mrtve) viruse hepatitisa A in dele virusa hepatitisa B. Na voljo je v obliki 1 ml vial in 1 ml napolnjenih injekcijskih brizg.
English: How has Twinrix Adult been studied?
Slovenian: Kako je bilo zdravilo Twinrix Adult raziskano?
English: What is Twinrix Adult?
Slovenian: Kaj je zdravilo Twinrix Adult?
English: What is Twinrix Adult used for?
Slovenian: Za kaj se zdravilo Twinrix Adult uporablja?
English: How is Twinrix Adult used?
Slovenian: Kako se zdravilo Twinrix Adult uporablja?
English: How does Twinrix Adult work?
Slovenian: Kako zdravilo Twinrix Adult deluje?
English: The application was submitted in the concerned member state (UK) under the mutual recognition procedure.
Slovenian: Vloga je bila predložena v zadevni državi članici (Združeno kraljestvo) v skladu s postopkom medsebojnega priznavanja.
English: Canazole clotrimazole cream was authorised in Ireland on 8 December 2000 under Article 4.8 (a) (iii) of Directive 65/65/EEC.
Slovenian: Zdravilo Canazole klotrimazol krema je bilo odobreno na Irskem dne 8. decembra 2000 v skladu s členom 4.8(a)(iii) Direktive 65/65/EGS.
English: The totality of data submitted does not support the conclusion that the product is therapeutically equivalent.
Slovenian: Skupni predloženi podatki ne utemeljujejo zaključka, da je zdravilo terapevtsko enakovredno.
English: Differences in droplets size and their possible effect in tissue penetration were not explained.
Slovenian: Razlike v velikosti kapljic in njihov možni učinek na prodiranje v tkivo niso bili pojasnjeni.
English: In addition, the CHMP considered that the preservative efficacy test lacked the methodological details which would allow a correct interpretation.
Slovenian: CHMP je prav tako menil, da test učinkovitosti konzervansa ni vseboval metodoloških podrobnosti, ki bi omogočile pravilno razlago.
English: Key pharmaceutical parameters, such as the dissolution of drug substance in the oily phase were not appropriately validated.
Slovenian: Glavni farmacevtski parametri, kot je raztapljanje zdravilne učinkovine v oljni fazi, niso bili ustrezno preverjeni.
English: Comparative in vitro microbial tests to investigate the antimicrobial nature of the drug product were not provided.
Slovenian: Primerjalni mikrobiološki testi in vitro za proučitev antimikrobnih lastnosti zdravila niso bili predloženi.
English: It was not possible to discuss variability between and within batches of the test and reference products as information on the necessary batches of each product was not provided.
Slovenian: Razprava o variabilnosti med posameznimi serijami testnega in referenčnega zdravila ter znotraj njih ni bila možna, saj podatki o potrebnih serijah posameznega zdravila niso bili predloženi.
English: Canazole Clotrimazole Cream 1% w/w is an anti-fungal agent indicated for the treatment of superficial fungal skin and mucous membrane infections, such as candidiasis, dermatophytoses and commensal yeast infections.
Slovenian: Zdravilo Canazole klotrimazol krema 1 % m/m je zdravilo proti glivicam, namenjeno zdravljenju glivičnih okužb površinske kože in sluznice, kot so kandidiaza, dermatofitoza in okužba s komenzalnimi kvasovkami.
English: The comparative quality data provided and the preservative efficacy test were, therefore, not considered sufficient to justify a waiver of the need to demonstrate therapeutic equivalence by clinical studies or other validated model, and these were therefore deemed necessary in this case to prove equivalence.
Slovenian: Predloženi primerjalni podatki o kakovosti in test učinkovitosti konzervansa tako niso zadostovali za utemeljitev opustitve potrebe po kliničnih študijah ali drugih validiranih modelih za dokaz terapevtske enakovrednosti, zato se je štelo, da so v tem primeru potrebni za dokaz enakovrednosti.
English: At the time of the initial authorisation, the need for therapeutic equivalence studies was waived based on quality data demonstrating that the proposed formulation was similar to the reference product with respect to formulation (except the benzyl alcohol concentration), pH and viscosity of the cream, globule size of the dispersed oil phase and size of the active substance present as particles.
Slovenian: V času prvotne odobritve je bila na podlagi podatkov o kakovosti, ki so dokazovali, da je predlagana formulacija referenčnemu zdravilu podobna glede formulacije (razen koncentracije benzilalkohola), vrednosti pH in viskoznosti kreme, velikosti globul v fazi razpršenega olja in velikosti zdravilne učinkovine, prisotne v obliki delcev, potreba po študijah terapevtske enakovrednosti opuščena.
English: The CHMP noted that inconsistent data were provided regarding the state of the drug substance in the drug product and critical quality attributes were not satisfactorily addressed.
Slovenian: CHMP je menil, da so bili predloženi podatki o stanju zdravilne učinkovine v zdravilu neskladni, kritične kakovostne lastnosti pa niso bile ustrezno obravnavane.
English: The CHMP considered the comparative quality data and a preservative efficacy test (in vitro) to demonstrate comparable anti-fungal activity provided.
Slovenian: CHMP je menil, da primerjalni podatki o kakovosti in test učinkovitosti konzervansa (in vitro) kažejo primerljivo delovanje proti glivicam.
English: However, the need for a therapeutic equivalence study or other validated model for the formulation to prove equivalence was considered essential by the concerned member state and the matter was referred to the CHMP.
Slovenian: Vendar je zadevna država članica menila, da je za potrditev enakovrednosti formulacije treba predložiti študijo terapevtske enakovrednosti ali druge validirane modele, zato je zadevo napotila na CHMP.
English: An appropriate skin permeation or similar in vitro studies should have been performed to investigate this matter.
Slovenian: Za podrobnejšo proučitev tega vprašanja bi morale biti izvedene ustrezne študije kožne prepustnosti ali podobne študije in vitro.
English: The proposals are acceptable with some improvements.
Slovenian: Predlogi so sprejemljivi z nekaj popravki.
English: The Rapporteurs are of the opinion that amended wording, the lower age limit of 55 years, is recommended.
Slovenian: Poročevalci menijo, da je uporaba spremenjenega besedila, nižja starostna meja 55 let, priporočena.
English: Placebo relative risk (95% confidence interval)
Slovenian: Placebo Relativno tveganje (95 % interval zaupanja)
English: However the effect of multiple doses is not known.
Slovenian: Toda učinek večkratnih odmerkov ni znan.
English: • Sexual inability in men, reduced sexual desire in men or women
Slovenian: • impotenca pri moških, zmanjšano spolno poželenje pri moških ali ženskah
English: Both subpopulations were prospectively stratified.
Slovenian: Obe podpopulaciji sta bili prospektivno stratificirani.
English: There are differences, however, in the results obtained from various trials (HOPE, EUROPA, PEACE, and PART 2).
Slovenian: Vendar pa v rezultatih, pridobljenih iz različnih preskušanj (HOPE, EUROPA, PEACE in PART 2), obstajajo razlike.
English: All patients n=4,645
Slovenian: Vsi bolniki n = 4.645 n =
English: The CHMP agreed that the correctness of this last sentence is questionable and that no substance specific data were presented and therefore deleted this comment.
Slovenian: CHMP je soglašal s tem, da je točnost tega zadnjega stavka vprašljiva in da niso bili predstavljeni nobeni podatki, ki bi se nanašali na to snov, zato je to pripombo izbrisal.
English: The nephroprotection indication presented the major area of disagreement.
Slovenian: Indikacija nefro zaščite je bila glavno področje nestrinjanja.
English: The HOPE study: Main results Ramipril
Slovenian: Študija HOPE: Glavni rezultati Ramipril
English: The current indication of ramipril in hypertension differs among the EU countries.
Slovenian: Trenutne indikacije ramiprila pri hipertenziji se med državami članicami EU razlikujejo.
English: Your doctor will reduce the initial dose and adjust your treatment more slowly.
Slovenian: Zdravnik bo zmanjšal začetni odmerek in bo bolj počasi prilagajal vaše zdravljenje.
English: • Do not take a double dose to make up for a forgotten tablet/capsule.
Slovenian: • Ne vzemite dvojnega odmerka, če ste pozabili vzeti tableto/kapsulo.
English: Rats, dogs and monkeys tolerated daily doses of 2, 2.5 and 8 mg/kg/d respectively without harmful effects.
Slovenian: Podgane, psi in opice so prenesli dnevne odmerke 2, 2,5 in 8 mg/kg/dan brez škodljivih učinkov.
English: In most countries the dose is doubled every 1-2 weeks, except in Hungary where the duration is 2-3 weeks.
Slovenian: V večini držav se odmerek podvoji vsak 1 do 2 tedna, razen na Madžarskem, kjer je to obdobje dolgo 2-3 tedne.
English: 08019 Barcelona Spain
Slovenian: 08019 Barcelona Španija
English: It also reduced neuroendocrine activation.
Slovenian: Zmanjša tudi nevroendokrino aktivacijo.
English: The main areas for harmonisation were: the sections 4.1, 4.2, 4.3, 4.4 and 4.6 of the summary of product information (SPC).
Slovenian: Uskladiti je bilo treba predvsem naslednje: poglavja 4.1, 4.2, 4.3, 4.4 in 4.6 povzetka glavnih značilnosti zdravila (SPC).
English: • If you are going to receive an anaesthetic.
Slovenian: • če boste dobili anestetik.
English: This may be a sign of your body holding onto more water than usual
Slovenian: To je lahko znak, da se v telesu zadržuje več vode kot po navadi.
English: Depending on the machine that is used, TRITACE may not be suitable for you
Slovenian: Odvisno od naprave, ki se za to uporablja, je mogoče, da zdravilo TRITACE ni primerno za vas.
English: The time frame for dose escalation of 2 to 4 weeks appears appropriate based on individual variability.
Slovenian: Časovni okvir za povečanje odmerka z dveh na štiri tedne se zdi ustrezen na podlagi individualne spremenljivosti.
English: The indication for cardiovascular prevention is justified by the results of HOPE study.
Slovenian: Indikacija za kardiovaskularno preventivo je utemeljena z rezultati študije HOPE.
English: NO-1325 Lysaker Norway
Slovenian: NO-1325 Lysaker Norveška
English: Selective inclusion of one secondary endpoint- all cause mortality- is not recommended.
Slovenian: Selektivno vključevanje enega sekundarnega pokazatelja - nespecifična umrljivost - ni priporočljivo.
English: • Severe stomach pain which may reach through to your back.
Slovenian: • Huda bolečina v želodcu, ki lahko sega v hrbet.
English: • Difficulty concentrating
Slovenian: • težave s koncentracijo
English: Tritace was included in the list of products for Summary of Products Characteristics (SPC) harmonisation, drawn up by the CMD(h), in accordance with Article 30(2) of Directive 2001/83/EC, as amended, as the above-mentioned medicinal product does not have the same SPC across EU Member States, Iceland and Norway.
Slovenian: Zdravilo Tritace je bilo vključeno na seznam zdravil za uskladitev povzetka glavnih značilnosti zdravila (SPC), ki ga je pripravil CMD(h), v skladu s členom 30(2) Direktive 2001/83/ES, kakor je bila spremenjena, saj zgoraj navedeno zdravilo nima enakega povzetka glavnih značilnosti zdravila v državah članicah EU, na Islandiji in Norveškem.
English: A. Juozapavičiaus g. 6/2 LT-09310 Vilnius Lithuania
Slovenian: A. Juozapavičiaus g. 6/2 LT-09310 Vilnius Litva
English: - the Summaries of Products Characteristic, labelling and package leaflet proposed by the Marketing Authorisation Holders has been assessed based on the documentation submitted and the scientific discussion within the Committee,
Slovenian: - so bili povzetki glavnih značilnosti zdravila, označevanje in navodilo za uporabo, ki so jih predlagali imetniki dovoljenja za promet z zdravilom, ocenjeni na podlagi predložene dokumentacije in znanstvene razprave znotraj Odbora,
English: Raynaud's phenomenon
Slovenian: Raynaudov pojav
English: The dose titration steps and target dose are based on the result of the AIRE study.
Slovenian: Postopna titracija odmerka in ciljni odmerek temeljita na rezultatih študije AIRE.