FrancophonIA/ELRC3.0 huggingface dataset:
English: The PRAC, as a consequence, concluded that the benefit-risk balance of the medicinal products Evra, Ioa and Zoely in the indication of contraception remains favourable, subject to the agreed conditions, restrictions, warnings, other changes to the product information and additional risk minimisation measures.
Slovenian: Posledično je PRAC zaključil, da je razmerje med tveganji in koristmi zdravil Evra, Ioa in Zoely za indikacijo kontracepcije še naprej ugodno pod pogojem, da se upoštevajo dogovorjeni pogoji, omejitve, opozorila in druge spremembe informacij o zdravilu ter dodatni ukrepi za zmanjšanje tveganja.
English: Medicinal products containing chlormadinone, desogestrel, dienogest, drospirenone, etonogestrel, gestodene, norelgestromin, norgestimate or nomegestrol are authorised in the European Union as combined hormonal contraceptives (CHCs).
Slovenian: Zdravila, ki vsebujejo klormadinon, dezogestrel, dienogest, drospirenon, etonogestrel, gestoden, norelgestromin, norgestimat ali nomegestrol, so v Evropski uniji odobrena kot kombinirani hormonski kontraceptivi.
English: • The PRAC considered that in view of the currently available safety data, the benefit-risk balance of combined hormonal contraceptives is favourable, subject to restrictions, warnings and other changes to the product information.
Slovenian: • PRAC je na podlagi vseh trenutno razpoložljivih podatkov o varnosti zaključil, da je razmerje med tveganji in koristmi kombiniranih hormonskih kontraceptivov ugodno pod pogojem, da se upoštevajo omejitve, opozorila in druge spremembe informacij o zdravilu.
English: • The estimated incidence of risk is higher with the progestogens etonogestrel and norelgestromin, with between 6 and 12 cases yearly per 10,000 women.
Slovenian: • da je ocenjena incidenca tveganja večja pri progestogenih etonogestrelu in norelgestrominu (letno od 6-12 primerov na 10 000 žensk);
English: The CHMP considered the below PRAC recommendation dated 10 October 2013 with regards to combined hormonal contraceptives containing chlormadinone, desogestrel, dienogest, drospirenone, etonogestrel, gestodene, norelgestromin, norgestimate or nomegestrol.
Slovenian: CHMP je proučil spodnje priporočilo odbora PRAC z dne 10. oktobra 2013 v zvezi s kombiniranimi hormonskimi kontraceptivi, ki vsebujejo klormadinon, dezogestrel, dienogest, drospirenon, etonogestrel, gestoden, norelgestromin, norgestimat ali nomegestrol.
English: • The estimated incidence of risk is also higher with the progestogens gestodene, desogestrel, drospirenone, with between 9 and 12 cases yearly per 10,000 women.
Slovenian: • da je ocenjena incidenca tveganja večja tudi pri progestogenih gestodenu, dezogestrelu in drospirenonu (letno od 9-12 primerov na 10 000 žensk);
English: It has been shown that risk of VTE is highest during the first year a woman starts hormonal contraceptives or when she re-starts after a period of non-use of at least one month (Dinger et al,.
Slovenian: Dokazano je bilo, da je tveganje za VTE največje prvo leto po začetku jemanja hormonskih kontraceptivov ali ko jih ženska začne ponovno jemati po več kot enomesečni prekinitvi (Dinger in sod., 2007, Sidney in sod., 2013).
English: Many studies have evaluated the risk of VTE and its complications (deep vein thrombosis, pulmonary embolism) among users of different CHCs.
Slovenian: Tveganje za VTE in z njo povezane zaplete (globoko vensko trombozo in pljučno embolijo) pri uporabnicah različnih kombiniranih hormonskih kontraceptivov so proučevali v številnih študijah.
English: Also there are certain hereditary thrombophilic defects that increase the risk.
Slovenian: Tveganje povečujejo tudi nekatere dedne trombofilne bolezni.
English: In particular, these medicinal products should be contraindicated in patients with multiple risk factors (overweight, smoking, hypertension, increasing age etc.), in patients after major surgery with prolonged immobilisation and patients with history or hereditary predisposition of venous thrombosis.
Slovenian: Predvsem morajo biti ta zdravila kontraindicirana pri bolnicah z več dejavniki tveganja (prekomerna telesna masa, kajenje, hipertenzija, višja starost itd.), pri bolnicah, ki so prestale večji kirurški poseg z daljšo imobilizacijo, in bolnicah z anamnezo venske tromboze ali dedno predispozicijo zanjo.
English: For chlormadinone this will be investigated through a post-authorisation safety study, which is further discussed below.
Slovenian: Tveganje pri uporabi klormadinona bodo raziskali v študiji varnosti zdravila v obdobju trženja, ki je podrobneje obravnavana v nadaljevanju.
English: However, the CHMP considered that the section on Fertility, pregnancy and lactation of the SmPC should be amended to reflect the increased risk of VTE in the post-partum period, to ensure consistency with the warning section of the SmPC.
Slovenian: Vendar pa je menil, da je treba spremeniti poglavje povzetka glavnih značilnosti zdravila o plodnosti, nosečnosti in dojenju, da se vključijo informacije o povečanem tveganju za VTE v obdobju po porodu, ki bodo skladne s poglavjem povzetka glavnih značilnosti zdravila z opozorili.
English: The risk of VTE with CHCs differs among products depending on the type of progestogen they contain.
Slovenian: Tveganje za VTE pri uporabi kombiniranih hormonskih kontraceptivov se med posameznimi kontraceptivi razlikuje, in sicer je odvisno od vrste vsebovanega progestogena.
English: Having considered all the above, the PRAC concluded that the benefit-risk balance of the medicinal products Evra, Ioa and Zoely in the indication of contraception remains favourable, subject to the inclusion of the restrictions, warnings and other changes to the product information agreed.
Slovenian: Potem ko je proučil vse navedeno, je PRAC zaključil, da je razmerje med tveganji in koristmi zdravilEvra, Ioa in Zoely za indikacijo kontracepcije še naprej ugodno pod pogojem, da se v informacije o zdravilu vključijo dogovorjene omejitve, opozorila in druge spremembe.
English: Checking personal and family history of VTE before prescribing combined CHC medicinal products is, therefore, recommended in the product information of the products.
Slovenian: Zato je v informacije o zdravilih vključeno priporočilo o preverjanju osebne in družinske anamneze VTE, preden se predpišejo kombinirani hormonski kontraceptivi.
English: Furthermore, proactive information to communicate the outcome of the present review and to highlight the risk of the thromboembolic events through a direct healthcare professional communication (DHPC) was recommended.
Slovenian: Prav tako je priporočil aktivno obveščanje preko neposrednega obvestila zdravstvenim delavcem (DHPC), da se jim sporoči izid tega pregleda in se jih opozori na tveganje za trombembolične dogodke.
English: Pierre Demolis (FR)
Slovenian: Priloga IV
English: • For CHCs containing chlormadinone, dienogest and nomegestrol, the available data are insufficient to know how the risk compares with the other CHCs.
Slovenian: • da je za kombinirane hormonske kontraceptive, ki vsebujejo klormadinon, dienogest in nomegestrol, na voljo premalo podatkov, da bi lahko ugotovili, kakšno je tveganje v primerjavi z drugimi kombinirani hormonskimi kontraceptivi.
English: None.
Slovenian: Nikakršnih.
English: This summary was last updated in February 2014.
Slovenian: Povzetek je bil nazadnje posodobljen februarja 2014.
English: It contains a strain called GM 199.
Slovenian: Vsebuje sev GM 199.
English: No field studies were conducted.
Slovenian: Terenskih študij niso izvajali.
English: Other information about Parvoduk:
Slovenian: Druge informacije o zdravilu Parvoduk:
English: No side effects have been reported to date.
Slovenian: Doslej niso poročali o nikakršnih neželenih učinkih.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Parvoduk on 11/04/2014.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Parvoduk, veljavno po vsej Evropski uniji, odobrila 11. aprila 2014.
English: The effectiveness of Parvoduk was investigated in laboratory studies.
Slovenian: Učinkovitost zdravila Parvoduk je bila raziskana v laboratorijskih študijah.
English: Parvoduk is a vaccine.
Slovenian: Zdravilo Parvoduk je cepivo.
English: What is the risk associated with Parvoduk?
Slovenian: Kakšna tveganja so povezana z zdravilom Parvoduk?
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Parvoduk exceed the risks for the approved indication and recommended that Parvoduk be given a marketing authorisation.
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi zdravila Parvoduk večje od z njim povezanih tveganj za odobreno indikacijo, in priporočil odobritev dovoljenja za promet z zdravilom Parvoduk.
English: The withdrawal period is the time allowed after administration of the medicine and before the animal can be slaughtered and the meat used for human consumption or eggs or milk used for human consumption.
Slovenian: Karenca je časovno obdobje, ki mora preteči po uporabi zdravila, preden se lahko žival zakolje in meso, jajca ali mleko uporabijo za prehrano ljudi.
English: The benefit/risk balance may be found in the scientific discussion module of this EPAR.
Slovenian: Razmerje med koristmi in tveganji najdete v modulu o znanstveni razpravi v tem evropskem javnem poročilu o oceni zdravila (EPAR).
English: What benefit has Parvoduk shown during the studies?
Slovenian: Kakšne koristi je zdravilo Parvoduk izkazalo med študijami?
English: The measure of effectiveness was reduction in death rates, stunting of growth, feather abnormalities and damage to organs seen at post-mortem.
Slovenian: Merilo učinkovitosti je bilo zmanjšanje smrtnosti, upočasnjene rasti, nenormalnosti perja in poškodb organov, ki so bile ugotovljene posmrtno.
English: Growth after exposure to Muscovy duck parvovirus or goose parvovirus was improved in vaccinated ducklings by 70% and 110%, respectively.
Slovenian: Rast po izpostavljenosti parvovirusu rac moškatnih bleščavk ali parvovirusu gosi se je pri cepljenih mladičih povečala za 70 % oziroma 110 %.
English: Although the weakened virus in Parvoduk has not been shown to pass between birds or to cause disease, all the ducklings in a flock should be vaccinated to reduce the risk of this happening.
Slovenian: Čeprav ni znano, da bi se oslabljeni virus v zdravilu Parvoduk prenašal med pticami ali povzročil bolezen, je treba cepiti vse mladiče v jati, da bi zmanjšali tveganje tega pojava.
English: The Muscovy duck parvovirus in Parvoduk is alive but it has been attenuated (weakened) so that it does not cause disease.
Slovenian: Parvovirus rac moškatnih bleščavk v zdravilu Parvoduk je živ, vendar atenuiran (oslabljen), tako da ne povzroča bolezni.
English: The laboratory studies showed that, two weeks after vaccination, Parvoduk prevented deaths in the ducklings and reduced damage to organs.
Slovenian: Laboratorijske študije so pokazale, da je zdravilo Parvoduk dva tedna po cepljenju preprečilo smrt mladičev in zmanjšalo poškodbe organov.
English: Week-old ducklings show a range of signs including death and muscle weakness whilst older ducklings display stunted growth, nervous symptoms and feather abnormalities.
Slovenian: Teden dni stari mladiči izkazujejo številne simptome, vključno s smrtjo in oslabelostjo mišic, medtem ko je pri starejših mladičih opaziti upočasnjeno rast, živčne simptome in nenormalnost perja.
English: Why has Parvoduk been approved?
Slovenian: Zakaj je bilo zdravilo Parvoduk odobreno?
English: The vaccine is given to day-old ducklings as an injection under the skin, repeated after 16 days.
Slovenian: Cepivo se daje mladičem pri enem dnevu starosti z injekcijo v podkožje, injiciranje pa se nato ponovi po 16 dneh.
English: In addition it was shown that Parvoduk remains effective until the ducklings are aged six weeks, which means that the ducklings are protected during the period when they are at risk of Muscovy duck parvovirosis and Derzsy's disease.
Slovenian: Poleg tega je bilo dokazano, da cepivo Parvoduk ostane učinkovito, dokler mladiči ne dosežejo starosti šestih tednov, kar pomeni, da so ti zaščiteni v obdobju, ko so izpostavljeni tveganju, da bodo zboleli za parvovirozo rac moškatnih bleščavk in Derzsyjevo boleznijo.
English: This was considered acceptable, given the laboratory data and taking into account that the Muscovy duck is a minor species.
Slovenian: To je bilo glede na laboratorijske podatke in dejstvo, da so race moškatne bleščavke manj pomembna vrsta, označeno kot sprejemljivo.
English: Because goose parvovirus is very similar to Muscovy duck parvovirus, the immune response also provides protection if the animal is exposed to goose parvovirus.
Slovenian: Ker je parvoviroza gosi zelo podobna parvovirozi rac moškatnih bleščavk imunski odziv zagotavlja tudi zaščito v primeru izpostavljenosti parvovirozi gosi.
English: Parvoduk is available as a suspension and diluent for injection.
Slovenian: Zdravilo Parvoduk je na voljo v obliki suspenzije in vehikla za injiciranje.
English: Derzsy's disease is a similar infection caused by the closely related virus, goose parvovirus.
Slovenian: Derzsyjeva bolezen je podobna okužba, ki jo povzroča zelo soroden virus - parvovirus gosi.
English: What is Parvoduk used for?
Slovenian: Za kaj se zdravilo Parvoduk uporablja?
English: One-day-old ducklings were given a single injection of Parvoduk and then exposed two weeks later to either Muscovy duck parvovirus or goose parvovirus.
Slovenian: En dan stare mladiče so cepili z eno injekcijo zdravila Parvoduk in jih dva tedna kasneje izpostavili bodisi parvovirusu rac moškatnih bleščavk ali parvovirusu gosi.
English: In the future, if the animals are exposed to Muscovy duck parvovirus, the immune system will be able to respond more quickly.
Slovenian: Ob morebitni ponovni izpostavitvi parvovirusu rac moškatnih bleščavk se bo imunski sistem lahko odzval hitreje.
English: When Parvoduk is given to Muscovy ducks the animals' immune system recognises the viruses as ‘foreign' and makes antibodies against them.
Slovenian: Ko race moškatne bleščavke cepimo z zdravilom Parvoduk, njihov imunski sistem viruse prepozna kot „tujke“ in proti njim razvije protitelesa.
English: Two further studies were carried out to investigate the effects of Parvoduk in ducklings who had inherited protective antibodies against Muscovy duck parvovirus or goose parvovirus from their mother.
Slovenian: Dve nadaljnji študiji sta bili opravljeni, da bi preiskali učinke zdravila Parvoduk pri mladičih, ki so po materi podedovali zaščitna protitelesa proti parvovirusu rac moškatnih bleščavk ali parvovirusu gosi.
English: Parvoduk is a veterinary vaccine that contains live attenuated (weakened) Muscovy duck parvovirus.
Slovenian: Zdravilo Parvoduk je veterinarsko cepivo, ki vsebuje živ atenuiran (oslabljen) parvovirus rac moškatnih bleščavk.
English: This will help protect them against Muscovy duck parvovirosis.
Slovenian: To bo pripomoglo k zaščiti rac pred parvovirozo rac moškatnih bleščavk.
English: How has Parvoduk been studied?
Slovenian: Kako je bilo zdravilo Parvoduk raziskano?
English: Muscovy duck parvovirus (live attenuated)
Slovenian: Parvovirus rac moškatnih bleščavk (živ, atenuiran)
English: Parvoduk is used to protect Muscovy ducks against Muscovy duck parvovirosis and Derzsy's disease.
Slovenian: Zdravilo Parvoduk se uporablja za zaščito rac moškatnih bleščavk pred parvovirozo rac moškatnih bleščavk in Derzsyjevo boleznijo.
English: How does Parvoduk work?
Slovenian: Kako zdravilo Parvoduk deluje?
English: The further study showed that Parvoduk vaccination of ducklings was not counteracted by protective antibodies from their mother.
Slovenian: Nadaljnja študija je pokazala, da zaščitna protitelesa, podedovana po materi, niso imela negativnega učinka na cepljenje mladičev z zdravilom Parvoduk.
English: Muscovy duck parvovirosis is an infectious disease caused by Muscovy duck parvovirus.
Slovenian: Parvoviroza rac moškatnih bleščavk je nalezljiva bolezen, ki jo povzroča parvovirus rac moškatnih bleščavk.
English: What is Parvoduk?
Slovenian: Kaj je zdravilo Parvoduk?
English: The withdrawal period for Parvoduk is zero days.
Slovenian: Karenca za zdravilo Parvoduk je nič dni.
English: What is the withdrawal period?
Slovenian: Kako dolgo traja obdobje karence?
English: MA (EU) number (Invented) name Strength Pharmaceutical Form
Slovenian: (Izmišljeno) ime Jakost Farmacevtska oblika
English: This summary was last updated in 01/2018.
Slovenian: Povzetek je bil nazadnje posodobljen 01/2018.
English: The recommended dose is one tablet a day, taken with food.
Slovenian: Priporočeni odmerek je ena tableta na dan, ki se vzame s hrano.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Genvoya on 19 November 2015.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Genvoya, veljavno po vsej Evropski uniji, izdala 19. novembra 2015.
English: The CHMP also considered that combining the medicines in a single tablet simplifies treatment.
Slovenian: Odbor CHMP je prav tako menil, da združitev zdravil v eni tableti poenostavlja zdravljenje.
English: What measures are being taken to ensure the safe and effective use of Genvoya?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Genvoya?
English: This is a summary of the European public assessment report (EPAR) for Genvoya.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Genvoya.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Genvoya's benefits are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Genvoya večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: Other information about Genvoya
Slovenian: Druge informacije o zdravilu Genvoya
English: The full EPAR for Genvoya 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 Genvoya je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Genvoya must not be taken with certain other medicines because of the possibility of harmful interactions.
Slovenian: Zdravilo Genvoya se ne sme jemati z nekaterimi drugimi zdravili zaradi možnosti škodljivih interakcij.
English: This reduces the virus's ability to replicate and slows down the spread of infection.
Slovenian: To zmanjšuje sposobnost virusa, da se razmnožuje, in upočasni širjenje okužbe.
English: It is used in adults and adolescents aged over 12 years whose disease is not expected to be resistant to any of the antiviral substances in Genvoya.
Slovenian: Uporablja se pri odraslih in mladostnikih, starejših od 12 let, pri katerih ni pričakovati, da bo njihova bolezen odporna proti kateri koli od protivirusnih učinkovin v zdravilu Genvoya.
English: Other side effects include abnormal dreams, dizziness, feeling tired, and diarrhoea.
Slovenian: Drugi neželeni učinki vključujejo nenavadne sanje, omotičnost, utrujenost in drisko.
English: In a supporting study, patients who were being treated with effective HIV treatment either continued with the same treatment or were switched to Genvoya.
Slovenian: V podporni študiji so bolniki, ki so bili deležni učinkovitega zdravljenja okužbe z virusom HIV, bodisi nadaljevali z enakim zdravljenjem ali pa so prešli na zdravilo Genvoya.
English: The main measure of effectiveness was based on the reduction of the amount of HIV-1 in the blood.
Slovenian: Glavno merilo učinkovitosti je bilo zmanjšanje količine virusa HIV-1 v krvi.
English: Further data indicated that Genvoya can be used safely in children as young as 6 years of age.
Slovenian: Nadaljnji podatki so pokazali, da je zdravilo Genvoya varno za uporabo tudi pri mlajših otrocih, starih šest let.
English: After 48 weeks around 90% of patients treated with both Genvoya (800 of 866 patients) and the comparator (784 of 867 patients) had responded to treatment.
Slovenian: Po 48 tednih se je okoli 90 % bolnikov, zdravljenih tako z zdravilom Genvoya (800 od 866 bolnikov) kot s primerjalnim zdravilom (784 od 867 bolnikov), odzvalo na zdravljenje.
English: The infection was considered to have responded to treatment if the viral load in the patient's blood was less than 50 of HIV-1 RNA copies/ml.
Slovenian: Za okužbo je veljalo, da se je odzvala na zdravljenje, če je bila virusna obremenitev v bolnikovi krvi manjša od 50 HIV-1 RNK kopij/ml.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Genvoya 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 Genvoya upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: The most common side effect with Genvoya (which may affect more than 1 in 10 people) is nausea (feeling sick).
Slovenian: Najpogostejši neželeni učinek zdravila Genvoya (ki lahko prizadene več kot 1 osebo od 10) je navzeja (slabost).
English: Genvoya is available as tablets, each containing 150 mg elvitegravir, 150 mg cobicistat, 200 mg emtricitabine and 10 mg tenofovir alafenamide.
Slovenian: Zdravilo Genvoya je na voljo v obliki tablet, od katerih vsaka vsebuje 150 mg elvitegravirja, 150 mg kobicistata, 200 mg emtricitabina in 10 mg alafenamidtenofovirata.
English: Genvoya's side effects were similar to those of the individual medicines.
Slovenian: Neželeni učinki zdravila Genvoya so bili podobni tistim, ki so značilni za posamezna zdravila.
English: For more information about treatment with Genvoya, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Genvoya preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: By blocking an enzyme called integrase, elvitegravir stops the virus's genetic material from integrating into the genetic material of the cells it has infected.
Slovenian: Z zaviranjem encima, imenovanega integraza, elvitegravir prepreči vključitev genskega materiala virusa v genski material celic, ki jih je okužil.
English: This boosts elvitegravir's antiviral effect.
Slovenian: To okrepi protivirusni učinek elvitegravirja.
English: Genvoya elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide
Slovenian: Genvoya elvitegravir/kobicistat/emtricitabin/alafenamidtenofovirat
English: Genvoya is an antiviral medicine used to treat individuals infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Slovenian: Zdravilo Genvoya je protivirusno zdravilo za zdravljenje posameznikov, ki so okuženi z virusom humane imunske pomanjkljivosti tipa 1 (HIV-1), tj. virusom, ki povzroča sindrom pridobljene imunske pomanjkljivosti (aids).
English: What are the risks associated with Genvoya?
Slovenian: Kakšna tveganja so povezana z zdravilom Genvoya?
English: Genvoya was investigated in two main studies involving 1,733 adults infected with HIV-1 who had not been treated previously.
Slovenian: Zdravilo Genvoya so proučevali v dveh glavnih študijah s 1 733 odraslimi, okuženimi z virusom HIV-1, ki predhodno še niso bili zdravljeni.
English: What is Genvoya and what is it used for?
Slovenian: Kaj je zdravilo Genvoya in za kaj se uporablja?
English: Genvoya contains four active substances.
Slovenian: Zdravilo Genvoya vsebuje štiri zdravilne učinkovine.
English: What benefits of Genvoya have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Genvoya izkazalo v študijah?