FrancophonIA/ELRC3.0 huggingface dataset:
English: The MAH believes that the impact of these analytical findings on the conclusions of the clinical studies is limited, because clinical efficacy in both studies is based on a comparison of testosterone levels attained during treatment for the MAH's product and the comparator drug.
Slovenian: Imetnik dovoljenja za promet z zdravilom meni, da je vpliv teh analitičnih ugotovitev na zaključke kliničnih študij omejen, saj klinična učinkovitost obeh študij temelji na primerjavi ravni testosterona, doseženih med zdravljenjem z zdravilom imetnika dovoljenja za promet z zdravilom in s primerjalnim zdravilom.
English: Therefore, neither the comparative study design nor the cited results of the study can compensate for the breach of the legal requirements to provide GCPcompliant studies in support of a MAA.
Slovenian: Zato niti primerjalna študija niti navedeni rezultati študije ne morejo odtehtati kršitev pravnih zahtev, da bi bilo na ta način mogoče zagotoviti študije v skladu z dobro klinično prakso v podporo vlogi za pridobitev dovoljenja za promet z zdravilom.
English: Based on the totality of data submitted, the CHMP considered that therapeutic equivalence with Zoladex had not been demonstrated and as such the benefit risk ratio for this generic product was considered negative until the MAH can demonstrate therapeutic equivalence with the reference product.
Slovenian: Na podlagi vseh predloženih podatkov je CHMP menil, da terapevtska enakovrednost zdravilu Zoladex ni bila dokazana ter da je razmerje med tveganji in koristmi za to generično zdravilo negativno, vse dokler imetnik dovoljenja za promet z zdravilom ne dokaže terapevtske enakovrednosti referenčnemu zdravilu.
English: The results of these studies were submitted in a number of marketing authorisation applications of goserelin-containing generic medicinal products to demonstrate therapeutic equivalence with the reference product Zoladex in the course of a MAA under Article.
Slovenian: Rezultati teh študij so bili predloženi v številnih vlogah za pridobitev dovoljenja za promet z generičnimi zdravili, ki vsebujejo goserelin, da bi se dokazala terapevtska enakovrednost zdravila referenčnemu zdravilu Zoladex v okviru vloge za pridobitev dovoljenja za promet z zdravilom iz člena 10(3), tj. hibridne vloge.
English: The MAH agreed with the authorities that GCP violations have happened at the bioanalytical testing facility of the contract laboratory and has taken extensive measures to correct these facts for future clinical trials.
Slovenian: Stališče imetnika dovoljenja za promet z zdravilom Imetnik dovoljenja za promet z zdravilom se je strinjal z organi, da je bila v pogodbenem laboratoriju za izvajanje bioanalitičnega preskušanja kršena dobra klinična praksa, in je sprejel obsežne ukrepe za odpravo tovrstnih kršitev v prihodnjih kliničnih preskušanjih.
English: Therefore, the Committee recommends the suspension of the marketing authorisations, subject to the conditions outlined in Annex III of the Opinion.
Slovenian: Odbor zato ob upoštevanju pogojev iz Dodatka III k Mnenju priporoča začasni umik dovoljenj za promet z zdravilom.
English: Analytical inadequacies would affect comparator and MAH's product in the same way: Since the clinical efficacy was based on a comparison between two products analytical errors would be expected to affect both products in the same way.
Slovenian: Ker je klinična učinkovitost temeljila na primerjavi obeh zdravil, bi bilo pričakovati, da analitične napake vplivajo na obe zdravili v enaki meri.
English: Critical violations of fundamental standards of ICH GCP and internationally accepted laboratory standards during the bioanalytical analyses of the blood samples from both GOS/001 (1-month depot formulation) and GOS/002 (1 and 3-month depot formulation) were uncovered.
Slovenian: V obeh študijah GOS/001 (enomesečna depo formulacija) in GOS/002 (eno- in trimesečna depo formulacija) so bile med izvajanjem bioanalitičnih analiz vzorcev krvi ugotovljene kritične kršitve temeljnih standardov dobre klinične prakse ICH in mednarodno sprejetih laboratorijskih standardov.
English: Invented Name Strength Pharmaceutical Form
Slovenian: (Izmišljeno) ime Jakost Farmacevtska oblika Pot uporabe Stična ovojnina Velikost pakiranja
English: 3 pre-filled syringes
Slovenian: 3 napolnjene injekcijske brizge
English: 3 pre-filled pens
Slovenian: 3 napolnjeni injekcijski peresniki
English: This summary was last updated in October 2017.
Slovenian: Povzetek je bil nazadnje posodobljen oktobra 2017.
English: In the future, if
Slovenian: Če bodo živali v prihodnje
English: Vaccination campaigns are conducted normally twice a year in spring and autumn for consecutive years, until at least 2 years after the last confirmed case of rabies in the area.
Slovenian: Kampanje cepljenja se običajno izvajajo dvakrat letno, spomladi in jeseni, in sicer vsako leto, dokler ne mineta vsaj dve leti od zadnjega potrjenega primera stekline na tem območju.
English: The baits are distributed by land or air and the vaccination area should be larger than 5,000 km2.
Slovenian: Vabe se polagajo po kopnem ali iz zraka, območje cepljenja pa naj bo večje od 5 000 km2.
English: The protection against the virus lasts at least 6 months.
Slovenian: Zaščita pred virusom traja vsaj šest mesecev.
English: The full EPAR for Rabitec can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila Rabitec je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: Protection lasts at least 6 months after vaccination.
Slovenian: Zaščita traja vsaj šest mesecev po cepljenju.
English: It is not intended to provide practical advice on how to use Rabitec.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: Appropriate measures should be taken to prevent contamination such as wearing protective clothes and disposable rubber gloves, since the vaccine has been prepared with modified live virus.
Slovenian: Za preprečevanje kontaminacije je treba izvesti ustrezne ukrepe, kot je nošenje zaščitnih oblačil in gumijastih rokavic za enkratno uporabo, saj je cepivo pripravljeno z modificiranim živim virusom.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Rabitec'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 veterinarski medicini (CVMP) pri agenciji je zaključil, da so koristi zdravila Rabitec večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: It presents a risk for people since it can be transmitted by bites or saliva from an infected animal.
Slovenian: Pomeni tveganje za ljudi, saj se lahko prenaša z ugrizi ali slino okužene živali.
English: This is a summary of the European public assessment report (EPAR) for Rabitec.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Rabitec.
English: The baits should be handled with care.
Slovenian: Z vabami je treba ravnati previdno.
English: In case of skin or eye contact with the vaccine fluid the affected area should be rinsed immediately with water.
Slovenian: V primeru stika tekočine cepiva s kožo ali očmi je treba prizadeto področje nemudoma izprati z vodo.
English: What benefits of Rabitec have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Rabitec izkazalo v študijah?
English: Why is Rabitec approved?
Slovenian: Zakaj je bilo zdravilo Rabitec odobreno?
English: To protect rabies free areas, vaccination may also be carried out at the border of these areas (vaccination belts) or in the form of spot vaccinations.
Slovenian: Za zaščito območij, kjer stekline ni, se cepljenje lahko izvaja na meji teh območij (cepitveni pas) ali v obliki točkovnih cepljenj.
English: Rabitec rabies virus vaccine (live)
Slovenian: Rabitec cepivo proti virusu stekline (živo)
English: The number of baits distributed depends on the density of the fox and raccoon dog population and the nature of the vaccination area.
Slovenian: Število položenih vab je odvisno od gostote populacije lisic in rakunastih psov ter narave območja cepljenja.
English: What is Rabitec and what is it used for?
Slovenian: Kaj je zdravilo Rabitec in za kaj se uporablja?
English: When a fox or raccoon dog chews a bait and the vaccine is released in the animal's mouth, the immune system recognises the virus as ‘foreign' and makes defences against it.
Slovenian: Ko lisica ali rakunasti pes prežveči vabo in se cepivo sprosti v usta živali, imunski sistem prepozna virus kot tujek in proti njemu tvori protitelesa.
English: Rabitec is a vaccine.
Slovenian: Zdravilo Rabitec je cepivo.
English: animals are exposed to the rabies virus, the immune system will be able to respond more quickly, which will help to protect against the disease.
Slovenian: izpostavljene virusu stekline, se bo njihov imunski sistem lahko hitreje odzval, kar bo živali pomagalo pri zaščiti pred boleznijo.
English: What are the risks associated with Rabitec?
Slovenian: Kakšna tveganja so povezana z zdravilom Rabitec?
English: Laboratory studies showed that around 90% of foxes and raccoon dogs produce antibodies against the rabies virus within 15 days of eating the bait.
Slovenian: Laboratorijske študije so pokazale, da v 15 dneh po zaužitju vabe protitelesa proti virusu stekline tvori približno 90 % lisic in rakunastih psov.
English: For the full list of restrictions, see the package leaflet.
Slovenian: Znanih neželenih učinkov ni. Za celoten seznam omejitev glejte navodilo za uporabo.
English: Rabies is a life threatening viral disease that causes inflammation in the brain.
Slovenian: Steklina je smrtno nevarna virusna bolezen, ki povzroča vnetje možganov.
English: Safety information has been included in the summary of product characteristics and the package leaflet for Rabitec, including the appropriate precautions to be followed by healthcare professionals and people who handle the product or come into contact with it.
Slovenian: V povzetek glavnih značilnosti zdravila Rabitec in navodilo za njegovo uporabo so bile vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in osebe, ki ravnajo z zdravilom ali pridejo v stik z njim.
English: Rabitec is available as a liquid (suspension) contained in a bait pellet scented with fish meal to be chewed.
Slovenian: Zdravilo Rabitec je na voljo v obliki tekočine (suspenzije) v peletu vabe z vonjem po ribah, ki ga žival prežveči.
English: Rabitec is a veterinary vaccine used to protect wild foxes and raccoon dogs against rabies.
Slovenian: Zdravilo Rabitec je cepivo za uporabo v veterinarski medicini, ki se uporablja za zaščito lisic in rakunastih psov pred steklino.
English: Other information about Rabitec?
Slovenian: Druge informacije o zdravilu Rabitec
English: For more information about treatment with Rabitec, read the package leaflet.
Slovenian: Za več informacij o zdravljenju z zdravilom Rabitec preberite navodilo za uporabo.
English: Rabitec contains a modified live rabies virus which has been weakened so that it does not cause disease.
Slovenian: Zdravilo Rabitec vsebuje modificiran živ virus stekline, ki je bil oslabljen tako, da ne povzroča bolezni.
English: Rabitec contains a weakened rabies virus that does not cause the disease.
Slovenian: Zdravilo Rabitec vsebuje oslabljen virus stekline, ki ne povzroča bolezni.
English: How is Rabitec used?
Slovenian: Kako se zdravilo Rabitec uporablja?
English: How does Rabitec work?
Slovenian: Kako zdravilo Rabitec deluje?
English: Medical advice should be sought immediately and the package leaflet or label shown to the doctor, who should follow WHO recommendations for rabies exposure.
Slovenian: Nemudoma poiščite zdravniško pomoč in zdravniku pokažite navodilo za uporabo ali nalepko.
English: The European Commission granted a marketing authorisation valid throughout the EU for Rabitec on 1 December 2017.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Rabitec, veljavno po vsej Evropski uniji, izdala
English: Sandoz Farmacêutica Lda.
Slovenian: Portugalska Sandoz Farmacêutica Lda.
English: This summary was last updated in 08-2016.
Slovenian: Povzetek je bil nazadnje posodobljen MM-2016.
English: Atazanavir Mylan is available as capsules (150 mg, 200 mg and 300 mg).
Slovenian: Zdravilo Atazanavir Mylan je na voljo v obliki kapsul (150 mg, 200 mg in 300 mg).
English: It blocks an enzyme called protease, which is needed for the virus to multiply.
Slovenian: Zavira encim, imenovan proteaza, ki je potreben za razmnoževanje virusa.
English: The full EPAR for Atazanavir Mylan 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 Atazanavir Mylan je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It can only be obtained with a prescription and treatment should be started by a doctor who has experience in the treatment of HIV infection.
Slovenian: Izdaja zdravila je le na recept, zdravljenje z njim pa mora uvesti zdravnik, ki ima izkušnje z zdravljenjem okužbe z virusom HIV.
English: It is used together with low-dose ritonavir and other antiviral medicines to treat patients aged 6 years and over.
Slovenian: Uporablja se skupaj z majhnim odmerkom ritonavirja in drugimi protivirusnimi zdravili za zdravljenje bolnikov, starih 6 let in več.
English: This is a summary of the European public assessment report (EPAR) for Atazanavir Mylan.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Atazanavir Mylan.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Atazanavir Mylan have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo zdravstveni delavci in bolniki upoštevati za varno in učinkovito uporabo zdravila Atazanavir Mylan, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: The medicine is not expected to work in patients in whom many medicines in the same class as Atazanavir Mylan (protease inhibitors) do not work.
Slovenian: Ni pričakovati, da bi zdravilo učinkovalo pri bolnikih, pri katerih številna zdravila istega razreda kot zdravilo Atazanavir Mylan (zaviralci proteaze) ne učinkujejo.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Atazanavir Mylan has been shown to have comparable quality and to be bioequivalent to Reyataz.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Atazanavir Mylan primerljivo raven kakovosti kot zdravilo Reyataz ter da mu je biološko enakovredno.
English: Atazanavir Mylan, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Slovenian: Zdravilo Atazanavir Mylan v kombinaciji z drugimi protivirusnimi zdravili zniža količino virusa HIV v krvi in jo vzdržuje na nizki ravni.
English: What measures are being taken to ensure the safe and effective use of Atazanavir Mylan?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Atazanavir Mylan?
English: The Committee recommended that Atazanavir Mylan be approved for use in the EU.
Slovenian: Priporočil je, da se zdravilo Atazanavir Mylan odobri za uporabo v EU.
English: Atazanavir Mylan is an HIV medicine used to treat patients infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immunodeficiency syndrome (AIDS).
Slovenian: Zdravilo Atazanavir Mylan je zdravilo proti virusu HIV, ki se uporablja za zdravljenje bolnikov, okuženih z virusom humane imunske pomanjkljivosti tipa 1 (HIV-1), tj. virusom, ki povzroča sindrom pridobljene imunske pomanjkljivosti (AIDS).
English: Atazanavir Mylan is normally given with ritonavir to boost its action but doctors can consider stopping ritonavir in adults in some specific situations.
Slovenian: Zdravilo Atazanavir Mylan se običajno daje z ritonavirjem za okrepitev njegovega delovanja, zdravniki pa lahko v nekaterih posebnih primerih razmislijo o prenehanju dajanja ritonavirja pri odraslih.
English: Because Atazanavir Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Slovenian: Ker je zdravilo Atazanavir Mylan generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
English: Atazanavir Mylan does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Slovenian: Zdravilo Atazanavir Mylan ne zdravi okužbe z virusom HIV ali aidsa, lahko pa upočasni slabšanje imunskega sistema ter razvoj okužb in bolezni, povezanih z aidsom.
English: Doctors should prescribe Atazanavir Mylan only after they have looked at which medicines the patient has taken and carried out tests to establish that the virus is likely to respond to Atazanavir Mylan.
Slovenian: Zdravniki lahko zdravilo Atazanavir Mylan predpišejo šele, ko preverijo, katera zdravila je bolnik jemal prej, in ko opravijo preiskave za ugotovitev verjetnosti, da se bo virus odzval na zdravilo Atazanavir Mylan.
English: For more information about treatment with Atazanavir Mylan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Atazanavir Mylan preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: This means that Atazanavir Mylan is similar to a ‘reference medicine' already authorised in the European Union (EU) called Reyataz.
Slovenian: To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Reyataz.
English: In younger patients, the dose of Atazanavir Mylan depends on body weight.
Slovenian: Pri mlajših bolnikih je odmerek zdravila Atazanavir Mylan odvisen od njihove telesne mase.
English: What are the benefits and risks of Atazanavir Mylan?
Slovenian: Kakšne so koristi in tveganja, povezani z zdravilom Atazanavir Mylan?
English: For practical information about using Atazanavir Mylan, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Atazanavir Mylan naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: Therefore, the CHMP's view was that, as for Reyataz, the benefit outweighs the identified risk.
Slovenian: Zato je menil, da njegove koristi enako kot pri zdravilu Reyataz odtehtajo znana tveganja.
English: Because Atazanavir Mylan is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Reyataz.
Slovenian: Ker je zdravilo Atazanavir Mylan generično zdravilo, so bile študije pri ljudeh omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Reyataz.
English: Atazanavir Mylan is a ‘generic medicine'.
Slovenian: Zdravilo Atazanavir Mylan je „generično zdravilo“.
English: Other information about Atazanavir Mylan
Slovenian: Druge informacije o zdravilu Atazanavir Mylan
English: What is Atazanavir Mylan and what is it used for?
Slovenian: Kaj je zdravilo Atazanavir Mylan in za kaj se uporablja?
English: The active substance in Atazanavir Mylan, atazanavir, is a protease inhibitor.
Slovenian: Zdravilna učinkovina zdravila Atazanavir Mylan, atazanavir, je zaviralec proteaze.
English: Why is Atazanavir Mylan approved?
Slovenian: Zakaj je bilo zdravilo Atazanavir Mylan odobreno?
English: Atazanavir Mylan contains the active substance atazanavir.
Slovenian: Zdravilo Atazanavir Mylan vsebuje zdravilno učinkovino atazanavir.
English: How is Atazanavir Mylan used?
Slovenian: Kako se zdravilo Atazanavir Mylan uporablja?
English: How does Atazanavir Mylan work?
Slovenian: Kako zdravilo Atazanavir Mylan deluje?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Atazanavir Mylan on 22 August 2016.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Atazanavir Mylan, veljavno po vsej Evropski uniji, izdala <datum izdaje dovoljenja za promet z zdravilom>.
English: How has Atazanavir Mylan been studied?
Slovenian: Kako je bilo zdravilo Atazanavir Mylan raziskano?
English: It is not intended to provide practical advice on how to use Atazanavir Mylan.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: The application was submitted to the reference Member State (RMS): Austria and the concerned Member States (CMS): Denmark, Spain, Finland, France, Germany, Ireland, The Netherlands, Poland, Portugal, Sweden and the United Kingdom.
Slovenian: Vloga je bila predložena referenčni državi članici Avstriji in zadevnim državam članicam Danski, Španiji, Finski, Franciji, Nemčiji, Irski, Nizozemski, Poljski, Portugalski, Švedski in Združenemu kraljestvu.
English: Furthermore, reference to other existing marketing authorisations is not relevant due to different targets populations and/or safety profile.
Slovenian: Poleg tega sklicevanje na druga obstoječa dovoljenja za promet z zdravilom zaradi različnih ciljnih populacij in/ali varnostnega profila ni relevantno.
English: Following the adoption of the CHMP Opinion during the June 2017 CHMP meeting, the applicant Debrégeas & Associés (D&A) requested a re-examination of the Opinion.
Slovenian: Po sprejetju mnenja odbora CHMP na seji odbora CHMP junija 2017 je predlagatelj, družba Debrégeas & Associés (D&A), zahteval ponovno preučitev mnenja.
English: The application in Germany was withdrawn during the DCP.
Slovenian: Vloga v Nemčiji je bila med decentraliziranim postopkom umaknjena.
English: The study duration should enable to conclude on efficacy and include at least 3 months of treatment and a predefined follow-up period.
Slovenian: Študija bi morala trajati vsaj tako dolgo, da bo mogoče izpeljati zaključke o učinkovitosti, vključevati vsaj tri mesece zdravljenja in vnaprej opredeljeno obdobje spremljanja.
English: The CHMP consulted an ad-hoc expert meeting on some of the aspects that formed part of the detailed grounds submitted by Debrégeas & Associés (D&A).
Slovenian: Odbor CHMP se je posvetoval s strokovnjaki na izrednem sestanku glede nekaterih vidikov, ki so del podrobno opisanih razlogov, ki jih je predložila družba Debrégeas & Associés (D&A).
English: As the efficacy of the medicinal product is not established, the relevance of the risk minimization measures could not be confirmed.
Slovenian: Ker učinkovitost zdravila ni bila dokazana, ustreznosti ukrepov za zmanjšanje tveganja ni mogoče potrditi.
English: However, it was recognised that it could be useful from the clinical perspective to have a product that could be used in both settings (acute withdrawal and maintenance of abstinence).
Slovenian: Priznali pa so, da bi bilo s kliničnega stališča koristno imeti zdravilo, ki bi se lahko uporabljalo v obeh primerih (pri akutni odtegnitvi in vzdrževanju abstinence).
English: As none of the subgroup analyses had been pre-specified, these are inherently weakened by their post-hoc derived nature.
Slovenian: Ker nobena od analiz podskupin ni bila vnaprej opredeljena, so že same po sebi šibke zaradi svoje post-hoc narave.
English: The experts agreed that while the data currently available support a plausible effect and is encouraging, the strength of efficacy evidence is insufficient.
Slovenian: Strokovnjaki so se strinjali, da trenutno razpoložljivi podatki sicer podpirajo verjeten učinek in so spodbudni, vendar je moč dokazov o učinkovitosti nezadostna.