natgillin/translations-raw huggingface dataset:
The benefit could be qualified as limited, however the effect size cannot be accurately quantified due to methodological deficiencies of available studies (e. g. in most cases baseline values were not stated, precluding an adequate assessment of the improvement observed; neither the statistical nor the clinical significance of this effect size could be precisely quantified, as the statistical plan was not clear or was absent; the presentation of the results was poor).
Njegovo korist je mogoče označiti kot omejeno, vendar pa obsega učinka zaradi metodoloških pomanjkljivosti razpoložljivih študij (v večini primerov npr. izhodiščne vrednosti niso bile navedene, kar onemogoča ustrezno oceno ugotovljenega izboljšanja; ne statističnega ne kliničnega pomena tega obsega učinka ni bilo mogoče točno ovrednotiti, saj statistični načrt ni bil jasen ali ni obstajal; predstavitev rezultatov je bila slaba) ni mogoče točno ovrednotiti.
Regulatory actions were also taken in some other EU Member States where the product is authorised and veralipride's product information was restricted with the aim to reduce the risk of patients developing side effects.
Zakonski ukrepi so bili sprejeti tudi v nekaterih drugih državah članicah EU, v katerih je izdelek odobren, tako da bile z namenom, da bi zmanjšali tveganje za pojav neželenih učinkov pri bolnikih, informacije o izdelku zaostrene.
However, tardive dyskinesia may still occur within the first 3 months of treatment.
Vendar pa lahko tardivna diskinezija še vedno nastopi v prvih 3 mesecih zdravljenja.
As for the other adverse events related with the blockage of the dopamine receptor, especially hyperprolactinemia is a concern.
Glede drugih neželenih učinkov, povezanih z blokado dopaminskega receptorja, je glavni pomislek zlasti hiperprolaktinemija.
-Restriction of the treatment duration to 3 months in combination with monthly examination in an effort to limit the psychiatric and neurological adverse events.
-Omejitev trajanja zdravljenja na 3 mesece v kombinaciji z mesečnimi pregledi, da bi tako omejili psihiatrične in nevrološke neželene učinke.
ANNEX I LIST OF THE INVENTED NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
DODATEK I SEZNAM IMEN, FARMACEVTSKA OBLIKA, JAKOST ZDRAVILA, POT UPORABE ZDRAVILA, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
The CHMP therefore concluded on 19 July 2007 that the benefit/risk balance of veralipride containing medicinal products is not positive under normal conditions of use.
CHMP je zato 19. julija 2007 zaključil, da razmerje med tveganji in koristmi zdravil, ki vsebujejo veraliprid, pri normalnih pogojih uporabe ni pozitivno.
In addition, the effect size cannot be accurately quantified due to methodological shortcomings and the duration of the trials was too short to allow for proper assessment of maintenance of efficacy.
Obsega učinka tudi ni mogoče točno ovrednotiti zaradi metodoloških pomanjkljivosti, trajanje študij pa je bilo prekratko, da bi dopuščalo ustrezno oceno vzdrževanja učinkovitosti.
The CHMP took note of the MAH's proposals, some of which had already been introduced in some countries, in an effort to limit these risks like:
CHMP se je seznanil s predlogi imetnika dovoljenja za promet z zdravilom, med katerimi so bili nekateri v nekaterih državah že uvedeni, da bi tako zmanjšali ta tveganja.
Therefore, the CHMP recommended the withdrawal of all Marketing Authorisations for medicinal products containing veralipride throughout Europe.
Posledično je CHMP predlagal umik vseh dovoljenj za promet z zdravili, ki vsebujejo veraliprid, po celi Evropi.
Lastly, QT-prolongation is a class-effect of dopamine-antagonists.
Podaljšanje QT je učinek, značilen za cel razred dopaminskih antagonistov.
The proposed intermittent treatment of 20 days, followed by a 10 day period of non-treatment, may temper this effect on the prolactin level, but it is unknown whether this measure has any effect on the adverse event pattern.
Predlagano intermitentno zdravljenje, trajajoče 20 dni, ki mu sledi 10 dnevno obdobje nezdravljenja, utegne zmanjšati ta vpliv na raven prolaktina, vendar pa ni znano, ali ima ta ukrep kakršenkoli vpliv na vzorec neželenih učinkov.
ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR WITHDRAWAL OF THE MARKETING AUTHORISATION PRESENTED BY THE EMEA
DODATEK II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA UMIK DOVOLJENJA ZA PROMET Z ZDRAVILOM, KI JIH JE PREDSTAVILA EVROPSKA AGENCIJA ZA ZDRAVILA
-Recommendations of medical breast monitoring and intermittent schedule (20 days followed by a 10day period of non-treatment) to reduce the risk of hyperprolactinemia, aimed to improve the breast safety (however, it is unknown whether this measure has any effect on the observed adverse event pattern related to hyperprolactinemia like breast enlargement, galactorrhoea and risk for patients with prolactin-dependent tumours such as pituitary gland prolactinoma and breast cancer).
-Priporočilo za zdravniške preglede dojk in intermitentno shemo (20 dni zdravljenja, ki mu sledi 10 dnevno obdobje nezdravljenja), da bi tako zmanjšali tveganje za hiperprolaktinemijo, vse z namenom izboljšanja varnosti za zdravje dojk (vendar pa ni znano, ali ima ta ukrep kakšen vpliv na opažen vzorec neželenih učinkov v zvezi z hiperprolaktinemijo kot so povečanje dojk, galaktoreja in tveganje za paciente s tumorji, odvisnimi od prolaktina, kot so prolaktinom hipofize ali rak dojke.
Overall, the restriction to limit the use of veralipride to 3 months in combination with monthly medical neurological examinations and breast monitoring is not considered adequate to limit the risk of all adverse effects reported with veralipride and adequately treat the vasomotor symptoms associated with the menopause.
Celostno gledano, omejitev uporabe veraliprida do največ 3 mesece v kombinaciji z mesečnimi zdravniškimi nevrološkimi pregledi in pregledi dojk ni bila ocenjena kot zadostna za omejitev tveganja za pojav vseh neželenih učinkov, o katerih so poročali pri uporabi veraliprida, in za ustrezno zdravljenje vazomotornih simptomov, povezanih z menopavzo.
The CHMP has recommended the withdrawal of the Marketing Authorisations for the medicinal products containing veralipride referred to in Annex I.
CHMP je predlagal umik dovoljenj za promet z zdravili, ki vsebujejo veraliprid, omenjenih v Dodatku I.
• The Committee, as a consequence, concluded that the benefit/risk balance of veralipride containing medicinal products is not positive under normal conditions of use.
• Odbor je posledično zaključil, da razmerje med tveganji in koristmi zdravil, vsebujočih veraliprid, pri normalnih pogojih uporabe ni pozitivno.
In view of the available clinical data the CHMP concluded that the risks associated with the use of veralipride in the treatment of hot flushes associated with the menopause, mainly the neurological reactions (dyskinesia, extrapyramidal disorder, Parkinson syndrome) and psychiatric reactions (depression, anxiety, withdrawal syndrome) outweigh the limited benefits.
Z ozirom na razpoložljive klinične podatke je CHMP zaključil, da tveganja, povezana z uporabo veraliprida za zdravljenje navalov vročice, ki so povezani z menopavzo, zlasti nevrološke reakcije (diskinezija, ekstrapiramidalni zaplet, Parkinsonov sindrom) in psihiatrične reakcije (depresija, anksioznost, sindrom odtegnitve) presegajo omejene koristi.
In order to avoid psychiatric AE, extrapyramidal symptoms and tardive dyskinesia, the MAH proposed a maximally allowed duration of 3 months veralipride treatment.
Da bi preprečil psihiatrične neželene učinke, ekstrapiramidalne simptome in tardivno diskinezijo, je imetnik dovoljenja za promet predlagal najdaljše dopustno trajanje zdravljenja z veralipridom 3 mesece.
-Introduction of warnings regarding class effects of neuroleptic medicines (neuroleptic malignant syndrome, QT prolongation, tardive dyskinesia) and withdrawal symptoms such as anxiety and depressive syndrome.
-Vključitev opozorila glede učinkov, značilnih za cel razred nevroleptikov (nevroleptični maligni sindrom, podaljšanje QT, tardivna diskinezija), in simptomov odtegnitve, kot so anksioznost in depresivni sindrom.
• The Committee considered that veralipride containing medicinal products only showed limited efficacy in the treatment of hot flushes associated with the menopause;
• Odbor je bil mnenja, da zdravila, ki vsebujejo veraliprid, izkazujejo le omejeno učinkovitost pri zdravljenju navalov vročice, povezanih z menopavzo;
• The Committee concluded, in view of available data, that the risks associated with the use of veralipride in the treatment of hot flushes associated with the menopause outweigh the limited benefits.
• Z ozirom na razpoložljive klinične podatke je Odbor zaključil, da tveganja, povezana z uporabo veraliprida pri zdravljenju navalov vročice, ki so povezani z menopavzo, presegajo omejene koristi.
Veralipride treatment is contra-indicated in patients with prolactindependent tumours such as pituitary gland prolactinoma and breast cancer.
Zdravljenje z veralipridom je kontraindicirano pri bolnikih s tumorji, odvisnimi od prolaktina, kot so prolaktinom hipofize ali rak dojke.
Veralipride is a benzamide neuroleptic medicine indicated in the treatment of vasomotor symptoms associated with the menopause.
Veraliprid je benzamidno nevroleptično zdravilo, indicirano za zdravljenje vazomotoričnih simptomov, povezanih z menopavzo.
Neurological adverse events referred to extrapyramidal symptoms and particularly tardive dyskinesias have been reported with veralipride and represent a real concern due to their potential seriousness and irreversibility.
Pri uporabi veraliprida so poročali o nevroloških neželenih učinkih, nanašajočih se na ekstrapiramidalne simptome in zlasti tardivne diskinezije, ki predstavljajo realen pomislek zaradi njihove potencialne resnosti in nepovratnosti.
Cases of not predictable and potentially irreversible tardive dyskinesia, as well as early extrapyramidal symptoms, depression, anxiety and withdrawal reactions have been reported with veralipride treatment; these risks together with the risk of hyperprolactinemia, and the class effect risk on QTprolongation are considered a concern.
V povezavi z zdravljenjem z veralipridom so poročali o primerih nenapovedljive in potencialno nepovratne tardivne diskinezije, kakor tudi o zgodnjih ekstrapiramidalnih simptomih, depresiji, anksioznosti in sindromu odtegnitve; ta tveganja skupaj s tveganjem za hiperprolaktinemijo ter za podaljšanje QT, ki je značilno za celoten razred teh zdravil, so ocenjena kot zadržek.
• The Committee considered that neurological reactions (dyskinesia, extrapyramidal disorder, Parkinson syndrome) and psychiatric reactions (depression, anxiety, withdrawal syndrome) have been reported with veralipride, including tardive dyskinesia which may be potentially irreversible.
• Odbor je ugotovil, da so pri uporabi veraliprida poročali o nevroloških reakcijah (diskineziji, ekstrapiramidalnem zapletu, Parkinsonovem sindromu) in psihiatričnih reakcijah (depresiji, anksioznosti, sindromu odtegnitve), vključno s tardivno diskinezijo, ki je potencialno lahko nepovratna.
The CHMP concluded that the data submitted showed only limited effect of veralipride in the treatment of vasomotor symptoms associated with the menopause.
CHMP je zaključil, da predloženi podatki izkazujejo zgolj omejen učinek veraliprida pri zdravljenju vazomotoričnih simptomov, povezanih z menopavzo.
Member State Marketing Authorisation Holder
PODLAGA ZA UMIK DOVOLJENJA ZA PROMET
Based on the submitted data, there appears to be an effect for veralipride in the treatment of vasomotor symptoms associated with the menopause.
Na podlagi predloženih podatkov je videti, da ima veraliprid določen učinek pri zdravljenju vazomotoričnih simptomov, povezanih z menopavzo.
Psychiatric adverse events mainly referred to depressive and anxiety states have also been reported with veralipride.
Ravno tako so pri uporabi veraliprida poročali o psihiatričnih neželenih učinkih, nanašajočih se na depresivna in anksiozna stanja.
Physicians and patients should be made aware that there is an ad hoc advisory service available to provide information on leflunomide plasma level laboratory
Zdravnike in bolnike je potrebno obvestiti, da je na razpolago za ta namen posvetovalna služba za posredovanje informacij o laboratorijskem testiranju plazemskih vrednosti leflunomida.
• The identified risk of synergistic hepato- or haematotoxicity associated with combination therapy with another Disease-Modifying Antirheumatic Drug (e.g. methotrexate)
• O ugotovljenem tveganju za sinergistično hepatotoksičnost ali hematotoksičnost v povezavi s kombinirano terapijo z drugimi imunomodulirajočimi protirevmatičnimi zdravili (DMARDdisease-modifying antirheumatic drug) (na primer metotreksat).
The Member States shall ensure that the Marketing Authorisation Holder (MAH) provides physicians who are expected to prescribe/use Leflunomide Teva with a physician educational pack containing the following:
Imetnik dovoljenja za promet z zdravilom bo poskrbel, da bodo vsi zdravniki, ki bi lahko predpisovali zdravilo Leflunomid Teva dobili izobraževalno gradivo, ki vsebuje:
The information provided in the Physician Leaflet should provide information on dose reduction, discontinuation and wash out procedures in the event of
Informacije v navodilu za zdravnika morajo vsebovati podatke o prilagajanju odmerka, prenehanju zdravljenja in postopkih izločanja učinkovine v primeru povišanih vrednosti ALT.
• The Summary of Product Characteristics • Physician Leaflet
• Povzetek glavnih značilnosti zdravila • Navodilo za zdravnika.
Treatment lasted between six months and a year.
Zdravljenje je trajalo od šest mesecev do enega leta.
The exact way that they work in treating viral diseases is not fully understood, but it is thought that they act as immunomodulators (substances that modify how the immune system works).
Natančen način njihovega delovanja pri zdravljenju virusnih boleznih ni v celoti znan, vendar se domneva, da delujejo kot imunomodulatorji (snovi, ki spreminjajo način delovanja imunskega sistema).
The company presented the results of two main studies involving a total of 2,255 adults with hepatitis C infection who had not previously been treated.
Družba je predstavila rezultate dveh glavnih študij, ki sta vključevali skupaj 2 255 odraslih, okuženih s hepatitisom C, ki pred tem še niso bili zdravljeni.
The effects of Joulferon were first tested in experimental models before being studied in humans.
Učinki zdravila Joulferon so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
It was to be available as an injection pen and as vials.
Na voljo naj bi bilo kot injekcijski peresnik in viale.
The main measure of effectiveness was based on the level of hepatitis C virus circulating in the blood six months after the end of treatment.
Glavno merilo učinkovitosti je bila raven virusa hepatitisa C v krvi šest mesecev po koncu zdravljenja.
The company informed the CHMP that the withdrawal has no impact on ongoing clinical trials, and that it will continue to make Joulferon available to patients enrolled in these trials.
Družba je CHMP obvestila, da umik nima nobenega vpliva na klinična preskušanja, ki potekajo, in da bo zdravilo Joulferon še naprej na voljo bolnikom, ki so vključeni v ta preskušanja.
On 16 April 2010, Novartis Europharm Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Joulferon, for the treatment of hepatitis C infection.
Družba Novartis Europharm Limited je dne 16. aprila 2010 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za dovoljenje za promet z zdravilom Joulferon, namenjenim za zdravljenje okužb s hepatitisom C.
This means that the CHMP was still evaluating the initial documentation provided by the company.
To pomeni, da je CHMP takrat še ocenjeval začetno dokumentacijo, ki jo je predložila.
As the CHMP was evaluating the initial documentation provided by the company, it had not yet made any recommendations.
Ker je bil CHMP v postopku ocenjevanja začetne dokumentacije, ki jo je predložila družba, še ni podal nikakršnih priporočil.
Albinterferon alfa-2b is a ‘fusion protein' made up of interferon alfa-2b, which is already available in antiviral medicines in the European Union (EU), attached to a protein called albumin.
Albinterferon alfa-2b je „fuzijski protein“ iz interferona alfa-2b, ki je že na voljo v protivirusnih zdravilih v Evropski uniji (EU), in se veže na beljakovino, imenovano albumin.
What is Joulferon?
Kaj je zdravilo Joulferon?
Joulferon is a powder and solvent to be made up into a solution for injection.
Zdravilo Joulferon je prašek in topilo za pripravo raztopine za injiciranje.
Attaching the interferon to albumin helps to prolong its action against the hepatitis C virus after each injection.
Vezanje interferona na albumin omogoča, da na virus hepatitisa C po vsaki injekciji deluje dalj časa.
Joulferon was expected to be used to treat adults with long-term hepatitis C (a disease of the liver due to infection with the hepatitis C virus).
Zdravilo Joulferon naj bi se uporabljalo za zdravljenje odraslih z dolgotrajnim hepatitisom C (boleznijo jeter, ki je posledica okužbe z virusom hepatitisa C).
Both groups of patients also took ribavirin (another medicine used in hepatitis C).
Obe skupini bolnikov sta prejeli tudi ribavirin (drugo zdravilo proti hepatitisu C).
It contains the active substance albinterferon alfa-2b.
Vsebuje zdravilno učinkovino albinterferon alfa-2b.
The albinterferon alfa-2b in Joulferon is produced by a method known as ‘recombinant DNA technology': it is made by a yeast that has received a gene (DNA), which makes it able to produce albinterferon alfa2b.
Albinterferon alfa-2b, ki ga vsebuje zdravilo Joulferon, se proizvaja po metodi, imenovani „tehnologija rekombinantne DNK“: proizvaja ga bakterija, ki je prejela gen (DNK), s čimer lahko tvori albinterferon alfa-2b.
What was Joulferon expected to be used for?
Za kaj naj bi se zdravilo Joulferon uporabljalo?
It was to be used in adults whose liver was damaged and who had not previously been treated with interferon alfa (another medicine for hepatitis C).
Uporabljalo naj bi se pri bolnikih z okvaro jeter in pri tistih, ki pred tem niso bili zdravljeni z interferonom alfa (drugim zdravilom proti hepatitisu C).
How is Joulferon expected to work?
Kako naj bi zdravilo Joulferon delovalo?
The studies compared Joulferon with peginterferon alfa2a (another medicine used to treat hepatitis C).
V obeh študijah so zdravilo Joulferon primerjali s peginterferonom alfa-2a (drugim zdravilom za zdravljenje hepatitisa C).
The active substance in Joulferon, albinterferon alfa-2b, belongs to the group ‘interferons'.
Zdravilna učinkovina zdravila Joulferon, albinterferon alfa-2b, spada v skupino interferonov.
The general health of the animals was not affected.
Splošno zdravje živali ni bilo prizadeto.
The conjugate is adjuvanted to increase the level and duration of effect.
Konjugat je dodan za povečanje stopnje in trajanja učinka.
Aggressive and sexual (mounting) behaviours are also reduced.
Agresivno in spolno (zaskakovanje) vedenje je tudi zmanjšano.
An increasing proportion will return to normal function after this time.
Po tem času se bo povečan del vrnil v normalno funkcijo.
The frequency of adverse reactions is defined using the following convention:
Pogostost neželenih učinkov je določena po naslednjem dogovoru:
Avoid introduction of contamination.
Izogibajte se kontaminaciji.
This reflects the time needed for clearance of boar taint compounds already present at the time of vaccination as well as the variability of response between individual animals.
To odraža čas, ki je potreben za očiščenje sestavin vonja po merjascu, ki so že prisotne v času cepljenja kot tudi raznolikost odziva med posameznimi živalmi.
Seek prompt medical advice even if only a very small amount is injected and take the package leaflet with you.
Poiščite takojšen zdravniški nasvet čeprav je bila injicirana le majhna količina in vzemite navodilo za uporabo s seboj.
Advice to the user in the event of accidental self-injection:
Namenjeno uporabniku v primeru nenamernega samo-injiciranja:
This effect is apparent within one week of treatment but it may take up to 3 weeks for any existing concentrations of boar taint compounds to be reduced to insignificant levels.
Ta učinek je opazen v enem tednu po zdravljenju, vendar lahko traja do 3 tedne, da se obstoječe koncentracije vseh sestavin vonja po merjascu znižajo na nezaznaven nivo.
The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
SPC tabela 1 (dovoljene snovi) priloge Uredbe Komisije (EU) št.37/2010 določa, da MRL ni potreben ali pa, kot so uporabljene v tem zdravilu za uporabo v veterinarski medicini, niso vključene v Uredbo(ES) št. 470/2009.
In a small number of animals death occurred following the reaction, however most animals recovered without treatment and did not appear to react to subsequent vaccinations.
Zelo majhno število živali reakcije ni preživelo, večina živali pa si je opomogla brez zdravljenja, pri naslednjih cepljenjih pa se reakcije niso ponovile.
As skatole levels are not fully dependent on sexual status, both dietary and hygiene management procedures to reduce skatole levels are also important.
Ker nivo skatola ni popolnoma odvisen od spolnega statusa, je za znižanje nivoja skatola pomembno tako upravljanje s prehrano kot tudi s higieno.
Avoid injecting pigs that are wet and dirty.
Izogibajte se injiciranja mokrim in umazanim prašičem.
These may include a temporary reduction in sexual hormones and reproductive functions in both men and women and an adverse effect on pregnancy.
To lahko vključuje začasno zmanjšanje spolnih hormonov in reproduktivne funkcije tako pri moškem kot pri ženski ter neželen učinek na nosečnost.
The recommended time for slaughter is 4 to 6 weeks after the final injection.
Priporočen čas zakola je 4 do 6 tednov po zadnjem injiciranju.
In case of suspected misdosing, the animal should be revaccinated immediately.
V primeru suma nepravilnega odmerjanja, se živali nemudoma ponovno cepi.
This directly controls the production of androstenone and, by removing the inhibitory effect of testicular steroids on hepatic metabolism, indirectly reduces levels of skatole.
To direktno kontrolira nastanek androstenona ter z odstranitvijo inhibitornega učinka testikularnih steroidov na metabolizem jeter, indirektno zniža raven skatola.
The effects of immunisation derive from the reduction in testicular function resulting from reduced GnRF activity.
Učinki imunizacije izvirajo iz znižane funkcije testisov, ki je rezultat znižane GnRF aktivnosti.
The veterinary medicinal product must not be administered by pregnant women or those who may be pregnant.
Tega zdravila ne smejo dajati nosečnice ali ženske, ki bi lahko bile noseče.
A transient increase in body temperature of 0.2 to 1.7°C was observed during the 24 hours after administration, returning to normal after two days.
Prehodno povišanje telesne temperature za 0,2 do 1,7°C je bilo opaženo v 24 urah po dajanju, po dveh dneh pa se je vrnila na normalno.
As a guide, use a short needle to give 12 to 15 mm penetration.
Uporabite varnostno brizgo s kratko iglo, ki omogoči 12 do 15 mm penetracije.
The needle should be directed perpendicular to the skin surface.
Igla naj bo usmerjena pravokotno na površino kože.
Only healthy animals should be immunised.
Imunizira se lahko samo zdrave živali.
Reduction of androstenone and skatole levels has been demonstrated from 4 to 6 weeks post second vaccination.
Znižanje nivoja androstenona in skatola je bila dokazana od 4 do 6 tednov po drugem cepljenju.
Shelf life after first opening: 28 days at 2-8 °C.
Rok uporabnosti po prvem odpiranju stične ovojnine: 28 dni 2-8°C.