FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Slovenian: Glavno merilo učinkovitosti je bila raven virusa hepatitisa C v krvi šest mesecev po koncu zdravljenja.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: This means that the CHMP was still evaluating the initial documentation provided by the company.
Slovenian: To pomeni, da je CHMP takrat še ocenjeval začetno dokumentacijo, ki jo je predložila.
English: As the CHMP was evaluating the initial documentation provided by the company, it had not yet made any recommendations.
Slovenian: Ker je bil CHMP v postopku ocenjevanja začetne dokumentacije, ki jo je predložila družba, še ni podal nikakršnih priporočil.
English: 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.
Slovenian: 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.
English: What is Joulferon?
Slovenian: Kaj je zdravilo Joulferon?
English: Joulferon is a powder and solvent to be made up into a solution for injection.
Slovenian: Zdravilo Joulferon je prašek in topilo za pripravo raztopine za injiciranje.
English: Attaching the interferon to albumin helps to prolong its action against the hepatitis C virus after each injection.
Slovenian: Vezanje interferona na albumin omogoča, da na virus hepatitisa C po vsaki injekciji deluje dalj časa.
English: 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).
Slovenian: Zdravilo Joulferon naj bi se uporabljalo za zdravljenje odraslih z dolgotrajnim hepatitisom C (boleznijo jeter, ki je posledica okužbe z virusom hepatitisa C).
English: Both groups of patients also took ribavirin (another medicine used in hepatitis C).
Slovenian: Obe skupini bolnikov sta prejeli tudi ribavirin (drugo zdravilo proti hepatitisu C).
English: It contains the active substance albinterferon alfa-2b.
Slovenian: Vsebuje zdravilno učinkovino albinterferon alfa-2b.
English: 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.
Slovenian: 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.
English: What was Joulferon expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Joulferon uporabljalo?
English: 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).
Slovenian: 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).
English: How is Joulferon expected to work?
Slovenian: Kako naj bi zdravilo Joulferon delovalo?
English: The studies compared Joulferon with peginterferon alfa2a (another medicine used to treat hepatitis C).
Slovenian: V obeh študijah so zdravilo Joulferon primerjali s peginterferonom alfa-2a (drugim zdravilom za zdravljenje hepatitisa C).
English: The active substance in Joulferon, albinterferon alfa-2b, belongs to the group ‘interferons'.
Slovenian: Zdravilna učinkovina zdravila Joulferon, albinterferon alfa-2b, spada v skupino interferonov.
English: The general health of the animals was not affected.
Slovenian: Splošno zdravje živali ni bilo prizadeto.
English: The conjugate is adjuvanted to increase the level and duration of effect.
Slovenian: Konjugat je dodan za povečanje stopnje in trajanja učinka.
English: Aggressive and sexual (mounting) behaviours are also reduced.
Slovenian: Agresivno in spolno (zaskakovanje) vedenje je tudi zmanjšano.
English: An increasing proportion will return to normal function after this time.
Slovenian: Po tem času se bo povečan del vrnil v normalno funkcijo.
English: The frequency of adverse reactions is defined using the following convention:
Slovenian: Pogostost neželenih učinkov je določena po naslednjem dogovoru:
English: Avoid introduction of contamination.
Slovenian: Izogibajte se kontaminaciji.
English: 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.
Slovenian: 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.
English: Seek prompt medical advice even if only a very small amount is injected and take the package leaflet with you.
Slovenian: Poiščite takojšen zdravniški nasvet čeprav je bila injicirana le majhna količina in vzemite navodilo za uporabo s seboj.
English: Advice to the user in the event of accidental self-injection:
Slovenian: Namenjeno uporabniku v primeru nenamernega samo-injiciranja:
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: Zelo majhno število živali reakcije ni preživelo, večina živali pa si je opomogla brez zdravljenja, pri naslednjih cepljenjih pa se reakcije niso ponovile.
English: As skatole levels are not fully dependent on sexual status, both dietary and hygiene management procedures to reduce skatole levels are also important.
Slovenian: Ker nivo skatola ni popolnoma odvisen od spolnega statusa, je za znižanje nivoja skatola pomembno tako upravljanje s prehrano kot tudi s higieno.
English: Avoid injecting pigs that are wet and dirty.
Slovenian: Izogibajte se injiciranja mokrim in umazanim prašičem.
English: These may include a temporary reduction in sexual hormones and reproductive functions in both men and women and an adverse effect on pregnancy.
Slovenian: To lahko vključuje začasno zmanjšanje spolnih hormonov in reproduktivne funkcije tako pri moškem kot pri ženski ter neželen učinek na nosečnost.
English: The recommended time for slaughter is 4 to 6 weeks after the final injection.
Slovenian: Priporočen čas zakola je 4 do 6 tednov po zadnjem injiciranju.
English: In case of suspected misdosing, the animal should be revaccinated immediately.
Slovenian: V primeru suma nepravilnega odmerjanja, se živali nemudoma ponovno cepi.
English: This directly controls the production of androstenone and, by removing the inhibitory effect of testicular steroids on hepatic metabolism, indirectly reduces levels of skatole.
Slovenian: To direktno kontrolira nastanek androstenona ter z odstranitvijo inhibitornega učinka testikularnih steroidov na metabolizem jeter, indirektno zniža raven skatola.
English: The effects of immunisation derive from the reduction in testicular function resulting from reduced GnRF activity.
Slovenian: Učinki imunizacije izvirajo iz znižane funkcije testisov, ki je rezultat znižane GnRF aktivnosti.
English: The veterinary medicinal product must not be administered by pregnant women or those who may be pregnant.
Slovenian: Tega zdravila ne smejo dajati nosečnice ali ženske, ki bi lahko bile noseče.
English: 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.
Slovenian: 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.
English: As a guide, use a short needle to give 12 to 15 mm penetration.
Slovenian: Uporabite varnostno brizgo s kratko iglo, ki omogoči 12 do 15 mm penetracije.
English: The needle should be directed perpendicular to the skin surface.
Slovenian: Igla naj bo usmerjena pravokotno na površino kože.
English: Only healthy animals should be immunised.
Slovenian: Imunizira se lahko samo zdrave živali.
English: Reduction of androstenone and skatole levels has been demonstrated from 4 to 6 weeks post second vaccination.
Slovenian: Znižanje nivoja androstenona in skatola je bila dokazana od 4 do 6 tednov po drugem cepljenju.
English: Shelf life after first opening: 28 days at 2-8 °C.
Slovenian: Rok uporabnosti po prvem odpiranju stične ovojnine: 28 dni 2-8°C.
English: Accidental self-injection may produce similar effects in people to those seen in pigs.
Slovenian: Nenamerno samo-injiciranje lahko pri ljudeh povzroči enak učinek kot pri prašičih.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 11/05/ 2009
Slovenian: Datum pridobitve dovoljenja za promet: 11. maj 2009 Datum zadnjega podaljšanja dovoljenja za promet: 11/04/2014
English: Immunisation with Improvac induces an immune response against endogenous gonadotrophin releasing factor (GnRF), a factor that controls testicular function via the gonadotropic hormones LH and FSH.
Slovenian: Imunizacija z Improvac-om izzove imunski odgovor proti endogenemu gonadotropin sproščajočemu faktorju (GnRF), faktorju, ki kontrolira delovanje testisov preko gonadotropnih hormonov LH in FSH.
English: If self-injection with Improvac is suspected, reproductive physiology should be monitored by assay of testosterone or oestrogen levels (as appropriate).
Slovenian: Če sumite na samo-injiciranje z Improvac-om, je potrebno kontrolirati fiziologijo reprodukcije z določanjem nivoja testosterona ali estrogena (kot primerno).
English: Moreover, fully immunised boars develop metabolic characteristics typical of surgically castrated animals, including reduced concentrations of skatole, another key contributor to boar taint.
Slovenian: Poleg tega polno imunizirani merjasci razvijejo metabolične lastnosti, ki so tipične za kirurško kastrirane živali vključno z znižano koncentracijo skatola, drugim ključnim dejavnikom vonja po merjascu.
English: Accidental vaccination of male breeding stock may affect subsequent fertility.
Slovenian: Nenamerno cepljenje moške vzrejne črede lahko vpliva na poznejšo plodnost.
English: Clinically meaningful suppression of gonadal function should be managed with supportive endocrine replacement therapy until normal function returns.
Slovenian: Klinično pomembna supresija funkcij spolnih žlez naj se nadzira s podporno endokrino nadomestno terapijo dokler se ne povrne normalna funkcija.
English: Note that when using a safety vaccinator part of the needle will be covered by the needle guard and will not penetrate the pig.
Slovenian: Ko uporabljate varnostni aplikator, upoštevajte, da bo del igle prekrit s ščitnikom in ne bo penetriral v žival.
English: For use as an alternative to physical castration for the reduction of boar taint caused by the key boar taint compound androstenone, in entire male pigs following the onset of puberty.
Slovenian: Za uporabo kot alternativa fizični kastraciji za zmanjšanje vonja po merjascu, ki ga povzroča ključna sestavina vonja po merjascu androstenon v celotnem prašiču samcu po nastopu pubertete.
English: This leads to reduced production and concentration of testosterone and other testicular steroids, including androstenone, one of the main substances responsible for boar taint.
Slovenian: To vodi do zmanjšanega nastajanja in koncentracije testosterona in drugih testikularnih steroidov, vključno z androstenonom, ene izmed glavnih spojin, odgovornih za vonj po merjascu.
English: Accidental self-injection could temporarily affect reproductive physiology of both men and women and may adversely affect pregnancy.
Slovenian: Nenamerno samo-injiciranje lahko začasno vpliva na fiziologijo reprodukcije pri moškem in ženski in lahko škodljivo učinkuje na nosečnost.
English: Another key contributor to boar taint, skatole, may also be reduced as an indirect effect.
Slovenian: Druga ključna sestavina vonja po merjascu, skatol, se lahko zaradi indirektnega učinka zniža.
English: In the event of accidental self-injection, wash the injury thoroughly with clean running water.
Slovenian: V primeru nenamernega samo-injiciranja natančno operite poškodbo s čisto, tekočo vodo.
English: Water for injections
Slovenian: Voda za injiciranje
English: Reduction of aggressive and sexual (mounting) behaviours can be expected from 1 to 2 weeks post second vaccination.
Slovenian: Zmanjšanje agresivnega in spolnega (zaskakovanje) vedenja lahko pričakujemo od 1 do 2 tedna po drugem cepljenju.
English: Advice to the physician:
Slovenian: Namenjeno zdravniku:
English: Boars given an initial dose of Improvac are immunologically primed but retain their full testicular function until they receive the second dose, which induces a strong immune response to GnRF and causes temporary immunological suppression of testicular function.
Slovenian: Merjasci, ki prejmejo začetni odmerek Improvac-a, so osnovno imunizirani toda ohranijo svojo polno funkcijo testisov, dokler ne prejmejo drugega odmerka, ki inducira močan imunski odgovor proti GnRF in povzroči začasno imunološko supresijo funkcije testisov.
English: Depending on the type of safety vaccinator, pressure may also be put on the skin and push the needle a few millimetres deeper into the tissue.
Slovenian: Glede na vrsto varnostnega aplikatorja, ki ga uporabljate, bo morda potrebno nekoliko povečati pritisk na kožo in na ta način potisniti iglo nekoliko globje v tkivo.
English: (a synthetic peptide analogue of GnRF conjugated to diphtheria toxoid) Adjuvant:
Slovenian: (sintetični peptidni analog GnRF konjugiran na toksoid davice) Dodatek:
English: The largest reactions were seen around 7 days post administration when the maximum size was 13 x 7 cm. By two weeks post administration the maximum size had decreased to 8 x 4 cm, showing a gradual resolution of the local reactions.
Slovenian: Največje reakcije so bile vidne 7 dni po dajanju, ko je bila največja velikost 13 x 7 cm. Do drugega tedna po dajanju se je največja velikost zmanjšala na 8 x 4 cm, kar kaže na postopno izginevanje lokalne reakcije.
English: In case of skin contact, wash immediately with soap and water.
Slovenian: V primeru stika s kožo, takoj sperite z milom in vodo.
English: The active ingredient in this immunological is a synthetically produced analogue of GnRF, which is conjugated with an immunogenic carrier protein.
Slovenian: Zdravilna učinkovina v tem imunološkem zdravilu je sintetično izdelan analog GnRF, ki je konjugiran z imunogenim nosilnim proteinom.
English: A transient increase in rectal temperature (post-vaccination hyperthermia) of around 0.5 °C is very commonly observed during the 24-hours period post vaccination.
Slovenian: Prehodno povišanje rektalne temperature (post vakcinalna hipertermija) okoli 0,5 °C se lahko opazi v obdobju 24 ur po cepljenju.
English: If slaughter is intended to be later than 10 weeks after the second dose a third dose should be given 4 to 6 weeks before the planned slaughter date.
Slovenian: Če je zakol načrtovan kasneje kot 10 tednov po drugem odmerku, je treba 4 do 6 tednov pred načrtovanim datumom zakola žival cepiti s tretjim odmerkom.
English: If pigs cannot be slaughtered within this recommended period the available trial data support that pigs may still be sent for slaughter up to 10 weeks after the final injection with minimal risk of boar taint.
Slovenian: Če prašiči ne morejo biti zaklani v priporočenem obdobju, se lahko prašiče pošlje v klanje do 10 tednov po zadnjem injiciranju z minimalnim tveganjem za vonj po merjascu, kar je podprto z dosegljivimi podatki poskusov.
English: In very rare cases anaphylactoid type reactions (dyspnoea, collapse, cyanosis and hypersalivation associated with or without muscle twitching or emesis) have been observed within a few minutes after the first vaccination with a duration of up to 30 minutes.
Slovenian: V zelo redkih primerih so v nekaj minutah po prvem cepljenju opazili anafilaktoiden tip reakcije (dispneja, kolaps, cianoza in povečano slinjenje, v povezavi ali pa tudi brez povezave s trzanjem mišic ali bruhanjem), ki traja do 30 minut.
English: The veterinary medicinal product must only be used with a safety vaccinator which has a dual safety system providing both a needle guard and a mechanism to prevent accidental operation of the trigger.
Slovenian: Zdravilo se mora uporabljati samo z varnostnim aplikatorjem, ki ima dvojni varnostni sistem, opremljen z varovalom za iglo in s sistemom, ki preprečuje naključno delovanje sprožilca.
English: The risk of a physiological effect is greater after a second or subsequent accidental injection than after a first injection.
Slovenian: Tveganje za fiziološki učinek je večje po drugem ali poznejšem nenamernem samo-injiciranju kot po prvi injekciji.
English: Do not administer the veterinary medicinal product in the future.
Slovenian: V prihodnosti zdravila ne uporabljajte.
English: Diethylaminoethyl (DEAE)-Dextran, an aqueous, non-mineral oil-based adjuvant
Slovenian: Dietilaminoetil (DEAE)-dekstran, vodni, ne mineralni, dodatek na oljni osnovi
English: A reduction of typical male behaviour such as mounting and aggressiveness when mixed with non-penmates can be expected after the second vaccination.
Slovenian: Zmanjšanje tipičnega moškega obnašanja, kot sta zaskakovanje in agresivnost se pričakuje po drugem cepljenju.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Improvac solution for injection for pigs
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Improvac raztopina za injiciranje za prašiče
English: Do not use in male pigs intended for breeding.
Slovenian: Ne uporabite pri prašičih samcih, ki so namenjeni za vzrejo.
English: 1348 Louvain-la-Neuve BELGIUM
Slovenian: Rue Laid Burniat 1 1348 Louvain-la-Neuve BELGIJA
English: Induction of antibodies against GnRF to produce a temporary immunological suppression of testicular function.
Slovenian: Indukcija protiteles proti GnRF za dosego začasne imunološke supresije funkcije testisov.
English: STATEMENT OF ACTIVE SUBSTANCES One dose (2 ml) contains:
Slovenian: En odmerek (2 ml) vsebuje:
English: Improvac has been shown to be safe in male pigs from 8 weeks of age onwards.
Slovenian: Improvac je pokazal varno uporabo pri živalih v starosti od 8 tednov naprej.
English: Administer by subcutaneous injection in the neck, immediately behind the ear, using a safety vaccinator.
Slovenian: Injicirajte subkutano v vrat neposredno za ušesom.
English: Entire male pigs from 8 weeks of age onwards should be vaccinated with 2 doses of 2 ml at least 4 weeks apart, with the second dose normally given 4 to 6 weeks prior to slaughter.
Slovenian: Vsi prašiči samci od 8 tedna starosti dalje naj bodo cepljeni z 2 odmerkoma s po 2 ml vsaj 4 tedne narazen, z drugim odmerkom običajno 4 do 6 tednov pred zakolom.
English: To avoid intramuscular deposition and lesions, it is recommended to use a shorter needle to give 5 mm to 9 mm penetration in undersized pigs and pigs younger than 16 weeks of age.
Slovenian: Da bi preprečili nenamerno intramuskularno injiciranje, pri manjših prašičih in pujskih, mlajših od 16 tednov, priporočamo uporabo krajše igle, ki omogoči 5 do 9 mm penetracije.
English: CONTRAINDICATIONS Do not use in female pigs.
Slovenian: KONTRAINDIKACIJE Ne uporabite pri svinjah.
English: The onset of immunity (induction of anti-GnRF antibodies) can be expected within 1 week post second vaccination.
Slovenian: Začetek imunosti (indukcija proti-GnRF protiteles) se lahko pričakuje v enem tednu po drugem cepljenju.
English: Do not use in female pigs.
Slovenian: Ne uporabite pri svinjah.
English: SC Read package leaflet before use.
Slovenian: s.c. Pred uporabo preberite navodilo za uporabo.
English: Administration of a double dose of Improvac (4 ml) to 8 week old piglets very commonly resulted in palpable injection site reactions.
Slovenian: Po dajanju dvojnega odmerka Improvac-a (4 ml) 8 tednov starim prašičkom so bile pogoste tipljive reakcije na mestu injiciranja.
English: In case of eye contact, rinse immediately with copious amounts of water.
Slovenian: V primeru stika z očmi, takoj izperite z veliko količino vode.
English: Once broached, the container should be returned to the refrigerator and then can be broached once more during the next 28 days, then discarded immediately after use.
Slovenian: Načet vsebnik morajo vrnete v hladilnik in ga nato v naslednjih 28 dneh še enkrat odprete, nato pa zavržete takoj po uporabi.
English: The active substance, being a principle of biological origin intended to produce active immunity, is not within the scope of Regulation (EC) No 470/2009.
Slovenian: C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL) Učinkovina biološkega izvora namenjena vzbujanju aktivne imunosti, ni vključena v Uredbo(ES) št.
English: Polyethylene bottle of 100 ml (50 doses) or 250 ml (125 doses) sealed with a rubber closure and secured with an aluminium cap.
Slovenian: Polietilenska plastenka s po 100 ml (50 odmerki) ali 250 ml (125 odmerki) zaprta z gumijastim zamaškom in zavarovana z aluminijasto zaporko.
English: Special care should be taken to avoid accidental self-injection and needle stick injury when administering the veterinary medicinal product.
Slovenian: Posebej je treba paziti, da se pri dajanju zdravila izognete nenamernemu samo-injiciranju in poškodbi s konico igle.
English: These circumstances should be taken into account when choosing an appropriate needle length.
Slovenian: Pri odločitvi za dolžino igle, ki jo boste uporabili, upoštevajte zgoraj navedeno.
English: When administered to older pigs (14-23 weeks of age) injection site swellings ranging from 2 cm to 5 cm in diameter are commonly observed, and injection site reactions at slaughter are commonly observed if the second vaccination is given only 4 weeks before slaughter.
Slovenian: Pri dajanju starejšim prašičem (14-23 tednov starosti) so na mestu injiciranja pogosto opazne otekline razpona od 2 do 5 cm v premeru, če pa je bilo drugo cepljenje izvedeno samo 4 tedne pred klanjem, so pri zakolu pogosto opazne tudi reakcije na mestu injiciranja.
English: Polyethylene (HDPE) bottle of, 100 ml (50 doses) or 250 ml (125 doses) sealed with a rubber closure and secured with an aluminium cap.
Slovenian: Polietilenska (HDPE) plastenka s po , 100 ml (50 odmerki) ali 250 ml (125 odmerki) zaprta z gumijastim zamaškom in zavarovana z aluminijasto zaporko.