FrancophonIA/ELRC3.0 huggingface dataset:
English: The active substance in Joulferon, albinterferon alfa-2b, belongs to the group ‘interferons'.
Danish: Det aktive stof i Joulferon, albinterferon alfa-2b, hører til gruppen af ”interferoner”.
English: Both groups of patients also took ribavirin (another medicine used in hepatitis C).
Danish: Begge patientgrupper fik også ribavirin (et andet lægemiddel til behandling af hepatitis C).
English: The studies compared Joulferon with peginterferon alfa2a (another medicine used to treat hepatitis C).
Danish: Undersøgelserne sammenlignede Joulferon med peginterferon alfa-2a (et andet lægemiddel til behandling af hepatitis C).
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).
Danish: Joulferon forventedes anvendt til behandling af voksne patienter med langvarig hepatitis C (leverbetændelse forårsaget af hepatitis C-virus).
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.
Danish: Joulferon fremstilles ved hjælp af en metode kaldet ”rekombinant dna-teknologi”": Det fremstilles af en gærcelle, som har modtaget et gen (dna), der sætter den i stand til at producere albinterferon alfa-2b.
English: An increasing proportion will return to normal function after this time.
Danish: En stigende andel vil herefter vende tilbage til normalfunktion.
English: ATCvet code: QG03XA91.
Danish: ATCvet-kode: QG03XA91.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 11/05/ 2009
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 11/05/2009
English: The general health of the animals was not affected.
Danish: Dyrenes almene sundhed blev ikke påvirket.
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.
Danish: I et lille antal dyr indtraf døden efter reaktionen, men de fleste dyr kom sig uden behandling og syntes ikke at reagere på de efterfølgende vaccinationer.
English: A gradual resolution of the local reactions occurs, but in 20-30% of the animals these may persist for more than 42 days.
Danish: De lokale reaktioner forsvinder gradvist, men hos 20-30 % af dyrene kan de vare i mere end 42 dage.
English: The veterinary medicinal product must not be administered by pregnant women or those who may be pregnant.
Danish: Veterinærlægemidlet må ikke administreres af gravide kvinder eller kvinder, der kan være gravide.
English: Advice to the user in the event of accidental self-injection:
Danish: Råd til brugeren i tilfælde af utilsigtet selvinjektion:
English: Only healthy animals should be immunised.
Danish: Kun raske dyr bør immuniseres.
English: Administer by subcutaneous injection in the neck, immediately behind the ear, using a safety vaccinator.
Danish: Administreres som subkutan injektion i nakken, lige bag øret, under anvendelse af en sikkerhedsvaccinator.
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.
Danish: Hjælpestofferne (inklusive adjuvanser) anført under punkt 6.1 i SPC'et er enten tilladte hjælpestoffer, hvor tabel 1 i bilaget til Kommissionens forordning (EU) Nr. 37/2010 indikerer, at MRL-værdier ikke er påkrævet, eller som ikke anses for at være omfattet af Forordning (EC) nr. 470/2009, når de anvendes i dette veterinærlægemiddel.
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.
Danish: Afhængig af typen af sikkerhedsvaccinator, vil der også kunne udløses et tryk mod huden og skubbe kanylen nogle få millimeter dybere ind i vævet.
English: Advice to the physician:
Danish: Råd til lægen:
English: Seek prompt medical advice even if only a very small amount is injected and take the package leaflet with you.
Danish: Søg omgående lægehjælp, også selvom det kun drejer sig om en meget lille mængde, og tag indlægssedlen med dig.
English: Date of last renewal: 10/04/2014
Danish: Dato for seneste fornyelse af markedsføringstilladelse: 10/04/2014
English: As skatole levels are not fully dependent on sexual status, both dietary and hygiene management procedures to reduce skatole levels are also important.
Danish: Da skatolniveauet ikke er fuldstændig afhængigt af seksualstatus, er både fodermæssige og hygiejniske kontrolprocedurer til reduktion af skatolniveauer ligeledes vigtige.
English: Avoid injecting pigs that are wet and dirty.
Danish: Undgå at vaccinere grise, som er våde og snavsede.
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.
Danish: Bemærk, at hvis der anvendes en sikkerhedsvaccinator, vil en del af kanylen være dækket af kanylebeskytter og vil ikke penetrere grisen.
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.
Danish: Dette afspejler den tid, der er nødvendig for clearance af ornelugtfremkaldende stoffer, der allerede er til stede på vaccinationstidspunktet samt variabiliteten i respons mellem de enkelte dyr.
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.
Danish: Dette medfører nedsat produktion og koncentration af testosteron og andre testikelsteroider, herunder androstenon, en af de hovedsubstanser, der er ansvarlige for ornelugt.
English: In case of skin contact, wash immediately with soap and water.
Danish: Ved hudkontakt afvaskes straks med sæbe og vand.
English: After first broaching with a sterile needle, the container should be returned to the refrigerator.
Danish: Efter første anbrud med en steril nål skal flasken stilles i køleskab.
English: If self-injection with Improvac is suspected, reproductive physiology should be monitored by assay of testosterone or oestrogen levels (as appropriate).
Danish: Hvis der er mistanke om selvinjektion med Improvac, skal reproduktionsfysiologien overvåges ved målinger af testosteron- eller østrogenniveauer (efter omstændighederne).
English: Moreover, fully immunised boars develop metabolic characteristics typical of surgically castrated animals, including reduced concentrations of skatole, another key contributor to boar taint.
Danish: Endvidere udvikler fuldt immuniserede orner metaboliske karakteristika, der er typiske for kirurgisk kastrerede dyr herunder reducerede koncentrationer af skatol, der er en anden nøglesubstans for ornelugt.
English: A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Danish: Beslutning om at anvende denne vaccine før eller efter et andet veterinært lægemiddel skal derfor foretages fra gang til gang.
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.
Danish: Den største reaktion blev set ca. 7 dage efter administration med en maksimal størrelse på 13 ×7 cm. To uger efter administrationen var den maksimale størrelse aftaget til 8 ×4 cm, og der sås en gradvis reduktion af de lokale reaktioner.
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.
Danish: For at undgå intramuskulær aflejring og læsioner, anbefales det at anvende en kortere kanyle for at opnå en penetration på 5 mm til 9 mm hos meget små grise og grise, der er yngre end 16 uger.
English: In the event of accidental self-injection, wash the injury thoroughly with clean running water.
Danish: Ved utilsigtet selvinjektion skal skadestedet vaskes grundigt med rent, rindende vand.
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.
Danish: Immunisering med Improvac medfører et immunrespons mod endogen gonadotropin-releasing factor (GnRF), en faktor som kontrollerer testikelfunktion via de gonadotrope hormoner LH og FSH.
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.
Danish: Aktiv substans som principielt er af biologisk oprindelse hvis formål er at producere aktiv immunitet falder ikke indenfor anvendelsesområdet af Forordning (EF) nr. 470/2009 når det anvendes som i dette veterinære lægemiddel.
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.
Danish: Hvis slagtning er planlagt til senere end 10 uger efter den anden dosis, skal der gives en tredje dosis 4-6 uger inden den planlagte slagtningsdato.
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.
Danish: Dette nedsætter direkte androstenonproduktionen, og, ved at fjerne testikelhormonernes hæmmende virkning på den hepatiske metabolisme reducerer det indirekte skatolkoncentrationen.
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.
Danish: Hvis grisen ikke kan slagtes inden for denne periode, understøtter tilgængelige data, at grise stadig kan sendes til slagtning op til 10 uger efter den afsluttende vaccination med minimal risiko for ornelugt.
English: The recommended time for slaughter is 4 to 6 weeks after the final injection.
Danish: Det anbefalede tidspunkt for slagtning er 4 til 6 uger efter den afsluttende injektion.
English: In case of eye contact, rinse immediately with copious amounts of water.
Danish: Ved øjenkontakt skylles straks med rigelige mængder vand.
English: The conjugate is adjuvanted to increase the level and duration of effect.
Danish: Konjugatet er tilsat en adjuvans, som øger niveauet og virkningens varighed.
English: GnRF analogue-protein conjugate: Zoetis Belgium SA Rue Laid Burniat 1
Danish: GnRF - analog - proteinkonjugat: Zoetis Belgium SA Rue Laid Burniat 1
English: The veterinary medicinal product should be stored safely out of the reach of children.
Danish: Veterinærlægemidlet skal opbevares sikkert og utilgængeligt for børn.
English: EXPIRY DATE EXP {month/year} Once broached, use by ...
Danish: 10. UDLØBSDATO EXP {måned/år} Efter anbrud, anvendes inden ....
English: These may include a temporary reduction in sexual hormones and reproductive functions in both men and women and an adverse effect on pregnancy.
Danish: Disse indbefatter en midlertidig reduktion i kønshormoner og reproduktive funktioner hos både mænd og kvinder og uønskede virkninger på graviditet.
English: Administration of a double dose of Improvac (4 ml) to 8 week old piglets very commonly resulted in palpable injection site reactions.
Danish: Administration af en dobbeltdosis Improvac (4 ml) til 8 uger gamle pattegrise resulterede meget hyppigt i palpable reaktioner på injektionsstedet.
English: Synthetic GnRF peptide analogue: Auspep Clinical Peptides PTY Ltd. 15, Mareno Road, Tullamarine, 3052 Victoria
Danish: Auspep Clinical Peptides PTY Ltd. 15, Mareno Road, Tullamarine, 3052 Victoria AUSTRALIEN
English: Marketing authorisation holder and manufacturer responsible for batch release: Zoetis Belgium SA
Danish: Indehaver af markedsføringstilladelsen og fremstiller ansvarlig for batchfrigivelse: Zoetis Belgium SA
English: Aggressive and sexual (mounting) behaviours are also reduced.
Danish: Aggressivitet og bedækningsadfærd bliver også reduceret.
English: Do not administer the veterinary medicinal product in the future.
Danish: Du må ikke fremover administrere veterinærlægemidlet.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One dose (2 ml) contains:
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Én dosis (2 ml) indeholder:
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.
Danish: I meget sjældne tilfælde er anafylaktiske reaktioner (dyspnø, sammenbrud, cyanose og øget spytafsondring, med eller uden muskeltrækninger eller opkastning) blevet observeret inden for et par minutter efter den første vaccination med varighed op til 30 minutter.
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.
Danish: Veterinærlægemidlet må kun anvendes med en sikkerhedsvaccinator, som har et dobbelt sikkerhedssystem med både en kanylebeskytter og en mekanisme, der forebygger utilsigtet aktivering af udløseren.
English: As a guide, use a short needle to give 12 to 15 mm penetration.
Danish: Som en rettesnor kan en kort kanyle med 12-15 mm penetration anvendes.
English: SPECIAL WARNING(S), IF NECESSARY Accidental self-injection is dangerous.
Danish: SÆRLIG(E) ADVARSEL/ADVARSLER, OM NØDVENDIGT Utilsigtet selvinjektion er farlig.
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.
Danish: Virkningen ses inden for den første uge af behandlingen, men det kan vare op til 3 uger inden alle tilstedeværende koncentrationer af ornelugt er reduceret til ubetydelige niveauer.
English: Excipient: Chlorocresol
Danish: Hjælpestof: Chlorcresol
English: The container can be broached once more only during the next 28 days, then discarded immediately after use.
Danish: Flasken kan brydes kun en gang til inden 28 dage, hvorefter den kasseres umiddelbart efter anvendelse.
English: In case of suspected misdosing, the animal should be revaccinated immediately.
Danish: Hvis der er mistanke om hvorvidt en dosis er givet korrekt, skal dyret straks revaccineres.
English: Accidental self-injection could temporarily affect reproductive physiology of both men and women and may adversely affect pregnancy.
Danish: Utilsigtet selvinjektion kan midlertidigt påvirke reproduktionsfysiologien hos både mænd og kvinder og kan have uønskede virkninger på graviditet.
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.
Danish: En forbigående stigning i legemstemperaturen fra 0,2 til 1,7 °C blev observeret i en 24-timers periode efter vaccinationen, med tilbagevenden til normaltemperaturen efter to dage.
English: Diethylaminoethyl (DEAE)-Dextran, an aqueous, non-mineral oil-based adjuvant
Danish: Diethylaminoethyl (DEAE)-dextran, en vandig, ikke-mineralsk oliebaseret adjuvans
English: The effects of immunisation derive from the reduction in testicular function resulting from reduced GnRF activity.
Danish: Virkningen af immuniseringen hidrører fra reduktion af testikelfunktionen, der er et resultat af nedsat GnRF-aktivitet.
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.
Danish: Orner, der får en initialdosis Improvac, er immunologisk 'primet', men bevarer deres fulde testikelfunktion, indtil de får den anden dosis, som inducerer et stærkt immunrespons mod GnRF og medfører midlertidig immunologisk undertrykkelse af testikelfunktionen.
English: The patient should be advised not to administer Improvac and/or any other veterinary medicinal products with similar action in the future.
Danish: Patienterne skal frarådes at administrere Improvac og/eller andre veterinærlægemidler med tilsvarende virkning fremover.
English: The patient should be advised not to administer Improvac and/or any other product with similar action in the future.
Danish: Patienterne skal frarådes at administrere Improvac og/eller andre lægemidler med tilsvarende virkning fremover.
English: Accidental vaccination of male breeding stock may affect subsequent fertility.
Danish: Utilsigtet vaccination af hangrise til avl kan efterfølgende påvirke fertiliteten.
English: The active ingredient in this immunological is a synthetically produced analogue of GnRF, which is conjugated with an immunogenic carrier protein.
Danish: Det aktive stof i Improvac er en syntetisk fremstillet analog af GnRF, som er konjugeret med et immunogent bærerprotein.
English: Do not use in male pigs intended for breeding.
Danish: Må ikke anvendes til hangrise, der er beregnet til avl.
English: Reduction of aggressive and sexual (mounting) behaviours can be expected from 1 to 2 weeks post second vaccination.
Danish: Reduktion af aggressive og seksuelle (montage) adfærd kan forventes fra 1 til 2 uger efter anden vaccination.
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER AF DET BIOLOGISK AKTIVE STOF OG FREMSTILLER(E) ANSVARLIG FOR BATCHFRIGIVELSE
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY OR USE C. STATEMENT OF THE MRLs
Danish: BILAG II A. FREMSTILLER AF DET BIOLOGISK AKTIVE STOF OG FREMSTILLER(E) ANSVARLIG FOR BATCHFRIGIVELSE B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG BRUG C. ANGIVELSE AF MRL-VÆRDIER
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.
Danish: Hangrise fra 8 uger og derover bør vaccineres med 2 doser à 2 ml med mindst 4 ugers mellemrum, hvor den anden dosis sædvanligvis gives 4-6 uger inden slagtning.
English: Accidental self-injection may produce similar effects in people to those seen in pigs.
Danish: Utilsigtet selvinjektion kan medføre ens virkninger hos mennesker og grise.
English: The onset of immunity (induction of anti-GnRF antibodies) can be expected within 1 week post second vaccination.
Danish: Virkningen af immunisering (dannelse af anti-GnRF-antistoffer) kan forventes inden for 1 uge efter anden vaccination.
English: Male pigs (from 8 weeks of age).
Danish: Hangris (fra 8 uger).
English: Induction of antibodies against GnRF to produce a temporary immunological suppression of testicular function.
Danish: Induktion af antistoffer mod GnRF for at inducere en midlertidig immunologisk suppression af testikelfunktionen.
English: WITHDRAWAL PERIOD (S) Withdrawal period(s): Zero days.
Danish: TILBAGEHOLDELSESTID(ER) Tilbageholdelsestid: 0 dage.
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.
Danish: En forbigående forøget rektaltemperatur (postvaccinationshypertermi) på ca. 0,5 °C kan ses i 24 timer efter vaccination.
English: A reduction of typical male behaviour such as mounting and aggressiveness when mixed with non-penmates can be expected after the second vaccination.
Danish: Reduktion af typisk orneadfærd, f.eks. opspring på stifæller og aggressivitet, kan forventes efter den anden vaccination.
English: (a synthetic peptide analogue of GnRF conjugated to diphtheria toxoid) Adjuvant:
Danish: (en syntetisk peptidanalog til GnRF konjugeret til difteritoksoid) Adjuvans:
English: Outer packaging:
Danish: Ydre emballage:
English: Polyethylene bottle of 100 ml (50 doses) or 250 ml (125 doses) sealed with a rubber closure and secured with an aluminium cap.
Danish: Polyethylenflaske med 100 ml (50 doser) eller 250 ml (125 doser), forseglet med gummilukke og sikret med en hætte af aluminium.
English: When administered to pigs at the youngest recommended age (8 weeks), injection site swellings of up to 4 x 8 cm are very commonly observed.
Danish: Når lægemidlet administreres til grise på den laveste anbefalede alder (8 uger), er hævelser på injektionsstedet på op til 4 × 8 cm meget almindeligt.
English: Pharmacotherapeutic group: Gonadotropin releasing factor analogue, conjugated.
Danish: Farmakoterapeutisk gruppe: gonadotropin-releasing analog, konjugeret.
English: TARGET SPECIES Male pigs (from 8 weeks of age).
Danish: DYREARTER Hangris (fra 8 uger).
English: Reduction of androstenone and skatole levels has been demonstrated from 4 to 6 weeks post second vaccination.
Danish: Der er påvist reduktion af androstenon og skatol fra 4 til 6 uger efter anden vaccination.
English: STATEMENT OF ACTIVE SUBSTANCES One dose (2 ml) contains:
Danish: ANGIVELSE AF AKTIVE STOFFER En dosis (2 ml) indeholder:
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.
Danish: Når lægemidlet gives til ældre grise (14-23 uger) er hævelser på 2 cm til 5 cm i diameter ved injektionsstedet en almindelig observation, og reaktioner på injektionsstedet ved slagtning ses almindeligvis, hvis anden vaccination gives blot 4 uger før slagtning.
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.
Danish: Polyethylen (HDPE)-flaske med 100 ml (50 doser) eller 250 ml (125 doser), forseglet med gummiprop og sikret med en hætte af aluminium.
English: Improvac has been shown to be safe in male pigs from 8 weeks of age onwards.
Danish: Improvacs sikkerhed er påvist hos hangrise fra 8 uger og derover.
English: The risk of a physiological effect is greater after a second or subsequent accidental injection than after a first injection.
Danish: Risikoen for en fysiologisk virkning er større efter anden eller en efterfølgende utilsigtet vaccination end efter den første injektion.
English: The risk of these effects occurring is greater after a second or subsequent accidental injection than after a first injection.
Danish: Risikoen for forekomst af disse virkninger er større efter anden eller en efterfølgende utilsigtet vaccination end efter den første injektion.
English: Clinically meaningful suppression of gonadal function should be managed with supportive endocrine replacement therapy until normal function returns.
Danish: Suppression af kønskirtlerne behandles med en klinisk tilfredsstillende endokrin substitutionsterapi, ind til den normale funktion vender tilbage.
English: − very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Danish: − Meget sjælden (færre end 1 dyr ud af 10.000 behandlede dyr, herunder isolerede rapporter).
English: CONTRAINDICATIONS Do not use in female pigs.
Danish: KONTRAINDIKATIONER Må ikke anvendes til sogrise.
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.
Danish: Anvendes som alternativ til fysisk kastration til reduktion af ornelugt forårsaget af androstenon, der er nøglesubstansen for ornelugt hos ikke-kastrerede hangrise efter begyndt kønsmodning.
English: STATEMENT OF ACTIVE SUBSTANCES GnRF analogue-protein conjugate min. 300 µg/2 ml
Danish: ANGIVELSE AF AKTIVE STOFFER GnRF analog-proteinkonjugat min. 300 µg/2 ml