FrancophonIA/ELRC3.0 huggingface dataset:
English: This summary was last updated in September 2017.
Danish: Dette sammendrag blev sidst ajourført i september 2017.
English: The European Commission granted a marketing authorisation valid throughout the EU for Improvac on 11 May 2009.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Improvac den 11. maj 2009.
English: What is the withdrawal period in food-producing animals?
Danish: Hvad er tilbageholdelsestiden for levnedsmiddelproducerende dyr?
English: The injection is given under the skin in the neck just behind the ear.
Danish: Injektionen gives under huden i nakken lige bag øret.
English: EPAR summary for the public
Danish: EPAR - sammendrag for offentligheden
English: The full EPAR for Improvac can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Improvac findes på agenturets websted under: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Improvac.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Improvac.
English: In case of skin or eye contact the affected area should be rinsed immediately with water.
Danish: I tilfælde af hud- eller øjenkontakt skal det berørte område omgående skylles med vand.
English: The withdrawal period for meat from pigs treated with Improvac is ‘zero' days, which means there is no mandatory waiting time.
Danish: Tilbageholdelsestiden for kød fra svin, der behandles med Improvac, er "nul" dage, hvilket vil sige, at der ikke er nogen påkrævet ventetid.
English: These may include a temporary reduction in sex hormone levels and reduced ability to reproduce in men and in women, including problems with pregnancy.
Danish: Disse kan omfatte en midlertidig reduktion af kønshormonniveauerne og nedsat reproduktionsevne hos mænd og kvinder, herunder problemer med graviditet.
English: The withdrawal period is the time required after administration of a medicine before an animal can be slaughtered and the meat used for human consumption.
Danish: Tilbageholdelsestiden er den tid, der skal gå efter administration af et lægemiddel, før et dyr kan slagtes, og kødet kan anvendes til menneskeligt konsum.
English: Special care should be taken to avoid accidental self-injection.
Danish: Der bør udvises særlig omhu for at undgå utilsigtet selvinjektion.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Improvac's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Dyr (CVMP) konkluderede, at fordelene ved Improvac opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: What is Improvac and what is it used for?
Danish: Hvad er Improvac, og hvad anvendes det til?
English: It explains how the Agency assessed this veterinary medicine to recommend its authorisation in the European Union (EU) and its conditions of use.
Danish: Det forklarer, hvordan agenturet vurderede dette veterinærlægemiddel for at kunne anbefale udstedelse af en markedsføringstilladelse i EU og fastlægge anvendelsesbetingelserne.
English: Improvac also reduces aggressive and sexual (mounting) behaviour in pigs.
Danish: Improvac reducerer også aggressiv og seksuel adfærd (bedækningsadfærd) hos grisene.
English: What are the precautions for the person who gives the medicine or comes into contact with the animal?
Danish: Hvilke forholdsregler skal der træffes af den, der indgiver lægemidlet eller kommer i berøring med dyret?
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 injektion end efter den første injektion.
English: The most common side effects with Improvac (which may affect more than 1 in 10 pigs) are injection site swelling, which gradually resolves but in 20 to 30% of animals will last for more than 6 weeks, and a short-lived increase in body temperature of around 0.5 ˚C within 24 hours of vaccination.
Danish: De hyppigste bivirkninger ved Improvac (som kan forekomme hos mere end 1 ud af 10 grise) er hævelse omkring injektionsstedet, der fortager sig efterhånden, men som hos 20-30 % af dyrene kan vare i mere end 6 uger, samt en kortvarig temperaturstigning på ca. 0,5 ˚C inden for 24 timer efter vaccinationen.
English: It is not intended to provide practical advice on how to use Improvac.
Danish: Det er ikke en praktisk vejledning i, hvordan Improvac bør anvendes.
English: The first injection had a limited effect, but the second injection is followed by production of antibodies against GnRF.
Danish: Den første injektion har en begrænset virkning, mens den anden injektion resulterer i, at der dannes antistoffer mod GnRF.
English: Improvac must not be given to pigs by women who are or who may be pregnant.
Danish: Improvac må ikke gives til grise af gravide kvinder eller kvinder, der kan være gravide.
English: Improvac is used as an alternative to physical castration (removal of the testes) to reduce the presence of these compounds.
Danish: Improvac anvendes som et alternativ til fysisk kastration (fjernelse af testiklerne) for at reducere tilstedeværelsen af disse stoffer.
English: The levels of antibodies decline with time but are still high enough to be reliably effective 4 to 6 weeks after the second injection.
Danish: Niveauerne af antistoffer aftager med tiden, men de er stadig høje nok til at have en pålidelig virkning 4-6 uger efter den anden injektion.
English: Why is Improvac approved?
Danish: Hvorfor blev Improvac godkendt?
English: The first injection is from 8 weeks of age and the second 4 to 6 weeks before slaughter.
Danish: Den første injektion gives fra 8-ugers alderen, og den anden gives 4-6 uger inden slagtning.
English: Boar taint is caused by the production and build-up of the natural compounds androstenone and skatole in the flesh of these animals.
Danish: Ornelugten skyldes produktion og ophobning af de naturlige stoffer androstenon og skatol i vævet hos disse dyr.
English: Improvac must only be used with a safety device including a needle guard and a mechanism to prevent accidental operation of the trigger.
Danish: Improvac må kun anvendes med en sikkerhedsanordning, som omfatter en kanylebeskytter og en mekanisme, der forebygger utilsigtet aktivering af udløseren.
English: Skatole, the other major cause of boar taint, is produced in the intestines and levels are reduced since the reduced level of sex hormones allows the liver to metabolise (break it down) more efficiently.
Danish: Skatol, der er den anden årsag til ornelugt, og som produceres i tarmene, reduceres, fordi det nedsatte niveau af kønshormoner giver leveren mulighed for at metabolisere (nedbryde) skatol mere effektivt.
English: This temporarily inhibits release of steroids from the testicles, including androstenone, one of the two causes of boar taint.
Danish: Dette hæmmer midlertidigt frigivelsen af steroider fra testiklerne, herunder androstenon, som er et af de to steroider, der giver ornelugt.
English: In addition Improvac treated pigs had reduced blood levels of testosterone.
Danish: Derudover har Improvac-behandlede grise et reduceret niveau af testosteron i blodet.
English: Boar taint is the offensive odour or taste which may be present in pork or pork products from non-castrated mature male pigs.
Danish: Ornelugten er den ubehagelige lugt eller smag, som svinekød og svinekødsprodukter fra ikke-kastrerede modne hangrise kan have.
English: Improvac starts to be effective within 1 week after the second injection.
Danish: Improvacs virkning indtræder i løbet af 1 uge efter den anden injektion.
English: Androstenone and skatole levels are reduced from 4 to 6 weeks after the second injection and reduction of aggression and sexual behaviour is seen from 1 to 2 weeks after the second injection.
Danish: Androstenon- og skatolniveauerne reduceres fra 4-6 uger efter den anden injektion, og en nedsættelse af aggressiv og seksuel adfærd ses fra 1-2 uger efter den anden injektion.
English: In case of accidental self-injection, medical advice should be sought immediately and the package leaflet or label shown to the doctor.
Danish: Ved utilsigtet selvinjektion skal der straks søges lægehjælp, og indlægssedlen eller etiketten skal vises til lægen.
English: Improvac works by stimulating the pig's immune system to produce antibodies against gonadotropin-releasing hormone (GnRH), part of the system that controls sexual development.
Danish: Improvac virker ved at stimulere grisens immunsystem til at producere antistoffer mod gonadotropin-frigørende hormon (GnRH), der indgår i det system, som kontrollerer kønsmodningen.
English: Accidental self-injection of Improvac may produce similar effects in people to those seen in pigs.
Danish: Utilsigtet selvinjektion af Improvac kan hos mennesker medføre de samme virkninger som hos grise.
English: What are the risks associated with Improvac?
Danish: Hvilke risici er der forbundet med Improvac?
English: Three field studies investigated the effectiveness of Improvac in reducing aggression and sexual behaviour in pigs.
Danish: Tre feltundersøgelser har vurderet Improvacs effekt med hensyn til at reducere aggressiv og seksuel adfærd hos grise.
English: Improvac also contains a compound derived from the sugar dextran as an adjuvant (ingredient that strengthens the immune response).
Danish: Improvac indeholder også et stof, der er udvundet af sukkerarten dextran som en såkaldt adjuvans (et hjælpestof, der forstærker immunreaktionen).
English: Two studies showed reduction of aggression and mounting from 1 to 2 weeks after the second injection of Improvac, while the third studied the long term effect on aggression and mounting after 4 weeks only.
Danish: To af feltundersøgelserne viste reduceret aggression og bedækningsadfærd fra 1-2 uger efter den anden Improvac-injektion, mens den tredje undersøgelse kun vurderede langtidseffekten på aggression og bedækningsadfærd efter 4 uger.
English: Improvac is a veterinary medicine used in male pigs to reduce ‘boar taint' in the meat obtained from them after slaughter.
Danish: Improvac er et veterinærlægemiddel, der anvendes hos hangrise til reduktion af ornelugten i det kød, der opnås efter slagtning.
English: Other information about Improvac?
Danish: Andre oplysninger om Improvac
English: Improvac is given to male pigs as two injections with at least a 4 week interval.
Danish: Improvac gives til hangrise i form af 2 injektioner med mindst 4 ugers mellemrum.
English: For the full list of restrictions and all side effects reported with Improvac, see the package leaflet.
Danish: Den fuldstændige liste over begrænsninger og bivirkninger ved Improvac fremgår af indlægssedlen.
English: Safety information has been included in the summary of product characteristics and the package leaflet for Improvac, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.
Danish: Der er anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Improvac, herunder passende forholdsregler, som skal følges af sundhedspersoner og den, der er ejer af eller ansvarlig for dyret.
English: Improvac is available as a solution for injection and can only be obtained with a prescription.
Danish: Improvac fås som injektionsvæske og udleveres kun efter recept.
English: The active substance in Improvac is an analogue of (similar to) gonatadotropin releasing factor (GnRF) linked to a carrier protein obtained from the bacterium Corynebacterium diphtheriae.
Danish: Det aktive stof i Improvac er en analog til (kemisk beslægtet med) GnRH (gonadotropin-frigørende hormon), der er forbundet med et bærerprotein, som er udvundet af bakterien Corynebacterium diphtheriae.
English: Improvac gonadotropin releasing factor (GnRF) analogue-protein conjugate
Danish: Improvac gonadotropin-frigørende hormon (GnRH)-analogproteinkonjugat
English: Improvac must not be given to female pigs or to male pigs intended for breeding.
Danish: Improvac må ikke anvendes til sogrise eller til hangrise, der er beregnet til avl.
English: In a number of field studies pigs treated with Improvac were comparable to surgically castrated pigs in terms of levels of androstenone and skatole at slaughter.
Danish: En række feltundersøgelser har vist, at niveauet af androstenon og skatol ved slagtning hos Improvac-behandlede grise svarer til niveauet hos kirurgisk kastrerede grise.
English: Improvac contains the active substance gonadotropin releasing factor (GnRF) analogue-protein conjugate.
Danish: Improvac indeholder det aktive stof gonadotropin-frigørende hormon (GnRH)-analogproteinkonjugat.
English: What benefits of Improvac have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Improvac?
English: For further information, see the package leaflet.
Danish: De nærmere oplysninger fremgår af indlægssedlen.
English: How is Improvac used?
Danish: Hvordan anvendes Improvac?
English: For more information about treatment with Improvac, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Danish: Hvis du som ejer eller ansvarlig for dyret ønsker yderligere oplysninger om behandling med Improvac, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: For practical information about using Improvac, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Danish: Hvis du som ejer eller ansvarlig for dyret ønsker praktisk vejledning om anvendelsen af Improvac, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: How does Improvac work?
Danish: Hvordan virker Improvac?
English: This summary was last updated in 05-2012.
Danish: Dette sammendrag blev sidst ajourført i 05-2012.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Preotact on 24 April 2006.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Preotact den 24. april 2006.
English: EPAR summary for the public
Danish: EPAR sammendrag for offentligheden
English: The full EPAR for Preotact can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Preotact findes på agenturets websted: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This is a summary of the European public assessment report (EPAR) for Preotact.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Preotact.
English: The medicine can only be obtained with a prescription.
Danish: Lægemidlet udleveres kun efter recept.
English: It also increases the absorption of calcium from food and prevents too much calcium from being lost in the urine.
Danish: Det øger også optagelsen af calcium fra fødevarer og forebygger, at der går for meget calcium tabt i urinen.
English: Other information about Preotact
Danish: Andre oplysninger om Preotact
English: About two-thirds of the women continued taking Preotact for up to two years, and their bone density was measured.
Danish: Ca. to tredjedele af kvinderne fortsatte med at tage Preotact i op til 2 år, og deres knogletæthed blev målt.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Preotact.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Preotact.
English: It must also not be used in patients:
Danish: Preotact må ikke anvendes til patienter:
English: The risk reduction was higher in women who already had a fractured vertebra in the past, and in women whose score for spine bone density was already low at the start of the study, indicating that they had a more fragile spine.
Danish: Risikobegrænsningen var større hos kvinder, som allerede tidligere havde haft en brækket hvirvel, og hos kvinder, hvis score for knoglemassen i rygsøjlen allerede var lav ved undersøgelsens begyndelse, hvilket viser, at de havde en mere skrøbelig rygsøjle.
English: The main measure of effectiveness was the rate of vertebral fractures after 18 months of treatment.
Danish: Den vigtigste målestok for virkningen var hyppigheden af vertebrale frakturer efter 18 måneders behandling.
English: The CHMP decided that Preotact's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Preotact er større end risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: It is produced by a method known as ‘recombinant DNA technology': the hormone is made by a bacterium that has received a gene (DNA) that makes it able to produce it.
Danish: Det produceres via en metode, der er kendt som ‘rekombinant DNA-teknologi': Hormonet produceres af en bakterie, der har modtaget et gen (DNA), som gør den i stand til at producere dette stof.
English: • who have any disorder that affects the calcium and phosphate balance in the body,
Danish: • som har en eventuel lidelse, der påvirker calcium- og phosphatbalancen i kroppen,
English: • who have a bone disease that is not osteoporosis,
Danish: • som har en knoglesygdom, der ikke er osteoporose,
English: For more information about treatment with Preotact, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Preotact, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Preotact has been studied in one main study involving 2,532 women with postmenopausal osteoporosis.
Danish: Preotact blev undersøgt i én hovedundersøgelse med deltagelse af 2 532 kvinder med postmenopausal osteoporose.
English: The recommended dose of Preotact is 100 micrograms, given once a day as an injection under the skin into the abdomen.
Danish: Den anbefalede dosis af Preotact er 100 mikrogram givet en gang dagligt som en injektion under huden i abdomen.
English: Preotact was compared with placebo (a dummy treatment).
Danish: Preotact blev sammenlignet med placebo (en uvirksom behandling).
English: • who have bone cancer or cancer that has spread to the bones,
Danish: • som har knoglekræft eller kræft, der har spredt sig til knoglerne,
English: Preotact parathyroid hormone
Danish: Preotact parathyroidhormon
English: Osteoporosis happens when not enough new bone grows to replace the bone that is naturally broken down.
Danish: Osteoporose opstår, når der ikke dannes tilstrækkeligt knoglemasse til at erstatte den knoglemasse, som naturligt nedbrydes.
English: The bone density was also the main measure in another study, which looked at the use of Preotact with or without alendronate (a bisphosphonate).
Danish: Knogletætheden var også hovedmålestokken i en anden undersøgelse, som så nærmere på brugen af Preotact med eller uden alendronat (et bisphosphonat).
English: Gradually, the bones become thin and fragile, and more likely to break (fracture).
Danish: Gradvis bliver knoglerne tynde og skøre, og sandsynligheden for brud (fraktur) øges.
English: The most common side effects with Preotact (seen in more than 1 patient in 10) are hypercalcaemia (high blood calcium levels), hypercalciuria (high calcium levels in the urine) and nausea (feeling sick).
Danish: De hyppigste bivirkninger ved Preotact (som ses hos flere end 1 ud af 10 patienter) er hypercalcæmi (højt calciumindhold i blodet) hypercalcuri (højt calciumindhold i urinen) og kvalme.
English: Preotact significantly reduced the risk of having a vertebral fracture, in comparison with placebo: after 18 months, there were 42 vertebral fractures in the placebo group (3.37) and 17 in the Preotact group (1.32).
Danish: Efter 18 måneder var der 42 vertebrale frakturer i placebogruppen (3,37 ) og 17 i Preotact-gruppen (1,32 ).
English: Preotact must not be used in people who are hypersensitive (allergic) to parathyroid hormone or any of the other ingredients.
Danish: Preotact må ikke anvendes af personer, som er overfølsomme (allergiske) over for parathyroidhormon eller et af de øvrige stoffer.
English: The study of Preotact with alendronate showed that using alendronate after Preotact can bring further increases in bone density.
Danish: Undersøgelsen af Preotact med alendronat viste, at anvendelse af alendronat efter Preotact kunne bevirke yderligere forøgelser af knogletætheden.
English: When the cartridge is inserted in the special injection pen and the pen screwed together, or when the pre-filled pen is prepared for use, the powder and solvent mix to make up the solution for injection.
Danish: Når cylinderampullen sættes ind i den særlige injektionspen og pennen er skruet sammen, eller når den fyldte injektionspen gøres klar til anvendelse, blandes pulver og solvens, så de til sammen udgør opløsningen til injektion.
English: Osteoporosis is more common in women after the menopause, when the levels of the female hormone oestrogen fall.
Danish: Osteoporose er mere almindelig hos kvinder efter overgangsalderen, når mængden af det kvindelige hormon østrogen falder.
English: Patients may inject themselves once they have been trained (a user manual is supplied).
Danish: Patienterne kan give sig selv indsprøjtningen, når de har lært teknikken (der medfølger en brugsanvisning til pennen).
English: What is the risk associated with Preotact?
Danish: Hvilken risiko er der forbundet med Preotact?
English: Increases in bone density were also seen during the study.
Danish: I undersøgelsen blev der også observeret stigninger i knogletætheden.
English: The parathyroid hormone in Preotact is identical to the human parathyroid hormone.
Danish: Parathyroidhormonet i Preotact er identisk med det menneskelige parathyroidhormon.
English: Preotact is a medicine that contains the active substance parathyroid hormone.
Danish: Preotact er et lægemiddel, der indeholder det aktive stof parathyroidhormon.
English: Preotact has been shown to significantly reduce vertebral (spine) fractures, but not hip fractures.
Danish: Det er påvist, at Preotact i væsentlig grad begrænser forekomsten af vertebrale frakturer (i rygsøjlen), men ikke hoftefrakturer.
English: • who are having or have had radiation therapy to the skeleton,
Danish: • som har eller har fået stråleterapi på knoglerne,
English: Preotact is used for the treatment of osteoporosis (a disease that makes bones fragile) in postmenopausal women who are at high risk of fractures.
Danish: Preotact anvendes til behandling af osteoporose (en sygdom, der gør knogler skøre) hos postmenopausale kvinder, som er i højrisikogruppen for brud.
English: Preotact contains parathyroid hormone, which stimulates bone formation by acting on osteoblasts (bone forming cells).
Danish: Preotact indeholder parathyroidhormon, som stimulerer knogledannelsen ved at indvirke på osteoblasterne (knogledannende celler).
English: For the full list of all side effects with Preotact, see the package leaflet.
Danish: Den fuldstændige liste over alle bivirkningerne ved Preotact fremgår af indlægssedlen.
English: It is available as a powder and solvent, contained within a cartridge, to be made up into a solution for injection using a special injection pen.
Danish: Det fås som et pulver og solvens i en cylinderampul, der til sammen udgør en opløsning til injektion med en særlig injektionspen.
English: What is Preotact used for?
Danish: Hvad anvendes Preotact til?