FrancophonIA/ELRC3.0 huggingface dataset:
English: This summary was last updated in September 2017.
Slovenian: Povzetek je bil nazadnje posodobljen septembra 2017.
English: EPAR summary for the public
Slovenian: Povzetek EPAR za javnost
English: The injection is given under the skin in the neck just behind the ear.
Slovenian: Injekcija se vbrizga pod kožo v vrat neposredno za ušesom.
English: The European Commission granted a marketing authorisation valid throughout the EU for Improvac on 11 May 2009.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Improvac, veljavno po vsej Evropski uniji, izdala 11. maja 2009.
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.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila Improvac je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: In case of skin or eye contact the affected area should be rinsed immediately with water.
Slovenian: V primeru stika s kožo ali očmi je treba prizadeto področje nemudoma izprati z vodo.
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.
Slovenian: To lahko vključujejo začasno zmanjšanje ravni spolnih hormonov in zmanjšano zmožnost razmnoževanja pri moških in ženskah, vključno s težavami z nosečnostjo.
English: It explains how the Agency assessed this veterinary medicine to recommend its authorisation in the European Union (EU) and its conditions of use.
Slovenian: Pojasnjuje, kako je agencija ocenila to zdravilo za uporabo v veterinarski medicini, na podlagi česar je priporočila njegovo odobritev v Evropski uniji (EU) in pogoje njegove uporabe.
English: This is a summary of the European public assessment report (EPAR) for Improvac.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Improvac.
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.
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini (CVMP) pri agenciji je zaključil, da so koristi zdravila Improvac večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: The first injection had a limited effect, but the second injection is followed by production of antibodies against GnRF.
Slovenian: Prva injekcija je imela omejen učinek, drugi injekciji pa je sledilo nastajanje protiteles proti GnRF.
English: What is Improvac and what is it used for?
Slovenian: Kaj je zdravilo Improvac in za kaj se uporablja?
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.
Slovenian: Najpogostejša neželena učinka zdravila Improvac (ki lahko prizadeneta več kot 1 prašiča od 10) sta oteklina na mestu injiciranja, ki sicer postopno izzveni, a pri 20 do 30 % živalih vseeno traja več kot šest tednov, in kratkotrajno povišanje telesne temperature za približno 0,5 ˚C v 24 urah po cepljenju.
English: It is not intended to provide practical advice on how to use Improvac.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: The risk of these effects occurring is greater after a second or subsequent accidental injection than after a first injection.
Slovenian: Tveganje za pojav teh učinkov je večje po drugem ali poznejšem nenamernem injiciranju kot po prvem injiciranju.
English: What are the precautions for the person who gives the medicine or comes into contact with the animal?
Slovenian: Kakšne previdnostne ukrepe mora upoštevati oseba, ki daje zdravilo ali pride v stik z živaljo?
English: Improvac must not be given to pigs by women who are or who may be pregnant.
Slovenian: Zdravila Improvac prašičem ne smejo dajati ženske, ki so ali bi lahko bile noseče.
English: Three field studies investigated the effectiveness of Improvac in reducing aggression and sexual behaviour in pigs.
Slovenian: V treh terenskih študijah so proučevali učinkovitost zdravila Improvac pri zmanjševanju agresivnosti in spolnega vedenja pri prašičih.
English: Improvac also reduces aggressive and sexual (mounting) behaviour in pigs.
Slovenian: Prav tako zmanjša agresivno in spolno vedenje (zaskakovanje) pri prašičih.
English: What is the withdrawal period in food-producing animals?
Slovenian: Kako dolgo traja karenca pri živalih, namenjenih za proizvodnjo hrane?
English: Why is Improvac approved?
Slovenian: Zakaj je bilo zdravilo Improvac odobreno?
English: Improvac starts to be effective within 1 week after the second injection.
Slovenian: Zdravilo Improvac začne učinkovati v enem tednu po drugi injekciji.
English: Boar taint is caused by the production and build-up of the natural compounds androstenone and skatole in the flesh of these animals.
Slovenian: Vonj po merjascu je posledica nastajanja in kopičenja naravnih spojin androstenona in skatola v mesu teh živali.
English: The first injection is from 8 weeks of age and the second 4 to 6 weeks before slaughter.
Slovenian: Prva injekcija se daje pri starosti od osem tednov dalje, druga pa od štiri do šest tednov pred zakolom.
English: Accidental self-injection of Improvac may produce similar effects in people to those seen in pigs.
Slovenian: Nenamerno samoinjiciranje zdravila Improvac lahko pri ljudeh povzroči podobne učinke kot pri prašičih.
English: The withdrawal period for meat from pigs treated with Improvac is ‘zero' days, which means there is no mandatory waiting time.
Slovenian: Karenca za meso prašičev, zdravljenih z zdravilom Improvac, je nič dni, kar pomeni, da ni obvezne čakalne dobe.
English: Improvac must only be used with a safety device including a needle guard and a mechanism to prevent accidental operation of the trigger.
Slovenian: Zdravilo Improvac se lahko uporablja samo z varnostnim pripomočkom, ki vključuje varovalo za iglo in mehanizem za preprečevanje naključnega delovanja sprožilca.
English: Boar taint is the offensive odour or taste which may be present in pork or pork products from non-castrated mature male pigs.
Slovenian: Vonj po merjascu je neprijeten vonj ali okus, ki je lahko prisoten v svinjini ali izdelkih iz prašičjega mesa nekastriranih dozorelih prašičih.
English: What benefits of Improvac have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Improvac izkazalo v študijah?
English: This temporarily inhibits release of steroids from the testicles, including androstenone, one of the two causes of boar taint.
Slovenian: S tem se začasno zavre sproščanje steroidov iz mod, vključno z androstenonom, ki je eden od dveh povzročiteljev vonja po merjascu.
English: What are the risks associated with Improvac?
Slovenian: Kakšna tveganja so povezana z zdravilom Improvac?
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.
Slovenian: Skatol, drugi glavni povzročitelj vonja po merjascu, nastaja v črevesju, njegova količina pa se zmanjša zaradi znižanih ravni spolnih hormonov, kar omogoča, da ga jetra učinkoviteje presnavljajo (razgrajujejo).
English: Improvac is used as an alternative to physical castration (removal of the testes) to reduce the presence of these compounds.
Slovenian: Zdravilo Improvac se uporablja kot alternativa fizični kastraciji (odstranitvi mod) za zmanjšanje prisotnosti teh spojin.
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.
Slovenian: Količina protiteles sčasoma upada, vendar jih je še vedno dovolj, da so zanesljivo učinkovita od štiri do šest tednov po drugi injekciji.
English: For the full list of restrictions and all side effects reported with Improvac, see the package leaflet.
Slovenian: Za celoten seznam omejitev in neželenih učinkov, o katerih so poročali pri uporabi zdravila Improvac, glejte navodilo za uporabo.
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.
Slovenian: V dveh študijah so dokazali zmanjšanje agresivnosti in zaskakovanja v enem do dveh tednih po drugi injekciji zdravila Improvac, v tretji študiji pa so proučevali samo dolgoročni učinek na agresivnost in zaskakovanje po štirih tednih.
English: In addition Improvac treated pigs had reduced blood levels of testosterone.
Slovenian: Poleg tega so imeli prašiči, zdravljeni z zdravilom Improvac, nižje ravni testosterona v krvi.
English: For further information, see the package leaflet.
Slovenian: Za več informacij glejte navodilo za uporabo.
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.
Slovenian: Zdravilo Improvac spodbudi imunski sistem prašiča k tvorbi protiteles proti gonadotropin sproščajočemu hormonu (GnRH), ki je del sistema, ki nadzoruje spolni razvoj.
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.
Slovenian: Ravni androstenona in skatola se znižajo v štirih do šestih tednih po drugi injekciji, agresivnost in spolno vedenje pa v enem do dveh tednih po drugi injekciji.
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.
Slovenian: Karenca je čas, ki mora preteči po uporabi zdravila, preden se lahko žival zakolje in meso uporabi za prehrano ljudi.
English: Improvac is given to male pigs as two injections with at least a 4 week interval.
Slovenian: Zdravilo se prašičem daje v obliki dveh injekcij z vsaj štiritedenskim razmakom.
English: Other information about Improvac?
Slovenian: Druge informacije o zdravilu Improvac
English: In case of accidental self-injection, medical advice should be sought immediately and the package leaflet or label shown to the doctor.
Slovenian: V primeru nenamernega samoinjiciranja nemudoma poiščite zdravniško pomoč in zdravniku pokažite navodilo za uporabo ali nalepko.
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.
Slovenian: V več terenskih študijah so imeli prašiči, zdravljeni z zdravilom Improvac, ob zakolu primerljive ravni androstenona in skatola kot kirurško kastrirani prašiči.
English: Special care should be taken to avoid accidental self-injection.
Slovenian: Da bi se izognili samoinjiciranju, je potrebna še posebna previdnost.
English: Improvac is a veterinary medicine used in male pigs to reduce ‘boar taint' in the meat obtained from them after slaughter.
Slovenian: Improvac je zdravilo za uporabo v veterinarski medicini, ki se uporablja pri prašičjih samcih za zmanjševanje vonja po merjascu v mesu, ki ga od njih pridobijo po zakolu.
English: Improvac is available as a solution for injection and can only be obtained with a prescription.
Slovenian: Zdravilo Improvac je na voljo v obliki raztopine za injiciranje, njegovo predpisovanje in izdaja pa je le na recept.
English: Improvac must not be given to female pigs or to male pigs intended for breeding.
Slovenian: Zdravilo Improvac se ne sme dajati svinjam ali prašičem, namenjenim za vzrejo.
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.
Slovenian: Zdravilna učinkovina v zdravilu Improvac je analog (tj. podobna snov) gonadotropin sproščajočega faktorja (GnRF), vezan na nosilno beljakovino, pridobljeno iz bakterije Corynebacterium diphtheriae.
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.
Slovenian: V povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo so bile vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in lastniki ali skrbniki živali.
English: Improvac gonadotropin releasing factor (GnRF) analogue-protein conjugate
Slovenian: Improvac analog gonadotropin sproščajočega faktorja (GnRF) - konjugiran protein
English: For practical information about using Improvac, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Improvac naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
English: For more information about treatment with Improvac, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Improvac naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
English: How is Improvac used?
Slovenian: Kako se zdravilo Improvac uporablja?
English: Improvac also contains a compound derived from the sugar dextran as an adjuvant (ingredient that strengthens the immune response).
Slovenian: Zdravilo Improvac kot dodatek (sestavino, ki okrepi imunski odziv) vsebuje tudi spojino, pridobljeno iz sladkorja dekstrana.
English: Improvac contains the active substance gonadotropin releasing factor (GnRF) analogue-protein conjugate.
Slovenian: Zdravilo Improvac vsebuje zdravilno učinkovino analog gonadotropin sproščajočega faktorja (GnRF)konjugiran protein.
English: How does Improvac work?
Slovenian: Kako zdravilo Improvac deluje?
English: This summary was last updated in 05-2012.
Slovenian: Povzetek je bil nazadnje posodobljen 05-2012.
English: It must also not be used in patients:
Slovenian: Prav tako se ne sme uporabljati pri bolnikih:
English: The European Commission granted a marketing authorisation valid throughout the European Union for Preotact on 24 April 2006.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Preotact, veljavno po vsej Evropski uniji, odobrila dne 24. aprila 2006.
English: The main measure of effectiveness was the rate of vertebral fractures after 18 months of treatment.
Slovenian: Glavno merilo učinkovitosti je bilo število vretenčnih zlomov po 18 mesecih zdravljenja.
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.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Preotact je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: It also increases the absorption of calcium from food and prevents too much calcium from being lost in the urine.
Slovenian: Poleg tega poveča absorpcijo kalcija iz hrane in preprečuje izgubo velike količine kalcija v urinu.
English: Preotact has been studied in one main study involving 2,532 women with postmenopausal osteoporosis.
Slovenian: Zdravilo Preotact so raziskovali v eni glavni študiji, ki je vključevala 2 532 žensk s postmenopavzalno osteoporozo.
English: • who have bone cancer or cancer that has spread to the bones,
Slovenian: • ki imajo kostnega raka ali raka, ki se je razširil na kosti;
English: About two-thirds of the women continued taking Preotact for up to two years, and their bone density was measured.
Slovenian: Okoli dve tretjini žensk je zdravilo Preotact jemalo še dve leti, pri čemer so merili njihovo kostno gostoto.
English: This is a summary of the European public assessment report (EPAR) for Preotact.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Preotact.
English: Other information about Preotact
Slovenian: Druge informacije o zdravilu Preotact
English: What benefit has Preotact shown during the studies?
Slovenian: Kakšne koristi je zdravilo Preotact izkazalo med študijami?
English: For more information about treatment with Preotact, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Preotact preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: What is the risk associated with Preotact?
Slovenian: Kakšna tveganja so povezana z zdravilom Preotact?
English: • who have a bone disease that is not osteoporosis,
Slovenian: • ki imajo kakršno koli drugo kostno bolezen, ki ni osteoporoza;
English: • who have any disorder that affects the calcium and phosphate balance in the body,
Slovenian: • ki imajo kakršno koli obolenje, ki vpliva na uravnavanje ravni kalcija in fosfatov v telesu;
English: The medicine can only be obtained with a prescription.
Slovenian: Izdaja zdravila je le na recept.
English: The recommended dose of Preotact is 100 micrograms, given once a day as an injection under the skin into the abdomen.
Slovenian: Priporočeni odmerek zdravila Preotact je 100 mikrogramov, ki se enkrat na dan injicira pod kožo v predel trebuha.
English: The CHMP decided that Preotact's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: CHMP je zaključil, da so koristi zdravila Preotact večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
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).
Slovenian: Najpogostejši neželeni učinki zdravila Preotact (opaženi pri več kot 1 od 10 bolnikov) so hiperkalciemija (visoka raven kalcija v krvi), hiperkalciurija (visoka raven kalcija v urinu) in navzeja (slabost).
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.
Slovenian: Najbolj se je tveganje zmanjšalo pri ženskah, ki so v preteklosti že imele zlomljena vretenca, in pri ženskah, ki so imele že na začetku pri merjenju nizko kostno gostoto hrbtenice, kar kaže na to, da so imele krhkejšo hrbtenico.
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.
Slovenian: Proizvaja se z metodo, znano kot „tehnologija rekombinantne DNK“, pri kateri bakterija prejme gen (DNK), s katerim lahko tvori hormon.
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.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Preotact, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: Gradually, the bones become thin and fragile, and more likely to break (fracture).
Slovenian: Kosti se tako postopoma redčijo in postajajo krhkejše ter posledično bolj lomljive (podvržene zlomu).
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).
Slovenian: Zdravilo Preotact je v primerjavi s placebom znatno zmanjšalo tveganje za vretenčni zlom: po 18 mesecih je bilo v skupini, ki je prejemala placebo, zabeleženih 42 vretenčnih zlomov (3,37 %), medtem ko je bilo v skupini, ki je prejemala zdravilo Preotact, zabeleženih 17 zlomov (1,32 %).
English: Osteoporosis is more common in women after the menopause, when the levels of the female hormone oestrogen fall.
Slovenian: Osteoporoza je pogostejša pri ženskah v obdobju po menopavzi, ko upade količina ženskega hormona estrogena.
English: Preotact must not be used in people who are hypersensitive (allergic) to parathyroid hormone or any of the other ingredients.
Slovenian: Zdravila Preotact ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) paratiroidni hormon ali katero koli drugo sestavino zdravila.
English: Why has Preotact been approved?
Slovenian: Zakaj je bilo zdravilo Preotact odobreno?
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).
Slovenian: Kostna gostota je bila prav tako glavno merilo v drugi študiji, v kateri so proučevali uporabo zdravila Preotact v kombinaciji z alendronatom (difosfonatom) ali brez njega.
English: Preotact parathyroid hormone
Slovenian: Preotact paratiroidni hormon
English: Patients may inject themselves once they have been trained (a user manual is supplied).
Slovenian: Bolnice si lahko zdravilo injicirajo same, potem ko so bile za to ustrezno usposobljene (navodila za uporabo so priložena).
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.
Slovenian: Ko se vložek vstavi v posebni injekcijski peresnik in se ta tesno privije ali ko se napolnjeni injekcijski peresnik pripravi za uporabo, se prašek in vehikel zmešata v raztopino za injiciranje.
English: The study of Preotact with alendronate showed that using alendronate after Preotact can bring further increases in bone density.
Slovenian: Študija uporabe zdravila Preotact v kombinaciji z alendronatom je pokazala, da lahko uporaba alendronata po jemanju zdravila Preotact še dodatno poveča kostno gostoto.
English: Osteoporosis happens when not enough new bone grows to replace the bone that is naturally broken down.
Slovenian: Do osteoporoze pride, ko tvorjenje nove kostne mase ni več zadostno, da bi nadomestilo naravno razgradnjo kosti.
English: Preotact was compared with placebo (a dummy treatment).
Slovenian: Zdravilo Preotact so primerjali s placebom (zdravilom brez zdravilne učinkovine).
English: Increases in bone density were also seen during the study.
Slovenian: V študiji so zabeležili tudi povečanje kostne gostote.
English: Preotact has been shown to significantly reduce vertebral (spine) fractures, but not hip fractures.
Slovenian: Dokazano je bilo, da zdravilo Preotact znatno zmanjšuje tveganje za vretenčne zlome (zlome hrbtenice), ne pa tudi tveganja za zlom kolka.
English: What is Preotact?
Slovenian: Kaj je zdravilo Preotact?
English: For the full list of all side effects with Preotact, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Preotact, glejte navodilo za uporabo.
English: The parathyroid hormone in Preotact is identical to the human parathyroid hormone.
Slovenian: Paratiroidni hormon v zdravilu Preotact je povsem enak človeškemu paratiroidnemu hormonu.
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.
Slovenian: Zdravilo Preotact se uporablja za zdravljenje osteoporoze (bolezni, ki povzroča krhkost kosti) pri ženskah v obdobju po menopavzi, pri katerih obstaja povečano tveganje za zlom kosti.
English: Preotact contains parathyroid hormone, which stimulates bone formation by acting on osteoblasts (bone forming cells).
Slovenian: Zdravilo Preotact vsebuje paratiroidni hormon, ki stimulira tvorbo kosti tako, da deluje na osteoblaste (celice, ki tvorijo kostno maso).