natgillin/translations-raw huggingface dataset:
EPAR summary for the public
Kokkuvõte üldsusele
The European Commission granted a marketing authorisation valid throughout the EU for Improvac on 11 May 2009.
Euroopa Komisjon andis Improvaci müügiloa, mis kehtib kogu Euroopa Liidus, 11. mail 2009.
The full EPAR for Improvac can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Euroopa avaliku hindamisaruande täistekst Improvaci kohta on ameti veebilehel: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
The injection is given under the skin in the neck just behind the ear.
Vaktsiini süstitakse kaelanaha alla, otse kõrva taha.
Improvac must not be given to pigs by women who are or who may be pregnant.
Improvaci ei tohi sigadele manustada naised, kes on või võivad olla rasedad.
This summary was last updated in September 2017.
Kokkuvõtte viimane uuendus: 09-2017.
Improvac also reduces aggressive and sexual (mounting) behaviour in pigs.
Improvac vähendab sigadel ka agressiivset ja seksuaalset käitumist (selgatõusmine).
What is the withdrawal period in food-producing animals?
Kui pikk on keeluaeg toiduloomadel?
It explains how the Agency assessed this veterinary medicine to recommend its authorisation in the European Union (EU) and its conditions of use.
Selles selgitatakse, kuidas amet hindas veterinaarvaktsiini, et soovitada müügiloa andmist Euroopa Liidus ja kasutustingimusi.
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.
Veterinaarravimite komitee järeldas, et Improvaci kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas vaktsiini kasutamise Euroopa Liidus heaks kiita.
What is Improvac and what is it used for?
Mis on Improvac ja milleks seda kasutatakse?
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.
Improvaci kõige sagedamad kõrvaltoimed (võivad esineda enam kui 1 loomal 10st) on süstekoha turse, mis taandub aja jooksul, kuid 20-30%-l loomadest võib see püsida kauem kui 6 nädalat, ning lühiajaline kehatemperatuuri tõus ligikaudu 0,5 °C võrra 24 tunni jooksul vaktsineerimisest.
This is a summary of the European public assessment report (EPAR) for Improvac.
See on vaktsiini Improvac Euroopa avaliku hindamisaruande kokkuvõte.
Improvac starts to be effective within 1 week after the second injection.
Improvaci toime avaldub 1 nädala jooksul pärast teist süstet.
These may include a temporary reduction in sex hormone levels and reduced ability to reproduce in men and in women, including problems with pregnancy.
Muu hulgas võib see ajutiselt vähendada suguhormoonide sisaldust ning meeste ja naiste viljakust, sh tekitada rasedusprobleeme.
Why is Improvac approved?
Miks Improvac heaks kiideti?
Three field studies investigated the effectiveness of Improvac in reducing aggression and sexual behaviour in pigs.
Kolmes väliuuringus uuriti Improvaci efektiivsust agressiivse ja seksuaalse käitumise vähendamisel.
Improvac must only be used with a safety device including a needle guard and a mechanism to prevent accidental operation of the trigger.
Improvaci peab kasutama üksnes koos ohutusseadmega, millel on nõelakaitse ja mehhanism, mis takistab päästiku juhuslikku vajutamist.
The first injection is from 8 weeks of age and the second 4 to 6 weeks before slaughter.
Esimene süst tehakse alates 8. elunädala vanuses ja teine 4-6 nädalat enne tapmist.
Improvac is given to male pigs as two injections with at least a 4 week interval.
Improvaci manustatakse kultidele kahe süstena, vähemalt 4-nädalase vaheajaga.
The withdrawal period for meat from pigs treated with Improvac is ‘zero' days, which means there is no mandatory waiting time.
Improvaciga vaktsineeritud sigade liha keeluaeg on 0 päeva, mis tähendab, et keeluaega ei ole.
Improvac is used as an alternative to physical castration (removal of the testes) to reduce the presence of these compounds.
Improvaci kasutatakse alternatiivina füüsilisele kastratsioonile (munandite eemaldamisele), et vähendada nende ühendite sisaldust.
It is not intended to provide practical advice on how to use Improvac.
Hindamisaruandes ei anta Improvaci kasutamise praktilisi nõuandeid.
Accidental self-injection of Improvac may produce similar effects in people to those seen in pigs.
Improvaci juhuslik enesesüstimine võib tekitada inimesel sama reaktsiooni kui sigadel.
The risk of these effects occurring is greater after a second or subsequent accidental injection than after a first injection.
Nende nähtude tekkerisk on pärast teist või korduvat juhuslikku enesesüstimist suurem kui pärast esimest süstet.
Boar taint is caused by the production and build-up of the natural compounds androstenone and skatole in the flesh of these animals.
Kuldilõhna põhjustab looduslike ühendite androstenooni ja skatooli teke ja kogunemine nende loomade lihas- ja rasvkoes.
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.
Kahes uuringus vähenes sigadel agressiivne käitumine ja selgatõusmine 1-2 nädala möödudes teisest Improvaci süstest ning kolmandas uuringus vaadeldi pikaajalist toimet agressiivsele käitumisele ja selgatõusmisele üksnes pärast 4 nädalat.
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.
Keeluaeg on alates vaktsiini manustamisest arvestatav aeg, mille jooksul ei tohi looma tappa ega tema liha inimtoiduks tarvitada.
For the full list of restrictions and all side effects reported with Improvac, see the package leaflet.
Improvaci kohta teatatud piirangute ja kõrvaltoimete täielik loetelu on pakendi infolehel.
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.
Androstenooni- ja skatoolisisaldus väheneb 4-6 nädala möödudes teisest süstest ning agressiivne ja seksuaalne käitumine 1-2 nädala möödudes teisest süstest.
Other information about Improvac?
Muu teave Improvaci kohta
The levels of antibodies decline with time but are still high enough to be reliably effective 4 to 6 weeks after the second injection.
Aja jooksul antikehade sisaldus väheneb, ent on sellegipoolest piisavalt suur, et toime püsiks 4-6 nädala jooksul pärast teist süstet.
What are the risks associated with Improvac?
Mis riskid Improvaciga kaasnevad?
In case of accidental self-injection, medical advice should be sought immediately and the package leaflet or label shown to the doctor.
Juhusliku enesesüstimise korral tuleb pöörduda otsekohe arsti poole ja näidata talle pakendi infolehte või etiketti.
Special care should be taken to avoid accidental self-injection.
Juhuslikku enesesüstimist tuleb väga hoolikalt vältida.
In case of skin or eye contact the affected area should be rinsed immediately with water.
Vaktsiini juhuslikul sattumisel nahale või silma tuleb seda kohta otsekohe pesta veega.
In addition Improvac treated pigs had reduced blood levels of testosterone.
Peale selle oli Improvaciga vaktsineeritud sigadel vere testosteroonisisaldus väiksem.
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.
Ravimi omaduste kokkuvõttesse ja pakendi infolehele lisati Improvaci ohutusteave, kus on ka tervishoiuspetsialistide ja loomaomanike või -pidajate võetavad meetmed.
The first injection had a limited effect, but the second injection is followed by production of antibodies against GnRF.
Uuringutes tõendati, et esimese süste toime on piiratud, ent teise süste järel tekivad GnRF-vastased antikehad.
Improvac is a veterinary medicine used in male pigs to reduce ‘boar taint' in the meat obtained from them after slaughter.
Improvac on veterinaarvaktsiin, mida kasutatakse kultidel, et vähendada kuldilõhna lihal, mida saadakse loomadelt pärast tapmist.
What are the precautions for the person who gives the medicine or comes into contact with the animal?
Milliseid ettevaatusmeetmeid peab võtma loomale vaktsiini andev või loomaga kokku puutuv inimene?
Boar taint is the offensive odour or taste which may be present in pork or pork products from non-castrated mature male pigs.
Kuldilõhn on ebameeldiv lõhn või maitse, mis võib esineda kastreerimata suguküpsete kultide lihal või nende lihast valmistatud toodetel.
This temporarily inhibits release of steroids from the testicles, including androstenone, one of the two causes of boar taint.
Sellega pärsib Improvac ajutiselt steroidide, sealhulgas androstenooni (üks kahest kuldilõhna põhjustavast looduslikust ühendist) vabastamist munanditest.
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.
Teine kuldilõhna põhjustav looduslik ühend skatool tekib soolestikus ning skatoolisisaldus väheneb selle tõttu, et suguhormoonide sisalduse vähenemise tulemusena suudab maks skatooli tõhusamalt metaboliseerida (lagundada).
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.
Improvaci toimeaine on gonadotropiini vabastava faktori (GnRF) analoog (sarnane aine), mis on seotud bakterist Corynebacterium diphtheriae saadud kandevalguga.
How is Improvac used?
Kuidas Improvaci kasutatakse?
For practical information about using Improvac, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Kui loomaomanikud või -pidajad vajavad Improvaci kasutamise praktilisi nõuandeid, peavad nad lugema pakendi infolehte või pöörduma oma veterinaararsti või apteekri poole.
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.
Mitmes väliuuringus oli Improvaciga vaktsineeritud sigade androstenooni- ja skatoolisisaldus tapmisel võrreldav androstenooni- ja skatoolisisaldusega kirurgiliselt kastreeritud sigadel.
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.
Improvac stimuleerib sea immuunsüsteemi tootma antikehi gonadotropiini vabastava hormooni (GnRH) vastu, mis reguleerib immuunsüsteemis sugulist arengut.
Improvac gonadotropin releasing factor (GnRF) analogue-protein conjugate
Improvac gonadotropiini vabastava faktori (GnRF) analoogvalgu konjugaat
Improvac is available as a solution for injection and can only be obtained with a prescription.
Improvaci turustatakse süstelahusena ja see on retseptivaktsiin.
What benefits of Improvac have been shown in studies?
Milles seisneb uuringute põhjal Improvaci kasulikkus?
Improvac also contains a compound derived from the sugar dextran as an adjuvant (ingredient that strengthens the immune response).
Improvac sisaldab immuunvastuse tugevdamiseks ka adjuvanti (dekstraani (teatud suhkur) derivaat).
For further information, see the package leaflet.
Üksikasjalik teave on pakendi infolehel.
Improvac must not be given to female pigs or to male pigs intended for breeding.
Improvaci ei tohi kasutada emistel ega kultidel, keda kavatsetakse kasutada tõuaretuseks.
Improvac contains the active substance gonadotropin releasing factor (GnRF) analogue-protein conjugate.
Improvac sisaldab toimeainena gonadotropiini vabastava faktori (GnRF) analoogvalgu konjugaati.
How does Improvac work?
Kuidas Improvac toimib?
This summary was last updated in 05-2012.
Kokkuvõtte viimane uuendus: 05-2012
The European Commission granted a marketing authorisation valid throughout the European Union for Preotact on 24 April 2006.
Euroopa Komisjon andis Preotacti müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 24. aprillil 2006.
It must also not be used in patients:
Ravimit ei tohi kasutada patsiendid,
The full EPAR for Preotact can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Euroopa avaliku hindamisaruande täistekst Preotacti kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Other information about Preotact
Muu teave Preotacti kohta
About two-thirds of the women continued taking Preotact for up to two years, and their bone density was measured.
Ligikaudu kaks kolmandikku naistest jätkas Preotacti kasutamist kuni kahe aasta jooksul, mille järel mõõdeti nende luutihedust.
The main measure of effectiveness was the rate of vertebral fractures after 18 months of treatment.
Efektiivsuse põhinäitaja oli lülisambamurdude osakaal 18kuulise ravi järel.
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.
Risk vähenes rohkem naistel, kellel oli varem esinenud lülisambamurd, ja naistel, kelle lülisambaluu tihedusenäit oli juba uuringu alguses madal, viidates hapramale lülisambale.
The bone density was also the main measure in another study, which looked at the use of Preotact with or without alendronate (a bisphosphonate).
Luutihedus oli peamine näitaja ka teises uuringus, milles vaadeldi Preotacti kasutamist koos alendronaadiga (bisfosfonaat) või ilma selleta.
Preotact parathyroid hormone
Preotact paratüreoidhormoon
Patients may inject themselves once they have been trained (a user manual is supplied).
Patsiendid võivad ennast ise süstida, kui nad on seda õppinud (kaasas on kasutusõpetus).
The CHMP decided that Preotact's benefits are greater than its risks and recommended that it be given marketing authorisation.
Inimravimite komitee otsustas, et Preotacti kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
Preotact has been studied in one main study involving 2,532 women with postmenopausal osteoporosis.
Preotacti toimet on uuritud ühes põhiuuringus, milles osales 2532 menopausijärgses eas osteoporoosiga naist.
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).
Võrreldes platseeboga vähendas Preotact märkimisväärselt lülisambamurru riski: pärast 18kuulist ravi oli platseeborühmas 42 lülisambamurru juhtu (3,37%) ja Preotacti rühmas 17 juhtu (1,32%).
• who have a bone disease that is not osteoporosis,
• kellel on muu luuhaigus, mis ei ole osteoporoos;
It also increases the absorption of calcium from food and prevents too much calcium from being lost in the urine.
Ravim suurendab ka kaltsiumi imendumist toidust ning takistab liiga suure kaltsiumikoguse eritumist uriiniga.
Gradually, the bones become thin and fragile, and more likely to break (fracture).
Luud muutuvad järk-järgult urbsemaks ja hapramaks ning murduvad kergesti.
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.
Seda toodetakse rekombinant-DNA-tehnikana tuntud meetodil: hormooni toodab bakter, millele on lisatud selle teket võimaldav geen (DNA).
For more information about treatment with Preotact, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Kui vajate Preotactiga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
What is the risk associated with Preotact?
Mis riskid Preotactiga kaasnevad?
This is a summary of the European public assessment report (EPAR) for Preotact.
See on ravimi Preotact Euroopa avaliku hindamisaruande kokkuvõte.
Increases in bone density were also seen during the study.
Uuringu käigus tuvastati ka luutiheduse suurenemine.
The study of Preotact with alendronate showed that using alendronate after Preotact can bring further increases in bone density.
Preotacti ja alendronaadi uuring näitas, et alendronaadi kasutamine pärast Preotacti võib luutihedust veelgi suurendada.
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).
Preotacti kõige sagedamad kõrvalnähud (esinenud enam kui 1 patsiendil 10st) on hüperkaltseemia (vere suur kaltsiumisisaldus), hüperkaltsiuuria (kaltsiumirohkus uriinis) ja iiveldus.
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.
Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
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.
Kui kolbampulli sisu sisestatakse spetsiaalsesse pensüstlisse ja pensüstel keeratakse kokku või kui eeltäidetud pensüstel seatakse kasutusvalmis, siis pulber ja lahusti segunevad ja moodustavad süstelahuse.
Preotact was compared with placebo (a dummy treatment).
Preotacti võrreldi platseeboga (näiv ravim).
Preotact must not be used in people who are hypersensitive (allergic) to parathyroid hormone or any of the other ingredients.
Preotacti ei tohi kasutada inimesed, kes on paratüreoidhormooni või ravimi mis tahes muu koostisaine suhtes ülitundlikud (allergilised).
The parathyroid hormone in Preotact is identical to the human parathyroid hormone.
Preotactis sisalduv paratüreoidhormoon on identne inimese paratüreoidhormooniga.
Osteoporosis happens when not enough new bone grows to replace the bone that is naturally broken down.
Osteoporoos tekib, kui loomulikul teel laguneva luukoe asemele ei kasva piisavalt uut luukude.
Osteoporosis is more common in women after the menopause, when the levels of the female hormone oestrogen fall.
Osteoporoos on sagedam naistel pärast menopausi, kui naissuguhormooni östrogeeni sisaldus väheneb.
• who have bone cancer or cancer that has spread to the bones,
• kellel on luuvähk või luudesse levinud vähk;
Preotact has been shown to significantly reduce vertebral (spine) fractures, but not hip fractures.
On tõestatud, et Preotact vähendab oluliselt lülisambamurde, kuid mitte puusamurde.
What is Preotact?
Mis on Preotact?
The recommended dose of Preotact is 100 micrograms, given once a day as an injection under the skin into the abdomen.
Soovituslik annus on 100 mikrogrammi Preotacti manustatuna üks kord ööpäevas subkutaanse (nahaaluse) süstina kõhupiirkonda.
Preotact is a medicine that contains the active substance parathyroid hormone.
Preotact on ravim, mis sisaldab toimeainena paratüreoidhormooni.
• who are having or have had radiation therapy to the skeleton,
• kes saavad või on saanud luustiku kiiritusravi;
• who have any disorder that affects the calcium and phosphate balance in the body,
• kellel on häire, mis mõjutab organismi kaltsiumitasakaalu;
Patients may also need to take calcium and vitamin D supplements if they do not have enough from their diet. Preotact can be used for up to 24 months, after which patients can be treated with a bisphosphonate (a medicine that reduces bone loss).
Preotacti tohib kasutada kuni 24 kuud ja seejärel tohib patsiente ravida bisfosfonaatidega (ravim, mis vähendab luukoe hävimist).
Preotact contains parathyroid hormone, which stimulates bone formation by acting on osteoblasts (bone forming cells).
Preotact sisaldab paratüreoidhormooni, mis avaldab toimet osteoblastidele (luukude moodustavatele rakkudele), stimuleerides luu moodustumist.
Preotact is used for the treatment of osteoporosis (a disease that makes bones fragile) in postmenopausal women who are at high risk of fractures.
Preotacti kasutatakse osteoporoosi (luu-urbnemise) raviks menopausijärgsetel naistel, kellel on kõrge luumurrurisk.
Why has Preotact been approved?
Miks Preotact heaks kiideti?
The medicine can only be obtained with a prescription.
Preotact on retseptiravim.
For the full list of all side effects with Preotact, see the package leaflet.
Preotacti kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
How is Preotact used?
Kuidas Preotacti kasutatakse?
What is Preotact used for?
Milleks Preotacti kasutatakse?
• with severely reduced kidney or liver function.
• kellel on raske maksa või neeru talitlushäire.
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.
Seda turustatakse kolbampullidena, mis sisaldavad pulbrit ja lahustit, millest valmistatakse spetsiaalses pensüstlis süstelahus.
It is also available as a pre-filled pen incorporating the cartridge containing the powder and solvent Each cartridge contains 14 doses.
Seda turustatakse ka eeltäidetud pensüstlitena, mis sisaldavad kolbampulle pulbri ja lahustiga.
What benefit has Preotact shown during the studies?
Milles seisnes uuringute põhjal Preotacti kasulikkus?
• with unexplained high levels of alkaline phosphatase (an enzyme),
• kelle veres on tundmatul põhjusel liiga palju ensüümi aluselist fosfataasi;
How has Preotact been studied?
Kuidas Preotacti uuriti?
How does Preotact work?
Kuidas Preotact toimib?
EMA/619580/2012 EMEA/H/C/002568
EMEA/H/C/002568
As a result, it stops the growth of tumour cells and eventually kills them.
Selle tulemusena pärsib see aine kasvajarakkude kasvu ja lõpuks hävitab need.
It is used to treat:
Seda kasutatakse järgmistel näidustustel:
This summary was last updated in 06-2012.
Kokkuvõtte viimane uuendus: november 2012.
For other types of cancer, treatment is stopped if the disease gets worse or the patient cannot tolerate the treatment.
Teiste vähiliikide korral ravi peatatakse, kui haigus süveneb või patsient ei talu ravi.
Treatment is continued for six months after colon surgery.
Ravi jätkatakse 6 kuu jooksul pärast käärsooleoperatsiooni.
The full EPAR for Capecitabine Medac can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Euroopa avaliku hindamisaruande täistekst Capecitabine Medaci kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
5-FU is an analogue of pyrimidine.
5-FU on pürimidiini analoog.
The European Commission granted a marketing authorisation valid throughout the European Union for Capecitabine Medac on 19 November 2012.
Euroopa Komisjon andis Capecitabine Medaci müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 19. novembril 2012.
It is available as tablets (150, 300 and 500 mg).
Seda turustatakse tablettidena (150, 300 ja 500 mg).
It is taken as tablets, while 5-FU normally needs to be injected.
Seda manustatakse tablettidena, ent 5FU-d on tavaliselt vaja süstida.
Capecitabine Medac tablets should be swallowed with water within 30 minutes after a meal.
Capecitabine Medaci tabletid võetakse koos veega 30 minuti jooksul pärast sööki.
For more information on generic and hybrid medicines, see the questionand-answer document here.
Lisateave geneeriliste ja hübriidravimite kohta on teabedokumendis siin.
The company provided data from the published literature on capecitabine.
Ettevõte esitas kapetsitabiini kohta avaldatud kirjandusest pärinevad andmed.