natgillin/translations-raw huggingface dataset:
Eklira Genuair is a medicine that is used to relieve the symptoms of chronic obstructive pulmonary disease (COPD) in adults.
Eklira Genuair je zdravilo, ki se uporablja za lajšanje simptomov pri odraslih bolnikih s kronično obstruktivno pljučno boleznijo (KOPB).
The study compared two doses of Eklira Genuair (200 and 400 micrograms) inhaled twice a day with placebo.
V študiji so dva odmerka zdravila Eklira Genuair (200 in 400 mikrogramov), ki so ju bolniki vdihovali dvakrat na dan, primerjali s placebom.
The most common side effects with Eklira Genuair (which may affect more than 5 patients in 100) are headache and nasopharyngitis (inflammation of the nose and throat).
Najpogostejša neželena učinka zdravila Eklira Genuair (ki se lahko pojavita pri več kot 5 bolnikih od 100) sta glavobol in nazofaringitis (vnetje nosu in žrela).
What benefits of Eklira Genuair have been shown in studies?
Kakšne koristi je zdravilo Eklira Genuair izkazalo v študijah?
A main study involving 828 patients with COPD found that Eklira Genuair was more effective than placebo (a dummy treatment) at improving how well the lungs work.
V glavni študiji, v katero je bilo vključenih 828 bolnikov s KOPB, so ugotovili, da je zdravilo Eklira Genuair pri izboljševanju delovanja pljuč učinkovitejše od placeba (zdravila brez zdravilne učinkovine).
Other common side effects (which may affect more than 1 patient in 100) are sinusitis (inflammation of the sinuses), cough, nausea (feeling sick) and diarrhoea.
Drugi pogosti neželeni učinki (ki se lahko pojavijo pri več kot 1 bolniku od 100) so sinuzitis (vnetje sinusov), kašelj, navzeja (slabost) in driska.
For practical information about using Eklira Genuair, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Eklira Genuair naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
COPD is a long-term disease in which the airways and air sacs inside the lungs become damaged or blocked, leading to difficulty breathing.
Kronična obstruktivna pljučna bolezen je dolgotrajna bolezen, pri kateri so dihalne poti in zračni mešički v pljučih poškodovani ali zamašeni, zaradi česar je dihanje oteženo.
The main measure of effectiveness was how Eklira Genuair improved patients' forced expiratory volumes (FEV1, the maximum volume of air a person can breathe out in one second).
Glavno merilo učinkovitosti je bilo izboljšanje forsiranega ekspiracijskega volumna (FEV1, največje količine zraka, ki jo oseba lahko izdihne v eni sekundi) po uporabi zdravila Eklira Genuair.
Why is Eklira Genuair approved?
Zakaj je bilo zdravilo Eklira Genuair odobreno?
It is not intended to provide practical advice on how to use Eklira Genuair.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
The CHMP also noted that there were no major safety concerns with Eklira Genuair, with side effects being reversible and similar to other antimuscarinic bronchodilator medicines.
Ugotovil je tudi, da ni večjih zadržkov glede njegove varnosti, saj so njegovi neželeni učinki obvladljivi in podobni kot pri drugih antimuskarinskih bronhodilatatorjih.
For the full list of all side effects and restrictions with Eklira Genuair, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Eklira Genuair glejte navodilo za uporabo.
What are the risks associated with Eklira Genuair?
Kakšna tveganja so povezana z zdravilom Eklira Genuair?
Eklira Genuair is available as an inhalation powder in a portable inhaler device.
Zdravilo Eklira Genuair je na voljo v obliki praška za inhaliranje v prenosnem inhalatorju.
The active substance in Eklira Genuair, aclidinium bromide, is an antimuscarinic bronchodilator.
Zdravilna učinkovina zdravila Eklira Genuair, aklidinijev bromid, je antimuskarinski bronhodilatator.
On average, after six months of treatment, the FEV1 in patients who used 200 and 400 micrograms Eklira Genuair increased compared with placebo by 99 ml and 128 ml respectively.
V povprečju se je FEV1 po šestmesečnem zdravljenju pri bolnikih, ki so prejemali 200 mikrogramov ali 400 mikrogramov zdravila Eklira Genuair, v primerjavi s placebom povečal za 99 ml oziroma 128 ml. 400-mikrogramski odmerek zdravila Eklira Genuair ustreza vdihu, ki dovede 322 mikrogramov aklidinija.
Eklira Genuair contains the active substance aclidinium bromide.
Zdravilo Eklira Genuair vsebuje zdravilno učinkovino aklidinijev bromid.
Eklira Genuair can only be obtained with a prescription.
Predpisovanje in izdaja zdravila Eklira Genuair je le na recept.
How is Eklira Genuair used?
Kako se zdravilo Eklira Genuair uporablja?
The recommended dose of Eklira Genuair is one inhalation twice a day.
Priporočeni odmerek zdravila Eklira Genuair je en vdih dvakrat na dan. Za podrobnejše informacije o pravilni uporabi inhalatorja glejte navodilo za uporabo.
This helps to keep the airways open and allows the patient to breathe more easily.
Po vdihu aklidinijevega bromida se mišice dihalnih poti sprostijo, kar pomaga ohranjati dihalne poti odprte in bolniku olajša dihanje.
Muscarinic receptors control the contraction of muscles and when aclidinium bromide is inhaled, it relaxes the muscles of the airways.
Muskarinski receptorji nadzirajo krčenje mišic.
How does Eklira Genuair work?
Kako zdravilo Eklira Genuair deluje?
This summary was last updated in January 2009.
Povzetek je bil nazadnje posodobljen 01-2009.
If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR).
Če želite več informacij, ki temeljijo na priporočilih CVMP, preberite znanstveno razpravo (ki je prav tako del EPAR).
These reactions resolve spontaneously over a period of approximately 14-21 days without any major consequence on the general health status of the animals.
Te reakcije po približno 14 do 21 dneh minejo brez večjih posledic za splošno zdravstveno stanje živali.
This active immune response helps to protect the pig against the disease caused by this virus.
Ta aktivni imunski odziv pomaga zaščititi prašiče proti bolezni, ki jo povzroča ta virus.
It is generally accepted that infection with PCV2 is essential but not sufficient to cause disease.
Splošno sprejeto dejstvo je, da je okužba z virusom PCV2 ključna, vendar sama ne zadostuje za povzročitev bolezni.
The vaccine is given by injection into a muscle in the neck, in the area behind the ear.
Cepivo se injicira v vratno mišico v predelu za ušesom.
Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against a disease.
Cepiva delujejo tako, da imunski sistem (naravne obrambne mehanizme telesa) „učijo“, kako naj se brani pred boleznijo.
These studies have been performed under laboratory conditions as well as under typical farming conditions representative of different pig production systems.
Te študije so izvedli pod laboratorijskimi pogoji ter tipičnimi pogoji reje, ki predstavljajo različne sisteme za rejo prašičev.
What is the time allowed before the animal can be slaughtered and the meat used for human consumption (withdrawal period)?
Koliko časa mora preteči, preden se lahko žival zakolje in meso uporabi za prehrano ljudi (obdobje karence)?
Occasionally, an increase of rectal temperature up to 2.5 °C lasting less than 24 hours may occur.
Občasno se lahko za do 2,5 °C poveča rektalna temperatura, kar traja manj kot 24 ur.
Through this the immune system will be able to react more quickly when it is exposed to the virus.
Zaradi tega se lahko imunski sistem pri izpostavitvi virusu hitreje odzove.
Onset of protection against PCV2 occurs from as early as two weeks after the injection and lasts for 22 weeks.
Zaščita proti virusu PCV2 začne delovati dva tedna po injiciranju in traja 22 tednov.
In pigs transient local reactions at the injection site may occur after vaccination mainly in the form of a hard, warm and sometimes painful swelling (diameter up to 10 cm).
Pri prašičih se lahko po cepljenju na mestu injiciranja pojavijo prehodne lokalne reakcije, večinoma v obliki trdne, tople in včasih boleče otekline (premera do 10 cm).
When a pig is given the vaccine, the pig's immune system recognises the protein as ‘foreign' and reacts by building up an active immune response.
Ko prašiča cepimo, njegov imunski sistem prepozna beljakovino kot „tujo“ in se nanjo odzove z aktiviranjem imunskega odziva.
Vaccination may result in a transient impairment of growth rate in the immediate period after administration of the vaccine.
Zaradi cepljenja se lahko v obdobju po dajanju cepiva prehodno zmanjša rast.
The vaccine does not contain any live PCV2.
Cepivo ne vsebuje živega virusa PCV2.
The European Commission granted a marketing authorisation valid throughout the European Union for Porcilis PCV to Intervet International BV on 12/ 01/ 2009.
Evropska komisija je dovoljenje za promet z zdravilom Porcilis PCV, veljavno po vsej Evropski uniji, odobrila družbi Intervet International BV dne 12. januarja 2009.
Accidental injection/self injection may result in severe pain and swelling, particularly if injected into a joint or finger, and, in rare cases, could result in the loss of the affected finger if prompt medical attention is not given.
Nenamerno injiciranje/samoinjiciranje lahko povzroči hude bolečine in otekline, zlasti ob injiciranju v sklep ali prst, in lahko v izjemnih primerih, če ni zagotovljena takojšnja zdravniška oskrba, pripelje do izgube prizadetega prsta.
Some piglets may be depressed and show a reduced feed intake for up to 5 days.
Pri nekaterih pujskih se lahko pojavi pobitost in pojedo manj krme, kar lahko traja do 5 dni.
Other information about Porcilis PCV:
Druge informacije o zdravilu Porcilis PCV:
Information on the prescription status of this product may be found on the outer package.
Podatki o predpisovanju tega zdravila so navedeni na zunanji ovojnini.
PCV2 associated infections may include clinical signs such as weight loss or failure to grow, enlarged lymph nodes, difficulty in breathing, diarrhoea, pale skin and jaundice (yellowing of the skin).
Okužbe, povezane z virusom PCV2, lahko vključujejo klinične znake, kot so hujšanje ali zavrta rast, povečane bezgavke, težave z dihanjem, driska, bledost in zlatenica (rumeno obarvanje kože).
A transient increase in body temperature, normally not exceeding 1°C, may occur until 2 days after vaccination.
Do dva dni po cepljenju se lahko prehodno, običajno ne za več kot 1 °C, poveča telesna temperatura.
Porcilis PCV is a vaccine for use in pigs, which is available as an emulsion for injection.
Zdravilo Porcilis PCV je cepivo za uporabo pri prašičih in je na voljo v obliki emulzije za injiciranje.
The withdrawal period is zero days.
Obdobje karence je nič dni.
Immediate systemic hypersensitivitylike reactions may occur after vaccination, resulting in minor neurological symptoms such as tremors and/or excitation, which normally resolve within minutes without requiring treatment.
Po cepljenju se lahko pojavijo takojšnje sistemske, preobčutljivostnim podobne reakcije z blagimi nevrološkimi simptomi v obliki tremorja in/ali razdraženosti, ki običajno minejo v nekaj minutah brez zdravljenja.
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) PORCILIS PCV EPAR summary for the public
EMEA/V/C/135 EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) PORCILIS PCV Povzetek EPAR za javnost
Porcilis PCV contains mineral oil.
Zdravilo Porcilis PCV vsebuje mineralno olje.
It contains a protein (antigen) from the porcine circovirus type 2 virus (PCV2).
Vsebuje beljakovino (antigen) iz cirkovirusa prašičev tipa 2 (PCV2).
Porcine circovirus type 2 (PCV2) is known to cause a wide variety of syndromes in pigs, together known as Porcine circovirus type 2-related diseases (PCVD).
Znano je, da cirkovirus prašičev tipa 2 (PCV2) povzroča najrazličnejše sindrome pri prašičih, ki so skupaj znani kot bolezni, povezane s cirkovirusom prašičev tipa 2 (PCVD).
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Porcilis PCV exceed the risks for the active immunisation of pigs, over the age of three days, against PCV2, and recommended that Porcilis PCV be given a marketing authorisation.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi zdravila Porcilis PCV za aktivno imunizacijo prašičev, starejših od treh dni, pred virusom PCV2, večje od z njim povezanih tveganj, in priporočil, da se za zdravilo Porcilis PCV odobri dovoljenje za promet.
Porcilis PCV is a vaccine.
Zdravilo Porcilis PCV je cepivo.
What benefit has Porcilis PCV shown during the studies?
Kakšne koristi je zdravilo Porcilis PCV izkazalo med študijami?
This helps to reduce the amount of virus in the animal's blood and lymphoid tissues and to reduce weight loss associated with PCV2 infection occurring during the fattening period.
S tem pomagamo zmanjšati količino virusov v krvi živali in njenih limfnih tkivih ter zmanjšati hujšanje pri okužbi s PCV2 v obdobju pitanja.
Porcilis PCV has been studied in pigs in a number of trials.
Zdravilo Porcilis PCV so raziskovali pri prašičih v več preskušanjih.
The immune response to vaccination was monitored by determining antibody titres in the vaccinated animals.
izločanje virusa z iztrebki in skozi nos. Imunski odziv na cepljenje so spremljali z določanjem titrov protiteles pri cepljenih živalih.
Porcilis PCV is used to vaccinate pigs from three days of age against PCV2 infection.
Zdravilo Porcilis PCV se uporablja za cepljenje prašičev, starejših od treh dni, proti okužbi z virusom PCV2.
The trials showed that vaccination of pigs with Porcilis PCV helps to reduce the amount of virus in the animal's blood and lymphoid tissues and to reduce weight loss associated with PCV2 infection occurring during the fattening period.
Preskušanja so pokazala, da cepljenje prašičev z zdravilom Porcilis PCV pomaga zmanjšati količino virusov v krvi živali in njenih limfnih tkivih ter zmanjšati hujšanje pri okužbi s PCV2 v obdobju pitanja.
Porcilis PCV contains small amounts of a protein from PCV2.
Zdravilo Porcilis PCV vsebuje majhno količino beljakovin iz virusa PCV2.
What is the risk associated with Porcilis PCV?
Kakšna tveganja so povezana z zdravilom Porcilis PCV?
Why has Porcilis PCV been approved?
Zakaj je bilo zdravilo Porcilis PCV odobreno?
What is Porcilis PCV used for?
Za kaj se zdravilo Porcilis PCV uporablja?
How has Porcilis PCV been studied?
Kako je bilo zdravilo Porcilis PCV raziskano?
What is Porcilis PCV?
Kaj je zdravilo Porcilis PCV?
monitored included weight gain, mortality as well as faecal and nasal shedding.
Merila učinkovitosti, ki so jih opazovali, so bila povečanje telesne mase, smrtnost ter
How does Porcilis PCV work?
Kako zdravilo Porcilis PCV deluje?
MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administration
Farmacevtska oblika Pot uporabe Stična ovojnina Velikost pakiranja filmsko obložena tableta Peroralna uporaba steklenička (sklenená)
3.5 mg/ml Concentrate for solution for infusion
Koncentrat za raztopino za infundiranje
Unituxin
Unituxin mg/ml
This summary was last updated in April 2013.
Povzetek je bil nazadnje posodobljen aprila 2013.
This will help to protect against the disease.
Ta mu bodo pomagala pri obrambi pred boleznijo.
A slight increase in body temperature, by up to 1.5 °C, may occur for one or two days.
Za dan ali dva se lahko za do 1,5 °C poviša telesna temperatura.
The laboratory studies showed that horses developed protection two weeks after primary vaccination.
Laboratorijske študije so pokazale, da so konji razvili zaščito dva tedna po osnovnem cepljenju.
After this a single injection should be given each year as a booster.
Nato je vsako leto treba dati enkratno injekcijo obnovitvenega odmerka.
Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against a disease.
Cepiva delujejo tako, da imunski sistem (naravni obrambni mehanizem telesa) „naučijo‟, kako naj se brani pred boleznijo.
The duration of protection was 12 months after primary vaccination as well as after the yearly single booster vaccination.
Zaščita je trajala 12 mesecev tako po osnovnem cepljenju kot tudi po letnem enkratnem obnovitvenem odmerku.
The first involved 128 pregnant mares of mixed breeds and the second involved 41 pregnant thoroughbred mares.
V prvo je bilo vključenih 128 brejih kobil mešanih pasem, v drugo pa 41 brejih čistokrvnih kobil.
The effectiveness of Equilis West Nile was first studied in a number of laboratory studies that examined how long it took to achieve protection after vaccination, and how long the protection lasted.
Učinkovitost cepiva Equilis West Nile so najprej raziskali v več laboratorijskih študijah, v katerih so proučevali, koliko časa je trajalo, da se je po cepljenju razvila zaščita in kako dolgo je trajala.
The vaccine was also compared with placebo in two other field studies involving pregnant mares.
Cepivo so s placebom primerjali tudi v drugih dveh terenskih študijah, v katerih so bile vključene breje kobile.
It contains a strain called Yellow Fever-West Nile (YF-WN).
Vsebuje sev, imenovan rumena mrzlica-West Nile (Yellow Fewer-West Nile - YF-WN).
The withdrawal period is the time allowed after administration of the medicine and before the animal can be slaughtered and the meat used for human consumption or milk used for human consumption.
Obdobje karence je čas, ki mora preteči po uporabi zdravila, preden se lahko žival zakolje in meso ali mleko uporabi za prehrano ljudi.
West Nile virus is an infection that is transmitted by mosquitoes and can cause severe disease and fatal brain infections in infected horses.
Virus West Nile je okužba, ki jo prenašajo komarji in lahko pri okuženih konjih povzroči resno bolezen ter smrtne okužbe možganov.
The first of these involved 173 horses at least six months of age, in which vaccination with Equilis West Nile was compared with a placebo (dummy injection).
V prvo je bilo vključenih 173 konjev, starih najmanj šest mesecev, pri katerih so cepivo Equilis West Nile primerjali s placebom (zdravilom brez zdravilne učinkovine).
The measure of effectiveness in all the field studies was the number of horses which developed protective antibody levels against West Nile virus.
Merilo učinkovitosti v vseh terenskih študijah je bilo število konjev, ki so razvili zadostne ravni protiteles za zaščito proti virusu West Nile.
The vaccine is initially given to horses over six months of age as two injections into the muscle, three to five weeks apart.
Najprej se konjem, starejšim od šestih mesecev, v mišico vbrizga dve injekciji cepiva v razmiku od treh do petih tednov.
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Equilis West Nile exceed the risks for the treatment of the approved indication and recommended that Equilis West Nile be given a marketing authorisation.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi cepiva Equilis West Nile za zdravljenje odobrene indikacije večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
Equilis West Nile contains small amounts of West Nile virus that has been inactivated (killed) so that it can no longer cause disease.
Cepivo Equilis West Nile vsebuje majhne količine virusa West Nile, ki je bil inaktiviran (uničen), tako da ne more več povzročati bolezni.
A mild short-lived swelling may develop at the injection site which resolves in one to five days.
Na mestu injiciranja se lahko pojavi rahla prehodna oteklina, ki izgine po enem do petih dneh.
Other information about Equilis West Nile:
Druge informacije o zdravilu Equilis West Nile:
In future if the animals are exposed to West Nile virus the immune system will be able to respond more quickly.
Ob ponovni izpostavitvi virusu West Nile v prihodnosti se bo imunski sistem tako hitreje odzval.
Flavivirus strain YF-WN
Equilis West Nile sev flavivirusa YF-WN
The European Commission granted a marketing authorisation valid throughout the European Union, for Equilis West Nile on 6 June 2013.
Evropska komisija je dovoljenje za promet s cepivom Equilis West Nile, veljavno po vsej Evropski uniji, odobrila dne 06/06/2013.
The benefit - risk balance may be found in the scientific discussion module of this EPAR.
Za razmerje med koristmi in tveganji glejte modul o znanstveni razpravi v tem povzetku.
Equilis West Nile contains an adjuvant to enhance the immune response.
Cepivo Equilis West Nile vsebuje adjuvans za povečanje imunskega odziva.
The main field study showed that vaccination with Equilis West Nile when given as recommended produced protective antibody levels in 94% of the vaccinated horses at day 42 of the study.
Glavna terenska študija je pokazala, da je imelo po cepljenju s cepivom Equilis West Nile po priporočeni shemi na 42. dan študije zadostne ravni protiteles za zaščito 94 % cepljenih konjev.
When Equilis West Nile is given to horses, their immune system recognises the virus contained in the vaccine as ‘foreign' and makes antibodies to defend against it.
Ko konji prejmejo cepivo Equilis West Nile, njihov imunski sistem prepozna virus v cepivu kot „tujek‟ in proti njemu tvoriti protitelesa.
Equilis West Nile is used to vaccinate horses from six months of age against West Nile virus.
Cepivo Equilis West Nile se uporablja za cepljenje konjev, starejših od šestih mesecev, proti virusu West Nile.
The studies in pregnant mares showed that 89% of the vaccinated mixed-breed mares and 95% of the vaccinated thoroughbred mares produced protective antibody levels.
Študiji pri brejih kobilah sta pokazali, da je zadostne ravni protiteles za zaščito tvorilo 89 % cepljenih kobil mešanih pasem in 95 % cepljenih čistokrvnih kobil.
Equilis West Nile was also studied in three field studies.
Cepivo Equilis West Nile so raziskali tudi v treh terenskih študijah.
If the product is accidentally self-injected, medical advice should be sought immediately and the package leaflet or label shown to the doctor.
V primeru nenamernega samoinjiciranja cepiva se je treba takoj posvetovati z zdravnikom in mu pokazati navodilo za uporabo ali ovojnino.
Equilis West Nile is a veterinary vaccine that contains inactivated (killed) West Nile virus.
Equilis West Nile je cepivo za uporabo v veterinarski medicini, ki vsebuje inaktiviran (uničen) virus West Nile.
What benefit has Equilis West Nile shown during the studies?
Kakšne koristi je zdravilo Equilis West Nile izkazalo med študijami?
What is the risk associated with Equilis West Nile?
Kakšna tveganja so povezana z zdravilom Equilis West Nile?
Why has Equilis West Nile been approved?
Zakaj je bilo zdravilo Equilis West Nile odobreno?
The withdrawal period for Equilis West Nile is zero days.
Obdobje karence za cepivo Equilis West Nile je nič dni.
How has Equilis West Nile been studied?
Kako je bilo zdravilo Equilis West Nile raziskano?
What is Equilis West Nile?
Kaj je zdravilo Equilis West Nile?
How does Equilis West Nile work?
Kako zdravilo Equilis West Nile deluje?
What is Equilis West Nile used for?
Za kaj se zdravilo Equilis West Nile uporablja?
EMA/CHMP/800908/2012 EMEA/H/C/002609
13. december 2012 EMA/130454/2013 EMEA/H/C/002609
This means that it was intended to be similar to a biological medicine (the ‘reference medicine') that is already authorised in the European Union (EU).
To pomeni, da naj bi bilo podobno biološkemu zdravilu („referenčnemu zdravilu“), ki je že odobreno v Evropski uniji (EU).
It was to be available as a suspension for injection.
Na voljo naj bi bilo v obliki suspenzije za injiciranje.
The inspection, carried out by the German, Swedish and UK medicines agencies, identified a number of critical and major findings which revealed a failure to conduct the studies in compliance with Good Clinical Practice (GCP) and seriously questioned the reliability of the study data.
Pregled, ki so ga opravile agencije za zdravila iz Nemčije, Švedske in Združenega kraljestva, je prinesel številne kritične in pomembne ugotovitve, ki so razkrile, da študije niso bile izvedene v skladu z dobro klinično prakso, in je povzročil resne pomisleke glede zanesljivosti podatkov iz študij.