natgillin/translations-raw huggingface dataset:
The marketing authorisation holder (MAH) submitted a variation application to add a new therapeutic indication: “Indirect protection against the transmission of pathogen Leishmania infantum by sand flies (Phlebotomus perniciosus) thereby reducing the risk of canine leishmaniosis for 7 to 8 months”.
Imetnik dovoljenja za promet z zdravilom je predložil vlogo za spremembo pogojev dovoljenj, da bi dodal novo terapevtsko indikacijo: „posredna zaščita pred prenosom patogena Leishmania infantum s peščenimi muhami (Phlebotomus perniciosus), s čimer se tveganje za pasjo leishmaniozo zmanjša v sedmih do osmih mesecih“.
Efficacy evaluation was based on the comparison of the percentage of animals infected by L. infantum in the treated and untreated groups at the end of the study.
Ocena učinkovitosti je temeljila na primerjavi odstotka živali, okuženih s parazitom L. infantum, v zdravljeni in nezdravljeni skupini ob koncu študije.
• the CVMP considered that the efficacy of Seresto, and its associated name Foresto, relating to the transmission or occurrence of Leishmania infantum in dogs has been satisfactorily demonstrated in the field studies provided;
• odbor CVMP je ocenil, da je bila učinkovitost zdravila Seresto in povezanega imena Foresto, kar zadeva prenos ali pojavljanje parazita Leishmania infantum pri psih, v predloženih terenskih študijah zadovoljivo dokazana;
Mommaertslaan 14 1831 Diegem (Machelen),
1831 Diegem (Machelen), Belgium
The MAH also provided an alternative analysis of the laboratory data from all 3 studies using ratios of fed to unfed sand flies for efficacy calculation.
Imetnik dovoljenja za promet z zdravilom je predložil tudi nadomestno analizo laboratorijskih podatkov iz vseh treh študij, pri čemer je za izračun učinkovitosti uporabil razmerja med hranjenimi in nehranjenimi peščenimi muhami.
Data from 3 clinical field studies performed in endemic areas indicate a significant reduction in the risk of Leishmania infantum transmission by sand flies in treated dogs compared to non-treated dogs.
Podatki iz treh terenskih kliničnih študij izvedenih v Leishmania infantum endemičnih področjih, kažejo na znatno zmanjšanje tveganja za prenos Leishmanium infantum iz peščenih muh pri zdravljenih psih v primerjavi z nezdravljenimi psi.
Three field studies, performed in situations with high infection pressure for leishmaniosis, demonstrated that the occurrence of new cases of L. infantum is significantly reduced in dogs treated with Seresto.
Tri terenske študije, opravljene v okoliščinah velikega okužbenega pritiska, so pokazale, da je pojavljanje novih primerov L. infantum pri psih, zdravljenih z zdravilom Seresto, pomembno manjše.
As a result, bites by sand flies may occur, and the transmission of Leishmania infantum cannot be completely excluded.
Kljub temu lahko pride do ugriza peščene muhe in prenos Leishmanium infantum ni izključen.
Therefore, whilst it was concluded that the claim ‘to significantly reduce the occurrence of infection with Leishmania infantum for up to 8 months due to repellent (anti-feeding) action of the product on sand flies' should not be included in the SPC, an amended indication, which accurately reflects the data provided, ‘reduction of the risk of infection with Leishmania infantum via transmission by sand flies for up to 8 months' was considered acceptable.
To pomeni, da je bilo zaključeno, da se trditev „za pomembno zmanjšanje pojavljanja okužbe s parazitom Leishmania infantum v obdobju do osem mesecev zaradi repelentnega (zaviranje hranjenja) učinkovanja zdravila na peščene muhe“ ne vključi v povzetek glavnih značilnosti zdravila, sprejemljiva pa je popravljena indikacija, ki ustrezno odraža predložene podatke, „zmanjševanje tveganja za okužbo s parazitom Leishmania infantum s prenosom s peščenimi muhami v obdobju do osem mesecev.“
Depending on the infection pressure by sand flies the efficacy in the reduction of the risk of infection with leishmaniosis ranged from 88.3 to 100%.
Glede na prisotnost dejavnikov okužbe znaša učinkovitost zdravila za zmanjšanje tveganja za leišmanijozo od 88,3 do
Animals were defined as noninfected by Leishmania when seronegative for circulating anti-L. infantum antibodies and negative to PCR of skin tissue and bone marrow aspirate samples.
Živali so bile opredeljene kot neokužene s parazitom Leishmania, če so bile seronegativne za protitelesa proti L. infantum in negativne pri PCR vzorcev tkiva kože in aspirata kostnega mozga.
The second field study was a negatively-controlled, single centre, partially-blinded, clinical field study.
Druga terenska študija je bila negativno kontrolirana, enocentrična, delno slepa klinična terenska študija.
The three field studies provided demonstrated that, depending on the infection pressure by sand flies, use of Seresto reduced the risk of infection with L. infantum by 88.3-100%.
Tri predložene terenske študije so pokazale, da je uporaba zdravila Seresto tveganje za okužbo z L. infantum zmanjšala za 88,3-100%, odvisno od okužbenega pritiska peščene muhe.
Efficacy evaluation for Seresto was based on the comparison of the percentage of animals infected by L. infantum in the Seresto treated and untreated groups at the end of the study.
Ocena učinkovitosti zdravila Seresto je temeljila na primerjavi odstotka živali, okuženih s parazitom L. infantum, v skupini, zdravljeni z zdravilom Seresto, in nezdravljeni skupini ob koncu študije.
Data from efficacy studies against sand flies (Phlebotomus perniciosus) showed a variable sand fly repellent (anti-feeding) efficacy ranging from 65 to 89% for 7-8 months following initial application of the collar.
Podatki študij učinkovitosti zdravila proti peščenim muham (Phlebotomus perniciosus) kažejo variabilno repelentno (preprečevanje hranjenja) učinkovitost v območju od 65 do 89% v obdobju 7-8 mesecev od namestitve ovratnice.
Although a significant reduction in the incidence of L. infantum in dogs has been demonstrated, the product has shown variable repellent (anti-feeding) and insecticidal efficacy against the sand fly P. perniciosus.
Čeprav je bilo dokazano pomembno zmanjšanje pojavnosti L. infantum pri psih, je zdravilo pokazalo različno repelentno (zaviranje hranjenja) in insekticidno učinkovitost proti peščeni muhi P. perniciosus.
For the protective claim sought, demonstration of an anti-feeding activity for Seresto against sand flies was considered a prerequisite by the CVMP as the active substances in the Seresto collar, imidacloprid and flumethrin, have no known efficacy against Leishmania and therefore, any preventative efficacy against leishmaniosis is purely a result of efficacy against the sand fly.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je menil, da je predpogoj za potrditev trditve o zaščitnem učinku dokazilo, da zdravilo Seresto zavira hranjenje peščenih muh, saj zdravilni učinkovini v ovratnici z zdravilom Seresto, imidakloprid in flumetrin, nimata znanega učinka proti parazitu Leishmania, zato je kakršna koli preventivna učinkovitost proti leishmaniozi izključno posledica učinkovitosti proti peščeni muhi.
Reduction of the risk of infection with Leishmania infantum via transmission by sand flies for up to 8 months.
Zdravilo zmanjša tveganje za infekcijo z Leishmania infantum, prenašalca peščene muhe, v obdobju 8 mesecev.
the CVMP has recommended the granting of the variation of the marketing authorisations for Seresto and its associated name Foresto with amendment to the summary of product characteristics, labelling and package leaflet of the reference Member State.
• odbor CVMP je ocenil, da stalno nizka razmerja med hranjenimi in nehranjenimi samicami peščene muhe, opazovana v laboratorijskih študijah, podpirajo rezultate terenske študije, je odbor CVMP zato priporočil odobritev spremembe pogojev dovoljenj za promet za zdravilo Seresto in povezano ime Foresto s spremembo povzetka glavnih značilnosti zdravila, označevanja in navodila za uporabo referenčne države članice.
Route of administration
Navodilo za uporabo
The MAH has provided three GCP-compliant laboratory studies, conducted in order to determine the anti-feeding and insecticidal efficacy of the test product against sand flies.
Imetnik dovoljenja za promet z zdravilom je predložil tri z dobro klinično prakso skladne laboratorijske študije, ki so bile izvedene za določitev učinkovitosti preskusnega zdravila proti peščenim muham pri preprečevanju hranjenja in insekticidne učinkovitosti.
The application was submitted as a Type II variation for the addition of the new therapeutic indication ‘to significantly reduce the occurrence of infection with Leishmania infantum for up to 8 months due to repellent (anti-feeding) action of the product on sand flies'.
Vloga je bila predložena kot sprememba tipa II za vključitev nove terapevtske indikacije „Za pomembno zmanjšanje pojava okužbe s parazitom Leishmania infantum v obdobju do osem mesecev zaradi repelentnega (preprečevanje hranjenja) delovanja zdravila na peščene muhe.“ Ocena razmerja med tveganji in koristmi je bila pripravljena na tej podlagi.
Marketing authorisation holder
Imetnik dovoljenja za promet z zdravilom
Although a significant reduction in the incidence of Leishmania infantum in dogs has been demonstrated, the product has shown variable repellent (anti-feeding) and insecticidal efficacy against the sand fly Phlebotomus perniciosus.
Čeprav se je pojavnost infekcije z Leishmanium infantum pri psih zmanjšala, ima zdravilo spremenljiv repelentni (preprečevanje hranjenja) in insekticidni učinek proti peščeni muhi Phlebotomus perniciosus.
Laboratory studies did not demonstrate a sufficient anti-feeding (repellent) effect against sand flies (P. perniciosus) to support a direct indication against the sand fly.
Laboratorijske študije niso pokazale zadostnega učinka zaviranja hranjenja (repelentnega učinka) na peščene muhe (P. perniciosus), da bi podprli neposredno indikacijo proti peščeni muhi, vendar pa podpirajo rezultate terenskih študij stalno nizka razmerja med hranjenimi in nehranjenimi samicami, ugotovljena v laboratorijskih študijah.
2 Guideline for the testing and evaluation of the efficacy of antiparasitic substances for the treatment and prevention of tick and flea infestations in dogs and cats (EMA/CVMP/EWP/005/2000-Rev.2) - link skin tissue being collected on study days 0, 90, 180, 210, and 300 (i.e. in the post-treatment phase), and samples of bone marrow collected on study days 0 and D300.
2 Guideline for the testing and evaluation of the efficacy of antiparasitic substances for the treatment and prevention of tick and flea infestations in dogs and cats (EMA/CVMP/EWP/005/2000-Rev.2) - link dan.
Seresto collier grands chiens
Seresto collier grands chiens imidakloprid/ flumetrin
The indication proposed by the RMS, and agreed by the majority of the concerned Member States (CMSs), at the referral stage was “To significantly reduce the occurrence of infection with Leishmania infantum for up to 8 months due to repellent (anti-feeding) action of the product on sand flies.”
Nova indikacija za preprečevanje prenosa L. infantum se torej lahko sprejme le, če bi bil del te klinične indikacije tudi prenašalec, tj. P. perniciosus.“ Indikacija, ki jo predlaga referenčna država članica in s katero se strinja večina zadevnih držav članic, je bila med napotitvijo „Za pomembno zmanjšanje pojava okužbe s parazitom Leishmania infantum v obdobju do osmih mesecev zaradi repelentnega (preprečevanje hranjenja) učinkovanja zdravila na peščene muhe.“
This summary was last updated in February 2015.
Ta povzetek je bil nazadnje posodobljen februarja 2015.
The European Commission granted a marketing authorisation valid throughout the European Union, for Zuprevo on 6 May 2011.
Evropska komisija je dovoljenje za promet z zdravilom Zuprevo, veljavno po vsej Evropski uniji, izdala 6. maja 2011.
In case of accidental contact, the skin should be washed immediately with soap and water, and the eyes flushed with clean water.
V primeru nenamernega stika je treba kožo nemudoma umiti z milom in vodo, oči pa izprati s čisto vodo.
Other information about Zuprevo:
Druge informacije o zdravilu Zuprevo:
This means that the antibiotic may no longer work on bacteria infecting either animals or humans.
To pomeni, da antibiotik morda nima več učinka na bakterije, s katerimi s okužene živali ali ljudje.
Antibiotic resistance is the ability of bacteria to grow in the presence of an antibiotic that would normally kill them or limit their growth.
S pridobitvijo odpornosti na antibiotike dobijo bakterije sposobnost za rast kljub prisotnosti antibiotika, ki bi jih sicer običajno uničil ali omejil njihovo rast.
Cattle may also experience pain at the time of injection.
Govedo lahko poleg tega ob injiciranju občuti bolečino.
The animal should be monitored and if signs of respiratory problems are still present after two days (pigs) or two to three days (cattle), the treatment should be switched to another antibiotic.
Žival je treba spremljati in če so klinični znaki respiratorne bolezni po dveh dneh (prašiči) ali po dveh do treh dneh (govedo) še vedno prisotni, je treba uporabiti drug antibiotik.
Special caution should be taken to avoid accidental self-injection, as laboratory studies in dogs showed cardiovascular effects after intramuscular injection of high doses of tildipirosin.
Posebej je treba paziti, da ne pride do nenamernega samoinjiciranja, saj so laboratorijske študije na psih pokazale kardiovaskularne učinke po intramuskularnem injiciranju visokih odmerkov tildipirozina.
What benefit has Zuprevo shown during the studies?
Kakšne koristi je zdravilo Zuprevo izkazalo med študijami?
In the field studies, the medicine was compared with other antibiotics used in these diseases (tulathromycin or florfenicol).
V terenskih študijah so zdravilo primerjali z drugimi antibiotiki, ki se uporabljajo za zdravljenje teh bolezni (tulatromicinom ali florfenikolom).
Zuprevo is available as a solution for injection containing tildipirosin 40 mg/ml (for pigs) or 180 mg/ml (for cattle).
Na voljo je kot raztopina za injiciranje, ki vsebuje tildipirozin v odmerku 40 mg/ml (za prašiče) ali 180 mg/ml (za govedo).
The treatment studies looked at the improvement of the signs of respiratory disease and the prevention studies looked at the absence of signs of infection (fever, respiratory or behaviour abnormalities) in animals exposed to infection.
V študijah zdravljenja so proučevali izboljšanje znakov respiratorne bolezni, v študijah preprečevanja bolezni pa odsotnost znakov okužbe (vročine, respiratornih ali vedenjskih odstopanj) pri živalih, izpostavljenih okužbi.
The withdrawal period for meat is nine days for pigs and 47 days for cattle.
Karenca za meso je devet dni pri prašičih in 47 dni pri govedu.
The CVMP concluded that the benefits of Zuprevo outweigh the risks for the approved indications and recommended that Zuprevo be given a marketing authorisation.
CVMP je zaključil, da so koristi zdravila Zuprevo večje od z njim povezanih tveganj, kadar se uporablja za odobrene indikacije, in priporočil, da se zanj izda dovoljenje za promet.
229 pigs were treated with Zuprevo and 227 pigs were untreated controls that received saline.
Zdravilo Zuprevo je prejelo 229 prašičev, za namene kontrole pa je bilo uporabljenih 227 prašičev, ki niso prejeli zdravila temveč le fiziološko raztopino.
The dose to use is calculated according to the animal's weight.
Odmerek se izračuna na podlagi telesne mase živali.
It works by blocking the bacterias' ribosomes, the parts of the cell where proteins are produced, and blocking the growth of bacteria.
Deluje tako, da zavira ribosome bakterij (dele celic, na katerih poteka sinteza beljakovin) in preprečuje rast bakterij.
Zuprevo should only be used when the bacteria are sensitive to tildipirosin.
Zdravilo Zuprevo se lahko uporablja samo, kadar so bakterije občutljive na tildipirozin.
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 tega evropskega javnega poročila o oceni zdravila (EPAR).
What is the risk associated with Zuprevo?
Kakšna tveganja so povezana z zdravilom Zuprevo?
Animals treated with Zuprevo may develop a swelling at the site of the injection, especially when larger volumes are used, therefore each injection is limited to a maximum volume (5 ml in pigs and 10 ml in cattle).
Pri živalih, ki so prejemale zdravilo Zuprevo, se lahko na mestu injiciranja pojavi oteklina, zlasti pri večjih odmerkih, zato je vsako injiciranje omejeno na največji dovoljeni odmerek (5 ml pri prašičih in 10 ml pri govedu).
Zuprevo should not be used in animals that are hypersensitive (allergic) to macrolide antibiotics or to any of the excipients.
Zdravilo Zuprevo se ne sme uporabljati pri živalih, ki so preobčutljive za (alergične na) makrolidne antibiotike ali katero koli pomožno snov zdravila.
The effectiveness of Zuprevo used for treatment and metaphylaxis of SRD in diseased pigs as well as in clinically healthy in-contact pigs was investigated in a field study in which an outbreak of SRD was confirmed with at least 30% of the pens showing clinical signs of SRD, including at least 10% of animals per pen within 1 day or 20% within 2 days or 30% within 3 days.
Učinkovitost zdravila Zuprevo pri zdravljenju in metafilaksi respiratorne bolezni pri prašičih pri obolelih živalih in klinično zdravih živalih, ki so v stiku z obolelimi živalmi, je bila proučena v terenski študiji, v katerih so izbruh respiratorne bolezni potrdili pri vsaj 30 % ograd, kjer so bili prisotni klinični znaki respiratorne bolezni pri prašičih, in sicer pri vsaj 10 % živali na ogrado po enem dnevu ali 20 % po dveh dneh oziroma 30 % v treh dneh.
The swelling can last for up to three days in pigs, and one to two weeks in cattle.
Oteklina lahko pri prašičih traja do tri dni, pri govedu pa od enega do dveh tednov.
Zuprevo is a veterinary medicine that contains tildipirosin.
Zuprevo je zdravilo, ki vsebuje tildipirozin.
Zuprevo is an antibiotic that belongs to the group ‘macrolides'.
Zdravilo Zuprevo je antibiotik, ki spada v skupino makrolidov.
During severe outbreaks of SRD Zuprevo can also be used metaphylactically which means to treat at the same time both diseased pigs and those clincially healthy pigs in close contact with them, to prevent them from developing clinical signs and to prevent further spread of the disease.
V primeru hudih izbruhov respiratorne bolezni pri prašičih se lahko uporablja tudi metafilaktično, kar pomeni, da se z njim zdravi bolne prašiče in istočasno klinično zdrave prašiče, ki so v tesnem stiku z obolelimi živalmi, da bi pri teh preprečili razvoj kliničnih znakov bolezni in posledično nadaljnje širjenje bolezni.
Zuprevo is an antibiotic used in pigs to treat swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica and Haemophilus parasuis.
Zdravilo Zuprevo je antibiotik za uporabo pri prašičih za zdravljenje respiratorne bolezni pri prašičih (SRD), ki jo povzročajo bakterije Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica in Haemophilus parasuis.
When using the antibiotic Zuprevo, it is essential to closely follow the instructions in the package leaflet to minimise the development of antibiotic resistance.
Pri uporabi antibiotika Zuprevo je pomembno slediti napotkom v navodilu za uporabo, da se razvoj odpornosti na antibiotike zmanjša na najnižjo možno raven.
When Zuprevo was used for treatment and metaphylaxis of SRD in diseased and clinically healthy incontact pigs approximately 86% of the healthy pigs remained free of clinical signs of disease compared with approximately 65% of pigs in the untreated control group.
Kadar se je zdravilo Zuprevo uporabljalo za zdravljenje in metafilakso respiratorne bolezni pri obolelih in klinično zdravih prašičih v stiku z obolelimi živalmi, se klinični znaki bolezni niso pojavili pri približno 86 % zdravih prašičev v primerjavi s 65 % prašičev v kontrolni skupini nezdravljenih prašičev.
This medicine is not allowed to be used in animals producing milk for human consumption.
Zdravilo Zuprevo se ne sme uporabljati pri živalih, ki dajejo mleko za prehrano ljudi.
Zuprevo is given as a single injection, into muscle for pigs, and under the skin for cattle.
Zdravilo Zuprevo se injicira v enem odmerku, in sicer v mišico pri prašičih in v podkožje pri govedu.
Why has Zuprevo been approved?
Zakaj je bilo zdravilo Zuprevo odobreno?
What is Zuprevo used for?
Za kaj se zdravilo Zuprevo uporablja?
Zuprevo is used in cattle to treat and prevent bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni.
Uporablja se tudi za zdravljenje ali preprečevanje respiratorne bolezni pri govedu (BRD), ki jo povzročajo bakterije Mannheimia haemolytica, Pasteurella multocida in Histophilus somni.
The studies in SRD included pigs between three and 21 weeks of age, and those in BRD included cattle between one and 24 months of age.
Študije respiratorne bolezni pri prašičih so bile izvedene pri prašičih, starih od tri do 21 tednov, študije respiratorne bolezni pri govedu pa pri govedu, staremu od enega do 24 mesecev.
How has Zuprevo been studied?
Kako je bilo zdravilo Zuprevo raziskano?
Laboratory as well as field studies were conducted to look at the use of Zuprevo in both the treatment and metaphylaxis of SRD and the treatment and prevention of BRD.
Izvedene so bile laboratorijske in terenske študije, da bi se proučila uporaba zdravila Zuprevo pri zdravljenju in metafilaksi respiratorne bolezni pri prašičih in ter preprečevanju respiratorne bolezni pri govedu.
When used to prevent BRD, the presence of the disease in the herd should be confirmed before use.
Kadar se zdravilo Zuprevo uporablja za preprečevanje respiratorne bolezni pri govedu, je treba najprej ugotoviti, ali je bolezen v čredi prisotna.
medical advice should be sought immediately and the package leaflet or the label should be shown to the doctor.
V primeru nenamernega samoinjiciranja se takoj posvetujte z zdravnikom in mu pokažite navodilo za uporabo ali ovojnino.
How does Zuprevo work?
Kako zdravilo Zuprevo deluje?
Tildipirosin may cause sensitisation by skin contact.
V stiku s kožo lahko tildipirozin povzroči reakcijo.
The medicine should not be given into a blood vessel.
Zdravilo Zuprevo se ne sme dati v žilo.
What is Zuprevo?
Kaj je zdravilo Zuprevo?
The effectiveness of Zuprevo was shown to be comparable to that of tulathromycin or florfenicol in the treatment of SRD, and in the treatment and prevention of BRD.
Pri zdravljenju respiratorne bolezni pri prašičih ter zdravljenju in preprečevanju respiratorne bolezni pri govedu se je zdravilo Zuprevo izkazalo za primerljivo tulatromicinu ali florfenikolu.
1 Quarter 2026
1. četrtletje 2026
• Advice if such symptoms occur
• nasvet, če se pojavijo taki simptomi
Smoking and alcohol
Kajenje in alkohol
Due to the increased urine production it is also important that you always have access to a toilet.
Zaradi povečanega nastajanja urina je pomembno tudi, da imate vedno dostop do stranišča.
Date of first authorisation: 27 May 2015
Datum prve odobritve: 27 05 2015
Patients were treated for up to 3 years.
Bolniki so bili zdravljeni do 3 leta.
Not known: frequency cannot be estimated from the available data
Neznani: pogostnosti ni mogoče oceniti iz razpoložljivih podatkov
Access to water
Dostop do vode
The lower dose is taken 8 hours later.
Nižji odmerek vzemite pa 8 ur kasneje.
Your doctor will be able to decide what is suitable for you.
Vaš zdravnik se bo odločil, kaj je za vas najprimernejše.
Recommended guidelines for permanent discontinuation include:
Priporočene smernice za stalno ukinitev vključujejo:
• if you do not realise when you are thirsty
• če ne morete zaznati, da ste žejni.
• allergic reactions (see above)
• alergijska reakcija (glejte zgoraj)
Drinking enough water
Zadostno pitje vode
In addition the study should also provide information on
Poleg tega bo študija dala tudi informacije o
In particular let your doctor know if you are taking:
Zdravniku še zlasti povejte, če jemljete:
Remember to take the medicine pack with you so that it is clear what you have taken.
Ne pozabite vzeti s seboj škatle zdravil, da bo jasno, kaj ste vzeli.