natgillin/translations-raw huggingface dataset:
This means that they kill parasites that come into contact with the skin or fur of animals, such as fleas, ticks or flying insects.
To pomeni, da uničijo parazite, ki pridejo v stik s kožo ali dlako živali, kot so bolhe, klopi ali leteči insekti.
Treated dogs should not be permitted to sleep with their owners, especially children, on the day of treatment.
Psi, ki so prejeli zdravilo, na dan zdravljenja ne smejo spati s svojimi lastniki, zlasti ne z otroki.
The European Medicines Agency decided that Vectra 3D's benefits are greater than its risks and it can be authorised for use in the EU.
Evropska agencija za zdravila je zaključila, da so koristi zdravila Vectra 3D večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
Vectra 3D received a marketing authorisation valid throughout the EU on 4 December 2013.
Zdravilo Vectra 3D je pridobilo dovoljenje za promet, veljavno po vsej Evropski uniji 4. decembra 2013.
People with known hypersensitivity (allergy) to any of the ingredients should avoid contact with the product.
Osebe z znano preobčutljivostjo za (alergijo na) katero koli sestavino zdravila naj se izogibajo stiku z zdravilom.
People applying the medicine should not smoke, eat or drink and should wash their hands thoroughly after handling the product.
Osebe med nanosom zdravila ne smejo kaditi, jesti ali piti, po uporabi zdravila pa si morajo temeljito umiti roke.
Other information about Vectra 3D
Druge informacije o zdravilu Vectra 3D
The effectiveness of Vectra 3D against fleas, ticks, mosquitoes and flies was investigated in 24 laboratory studies and in two field studies.
Učinkovitost zdravila Vectra 3D proti bolham, klopom, komarjem in muham so proučevali v 24 laboratorijskih študijah in dveh študijah na terenu.
The active substances in Vectra 3D act as ‘ectoparasiticides'.
Učinkovine v zdravilu Vectra 3D delujejo kot „ektoparaziticidi“.
Its actions last for up to a month, and it prevents fleas from hatching and developing for two months.
Zdravilo deluje največ en mesec, izvalitev in razvoj bolh pa preprečuje dva meseca.
Pyriproxyfen is an insect growth regulator which stops the flea life cycle by causing production of infertile eggs as well as blocking development of juvenile flea stages into adults.
Piriproksifen je regulator rasti insektov, ki prekine življenjski cikel bolh, tako da povzroči proizvodnjo neplodnih jajčec ter obenem zatre razvoj mladih bolh v odrasle bolhe.
The application site should be allowed to dry before the dog is allowed to come into contact with fabrics or furnishings.
Mesto nanosa se mora posušiti, preden se psu dovoli stik s tkaninami ali pohištvom.
Other side effects with Vectra 3D (which may affect up to 1 in 1000 dogs) are behavioural disorders such as increased activity, barking or signs of anxiety, lethargy (lack of energy), or anorexia (loss of appetite), and nervous system signs such as muscle tremor (shaking).
Drugi neželeni učinki zdravila Vectra 3D (ki se lahko pojavijo pri največ 1 od 1000 psov) so vedenjske motnje, kot so povečana aktivnost, lajanje ali znaki tesnobe, letargija (pomanjkanje energije) ali anoreksija (izguba teka) in znaki živčnega sistema, kot je mišični tremor (tresenje).
Vectra 3D is a veterinary medicine used on dogs to treat and prevent flea and tick infestations and to repel sand flies, mosquitoes and stable flies.
Vectra 3D je zdravilo za uporabo v veterinarski medicini, ki se uporablja pri psih za zdravljenje in preprečevanje infestacij z bolhami in klopi ter za odganjanje peščenih muh, komarjev in hlevskih muh.
The content of one full Vectra 3D applicator is applied directly to the dog's skin, after parting its fur, either in one or more spots on the back, depending on the dog's weight, or in a continuous line along the centre of the back from the base of the tail to the shoulder blades.
Vsebina enega celotnega aplikatorja zdravila Vectra 3D se nanese neposredno na kožo psa po razmiku dlake na eno ali več mest na hrbtu, odvisno od telesne mase psa, ali v neprekinjeni liniji po sredini hrbta od korena repa do lopatic.
An overview of Vectra 3D and why it is authorised in the EU
Pregled zdravila Vectra 3D in zakaj je odobreno v EU
For a full list of all side-effects reported with Vectra 3D, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Vectra 3D, glejte navodilo za uporabo.
Vectra 3D (dinotefuran / pyriproxyfen / permethrin)
Vectra 3D (dinotefuran/piriproksifen/permetrin)
If skin or eye irritation persists, or if the veterinary medicine is accidentally swallowed, immediate medical advice should be sought and the package leaflet or label shown to the doctor.
Če draženje kože ali očesa ne preneha ali če pride do nenamernega zaužitja zdravila za uporabo v veterinarski medicini, nemudoma poiščite zdravniško pomoč in zdravniku pokažite navodilo za uporabo ali nalepko.
Why is Vectra 3D authorised in the EU?
Zakaj je zdravilo Vectra 3D odobreno v EU?
What is Vectra 3D and what is it used for?
Kaj je zdravilo Vectra 3D in za kaj se uporablja?
What are the risks associated with Vectra 3D?
Kakšna tveganja so povezana z zdravilom Vectra 3D?
Children must not handle treated dogs for at least four hours after application of the veterinary medicine.
Psi, ki so prejeli zdravilo, vsaj štiri ure po nanosu zdravila za uporabo v veterinarski medicini ne smejo priti v stik z otroki.
What benefits of Vectra 3D have been shown in studies?
Kakšne koristi je zdravilo Vectra 3D izkazalo v študijah?
Dinotefuran acts on nerve receptors called nicotinic acetylcholine receptors and permethrin interferes with sodium channels on nerves that play a role in transmitting signals; when given together, they reinforce each other's action.
Dinotefuran deluje na živčne receptorje, imenovane nikotinski acetilholinski receptorji, permetrin pa deluje na natrijeve kanalčke na živcih, ki sodelujejo pri prenašanju signalov.
The second field study involved 278 dogs with flea infestations which were treated three times at monthly intervals either with Vectra 3D or another spot-on product containing fipronil and (s)methoprene.
V drugo študijo na terenu je bilo vključenih 278 psov z infestacijami bolh, ki so v enomesečnih intervalih trikrat prejeli zdravilo Vectra 3D ali drugo zdravilo za kožni nanos, ki vsebuje fipronil in (s)-metopren.
The most common side effects with Vectra 3D (which may affect up to 1 in 1000 dogs) are short-lived redness, itching or other signs of discomfort at the application site.
Najpogostejši neželeni učinki zdravila Vectra 3D (ki se lahko pojavijo pri največ 1 od 1000 psov) so kratkotrajna rdečica, srbenje ali drugi znaki neugodja na mestu nanosa.
The dogs treated with Vectra 3D had an average tick reduction of 94% over 4 weeks compared with 97% with the other product.
Pri psih, zdravljenih z zdravilom Vectra 3D, je v štirih tednih povprečno zmanjšanje klopov znašalo 94 % v primerjavi s 97 % pri psih, ki so bili zdravljeni z drugim zdravilom.
The first field study involved 485 dogs with flea and/or tick infestations.
V prvo študijo na terenu je bilo vključenih 485 psov z infestacijami bolh, klopov ali obojega.
Dinotefuran and permethrin are insecticides which kill insects by acting on their nervous system by different mechanisms; permethrin also acts similarly on ticks.
Dinotefuran in permetrin sta insekticida, ki insekte uničita tako, da z različnimi mehanizmi delujeta na njihov živčni sistem.
Vectra 3D contains three active substances: dinotefuran, pyriproxyfen and permethrin.
Zdravilo Vectra 3D vsebuje tri učinkovine: dinotefuran, piriproksifen in permetrin.
Vectra 3D must not be used on cats and they must not be allowed to groom dogs recently treated with the medicine, as it may cause harmful effects that could be fatal.
Prav tako je treba preprečiti njihov stik s psi, ki so pred kratkim prejeli zdravilo, saj lahko to povzroči škodljive učinke, ki so lahko usodni.
Vectra 3D can be obtained without a prescription and is available as a spot-on solution in applicators of five different strengths for use on dogs of different weights.
Zdravilo Vectra 3D je na voljo v obliki raztopine za kožni nanos, v aplikatorjih s petimi različnimi jakostmi za uporabo pri psih različnih telesnih mas, njegova izdaja pa je brez recepta.
It showed that Vectra 3D-treated dogs had an average flea count reduction of 95% compared with 97% for the dogs treated with fipronil and (s)-methoprene.
Študija je pokazala, da je pri psih, ki so prejeli zdravilo Vectra 3D, zmanjšanje povprečnega števila bolh znašalo 95 % v primerjavi s 97 % pri psih, ki so prejeli fipronil in (s)-metopren.
How does Vectra 3D work?
Kako zdravilo Vectra 3D deluje?
How is Vectra 3D used?
Kako se zdravilo Vectra 3D uporablja?
If accidental exposure to the eyes occurs, the eyes should be thoroughly rinsed with water and in case of accidental exposure to the skin, the skin should be washed immediately with soap and water.
V primeru nenamernega stika zdravila s kožo je treba kožo nemudoma sprati z milom in vodo.
It showed that dogs treated once with Vectra 3D had fleas reduced by 79% over the 4 week study period compared with a reduction of 57% for dogs treated once with another spot-on product containing two other substances
Študija je pokazala, da se je pri psih, ki so prejeli enkratni odmerek zdravila Vectra 3D, v času štiritedenske študije število bolh zmanjšalo za 79 % v primerjavi s 57 % pri psih, ki so prejeli enkratni odmerek drugega zdravila za kožni nanos, ki vsebuje dve drugi učinkovini za zatiranje bolh in klopov, tj. fipronil in (s)-metopren.
The requested Community contribution of €46m will be reduced to €37m.
Zahtevani prispevek Skupnosti v višini 46 milijonov EUR se bo zmanjšal na 37 milijonov EUR.
Good progress was made in the field of international collaboration on inspections.
Dober napredek je bil dosežen na področju mednarodnega sodelovanja pri inšpekcijskem nadzoru.
− 1 member of the Commission.
1 član Komisije.
The number of applications is also in line with forecasts.
Tudi število vlog je v skladu s predvidevanji.
Simplification of the contractual arrangements between the EMEA and the national competent authorities of the Member States: development of a cooperation agreement
Poenostavitev pogodbenih ureditev med agencijo EMEA in nacionalnimi pristojnimi organi držav članic: priprava sporazuma o sodelovanju
Alternates and other participants
Namestniki in drugi udeleženci
London, 1 October 2009
London, 1. oktobra 2009
Amendments to the fee implementing rules
Spremembe izvedbenih pravil o pristojbinah
Having reviewed the level of cooperation between the EU and FDA, all parties concluded that the cooperation between the two regulators is successful and both parties regard each other as primary international partners in the regulatory field.
Potem ko so vse strani pregledale stopnjo sodelovanja med EU in uradom FDA, so sklenile, da je sodelovanje med obema regulatorjema uspešno in da obe strani štejeta druga drugo kot glavna mednarodna partnerja na regulativnem področju.
Budget 2010 update
Posodobljen proračun za leto 2010
The assessment of cost-effectiveness and subsequent decisions on reimbursement, on the other hand, should be left at the level of individual Member States.
Ocena stroškovne učinkovitosti in naknadne odločitve o povračilu pa morajo ostati na ravni posameznih držav članic.
Fifteen national competent authorities participate in the work of the costing group, and ten of them have submitted costing data.
Petnajst nacionalnih pristojnih organov sodeluje v delu skupine za stroške in deset jih je predložilo podatke o razčlenitvi stroškov.
Draft agenda for 1 October 2009 meeting
Osnutek dnevnega reda za sestanek 1. oktobra 2009
The Board generally supported the introduction of quantitative indicators.
Upravni odbor je na splošno podprl uvedbo količinskih kazalnikov.
The Agency's Committee for Advanced Therapies, inaugurated at the beginning of the year, has issued its first opinions.
Odbor Agencije za napredno zdravljenje (Committee for Advanced Therapies), ustanovljen na začetku leta, je izdal prva mnenja.
The EU (European Commission/EMEA) - FDA meeting The meeting took place on the 27-29 September.
Sestanek med EU (Evropsko komisijo/agencijo EMEA) in Uradom za živila in zdravila (FDA) Sestanek je potekal od 27. do 29. septembra.
In March 2009, the Management Board adopted a preliminary draft budget for 2010 of €211m.
Upravni odbor je marca 2009 sprejel predhodni predlog proračuna za leto 2010 v višini 211 milijonov EUR.
Apologies
Opravičen
The proposed rules transpose the rules that are applied in the European Commission for secondment of their staff to organisations outside the EU.”
S predlaganimi pravili se prenašajo pravila, ki se uporabljajo pri Evropski komisiji za dodelitev njenega osebja organizacijam zunaj EU.“
The approval of vaccines was based on the concept of H5N1 mock-up vaccines developed by the Agency in 2003.
Cepivi sta bili odobreni na podlagi zasnove H5N1 modelnih cepiv, ki jih je agencija razvila leta 2003.
The information on conflicts of interests will also constitute a part of the documentation submitted during the formal consultation process.
Informacija o navzkrižju interesov bo tudi sestavni del dokumentacije, ki se predloži med formalnim posvetovalnim postopkom.
The Agency's revenue and expenditure is in line with the plans.
Njeni prihodki in odhodki so v skladu z načrti.
− 2 members of the EMEA;
2 člana agencije EMEA;
Pandemic vaccines
Pandemična cepiva
The Board will send a summary of this discussion to the Director General of DG Enterprise and Industry.
Upravni odbor bo poslal povzetek te razprave generalnemu direktorju GD za podjetništvo in industrijo.
The first draft is undergoing internal consultation with the Agency's staff, members of the scientific committees and the working parties.
O prvem osnutku poteka notranje posvetovanje z osebjem agencije, člani znanstvenih odborov in delovnimi skupinami.
The Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion on two pandemic vaccines.
Odbor za zdravila za uporabo v humani medicini (Committee for Medicinal Products for Human Use, CHMP) je podal pozitivno mnenje o dveh pandemičnih cepivih.
Work-sharing and collaboration among the Member States is necessary, since the evaluation of added therapeutic value is scientific work whose results can be used by all interested Member States.
Potrebna je delitev dela in sodelovanje med državami članicami, saj je vrednotenje dodane terapevtske vrednosti znanstveno delo, katerega rezultate lahko uporabljajo vse zainteresirane države članice.
The pilot on the assessment of evaluation costs in the national competent authorities is ongoing.
Pilotni projekt ocene stroškov vrednotenja v nacionalnih pristojnih organih še poteka.
The Agency is largely on track with the implementation of its main objectives and is adhering to the majority of its performance indicators.
Agencija v splošnem dobro sledi izvajanju svojih glavnih ciljev in upošteva večino svojih kazalnikov uspešnosti.
The Budget Committee of the European Parliament indicated that the fee-earning agencies would have access to the surplus revenue from previous years.
Proračunski odbor Evropskega parlamenta je navedel, da bodo imele agencije, ki dobivajo prihodek iz pristojbin, dostop do presežka prihodka iz prejšnjih let.
The Management Board discussed that currently there is a lot of duplication in the area of health technology assessment (HTA) among Member States.
Upravni odbor je razpravljal, da je trenutno veliko podvajanja pri ocenjevanju zdravstvenih tehnologij (HTA) med državami članicami.
The Commission representative agreed to inform the European Commission of the concerns raised, and reiterated the need to find a timely solution enabling the appointment procedure to be completed by mid 2010.
Predstavnik komisije se je strinjal, da Evropsko komisijo obvesti o izraženih pomislekih, in ponovil, da je treba najti pravočasno rešitev, ki bo omogočila, da se postopek imenovanja konča do sredine leta 2010.
The Agency is in the process of developing a new road map.
Agencija trenutno pripravlja nov časovni načrt.
The Executive Director has recently attended the European Parliament, where he discussed the topic of pandemic-influenza vaccines.
Izvršni direktor se je pred kratkim udeležil seje Evropskega parlamenta, na kateri je razpravljal o cepivih za pandemično gripo.
Setting up a subgroup of the Management Board to replace the Telematics steering committee
Ustanovitev podskupine upravnega odbora, ki bo nadomestila usmerjevalni odbor za telematiko
The topic coordinators, Jean Marimbert and Marcus Müllner, have reviewed the proposal and gave positive feedback.
Tematska koordinatorja Jean Marimbert in Marcus Müllne sta predlog pregledala in podala pozitivno povratno informacijo.
The Board noted the proposed dates for 2011 as follows: 16 and 17 March, 16 June, 6 October and 15 December.
Upravni odbor se je seznanil s predlaganimi datumi za leto 2011: 16. in 17. marec, 16. junij, 6. oktober in 15. december.
The data is provided in line with the costing methodology agreed by the Management Board.
Podatki so pripravljeni v skladu z metodologijo razčlenitve stroškov, ki jo je sprejel upravni odbor.
A request will be sent to the Heads of Medicines Agencies and the European Commission to nominate representatives to the committee.
Vodjem agencij za zdravila in Evropski komisiji bo poslana zahteva, da v odbor imenujejo predstavnike.
The Board expressed its willingness to meet with Commissioners to discuss the concerns expressed.
Upravni odbor je izrazil pripravljenost, da se sestane s komisarji za razpravo o izraženih pomislekih.
Meeting dates for 2010 and provisional meeting dates for 2011
Datumi sej za leto 2010 in predvideni datumi za leto 2011
The latter seems to be due to the difficulty experienced by the Member States in allocating scientific resources to work in the field of traditional medicinal products.
Zdi se, da slednje izhaja iz težav držav članic pri dodeljevanju znanstvenih virov za delo na področju tradicionalnih zdravil.
The proposal aims to simplify the governance structure, rationalise reporting lines and confirm the appropriate representation of the network.
Namen predloga je poenostaviti strukturo vodenja, racionalizirati poročanje in potrditi ustrezno zastopanje mreže.
Update on the pilot project on revision of the payment system
Poročilo o pilotnem projektu o reviziji plačilnega sistema
It was reiterated that the overall objective of the exercise is to bring the system better in line with the requirements of good governance and ensure that the remuneration system is justified, manageable and transparent.
Ponovili so, da je splošni cilj tega bolje uskladiti sistem z zahtevami dobrega vodenja in zagotoviti, da je plačilni sistem upravičen, vodljiv in pregleden.
The Agency's long-term strategy will be coordinated with the strategy paper of the Heads of Medicines Agencies (HMA).
Dolgoročna strategija bo usklajena s strateškim dokumentom vodij agencij za zdravila (HMA).
The Board will be asked to approve the 2010 part of the plan as part of the work programme and budget discussion 2010 in December.
Upravni odbor bo zaprošen, da decembra odobri del načrta za leto 2010 v okviru delovnega programa in razprave o proračunu za leto 2010.
This topic will be addressed during the future review of the Fee Regulation.
Ta tema bo obravnavana med prihodnjo revizijo uredbe o pristojbinah.
The proposal also links to the ongoing work at HMA-EMEA level, where a joint training team looks into a strategy aimed at further enhancing skills of the regulators.
Predlog se navezuje tudi na tekoče delo na ravni HMA-EMEA, kjer skupna ekipa za usposabljanje raziskuje strategijo za nadaljnjo okrepitev spretnosti in znanja regulatorjev.
In view of the reduction of planned revenue, the Agency's senior management is reviewing areas where savings could be made and projects scheduled for 2010 be cut.
Zaradi zmanjšanja načrtovanega prihodka višje vodstvo agencije pregleduje področja, na katerih bi bilo mogoče prihraniti, in projekte, načrtovane za leto 2010, ki bi jih bilo mogoče opustiti.
The Management Board wrote to the Commission regarding this issue in June and provided a response to the European Commission's letter in August.
Upravni odbor je junija o tem vprašanju pisal Komisiji in avgusta poslal odgovor na dopis Evropske komisije.
The text should read: “The Board discussed the EMEA rules on attachment of staff.
Besedilo bi se moralo glasiti: „Upravni odbor je razpravljal o pravilih agencije EMEA o dodelitvi osebja.
− Mike O'Donovan (representative of the patients' organisations).
Mika O'Donovana (predstavnik organizacij bolnikov).
Amendments to the implementing rules based on this proposal will be submitted to the Board in December 2009.
Spremembe izvedbenih pravil na podlagi tega predloga so bile upravnemu odboru predložene decembra 2009.
The Board thanked the Agency, its staff and the members of the scientific committees for their effective work and the timeliness of the scientific opinions in light of the public-health benefits of the H1N1 pandemic vaccines.
Upravni odbor se je zahvalil agenciji, njenemu osebju in članom znanstvenih odborov za učinkovito delo in pravočasno predložitev znanstvenih mnenj glede koristi pandemičnih cepiv H1N1 za javno zdravje.
Implementation of Staff Regulation: Rules on attachment of staff The item was taken off the agenda.
Izvajanje kadrovskih predpisov: pravila o dodelitvi osebja Točka je bila umaknjena z dnevnega reda.
While recognising that the interests of the healthcare professionals (HCP) organisations are more diverse than those of the patients, the Board asked to continue to explore ways on how to best develop interaction with healthcare professionals.
Čeprav upravni odbor priznava, da so interesi organizacij zdravstvenih strokovnjakov (HCP) bolj raznoliki od interesov bolnikov, pa je zaprosil, da se še naprej proučujejo načini, kako najbolje razvijati sodelovanje z zdravstvenimi strokovnjaki.
The document contains amendments discussed and agreed by the telematics steering committee in relation to the new pharmaceutical package and the funding gap.
Dokument vsebuje spremembe, o katerih so razpravljali in se o njih dogovorili na usmerjevalnem odboru za telematiko v zvezi z novim farmacevtskim svežnjem in primanjkljajem v financiranju.
While the Management Board is awaiting a reply from the Commission to its latest correspondence, the Board considers that this issue remains open, and expects that the publication of the vacancy notice will not proceed without the outstanding issue being resolved.
Medtem ko upravni odbor čaka na odgovor Komisije na njegov zadnji dopis, šteje, da to vprašanje ostaja odprto, in pričakuje, da prosto delovno mesto ne bo objavljeno, dokler se to vprašanje ne reši.
Collaboration between the regulators and the HTA bodies also needs to be developed, in order to reduce avoidable differences in requirements in both fields.
Treba je razvijati tudi sodelovanje med regulatorji in organi za ocenjevanje zdravstvenih tehnologij, da bi se zmanjšale razlike v zahtevah na obeh področjih, ki se jim je mogoče izogniti.
A correction was introduced under point 16 of the minutes (rules on attachment of staff).
V točko 16 zapisnika je bil vnesen popravek (Dodelitev osebja).
A significant amount of resources was allocated to work relating to the H1N1 pandemic.
Veliko sredstev je bilo dodeljenih za raziskave pandemične gripe H1N1.
Some members of the Board requested additional time to review the proposal ahead of its approval.
Nekateri člani upravnega odbora so prosili za dodaten čas, da predlog pregledajo pred odobritvijo.
The work to develop and introduce qualitative indicators will commence.
Začela se bo priprava in uvajanje količinskih kazalnikov.
The present proposal contains comments received and also includes a new proposal for quantitative performance indicators - compliance with set timelines.
Zdajšnji predlog vsebuje prejete pripombe in vključuje nov predlog količinskih kazalnikov uspešnosti ter skladnost s časovnim okvirjem.