natgillin/translations-raw huggingface dataset:
Prof. Pieter de Graeff
prof. Pieter de Graeff dr. Ondřej Slanař
However, because the concerned Member States were not able to reach an agreement, the Dutch medicines regulatory agency referred the matter to the CHMP for arbitration on 2 December 2008.
Ker pa zadevne države članice niso dosegle soglasja, je nizozemski regulatorni organ 2. decembra 2008 zadevo napotil na CHMP v arbitražo.
Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP was of the opinion that bioequivalence between Ciclosporin IDL and the reference medicine had not been sufficiently demonstrated.
Na podlagi ocene trenutno razpoložljivih podatkov in znanstvene razprave v okviru Odbora je CHMP menil, da biološka enakovrednost med zdravilom Ciclosporin IDL in referenčnim zdravilom ni bila zadostno dokazana.
Ciclosporin IDL is a generic medicine that is based on a reference medicine authorised in Germany (Sandimmun Optoral 25 mg capsules).
Zdravilo Ciclosporin IDL je generično zdravilo, ki temelji na referenčnem zdravilu, odobrenem v Nemčiji (Sandimmun Optoral 25 mg kapsule).
An autoimmune disease is a disease which is caused by the body's own defence system attacking normal tissue, such as psoriasis (a disease causing red, scaly patches on the skin), atopic dermatitis (eczema, an itchy red rash), nephrotic syndrome (a kidney disease) and rheumatoid arthritis (inflammation of the joints).
Avtoimunska bolezen je bolezen, ki jo povzroča obrambni sistem telesa, ki napade normalno tkivo, kot so psoriaza (bolezen, ki povzroča rdeče, luskaste zaplate na koži), atopični dermatitis (ekcem, srbeč rdeč izpuščaj), nefrotski sindrom (obolenje ledvic) in revmatoidni artritis (vnetje sklepov).
London, 23 April 2009 Doc.
London, 22 julija 2010 Ref. dok.
It is used in patients who have had a transplant, to prevent rejection (when the immune system attacks the transplanted organ).
Uporablja se pri bolnikih, pri katerih je bila opravljena presaditev, za preprečevanje zavrnitve presadka (ko imunski sistem napade presajeni organ).
In addition the Committee has also recommended that the marketing authorisation for Ciclosporin IDL in the Netherlands and other member states in the EU where the product has been authorised should be suspended until satisfactory bioequivalence data are obtained.
Poleg tega je Odbor priporočil, da je treba dovoljenje za promet z zdravilom Ciclosporin IDL na Nizozemskem in v drugih državah članicah EU, v katerih je zdravilo pridobilo dovoljenje za promet, začasno umakniti, dokler ne bodo na voljo zadostni podatki o biološki enakovrednosti.
Why was Ciclosporin IDL reviewed?
Zakaj je bilo zdravilo Ciclosporin IDL pregledano?
It is also used to treat or prevent graft-versus-host disease (when the immune system of the transplanted organ attacks the patient's tissues).
Uporablja se tudi za zdravljenje ali preprečevanje bolezni presadka proti gostitelju (ko imunski sistem presajenega organa napade bolnikova tkiva).
The company International Drug Licensing (IDL) submitted Ciclosporin IDL for mutual recognition on the basis of the initial authorisation granted by the Netherlands on 10 August 2007.
Družba International Drug Licensing (IDL) je dne 10. avgusta 2007 predložila vlogo za medsebojno priznavanje zdravila Ciclosporin IDL na podlagi prvotnega dovoljenja za promet, odobrenega na Nizozemskem.
The grounds for the referral were that five of the concerned Member States did not agree that enough evidence had been presented to show that Ciclosporin IDL was ‘bioequivalent' to the reference medicine.
Podlaga za napotitev je bila, ker se pet zadevnih držav članic ni strinjalo, da so bili predloženi zadostni dokazi o biološki enakovrednosti zdravila Ciclosporin IDL referenčnemu zdravilu.
Ciclosporin IDL is also used to treat autoimmune diseases.
Zdravilo Ciclosporin IDL se uporablja tudi za zdravljenje avtoimunskih bolezni.
What is Ciclosporin IDL?
Kaj je zdravilo Ciclosporin IDL?
The CHMP therefore concluded that the benefits of Ciclosporin IDL do not outweigh its risks, and that the marketing authorisation should not be granted in the concerned Member States.
CHMP je zato zaključil, da koristi zdravila Ciclosporin IDL ne odtehtajo z njim povezanih tveganj, in priporočil, da se dovoljenje za promet z zdravilom v zadevnih državah članicah ne odobri.
It acts on some special cells in the immune system called T-cells that are responsible for attacking transplanted organs or, in auto-immune diseases, normal tissue.
Zdravilna učinkovina zdravila Ciclosporin IDL, ciklosporin, deluje na nekatere posebne celice v imunskem sistemu, imenovane celice T, ki so odgovorne za to, da napadajo presajene organe ali, pri avtoimunskih boleznih, normalno tkivo.
The European Medicines Agency has completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Ciclosporin IDL.
Evropska agencija za zdravila je 23. aprila 2009 po nesoglasju med državami članicami Evropske unije (EU) glede odobritve zdravila Ciclosporin IDL zaključila arbitražni postopek.
The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Ciclosporin IDL do not outweigh its risks, and that the marketing authorisation granted in the Netherlands cannot be recognised in other Member States of the EU.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da koristi zdravila Ciclosporin IDL ne odtehtajo njegovih tveganj ter da se dovoljenje za promet z zdravilom, odobreno na Nizozemskem, ne more priznati v drugih državah članicah EU in da je treba zato dovoljenje za promet z zdravilom na Nizozemskem začasno umakniti.
Company responses provided on: 16 January 2009 Opinion date:
Odgovori družbe, poslani dne:
18 December 2008
Datum začetka napotitvenega posto 18. december 2008
Ciclosporin IDL is an immunosuppressive medicine.
Ciclosporin IDL je imunosupresivno zdravilo (zdravilo, ki zmanjšuje delovanje imunskega sistema, tj. naravne obrambe telesa).
A European Commission decision on this opinion will be issued in due course.
Evropska komisija je odločbo izdala 22. julija 2010.
The active substance in Ciclosporin IDL, ciclosporin, is an immunosuppressive agent.
Družba International Drug Licensing, ki trži zdravilo Ciclosporin IDL, je zahtevala ponovno presojo mnenja.
2 protective mats
2 zaščitni podlogi
Powder: 500 U; Solvent: 5 ml
prašek: 500 U; vehikel: 5 ml
Intravenous use powder: vial (glass); solvent: vial (glass)
500 U prašek in vehikel za raztopino za injiciranje intravenska uporaba prašek: viala (steklo); vehikel: viala (steklo)
2 powder vials 2 solvent vials 2 filter transfer devices
2 viali s praškom 2 viali z vehiklom 2 pripravi za prenos s filtrom 2 10 ml brizgi za enkratno uporabo 2 kompleta za punkcijo vene
It may be used:
Uporablja se lahko:
This summary was last updated in September 2019.
Povzetek je bil nazadnje posodobljen septembra 2019.
The veterinarian will decide if additional treatment is needed.
Veterinar bo presodil, ali je potrebno kakršno koli dodatno zdravljenje.
Further information on Bravecto can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/bravecto.
Nadaljnje informacije o zdravilu Bravecto so na voljo na spletni strani agencije: ema.europa.eu/medicines/veterinary/EPAR/bravecto.
Bravecto received a marketing authorisation valid throughout the EU on 11 February 2014.
Zdravilo Bravecto je pridobilo dovoljenje za promet, veljavno po vsej Evropski uniji, 11. februarja 2014.
Other information about Bravecto
Druge informacije o zdravilu Bravecto
The European Medicines Agency decided that Bravecto's benefits are greater than its risks and it can be authorised for use in the EU.
Evropska agencija za zdravila je odločila, da so koristi zdravila Bravecto večje od z njim povezanih tveganj, in da se lahko odobri za uporabo v EU.
People handling the medicine should not smoke, eat or drink and should wash their hands thoroughly after handling the product.
Osebe med uporabo zdravila ne smejo kaditi, jesti ali piti in si morajo po uporabi zdravila temeljito umiti roke.
What is Bravecto and what is it used for?
Kaj je zdravilo Bravecto in za kaj se uporablja?
What are the risks associated with Bravecto?
Kakšna tveganja so povezana z zdravilom Bravecto?
Used pipettes should be disposed of immediately.
Uporabljene merilne kapalke je treba nemudoma zavreči.
What benefits of Bravecto have been shown in studies?
Kakšne koristi je zdravilo Bravecto izkazalo v študijah?
In case of eye contact, the affected area should be rinsed immediately with water.
V primeru stika z očmi je treba prizadeto področje nemudoma izprati z vodo.
It blocks the normal movement of charged chloride particles (ions) in and out of nerve cells, especially those associated with gamma-aminobutyric acid (GABA) and glutamate, two substances that convey messages between nerves (neurotransmitters).
Zavira normalno prehajanje nabitih kloridnih delcev (ionov) v živčne celice in iz njih, in sicer zlasti tistih, ki so povezani z gama-aminomasleno kislino (GABA) in glutamatom, tj. dvema snovema, ki prenašata sporočila med živci (živčna prenašalca).
An overview of Bravecto and why it is authorised in the EU
Pregled zdravila Bravecto in zakaj je odobreno v EU
Why is Bravecto authorised in the EU?
Zakaj je zdravilo Bravecto odobreno v EU?
For ear mite infestations, a veterinary check is advised 28 days after treatment.
Za zdravljenje infestacij z ušesnimi garjami je priporočljiv veterinarski pregled 28 dni po zdravljenju.
Contact with skin and/or eyes should be avoided including hand to eye contact.
Treba se je izogibati stiku s kožo in/ali očmi ter dotiku oči z rokami.
This means that it kills parasites that live on or in the skin or in the fur or ears of animals, such as fleas, ticks and mites.
To pomeni, da uničuje zajedavce, ki živijo na koži ali v njej ali v dlaki ali ušesih živali, kot so bolhe, klopi in garjavci.
The product should be kept in the original package until use, in order to prevent children directly accessing the medicine.
Do uporabe ga je treba shranjevati v originalni ovojnini, da se otrokom prepreči neposreden stik z njim.
The effectiveness of Bravecto against fleas and ticks was investigated in both laboratory and field studies.
Učinkovitost zdravila Bravecto proti bolham in klopom so proučevali v laboratorijskih in terenskih študijah.
The main measure of effectiveness was the reduction in the number of fleas and ticks in the infested dogs during the 3 months after receiving treatment.
Glavno merilo učinkovitosti je bilo zmanjšanje števila bolh in klopov na infestiranih psih v treh mesecih po dajanju zdravila.
For optimal tick control, treatment should be repeated every 8 to 12 weeks depending on the tick species.
Za optimalen nadzor nad klopi je treba zdravljenje ponoviti vsakih osem do 12 tednov, odvisno od vrste klopov.
Fluralaner kills fleas before they can lay eggs and so helps to reduce contamination of the dogs' or cats' environment.
Fluralaner uniči bolhe, preden izležejo jajčeca, s čimer pomaga zmanjšati kontaminacijo okolice psa ali mačke.
Fluralaner kills fleas, ticks and mites that have ingested the dog's or cat's blood by acting on their nervous system.
Fluralaner uniči bolhe, klope in garjavce, ki so zaužili kri psa ali mačke, tako da deluje na njihov živčni sistem.
The active substance in Bravecto, fluralaner, acts as an ‘ectoparasiticide'.
Učinkovina v zdravilu Bravecto, fluralaner, deluje kot ektoparaziticid.
For more information about using Bravecto, see the package leaflet or contact your veterinarian or pharmacist.
Za več informacij glede uporabe zdravila Bravecto glejte navodilo za uporabo ali se posvetujte z veterinarjem ali farmacevtom.
Because parasites must start feeding on the dog or cat in order to be killed by the medicine, they might still be able to transmit any diseases with which they may be infected.
Ker lahko zdravilo parazite uniči šele potem, ko se začnejo hraniti s krvjo psa ali mačke, še vedno obstaja možnost prenosa bolezni, s katerimi so morda okuženi.
Bravecto contains the active substance fluralaner.
Zdravilo Bravecto vsebuje učinkovino fluralaner.
How does Bravecto work?
Kako zdravilo Bravecto deluje?
Bravecto was effective against fleas and ticks for up to 12 weeks after treatment, and was as effective as fipronil in terms of the percentage of dogs and cats as well as households free of fleas and ticks.
Zdravilo Bravecto je bilo učinkovito proti bolham in klopom do 12 tednov po zdravljenju in je bilo enako učinkovito kot fipronil z vidika deleža psov in mačk ter gospodinjstev brez bolh in klopov.
Bravecto spot-on solution should be kept away from heat, sparks, open flames or other fire sources as it is highly flammable.
Zdravilo Bravecto v obliki raztopine za kožni nanos je treba hraniti ločeno od vročine, isker, odprtega ognja ali drugih virov vžiga, saj je zelo vnetljivo.
This product is harmful if swallowed.
Zdravilo je škodljivo pri zaužitju.
• as part of the management of flea allergy dermatitis (an allergic reaction to flea bites) in dogs and cats
• kot del obvladovanja alergijskega dermatitisa, ki ga povzročajo bolhe (alergijske reakcije na ugrize bolh) pri mačkah in psih;
For dogs, several spots may be applied from the initial spot in a line to the base of the tail.
Pri psih se lahko nanese na več mest, in sicer od mesta prvotnega nanosa v smeri proti korenu repa.
It takes up to 48 hours for the application site to become dry but it will be noticeable for longer.
Da se mesto nanosa posuši, traja do 48 ur, opazno pa je še dlje časa.
For the full list of all side effects reported with Bravecto, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Bravecto, glejte navodilo za uporabo.
In cats, Bravecto kills fleas within 12 hours and ticks within 48 hours.
Pri mačkah zdravilo bolhe uniči v 12 urah in klope v 48 urah.
Bravecto is a veterinary medicine used to treat parasitic infestations in dogs and cats.
Zdravilo Bravecto je zdravilo, ki se uporablja v veterinarski medicini za zdravljenje infestacij s paraziti pri psih in mačkah.
The most common side effects of the tablets in dogs (which may affect more than 1 in 100 animals) are mild and short-lived diarrhoea, vomiting, lack of appetite and drooling.
Najpogostejši neželeni učinki tablet pri psih (ki lahko prizadenejo več kot 1 žival od 100) so blaga in prehodna driska, bruhanje, pomanjkanje teka in slinjenje.
In order to be exposed to the active substance, parasites must attach to the skin and commence feeding on the dog or cat.
Da bi bili paraziti izpostavljeni učinkovini, se morajo pritrditi na kožo ter začeti hraniti s krvjo psa ali mačke.
Bravecto spot-on solution and the wet skin of a recently treated animal may be slightly irritating to skin and/or eyes.
Zdravilo Bravecto v obliki raztopine za kožni nanos in vlažna koža živali, ki je pred kratkim prejela zdravilo, sta lahko rahlo dražilna za kožo in/ali oči.
In case of spillage on table or floor surfaces, excess Bravecto spot-on solution should be removed using paper tissue and the area cleaned with a detergent.
V primeru razlitja po mizi ali talnih površinah zdravilo Bravecto v obliki raztopine za kožni nanos odstranite s papirnatimi brisačami in očistite površino s čistilom.
The most common side effect of the spot-on solution (which may affect more than 1 in 100 animals) is a mild short-lived skin reaction at the application site, such as erythema (redness) and pruritus (itching) or hair loss.
Najpogostejši neželeni učinek raztopine za kožni nanos (ki lahko prizadene več kot 1 žival od 100) je blaga prehodna kožna reakcija na mestu nanosa, kot sta eritem (pordelost) in pruritus (srbenje) ali izguba dlak.
If the product is accidentally swallowed by a person, the advice of a doctor should be sought immediately and the package leaflet or label shown to the doctor.
Če človek zdravilo nenamerno zaužije, se mora nemudoma posvetovati z zdravnikom in mu pokazati navodilo za uporabo ali nalepko.
How is Bravecto used?
Kako se zdravilo Bravecto uporablja?
As demodectic mange is caused by a number of factors, it is advisable for any underlying disease to be treated.
Ker garjavost vrste Demodex canis povzroča več dejavnikov, je treba zdraviti tudi vsa sočasna obolenja.
Bravecto and the comparator medicine were both 100% effective as all treated dogs were free from live mites when skin scrapings were taken on days 56 and 84 after treatment.
Zdravilo Bravecto in primerjano zdravilo sta bila 100-odstotno učinkovita, saj pri nobenem psu v postružkih kože, odvzetih 56 in 84 dni po zdravljenju, niso našli živih garjavcev.
The field study showed that Bravecto was effective in reducing the number of fleas and ticks in dogs with existing flea or tick infestations and that its effects against fleas and most tick species persisted for 3 months.
Terenska študija je pokazala, da je bilo zdravilo Bravecto učinkovito pri zmanjšanju števila bolh in klopov pri psih, ki so bili infestirani z bolhami ali klopi, in da so njegovi učinki proti bolham in večini vrst klopov trajali tri mesece.
• to treat ear mite infestations in cats.
• za zdravljenje infestacij z ušesnimi garjami pri mačkah.
The content of one full Bravecto pipette is applied to the dog or cat's skin between the shoulder blades of the dog and at the base of the skull of the cat.
Vsebina polne merilne kapalke zdravila Bravecto se nanese na kožo psa ali mačke, in sicer med lopatice pri psu in na spodnji del lobanje pri mački.
After being given, its actions last for 12 weeks against fleas and 8 to 12 weeks against ticks.
Po uporabi zdravilo proti bolham deluje 12 tednov, proti klopom pa od osem do 12 tednov.
The spot-on solution and tablets are available in different strengths for dogs and cats of different weights.
Raztopina za kožni nanos in tablete so na voljo v različnih jakostih za pse in mačke z različnimi telesnimi masami.
• to treat flea and tick infestations in dogs and cats
• za zdravljenje infestacij z bolhami in klopi pri psih in mačkah;
In an EU field study involving 561 dogs with flea and/or tick infestations, the effects of Bravecto tablets were compared with those of another product, fipronil, that kills fleas and ticks, applied as a spot-on solution to the skin of the dogs.
V terenski študiji, ki so jo opravili v EU in v katero je bilo vključenih 561 psov z bolhami in/ali klopi, so učinke zdravila Bravecto v obliki tablet primerjali z učinki drugega zdravila za uničenje bolh in klopov, fipronila, ki se v obliki raztopine za kožni nanos nanese na kožo psov.
Bravecto can only be obtained with a prescription.
Predpisovanje in izdaja zdravila Bravecto je le na recept.
If skin reactions occur, a doctor sould be consulted and the product leaflet or label shown to the doctor.
Če pride do reakcij na koži, se je treba posvetovati z zdravnikom in mu pokazati navodilo za uporabo ali nalepko.
In a study conducted in the EU involving cats with ear mites, the effectiveness of Bravecto was >90% based on presence of live ear mites at day 28 after treatment.
V študiji, ki so jo opravili v EU in v katero so bile vključene mačke z ušesnimi garjami, so z določanjem prisotnosti živih ušesnih garjavcev 28 dni po zdravljenju za zdravilo Bravecto ugotovili več kot 90odsotno učinkovitost.
Bravecto is available as a spot-on solution in a pipette for use on dogs and cats and as chewable tablets for use in dogs.
Zdravilo Bravecto je na voljo v obliki raztopine za kožni nanos v merilni kapalki za uporabo pri psih in mačkah ter v obliki žvečljivih tablet za uporabo pri psih.
The animal's application site should no longer be noticeable before resuming contact with the site of application.
Pred nadaljnjimi stiki z mestom nanosa slednje na živali ne sme biti več opazno.
Bravecto tablets are given around the dog's feeding time as a tablet of the appropriate strength for the dog's bodyweight.
Zdravilo Bravecto v obliki tablet se daje približno v času hranjenja, pri čemer se uporabi ena tableta, katere jakost ustreza telesni masi psa.
• to treat demodectic and sarcoptic mange (skin infestation caused by two different mites) in dogs
• za zdravljenje infestacij z garjavci vrste Demodex canis in Sarcoptes scabiei (kožne garjavosti, ki jo povzročata dve vrsti garjavcev) pri psih;
Treatment should be repeated every twelve weeks for optimal flea control.
Za optimalen nadzor nad bolhami je treba zdravljenje ponoviti vsakih 12 tednov.
The pipette to use is selected on the basis of the dog or cat's weight.
Merilno kapalko je treba izbrati na podlagi telesne mase psa ali mačke.
Bravecto kills fleas within 8 hours and ticks within 12 hours in dogs.
Pri psih zdravilo Bravecto bolhe uniči v osmih urah, klope pa v 12 urah.
A study conducted in Europe involved dogs with sarcoptic mange and compared Bravecto chewable tablets and Bravecto spot-on solution to another medicine authorised to treat sarcoptic mange.
V študiji, ki so jo opravili v EU in v katero so bili vključeni psi z infestacijo z garjavci vrste Sarcoptes scabiei, so primerjali zdravilo Bravecto v obliki žvečljivih tablet in v obliki raztopine za kožni nanos z drugim zdravilom, odobrenim za zdravljenje te vrste garjavosti.
Effectiveness was 95% and 94% for Bravecto chewable tablets and Bravecto spot-on solution respectively based on the percentage of dogs free from live mites at days 56 and 84 after treatment.
Učinkovitost, ki je bila opredeljena kot odstotek psov brez živih garjavcev 56 in 84 dni po zdravljenju, je bila za zdravilo Bravecto v obliki žvečljivih tablet 95-odstotna, v obliki raztopine za kožni nanos pa 94-odstotna.
Two further EU field studies involved dogs and cats with flea and/or tick infestations and compared the effects of Bravecto spot-on solution with fipronil spot-on solution.
V dveh drugih terenskih študijah, ki so ju opravili v EU in sta vključevali pse in mačke, infestirane z bolhami in/ali klopi, so primerjali učinke zdravila Bravecto v obliki raztopine za kožni nanos s fipronilom v obliki raztopine za kožni nanos.
A single treatment is required for demodectic and sarcoptic mange in dogs and ear mites in cats.
Za zdravljenje infestacij z garjavci vrste Demodex canis in Sarcoptes scabiei pri psih in infestacij z ušesnimi garjami pri mačkah se opravi eno zdravljenje.
Treatment should be repeated every 12 weeks for optimal flea and tick control.
Za optimalen nadzor nad bolhami in klopi je treba zdravljenje ponoviti vsakih 12 tednov.
A study conducted in Europe looked at the effectiveness of Bravecto chewable tablets and Bravecto spot-on solution in dogs with demodectic mange.
V študiji, ki so jo opravili v EU, so preučevali učinkovitost zdravila Bravecto v obliki žvečljivih tablet in v obliki raztopine za kožni nanos pri psih z infestacijo z garjavci vrste Demodex canis.
If skin contact occurs, the affected area should be washed immediately with soap and water
Pri stiku kože z zdravilom je treba kožo nemudoma sprati z milom in vodo.
Suitable gloves should be worn when handling or giving Bravecto spot-on solution to dogs and cats.
Pri uporabi ali dajanju zdravila v obliki raztopine za kožni nanos pri psih in mačkah nosite ustrezne rokavice.
The need for and frequency of re-treatment for sarcoptic mange should follow veterinary advice.
Pri garjavosti vrste Demodex canis mora veterinar presoditi o potrebi po ponovitvi zdravljenja in njegovi pogostosti.
After being given, its actions last for 12 weeks against fleas and ticks.
Po nanosu zdravilo proti bolham in klopom deluje 12 tednov.
Revaccinate annually.
Cepljenje ponovimo vsako leto.
Any reconstituted vaccine remaining at the end of this time should be discarded.
Rekonstituirano cepivo, ki bi po tem času še ostalo, je treba zavreči.