FrancophonIA/ELRC3.0 huggingface dataset:
English: The CVMP also recommended that the use of the product should be based on culture and sensitivity testing of micro-organisms from diseased cases on farm or from recent previous experience on the farm, as resistance against potentiated sulphonamides may vary.
Slovenian: Priporočil je tudi uporabo zdravila na podlagi testiranja kultur in občutljivosti mikroorganizmov iz obolelih primerov na kmetiji ali nedavnih izkušenj na kmetiji, saj se lahko odpornost na okrepljene sulfonamide spreminja.
English: OPINION FOLLOWING AN ARTICLE 34 REFERRAL FOR METHOXASOL-T
Slovenian: MNENJE V ZVEZI Z NAPOTITVIJO V SKLADU S ČLENOM 34 ZA ZDRAVILO METHOXASOL-T
English: The CVMP recommended in relation to the pharmacokinetic properties described that the inclusion of environmental effects should be deleted.
Slovenian: CVMP je v zvezi z opisanimi farmakokinetičnimi lastnostmi priporočil izbris navedbe o okoljskih učinkih.
English: An intended application for a marketing authorisation of a generic triggered Germany to submit the referral regarding the divergent decisions taken on Methoxasol-T.
Slovenian: Zaradi načrtovane vloge za dovoljenje za promet z generičnim zdravilom je Nemčija sprožila napotitveni postopek zaradi različnih odločitev o zdravilu Methoxasol-T.
English: • Pigs: treatment and prevention of respiratory infections caused by Actinobacillus pleuropneumoniae susceptible to trimethoprim and sulfamethoxazole where the disease has been diagnosed in the herd.
Slovenian: • Prašiči: zdravljenje in preprečevanje okužb dihal, ki jih povzroča bakterija Actinobacillus pleuropneumoniae, občutljiva na trimetroprim in sulfametoksazol, kadar je bila bolezen diagnosticirana v čredi;
English: Having considered the grounds for referral and the responses provided by the Marketing Authorisation Holder, CVMP concluded that the benefit/risk balance of the product is positive for use in both pigs and broilers subject to recommended changes to the Summary of Product Characteristics and product information, and that the concerns raised by Germany should not prevent the granting of a marketing authorisation.
Slovenian: Ob upoštevanju razlogov za napotitev in odgovorov, ki jih je predložil imetnik dovoljenja za promet, je CVMP zaključil, da je razmerje med koristmi in tveganji za uporabo zdravila pri prašičih in pitovnih piščancih pozitivno, ob upoštevanju priporočenih sprememb v povzetku glavnih značilnosti zdravila in informacijah o zdravilu, ter da izraženi zadržki Nemčije ne bi smeli preprečiti odobritve dovoljenja za promet z zdravilom.
English: • Broilers: treatment and prevention of respiratory infections caused by Escherichia coli susceptible to trimethoprim and sulfamethoxazole where the disease has been diagnosed in the flock.
Slovenian: • Pitovni piščanci: zdravljenje in preprečevanje okužb dihal, ki jih povzroča bakterija Escherichia coli, občutljiva na trimetroprim in sulfametoksazol, kadar je bila bolezen diagnosticirana v jati.
English: The Marketing Authorisation Holder submitted written responses, defending the indications, recommended dose and shelf life, and proposing a harmonised SPC text.
Slovenian: Imetnik dovoljenja za promet z zdravilom je predložil pisne odgovore ter z njimi zagovarjal indikacije, priporočeno odmerjanje in rok uporabnosti ter predlagal usklajeno besedilo povzetka glavnih značilnosti zdravila.
English: To propose and justify a harmonised text of the Summary of Product Characteristics (SPC), including posology and method of administration as well as withdrawal periods for pigs and poultry.
Slovenian: Pri perutnini je bila potrebna obrazložitev glede trenutne uporabe zdravila, zlasti glede odmerka, uporabljenega ali predpisanega na terenu; 5. predlaga in s podatki utemelji primeren rok uporabnosti zdravila, vključno z rokom uporabnosti po odprtju vsebnika, kadar je to ustrezno; 6. predlaga in utemelji usklajeno besedilo povzetka glavnih značilnosti zdravila (SPC), vključno z odmerjanjem in načinom uporabe ter karenco za prašiče in perutnino.
English: To justify compliance of the dossier with respect to the requirements for obtaining a marketing authorisation (Annex I of Directive 2001/82/EC, as amended).
Slovenian: Imetnik dovoljenja za promet z zdravilom je bil naprošen, da: 1. predloži ustrezne dele dokumentacije, ki je bila predložena v posameznih državah članicah ob vložitvi vloge, in natančno opredeli razlike med posameznimi dokumentacijami; 2. utemelji skladnost dokumentacije glede zahtev za pridobitev dovoljenja za promet z zdravilom (Priloga I Direktive 2001/82/ES, kakor je bila spremenjena); 3. preuči vprašanja, izpostavljena v obvestilu o napotitvi, na podlagi katerih je bilo dovoljenje za promet z zdravilom v Nemčiji zavrnjeno; 4. s podatkih s terena utemelji uporabo zdravila in ustreznost priporočenega odmerka za vsako od navedenih indikacij pri prašičih in perutnini.
English: These signs usually resolve without treatment.
Slovenian: Ti znaki običajno izzvenijo brez zdravljenja.
English: Sarolaner
Slovenian: Simparica sarolaner
English: The European Commission granted a marketing authorisation valid throughout the EU for Simparica on 6 November 2015.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Simparica, veljavno po vsej Evropski uniji, izdala 6. novembra 2015.
English: The full EPAR for Simparica can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila za zdravilo Simparica je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Simparica's benefits are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini (CVMP) pri agenciji je zaključil, da so koristi zdravila Simparica večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: Sarolaner kills fleas before they can lay eggs and so helps to reduce contamination of the dog's environment.
Slovenian: Sarolaner ubije bolhe, preden te lahko izležejo jajčeca, in tako pomaga zmanjšati kontaminacijo okolja psa.
English: This is a summary of the European public assessment report (EPAR) for Simparica.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Simparica.
English: Because fleas and ticks must start feeding on the dog in order to be killed by the medicine, the risk of transmission of diseases with which they may be infected cannot be excluded.
Slovenian: Ker se morajo bolhe in klopi začeti hraniti s krvjo psa, da bi jih zdravilo lahko uničilo, ni mogoče izključiti tveganja za prenos bolezni, s katerimi so ti zajedavci lahko okuženi.
English: What is Simparica and what is it used for?
Slovenian: Kaj je zdravilo Simparica in za kaj se uporablja?
English: Other information about Simparica
Slovenian: Druge informacije o zdravilu Simparica
English: The tablets should be kept in the original package until use in order to prevent children directly accessing the medicine.
Slovenian: Tablete je treba do uporabe hraniti v originalni embalaži, da bi preprečili neposreden dostop otrok do njih.
English: What are the risks associated with Simparica?
Slovenian: Kakšna tveganja so povezana z zdravilom Simparica?
English: What benefits of Simparica have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Simparica izkazalo v študijah?
English: It is not intended to provide practical advice on how to use Simparica.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: This means that it kills parasites that live on the skin or in the fur of animals, such as fleas, ticks and mites.
Slovenian: To pomeni, da uničuje zajedavce, ki živijo na koži ali v dlaki živali, kot so bolhe, klopi in garjavci.
English: 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).
Slovenian: Zavira normalno prehajanje nabitih kloridnih delcev (ionov) v živčne celice in iz njih, in sicer zlasti tistih, ki so povezani z gamaaminomasleno kislino (GABA) in glutamatom, tj. dvema snovema, ki prenašata sporočila med živci (živčna prenašalca).
English: Simparica was as effective as moxidectin/imidacloprid and the percentage of Simparica-treated dogs with no live mites was 15%, 69%, 93%, 94%, 100% and 100% on days 30, 60, 90, 120, 150 and 180, respectively.
Slovenian: Zdravilo Simparica je bilo enako učinkovito kot moksidektin/imidakloprid, pri čemer je bil delež psov, ki so bili zdravljeni z zdravilom Simparica in niso kazali znakov prisotnosti živih garjavcev, 15 %, 69 %, 93 %, 94 %, 100 % in 100 % na 30., 60., 90., 120., 150. oziroma na 180. dan po opravljenem zdravljenju.
English: For treatment of ear mite infestations a single dose should be given.
Slovenian: Za zdravljenje infestacij z ušesnimi garjavci se daje en sam odmerek.
English: It contains the active substance sarolaner.
Slovenian: Vsebuje zdravilno učinkovino sarolaner.
English: Treatment should be continued until skin scrapings are negative on at least two consecutive occasions one month apart.
Slovenian: Zdravljenje je treba nadaljevati, dokler rezultat kožnega brisa ni negativen pri vsaj dveh zaporednih pregledih, med katerima mora biti enomesečni razmik.
English: Simparica is available as chewable tablets (5, 10, 20, 40, 80 and 120 mg) and can only be obtained with a prescription.
Slovenian: Zdravilo Simparica je na voljo v obliki žvečljivih tablet (5 mg, 10 mg, 20 mg, 40 mg, 80 mg in 120 mg), njegovo predpisovanje in izdaja pa je le na recept.
English: Why is Simparica approved?
Slovenian: Zakaj je bilo zdravilo Simparica odobreno?
English: The effectiveness of Simparica against fleas was investigated in a field study in dogs infested with at least five live fleas.
Slovenian: Učinkovitost zdravila Simparica proti bolham so raziskovali v terenski študiji, v katero so bili vključeni psi z vsaj petimi živimi bolhami.
English: Side effects with Simparica are not common.
Slovenian: Neželeni učinki zdravila Simparica niso pogosti.
English: A field study was conducted in dogs infested with at least three live attached ticks.
Slovenian: Izvedena je bila tudi terenska študija pri psih z vsaj tremi živimi pritrjenimi klopi.
English: As other conditions contribute to demodectic mange, any underlying diseases should also be treated.
Slovenian: Ker druge bolezni prispevajo h garjavosti vrste Demodex canis, je treba zdraviti tudi vsa sočasna obolenja.
English: However, the following side effects are seen in less than 1 dog in 10,000: mild and short-lived vomiting and diarrhoea as well as tremor (shaking), ataxia (inability to coordinate body movements) or convulsions.
Slovenian: Ne glede na to so bili pri manj kot 1 psu od 10 000 opaženi naslednji neželeni učinki: blago in kratkotrajno bruhanje in driska, tresavica, ataksija (nezmožnost kooridnacije telesnih gibov) ali konvulzije.
English: Simparica can be used as part of the management of flea allergy dermatitis (an allergic reaction to flea bites).
Slovenian: Zdravilo Simparica se lahko uporablja kot del zdravljenja alergijskega dermatitisa, ki ga povzročajo bolhe (alergijske reakcije na ugrize bolh).
English: The active substance in Simparica, sarolaner acts as an ‘ectoparasiticide'.
Slovenian: Zdravilna učinkovina v zdravilu Simparica, sarolaner, deluje kot ektoparaziticid.
English: Another study involved dogs infested with sarcoptic mange.
Slovenian: Opravljena je bila tudi študija, ki je vključevala pse z garjami vrste Sarcoptes scabiei.
English: For Simparica the percentage of dogs with no live ear mites present was 91% at day 30 increasing to 99% on day 60, following two treatments.
Slovenian: Pri zdravljenju z zdravilom Simparica je bil delež psov, pri katerih na 30. dan po zdravljenju ni bilo več prisotnih živih ušesnih garjavcev, 91 %, ki je na 60. dan, tj. po dveh zdravljenjih, narastel na 99 %.
English: Simparica is a veterinary medicine used to treat infestations with ticks and fleas, demodectic and sarcoptic mange (skin infestations caused by two different types of mites) and ear mite infestations in dogs.
Slovenian: Zdravilo Simparica je zdravilo za uporabo v veterinarski medicini, ki je namenjeno zdravljenju infestacij s klopi in bolhami, garjavci vrste Demodex canis in Sarcoptes scabiei (kožne garjavosti, ki jo povzročata dve vrsti garjavcev) ter infestacij z ušesnimi garjavci pri psih.
English: For treatment of tick and flea infestations Simparica should be given once every month throughout the flea and/or tick season for optimal control.
Slovenian: Za zdravljenje infestacij s klopi in bolhami se zdravilo Simparica v sezoni klopov in/ali bolh daje enkrat mesečno, da bi dosegli optimalen nadzor.
English: How does Simparica work?
Slovenian: Kako zdravilo Simparica deluje?
English: Simparica was as effective as moxidectin/imidacloprid.
Slovenian: Zdravilo Simparica je bilo enako učinkovito kot moksidektin/imidakloprid.
English: In a study with 98 dogs with demodectic mange, 63 dogs were treated with Simparica monthly for up to six months and 35 dogs received moxidectin/imidacloprid.
Slovenian: V študiji, ki je zajela 98 psov z garjavci vrste Demodex canis, je bilo 63 psov zdravljenih enkrat na mesec z zdravilom Simparica v obdobju do šestih mesecev, medtem ko je 35 psov prejemalo moksidektin/imidakloprid.
English: 53 dogs were treated with Simparica for two months whilst 26 dogs were given a medicine containing moxidectin and imidacloprid.
Slovenian: 53 psov je dva meseca prejemalo zdravilo Simparica, 26 psov pa zdravilo, ki je vsebovalo moksidektin in imidakloprid.
English: 189 dogs were treated with Simparica for three months whilst 96 dogs were given another medicine, spinosad.
Slovenian: 189 psov je tri mesece prejemalo zdravilo Simparica, 96 psov pa drugo zdravilo, spinosad.
English: Safety information has been included in the summary of product characteristics and the package leaflet for Simparica, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.
Slovenian: V povzetek glavnih značilnosti zdravila Simparica in navodilo za njegovo uporabo so bile vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in lastniki ali skrbniki živali.
English: In a study involving dogs with ear mite infestation, 283 dogs were treated with Simparica and 131 dogs received moxidectin/imidacloprid (a spot-on mite treatment).
Slovenian: V študiji, ki je zajela pse z infestacijami ušesnih garjavcev, je bilo 283 psov zdravljenih z zdravilom Simparica, 131 psov pa je prejemalo moksidektin/imidakloprid (zdravilo proti garjam za kožni nanos).
English: After Simparica is given its activity against ticks and fleas lasts for at least 5 weeks.
Slovenian: Po dajanju zdravila Simparica učinek proti klopom in bolham traja najmanj pet tednov.
English: For treatment of sarcoptic mange, Simparica is given monthly for two consecutive months.
Slovenian: Za zdravljenje infestacij z garjami vrste Sarcoptes scabiei se zdravilo Simparica daje enkrat na mesec dva meseca zapored.
English: How is Simparica used?
Slovenian: Kako se zdravilo Simparica uporablja?
English: Simparica was as effective as fipronil in reducing tick counts for up to 90 days after treatment.
Slovenian: Zdravilo Simparica je bilo enako učinkovito pri zmanjševanju števila klopov kot zdravilo fipronil, kar je trajalo do 90 dni po zdravljenju.
English: For more information about treatment with Simparica, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Simparica naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
English: For practical information about using Simparica, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Simparica naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
English: Dogs with live mites on day 30 after initial treatment received a second treatment.
Slovenian: Psom, ki so imeli na 30. dan po prejetem zdravilu na koži žive garjavce, so zdravilo dali še enkrat.
English: Simparica was as effective as spinosad in reducing flea counts for up to 90 days after treatment.
Slovenian: Zdravilo Simparica je bilo enako učinkovito pri zmanjševanju števila bolh kot zdravilo spinosad, kar je trajalo do 90 dni po zdravljenju.
English: The appropriate strength tablet(s) should be used according to the dog's weight.
Slovenian: Ustrezna jakost tablete oziroma tablet se določi glede na telesno maso psa.
English: Simparica was as effective as moxidectin and imidacloprid in eliminating live mites in skin scrapings.
Slovenian: Zdravilo Simparica je bilo pri odpravljanju živih garjavcev v kožnih ostružkih enako učinkovito kot moksidektin in imidakloprid.
English: 122 dogs were treated with Simparica for three months whilst 59 dogs were treated with another medicine, fipronil, against ticks.
Slovenian: 122 psov je proti klopom tri mesece prejemalo zdravilo Simparica, 59 psov pa drugo zdravilo, fipronil.
English: For treatment of demodectic mange Simparica should be given once a month for at least three months.
Slovenian: Za zdravljenje infestacij z garjami vrste Demodex canis se zdravilo Simparica daje enkrat na mesec najmanj tri mesece zapored.
English: In order to be exposed to the active substance, fleas and ticks must attach to the skin and commence feeding on the dog's blood.
Slovenian: Da bi bili bolhe in klopi izpostavljeni zdravilni učinkovini, se morajo pritrditi na kožo in se začeti hraniti s krvjo psa. Sarolaner ubije zajedavce, ki so zaužili kri psa, tako da deluje na njihov živčni sistem.
English: The risk of excess iron build-up was considered limited but should be followed up after approval.
Slovenian: Tveganje za kopičenje presežka železa je bilo ocenjeno kot majhno, vendar ga je treba po odobritvi spremljati.
English: The tablets must be chewed and not swallowed whole.
Slovenian: Tablete je treba prežvečiti in se jih ne sme pogoltniti celih.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Velphoro on 26 August 2014.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Velphoro, veljavno po vsej Evropski uniji, izdala 26. avgusta 2014.
English: There were no major safety concerns and although tolerability is slightly lower than with sevelamer, the overall safety profile was acceptable.
Slovenian: Večjih pomislekov glede varnosti ni bilo in čeprav bolniki zdravilo nekoliko slabše prenašajo kot sevelamer, je splošni varnostni profil sprejemljiv.
English: The full EPAR and risk management plan summary for Velphoro can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) in povzetek načrta obvladovanja tveganj za zdravilo Velphoro sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Velphoro's benefits are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Velphoro večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: Patients with severe kidney disease cannot eliminate phosphate from their bodies.
Slovenian: Bolniki s hudo boleznijo ledvic ne morejo izločiti fosfatov iz telesa.
English: The dose of Velphoro should be adjusted every two to four weeks, until an acceptable level of phosphate in the blood is reached, which should then be monitored regularly.
Slovenian: Odmerek zdravila Velphoro je treba prilagoditi vsaka dva do štiri tedne, dokler niso dosežene sprejemljive ravni fosfatov v krvi, ki jih je nato treba redno spremljati.
English: What measures are being taken to ensure the safe and effective use of Velphoro?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Velphoro?
English: This is a summary of the European public assessment report (EPAR) for Velphoro.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Velphoro.
English: Other information about Velphoro
Slovenian: Druge informacije o zdravilu Velphoro
English: The study looked at the change in the amount of phosphate in the blood, measured in units of mmol/L.
Slovenian: V študiji so proučevali spremembo količine fosfatov v krvi, ki so jo merili v enotah mmol/l.
English: After 3 months of treatment, blood-phosphate levels fell on average by 0.7 mmol/L with Velphoro compared with 0.8 mmol/L with sevelamer, and after 6 months of treatment 53% of patients on Velphoro had normal blood-phosphate levels (1.13 to 1.78 mmol/L) compared with 54% of patients on sevelamer.
Slovenian: Po 3 mesecih zdravljenja so se ravni fosfatov v krvi v povprečju znižale za 0,7 mmol/l pri uporabi zdravila Velphoro in za 0,8 mmol/l pri uporabi sevelamerja, po 6 mesecih zdravljenja pa so normalne ravni fosfatov v krvi (od 1,13 do 1,78 mmol/l) zabeležili pri 53 % bolnikov, ki so prejemali zdravilo Velphoro, in pri 54 % bolnikov, ki so prejemali sevelamer.
English: The recommended starting dose is 1,500 mg (3 tablets) a day, taken in divided doses together with meals.
Slovenian: Priporočeni začetni odmerek je 1 500 mg (3 tablete) na dan, ki se jemlje v deljenih odmerkih ob obrokih.
English: This leads to hyperphosphataemia (high blood phosphate levels), which, in the long term, can cause complications such as heart and bone disease.
Slovenian: Zaradi tega se pojavi hiperfosfatemija (visoke ravni fosfatov v krvi), ki lahko čez čas povzroči zaplete, kot so bolezni srca in kosti.
English: Velphoro is available as chewable tablets (containing 500 mg of iron).
Slovenian: Zdravilo Velphoro je na voljo v obliki žvečljivih tablet (ki vsebujejo 500 mg železa).
English: A risk management plan has been developed to ensure that Velphoro is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Velphoro je bil pripravljen načrt obvladovanja tveganj.
English: After 6 months, more than half of the patients could then continue on the same treatment for up to one year, while a small group received Velphoro at a lower dose for three weeks only.
Slovenian: Po 6 mesecih je lahko več kot polovica bolnikov še naprej prejemala enako zdravljenje do enega leta, manjša skupina pa je le tri tedne prejemala manjše odmerke zdravila Velphoro.
English: It is not intended to provide practical advice on how to use Velphoro.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: The CHMP concluded that Velphoro showed a clear beneficial effect in lowering phosphate levels.
Slovenian: Zaključil je tudi, da je zdravilo Velphoro izkazalo jasen koristen učinek na zniževanje ravni fosfatov.
English: For more information about treatment with Velphoro, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Velphoro preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Velphoro has been studied in one main study involving 1,059 adults with long-term kidney disease and hyperphosphataemia.
Slovenian: Zdravilo Velphoro so proučili v eni glavni študiji, v kateri je sodelovalo 1 059 odraslih z dolgotrajno boleznijo ledvic ali hiperfosfatemijo.
English: What benefits of Velphoro have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Velphoro izkazalo v študijah?