FrancophonIA/ELRC3.0 huggingface dataset:
English: In case of skin or eye contact, the affected area should be rinsed immediately with water.
Slovenian: V primeru stika s kožo ali očmi je treba prizadeto področje nemudoma izprati z vodo.
English: Because ticks must start feeding on the cat in order to be killed by the medicine, the risk of transmission of diseases that they may carry cannot be excluded.
Slovenian: Ker se morajo klopi začeti hraniti s krvjo mačke, da bi jih zdravilo lahko uničilo, ni mogoče izključiti tveganja za prenos bolezni, s katerimi so ti lahko okuženi.
English: Felisecto Plus (selamectin / sarolaner)
Slovenian: Felisecto Plus (selamektin/sarolaner)
English: This results in uncontrolled activity of the nervous system and the paralysis and death of the parasites.
Slovenian: S tem povzroči nenadzorovano delovanje živčnega sistema ter paralizo in smrt zajedavcev.
English: Used pipettes of the medicine must be disposed of immediately.
Slovenian: Uporabljene merilne kapalke zdravila je treba takoj odvreči.
English: On the day of treatment, treated cats must not be allowed to sleep in the same bed as their owner, especially children.
Slovenian: Na dan nanosa zdravila zdravljene mačke ne smejo spati v isti postelji z lastniki, zlasti ne z otroki.
English: The European Medicines Agency decided that Felisecto Plus's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je odločila, da so koristi zdravila Felisecto Plus večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: It can also be used as part of a treatment for flea allergy dermatitis (an allergic reaction to flea bites)
Slovenian: Uporablja se lahko tudi kot del zdravljenja alergijskega dermatitisa, ki ga povzročajo bolhe (alergijske reakcije na ugrize bolh),
English: Sarolaner is effective against ticks and fleas.
Slovenian: Sarolaner je učinkovit proti klopom in bolham.
English: This authorisation was based on the authorisation granted to Stronghold Plus in 2017 (‘informed consent').
Slovenian: Izdaja tega dovoljenja je temeljila na dovoljenju za promet z zdravilom Stronghold Plus, ki je bilo izdano leta 2017 („uporaba dokumentacije s soglasjem“).
English: The strength and number of pipettes used depends on the weight of the cat being treated.
Slovenian: Jakost in število merilnih kapalk, ki jih uporabljamo, sta odvisna od teže mačke, ki jo zdravimo.
English: Felisecto Plus received a marketing authorisation valid throughout the EU on 26 April 2019.
Slovenian: Zdravilo Felisecto Plus je pridobilo dovoljenje za promet, veljavno po vsej Evropski uniji, 26/04/2019.
English: In order to be exposed to selamectin and sarolaner, fleas and ticks must commence feeding on the cat's blood.
Slovenian: Da bi bili bolhe in klopi izpostavljeni selamektinu in sarolanerju, se morajo začeti hraniti s krvjo mačke.
English: If the product is accidentally swallowed by a person, the advice of a doctor should be sought immediately.
Slovenian: Če človek zdravilo nenamerno zaužije, se mora nemudoma posvetovati z zdravnikom.
English: Felisecto Plus must only be used when there is a need to treat ticks and one or more of the above parasites.
Slovenian: Zdravilo Felisecto Plus se lahko uporablja le, ko obstaja potreba po zdravljenju klopov in ene ali več vrst zgoraj navedenih zajedavcev.
English: People with sensitive skin or who are hypersensitive (allergic) to selamectin or sarolaner should handle Felisecto Plus with caution.
Slovenian: Osebe z občutljivo kožo ali preobčutljivostjo za (alergičnostjo na) selamektin ali sarolaner, morajo z zdravilom Felisecto Plus ravnati previdno.
English: The effectiveness of Felisecto Plus was investigated in a field study in cats naturally infested with fleas.
Slovenian: Učinkovitost zdravila Felisecto Plus so raziskovali v terenski študiji pri mačkah, ki so bile naravno okužene z bolhami.
English: Felisecto Plus is a medicine used to treat mixed infestations with both ticks and other parasites that may be found on the skin or fur of cats, such as fleas, ear mites and lice and/or worms that can enter and infect the body.
Slovenian: Felisecto Plus je zdravilo, ki se uporablja za zdravljenje mešanih infestacij s klopi in drugimi paraziti, ki jih je mogoče najti na koži ali dlaki mačk, kot so bolhe, ušesne garje in uši ter/ali črvi, ki lahko vstopijo v telo in ga okužijo.
English: Children must not be allowed to play with treated cats for 4 hours after treatment.
Slovenian: Otroci se z zdravljenimi mačkami ne smejo igrati še štiri ure po nanosu zdravila.
English: Other information about Felisecto Plus
Slovenian: Druge informacije o zdravilu Felisecto Plus
English: This causes the paralysis or death of the parasites.
Slovenian: To povzroči paralizo in pogin zajedavcev.
English: Felisecto Plus must not be used in cats suffering from other diseases or in cats that are weak and underweight (for their age).
Slovenian: Zdravilo Felisecto Plus se ne sme uporabljati pri mačkah, obolelih zaradi drugih bolezni, ali mačkah, ki so oslabljene ali podhranjene (glede na starost).
English: The company that makes Stronghold Plus has agreed that its scientific data can be used for Felisecto Plus (‘informed consent').
Slovenian: Podjetje, ki proizvaja zdravilo Stronghold Plus, se strinja, da se lahko znanstveni podatki o tem zdravilu uporabijo tudi za zdravilo Felisecto Plus („uporaba dokumentacije s soglasjem“).
English: A second field study was conducted in cats naturally infested with ticks.
Slovenian: Druga terenska študija je bila izvedena z mačkami, ki so bile naravno okužene s klopi.
English: For more information about using Felisecto Plus, see the package leaflet or contact your veterinarian or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Felisecto Plus glejte navodilo za uporabo ali se posvetujte z veterinarjem ali farmacevtom.
English: Felisecto Plus kills fleas and some ticks within 24 hours and it continues to work for 5 weeks against fleas and 4 to 5 weeks against ticks (depending on the type).
Slovenian: Zdravilo Felisecto Plus povzroča pogin bolh in nekaterih vrst klopov v 24 urah ter nadaljnjih pet tednov učinkuje proti bolham in od štiri do pet tednov proti klopom (odvisno od vrste).
English: Sarolaner blocks the normal movement of charged chloride particles 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 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 (živčnima prenašalcem).
English: It is recommended to treat cats in the evening.
Slovenian: Priporoča se, da se zdravilo nanese zvečer.
English: The most common side effects with Felisecto Plus (which may affect up to 1 in 100 cats) are mild to moderate alopecia (hair loss) at the application site, erythema (reddening of the skin) and drooling.
Slovenian: Najpogostejši neželeni učinki zdravila Felisecto Plus (ki lahko prizadenejo največ 1 mačko od 100) so blaga do zmerna alopecija (izpadanje dlake) na mestu nanosa, eritem (pordelost kože) in slinjenje.
English: An overview of Felisecto Plus and why it is authorised in the EU
Slovenian: Pregled zdravila Felisecto Plus in zakaj je odobreno v EU
English: Why is Felisecto Plus authorised in the EU?
Slovenian: Zakaj je zdravilo Felisecto Plus odobreno v EU?
English: The content of the pipette is squeezed onto the skin after parting the fur at the base of the cat's neck in front of the shoulder blades.
Slovenian: Vsebino merilne kapalke iztisnemo na kožo, potem ko razmaknemo dlako v predelu zatilja mačke v sprednjem delu lopatic.
English: Hands should be washed after use and any product in contact with the skin should be washed off immediately with soap and water.
Slovenian: Po uporabi zdravila si je treba umiti roke ter nemudoma z milom in vodo sprati izdelke, ki pridejo v stik s kožo.
English: Safety information has been included in the summary of product characteristics and the package leaflet for Felisecto Plus, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.
Slovenian: V povzetek glavnih značilnosti zdravila 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: What are the risks associated with Felisecto Plus?
Slovenian: Kakšna tveganja so povezana z zdravilom Felisecto Plus?
English: • to treat and prevent flea infestations.
Slovenian: • zdravljenje in preprečevanje infestacij z bolhami.
English: Treated animals must not be touched until the application area is dry.
Slovenian: Izogibati se je treba dotikanja živali, na katere je bilo naneseno zdravilo, dokler se mesto nanosa ne posuši.
English: Use of the medicine may result in mild and short-lived itching at the application site.
Slovenian: Uporaba zdravila lahko povzroči blago in kratkotrajno srbenje na mestu nanosa.
English: What is Felisecto Plus and what is it used for?
Slovenian: Kaj je zdravilo Felisecto Plus in za kaj se uporablja?
English: Selamectin is effective against fleas, ear mites, biting lice, heartworm larvae, roundworms and hookworms.
Slovenian: Selamektin učinkuje proti bolham, ušesnim garjam, ušem, ličinkam srčne gliste, valjastim in kavljastim črvom.
English: What benefits of Felisecto Plus have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Felisecto Plus izkazalo v študijah?
English: Felisecto Plus contains selamectin and sarolaner, which are antiparasitic medicines.
Slovenian: Zdravilo Felisecto Plus vsebuje učinkovini selamektin in sarolaner, ki sta antiparazitski zdravili.
English: Two laboratory studies were conducted in cats with intestinal worms which showed Felisecto Plus to have more than 94% effectiveness.
Slovenian: Izvedeni sta bili dve laboratorijski študiji z mačkami z intestinalnimi črvi, ki sta pokazali, da ima zdravilo Felisecto Plus več kot 94-odstotno učinkovitost.
English: Felisecto Plus was as effective as the other medicine and reduced tick counts by more than 90%.
Slovenian: Zdravilo Felisecto Plus je bilo enako učinkovito kot drugo zdravilo in je zmanjšalo število klopov za več kot 90 %.
English: Felisecto Plus is highly flammable and should be kept away from heat, sparks, any open flame or other sources of ignition.
Slovenian: Zdravilo Felisecto Plus je lahko vnetljivo, zato ga je treba hraniti zaščitenega pred vročino, iskrami, odprtim plamenom ali drugimi vnetljivimi viri.
English: Cats were treated with Felisecto Plus monthly for 3 months or another medicine, containing fipronil.
Slovenian: Mačke so tri mesece zapored enkrat na mesec zdravili z zdravilom Felisecto Plus ali drugim zdravilom, ki je vsebovalo fipronil.
English: A laboratory study with cats infested with biting lice showed selamectin to eliminate biting lice for 42 days after treatment compared to placebo treated cats.
Slovenian: Laboratorijska študija z mačkami, okuženimi z ušmi, je pokazala, da selamektin uši odpravi v 42 dneh po zdravljenju v primerjavi z mačkami, zdravljenimi s placebom.
English: Two laboratory studies with cats artificially infested with ear mites showed Felisecto Plus to reduce ear mites by more than 90% 30 days after a single treatment.
Slovenian: Dve laboratorijski študiji z mačkami, umetno okuženimi z ušesnimi garjami, sta pokazali, da zdravilo Felisecto Plus zmanjšuje ušesne garje za več kot 90 % v 30 dneh po enem samem zdravljenju.
English: Cats were treated with Felisecto Plus monthly for 3 months or another similar antiparasitic medicine, containing imidacloprid and moxidectin.
Slovenian: Mačke so bile tri mesece zapored enkrat na mesec zdravili z zdravilom Felisecto Plus ali drugim podobnim antiparazitskim zdravilom, ki je vsebovalo imidakloprid in moksidektin.
English: • to treat adult roundworms and adult hookworms in the gut
Slovenian: • zdravljenje infestacij z odraslimi valjastimi črvi in odraslimi intestinalnimi kavljastimi črvi,
English: A laboratory study with cats artificially infected with heartworm showed Felisecto Plus to be effective for the prevention of heartworm disease.
Slovenian: Laboratorijska študija z mačkami, ki so bile umetno okužene s srčno glisto, je pokazala, da zdravilo Felisecto Plus učinkovito preprečuje obolenje srčne glistavosti.
English: Felisecto Plus was as effective as the other medicine and reduced flea counts by more than 95%.
Slovenian: Zdravilo Felisecto Plus je bilo enako učinkovito kot drugo zdravilo in je zmanjšalo število bolh za več kot 95 %.
English: • to prevent heartworm disease
Slovenian: • preprečevanje obolenja srčne glistavosti.
English: Felisecto Plus contains two active substances, selamectin and sarolaner.
Slovenian: Zdravilo Felisecto Plus vsebuje dve učinkovini, selamektin in sarolaner.
English: Felisecto Plus is harmful after swallowing.
Slovenian: Zdravilo Felisecto Plus je nevarno ob zaužitju.
English: How is Felisecto Plus used?
Slovenian: Kako se zdravilo Felisecto Plus uporablja?
English: The medicine must be kept in its packaging until use, in order to prevent access by children.
Slovenian: Da bi preprečili dostop otrokom, je treba zdravilo do uporabe hraniti v originalni ovojnini.
English: Felisecto Plus is available as a spot-on solution in three different strengths and can only be obtained with a prescription.
Slovenian: Zdravilo Felisecto Plus je na voljo v obliki raztopine za kožni nanos v treh jakostih.
English: • to treat tick infestations
Slovenian: • zdravljenje infestacij s klopi,
English: How does Felisecto Plus work?
Slovenian: Kako zdravilo Felisecto Plus deluje?
English: • to treat biting lice infestations
Slovenian: • zdravljenje infestacij z ušmi,
English: The defect has been corrected in the new system.
Slovenian: Napaka je bila v novem sistemu odpravljena.
English: Ionsys fentanyl
Slovenian: Ionsys fentanil
English: All the studies described above were carried out with a different delivery device, which was recalled from the market in 2008 because of a defect in the design of the system.
Slovenian: Vse študije, navedene zgoraj, so bile izvedene z drugačno napravo za dovajanje, ki je bila leta 2008 zaradi napake v zasnovi sistema odpoklicana s trga.
English: Ionsys can be used up to six times in one hour, but for no more than 80 doses within a 24-hour period.
Slovenian: Ionsys je mogoče uporabiti do šestkrat na uro, vendar največ 80 odmerkov v 24-urnem obdobju.
English: The system will stop working 24 hours after the first dose or after 80 doses have been delivered, whichever comes first.
Slovenian: Sistem bo prenehal delovati 24 ur po prvem odmerku ali po prejemu 80 odmerkov, odvisno od tega, kar od navedenega nastopi prej.
English: What measures are being taken to ensure the safe and effective use of Ionsys?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Ionsys?
English: The full EPAR and risk management plan summary for Ionsys 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 Ionsys sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The safety profile is acceptable and is similar to morphine given by injection into a vein.
Slovenian: Varnostni profil je sprejemljiv in je podoben varnostnemu profilu morfija, ki se injicira v žilo.
English: The proportion of patients who stopped treatment because their pain was not controlled was lower in patients treated with Ionsys (and ranged between 8% and 27%) than in those treated with placebo (where it ranged between 40 and 57%).
Slovenian: Delež bolnikov, ki so prekinili zdravljenje, ker njihova bolečina ni bila ustrezno uravnana, je bil manjši pri bolnikih, zdravljenih z zdravilom Ionsys (znašal je med 8 in 27 %), kot pri bolnikih, ki so prejemali placebo (kjer je znašal med 40 in 57 %).
English: This is a summary of the European public assessment report (EPAR) for Ionsys.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Ionsys.
English: The most serious side effects are hypotension (low blood pressure) and apnoea (pauses in breathing) and patients should be closely monitored for these.
Slovenian: Najresnejša stranska učinka sta hipotenzija (nizek krvni tlak) in apneja (prekinitve dihanja), bolnike pa je treba v zvezi z njima pozorno spremljati.
English: Ionsys can only be used in hospital.
Slovenian: Zdravilo Ionsys se lahko uporablja zgolj v bolnišnicah.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Ionsys' 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 Ionsys večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: Other information about Ionsys
Slovenian: Druge informacije o zdravilu Ionsys
English: Ionsys must be removed by a doctor or nurse and before the patient leaves the hospital.
Slovenian: Sistem Ionsys mora zdravnik ali medicinska sestra odstraniti, in sicer preden bolnik zapusti bolnišnico.
English: A doctor or a nurse applies the transdermal system to the patient's skin on the chest or upper arm.
Slovenian: Zdravnik ali medicinska sestra namesti transdermalni sistem na bolnikovo kožo na prsih ali nadlahti.
English: The other four studies compared Ionsys with morphine given by injection into a vein, and looked at the number of patients who judged their pain relief as ‘good' or ‘excellent'.
Slovenian: V drugih štirih študijah so zdravilo Ionsys primerjali z morfijem, injiciranim v žilo, pri čemer so beležili število bolnikov, ki so stopnjo olajšanja bolečine označili kot „dobro“ ali „odlično“.
English: Ionsys must not be used in patients with severe respiratory depression (breathing problems) or with a rare condition called cystic fibrosis.
Slovenian: Zdravilo Ionsys se ne sme uporabljati za zdravljenje bolnikov s hudo depresijo dihanja (težavami z dihanjem) ali redko boleznijo, imenovano cistična fibroza.
English: A risk management plan has been developed to ensure that Ionsys is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Ionsys je bil pripravljen načrt obvladovanja tveganj.
English: Treatment should be given under the guidance of a doctor experienced in the use of opioids such as fentanyl.
Slovenian: Zdravljenje je treba izvajati pod vodstvom zdravnika, ki ima izkušnje z zdravljenjem z opioidi, kot je fentanil.
English: These studies showed that Ionsys is as at least as effective as morphine at controlling pain.
Slovenian: Te študije so pokazale, da je zdravilo Ionsys pri nadzorovanju bolečine vsaj tako učinkovito kot morfij.
English: The most common side effects with Ionsys (which may affect more than 1 in 10 people) are nausea (feeling sick), vomiting and erythema (redness) at the application site.
Slovenian: Najpogostejši neželeni učinki zdravila Ionsys (ki lahko prizadenejo več kot 1 osebo od 10) so navzeja (slabost), bruhanje in eritem (rdečina) na mestu namestitve sistema.
English: The CHMP considered Ionsys to be effective at managing pain after an operation and the fact that is not given by injection could be of benefit to patients.
Slovenian: Menil je, da je zdravilo Ionsys učinkovito pri zdravljenju pooperativnih bolečin in da bi dejstvo, da se ne daje z injekcijo, lahko bilo koristno za bolnike.
English: In three of the studies, Ionsys was compared with placebo (a dummy system).
Slovenian: V treh študijah so zdravilo Ionsys primerjali s placebom (sistemom brez zdravilne učinkovine).
English: In addition, the company that market Ionsys will provide all healthcare professionals expected to use Ionsys educational material with information on the adequate use of the product.
Slovenian: Poleg tega bo družba, ki trži zdravilo Ionsys, vsem zdravstvenim delavcem, ki naj bi uporabljali to zdravilo, priskrbela izobraževalno gradivo z informacijami o njegovi ustrezni uporabi.
English: What are the risks associated with Ionsys?
Slovenian: Kakšna tveganja so povezana z zdravilom Ionsys?
English: These are usually mild to moderate in severity.
Slovenian: Ti neželeni učinki so po resnosti navadno blagi do zmerni.
English: For more information about treatment with Ionsys, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Ionsys preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Ionsys, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Ionsys in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: What benefits of Ionsys have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Ionsys izkazalo v študijah?
English: Why is Ionsys approved?
Slovenian: Zakaj je bilo zdravilo Ionsys odobreno?
English: Due to the potential of abuse with fentanyl, the doctor should evaluate whether the patient has a history of drug abuse before giving Ionsys and if so follow the patient closely.
Slovenian: Zaradi možnosti zlorabe fentanila mora zdravnik pred dajanjem zdravila Ionsys pri bolniku oceniti morebitno zlorabo zdravil v preteklosti in ga, če je temu tako, pozorno spremljati.
English: What is Ionsys and what is it used for?
Slovenian: Kaj je zdravilo Ionsys in za kaj se uporablja?
English: It is not intended to provide practical advice on how to use Ionsys.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: Ionsys is a transdermal system used to control moderate to severe pain after an operation in adults who are in hospital.
Slovenian: Zdravilo Ionsys je transdermalni sistem, ki se uporablja za nadzor zmerne do hude pooperativne bolečine pri odraslih bolnikih v bolnišnicah.
English: When in pain, the patient uses a button on the Ionsys system to start the delivery of a dose of fentanyl (40 micrograms).
Slovenian: Če bolnik začuti bolečino, pritisne stikalo na sistemu Ionsys, s čimer sproži dajanje odmerka fentanila (40 mikrogramov).
English: For the full list of all side effects reported with Ionsys, see the package leaflet.
Slovenian: Za celoten seznam vseh neželenih učinkov, o katerih so poročali pri uporabi zdravila Ionsys, glejte navodilo za uporabo.
English: For practical information about using Ionsys, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Ionsys naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: Once in the bloodstream, fentanyl acts on receptors in the brain and spinal cord to control pain.
Slovenian: Fentanil začne z vstopom v krvni obtok delovati na receptorje v možganih in hrbtenjači ter tako nadzoruje bolečino.
English: When the patient activates Ionsys, a dose of fentanyl moves through the skin into the bloodstream.
Slovenian: Ko bolnik aktivira sistem Ionsys, preide odmerek fentanila skozi kožo v krvni obtok.
English: Ionsys contains the active substance fentanyl, which is a strong opioid painkiller.
Slovenian: Zdravilo Ionsys vsebuje zdravilno učinkovino fentanil, ki je močno opioidno zdravilo za lajšanje bolečine.
English: How does Ionsys work?
Slovenian: Kako zdravilo Ionsys deluje?
English: It contains the active substance fentanyl.
Slovenian: Vsebuje zdravilno učinkovino fentanil.