FrancophonIA/ELRC3.0 huggingface dataset:
English: Selamectin activates special proteins called ‘chloride channels' on the surface of nerve and muscle cells of the parasite, allowing charged chloride particles to enter nerve cells and disrupting their normal electrical activity.
Croatian: Selamektin aktivira posebne bjelančevine pod nazivom „kloridni kanali” na površini živčanih i mišićnih stanica parazita, čime se omogućuje nabijenim česticama klorida da uđu u živčane stanice i ometa se njihova normalna električna aktivnost.
English: A second field study was conducted in cats naturally infested with ticks.
Croatian: Drugo ispitivanje provedeno je na mačkama prirodno infestiranim krpeljima.
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).
Croatian: Sarolaner inhibira normalno kretanje nabijenih čestica klorida u živčanim stanicama i iz njih, posebno onih povezanih s gama-aminobutričnom kiselinom (GABA) i glutamatom, dvjema tvarima koje prenose poruke između živaca (neurotransmiteri).
English: This authorisation was based on the authorisation granted to Stronghold Plus in 2017 (‘informed consent').
Croatian: Odobrenje se temeljilo na odobrenju koje je izdano za VMP Stronghold Plus 2017. („informirani pristanak”).
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.
Croatian: Felisecto Plus je veterinarsko-medicinski proizvod koji se primjenjuje za tretiranje mješovitih infestacija krpeljima i drugim parazitima koji se mogu pronaći na koži ili krznu mačaka, kao što su buhe, ušni šugarci i uši i/ili crvi koji mogu ući u tijelo i zaraziti ga.
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.
Croatian: Sadržaj pipete istisne se na kožu nakon što se razdvoji dlaka na bazi vrata mačke ispred leđnih lopatica.
English: Selamectin is effective against fleas, ear mites, biting lice, heartworm larvae, roundworms and hookworms.
Croatian: Selamektin je učinkovit protiv buha, ušnog šugarca, grizućih ušiju, larvi srčanih crva, okruglih crva i ankilostoma.
English: • to treat and prevent flea infestations.
Croatian: • tretiranje i prevenciju infestacije buhama.
English: Other information about Felisecto Plus
Croatian: Ostale informacije o VMP-u Felisecto Plus
English: Felisecto Plus must only be used when there is a need to treat ticks and one or more of the above parasites.
Croatian: Felisecto Plus smije se primijeniti samo ako životinju treba tretirati protiv krpelja i jednog ili više od prethodno navedenih parazita.
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.
Croatian: Najčešće nuspojave VMP-a Felisecto Plus (mogu se javiti u do 1 na 100 mačaka) su blaga do umjerena alopecija (gubitak dlake) na mjestu nanošenja, eritem (crvenilo kože) i slinjenje.
English: The effectiveness of Felisecto Plus was investigated in a field study in cats naturally infested with fleas.
Croatian: Učinkovitost VMP-a Felisecto Plus ispitana je u terenskom ispitivanju mačaka koje su bile prirodno infestirane buhama.
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.
Croatian: Europska agencija za lijekove zaključila je da koristi od VMP-a Felisecto Plus nadmašuju s njim povezane rizike te da može biti odobren za primjenu u EU-u.
English: Felisecto Plus is harmful after swallowing.
Croatian: Felisecto Plus je štetan ako se proguta.
English: Why is Felisecto Plus authorised in the EU?
Croatian: Zašto je Felisecto Plus odobren u EU-u?
English: Use of the medicine may result in mild and short-lived itching at the application site.
Croatian: Primjena VMP-a može rezultirati blagim i kratkotrajnim svrbežom na mjestu nanošenja.
English: An overview of Felisecto Plus and why it is authorised in the EU
Croatian: Pregled VMP-a Felisecto Plus i zašto je odobren u EU-u
English: Felisecto Plus is available as a spot-on solution in three different strengths and can only be obtained with a prescription.
Croatian: Felisecto Plus dostupan je kao otopina za nakapavanje u tri različite jačine i izdaje se samo na veterinarski recept.
English: If the product is accidentally swallowed by a person, the advice of a doctor should be sought immediately.
Croatian: U slučaju da se VMP slučajno proguta, potrebno je odmah potražiti liječničku pomoć.
English: Felisecto Plus contains two active substances, selamectin and sarolaner.
Croatian: Felisecto Plus sadrži dvije djelatne tvari, selamektin i sarolaner.
English: What are the risks associated with Felisecto Plus?
Croatian: Koji su rizici povezani s VMP-om Felisecto Plus?
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.
Croatian: U dvama laboratorijskim ispitivanjima na mačkama umjetno infestiranima ušnim šugarcem pokazalo se da se primjenom VMP-a Felisecto Plus smanjio njihov broj za više od 90 % 30 dana nakon samo jednog liječenja.
English: What is Felisecto Plus and what is it used for?
Croatian: Što je Felisecto Plus i za što se primjenjuje?
English: For more information about using Felisecto Plus, see the package leaflet or contact your veterinarian or pharmacist.
Croatian: Za dodatne informacije o primjeni VMP-a Felisecto Plus pogledajte uputu o VMP-u, odnosno obratite se svojem veterinaru ili ljekarniku.
English: A laboratory study with cats artificially infected with heartworm showed Felisecto Plus to be effective for the prevention of heartworm disease.
Croatian: Laboratorijsko ispitivanje provedeno na mačkama umjetno zaraženim srčanim crvom pokazalo je da Felisecto Plus učinkovito sprječava bolest srčanog crva.
English: Felisecto Plus was as effective as the other medicine and reduced flea counts by more than 95%.
Croatian: Felisecto Plus bio je učinkovit kao i drugi VMP te je smanjio broj buha za više od 95 %.
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.
Croatian: U laboratorijskom ispitivanju provedenom na mačkama infestiranima grizućim ušima utvrđeno je da je selamektin uklonio grizuće uši 42 dana nakon liječenja u usporedbi s mačkama koje su primale prividno liječenje.
English: Cats were treated with Felisecto Plus monthly for 3 months or another similar antiparasitic medicine, containing imidacloprid and moxidectin.
Croatian: Mačke su tretirane VMP-om Felisecto Plus jednom mjesečno tijekom tri mjeseca ili nekim drugim sličnim VMP-om protiv parazita koji sadrže imidakloprid i moksidektin.
English: For more information, see the package leaflet.
Croatian: Za dodatne informacije pročitajte uputu o VMP-u.
English: How is Felisecto Plus used?
Croatian: Kako se Felisecto Plus koristi?
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.
Croatian: U sažetku opisa svojstava, kao i u uputi o VMP-u Felisecto Plus, nalaze se informacije o sigurnosti primjene, uključujući odgovarajuće mjere opreza kojih se veterinari te vlasnici životinja ili uzgajivači trebaju pridržavati.
English: Cats were treated with Felisecto Plus monthly for 3 months or another medicine, containing fipronil.
Croatian: Mačke su tretirane VMPom Felisecto Plus jednom mjesečno tijekom tri mjeseca ili nekim drugim VMP-om protiv parazita koji sadrže fipronil.
English: Two laboratory studies were conducted in cats with intestinal worms which showed Felisecto Plus to have more than 94% effectiveness.
Croatian: U dvama laboratorijskim ispitivanjima provedenima na mačkama sa želučano-crijevnim oblićima utvrđeno je da je učinkovitost VMP-a Felisecto Plus bila veća od 94 %.
English: • to treat tick infestations
Croatian: • tretiranje infestacija krpeljima
English: • to prevent heartworm disease
Croatian: • sprječavanje bolesti srčanog crva
English: Felisecto Plus contains selamectin and sarolaner, which are antiparasitic medicines.
Croatian: Felisecto Plus sadrži antiparazitike selamektin i sarolaner.
English: How does Felisecto Plus work?
Croatian: Kako djeluje Felisecto Plus?
English: Felisecto Plus was as effective as the other medicine and reduced tick counts by more than 90%.
Croatian: Felisecto Plus bio je učinkovit kao i drugi VMP te je smanjio broj krpelja za više od
English: What benefits of Felisecto Plus have been shown in studies?
Croatian: Koje su koristi od VMP-a Felisecto Plus utvrđene u ispitivanjima?
English: • to treat adult roundworms and adult hookworms in the gut
Croatian: • tretiranje odraslih crijevnih oblića i ankilostoma
English: • to treat ear mites
Croatian: • tretiranje ušnog šugarca
English: The defect has been corrected in the new system.
Croatian: Nedostatak je ispravljen u novom sustavu.
English: Ionsys can only be used in hospital.
Croatian: Ionsys se može koristiti samo u bolnici.
English: Ionsys fentanyl
Croatian: Ionsys fentanil
English: The system will stop working 24 hours after the first dose or after 80 doses have been delivered, whichever comes first.
Croatian: Sustav obustavlja rad nakon 24 sata nakon prve doze ili nakon 80 isporučenih doza, što god prvo nastupi.
English: Ionsys can be used up to six times in one hour, but for no more than 80 doses within a 24-hour period.
Croatian: Ionsys se može koristiti do šest puta unutar sat vremena, no ne više od 80 doza unutar razdoblja od 24 sata.
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.
Croatian: Sva prethodno opisana ispitivana provedena su s drugačijim uređajem za isporuku, koji je kasnije povučen s tržišta u 2008. uslijed nedostatka u dizajnu sustava.
English: It is a well-known substance, which has been used to control pain for many years.
Croatian: Ovo je dobro poznata tvar koja se koristi za kontrolu boli tijekom dugog niza godina.
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.
Croatian: Cjeloviti EPAR kao i sažetak plana upravljanja rizikom za lijek Ionsys nalaze se na internetskim stranicama 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.
Croatian: Sigurnosan profil je prihvatljiv i sličan morfiju koji se primjenjuje injekcijom u venu.
English: Ionsys must be removed by a doctor or nurse and before the patient leaves the hospital.
Croatian: Ionsys treba ukloniti liječnik ili medicinska sestra prije nego što bolesnik napusti bolnicu.
English: These studies showed that Ionsys is as at least as effective as morphine at controlling pain.
Croatian: Ova su ispitivanja pokazala da je Ionsys najmanje djelotvoran kao morfij u kontroliranju boli.
English: A doctor or a nurse applies the transdermal system to the patient's skin on the chest or upper arm.
Croatian: Liječnik ili medicinska sestra primjenjuju transdermalni sustav na kožu bolesnika na prsa ili nadlakticu.
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%).
Croatian: Omjer bolesnika koji je prekinuo terapiju jer se njihova bol nije mogla kontrolirati bio je manji u bolesnika liječenih lijekom Ionsys (i raspon je bio između 8% i 27%) u odnosu na one liječene placebom (kada je raspon bio 40 i 57%).
English: Other information about Ionsys
Croatian: Ostale informacije o lijeku Ionsys
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'.
Croatian: Druga četiri ispitivanja usporedila su Ionsys s morfijem koji se uzimao kao injekcija u venu, te je istražio broj bolesnika koji su ocijenili ublažavanje svoje boli kao "dobro" ili "odlično".
English: Ionsys must not be used in patients with severe respiratory depression (breathing problems) or with a rare condition called cystic fibrosis.
Croatian: Ionsys se ne smije koristiti u bolesnika s ozbiljnom respiratornom depresijom (problemima u disanju) ili s rijetkim stanjem naziva cistična fibroza.
English: It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use.
Croatian: Objašnjava kako je Odbor ocijenio lijek da bi preporučio njegovo odobrenje u EU-u te uvjete za njegovu primjenu.
English: This is a summary of the European public assessment report (EPAR) for Ionsys.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Ionsys.
English: What is Ionsys and what is it used for?
Croatian: Što je Ionsys i za što se koristi?
English: What measures are being taken to ensure the safe and effective use of Ionsys?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Ionsys?
English: When in pain, the patient uses a button on the Ionsys system to start the delivery of a dose of fentanyl (40 micrograms).
Croatian: Ako osjeća bol, bolesnik koristi gumb na sustavu Ionsys kako bi započeo isporuku doze fentanila (40 mikrograma).
English: Why is Ionsys approved?
Croatian: Zašto je Ionsys odobren?
English: Ionsys is a transdermal system used to control moderate to severe pain after an operation in adults who are in hospital.
Croatian: Ionsys je transdermalni sustav koji se koristi za kontrolu ozbiljne boli nakon operacije u odraslih osoba koje su u bolnici.
English: These are usually mild to moderate in severity.
Croatian: Nuspojave su najčešće blage ili umjerene u ozbiljnosti.
English: The most serious side effects are hypotension (low blood pressure) and apnoea (pauses in breathing) and patients should be closely monitored for these.
Croatian: Najčešće ozbiljne nuspojave su hipotenzija (niski krvni tlak) i apneja (pauze u disanju), te stoga bolesnike treba pažljivo pratiti kako bi se uočile ove nuspojave.
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.
Croatian: Najčešće nuspojave lijeka Ionsys (mogu se javiti u više od 1 na 10 osoba) su mučnina (osjećaj slabosti), povraćanje, i eritema (crvenilo) na mjestu primjene.
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.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji odlučio je da koristi od lijeka Ionsys nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za korištenje u Europskoj uniji.
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.
Croatian: Nadalje, tvrtka koja lijek Ionsys stavlja u promet, zdravstvenim će djelatnicima za koje se očekuje da će koristiti lijek Ionsys dostaviti edukacijske materijale s informacijama o primjerenoj uporabi proizvoda.
English: A risk management plan has been developed to ensure that Ionsys is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Ionsys.
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.
Croatian: CHMP je zaključio da je Ionsys djelotvoran u upravljanju boli nakon operacije i činjenica da se ne primjenjuje injekcijom mogla bi predstavljati prednost za bolesnike.
English: In three of the studies, Ionsys was compared with placebo (a dummy system).
Croatian: U tri ispitivanja, Ionsys je uspoređen s placebom (prividnim liječenjem).
English: It is not intended to provide practical advice on how to use Ionsys.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Ionsys.
English: Treatment should be given under the guidance of a doctor experienced in the use of opioids such as fentanyl.
Croatian: Terapija se daje samo pod nadzorom liječnika iskusnog u primjeni opioida poput fentanila.
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.
Croatian: Uslijed potencijalne zlouporabe fentanila, liječnik treba ocijeniti postoji li kod bolesnika povijest zlouporabe droga prije nego započne primjenu lijeka Ionsys, te ako je ista prisutna bolesnika treba pažljivo pratiti.
English: Once in the bloodstream, fentanyl acts on receptors in the brain and spinal cord to control pain.
Croatian: Nakon što dospije u krvotok, fentanil djeluje na receptore u mozgu i kralježničnoj moždini kako bi se bol kontrolirala.
English: Ionsys contains the active substance fentanyl, which is a strong opioid painkiller.
Croatian: Ionsys sadrži djelatnu tvar fentanil, koji je snažan opioidni analgetik.
English: For more information about treatment with Ionsys, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Ionsys pročitajte u uputi o lijeku (također dio EPAR-a), ili se obratite svom liječniku ili ljekarniku.
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.
Croatian: Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi o lijeku za lijek Ionsys nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: When the patient activates Ionsys, a dose of fentanyl moves through the skin into the bloodstream.
Croatian: Kada bolesnik aktivira Ionsys, doza fentanila transportira se kroz kožu u krvotok.
English: What are the risks associated with Ionsys?
Croatian: Koji su rizici povezani s lijekom Ionsys?
English: Ionsys transdermal system delivers the active substance, fentanyl, through the skin.
Croatian: Transdermalni sustav Ionsys isporučuje djelatnu tvar, fentanil, kroz kožu.
English: For practical information about using Ionsys, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Ionsys bolesnici trebaju pročitati u uputi o lijeku ili se obratiti svom liječniku ili ljekarniku.
English: How does Ionsys work?
Croatian: Kako djeluje Ionsys?
English: What benefits of Ionsys have been shown in studies?
Croatian: Koje su koristi lijeka Ionsys utvrđene u ispitivanjima?
English: How is Ionsys used?
Croatian: Kako se Ionsys koristi?
English: It contains the active substance fentanyl.
Croatian: Sadrži djelatnu tvar fentanil.
English: For the full list of all side effects reported with Ionsys, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Ionsys potražite u uputi o lijeku.
English: Ionsys has been shown to be effective at controlling pain after an operation in seven main studies involving a total of around 3,300 patients.
Croatian: U sedam glavnih ispitivanja, koja su obuhvatila otprilike 3.300 bolesnika, dokazano je da je Ionsys djelotvoran u kontroli boli nakon kirurškog zahvata.
English: List of the names, pharmaceutical form(s), strength(s) of the medicinal product(s), route(s) of administration, applicant(s) in the Member States
Croatian: Popis naziva, farmaceutskog(ih) oblika, jačine(a) lijek(ov)a, put(ev)a primjene, podnositelj(a) zahtjeva u državama članicama
English: Content (concentration)
Croatian: Put primjene Sastav (koncentracija)
English: (Invented) Name
Croatian: Podnositelj zahtjeva (Zaštićeno) ime Naziv
English: Check with the doctor if you are unsure.
Croatian: Provjerite kod liječnika ako niste sigurni.
English: Currently available data are described in sections 5.1 and 5.2.
Croatian: Trenutno dostupni podaci opisani su u dijelovima 5.1 i 5.2.
English: - if you have severe high blood pressure.
Croatian: - ako imate jako visok krvni tlak.
English: Overall population (ITT)
Croatian: Cjelokupna populacija (ITT)
English: • if you are a child (less than 18 years of age), this medicine is not appropriate for you.
Croatian: • ako ste dijete (mlađi od 18 godina), ovaj lijek nije prikladan za Vas.
English: If you receive more of this medicine than you should
Croatian: Ako primite više ovog lijeka nego što ste trebali
English: 3.5 hours
Croatian: 3,5 sati
English: The majority of these cases were non-fatal.
Croatian: Većina tih slučajeva nije imala smrtonosni ishod.
English: • if you are taking, or have recently taken or might take any other medicines.
Croatian: • ako uzimate ili ste nedavno uzimali ili biste mogli uzeti bilo koje lijekove
English: Half-life (minutes)
Croatian: Poluvijek (minute)
English: The doctor will decide for how long you should be treated.
Croatian: Liječnik će odlučiti koliko dugo trebate biti liječeni.
English: • before the start of the injection or infusion, the doctor will tell you about the signs of allergic reaction.
Croatian: • prije nego počnete s injekcijom ili infuzijom, liječnik će Vas obavijestiti o znakovima alergijske reakcije.
English: Necessary preparations should be made to deal with this.
Croatian: Za ovakve reakcije, potrebno je izvršiti potrebne pripreme.
English: Your doctor will decide whether or not this treatment is appropriate for you.
Croatian: Vaš će liječnik odlučiti je li ova terapija prikladna za Vas ili nije.
English: - if you have an infection of the heart tissue.
Croatian: - ako imate infekciju srčanog tkiva.
English: There is currently no indication for the use of Angiox in children less than 18 years old and no recommendation on a posology can be made.
Croatian: Trenutno nema indikacija za primjenu Angioxa u djece mlađe od 18 godina i ne mogu se dati preporuke o doziranju.
English: If you cannot get access to your doctor go immediately to the Emergency Department of your nearest hospital
Croatian: Ako ne možete doći do svog liječnika odmah otiđite do odjela hitne pomoći u najbližu bolnicu
English: Your doctor will decide how to treat you, including stopping the drug and monitoring for signs of ill effects.
Croatian: Vaš liječnik odlučit će kako Vas liječiti, uključujući prestanak davanja lijeka i nadziranje znakova negativnih učinka.
English: However, the maximal ACT values for all groups (adults and all paediatric groups) converge at a similar level near an ACT of 400 seconds.
Croatian: No maksimalne vrijednosti ACT-a u svim skupinama (odrasli i sve pedijatrijske skupine) konvergiraju pri sličnoj razini blizu ACT-a od 400 sekundi.
English: If you get any of the following, potentially serious, side effects:
Croatian: Ako dobijete bilo koju od sljedećih, potencijalno ozbiljnih, nuspojava:
English: The dose given depends on your weight and on the kind of treatment you are being given.
Croatian: Primijenjena doza ovisi o Vašoj tjelesnoj težini i vrsti liječenja koje primate.
English: A total of 92.9% of patients treated underwent primary PCI as their primary management strategy.
Croatian: Ukupno 92,9% liječenih bolesnika prošlo je primarnu PCI kao njihovu primarnu strategiju liječenja.