FrancophonIA/ELRC3.0 huggingface dataset:
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Stronghold Plus's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Odbor za veterinarsko-medicinske proizvode (CVMP) pri Agenciji odlučio je da koristi od veterinarsko-medicinskog proizvoda Stronghold Plus nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za korištenje u Europskoj uniji.
English: Stronghold 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 live inside the body.
Croatian: Stronghold Plus je VMP koji se koristi za tretiranje miješanih infestacija krpeljima i drugim parazitima koji se mogu naći na koži i krznu mačaka, kao što su buhe, ušni šugarci, uši ili crvi koji žive u tijelu.
English: Stronghold Plus is available as a spot-on solution in three different strengths and can only be obtained with a prescription.
Croatian: Stronghold Plus je dostupan kao otopina za nakapavanje u tri različite jačine, a izdaje se samo na veterinarski recept.
English: The contents of the pipette are 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 iznad leđnih lopatica.
English: The effectiveness of Stronghold Plus was investigated in a field study in cats naturally infested with fleas.
Croatian: Učinkovitost VMP-a Stronghold Plus ispitivana je u terenskom ispitivanju u mačaka prirodno zaraženih buhama.
English: Selamectin is effective against fleas, ear mites, biting lice, heartworms, roundworms and hookworms.
Croatian: Selamectin je učinkovit protiv buha, ušnog šugarca, krpelja, srčanih crva, okruglih crva i crva s kukicama.
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: Laboratorijsko ispitivanje s mačkama zaraženim ušima pokazalo je da selamectin uklanja uši u roku od 42 dana nakon primjene VMP-a u usporedbi s mačkama koje su tretirane placebom.
English: How is Stronghold Plus used?
Croatian: Kako se Stronghold Plus koristi?
English: • to treat and prevent flea infestations.
Croatian: • tretiranje infestacije buhama i prevenciju infestacije.
English: Stronghold Plus was as effective as the other medicine and reduced tick counts by more than 90%.
Croatian: Stronghold Plus bio je učinkovit kao i drugi VMP te je smanjio broj krpelja za više od 90 %.
English: Stronghold Plus was as effective as the other medicine and reduced flea counts by more than 95%.
Croatian: Stronghold Plus bio je učinkovit kao i drugi VMP te je smanjio broj buha za više od 95 %.
English: Cats were treated with Stronghold Plus monthly for 3 months or another antiparasitic medicine, containing imidacloprid and moxidectin.
Croatian: Mačke su tretirane VMP-om Stronghold Plus mjesečno tijekom 3 mjeseca ili nekim drugim VMP-om protiv parazita koji sadrže imidakloprid i moksidektin.
English: Two laboratory studies with cats artificially infested with ear mites showed Stronghold Plus to reduce ear mites by more than 90% 30 days after a single treatment.
Croatian: Dva laboratorijska ispitivanja u mačaka umjetno zaraženih ušnim buhama pokazala su da Stronghold Plus smanjuje zaraženost za više od 90 % 30 dana nakon jedne primjene VMP-a.
English: A laboratory study with cats artificially infected with heartworm showed Stronghold Plus to be effective for the prevention of heartworm disease.
Croatian: Laboratorijska ispitivanja provedena na mačkama umjetno zaraženim srčanim crvom pokazala su da Stronghold Plus učinkovito sprječava bolest srčanog crva.
English: Two laboratory studies were conducted in cats with intestinal worms which showed Stronghold Plus to have more than 94% efficacy.
Croatian: Dva laboratorijska ispitivanja provedena su u mačaka s crijevnim crvima koja su pokazala djelotvornost VMP-a Stronghold Plus u više od 94 % slučajeva.
English: Cats were treated with Stronghold Plus monthly for 3 months or another medicine, containing fipronil.
Croatian: Mačke su tretirane VMP-om Stronghold Plus mjesečno tijekom 3 mjeseca ili nekim drugim VMP-om protiv parazita koji sadrže fipronil.
English: Hands should be washed after use and any product in contact with the skin should be washed off immediately with soap and water.
Croatian: Poslije primjene VMP-a potrebno je sapunom i vodom odmah oprati ruke i svaki predmet koji je bio u doticaju s kožom.
English: Safety information has been included in the summary of product characteristics and the package leaflet for Stronghold 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 Stronghold Plus, nalaze se informacije o sigurnosti primjene, uključujući odgovarajuće mjere opreza kojih se veterinari te vlasnici životinja ili uzgajivači trebaju pridržavati.
English: For practical information about using Stronghold Plus, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Croatian: Praktične informacije o primjeni VMP-a Stronghold Plus, vlasnici životinja ili uzgajivači trebaju pročitati u uputi o VMP-u, odnosno obratiti se svom veterinaru ili ljekarniku.
English: For more information about treatment with Stronghold Plus, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Croatian: Više informacija o terapiji VMP-om Stronghold Plus vlasnici životinja ili uzgajivači trebaju pročitati u uputi o VMP-u, odnosno trebaju se obratiti svom veterinaru ili ljekarniku.
English: What benefits of Stronghold Plus have been shown in studies?
Croatian: Koje su koristi veterinarsko-medicinskog proizvoda Stronghold Plus utvrđene u ispitivanjima?
English: • to treat adult roundworms and adult hookworms in the gut
Croatian: • tretiranje odraslih crijevnih oblića i crijevnih trakavica
English: How does Stronghold Plus work?
Croatian: Kako djeluje Stronghold Plus?
English: The full EPAR for Azomyr can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Cjeloviti EPAR za lijek Azomyr nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The recommended dose for adults and adolescents (12 years of age and over) is 5 mg once a day.
Croatian: Preporučena doza za odrasle osobe i adolescente (u dobi od 12 i stariji) iznosi 5 mg jednom na dan.
English: Azomyr has also been studied in 416 patients with urticaria.
Croatian: Azomyr je također ispitivan u 416 bolesnika s urtikarijom.
English: This is a summary of the European public assessment report (EPAR) for Azomyr.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Azomyr.
English: For more information about treatment with Azomyr, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Azomyr pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Azomyr on 15 January 2001.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Azomyr na snazi u Europskoj uniji od 15. siječnja 2001.
English: In all studies, the effectiveness of Azomyr was compared with that of placebo (a dummy treatment).
Croatian: U svim ispitivanjima, djelotvornost lijepa Azomyr uspoređena je s onom placeba (liječenja bez djelatne tvari).
English: In the two studies in urticaria, the decrease in symptom score after six weeks of treatment with Azomyr was 58 and 67%, compared with 40 and 33% in placebo-treated patients.
Croatian: U dva ispitivanja kod urtikarije, smanjenje u rezultatu simptoma nakon šest tjedana terapije lijekom Azomyr bilo je 58 do 67 %, u usporedbi sa 40 i 33 % u bolesnika liječenih placebom.
English: Azomyr is a medicine containing the active substance desloratadine.
Croatian: Azomyr je lijek koji sadrži djelatnu tvar desloratadin.
English: Azomyr has been studied in a total of eight studies involving about 4,800 adult and adolescent patients with allergic rhinitis (including four studies in seasonal allergic rhinitis, and two studies in patients who also had asthma).
Croatian: Azomyr je ispitivan u ukupno osam ispitivanja koja su obuhvatila 4 800 odraslih osoba i adolescenata s alergijskim rinitisom (uključujući ispitivanja u slučaju sezonskog alergijskog rinitisa i dva ispitivanja u bolesnika koji su također imali astmu).
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Azomyr.
Croatian: Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet te preporuke o uvjetima za primjenu lijeka Azomyr.
English: Other information about Azomyr
Croatian: Ostale informacije o lijeku Azomyr
English: The active substance in Azomyr, desloratadine, is an antihistamine.
Croatian: Djelatna tvar lijeka Azomyr, desloratadin, je antihistamin.
English: In allergic rhinitis, looking at the results of all studies taken together, two weeks of treatment with 5 mg Azomyr led to an average decrease in symptom score of 25 to 32%, compared with a decrease of 12 to 26% in the patients receiving placebo.
Croatian: U slučaju alergijskog rinitisa, promatrajući rezultate svih ispitivanja zajedno, nakon dva tjedna nakon terapije lijekom Azomyr od 5 mg došlo je do prosječnog smanjenja simptoma od 25 do 32 %, u usporedbi sa smanjenjem od 12 do 26 % u bolesnika koji su primali placebo.
English: What is Azomyr?
Croatian: Što je Azomyr?
English: Azomyr is used to relieve the symptoms of allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or allergy to dust mites) or urticaria (a skin condition caused by an allergy, with symptoms including itching and hives).
Croatian: Azomyr se koristi za ublažavanje simptoma alergijskog rinitisa (upale nosnih putova uzrokovane alergijom, primjerice, alergijom na sijeno ili alergijom na prašinske grinje) ili urtikarije (stanje kože uzrokovano alergijom, sa simptomima koji uključuju svrbež i osip).
English: Azomyr must not be used in people who are hypersensitive (allergic) to desloratadine, loratadine or any of the other ingredients.
Croatian: Azomyr se ne smije primjenjivati u osoba koje su preosjetljive (alergične) na desloratadin ili na bilo koju drugu pomoćnu tvar.
English: What is the risk associated with Azomyr?
Croatian: Koji su rizici povezani s lijekom Azomyr?
English: The Committee recommended that Azomyr be given marketing authorisation.
Croatian: Odbor je preporučio izdavanje odobrenja za stavljanje lijeka Azomyr u promet.
English: Why has Azomyr been approved?
Croatian: Zašto je Azomyr odobren?
English: The effectiveness of Azomyr was measured by looking at the change in the symptoms (nasal discharge, itching, sneezing and congestion) before and after two or four weeks of treatment.
Croatian: Djelotvornost lijeka Azomyr mjerena je promatranjem promjena simptoma (iscjedak iz nosa, svrbež, kihanje i zatvor) prije i nakon dva ili četiri tjedna terapije.
English: What is Azomyr used for?
Croatian: Za što se Azomyr koristi?
English: What benefit has Azomyr shown during the studies?
Croatian: Koje su koristi lijeka Azomyr utvrđene u ispitivanjima?
English: For the full list of all side effects reported with Azomyr, see the Package Leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Azomyr potražite u uputi o lijeku.
English: How is Azomyr used?
Croatian: Kako se Azomyr koristi?
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Azomyr's benefits are greater than its risks for the relief of symptoms associated with allergic rhinitis or urticaria.
Croatian: CHMP je odlučio da koristi lijeka Azomyr premašuju s njim povezane rizike za ublažavanje simptoma povezanih s alergijskim rinitisom ili urtikarijom i preporučio je izdavanje odobrenja za stavljanje lijeka u promet
English: How does Azomyr work?
Croatian: Kako djeluje Azomyr?
English: How has Azomyr been studied?
Croatian: Kako je Azomyr ispitivan?
English: Based on best response
Croatian: Temeljeno na najboljem odgovoru
English: None of the adverse events was considered serious.
Croatian: Nijedan štetni događaj nije se smatrao ozbiljnim.
English: This will make the injection more comfortable.
Croatian: Ovo će injekciju učiniti ugodnijom.
English: In rare cases allergic reactions may be severe.
Croatian: U rijetkim slučajevima alergijske reakcije mogu biti teške.
English: The median time to surgery was 261 days.
Croatian: Medijan vremena do operacije bio je 261 dan.
English: It is especially important that you tell your doctor if you are being treated with
Croatian: Posebno je važno da kažete svom liječniku ako se liječite
English: 1 CI = Exact Confidence Interval
Croatian: 1 CI = egzaktan interval pouzdanosti
English: The European Medicines Agency has deferred the obligation to submit the final results of this study.
Croatian: Europska agencija za lijekove odgodila je obavezu podnošenja završnih rezultata ovog ispitivanja.
English: • in patients with advanced cancer: development of another form of cancer.
Croatian: • u bolesnika s uznapredovalim rakom: razvoj drugog oblika raka.
English: Date of latest renewal: 4 April 2016
Croatian: Datum posljednje obnove odobrenja: 4. travnja 2016.
English: Within these active-controlled clinical trials, safety was evaluated in 5,931 patients.
Croatian: U sklopu ovih aktivno kontroliranih ispitivanja sigurnost je procijenjena u 5931 bolesnika.
English: What XGEVA is and what it is used for
Croatian: Što je XGEVA i za što se koristi
English: These pain improvements were maintained at all subsequent evaluations.
Croatian: Ovo poboljšanje u osjetu boli se održavalo kod svih sljedećih procjena.
English: Number of patients with an objective response
Croatian: Broj bolesnika s objektivnim odgovorom
English: Based on these limited data, the adverse event profile appeared to be similar to adults.
Croatian: Temeljem ovih ograničenih podataka čini se da je profil štetnih događaja sličan onome kod odraslih.
English: Patients with rare hereditary problems of fructose intolerance should not take this medicinal product.
Croatian: Bolesnici s rijetkim nasljednim poremećajima intolerancije fruktoze ne bi smjeli uzimati ovaj lijek.
English: If you wear dentures you should make sure these fit properly.
Croatian: Ako nosite zubnu protezu trebate biti sigurni da dobro prianja.
English: • excessive sweating,
Croatian: • prekomjerno znojenje,
English: It must be used within this 30 days period.
Croatian: XGEVA se mora iskoristiti u roku od tih 30 dana.
English: Increasing body weight was associated with decreases in systemic exposure, and vice versa.
Croatian: Povećanje tjelesne težine povezano je sa smanjenjem sistemske izloženosti i obrnuto.
English: Clinical characteristics of these cases were similar between treatment groups.
Croatian: Kliničke karakteristike ovih slučajeva bile su slične među tim skupinama bolesnika.
English: No overall differences in safety or efficacy were observed between geriatric patients and younger patients.
Croatian: Nisu primijećene ukupne razlike u sigurnosti i djelotvornosti između gerijatrijskih bolesnika i mlađih bolesnika.
English: This includes medicines obtained without a prescription.
Croatian: Ovo uključuje i one lijekove koje ste nabavili bez recepta.
English: Effect on pain
Croatian: Učinak na bol
English: Of the remaining 15 patients, 10 (67%) radiographic measurements showed no progression of the target lesion.
Croatian: Što se tiče preostalih 15 bolesnika, 10 (67%) radioloških mjerenja nije pokazalo napredovanje ciljnih lezija.
English: Events have occurred during treatment and up to 9 months after treatment was discontinued (see section 4.4).
Croatian: Događaji su se pojavljivali tijekom liječenja i do 9 mjeseci nakon prekida liječenja (vidjeti dio 4.4).
English: For instructions for use, handling and disposal see section 6.6.
Croatian: Za upute za uporabu, rukovanje i odlaganje vidjeti dio 6.6.
English: It is important to try to prevent osteonecrosis of the jaw developing as it may be a painful condition that can be difficult to treat.
Croatian: Važno je pokušati spriječiti razvoj osteonekroze čeljusti jer to može biti bolno stanje koje je teško liječiti.
English: It is important to tell your doctor if you are pregnant, think you may be pregnant, or plan to get pregnant.
Croatian: Obavijestite svog liječnika ako ste trudni, mislite da ste trudni ili planirate zatrudnjeti.
English: RANKL exists as a transmembrane or soluble protein.
Croatian: RANKL postoji kao transmembranski ili topljivi protein.
English: Efficacy results from study 4 are presented in figure 2 and table 3.
Croatian: Rezultati djelotvornosti iz ispitivanja 4 prikazani su na slici 2 i u tablici 3.
English: 1 See section Description of selected adverse reactions 2 See section Other special populations 3 See section 4.4
Croatian: 1 Vidjeti dio Opis izdvojenih nuspojava 2 Vidjeti dio Ostale posebne populacije 3 Vidjeti dio 4.4
English: Regular monitoring of calcium levels is especially important in these patients.
Croatian: Redovito praćenje razine kalcija je posebno važno u ovih bolesnika.
English: The median duration of response was not estimable (four patients experienced disease progressions following an objective response).
Croatian: Medijan vremena trajanja odgovora nije se mogao procijeniti (kod 4 bolesnika bolest je napredovala nakon objektivnog odgovora).
English: The overall incidence of clinically significant hypocalcaemia was 9%.
Croatian: Ukupna incidencija klinički značajne hipokalcijemije bila je 9%.
English: Secondary outcome measures included superiority of time to first SRE, superiority of time to first and subsequent SRE, and overall survival.
Croatian: Sekundarne mjere ishoda uključivale su superiornost vremena do prvog SRE, superiornost vremena do prvog i sljedećeg SRE te ukupno preživljenje.
English: Overall safety profile is consistent in all approved indications for XGEVA.
Croatian: Sveukupan sigurnosni profil konzistentan je za sve odobrene indikacije za lijek XGEVA.
English: Upon enrolment of 305 patients in studies 5 and 6 a retrospective independent review of radiographic imaging data was performed.
Croatian: Prilikom uključivanja 305 bolesnika u ispitivanjima 5 i 6 napravljen je retrospektivni nezavisni pregled radioloških nalaza.
English: Each pack contains one, three or four single use vials.
Croatian: Svako pakiranje sadrži jednu, tri ili četiri bočice za jednokratnu upotrebu.
English: First SRE
Croatian: Prvi SRE
English: However, due to its character it is unlikely that denosumab has any potential for genotoxicity.
Croatian: Međutim, s obzirom na njegove osobine, nije vjerojatno da denosumab ima bilo kakav genotoksični potencijal.
English: XGEVA has no or negligible influence on the ability to drive and use machines.
Croatian: XGEVA ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Pack sizes of one, three or four.
Croatian: Pakiranja od jedne, tri ili četiri bočice.
English: • Before receiving treatment, tell your doctor/nurse (healthcare professional) if you have any problems with your mouth or teeth.
Croatian: • Prije početka liječenja, obavijestite svog liječnika/medicinsku sestru (zdravstvenog radnika) ako imate probleme sa usnom šupljinom ili zubima.
English: Between weeks 9 and 49, median trough levels varied by less than 9%.
Croatian: Između 9. i 49. tjedna medijan najnižih postignutih razina varirao je za manje od 9%.
English: What XGEVA looks like and contents of the pack
Croatian: Kako XGEVA izgleda i sadržaj pakiranja
English: An investigator assessment reported that all 18 adolescent patients had a best response of stable disease or better (complete response in 2 patients, partial response in 8 patients, and stable disease in 8 patients).
Croatian: Ocjena ispitivača pokazala je da je svih 18 adolescentnih bolesnika imalo kao najbolji odgovor stabilnu bolest ili bolje od toga (potpuni odgovor u 2 bolesnika, djelomični odgovor u 8 bolesnika i stabilna bolest u 8 bolesnika).
English: If you are being treated for giant cell tumour of bone, you will receive an additional dose 1 week and 2 weeks after the first dose.
Croatian: Ukoliko se liječite zbog gigantocelularnog tumora kosti, primit ćete dodatnu dozu 1 tjedan i 2 tjedna nakon prve doze.
English: • The entire contents of the vial should be injected.
Croatian: • Potrebno je injicirati čitav sadržaj bočice.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine, since it contains sorbitol (E420).
Croatian: Ako Vam je liječnik rekao da ne podnosite neke šećere, kontaktirajte ga prije uzimanja ovoga lijeka budući da sadrži sorbitol (E420).
English: The median time to response was 3.1 months (95% CI: 2.89, 3.65).
Croatian: Medijan vremena do odgovora je bio 3,1 mjesec (95% CI: 2,89, 3,65).
English: Atypical femoral fractures may occur with little or no trauma in the subtrochanteric and diaphyseal regions of the femur.
Croatian: Atipične femoralne frakture mogu se pojaviti uz slabu ozljedu ili bez ozljede u subtrohanternoj i dijafizealnoj regiji femura.
English: In general, monoclonal antibodies are not eliminated via hepatic metabolic mechanisms.
Croatian: Općenito, monoklonska protutijela ne eliminiraju se putem jetrenih metaboličkih mehanizama.
English: In order to reduce the risk of developing osteonecrosis of the jaw, there are some precautions you should take:
Croatian: Kako bi se smanjio rizik od razvoja osteonekroze čeljusti, trebate poduzeti neke mjere opreza:
English: Hypocalcaemia1, 2
Croatian: Hipokalcijemija1, 2
English: The pharmacokinetic profile in paediatric populations has not been assessed.
Croatian: Farmakokinetički profil u pedijatrijskoj populaciji nije procijenjen.
English: No dose adjustment is required in elderly patients.
Croatian: Nije potrebna prilagodba doze u starijih bolesnika.
English: RANKL is essential for the formation, function and survival of osteoclasts, the sole cell type responsible for bone resorption.
Croatian: RANKL je nužan za stvaranje, funkciju i preživljavanje osteoklasta, jedinog tipa stanica odgovornog za resorpciju kosti.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 13 July 2011
Croatian: Datum prvog odobrenja: 13. srpnja 2011.
English: • another medicine containing denosumab
Croatian: • drugim lijekom koji sadrži denosumab
English: Standard tests to investigate the genotoxicity potential of denosumab have not been evaluated, since such tests are not relevant for this molecule.
Croatian: Standardni testovi za ispitivanje genotoksičnog potencijala denosumaba nisu rađeni budući da takvi testovi nisu relevantni za ovu molekulu.
English: Pharmacotherapeutic group: Drugs for treatment of bone diseases - other drugs affecting bone structure and mineralisation, ATC code: M05BX04
Croatian: Farmakoterapijska skupina: Lijekovi za liječenje bolesti kosti - ostali lijekovi koji djeluju na koštanu strukturu i mineralizaciju, ATK oznaka: M05BX04
English: Your doctor will monitor you for signs and symptoms of high levels of calcium, after you stop receiving XGEVA.
Croatian: Vaš liječnik pratit će vas radi znakova i simptoma visoke razine kalcija nakon što prestanete primati lijek XGEVA.
English: Study 2 other solid tumours** or multiple myeloma
Croatian: Ispitivanje 2 drugi solidni tumori** ili multipli mijelom
English: Your doctor will discuss this with you.
Croatian: O tome ćete se posavjetovati s liječnikom.