FrancophonIA/ELRC3.0 huggingface dataset:
English: It can also be used as part of a treatment for flea allergy dermatitis (skin inflammation), to prevent heartworm disease in cats and dogs, to treat ear mites in cats and dogs, to treat adult intestinal roundworms and hookworms in cats, to treat adult intestinal roundworms in dogs, to treat biting lice infestations in cats and dogs, to treat sarcoptic mange (scabies) in dogs.
Croatian: Može se primjenjivati i kao dio liječenja alergijskog dermatitisa (upale kože) uzrokovanog buhama; za sprječavanje bolesti srčanog crva u pasa i mačaka; za tretiranje ušnog šugarca u pasa i mačaka; za tretiranje odraslih crijevnih oblića i ankilostoma u mačaka; za tretiranje odraslih crijevnih oblića u pasa; za tretiranje infestacije paušima u pasa i mačaka; za liječenje sarkoptoze (šuge) u pasa.
English: Why is Evicto authorised in the EU?
Croatian: Zašto je VMP Evicto odobren u EU-u?
English: Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Stronghold, and do not need to be repeated for Evicto.
Croatian: Ispitivanja omjera koristi i rizika djelatne tvari u odobrenim primjenama već su provedena s referentnim VMP-om Stronghold i ne treba ih ponavljati za VMP Evicto.
English: Therefore, the Agency's view was that, as for Stronghold, the benefit of Evicto outweighs the identified risk and it can be authorised for use in the EU.
Croatian: Stoga je mišljenje Agencije da korist od VMP-a Evicto, kao i kod VMP-a Stronghold, nadmašuje utvrđeni rizik te se može izdati odobrenje za njegovu primjenu u EU-u.
English: Because Evicto is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Croatian: Budući da je Evicto generički VMP, smatra se da su njegove koristi i rizici isti kao i oni referentnog VMP-a.
English: Evicto is an antiparasitic medicine used to treat and prevent infestations with parasites that live on the skin or in the fur of cats and dogs, such as fleas and mites, as well as treating worms that live inside the body.
Croatian: Evicto je antiparazitik koji se primjenjuje za liječenje i sprječavanje infestacija parazitima koji žive na koži ili u dlaci pasa i mačaka, kao što su buhe i šugarci, te oblićima koji žive unutar tijela.
English: Evicto contains the active substance selamectin and is a ‘generic medicine'.
Croatian: Evicto sadrži djelatnu tvar selamektin te je „generički lijek”.
English: For more information about using Evicto, see the package leaflet or contact your veterinarian or pharmacist.
Croatian: Za dodatne informacije o primjeni VMP-a Evicto pogledajte uputu o VMP-u odnosno obratite se veterinaru ili ljekarniku.
English: It is used in the following ways: to treat and prevent flea infestations in cats and dogs, by killing adult fleas, their larvae and their eggs on the animal, and in the litters of pregnant or nursing cats or dogs.
Croatian: Primjenjuje se na sljedeće načine: za liječenje i sprječavanje infestacija buhama u pasa i mačaka uništavanjem odraslih buha, njihovih larvi i jajašaca na životinji te u izmetu skotnih ženki i onih u laktaciji.
English: How does Evicto work?
Croatian: Kako djeluje Evicto?
English: Safety information has been included in the summary of product characteristics and the package leaflet for Evicto, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.
Croatian: U sažetku opisa svojstava i u uputi o VMP-u Evicto nalaze se informacije o sigurnosti primjene, uključujući odgovarajuće mjere opreza kojih se veterinari te vlasnici životinja ili uzgajivači trebaju pridržavati.
English: How has Evicto been studied?
Croatian: Kako je Evicto ispitivan?
English: Evicto received a marketing authorisation valid throughout the EU on 19 July 2019.
Croatian: VMP Evicto dobio je odobrenje za stavljanje u promet koje je na snazi u Europskoj uniji od
English: The precautions are the same as for the reference medicine since Evicto is a generic medicine.
Croatian: Budući da je Evicto generički VMP, mjere opreza iste su kao i kod referentnog VMP-a.
English: They are used over a period of 2 to 4 weeks.
Croatian: Koriste se tijekom razdoblja od 2 do 4 tjedna.
English: Moreover, the intended use does not require medical supervision.
Croatian: Nadalje, predviđena uporaba ne zahtijeva liječnički nadzor.
English: Betula pendula Roth and/or Betula pubescens Ehrh., folium
Croatian: Betula pendula Roth i/ili Betula pubescens Ehrh., folium
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom healthcare practitioner should be consulted.
Croatian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom20. listopada 2015.
English: Committee on Herbal Medicinal Products (HMPC)
Croatian: Povjerenstvo za biljne lijekove (HMPC)
English: This means that, although there is insufficient evidence from clinical trials, the effectiveness of these herbal medicines is plausible and there is evidence that they have been used safely in this way for at least 30 years (including at least 15 years within the EU).
Croatian: To znači da, iako nema dovoljno dokaza iz kliničkih ispitivanja, učinkovitost ovih biljnih lijekova je vjerojatna te postoji dokaz o njihovoj sigurnoj uporabi na opisani način tijekom najmanje 30 godina (uključujući najmanje 15 godina na području EU).
English: Although there are few clinical studies, including a study in 15 patients with urinary tract infections which suggested a positive effect on the urinary infection, data are too limited to be used as evidence.
Croatian: Iako postoji nekoliko kliničkih ispitivanja, uključujući ispitivanje provedeno na 15 bolesnika s infekcijama mokraćnih putova koja ukazuju na pozitivno djelovanje na urinarne infekcije, podaci su previše ograničeni da bi se koristili kao dokazi.
English: Birch leaf medicines should only be used in adults and adolescents above 12 years of age.
Croatian: Lijekovi koji sadrže brezov list se smiju koristiti samo u odraslih osoba i adolescenata starijih od 12 godina.
English: Birch leaf EMA/482160/2015
Croatian: Brezov list EMA/482160/2015
English: The leaves for medicinal use are obtained either from trees that have been cultivated or found in the wild.
Croatian: Lišće za medicinsku uporabu dobiva se prikupljanjem sa stabla koja su kultivirana ili pronađena u divljini.
English: If symptoms persist during treatment, a doctor or a qualified
Croatian: Ako simptomi ustraju tijekom liječenja, treba se savjetovati s liječnikom ili kvalificiranim zdravstvenim radnikom.
English: For detailed information on the studies assessed by the HMPC, see the HMPC assessment report.
Croatian: Za detaljnije informacije o ispitivanjima koja je HMPC ocijenio pogledajte izvješće HMPC-a.
English: This summary is not intended to provide practical advice on how to use medicines containing birch leaf.
Croatian: Svrha ovog sažetka nije pružanje praktičnih savjeta o načinu uporabe lijekova koji sadrže brezov list.
English: Their frequency is unknown.
Croatian: Učestalost nuspojava je nepoznata.
English: Further information on the risks associated with birch leaf medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Croatian: Više informacija o rizicima povezanim s lijekovima koji sadrže brezov list, uključujući odgovarajuće mjere opreza za njihovu sigurnu uporabu, nalazi se u monografiji u rubrici „All documents” na internetskoj stranici Agencije: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Any applications for the licensing of medicines containing birch leaf have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Croatian: Svi zahtjevi za odobrenje lijekova koji sadrže brezov list moraju se podnijeti nacionalnim tijelima nadležnim za lijekove, koja ocjenjuju zahtjev za biljni lijek i uzimaju u obzir znanstvene zaključke HMPC-a.
English: Information on the use and licensing of birch leaf medicines in EU Member States should be obtained from the relevant national authorities.
Croatian: Informacije o uporabi i odobrenju lijekova koji sadrže brezov list u državama članicama EU-a mogu se dobiti od nadležnih nacionalnih tijela.
English: Further information on the HMPC assessment of birch leaf medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Croatian: Dodatne informacije o HMPC-ovoj ocjeni lijekova koji sadrže brezov list, uključujući pojedinosti zaključaka Povjerenstva, nalaze se u dokumentu u rubrici „All documents” na internetskoj stranici Agencije: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: The HMPC concluded that, on the basis of its long-standing use, birch leaf medicines can be used in minor problems affecting the urinary tract (structures that carry urine) to increase the production of urine, in order to achieve flushing of the urinary tract.
Croatian: HMPC je zaključio da se, na temelju njihove dugotrajne uporabe, lijekovi koji sadrže brezov list mogu koristiti u slučaju manjih problema koji zahvaćaju mokraćne putove (strukture koje prenose urin) kako bi se povećalo stvaranje urina sa ciljem ispiranja mokraćnih putova.
English: Herbal medicines containing birch leaf preparations are usually available as herbal tea or in solid and liquid forms to be taken by mouth.
Croatian: Biljni lijekovi koji sadrže pripravke brezova lista obično su dostupni kao biljni čaj ili u krutom i tekućem obliku za primjenu kroz usta.
English: The HMPC conclusions on the use of birch leaf medicines to increase the production of urine are based on their ‘traditional use' in minor urinary tract problems.
Croatian: Zaključci HMPC-a o uporabi lijekova koji sadrže brezov list za povećanje stvaranja urina temelje se na njihovoj "tradicionalnoj primjeni" u slučaju manjih problema mokraćnih putova.
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing birch leaf.
Croatian: Države članice EU-a uzimaju u obzir zaključke HMPC-a prilikom ocjenjivanja zahtjeva za odobrenje biljnih lijekova koji sadrže brezov list.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of birch leaf.
Croatian: Ovaj dokument predstavlja sažetak znanstvenih zaključaka Povjerenstva za biljne lijekove (HMPC) u pogledu medicinske uporabe brezovog lista.
English: Birch leaf is the common name for the leaves of the tree Betula pendula Roth and/or Betula pubescens Ehrh.
Croatian: Brezov list je uobičajen naziv za lišće stabla Betula pendula Roth i/ili Betula pubescens Ehrh, ili hibrida obje vrste.
English: Side effects that have been reported with birch leaf medicines include diarrhoea, feeling or being sick, and allergic reactions such as itching, rash and stuffy and runny nose.
Croatian: Nuspojave koje su prijavljene s lijekovima koji sadrže brezov list su proljev, mučnina i povraćanje i alergijske reakcije poput svrbeža, osipa te začepljenog nosa ili curenja nosa.
English: Extracts are prepared using a technique to extract compounds from plant material by dissolving them in a solvent (such as water or alcohol).
Croatian: Ekstrakti se pripremaju ekstrakcijom spojeva iz biljnog materijala otapajući ih u otapalu (poput primjerice u vodi ili alkoholu).
English: For dry extracts the solvent is then evaporated to obtain the extract.
Croatian: U slučaju suhih ekstrakta, otapalo se zatim uparava kako bi se dobio ekstrakt.
English: Birch leaf preparations are obtained by powdering or comminuting (reducing into tiny pieces) the dried leaf, or as dry or liquid extracts.
Croatian: Pripravci brezova lista dobivaju se mljevenjem u prah ili usitnjavanjem (usitnjavanjem u male komadiće) osušenog lišća, ili u obliku suhih ili tekućih ekstrakta.
English: What are the risks associated with birch leaf medicines?
Croatian: Koji su rizici povezani s lijekovima koji sadrže brezov list?
English: They must also not be used in patient with conditions where a reduced fluid intake is recommended (such as severe heart or kidney disease).
Croatian: Lijekovi koji sadrže brezov list ne smiju se koristiti u bolesnika sa stanjima za koja se preporučuje smanjeni unos tekućine (poput teških bolesti srca ili bubrega).
English: For more information about treatment with birch leaf medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekovima koji sadrže brezov list pročitajte u uputi o lijeku priloženoj uz lijek, odnosno obratite se svom liječniku ili ljekarniku.
English: What is birch leaf?
Croatian: Što je brezov list?
English: For practical information about using birch leaf medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.
Croatian: Za praktične informacije o uporabi lijekova koji sadrže brezov list bolesnici trebaju pročitati uputu o lijeku priloženu uz lijek, odnosno obratiti se svojem liječniku ili ljekarniku.
English: Other information about birch leaf medicines
Croatian: Ostale informacije o lijekovima koji sadrže brezov list
English: What evidence supports the use of birch leaf medicines?
Croatian: Koji dokazi potkrjepljuju uporabu lijekova koji sadrže brezov list?
English: How are birch leaf medicines approved in the EU?
Croatian: Kako se u EU-u odobravaju lijekovi koji sadrže brezov list?
English: Birch leaf medicines must not be used in patients who are hypersensitive (allergic) to birch leaf or birch pollen.
Croatian: Lijekovi koji sadrže brezov list ne smiju se koristiti u bolesnika koji su preosjetljivi (alergični) na brezov list ili na pelud breze.
English: Detailed instruction on how to take birch leaf medicines and who can use them can be found in the package leaflet that comes with the medicine.
Croatian: lijekova koji sadrže brezov list i tko ih može primjenjivati navedene su u uputi o lijeku koja je priložena uz lijek.
English: Birch leaf
Croatian: Brezov list
English: Hence, the HMPC conclusions on the use of birch leaf medicines are based on their long-standing use.
Croatian: Zaključci HMPC-a temelje se na dugotrajnoj primjeni lijekova koji sadrže brezov list.
English: Children from birth to 23 months:
Croatian: Djeca od rođenja do 23 mjeseca:
English: Do not store it for future use.
Croatian: Ne pohranjujte je za buduću uporabu.
English: • Risk management plan (RMP)
Croatian: - Plan upravljanja rizikom (RMP)
English: As needed.
Croatian: Po potrebi.
English: The food should be immediately and completely consumed.
Croatian: Hranu treba odmah i u cijelosti konzumirati.
English: This is a longterm treatment, possibly lasting for months or years.
Croatian: To je dugotrajno liječenje koje bi moglo trajati mjesecima ili godinama.
English: Body weight, height and sexual development
Croatian: Tjelesna težina, visina i spolni razvoj
English: Frequency not known (cannot be estimated from the available data)
Croatian: Učestalost nije poznata (ne može se procijeniti iz dostupnih podataka).
English: and Once (1×)
Croatian: i jednom (1×)
English: Your doctor will calculate the dose you need and tell you how many tablets to take each day.
Croatian: Liječnik će izračunati kolika Vam doza treba i reći koliko tableta trebate uzimati svakoga dana.
English: Interaction with food
Croatian: Interakcija s hranom
English: Date of first authorisation:
Croatian: Datum prvog odobrenja:
English: In the clinical setting, this effect may be more pronounced.
Croatian: U kliničkom okruženju, ovaj učinak može biti jače izražen.
English: Every 2 weeks during first month of therapy.
Croatian: Svaka 2 tjedna tijekom prvog mjeseca terapije.
English: 9/l) (see section 4.5).
Croatian: 9/1) (vidjeti dio 4.5).
English: Do not take a double dose on the next day to make up for the forgotten tablet(s).
Croatian: Sljedećeg dana nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu tabletu(e).
English: 1, neutropenia
Croatian: 1, neutropenija
English: Upon multiple dosing exposure increased by an accumulation factor of 1.3 to 2.3.
Croatian: Primjenom višestrukih doza izloženost se povećavala s faktorom akumulacije od 1,3 do 2,3.
English: 2900 Komarom HUNGARY
Croatian: 2900 Komarom MAĐARSKA
English: Take your next dose as scheduled.
Croatian: Iduću dozu uzmite prema uobičajenom rasporedu.
English: • Additional risk minimisation measures
Croatian: - Dodatne mjere minimizacije rizika
English: Over time, the excess iron can damage important organs such as the liver and heart.
Croatian: Višak željeza s vremenom može oštetiti važne organe, poput jetre i srca.
English: Doses (in mg/kg) must be calculated and rounded to the nearest whole tablet size.
Croatian: Doze (u mg/kg) se moraju izračunati i zaokružiti do najbliže doze cijele tablete.
English: The dosing recommendations for elderly patients are the same as described above.
Croatian: Preporučeno doziranje za starije bolesnike je isto kao i gore opisano.
English: OUTER CARTON (BLISTER AND BOTTLE)
Croatian: VANJSKA KUTIJA (BLISTER I BOCA)
English: As the patient grows the doctor will adjust the dose.
Croatian: Kako pacijenti budu rasli, liječnik će prilagođavati dozu.
English: Medical treatment may be necessary.
Croatian: Možda će biti potrebna medicinska skrb.
English: Treatment may be reinitiated depending on the individual clinical circumstances.
Croatian: Liječenje se može ponovno uvesti ovisno o individualnim kliničkim okolnostima.
English: Since dosing is individually adjusted according to response this is not expected to have clinical consequences.
Croatian: Budući da se doziranje individualno prilagođava u skladu s odgovorom bolesnika, ne očekuje se da bi to moglo imati kliničke posljedice.
English: Show them the pack of tablets.
Croatian: Pokažite liječniku pakiranje tableta.
English: Similar findings were observed in neonatal and juvenile animals.
Croatian: Slični su nalazi opaženi i u neonatalnih i mladih životinja.
English: Do not throw away any medicines via wastewater or household waste.
Croatian: - Nikada nemojte nikakve lijekove bacati u otpadne vode ili kućni otpad.
English: Some side effects could become serious.
Croatian: Neke nuspojave mogu postati ozbiljne.
English: In children younger than 6 years old exposure was about 50% lower than in adults.
Croatian: U djece mlađe od 6 godina izloženost je bila oko 50% niža od one u odraslih.
English: Older people (age 65 years and over)
Croatian: Starije osobe (65 godina i više)
English: Annually in paediatric patients.
Croatian: Godišnje u pedijatrijskih bolesnika.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity or carcinogenic potential.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti ili kancerogenog potencijala.
English: Acute pancreatitis has been reported, particularly in children and adolescents.
Croatian: Prijavljen je akutni pankreatitis, naročito u djece i adolescenata.
English: Gastrointestinal perforation 1, acute pancreatitis
Croatian: gastrointestinalna perforacija1, akutni pankreatitis1
English: [Bottles]:
Croatian: [Boce]:
English: - This medicine has been prescribed only for you or your child. Do not pass it on to others.
Croatian: - Ovaj je lijek propisan samo Vama ili Vašem djetetu.
English: Elderly patients (≥65 years of age)
Croatian: Stariji bolesnici (≥ 65 godina starosti)
English: The Cmax was increased by 30% (90% CI: 20.3% - 40.0%); however a clinical exposure/response analysis revealed no evidence of clinically relevant effects of such an increase.
Croatian: Cmax je bio povišen za 30% (90% CI: 20,3% - 40,0%); međutim analiza kliničke izloženosti/odgovora nije otkrila nikakve dokaze klinički relevantnih učinaka takvog povišenja.
English: However, a contributory or aggravating role cannot be excluded.
Croatian: Međutim, ne može se isključiti uloga u doprinosu ili pogoršanju ovih stanja.
English: A higher or lower starting dose may be recommended by your doctor based on your individual treatment needs.
Croatian: Liječnik može preporučiti višu ili nižu početnu dozu, ovisno o Vašim individualnim potrebama.
English: The film-coated tablets should be swallowed whole with some water.
Croatian: Filmom obložene tablete treba progutati cijele uz malo vode.
English: Other information
Croatian: Druge informacije
English: Most of the side effects are mild to moderate and will generally disappear after a few days to a few weeks of treatment.
Croatian: Nuspojave su većinom blage do umjerene i obično nestaju nakon nekoliko dana do nekoliko tjedana liječenja.
English: The safety and efficacy of Deferasirox Mylan in children from birth to 23 months of age have not been established.
Croatian: Sigurnost i djelotvornost lijeka Deferasiroks Mylan u djece u dobi od rođenja do 23 mjeseca nisu ustanovljene.
English: Additional periodic distributions after launch should be performed, notably after substantial safety modifications of the product information justifying educational material updates.
Croatian: Potrebno je provoditi dodatnu periodičku distribuciju nakon stavljanja lijeka u promet, posebno nakon značajnih sigurnosnih izmjena informacija o lijeku koje opravdavaju nadopunu edukacijskog materijala.
English: Target range
Croatian: Ciljni raspon
English: - if you are currently taking any other iron chelator medicines.
Croatian: - ako trenutno uzimate bilo koje druge lijekove koji su također kelatori željeza.
English: If you stop taking it, the excess iron will no longer be removed from your body (see also above section “How long to take Deferasirox Mylan”).
Croatian: Ako ga prestanete uzimati, višak željeza više se neće uklanjati iz Vašeg tijela (pogledajte također dio „Koliko dugo uzimati Deferasiroks Mylan”).
English: • Tear in stomach or intestine wall that can be painful and cause nausea
Croatian: - Probijanje stijenke želuca ili crijeva koje može biti bolno i uzrokovati mučninu
English: The rashes resolve spontaneously in most cases.
Croatian: Osipi u većini slučajeva prolaze spontano.
English: The study enrolled 145 adult and 21 paediatric patients.
Croatian: U ispitivanje je bilo uključeno 145 odraslih bolesnika i 21 pedijatrijski bolesnik.
English: Concomitant administration of deferasirox and busulfan resulted in an increase of busulfan exposure (AUC), but the mechanism of the interaction remains unclear.
Croatian: Istodobna primjena deferasiroksa i busulfana imala je za posljedicu povećanje izloženosti busulfanu (AUC), ali mehanizam interakcije nije jasan.
English: Mylan Hungary Kft., Mylan utca 1, Komárom 2900, Hungary
Croatian: Mylan Hungary Kft., Mylan utca 1, Komárom, 2900, Mađarska
English: In some cases, only a stabilisation of the serum creatinine values has been observed after dose reduction.
Croatian: U nekim je slučajevima bila zapažena samo stabilizacija vrijednosti serumskog kreatinina nakon smanjenja doze.
English: In 250 patients who were followed for up to five years, no further decrease in mean creatinine clearance levels was observed.
Croatian: U 250 bolesnika koji su praćeni do pet godina nije primijećeno daljnje smanjenje u srednjim razinama klirensa kreatinina.
English: If possible, evaluation of the pharmacokinetics (AUC, clearance) of a busulfan test dose should be performed to allow dose adjustment.
Croatian: Ako je moguće, potrebno je ocijeniti farmakokinetiku (AUC, klirens) testne doze busulfana kako bi se omogućila prilagodba doze.
English: If you think you may be allergic, ask your doctor for advice.
Croatian: Ako mislite da biste mogli biti alergični, posavjetujte se sa svojim liječnikom.
English: Some side effects could be serious and need immediate medical attention.
Croatian: Neke nuspojave mogu biti ozbiljne i treba ih odmah liječiti.