FrancophonIA/ELRC3.0 huggingface dataset:
English: This document is a summary of the European Public Assessment Report (EPAR) for Kepivance.
Croatian: Nositelj odobrenja će periodička izvješća o neškodljivosti za ovaj lijek podnositi u skladu s referentnim popisom datuma EU (EURD popis) predviđenim člankom 107(c) stavkom 7 Direktive
English: In patients receiving chemotherapy and radiotherapy, the cells are not replaced as quickly, which leads to the development of mucositis.
Croatian: Međutim, u bolesnika liječenih kemoterapijom i/ili radioterapijom postoji veći rizik od razvoja sekundarnih tumora od kojih neki mogu izražavati receptore za čimbenike rasta keratinocita i teoretski mogu biti stimulirani ligandima receptora za čimbenike rasta keratinocita.
English: What benefit has Kepivance shown during the studies?
Croatian: Nema odgovarajućih podataka o primjeni Kepivancea u trudnica.
English: This study is still ongoing.
Croatian: Ispitivanje se i dalje provodi.
English: With regard to its safety, the data do not reveal any unacceptable concerns.
Croatian: U pogledu sigurnosti, podatci ne upućuju na neprihvatljive razloge za zabrinutost.
English: The studies will include children below 2 years of age, for whom there are currently no data.
Croatian: Ispitivanjima će se obuhvatiti djeca u dobi do dvije godine, za koju trenutačno nema podataka.
English: Brineura is infused directly into the brain.
Croatian: Brineura se ubrizgava izravno u mozak.
English: Brineura has been authorised under ‘exceptional circumstances'.
Croatian: Lijek Brineura odobren je u „iznimnim okolnostima”.
English: A patient's final score was the sum of the two scores.
Croatian: Konačna ocjena pojedinog bolesnika bila je zbroj dviju navedenih ocjena.
English: The treatment can continue for as long as the patient benefits from it.
Croatian: Liječenje može trajati onoliko dugo koliko bolesnik ima koristi od liječenja.
English: This is a summary of the European public assessment report (EPAR) for Brineura.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Brineura.
English: This is because it has not been possible to obtain complete information about Brineura due to the rarity of the disease.
Croatian: Razlog tomu je nemogućnost dobivanja potpunih informacija o lijeku Brineura zbog rijetkosti bolesti.
English: What measures are being taken to ensure the safe and effective use of Brineura?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Brineura?
English: The rating was done by doctors who gave patients individual scores for movement and language skills (where 0 means most severe and 3 is normal).
Croatian: Ocjenjivanje su proveli liječnici koji su pojedinačno ocijenili motoričke i jezične vještine svakog bolesnika (pri čemu je 0 najlošije, a 3 normalno).
English: To reduce the risk of infusion-related reactions, patients may be given other medicines before or during treatment with Brineura or the infusion may be slowed down.
Croatian: Kako bi se smanjio rizik od reakcija u vezi s infuzijom, bolesnicima se mogu davati drugi lijekovi prije ili nakon liječenja lijekom Brineura ili se infuzija može usporiti.
English: Brineura is a medicine for treating neuronal ceroid lipofuscinosis type 2 (CLN2 disease), an inherited condition in children that leads to progressive brain damage.
Croatian: Brineura je lijek koji se upotrebljava za liječenje neuronalne ceroidne lipofuscinoze tipa 2 (CLN2), nasljedne bolesti u djece koja dovodi do progresivnog oštećenja mozga.
English: The full EPAR for Brineura can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Brineura nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Since Brineura has been approved under exceptional circumstances, the company that markets it will provide further data from studies on the safety of Brineura, including the risk of allergic reactions when used long-term, and on its long-term effectiveness in delaying or stopping worsening of movement and language skills.
Croatian: Budući da je lijek Brineura odobren u iznimnim okolnostima, tvrtka koja ga stavlja na tržište pružit će dodatne podatke iz ispitivanja o sigurnosti lijeka Brineura, uključujući rizik od alergijskih reakcija kad se on upotrebljava kroz dulje razdoblje, i o dugoročnoj učinkovitosti u usporavanju ili zaustavljanju regresije motoričkih i jezičnih vještina.
English: Because the number of patients with CLN2 is low, the disease is considered ‘rare', and Brineura was designated an ‘orphan medicine' (a medicine used in rare diseases) on 13 March 2013.
Croatian: Budući da je broj bolesnika s CLN2 nizak, dotična se bolest smatra „rijetkom” te je lijek Brineura dobio status „lijeka za rijetke bolesti” od 13. ožujka 2013.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Brineura can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Croatian: Sažetak mišljenja Odbora za lijekove za rijetke bolesti o lijeku Brineura možete naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: The medicine is infused directly into the brain in order to bypass the blood-brain barrier, a protective barrier that separates the blood stream from the brain, and prevents substances such as medicines, from entering brain tissue.
Croatian: Lijek se ubrizgava izravno u mozak kako bi se zaobišla krvno-moždana barijera, zaštitna barijera koja odvaja krvotok od mozga i sprečava da tvari kao što su lijekovi prodru u moždano tkivo.
English: What is Brineura and what is it used for?
Croatian: Što je Brineura i za što se koristi?
English: In a study in which 23 children (average age of 4 years) were treated with Brineura for almost a year, 20 of them (87%) did not experience the 2-point decline in movement and language skills seen historically in patients not receiving treatment.
Croatian: Ispitivanje je obuhvatilo 23 djece (prosječne dobi od četiri godine) koja su liječena lijekom Brineura tijekom gotovo jedne godine, od čega se u 20 djece (87 %) nije pojavila regresija od dva posto u motoričkim i jezičnim vještinama koja se inače javlja u bolesnika koji ne primaju lijek.
English: The most common side effects with Brineura (which may affect more than 1 in 5 people) are fever, low levels of protein in CSF (the fluid in the brain and spinal cord), abnormalities in ECG (a test of the heart's activity), vomiting, upper respiratory tract infections (nose and throat infections), and hypersensitivity (allergic) reactions.
Croatian: Najčešće nuspojave lijeka Brineura (koje se mogu javiti u više od 1 na 5 osoba) su povišena temperatura, snižene razine bjelančevina u cerebrospinalnoj tekućini (tekućina u mozgu i kralježničkoj moždini), nepravilnosti EKG-a (ispitivanje srčane aktivnosti), povraćanje, infekcije gornjih dišnih putova (infekcije nosa i grla) i hipersenzitivne (alergijske) reakcije.
English: The infusions are given once every two weeks by a healthcare professional knowledgeable about giving medicines into the brain.
Croatian: Infuzija se prima jedanput u dva tjedna, a provodi je zdravstveni radnik osposobljen za davanje lijekova u mozak.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Brineura have also been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Brineura nalaze se također u sažetku opisa svojstava i u uputi o lijeku.
English: Other information about Brineura
Croatian: Ostale informacije o lijeku Brineura
English: The active substance in Brineura, cerliponase alfa, is a copy of TPP1 and is used as a replacement for the missing enzyme.
Croatian: Djelatna tvar u lijeku Brineura, cerliponase alfa, kopija je enzima TPP1 te se upotrebljava kao zamjena za enzim koji nedostaje.
English: It is not intended to provide practical advice on how to use Brineura.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Brineura.
English: Why is Brineura approved?
Croatian: Zašto je lijek Brineura odobren?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) therefore concluded that Brineura's 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 lijeka Brineura nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za primjenu u Europskoj uniji.
English: Available data show that Brineura helps slow the decline in movement and language skills in patients with CLN2, a condition for which there are no other treatments.
Croatian: Dostupni podatci dokazuju da lijek Brineura pomaže u usporavanju regresije motoričkih i jezičnih vještina u bolesnika koji boluju od CLN2, bolesti za koju ne postoje drugi lijekovi.
English: What are the risks associated with Brineura?
Croatian: Koji su rizici povezani s lijekom Brineura?
English: For more information about treatment with Brineura, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Brineura pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
English: Brineura must not be given to patients who have experienced life-threatening hypersensitivity (allergic) reactions with Brineura and whose symptoms re-occurred when Brineura was given again.
Croatian: Lijek Brineura ne smije se davati bolesnicima koji su uz primjenu lijeka Brineura imali hipersenzitivne (alergijske) reakcije opasne po život te onima čiji su se simptomi ponovno javili kad je lijek Brineura ponovno primijenjen.
English: Finally, patients must not be given Brineura while there are any problems with the device, such as leakage or infection.
Croatian: Naposljetku, lijek Brineura se ne smije davati bolesnicima ako postoji bilo kakav problem s uređajem, kao što je curenje ili infekcija.
English: In a follow-up study the benefits of Brineura lasted for another year, with the results showing the disease could be delayed in the majority of patients.
Croatian: Longitudinalnim ispitivanjem utvrđeno je da su koristi od lijeka Brineura potrajale još jednu godinu, a rezultati pokazuju da se progresija bolesti usporila u većine bolesnika.
English: Brineura can only be obtained with a prescription.
Croatian: Lijek Brineura izdaje se samo na recept.
English: Patients with CLN2 lack an enzyme required for normal brain development called tripeptidyl-peptidase1 (TPP1).
Croatian: Bolesnicima koji boluju od CLN2 nedostaje enzim tripeptidil peptidaza I (TPP1), koji je potreban za normalan razvoj mozga.
English: It must also not be given to patients who have had a shunt implanted to drain extra fluid from the brain.
Croatian: Osim toga, lijek se ne smije davati bolesnicima kojima je ugrađen odvod za drenažu viška tekućine iz mozga.
English: What information is still awaited for Brineura?
Croatian: Koje se još informacije očekuju o lijeku Brineura?
English: How is Brineura used?
Croatian: Kako se Brineura koristi?
English: Before the first infusion, the patient will need to have surgery to implant a device, which runs from the outside of the skull through to the fluid cavity in the brain where the medicine is delivered to.
Croatian: Bolesniku se prije prve infuzije operacijom ugrađuje uređaj koji prolazi od vanjskog dijela lubanje do moždane šupljine u kojoj se nalazi tekućina i u koju se lijek prenosi.
English: For practical information about using Brineura, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Brineura bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svom liječniku ili ljekarniku.
English: Brineura contains the active substance cerliponase alfa.
Croatian: Lijek Brineura sadrži djelatnu tvar cerliponase alfa.
English: Brineura has been shown in early studies to reduce the rate at which the disease worsens as measured with standard rating scale.
Croatian: U ranim je ispitivanjima dokazano da lijek Brineura smanjuje stopu progresije bolesti prema standardnoj ljestvici ocjenjivanja.
English: What benefits of Brineura have been shown in studies?
Croatian: Koje su koristi lijeka Brineura dokazane u ispitivanjima?
English: The company that markets Brineura will ensure that all healthcare professionals expected to use this medicine are provided with training material on how to use it and how to avoid problems with the device such as infection or blockage.
Croatian: Tvrtka koja stavlja na tržište lijek Brineura osigurat će materijale za obuku o načinu uporabe i sprečavanju problema s uređajem, kao što su infekcija ili začepljenje, svim zdravstvenim radnicima koji budu primjenjivali ovaj lijek.
English: For the full list of all side effects reported with Brineura, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Brineura potražite u uputi o lijeku.
English: This summary was last updated in January 2018.
Croatian: Sažetak je posljednji put ažuriran u siječnju 2018.
English: In both cases, treatment is for five consecutive days.
Croatian: U oba se slučaja tretiranje primjenjuje pet uzastopnih dana.
English: The medicine is effective against the worms and their eggs.
Croatian: Lijek je djelotvoran protiv crva i njihovih jaja.
English: As a result, the cells cannot divide and eventually die.
Croatian: Kao rezultat toga, stanice se ne mogu dijeliti i naposljetku odumiru.
English: The full EPAR for Panacur AquaSol can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za VMP Panacur AquaSol nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: The withdrawal period for eggs is zero days.
Croatian: Razdoblje karencije za jaja iznosi nula dana.
English: In case of skin or eye contact, the affected area should be rinsed immediately with water and any contaminated clothes should be removed.
Croatian: U slučaju kontakta s kožom ili očima zahvaćeno područje treba odmah isprati vodom te je potrebno skinuti kontaminiranu odjeću.
English: Panacur AquaSol fenbendazole
Croatian: Panacur AquaSol fenbendazol
English: The medicine should not be allowed to enter surface waters as it has harmful effects on aquatic organisms.
Croatian: Ne smije se dozvoliti da VMP dođe u površinske vode jer štetno djeluje na vodene organizme.
English: Protective gloves must be worn at all times whilst handling the product and cleaning the measuring device.
Croatian: Obvezno je nošenje zaštitnih rukavica prilikom rukovanja proizvodom i čišćenja mjerne naprave.
English: It works by interfering with the formation of tube-like structures called ‘microtubules' inside the cells of the worm that are needed to perform vital functions such as growth and cell division.
Croatian: Djeluje tako što inhibira formulaciju tubulina u „mikrotubule” unutar stanica crva koje su potrebne za provođenje vitalnih funkcija poput rasta i diobe stanica.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Panacur AquaSol'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 zaključio je da koristi od VMP-a Panacur AquaSol nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za primjenu u Europskoj uniji.
English: The first study included 432 pigs infected with Ascaris suum and the second study included 102 pigs infected with Oesophagostomum species.
Croatian: Prvo je ispitivanje obuhvatilo 432 svinje zaražene nematodima Ascaris suum, a drugo je ispitivanje obuhvatilo 102 svinje zaražene vrstama Oesophagostomum.
English: Repeated use of Panacur AquaSol or a similar anthelmintic may result in resistance.
Croatian: Ponovljena uporaba VMP-a Panacur AquaSol ili sličnog antihelmintika može rezultirati otporom.
English: The European Commission granted a marketing authorisation valid throughout the EU, for Panacur AquaSol on 09/12/2011.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za VMP Panacur AquaSol na snazi u Europskoj uniji od 9. 12. 2011.
English: Panacur AquaSol is available as an oral suspension (200 mg/ml) for use in drinking water and can only be obtained with a prescription.
Croatian: VMP Panacur AquaSol dostupan je kao oralna suspenzija (200 mg/ml) za primjenu u vodi za piće i izdaje se samo na veterinarski recept.
English: The person administering Panacur AquaSol should avoid contact with his/her skin, eye and moist body surfaces (mucous membranes) as the medicine may cause reactions, including skin irritation.
Croatian: Osobe koje primjenjuju Panacur AquaSol trebaju izbjegavati kontakt s kožom, očima i vlažnim tjelesnim površinama (sluznicama) jer VMP može izazvati reakcije, uključujući nadraženost kože.
English: The active substance in Panacur AquaSol, fenbendazole, is a well-known anthelmintic, a substance that is active against helminths (parasitic worms).
Croatian: Djelatna tvar VMP-a Panacur AquaSol, fenbendazol, poznati je antihelmintik, tvar koja je aktivna protiv helminta (parazitskih crva).
English: The amount added is based on the combined weight of all the pigs to be treated, with 2.5 mg added for each kg bodyweight on each treatment day (two or three consecutive days respectively).
Croatian: Dodana količina izračunava se iz ukupne procijenjene tjelesne težine cijele skupine svinja koje treba liječiti, pri čemu se 2,5 mg dodaje za svaki kg tjelesne težine na svaki dan liječenja (dva, odnosno tri uzastopna dana).
English: • Trichuris suis (adult stages).
Croatian: • Trichuris suis (odrasli stadiji).
English: This is a summary of the European public assessment report (EPAR) for Panacur AquaSol.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) o veterinarsko-medicinskom proizvodu Panacur AquaSol.
English: A further field study involved chickens bred for laying and broiler breeders (chickens producing parent stock for chickens bred for meat), infected with Capillaria worms.
Croatian: Provedeno je i dodatno terensko ispitivanje na kokošima nesilicama i uzgojnim brojlerima (kokoši iz roditeljske skupine tovnih pilića) koji su zaraženi crvima Capillaria.
English: It is not intended to provide practical advice on how to use Panacur AquaSol.
Croatian: Svrha sažetka nije davati praktične savjete o korištenju VMP-a Panacur AquaSol.
English: In both studies, animals received either treatment with Panacur AquaSol or no treatment at all.
Croatian: U oba ispitivanja životinje su primile terapiju VMP-om Panacur AquaSol ili uopće nisu primile terapiju.
English: Pregnant women must take extra precautions when handling Panacur AquaSol as effects on the developing baby cannot be excluded.
Croatian: Trudnice moraju biti posebno oprezne prilikom rukovanja VMP-om Panacur AquaSol jer nije moguće isključiti učinke na nerođenu bebu.
English: Before allowing the animals to access the medicated water, the water delivery system should be drained and flushed with the medicated water.
Croatian: Prije nego što se životinjama dopusti pristup vodi koja sadrži VMP, sustav za napajanje treba isprazniti i potom napuniti vodom koja sadrži VMP.
English: Other information about Panacur AquaSol
Croatian: Ostale informacije o VMP-u Panacur AquaSol
English: What is Panacur AquaSol and what is it used for?
Croatian: Što je Panacur AquaSol i za što se koristi?
English: Panacur AquaSol was tested in three field studies involving pigs.
Croatian: Panacur AquaSol ispitivan je u trima terenskim ispitivanjima na svinjama.
English: It is also the time required after administration of the medicine before eggs can be used for human consumption.
Croatian: To je također vrijeme koje treba proći nakon primjene VMP-a prije nego što ljudi smiju konzumirati jaja dotične životinje.
English: Panacur AquaSol may be toxic if ingested by humans.
Croatian: Panacur AquaSol može biti otrovan za ljude nakon gutanja.
English: There are currently no known side effects associated with Panacur AquaSol.
Croatian: Trenutno nema poznatih nuspojava povezanih s VMP-om Panacur AquaSol.
English: What are the risks associated with Panacur AquaSol?
Croatian: Koji su rizici povezani s VMP-om Panacur AquaSol?
English: After treatment with Panacur AquaSol, the number of Trichuris suis eggs was reduced by 90%.
Croatian: Nakon liječenja VMP-om Panacur AquaSol broj jaja nematoda Trichuris suis smanjio se za 90 %.
English: Why is Panacur AquaSol approved?
Croatian: Zašto je Panacur AquaSol odobren?
English: In a third study, 254 pigs infected with Trichuris suis were treated either with Panacur AquaSol or received no treatment.
Croatian: U trećem su ispitivanju 254 svinje zaražene nematodima Trichuris suis liječene VMP-om Panacur AquaSol ili uopće nisu liječene.
English: Panacur AquaSol treatment at 2 mg/kg for 5 days reduced worm counts by 100%.
Croatian: Liječenjem VMP-om Panacur AquaSol pri dozama od 2 mg/kg tijekom 5 dana broj nematoda smanjio se za 100 %.
English: The effectiveness of Panacur AquaSol was also investigated in a field study involving chickens bred for laying and chickens bred for meat, infected with Ascaridia galli or Heterakis gallinarum.
Croatian: Djelotvornost VMP-a Panacur AquaSol također je ispitivana u terenskom ispitivanju na kokošima nesilicama i tovnim pilićima zaraženima nematodima Ascaridia galli ili Heterakis gallinarum.
English: The withdrawal period is the time required after administration of the medicine before the animal can be slaughtered and the meat used for human consumption.
Croatian: Razdoblje karencije je vrijeme koje treba proći od primjene VMP-a do klanja životinje i korištenja mesa za prehranu ljudi.
English: After treatment with Panacur AquaSol, no Ascaris suum or Oesophagostomum eggs could be detected in the faeces of the pigs.
Croatian: Nakon liječenja VMP-om Panacur AquaSol, u izmetu svinja nisu otkrivena jaja nematoda Ascaris suum ili Oesophagostomum.
English: • Oesophagostomum worms (adult stages);
Croatian: • crvi Oesophagostomum (odrasli stadiji)
English: The withdrawal period for chicken meat and offal is six days for the 1 mg fenbendazole/kg dose and nine days for the 2 mg fenbendazole/kg dose.
Croatian: Razdoblje karencije za meso i iznutrice pilića liječenih dozama od 1 mg fenbendazola/kg iznosi šest dana, a za meso i iznutrice pilića liječenih dozama od 2 mg fenbendazola/kg devet dana.
English: Panacur AquaSol is used for the treatment and control of three types of roundworm infections in the gut of pigs:
Croatian: Panacur AquaSol koristi se za liječenje i kontrolu tri tipa gastrointestinalnih nematoda u crijevima svinja:
English: Panacur AquaSol is also used for the treatment of three types of roundworm infections in the gut of chickens:
Croatian: Panacur AquaSol također se koristi za liječenje tri tipa gastrointestinalnih nematoda u crijevima kokoši:
English: For chickens, Panacur AquaSol is added to their drinking water in a quantity that aims to supply each chicken 1 mg fenbendazole per kg bodyweight daily for treating Ascaridia galli and Heterakis gallinarum and 2 mg fenbendazole per kg bodyweight daily for Capillaria infections.
Croatian: Za kokoši se Panacur AquaSol dodaje u njihovu vodu za piće u količini koja svakoj kokoši treba omogućiti dozu od 1 mg fenbendazola po kg tjelesne težine dnevno za tretiranje infekcija Ascaridia galli i Heterakis gallinarum, odnosno 2 mg fenbendazola po kg tjelesne težine dnevno za tretiranje infekcija Capillaria.
English: Treatment with Panacur Aquasol at 1 mg/kg for 5 days in chickens reduced intestinal worm counts by 91% for Ascaridia galli and 98% for Heterakis gallinarum.
Croatian: U kokoši se nakon liječenja VMP-om Panacur AquaSol pri dozama od 1 mg/kg tijekom 5 dana broj nematoda Ascaridia galli smanjio za 91 %, a broj nematoda Heterakis gallinarum za 98 %.