FrancophonIA/ELRC3.0 huggingface dataset:
English: The decision to start a child on treatment should be based on careful consideration of their individual needs, as not all children with chronic hepatitis B infection require treatment.
Croatian: Odluka da se započne terapija u djeteta treba se temeljiti na pažljivom razmatranju individualnih potreba budući da sva djeca s infekcijom kroničnim hepatitisom B ne zahtijevaju liječenje.
English: What measures are being taken to ensure the safe and effective use of Baraclude?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Baraclude?
English: This study looked at the reduction in viral DNA in the blood after 24 weeks.
Croatian: Ovo je ispitivanje istražilo smanjenje u virusnoj DNK u krvi nakon 24 tjedna.
English: The 1 mg daily dose is also used in adults with decompensated liver disease and stopping treatment is not recommended in these patients.
Croatian: Dnevna doza od 1 mg također se koristi u odraslih bolesnika s dekompenziranom bolešću jetre, te se ne preporuča prekidanje liječenja u ovih bolesnika.
English: It can also be considered for children aged from 2 to 18 years but only in those with compensated liver disease.
Croatian: Može se razmotriti i primjena u pedijatrijskih bolesnika u dobi od 2 do 18 godina, ali samo u onih s kompenziranom bolešću jetre.
English: The most common side effects seen with Baraclude are headache (seen in 9% of patients), fatigue (tiredness, 6%), dizziness (4%) and nausea (feeling sick, 3%).
Croatian: Najčešće nuspojave uočene s lijekom Baraclude su glavobolja (uočena u 9% bolesnika), iscrpljenost (umor, 6%), vrtoglavica (4%) i mučnina (osjećaj slabosti, 3%).
English: It is used in adults with signs of ongoing liver injury (such as inflammation and fibrosis) when the liver is still working properly (compensated liver disease) and also when the liver is no longer working properly (decompensated liver disease).
Croatian: Koristi se u odraslih bolesnika sa znakovima kontinuiranog oštećenja jetre (poput upale i fibroze) u slučaju kada jetra još uvijek funkcionira ispravno (kompenzirana bolest jetre) te kada jetra više ne funkcionira ispravno (dekompenzirana bolest jetre).
English: A risk management plan has been developed to ensure that Baraclude is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Baraclude.
English: Two of the studies were carried out in 1,363 patients who had not been treated with nucleoside analogues before.
Croatian: Dva su ispitivanja provedena na 1.363 bolesnika koji prethodno nisu liječeni analozima nukleozida.
English: The third study was carried out in 293 patients whose infection was no longer responding to lamivudine treatment.
Croatian: Treće je ispitivanje provedeno na 293 bolesnika čija infekcija nije više odgovarala na liječenje lamivudinom.
English: Patients who have not been treated before with a nucleoside analogue receive a 0.5 mg dose, while those who have received lamivudine before but whose infection is no longer responding to it are given a 1 mg dose.
Croatian: Bolesnici koji nisu prethodno liječeni analogom nukleozida primaju dozu od 0,5 mg, dok oni liječeni lamivudinom, no čija infekcija više ne odgovara na ovaj lijek primaju dozu od 1 mg.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Baraclude, 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 Baraclude nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: For more information about treatment with Baraclude, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Baraclude pročitajte u uputi o lijeku (također dio EPAR-a), ili se obratite svom liječniku ili ljekarniku
English: Children weighing less than 32.6 kg should be given the oral solution, while those weighing 32.6 kg and above can also be given the 0.5 mg tablets.
Croatian: Djeca lakša od 32,6 kg trebaju primati peroralnu otopinu, dok djeca s tjelesnom težinom od 32,6 kg i teža mogu uzimati tablete od 0,5 mg.
English: The study looked at the reductions in levels of the virus in the blood and the number of patients who developed antibody to a viral protein (known as e-antigen) and no longer had e-antigen in their blood after 48 weeks of treatment.
Croatian: Ispitivanje je istražilo smanjenja u koncentracijama virusa u krvi i broju bolesnika koji su razvili protutijela na virusni protein (poznat pod nazivom e-antigen) te više nisu imali e-antigen u svojoj krvi nakon 48 tjedana liječenja.
English: Why has Baraclude been approved?
Croatian: Zašto je Baraclude odobren?
English: The studies looked at how the liver damage had evolved after 48 weeks treatment by examining samples of liver tissue and measuring signs of the disease such as the levels of a liver enzyme (ALT) or viral DNA in the blood.
Croatian: Ispitivanje je ispitalo kako se oštećenje jetre razvilo nakon liječenja od 48 tjedana ispitivajući uzorke jetre i mjereći znakove bolesti poput razina jetrenih enzima (ALT) i virusne DNK u krvi.
English: Entecavir stops the virus making DNA, and prevents it from multiplying and spreading.
Croatian: Entekavir sprječava virus da proizvede DNK, kao i umnožavanje i širenje virusa.
English: What is the risk associated with Baraclude?
Croatian: Koji su rizici povezani s lijekom Baraclude?
English: The CHMP concluded that Baraclude's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: CHMP je odlučio da koristi od lijeka Baraclude nadmašuju s njim povezane rizike te je preporučio davanje odobrenja za stavljanje lijeka u promet.
English: Resistance to entecavir (when a virus becomes insensitive to the antiviral) has been seen in lamivudine-refractory patients.
Croatian: Rezistencija na entekavir (kada lijek postane neosjetljiv na antivirotik) uočena je u bolesnika refrakternih na liječenje lamivudinom.
English: Entecavir interferes with the action of a viral enzyme, DNA polymerase, which is involved in the formation of viral DNA.
Croatian: Entekavir interferira s djelovanjem virusnog enzima, polimeraze DNK, koji je uključen u formiranje virusne DNK.
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 Baraclude.
Croatian: Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi preporučio njegovo odobrenje u EU-u te uvjete za njegovu primjenu.
English: In adults with decompensated liver disease, there was a greater reduction in viral DNA with Baraclude than with adefovir dipivoxil.
Croatian: U odraslih osoba s dekompenziranom bolešću jetre, prisutno je veće smanjenje u virusnoj DNK s lijekom Baraclude u odnosu na adefovir dipivoksil.
English: At the end of the study, 55% of the patients treated with Baraclude had both a normal ALT level and undetectable viral DNA in their blood, while 4% of those treated with lamivudine showed the same results.
Croatian: Po završetku ispitivanja, 55% bolesnika liječenih lijekom Baraclude imalo je normalne razine ALT-a i neotkrivenu virusnu DNK u krvi dok je 4% bolesnika liječenih lamivudinom imalo iste rezultate.
English: Baraclude was also shown to be effective in the children's study: 24% of children in the Baraclude group achieved the primary goal of having a viral DNA level of less than 50 IU/ml plus production of antibody to e-antigen and no e-antigen in their blood compared with 2% of children in the placebo group.
Croatian: Baraclude se također pokazao djelotvornim u pedijatrijskom ispitivanju: 24% djece u grupi koja je primala lijek Baraclude postiglo je primaran cilj smanjivanja virusne DNK ispod razine od 50 IU/ml kao i stvaranje protutijela na e-antigen i neprisutnost e-antigena u krvi u usporedbi s 2% djece u grupi koja je primala placebo.
English: Baraclude is used to treat chronic (long-term) hepatitis B (an infectious disease of the liver, caused by the hepatitis B virus).
Croatian: Baraclude je indiciran za liječenje dugoročne (kronične) infekcije virusom hepatitisa B (zarazne bolesti jetre uzrokovane virusom hepatitisa B).
English: What is Baraclude?
Croatian: Što je Baraclude?
English: Treatment with Baraclude should be started by a doctor with experience in the management of chronic hepatitis B.
Croatian: Liječenje lijekom Baraclude mora započeti liječnik s iskustvom u liječenju kronične infekcije hepatitisom B.
English: Baraclude has been shown to be effective at suppressing the virus in adults with both compensated and decompensated liver disease.
Croatian: Dokazano je da je Baraclude djelotvoran u supresiji virusa u odraslih osoba s kompenziranom i dekompenziranom bolešću jetre.
English: Baraclude was also compared with another medicine, adefovir dipivoxil, in 195 patients with chronic hepatitis B with decompensated liver disease.
Croatian: Baraclude je također uspoređen s drugim lijekom, adefovir dipivoksilom, kod 195 bolesnika s kroničnim hepatitisom B s dekompenziranom bolešću jetre.
English: In adults with compensated liver disease, Baraclude was more effective than lamivudine in patients who had not been treated with nucleoside analogues before: an improvement in the condition of the liver was seen in just over 70% of the patients treated with Baraclude, against just over 60% of the patients treated with lamivudine.
Croatian: U odraslih osoba s kompenziranom bolešću jetre, Baraclude je bio djelotvorniji od lamivudina u bolesnika koji nisu prethodno liječeni analozima nukleozida: poboljšanje u stanju jetre uočeno je kod nešto više od 70% bolesnika liječenih lijekom Baraclude, u odnosu na nešto više od 60% bolesnika liječenih lijekom lamivudin.
English: The active substance in Baraclude, entecavir, is an antiviral belonging to the class of the nucleoside analogues.
Croatian: Djelatna tvar lijeka Baraclude, entekavir, je antivirotik koji se ubraja u kategoriju analoga nukleozida.
English: For adults with compensated liver disease, the dose depends on whether or not the patient has been previously treated with a medicine in the same group as Baraclude
Croatian: Doza u odraslih bolesnika s kompenziranom bolešću jetre ovisi o tome je li bolesnik prethodno liječen lijekom u istoj grupi kao Baraclude (analogom nukleozida, poput lamivudina).
English: Baraclude was also more effective than lamivudine in patients refractory to lamivudine: 55% of patients treated with Baraclude had improvements in the condition of their liver, against 28% of those treated with lamivudine.
Croatian: Baraclude je bio također učinkovitiji od lamivudina u bolesnika refrakternih na liječenje lamivudinom: 55% bolesnika liječenih lijekom Baraclude imalo je poboljšanje u stanju jetre u odnosu na 28% onih liječenih lamivudinom.
English: Baraclude was compared with lamivudine in three main studies in adults with chronic hepatitis B who had compensated liver disease.
Croatian: Baraclude je uspoređen s lamivudinom u tri glavna ispitivanja u odraslih bolesnika sa kroničnim hepatitisom B s kompenziranom bolesti jetre.
English: For more information on the use of the medicine in children, see the summary of product characteristics (also part of the EPAR).
Croatian: Potpune informacije o primjeni lijeka u djece pročitajte u sažetku opisa svojstava lijeka (također dio EPAR-a).
English: Baraclude is an antiviral medicine that contains the active substance entecavir.
Croatian: Baraclude je antivirotik koji sadrži djelatnu tvar entekavir.
English: What is Baraclude used for?
Croatian: Za što se Baraclude koristi?
English: What benefit has Baraclude shown during the studies?
Croatian: Koje su koristi lijeka Baraclude utvrđene u ispitivanjima?
English: How has Baraclude been studied?
Croatian: Kako je Baraclude ispitan?
English: How is Baraclude used?
Croatian: Kako se Baraclude koristi?
English: In a children's study, 180 children aged 2 to 18 years who had chronic hepatitis B were randomly selected to be given either Baraclude or placebo (a dummy treatment).
Croatian: U pedijatrijskom ispitivanju, 180 djece u dobi od 2 do 18 godina s kroničnim hepatitisom
English: For the full list of side effects and restrictions with Baraclude, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Baraclude potražite u uputi o lijeku.
English: How does Baraclude work?
Croatian: Kako djeluje Baraclude?
English: Date of first authorisation: 25/11/1999.
Croatian: Datum prvog odobrenja: 25/11/1999.
English: On the day of treatment, children must not handle treated animals and the animals should not be permitted to sleep with their owners, especially children.
Croatian: Na dan liječenja, djeca ne bi smjela rukovati tretiranim životinjama, te životinjama ne bi smjelo biti dozvoljeno spavati kraj svojih vlasnika, posebice djece.
English: Appropriate combination of pipettes
Croatian: odgovarajuća kombinacija pipeta
English: The pipettes are colour coded as follows:
Croatian: Pipete su kodirane bojama na sljedeći način:
English: Stronghold should not enter water courses as this may be dangerous for fish and other aquatic organisms.
Croatian: Stronghold ne bi smio ući u vodene tokove pošto može biti opasan za ribe i ostale vodene organizme.
English: Squeeze the pipette firmly to empty the contents in one spot.
Croatian: Pritisnite pipetu čvrsto da biste ispraznili sadržaj na jednom mjestu.
English: 60/120 Appropriate combination of pipettes
Croatian: 60/120 odgovarajuća kombinacija pipeta
English: Used applicators should be disposed of immediately and not left within the sight or reach of children.
Croatian: Iskorišteni aplikatori trebaju se odmah odložiti te ne bi smjeli ostavljeni unutar pogleda i dosega djece.
English: Date of last renewal: 01/10/2009.
Croatian: Datum posljednjeg produljenja odobrenja: 01/10/2009.
English: This product is highly flammable; keep away from heat, sparks, open flames or other sources of ignition.
Croatian: Ovaj je proizvod vrlo zapaljiv; držati ga dalje od izvora topline, iskri, otvorenog plamena ili ostalih zapaljivih izvora.
English: 3 pipettes 15 pipettes
Croatian: 3 pipete 15 pipeta
English: A further veterinary examination 30 days after treatment is recommended as some animals may require a second treatment.
Croatian: Preporučuje se 30 dana nakon primjene obaviti daljnji veterinarski pregled jer je kod nekih životinja potrebno ponoviti primjenu.
English: Pharmacotherapeutic group: antiparasitic products, insecticides and repellents, macrocyclic lactones.
Croatian: Farmakoterapijska grupa antiparazitska sredstva, insekticidi i repelenti, makrociklički laktoni.
English: The veterinary medicinal product is in translucent polypropylene single-dose pipettes in an aluminium and aluminium/PVC blister overwrap.
Croatian: Veterinarsko-medicinski proizvod je u prozirnim polipropilenskim pipetama pojedinačnih doza u aluminijskim i aluminijskim/PVC blisterskim omotima.
English: If significant licking does occur, a brief period of hypersalivation may rarely be observed in cats.
Croatian: Ako i dođe do povećeg lizanja životinje, kratko razdoblje hipersalivacije može se rijetko opaziti u mačaka.
English: The appropriate length of the treatment period for individual parasites is specified below.
Croatian: Odgovarajuća duljina terapije za pojedinu vrstu parazita navedena je niže.
English: Administer Stronghold in accordance with the following table:
Croatian: Primjenjujte Strongholdu skladu sa sljedećom tablicom:
English: Butylated hydroxytoluene Dipropylene glycol methyl ether Isopropyl alcohol
Croatian: Dipropilen glikol metil eter Izopropilni alkohol
English: Wash hands after use and wash off any product in contact with the skin immediately with soap and water.
Croatian: Operite ruke nakon primjene i odmah sapunom i vodom isperite proizvod koji je došao u kontakt s kožom.
English: This veterinary medicinal product is to be applied to the skin surface only.
Croatian: Ovaj se veterinarsko-medicinski proizvod primjenjuje samo na površini kože.
English: Avoid contact between the veterinary medicinal product and your fingers.
Croatian: Izbjegavajte kontakt veterinarsko-medicinskog proizvoda i prstiju.
English: This veterinary medicinal product is not effective against adult D. immitis.
Croatian: Ovaj veterinarsko - medicinski proizvod nije učinkovit protiv odrasle D. immitis.
English: Administered volume (nominal pipette size, ml)
Croatian: Primijenjen volumen (nominalna veličina pipete - ml)
English: Rose
Croatian: ružičasta
English: If accidental eye exposure occurs, flush the eyes immediately with water and seek medical advice immediately and show the package leaflet or the label to the physician.
Croatian: U slučaju dodira s očima, odmah ih isperite vodom i potražite liječnički savjet odmah i pokazati liječniku uputu ili naljepnicu.
English: On rare occasions in cats and dogs, application of the veterinary medicinal product may produce a local temporary clumping of the hair at the application site and/or an occasional appearance of a small quantity of a white powder.
Croatian: U rijetkim slučajevima u mačaka i pasa, primjena ovog veterinarsko-medicinskog proizvoda može uzrokovati lokalno privremeno mršenje dlake na mjestu primjene i/ili povremenu pojavu male količine bijelog praha.
English: Containers and residual contents should be disposed of along with collected domestic refuse to avoid contamination of any water courses.
Croatian: Opremu i zaostali sadržaj treba odlagati zajedno s prikupljenim kućnim otpadom kako bi se izbjegla kontaminacija vodenih tokova.
English: This breaks the flea life cycle and prevents flea infestations.
Croatian: Time se prekida životni ciklus buha i sprječava infestacija buhama.
English: Butylated hydroxytoluene 0.08%.
Croatian: Butilhidroksitoluen 0,08% Bezbojna do žuta otopina.
English: Stronghold was administered at 10 times the recommended dose, and no undesirable effects were observed.
Croatian: Stronghold je primijenjen u deseterostrukoj preporučenoj dozi bez štetnih reakcija.
English: Stronghold has been tested with no other adverse reactions in over 100 different pure and mixed breeds of dogs including Collies, and in mixed breeds and 16 pure breeds of cats.
Croatian: Testiranje Strongholda bez ikakvih drugih nuspojava izvršeno je na više od 100 različitih čistokrvnih i križanih pasmina pasa uključujući škotske ovčare, te na križanim pasminama i na 16 čistokrvnih pasmina mačaka.
English: People with sensitive skin or known allergy to veterinary medicinal products of this type should handle the veterinary medicinal product with caution.
Croatian: Osobe s osjetljivom kožom ili poznatom alergijom na veterinarsko-medicinske proizvode ovog tipa trebaju oprezno rukovati veterinarsko-medicinskim proizvodom.
English: Stronghold may be safely administered to animals infected with adult heartworms, however, it is recommended, in accordance with good veterinary practice, that all animals 6 months of age or more living in countries where a vector exists should be tested for existing adult heartworm infections before beginning medication with Stronghold.
Croatian: Stronghold se može sigurno primjenjivati na životinjama inficiranim odraslim srčanim crvima, međutim, preporučuje se, sukladno dobroj veterinarskoj praksi, da se sve životinje stare 6 mjeseci ili starije koje žive u zemljama u kojima postoji vektor testiraju na postojeće infekcije odraslim srčanim crvom prije početka liječenja Strongholdom.
English: Apply the tip of the Stronghold pipette directly to the skin without massaging.
Croatian: Prislonite vrh pipete Strongholda izravno na kožu bez utrljavanja.
English: It is also recommended that dogs should be tested periodically for adult heartworm infections, as an integral part of a heartworm prevention strategy, even when Stronghold has been administered monthly.
Croatian: Također se preporučuje periodično testiranje pasa na infekcije odraslim srčanim crvima, kao integralni dio strategije prevencije invazije srćanim crvima, čak i kada se Stronghold primjenjuje svaki mjesec.
English: This is normal and will disappear typically within 24 hours of treatment administration and does not affect either the safety or efficacy of the veterinary medicinal product.
Croatian: Ta je pojava normalna i obično nestaje unutar 24 sata nakon primjene terapije i ne utječe ni na neškodljivost ni na djelotvornost veterinarsko-medicinskog proizvoda.
English: Very rarely, as with other macrocyclic lactones, reversible neurological signs, including seizures, have been observed after use of the veterinary medicinal product in both dogs and cats.
Croatian: Vrlo rijetko, kao i u drugih makrocikličkih laktona, nakon upotrebe veterinarsko-medicinskog proizvoda uočeni su reverzibilni neurološki znaci, uključujući napadaje, i u pasa i u mačaka.
English: Remove the Stronghold pipette from its protective package.
Croatian: Izvadite pipetu Strongholda iz zaštitnog pakovanja.
English: Stronghold is available in packs of three pipettes (for all pipette sizes), six pipettes (for all pipette sizes except 15 mg selamectin), or fifteen pipettes (for 15 mg selamectin pipette size only).
Croatian: Stronghold je dostupan u pakovanjima od tri pipete (za sve veličine pipeta), šest pipeta (za sve veličine pipeta osim 15 mg selamektina) ili petnaest pipeta (samo za veličina pipeta od 15 mg selamektina).
English: The veterinary medicinal product may be administered year-round or at least within one month of the animal's first exposure to mosquitoes and monthly thereafter until the end of the mosquito season.
Croatian: Veterinarsko-medicinski proizvod može se primjenjivati tijekom cijele godine ili barem unutar mjesec dana od prve izloženosti životinje komarcima, a nakon toga svaki mjesec do kraja sezone komaraca.
English: Debris from selamectintreated pets kills flea eggs and larvae not previously exposed to selamectin and thus may aid in the control of existing environmental flea infestations in areas to which the animal has access.
Croatian: Ostaci s ljubimaca tretiranih selamektinom ubijaju jaja buha i larve koje prethodno nisu bile izložene selamektinu i tako mogu pomoći u kontroliranju postojećih infestacija buhama u okolišu u područjima u koja životinja ima pristup.
English: If a dose is missed and a monthly interval between dosing is exceeded then immediate administration of the veterinary medicinal product and resumption of monthly dosing will minimise the opportunity for the development of adult heartworms.
Croatian: Ako se propusti jedna doza i premaši mjesečni interval između doziranja, trenutna primjena veterinarsko-medicinskog proizvoda i nastavak mjesečnog doziranja maksimalno će smanjiti mogućnost razvijanja odraslih srčanih crva.
English: Stronghold can be used in breeding, pregnant and lactating cats and dogs.
Croatian: Stronghold se može primjenjivati u rasplodnih mačaka i pasa, te tijekom graviditeta i laktacije.
English: Use of the veterinary medicinal product in cats has on rare occasions been associated with a mild transient alopecia at the site of application.
Croatian: Upotreba ovog veterinarsko-medicinskog proizvoda u mačaka u rijetkim je prilikama bila povezana s blagom prolaznom alopecijom na mjestu primjene.
English: 2.6-5.0 Violet 5.1-10.0 Brown 10.1-20.0 Red 20.1-40.0 Green 40.1-60.0 Plum 360
Croatian: 2,6 - 5,0 ljubičasta 30 5,1 - 10,0 smeđa 10,1 - 20,0 crvena 20,1 - 40,0 zelena 40,1 - 60,0 boja šljive 360
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE CARTON LABEL, 15 mg (3 and 15 pipettes)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU KARTONSKA ETIKETA, 15 mg (3 i 15 pipeta)